Council Directive 2009/158/ECDangos y teitl llawn

ANNEX I U.K.

The national reference laboratories for avian diseases designated in accordance with Article 4 shall be responsible in each Member State for coordinating the diagnostic methods provided for in this Directive. To this end:

(a)

they may supply approved laboratories with the reagents needed for diagnostic testing;

(b)

they shall monitor the quality of reagents used by the laboratories approved for the purpose of carrying out the diagnostic tests provided for in this Directive;

(c)

they shall organise periodic comparative tests.

ANNEX II U.K. APPROVAL OF ESTABLISHMENTS

CHAPTER I U.K. GENERAL RULES

1. In order to be approved by the competent authority for the purposes of intra-Community trade, establishments must: U.K.

(a)

satisfy the conditions as regards facilities and operation set out in Chapter II;

(b)

apply and adhere to a disease surveillance programme approved by the competent central veterinary authority, taking into account the requirements of Chapter III;

(c)

provide every facility for the carrying out of the operations listed in point (d);

(d)

be subject to the supervision of the competent veterinary authority within the context of an organised form of animal health monitoring. Such monitoring shall include in particular:

• at least one inspection visit per year by the official veterinarian, supplemented by checks to verify the application of hygiene measures and the operation of the establishment in accordance with the conditions in Chapter II,

• the recording by the farmer of all the information necessary for the continuous monitoring of the health status of the establishment by the competent veterinary authority,

(e)

contain only poultry.

2. The competent authority shall give each establishment which complies with the conditions laid down in point 1 a distinguishing number, which may be the same as that given pursuant to Regulation (EC) No 1234/2007. U.K.

CHAPTER II U.K. FACILITIES AND OPERATION

A.

Pedigree breeding, breeding and rearing establishments U.K.

1. Facilities U.K.

(a)

The setting and layout of the facilities must be compatible with the type of production pursued, ensuring that the introduction of disease can be prevented or, if an outbreak occurs, that it can be controlled. If an establishment houses several species of poultry, there must be a clear separation between them.

(b)

The facilities must provide good conditions of hygiene and allow health monitoring to be carried out.

(c)

The equipment must be compatible with the type of production pursued, and allow cleansing and disinfection of the facilities and of vehicles for transporting poultry and eggs at the most suitable spot.

2. Rearing U.K.

(a)

Rearing techniques must be based as far as possible on the ‘protected rearing’ principle and on the ‘all-in/all-out’ principle. Cleansing, disinfection and depopulation must be carried out between batches.

(b)

Pedigree-breeding, breeding and rearing establishments must house only poultry:

• from the establishment itself, and/or,

• from other pedigree-breeding, breeding or rearing establishments in the Community approved in accordance with Article 6(a)(i), and/or,

• imported from third countries in accordance with this Directive,

(c)

Hygiene rules must be drawn up by the management of the establishment; personnel must wear appropriate working clothing and visitors protective clothing.

(d)

Buildings, pens and equipment must be kept in good repair.

(e)

[F1 Eggs must be:

(i)

collected at frequent intervals, at least daily and as soon as possible after laying;

(ii)

cleaned and disinfected as soon as possible, unless disinfection takes place at a hatchery in the same Member State;

(iii)

placed either in new or in clean and disinfected packaging material.]

(f)

The farmer must notify the authorised veterinarian of any variation in production performance or any other sign suggesting the presence of a contagious poultry disease. As soon as disease is suspected, the authorised veterinarian must send the samples needed for making or confirming the diagnosis to an approved laboratory.

(g)

A flock history, register or data medium must be kept for each flock for at least two years after the disposal of the flock and must show:

• arrivals and departures,

• production performance,

• morbidity and mortality with causes,

• any laboratory tests and the results thereof,

• the place of origin of the poultry,

• the destination of eggs,

(h)

Where a contagious poultry disease occurs, the results of laboratory tests must be communicated immediately to the authorised veterinarian.

Textual Amendments

F1 Substituted by Commission Decision of 1 April 2011 amending Annexes II to IV to Council Directive 2009/158/EC on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (notified under document C(2011) 2068) (Text with EEA relevance) (2011/214/EU).

B.

Hatcheries U.K.

1. Facilities U.K.

(a)

A hatchery must be physically and operationally separate from rearing facilities. The layout must be such as to allow the various functional units listed below to be kept separate:

• egg storage and grading,

• disinfection,

• pre-incubation,

• hatching,

• preparation and packaging of goods for dispatch,

(b)

Buildings must be protected against birds coming from outside and rodents; floors and walls must be of hard-wearing, impervious and washable materials; natural or artificial lighting and air flow and temperature systems must be of an appropriate type; provision must be made for the hygienic evacuation of waste (eggs and chicks).

(c)

Equipment must have smooth and waterproof surfaces.

2. Operation U.K.

(a)

Operation must be based on a one-way circuit for eggs, mobile equipment and personnel.

(b)

Hatching eggs must be:

• from Community pedigree breeding or breeding establishments approved in accordance with Article 6(a)(i),

• imported from third countries in accordance with this Directive,

(c)

Hygiene rules must be drawn up by the management of the establishment; personnel must wear appropriate working clothing and visitors protective clothing.

(d)

Buildings and equipment must be kept in good repair.

(e)

The following must be disinfected:

• [F1 eggs, between the time of their arrival at the hatchery and the incubation process or at the time of their dispatch for trade within the Union or export to a third country, unless they have been previously disinfected at the breeding establishment of origin,]

• the incubators, regularly,

• hatchers and equipment, after the hatching of each batch,

(f)

A programme of microbiological quality control must be used to assess the health status of the hatchery.

(g)

The farmer must notify the authorised veterinarian of any variation in production performance or any other sign suggesting the presence of a contagious poultry disease. As soon as contagious disease is suspected, the authorised veterinarian must send the samples needed for making or confirming the diagnosis to an approved laboratory and inform the competent veterinary authority, which shall decide on appropriate measures to be taken.

(h)

A flock history, register or data medium for the hatchery must be kept for at least two years showing, if possible by flock:

• the origin of the eggs and their arrival date,

• hatching yields,

• any abnormalities,

• any laboratory tests and the results thereof,

• details of any vaccination programmes,

• the number and the destination of incubated eggs which have not hatched,

• the destination of day-old chicks,

(i)

Where a contagious poultry disease occurs, the results of laboratory tests must be communicated immediately to the authorised veterinarian.

[F1 CHAPTER III U.K. DISEASE SURVEILLANCE PROGRAMME

Without prejudice to health measures and to Articles 16 and 17, disease surveillance programmes must, as a minimum, comprise surveillance of the infections and species listed in Sections A to D.

A. Salmonella Pullorum (1) , Salmonella Gallinarum (2) and Salmonella arizonae (3) infections U.K.

1. Species concerned U.K.

(a)

Salmonella Pullorum and Salmonella Gallinarum: fowls, turkeys, guinea fowls, quails, pheasants, partridges and ducks.

(b)

Salmonella arizonae : turkeys.

2. Disease surveillance programme U.K.

(a)

Serological and/or bacteriological tests must be used to determine whether an infection is present (4) .

(b)

Samples for testing must be taken, as appropriate, from blood, embryos that fail to hatch (namely embryos dead-in-shell), second grade chicks, meconium, post mortem tissues, especially liver, spleen, ovary/oviduct and ileo-caecal junction (5) .

(c)

Direct enrichment in Selenite-cysteine broth for faecal/meconium and intestinal samples is to be used. Non-selective pre-enrichment followed by selective enrichment in soya based Rappaport-Vassiliadis (RVS) broth or Müller-Kauffmann Tetrathionate-novobiocin broth (MKTTn) may be used for samples (such as embryos dead-in-shell) where competing flora is expected to be minimal (6) , (7) .

(d)

When blood samples are taken from a flock for serological testing for Salmonella Pullorum and Salmonella Gallinarum or Salmonella arizonae , the prevalence of infection in the Member State concerned and its past incidence in the establishment must be allowed for in determining the number of samples to be taken. However, a statistically valid number of samples for serological and/or bacteriological testing to detect infection must always be taken.

(e)

Flocks must be inspected during each laying period at the best time for detecting the disease in question.

(f)

Samples for bacteriological testing must not be taken from poultry or eggs that have been treated with antimicrobial medicinal products during the 2 to 3 weeks prior to testing.

(g)

Detection techniques must be capable of differentiating serological responses to Salmonella Pullorum and Salmonella Gallinarum infection from serological responses due to the use of Salmonella Enteritidis vaccine, where this vaccine is used (8) . Such vaccination must therefore not be used if serological monitoring is to be used. If vaccination has been used, bacteriological testing must be used, but the confirmation method used must be capable of differentiating live vaccinal strains from field strains.

B. Mycoplasma gallisepticum and Mycoplasma meleagridis infections U.K.

1. Species concerned U.K.

(a)

Mycoplasma gallisepticum : fowls and turkeys.

(b)

Mycoplasma meleagridis : turkeys.

2. Disease surveillance programme U.K.

(a)

The presence of infection must be tested by validated serological and/or bacteriological and/or molecular tests. The presence of air sacculitis lesions in day-old chicks and turkey poults suggests that a Mycoplasma infection is present and must be investigated.

(b)

Samples for testing for the presence of Mycoplasma infection must be taken, as appropriate, from blood, day-old chicks and turkey poults, sperm, or swabs taken from the trachea, the choanae, cloaca or air sacs and in particular for the detection of Mycoplasma meleagridis samples must be taken from oviduct and penis of turkeys.

(c)

Tests for detecting Mycoplasma gallisepticum or Mycoplasma meleagridis must be performed on a representative sample in order to allow continuous surveillance of the infection during rearing and laying, namely just before the start of laying and every 3 months thereafter.

C. Results and measures to be taken U.K.

If there are no reactors, the test must be deemed to be negative. Otherwise, the flock must be deemed to be suspect and the measures set out in Chapter IV must be applied to it.

D. In the case of holdings which consist of two or more separate production units, the competent veterinary authority may derogate from the measures set out in point 3(b) of Chapter IV required for restoring of approval as regards healthy production units on a holding where the infection is present provided that the authorised veterinarian has confirmed that the structure and size of those production units and the operations carried out there are such that the production units provide completely separate facilities for housing, keeping and feeding, so that the disease in question cannot spread from one production unit to another. U.K.

CHAPTER IV U.K. CRITERIA FOR SUSPENDING OR WITHDRAWING APPROVAL OF AN ESTABLISHMENT

1. Approval granted to an establishment must be suspended: U.K.

(a)

when the conditions laid down in Chapter II are no longer met;

(b)

until an investigation appropriate to the disease has been completed,

if:

• an outbreak of avian influenza or Newcastle disease is suspected at the establishment,

• the establishment has received poultry or hatching eggs from an establishment with a suspected or confirmed outbreak of avian influenza or Newcastle disease,

• contact liable to transmit the infection has occurred between the establishment and the site of an outbreak of avian influenza or Newcastle disease;

(c)

until such time as new tests are performed, if the results of surveillance carried out in accordance with the conditions laid down in Chapters II and III for infection by Salmonella Pullorum, Salmonella Gallinarum, Salmonella arizonae , Mycoplasma gallisepticum or Mycoplasma meleagridis give cause to suspect an outbreak;

(d)

until completion of the appropriate measures required by the official veterinarian, if the establishment is found not to conform with the requirements of point 1(a), (b) and (c) of Chapter I.

2. Approval must be withdrawn if: U.K.

(a)

an outbreak of avian influenza or Newcastle disease is confirmed on the establishment;

(b)

a second test of an appropriate type confirms an outbreak of infection by Salmonella Pullorum, Salmonella Gallinarum, Salmonella arizonae , Mycoplasma gallisepticum or Mycoplasma meleagridis ;

(c)

after a second notice served by the official veterinarian on the person responsible for the establishment, action to bring the establishment into line with the requirements of point 1(a), (b) and (c) of Chapter I, has not been taken.

3. Conditions for restoring approval if: U.K.

(a)

approval has been withdrawn because of an outbreak of avian influenza or Newcastle disease, it may be restored 21 days after cleansing and disinfection if sanitary slaughter has been carried out;

(b)

approval has been withdrawn because of an outbreak caused by:

• Salmonella Pullorum and Salmonella Gallinarum, or Salmonella arizonae , it may be restored after negative results have been recorded in two tests performed with an interval of at least 21 days on the establishment following sanitary slaughter of the infected flock and after disinfection for which the effectiveness has been verified by suitable tests on dried surfaces,

• Mycoplasma gallisepticum or Mycoplasma meleagridis , it may be restored either after negative results have been recorded in two tests performed on the entire flock with an interval of at least 60 days or after negative results have been recorded in two tests performed with an interval of at least 21 days on the establishment after disinfection following sanitary slaughter of the entire infected flock.]

ANNEX III U.K. POULTRY VACCINATION CONDITIONS

[F1 1. Vaccines used for vaccinating poultry or flocks producing hatching eggs must have a marketing authorisation issued by the competent authority of any Member State.] U.K.

2. The criteria for using vaccines against Newcastle disease in the context of routine-vaccination programmes may be determined by the Commission. U.K.

[F2 3. In relation to vaccination against any Salmonella serotype the following conditions shall be met: U.K.

(a)

Salmonella vaccination programmes must not interfere with serological detection in the context of field investigation, or result in false-positive tests;

(b)

live Salmonella vaccines must not be used in the framework of national control programmes:

(i)

in breeding or productive poultry during their reproductive or laying stage unless the safety of their use has been demonstrated and they are authorised for such purpose in accordance with Directive 2001/82/EC of the European Parliament and of the Council (9) ;

(ii)

where the manufacturer does not provide an appropriate method to distinguish bacteriologically wild-type strains of Salmonella from vaccine strains.]

Textual Amendments

F2 Inserted by Commission Decision of 1 April 2011 amending Annexes II to IV to Council Directive 2009/158/EC on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (notified under document C(2011) 2068) (Text with EEA relevance) (2011/214/EU).

[F1 ANNEX IV U.K. VETERINARY CERTIFICATES FOR TRADE WITHIN THE UNION (Models 1 to 6)

[F3 MODEL 1 U.K.

Textual Amendments

F3 Substituted by Commission Implementing Decision of 21 December 2011 amending Annexes II and IV to Council Directive 2009/158/EC on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (notified under document C(2011) 9518) (Text with EEA relevance) (2011/879/EU).

MODEL 2 U.K.

MODEL 3] U.K.

MODEL 4 U.K.

MODEL 5 U.K.

MODEL 6] U.K.

ANNEX V U.K. COMPULSORILY NOTIFIABLE DISEASES

• Avian influenza,

• Newcastle disease,

ANNEX VI U.K.

PART A U.K. Repealed Directive with list of its successive amendments (referred to in Article 36)

Council Directive 90/539/EEC (OJ L 303, 31.10.1990, p. 6).
Council Directive 91/494/EEC (OJ L 268, 24.9.1991, p. 35).	only Article 19(2)
Council Directive 91/496/EEC (OJ L 268, 24.9.1991, p. 56).	only as regards the reference to Directive 90/539/EEC in Article 26(2)
Council Directive 92/65/EEC (OJ L 268, 14.9.1992, p. 54).	only Article 7(B), second subparagraph
Commission Decision 92/369/EEC (OJ L 195, 14.7.1992, p. 25).
Council Directive 93/120/EC (OJ L 340, 31.12.1993, p. 35).
1994 Act of Accession, Annex I, Points V.E.I.2.A.4 (OJ C 241, 29.8.1994, p. 132).
Council Directive 1999/90/EC (OJ L 300, 23.11.1999, p. 19).
Commission Decision 2000/505/EC (OJ L 201, 9.8.2000, p. 8).	only Article 1 and Annex
Commission Decision 2001/867/EC (OJ L 323, 7.12.2001, p. 29).
Council Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).	only Annex III, point 13
2003 Act of Accession, Annex II, Point 6.B.I.17 (OJ L 236, 23.9.2003, p. 381).
Council Directive 2006/104/EC (OJ L 363, 20.12.2006, p. 352).	only Annex, point I.3
Commission Decision 2006/911/EC (OJ L 346, 9.12.2006, p. 41).	only Annex, point 4
Commission Decision 2007/594/EC (OJ L 227, 31.8.2007, p. 33).
Commission Decision 2007/729/EC (OJ L 294, 13.11.2007, p. 26).	only Annex, point 2
Council Directive 2008/73/EC (OJ L 219, 14.8.2008, p. 40).	only Article 11

PART B U.K. List of time-limits for transposition into national law (referred to in Article 36)

Directive	Time-limit for transposition
90/539/EEC	1 May 1992
91/494/EEC	1 May 1992
91/496/EEC	1 July 1992
92/65/EEC	31 December 1993
93/120/EC	1 January 1995
1999/90/EC	30 June 2000
2006/104/EC	1 January 2007
2008/73/EC	1 January 2010

ANNEX VII U.K. CORRELATION TABLE

a Amending Directive 90/425/EEC.
Directive 90/539/EEC	This Directive
Article 1	Article 1
Article 2, first paragraph	Article 2, first paragraph
Article 2, second paragraph, points (1) to (14)	Article 2, second paragraph, points (1) to (14)
Article 2, second paragraph, point (16)	Article 2, second paragraph, point (15)
Article 2, second paragraph, point (17)	Article 2, second paragraph, point (16)
Article 3(1)	Article 3(1), first subparagraph
Article 3(2)	Article 3(1), second subparagraph
Article 3(3), first and second indents	Article 3(2)(a) and (b)
Article 4	Article 4
Article 5(a), first subparagraph	Article 5(a), first subparagraph
Article 5(a), second subparagraph, first, second and third indents	Article 5(a), second subparagraph, (i), (ii) and (iii)
Article 5(b), (c) and (d)	Article 5(b), (c) and (d)
Article 6(1)(a), (b) and (c)	Article 6(a)(i), (ii) and (iii)
Article 6(2)	Article 6(b)
Article 6a	Article 7
Article 7, first paragraph, point (1), first indent	Article 8(1)(a)(i)
Article 7, first paragraph, point (1), second indent	Article 8(1)(a)(ii)
Article 7, first paragraph, point (1), second indent, first subindent	Article 8(1)(a)(iii), first indent
Article 7, first paragraph, point (1), second indent, second subindent	Article 8(1)(a)(iii), second indent
Article 7, first paragraph, point (2)	Article 8(1)(b)
Article 7, first paragraph, point (3)	Article 8(1)(c)
Article 7, second paragraph	Article 8(2)
Article 8	Article 9
Article 9	Article 10
Article 9a	—
Article 9b	—
Article 10	Article 11
Article 10a	Article 12
Article 10b	Article 13
Article 11(1)	Article 14(1)
Article 11(2), first to fifth indents	Article 14(2), first subparagraph, points (a) to (e)
Article 11(2), sixth indent	Article 14(2), second subparagraph
Article 11(3)	Article 14(3)
Article 12(1)(a), first, second and third indents	Article 15(1)(a)(i), (ii) and (iii)
Article 12(1)(b), first and second indents	Article 15(1)(b)(i) and (ii)
Article 12(1)(c), first, second and third indents	Article 15(1)(c)(i), (ii) and (iii)
Article 12(1)(d), first and second indents	Article 15(1)(d)(i) and (ii)
Article 12(2), first, second and third subparagraphs	Article 15(2), first, second and third subparagraphs
Article 12(2), fourth subparagraph, first, second and third indents	Article 15(2), fourth subparagraph, points (a), (b) and (c)
Article 12(2), fifth subparagraph	—
Article 12(3)(i) and (ii)	Article 15(3)(a) and (b)
Article 13(1), first to seventh indents	Article 16(1)(a) to (g)
Article 13(2), first subparagraph	Article 16(2)
Article 13(2), second subparagraph	—
Article 13(3)	Article 16(3)
Article 13(4)	—
Article 14(1), first to fifth indents	Article 17(1)(a) to (e)
Article 14(2)	Article 17(2)
Article 14(3)	Article 17(3)
Article 14(4)	—
Article 15(1), first subparagraph, first and second indents	Article 18(1)(a) and (b)
Article 15(1), second subparagraph, point (a)	Article 18(2)(a)
Article 15(1), second subparagraph, point (b), first to fourth indents	Article 18(2)(b)(i) to (iv)
Article 15(2)	Article 18(3)
Article 15(3), first and second indents	Article 18(4)(a) and (b)
Article 15(4)(a)	Article 18(5), first subparagraph
Article 15(4)(b)	Article 18(5), second subparagraph
Article 15(4)(c)	Article 18(5), third subparagraph
Article 15(5), first, second and third indents	Article 18(6)(a), (b) and (c)
Article 15(6)	Article 18(7)
Article 16	Article 19
Article 17, first to seventh indents	Article 20(a) to (g)
Article 18	Article 21
Article 20	Article 22
Article 21	Article 23
Article 22(1)	Article 24(1)
Article 22(2)	—
Article 22(3)	Article 24(2)
Article 23	Article 25
Article 24	Article 26
Article 25	Article 27
Article 26	Article 28
Article 27a	Article 29
Article 28	Article 30
Article 29(1)	Article 31
Article 30(1)	Article 32
Article 30(2)	—a
Article 31	—
Article 32(1)	Article 33(1)
Article 32(2)	Article 33(2)
Article 32(3)	—
Article 33(1)	—
Article 33(2)	Article 33(3)
Article 34	Article 34
Article 36	—
—	Article 35
—	Article 36
—	Article 37
Article 37	Article 38
Annex I, point 2	Annex I
Annex II, Chapters I, II and III	Annex II, Chapters I, II and III
Annex II, Chapter IV, points 1 and 2	Annex II, Chapter IV, points 1 and 2
Annex II, Chapter IV, point 3(a)	Annex II, Chapter IV, point 3(a)
Annex II, Chapter IV, point 3(b)(i) and (ii)	Annex II, Chapter IV, point 3(b), first and second indents
Annexes III, IV and V	Annexes III, IV and V
—	Annex VI
—	Annex VII

(1)

[F1 Salmonella Pullorum means Salmonella enterica subspecies enterica serovar Gallinarum biochemical variant (biovar) Pullorum.]

(2)

[F1 Salmonella Gallinarum means Salmonella enterica subspecies enterica serovar Gallinarum biochemical variant (biovar) Gallinarum.]

(3)

[F1 Salmonella arizonae means Salmonella enterica subspecies arizonae serogroup K (O18) arizonae.]

(4)

[F1 Note that serological testing in avian species other than fowls may sometimes result in an unacceptable proportion of false-positive reactions.]

(5)

[F1 [F3 Note that environmental samples are generally not suitable for reliable detection of Salmonella pullorum and Salmonella gallinarum , but are suitable for Salmonella arizonae.] ]

(6)

[F1 Note that direct plating of aseptically collected tissues on to a minimally selective agar, such as MacConkey agar, is also useful for diagnosis.]

(7)

[F1 [F3 Salmonella pullorum and Salmonella gallinarum do not readily grow in the modified semi-solid Rappaport Vassiliadis (MSRV) medium that is used for monitoring of zoonotic Salmonella spp. in the Union, but it is suitable for Salmonella arizonae.] ]

(8)

[F1 Note that there is currently no test that can differentiate between the response to Salmonella Pullorum and Salmonella Gallinarum infection and vaccination for this serotype.]

(9)

[F2 OJ L 311, 28.11.2001, p. 1 .]

Textual Amendments

F1 Substituted by Commission Decision of 1 April 2011 amending Annexes II to IV to Council Directive 2009/158/EC on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (notified under document C(2011) 2068) (Text with EEA relevance) (2011/214/EU).

F2 Inserted by Commission Decision of 1 April 2011 amending Annexes II to IV to Council Directive 2009/158/EC on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (notified under document C(2011) 2068) (Text with EEA relevance) (2011/214/EU).

F3 Substituted by Commission Implementing Decision of 21 December 2011 amending Annexes II and IV to Council Directive 2009/158/EC on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (notified under document C(2011) 9518) (Text with EEA relevance) (2011/879/EU).