OJ L 273, 10.10.2002, p. 1.

OJ L 31, 1.2.2002, p. 1.

OJ L 86, 6.4.1979, p. 30.

http://www.defra.gov.uk/corporate/vla/science/science-tse-rl-confirm.htm

Design prevalence is used to determine the size of a testing survey expressed in terms of target points. If the actual prevalence is greater than the selected design prevalence, the survey is highly likely to detect disease.

OJ 121, 29.7.1964, p. 2012/64.

OJ L 99, 20.4.1996, p. 14.

OJ L 273, 10.10.2002, p. 1.

OJ L 21, 28.1.2004, p. 11.

OJ L 349, 24.12.2002, p. 105.

OJ L 349, 24.12.2002, p. 105.

OJ L 139, 30.4.2004, p. 55, as corrected by OJ L 226, 25.6.2004, p. 22.

Substituted by Commission Regulation (EC) No 1234/2003 of 10 July 2003 amending Annexes I, IV and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Regulation (EC) No 1326/2001 as regards transmissible spongiform encephalopathies and animal feeding (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 727/2007 of 26 June 2007 amending Annexes I, III, VII and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 722/2007 of 25 June 2007 amending Annexes II, V, VI, VIII, IX and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 2245/2003 of 19 December 2003 amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in ovine and caprine animals.

Deleted by Commission Regulation (EC) No 688/2006 of 4 May 2006 amending Annexes III and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the monitoring of transmissible spongiform encephalopathies and specified risk material of bovine animals in Sweden (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 657/2006 of 10 April 2006 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the United Kingdom and repealing Council Decision 98/256/EC and Decisions 98/351/EC and 1999/514/EC (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 36/2005 of 12 January 2005 amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animals (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 1292/2005 of 5 August 2005 amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards animal nutrition (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 357/2008 of 22 April 2008 amending Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 1428/2007 of 4 December 2007 amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).

Inserted by Commission Regulation (EC) No 1428/2007 of 4 December 2007 amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 260/2003 of 12 February 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the eradication of transmissible spongiform encephalopathies in ovine and caprine animals and rules for the trade in live ovine and caprine animals and bovine embryos (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 1492/2004 of 23 August 2004 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards eradication measures for transmissible spongiform encephalopathies in bovine, ovine and caprine animals, the trade and importation of semen and embryos of ovine and caprine animals and specified risk material (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 876/2004 of 29 April 2004 amending Annex VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards trade in ovine and caprine animals for breeding (Text with EEA relevance).

Inserted by Commission Regulation (EC) No 1492/2004 of 23 August 2004 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards eradication measures for transmissible spongiform encephalopathies in bovine, ovine and caprine animals, the trade and importation of semen and embryos of ovine and caprine animals and specified risk material (Text with EEA relevance).

Deleted by Commission Regulation (EC) No 722/2007 of 25 June 2007 amending Annexes II, V, VI, VIII, IX and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 1275/2007 of 29 October 2007 amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).

Inserted by Commission Regulation (EC) No 1275/2007 of 29 October 2007 amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 1915/2003 of 30 October 2003 amending Annexes VII, VIII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the trade and import of ovine and caprine animals and the measures following the confirmation of transmissible spongiform encephalopathies in bovine, ovine and caprine animals (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 1974/2005 of 2 December 2005 amending Annexes X and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards national reference laboratories and specified risk material (Text with EEA relevance).

Inserted by Council Regulation (EC) No 1791/2006 of 20 November 2006 adapting certain Regulations and Decisions in the fields of free movement of goods, freedom of movement of persons, company law, competition policy, agriculture (including veterinary and phytosanitary legislation), transport policy, taxation, statistics, energy, environment, cooperation in the fields of justice and home affairs, customs union, external relations, common foreign and security policy and institutions, by reason of the accession of Bulgaria and Romania.

Substituted by Commission Regulation (EC) No 315/2008 of 4 April 2008 amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the lists of rapid tests (Text with EEA relevance).

Substituted by Commission Regulation (EC) No 1139/2003 of 27 June 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring programmes and specified risk material.

http://www.legislation.gov.uk/eur/2001/999/annexes/2008-04-26Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathiesRegulation (EC) No 999/2001 of the European Parliament and of the CouncilRegulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathiesKing's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02001R0999-20080426texttext/xmlen2024-05-192008-04-26ANNEX ISPECIFIC DEFINITIONS1.

For the purpose of this Regulation, the following definitions set out in Regulation (EC) No 1774/2002 of the European Parliament and of the Council, Regulation (EC) No 178/2002 of the European Parliament and of the Council and Council Directive 79/373/EEC shall apply:

(a)

Regulation (EC) No 1774/2002:

(i)

farmed animal in Article 2(1)(f);

(ii)

petfood in point 41 of Annex I;

(iii)

processed animal protein in point 42 of Annex I;

(iv)

gelatine in point 26 of Annex I;

(v)

blood products in point 4 of Annex I;

(vi)

bloodmeal in point 6 of Annex I; and

(vii)

fishmeal in point 24 of Annex I.

(b)

the definition of feedingstuff in Article 3(4) of Regulation (EC) No 178/2002;

(c)

the definition of complete feedingstuff in Article 2(d) of Directive 79/373/EEC.

2.

For the purpose of this Regulation, the following definitions shall also apply:

(a)

indigenous case of BSE means a case of bovine spongiform encephalopathy which has not been clearly demonstrated to be due to infection prior to importation as a live animal;

(b)

discrete adipose tissue means internal and external body fat removed during the slaughter and cutting process, in particular fresh fat from the heart, caul and kidney of bovine animals, and fat from cutting rooms;

(c)

cohort means a group of bovine animals which includes both:

(i)

animals born in the same herd as the affected bovine animal, and within 12 months preceding or following the date of birth of the affected bovine animal; and

(ii)

animals which at any time during the first year of their lives were reared together with the affected bovine animal during the first year of its life;

(d)

index case means the first animal on a holding, or in an epidemiologically defined group, in which a TSE infection is confirmed;

(e)

TSE in Small Ruminants means a transmissible spongiform encephalopathy case detected in an ovine or caprine animal following a confirmatory test for abnormal PrP protein;

(f)

scrapie case means a transmissible spongiform encephalopathy confirmed case in an ovine or caprine animal where a diagnosis of BSE has been excluded in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants;

(g)

classical scrapie case means a scrapie confirmed case classified as classical in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants;

(h)

atypical scrapie case means a scrapie confirmed case which is distinguishable from classical Scrapie in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants.

ANNEX IIDETERMINATION OF BSE STATUSCHAPTER ACriteria

The BSE status of Member States or third countries or regions thereof (hereinafter referred to as countries or regions), shall be determined on the basis of the criteria set out in points (a) to (e).

In the country or region:

(a)

a risk analysis in accordance with the provisions of Chapter B, identifying all the potential factors for BSE occurrence and their historic perspective in the country or region, is carried out;

(b)

a system of continuous surveillance and monitoring of BSE relating in particular to the risks described in Chapter B and complying with the minimal surveillance requirements laid down in Chapter D is in place;

(c)

an on-going awareness programme for veterinarians, farmers, and workers involved in transportation, marketing and slaughter of bovine animals, to encourage reporting of all cases showing clinical signs consistent with BSE in target sub-populations as defined in Chapter D of this Annex is in place;

(d)

an obligation to notify and investigate all bovine animals showing clinical signs consistent with BSE is in force;

(e)

the examination of brain or other tissues collected within the framework of the surveillance and monitoring system referred to in point (b) is carried out in an approved laboratory.

CHAPTER BRisk analysis1.Structure of the risk analysis

The risk analyses shall comprise a release assessment and an exposure assessment.

2.Release assessment (external challenge)2.1.The release assessment shall consist of assessing the likelihood that the BSE agent has either been introduced into the country or region via commodities potentially contaminated with a BSE agent, or is already present in the country or region.

The following risk factors shall be taken into account:

(a)

the presence or absence of the BSE agent in the country or region and, if the agent is present, its prevalence based on the outcome of surveillance activities;

(b)

the production of meat-and-bone meal or greaves from the BSE indigenous ruminant population;

(c)

imported meat-and-bone meal or greaves;

(d)

imported bovine and ovine and caprine animals;

(e)

imported animal feed and feed ingredients;

(f)

imported products of ruminant origin for human consumption, which may have contained tissues listed in point 1 of Annex V and may have been fed to bovine animals;

(g)

imported products of ruminant origin for in vivo use in bovine animals.

2.2.

Special eradication schemes, surveillance and other epidemiological investigations (especially surveillance for BSE conducted on the bovine animals population) relevant to the risk factors listed in point 2.1 should be taken into account in carrying out the release assessment.

3.Exposure assessment

The exposure assessment shall consist of assessing the likelihood of exposure of bovine animals to the BSE agent, through a consideration of the following:

(a)

recycling and amplification of the BSE agent through consumption by bovine animals of meat-and-bone meal or greaves of ruminant origin, or other feed or feed ingredients contaminated with these;

(b)

the use of ruminant carcasses (including from fallen stock), by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of animal feed manufacture;

(c)

the feeding or not of ruminants with meat-and-bone meal and greaves derived from ruminants, including measures to prevent cross-contamination of animal feed;

(d)

the level of surveillance for BSE conducted on the bovine animals population to that time and the results of that surveillance.

CHAPTER CDefinition of categoriesI.COUNTRY OR REGION WITH A NEGLIGIBLE BSE RISK

A country or region:

(1)

where a risk analysis in accordance with Chapter B has been conducted in order to identify the historical and existing risk factors;

(2)

which has demonstrated that appropriate specific measures have been taken for the relevant period of time defined below to manage each identified risk;

(3)

which has demonstrated that Type B surveillance, in accordance with Chapter D, is in place, and the relevant points target, in accordance with Table 2 thereof, has been met; and

(4)

which is:

(a)

either in the following situation:

(i)

in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to have been imported and has been completely destroyed;

(ii)

the criteria in points (c), (d) and (e) of Chapter A of this Annex have been complied with for at least seven years; and

(iii)

it has been demonstrated through an appropriate level of control and audit that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;

(b)

or in the following situation:

(i)

there has been one or more BSE indigenous cases in the country or region but every BSE indigenous case was born more than 11 years ago;

(ii)

the criteria in points (c), (d) and (e) of Chapter A have been complied with for at least seven years;

(iii)

it has been demonstrated through an appropriate level of control and audit that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;

(iv)

the following animals, if alive in the country or region, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed:

all BSE cases,

all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or

if the results of the investigation referred to in the second indent are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases.

II.COUNTRY OR REGION WITH A CONTROLLED BSE RISK

A country or region

(1)

where a risk analysis based on the information laid down in Chapter B has been conducted in order to identify the historical and existing risk factors;

(2)

which has demonstrated that appropriate measures are been taken to manage all identified risks, but those measures have not been taken for the relevant period of time;

(3)

which has demonstrated that Type A surveillance, in accordance with Chapter D, is in place and the relevant points target, in accordance with Table 2, has been met. Type B surveillance may replace Type A surveillance once the relevant points target is met; and

(4)

which is:

(a)

either in the following situation:

(i)

in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to have been imported and has been completely destroyed, the criteria in points (c), (d) and (e) of Chapter A are complied with, and it can be demonstrated through an appropriate level of control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;

(ii)

the criteria in points (c), (d) and (e) of Chapter A have been complied with for a period shorter than seven years; and/or

(iii)

it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived from ruminants to ruminants have been in place for eight years;

(b)

or in the following situation:

(i)

in the country or region there has been a BSE indigenous case, the criteria in points (c), (d) and (e) of Chapter A are complied with, and it can be demonstrated through an appropriate level of control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;

(ii)

the criteria in points (c) to (e) of Chapter A of this Annex have been complied with for a period shorter than seven years; and/or

(iii)

it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived from ruminants to ruminants have been in place for at least eight years;

(iv)

the following animals, if alive in the country or region, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed: and

all BSE cases, and

all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or

if the results of the investigation referred to in the second indent are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases.

III.COUNTRY OR REGION WITH UNDETERMINED BSE RISK

A country or region for which the determination of BSE status has not been concluded, or which does not meet the conditions to be fulfilled by the country or region to be classified in one of the other categories.

CHAPTER DMinimal surveillance requirements1.Surveillance types

For the purpose of this Annex, the following definitions shall apply:

(a)

Type A surveillance

The application of Type A surveillance will allow the detection of BSE at a design prevalence of at least one case per 100 000 in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %;

(b)

Type B surveillance

The application of Type B surveillance will allow the detection of BSE at a design prevalence of at least one case per 50 000 in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %.

Type B surveillance may be carried out by countries or region of negligible BSE risk status to confirm the conclusions of the risk analysis, for example by demonstrating the effectiveness of the measures mitigating any risk factors identified, through surveillance targeted to maximise the likelihood of identifying failures of such measures.

Type B surveillance may also be carried out by countries or regions of controlled BSE risk status, following the achievement of the relevant points target using Type A surveillance, to maintain confidence in the knowledge gained through Type A surveillance.

For the purpose of this Annex, the following four sub-populations of bovine animals have been identified for surveillance purposes:

(a)

bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects);

(b)

bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter);

(c)

bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock);

(d)

bovine animals over 36 months of age at routine slaughter.

2.Surveillance strategy2.1.

The surveillance strategy shall be designed to ensure that samples are representative of the herd of the country or region, and include consideration of demographic factors such as production type and geographic location, and the potential influence of culturally unique husbandry practices. The approach used and the assumptions made shall be fully documented, and the documentation retained for seven years.

2.2.

In order to implement the surveillance strategy for BSE, a country shall use documented records or reliable estimates of the age distribution of the adult bovine animals population and the number of bovine animals tested for BSE stratified by age and by sub-population within the country or region.

3.Points values and point targets

Surveillance samples must meet the point targets set out in Table 2, on the basis of point values fixed in Table 1. All clinical suspects shall be investigated, regardless of the number of points accumulated. A country shall sample at least three out of the four sub-populations. The total points for samples collected shall be accumulated over a period of a maximum of seven consecutive years to achieve the target number of points. The total points accumulation shall be periodically compared to the target number of points for a country or region.

Table 1Surveillance point values for samples collected from animals in the given sub-population and age category

Surveillance sub-population

Routine slaughter

Fallen stock

Casualty slaughter

Clinical suspect

Age ≥ 1 year and < 2 years

0,01

0,2

0,4

N/A

Age ≥ 2 years and < 4 years (young adult)

0,1

0,2

0,4

260

Age ≥ 4 years and < 7 years (middle adult)

0,2

0,9

1,6

750

Age ≥ 7 years and < 9 years (older adult)

0,1

0,4

0,7

220

Age ≥ 9 years (aged)

0,0

0,1

0,2

45

Bovine animals over 36 months of age at routine slaughter.

Bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock).

Bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter).

Bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects).

Table 2Points targets for different adult bovine animals population sizes in a country or region

Points targets for countries or regions

Adult bovine animals population size(24 months and older)

Type A surveillance

Type B surveillance

1 000 000

300 000

150 000

800 000-1 000 000

240 000

120 000

600 000-800 000

180 000

90 000

400 000-600 000

120 000

60 000

200 000-400 000

60 000

30 000

100 000-200 000

30 000

15 000

50 000-100 000

15 000

7 500

25 000-50 000

7 500

3 750

4.Specific targeting

Within each of the sub-populations above in a country or region, a country may target bovine animals identifiable as imported from countries or regions where BSE has been detected and bovine animals which have consumed potentially contaminated feedstuffs from countries or regions where BSE has been detected.

5.BSE surveillance model

A country may choose to use the full BSurvE model or an alternative method based on the BSurvE model to estimate its BSE presence/prevalence.

6.Maintenance surveillance

Once the points target has been achieved, and in order to continue to designate the status of a country or region as controlled BSE risk or negligible risk, surveillance can be reduced to Type B surveillance (provided all other indicators remain positive). However, to continue to comply with the requirements laid down in this Chapter, ongoing annual surveillance must continue to include at least three of the four prescribed sub-populations. In addition all bovine animals clinically suspected of being infected with BSE shall be investigated regardless of the number of points accumulated. The annual surveillance in a country or region following the achievement of the required points target, shall be no less than the amount required for one-seventh of its total Type B surveillancetarget.

ANNEX IIIMONITORING SYSTEMCHAPTER AI.MONITORING IN BOVINE ANIMALS1.General

Monitoring in bovine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3(1)(b).

2.Monitoring in animals slaughtered for human consumption2.1.All bovine animals over 24 months of age:

subject to special emergency slaughtering as defined in Article 2(n) of Council Directive 64/433/EEC, or

slaughtered in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, except animals without clinical signs of disease slaughtered in the context of a disease eradication campaign,

shall be tested for BSE.

2.2.All bovine animals over 30 months of age:

subject to normal slaughter for human consumption, or

slaughtered in the context of a disease eradication campaign in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, but showing no clinical signs of disease,

shall be tested for BSE.

2.3.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.Monitoring in animals not slaughtered for human consumption3.1.All bovine animals over 24 months of age which have died or been killed but which were not:

killed for destruction pursuant to Commission Regulation (EC) No 716/96,

killed in the framework of an epidemic, such as foot-and-mouth disease,

slaughtered for human consumption,

shall be tested for BSE.

3.2.

Member States may decide to derogate from the provisions of point 3.1 in remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and submit a list of the derogated areas. The derogation shall not cover more than 10 % of the bovine population in the Member State.

4.Monitoring in animals purchased for destruction pursuant to Regulation (EC) No 716/96

All animals born between 1 August 1995 and 1 August 1996 killed for destruction pursuant Regulation (EC) No 716/96 shall be tested for BSE.

5.Monitoring in other animals

In addition to the testing referred to in points 2 to 4, Member States may on a voluntary basis decide to test other bovine animals on their territory, in particular where those animals originate from countries with indigenous BSE, have consumed potentially contaminated feedingstuffs or were born or derived from BSE infected dams.

6.Measures following testing6.1.

Where an animal slaughtered for human consumption has been selected for testing for BSE, the health marking provided for in Chapter XI of Annex I to Directive 64/433/EEC shall not be carried out on the carcase of that animal until a negative result to the rapid test has been obtained.

6.2.

Member States may derogate from the provisions of point 6.1 where an official system is in place in the slaughterhouse ensuring that no parts of examined animals bearing the health mark leave the slaughterhouse until a negative result to the rapid test has been obtained.

6.3.

All parts of the body of an animal tested for BSE including the hide shall be retained under official control until a negative result to the rapid test has been obtained, unless they are disposed of in accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council.

6.4.

All parts of the body of an animal found positive or inconclusive to the rapid test including the hide shall be disposed of in accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002, apart from material to be retained in conjunction with the records provided for in Chapter B(III).

6.5.

Where an animal slaughtered for human consumption is found positive or inconclusive to the rapid test, at least the carcase immediately preceding and the two carcases immediately following the tested positive or inconclusive animal on the same slaughter line shall be destroyed in accordance with point 6.4. By way of derogation, Member States may decide to destroy the aforementioned carcases only if the result of the rapid test is confirmed to be positive or inconclusive by confirmatory examinations referred to in Annex X, Chapter C, point 3.1(b).

6.6.

Member States may derogate from the provisions of point 6.5 where a system is in place in the slaughterhouse preventing contamination between carcase.

II.MONITORING IN OVINE AND CAPRINE ANIMALS1.General

Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b).

2.Monitoring in ovine and caprine animals slaughtered for human consumption(a)

Member States in which the population of ewes and ewe lambs put to the ram exceeds 750 000 animals shall test in accordance with the sampling rules set out in point 4 a minimum annual sample of 10 000 ovine animals slaughtered for human consumption;

(b)

Member States in which the population of goats which have already kidded and goats mated exceeds 750 000 animals shall test in accordance with the sampling rules set out in point 4 a minimum annual sample of 10 000 caprine animals slaughtered for human consumption;

(c)

Where a Member State experiences difficulty in collecting sufficient numbers of healthy slaughtered ovine or caprine animals to reach its allotted minimum sample size established in points (a) and (b), it may choose to replace a maximum of 50 % of its minimum sample size by testing dead ovine or caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3. In addition a Member State may choose to replace a maximum of 10 % of its minimum sample size by testing ovine or caprine animals killed in the framework of a disease eradication campaign over the age of 18 months at the ratio of one to one.

3.Monitoring in ovine and caprine animals not slaughtered for human consumption

Member States shall test, in accordance with the sampling rules set out in point 4 and the minimum sample sizes indicated in Table A and Table B, ovine and caprine animals which have died or been killed, but which were not:

killed in the framework of a disease eradication campaign, or

slaughtered for human consumption.

Table A

Member State population of ewes and ewe lambs put to the ram

Minimum sample size of dead ovine animals

> 750 000

10 000

100 000-750 000

1 500

40 000-100 000

100 % up to 500

< 40 000

100 % up to 100

Minimum sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets.

Table B

Member State population of goats which have already kidded and goats mated

Minimum sample size of dead caprine animals

> 750 000

10 000

250 000-750 000

1 500

40 000-250 000

100 % up to 500

< 40 000

100 % up to 100

Minimum sample sizes are set to take account of the size of the caprine population in the individual Member States and are intended to provide achievable targets.

4.Sampling rules applicable to the animals referred to in points 2 and 3

The animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum.

The age of the animals shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.

The sample selection shall be designed with a view to avoid the over-representation of any group as regards the origin, age, breed, production type or any other characteristic.

The sampling shall be representative for each region and season. Multiple sampling in the same flock shall be avoided, wherever possible. Member States shall aim their monitoring programmes to achieve, wherever possible, that in successive sampling years all officially registered holdings with more than 100 animals and where TSE cases have never been detected are subject to TSE testing.

The Member States shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from sampling.

However, Member States may decide to exclude from the sampling remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and shall submit a list of those remote areas where the derogation applies. The derogation shall not cover more than 10 % of the ovine and caprine population in the Member State concerned.

5.Monitoring in infected flocks

Animals over 18 months of age or have more than two permanent incisors erupted through the gum, and which are killed for destruction in accordance with Annex VII, point 2.3(b)(i) or (ii) or point 5(a), shall be tested based on the selection of a simple random sample, in accordance with the sample size indicated in the following table.

Number of animals over 18 months of age or which have more than two permanent incisors erupted through the gum, killed for destruction in the herd or flock

Minimum sample size

70 or less

All eligible animals

80

68

90

73

100

78

120

86

140

92

160

97

180

101

200

105

250

112

300

117

350

121

400

124

450

127

500 or more

150

6.Monitoring in other animals

In addition to the monitoring programmes set out in points 2, 3 and 4, Member States may on a voluntary basis carry out monitoring in other animals, in particular:

animals used for dairy production,

animals originating from countries with indigenous TSEs,

animals which have consumed potentially contaminated feedingstuffs,

animals born or derived from TSE infected dams.

7.Measures following testing of ovine and caprine animals7.1.

Where an ovine or caprine animal slaughtered for human consumption has been selected for TSE testing in accordance with point 2, its carcase shall not be marked with the health marking provided for in Section I, Chapter III of Annex I to Regulation (EC) No 854/2004 until a negative result to the rapid test has been obtained.

7.2.

Member States may derogate from point 7.1. where a system approved by the competent authority is in place in the slaughterhouse ensuring that all parts of an animal can be traced and that no parts of the animals tested bearing the health mark can leave the slaughterhouse until a negative result to the rapid test has been obtained.

7.3.

All parts of the body of a tested animal, including the hide, shall be retained under official control until a negative result has been obtained to the rapid test, except for animal by-products directly disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002.

7.4.

Except for the material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, all parts of the body of an animal found positive to the rapid test, including the hide, shall be directly disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002.

8.Genotyping8.1.

The prion protein genotype for the codons 136, 154 and 171 shall be determined for each positive TSE case in sheep. TSE cases found in sheep of genotypes which encode alanine on both alleles at codon 136, arginine on both alleles at codon 154 and arginine on both alleles at codon 171 shall immediately be reported to the Commission. Where the positive TSE case is an atypical scrapie case the prion protein genotype for the codon 141 shall be determined.

8.2.

In addition to the animals genotyped in accordance with point 8.1, the prion protein genotype for the codons 136, 141, 154 and 171 of a minimum sample of ovine animals shall be determined. In the case of Member States with an adult sheep population of more than 750 000 animals, this minimum sample shall consist of at least 600 animals. In the case of other Member States the minimum sample shall consist of at least 100 animals. The samples may be chosen from animals slaughtered for human consumption, from animals dead-on-farm or from live animals. The sampling should be representative of the entire ovine population.

III.MONITORING IN OTHER ANIMAL SPECIES

Member States may on a voluntary basis carry out monitoring for TSEs in animal species other than bovine, ovine and caprine animals.

CHAPTER BREPORTING AND RECORDING REQUIREMENTSI.REQUIREMENTS ON MEMBER STATESA.Information to be presented by Member States in their annual report as provided for in Article 6(4)1.

The number of suspected cases placed under official movement restrictions in accordance with Article 12(1), per animal species.

2.

The number of suspected cases subject to laboratory examination in accordance with Article 12(2), per animal species, including the results of the rapid and confirmatory tests (number of positives and negatives) and, with regard to bovine animals, an estimation of the age distribution of all tested animals. The age distribution should be grouped whenever possible as follows: below 24 months, distribution per 12 months between 24 and 155 months, and above 155 months of age.

3.

The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated pursuant to Article 12(1) and (2).

4.

The number of bovine animals tested within each subpopulation referred to in Chapter A, Part (I), points 2.1., 2.2., 2.3., 3.1., 4.1., 4.2., 4.3. and 5. The method for the sample selection, the results of the rapid and confirmatory tests and an estimation of the age distribution of the tested animals grouped as set out in point 2 shall be provided.

5.

The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter A, Part II, points 2, 3 and 5 together with the method for sample selection and the results of the rapid and confirmatory tests.

6.

The geographical distribution, including the country of origin if not the same as the reporting country, of positive cases of BSE and scrapie. The year, and where possible the month of birth shall be given for each TSE case in bovine, ovine and caprine animals. TSE cases which have been considered atypical and the reasons why shall be indicated. For scrapie cases, the results of the primary molecular testing with a discriminatory immuno-blotting, referred to in Annex X, Chapter C, point 3.2.(c)(i), shall be reported.

7.

In animals other than bovine, ovine and caprine, the number of samples and confirmed TSE cases per species.

8.

The genotype, and where possible the breed, of each ovine animal either found positive to TSE or sampled in accordance with Chapter A, Part II, points 8.1. and 8.2.

B.Reporting periods

The compilation of reports containing the information referred to in A and forwarded to the Commission on a monthly basis or, with regard to the information referred to in point 8 on a quarterly basis, may constitute the annual report as required by Article 6(4), provided that the information is updated whenever additional information becomes available.

II.INFORMATION TO BE PRESENTED BY THE COMMISSION IN ITS SUMMARY

The summary shall be presented in a tabled format covering at least the information referred to in part I for each Member State.

III.RECORDS1.The competent authority shall keep, for seven years, records of:

the number and types of animals placed under movement restrictions as referred to in Article 12(1),

the number and outcome of clinical and epidemiological investigations as referred to in Article 12(1),

the number and outcome of laboratory examinations as referred to in Article 12(2),

the number, identity and origin of animals sampled in the framework of the monitoring programmes as referred to in Chapter A and, where possible, age, breed and anamnestic information,

the prion protein genotype of positive TSE cases in sheep.

2.

The investigating laboratory shall keep, for seven years, all records of testing, in particular laboratory workbooks and, where appropriate, paraffin blocks and photographs of western blots.

ANNEX IVANIMAL FEEDINGI.Extension of the prohibition provided for in Article 7(1)

The prohibition provided for in Article 7(1) shall be extended to the feeding:

(a)

to farmed animals, with the exception of the feeding to carnivorous fur producing animals, of:

(i)

processed animal protein;

(ii)

gelatine of ruminant origin;

(iii)

blood products;

(iv)

hydrolysed protein;

(v)

dicalcium phosphate and tricalcium phosphate of animal origin (dicalcium phosphate and tricalcium phosphate);

(vi)

feedingstuffs containing the proteins listed in points (i) to (v).

(b)

to ruminants, of animal protein and feedingstuffs containing such protein.

II.Derogations from the prohibitions provided for in Article 7(1) and (2), and specific conditions for the application of such derogations.A.

The prohibitions provided for in Article 7(1) and (2) shall not apply to:

(a)

the feeding to farmed animals of the proteins referred to in points (i), (ii), (iii) and (iv) and of feedingstuffs derived from such proteins:

(i)

milk, milk-based products and colostrum;

(ii)

eggs and egg products;

(iii)

gelatine derived from non-ruminants;

(iv)

hydrolysed proteins derived from parts of non-ruminants and from ruminant hides and skins;

(b)

the feeding to non-ruminant farmed animals of the proteins referred to in points (i), (ii) and (iii), and of products derived from such proteins:

(i)

fishmeal, in accordance with the conditions laid down in point B;

(ii)

dicalcium phosphate and tricalcium phosphate, in accordance with the conditions laid down in point C;

(iii)

blood products derived from non-ruminants in accordance with the conditions laid down in point D;

(c)

the feeding to fish of blood meal derived from non-ruminants in accordance with the conditions laid down in point D;

(d)

the feeding to farmed animals of tuber and root crops and feedingstuffs containing such products following the detection of bone spicules may be permitted by the Member States if there has been a favourable risk assessment. The risk assessment shall take into account at least the amount and possible source of contamination and the final destination of the consignment.

B.

The following conditions shall apply for the use of fishmeal referred to in point A(b)(i) and feedingstuffs containing fishmeal in the feeding of non-ruminant farmed animals (not applicable to the feeding of carnivorous fur producing animals):

(a)

the fishmeal shall be produced in processing plants dedicated exclusively to the production of fish derived products;

(b)

before release for free circulation in the Community, each consignment of imported fishmeal shall be analysed by microscopy in accordance with Directive 2003/126/EC;

(c)

feedingstuffs containing fishmeal shall be produced in establishments which do not produce feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.

By way of derogation from point (c):

(i)

a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing fishmeal shall not be required for home compounders:

registered by the competent authority,

keeping only non-ruminants,

producing complete feedingstuffs for use only in the same holding, and

provided that the feedingstuffs containing fishmeal used in the production contain less than 50 % crude protein;

(ii)

the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing fishmeal for other animal species may be authorised by the competent authority subject to the following conditions:

bulk and packaged feedingstuffs destined for ruminants are kept in facilities physically separate from those for bulk fishmeal and bulk feedingstuffs containing fishmeal during storage, transport and packaging,

feedingstuffs destined for ruminants are manufactured in facilities physically separate from facilities where feedingstuffs containing fishmeal are manufactured,

records detailing the purchases and uses of fishmeal and the sales of feedingstuffs containing fishmeal are kept available to the competent authority for at least five years, and

routine tests are carried out on feedingstuffs destined for ruminants to ensure that prohibited proteins including fishmeal are not present.

(d)

The label and accompanying document of feedingstuffs containing fishmeal shall clearly indicate the words contains fishmeal — shall not be fed to ruminants.

(e)

Bulk feedingstuffs containing fishmeal shall be transported by means of vehicles which do not at the same time transport feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination.

(f)

The use and storage of feedingstuffs containing fishmeal shall be prohibited in farms where ruminants are kept.

By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing fishmeal in farms where ruminants are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing fishmeal are fed to ruminants.

C.

The following conditions shall apply for the use of dicalcium phosphate and tricalcium phosphate referred to in point A(b)(ii) and feedingstuffs containing such proteins in the feeding of non-ruminant farmed animals (not applicable to the feeding of carnivorous fur producing animals):

(a)

Feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be produced in establishments which do not prepare feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.

By way of derogation from that condition:

(i)

a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall not be required for home compounders:

registered by the competent authority,

keeping only non-ruminants,

producing complete feedingstuffs for use only in the same holding, and

provided that the feedingstuffs containing dicalcium phosphate or tricalcium phosphate used in the production contain less than 10 % total phosphorus;

(ii)

the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing dicalcium phosphate or tricalcium phosphate for other animal species may be authorised by the competent authority subject to the following conditions:

bulk and packaged feedingstuffs destined for ruminants are manufactured in facilities physically separate from those where feedingstuffs containing dicalcium phosphate or tricalcium phosphate are manufactured,

bulk feedingstuffs destined for ruminants are during storage, transport and packaging kept in facilities physically separate from those for bulk dicalcium phosphate, bulk tricalcium phosphate and bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate,

records detailing the purchases and uses of dicalcium phosphate or tricalcium phosphate and the sales of feedingstuff containing dicalcium phosphate or tricalcium phosphate are kept available to the competent authority for at least five years.

(b)

The label and accompanying document of the feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall clearly indicate the words contains dicalcium/tricalcium phosphate of animal origin – shall not be fed to ruminants.

(c)

Bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be transported by means of vehicles which do not at the same time transport feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination.

(d)

The use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be prohibited in farms where ruminants are kept.

By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate in farms where ruminants are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing dicalcium phosphate or tricalcium phosphate are fed to ruminants.

D.

The following conditions shall apply for the use of blood products referred to in point A(b)(iii) and blood meal referred to in point A(c) and of feedingstuffs containing such proteins, in the feeding of respectively non-ruminant farmed animals and fish:

(a)

The blood shall be derived from EU approved slaughterhouses which do not slaughter ruminants and which are registered as not slaughtering ruminants, and it shall be transported directly to the processing plant in vehicles dedicated exclusively to the transport of non-ruminant blood. If the vehicle was previously used for the transport of ruminant blood, it shall be, following cleaning, inspected by the competent authority before the transport of non-ruminant blood.

By way of derogation from that condition, the competent authority may permit the slaughter of ruminants in a slaughterhouse collecting non-ruminant blood intended for the production of blood products and blood meal for use in feed for respectively non-ruminant farmed animals and fish if the slaughterhouse has a recognised control system. That control system shall at least include:

keeping the slaughtering of non-ruminants physically separate from the slaughtering of ruminants,

keeping collection, storage, transport and packaging facilities for blood of ruminant origin physically separate from those for blood of non-ruminant origin, and

regular sampling and analysis of blood of non-ruminant origin to detect the presence of ruminant proteins

(b)

The blood products and blood meal shall be produced in an establishment exclusively processing non-ruminant blood.

By way of derogation from that condition, the competent authority may permit the production of blood products and blood meal for use in feed for respectively non-ruminant farmed animals and fish in establishments processing ruminant blood, which have a recognised control system in place preventing cross-contamination. That control system shall at least include:

processing of non-ruminant blood in a closed system physically separate from the processing of ruminant blood,

keeping of bulk raw material and bulk finished products of ruminant origin during storage, transport and packaging in facilities physically separate from those for bulk raw material and bulk finished products of non-ruminant origin, and

regular sampling and analysis of non-ruminant blood products and blood meal to detect the presence of ruminant proteins.

(c)

Feedingstuffs containing blood products or blood meal shall be produced in establishments which do not prepare feedingstuffs for respectively ruminants or farmed animals other than fish and which are authorised for this purpose by the competent authority.

By way of derogation from that condition:

(i)

a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing blood products or blood meal shall not be required for home compounders:

registered by the competent authority,

keeping only non-ruminants in case blood products are used, or only fish in case blood meal is used,

producing complete feedingstuffs for use only in the same holding, and

provided that the feedingstuffs containing blood products or blood meal used in the production contain less than 50 % total protein.

(ii)

the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing blood products or blood meal for respectively non-ruminant farmed animals or fish may be authorised by the competent authority subject to the following conditions:

bulk and packaged feedingstuffs destined for ruminants or farmed animals other than fish are manufactured in facilities physically separate from those where feedingstuffs containing respectively blood products or blood meal are manufactured,

bulk feedingstuffs kept, during storage transport and packaging, in physically separate facilities as follow:

(a)

feedingstuff destined for ruminants is kept separate from blood products and from feedingstuffs containing blood products;

(b)

feedingstuff destined for farmed animals other than fish is kept separate from blood meal and feedingstuffs containing blood meal,

records detailing the purchases and uses of blood products and blood meal, and the sales of feedingstuffs containing such products, are kept available to the competent authority for at least five years.

(d)

The label, accompanying commercial document or health certificate, as appropriate, of the feedingstuffs containing blood products or blood meal shall clearly indicate the words contains blood products – shall not be fed to ruminants or contains blood meal – shall only be fed to fish as appropriate.

(e)

Bulk feedingstuffs containing blood products shall be transported by means of vehicles which do not transport at the same time feedingstuffs for ruminants and bulk feedingstuffs containing blood meal by means of vehicles which do not transport at the same time feedingstuffs for farmed animals other than fish. If the vehicle is subsequently used for the transport of feedingstuffs intended for respectively ruminants or farmed animals other than fish, it shall be thoroughly cleaned in accordance with a procedure to avoid cross-contamination approved by the competent authority.

(f)

The use and storage of feedingstuffs containing blood products shall be prohibited in farms where ruminants are kept, and that of feedingstuffs containing blood meal shall be prohibited in farms where farmed animals other than fish are kept.

By way of derogation, the competent authority may permit the use and storage of feedingstuffs containing respectively blood products or blood meal in farms where respectively ruminants or farmed animals other than fish are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing respectively blood products or blood meal are fed to respectively ruminants or species other than fish.

III.General implementing conditionsA.

This Annex shall apply without prejudice to the provisions in Regulation (EC) No 1774/2002.

B.

Member States shall keep up-to-date lists of:

(a)

slaughterhouses approved for the collection of blood in accordance with point D(a) of Part II;

(b)

approved processing plants producing dicalcium phosphate, tricalcium phosphate, blood products or blood meal, and

(c)

establishments, with the exception of home compounders, authorised for manufacturing feedingstuffs containing fishmeal and the proteins referred to in point (b) which operate in accordance with the conditions laid down in points B(c), C(a) and D(c) of Part II.

C.(a)

Bulk processed animal protein, with the exception of fishmeal, and bulk products, including feedingstuffs, organic fertilisers and soil improvers, containing such proteins, shall be stored and transported in dedicated facilities. The store or vehicle may only be used for other purposes, following cleaning, and after having been inspected by the competent authority.

(b)

Bulk fishmeal referred to in point A(b)(i) of Part II, bulk dicalcium phosphate and bulk tricalcium phosphate referred to in point A(b)(ii) of Part II, blood products referred to in point A(b)(iii) of Part II and blood meal referred to in point A(c) of Part II shall be stored and transported in stores and vehicles dedicated to that purpose.

(c)

By way of derogation from point (b):

(i)

stores or vehicles may be used for the storage and transport of feedingstuffs containing the same protein;

(ii)

stores or vehicles, following cleaning, may be used for other purposes after having been inspected by the competent authority; and

(iii)

stores and vehicles transporting fishmeal may be used for other purposes if the company has a control system in place, recognised by the competent authority, to prevent cross-contamination. The control system shall at least include:

records on material transported and cleaning of the vehicle, and

regular sampling and analysis of feedingstuffs transported to detect the presence of fishmeal.

The competent authority shall carry out frequent on-the-spot checks to verify the correct application of the above control system.

D.

Feedingstuffs, including petfood, which contain blood products of ruminant origin or processed animal proteins, other than fishmeal, shall not be manufactured in establishments which produce feedingstuffs for farmed animals, with the exception of feedingstuffs for carnivorous fur producing animals.

Bulk feedingstuffs, including petfood, which contain blood products of ruminant origin or processed animal proteins, other than fishmeal, shall during storage, transport and packaging be kept in facilities physically separate from facilities for bulk feedingstuffs for farmed animals, with the exception of feedingstuffs for carnivorous fur producing animals.

Petfood and feedingstuffs intended for carnivorous fur producing animals containing dicalcium phosphate or tricalcium phosphate referred to in point A(b)(ii) of Part II, and blood products referred to in point A(b)(iii) of Part II shall be manufactured and transported in accordance with points C(a) and (c) and points D(c) and (e), respectively of Part II.

E.1.

The export to third countries of processed animal proteins derived from ruminants, and of products containing such processed animal proteins, shall be prohibited.

2.

The export of processed animal proteins derived from non-ruminants and of products containing such proteins shall only be permitted by the competent authority subject to the following conditions:

they are destined for uses not prohibited by Article 7,

a written agreement with the third country is made prior to exportation, which includes an undertaking from the third country to respect the final use and not to re-export the processed animal protein or products containing such proteins for uses prohibited by Article 7.

3.

Member States which permit exports in accordance with point 2 shall for the effective implementation of this Regulation inform the Commission and the other Member States of all terms and conditions as agreed with the third country concerned, in the context of the Standing Committee on the Food Chain and Animal Health.

Points 2 and 3 shall not apply to:

exports of fishmeal, provided it fulfils the conditions set out in point B of Part II,

products containing fishmeal,

petfood.

F.

The competent authority shall carry out documentary and physical checks, including tests on feedingstuffs, throughout the production and distribution chain in accordance with Directive 95/53/EC to control compliance with its provisions and with the provisions of this Regulation. Where any presence of prohibited animal protein is detected, Directive 95/53/EC shall apply. The competent authority shall verify on a regular basis the competence of laboratories carrying out analyses for such official controls, in particular by evaluating the results of ring trials. If the competence is considered unsatisfactory, a re-training of the laboratory staff shall be undertaken as the minimal corrective measure.

ANNEX VSPECIFIED RISK MATERIAL1.Definition of specified risk material

The following tissues shall be designated as specified risk material if they come from animals whose origin is in a Member State or third country or of one of their region with a controlled or undetermined BSE risk:

(a)

as regards bovine animals:

(i)

the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged over 12 months;

(ii)

the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia, of animals aged over 30 months; and

(iii)

the tonsils, the intestines from the duodenum to the rectum and the mesentery of animals of all ages.

(b)

as regards ovine and caprine animals

(i)

the skull including the brain and eyes, the tonsils and the spinal cord of animals aged over 12 months or which have a permanent incisor erupted through the gum, and

(ii)

the spleen and ileum of animals of all ages.

2.Derogation for Member States

By way of derogation from point 1, tissues listed in that point whose origin is in Member States with a negligible BSE risk shall continue to be considered as specified risk material.

3.Marking and disposal

Specified risk material shall be stained with a dye or, as appropriate, otherwise marked, immediately on removal, and disposed of in accordance with the provisions laid down in Regulation (EC) No 1774/2002, and in particular in Article 4(2) thereof.

4.Removal of specified risk material4.1.Specified risk material shall be removed at:(a)

slaughterhouses, or, as appropriate, other places of slaughter;

(b)

cutting plants, in the case of vertebral column of bovine animals;

(c)

where appropriate, in intermediate plants referred to in Article 10 of Regulation (EC) No 1774/2002 or users and collection centres authorised and registered pursuant to Article 23(2)(c)(iv), (vi) and (vii) of Regulation (EC) No 1774/2002.

4.2.By way of derogation from point 4.1, the use of an alternative test to the removal of specified risk material may be authorised under the following conditions:(a)

tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material;

(b)

no bovine, ovine or caprine product intended for human food or animal feed may leave the slaughterhouse before the competent authority has received and accepted the results of the tests on all slaughtered animals potentially contaminated if BSE has been confirmed in one of them;

(c)

when an alternative test gives a positive result, all bovine, ovine and caprine material which has been potentially contaminated in the slaughterhouse is destroyed in accordance with point 3, unless all parts of the body including the hide of the affected animal can be identified and kept separate.

4.3.By way of derogation from point 4.1, Member States may decide to allow:(a)

the removal of spinal cord of ovine and caprine animals in cutting plants specifically authorised for this purpose;

(b)

the removal of bovine vertebral column from carcasses or parts of carcasses in butcher shops specifically authorised, monitored and registered for this purpose;

(c)

the harvesting of head meat from bovine animals in cutting plants specifically authorised for this purpose in accordance with the provisions laid down in point 9.

4.4.

The rules on removal of specified risk material laid down in this Chapter shall not apply to Category 1 material as defined in Regulation (EC) No 1774/2002 used under the supervision of competent authorities for feeding of endangered and protected species of necrophagous birds.

5.Measures concerning mechanically separated meat

Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 9(3), it shall be prohibited in all Member States to use bones or bone-in cuts of bovine, ovine and caprine animals for the production of mechanically separated meat.

6.Measures concerning laceration of tissues

Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 8(3), in all Member States, until all Member States are classified as countries with negligible BSE risk, laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity after stunning shall be prohibited in bovine, ovine or caprine animals whose meat is intended for human or animal consumption.

7.Harvesting of tongues from bovine animals

Tongues of bovine animals of all ages intended for human or animal consumption shall be harvested at the slaughterhouse by a transverse cut rostral to the lingual process of the basihyoid bone.

8.Harvesting of bovine head meat8.1.Head meat of bovine animals above 12 months of age shall be harvested at slaughterhouses, in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat with central nervous system tissue. The system shall include at least the following provisions:(a)

harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline;

(b)

where the heads are removed from the conveyor or hooks before harvesting the head meat, the frontal shot hole and foramen magnum shall be sealed with an impermeable and durable stopper. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;

(c)

head meat shall not be harvested from heads where the eyes are damaged or lost immediately prior to, or after slaughter, or which are otherwise damaged in a way which might result in contamination of the head with central nervous tissue;

(d)

head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent;

(e)

without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during the harvesting, in particular in the case when the seal referred to in the second indent is lost or the eyes damaged during the activity:

(f)

a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.

8.2.

By way of derogation from the requirements of point 8.1, Member States may decide to apply at the slaughterhouse an alternative control system for the harvesting of bovine head meat, leading to an equivalent reduction in the level of contamination of head meat with central nervous system tissue. A sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. Member States using this derogation shall inform the Commission and the other Member States in the framework of the Standing Committee of the Food Chain and Animal Health of their control system and the results of the sampling.

8.3.

If the harvesting is performed without removing the bovine head from the conveyor or hooks, points 8.1 and 8.2 shall not apply.

9.Harvesting of bovine head meat in authorised cutting plants

By way of derogation from point 8, Member States may decide to allow the harvesting of head meat from bovine in cutting plants specifically authorised for this purpose and provided that the following conditions are complied with:

(a)

the heads intended for transport to the cutting plant shall be suspended on a rack during the storing period and the transport from the slaughterhouse to the cutting plant;

(b)

the frontal shot hole and the foramen magnum shall be properly sealed with an impermeable and durable stopper before being moved from the conveyor or hooks to the racks. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;

(c)

the heads which have not been properly sealed in accordance with point (b), where the eyes are damaged or lost immediately prior to or after slaughter or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue shall be excluded from transport to the specifically authorised cutting plants;

(d)

a sampling plan for the slaughterhouse using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify the proper implementation of the measures to reduce contamination;

(e)

the harvesting of head meat shall be carried out in accordance with a control system, recognized by the competent authority, to ensure the prevention of possible contamination of head meat. The system shall include at least:

(i)

all heads shall be visually checked for signs of contamination or damage and proper sealing before the harvesting of the head meat begins;

(ii)

head meat shall not be harvested from heads which have not been properly sealed, where the eyes are damaged or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue. Head meat shall also not be harvested from any head where contamination from such heads is suspected;

(iii)

without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during transport and harvesting, in particular where the seal is lost or the eyes damaged during the activity;

(f)

a sampling plan for the cutting plant using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.

10.Rules on trade and export10.1.

Member States may allow dispatch of heads or of un-split carcasses containing specified risk material to another Member State only after that Member State has agreed to receive the material and has approved the conditions of dispatch and transport.

10.2.

By way of derogation from point 10.1, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be dispatched from one Member State to another without the latter's prior agreement.

10.3.

Exports outside the Community of heads and of fresh meat of bovine, ovine or caprine animals containing specified risk materials shall be prohibited.

11.Controls11.1.

Member States shall carry out frequent official controls to verify the correct application of this Annex and shall ensure that measures are taken to avoid any contamination, particularly in slaughterhouses, cutting plants or other places where specified risk material is removed, such as butcher shops or establishments referred in point 4.1 (c).

11.2.

Member States shall in particular set up a system to ensure and check that specified risk material is handled and disposed of in accordance with Regulation (EC) No 999/2001 and Regulation (EC) No 1774/2002.

11.3.A control system shall be put in place for the removal of the vertebral column as specified in point 1(a). The system shall include at least the following measures:(a)

when removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000;

(b)

specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as the number where removal of the vertebral column is not required, shall be added on the commercial document relating to consignments of meat. When applicable, the specific information shall be added to the document referred to in Article 2(1) of Commission Regulation (EC) No 136/2004 in the case of imports;

(c)

butcher shops shall keep, for at least one year, the commercial documents referred to in (b).

ANNEX VIPRODUCTS OF ANIMAL ORIGIN DERIVED FROM OR CONTAINING RUMINANT MATERIAL, AS REFERRED TO IN ARTICLE 9(1)

The use of ruminant material for the production of the following products of animal origin is prohibited as referred to in Article 9(1):

(a)

mechanically recovered meat;

(b)

dicalcium phosphate intended as feedingstuffs for livestock;

(c)

gelatine, unless it is produced from ruminant hides;

(d)

derivatives made from rendered ruminant fat;

(e)

rendered ruminant fat, unless it was produced from:

(i)

discrete adipose tissue declared fit for human consumption;

(ii)

raw materials which were processed in accordance with the standards referred to in Directive 90/667/EEC.

ANNEX VIIERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHYCHAPTER AMeasures following confirmation of the presence of a TSE1.The inquiry referred to in Article 13(1)(b) must identify:(a)

in the case of bovine animals:

all other ruminants on the holding of the animal in which the disease was confirmed,

where the disease was confirmed in a female animal, its progeny born within two years prior to, or after, clinical onset of the disease,

all animals of the cohort of the animal in which the disease was confirmed,

the possible origin of the disease,

other animals on the holding of the animal in which the disease was confirmed or on other holdings which may have become infected by the TSE agent or been exposed to the same feed or contamination source,

the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;

(b)

in the case of ovine and caprine animals:

all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed,

in so far as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny of the female animal in which the disease was confirmed,

all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those referred to in the second indent,

the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source,

the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question.

2.The measures laid down in Article 13(1)(c) shall comprise at least:2.1.

In the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may decide:

not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been provided that such animals did not have access to the same feed as the affected animal,

to defer the killing and destruction of animals in the cohort referred to in the third indent of point 1(a) until the end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can be ensured that they are completely destroyed following death.

2.2.

If a TSE is suspected in an ovine or caprine animal on a holding in a Member State, all other ovine and caprine animals from that holding shall be placed under official movement restriction until the results of the examination are available. If there is evidence that the holding where the animal was present when the TSE was suspected is not likely to be the holding where the animal could have been exposed to a TSE, the competent authority may decide that other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available.

2.3.

In the case of confirmation of TSE in an ovine or caprine animal:

(a)

if BSE cannot be excluded after the results of a ring trial carried out in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b);

(b)

if BSE is excluded in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), pursuant to the decision of the competent authority:

either

(i)

the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). The conditions set out in point 3 shall apply to the holding;

or

(ii)

the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of:

breeding rams of the ARR/ARR genotype,

breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph,

sheep carrying at least one ARR allele which are intended solely for slaughter,

if the competent authority so decides, sheep and goats less than three months old which are intended solely for slaughter.

The conditions set out in point 3 shall apply to the holding;

or

(iii)

a Member State may decide not to kill and destroy the animals, identified by the inquiry referred to in the second and third indents of point 1(b) where it is difficult to obtain replacement ovine animals of a known genotype or where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, or based on a reasoned consideration of all the epidemiological factors. The conditions set out in point 4 shall apply to the holding;

(c)

by way of derogation from the measures set out in point (b), and only where the TSE case confirmed on a holding is an atypical scrapie case, the Member State may decide to apply the measures laid down in point 5.

(d)

Member States may decide:

(i)

to replace the killing and complete destruction of all animals referred to in b(i) by slaughtering for human consumption;

(ii)

to replace the killing and complete destruction of animals referred to in b(ii) by slaughtering for human consumption;

provided that:

the animals are slaughtered within the territory of the concerned Member State,

all animals which are over 18 months of age or have more than two permanent incisors erupted through the gum and are slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2(b);

(e)

the prion protein genotype of ovine animals, up to a maximum of 50, killed and destroyed or slaughtered for human consumption in accordance with points (b)(i) and (iii) shall be determined;

(f)

Where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, a Member State may decide to delay the destruction of animals as referred to in point 2.3 (b)(i) and (ii) for up to five breeding years.

2.4.

If the infected animal has been introduced from another holding, a Member State may decide, based on the history of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed; in the case of land used for common grazing by more than one flock, Member States may decide to limit the application of those measures to a single flock, based on a reasoned consideration of all the epidemiological factors; where more than one flock is kept on a single holding, Member States may decide to limit the application of the measures to the flock in which the TSE has been confirmed, provided it has been verified that the flocks have been kept isolated from each other and that the spread of infection between the flocks through either direct or indirect contact is unlikely.

3.Following the application on a holding of the measures referred to in point 2.3(a) and (b)(i) and (ii):3.1.

Only the following animals may be introduced to the holding(s):

(a)

male sheep of the ARR/ARR genotype;

(b)

female sheep carrying at least one ARR allele and no VRQ allele;

(c)

caprine animals, provided that:

(i)

no ovine animals for breeding other than those of the genotypes referred to in points (a) and (b) are present on the holding;

(ii)

thorough cleaning and disinfection of all animal housing on the premises has been carried out following destocking.

3.2.

Only the following ovine germinal products may be used in the holding(s):

(a)

semen from rams of the ARR/ARR genotype;

(b)

embryos carrying at least one ARR allele and no VRQ allele.

3.3.

Movement of the animals from the holding shall be subject to the following conditions:

(a)

movement of ARR/ARR sheep from the holding shall not be subject to any restriction;

(b)

sheep carrying only one ARR allele may be moved from the holding only to go directly for slaughter for human consumption or for the purposes of destruction; however,

ewes carrying one ARR allele and no VRQ allele may be moved to other holdings which are restricted following the application of measures in accordance with point 2.3(b)(ii) or 4,

if the competent authority so decides, lambs and kids may be moved to one other holding solely for the purposes of fattening prior to slaughter; the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter;

(c)

caprine animals may be moved provided that the holding is subjected to intensified TSE monitoring, including the testing of all caprine animals which are over the age of 18 months and:

(i)

are slaughtered for human consumption at the end of their productive lives; or

(ii)

have died or been killed on the holding, and meet the conditions set out to in Annex III, Chapter A, Part II, point 3;

(d)

if the Member State so decides, lambs and kids less than three months old may be moved from the holding to go directly for slaughter for human consumption.

3.4.

The restrictions set out in points 3.1, 3.2 and 3.3 shall continue to apply to the holding for a period of two years from:

(a)

the date of attainment of ARR/ARR status by all ovine animals on the holding; or

(b)

the last date when any ovine or caprine animal was kept on the premises; or

(c)

the date when the intensified TSE monitoring set out in 3.3(c) commenced; or

(d)

the date when all breeding rams on the holding are of ARR/ARR genotype and all breeding ewes carry at least one ARR allele and no VRQ allele, provided that during the two-year period, negative results are obtained from TSE testing of the following animals over the age of 18 months:

an annual sample of ovine animals slaughtered for human consumption at the end of their productive lives in accordance with the sample size referred to in the Table in Annex III, Chapter A, Part II, point 5, and

all ovine animals referred to in Annex III, Chapter A, Part II, point 3 which have died or been killed on the holding.

4.Following the application on a holding of the measures set out in point 2.3(b)(iii) and for a period of two breeding years following the detection of the last TSE case:(a)

all ovine and caprine animals on the holding shall be identified;

(b)

all ovine and caprine animals on the holding may be moved only within the territory of the concerned Member State for slaughter for human consumption or for the purposes of destruction; all animals over the age of 18 months slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b);

(c)

the competent authority shall ensure that embryos and ova are not dispatched from the holding;

(d)

only the semen from rams of the ARR/ARR genotype and embryos carrying at least one ARR allele and no VRQ allele may be used in the holding;

(e)

all ovine and caprine animals which are over the age of 18 months which have died or been killed on the holding shall be subject to TSE testing;

(f)

only male sheep of the ARR/ARR genotype and female ovine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions set out in point 3.4 may be introduced in the holding;

(g)

only caprine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions of point 3.4 may be introduced in the holding;

(h)

All ovine and caprine animals in the holding shall be subject to common grazing restrictions to be determined by the competent authority, based on a reasoned consideration of all the epidemiological factors;

(i)

by way of derogation of point (b) if the competent authority so decides, lambs and kids may be moved to another holding within the same Member State solely for the purposes of fattening prior to slaughter; provided that the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter.

5.Following the application of the derogation provided for in point 2.3(c) the following measures shall apply:(a)

either the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). Member States may decide to determine the prion protein genotype of ovine animals which have been killed and destroyed;

(b)

or, for a period of two breeding years following the detection of the last TSE case, at least the following measures:

(i)

all ovine and caprine animals in the holding shall be identified;

(ii)

the holding must be subject to intensified TSE monitoring for a two years period, including the testing of all ovine and caprine animals which are over the age of 18 months and slaughtered for human consumption and all ovine and caprine animals over the age of 18 which have died or been killed on the holding;

(iii)

the competent authority shall ensure that live ovine and caprine animals, embryos and ova from the holding are not dispatched to other Member States or third countries.

6.

Member States applying the measures set out in point 2.3(b)(iii) or the derogations provided for in points 2.3(c) and (d) shall notify to the Commission an account of the conditions and criteria used for granting them. Where additional TSE cases are detected in flocks where derogations are applied, the conditions for granting such derogations shall be reassessed.

CHAPTER BMinimum requirements for a breeding programme for resistance to TSEs in sheep in accordance with Article 6aPART 1General requirements1.

The breeding programme shall concentrate on flocks of high genetic merit.

2.A database shall be established containing at least the following information:(a)

the identity, breed and number of animals in all flocks participating in the breeding programme;

(b)

the identification of the individual animals sampled under the breeding programme;

(c)

the results of any genotyping tests.

3.

A system of uniform certification shall be established in which the genotype of each animal sampled under the breeding programme is certified by reference to its individual identification number.

4.

A system for the identification of animals and samples, the processing of samples and the delivery of results shall be established which minimises the possibility of human error. The effectiveness of that system shall be subject to regular random checking.

5.

Genotyping of blood or other tissues collected for the purposes of the breeding programme shall be carried out in laboratories that have been approved under that programme.

6.

The competent authority of the Member State may assist breed societies, to establish genetic banks consisting of semen, ova and/or embryos representative of prion protein genotypes which are likely to become rare as a result of the breeding programme.

7.Breeding programmes shall be drawn up for each breed, taking account of:(a)

frequencies of the different alleles within the breed;

(b)

rarity of the breed;

(c)

avoidance of inbreeding or genetic drift.

PART 2Specific rules for participating flocks1.

The breeding programme shall be aimed at increasing the frequency of the ARR allele within the sheep flock, while reducing the prevalence of those alleles which have been shown to contribute to susceptibility to TSEs.

2.The minimum requirements for participating flocks shall be the following:(a)

all animals in the flock that are to be genotyped shall be individually identified using secure means;

(b)

all rams intended for breeding within the flock to shall be genotyped before being used for breeding;

(c)

any male animal carrying the VRQ allele shall be slaughtered or castrated, within six months following the determination of its genotype; any such animal shall not leave the holding except for slaughter;

(d)

female animals that are known to carry the VRQ allele shall not leave the holding except for slaughter;

(e)

male animals, including semen donors used for artificial insemination, other than those certified under the breeding programme, shall not be used for breeding within the flock.

3.

Member States may decide to grant derogations from the requirements set out in point 2(c) and (d) for the purposes of protection of breeds and production traits.

4.

Member States shall inform the Commission of derogations granted under point 3 and of the criteria used.

PART 3The framework for the recognition of the TSE-resistant status of flocks of sheep1.The framework shall recognise the TSE-resistant status of flocks of sheep that as a result of participation in the breeding programme as provided for in Article 6a, satisfy the criteria required in the programme.

This recognition shall be granted on at least the following two levels:

(a)

level I flocks shall be flocks composed entirely of sheep of the ARR/ARR genotype;

(b)

level II flocks shall be flocks whose progeny have been sired exclusively by rams of the ARR/ARR genotype.

Member States may decide to grant recognition on further levels to suit national requirements.

2.Regular random sampling of sheep from TSE-resistant flocks shall be carried out:(a)

on the farm or at the slaughterhouse to verify their genotype;

(b)

in the case of level I flocks, in animals over 18 months of age at the slaughterhouse, for TSE testing in accordance with Annex III.

PART 4Reports to be provided to the Commission by the Member States

Member States introducing national breeding programmes to select for resistance to TSE in their ovine populations shall notify to the Commission the requirements for such programmes and shall provide an annual report on their progress. The report for each calendar year shall be submitted at the latest by 31 March of the following year.

ANNEX VIIIPLACING ON THE MARKET AND EXPORTCHAPTER AConditions for intra-Community trade in live animals, semen and embryosI.CONDITIONS WHICH APPLY TO OVINE.AND CAPRINE.ANIMALS AND SEMEN AND EMBRYOS TREREOF

The following conditions shall apply to trade in ovine and caprine animals:

(a)

ovine and caprine animals for breeding shall either be sheep of the ARR/ARR prion protein genotype, as defined in Annex I of Commission Decision 2002/1003/EC, or they shall have been kept continuously since birth or for the last three years on a holding or holdings which have satisfied the following requirements for at least three years:

(i)

until 30 June 2007:

it is subject to regular official veterinary checks,

the animals are marked,

no case of scrapie has been confirmed,

checking by sampling of old female animals intended for slaughter is carried out,

females, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.

From 1 July 2004 at the latest, the holding or holdings shall begin to satisfy the following additional requirements:

all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding shall be examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b), and

ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, shall be introduced into the holding only if they come from a holding which complies with the same requirements.

(ii)

from 1 July 2007:

it is subject to regular official veterinary checks,

the animals are identified in conformity with Community legislation,

no case of scrapie has been confirmed,

all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding have been examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b),

ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.

If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c), ovine and caprine animals for breeding shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2).

(b)

a Member State which has a compulsory or voluntary national scrapie control program for all or part of its territory:

(i)

may submit the said program to the Commission, outlining in particular:

the distribution of the disease in the Member State,

the reasons for the program, taking into consideration the importance of the disease and the cost/benefit ratio,

the geographical area in which the program will be implemented,

the status categories defined for holdings and the standards which must be attained in each such category,

the test procedures to be used,

the program monitoring procedures,

the action to be taken if, for any reason, a holding loses its status,

the measures to be taken if the results of checks carried out in accordance with the provisions of the program are positive,

(ii)

the program referred to in point (i) may be approved if it complies with the criteria laid down in that point, in accordance with the procedure referred to in Article 24(2). The additional guarantees, general or specific, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the program in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally,

(iii)

amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2). Amendments to the guarantees which have been defined in accordance with point (ii) may be approved in accordance with that procedure,

(c)

where a Member State considers that its territory or part of its territory is free from scrapie:

(i)

it is to submit to the Commission appropriate supporting documentation, setting out in particular:

the history of the occurrence of the disease in its territory,

the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation,

the period over which the surveillance was carried out,

the arrangements for verifying the absence of the disease,

(ii)

the additional guarantees, general or specific, which may be required in intra-Community trade are to be defined in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally,

(iii)

the Member State concerned is to notify the Commission of any change in the details specified in point (i) which relate to the disease. The guarantees defined in accordance with point (ii) may, in the light of such notification, be amended or withdrawn in accordance with the procedure referred to in Article 24(2),

(d)

from 1 January 2005 semen and embryos of ovine and caprine animals shall:

(i)

be collected from animals which have been kept continuously since birth or for the last three years of their life on a holding or holdings which have satisfied the requirements of subparagraph (a)(i) or, as appropriate, (a)(ii) for three years or

(ii)

in the case of ovine semen, be collected from male animals of the ARR/ARR prion protein genotype as defined in Annex I to Commission Decision 2002/1003/ECor

(iii)

in the case of ovine embryos, be of the ARR/ARR prion protein genotype as defined in Annex I to Decision 2002/1003/EC.

II.CONDITIONS WICH APPLY TO BOVINE ANIMALS

The United Kingdom shall ensure that bovine animals born or reared on its territory before 1 August 1996 are not dispatched from its territory to other Member States or third countries.

CHAPTER BConditions relating to progeny of TSE suspect or confirmed animals referred to in Article 15(2)

It shall be prohibited to place on the market the last-born progeny to which female bovine animals infected with a TSE or BSE-confirmed ovine or caprine animals gave birth during the preceding two-year period or during the period that followed the appearance of the first clinical signs of the onset of the disease.

CHAPTER CConditions for intra-Community trade in certain products of animal origin
SECTION AProducts

The following products of animal origin are exempt from the prohibition referred to in Article 16(3), provided that they are derived from bovine, ovine and caprine animals that satisfy the requirements of Section B:

fresh meat,

minced meat,

meat preparations,

meat products.

SECTION BRequirements

The products referred to in Section A must satisfy the following requirements:

(a)

the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;

(b)

the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(c)

the products of bovine, ovine and caprine animal origin are not derived from:

(i)

specified risk material as defined in Annex V;

(ii)

nervous and lymphatic tissues exposed during the deboning process; and

(iii)

mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

CHAPTER DConditions applicable to exports

Live bovine animals and products of animal origin derived therefrom are to be subject — as regards exports to third countries — to the rules laid down in this Regulation for intra-Community trade.

ANNEX IXIMPORTATION INTO THE COMMUNITY OF LIVE ANIMALS, EMBRYOS, OVA AND PRODUCTS OF ANIMAL ORIGINCHAPTER A

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER BImports of bovine animals
SECTION AImports from a country or a region with a negligible BSE risk

Imports of bovine animals from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:

(a)

the animals were born and continuously reared in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;

(b)

the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II; and

(c)

if there have been BSE indigenous cases in the country concerned, the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.

SECTION BImports from a country or a region with a controlled BSE risk

Imports of bovine animals from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that:

(a)

the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;

(b)

the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of Annex II;

(c)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.

SECTION CImports from a country or a region with undetermined BSE risk

Imports of bovine animals from a country or a region with an undetermined BSE risk shall be subject to the presentation of an animal health certificate attesting that:

(a)

the country or region has not been categorized in accordance with Article 5(2) of Regulation (EC) No 999/2001 or has been categorized as a country or region with undetermined BSE risk;

(b)

the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of Annex II;

(c)

the animals were born at least two years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.

CHAPTER CImports of products of animal origin from bovine, ovine or caprine animals
SECTION AProducts

The following products of bovine, ovine and caprine animal origin, as defined by Regulation (EC) No 853/2004 of the European Parliament and of the Council shall be subject to the conditions laid down in Sections B, C and D depending on the BSE risk category of the country of origin:

fresh meat,

minced meat and meat preparations,

meat products,

treated intestines,

rendered animal fats,

greaves, and

gelatine.

SECTION BImports from a country or a region with a negligible BSE risk

Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:

(a)

the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;

(b)

the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;

(c)

if in the country or region there have been BSE indigenous cases:

(i)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(ii)

the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

SECTION CImports from a country or a region with a controlled BSE risk1.Imports of products of bovine, ovine and caprine animal origin referred to in section A from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that:(a)

the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;

(b)

the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;

(c)

animals from which the products of bovine, ovine and caprine animal origin destined for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(d)

the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

2.

By way of derogation from point 1(d) carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported.

3.

When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a blue stripe on the label referred to in Regulation (EC) No 1760/2000.

4.

The number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as he number where removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.

5.In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the presentation of an animal health certificate attesting that:(a)

the country or region is classified in accordance with Article 5(2) as a country or region posing a controlled BSE risk;

(b)

the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante-mortem and post-mortem inspections;

(c)

if the intestines are sourced from a country or region where there have been BSE indigenous cases:

(i)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(ii)

the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V.

SECTION DImports from a country or a region with an undetermined BSE risk1.Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with an undetermined BSE risk, shall be subject to the presentation of an animal health certificate attesting that:(a)

the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;

(b)

the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(c)

the products of bovine, ovine and caprine animal origin are not derived from:

(i)

specified risk material as defined in Annex V;

(ii)

nervous and lymphatic tissues exposed during the deboning process;

(iii)

mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

2.

By way of derogation from point 1(c), carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported.

3.

When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000.

4.

Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required and from which removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.

5.In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the presentation of an animal health certificate attesting that:(a)

the country or region is classified in accordance with Article 5(2) as a country or region posing an undetermined BSE risk;

(b)

the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante-mortem and post-mortem inspections;

(c)

if the intestines are sourced from a country or region where there have been BSE indigenous cases:

(i)

the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(ii)

the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V.

CHAPTER DImports of animal by-products and processed products derived therefrom from bovine, ovine and caprine animal origin
SECTION AAnimal by-products

This Chapter shall apply to the following animal by-products and processed products derived therefrom from bovine, ovine and caprine animal origin as referred to in Regulation (EC) No 1774/2002:

rendered fats,

pet food,

blood products,

the processed animal protein,

bones and bone products,

category 3 material, and

gelatine.

SECTION B

Imports of the animal by-products processed products derived therefrom from bovine, ovine and caprine animal origin referred to in Section A. shall be subject to the presentation of an animal health certificate attesting that:

(a)

the animal by-product does not contain and is not derived from specified risk material as defined in Annex V or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

(b)

the animals from which this animal by-product is derived, have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity,

or

(c)

the animal by-product does not contain and is not derived from bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk.

CHAPTER EImports of ovine and caprine animals

Ovine and caprine animals imported into the Community after 1 October 2003 are to be subject to the presentation of an animal health certificate attesting that:

(a)

either they were born in and continuously reared on holdings in which a case of scrapie has never been diagnosed, and, in the case of ovine and caprine animals for breeding, they satisfy the requirements of subparagraph (i) of point (a) of Chapter A(I) of Annex VIII;

(b)

or they are sheep of the ARR/ARR prion protein genotype, as defined in Annex I to Commission Decision 2002/1003/EC, coming from a holding where no case of scrapie has been reported in the last six months.

If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of Annex VIII, they shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2).

CHAPTER FImports of products of animal origin from farmed and wild cervid animals1.When fresh meat, minced meat, meat preparations and meat products as defined by Regulation (EC) No 853/2004, derived from farmed cervid animals, are imported into the Community from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows:

This product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognized by the competent authority with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected.

2.When fresh meat, minced meat, meat preparations and meat products as defined by Regulation (EC) No 853/2004, derived from wild cervid animals, are imported into the Community from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows:

This product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognized by the competent authority with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected.

CHAPTER G

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CHAPTER HImport of ovine and caprine semen and embryos

Semen and embryos of ovine and caprine animals imported into the Community from 1 January 2005 shall satisfy the requirements of Annex VIII, Chapter A(I)(d).

ANNEX XREFERENCE LABORATORIES, SAMPLING AND LABORATORY ANALYSIS METHODSCHAPTER ANational reference laboratories1.The designated national reference laboratory is to:(a)

have at its disposal facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type and strain of the agent of TSE, and to confirm results obtained by regional diagnostic laboratories. Where it is not capable of identifying the strain-type of the agent, it shall set up a procedure to ensure that the identification of the strain is referred to the Community reference laboratory;

(b)

verify diagnostic methods used in regional diagnostic laboratories;

(c)

be responsible for coordination of diagnostic standards and methods within the Member State. To this end, it:

may provide diagnostic reagents to laboratories approved by the Member State;

is to control the quality of all diagnostic reagents used in the Member State;

is to periodically arrange comparative tests;

is to hold isolates of the agents of the disease in question, or corresponding tissues containing such agents, coming from cases confirmed in the Member State;

is to ensure confirmation of results obtained in diagnostic laboratories designated by the Member State;

(d)

is to cooperate with the Community reference laboratory.

2.

However, by way of derogation from point 1, Member States which do not have a national reference laboratory are to use the services of the Community reference laboratory or of national reference laboratories in other Member States.

3.The national reference laboratories are:

Austria:

Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, Institut für veterinärmedizinische Untersuchungen Mödling

Robert Koch Gasse 17

A-2340 Mödling

Belgium:

CERVA -CODA-VAR

Centre d'Étude et de Recherches Vétérinaires et Agrochimiques

Centrum voor Onderzoek in Diergeneeskunde en Agrochemie

Veterinary and Agrochemical Research Centre

Groeselenberg 99

B-1180 Bruxelles

Bulgaria:

Национален диагностичен научноизследователски ветеринарномедицински институт Проф. Д-р Георги Павлов

Национална референтна лаборатория Tрансмисивни спонгиформни енцефалопатии

бул. Пенчо Славейков

София 1606

(National Diagnostic Veterinary Research Institute Prof. Dr. Georgi Pavlov National Reference Laboratory for Transmissible Spongiform Encephalopathies

15, Pencho Slaveykov Blvd.

1606 Sofia)

Cyprus:

State Veterinary Laboratories

Veterinary Services

CY-1417 Athalassa

Nicosia

Czech Republic:

Státní veterinární ústav Jihlava

Rantířovská 93

586 05 Jihlava

Denmark:

Danmarks Fødevareforskning

Bülowsvej 27

DK-1790 København V

Estonia:

Veterinaar- ja Toidulaboratoorium

Kreutzwaldi 30

Tartu 51006

Finland:

Eläinlääkintä- ja elintarvikelaitos

Hämeentie 57

FIN-00550 Helsinki

France:

Agence française de sécurité sanitaire des aliments

Laboratoire de pathologie bovine

31, avenue Tony Garnier

69 364 LYON CEDEX 07

Germany:

Friedrich-Loeffler-Institut, Bundesforschungsinstitut für Tiergesundheit

Anstaltsteil Insel Riems Boddenblick 5A

D-17498 Insel Riems

Greece:

Ministry of Agriculture — Veterinary Laboratory of Larisa

7th km of Larisa — Trikala Highway

GR-411 10 Larisa

Hungary:

Országos Állategészségügyi Intézet (OÁI)

Pf. 2.

Tábornok u. 2.

H-1581 Budapest

Ireland:

Central Veterinary Research Laboratory

Young's Cross

Celbridge

Co. Kildare

Italy:

Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d’Aosta — CEA

Via Bologna, 148

I-10154 Torino

Latvia:

State Veterinary Medicine Diagnostic Centre

Lejupes Str. 3

Riga LV 1076

Lithuania:

Nacionalinė veterinarijos laboratorija

J. Kairiūkščio g. 10

LT-08409 Vilnius

Luxembourg:

CERVA -CODA-VAR

Centre d'Étude et de Recherches Vétérinaires et Agrochimiques

Centrum voor Onderzoek in Diergeneeskunde en Agrochemie

Veterinary and Agrochemical Research Centre

Groeselenberg 99

B-1180 Bruxelles

Malta:

National Veterinary Laboratory

Albert Town Marsa

Netherlands:

Centraal Instituut voor Dierziektecontrole-Lelystad

Houtribweg 3g

8221 RA Lelystad

Postbus 2004

8203 AA Lelystad

Poland:

Państwowy Instytut Weterynaryjny (PIWet)

24-100 Puławy

al. Partyzantów 57

Portugal:

Laboratório Nacional de Investigação Veterinária Estrada de Benfica

701 P-1500 Lisboa

Romania:

Institutul de Diagnostic și Sănătate Animală

Strada Dr. Staicovici nr. 63, sector 5

codul 050557, București.

Slovakia:

State Veterinary Institute Zvolen

Pod dráhami 918

SK-960 86, Zvolen

Slovenia:

National Veterinary Institute

Gerbičeva 60

1000 Ljubljana

Spain:

Laboratorio Central de Veterinaria (Algete)

Ctra. de Algete km. 8

28110 Algete (Madrid)

Sweden:

National Veterinary Institute

S-751 89 Uppsala

United Kingdom:

Veterinary Laboratories Agency

Woodham Lane

New Haw Addlestone Surrey KT15 3NB

CHAPTER BCommunity reference laboratory1.The Community reference laboratory for TSEs is:

The Veterinary Laboratories Agency

Woodham Lane

New Haw

Addlestone

Surrey KT15 3NB

United Kingdom

2.The functions and duties of the Community reference laboratory are:(a)

to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing BSE, specifically by:

storing and supplying corresponding tissues containing the agent, for the development or production of the relevant diagnostic tests or for typing strains of the agent;

supplying standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in the Member States;

building up and retaining a collection of corresponding tissues containing the agents and strains of TSEs;

organising periodic comparative tests of diagnostic procedures at Community level;

collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community;

characterising isolates of the TSE agent by the most up-to-date methods to allow greater understanding of the epidemiology of the disease;

keeping abreast of trends in surveillance, epidemiology and prevention of TSEs throughout the world;

maintaining expertise on prion diseases to enable rapid differential diagnosis;

acquiring a thorough knowledge of the preparation and use of diagnostic methods used to control and eradicate TSEs;

(b)

to assist actively in the diagnosis of outbreaks of TSEs in Member States by studying samples from TSE-infected animals sent for confirmatory diagnosis, characterisation and epidemiological studies;

(c)

to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community.

CHAPTER CSampling and laboratory testing1.Sampling

Any samples intended to be examined for the presence of a TSE shall be collected using the methods and protocols laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the International Office for Epizooties (IOE/OIE) (the Manual). In addition, or in the absence, of OIE methods and protocols, and to ensure that sufficient material is available, the competent authority shall ensure the use of sampling methods and protocols in accordance with guidelines issued by the Community Reference Laboratory. In particular the competent authority shall collect the appropriate tissues, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE in small ruminants and shall keep at least half of the collected tissues fresh but not frozen until the result of the rapid test is negative. Where the result is positive or inconclusive the residual tissues must be processed in accordance with the Community reference laboratory guidelines.

The samples shall be correctly marked as to the identity of the sampled animal.

2.Laboratories

Any laboratory examination for TSE shall be carried out in laboratories approved for that purpose by the competent authority.

3.Methods and protocols3.1.Laboratory testing for the presence of BSE in bovine animals(a)Suspect cases

Samples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods laid down in the Manual (immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy). However, rapid tests cannot be used for this purpose.

If the result of one of those examinations is positive, the animals shall be regarded a positive BSE case.

(b)BSE monitoring

Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I (Monitoring in bovine animals) shall be examined by a rapid test.

When the result of the rapid test is inconclusive or positive, the sample shall immediately be subject to confirmatory examinations in an official laboratory. The confirmatory examination shall start by a histopathological examination of the brainstem as laid down in the latest edition of the Manual, except where the material is autolysed or otherwise not suitable for examination by histopathology. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by one of the other diagnostic methods referred to in (a).

An animal shall be regarded a positive BSE case, if the result of the rapid test is positive or inconclusive, and either

the result of the subsequent histopathological examination is positive, or

the result of another diagnostic method referred to in (a) is positive.

3.2.Laboratory testing for the presence of TSE in ovine and caprine animals(a)Suspect cases

Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as laid down in the Manual. However, rapid tests cannot be used for this purpose.

If the result of one of those examinations is positive, the animal shall be regarded a positive scrapie case.

(b)TSE monitoring

Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part II (Monitoring in ovine and caprine animals) shall be examined by a rapid test using the appropriate methods and protocols, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE.

When the result of the rapid test is inconclusive or positive, the sampled tissues shall immediately be sent to an official laboratory for confirmatory examinations by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in (a). If the result of the confirmatory examination is negative or inconclusive, additional confirmatory testing shall be carried out according the guidelines of the Community reference laboratory.

If the result of one of the confirmatory examination is positive, the animal shall be regarded a positive TSE case.

(c)Further examination of positive scrapie cases(i)

Primary molecular testing with a discriminatory immuno-blotting

Samples from clinical suspect cases and from animals tested in accordance with Annex III, Chapter A, Part II, points 2 and 3 which are regarded as positive scrapie cases following the examinations referred to in points (a) or (b), or which display characteristics which are deemed by the testing laboratory to merit investigation, shall be forwarded for further examination by a primary molecular typing method to:

Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France, or

Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom, or

to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community Reference Laboratory for the use of a molecular typing method, or

on a provisional basis until 1 May 2005, the laboratories approved for this purpose by the CRL panel of experts.

(ii)

Ring trial with additional molecular testing methods

Samples from scrapie cases in which the presence of BSE cannot be excluded according to the guidelines issued by the Community Reference Laboratory by the primary molecular testing referred to in (i), shall be forwarded immediately to the laboratories listed in point (d) after consultation with the Community Reference Laboratory, and with all the relevant information available. They shall be submitted to a ring trial with at least:

a second discriminatory immuno-blotting,

a discriminatory immunocytochemistry, and

a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay)

carried out in the laboratories approved for the relevant method as listed in point (d). Where samples are unsuitable for immunocytochemistry, the Community Reference Laboratory will direct appropriate alternative testing within the ring trial.

The results shall be interpreted by the Community Reference Laboratory assisted by a panel of experts including a representative of the relevant National Reference Laboratory. The Commission shall be informed immediately about the outcome of that interpretation. Samples indicative for BSE by three different methods and samples inconclusive in the ring trial shall be further analysed by a mouse bioassay for final confirmation.

Further testing of positive TSE samples detected in infected flocks on the same holding shall be carried out at least on the first two positive TSE cases detected every year following the index case.

(d)Laboratories approved for performing further examination by molecular typing methods

The laboratories approved for further molecular typing are:

Agence Française de Sécurité Sanitaire des Aliments

Laboratoire de pathologie bovine

31, avenue Tony Garnier

BP 7033

F-69342 Lyon Cedex

Centre CEA Fontenay-aux-Roses, BP 6

F-92265 Fontenay-aux-Roses Cedex

Service de Pharmacologie et d’Immunologie

Centre CEA Saclay, bâtiment 136

F-91191 Gif-sur-Yvette Cedex

Veterinary Laboratories Agency

Woodham Lane

New Haw

Addlestone

Surrey KT15 3NB

United Kingdom

3.3.Laboratory testing for the presence of TSEs in species other than those referred to in points 3.1. and 3.2.

Where methods and protocols are established for tests carried out to confirm the suspected presence of a TSE in a species other than bovine, ovine and caprine, they shall include at least a histopathological examination of brain tissue. The competent authority may also require laboratory tests such as immunocytochemistry, immuno-blotting, demonstration of characteristic fibrils by electron microscopy or other methods designed to detect the disease associated form of the prion protein. In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive. At least three different examinations shall be carried out in the event of the first appearance of the disease.

In particular, where BSE is suspected in a species other than bovine animals, samples shall be submitted for strain-typing, where possible.

4.Rapid tests

For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:

immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),

chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation),

microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),

sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),

microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),

conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),

chemiluminescent ELISA for qualitative determination of PrPSc (CediTect BSE test),

immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA),

lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),

two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrPSc (Roboscreen Beta Prion BSE EIA Test Kit),

sandwich ELISA for the detection of Proteinase K-resistant PrPSc (Roche Applied Science PrionScreen),

antigen-capture ELISA using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Fujirebio FRELISA BSE post-mortem rapid BSE Test).

For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals:

conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),

sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),

sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE Sheep/Goat test),

chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer TSE Kit version 2.0),

microplate-based immunoassay for the detection of PrPSc (Enfer TSE Version 3),

immunoassay using a chemical polymer for selective PrPSc capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA),

microplate-based chemiluminiscent immunoassay for the detection of PrPSc in ovine tissues (POURQUIER’S-LIA Scrapie),

immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western Small Ruminant test),

microplate-based chemiluminescent immunoassay for the detection of Proteinase K-resistant PrPSc (Prionics Check LIA Small Ruminants).

In all tests, sample tissue on which the test must be applied must comply with the manufacturer’s instructions for use.

Producers of rapid tests must have a quality assurance system in place that has been approved by the Community Reference Laboratory (CRL) and ensures that the test performance does not change. Producers must provide the CRL with the test protocols.

Changes to rapid tests and to test protocols may only be made after prior notification to the CRL and provided that the CRL finds that the change does not alter the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories.

5.Alternative tests

(To be defined)

ANNEX XITRANSITIONAL MEASURES REFERRED TO IN ARTICLES 22 AND 23A.Concerning specified risk material, mechanically recovered meat and slaughtering techniques1.

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

13.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

14.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B.Concerning statistical surveys1.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C.Concerning prohibitions on animal feeding

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D.Concerning placing on the market and export1.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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<temporalGroup eId="period34">
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</temporalGroup>
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<timeInterval start="#effective-date-8" refersTo="#period-concept35"/>
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</temporalGroup>
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<timeInterval start="#effective-date-9" end="#effective-date-10" refersTo="#period-concept37"/>
</temporalGroup>
<temporalGroup eId="period38">
<timeInterval start="#effective-date-9" end="#effective-date-14" refersTo="#period-concept38"/>
</temporalGroup>
<temporalGroup eId="period39">
<timeInterval start="#effective-date-9" end="#effective-date-19" refersTo="#period-concept39"/>
</temporalGroup>
</temporalData>
<references source="#source">
<TLCOrganization eId="source" href="http://www.legislation.gov.uk/id/publisher/KingsOrQueensPrinterOfActsOfParliament" showAs="King's Printer of Acts of Parliament"/>
<passiveRef href="http://www.legislation.gov.uk/id/uksi/2019/1220" showAs="The Animal Health, Invasive Alien Species, Plant Breeders’ Rights and Seeds (Amendment etc.) (EU Exit) Regulations 2019"/>
<passiveRef href="http://www.legislation.gov.uk/id/uksi/2019/1229" showAs="The Animal Health and Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019"/>
<passiveRef href="http://www.legislation.gov.uk/id/uksi/2019/170" showAs="The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019"/>
<passiveRef href="http://www.legislation.gov.uk/id/uksi/2019/588" showAs="The Animals (Legislative Functions) (EU Exit) Regulations 2019"/>
<passiveRef href="http://www.legislation.gov.uk/id/uksi/2020/1388" showAs="The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020"/>
<TLCLocation eId="e+w+s+ni" href="/ontology/jurisdictions/uk.EnglandWalesScotlandNorthernIreland" showAs="England, Wales, Scotland, Northern Ireland"/>
<TLCConcept eId="period-concept1" href="/ontology/time/2005.01.01" showAs="since 2005-01-01"/>
<TLCConcept eId="period-concept2" href="/ontology/time/2005.01.01-2015.01.01" showAs="from 2005-01-01 until 2015-01-01"/>
<TLCConcept eId="period-concept3" href="/ontology/time/2005.01.01-2020.12.31" showAs="from 2005-01-01 until 2020-12-31"/>
<TLCConcept eId="period-concept4" href="/ontology/time/2005.02.11" showAs="since 2005-02-11"/>
<TLCConcept eId="period-concept5" href="/ontology/time/2005.02.11-2009.03.19" showAs="from 2005-02-11 until 2009-03-19"/>
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<TLCConcept eId="period-concept7" href="/ontology/time/2005.02.11-2013.07.01" showAs="from 2005-02-11 until 2013-07-01"/>
<TLCConcept eId="period-concept8" href="/ontology/time/2005.02.11-2015.01.01" showAs="from 2005-02-11 until 2015-01-01"/>
<TLCConcept eId="period-concept9" href="/ontology/time/2005.02.11-2016.02.03" showAs="from 2005-02-11 until 2016-02-03"/>
<TLCConcept eId="period-concept10" href="/ontology/time/2005.02.11-2016.09.08" showAs="from 2005-02-11 until 2016-09-08"/>
<TLCConcept eId="period-concept11" href="/ontology/time/2005.02.11-2017.11.20" showAs="from 2005-02-11 until 2017-11-20"/>
<TLCConcept eId="period-concept12" href="/ontology/time/2005.02.11-2020.12.31" showAs="from 2005-02-11 until 2020-12-31"/>
<TLCConcept eId="period-concept13" href="/ontology/time/2005.09.01" showAs="since 2005-09-01"/>
<TLCConcept eId="period-concept14" href="/ontology/time/2005.09.01-2008.10.20" showAs="from 2005-09-01 until 2008-10-20"/>
<TLCConcept eId="period-concept15" href="/ontology/time/2006.05.25" showAs="since 2006-05-25"/>
<TLCConcept eId="period-concept16" href="/ontology/time/2006.05.25-2013.07.01" showAs="from 2006-05-25 until 2013-07-01"/>
<TLCConcept eId="period-concept17" href="/ontology/time/2007.01.19-2013.07.01" showAs="from 2007-01-19 until 2013-07-01"/>
<TLCConcept eId="period-concept18" href="/ontology/time/2007.07.17" showAs="since 2007-07-17"/>
<TLCConcept eId="period-concept19" href="/ontology/time/2007.07.17-2008.07.10" showAs="from 2007-07-17 until 2008-07-10"/>
<TLCConcept eId="period-concept20" href="/ontology/time/2007.07.17-2008.09.29" showAs="from 2007-07-17 until 2008-09-29"/>
<TLCConcept eId="period-concept21" href="/ontology/time/2007.07.17-2009.02.24" showAs="from 2007-07-17 until 2009-02-24"/>
<TLCConcept eId="period-concept22" href="/ontology/time/2007.07.17-2009.03.19" showAs="from 2007-07-17 until 2009-03-19"/>
<TLCConcept eId="period-concept23" href="/ontology/time/2007.07.17-2011.03.18" showAs="from 2007-07-17 until 2011-03-18"/>
<TLCConcept eId="period-concept24" href="/ontology/time/2007.07.17-2013.06.01" showAs="from 2007-07-17 until 2013-06-01"/>
<TLCConcept eId="period-concept25" href="/ontology/time/2007.07.17-2013.07.01" showAs="from 2007-07-17 until 2013-07-01"/>
<TLCConcept eId="period-concept26" href="/ontology/time/2007.07.17-2015.01.01" showAs="from 2007-07-17 until 2015-01-01"/>
<TLCConcept eId="period-concept27" href="/ontology/time/2007.07.17-2015.08.05" showAs="from 2007-07-17 until 2015-08-05"/>
<TLCConcept eId="period-concept28" href="/ontology/time/2007.07.17-2016.09.08" showAs="from 2007-07-17 until 2016-09-08"/>
<TLCConcept eId="period-concept29" href="/ontology/time/2007.07.17-2017.07.01" showAs="from 2007-07-17 until 2017-07-01"/>
<TLCConcept eId="period-concept30" href="/ontology/time/2007.07.17-2018.01.01" showAs="from 2007-07-17 until 2018-01-01"/>
<TLCConcept eId="period-concept31" href="/ontology/time/2007.07.17-2020.12.31" showAs="from 2007-07-17 until 2020-12-31"/>
<TLCConcept eId="period-concept32" href="/ontology/time/2007.11.02-2009.02.24" showAs="from 2007-11-02 until 2009-02-24"/>
<TLCConcept eId="period-concept33" href="/ontology/time/2007.11.02-2011.03.18" showAs="from 2007-11-02 until 2011-03-18"/>
<TLCConcept eId="period-concept34" href="/ontology/time/2007.11.02-2017.07.01" showAs="from 2007-11-02 until 2017-07-01"/>
<TLCConcept eId="period-concept35" href="/ontology/time/2008.01.15" showAs="since 2008-01-15"/>
<TLCConcept eId="period-concept36" href="/ontology/time/2008.01.15-2008.09.29" showAs="from 2008-01-15 until 2008-09-29"/>
<TLCConcept eId="period-concept37" href="/ontology/time/2008.04.26-2008.07.10" showAs="from 2008-04-26 until 2008-07-10"/>
<TLCConcept eId="period-concept38" href="/ontology/time/2008.04.26-2009.03.19" showAs="from 2008-04-26 until 2009-03-19"/>
<TLCConcept eId="period-concept39" href="/ontology/time/2008.04.26-2015.05.27" showAs="from 2008-04-26 until 2015-05-27"/>
</references>
<notes source="#source">
<note class="footnote" eId="f00015">
<p>
<ins class="substitution O008002M002-f00015">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2002.273.01.0001.01.ENG">OJ L 273, 10.10.2002, p. 1</ref>
</ins>
<ins class="substitution O008002M002-f00015">.</ins>
</p>
</note>
<note class="footnote" eId="f00016">
<p>
<ins class="substitution O008002M002-f00016">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2002.031.01.0001.01.ENG">OJ L 31, 1.2.2002, p. 1</ref>
</ins>
<ins class="substitution O008002M002-f00016">.</ins>
</p>
</note>
<note class="footnote" eId="f00017">
<p>
<ins class="substitution O008002M002-f00017">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1979.086.01.0030.01.ENG">OJ L 86, 6.4.1979, p. 30</ref>
</ins>
<ins class="substitution O008002M002-f00017">.</ins>
</p>
</note>
<note class="footnote" eId="f00018">
<p>
<ins class="substitution O008002M002-f00018">
<ins class="substitution O024001M012-f00018">http://www.defra.gov.uk/corporate/vla/science/science-tse-rl-confirm.htm</ins>
</ins>
</p>
</note>
<note class="footnote" eId="f00019">
<p>
<ins class="substitution O024001M001-f00019">Design prevalence is used to determine the size of a testing survey expressed in terms of target points. If the actual prevalence is greater than the selected design prevalence, the survey is highly likely to detect disease.</ins>
</p>
</note>
<note class="footnote" eId="f00024">
<p>
<ins class="substitution O011001M001-f00024">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.P_.1964.121.01.2012.01.ENG">OJ 121, 29.7.1964, p. 2012/64</ref>
</ins>
<ins class="substitution O011001M001-f00024">.</ins>
</p>
</note>
<note class="footnote" eId="f00025">
<p>
<ins class="substitution O011001M001-f00025">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.1996.099.01.0014.01.ENG">OJ L 99, 20.4.1996, p. 14</ref>
</ins>
<ins class="substitution O011001M001-f00025">.</ins>
</p>
</note>
<note class="footnote" eId="f00026">
<p>
<ins class="substitution O011001M001-f00026">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2002.273.01.0001.01.ENG">OJ L 273, 10.10.2002, p. 1</ref>
</ins>
<ins class="substitution O011001M001-f00026">.</ins>
</p>
</note>
<note class="footnote" eId="f00029">
<p>
<ins class="substitution O024001M002-f00029">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2004.021.01.0011.01.ENG">OJ L 21, 28.1.2004, p. 11</ref>
</ins>
<ins class="substitution O024001M002-f00029">.</ins>
</p>
</note>
<note class="footnote" eId="f00030">
<p>
<ins class="substitution O007001M002-f00030">
<ins class="substitution O013001M001-f00030">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2002.349.01.0105.01.ENG">OJ L 349, 24.12.2002, p. 105</ref>
</ins>
</ins>
<ins class="substitution O007001M002-f00030">
<ins class="substitution O013001M001-f00030">.</ins>
</ins>
</p>
</note>
<note class="footnote" eId="f00031">
<p>
<ins class="substitution O007001M002-f00031">
<ins class="O014001M005-f00031">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2002.349.01.0105.01.ENG">OJ L 349, 24.12.2002, p. 105</ref>
</ins>
</ins>
<ins class="substitution O007001M002-f00031">
<ins class="O014001M005-f00031">.</ins>
</ins>
</p>
</note>
<note class="footnote" eId="f00032">
<p>
<ins class="substitution O024001M008-f00032">
<ins class="substitution O025001M001-f00032">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2004.139.01.0055.01.ENG">OJ L 139, 30.4.2004, p. 55</ref>
</ins>
</ins>
<ins class="substitution O024001M008-f00032">
<ins class="substitution O025001M001-f00032">, as corrected by </ins>
</ins>
<ins class="substitution O024001M008-f00032">
<ins class="substitution O025001M001-f00032">
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2004.226.01.0022.01.ENG">OJ L 226, 25.6.2004, p. 22</ref>
</ins>
</ins>
<ins class="substitution O024001M008-f00032">
<ins class="substitution O025001M001-f00032">.</ins>
</ins>
</p>
</note>
<note class="commentary F" eId="c000004">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2003/1234">Commission Regulation (EC) No 1234/2003 of 10 July 2003 amending Annexes I, IV and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council and Regulation (EC) No 1326/2001 as regards transmissible spongiform encephalopathies and animal feeding (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000005">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2007/727">Commission Regulation (EC) No 727/2007 of 26 June 2007 amending Annexes I, III, VII and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000006">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2007/722">Commission Regulation (EC) No 722/2007 of 25 June 2007 amending Annexes II, V, VI, VIII, IX and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000007">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2003/2245">Commission Regulation (EC) No 2245/2003 of 19 December 2003 amending Annex III to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring of transmissible spongiform encephalopathies in ovine and caprine animals</ref>
.
</p>
</note>
<note class="commentary F" eId="c000008">
<p>
Deleted by
<ref href="http://www.legislation.gov.uk/id/eur/2006/688">Commission Regulation (EC) No 688/2006 of 4 May 2006 amending Annexes III and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the monitoring of transmissible spongiform encephalopathies and specified risk material of bovine animals in Sweden (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000009">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2006/657">Commission Regulation (EC) No 657/2006 of 10 April 2006 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the United Kingdom and repealing Council Decision 98/256/EC and Decisions 98/351/EC and 1999/514/EC (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000010">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2005/36">Commission Regulation (EC) No 36/2005 of 12 January 2005 amending Annexes III and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards epidemio-surveillance for transmissible spongiform encephalopathies in bovine, ovine and caprine animals (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000011">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2005/1292">Commission Regulation (EC) No 1292/2005 of 5 August 2005 amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards animal nutrition (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000012">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2008/357">Commission Regulation (EC) No 357/2008 of 22 April 2008 amending Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000013">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2007/1428">Commission Regulation (EC) No 1428/2007 of 4 December 2007 amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000014">
<p>
Inserted by
<ref href="http://www.legislation.gov.uk/id/eur/2007/1428">Commission Regulation (EC) No 1428/2007 of 4 December 2007 amending Annex VII to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000015">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2003/260">Commission Regulation (EC) No 260/2003 of 12 February 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the eradication of transmissible spongiform encephalopathies in ovine and caprine animals and rules for the trade in live ovine and caprine animals and bovine embryos (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000016">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2004/1492">Commission Regulation (EC) No 1492/2004 of 23 August 2004 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards eradication measures for transmissible spongiform encephalopathies in bovine, ovine and caprine animals, the trade and importation of semen and embryos of ovine and caprine animals and specified risk material (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000017">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2004/876">Commission Regulation (EC) No 876/2004 of 29 April 2004 amending Annex VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards trade in ovine and caprine animals for breeding (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000018">
<p>
Inserted by
<ref href="http://www.legislation.gov.uk/id/eur/2004/1492">Commission Regulation (EC) No 1492/2004 of 23 August 2004 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards eradication measures for transmissible spongiform encephalopathies in bovine, ovine and caprine animals, the trade and importation of semen and embryos of ovine and caprine animals and specified risk material (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000019">
<p>
Deleted by
<ref href="http://www.legislation.gov.uk/id/eur/2007/722">Commission Regulation (EC) No 722/2007 of 25 June 2007 amending Annexes II, V, VI, VIII, IX and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000020">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2007/1275">Commission Regulation (EC) No 1275/2007 of 29 October 2007 amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000021">
<p>
Inserted by
<ref href="http://www.legislation.gov.uk/id/eur/2007/1275">Commission Regulation (EC) No 1275/2007 of 29 October 2007 amending Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000022">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2003/1915">Commission Regulation (EC) No 1915/2003 of 30 October 2003 amending Annexes VII, VIII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the trade and import of ovine and caprine animals and the measures following the confirmation of transmissible spongiform encephalopathies in bovine, ovine and caprine animals (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000023">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2005/1974">Commission Regulation (EC) No 1974/2005 of 2 December 2005 amending Annexes X and XI to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards national reference laboratories and specified risk material (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000024">
<p>
Inserted by
<ref href="http://www.legislation.gov.uk/id/eur/2006/1791">Council Regulation (EC) No 1791/2006 of 20 November 2006 adapting certain Regulations and Decisions in the fields of free movement of goods, freedom of movement of persons, company law, competition policy, agriculture (including veterinary and phytosanitary legislation), transport policy, taxation, statistics, energy, environment, cooperation in the fields of justice and home affairs, customs union, external relations, common foreign and security policy and institutions, by reason of the accession of Bulgaria and Romania</ref>
.
</p>
</note>
<note class="commentary F" eId="c000025">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2008/315">Commission Regulation (EC) No 315/2008 of 4 April 2008 amending Annex X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the lists of rapid tests (Text with EEA relevance)</ref>
.
</p>
</note>
<note class="commentary F" eId="c000026">
<p>
Substituted by
<ref href="http://www.legislation.gov.uk/id/eur/2003/1139">Commission Regulation (EC) No 1139/2003 of 27 June 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards monitoring programmes and specified risk material</ref>
.
</p>
</note>
</notes>
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<dc:description>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</dc:description>
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<ukm:Section Ref="annex-IX" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX">Annex 9 </ukm:Section>
<ukm:Section Ref="annex-IX-chapter-E" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/E">Ch. E</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-64-a-i" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/64/a/i">reg. 2(64)(a)(i)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectedClass="EuropeanUnionRegulation" AffectedNumber="999" AffectingEffectsExtent="E+W+S+N.I." AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingNumber="170" AffectedYear="2001" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingYear="2019" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(64) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(t)" URI="http://www.legislation.gov.uk/id/effect/key-8d27f7852fc45cb9823a9d73dd8c8d52" AffectingProvisions="reg. 2(64)(a)(ii)" EffectId="key-8d27f7852fc45cb9823a9d73dd8c8d52" RequiresApplied="false" AffectedProvisions="Annex 9 Ch. E point 5" Row="148" Comments="IP completion day" Type="words substituted" Modified="2022-07-29T11:32:18Z">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-IX" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX">Annex 9 </ukm:Section>
<ukm:Section Ref="annex-IX-chapter-E" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/E">Ch. E</ukm:Section>
point 5
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-64-a-ii" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/64/a/ii">reg. 2(64)(a)(ii)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedNumber="999" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingNumber="170" URI="http://www.legislation.gov.uk/id/effect/key-c97075b2d1e084a82d62205a7a218e1e" AffectingProvisions="reg. 2(64)(a)(iii)" AffectingYear="2019" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(64) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(t)" AffectingEffectsExtent="E+W+S+N.I." AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedClass="EuropeanUnionRegulation" Type="words substituted" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedProvisions="Annex 9 Ch. E point 6" AffectingClass="UnitedKingdomStatutoryInstrument" Row="149" EffectId="key-c97075b2d1e084a82d62205a7a218e1e" Comments="IP completion day" RequiresApplied="false" Modified="2022-07-29T11:32:18Z" AffectedYear="2001">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-IX" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX">Annex 9 </ukm:Section>
<ukm:Section Ref="annex-IX-chapter-E" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/E">Ch. E</ukm:Section>
point 6
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-64-a-iii" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/64/a/iii">reg. 2(64)(a)(iii)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedClass="EuropeanUnionRegulation" AffectingProvisions="reg. 2(64)(b)" AffectingYear="2019" AffectedYear="2001" Comments="IP completion day" AffectedNumber="999" Row="154" RequiresApplied="false" Modified="2022-07-29T11:32:18Z" URI="http://www.legislation.gov.uk/id/effect/key-71ab7adf58730c1ad60deb7d8a1131ec" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Type="words substituted" EffectId="key-71ab7adf58730c1ad60deb7d8a1131ec" AffectedProvisions="Annex 9 Ch. F point 1" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(64) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(t)" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingEffectsExtent="E+W+S+N.I." AffectingNumber="170" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-IX" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX">Annex 9 </ukm:Section>
<ukm:Section Ref="annex-IX-chapter-F" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/F">Ch. F</ukm:Section>
point 1
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-64-b" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/64/b">reg. 2(64)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Notes="This amendment not applied to legislation.gov.uk. Reg. 2(64) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(t)" AffectingEffectsExtent="E+W+S+N.I." AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" EffectId="key-5051cdad3ef90e463d07de912ebea2bd" Modified="2022-07-29T11:32:18Z" AffectedProvisions="Annex 9 Ch. F point 2" AffectingNumber="170" AffectingYear="2019" AffectingProvisions="reg. 2(64)(b)" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedYear="2001" AffectedClass="EuropeanUnionRegulation" AffectedNumber="999" URI="http://www.legislation.gov.uk/id/effect/key-5051cdad3ef90e463d07de912ebea2bd" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Type="words substituted" Row="155" Comments="IP completion day" RequiresApplied="false">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-IX" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX">Annex 9 </ukm:Section>
<ukm:Section Ref="annex-IX-chapter-F" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/F">Ch. F</ukm:Section>
point 2
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-64-b" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/64/b">reg. 2(64)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(64) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(t)" Comments="IP completion day" AffectingClass="UnitedKingdomStatutoryInstrument" URI="http://www.legislation.gov.uk/id/effect/key-7c21eda2f0ef813f1f2aca21c6ce08c6" EffectId="key-7c21eda2f0ef813f1f2aca21c6ce08c6" AffectedClass="EuropeanUnionRegulation" Type="words substituted" Row="158" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedNumber="999" AffectingYear="2019" AffectingNumber="170" RequiresApplied="false" Modified="2022-07-29T11:32:18Z" AffectedProvisions="Annex 9 Ch. H" AffectingProvisions="reg. 2(64)(c)" AffectingEffectsExtent="E+W+S+N.I." AffectedYear="2001">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-IX" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX">Annex 9 </ukm:Section>
<ukm:Section Ref="annex-IX-chapter-H" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/H">Ch. H</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-64-c" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/64/c">reg. 2(64)(c)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingProvisions="reg. 5(2)(g)" AffectedClass="EuropeanUnionRegulation" AffectingYear="2019" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/1220" AffectedProvisions="Annex 9 Ch. D s. B point 2" AffectedYear="2001" AffectingNumber="1220" Type="words substituted by S.I. 2019/170, reg. 2(64)(za) (as inserted)" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Modified="2022-07-29T11:32:18Z" AffectedNumber="999" RequiresApplied="false" Notes="This amendment not applied to legislation.gov.uk. Reg. 5(2)(g) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 22(2)(a)(iii)" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Row="178" AffectingClass="UnitedKingdomStatutoryInstrument" URI="http://www.legislation.gov.uk/id/effect/key-d02a9a22289b2f7bce23e862fe89b27a" Comments="IP completion day" AffectingEffectsExtent="E+W+S+N.I." EffectId="key-d02a9a22289b2f7bce23e862fe89b27a">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-IX-chapter-D" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/D">Annex 9 Ch. D </ukm:Section>
<ukm:Section Ref="annex-IX-chapter-D-section-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/D/section/B">s. B</ukm:Section>
point 2
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Animal Health, Invasive Alien Species, Plant Breeders’ Rights and Seeds (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingTitle>The Animal Health, Invasive Alien Species, Plant Breeders' Rights and Seeds (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-5-2-g" URI="http://www.legislation.gov.uk/id/uksi/2019/1220/regulation/5/2/g">reg. 5(2)(g)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1-2-b" URI="http://www.legislation.gov.uk/id/uksi/2019/1220/regulation/1/2/b">reg. 1(2)(b)</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Type="words substituted" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedYear="2001" AffectingNumber="1229" Comments="IP completion day - This amendment has been superseded by the amendment by S.I. 2020/1388 reg. 20(2)(t) (which amends S.I. 2019/170 reg. 2(64)) This amendment has been superseded by the amendment by S.I. 2020/1388 reg. 20(2)(t) (which amends S.I. 2019/170 reg. 2(64)). The SI Registrar have been emailed about this lex error and whether S.I. 2019/1229 reg. 2(5) should have been revoked. - This amendment has been superseded by the amendment by S.I. 2020/1388 reg. 20(2)(t) (which amends S.I. 2019/170 reg. 2(64)). The SI Registrar have been emailed about this lex error and whether S.I. 2019/1229 reg. 2(5) should have been revoked." AffectingProvisions="reg. 2(5)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/1229" AffectedNumber="999" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedClass="EuropeanUnionRegulation" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" EffectId="key-f3e2ea30d007f4a0e3f23721e2263676" AffectedProvisions="Annex 9 Ch. D s. B point 2" URI="http://www.legislation.gov.uk/id/effect/key-f3e2ea30d007f4a0e3f23721e2263676" RequiresApplied="false" AffectingEffectsExtent="E+W+S+N.I." Row="179" Notes="This amendment not applied to legislation.gov.uk. Operative words in reg. 2(64) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(t)" AffectingYear="2019" Modified="2022-07-29T11:32:18Z">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-IX-chapter-D" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/D">Annex 9 Ch. D </ukm:Section>
<ukm:Section Ref="annex-IX-chapter-D-section-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/IX/chapter/D/section/B">s. B</ukm:Section>
point 2
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Animal Health and Genetically Modified Organisms (Amendment) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-5" URI="http://www.legislation.gov.uk/id/uksi/2019/1229/regulation/2/5">reg. 2(5)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1-3" URI="http://www.legislation.gov.uk/id/uksi/2019/1229/regulation/1/3">reg. 1(3)</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedYear="2001" EffectId="key-844ecb45a8cf61d13164f71038c24b7d" AffectingYear="2019" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingEffectsExtent="E+W+S+N.I." Type="words substituted" AffectedNumber="999" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(34) substituted immediately before IP completion day by S.I. 2019/1220, regs. 1(2)(b), 5(2)(d)(iii)" RequiresApplied="false" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingNumber="170" AffectedClass="EuropeanUnionRegulation" URI="http://www.legislation.gov.uk/id/effect/key-844ecb45a8cf61d13164f71038c24b7d" Comments="IP completion day" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Row="190" Modified="2022-07-29T11:32:18Z" AffectingProvisions="reg. 2(34)" AffectedProvisions="Annex 5 point 1">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-V" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/V">Annex 5</ukm:Section>
point 1
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-34" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/34">reg. 2(34)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect URI="http://www.legislation.gov.uk/id/effect/key-bdffe0c5b336076dc427b734c53729ac" Comments="IP completion day" AffectingEffectsExtent="E+W+S+N.I." AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingNumber="170" Modified="2022-07-29T11:32:18Z" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(37) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(l)" EffectId="key-bdffe0c5b336076dc427b734c53729ac" RequiresApplied="false" Type="words omitted" AffectedProvisions="Annex 5 point 5" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedClass="EuropeanUnionRegulation" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Row="194" AffectedYear="2001" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingProvisions="reg. 2(37)" AffectedNumber="999" AffectingYear="2019">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-V" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/V">Annex 5</ukm:Section>
point 5
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-37" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/37">reg. 2(37)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingYear="2019" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedYear="2001" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Comments="IP completion day" RequiresApplied="false" Type="words substituted" AffectingNumber="170" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(48)(d)(e) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(n)(ii)(iii)" AffectedNumber="999" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedProvisions="Annex 7 Ch. B point 2.2.2(c)" AffectedClass="EuropeanUnionRegulation" URI="http://www.legislation.gov.uk/id/effect/key-a366aaced4c2a9a8685cd85be3da9813" Modified="2022-07-29T11:32:18Z" AffectingProvisions="reg. 2(48)(d)(i)" AffectingEffectsExtent="E+W+S+N.I." EffectId="key-a366aaced4c2a9a8685cd85be3da9813" Row="223">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 2.2.2(c)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-48-d-i" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/48/d/i">reg. 2(48)(d)(i)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedNumber="999" URI="http://www.legislation.gov.uk/id/effect/key-3e35df4e668e4fcc8642963c62b6c697" Row="224" AffectingClass="UnitedKingdomStatutoryInstrument" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(48)(d)(e) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(n)(ii)(iii)" EffectId="key-3e35df4e668e4fcc8642963c62b6c697" AffectingYear="2019" Type="words substituted" AffectedClass="EuropeanUnionRegulation" AffectedProvisions="Annex 7 Ch. B point 2.2.2(c)" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" RequiresApplied="false" Modified="2022-07-29T11:32:18Z" AffectingProvisions="reg. 2(48)(d)(ii)" Comments="IP completion day" AffectingEffectsExtent="E+W+S+N.I." AffectedYear="2001" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectingNumber="170">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 2.2.2(c)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-48-d-ii" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/48/d/ii">reg. 2(48)(d)(ii)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Type="words substituted" EffectId="key-4a5388058a552bdbcdc36fa6c6e0c386" AffectedProvisions="Annex 7 Ch. B point 2.2.2(c)(i)" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingEffectsExtent="E+W+S+N.I." AffectedNumber="999" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Modified="2022-07-29T11:32:18Z" URI="http://www.legislation.gov.uk/id/effect/key-4a5388058a552bdbcdc36fa6c6e0c386" AffectingYear="2019" AffectingProvisions="reg. 2(48)(d)(iii)" Row="225" AffectingNumber="170" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(48)(d)(e) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(n)(ii)(iii)" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" RequiresApplied="false" AffectedClass="EuropeanUnionRegulation" Comments="IP completion day" AffectedYear="2001">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 2.2.2(c)(i)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-48-d-iii" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/48/d/iii">reg. 2(48)(d)(iii)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Comments="IP completion day" AffectingEffectsExtent="E+W+S+N.I." AffectingNumber="170" AffectingYear="2019" URI="http://www.legislation.gov.uk/id/effect/key-04d14c9613c13347f36076f721830b2e" RequiresApplied="false" Modified="2022-07-29T11:32:18Z" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(48)(d)(e) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(n)(ii)(iii)" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedClass="EuropeanUnionRegulation" AffectedProvisions="Annex 7 Ch. B point 2.2.2(c)(iii)" AffectedNumber="999" EffectId="key-04d14c9613c13347f36076f721830b2e" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedYear="2001" AffectingProvisions="reg. 2(48)(d)(iv)" Type="words substituted" Row="226">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 2.2.2(c)(iii)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-48-d-iv" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/48/d/iv">reg. 2(48)(d)(iv)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingEffectsExtent="E+W+S+N.I." AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedProvisions="Annex 7 Ch. B point 2.2.2(d)" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(48)(d)(e) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(n)(ii)(iii)" AffectedYear="2001" Comments="IP completion day - NB this amendment is itself amended immediately before IP completion day by 2019 SI1229, reg. 3(2)(a): "in paragraph (48)(e)(i)(aa), omit “in the words before point (a),”." This changes the positioning of the amendment." AffectingYear="2019" Modified="2022-07-29T11:32:18Z" AffectedNumber="999" AppendedCommentary="(as amended by S.I. 2019/1229, regs. 1(3), 3(2)(a)); 2020 c. 1, Sch. 5 para. 1(1)" AffectingClass="UnitedKingdomStatutoryInstrument" RequiresApplied="false" AffectingProvisions="reg. 2(48)(e)(i)(aa)" Row="227" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingNumber="170" EffectId="key-18686146d04c016c71079e41ddc75f9f" AffectedClass="EuropeanUnionRegulation" URI="http://www.legislation.gov.uk/id/effect/key-18686146d04c016c71079e41ddc75f9f" Type="words substituted">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 2.2.2(d)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-48-e-i-aa" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/48/e/i/aa" FoundRef="regulation-2">reg. 2(48)(e)(i)(aa)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedNumber="999" Type="words substituted" Row="228" URI="http://www.legislation.gov.uk/id/effect/key-e17f89462542cab8635dbb7968020ca9" AffectedProvisions="Annex 7 Ch. B point 2.2.2(d)" AffectedClass="EuropeanUnionRegulation" AffectingYear="2019" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Comments="IP completion day" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedYear="2001" RequiresApplied="false" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(48)(d)(e) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(n)(ii)(iii)" Modified="2022-07-29T11:32:18Z" AffectingNumber="170" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingEffectsExtent="E+W+S+N.I." AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingProvisions="reg. 2(48)(e)(i)(bb)" EffectId="key-e17f89462542cab8635dbb7968020ca9">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 2.2.2(d)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-48-e-i-bb" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/48/e/i/bb" FoundRef="regulation-2">reg. 2(48)(e)(i)(bb)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingClass="UnitedKingdomStatutoryInstrument" AffectedNumber="999" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Modified="2022-07-29T11:32:18Z" Type="words substituted" AffectingNumber="170" RequiresApplied="false" Row="229" URI="http://www.legislation.gov.uk/id/effect/key-efcf11abac35b368610dff0e490c6698" AffectedYear="2001" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedProvisions="Annex 7 Ch. B point 2.2.2(d)" AffectedClass="EuropeanUnionRegulation" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingEffectsExtent="E+W+S+N.I." Comments="IP completion day" AffectingYear="2019" AffectingProvisions="reg. 2(48)(e)(ii)" EffectId="key-efcf11abac35b368610dff0e490c6698" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(48)(d)(e) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(n)(ii)(iii)">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 2.2.2(d)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-48-e-ii" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/48/e/ii">reg. 2(48)(e)(ii)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingProvisions="reg. 2(48)(e)(iii)" AffectingEffectsExtent="E+W+S+N.I." Modified="2022-07-29T11:32:18Z" URI="http://www.legislation.gov.uk/id/effect/key-089377143de76ff7c967665503086398" AffectingYear="2019" Row="230" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(48)(d)(e) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(n)(ii)(iii)" EffectId="key-089377143de76ff7c967665503086398" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedProvisions="Annex 7 Ch. B point 2.2.2(d)" AffectedClass="EuropeanUnionRegulation" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingNumber="170" RequiresApplied="false" Type="words substituted" AffectedNumber="999" AffectedYear="2001" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Comments="IP completion day" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 2.2.2(d)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-48-e-iii" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/48/e/iii">reg. 2(48)(e)(iii)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedNumber="999" Row="237" AppendedCommentary="(as amended by S.I. 2019/1229, regs. 1(3), 3(2)(b)(i)); 2020 c. 1, Sch. 5 para. 1(1)" AffectedClass="EuropeanUnionRegulation" AffectingEffectsExtent="E+W+S+N.I." Type="words substituted" AffectedProvisions="Annex 7 Ch. B point 4.2" AffectingYear="2019" AffectingNumber="170" EffectId="key-b2dd24d374c4fb719523026eacafeaf3" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(51)(51a)(52) substituted for reg. 2(51)(51a)(52) immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(q)" Comments="IP completion day - NB this amendment is itself amended immediately before IP completion day by 2019 SI1229, reg. 3(2)(b)(i): "in sub-paragraph (a), for “4.2(b)” substitute “4.2”." This changes the positioning of the amendment." AffectingClass="UnitedKingdomStatutoryInstrument" URI="http://www.legislation.gov.uk/id/effect/key-b2dd24d374c4fb719523026eacafeaf3" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedYear="2001" Modified="2022-07-29T11:32:18Z" RequiresApplied="false" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectingProvisions="reg. 2(51)(a)">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 4.2
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-51-a" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/51/a">reg. 2(51)(a)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingYear="2019" Comments="IP completion day - NB this amendment is itself amended immediately before IP completion day by 2019 SI1229, reg. 3(2)(b)(ii): "in sub-paragraph (b), for “4.3(c)” substitute “4.3”." This changes the positioning of the amendment." Modified="2022-07-29T11:32:18Z" RequiresApplied="false" AffectedNumber="999" AffectingProvisions="reg. 2(51)(b)" AffectedProvisions="Annex 7 Ch. B point 4.3" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" EffectId="key-351012d090ddf58bfe80d454914a3de6" AppendedCommentary="(as amended by S.I. 2019/1229, regs. 1(3), 3(2)(b)(ii)); 2020 c. 1, Sch. 5 para. 1(1)" Row="238" AffectedClass="EuropeanUnionRegulation" AffectingNumber="170" Type="words substituted" AffectedYear="2001" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(51)(51a)(52) substituted for reg. 2(51)(51a)(52) immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(q)" URI="http://www.legislation.gov.uk/id/effect/key-351012d090ddf58bfe80d454914a3de6" AffectingEffectsExtent="E+W+S+N.I." AffectingClass="UnitedKingdomStatutoryInstrument">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 4.3
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-51-b" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/51/b">reg. 2(51)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Type="words substituted" Modified="2022-07-29T11:32:18Z" AffectingEffectsExtent="E+W+S+N.I." Row="239" RequiresApplied="false" AffectedProvisions="Annex 7 Ch. B point 4.4(b)" AffectedNumber="999" AffectingProvisions="reg. 2(52)(a)" URI="http://www.legislation.gov.uk/id/effect/key-45f291bb15a4aeae7c904c831b36b1a3" AffectedYear="2001" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(51)(51a)(52) substituted for reg. 2(51)(51a)(52) immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(q)" AffectingYear="2019" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedClass="EuropeanUnionRegulation" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" EffectId="key-45f291bb15a4aeae7c904c831b36b1a3" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Comments="IP completion day" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingNumber="170">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 4.4(b)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-52-a" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/52/a">reg. 2(52)(a)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingClass="UnitedKingdomStatutoryInstrument" AffectedYear="2001" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectingProvisions="reg. 2(52)(b)" AffectedProvisions="Annex 7 Ch. B point 4.4(b)(ii)" AffectedClass="EuropeanUnionRegulation" Type="words substituted" AffectingNumber="170" AffectingEffectsExtent="E+W+S+N.I." AffectedNumber="999" RequiresApplied="false" Comments="IP completion day" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Row="240" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(51)(51a)(52) substituted for reg. 2(51)(51a)(52) immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(q)" AffectingYear="2019" Modified="2022-07-29T11:32:18Z" EffectId="key-578c967375f7c4e7d2c4871d5b802602" URI="http://www.legislation.gov.uk/id/effect/key-578c967375f7c4e7d2c4871d5b802602">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 4.4(b)(ii)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-52-b" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/52/b">reg. 2(52)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedProvisions="Annex 7 Ch. B point 4.5" EffectId="key-47c5e28f5d965aaac2f202b89f915506" AffectedClass="EuropeanUnionRegulation" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectingYear="2019" URI="http://www.legislation.gov.uk/id/effect/key-47c5e28f5d965aaac2f202b89f915506" Notes="This amendment not applied to legislation.gov.uk. Operative words in reg. 2(53) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(r)" AffectingProvisions="reg. 2(53)" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Modified="2022-07-29T11:32:18Z" Row="241" Type="words substituted" AffectingNumber="170" AffectingEffectsExtent="E+W+S+N.I." AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Comments="IP completion day" RequiresApplied="false" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedYear="2001" AffectedNumber="999">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VII" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII">Annex 7 </ukm:Section>
<ukm:Section Ref="annex-VII-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VII/chapter/B">Ch. B</ukm:Section>
point 4.5
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-53" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/53">reg. 2(53)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingProvisions="reg. 2(60)" AffectingYear="2019" EffectId="key-d75f2729130a9b56af608f5f47b271da" URI="http://www.legislation.gov.uk/id/effect/key-d75f2729130a9b56af608f5f47b271da" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Type="omitted" AffectedYear="2001" Row="341" AffectedNumber="999" AffectingEffectsExtent="E+W+S+N.I." AffectedProvisions="Annex 8 Ch. A s. A point 2-4" RequiresApplied="false" Modified="2022-07-29T11:32:18Z" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(60) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(s)" AffectedClass="EuropeanUnionRegulation" Comments="IP completion day" AffectingNumber="170">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-VIII-chapter-A" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VIII/chapter/A">Annex 8 Ch. A </ukm:Section>
<ukm:Section Ref="annex-VIII-chapter-A-section-A" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/VIII/chapter/A/section/A">s. A</ukm:Section>
point 2-4
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-60" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/60">reg. 2(60)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingEffectsExtent="E+W+S+N.I." EffectId="key-7fa623d7bc16537d0daaf341509bcbc6" URI="http://www.legislation.gov.uk/id/effect/key-7fa623d7bc16537d0daaf341509bcbc6" Modified="2022-07-29T11:32:18Z" AffectedClass="EuropeanUnionRegulation" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Row="357" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(66)(67) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(v)" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedYear="2001" RequiresApplied="false" AffectingNumber="170" AffectingProvisions="reg. 2(66)(a)(i)" AffectedProvisions="Annex 10 Ch. A point 1(a)" Comments="IP completion day" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Type="words omitted" AffectedNumber="999" AffectingYear="2019">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-X" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X">Annex 10 </ukm:Section>
<ukm:Section Ref="annex-X-chapter-A" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/A">Ch. A</ukm:Section>
point 1(a)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-66-a-i" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/66/a/i">reg. 2(66)(a)(i)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Type="words substituted" AffectedClass="EuropeanUnionRegulation" EffectId="key-43475492e2a01bfd0313233935b14e0a" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(66)(67) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(v)" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedNumber="999" Row="358" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectedYear="2001" URI="http://www.legislation.gov.uk/id/effect/key-43475492e2a01bfd0313233935b14e0a" Modified="2022-07-29T11:32:18Z" AffectingEffectsExtent="E+W+S+N.I." RequiresApplied="false" Comments="IP completion day" AffectedProvisions="Annex 10 Ch. A point 1(c)" AffectingNumber="170" AffectingProvisions="reg. 2(66)(a)(ii)" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingYear="2019">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-X" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X">Annex 10 </ukm:Section>
<ukm:Section Ref="annex-X-chapter-A" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/A">Ch. A</ukm:Section>
point 1(c)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-66-a-ii" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/66/a/ii">reg. 2(66)(a)(ii)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedYear="2001" AffectedNumber="999" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectingEffectsExtent="E+W+S+N.I." AffectedClass="EuropeanUnionRegulation" EffectId="key-92322f93e5b18ca6de810e766a984910" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(66)(67) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(v)" AffectingNumber="170" AffectedProvisions="Annex 10 Ch. A point 1(d)" URI="http://www.legislation.gov.uk/id/effect/key-92322f93e5b18ca6de810e766a984910" Modified="2022-07-29T11:32:18Z" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Row="359" RequiresApplied="false" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingYear="2019" AffectingClass="UnitedKingdomStatutoryInstrument" Comments="IP completion day" Type="omitted" AffectingProvisions="reg. 2(66)(a)(iii)">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-X" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X">Annex 10 </ukm:Section>
<ukm:Section Ref="annex-X-chapter-A" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/A">Ch. A</ukm:Section>
point 1(d)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-66-a-iii" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/66/a/iii">reg. 2(66)(a)(iii)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(66)(67) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(v)" Modified="2022-07-29T11:32:18Z" Comments="IP completion day" AffectedClass="EuropeanUnionRegulation" AffectingYear="2019" AffectingProvisions="reg. 2(66)(b)" AffectingEffectsExtent="E+W+S+N.I." AffectedNumber="999" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" RequiresApplied="false" URI="http://www.legislation.gov.uk/id/effect/key-103f4abca42dfa2be81fb889968dd14e" AffectedProvisions="Annex 10 Ch. A point 2" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Type="omitted" EffectId="key-103f4abca42dfa2be81fb889968dd14e" AffectingNumber="170" AffectedYear="2001" Row="360" AffectingClass="UnitedKingdomStatutoryInstrument">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-X" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X">Annex 10 </ukm:Section>
<ukm:Section Ref="annex-X-chapter-A" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/A">Ch. A</ukm:Section>
point 2
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-66-b" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/66/b">reg. 2(66)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedProvisions="Annex 10 Ch. A point 3" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(66)(67) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(v)" AffectedClass="EuropeanUnionRegulation" AffectingEffectsExtent="E+W+S+N.I." URI="http://www.legislation.gov.uk/id/effect/key-0db53175568100b2b5bdcc98b8cf7b6b" RequiresApplied="false" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" EffectId="key-0db53175568100b2b5bdcc98b8cf7b6b" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedNumber="999" AffectingClass="UnitedKingdomStatutoryInstrument" Comments="IP completion day" Type="substituted" AffectingProvisions="reg. 2(66)(c)" AffectingYear="2019" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Modified="2022-07-29T11:32:18Z" AffectedYear="2001" Row="361" AffectingNumber="170">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-X" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X">Annex 10 </ukm:Section>
<ukm:Section Ref="annex-X-chapter-A" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/A">Ch. A</ukm:Section>
point 3
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-66-c" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/66/c">reg. 2(66)(c)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Notes="This amendment not applied to legislation.gov.uk. Reg. 2(66)(67) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(v)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectingNumber="170" AffectingProvisions="reg. 2(67)" Modified="2022-07-29T11:32:18Z" Comments="IP completion day" AffectingEffectsExtent="E+W+S+N.I." Type="omitted" AffectingYear="2019" EffectId="key-1544dbc0bb27ceda85b620dd6a947aea" RequiresApplied="false" AffectedProvisions="Annex 10 Ch. B" Row="362" URI="http://www.legislation.gov.uk/id/effect/key-1544dbc0bb27ceda85b620dd6a947aea" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectedYear="2001" AffectedClass="EuropeanUnionRegulation" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedNumber="999">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-X" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X">Annex 10 </ukm:Section>
<ukm:Section Ref="annex-X-chapter-B" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/B">Ch. B</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-67" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/67">reg. 2(67)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedNumber="999" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedClass="EuropeanUnionRegulation" AffectedProvisions="Annex 10 Ch. C point 3.2(c)(i)" AffectingYear="2019" RequiresApplied="false" AffectingEffectsExtent="E+W+S+N.I." URI="http://www.legislation.gov.uk/id/effect/key-2b2b05057ea6ebe7e0cbc092064e0b6c" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Modified="2022-07-29T11:32:18Z" AffectingNumber="170" AffectingProvisions="reg. 2(72)(b)(i)" Comments="IP completion day" EffectId="key-2b2b05057ea6ebe7e0cbc092064e0b6c" Type="words omitted" Row="369" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(72)(b)(i) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(w)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedYear="2001">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="annex-X" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X">Annex 10 </ukm:Section>
<ukm:Section Ref="annex-X-chapter-C" URI="http://www.legislation.gov.uk/id/eur/2001/999/annex/X/chapter/C">C</ukm:Section>
h. C point 3.2(c)(i)
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-72-b-i" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/72/b/i">reg. 2(72)(b)(i)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingNumber="170" Modified="2022-07-29T11:32:18Z" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(3)(d) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(b)(ii)" Type="words substituted" AffectingEffectsExtent="E+W+S+N.I." AffectedNumber="999" EffectId="key-75679913580da79142887c5106d6dcbb" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingYear="2019" Row="440" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedProvisions="Art. 5(8)" AffectingProvisions="reg. 2(3)(d)" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectedClass="EuropeanUnionRegulation" RequiresApplied="false" URI="http://www.legislation.gov.uk/id/effect/key-75679913580da79142887c5106d6dcbb" Comments="IP completion day" AffectedYear="2001">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-5-8" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/5/8">Art. 5(8)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-3-d" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/3/d">reg. 2(3)(d)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Row="453" AffectedNumber="999" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/1220" AffectingEffectsExtent="E+W+S+N.I." AffectedProvisions="Art. 6(4)" AffectedClass="EuropeanUnionRegulation" AffectingClass="UnitedKingdomStatutoryInstrument" Modified="2022-07-29T11:32:18Z" AffectingProvisions="reg. 5(2)(b)" Comments="IP completion day" URI="http://www.legislation.gov.uk/id/effect/key-b0362606a8e3ac215fb47c2205d73812" Notes="This amendment not applied to legislation.gov.uk. Reg. 5(2)(b) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 22(2)(a)(i)" AffectedYear="2001" RequiresApplied="false" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" EffectId="key-b0362606a8e3ac215fb47c2205d73812" AffectingYear="2019" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Type="words substituted in earlier amending provision S.I. 2019/170, reg. 2(4)(c)(i)" AffectingNumber="1220">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-6-4" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/6/4">Art. 6(4)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Animal Health, Invasive Alien Species, Plant Breeders’ Rights and Seeds (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingTitle>The Animal Health, Invasive Alien Species, Plant Breeders' Rights and Seeds (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-5-2-b" URI="http://www.legislation.gov.uk/id/uksi/2019/1220/regulation/5/2/b">reg. 5(2)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1-2-b" URI="http://www.legislation.gov.uk/id/uksi/2019/1220/regulation/1/2/b">reg. 1(2)(b)</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingClass="UnitedKingdomStatutoryInstrument" AffectingYear="2019" AffectedClass="EuropeanUnionRegulation" Comments="IP completion day" EffectId="key-b08fdf86405b3ce2edbf1ff24d718f2e" RequiresApplied="false" Modified="2022-07-29T11:32:18Z" AffectedProvisions="Art. 8(4)" AffectedNumber="999" AffectingEffectsExtent="E+W+S+N.I." URI="http://www.legislation.gov.uk/id/effect/key-b08fdf86405b3ce2edbf1ff24d718f2e" Type="words substituted" AffectingNumber="170" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingProvisions="reg. 2(6)(c)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Row="477" AffectedYear="2001" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(6)(c) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(d)(iii)" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-8-4" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/8/4">Art. 8(4)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-6-c" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/6/c">reg. 2(6)(c)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Type="words inserted" AffectingClass="UnitedKingdomStatutoryInstrument" URI="http://www.legislation.gov.uk/id/effect/key-c7762bcda29708fffb6a7c0929aecfaf" AffectedClass="EuropeanUnionRegulation" AffectedProvisions="Art. 15(1)" AffectingYear="2019" AffectedNumber="999" Row="507" Modified="2022-07-29T11:32:18Z" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(11)(a) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(f)" RequiresApplied="false" AffectingNumber="170" Comments="IP completion day" AffectingEffectsExtent="E+W+S+N.I." EffectId="key-c7762bcda29708fffb6a7c0929aecfaf" AffectingProvisions="reg. 2(11)(a)" AffectedYear="2001" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-15-1" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/15/1">Art. 15(1)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-11-a" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/11/a">reg. 2(11)(a)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingClass="UnitedKingdomStatutoryInstrument" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(12)(a)(b) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(g)" EffectId="key-bd6b6c8bec55881fd1f87cc31e90c29e" Comments="IP completion day" AffectingEffectsExtent="E+W+S+N.I." AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" RequiresApplied="false" AffectingYear="2019" AffectedNumber="999" Row="514" AffectedProvisions="Art. 16(1)" AffectingProvisions="reg. 2(12)(a)" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" URI="http://www.legislation.gov.uk/id/effect/key-bd6b6c8bec55881fd1f87cc31e90c29e" Modified="2022-07-29T11:32:18Z" AffectedYear="2001" AffectingNumber="170" Type="words inserted" AffectedClass="EuropeanUnionRegulation">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-16-1" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/16/1">Art. 16(1)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-12-a" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/12/a">reg. 2(12)(a)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedProvisions="Art. 16(2)" AffectedClass="EuropeanUnionRegulation" URI="http://www.legislation.gov.uk/id/effect/key-655f13b6db7a7eedbdde5e6e099b983d" AffectedNumber="999" Modified="2022-07-29T11:32:18Z" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Row="516" AffectingProvisions="reg. 2(12)(b)" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Comments="IP completion day" RequiresApplied="false" AffectedYear="2001" AffectingClass="UnitedKingdomStatutoryInstrument" Type="words substituted" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(12)(a)(b) omitted immediately before IP completion day by virtue of S.I. 2020/1388, regs. 1(2)(a), 20(2)(g)" AffectingNumber="170" AffectingYear="2019" EffectId="key-655f13b6db7a7eedbdde5e6e099b983d" AffectingEffectsExtent="E+W+S+N.I.">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-16-2" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/16/2">Art. 16(2)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-12-b" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/12/b">reg. 2(12)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" Type="substituted" AffectedYear="2001" AffectingEffectsExtent="E+W+S+N.I." AffectingProvisions="reg. 2(15)" AffectedClass="EuropeanUnionRegulation" AffectingNumber="170" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingYear="2019" Modified="2022-07-29T11:32:18Z" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Row="526" AffectedNumber="999" AffectingClass="UnitedKingdomStatutoryInstrument" RequiresApplied="false" Notes="This amendment not applied to legislation.gov.uk. Reg. 2(15) substituted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(h)" Comments="IP completion day" EffectId="key-ab45a18d621e965f7dfe09c2e49cd826" URI="http://www.legislation.gov.uk/id/effect/key-ab45a18d621e965f7dfe09c2e49cd826" AffectedProvisions="Art. 19">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-19" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/19">Art. 19</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-15" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/15">reg. 2(15)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect EffectId="key-0f8daa179cded87dd93249a01dbdf969" AffectedNumber="999" AffectingProvisions="reg. 2(16)" AffectedClass="EuropeanUnionRegulation" AffectingEffectsExtent="E+W+S+N.I." AffectingNumber="170" RequiresApplied="false" AffectedProvisions="Art. 21" URI="http://www.legislation.gov.uk/id/effect/key-0f8daa179cded87dd93249a01dbdf969" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" Type="omitted" AffectingYear="2019" Row="532" Notes="Art. 21 already deleted at 14.12.2019 PIT by Regulation (EU) 2017/625, Art. 153." AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectingClass="UnitedKingdomStatutoryInstrument" Comments="IP completion day - Art. 21 already deleted at 14.12.2019 PIT by Regulation (EU) 2017/625, Art. 153." AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/170" AffectedYear="2001" Modified="2022-07-29T11:32:18Z">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-21" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/21">Art. 21</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-2-16" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/2/16">reg. 2(16)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/170/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingEffectsExtent="E+W+S+N.I." Notes="This amendment not applied to legislation.gov.uk. S.I. 2019/588, reg. 4(16)(b) amended immediately before IP completion day by S.I. 2020/1463, regs. 1(2)(a), 6(3)(d)" AffectingNumber="588" AffectedYear="2001" AffectingYear="2019" Type="omitted" Comments="IP completion day" AffectedClass="EuropeanUnionRegulation" AffectedProvisions="Art. 23a(f)" AffectingProvisions="reg. 4(16)(b)" URI="http://www.legislation.gov.uk/id/effect/key-c7d2e41171d2367e64ccab3bd05f8a3d" AffectingClass="UnitedKingdomStatutoryInstrument" RequiresApplied="false" EffectId="key-c7d2e41171d2367e64ccab3bd05f8a3d" Modified="2022-07-29T11:32:18Z" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/588" AffectedNumber="999" AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" Row="539">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-23a-f" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/23a/f" FoundRef="article-23a">Art. 23a(f)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Animals (Legislative Functions) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4-16-b" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/4/16/b">reg. 4(16)(b)</ukm:Section>
</ukm:AffectingProvisions>
<ukm:Savings>
<ukm:Section Ref="regulation-12" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/12">reg. 12</ukm:Section>
</ukm:Savings>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/588/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Comments="IP completion day - art. 3(1B)(c) omitted prior to art. 3(1B) being inserted" AffectedYear="2001" URI="http://www.legislation.gov.uk/id/effect/key-cac987a5cc8477fc669311b97c29e76d" AffectingYear="2020" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingTerritorialApplication="E+W+S" Type="omitted in earlier amending S.I. 2019/170, reg. 2(2)(b)" RequiresApplied="false" AffectedClass="EuropeanUnionRegulation" AffectingProvisions="reg. 20(2)(a)(ii)(bb)" Row="960" AffectedProvisions="Art. 3(1B)(c)" Modified="2023-02-28T19:30:52Z" AffectedNumber="999" Notes="This amendment not applied to legislation.gov.uk. Operative words in reg. 2(2)(b) omitted immediately before IP completion day by S.I. 2020/1388, regs. 1(2)(a), 20(2)(a)(ii)(bb)" AffectingNumber="1388" AffectingURI="http://www.legislation.gov.uk/id/uksi/2020/1388" AffectingEffectsExtent="E+W+S+N.I." AffectedURI="http://www.legislation.gov.uk/id/eur/2001/999" EffectId="key-cac987a5cc8477fc669311b97c29e76d">
<ukm:AffectedTitle>Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-3-1B-c" URI="http://www.legislation.gov.uk/id/eur/2001/999/article/3/1B/c" FoundRef="article-3">Art. 3(1B)(c)</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-20-2-a-ii-bb" URI="http://www.legislation.gov.uk/id/uksi/2020/1388/regulation/20/2/a/ii/bb" FoundRef="regulation-20">reg. 20(2)(a)(ii)(bb)</ukm:Section>
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<hcontainer name="schedule" eId="annex-I" period="#period24">
<num>
<ins class="substitution O008002M002 first">
<noteRef href="#c000004" marker="F1" class="commentary attribute F"/>
ANNEX I
</ins>
</num>
<heading>
<ins class="substitution O008002M002">SPECIFIC DEFINITIONS</ins>
</heading>
<level eId="annex-I-division-1" period="#period6">
<num>
<ins class="substitution O008002M002">1.</ins>
</num>
<content>
<p>
<ins class="substitution O008002M002">For the purpose of this Regulation, the following definitions set out in Regulation (EC) No 1774/2002 of the European Parliament and of the Council</ins>
<noteRef href="#f00015" class="footnote" marker="15"/>
<ins class="substitution O008002M002">, Regulation (EC) No 178/2002 of the European Parliament and of the Council</ins>
<noteRef href="#f00016" class="footnote" marker="16"/>
<ins class="substitution O008002M002"> and Council Directive 79/373/EEC</ins>
<noteRef href="#f00017" class="footnote" marker="17"/>
<ins class="substitution O008002M002"> shall apply:</ins>
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<num>(a)</num>
<p>
<ins class="substitution O008002M002">Regulation (EC) No 1774/2002:</ins>
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<num>(i)</num>
<p>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002">farmed animal</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in Article 2(1)(f);</ins>
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<item>
<num>(ii)</num>
<p>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002">petfood</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in point 41 of Annex I;</ins>
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<item>
<num>(iii)</num>
<p>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002">processed animal protein</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in point 42 of Annex I;</ins>
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<item>
<num>(iv)</num>
<p>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002">gelatine</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in point 26 of Annex I;</ins>
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<item>
<num>(v)</num>
<p>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002">blood products</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in point 4 of Annex I;</ins>
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<item>
<num>(vi)</num>
<p>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002">bloodmeal</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in point 6 of Annex I; and</ins>
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</item>
<item>
<num>(vii)</num>
<p>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002">fishmeal</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in point 24 of Annex I.</ins>
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<num>(b)</num>
<p>
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<ins class="substitution O008002M002">feedingstuff</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in Article 3(4) of Regulation (EC) No 178/2002;</ins>
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<num>(c)</num>
<p>
<ins class="substitution O008002M002">the definition of </ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002">complete feedingstuff</ins>
<ins class="substitution O008002M002"></ins>
<ins class="substitution O008002M002"> in Article 2(d) of Directive 79/373/EEC.</ins>
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<level eId="annex-I-division-2" period="#period25">
<num>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012 first">
<noteRef href="#c000005" marker="F2" class="commentary attribute F"/>
2.
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">For the purpose of this Regulation, the following definitions shall also apply:</ins>
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<ins class="substitution O024001M012"></ins>
</ins>
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<ins class="substitution O024001M012">indigenous case of BSE</ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"> means a case of bovine spongiform encephalopathy which has not been clearly demonstrated to be due to infection prior to importation as a live animal;</ins>
</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">discrete adipose tissue</ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"> means internal and external body fat removed during the slaughter and cutting process, in particular fresh fat from the heart, caul and kidney of bovine animals, and fat from cutting rooms;</ins>
</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">cohort</ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"> means a group of bovine animals which includes both:</ins>
</ins>
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<blockList class="ordered">
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<num>(i)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">animals born in the same herd as the affected bovine animal, and within 12 months preceding or following the date of birth of the affected bovine animal; and</ins>
</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">animals which at any time during the first year of their lives were reared together with the affected bovine animal during the first year of its life;</ins>
</ins>
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<item>
<num>(d)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
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<ins class="substitution O024001M012">index case</ins>
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<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"> means the first animal on a holding, or in an epidemiologically defined group, in which a TSE infection is confirmed;</ins>
</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">TSE in Small Ruminants</ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"> means a transmissible spongiform encephalopathy case detected in an ovine or caprine animal following a confirmatory test for abnormal PrP protein;</ins>
</ins>
</p>
</item>
<item>
<num>(f)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">scrapie case</ins>
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<ins class="substitution O008002M002">
<ins class="substitution O024001M012"> means a transmissible spongiform encephalopathy confirmed case in an ovine or caprine animal where a diagnosis of BSE has been excluded in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants</ins>
</ins>
<noteRef href="#f00018" class="footnote" marker="18"/>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">;</ins>
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<num>(g)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">classical scrapie case</ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"> means a scrapie confirmed case classified as classical in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants;</ins>
</ins>
</p>
</item>
<item>
<num>(h)</num>
<p>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012">atypical scrapie case</ins>
</ins>
<ins class="substitution O008002M002">
<ins class="substitution O024001M012"></ins>
</ins>
<ins class="substitution O008002M002 last">
<ins class="substitution O024001M012 last"> means a scrapie confirmed case which is distinguishable from classical Scrapie in accordance with the criteria laid down in the Community reference laboratory's technical handbook on TSE strain characterisation in small ruminants.</ins>
</ins>
</p>
</item>
</blockList>
</content>
</level>
</hcontainer>
<hcontainer name="schedule" eId="annex-II" period="#period26">
<num>
<ins class="substitution O024001M001 first">
<noteRef href="#c000006" marker="F3" class="commentary attribute F"/>
ANNEX II
</ins>
</num>
<heading>
<ins class="substitution O024001M001">DETERMINATION OF BSE STATUS</ins>
</heading>
<level eId="annex-II-chapter-A" period="#period28" class="EUChapter">
<num>
<ins class="substitution O024001M001">CHAPTER A</ins>
</num>
<heading>
<ins class="substitution O024001M001">Criteria</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">The BSE status of Member States or third countries or regions thereof (hereinafter referred to as countries or regions), shall be determined on the basis of the criteria set out in points (a) to (e).</ins>
</p>
<p>
<ins class="substitution O024001M001">In the country or region:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M001">a risk analysis in accordance with the provisions of Chapter B, identifying all the potential factors for BSE occurrence and their historic perspective in the country or region, is carried out;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M001">a system of continuous surveillance and monitoring of BSE relating in particular to the risks described in Chapter B and complying with the minimal surveillance requirements laid down in Chapter D is in place;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M001">an on-going awareness programme for veterinarians, farmers, and workers involved in transportation, marketing and slaughter of bovine animals, to encourage reporting of all cases showing clinical signs consistent with BSE in target sub-populations as defined in Chapter D of this Annex is in place;</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M001">an obligation to notify and investigate all bovine animals showing clinical signs consistent with BSE is in force;</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O024001M001">the examination of brain or other tissues collected within the framework of the surveillance and monitoring system referred to in point (b) is carried out in an approved laboratory.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-II-chapter-B" period="#period26" class="EUChapter">
<num>
<ins class="substitution O024001M001">CHAPTER B</ins>
</num>
<heading>
<ins class="substitution O024001M001">Risk analysis</ins>
</heading>
<level eId="annex-II-chapter-B-division-1" period="#period26">
<num>
<ins class="substitution O024001M001">1.</ins>
</num>
<heading>
<ins class="substitution O024001M001">Structure of the risk analysis</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">The risk analyses shall comprise a release assessment and an exposure assessment.</ins>
</p>
</content>
</level>
<level eId="annex-II-chapter-B-division-2" period="#period26">
<num>
<ins class="substitution O024001M001">2.</ins>
</num>
<heading>
<ins class="substitution O024001M001">Release assessment (external challenge)</ins>
</heading>
<level eId="annex-II-chapter-B-division-2-division-2.1" period="#period26">
<num>
<ins class="substitution O024001M001">2.1.</ins>
</num>
<heading>
<ins class="substitution O024001M001">The release assessment shall consist of assessing the likelihood that the BSE agent has either been introduced into the country or region via commodities potentially contaminated with a BSE agent, or is already present in the country or region.</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">The following risk factors shall be taken into account:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M001">the presence or absence of the BSE agent in the country or region and, if the agent is present, its prevalence based on the outcome of surveillance activities;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M001">the production of meat-and-bone meal or greaves from the BSE indigenous ruminant population;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M001">imported meat-and-bone meal or greaves;</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M001">imported bovine and ovine and caprine animals;</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O024001M001">imported animal feed and feed ingredients;</ins>
</p>
</item>
<item>
<num>(f)</num>
<p>
<ins class="substitution O024001M001">imported products of ruminant origin for human consumption, which may have contained tissues listed in point 1 of Annex V and may have been fed to bovine animals;</ins>
</p>
</item>
<item>
<num>(g)</num>
<p>
<ins class="substitution O024001M001">imported products of ruminant origin for </ins>
<em>
<ins class="substitution O024001M001">in vivo</ins>
</em>
<ins class="substitution O024001M001"> use in bovine animals.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-II-chapter-B-division-2-division-2.2" period="#period26">
<num>
<ins class="substitution O024001M001">2.2.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M001">Special eradication schemes, surveillance and other epidemiological investigations (especially surveillance for BSE conducted on the bovine animals population) relevant to the risk factors listed in point 2.1 should be taken into account in carrying out the release assessment.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-II-chapter-B-division-3" period="#period18">
<num>
<ins class="substitution O024001M001">3.</ins>
</num>
<heading>
<ins class="substitution O024001M001">Exposure assessment</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">The exposure assessment shall consist of assessing the likelihood of exposure of bovine animals to the BSE agent, through a consideration of the following:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M001">recycling and amplification of the BSE agent through consumption by bovine animals of meat-and-bone meal or greaves of ruminant origin, or other feed or feed ingredients contaminated with these;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M001">the use of ruminant carcasses (including from fallen stock), by-products and slaughterhouse waste, the parameters of the rendering processes and the methods of animal feed manufacture;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M001">the feeding or not of ruminants with meat-and-bone meal and greaves derived from ruminants, including measures to prevent cross-contamination of animal feed;</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M001">the level of surveillance for BSE conducted on the bovine animals population to that time and the results of that surveillance.</ins>
</p>
</item>
</blockList>
</content>
</level>
</level>
<level eId="annex-II-chapter-C" period="#period18" class="EUChapter">
<num>
<ins class="substitution O024001M001">CHAPTER C</ins>
</num>
<heading>
<ins class="substitution O024001M001">Definition of categories</ins>
</heading>
<level eId="annex-II-chapter-C-division-I" period="#period18">
<num>
<ins class="substitution O024001M001">I.</ins>
</num>
<heading>
<ins class="substitution O024001M001">COUNTRY OR REGION WITH A NEGLIGIBLE BSE RISK</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">A country or region:</ins>
</p>
<blockList class="ordered">
<item>
<num>(1)</num>
<p>
<ins class="substitution O024001M001">where a risk analysis in accordance with Chapter B has been conducted in order to identify the historical and existing risk factors;</ins>
</p>
</item>
<item>
<num>(2)</num>
<p>
<ins class="substitution O024001M001">which has demonstrated that appropriate specific measures have been taken for the relevant period of time defined below to manage each identified risk;</ins>
</p>
</item>
<item>
<num>(3)</num>
<p>
<ins class="substitution O024001M001">which has demonstrated that Type B surveillance, in accordance with Chapter D, is in place, and the relevant points target, in accordance with Table 2 thereof, has been met; and</ins>
</p>
</item>
<item>
<num>(4)</num>
<p>
<ins class="substitution O024001M001">which is:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M001">either in the following situation:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M001">in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to have been imported and has been completely destroyed;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M001">the criteria in points (c), (d) and (e) of Chapter A of this Annex have been complied with for at least seven years; and</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M001">it has been demonstrated through an appropriate level of control and audit that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M001">or in the following situation:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M001">there has been one or more BSE indigenous cases in the country or region but every BSE indigenous case was born more than 11 years ago;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M001">the criteria in points (c), (d) and (e) of Chapter A have been complied with for at least seven years;</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M001">it has been demonstrated through an appropriate level of control and audit that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;</ins>
</p>
</item>
<item>
<num>(iv)</num>
<p>
<ins class="substitution O024001M001">the following animals, if alive in the country or region, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M001">all BSE cases,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M001">all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M001">if the results of the investigation referred to in the second indent are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</item>
</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-II-chapter-C-division-II" period="#period18">
<num>
<ins class="substitution O024001M001">II.</ins>
</num>
<heading>
<ins class="substitution O024001M001">COUNTRY OR REGION WITH A CONTROLLED BSE RISK</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">A country or region</ins>
</p>
<blockList class="ordered">
<item>
<num>(1)</num>
<p>
<ins class="substitution O024001M001">where a risk analysis based on the information laid down in Chapter B has been conducted in order to identify the historical and existing risk factors;</ins>
</p>
</item>
<item>
<num>(2)</num>
<p>
<ins class="substitution O024001M001">which has demonstrated that appropriate measures are been taken to manage all identified risks, but those measures have not been taken for the relevant period of time;</ins>
</p>
</item>
<item>
<num>(3)</num>
<p>
<ins class="substitution O024001M001">which has demonstrated that Type A surveillance, in accordance with Chapter D, is in place and the relevant points target, in accordance with Table 2, has been met. Type B surveillance may replace Type A surveillance once the relevant points target is met; and</ins>
</p>
</item>
<item>
<num>(4)</num>
<p>
<ins class="substitution O024001M001">which is:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M001">either in the following situation:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M001">in the country or region there has been no case of BSE, or, any case of BSE has been demonstrated to have been imported and has been completely destroyed, the criteria in points (c), (d) and (e) of Chapter A are complied with, and it can be demonstrated through an appropriate level of control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M001">the criteria in points (c), (d) and (e) of Chapter A have been complied with for a period shorter than seven years; and/or</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M001">it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived from ruminants to ruminants have been in place for eight years;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M001">or in the following situation:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M001">in the country or region there has been a BSE indigenous case, the criteria in points (c), (d) and (e) of Chapter A are complied with, and it can be demonstrated through an appropriate level of control and audit that neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M001">the criteria in points (c) to (e) of Chapter A of this Annex have been complied with for a period shorter than seven years; and/or</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M001">it cannot be demonstrated that controls over the feeding of meat-and-bone meal or greaves derived from ruminants to ruminants have been in place for at least eight years;</ins>
</p>
</item>
<item>
<num>(iv)</num>
<p>
<ins class="substitution O024001M001">the following animals, if alive in the country or region, are permanently identified, and their movements controlled, and, when slaughtered or at death, are completely destroyed: and</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M001">all BSE cases, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M001">all bovine animals which, during their first year of life, were reared with the BSE cases during their first year of life, and which investigation showed consumed the same potentially contaminated feed during that period, or</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M001">if the results of the investigation referred to in the second indent are inconclusive, all bovine animals born in the same herd as, and within 12 months of the birth of, the BSE cases.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</item>
</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-II-chapter-C-division-III" period="#period18">
<num>
<ins class="substitution O024001M001">III.</ins>
</num>
<heading>
<ins class="substitution O024001M001">COUNTRY OR REGION WITH UNDETERMINED BSE RISK</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">A country or region for which the determination of BSE status has not been concluded, or which does not meet the conditions to be fulfilled by the country or region to be classified in one of the other categories.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-II-chapter-D" period="#period26" class="EUChapter">
<num>
<ins class="substitution O024001M001">CHAPTER D</ins>
</num>
<heading>
<ins class="substitution O024001M001">Minimal surveillance requirements</ins>
</heading>
<level eId="annex-II-chapter-D-division-1" period="#period18">
<num>
<ins class="substitution O024001M001">1.</ins>
</num>
<heading>
<ins class="substitution O024001M001">Surveillance types</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">For the purpose of this Annex, the following definitions shall apply:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<em>
<ins class="substitution O024001M001">Type A surveillance</ins>
</em>
</p>
<p>
<ins class="substitution O024001M001">The application of Type A surveillance will allow the detection of BSE at a design prevalence</ins>
<noteRef href="#f00019" class="footnote" marker="19"/>
<ins class="substitution O024001M001"> of at least one case per </ins>
<ins class="substitution O024001M001">100 000</ins>
<ins class="substitution O024001M001"> in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<em>
<ins class="substitution O024001M001">Type B surveillance</ins>
</em>
</p>
<p>
<ins class="substitution O024001M001">The application of Type B surveillance will allow the detection of BSE at a design prevalence of at least one case per </ins>
<ins class="substitution O024001M001">50 000</ins>
<ins class="substitution O024001M001"> in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %.</ins>
</p>
<p>
<ins class="substitution O024001M001">Type B surveillance may be carried out by countries or region of negligible BSE risk status to confirm the conclusions of the risk analysis, for example by demonstrating the effectiveness of the measures mitigating any risk factors identified, through surveillance targeted to maximise the likelihood of identifying failures of such measures.</ins>
</p>
<p>
<ins class="substitution O024001M001">Type B surveillance may also be carried out by countries or regions of controlled BSE risk status, following the achievement of the relevant points target using Type A surveillance, to maintain confidence in the knowledge gained through Type A surveillance.</ins>
</p>
<p>
<ins class="substitution O024001M001">For the purpose of this Annex, the following four sub-populations of bovine animals have been identified for surveillance purposes:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M001">bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects);</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M001">bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter);</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M001">bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock);</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M001">bovine animals over 36 months of age at routine slaughter.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-II-chapter-D-division-2" period="#period18">
<num>
<ins class="substitution O024001M001">2.</ins>
</num>
<heading>
<ins class="substitution O024001M001">Surveillance strategy</ins>
</heading>
<level eId="annex-II-chapter-D-division-2-division-2.1" period="#period18">
<num>
<ins class="substitution O024001M001">2.1.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M001">The surveillance strategy shall be designed to ensure that samples are representative of the herd of the country or region, and include consideration of demographic factors such as production type and geographic location, and the potential influence of culturally unique husbandry practices. The approach used and the assumptions made shall be fully documented, and the documentation retained for seven years.</ins>
</p>
</content>
</level>
<level eId="annex-II-chapter-D-division-2-division-2.2" period="#period18">
<num>
<ins class="substitution O024001M001">2.2.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M001">In order to implement the surveillance strategy for BSE, a country shall use documented records or reliable estimates of the age distribution of the adult bovine animals population and the number of bovine animals tested for BSE stratified by age and by sub-population within the country or region.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-II-chapter-D-division-3" period="#period26">
<num>
<ins class="substitution O024001M001">3.</ins>
</num>
<heading>
<ins class="substitution O024001M001">Points values and point targets</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">Surveillance samples must meet the point targets set out in Table 2, on the basis of </ins>
<ins class="substitution O024001M001"></ins>
<ins class="substitution O024001M001">point values</ins>
<ins class="substitution O024001M001"></ins>
<ins class="substitution O024001M001"> fixed in Table 1. All clinical suspects shall be investigated, regardless of the number of points accumulated. A country shall sample at least three out of the four sub-populations. The total points for samples collected shall be accumulated over a period of a maximum of seven consecutive years to achieve the target number of points. The total points accumulation shall be periodically compared to the target number of points for a country or region.</ins>
</p>
<tblock class="tabular">
<heading>
<ins class="substitution O024001M001">Table 1</ins>
</heading>
<subheading>
<ins class="substitution O024001M001">Surveillance point values for samples collected from animals in the given sub-population and age category</ins>
</subheading>
<table>
<tr>
<th colspan="4">
<p>
<ins class="substitution O024001M001">Surveillance sub-population</ins>
</p>
</th>
</tr>
<tr>
<th>
<p>
<ins class="substitution O024001M001">Routine slaughter</ins>
<noteRef href="#f00020" class="footnote" marker="20"/>
</p>
</th>
<th>
<p>
<ins class="substitution O024001M001">Fallen stock</ins>
<noteRef href="#f00021" class="footnote" marker="21"/>
</p>
</th>
<th>
<p>
<ins class="substitution O024001M001">Casualty slaughter</ins>
<noteRef href="#f00022" class="footnote" marker="22"/>
</p>
</th>
<th>
<p>
<ins class="substitution O024001M001">Clinical suspect</ins>
<noteRef href="#f00023" class="footnote" marker="23"/>
</p>
</th>
</tr>
<tr>
<td colspan="4">
<p>
<ins class="substitution O024001M001">Age ≥ 1 year and < 2 years</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">0,01</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,2</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,4</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">N/A</ins>
</p>
</td>
</tr>
<tr>
<td colspan="4">
<p>
<ins class="substitution O024001M001">Age ≥ 2 years and < 4 years (young adult)</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">0,1</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,2</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,4</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">260</ins>
</p>
</td>
</tr>
<tr>
<td colspan="4">
<p>
<ins class="substitution O024001M001">Age ≥ 4 years and < 7 years (middle adult)</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">0,2</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,9</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">1,6</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">750</ins>
</p>
</td>
</tr>
<tr>
<td colspan="4">
<p>
<ins class="substitution O024001M001">Age ≥ 7 years and < 9 years (older adult)</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">0,1</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,4</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,7</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">220</ins>
</p>
</td>
</tr>
<tr>
<td colspan="4">
<p>
<ins class="substitution O024001M001">Age ≥ 9 years (aged)</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">0,0</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,1</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">0,2</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">45</ins>
</p>
</td>
</tr>
<tr class="tfoot">
<td colspan="4">
<tblock class="footnote" eId="f00020">
<p>
<ins class="substitution O024001M001">Bovine animals over 36 months of age at routine slaughter.</ins>
</p>
</tblock>
</td>
</tr>
<tr class="tfoot">
<td colspan="4">
<tblock class="footnote" eId="f00021">
<p>
<ins class="substitution O024001M001">Bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock).</ins>
</p>
</tblock>
</td>
</tr>
<tr class="tfoot">
<td colspan="4">
<tblock class="footnote" eId="f00022">
<p>
<ins class="substitution O024001M001">Bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter).</ins>
</p>
</tblock>
</td>
</tr>
<tr class="tfoot">
<td colspan="4">
<tblock class="footnote" eId="f00023">
<p>
<ins class="substitution O024001M001">Bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects).</ins>
</p>
</tblock>
</td>
</tr>
</table>
</tblock>
<tblock class="tabular">
<heading>
<ins class="substitution O024001M001">Table 2</ins>
</heading>
<subheading>
<ins class="substitution O024001M001">Points targets for different adult bovine animals population sizes in a country or region</ins>
</subheading>
<table>
<tr>
<th colspan="3">
<p>
<ins class="substitution O024001M001">Points targets for countries or regions</ins>
</p>
</th>
</tr>
<tr>
<th>
<p>
<ins class="substitution O024001M001">Adult bovine animals population size</ins>
<ins class="substitution O024001M001">(24 months and older)</ins>
</p>
</th>
<th>
<p>
<ins class="substitution O024001M001">Type A surveillance</ins>
</p>
</th>
<th>
<p>
<ins class="substitution O024001M001">Type B surveillance</ins>
</p>
</th>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001"></ins>
<ins class="substitution O024001M001">1 000 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">300 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">150 000</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">800 000</ins>
<ins class="substitution O024001M001">-</ins>
<ins class="substitution O024001M001">1 000 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">240 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">120 000</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">600 000</ins>
<ins class="substitution O024001M001">-</ins>
<ins class="substitution O024001M001">800 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">180 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">90 000</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">400 000</ins>
<ins class="substitution O024001M001">-</ins>
<ins class="substitution O024001M001">600 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">120 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">60 000</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">200 000</ins>
<ins class="substitution O024001M001">-</ins>
<ins class="substitution O024001M001">400 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">60 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">30 000</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">100 000</ins>
<ins class="substitution O024001M001">-</ins>
<ins class="substitution O024001M001">200 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">30 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">15 000</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">50 000</ins>
<ins class="substitution O024001M001">-</ins>
<ins class="substitution O024001M001">100 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">15 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">7 500</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O024001M001">25 000</ins>
<ins class="substitution O024001M001">-</ins>
<ins class="substitution O024001M001">50 000</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">7 500</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O024001M001">3 750</ins>
</p>
</td>
</tr>
</table>
</tblock>
</content>
</level>
<level eId="annex-II-chapter-D-division-4" period="#period18">
<num>
<ins class="substitution O024001M001">4.</ins>
</num>
<heading>
<ins class="substitution O024001M001">Specific targeting</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">Within each of the sub-populations above in a country or region, a country may target bovine animals identifiable as imported from countries or regions where BSE has been detected and bovine animals which have consumed potentially contaminated feedstuffs from countries or regions where BSE has been detected.</ins>
</p>
</content>
</level>
<level eId="annex-II-chapter-D-division-5" period="#period18">
<num>
<ins class="substitution O024001M001">5.</ins>
</num>
<heading>
<ins class="substitution O024001M001">BSE surveillance model</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001">A country may choose to use the full BSurvE model or an alternative method based on the BSurvE model to estimate its BSE presence/prevalence.</ins>
</p>
</content>
</level>
<level eId="annex-II-chapter-D-division-6" period="#period18">
<num>
<ins class="substitution O024001M001">6.</ins>
</num>
<heading>
<ins class="substitution O024001M001">Maintenance surveillance</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M001 last">Once the points target has been achieved, and in order to continue to designate the status of a country or region as controlled BSE risk or negligible risk, surveillance can be reduced to Type B surveillance (provided all other indicators remain positive). However, to continue to comply with the requirements laid down in this Chapter, ongoing annual surveillance must continue to include at least three of the four prescribed sub-populations. In addition all bovine animals clinically suspected of being infected with BSE shall be investigated regardless of the number of points accumulated. The annual surveillance in a country or region following the achievement of the required points target, shall be no less than the amount required for one-seventh of its total Type B surveillancetarget.</ins>
</p>
</content>
</level>
</level>
</hcontainer>
<hcontainer name="schedule" eId="annex-III" period="#period19">
<num>
<ins class="substitution O011001M001 first">
<noteRef href="#c000007" marker="F4" class="commentary attribute F"/>
ANNEX III
</ins>
</num>
<heading>
<ins class="substitution O011001M001">MONITORING SYSTEM</ins>
</heading>
<chapter eId="annex-III-chapter-A" period="#period19">
<num>
<ins class="substitution O011001M001">CHAPTER A</ins>
</num>
<level eId="annex-III-chapter-A-division-I" period="#period19">
<num>
<ins class="substitution O011001M001">I.</ins>
</num>
<heading>
<ins class="substitution O011001M001">MONITORING IN BOVINE ANIMALS</ins>
</heading>
<level eId="annex-III-chapter-A-division-I-division-1" period="#period4">
<num>
<ins class="substitution O011001M001">1.</ins>
</num>
<heading>
<ins class="substitution O011001M001">General</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">Monitoring in bovine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3(1)(b).</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-2" period="#period16">
<num>
<ins class="substitution O011001M001">2.</ins>
</num>
<heading>
<ins class="substitution O011001M001">Monitoring in animals slaughtered for human consumption</ins>
</heading>
<level eId="annex-III-chapter-A-division-I-division-2-division-2.1" period="#period7">
<num>
<ins class="substitution O011001M001">2.1.</ins>
</num>
<heading>
<ins class="substitution O011001M001">All bovine animals over 24 months of age:</ins>
</heading>
<content>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O011001M001">subject to </ins>
<ins class="substitution O011001M001">special emergency slaughtering</ins>
<ins class="substitution O011001M001"> as defined in Article 2(n) of Council Directive 64/433/EEC</ins>
<noteRef href="#f00024" class="footnote" marker="24"/>
<ins class="substitution O011001M001">, or</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">slaughtered in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, except animals without clinical signs of disease slaughtered in the context of a disease eradication campaign,</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O011001M001">shall be tested for BSE.</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-2-division-2.2" period="#period7">
<num>
<ins class="substitution O011001M001">2.2.</ins>
</num>
<heading>
<ins class="substitution O011001M001">All bovine animals over 30 months of age:</ins>
</heading>
<content>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O011001M001">subject to normal slaughter for human consumption, or</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">slaughtered in the context of a disease eradication campaign in accordance with Annex I, Chapter VI, point 28(c), to Directive 64/433/EEC, but showing no clinical signs of disease,</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O011001M001">shall be tested for BSE.</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-2-division-2.3" period="#period15" class=" repealed">
<num>
<noteRef href="#c000008" marker="F5" class="commentary F"/>
2.3.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
</level>
<level eId="annex-III-chapter-A-division-I-division-3" period="#period12">
<num>
<ins class="substitution O011001M001">3.</ins>
</num>
<heading>
<ins class="substitution O011001M001">Monitoring in animals not slaughtered for human consumption</ins>
</heading>
<level eId="annex-III-chapter-A-division-I-division-3-division-3.1" period="#period4">
<num>
<ins class="substitution O011001M001">3.1.</ins>
</num>
<heading>
<ins class="substitution O011001M001">All bovine animals over 24 months of age which have died or been killed but which were not:</ins>
</heading>
<content>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O011001M001">killed for destruction pursuant to Commission Regulation (EC) No 716/96</ins>
<noteRef href="#f00025" class="footnote" marker="25"/>
<ins class="substitution O011001M001">,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">killed in the framework of an epidemic, such as foot-and-mouth disease,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">slaughtered for human consumption,</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O011001M001">shall be tested for BSE.</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-3-division-3.2" period="#period12">
<num>
<ins class="substitution O011001M001">3.2.</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">Member States may decide to derogate from the provisions of point 3.1 in remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and submit a list of the derogated areas. The derogation shall not cover more than 10 % of the bovine population in the Member State.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-III-chapter-A-division-I-division-4" period="#period15">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O021001M002 first">
<noteRef href="#c000009" marker="F6" class="commentary attribute F"/>
4.
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O021001M002">Monitoring in animals purchased for destruction pursuant to Regulation (EC) No 716/96</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O021001M002">All animals born between </ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O021001M002">1 August 1995</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O021001M002"> and </ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O021001M002">1 August 1996</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O021001M002 last"> killed for destruction pursuant Regulation (EC) No 716/96 shall be tested for BSE.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-5" period="#period12">
<num>
<ins class="substitution O011001M001">5.</ins>
</num>
<heading>
<ins class="substitution O011001M001">Monitoring in other animals</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">In addition to the testing referred to in points 2 to 4, Member States may on a voluntary basis decide to test other bovine animals on their territory, in particular where those animals originate from countries with indigenous BSE, have consumed potentially contaminated feedingstuffs or were born or derived from BSE infected dams.</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-6" period="#period22">
<num>
<ins class="substitution O011001M001">6.</ins>
</num>
<heading>
<ins class="substitution O011001M001">Measures following testing</ins>
</heading>
<level eId="annex-III-chapter-A-division-I-division-6-division-6.1" period="#period10">
<num>
<ins class="substitution O011001M001">6.1.</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">Where an animal slaughtered for human consumption has been selected for testing for BSE, the health marking provided for in Chapter XI of Annex I to Directive 64/433/EEC shall not be carried out on the carcase of that animal until a negative result to the rapid test has been obtained.</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-6-division-6.2" period="#period10">
<num>
<ins class="substitution O011001M001">6.2.</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">Member States may derogate from the provisions of point 6.1 where an official system is in place in the slaughterhouse ensuring that no parts of examined animals bearing the health mark leave the slaughterhouse until a negative result to the rapid test has been obtained.</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-6-division-6.3" period="#period5">
<num>
<ins class="substitution O011001M001">6.3.</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">All parts of the body of an animal tested for BSE including the hide shall be retained under official control until a negative result to the rapid test has been obtained, unless they are disposed of in accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council</ins>
<noteRef href="#f00026" class="footnote" marker="26"/>
<ins class="substitution O011001M001">.</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-6-division-6.4" period="#period22">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O024001M013 first">
<noteRef href="#c000005" marker="F2" class="commentary attribute F"/>
6.4.
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O024001M013">All parts of the body of an animal found positive or inconclusive to the rapid test including the hide shall be disposed of in accordance with Article 4(2)(a) and (b) of Regulation (EC) No 1774/2002, apart from material to be retained in conjunction with the records provided for in Chapter B(III).</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-6-division-6.5" period="#period28">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O024001M013">6.5.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O024001M013 last">Where an animal slaughtered for human consumption is found positive or inconclusive to the rapid test, at least the carcase immediately preceding and the two carcases immediately following the tested positive or inconclusive animal on the same slaughter line shall be destroyed in accordance with point 6.4. By way of derogation, Member States may decide to destroy the aforementioned carcases only if the result of the rapid test is confirmed to be positive or inconclusive by confirmatory examinations referred to in Annex X, Chapter C, point 3.1(b).</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-I-division-6-division-6.6" period="#period10">
<num>
<ins class="substitution O011001M001">6.6.</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">Member States may derogate from the provisions of point 6.5 where a system is in place in the slaughterhouse preventing contamination between carcase.</ins>
</p>
</content>
</level>
</level>
</level>
<level eId="annex-III-chapter-A-division-II" period="#period25">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001 first">
<noteRef href="#c000010" marker="F7" class="commentary attribute F"/>
<ins class="substitution O024001M014 first">
<noteRef href="#c000005" marker="F2" class="commentary attribute F"/>
II.
</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">MONITORING IN OVINE AND CAPRINE ANIMALS</ins>
</ins>
</ins>
</heading>
<level eId="annex-III-chapter-A-division-II-division-1" period="#period18">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">1.</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">General</ins>
</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b).</ins>
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-2" period="#period25">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">2.</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Monitoring in ovine and caprine animals slaughtered for human consumption</ins>
</ins>
</ins>
</heading>
<level eId="annex-III-chapter-A-division-II-division-2-division-a" period="#period25">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">(a)</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Member States in which the population of ewes and ewe lambs put to the ram exceeds </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">750 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014"> animals shall test in accordance with the sampling rules set out in point 4 a minimum annual sample of </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">10 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014"> ovine animals slaughtered for human consumption;</ins>
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-2-division-b" period="#period25">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">(b)</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Member States in which the population of goats which have already kidded and goats mated exceeds </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">750 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014"> animals shall test in accordance with the sampling rules set out in point 4 a minimum annual sample of </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">10 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014"> caprine animals slaughtered for human consumption;</ins>
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-2-division-c" period="#period25">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">(c)</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Where a Member State experiences difficulty in collecting sufficient numbers of healthy slaughtered ovine or caprine animals to reach its allotted minimum sample size established in points (a) and (b), it may choose to replace a maximum of 50 % of its minimum sample size by testing dead ovine or caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3. In addition a Member State may choose to replace a maximum of 10 % of its minimum sample size by testing ovine or caprine animals killed in the framework of a disease eradication campaign over the age of 18 months at the ratio of one to one.</ins>
</ins>
</ins>
</p>
</content>
</level>
</level>
<level eId="annex-III-chapter-A-division-II-division-3" period="#period31">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">3.</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Monitoring in ovine and caprine animals not slaughtered for human consumption</ins>
</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Member States shall test, in accordance with the sampling rules set out in point 4 and the minimum sample sizes indicated in Table A and Table B, ovine and caprine animals which have died or been killed, but which were not:</ins>
</ins>
</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">killed in the framework of a disease eradication campaign, or</ins>
</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">slaughtered for human consumption.</ins>
</ins>
</ins>
</p>
</item>
</blockList>
<tblock class="tabular">
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Table A</ins>
</ins>
</ins>
</heading>
<table>
<tr>
<th>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Member State population of ewes and ewe lambs put to the ram</ins>
</ins>
</ins>
</p>
</th>
<th>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Minimum sample size of dead ovine animals</ins>
</ins>
</ins>
<noteRef href="#f00027" class="footnote" marker="27"/>
</p>
</th>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">> </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">750 000</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">10 000</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">100 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">-</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">750 000</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">1 500</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">40 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">-</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">100 000</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">100 % up to 500</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">< </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">40 000</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">100 % up to 100</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr class="tfoot">
<td colspan="2">
<tblock class="footnote" eId="f00027">
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Minimum sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets.</ins>
</ins>
</ins>
</p>
</tblock>
</td>
</tr>
</table>
</tblock>
<tblock class="tabular">
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Table B</ins>
</ins>
</ins>
</heading>
<table>
<tr>
<th>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Member State population of goats which have already kidded and goats mated</ins>
</ins>
</ins>
</p>
</th>
<th>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Minimum sample size of dead caprine animals</ins>
</ins>
</ins>
<noteRef href="#f00028" class="footnote" marker="28"/>
</p>
</th>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">> </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">750 000</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">10 000</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">250 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">-</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">750 000</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">1 500</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">40 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">-</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">250 000</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">100 % up to 500</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">< </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">40 000</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">100 % up to 100</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr class="tfoot">
<td colspan="2">
<tblock class="footnote" eId="f00028">
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Minimum sample sizes are set to take account of the size of the caprine population in the individual Member States and are intended to provide achievable targets.</ins>
</ins>
</ins>
</p>
</tblock>
</td>
</tr>
</table>
</tblock>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-4" period="#period31">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">4.</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Sampling rules applicable to the animals referred to in points 2 and 3</ins>
</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">The animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum.</ins>
</ins>
</ins>
</p>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">The age of the animals shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.</ins>
</ins>
</ins>
</p>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">The sample selection shall be designed with a view to avoid the over-representation of any group as regards the origin, age, breed, production type or any other characteristic.</ins>
</ins>
</ins>
</p>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">The sampling shall be representative for each region and season. Multiple sampling in the same flock shall be avoided, wherever possible. Member States shall aim their monitoring programmes to achieve, wherever possible, that in successive sampling years all officially registered holdings with more than 100 animals and where TSE cases have never been detected are subject to TSE testing.</ins>
</ins>
</ins>
</p>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">The Member States shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from sampling.</ins>
</ins>
</ins>
</p>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">However, Member States may decide to exclude from the sampling remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and shall submit a list of those remote areas where the derogation applies. The derogation shall not cover more than 10 % of the ovine and caprine population in the Member State concerned.</ins>
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-5" period="#period25">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">5.</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Monitoring in infected flocks</ins>
</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Animals over 18 months of age or have more than two permanent incisors erupted through the gum, and which are killed for destruction in accordance with Annex VII, point 2.3(b)(i) or (ii) or point 5(a), shall be tested based on the selection of a simple random sample, in accordance with the sample size indicated in the following table.</ins>
</ins>
</ins>
</p>
<tblock class="tabular">
<table>
<tr>
<th>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Number of animals over 18 months of age or which have more than two permanent incisors erupted through the gum, killed for destruction in the herd or flock</ins>
</ins>
</ins>
</p>
</th>
<th>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Minimum sample size</ins>
</ins>
</ins>
</p>
</th>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">70 or less</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">All eligible animals</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">80</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">68</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">90</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">73</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">100</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">78</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">120</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">86</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">140</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">92</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">160</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">97</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">180</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">101</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">200</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">105</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">250</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">112</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">300</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">117</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">350</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">121</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">400</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">124</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">450</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">127</ins>
</ins>
</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">500 or more</ins>
</ins>
</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">150</ins>
</ins>
</ins>
</p>
</td>
</tr>
</table>
</tblock>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-6" period="#period31">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">6.</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Monitoring in other animals</ins>
</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">In addition to the monitoring programmes set out in points 2, 3 and 4, Member States may on a voluntary basis carry out monitoring in other animals, in particular:</ins>
</ins>
</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">animals used for dairy production,</ins>
</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">animals originating from countries with indigenous TSEs,</ins>
</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">animals which have consumed potentially contaminated feedingstuffs,</ins>
</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">animals born or derived from TSE infected dams.</ins>
</ins>
</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-7" period="#period28">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">7.</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Measures following testing of ovine and caprine animals</ins>
</ins>
</ins>
</heading>
<level eId="annex-III-chapter-A-division-II-division-7-division-7.1" period="#period18">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">7.1.</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Where an ovine or caprine animal slaughtered for human consumption has been selected for TSE testing in accordance with point 2, its carcase shall not be marked with the health marking provided for in Section I, Chapter III of Annex I to Regulation (EC) No 854/2004 until a negative result to the rapid test has been obtained.</ins>
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-7-division-7.2" period="#period31">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">7.2.</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Member States may derogate from point 7.1. where a system approved by the competent authority is in place in the slaughterhouse ensuring that all parts of an animal can be traced and that no parts of the animals tested bearing the health mark can leave the slaughterhouse until a negative result to the rapid test has been obtained.</ins>
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-7-division-7.3" period="#period28">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">7.3.</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">All parts of the body of a tested animal, including the hide, shall be retained under official control until a negative result has been obtained to the rapid test, except for animal by-products directly disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002.</ins>
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-7-division-7.4" period="#period28">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">7.4.</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Except for the material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, all parts of the body of an animal found positive to the rapid test, including the hide, shall be directly disposed of in accordance with Article 4(2)(a), (b) or (e) of Regulation (EC) No 1774/2002.</ins>
</ins>
</ins>
</p>
</content>
</level>
</level>
<level eId="annex-III-chapter-A-division-II-division-8" period="#period30">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">8.</ins>
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">Genotyping</ins>
</ins>
</ins>
</heading>
<level eId="annex-III-chapter-A-division-II-division-8-division-8.1" period="#period18">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">8.1.</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">The prion protein genotype for the codons 136, 154 and 171 shall be determined for each positive TSE case in sheep. TSE cases found in sheep of genotypes which encode alanine on both alleles at codon 136, arginine on both alleles at codon 154 and arginine on both alleles at codon 171 shall immediately be reported to the Commission. Where the positive TSE case is an atypical scrapie case the prion protein genotype for the codon 141 shall be determined.</ins>
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-A-division-II-division-8-division-8.2" period="#period18">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">8.2.</ins>
</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">In addition to the animals genotyped in accordance with point 8.1, the prion protein genotype for the codons 136, 141, 154 and 171 of a minimum sample of ovine animals shall be determined. In the case of Member States with an adult sheep population of more than </ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014">750 000</ins>
</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">
<ins class="substitution O024001M014 last"> animals, this minimum sample shall consist of at least 600 animals. In the case of other Member States the minimum sample shall consist of at least 100 animals. The samples may be chosen from animals slaughtered for human consumption, from animals dead-on-farm or from live animals. The sampling should be representative of the entire ovine population.</ins>
</ins>
</ins>
</p>
</content>
</level>
</level>
</level>
<level eId="annex-III-chapter-A-division-III" period="#period11">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">III.</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001">MONITORING IN OTHER ANIMAL SPECIES</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M001 last">Member States may on a voluntary basis carry out monitoring for TSEs in animal species other than bovine, ovine and caprine animals.</ins>
</ins>
</p>
</content>
</level>
</chapter>
<chapter eId="annex-III-chapter-B" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003 first">
<noteRef href="#c000010" marker="F7" class="commentary attribute F"/>
CHAPTER B
</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">REPORTING AND RECORDING REQUIREMENTS</ins>
</ins>
</heading>
<level eId="annex-III-chapter-B-division-I" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">I.</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">REQUIREMENTS ON MEMBER STATES</ins>
</ins>
</heading>
<level eId="annex-III-chapter-B-division-I-division-A" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">A.</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">Information to be presented by Member States in their annual report as provided for in Article 6(4)</ins>
</ins>
</heading>
<level eId="annex-III-chapter-B-division-I-division-A-division-1" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">1.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">The number of suspected cases placed under official movement restrictions in accordance with Article 12(1), per animal species.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-B-division-I-division-A-division-2" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">2.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">The number of suspected cases subject to laboratory examination in accordance with Article 12(2), per animal species, including the results of the rapid and confirmatory tests (number of positives and negatives) and, with regard to bovine animals, an estimation of the age distribution of all tested animals. The age distribution should be grouped whenever possible as follows: </ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003"></ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">below 24 months</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003"></ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">, distribution per 12 months between 24 and 155 months, and </ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003"></ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">above 155 months</ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003"></ins>
</ins>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003"> of age.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-B-division-I-division-A-division-3" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">3.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated pursuant to Article 12(1) and (2).</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-B-division-I-division-A-division-4" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">4.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">The number of bovine animals tested within each subpopulation referred to in Chapter A, Part (I), points 2.1., 2.2., 2.3., 3.1., 4.1., 4.2., 4.3. and 5. The method for the sample selection, the results of the rapid and confirmatory tests and an estimation of the age distribution of the tested animals grouped as set out in point 2 shall be provided.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-B-division-I-division-A-division-5" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">5.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter A, Part II, points 2, 3 and 5 together with the method for sample selection and the results of the rapid and confirmatory tests.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-B-division-I-division-A-division-6" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">6.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">The geographical distribution, including the country of origin if not the same as the reporting country, of positive cases of BSE and scrapie. The year, and where possible the month of birth shall be given for each TSE case in bovine, ovine and caprine animals. TSE cases which have been considered atypical and the reasons why shall be indicated. For scrapie cases, the results of the primary molecular testing with a discriminatory immuno-blotting, referred to in Annex X, Chapter C, point 3.2.(c)(i), shall be reported.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-B-division-I-division-A-division-7" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">7.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">In animals other than bovine, ovine and caprine, the number of samples and confirmed TSE cases per species.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-B-division-I-division-A-division-8" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">8.</ins>
</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">The genotype, and where possible the breed, of each ovine animal either found positive to TSE or sampled in accordance with Chapter A, Part II, points 8.1. and 8.2.</ins>
</ins>
</p>
</content>
</level>
</level>
<level eId="annex-III-chapter-B-division-I-division-B" period="#period9">
<num>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">B.</ins>
</ins>
</num>
<heading>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003">Reporting periods</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">
<ins class="substitution O015001M003 last">The compilation of reports containing the information referred to in A and forwarded to the Commission on a monthly basis or, with regard to the information referred to in point 8 on a quarterly basis, may constitute the annual report as required by Article 6(4), provided that the information is updated whenever additional information becomes available.</ins>
</ins>
</p>
</content>
</level>
</level>
<level eId="annex-III-chapter-B-division-II" period="#period9">
<num>
<ins class="substitution O011001M001">II.</ins>
</num>
<heading>
<ins class="substitution O011001M001">INFORMATION TO BE PRESENTED BY THE COMMISSION IN ITS SUMMARY</ins>
</heading>
<content>
<p>
<ins class="substitution O011001M001">The summary shall be presented in a tabled format covering at least the information referred to in part I for each Member State.</ins>
</p>
</content>
</level>
<level eId="annex-III-chapter-B-division-III" period="#period9">
<num>
<ins class="substitution O011001M001">III.</ins>
</num>
<heading>
<ins class="substitution O011001M001">RECORDS</ins>
</heading>
<level eId="annex-III-chapter-B-division-III-division-1" period="#period9">
<num>
<ins class="substitution O011001M001">1.</ins>
</num>
<heading>
<ins class="substitution O011001M001">The competent authority shall keep, for seven years, records of:</ins>
</heading>
<content>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O011001M001">the number and types of animals placed under movement restrictions as referred to in Article 12(1),</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">the number and outcome of clinical and epidemiological investigations as referred to in Article 12(1),</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">the number and outcome of laboratory examinations as referred to in Article 12(2),</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">the number, identity and origin of animals sampled in the framework of the monitoring programmes as referred to in Chapter A and, where possible, age, breed and anamnestic information,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O011001M001">the prion protein genotype of positive TSE cases in sheep.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-III-chapter-B-division-III-division-2" period="#period9">
<num>
<ins class="substitution O011001M001">2.</ins>
</num>
<content>
<p>
<ins class="substitution O011001M001 last">The investigating laboratory shall keep, for seven years, all records of testing, in particular laboratory workbooks and, where appropriate, paraffin blocks and photographs of western blots.</ins>
</p>
</content>
</level>
</level>
</chapter>
</hcontainer>
<hcontainer name="schedule" eId="annex-IV" period="#period14">
<num>
<ins class="substitution O018001M001 first">
<noteRef href="#c000011" marker="F8" class="commentary attribute F"/>
ANNEX IV
</ins>
</num>
<heading>
<ins class="substitution O018001M001">ANIMAL FEEDING</ins>
</heading>
<level eId="annex-IV-division-I" period="#period13">
<num>
<ins class="substitution O018001M001">I.</ins>
</num>
<heading>
<ins class="substitution O018001M001">Extension of the prohibition provided for in Article 7(1)</ins>
</heading>
<content>
<p>
<ins class="substitution O018001M001">The prohibition provided for in Article 7(1) shall be extended to the feeding:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O018001M001">to farmed animals, with the exception of the feeding to carnivorous fur producing animals, of:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O018001M001">processed animal protein;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O018001M001">gelatine of ruminant origin;</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O018001M001">blood products;</ins>
</p>
</item>
<item>
<num>(iv)</num>
<p>
<ins class="substitution O018001M001">hydrolysed protein;</ins>
</p>
</item>
<item>
<num>(v)</num>
<p>
<ins class="substitution O018001M001">dicalcium phosphate and tricalcium phosphate of animal origin (dicalcium phosphate and tricalcium phosphate);</ins>
</p>
</item>
<item>
<num>(vi)</num>
<p>
<ins class="substitution O018001M001">feedingstuffs containing the proteins listed in points (i) to (v).</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O018001M001">to ruminants, of animal protein and feedingstuffs containing such protein.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-IV-division-II" period="#period14">
<num>
<ins class="substitution O018001M001">II.</ins>
</num>
<heading>
<ins class="substitution O018001M001">Derogations from the prohibitions provided for in Article 7(1) and (2), and specific conditions for the application of such derogations.</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>A.</num>
<p>
<ins class="substitution O018001M001">The prohibitions provided for in Article 7(1) and (2) shall not apply to:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O018001M001">the feeding to farmed animals of the proteins referred to in points (i), (ii), (iii) and (iv) and of feedingstuffs derived from such proteins:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O018001M001">milk, milk-based products and colostrum;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O018001M001">eggs and egg products;</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O018001M001">gelatine derived from non-ruminants;</ins>
</p>
</item>
<item>
<num>(iv)</num>
<p>
<ins class="substitution O018001M001">hydrolysed proteins derived from parts of non-ruminants and from ruminant hides and skins;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O018001M001">the feeding to non-ruminant farmed animals of the proteins referred to in points (i), (ii) and (iii), and of products derived from such proteins:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O018001M001">fishmeal, in accordance with the conditions laid down in point B;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O018001M001">dicalcium phosphate and tricalcium phosphate, in accordance with the conditions laid down in point C;</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O018001M001">blood products derived from non-ruminants in accordance with the conditions laid down in point D;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O018001M001">the feeding to fish of blood meal derived from non-ruminants in accordance with the conditions laid down in point D;</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O018001M001">the feeding to farmed animals of tuber and root crops and feedingstuffs containing such products following the detection of bone spicules may be permitted by the Member States if there has been a favourable risk assessment. The risk assessment shall take into account at least the amount and possible source of contamination and the final destination of the consignment.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>B.</num>
<p>
<ins class="substitution O018001M001">The following conditions shall apply for the use of fishmeal referred to in point A(b)(i) and feedingstuffs containing fishmeal in the feeding of non-ruminant farmed animals (not applicable to the feeding of carnivorous fur producing animals):</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O018001M001">the fishmeal shall be produced in processing plants dedicated exclusively to the production of fish derived products;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O018001M001">before release for free circulation in the Community, each consignment of imported fishmeal shall be analysed by microscopy in accordance with Directive 2003/126/EC;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O018001M001">feedingstuffs containing fishmeal shall be produced in establishments which do not produce feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.</ins>
</p>
<p>
<ins class="substitution O018001M001">By way of derogation from point (c):</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O018001M001">a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing fishmeal shall not be required for home compounders:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">registered by the competent authority,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">keeping only non-ruminants,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">producing complete feedingstuffs for use only in the same holding, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">provided that the feedingstuffs containing fishmeal used in the production contain less than 50 % crude protein;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O018001M001">the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing fishmeal for other animal species may be authorised by the competent authority subject to the following conditions:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">bulk and packaged feedingstuffs destined for ruminants are kept in facilities physically separate from those for bulk fishmeal and bulk feedingstuffs containing fishmeal during storage, transport and packaging,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">feedingstuffs destined for ruminants are manufactured in facilities physically separate from facilities where feedingstuffs containing fishmeal are manufactured,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">records detailing the purchases and uses of fishmeal and the sales of feedingstuffs containing fishmeal are kept available to the competent authority for at least five years, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">routine tests are carried out on feedingstuffs destined for ruminants to ensure that prohibited proteins including fishmeal are not present.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O018001M001">The label and accompanying document of feedingstuffs containing fishmeal shall clearly indicate the words contains fishmeal — shall not be fed to ruminants.</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O018001M001">Bulk feedingstuffs containing fishmeal shall be transported by means of vehicles which do not at the same time transport feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination.</ins>
</p>
</item>
<item>
<num>(f)</num>
<p>
<ins class="substitution O018001M001">The use and storage of feedingstuffs containing fishmeal shall be prohibited in farms where ruminants are kept.</ins>
</p>
<p>
<ins class="substitution O018001M001">By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing fishmeal in farms where ruminants are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing fishmeal are fed to ruminants.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>C.</num>
<p>
<ins class="substitution O018001M001">The following conditions shall apply for the use of dicalcium phosphate and tricalcium phosphate referred to in point A(b)(ii) and feedingstuffs containing such proteins in the feeding of non-ruminant farmed animals (not applicable to the feeding of carnivorous fur producing animals):</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O018001M001">Feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be produced in establishments which do not prepare feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.</ins>
</p>
<p>
<ins class="substitution O018001M001">By way of derogation from that condition:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O018001M001">a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall not be required for home compounders:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">registered by the competent authority,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">keeping only non-ruminants,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">producing complete feedingstuffs for use only in the same holding, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">provided that the feedingstuffs containing dicalcium phosphate or tricalcium phosphate used in the production contain less than 10 % total phosphorus;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O018001M001">the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing dicalcium phosphate or tricalcium phosphate for other animal species may be authorised by the competent authority subject to the following conditions:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">bulk and packaged feedingstuffs destined for ruminants are manufactured in facilities physically separate from those where feedingstuffs containing dicalcium phosphate or tricalcium phosphate are manufactured,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">bulk feedingstuffs destined for ruminants are during storage, transport and packaging kept in facilities physically separate from those for bulk dicalcium phosphate, bulk tricalcium phosphate and bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">records detailing the purchases and uses of dicalcium phosphate or tricalcium phosphate and the sales of feedingstuff containing dicalcium phosphate or tricalcium phosphate are kept available to the competent authority for at least five years.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O018001M001">The label and accompanying document of the feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall clearly indicate the words </ins>
<ins class="substitution O018001M001"></ins>
<ins class="substitution O018001M001">contains dicalcium/tricalcium phosphate of animal origin – shall not be fed to ruminants</ins>
<ins class="substitution O018001M001"></ins>
<ins class="substitution O018001M001">.</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O018001M001">Bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be transported by means of vehicles which do not at the same time transport feedingstuffs for ruminants. If the vehicle is subsequently used for the transport of feedingstuffs intended for ruminants, it shall be thoroughly cleaned in accordance with a procedure approved by the competent authority to avoid cross-contamination.</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O018001M001">The use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be prohibited in farms where ruminants are kept.</ins>
</p>
<p>
<ins class="substitution O018001M001">By way of derogation from that condition, the competent authority may permit the use and storage of feedingstuffs containing dicalcium phosphate or tricalcium phosphate in farms where ruminants are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing dicalcium phosphate or tricalcium phosphate are fed to ruminants.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>D.</num>
<p>
<ins class="substitution O018001M001">The following conditions shall apply for the use of blood products referred to in point A(b)(iii) and blood meal referred to in point A(c) and of feedingstuffs containing such proteins, in the feeding of respectively non-ruminant farmed animals and fish:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O018001M001">The blood shall be derived from EU approved slaughterhouses which do not slaughter ruminants and which are registered as not slaughtering ruminants, and it shall be transported directly to the processing plant in vehicles dedicated exclusively to the transport of non-ruminant blood. If the vehicle was previously used for the transport of ruminant blood, it shall be, following cleaning, inspected by the competent authority before the transport of non-ruminant blood.</ins>
</p>
<p>
<ins class="substitution O018001M001">By way of derogation from that condition, the competent authority may permit the slaughter of ruminants in a slaughterhouse collecting non-ruminant blood intended for the production of blood products and blood meal for use in feed for respectively non-ruminant farmed animals and fish if the slaughterhouse has a recognised control system. That control system shall at least include:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">keeping the slaughtering of non-ruminants physically separate from the slaughtering of ruminants,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">keeping collection, storage, transport and packaging facilities for blood of ruminant origin physically separate from those for blood of non-ruminant origin, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">regular sampling and analysis of blood of non-ruminant origin to detect the presence of ruminant proteins</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O018001M001">The blood products and blood meal shall be produced in an establishment exclusively processing non-ruminant blood.</ins>
</p>
<p>
<ins class="substitution O018001M001">By way of derogation from that condition, the competent authority may permit the production of blood products and blood meal for use in feed for respectively non-ruminant farmed animals and fish in establishments processing ruminant blood, which have a recognised control system in place preventing cross-contamination. That control system shall at least include:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">processing of non-ruminant blood in a closed system physically separate from the processing of ruminant blood,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">keeping of bulk raw material and bulk finished products of ruminant origin during storage, transport and packaging in facilities physically separate from those for bulk raw material and bulk finished products of non-ruminant origin, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">regular sampling and analysis of non-ruminant blood products and blood meal to detect the presence of ruminant proteins.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O018001M001">Feedingstuffs containing blood products or blood meal shall be produced in establishments which do not prepare feedingstuffs for respectively ruminants or farmed animals other than fish and which are authorised for this purpose by the competent authority.</ins>
</p>
<p>
<ins class="substitution O018001M001">By way of derogation from that condition:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O018001M001">a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing blood products or blood meal shall not be required for home compounders:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">registered by the competent authority,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">keeping only non-ruminants in case blood products are used, or only fish in case blood meal is used,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">producing complete feedingstuffs for use only in the same holding, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">provided that the feedingstuffs containing blood products or blood meal used in the production contain less than 50 % total protein.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O018001M001">the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing blood products or blood meal for respectively non-ruminant farmed animals or fish may be authorised by the competent authority subject to the following conditions:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">bulk and packaged feedingstuffs destined for ruminants or farmed animals other than fish are manufactured in facilities physically separate from those where feedingstuffs containing respectively blood products or blood meal are manufactured,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">bulk feedingstuffs kept, during storage transport and packaging, in physically separate facilities as follow:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O018001M001">feedingstuff destined for ruminants is kept separate from blood products and from feedingstuffs containing blood products;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O018001M001">feedingstuff destined for farmed animals other than fish is kept separate from blood meal and feedingstuffs containing blood meal,</ins>
</p>
</item>
</blockList>
</item>
<item>
<p>
<ins class="substitution O018001M001">records detailing the purchases and uses of blood products and blood meal, and the sales of feedingstuffs containing such products, are kept available to the competent authority for at least five years.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O018001M001">The label, accompanying commercial document or health certificate, as appropriate, of the feedingstuffs containing blood products or blood meal shall clearly indicate the words </ins>
<ins class="substitution O018001M001"></ins>
<ins class="substitution O018001M001">contains blood products – shall not be fed to ruminants</ins>
<ins class="substitution O018001M001"></ins>
<ins class="substitution O018001M001"> or </ins>
<ins class="substitution O018001M001"></ins>
<ins class="substitution O018001M001">contains blood meal – shall only be fed to fish</ins>
<ins class="substitution O018001M001"></ins>
<ins class="substitution O018001M001"> as appropriate.</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O018001M001">Bulk feedingstuffs containing blood products shall be transported by means of vehicles which do not transport at the same time feedingstuffs for ruminants and bulk feedingstuffs containing blood meal by means of vehicles which do not transport at the same time feedingstuffs for farmed animals other than fish. If the vehicle is subsequently used for the transport of feedingstuffs intended for respectively ruminants or farmed animals other than fish, it shall be thoroughly cleaned in accordance with a procedure to avoid cross-contamination approved by the competent authority.</ins>
</p>
</item>
<item>
<num>(f)</num>
<p>
<ins class="substitution O018001M001">The use and storage of feedingstuffs containing blood products shall be prohibited in farms where ruminants are kept, and that of feedingstuffs containing blood meal shall be prohibited in farms where farmed animals other than fish are kept.</ins>
</p>
<p>
<ins class="substitution O018001M001">By way of derogation, the competent authority may permit the use and storage of feedingstuffs containing respectively blood products or blood meal in farms where respectively ruminants or farmed animals other than fish are kept, if it is satisfied that on-farm measures are implemented to prevent that feedingstuffs containing respectively blood products or blood meal are fed to respectively ruminants or species other than fish.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-IV-division-III" period="#period14">
<num>
<ins class="substitution O018001M001">III.</ins>
</num>
<heading>
<ins class="substitution O018001M001">General implementing conditions</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>A.</num>
<p>
<ins class="substitution O018001M001">This Annex shall apply without prejudice to the provisions in Regulation (EC) No 1774/2002.</ins>
</p>
</item>
<item>
<num>B.</num>
<p>
<ins class="substitution O018001M001">Member States shall keep up-to-date lists of:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O018001M001">slaughterhouses approved for the collection of blood in accordance with point D(a) of Part II;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O018001M001">approved processing plants producing dicalcium phosphate, tricalcium phosphate, blood products or blood meal, and</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O018001M001">establishments, with the exception of home compounders, authorised for manufacturing feedingstuffs containing fishmeal and the proteins referred to in point (b) which operate in accordance with the conditions laid down in points B(c), C(a) and D(c) of Part II.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>C.</num>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O018001M001">Bulk processed animal protein, with the exception of fishmeal, and bulk products, including feedingstuffs, organic fertilisers and soil improvers, containing such proteins, shall be stored and transported in dedicated facilities. The store or vehicle may only be used for other purposes, following cleaning, and after having been inspected by the competent authority.</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O018001M001">Bulk fishmeal referred to in point A(b)(i) of Part II, bulk dicalcium phosphate and bulk tricalcium phosphate referred to in point A(b)(ii) of Part II, blood products referred to in point A(b)(iii) of Part II and blood meal referred to in point A(c) of Part II shall be stored and transported in stores and vehicles dedicated to that purpose.</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O018001M001">By way of derogation from point (b):</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O018001M001">stores or vehicles may be used for the storage and transport of feedingstuffs containing the same protein;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O018001M001">stores or vehicles, following cleaning, may be used for other purposes after having been inspected by the competent authority; and</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O018001M001">stores and vehicles transporting fishmeal may be used for other purposes if the company has a control system in place, recognised by the competent authority, to prevent cross-contamination. The control system shall at least include:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">records on material transported and cleaning of the vehicle, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">regular sampling and analysis of feedingstuffs transported to detect the presence of fishmeal.</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O018001M001">The competent authority shall carry out frequent on-the-spot checks to verify the correct application of the above control system.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</item>
<item>
<num>D.</num>
<p>
<ins class="substitution O018001M001">Feedingstuffs, including petfood, which contain blood products of ruminant origin or processed animal proteins, other than fishmeal, shall not be manufactured in establishments which produce feedingstuffs for farmed animals, with the exception of feedingstuffs for carnivorous fur producing animals.</ins>
</p>
<p>
<ins class="substitution O018001M001">Bulk feedingstuffs, including petfood, which contain blood products of ruminant origin or processed animal proteins, other than fishmeal, shall during storage, transport and packaging be kept in facilities physically separate from facilities for bulk feedingstuffs for farmed animals, with the exception of feedingstuffs for carnivorous fur producing animals.</ins>
</p>
<p>
<ins class="substitution O018001M001">Petfood and feedingstuffs intended for carnivorous fur producing animals containing dicalcium phosphate or tricalcium phosphate referred to in point A(b)(ii) of Part II, and blood products referred to in point A(b)(iii) of Part II shall be manufactured and transported in accordance with points C(a) and (c) and points D(c) and (e), respectively of Part II.</ins>
</p>
</item>
<item>
<num>E.</num>
<blockList class="ordered">
<item>
<num>1.</num>
<p>
<ins class="substitution O018001M001">The export to third countries of processed animal proteins derived from ruminants, and of products containing such processed animal proteins, shall be prohibited.</ins>
</p>
</item>
<item>
<num>2.</num>
<p>
<ins class="substitution O018001M001">The export of processed animal proteins derived from non-ruminants and of products containing such proteins shall only be permitted by the competent authority subject to the following conditions:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">they are destined for uses not prohibited by Article 7,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">a written agreement with the third country is made prior to exportation, which includes an undertaking from the third country to respect the final use and not to re-export the processed animal protein or products containing such proteins for uses prohibited by Article 7.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>3.</num>
<p>
<ins class="substitution O018001M001">Member States which permit exports in accordance with point 2 shall for the effective implementation of this Regulation inform the Commission and the other Member States of all terms and conditions as agreed with the third country concerned, in the context of the Standing Committee on the Food Chain and Animal Health.</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O018001M001">Points 2 and 3 shall not apply to:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O018001M001">exports of fishmeal, provided it fulfils the conditions set out in point B of Part II,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">products containing fishmeal,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O018001M001">petfood.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>F.</num>
<p>
<ins class="substitution O018001M001 last">The competent authority shall carry out documentary and physical checks, including tests on feedingstuffs, throughout the production and distribution chain in accordance with Directive 95/53/EC to control compliance with its provisions and with the provisions of this Regulation. Where any presence of prohibited animal protein is detected, Directive 95/53/EC shall apply. The competent authority shall verify on a regular basis the competence of laboratories carrying out analyses for such official controls, in particular by evaluating the results of ring trials. If the competence is considered unsatisfactory, a re-training of the laboratory staff shall be undertaken as the minimal corrective measure.</ins>
</p>
</item>
</blockList>
</content>
</level>
</hcontainer>
<hcontainer name="schedule" eId="annex-V" period="#period39">
<num>
<ins class="substitution O024001M002 first">
<noteRef href="#c000006" marker="F3" class="commentary attribute F"/>
ANNEX V
</ins>
</num>
<heading>
<ins class="substitution O024001M002">SPECIFIED RISK MATERIAL</ins>
</heading>
<level eId="annex-V-division-1" period="#period39">
<num>
<ins class="substitution O024001M002">1.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Definition of specified risk material</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M002">The following tissues shall be designated as specified risk material if they come from animals whose origin is in a Member State or third country or of one of their region with a controlled or undetermined BSE risk:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M002">as regards bovine animals:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M002">the skull excluding the mandible and including the brain and eyes, and the spinal cord of animals aged over 12 months;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M002">
<ins class="substitution O027001M002 first last">
<noteRef href="#c000012" marker="F9" class="commentary attribute F"/>
the vertebral column excluding the vertebrae of the tail, the spinous and transverse processes of the cervical, thoracic and lumbar vertebrae and the median sacral crest and wings of the sacrum, but including the dorsal root ganglia, of animals aged over 30 months; and
</ins>
</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M002">the tonsils, the intestines from the duodenum to the rectum and the mesentery of animals of all ages.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M002">as regards ovine and caprine animals</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M002">the skull including the brain and eyes, the tonsils and the spinal cord of animals aged over 12 months or which have a permanent incisor erupted through the gum, and</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M002">the spleen and ileum of animals of all ages.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-V-division-2" period="#period27">
<num>
<ins class="substitution O024001M002">2.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Derogation for Member States</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M002">By way of derogation from point 1, tissues listed in that point whose origin is in Member States with a negligible BSE risk shall continue to be considered as specified risk material.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-3" period="#period28">
<num>
<ins class="substitution O024001M002">3.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Marking and disposal</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M002">Specified risk material shall be stained with a dye or, as appropriate, otherwise marked, immediately on removal, and disposed of in accordance with the provisions laid down in Regulation (EC) No 1774/2002, and in particular in Article 4(2) thereof.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-4" period="#period28">
<num>
<ins class="substitution O024001M002">4.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Removal of specified risk material</ins>
</heading>
<level eId="annex-V-division-4-division-4.1" period="#period28">
<num>
<ins class="substitution O024001M002">4.1.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Specified risk material shall be removed at:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M002">slaughterhouses, or, as appropriate, other places of slaughter;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M002">cutting plants, in the case of vertebral column of bovine animals;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M002">where appropriate, in intermediate plants referred to in Article 10 of Regulation (EC) No 1774/2002 or users and collection centres authorised and registered pursuant to Article 23(2)(c)(iv), (vi) and (vii) of Regulation (EC) No 1774/2002.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-V-division-4-division-4.2" period="#period28">
<num>
<ins class="substitution O024001M002">4.2.</ins>
</num>
<heading>
<ins class="substitution O024001M002">By way of derogation from point 4.1, the use of an alternative test to the removal of specified risk material may be authorised under the following conditions:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M002">tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M002">no bovine, ovine or caprine product intended for human food or animal feed may leave the slaughterhouse before the competent authority has received and accepted the results of the tests on all slaughtered animals potentially contaminated if BSE has been confirmed in one of them;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M002">when an alternative test gives a positive result, all bovine, ovine and caprine material which has been potentially contaminated in the slaughterhouse is destroyed in accordance with point 3, unless all parts of the body including the hide of the affected animal can be identified and kept separate.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-V-division-4-division-4.3" period="#period28">
<num>
<ins class="substitution O024001M002">4.3.</ins>
</num>
<heading>
<ins class="substitution O024001M002">By way of derogation from point 4.1, Member States may decide to allow:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M002">the removal of spinal cord of ovine and caprine animals in cutting plants specifically authorised for this purpose;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M002">the removal of bovine vertebral column from carcasses or parts of carcasses in butcher shops specifically authorised, monitored and registered for this purpose;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M002">the harvesting of head meat from bovine animals in cutting plants specifically authorised for this purpose in accordance with the provisions laid down in point 9.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-V-division-4-division-4.4" period="#period28">
<num>
<ins class="substitution O024001M002">4.4.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M002">The rules on removal of specified risk material laid down in this Chapter shall not apply to Category 1 material as defined in Regulation (EC) No 1774/2002 used under the supervision of competent authorities for feeding of endangered and protected species of necrophagous birds.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-V-division-5" period="#period31">
<num>
<ins class="substitution O024001M002">5.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Measures concerning mechanically separated meat</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M002">Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 9(3), it shall be prohibited in all Member States to use bones or bone-in cuts of bovine, ovine and caprine animals for the production of mechanically separated meat.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-6" period="#period28">
<num>
<ins class="substitution O024001M002">6.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Measures concerning laceration of tissues</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M002">Notwithstanding the individual decisions referred to in Article 5(2), and by way of derogation from Article 8(3), in all Member States, until all Member States are classified as countries with negligible BSE risk, laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity after stunning shall be prohibited in bovine, ovine or caprine animals whose meat is intended for human or animal consumption.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-7" period="#period28">
<num>
<ins class="substitution O024001M002">7.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Harvesting of tongues from bovine animals</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M002">Tongues of bovine animals of all ages intended for human or animal consumption shall be harvested at the slaughterhouse by a transverse cut rostral to the lingual process of the basihyoid bone.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-8" period="#period31">
<num>
<ins class="substitution O024001M002">8.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Harvesting of bovine head meat</ins>
</heading>
<level eId="annex-V-division-8-division-8.1" period="#period18">
<num>
<ins class="substitution O024001M002">8.1.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Head meat of bovine animals above 12 months of age shall be harvested at slaughterhouses, in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat with central nervous system tissue. The system shall include at least the following provisions:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M002">harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M002">where the heads are removed from the conveyor or hooks before harvesting the head meat, the frontal shot hole and foramen magnum shall be sealed with an impermeable and durable stopper. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M002">head meat shall not be harvested from heads where the eyes are damaged or lost immediately prior to, or after slaughter, or which are otherwise damaged in a way which might result in contamination of the head with central nervous tissue;</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M002">head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent;</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O024001M002">without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during the harvesting, in particular in the case when the seal referred to in the second indent is lost or the eyes damaged during the activity:</ins>
</p>
</item>
<item>
<num>(f)</num>
<p>
<ins class="substitution O024001M002">a sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-V-division-8-division-8.2" period="#period31">
<num>
<ins class="substitution O024001M002">8.2.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M002">By way of derogation from the requirements of point 8.1, Member States may decide to apply at the slaughterhouse an alternative control system for the harvesting of bovine head meat, leading to an equivalent reduction in the level of contamination of head meat with central nervous system tissue. A sampling plan using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented. Member States using this derogation shall inform the Commission and the other Member States in the framework of the Standing Committee of the Food Chain and Animal Health of their control system and the results of the sampling.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-8-division-8.3" period="#period18">
<num>
<ins class="substitution O024001M002">8.3.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M002">If the harvesting is performed without removing the bovine head from the conveyor or hooks, points 8.1 and 8.2 shall not apply.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-V-division-9" period="#period31">
<num>
<ins class="substitution O024001M002">9.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Harvesting of bovine head meat in authorised cutting plants</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M002">By way of derogation from point 8, Member States may decide to allow the harvesting of head meat from bovine in cutting plants specifically authorised for this purpose and provided that the following conditions are complied with:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M002">the heads intended for transport to the cutting plant shall be suspended on a rack during the storing period and the transport from the slaughterhouse to the cutting plant;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M002">the frontal shot hole and the foramen magnum shall be properly sealed with an impermeable and durable stopper before being moved from the conveyor or hooks to the racks. Where the brainstem is sampled for laboratory testing for BSE, the foramen magnum shall be sealed immediately after that sampling;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M002">the heads which have not been properly sealed in accordance with point (b), where the eyes are damaged or lost immediately prior to or after slaughter or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue shall be excluded from transport to the specifically authorised cutting plants;</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M002">a sampling plan for the slaughterhouse using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify the proper implementation of the measures to reduce contamination;</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O024001M002">the harvesting of head meat shall be carried out in accordance with a control system, recognized by the competent authority, to ensure the prevention of possible contamination of head meat. The system shall include at least:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M002">all heads shall be visually checked for signs of contamination or damage and proper sealing before the harvesting of the head meat begins;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M002">head meat shall not be harvested from heads which have not been properly sealed, where the eyes are damaged or which were otherwise damaged in a way which might result in contamination of the head meat with central nervous tissue. Head meat shall also not be harvested from any head where contamination from such heads is suspected;</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M002">without prejudice to general rules on hygiene, specific working instructions shall be in place to prevent contamination of the head meat during transport and harvesting, in particular where the seal is lost or the eyes damaged during the activity;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(f)</num>
<p>
<ins class="substitution O024001M002">a sampling plan for the cutting plant using an appropriate laboratory test to detect central nervous system tissue shall be in place to verify that the measures to reduce contamination are properly implemented.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-V-division-10" period="#period31">
<num>
<ins class="substitution O024001M002">10.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Rules on trade and export</ins>
</heading>
<level eId="annex-V-division-10-division-10.1" period="#period31">
<num>
<ins class="substitution O024001M002">10.1.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M002">Member States may allow dispatch of heads or of un-split carcasses containing specified risk material to another Member State only after that Member State has agreed to receive the material and has approved the conditions of dispatch and transport.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-10-division-10.2" period="#period31">
<num>
<ins class="substitution O024001M002">10.2.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M002">By way of derogation from point 10.1, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be dispatched from one Member State to another without the latter's prior agreement.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-10-division-10.3" period="#period31">
<num>
<ins class="substitution O024001M002">10.3.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M002">Exports outside the Community of heads and of fresh meat of bovine, ovine or caprine animals containing specified risk materials shall be prohibited.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-V-division-11" period="#period28">
<num>
<ins class="substitution O024001M002">11.</ins>
</num>
<heading>
<ins class="substitution O024001M002">Controls</ins>
</heading>
<level eId="annex-V-division-11-division-11.1" period="#period28">
<num>
<ins class="substitution O024001M002">11.1.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M002">Member States shall carry out frequent official controls to verify the correct application of this Annex and shall ensure that measures are taken to avoid any contamination, particularly in slaughterhouses, cutting plants or other places where specified risk material is removed, such as butcher shops or establishments referred in point 4.1 (c).</ins>
</p>
</content>
</level>
<level eId="annex-V-division-11-division-11.2" period="#period28">
<num>
<ins class="substitution O024001M002">11.2.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M002">Member States shall in particular set up a system to ensure and check that specified risk material is handled and disposed of in accordance with Regulation (EC) No 999/2001 and Regulation (EC) No 1774/2002.</ins>
</p>
</content>
</level>
<level eId="annex-V-division-11-division-11.3" period="#period28">
<num>
<ins class="substitution O024001M002">11.3.</ins>
</num>
<heading>
<ins class="substitution O024001M002">A control system shall be put in place for the removal of the vertebral column as specified in point 1(a). The system shall include at least the following measures:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M002">when removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M002">specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as the number where removal of the vertebral column is not required, shall be added on the commercial document relating to consignments of meat. When applicable, the specific information shall be added to the document referred to in Article 2(1) of Commission Regulation (EC) No 136/2004</ins>
<noteRef href="#f00029" class="footnote" marker="29"/>
<ins class="substitution O024001M002"> in the case of imports;</ins>
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<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M002 last">butcher shops shall keep, for at least one year, the commercial documents referred to in (b).</ins>
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</content>
</level>
</level>
</hcontainer>
<hcontainer name="schedule" eId="annex-VI" period="#period35">
<num>
<ins class="substitution O024001M003 first">
<noteRef href="#c000006" marker="F3" class="commentary attribute F"/>
ANNEX VI
</ins>
</num>
<heading>
<ins class="substitution O024001M003 last">PRODUCTS OF ANIMAL ORIGIN DERIVED FROM OR CONTAINING RUMINANT MATERIAL, AS REFERRED TO IN ARTICLE 9(1)</ins>
</heading>
<content>
<blockContainer eId="annex-VI-paragraph-1" period="#period1">
<p>The use of ruminant material for the production of the following products of animal origin is prohibited as referred to in Article 9(1):</p>
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<blockContainer eId="annex-VI-paragraph-2" period="#period1">
<blockList class="ordered">
<item>
<num>(a)</num>
<p>mechanically recovered meat;</p>
</item>
<item>
<num>(b)</num>
<p>dicalcium phosphate intended as feedingstuffs for livestock;</p>
</item>
<item>
<num>(c)</num>
<p>gelatine, unless it is produced from ruminant hides;</p>
</item>
<item>
<num>(d)</num>
<p>derivatives made from rendered ruminant fat;</p>
</item>
<item>
<num>(e)</num>
<p>rendered ruminant fat, unless it was produced from:</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>discrete adipose tissue declared fit for human consumption;</p>
</item>
<item>
<num>(ii)</num>
<p>raw materials which were processed in accordance with the standards referred to in Directive 90/667/EEC.</p>
</item>
</blockList>
</item>
</blockList>
</blockContainer>
</content>
</hcontainer>
<hcontainer name="schedule" eId="annex-VII" period="#period36">
<num>
<ins class="substitution O024001M015 first">
<noteRef href="#c000005" marker="F2" class="commentary attribute F"/>
ANNEX VII
</ins>
</num>
<heading>
<ins class="substitution O024001M015">ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY</ins>
</heading>
<level eId="annex-VII-chapter-A" period="#period36" class="EUChapter">
<num>
<ins class="substitution O024001M015">CHAPTER A</ins>
</num>
<heading>
<ins class="substitution O024001M015">Measures following confirmation of the presence of a TSE</ins>
</heading>
<level eId="annex-VII-chapter-A-division-1" period="#period20">
<num>
<ins class="substitution O024001M015">1.</ins>
</num>
<heading>
<ins class="substitution O024001M015">The inquiry referred to in Article 13(1)(b) must identify:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">in the case of bovine animals:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M015">all other ruminants on the holding of the animal in which the disease was confirmed,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">where the disease was confirmed in a female animal, its progeny born within two years prior to, or after, clinical onset of the disease,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">all animals of the cohort of the animal in which the disease was confirmed,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">the possible origin of the disease,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">other animals on the holding of the animal in which the disease was confirmed or on other holdings which may have become infected by the TSE agent or been exposed to the same feed or contamination source,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">in the case of ovine and caprine animals:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M015">all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">in so far as they are identifiable, the parents, and in the case of females all embryos, ova and the last progeny of the female animal in which the disease was confirmed,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those referred to in the second indent,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-VII-chapter-A-division-2" period="#period36">
<num>
<ins class="substitution O024001M015">2.</ins>
</num>
<heading>
<ins class="substitution O024001M015">The measures laid down in Article 13(1)(c) shall comprise at least:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>2.1.</num>
<p>
<ins class="substitution O024001M015">In the case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in the second and third indents of point 1(a); however, the Member State may decide:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M015">not to kill and destroy animals of the cohort referred to in the third indent of point 1(a) if evidence has been provided that such animals did not have access to the same feed as the affected animal,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">to defer the killing and destruction of animals in the cohort referred to in the third indent of point 1(a) until the end of their productive life, provided that they are bulls continuously kept at a semen collection centre and it can be ensured that they are completely destroyed following death.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>2.2.</num>
<p>
<ins class="substitution O024001M015">If a TSE is suspected in an ovine or caprine animal on a holding in a Member State, all other ovine and caprine animals from that holding shall be placed under official movement restriction until the results of the examination are available. If there is evidence that the holding where the animal was present when the TSE was suspected is not likely to be the holding where the animal could have been exposed to a TSE, the competent authority may decide that other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available.</ins>
</p>
</item>
<item>
<num>2.3.</num>
<p>
<ins class="substitution O024001M015">In the case of confirmation of TSE in an ovine or caprine animal:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">if BSE cannot be excluded after the results of a ring trial carried out in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b);</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">if BSE is excluded in accordance with the procedure set out in Annex X, Chapter C, point 3.2(c), pursuant to the decision of the competent authority:</ins>
</p>
<p>
<ins class="substitution O024001M015">either</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M015">the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). The conditions set out in point 3 shall apply to the holding;</ins>
</p>
<p>
<ins class="substitution O024001M015">or</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M015">the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M015">breeding rams of the ARR/ARR genotype,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">breeding ewes carrying at least one ARR allele and no VRQ allele and, where such breeding ewes are pregnant at the time of the inquiry, the lambs subsequently born, if their genotype meets the requirements of this subparagraph,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">sheep carrying at least one ARR allele which are intended solely for slaughter,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">if the competent authority so decides, sheep and goats less than three months old which are intended solely for slaughter.</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O024001M015">The conditions set out in point 3 shall apply to the holding;</ins>
</p>
<p>
<ins class="substitution O024001M015">or</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M015">a Member State may decide not to kill and destroy the animals, identified by the inquiry referred to in the second and third indents of point 1(b) where it is difficult to obtain replacement ovine animals of a known genotype or where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, or based on a reasoned consideration of all the epidemiological factors. The conditions set out in point 4 shall apply to the holding;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M015">by way of derogation from the measures set out in point (b), and only where the TSE case confirmed on a holding is an atypical scrapie case, the Member State may decide to apply the measures laid down in point 5.</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M015">Member States may decide:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M015">to replace the killing and complete destruction of all animals referred to in b(i) by slaughtering for human consumption;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M015">to replace the killing and complete destruction of animals referred to in b(ii) by slaughtering for human consumption;</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O024001M015">provided that:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M015">the animals are slaughtered within the territory of the concerned Member State,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">all animals which are over 18 months of age or have more than two permanent incisors erupted through the gum and are slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods set out in Annex X, Chapter C, point 3.2(b);</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O024001M015">the prion protein genotype of ovine animals, up to a maximum of 50, killed and destroyed or slaughtered for human consumption in accordance with points (b)(i) and (iii) shall be determined</ins>
<ins class="substitution O024001M015">
<ins class="substitution O026001M002 first last">
<noteRef href="#c000013" marker="F10" class="commentary attribute F"/>
;
</ins>
</ins>
</p>
</item>
<item>
<num>(f)</num>
<p>
<ins class="substitution O024001M015">
<ins class="O026001M001 first last">
<noteRef href="#c000014" marker="F11" class="commentary attribute F"/>
Where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, a Member State may decide to delay the destruction of animals as referred to in point 2.3 (b)(i) and (ii) for up to five breeding years.
</ins>
</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>2.4.</num>
<p>
<ins class="substitution O024001M015">If the infected animal has been introduced from another holding, a Member State may decide, based on the history of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed; in the case of land used for common grazing by more than one flock, Member States may decide to limit the application of those measures to a single flock, based on a reasoned consideration of all the epidemiological factors; where more than one flock is kept on a single holding, Member States may decide to limit the application of the measures to the flock in which the TSE has been confirmed, provided it has been verified that the flocks have been kept isolated from each other and that the spread of infection between the flocks through either direct or indirect contact is unlikely.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-VII-chapter-A-division-3" period="#period20">
<num>
<ins class="substitution O024001M015">3.</ins>
</num>
<heading>
<ins class="substitution O024001M015">Following the application on a holding of the measures referred to in point 2.3(a) and (b)(i) and (ii):</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>3.1.</num>
<p>
<ins class="substitution O024001M015">Only the following animals may be introduced to the holding(s):</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">male sheep of the ARR/ARR genotype;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">female sheep carrying at least one ARR allele and no VRQ allele;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M015">caprine animals, provided that:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M015">no ovine animals for breeding other than those of the genotypes referred to in points (a) and (b) are present on the holding;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M015">thorough cleaning and disinfection of all animal housing on the premises has been carried out following destocking.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</item>
<item>
<num>3.2.</num>
<p>
<ins class="substitution O024001M015">Only the following ovine germinal products may be used in the holding(s):</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">semen from rams of the ARR/ARR genotype;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">embryos carrying at least one ARR allele and no VRQ allele.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>3.3.</num>
<p>
<ins class="substitution O024001M015">Movement of the animals from the holding shall be subject to the following conditions:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">movement of ARR/ARR sheep from the holding shall not be subject to any restriction;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">sheep carrying only one ARR allele may be moved from the holding only to go directly for slaughter for human consumption or for the purposes of destruction; however,</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M015">ewes carrying one ARR allele and no VRQ allele may be moved to other holdings which are restricted following the application of measures in accordance with point 2.3(b)(ii) or 4,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">if the competent authority so decides, lambs and kids may be moved to one other holding solely for the purposes of fattening prior to slaughter; the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M015">caprine animals may be moved provided that the holding is subjected to intensified TSE monitoring, including the testing of all caprine animals which are over the age of 18 months and:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M015">are slaughtered for human consumption at the end of their productive lives; or</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M015">have died or been killed on the holding, and meet the conditions set out to in Annex III, Chapter A, Part II, point 3;</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M015">if the Member State so decides, lambs and kids less than three months old may be moved from the holding to go directly for slaughter for human consumption.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>3.4.</num>
<p>
<ins class="substitution O024001M015">The restrictions set out in points 3.1, 3.2 and 3.3 shall continue to apply to the holding for a period of two years from:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">the date of attainment of ARR/ARR status by all ovine animals on the holding; or</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">the last date when any ovine or caprine animal was kept on the premises; or</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M015">the date when the intensified TSE monitoring set out in 3.3(c) commenced; or</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M015">the date when all breeding rams on the holding are of ARR/ARR genotype and all breeding ewes carry at least one ARR allele and no VRQ allele, provided that during the two-year period, negative results are obtained from TSE testing of the following animals over the age of 18 months:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M015">an annual sample of ovine animals slaughtered for human consumption at the end of their productive lives in accordance with the sample size referred to in the Table in Annex III, Chapter A, Part II, point 5, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M015">all ovine animals referred to in Annex III, Chapter A, Part II, point 3 which have died or been killed on the holding.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-VII-chapter-A-division-4" period="#period20">
<num>
<ins class="substitution O024001M015">4.</ins>
</num>
<heading>
<ins class="substitution O024001M015">Following the application on a holding of the measures set out in point 2.3(b)(iii) and for a period of two breeding years following the detection of the last TSE case:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">all ovine and caprine animals on the holding shall be identified;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">all ovine and caprine animals on the holding may be moved only within the territory of the concerned Member State for slaughter for human consumption or for the purposes of destruction; all animals over the age of 18 months slaughtered for human consumption shall be tested for the presence of TSE in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b);</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M015">the competent authority shall ensure that embryos and ova are not dispatched from the holding;</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M015">only the semen from rams of the ARR/ARR genotype and embryos carrying at least one ARR allele and no VRQ allele may be used in the holding;</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O024001M015">all ovine and caprine animals which are over the age of 18 months which have died or been killed on the holding shall be subject to TSE testing;</ins>
</p>
</item>
<item>
<num>(f)</num>
<p>
<ins class="substitution O024001M015">only male sheep of the ARR/ARR genotype and female ovine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions set out in point 3.4 may be introduced in the holding;</ins>
</p>
</item>
<item>
<num>(g)</num>
<p>
<ins class="substitution O024001M015">only caprine animals from holdings where no TSE cases have been detected or from flocks fulfilling the conditions of point 3.4 may be introduced in the holding;</ins>
</p>
</item>
<item>
<num>(h)</num>
<p>
<ins class="substitution O024001M015">All ovine and caprine animals in the holding shall be subject to common grazing restrictions to be determined by the competent authority, based on a reasoned consideration of all the epidemiological factors;</ins>
</p>
</item>
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M015">by way of derogation of point (b) if the competent authority so decides, lambs and kids may be moved to another holding within the same Member State solely for the purposes of fattening prior to slaughter; provided that the holding of destination shall not contain any ovine or caprine animals other than those being fattened prior to slaughter, and shall not dispatch live ovine or caprine animals to other holdings, except for direct slaughter.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-VII-chapter-A-division-5" period="#period20">
<num>
<ins class="substitution O024001M015">5.</ins>
</num>
<heading>
<ins class="substitution O024001M015">Following the application of the derogation provided for in point 2.3(c) the following measures shall apply:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">either the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b). Member States may decide to determine the prion protein genotype of ovine animals which have been killed and destroyed;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">or, for a period of two breeding years following the detection of the last TSE case, at least the following measures:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M015">all ovine and caprine animals in the holding shall be identified;</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M015">the holding must be subject to intensified TSE monitoring for a two years period, including the testing of all ovine and caprine animals which are over the age of 18 months and slaughtered for human consumption and all ovine and caprine animals over the age of 18 which have died or been killed on the holding;</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M015">the competent authority shall ensure that live ovine and caprine animals, embryos and ova from the holding are not dispatched to other Member States or third countries.</ins>
</p>
</item>
</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-VII-chapter-A-division-6" period="#period20">
<num>
<ins class="substitution O024001M015">6.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">Member States applying the measures set out in point 2.3(b)(iii) or the derogations provided for in points 2.3(c) and (d) shall notify to the Commission an account of the conditions and criteria used for granting them. Where additional TSE cases are detected in flocks where derogations are applied, the conditions for granting such derogations shall be reassessed.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-VII-chapter-B" period="#period25" class="EUChapter">
<num>
<ins class="substitution O024001M015">CHAPTER B</ins>
</num>
<heading>
<ins class="substitution O024001M015">Minimum requirements for a breeding programme for resistance to TSEs in sheep in accordance with Article 6a</ins>
</heading>
<level eId="annex-VII-chapter-B-part-1" period="#period18" class="EUPart">
<num>
<ins class="substitution O024001M015">PART 1</ins>
</num>
<heading>
<ins class="substitution O024001M015">General requirements</ins>
</heading>
<level eId="annex-VII-chapter-B-part-1-division-1" period="#period18">
<num>
<ins class="substitution O024001M015">1.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">The breeding programme shall concentrate on flocks of high genetic merit.</ins>
</p>
</content>
</level>
<level eId="annex-VII-chapter-B-part-1-division-2" period="#period18">
<num>
<ins class="substitution O024001M015">2.</ins>
</num>
<heading>
<ins class="substitution O024001M015">A database shall be established containing at least the following information:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">the identity, breed and number of animals in all flocks participating in the breeding programme;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">the identification of the individual animals sampled under the breeding programme;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M015">the results of any genotyping tests.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-VII-chapter-B-part-1-division-3" period="#period18">
<num>
<ins class="substitution O024001M015">3.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">A system of uniform certification shall be established in which the genotype of each animal sampled under the breeding programme is certified by reference to its individual identification number.</ins>
</p>
</content>
</level>
<level eId="annex-VII-chapter-B-part-1-division-4" period="#period18">
<num>
<ins class="substitution O024001M015">4.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">A system for the identification of animals and samples, the processing of samples and the delivery of results shall be established which minimises the possibility of human error. The effectiveness of that system shall be subject to regular random checking.</ins>
</p>
</content>
</level>
<level eId="annex-VII-chapter-B-part-1-division-5" period="#period18">
<num>
<ins class="substitution O024001M015">5.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">Genotyping of blood or other tissues collected for the purposes of the breeding programme shall be carried out in laboratories that have been approved under that programme.</ins>
</p>
</content>
</level>
<level eId="annex-VII-chapter-B-part-1-division-6" period="#period18">
<num>
<ins class="substitution O024001M015">6.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">The competent authority of the Member State may assist breed societies, to establish genetic banks consisting of semen, ova and/or embryos representative of prion protein genotypes which are likely to become rare as a result of the breeding programme.</ins>
</p>
</content>
</level>
<level eId="annex-VII-chapter-B-part-1-division-7" period="#period18">
<num>
<ins class="substitution O024001M015">7.</ins>
</num>
<heading>
<ins class="substitution O024001M015">Breeding programmes shall be drawn up for each breed, taking account of:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">frequencies of the different alleles within the breed;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">rarity of the breed;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M015">avoidance of inbreeding or genetic drift.</ins>
</p>
</item>
</blockList>
</content>
</level>
</level>
<level eId="annex-VII-chapter-B-part-2" period="#period18" class="EUPart">
<num>
<ins class="substitution O024001M015">PART 2</ins>
</num>
<heading>
<ins class="substitution O024001M015">Specific rules for participating flocks</ins>
</heading>
<level eId="annex-VII-chapter-B-part-2-division-1" period="#period18">
<num>
<ins class="substitution O024001M015">1.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">The breeding programme shall be aimed at increasing the frequency of the ARR allele within the sheep flock, while reducing the prevalence of those alleles which have been shown to contribute to susceptibility to TSEs.</ins>
</p>
</content>
</level>
<level eId="annex-VII-chapter-B-part-2-division-2" period="#period18">
<num>
<ins class="substitution O024001M015">2.</ins>
</num>
<heading>
<ins class="substitution O024001M015">The minimum requirements for participating flocks shall be the following:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">all animals in the flock that are to be genotyped shall be individually identified using secure means;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">all rams intended for breeding within the flock to shall be genotyped before being used for breeding;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M015">any male animal carrying the VRQ allele shall be slaughtered or castrated, within six months following the determination of its genotype; any such animal shall not leave the holding except for slaughter;</ins>
</p>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M015">female animals that are known to carry the VRQ allele shall not leave the holding except for slaughter;</ins>
</p>
</item>
<item>
<num>(e)</num>
<p>
<ins class="substitution O024001M015">male animals, including semen donors used for artificial insemination, other than those certified under the breeding programme, shall not be used for breeding within the flock.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-VII-chapter-B-part-2-division-3" period="#period18">
<num>
<ins class="substitution O024001M015">3.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">Member States may decide to grant derogations from the requirements set out in point 2(c) and (d) for the purposes of protection of breeds and production traits.</ins>
</p>
</content>
</level>
<level eId="annex-VII-chapter-B-part-2-division-4" period="#period18">
<num>
<ins class="substitution O024001M015">4.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M015">Member States shall inform the Commission of derogations granted under point 3 and of the criteria used.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-VII-chapter-B-part-3" period="#period18" class="EUPart">
<num>
<ins class="substitution O024001M015">PART 3</ins>
</num>
<heading>
<ins class="substitution O024001M015">The framework for the recognition of the TSE-resistant status of flocks of sheep</ins>
</heading>
<level eId="annex-VII-chapter-B-part-3-division-1" period="#period18">
<num>
<ins class="substitution O024001M015">1.</ins>
</num>
<heading>
<ins class="substitution O024001M015">The framework shall recognise the TSE-resistant status of flocks of sheep that as a result of participation in the breeding programme as provided for in Article 6a, satisfy the criteria required in the programme.</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M015">This recognition shall be granted on at least the following two levels:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">level I flocks shall be flocks composed entirely of sheep of the ARR/ARR genotype;</ins>
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</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">level II flocks shall be flocks whose progeny have been sired exclusively by rams of the ARR/ARR genotype.</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O024001M015">Member States may decide to grant recognition on further levels to suit national requirements.</ins>
</p>
</content>
</level>
<level eId="annex-VII-chapter-B-part-3-division-2" period="#period18">
<num>
<ins class="substitution O024001M015">2.</ins>
</num>
<heading>
<ins class="substitution O024001M015">Regular random sampling of sheep from TSE-resistant flocks shall be carried out:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M015">on the farm or at the slaughterhouse to verify their genotype;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M015">in the case of level I flocks, in animals over 18 months of age at the slaughterhouse, for TSE testing in accordance with Annex III.</ins>
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</item>
</blockList>
</content>
</level>
</level>
<level eId="annex-VII-chapter-B-part-4" period="#period18" class="EUPart">
<num>
<ins class="substitution O024001M015">PART 4</ins>
</num>
<heading>
<ins class="substitution O024001M015">Reports to be provided to the Commission by the Member States</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M015 last">Member States introducing national breeding programmes to select for resistance to TSE in their ovine populations shall notify to the Commission the requirements for such programmes and shall provide an annual report on their progress. The report for each calendar year shall be submitted at the latest by 31 March of the following year.</ins>
</p>
</content>
</level>
</level>
</hcontainer>
<hcontainer name="schedule" eId="annex-VIII" period="#period25">
<num>ANNEX VIII</num>
<heading>PLACING ON THE MARKET AND EXPORT</heading>
<chapter eId="annex-VIII-chapter-A" period="#period25">
<num>
<ins class="substitution O007001M002 first">
<noteRef href="#c000015" marker="F12" class="commentary attribute F"/>
CHAPTER A
</ins>
</num>
<heading>
<ins class="substitution O007001M002">
<ins class="substitution O014001M003 first last">
<noteRef href="#c000016" marker="F13" class="commentary attribute F"/>
Conditions for intra-Community trade in live animals, semen and embryos
</ins>
</ins>
</heading>
<level eId="annex-VIII-chapter-A-division-I" period="#period18">
<num>
<ins class="substitution O007001M002">
<ins class="substitution O024001M004 first">
<noteRef href="#c000006" marker="F3" class="commentary attribute F"/>
I.
</ins>
</ins>
</num>
<heading>
<ins class="substitution O007001M002">
<ins class="substitution O024001M004 last">CONDITIONS WHICH APPLY TO OVINE.AND CAPRINE.ANIMALS AND SEMEN AND EMBRYOS TREREOF</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O007001M002">The following conditions shall apply to trade in ovine and caprine animals:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001 first">
<noteRef href="#c000017" marker="F14" class="commentary attribute F"/>
ovine and caprine animals for breeding shall either be sheep of the ARR/ARR prion protein genotype, as defined in Annex I of Commission Decision 2002/1003/EC
</ins>
</ins>
<noteRef href="#f00030" class="footnote" marker="30"/>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">, or they shall have been kept continuously since birth or for the last three years on a holding or holdings which have satisfied the following requirements for at least three years:</ins>
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<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">until </ins>
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<ins class="substitution O007001M002">
<ins class="substitution O013001M001">30 June 2007</ins>
</ins>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">:</ins>
</ins>
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<blockList class="unordered">
<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">it is subject to regular official veterinary checks,</ins>
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<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">the animals are marked,</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">no case of scrapie has been confirmed,</ins>
</ins>
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<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">checking by sampling of old female animals intended for slaughter is carried out,</ins>
</ins>
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<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">females, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.</ins>
</ins>
</p>
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</blockList>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">From </ins>
</ins>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">1 July 2004</ins>
</ins>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001"> at the latest, the holding or holdings shall begin to satisfy the following additional requirements:</ins>
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<blockList class="unordered">
<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding shall be examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b), and</ins>
</ins>
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<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, shall be introduced into the holding only if they come from a holding which complies with the same requirements.</ins>
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</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">from </ins>
</ins>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">1 July 2007</ins>
</ins>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">:</ins>
</ins>
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<blockList class="unordered">
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<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">it is subject to regular official veterinary checks,</ins>
</ins>
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<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">the animals are identified in conformity with Community legislation,</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">no case of scrapie has been confirmed,</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">all animals referred to in Annex III, Chapter A, Part II, point 3 over the age of 18 months which have died or been killed on the holding have been examined for scrapie in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001">ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are introduced into the holding only if they come from a holding which complies with the same requirements.</ins>
</ins>
</p>
</item>
</blockList>
</item>
</blockList>
<p>
<ins class="substitution O007001M002">
<ins class="substitution O013001M001 last">If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c), ovine and caprine animals for breeding shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2).</ins>
</ins>
</p>
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<item>
<num>(b)</num>
<p>
<ins class="substitution O007001M002">a Member State which has a compulsory or voluntary national scrapie control program for all or part of its territory:</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O007001M002">may submit the said program to the Commission, outlining in particular:</ins>
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<blockList class="unordered">
<item>
<p>
<ins class="substitution O007001M002">the distribution of the disease in the Member State,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">the reasons for the program, taking into consideration the importance of the disease and the cost/benefit ratio,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">the geographical area in which the program will be implemented,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">the status categories defined for holdings and the standards which must be attained in each such category,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">the test procedures to be used,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">the program monitoring procedures,</ins>
</p>
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<item>
<p>
<ins class="substitution O007001M002">the action to be taken if, for any reason, a holding loses its status,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">the measures to be taken if the results of checks carried out in accordance with the provisions of the program are positive,</ins>
</p>
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</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O007001M002">the program referred to in point (i) may be approved if it complies with the criteria laid down in that point, in accordance with the procedure referred to in Article 24(2). The additional guarantees, general or specific, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the program in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally,</ins>
</p>
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<item>
<num>(iii)</num>
<p>
<ins class="substitution O007001M002">amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2). Amendments to the guarantees which have been defined in accordance with point (ii) may be approved in accordance with that procedure,</ins>
</p>
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</blockList>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O007001M002">where a Member State considers that its territory or part of its territory is free from scrapie:</ins>
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<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O007001M002">it is to submit to the Commission appropriate supporting documentation, setting out in particular:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O007001M002">the history of the occurrence of the disease in its territory,</ins>
</p>
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<item>
<p>
<ins class="substitution O007001M002">the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">the period over which the surveillance was carried out,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O007001M002">the arrangements for verifying the absence of the disease,</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O007001M002">the additional guarantees, general or specific, which may be required in intra-Community trade are to be defined in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally,</ins>
</p>
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<item>
<num>(iii)</num>
<p>
<ins class="substitution O007001M002">the Member State concerned is to notify the Commission of any change in the details specified in point (i) which relate to the disease. The guarantees defined in accordance with point (ii) may, in the light of such notification, be amended or withdrawn in accordance with the procedure referred to in Article 24(2)</ins>
<ins class="substitution O007001M002">
<ins class="substitution O014001M004 first last">
<noteRef href="#c000016" marker="F13" class="commentary attribute F"/>
,
</ins>
</ins>
</p>
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</blockList>
</item>
<item>
<num>(d)</num>
<p>
<ins class="substitution O007001M002">
<ins class="O014001M005 first">
<noteRef href="#c000018" marker="F15" class="commentary attribute F"/>
from
</ins>
</ins>
<ins class="substitution O007001M002">
<ins class="O014001M005">1 January 2005</ins>
</ins>
<ins class="substitution O007001M002">
<ins class="O014001M005"> semen and embryos of ovine and caprine animals shall:</ins>
</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O007001M002">
<ins class="O014001M005">be collected from animals which have been kept continuously since birth or for the last three years of their life on a holding or holdings which have satisfied the requirements of subparagraph (a)(i) or, as appropriate, (a)(ii) for three years or</ins>
</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O007001M002">
<ins class="O014001M005">in the case of ovine semen, be collected from male animals of the ARR/ARR prion protein genotype as defined in Annex I to Commission Decision 2002/1003/EC</ins>
</ins>
<noteRef href="#f00031" class="footnote" marker="31"/>
<ins class="substitution O007001M002">
<ins class="O014001M005">or</ins>
</ins>
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<num>(iii)</num>
<p>
<ins class="substitution O007001M002 last">
<ins class="O014001M005 last">in the case of ovine embryos, be of the ARR/ARR prion protein genotype as defined in Annex I to Decision 2002/1003/EC.</ins>
</ins>
</p>
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</item>
</blockList>
</content>
</level>
<level eId="annex-VIII-chapter-A-division-II" period="#period18">
<num>
<ins class="substitution O024001M005 first">
<noteRef href="#c000006" marker="F3" class="commentary attribute F"/>
II.
</ins>
</num>
<heading>
<ins class="substitution O024001M005">CONDITIONS WICH APPLY TO BOVINE ANIMALS</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M005">The United Kingdom shall ensure that bovine animals born or reared on its territory before </ins>
<ins class="substitution O024001M005">1 August 1996</ins>
<ins class="substitution O024001M005 last"> are not dispatched from its territory to other Member States or third countries.</ins>
</p>
</content>
</level>
</chapter>
<chapter eId="annex-VIII-chapter-B" period="#period1">
<num>CHAPTER B</num>
<level eId="annex-VIII-chapter-B-division-1" period="#period1">
<heading>Conditions relating to progeny of TSE suspect or confirmed animals referred to in Article 15(2)</heading>
<content>
<p>It shall be prohibited to place on the market the last-born progeny to which female bovine animals infected with a TSE or BSE-confirmed ovine or caprine animals gave birth during the preceding two-year period or during the period that followed the appearance of the first clinical signs of the onset of the disease.</p>
</content>
</level>
</chapter>
<chapter eId="annex-VIII-chapter-C" period="#period31">
<num>
<ins class="substitution O024001M006 first">
<noteRef href="#c000006" marker="F3" class="commentary attribute F"/>
CHAPTER C
</ins>
</num>
<heading>
<ins class="substitution O024001M006">Conditions for intra-Community trade in certain products of animal origin</ins>
</heading>
<section eId="annex-VIII-chapter-C-section-A" period="#period18">
<num>
<ins class="substitution O024001M006">SECTION A</ins>
</num>
<heading>
<ins class="substitution O024001M006">Products</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M006">The following products of animal origin are exempt from the prohibition referred to in Article 16(3), provided that they are derived from bovine, ovine and caprine animals that satisfy the requirements of Section B:</ins>
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<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M006">fresh meat,</ins>
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<ins class="substitution O024001M006">minced meat,</ins>
</p>
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<p>
<ins class="substitution O024001M006">meat preparations,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M006">meat products.</ins>
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</section>
<section eId="annex-VIII-chapter-C-section-B" period="#period18">
<num>
<ins class="substitution O024001M006">SECTION B</ins>
</num>
<heading>
<ins class="substitution O024001M006">Requirements</ins>
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<blockList class="ordered">
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<num>(a)</num>
<p>
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</item>
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<num>(b)</num>
<p>
<ins class="substitution O024001M006">the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;</ins>
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<ins class="substitution O024001M006">the products of bovine, ovine and caprine animal origin are not derived from:</ins>
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<p>
<ins class="substitution O024001M006">specified risk material as defined in Annex V;</ins>
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<p>
<ins class="substitution O024001M006">nervous and lymphatic tissues exposed during the deboning process; and</ins>
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<p>
<ins class="substitution O024001M006 last">mechanically separated meat obtained from bones of bovine, ovine or caprine animals.</ins>
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</item>
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</content>
</section>
</chapter>
<chapter eId="annex-VIII-chapter-D" period="#period3">
<num>CHAPTER D</num>
<level eId="annex-VIII-chapter-D-division-1" period="#period3">
<heading>Conditions applicable to exports</heading>
<content>
<p>Live bovine animals and products of animal origin derived therefrom are to be subject — as regards exports to third countries — to the rules laid down in this Regulation for intra-Community trade.</p>
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</level>
</chapter>
</hcontainer>
<hcontainer name="schedule" eId="annex-IX" period="#period32">
<num>ANNEX IX</num>
<heading>IMPORTATION INTO THE COMMUNITY OF LIVE ANIMALS, EMBRYOS, OVA AND PRODUCTS OF ANIMAL ORIGIN</heading>
<chapter eId="annex-IX-chapter-A" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
CHAPTER A
</num>
<content>
<p>
<del class="O024001M007000 first last">
<noteRef href="#c000019" marker="F16" class="commentary F"/>
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
</del>
</p>
</content>
</chapter>
<chapter eId="annex-IX-chapter-B" period="#period29">
<num>
<ins class="substitution O024001M008 first">
<noteRef href="#c000006" marker="F3" class="commentary attribute F"/>
CHAPTER B
</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports of bovine animals</ins>
</heading>
<section eId="annex-IX-chapter-B-section-A" period="#period29">
<num>
<ins class="substitution O024001M008">SECTION A</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports from a country or a region with a negligible BSE risk</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M008">Imports of bovine animals from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:</ins>
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<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M008">the animals were born and continuously reared in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M008">the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, part I, point (4) (b) (iv) of Annex II; and</ins>
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<num>(c)</num>
<p>
<ins class="substitution O024001M008">if there have been BSE indigenous cases in the country concerned, the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.</ins>
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<section eId="annex-IX-chapter-B-section-B" period="#period29">
<num>
<ins class="substitution O024001M008">SECTION B</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports from a country or a region with a controlled BSE risk</ins>
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<content>
<p>
<ins class="substitution O024001M008">Imports of bovine animals from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that:</ins>
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<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M008">the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M008">the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of Annex II;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M008">the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.</ins>
</p>
</item>
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</content>
</section>
<section eId="annex-IX-chapter-B-section-C" period="#period29">
<num>
<ins class="substitution O024001M008">SECTION C</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports from a country or a region with undetermined BSE risk</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M008">Imports of bovine animals from a country or a region with an undetermined BSE risk shall be subject to the presentation of an animal health certificate attesting that:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M008">the country or region has not been categorized in accordance with Article 5(2) of Regulation (EC) No 999/2001 or has been categorized as a country or region with undetermined BSE risk;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M008">the animals are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not exposed bovine animals as described in Chapter C, Part II, point (4)(b)(iv) of Annex II;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M008">the animals were born at least two years after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been effectively enforced or after the date of birth of the last BSE indigenous case if born after the date of the feed ban.</ins>
</p>
</item>
</blockList>
</content>
</section>
</chapter>
<chapter eId="annex-IX-chapter-C" period="#period33">
<num>
<ins class="substitution O024001M008">CHAPTER C</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports of products of animal origin from bovine, ovine or caprine animals</ins>
</heading>
<section eId="annex-IX-chapter-C-section-A" period="#period33">
<num>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001 first">
<noteRef href="#c000020" marker="F17" class="commentary attribute F"/>
SECTION A
</ins>
</ins>
</num>
<heading>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001">Products</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001">The following products of bovine, ovine and caprine animal origin, as defined by Regulation (EC) No 853/2004 of the European Parliament and of the Council</ins>
</ins>
<noteRef href="#f00032" class="footnote" marker="32"/>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001"> shall be subject to the conditions laid down in Sections B, C and D depending on the BSE risk category of the country of origin:</ins>
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<blockList class="unordered">
<item>
<p>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001">fresh meat,</ins>
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<item>
<p>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001">minced meat and meat preparations,</ins>
</ins>
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<item>
<p>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001">meat products,</ins>
</ins>
</p>
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<item>
<p>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001">treated intestines,</ins>
</ins>
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<item>
<p>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001">rendered animal fats,</ins>
</ins>
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<item>
<p>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001">greaves, and</ins>
</ins>
</p>
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<item>
<p>
<ins class="substitution O024001M008">
<ins class="substitution O025001M001 last">gelatine.</ins>
</ins>
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</content>
</section>
<section eId="annex-IX-chapter-C-section-B" period="#period29">
<num>
<ins class="substitution O024001M008">SECTION B</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports from a country or a region with a negligible BSE risk</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M008">Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with a negligible BSE risk shall be subject to the presentation of an animal health certificate attesting that:</ins>
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<blockList class="ordered">
<item>
<num>(a)</num>
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<ins class="substitution O024001M008">the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M008">the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M008">if in the country or region there have been BSE indigenous cases:</ins>
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<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M008">the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or</ins>
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</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M008">the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.</ins>
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</item>
</blockList>
</item>
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</content>
</section>
<section eId="annex-IX-chapter-C-section-C" period="#period34">
<num>
<ins class="substitution O024001M008">SECTION C</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports from a country or a region with a controlled BSE risk</ins>
</heading>
<level eId="annex-IX-chapter-C-section-C-division-1" period="#period29">
<num>
<ins class="substitution O024001M008">1.</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports of products of bovine, ovine and caprine animal origin referred to in section A from a country or a region with a controlled BSE risk shall be subject to the presentation of an animal health certificate attesting that:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M008">the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M008">the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M008">animals from which the products of bovine, ovine and caprine animal origin destined for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;</ins>
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<item>
<num>(d)</num>
<p>
<ins class="substitution O024001M008">the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.</ins>
</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-IX-chapter-C-section-C-division-2" period="#period29">
<num>
<ins class="substitution O024001M008">2.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M008">By way of derogation from point 1(d) carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported.</ins>
</p>
</content>
</level>
<level eId="annex-IX-chapter-C-section-C-division-3" period="#period29">
<num>
<ins class="substitution O024001M008">3.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M008">When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a blue stripe on the label referred to in Regulation (EC) No 1760/2000.</ins>
</p>
</content>
</level>
<level eId="annex-IX-chapter-C-section-C-division-4" period="#period29">
<num>
<ins class="substitution O024001M008">4.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M008">The number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as he number where removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.</ins>
</p>
</content>
</level>
<level eId="annex-IX-chapter-C-section-C-division-5" period="#period34">
<num>
<ins class="substitution O024001M008">
<ins class="O025001M002 first">
<noteRef href="#c000021" marker="F18" class="commentary attribute F"/>
5.
</ins>
</ins>
</num>
<heading>
<ins class="substitution O024001M008">
<ins class="O025001M002">In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the presentation of an animal health certificate attesting that:</ins>
</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M008">
<ins class="O025001M002">the country or region is classified in accordance with Article 5(2) as a country or region posing a controlled BSE risk;</ins>
</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M008">
<ins class="O025001M002">the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed </ins>
</ins>
<em>
<ins class="substitution O024001M008">
<ins class="O025001M002">ante-mortem</ins>
</ins>
</em>
<ins class="substitution O024001M008">
<ins class="O025001M002"> and </ins>
</ins>
<em>
<ins class="substitution O024001M008">
<ins class="O025001M002">post-mortem</ins>
</ins>
</em>
<ins class="substitution O024001M008">
<ins class="O025001M002"> inspections;</ins>
</ins>
</p>
</item>
<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M008">
<ins class="O025001M002">if the intestines are sourced from a country or region where there have been BSE indigenous cases:</ins>
</ins>
</p>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M008">
<ins class="O025001M002">the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or</ins>
</ins>
</p>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M008">
<ins class="O025001M002 last">the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V.</ins>
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</section>
<section eId="annex-IX-chapter-C-section-D" period="#period34">
<num>
<ins class="substitution O024001M008">SECTION D</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports from a country or a region with an undetermined BSE risk</ins>
</heading>
<level eId="annex-IX-chapter-C-section-D-division-1" period="#period29">
<num>
<ins class="substitution O024001M008">1.</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports of products of bovine, ovine and caprine animal origin referred to in Section A from a country or a region with an undetermined BSE risk, shall be subject to the presentation of an animal health certificate attesting that:</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M008">the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;</ins>
</p>
</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M008">the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;</ins>
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<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M008">the products of bovine, ovine and caprine animal origin are not derived from:</ins>
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<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O024001M008">specified risk material as defined in Annex V;</ins>
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<item>
<num>(ii)</num>
<p>
<ins class="substitution O024001M008">nervous and lymphatic tissues exposed during the deboning process;</ins>
</p>
</item>
<item>
<num>(iii)</num>
<p>
<ins class="substitution O024001M008">mechanically separated meat obtained from bones of bovine, ovine or caprine animals.</ins>
</p>
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</blockList>
</item>
</blockList>
</content>
</level>
<level eId="annex-IX-chapter-C-section-D-division-2" period="#period29">
<num>
<ins class="substitution O024001M008">2.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M008">By way of derogation from point 1(c), carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported.</ins>
</p>
</content>
</level>
<level eId="annex-IX-chapter-C-section-D-division-3" period="#period29">
<num>
<ins class="substitution O024001M008">3.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M008">When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column, shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000.</ins>
</p>
</content>
</level>
<level eId="annex-IX-chapter-C-section-D-division-4" period="#period29">
<num>
<ins class="substitution O024001M008">4.</ins>
</num>
<content>
<p>
<ins class="substitution O024001M008">Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required and from which removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.</ins>
</p>
</content>
</level>
<level eId="annex-IX-chapter-C-section-D-division-5" period="#period34">
<num>
<ins class="substitution O024001M008">
<ins class="O025001M003 first">
<noteRef href="#c000021" marker="F18" class="commentary attribute F"/>
5.
</ins>
</ins>
</num>
<heading>
<ins class="substitution O024001M008">
<ins class="O025001M003">In the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the presentation of an animal health certificate attesting that:</ins>
</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M008">
<ins class="O025001M003">the country or region is classified in accordance with Article 5(2) as a country or region posing an undetermined BSE risk;</ins>
</ins>
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<num>(b)</num>
<p>
<ins class="substitution O024001M008">
<ins class="O025001M003">the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed </ins>
</ins>
<em>
<ins class="substitution O024001M008">
<ins class="O025001M003">ante-mortem</ins>
</ins>
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<ins class="substitution O024001M008">
<ins class="O025001M003"> and </ins>
</ins>
<em>
<ins class="substitution O024001M008">
<ins class="O025001M003">post-mortem</ins>
</ins>
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<ins class="substitution O024001M008">
<ins class="O025001M003"> inspections;</ins>
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<ins class="O025001M003">if the intestines are sourced from a country or region where there have been BSE indigenous cases:</ins>
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<blockList class="ordered">
<item>
<num>(i)</num>
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<ins class="substitution O024001M008">
<ins class="O025001M003">the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or</ins>
</ins>
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<num>(ii)</num>
<p>
<ins class="substitution O024001M008">
<ins class="O025001M003 last">the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V.</ins>
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</section>
</chapter>
<chapter eId="annex-IX-chapter-D" period="#period21">
<num>
<ins class="substitution O024001M008">CHAPTER D</ins>
</num>
<heading>
<ins class="substitution O024001M008">Imports of animal by-products and processed products derived therefrom from bovine, ovine and caprine animal origin</ins>
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<section eId="annex-IX-chapter-D-section-A" period="#period23">
<num>
<ins class="substitution O024001M008">SECTION A</ins>
</num>
<heading>
<ins class="substitution O024001M008">Animal by-products</ins>
</heading>
<content>
<p>
<ins class="substitution O024001M008">This Chapter shall apply to the following animal by-products and processed products derived therefrom from bovine, ovine and caprine animal origin as referred to in Regulation (EC) No 1774/2002:</ins>
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<item>
<p>
<ins class="substitution O024001M008">rendered fats,</ins>
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<item>
<p>
<ins class="substitution O024001M008">pet food,</ins>
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</item>
<item>
<p>
<ins class="substitution O024001M008">blood products,</ins>
</p>
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<item>
<p>
<ins class="substitution O024001M008">the processed animal protein,</ins>
</p>
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<item>
<p>
<ins class="substitution O024001M008">bones and bone products,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M008">category 3 material, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O024001M008">gelatine.</ins>
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</section>
<section eId="annex-IX-chapter-D-section-B" period="#period21">
<num>
<ins class="substitution O024001M008">SECTION B</ins>
</num>
<content>
<p>
<ins class="substitution O024001M008">Imports of the animal by-products processed products derived therefrom from bovine, ovine and caprine animal origin referred to in Section A. shall be subject to the presentation of an animal health certificate attesting that:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O024001M008">the animal by-product does not contain and is not derived from specified risk material as defined in Annex V or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;</ins>
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</item>
<item>
<num>(b)</num>
<p>
<ins class="substitution O024001M008">the animals from which this animal by-product is derived, have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity,</ins>
</p>
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<ins class="substitution O024001M008">or</ins>
</p>
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<item>
<num>(c)</num>
<p>
<ins class="substitution O024001M008 last">the animal by-product does not contain and is not derived from bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a negligible BSE risk.</ins>
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</chapter>
<chapter eId="annex-IX-chapter-E" period="#period25">
<num>
<ins class="substitution O009001M003 first">
<noteRef href="#c000022" marker="F19" class="commentary attribute F"/>
CHAPTER E
</ins>
</num>
<heading>
<ins class="substitution O009001M003">Imports of ovine and caprine animals</ins>
</heading>
<content>
<p>
<ins class="substitution O009001M003">Ovine and caprine animals imported into the Community after </ins>
<ins class="substitution O009001M003">1 October 2003</ins>
<ins class="substitution O009001M003"> are to be subject to the presentation of an animal health certificate attesting that:</ins>
</p>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>
<ins class="substitution O009001M003">either they were born in and continuously reared on holdings in which a case of scrapie has never been diagnosed, and, in the case of ovine and caprine animals for breeding, they satisfy the requirements of subparagraph (i) of point (a) of Chapter A(I) of Annex VIII;</ins>
</p>
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<num>(b)</num>
<p>
<ins class="substitution O009001M003">or they are sheep of the ARR/ARR prion protein genotype, as defined in Annex I to Commission Decision 2002/1003/EC, coming from a holding where no case of scrapie has been reported in the last six months.</ins>
</p>
</item>
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<p>
<ins class="substitution O009001M003 last">If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of Annex VIII, they shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2).</ins>
</p>
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</chapter>
<chapter eId="annex-IX-chapter-F" period="#period29">
<num>
<ins class="substitution O024001M009 first">
<noteRef href="#c000006" marker="F3" class="commentary attribute F"/>
CHAPTER F
</ins>
</num>
<heading>
<ins class="substitution O024001M009">Imports of products of animal origin from farmed and wild cervid animals</ins>
</heading>
<level eId="annex-IX-chapter-F-division-1" period="#period29">
<num>
<ins class="substitution O024001M009">1.</ins>
</num>
<heading>
<ins class="substitution O024001M009">When fresh meat, minced meat, meat preparations and meat products as defined by Regulation (EC) No 853/2004, derived from farmed cervid animals, are imported into the Community from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows:</ins>
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<content>
<p class="BlockAmendment">
<mod>
<quotedStructure class="unknown unknown unknown single" startQuote="" endQuote="">
<p>
<ins class="substitution O024001M009"/>
<ins class="substitution O024001M009">This product contains or is derived exclusively from meat, excluding offal and spinal cord, of farmed cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognized by the competent authority with negative results and is not derived from animals coming from a herd where chronic wasting disease has been confirmed or is officially suspected.</ins>
<ins class="substitution O024001M009"/>
</p>
</quotedStructure>
</mod>
</p>
</content>
</level>
<level eId="annex-IX-chapter-F-division-2" period="#period29">
<num>
<ins class="substitution O024001M009">2.</ins>
</num>
<heading>
<ins class="substitution O024001M009">When fresh meat, minced meat, meat preparations and meat products as defined by Regulation (EC) No 853/2004, derived from wild cervid animals, are imported into the Community from Canada or the United States of America, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows:</ins>
</heading>
<content>
<p class="BlockAmendment">
<mod>
<quotedStructure class="unknown unknown unknown single" startQuote="" endQuote="">
<p>
<ins class="substitution O024001M009"/>
<ins class="substitution O024001M009">This product contains or is derived exclusively from meat, excluding offal and spinal cord, of wild cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognized by the competent authority with negative results and is not derived from animals coming from a region where chronic wasting disease has been confirmed in the last three years or is officially suspected.</ins>
<ins class="substitution O024001M009 last"/>
</p>
</quotedStructure>
</mod>
</p>
</content>
</level>
</chapter>
<chapter eId="annex-IX-chapter-G" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
CHAPTER G
</num>
<content>
<p>
<del class="O024001M010000 first">
<noteRef href="#c000019" marker="F16" class="commentary F"/>
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
</del>
</p>
<p>
<del class="O024001M010000 last">
<noteRef href="#c000019" marker="F16" class="commentary F"/>
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
</del>
</p>
</content>
</chapter>
<chapter eId="annex-IX-chapter-H" period="#period7">
<num>
<ins class="O014001M006 first">
<noteRef href="#c000018" marker="F15" class="commentary attribute F"/>
CHAPTER H
</ins>
</num>
<heading>
<ins class="O014001M006">Import of ovine and caprine semen and embryos</ins>
</heading>
<content>
<p>
<ins class="O014001M006">Semen and embryos of ovine and caprine animals imported into the Community from </ins>
<ins class="O014001M006">1 January 2005</ins>
<ins class="O014001M006 last"> shall satisfy the requirements of Annex VIII, Chapter A(I)(d).</ins>
</p>
</content>
</chapter>
</hcontainer>
<hcontainer name="schedule" eId="annex-X" period="#period38">
<num>ANNEX X</num>
<heading>REFERENCE LABORATORIES, SAMPLING AND LABORATORY ANALYSIS METHODS</heading>
<chapter eId="annex-X-chapter-A" period="#period17">
<num>CHAPTER A</num>
<heading>National reference laboratories</heading>
<level eId="annex-X-chapter-A-division-1" period="#period1">
<num>1.</num>
<heading>The designated national reference laboratory is to:</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>have at its disposal facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type and strain of the agent of TSE, and to confirm results obtained by regional diagnostic laboratories. Where it is not capable of identifying the strain-type of the agent, it shall set up a procedure to ensure that the identification of the strain is referred to the Community reference laboratory;</p>
</item>
<item>
<num>(b)</num>
<p>verify diagnostic methods used in regional diagnostic laboratories;</p>
</item>
<item>
<num>(c)</num>
<p>be responsible for coordination of diagnostic standards and methods within the Member State. To this end, it:</p>
<blockList class="unordered">
<item>
<p>may provide diagnostic reagents to laboratories approved by the Member State;</p>
</item>
<item>
<p>is to control the quality of all diagnostic reagents used in the Member State;</p>
</item>
<item>
<p>is to periodically arrange comparative tests;</p>
</item>
<item>
<p>is to hold isolates of the agents of the disease in question, or corresponding tissues containing such agents, coming from cases confirmed in the Member State;</p>
</item>
<item>
<p>is to ensure confirmation of results obtained in diagnostic laboratories designated by the Member State;</p>
</item>
</blockList>
</item>
<item>
<num>(d)</num>
<p>is to cooperate with the Community reference laboratory.</p>
</item>
</blockList>
</content>
</level>
<level eId="annex-X-chapter-A-division-2" period="#period1">
<num>2.</num>
<content>
<p>However, by way of derogation from point 1, Member States which do not have a national reference laboratory are to use the services of the Community reference laboratory or of national reference laboratories in other Member States.</p>
</content>
</level>
<level eId="annex-X-chapter-A-division-3" period="#period17">
<num>
<ins class="substitution O019001M001 first">
<noteRef href="#c000023" marker="F20" class="commentary attribute F"/>
3.
</ins>
</num>
<heading>
<ins class="substitution O019001M001">The national reference laboratories are:</ins>
</heading>
<content>
<tblock class="tabular">
<table>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Austria:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH, Institut für veterinärmedizinische Untersuchungen Mödling</ins>
</p>
<p>
<ins class="substitution O019001M001">Robert Koch Gasse 17</ins>
</p>
<p>
<ins class="substitution O019001M001">A-2340 Mödling</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Belgium:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">CERVA -CODA-VAR</ins>
</p>
<p>
<ins class="substitution O019001M001">Centre d'Étude et de Recherches Vétérinaires et Agrochimiques</ins>
</p>
<p>
<ins class="substitution O019001M001">Centrum voor Onderzoek in Diergeneeskunde en Agrochemie</ins>
</p>
<p>
<ins class="substitution O019001M001">Veterinary and Agrochemical Research Centre</ins>
</p>
<p>
<ins class="substitution O019001M001">Groeselenberg 99</ins>
</p>
<p>
<ins class="substitution O019001M001">B-1180 Bruxelles</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M001 first">
<noteRef href="#c000024" marker="F21" class="commentary attribute F"/>
Bulgaria:
</ins>
</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">
<ins class="O023001M001">Национален диагностичен научноизследователски ветеринарномедицински институт </ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"></ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001">Проф. Д-р Георги Павлов</ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"></ins>
</ins>
</p>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M001">Национална референтна лаборатория </ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"></ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001">Tрансмисивни спонгиформни енцефалопатии</ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"></ins>
</ins>
</p>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M001">бул. </ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"></ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001">Пенчо Славейков</ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"></ins>
</ins>
</p>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M001">София 1606</ins>
</ins>
</p>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M001">(National Diagnostic Veterinary Research Institute </ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"></ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001">Prof. Dr. Georgi Pavlov</ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"></ins>
</ins>
<ins class="substitution O019001M001">
<ins class="O023001M001"> National Reference Laboratory for Transmissible Spongiform Encephalopathies</ins>
</ins>
</p>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M001">15, Pencho Slaveykov Blvd.</ins>
</ins>
</p>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M001 last">1606 Sofia)</ins>
</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Cyprus:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">State Veterinary Laboratories</ins>
</p>
<p>
<ins class="substitution O019001M001">Veterinary Services</ins>
</p>
<p>
<ins class="substitution O019001M001">CY-1417 Athalassa</ins>
</p>
<p>
<ins class="substitution O019001M001">Nicosia</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Czech Republic:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Státní veterinární ústav Jihlava</ins>
</p>
<p>
<ins class="substitution O019001M001">Rantířovská 93</ins>
</p>
<p>
<ins class="substitution O019001M001">586 05 Jihlava</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Denmark:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Danmarks Fødevareforskning</ins>
</p>
<p>
<ins class="substitution O019001M001">Bülowsvej 27</ins>
</p>
<p>
<ins class="substitution O019001M001">DK-1790 København V</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Estonia:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Veterinaar- ja Toidulaboratoorium</ins>
</p>
<p>
<ins class="substitution O019001M001">Kreutzwaldi 30</ins>
</p>
<p>
<ins class="substitution O019001M001">Tartu 51006</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Finland:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Eläinlääkintä- ja elintarvikelaitos</ins>
</p>
<p>
<ins class="substitution O019001M001">Hämeentie 57</ins>
</p>
<p>
<ins class="substitution O019001M001">FIN-00550 Helsinki</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">France:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Agence française de sécurité sanitaire des aliments</ins>
</p>
<p>
<ins class="substitution O019001M001">Laboratoire de pathologie bovine</ins>
</p>
<p>
<ins class="substitution O019001M001">31, avenue Tony Garnier</ins>
</p>
<p>
<ins class="substitution O019001M001">69 364 LYON CEDEX 07</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Germany:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Friedrich-Loeffler-Institut, Bundesforschungsinstitut für Tiergesundheit</ins>
</p>
<p>
<ins class="substitution O019001M001">Anstaltsteil Insel Riems Boddenblick 5A</ins>
</p>
<p>
<ins class="substitution O019001M001">D-17498 Insel Riems</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Greece:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Ministry of Agriculture — Veterinary Laboratory of Larisa</ins>
</p>
<p>
<ins class="substitution O019001M001">7th km of Larisa — Trikala Highway</ins>
</p>
<p>
<ins class="substitution O019001M001">GR-411 10 Larisa</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Hungary:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Országos Állategészségügyi Intézet (OÁI)</ins>
</p>
<p>
<ins class="substitution O019001M001">Pf. 2.</ins>
</p>
<p>
<ins class="substitution O019001M001">Tábornok u. 2.</ins>
</p>
<p>
<ins class="substitution O019001M001">H-1581 Budapest</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Ireland:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Central Veterinary Research Laboratory</ins>
</p>
<p>
<ins class="substitution O019001M001">Young's Cross</ins>
</p>
<p>
<ins class="substitution O019001M001">Celbridge</ins>
</p>
<p>
<ins class="substitution O019001M001">Co. Kildare</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Italy:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d’Aosta — CEA</ins>
</p>
<p>
<ins class="substitution O019001M001">Via Bologna, 148</ins>
</p>
<p>
<ins class="substitution O019001M001">I-10154 Torino</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Latvia:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">State Veterinary Medicine Diagnostic Centre</ins>
</p>
<p>
<ins class="substitution O019001M001">Lejupes Str. 3</ins>
</p>
<p>
<ins class="substitution O019001M001">Riga LV 1076</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Lithuania:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Nacionalinė veterinarijos laboratorija</ins>
</p>
<p>
<ins class="substitution O019001M001">J. Kairiūkščio g. 10</ins>
</p>
<p>
<ins class="substitution O019001M001">LT-08409 Vilnius</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Luxembourg:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">CERVA -CODA-VAR</ins>
</p>
<p>
<ins class="substitution O019001M001">Centre d'Étude et de Recherches Vétérinaires et Agrochimiques</ins>
</p>
<p>
<ins class="substitution O019001M001">Centrum voor Onderzoek in Diergeneeskunde en Agrochemie</ins>
</p>
<p>
<ins class="substitution O019001M001">Veterinary and Agrochemical Research Centre</ins>
</p>
<p>
<ins class="substitution O019001M001">Groeselenberg 99</ins>
</p>
<p>
<ins class="substitution O019001M001">B-1180 Bruxelles</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Malta:</ins>
</p>
</td>
<td>
<p>
<ins class="substitution O019001M001">National Veterinary Laboratory</ins>
</p>
<p>
<ins class="substitution O019001M001">Albert Town Marsa</ins>
</p>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Netherlands:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Centraal Instituut voor Dierziektecontrole-Lelystad</ins>
</p>
<p>
<ins class="substitution O019001M001">Houtribweg 3g</ins>
</p>
<p>
<ins class="substitution O019001M001">8221 RA Lelystad</ins>
</p>
<p>
<ins class="substitution O019001M001">Postbus 2004</ins>
</p>
<p>
<ins class="substitution O019001M001">8203 AA Lelystad</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Poland:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Państwowy Instytut Weterynaryjny (PIWet)</ins>
</p>
<p>
<ins class="substitution O019001M001">24-100 Puławy</ins>
</p>
<p>
<ins class="substitution O019001M001">al. Partyzantów 57</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Portugal:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Laboratório Nacional de Investigação Veterinária Estrada de Benfica</ins>
</p>
<p>
<ins class="substitution O019001M001">701 P-1500 Lisboa</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M002 first">
<noteRef href="#c000024" marker="F21" class="commentary attribute F"/>
Romania:
</ins>
</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">
<ins class="O023001M002">Institutul de Diagnostic și Sănătate Animală</ins>
</ins>
</p>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M002">Strada Dr. Staicovici nr. 63, sector 5</ins>
</ins>
</p>
<p>
<ins class="substitution O019001M001">
<ins class="O023001M002 last">codul 050557, București.</ins>
</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Slovakia:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">State Veterinary Institute Zvolen</ins>
</p>
<p>
<ins class="substitution O019001M001">Pod dráhami 918</ins>
</p>
<p>
<ins class="substitution O019001M001">SK-960 86, Zvolen</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Slovenia:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">National Veterinary Institute</ins>
</p>
<p>
<ins class="substitution O019001M001">Gerbičeva 60</ins>
</p>
<p>
<ins class="substitution O019001M001">1000 Ljubljana</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Spain:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Laboratorio Central de Veterinaria (Algete)</ins>
</p>
<p>
<ins class="substitution O019001M001">Ctra. de Algete km. 8</ins>
</p>
<p>
<ins class="substitution O019001M001">28110 Algete (Madrid)</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">Sweden:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">National Veterinary Institute</ins>
</p>
<p>
<ins class="substitution O019001M001">S-751 89 Uppsala</ins>
</p>
</blockContainer>
</td>
</tr>
<tr>
<td>
<p>
<ins class="substitution O019001M001">United Kingdom:</ins>
</p>
</td>
<td>
<blockContainer class="BlockText">
<p>
<ins class="substitution O019001M001">Veterinary Laboratories Agency</ins>
</p>
<p>
<ins class="substitution O019001M001">Woodham Lane</ins>
</p>
<p>
<ins class="substitution O019001M001 last">New Haw Addlestone Surrey KT15 3NB</ins>
</p>
</blockContainer>
</td>
</tr>
</table>
</tblock>
</content>
</level>
</chapter>
<chapter eId="annex-X-chapter-B" period="#period2">
<num>CHAPTER B</num>
<heading>Community reference laboratory</heading>
<level eId="annex-X-chapter-B-division-1" period="#period1">
<num>1.</num>
<heading>The Community reference laboratory for TSEs is:</heading>
<content>
<blockContainer class="BlockText">
<p>The Veterinary Laboratories Agency</p>
<p>Woodham Lane</p>
<p>New Haw</p>
<p>Addlestone</p>
<p>Surrey KT15 3NB</p>
<p>United Kingdom</p>
</blockContainer>
</content>
</level>
<level eId="annex-X-chapter-B-division-2" period="#period1">
<num>2.</num>
<heading>The functions and duties of the Community reference laboratory are:</heading>
<content>
<blockList class="ordered">
<item>
<num>(a)</num>
<p>to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing BSE, specifically by:</p>
<blockList class="unordered">
<item>
<p>storing and supplying corresponding tissues containing the agent, for the development or production of the relevant diagnostic tests or for typing strains of the agent;</p>
</item>
<item>
<p>supplying standard sera and other reference reagents to the national reference laboratories in order to standardise the tests and reagents used in the Member States;</p>
</item>
<item>
<p>building up and retaining a collection of corresponding tissues containing the agents and strains of TSEs;</p>
</item>
<item>
<p>organising periodic comparative tests of diagnostic procedures at Community level;</p>
</item>
<item>
<p>collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community;</p>
</item>
<item>
<p>characterising isolates of the TSE agent by the most up-to-date methods to allow greater understanding of the epidemiology of the disease;</p>
</item>
<item>
<p>keeping abreast of trends in surveillance, epidemiology and prevention of TSEs throughout the world;</p>
</item>
<item>
<p>maintaining expertise on prion diseases to enable rapid differential diagnosis;</p>
</item>
<item>
<p>acquiring a thorough knowledge of the preparation and use of diagnostic methods used to control and eradicate TSEs;</p>
</item>
</blockList>
</item>
<item>
<num>(b)</num>
<p>to assist actively in the diagnosis of outbreaks of TSEs in Member States by studying samples from TSE-infected animals sent for confirmatory diagnosis, characterisation and epidemiological studies;</p>
</item>
<item>
<num>(c)</num>
<p>to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community.</p>
</item>
</blockList>
</content>
</level>
</chapter>
<chapter eId="annex-X-chapter-C" period="#period38">
<num>
<ins class="substitution O015001M004 first">
<noteRef href="#c000010" marker="F7" class="commentary attribute F"/>
CHAPTER C
</ins>
</num>
<heading>
<ins class="substitution O015001M004">Sampling and laboratory testing</ins>
</heading>
<level eId="annex-X-chapter-C-division-1" period="#period26">
<num>
<ins class="substitution O015001M004">
<ins class="substitution O024001M016 first">
<noteRef href="#c000005" marker="F2" class="commentary attribute F"/>
1.
</ins>
</ins>
</num>
<heading>
<ins class="substitution O015001M004">
<ins class="substitution O024001M016">Sampling</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O024001M016">Any samples intended to be examined for the presence of a TSE shall be collected using the methods and protocols laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the International Office for Epizooties (IOE/OIE) (the Manual). In addition, or in the absence, of OIE methods and protocols, and to ensure that sufficient material is available, the competent authority shall ensure the use of sampling methods and protocols in accordance with guidelines issued by the Community Reference Laboratory. In particular the competent authority shall collect the appropriate tissues, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE in small ruminants and shall keep at least half of the collected tissues fresh but not frozen until the result of the rapid test is negative. Where the result is positive or inconclusive the residual tissues must be processed in accordance with the Community reference laboratory guidelines.</ins>
</ins>
</p>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O024001M016 last">The samples shall be correctly marked as to the identity of the sampled animal.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-X-chapter-C-division-2" period="#period8">
<num>
<ins class="substitution O015001M004">2.</ins>
</num>
<heading>
<ins class="substitution O015001M004">Laboratories</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">Any laboratory examination for TSE shall be carried out in laboratories approved for that purpose by the competent authority.</ins>
</p>
</content>
</level>
<level eId="annex-X-chapter-C-division-3" period="#period22">
<num>
<ins class="substitution O015001M004">3.</ins>
</num>
<heading>
<ins class="substitution O015001M004">Methods and protocols</ins>
</heading>
<level eId="annex-X-chapter-C-division-3-division-3.1" period="#period5">
<num>
<ins class="substitution O015001M004">3.1.</ins>
</num>
<heading>
<ins class="substitution O015001M004">Laboratory testing for the presence of BSE in bovine animals</ins>
</heading>
<level eId="annex-X-chapter-C-division-3-division-3.1-division-a" period="#period5">
<num>
<ins class="substitution O015001M004">(a)</ins>
</num>
<heading>
<ins class="substitution O015001M004">Suspect cases</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">Samples from bovine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the tissues shall be subjected to an examination by one of the other diagnostic methods laid down in the Manual (immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy). However, rapid tests cannot be used for this purpose.</ins>
</p>
<p>
<ins class="substitution O015001M004">If the result of one of those examinations is positive, the animals shall be regarded a positive BSE case.</ins>
</p>
</content>
</level>
<level eId="annex-X-chapter-C-division-3-division-3.1-division-b" period="#period5">
<num>
<ins class="substitution O015001M004">(b)</ins>
</num>
<heading>
<ins class="substitution O015001M004">BSE monitoring</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">Samples from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part I (Monitoring in bovine animals) shall be examined by a rapid test.</ins>
</p>
<p>
<ins class="substitution O015001M004">When the result of the rapid test is inconclusive or positive, the sample shall immediately be subject to confirmatory examinations in an official laboratory. The confirmatory examination shall start by a histopathological examination of the brainstem as laid down in the latest edition of the Manual, except where the material is autolysed or otherwise not suitable for examination by histopathology. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by one of the other diagnostic methods referred to in (a).</ins>
</p>
<p>
<ins class="substitution O015001M004">An animal shall be regarded a positive BSE case, if the result of the rapid test is positive or inconclusive, and either</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O015001M004">the result of the subsequent histopathological examination is positive, or</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">the result of another diagnostic method referred to in (a) is positive.</ins>
</p>
</item>
</blockList>
</content>
</level>
</level>
<level eId="annex-X-chapter-C-division-3-division-3.2" period="#period22">
<num>
<ins class="substitution O015001M004">3.2.</ins>
</num>
<heading>
<ins class="substitution O015001M004">Laboratory testing for the presence of TSE in ovine and caprine animals</ins>
</heading>
<level eId="annex-X-chapter-C-division-3-division-3.2-division-a" period="#period5">
<num>
<ins class="substitution O015001M004">(a)</ins>
</num>
<heading>
<ins class="substitution O015001M004">Suspect cases</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Article 12(2) shall be subject to a histopathological examination as laid down in the latest edition of the Manual, except where the material is autolysed. Where the result of the histopathological examination is inconclusive or negative or where the material is autolysed, the sample shall be subjected to an examination by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as laid down in the Manual. However, rapid tests cannot be used for this purpose.</ins>
</p>
<p>
<ins class="substitution O015001M004">If the result of one of those examinations is positive, the animal shall be regarded a positive scrapie case.</ins>
</p>
</content>
</level>
<level eId="annex-X-chapter-C-division-3-division-3.2-division-b" period="#period26">
<num>
<ins class="substitution O015001M004">
<ins class="substitution O024001M017 first">
<noteRef href="#c000005" marker="F2" class="commentary attribute F"/>
(b)
</ins>
</ins>
</num>
<heading>
<ins class="substitution O015001M004">
<ins class="substitution O024001M017">TSE monitoring</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O024001M017">Samples from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Part II (Monitoring in ovine and caprine animals) shall be examined by a rapid test using the appropriate methods and protocols, according to the available scientific advice and the guidelines of the Community Reference Laboratory, in order to ensure the detection of all known strains of TSE.</ins>
</ins>
</p>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O024001M017">When the result of the rapid test is inconclusive or positive, the sampled tissues shall immediately be sent to an official laboratory for confirmatory examinations by immunocytochemistry, immuno-blotting or demonstration of characteristic fibrils by electron microscopy, as referred to in (a). If the result of the confirmatory examination is negative or inconclusive, additional confirmatory testing shall be carried out according the guidelines of the Community reference laboratory.</ins>
</ins>
</p>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O024001M017 last">If the result of one of the confirmatory examination is positive, the animal shall be regarded a positive TSE case.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-X-chapter-C-division-3-division-3.2-division-c" period="#period22">
<num>
<ins class="substitution O015001M004">(c)</ins>
</num>
<heading>
<ins class="substitution O015001M004">Further examination of positive scrapie cases</ins>
</heading>
<content>
<blockList class="ordered">
<item>
<num>(i)</num>
<p>
<ins class="substitution O015001M004">Primary molecular testing with a discriminatory immuno-blotting</ins>
</p>
<p>
<ins class="substitution O015001M004">Samples from clinical suspect cases and from animals tested in accordance with Annex III, Chapter A, Part II, points 2 and 3 which are regarded as positive scrapie cases following the examinations referred to in points (a) or (b), or which display characteristics which are deemed by the testing laboratory to merit investigation, shall be forwarded for further examination by a primary molecular typing method to:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O015001M004">Agence Française de Sécurité Sanitaire des Aliments, Laboratoire de pathologie bovine, 31, avenue Tony Garnier, BP 7033, F-69342, Lyon Cedex, France</ins>
<ins class="substitution O015001M004">, or</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">Veterinary Laboratories Agency, Woodham Lane, New Haw, Addlestone, Surrey KT15 3NB, United Kingdom</ins>
<ins class="substitution O015001M004">, or</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">to a laboratory, appointed by the competent authority, which has participated successfully in proficiency testing organised by the Community Reference Laboratory for the use of a molecular typing method, or</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">on a provisional basis until </ins>
<ins class="substitution O015001M004">1 May 2005</ins>
<ins class="substitution O015001M004">, the laboratories approved for this purpose by the CRL panel of experts.</ins>
</p>
</item>
</blockList>
</item>
<item>
<num>(ii)</num>
<p>
<ins class="substitution O015001M004">Ring trial with additional molecular testing methods</ins>
</p>
<p>
<ins class="substitution O015001M004">Samples from scrapie cases in which the presence of BSE cannot be excluded according to the guidelines issued by the Community Reference Laboratory by the primary molecular testing referred to in (i), shall be forwarded immediately to the laboratories listed in point (d) after consultation with the Community Reference Laboratory, and with all the relevant information available. They shall be submitted to a ring trial with at least:</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O015001M004">a second discriminatory immuno-blotting,</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">a discriminatory immunocytochemistry, and</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">a discriminatory ELISA (Enzyme linked ImmunoSorbent Assay)</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O015001M004">carried out in the laboratories approved for the relevant method as listed in point (d). Where samples are unsuitable for immunocytochemistry, the Community Reference Laboratory will direct appropriate alternative testing within the ring trial.</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O015001M004">The results shall be interpreted by the Community Reference Laboratory assisted by a panel of experts including a representative of the relevant National Reference Laboratory. The Commission shall be informed immediately about the outcome of that interpretation. Samples indicative for BSE by three different methods and samples inconclusive in the ring trial shall be further analysed by a mouse bioassay for final confirmation.</ins>
</p>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O024001M018 first last">
<noteRef href="#c000005" marker="F2" class="commentary attribute F"/>
Further testing of positive TSE samples detected in infected flocks on the same holding shall be carried out at least on the first two positive TSE cases detected every year following the index case.
</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-X-chapter-C-division-3-division-3.2-division-d" period="#period4">
<num>
<ins class="substitution O015001M004">(d)</ins>
</num>
<heading>
<ins class="substitution O015001M004">Laboratories approved for performing further examination by molecular typing methods</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">The laboratories approved for further molecular typing are:</ins>
</p>
<blockList class="unordered">
<item>
<blockContainer class="BlockText">
<p>
<ins class="substitution O015001M004">Agence Française de Sécurité Sanitaire des Aliments</ins>
</p>
<p>
<ins class="substitution O015001M004">Laboratoire de pathologie bovine</ins>
</p>
<p>
<ins class="substitution O015001M004">31, avenue Tony Garnier</ins>
</p>
<p>
<ins class="substitution O015001M004">BP 7033</ins>
</p>
<p>
<ins class="substitution O015001M004">F-69342 Lyon Cedex</ins>
</p>
</blockContainer>
</item>
<item>
<blockContainer class="BlockText">
<p>
<ins class="substitution O015001M004">Centre CEA Fontenay-aux-Roses, BP 6</ins>
</p>
<p>
<ins class="substitution O015001M004">F-92265 Fontenay-aux-Roses Cedex</ins>
</p>
</blockContainer>
</item>
<item>
<blockContainer class="BlockText">
<p>
<ins class="substitution O015001M004">Service de Pharmacologie et d’Immunologie</ins>
</p>
<p>
<ins class="substitution O015001M004">Centre CEA Saclay, bâtiment 136</ins>
</p>
<p>
<ins class="substitution O015001M004">F-91191 Gif-sur-Yvette Cedex</ins>
</p>
</blockContainer>
</item>
<item>
<blockContainer class="BlockText">
<p>
<ins class="substitution O015001M004">Veterinary Laboratories Agency</ins>
</p>
<p>
<ins class="substitution O015001M004">Woodham Lane</ins>
</p>
<p>
<ins class="substitution O015001M004">New Haw</ins>
</p>
<p>
<ins class="substitution O015001M004">Addlestone</ins>
</p>
<p>
<ins class="substitution O015001M004">Surrey KT15 3NB</ins>
</p>
<p>
<ins class="substitution O015001M004">United Kingdom</ins>
</p>
</blockContainer>
</item>
</blockList>
</content>
</level>
</level>
<level eId="annex-X-chapter-C-division-3-division-3.3" period="#period8">
<num>
<ins class="substitution O015001M004">3.3.</ins>
</num>
<heading>
<ins class="substitution O015001M004">Laboratory testing for the presence of TSEs in species other than those referred to in points 3.1. and 3.2.</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">Where methods and protocols are established for tests carried out to confirm the suspected presence of a TSE in a species other than bovine, ovine and caprine, they shall include at least a histopathological examination of brain tissue. The competent authority may also require laboratory tests such as immunocytochemistry, immuno-blotting, demonstration of characteristic fibrils by electron microscopy or other methods designed to detect the disease associated form of the prion protein. In any case at least one other laboratory examination shall be carried out if the initial histopathological examination is negative or inconclusive. At least three different examinations shall be carried out in the event of the first appearance of the disease.</ins>
</p>
<p>
<ins class="substitution O015001M004">In particular, where BSE is suspected in a species other than bovine animals, samples shall be submitted for strain-typing, where possible.</ins>
</p>
</content>
</level>
</level>
<level eId="annex-X-chapter-C-division-4" period="#period38">
<num>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001 first">
<noteRef href="#c000025" marker="F22" class="commentary attribute F"/>
4.
</ins>
</ins>
</num>
<heading>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Rapid tests</ins>
</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of BSE in bovine animals:</ins>
</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western test),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test & Enfer TSE Kit version 2.0, automated sample preparation),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">microplate-based immunoassay for the detection of PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> (Enfer TSE Version 3),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">microplate-based immunoassay (ELISA) which detects Proteinase K-resistant PrPRes with monoclonal antibodies (Prionics-Check LIA test),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">chemiluminescent ELISA for qualitative determination of PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> (CediTect BSE test),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">immunoassay using a chemical polymer for selective PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE Antigen Test Kit, EIA),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">lateral-flow immunoassay using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Prionics Check PrioSTRIP),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">two-sided immunoassay using two different monoclonal antibodies directed against two epitopes presented in a highly unfolded state of bovine PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> (Roboscreen Beta Prion BSE EIA Test Kit),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">sandwich ELISA for the detection of Proteinase K-resistant PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> (Roche Applied Science PrionScreen),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">antigen-capture ELISA using two different monoclonal antibodies to detect Proteinase K-resistant PrP fractions (Fujirebio FRELISA BSE post-mortem rapid BSE Test).</ins>
</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">For the purposes of carrying out the rapid tests in accordance with Articles 5(3) and 6(1), the following methods shall be used as rapid tests for the monitoring of TSE in ovine and caprine animals:</ins>
</ins>
</p>
<blockList class="unordered">
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">conformation-dependent immunoassay, BSE antigen test kit (Beckman Coulter InPro CDI kit),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE test),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">sandwich immunoassay for PrPRes carried out following denaturation and concentration steps (Bio-Rad Te-SeE Sheep/Goat test),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer TSE Kit version 2.0),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">microplate-based immunoassay for the detection of PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> (Enfer TSE Version 3),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">immunoassay using a chemical polymer for selective PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> capture and a monoclonal detection antibody directed against conserved regions of the PrP molecule (IDEXX HerdChek BSE-Scrapie Antigen Test Kit, EIA),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">microplate-based chemiluminiscent immunoassay for the detection of PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> in ovine tissues (POURQUIER’S-LIA Scrapie),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">immuno-blotting test based on a Western blotting procedure for the detection of the Proteinase K-resistant fragment PrPRes (Prionics-Check Western Small Ruminant test),</ins>
</ins>
</p>
</item>
<item>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">microplate-based chemiluminescent immunoassay for the detection of Proteinase K-resistant PrP</ins>
</ins>
<sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Sc</ins>
</ins>
</sup>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001"> (Prionics Check LIA Small Ruminants).</ins>
</ins>
</p>
</item>
</blockList>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">In all tests, sample tissue on which the test must be applied must comply with the manufacturer’s instructions for use.</ins>
</ins>
</p>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001">Producers of rapid tests must have a quality assurance system in place that has been approved by the Community Reference Laboratory (CRL) and ensures that the test performance does not change. Producers must provide the CRL with the test protocols.</ins>
</ins>
</p>
<p>
<ins class="substitution O015001M004">
<ins class="substitution O027001M001 last">Changes to rapid tests and to test protocols may only be made after prior notification to the CRL and provided that the CRL finds that the change does not alter the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories.</ins>
</ins>
</p>
</content>
</level>
<level eId="annex-X-chapter-C-division-5" period="#period8">
<num>
<ins class="substitution O015001M004">5.</ins>
</num>
<heading>
<ins class="substitution O015001M004">Alternative tests</ins>
</heading>
<content>
<p>
<ins class="substitution O015001M004 last">(To be defined)</ins>
</p>
</content>
</level>
</chapter>
</hcontainer>
<hcontainer name="schedule" eId="annex-XI" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
ANNEX XI
</num>
<heading>
<del class="O024001M011 first last">
<noteRef href="#c000019" marker="F16" class="commentary attribute F"/>
<ins class="substitution O008002M007 first last">
<noteRef href="#c000026" marker="F23" class="commentary attribute F"/>
TRANSITIONAL MEASURES REFERRED TO IN ARTICLES 22 AND 23
</ins>
</del>
</heading>
<level eId="annex-XI-division-A" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
A.
</num>
<heading>Concerning specified risk material, mechanically recovered meat and slaughtering techniques</heading>
<level eId="annex-XI-division-A-division-1" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
1.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-2" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
2.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-3" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
3.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-4" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
4.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-5" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
5.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-6" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
6.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-7" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
7.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-8" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
8.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-9" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
9.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-10" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
10.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-11" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
11.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-12" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
12.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-13" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
13.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-14" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
14.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-A-division-15" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
15.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
</level>
<level eId="annex-XI-division-B" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
B.
</num>
<heading>Concerning statistical surveys</heading>
<level eId="annex-XI-division-B-division-1" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
1.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-B-division-2" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
2.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
</level>
<level eId="annex-XI-division-C" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
C.
</num>
<heading>Concerning prohibitions on animal feeding</heading>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-D" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
D.
</num>
<heading>Concerning placing on the market and export</heading>
<level eId="annex-XI-division-D-division-1" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
1.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-D-division-2" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
2.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-D-division-3" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
3.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-D-division-n4" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
4.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-D-division-n5" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
4.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
<level eId="annex-XI-division-D-division-5" period="#period18" class=" repealed">
<num>
<noteRef href="#c000019" marker="F16" class="commentary F"/>
5.
</num>
<content>
<p>. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</p>
</content>
</level>
</level>
</hcontainer>
</hcontainer>
</portionBody>
</portion>
</akomaNtoso>