- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (01/01/2005)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
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
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Version Superseded: 11/02/2005
Point in time view as at 01/01/2005.
There are currently no known outstanding effects for the Regulation (EC) No 999/2001 of the European Parliament and of the Council.
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Textual Amendments
F1 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).
Regulation (EC) No 1774/2002:
‘ farmed animal ’ in Article 2(1)(f);
‘ petfood ’ in point 41 of Annex I;
‘ processed animal protein ’ in point 42 of Annex I;
‘ gelatine ’ in point 26 of Annex I;
‘ blood products ’ in point 4 of Annex I;
‘ bloodmeal ’ in point 6 of Annex I; and
‘ fishmeal ’ in point 24 of Annex I.
the definition of ‘ feedingstuff ’ in Article 3(4) of Regulation (EC) No 178/2002;
the definition of ‘ complete feedingstuff ’ in Article 2(d) of Directive 79/373/EEC.
‘ 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;
‘ 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;
‘ cohort ’ means a group of bovine animals which includes both:
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
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;
‘ index case ’ means the first animal on a holding, or in an epidemiologically defined group, in which a TSE infection is confirmed.] ]
Textual Amendments
F2 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).
The BSE status of a Member State or a third country or of one of their regions, hereinafter referred to as ‘country or region’, shall be determined on the basis of the following criteria:
the outcome of a risk analysis identifying all the potential factors for the appearance of BSE referred to in Chapter B and their development over time;
an education programme for veterinarians, breeders and those who transport, trade in and slaughter bovine animals, which seeks to encourage them to report all cases of neurological manifestations in adult bovine animals;
the compulsory reporting and examination of all bovine animals showing clinical signs of BSE;
a system of continuous surveillance and monitoring of BSE with particular reference to the risks described in Chapter B, taking account of the guidelines in the table of Chapter A of Annex III or in accordance with the appropriate international standards; reports on the number of examinations carried out and the results thereof must be kept for at least seven years;
the examination in an approved laboratory of samples of encephala or other tissues collected under the surveillance system mentioned in point (d).
The risk analysis referred to in Chapter A(a) shall be based on the following factors:
the consumption by bovine animals of meat and bone meal or greaves derived from ruminants;
the importation of meat and bone meal or greaves potentially contaminated by a TSE or animal feed containing meat and bone meal or greaves;
the importation of animals or ova/embryos potentially infected by a TSE;
the epidemiological status of the country or region in regard to animal TSEs;
the extent of knowledge about the structure of the bovine, ovine and caprine population in the country or region;
the source of animal waste, the parameters of the processes for treating such waste and the methods of producing animal feed.
The BSE status of Member States or third countries or one of the regions thereof shall be determined by classification into the following categories:
:
A country or region where a risk analysis based on the information laid down in Chapter B has been conducted which demonstrated that appropriate measures have been taken for the relevant period of time, to manage any risk identified and
EITHER no BSE case has been recorded and:
the criteria in Chapter A(b) to (e) have been complied with for at least seven years, or
the criteria in Chapter A(c) have been complied with for at least seven years and it has been demonstrated that for at least eight years no meat and bone meal or greaves derived from ruminants or mammals has been fed to ruminants;
OR where all cases of BSE have been clearly demonstrated to originate directly from the importation of live bovine animals or bovine embryos/ova, and all the affected bovine animals as well as, if these are females, their last progeny born within two years prior to, or after, the first clinical signs of onset of the disease, if alive in the country or region, have been killed and completely destroyed and, either
the criteria in Chapter A(b) to (e) have been complied with for at least seven years, or
the criteria in Chapter A(c) have been complied with for at least seven years and it has been demonstrated that for at least eight years no meat and bone meal or greaves have been fed to ruminants;
OR where the last indigenous case of BSE was reported more than seven years ago, the criteria in Chapter A(b) to (e) have been complied with for at least seven years and the feeding of ruminants with meat and bone meal and greaves derived from ruminants has been banned and the ban has been effectively enforced for at least eight years.
:
Country or region where a risk analysis as described in Chapter B has been conducted which demonstrates that appropriate measures have been taken for the relevant period of time to manage any risk identified, and
EITHER where there has been no case of BSE and:
the criteria in Chapter A(b) to (e) are complied with, but have not been complied with for seven years, or
it has been demonstrated that for at least eight years no meat and bone meal or greaves has been fed to ruminants, but the criteria in Chapter A(c) have not been complied with for seven years;
OR where all cases of BSE have been clearly demonstrated to originate directly from the importation of live bovine animals or bovine embryos/ova, and all the affected bovine animals as well as, if these are females, their last progeny born within two years prior to, or after, the first clinical signs of onset of the disease, if alive in the country or region, have been killed and completely destroyed, and either:
the criteria in Chapter A(b) to (e) are complied with, but have not been complied with for seven years, or
it has been demonstrated that for at least eight years no meat and bone meal or greaves has been fed to ruminants, but the criteria in Chapter A(c) have not been complied with for seven years.
:
Any country or region where a risk analysis based on the information referred to in Chapter B has been conducted which demonstrates that appropriate measures have been taken for the relevant period of time to manage any risk identified and:
EITHER the last indigenous case of BSE was reported more than seven years ago, the criteria in Chapter A(b) to (e) are complied with and the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants is effectively enforced, but:
the criteria in Chapter A(b) to (e) have not been complied with for seven years, or
the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants has not been effectively enforced for eight years;
OR where the last indigenous case has been reported less than seven years ago, the BSE incidence rate, calculated on the basis of indigenous cases, has been less than one case per million during each of the last four consecutive twelve-month periods within the bovine animal population over 24 months of age in the country or region or — when in a country or a region the bovine animal population over 24 months of age is less than 1 million animals — one case per real number of this population (calculated on the basis of Eurostat statistics), and where:
the ban on feeding ruminants with meat and bone meal and greaves derived from ruminants has been effectively enforced for at least eight years;
the criteria in Chapter A(b) to (e) have been complied with for at least seven years;
the affected bovine animals as well as:
if these are females, their last progeny born within two years prior to, or after, clinical onset of the disease;
all bovine animals from the cohort,
are killed and completely destroyed if they are still alive in the country or region concerned.
For this classification account may be taken, by way of derogation from point (iii), of the existence of other measures offering an equivalent level of protection in relation to the killing of animals at risk.
:
Any country or region where:
the criteria listed in Chapter A are complied with, and the BSE incidence rate, calculated over the past 12 months, has been greater than or equal to one indigenous case per million and less than or equal to one hundred cases per million within the bovine animal population over 24 months of age in the country or region; or
the criteria listed in Chapter A are complied with and the BSE incidence rate, calculated as specified in point 1 has been less than one indigenous case per million for less than four consecutive 12 month periods and the affected cattle as well as:
if these are females, their last progeny born within two years prior to, or after the first clinical signs of onset of the disease,
all bovine animals from the cohort,
if alive in the country or region, are killed and completely destroyed.
For this classification account may be taken, by way of derogation from this point, of the existence of other measures offering an equivalent level of protection in relation to the killing of animals at risk.
Countries or regions where the BSE incidence rate, calculated over the past 12 months, has been less than one indigenous case per million within the cattle population over 24 months of age in the country or region, but where a risk analysis as described in Chapter A has been conducted which demonstrates that at least one of the criteria enabling the country or region to be classified in category 2 or 3 is not complied with, must be regarded as countries or regions belonging to category 4.
:
Any country or region where:
the criteria listed in Chapter A are complied with, and the BSE incidence rate, calculated over the past 12 months, has been greater than one hundred cases per million within the bovine animal population over 24 months of age in the country or region; or
the BSE incidence rate, calculated over the past 12 months, has been greater than or equal to one case per million and less than or equal to one hundred cases per million within the bovine animal population over 24 months of age in the country or region, and at least one of the criteria listed in Chapter A is not complied with.
Textual Amendments
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).
subject to ‘special emergency slaughtering’ as defined in Article 2(n) of Council Directive 64/433/EEC (4) , 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.
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.
killed for destruction pursuant to Commission Regulation (EC) No 716/96 (5) ,
killed in the framework of an epidemic, such as foot-and-mouth disease,
slaughtered for human consumption,
shall be tested for BSE.
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.
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).
Member States in which the population of ewes and ewe lambs put to the ram exceeds 750 000 animals shall test a minimum annual sample of 10 000 ovine animals which are slaughtered for human consumption (7) . The animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum. The sampling shall be representative for each region and season. The sample selection shall be designed with a view to avoiding the over-representation of any group as regards the origin, age, breed, production type or any other characteristic. The age of the animals shall be estimated based on dentition, obvious signs of maturity or other reliable information. Multiple sampling in the same flock shall be avoided, where possible.
Ovine and caprine animals over 18 months of age or which have more than two permanent incisors erupted through the gum which have died or been killed, but which were not:
killed in the framework of a disease eradication campaign,
slaughtered for human consumption,
shall be tested in accordance with the sample sizes indicated in table A and table B respectively. The sampling shall be representative for each region and season. The sample selection shall be designed with a view to avoiding the over-representation of any group as regards the origin, age, breed, production type or any other characteristic. The age of the animal shall be estimated based on dentition, obvious signs of maturity or other reliable information. Multiple sampling in the same flock shall be avoided, where possible. The Member State shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from sampling
Member States may decide to exclude remote areas with a low animal density, where no collection of dead animals is organised, from the sampling. 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 ovine and caprine population in the Member State.
a 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. The sample sizes of 10 000 , 1 500 , 500 and 100 animals will allow the detection of a prevalence of 0,03%, 0,2 %, 0,6 % and 3 % respectively with a 95 % confidence. | |
Member State population of ewes and ewe lambs put to the ram | Minimum sample size of dead ovine animals a |
---|---|
> 750 000 | 10 000 |
100 000 - 750 000 | 1 500 |
40 000 - 100 000 | 500 |
< 40 000 | 100 |
a Sample sizes are set to take account of the size of the caprine populations in the individual Member States and are intended to provide achievable targets. The sample sizes of 5 000 , 1 500 , 500 and 50 animals will allow the detection of a prevalence of 0,06 %, 0,2 %, 0,6 % and 6 % respectively with a 95 % confidence. Where a Member State experiences difficulty in collecting sufficient numbers of dead caprine animals to reach its allotted sample size, it may choose to supplement its sample by testing caprine animals slaughtered for human consumption over the age of 18 months at the ratio of three caprine animals slaughtered for human consumption to one dead caprine animal. | |
Member State population of goats which have already kidded and goats mated | Minimum sample size of dead caprine animals a |
---|---|
> 750 000 | 5 000 |
250 000 - 750 000 | 1 500 |
40 000 - 250 000 | 500 |
< 40 000 | 50 |
From 1 October 2003 , animals over 12 months or which have a permanent incisor erupted through the gum, which are killed in accordance with the provisions of Annex VII, point 2(b)(i) or (ii) or point 2(c), shall be tested based on the selection of a simple random sample, in accordance with the sample size indicated in the table
a The sample size is calculated to be 95 % certain of including at least one positive if the disease is present at a minimum prevalence of 2 % in the test population. | |
Number of culled animals over 12 months in the herd or flock | Minimum sample size a |
---|---|
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 |
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,
Member States may on a voluntary basis carry out monitoring for TSE in animal species other than bovine, ovine and caprine animals.
The summary shall be presented in a tabled format covering at least the information referred to in part I for each Member State.
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.
to farmed animals, with the exception of the feeding of carnivorous fur producing animals, of:
processed animal protein;
gelatine of ruminant origin;
blood products;
hydrolysed protein;
dicalcium phosphate and tricalcium phosphate of animal origin;
feedingstuffs containing the proteins listed in points (a) to (e);
to ruminants of animal protein and feedingstuffs containing such protein.
the feeding to non-ruminants of the proteins referred to in (i), (ii) and (iii), and of feedingstuffs derived from such proteins, provided that those proteins have been processed where applicable in accordance with Article 19 of Regulation (EC) No 1774/2002:
fishmeal, in accordance with the conditions laid down in point B;
hydrolysed proteins derived from non-ruminants and ruminant hides and skins, in accordance with the conditions laid down in point C;
dicalcium phosphate and tricalcium phosphate, in accordance with the conditions laid down in point D;
the feeding to ruminants of the proteins referred to in (i), (ii) and (iii), and of products derived from such proteins, provided that the proteins have been processed where applicable in accordance with the provisions in Article 19 of Regulation (EC) No 1774/2002:
milk, milk-based products and colostrum;
eggs and egg products;
gelatine derived from non-ruminants;
the feeding to fish of blood products and bloodmeal derived from non-ruminants, provided that they have been processed where applicable in accordance with Article 19 of Regulation (EC) No 1774/2002 and of feedingstuffs derived from such proteins, in accordance with the conditions laid down in point E.
The fishmeal shall be produced in processing plants dedicated exclusively to the production of fish derived products, which shall be approved for this purpose by the competent authority in accordance with Article 17 of Regulation (EC) No 1774/2002.
Before release for free circulation in the Community, each consignment of imported fishmeal shall be analysed in accordance with Commission Directive 98/88/EC (8) .
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.
However, by way of derogation from that condition:
a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing fishmeal is not 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;
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 manufactured in facilities physically separate from facilities where feedingstuffs containing fishmeal are manufactured,
bulk feedingstuffs destined for ruminants are kept in facilities physically separate from facilities where bulk fishmeal and bulk feedingstuffs containing fishmeal are kept during storage, transport and packaging,
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 to ruminants to ensure that prohibited proteins including fishmeal are not present.
The label and accompanying document of feedingstuffs containing fishmeal shall clearly indicate the words ‘ contains fishmeal — cannot be fed to ruminants ’ .
Bulk feedingstuffs containing fishmeal shall be transported by means of vehicles which do not transport at the same time 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.
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 they are satisfied that on-farm measures are implemented to prevent that feedingstuffs containing fishmeal are fed to ruminants.
The hydrolysed proteins shall be produced in a processing plant approved by the competent authority in accordance with Article 17 of Regulation (EC) No 1774/2002.
Feedingstuffs containing hydrolysed proteins shall be produced in establishments which do not prepare feedingstuffs for ruminants and which are authorised for this purpose by the competent authority.
However, by way of derogation from that condition:
a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing hydrolysed proteins is not 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 hydrolysed proteins used in the production contain less than 50 % crude protein;
the production of feedingstuffs for ruminants in establishments which also produce feedingstuffs containing hydrolysed proteins 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 facilities where feedingstuffs containing hydrolysed proteins are manufactured,
bulk feedingstuffs destined for ruminants are kept in facilities physically separate from facilities where bulk hydrolysed proteins and bulk feedingstuffs containing hydrolysed proteins are kept during storage, transport and packaging,
records detailing the purchases and uses of hydrolysed proteins, and the sales of feedingstuffs containing hydrolysed proteins are kept available to the competent authority for at least five years.
The label and the accompanying document of the feedingstuffs containing hydrolysed proteins shall clearly indicate the words ‘ contains hydrolysed proteins — cannot be fed to ruminants ’ .
Bulk feedingstuffs containing hydrolysed proteins shall be transported by mean of vehicles which do not transport at the same time 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.
The use and storage of feedingstuffs containing hydrolysed proteins 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 hydrolysed proteins in farms where ruminants are kept, if they are satisfied that on-farm measures are implemented to prevent the feeding of feedingstuffs containing hydrolysed proteins to ruminants.
Dicalcium phosphate and tricalcium phosphate shall be produced in a processing plant approved by the competent authority in accordance with Article 17 of Regulation (EC) No 1774/2002.
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.
However, by way of derogation from that condition:
a specific authorisation for the production of complete feedingstuffs from feedingstuffs containing dicalcium phosphate or tricalcium phosphate is not 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;
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 facilities where feedingstuffs containing dicalcium phosphate or tricalcium phosphate are manufactured,
bulk feedingstuffs destined for ruminants are kept in facilities physically separate from facilities where bulk dicalcium phosphate and bulk tricalcium phosphate and bulk feedingstuffs containing dicalcium phosphate and tricalcium phosphate are kept during storage, transport and packaging,
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.
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 — cannot be fed to ruminants ’ .
Bulk feedingstuffs containing dicalcium phosphate or tricalcium phosphate shall be transported by mean of vehicles which do not transport at the same time 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.
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 they are satisfied that on-farm measures are implemented to prevent that feedingstuffs containing dicalcium phosphate or tricalcium phosphate are fed to ruminants.
the blood shall be derived from EU approved slaughterhouses not slaughtering ruminants which are registered as not slaughtering ruminants and shall be transported directly to the processing plant in vehicles dedicated exclusively to the transport of non-ruminant blood. If the vehicle was 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 slaughterhouses collecting non-ruminant blood intended for the production of blood meal and blood products for use in fish feed if these slaughterhouses have a recognised control system. The control system shall at least include:
the slaughtering of non-ruminants physically separate from the slaughtering of ruminants,
collection, storage, transport and packaging of blood from non-ruminant origin in facilities physically separate from facilities where blood of ruminant origin is collected, stored, transported and packaged, and
regular sampling and analysis of blood from non-ruminant origin for the presence of ruminant proteins;
the blood products and the bloodmeal shall be produced in an establishment exclusively processing non-ruminant blood and approved by the competent authority in accordance with Article 17 of Regulation (EC) No 1774/2002.
By way of derogation from that condition, the competent authority may permit the production of blood products for use in fish feed in establishments processing ruminant blood, which have a recognised control system in place preventing cross-contamination. The control system shall at least include:
processing of non-ruminant blood in a closed system physically separate from the processing of ruminant blood,
transport, storage and packaging of bulk raw material and bulk finished blood products of non-ruminant origin in facilities physically separate from facilities where bulk raw material and bulk finished products of ruminant origin are kept during storage, transport and packaging, and
regular sampling and analysis of non-ruminant blood products for the presence of ruminant proteins;
feedingstuffs containing blood products or bloodmeal shall be produced in establishments manufacturing fish feed which do not prepare feedingstuffs for other farmed animals, with the exception of carnivorous fur producing animals, and which are authorised for that purpose by the competent authority;
the label, accompanying commercial document or health certificate, as appropriate, of the feedingstuffs containing blood products or bloodmeal shall clearly indicate the words ‘ contains blood products — shall only be fed to fish ’ or ‘ contains bloodmeal — shall only be fed to fish ’ , as appropriate;
transport vehicles used for the transport of bulk fish feed containing blood products or bloodmeal shall not be used for the transport of feedingstuffs for other farmed animals, with the exception of carnivorous fur producing animals, unless the transport vehicle, following cleaning, has been inspected by the competent authority;
the use and storage of fish feed containing blood products or bloodmeal shall be prohibited in farms where other farmed animals, with the exception of carnivorous fur producing animals, are kept.
Bulk processed animal protein, with the exception of fishmeal, and bulk feedingstuffs containing such proteins, shall be stored and transported in dedicated facilities. The store or vehicle can only be used for other purposes, following cleaning, after having been inspected by the competent authority.
Bulk fishmeal, bulk hydrolysed proteins referred to in point A(a)(ii) of part I, bulk dicalcium phosphate and bulk tricalcium phosphate referred to in point A(a)(iii) of part I, and bloodmeal and blood products referred to in point A(c) of part I shall be stored and transported in stores and vehicles dedicated to that purpose.
By way of derogation from point (b):
stores or vehicles may be used for the storage and transport of feedingstuffs containing the same protein;
stores or vehicles, following cleaning, may be used for other purposes after having been inspected by the competent authority; 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 for the presence of fishmeal.
The competent authority shall carry out frequent spot checks to verify the correct application of the control plan.
Petfood and feedingstuffs intended for carnivorous fur producing animals containing fishmeal, hydrolysed proteins referred to in point A(a)(ii) of part I, dicalcium phosphate and tricalcium phosphate referred to in point A(a)(iii) of part I, and bloodmeal and blood products referred to in point A(c) of part I shall be manufactured and transported in accordance with the provisions referred to in points B(c) and (e), C(b) and (d), D(b) and (d) and E(c) and (e), respectively of part I.
The export of other processed animal proteins and blood products and products containing such proteins shall only be permitted 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, blood products and products containing such proteins for uses prohibited by Article 7.
Member States which allow such exportation shall inform the Commission and the other Member States of all terms and conditions as agreed with the third country concerned, for the effective implementation of this Regulation, in the context of the Standing Committee on the Food Chain and Animal Health.
The measures in this point shall not apply to fishmeal, provided it fulfils the conditions set out in point B, products containing such fishmeal, and petfood.
None.
the skull including the brain and eyes, the tonsils and the spinal cord of bovine animals aged over 12 months, and the intestines from the duodenum to the rectum of bovine animals of all ages;
the skull including the brain and eyes, the tonsils and the spinal cord of ovine and caprine animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen of ovine and caprine animals of all ages.
the entire head (excluding the tongue), including the brain, eyes, trigeminal ganglia and tonsils; the thymus; the spleen and the spinal cord of bovine animals aged over six months, and the intestines from the duodenum to the rectum of animals of all ages;
the vertebral column, including dorsal root ganglia, of bovine animals aged over 30 months;
the skull including the brain and eyes, the tonsils, the spinal cord of ovine and caprine animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen of ovine and caprine animals of all ages.
slaughterhouses;
cutting plants, high-risk processing plants or premises referred to in Articles 3 and 7 of Directive 90/667/EEC(10), under the supervision of a designated agent appointed by the competent authority. Those establishments shall be approved for that purpose by the competent authority.
However, the vertebral column may be removed at points of sale to the consumer situated in the territory of the Member State concerned.
Where specified risk material is not removed from dead animals which have not been slaughtered for human consumption, the parts of the body containing specified risk material or the entire body will be treated as specified risk material.
by incineration without pre-processing; or,
provided that the dye or marker remains detectable, after pre-processing:
tests must be carried out in slaughterhouses on all animals eligible for the removal of specified risk material;
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;
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.
specified risk material used in the production of products referred to in Article 1(2) are used solely for the authorised purpose;
where bovine, ovine or caprine animals enter a Member State placed in a numerically lower category, indicating a better BSE status, than that of the animals that enter, those animals remain under official supervision until slaughter or dispatch from its territory;
specified risk material, in particular where disposal takes place at establishments or premises other than slaughterhouses, is completely separated from other waste not destined for incineration, is collected separately and is disposed of in accordance with points 2, 3 and 4. Member States may allow dispatch of heads or carcasses containing specified risk material to another Member State after agreement with that other Member State both to receive the material and to apply the specific conditions applicable to such movements.
These points may be amended at the request of a Member State to allow the dispatch of specified risk material or the material processed therefrom to third countries for incineration. The conditions governing export shall be adopted at the same time, by the same procedure.
The use of ruminant material for the production of the following products of animal origin is prohibited as referred to in Article 9(1):
mechanically recovered meat;
dicalcium phosphate intended as feedingstuffs for livestock;
gelatine, unless it is produced from ruminant hides;
derivatives made from rendered ruminant fat;
rendered ruminant fat, unless it was produced from:
discrete adipose tissue declared fit for human consumption;
raw materials which were processed in accordance with the standards referred to in Directive 90/667/EEC.
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;
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 BSE agent to or from the holding in question.
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;
in the case of confirmation of TSE in an ovine or caprine animal, from 1 October 2003 , according to the decision of the competent authority:
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) or
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 two months old which are intended solely for slaughter;
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 scrapie 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;
in the case of confirmation of BSE in an ovine or caprine animal, 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).
male sheep of the ARR/ARR genotype;
female sheep carrying at least one ARR allele and no VRQ allele;
caprine animals, provided that:
no ovine animals for breeding other than those of the genotypes referred to in points (a) and (b) are present on the holding,
thorough cleaning and disinfection of all animal housing on the premises has been carried out following destocking,
the holding shall be subjected to intensified TSE monitoring, including the testing of all caprine animals which are over the age of 18 months and:
either are slaughtered for human consumption at the end of their productive lives, or
which have died or been killed on the holding, and which meet the criteria referred to in Annex III, Chapter A, Part II, point 3.
semen from rams of the ARR/ARR genotype;
embryos carrying at least one ARR allele and no VRQ allele.
movement of ARR/ARR sheep from the holding shall not be subject to any restriction;
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(b)(ii),
if the competent authority so decides, lambs carrying one ARR allele and no VRQ allele may be moved to one other holding solely for the purposes of fattening prior to slaughter; the destination holding 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;
if the Member State so decides, sheep and goats less than two months old may be moved from the holding to go directly for slaughter for human consumption; the head and organs of the abdominal cavity of such animals shall however be disposed of in accordance with Article 4(2)(a), (b) or (c) of Regulation (EC) No 1774/2002 of the European Parliament and of the Council (14) ,
without prejudice to subparagraph (c), sheep of genotypes not referred to in subparagraphs (a) and (b) may only be moved from the holding for the purposes of destruction.
the date of attainment of ARR/ARR status by all ovine animals on the holding or
the last date when any ovine or caprine animal was kept on the premises or
in the case of point 4(c), the date when the intensified TSE monitoring commenced or
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 three-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 indicated in the table in Annex III, Chapter A, Part II, point 4; and
all ovine animals referred to in Annex III, Chapter A, Part II, point 3 which have died or been killed on the holding.
delay the destruction of animals as referred to in point 2(b)(i) and (ii) for up to five breeding years;
allow ovine animals other than those referred to in point 4 to be introduced to the holdings referred to in point 2(b)(i) and (ii), provided that they do not carry a VRQ allele.
The following conditions shall apply to trade in ovine and caprine animals:
[F5ovine 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 (15) , 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:
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.
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).]
a Member State which has a compulsory or voluntary national scrapie control program for all or part of its territory:
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,
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,
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,
where a Member State considers that its territory or part of its territory is free from scrapie:
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,
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,
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) [F2,]
[F6from 1 January 2005 semen and embryos of ovine and caprine animals shall:
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
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 (16) or
in the case of ovine embryos, be of the ARR/ARR prion protein genotype as defined in Annex I to Decision 2002/1003/EC.] ]
Textual Amendments
F5 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).
F6 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).
The animals must have:
been born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years; or
been born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
The animals must have:
been born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals has been effectively enforced; and
been born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equivalent status.
Textual Amendments
F4 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).
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.
fresh meat;
minced meat;
meat preparations;
meat products;
petfood which is destined for domestic carnivores.
the animal has been clearly identifiable throughout its life, enabling it to be traced back to its dam and herd of origin; its unique eartag number, date and holding of birth and all movements after birth are recorded either in the animal's official passport or in an official computerised identification and tracing system; the identity of its dam is known;
the animal is more than six months but less than 30 months of age, determined by reference to an official computer record of its date of birth, or to the animal's official passport;
the competent authority has obtained and verified positive evidence that the dam of the animal has lived for at least six months after the birth of the eligible animal;
the dam of the animal has not developed BSE and is not suspected of having contracted BSE.
popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral iliac, renal, prefemoral, lumbar, costocervical, sternal, prescapular, axilliary, caudal and deep cervical.
tracing and controls prior to slaughter;
controls during slaughter;
controls during processing of petfood;
all labelling and certification requirements after slaughter to the point of sale.
A herd is a group of animals forming a separate and distinct unit, that is a group of animals which is managed, housed and kept separately from any other group of animals and which is identified with unique herd and animal identification numbers.
A herd is eligible when for at least seven years there has been no confirmed case of BSE, nor a suspect case for which the diagnosis of BSE has not been ruled out, in any animal which was still in or had moved through or from the herd.
As an exception to the provisions in point (b), a herd that has been in existence for less than seven years may be considered eligible, after a thorough investigation by the competent veterinary authority, on condition that:
all animals born or moved into the newly established herd complied with the conditions set out in point (2)(a), (d) and (e); and,
the herd has complied with the conditions set out in point (b) during its entire existence.
If a herd is newly established on a holding which experienced a confirmed case of BSE in any animal which was still in or had moved through or from a herd on that holding, the newly established herd can only be eligible after a thorough investigation by the competent veterinary authority, certifying compliance with each of the following conditions to the satisfaction of that authority:
all animals of the affected herd previously held on the same holding have been removed or killed;
all feed has been removed and destroyed and all feed containers thoroughly cleansed;
all buildings have been emptied and thoroughly cleansed before the new animals were admitted;
all conditions set out in point (c) have been complied with.
all records of the animal's birth, identity and movements are recorded on an official computerised tracing system;
the animal is more than six months but less than 30 months of age, determined by reference to an official computer record of its date of birth;
its dam has lived for at least six months after its birth;
its dam has not developed BSE and is not suspected of having contracted BSE;
the herd of birth of the animal and all herds through which it has moved are eligible.
popliteal, ischiatic, superficial inguinal, deep inguinal, medial and lateral iliac, renal, prefemoral, lumbar, costocervical, sternal, prescapular, axilliary, caudal and deep cervical.
tracing and controls prior to slaughter;
controls during slaughter;
controls during processing of petfood;
all labelling and certification requirements after slaughter to the point of sale.
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.
When importing from countries or regions placed in category 1, the competent authority is, for bovine animals and all commodities of bovine origin for which this Regulation lays down specific rules, to take account of the presentation of an international animal health certificate attesting that the country or region complies with the conditions in Annex II, Chapter C, to be placed in that category.
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
the bovine animals intended for export to the Community are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE-suspected females.
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
bovine animals intended for export to the Community:
are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and making it possible to establish that they are not the progeny of BSE suspect or confirmed females;
were born, raised and had remained in herds in which no case of BSE had been confirmed for at least seven years; or
were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
bovine animals intended for export to the Community:
are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and making it possible to establish that they are not the progeny of BSE suspect or confirmed females; and
were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years; or
were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals has been effectively enforced.
the feeding of farmed animals with proteins derived from mammals has been banned and the ban has been effectively enforced;
the affected bovine animals are killed and completely destroyed as well as:
if these are females, their last progeny born within two years prior to, or after the first clinical signs of the onset of the disease;
all bovine animals from the same cohort
if such animals are still alive in the country or region;
the animals intended for export to the Community:
were born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals was effectively enforced;
are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE suspect or confirmed females;
AND
either were born, raised and have remained in herds in which no case of BSE has ever been confirmed, and which contain only bovine animals born on the farm or coming from a herd of equal health status; or
were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equal health status.
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
the fresh meat and products of bovine animal origin intended for export to the Community do not contain or are not derived from specified risk material referred to in Annex V or mechanically recovered meat obtained from the bone of the head or vertebral column.
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
the fresh meat and products of bovine animal origin intended for export to the Community do not contain or are not derived from specified risk material referred to in Annex V or mechanically recovered meat obtained from the head or vertebral column.
they fulfil the conditions of Article 16(2) and those set out in sections II or III of Chapter C of Annex VIII;
the meat products intended for export to the Community do not contain or are not derived from any product referred to in Chapter F, nor from any specified risk material as defined in Annex V;
a system is in operation enabling the fresh meat and products of bovine animal origin intended for export to the Community to be traced back to the establishments from which they are derived;
the bovine animals from which the meat or meat products intended for export to the Community originate:
were identified by a permanent identification system enabling them to be traced back to the dam and herd of origin;
are not the progeny of BSE-suspect or confirmed females; and either:
were born after the date from which the ban on the feeding of farmed animals with proteins derived from mammals was effectively enforced; or
were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years;
the feeding of farmed animals with proteins derived from mammals has been banned and the ban has been effectively enforced;
the affected bovine animals are slaughtered and completely destroyed as well as:
if these are females, their last progeny born within two years prior to, or after, the first clinical signs of the onset of the disease;
all bovine animals from the same cohort
if they are still alive in the country or region.
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
the embryos/ova were collected, processed and stored in conformity with the provisions of Annexes A and B to Directive 89/556/EC(17).
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
ova/embryos destined for export to the Community are derived from females which:
are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the progeny of BSE-confirmed females;
are not the progeny of BSE-suspect or confirmed females;
were not suspected of being affected by BSE at the time of embryo collection;
the ova/embryos were collected, processed and stored in accordance with the provisions of Annexes A and B to Directive 89/556/EEC.
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
the ova/embryos intended for export to the Community are derived from females which:
are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the progeny of BSE-suspected or affected females;
are not affected with BSE;
were not suspected of being affected with BSE at the time of embryo collection; and
either were born after the date from which the ban on the feeding of ruminants with proteins derived from mammals was effectively enforced; or
were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years;
the ova/embryos were collected, processed and stored in conformity with the provisions of Annexes A and B to Directive 89/556/EEC.
the feeding of animals for breeding with proteins derived from mammals has been banned and the ban has been effectively enforced;
the affected bovine animals, and, if these are females, their last progeny born within two years prior to, or after, clinical onset of the disease, if alive in the country or region, are killed and completely destroyed;
ova/embryos intended for export to the Community are derived from females which:
are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin, and are not the progeny of BSE-suspected or confirmed females;
are not affected with BSE;
were not suspected of being affected with BSE at the time of embryo collection; and
either were born after the date from which the ban on the feeding of animals for breeding with proteins derived from mammals was effectively enforced;
or have never been fed with proteins derived from mammals and were born, raised and have remained in herds in which no case of BSE has been confirmed for at least seven years, and which contain only bovine animals born on the farm or coming from a herd of equal health status;
the ova/embryos were collected, processed and stored strictly in conformity with the provisions of Annexes A and B to Directive 89/556/EEC.
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:
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;
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).]
Textual Amendments
F7 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).
Imports into the Community from third countries or regions thereof, placed in category 5, of the products of animal origin referred to in Annex VIII, Chapter C, in accordance with Article 16(3) are to be prohibited if they contain or are derived from the following products or material derived from ruminant animals:
mechanically recovered meat;
dicalcium phosphate intended for feeding livestock;
gelatine unless produced from hides or skins;
rendered ruminant fat and derivatives made from it unless they were produced from discrete adipose tissue which was itself declared fit for human consumption, or from raw materials which were processed in accordance with the standards referred to in Decision 1999/534/EC.
When importing products of animal origin from third countries or regions thereof which are not placed in category 1, the appropriate certificates, as required by Community legislation, are to be supplemented by a declaration signed by the competent authority of the country of production, worded as follows:
‘The product of animal origin does not contain, and is not derived from, specified risk material as defined in Annex V to 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 or mechanically recovered meat obtained from bones of the head or vertebral column of bovine animals. The animals have not been slaughtered after stunning by means of a gas injected into the cranial cavity or killed instantaneously 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.’
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).]
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;
verify diagnostic methods used in regional diagnostic laboratories;
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;
is to cooperate with the Community reference laboratory.
Austria: | Bundesanstalt für Tierseuchenbekämpfung, 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 |
[F9Cyprus: | Εργαστήριο Αναφοράς για τις Ασθένειες των Ζώων, Κτηνιατρικές Υπηρεσίες,1417 Λευκωσία (National Reference Laboratory for Animal Health Veterinary Services CY-1417 Nicosia) |
Czech Republic: | Státní veterinární ústav Jihlava, Rantířovská 93, 586 05 Jihlava] |
Denmark: | Danish Veterinary Laboratory Bülowsvej 27 DK-1790 Copenhagen V |
[F9Estonia: | Veterinaar- ja Toidulaboratoorium Kreutzwaldi 30 51006 Tartu] |
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 BP 7033 F-69342 Lyon Cedex |
Germany: | Bundesforschungsanstalt für Viruskrankheiten der Tiere Anstaltsteil Insel Riems Boddenblick 5A D-17498 Insel Riems |
[F10Greece: | Ministry of Agriculture Veterinary Laboratory of Larisa 7th km of Larisa — Trikala Highway GR-411 10Larisa (rapid tests and immunological tests) Laboratory of Gross Pathology Faculty of Veterinary Medicine Aristotelian University of Thessaloniki Giannitson & Voutyra St. GR-546 27 Thessaloniki (histopathology)] |
[F9Hungary: | Országos Állategészségügyi Intézet (OÁI) Pf. 2. Tábornok u. 2. HU-1581-Budapest] |
Ireland: | Central Veterinary Research Laboratory Abbotstown Castleknock Dublin 15 Ireland |
Italy: | Istituto Zooprofilattico Sperimentale del Piemonte Liguria e Valle d'Aosta CEA Via Bologna I-148-10150 Torino |
[F9Latvia: | Valsts veterinārmedicīnas diagnostikas centrs Lejupes iela 3 LV-1076 Rīga |
Lithuania: | Nacionalinė veterinarijos laboratorija J. Kairiūkščio g. 10 LT-2021 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 |
[F9Malta: | National Veterinary Laboratory Marsa Malta] |
Netherlands: | Instituut voor Dierhouderij en Diergezondheid, ID-DLO Lelystad Edelhertweg 15 Postbus 658200 AB Lelystad Netherlands |
[F9Poland: | Laboratorium Zakładu Wirusologii Państwowego Instytutu Weterynaryjnego Al. Partyzantów 57 PL-24-100 Puławy] |
Portugal: | Laboratório Nacional de Investigação Veterinária Estrada de Benfica, 701 P-1500 Lisboa |
[F9Slovakia: | Neuroimunologický ústav SAV Dúbravská cesta 9 SK-942 45 Bratislava |
Slovenia: | Nacionalni veterinarski inštitut Gerbičeva 60 SI-1000 Ljubljana] |
Spain: | Laboratorio de la Facultad de Veterinaria Departamento de Patología Animal (Anatomía Patológica) Zaragoza Spain (BSE and scrapie, methods other than rapid tests) Laboratorio Central de Veterinaria de Algete Madrid Spain (rapid tests) Centro de Investigacion en Sanidad Anímal (CISA) Crta, De Algete al Casar de Talamanca 28130 Valdeolmos (Madrid) Spain (TSEs other than BSE or scrapie) |
Sweden: | National Veterinary Institute S-751 89 Uppsala |
United Kingdom | Veterinary Laboratories Agency Woodham Lane New Haw Addlestone Surrey KT15 3NB United Kingdom] |
Textual Amendments
F9 Inserted by Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded.
Textual Amendments
The Veterinary Laboratories Agency
Woodham Lane
New Haw
Addlestone
Surrey KT15 3NB
United Kingdom
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;
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;
to facilitate the training or retraining of experts in laboratory diagnosis with a view to the harmonisation of diagnostic techniques throughout the Community.
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 of standards for diagnostic tests and vaccines of the International Office for Epizooties (IOE/OIE) (hereinafter referred to as ‘the Manual’). In the absence of such methods and protocols, the samples shall be collected in a manner appropriate for the correct application of tests. The samples shall be correctly marked as to the identity of the sampled animal.
Any laboratory examination for TSE shall be carried out in laboratories approved for that purpose.
Suspect cases
Tissues 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 the above examinations is positive, the animals shall be regarded a positive BSE case.
BSE monitoring
Tissues from bovine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Section I (Monitoring in bovine animals) shall be examined by a rapid test.
When the result of the rapid test is inconclusive or positive, the tissues 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 tissues shall be subjected to an examination by one of the other diagnostic methods mentioned under (a).
An animal shall be regarded a positive BSE case if the result of the rapid test is positive or inconclusive, and
the result of the subsequent histopathological examination is positive, or
the result of another diagnostic method mentioned under (a) is positive.
Suspect cases
Tissues 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 tissues shall be subjected to an examination by immunocytochemistry or immuno-blotting, as laid down in the Manual. However, rapid tests cannot be used for this purpose.
If the result of one of the above examinations is positive, the animal shall be regarded a positive scrapie case.
Scrapie monitoring
Tissues from ovine and caprine animals sent for laboratory testing pursuant to the provisions of Annex III, Chapter A, Section II (Monitoring in ovine and caprine animals) shall be examined by a rapid test.
When the result of the rapid test is inconclusive or positive, the brainstem shall immediately be sent to an official laboratory for confirmatory examinations by immunocytochemistry or immuno-blotting, as referred to under (a).
An animal shall be regarded a positive scrapie case if the result of the confirmatory examination is positive.
The tests carried out to confirm the suspected presence of a TSE different from those referred to in points 3.1 and 3.2 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.
For the purposes of carrying out the rapid tests in accordance with Article 5(3) and Article 6(1), the following methods shall be used as rapid tests:
immuno-blotting test based on a Western blotting procedure for the detection of the protease-resistant fragment PrP Res (Prionics-Check Western test),
chemiluminescent ELISA test involving an extraction procedure and an ELISA technique, using an enhanced chemiluminescent reagent (Enfer test),
sandwich immunoassay for PrP Res carried out following denaturation and concentration steps (Bio-Rad TeSeE test, the former Bio-Rad Platelia test). However, existing stocks bearing the name ‘ Bio-Rad Platelia test ’ may be used within nine months from the date of entry into force of this Regulation,
microplate based immunoassay (ELISA) which detects protease-resistant PrP Res with monoclonal antibodies (Prionics-Check LIA test),
automated conformation-dependent immunoassay comparing the reactivity of a detection antibody to the protease-sensitive and protease-resistant forms of PrP Sc (some fraction of the protease-resistant PrP Sc is equivalent to PrP Res ) and to PrP C (InPro CDI-5 test).
The producer of the rapid tests must have a quality assurance system in place agreed by the Community reference laboratory, which ensures that the test performance does not change. The producer must provide the test protocol to the Community reference laboratory.
Modifications to the rapid test or to the test protocol may only be made following advance notification to the Community reference laboratory and provided that the Community reference laboratory finds that the modification does not reduce the sensitivity, specificity or reliability of the rapid test. That finding shall be communicated to the Commission and to the national reference laboratories.]
(To be defined)]
Textual Amendments
The following tissues are designated as specified risk material:
[F2the skull excluding the mandible and including the brain and eyes, 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, and the spinal cord of bovine animals aged over 12 months, and the tonsils, the intestines from the duodenum to the rectum and the mesentery of bovine animals of all ages;]
the skull including the brain and eyes, the tonsils and the spinal cord of ovine and caprine animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen and ileum of ovine and caprine animals of all ages.
The age specified in (i) for the removal of the bovine vertebral column may be adjusted by amending this Regulation in the light of the statistical probability of the occurrence of BSE in the relevant age groups of the Community's bovine population, based on the results of BSE monitoring as established by Chapter A.I of Annex III.
In addition to the specified risk material listed in (a), the following tissues must be designated as specified risk material in the United Kingdom of Great Britain and Northern Ireland: the entire head excluding the tongue, including the brain, eyes and trigeminal ganglia; the thymus, the spleen and the spinal cord of bovine animals aged over six months.
Textual Amendments
born, continuously reared and slaughtered in Member States for which a scientific evaluation established that the occurrence of BSE in native bovine animals is highly unlikely, or unlikely but not excluded; or
born after the date of effective enforcement of the prohibition on the feeding of mammalian protein to ruminants in Member States with reported BSE in native animals or for which a scientific evaluation established that the occurrence of BSE in native bovine animals is likely.
The United Kingdom and Sweden may benefit from this derogation on the basis of previously submitted and evaluated evidence. Other Member States may apply for this derogation by submitting conclusive supporting evidence to the Commission regarding point (a) or (b), as appropriate.
Member States benefiting from this derogation shall, in addition to the requirements laid down in Annex III, Chapter A, Section I, ensure that one of the approved rapid tests listed in Annex X, Chapter C, point 4, is applied to all bovine animals over 30 months of age which:
have died on the farm or in transport, but which have not been slaughtered for human consumption, with the exception of those dead animals in remote areas with a low animal density situated in Member States where the occurrence of BSE is unlikely;
were subject to normal slaughter for human consumption.
This derogation shall not be granted to allow the use of vertebral column and dorsal root ganglia from bovine animals aged over 30 months from the United Kingdom.
Experts from the Commission may carry out on-the-spot checks to further verify the submitted evidence in accordance with Article 21.]
slaughterhouses, or, as appropriate, other places of slaughter;
cutting plants, in the case of vertebral column of bovine animals;
where appropriate, in intermediate plants referred to in Regulation (EC) No 1774/2002 of the European Parliament and of the Council (18) , Article 10 or users and collection centres authorised and registered pursuant to Regulation (EC) No 1774/2002, Article 23(2)(c)(iv), (vi) and (vii).
The above provisions shall not apply to category 1 material for feeding of necrophagous birds in accordance with Article 23(2)(d) of Regulation (EC) No 1774/2002.
harvesting shall take place in a dedicated area, physically separated from the other parts of the slaughterline,
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,
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,
head meat shall not be harvested from heads which have not been properly sealed in accordance with the second indent,
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,
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.
removal of spinal cord of ovine and caprine animals in cutting plants specifically authorised for this purpose;
removal of vertebral column from carcases or parts of carcases in butcher shops specifically authorised, monitored and registered for this purpose;
harvesting of head meat from bovine in cutting plants specifically authorised for this purpose in accordance with the following provisions:
bovine heads intended for transport to cutting plants specifically authorised for the harvesting of head meat, shall comply with the following provisions:
the heads shall be suspended on a rack during the storing period and the transport from the slaughterhouse to the specifically authorised cutting plant,
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,
the heads which have not been properly sealed in accordance with the second indent, 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,
a sampling plan 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;
the harvesting of head meat from bovine heads in cutting plants specifically authorised for this purpose shall be in accordance with a control system, recognised by the competent authority, to ensure the prevention of possible contamination of head meat. The system shall include at least:
all heads shall be visually controlled for signs of contamination or damage and proper sealing before the commencement of the harvesting of the head meat,
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,
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,
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 shall in particular set up a system to ensure and check that:
specified risk material used for purposes authorised pursuant to Article 1(2) and to Regulation (EC) No 1774/2002 are used solely for authorised purposes;
specified risk material is disposed of in accordance with Regulation (EC) No 1774/2002.
However, carcases, half carcases or half carcases cut into no more than three wholesale cuts, and quarters containing no specified risk material other than vertebral column, including dorsal root ganglia, may be imported into a Member State, or dispatched to another Member State without the latter's prior agreement
when removal of the vertebral column is not required, carcases or wholesale cuts of carcases of bovine animals containing vertebral column, shall be identified by a blue stripe on the label referred to in Regulation (EC) No 1760/2000;
a specific indication of the number of bovine carcases or wholesale cuts of carcases, 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 commercial document referred to in Article 3(1)(A)(f)(ii) of Directive 64/433/EEC or to the document referred to in Article 1(2) of Commission Decision 93/13/EEC (19) , as applicable;
butcher shops shall keep, for at least one year, the commercial documents referred to in (b).
The products of animal origin listed below shall be subject to the conditions laid down in (b) on import into the Community:
the specified risk material referred to in point 1(a),
fresh meat: the meat defined by Directive 64/433/EEC,
minced meat and meat preparations: the minced meat and meat preparations defined by Directive 94/65/EC (20) ,
meat products: the meat products defined by Directive 77/99/EEC (21) ,
other products of animal origin: other products of animal origin as defined by Directive 77/99/EEC,
rendered fats as referred to in Regulation (EC) No 1774/2002,
gelatine as referred to by Directive 92/118/EEC and Regulation (EC) No 1774/2002,
pet food as referred to in Regulation (EC) No 1774/2002,
blood products as referred to in Regulation (EC) No 1774/2002
the processed animal protein referred to in Regulation (EC) No 1774/2002,
bones and bone products as referred to in Regulation (EC) No 774/2002,
category 3 material as referred to in Regulation (EC) No 1774/2002.
Any reference to ‘ products of animal origin ’ designates products of animal origin listed in this point and does not concern other products of animal origin containing or derived from those products of animal origin.
When the abovementioned products of animal origin, containing material from bovine, ovine or caprine animals are imported into the Community from third countries or regions thereof, the health certificates shall be accompanied by a declaration signed by the competent authority of the country of production, worded as follows:
‘This product does not contain and is not derived from:
either (22)
specified risk material as defined in Annex XI, section A, to Regulation (EC) No 999/2001 produced after 31 March 2001 , or mechanically recovered meat obtained from bones of bovine, ovine or caprine animals produced after 31 March 2001 . After 31 March 2001 the bovine, ovine and caprine animals, from which this 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 after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity.
Carcases, half carcases and quarter carcases may contain vertebral column on import;
or ( 1 )
bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in the following countries:
[F13Argentina
Australia
Botswana
Brazil
Chile
El Salvador
Iceland
Namibia
Territoire français de la Nouvelle Calédonie
New Zealand
Nicaragua
Panama
Paraguay
Singapore
Swaziland
Uruguay
Vanuatu.’] ]
Textual Amendments
F13 Substituted by Commission Regulation (EC) No 1809/2003 of 15 October 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards rules for importation of live bovine animals and products of bovine, ovine and caprine origin from Costa Rica and New Caledonia (Text with EEA relevance).
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F14 Deleted by Commission Regulation (EC) No 1494/2002 of 21 August 2002 amending Annexes III, VII and XI to Regulation (EC) No 999/2001 of the European Parliament and the Council as regards monitoring of bovine spongiform encephalopathy, eradication of transmissible spongiform encephalopathy, removal of specified risk materials and rules for importation of live animals and products of animal origin (Text with EEA relevance).
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F15 Deleted 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).
[F17. . . . .]
Council Decision 98/256/EC of 16 March 1998 concerning emergency measures to protect against bovine spongiform encephalopathy, amending Decision 94/474/EC and repealing Decision 96/239/EC.
Commission Decision 98/351/EC of 29 May 1998 setting the date on which dispatch from Northern Ireland of bovine products under the Export Certified Herds Scheme may commence by virtue of Article 6(5) of Council Decision 98/256/EC.
Commission Decision 1999/514/EC of 23 July 1999 setting the date on which dispatch from the United Kingdom of bovine products under the date-based export scheme may commence by virtue of Article 6(5) of Council Decision 98/256/EC.]
[F18. . . . .]
[F18. . . . .]
[F18. . . . .]
[F18. . . . .]
Textual Amendments
F17 Deleted 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).
the feeding of ruminants with proteins derived from mammals has been banned and the ban has been effectively enforced;
the bovine animals intended for export to the Community are identified by a permanent identification system enabling them to be traced back to the dam and herd of origin and are not the progeny of BSE suspected females.
Argentina
Australia
Botswana
Brazil
Chile
El Salvador
Iceland
Namibia
Territoire français de la Nouvelle Calédonie
New Zealand
Nicaragua
Panama
Paraguay
Singapore
Swaziland
Uruguay
Vanuatu.] ]
When the farmed game meat defined by Council Directive 91/495/EEC (23) , meat preparations defined by Council Directive 94/65/EC (24) , and meat products defined by Council Directive 77/99/EEC (25) , 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 cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised 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.’
When game meat as defined by Council Directive 92/45/EEC (26) , meat preparations defined by Council Directive 94/65/EC, and meat products defined by Council Directive 77/99/EEC, derived from wild cervid animals, is imported into the Community from Canada or the United States of America, the health certificate 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 cervid animals which have been examined for chronic wasting disease by histopathology, immunohistochemistry or other diagnostic method recognised 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.’ ]
Textual Amendments
Textual Amendments
F16 Inserted by Commission Regulation (EC) No 1326/2001 of 29 June 2001 laying down transitional measures to permit the changeover to the Regulation of the European Parliament and of the Council (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, and amending Annexes VII and XI to that Regulation.
[F3The sample size has been calculated to detect a prevalence of 0,03 % with a 95 % confidence in slaughtered animals. The sample is restricted to Member States with a large sheep population.]
Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and amending Directive 90/425/EEC (OJ L 363, 27.12.1990, p. 51). Directive as last amended by the 1994 Act of Accession.
Commission Decision 92/562/EEC of 17 November 1992 on the approval of alternative heat treatment systems for processing high-risk material (OJ L 359, 9.12.1992, p. 23). Decision as amended by the 1994 Act of Accession.
Council Decision 1999/534/EC of 19 July 1999 on measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies and amending Commission Decision 97/735/EC (OJ L 204, 4.8.1999, p. 37).
Commission Decision 97/735/EC of 21 October 1997 concerning certain protection measures with regard to trade in certain types of mammalian animal waste (OJ L 294, 28.10.1997, p. 7). Decision as amended by Council Decision 1999/534/EC (OJ L 204, 4.8.1999, p. 37).
[F4 [F5 OJ L 349, 24.12.2002, p. 105 .] ]
[F4 [F6 OJ L 349, 24.12.2002, p. 105 .] ]
Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in importation from third countries of embryos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1). Directive as last amended by Commission Decision 94/113/EC (OJ L 53, 24.2.1994, p. 23).
[F11Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations ( OJ L 368, 31.12.1994, p. 10 ).]
[F11Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community trade in meat products ( OJ L 26, 31.1.1977, p. 85 ). Directive as last amended by Council Directive 97/76/EC ( OJ L 10, 16.1.1998, p. 25 ).]
[F11Delete one of these as appropriate. ’]
Textual Amendments
F1 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).
F2 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).
F3 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.
F4 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).
F5 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).
F6 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).
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Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.
Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.
Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys