EN Official Journal of the European Union L 337/128

COUNCIL DECISION (EU) 2015/2367

of 30 November 2015

on the position to be taken on behalf of the European Union within the Joint Veterinary Committee set up by the Agreement between the European Community and the Swiss Confederation on trade in agricultural products in relation to Decision No 1/2015 regarding the amendment of Appendices 1, 2, 3, 4, 5, 6, 7, 10 and 11 to Annex 11 to the Agreement

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(4) in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1) The Agreement between the European Community and the Swiss Confederation on trade in agricultural products (1) (‘the Agriculture Agreement’) entered into force on 1 June 2002.

(2) Under Article 19(1) of Annex 11 to the Agriculture Agreement, the Joint Veterinary Committee is responsible for considering any matter arising in connection with the said Annex and its implementation, and for carrying out the tasks provided for therein. Article 19(3) of that Annex authorises the Joint Veterinary Committee to amend the Appendices to Annex 11, in particular with a view to their adaptation and updating.

(3) The first subparagraph of Article 5(2) of Decision 2002/309/EC, Euratom of the Council and of the Commission (2) provides that the Community position within the Joint Committee for Agriculture and the Joint Veterinary Committee is to be adopted by the Council on a proposal from the Commission.

(4) The European Union should adopt the position it is to take within the Joint Veterinary Committee regarding the necessary amendments.

(5) Decision No 1/2015 of the Joint Veterinary Committee set up by the Agriculture Agreement (‘Decision No 1/2015 of the Joint Veterinary Committee’) should enter into force on the day of its adoption.

(6) In order to avoid a discontinuation of existing and well-functioning practices and to ensure a legal continuity which would not cause any foreseeable negative consequences, Decision No 1/2015 of the Joint Veterinary Committee should provide for the retroactive application of that Decision with effect from 1 January 2015,

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted on behalf of the European Union within the Joint Veterinary Committee set up by Article 19(1) of Annex 11 to the Agriculture Agreement regarding the amendment of Appendices 1, 2, 3, 4, 5, 6, 7, 10 and 11 to Annex 11 shall be based on the draft decision of the Joint Veterinary Committee attached to this Decision.

Article 2

This Decision shall enter into force on the day of its adoption.

Done at Brussels, 30 November 2015. For the Council The President É. SCHNEIDER

(1) OJ L 114, 30.4.2002, p. 132.

(2) 2002/309/EC, Euratom: Decision of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation, of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation (OJ L 114, 30.4.2002, p. 1).

DRAFT DECISION No 1/2015 OF THE JOINT VETERINARY COMMITTEE SET UP BY THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON TRADE IN AGRICULTURAL PRODUCTS of… regarding the amendment of Appendices 1, 2, 3, 4, 5, 6, 7, 10 and 11 to Annex 11 to the Agreement THE JOINT VETERINARY COMMITTEE, Having regard to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (1) and in particular Article 19(3) of Annex 11 thereto, Whereas: (1) The Agreement between the European Community and the Swiss Confederation on trade in agricultural products ("the Agriculture Agreement") entered into force on 1 June 2002. (2) Under Article 19(1) of Annex 11 to the Agriculture Agreement, the Joint Veterinary Committee set up by the Agriculture Agreement ("the Joint Veterinary Committee") is responsible for considering any matter arising in connection with the said Annex and its implementation, and for carrying out the tasks provided for therein. Article 19(3) of that Annex authorises the Joint Veterinary Committee to amend the Appendices thereto, in particular with a view to their adaptation and updating. (3) Decision No 2/2003 of the Joint Veterinary Committee (2) amended Appendices 1, 2, 3, 4, 5, 6 and 11 to Annex 11 to the Agriculture Agreement for the first time. (4) Decision No 1/2013 of the Joint Veterinary Committee (3) last amended Appendices 1, 2, 3, 5, 6 and 10 of Annex 11 to the Agriculture Agreement. (5) A number of European Union and Swiss legislative provisions have been amended since the last amendment to Appendices 1, 2, 3, 5, 6 and 10 of Annex 11 to the Agricultural Agreement by Decision No 1/2013 of the Joint Veterinary Committee. Given the scale of the amendments, the references to the legislation were updated. (6) On 1 January 2013, the Swiss Federal Veterinary Office was transferred within the Federal Ministry of the Interior and merged with the Food Safety Division of the Federal Public Health Office to form one new agency on 1 January 2014. The new agency is called the Federal Food Safety and Veterinary Office. Following the merger, various legislative texts have had to be amended. (7) Switzerland has submitted to the Joint Veterinary Committee its plan stating the measures it intends to implement for the approval of its establishments for the purposes of Article 3 of Council Directive 2009/158/EC (4). Pursuant to the Agriculture Agreement, the Joint Veterinary Committee is the competent authority for approving this plan. (8) Until 31 December 2014, Switzerland may derogate from the Trichinella examination of carcasses and meat of domestic swine kept for fattening and slaughter in low-capacity slaughter establishments. These carcasses and meat and meat products produced from them must be marked with a special health stamp and may not be traded with the Member States of the European Union, in accordance with the provisions of Article 9a of the ordinance of the Federal Department of Home Affairs of 23 November 2005 on food products of animal origin (RS 817.022.108). Commission Regulation (EU) No 216/2014 (5) amends the specific rules applicable to the official controls on Trichinella in meat and provides for the delayed application of some provisions. In order to facilitate the gradual amendment of current practice in Switzerland, the possibility of a derogation for the Trichinella examination should be extended until 31 December 2016. (9) In order to avoid a discontinuation of existing and well-functioning practices and to ensure a legal continuity which would not cause any foreseeable negative consequences it is appropriate to apply this Decision retroactively with effect from 1 January 2015. (10) This Decision should enter into force on the day it is adopted. (11) Appendices 1, 2, 3, 4, 5, 6, 7, 10 and 11 of Annex 11 to the Agriculture Agreement should be amended accordingly, HAS ADOPTED THIS DECISION: Article 1 Appendices 1, 2, 3, 4, 5, 6, 7, 10 and 11 of Annex 11 to the Agriculture Agreement are amended in accordance with Annexes I to IX to this Decision. Article 2 The plan submitted by Switzerland concerning the measures it intends to take for the approval of its establishments pursuant to Article 3 of Directive 2009/158/EC is recognised as being in line with the requirements of that Directive. Article 3 This Decision, drawn up in duplicate, shall be signed by the joint chairmen or other persons empowered to act on behalf of the Parties to the Agriculture Agreement. Article 4 This Decision shall enter into force on the day of its adoption. It shall apply retroactively with effect from 1 January 2015. Done at Berne, For the Swiss Confederation For the European Union (1) OJ L 114, 30.4.2002, p. 132. (2) Decision No 2/2003 of the Joint Veterinary Committee set up by the Agreement between the European Community and the Swiss Confederation on trade in agricultural products of 25 November 2003 amending Appendices 1, 2, 3, 4, 5, 6 and 11 to Annex 11 to the Agreement (2004/78/EC) (OJ L 23, 28.1.2004, p. 27). (3) Decision No 1/2013 of the Joint Veterinary Committee set up by the Agreement between the European Community and the Swiss Confederation on trade in agricultural products of 22 February 2013 regarding the amendment of Appendices 1, 2, 3, 5, 6 and 10 to Annex 11 to the Agreement (2013/479/EU) (OJ L 264, 5.10.2013, p. 1). (4) Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (OJ L 343, 22.12.2009, p. 74). (5) Commission Regulation (EU) No 216/2014 of 7 March 2014 amending Regulation (EC) No 2075/2005 laying down specific rules on official controls for Trichinella in meat (OJ L 69, 8.3.2014, p. 85).

ANNEX I Appendix 1 of Annex 11 to the Agricultural Agreement shall be replaced by the following: ‘Appendix 1 Control measures/notification of diseases I. Foot and mouth disease A. LEGISLATION (1) European Union Switzerland Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (OJ L 306, 22.11.2003, p. 1). 1. Law on epizootic diseases (LFE; RS 916.40) of 1 July 1966, and in particular Articles 1 to 10b thereof (objectives, measures against highly contagious epizootic diseases) and 57 (technical implementation provisions, international collaboration); 2. Ordinance on epizootic diseases (OFE; RS 916.401) of 27 June 1995, in particular Articles 2 (highly contagious epizootic diseases), 49 (handling micro-organisms that are pathogenic for animals), 73 and 74 (cleaning and disinfection), 77 to 98 (common provisions concerning highly contagious epizootic diseases), 99 to 103 (specific measures concerning foot-and-mouth disease); 3. Ordinance of 28 June 2000 on the organisation of the Département fédéral de l'intérieur (Org DFI; RS 172.212.1), and in particular Article 12 thereof (reference laboratory, registration, monitoring and provision of vaccine against foot-and-mouth disease). B. IMPLEMENTING ARRANGEMENTS 1. The Commission and the Federal Food Safety and Veterinary Office shall notify each other of any intention to carry out emergency vaccinations. In extreme emergencies, notification may cover the decision as taken and the rules and procedures governing its implementation. At all events, consultations must be held as soon as possible within the Joint Veterinary Committee. 2. Pursuant to Article 97 of the Ordinance on epizootic diseases, Switzerland has established a contingency plan, which is published on the website of the Federal Food Safety and Veterinary Office. 3. The joint reference laboratory for identifying the foot-and-mouth virus shall be: The Pirbright Institute, Pirbright Laboratory, Ash Road, Pirbright, Surrey, GU24 0NF, United Kingdom. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in Annex XVI to Directive 2003/85/EC. II. Classical swine fever A. LEGISLATION (2) European Union Switzerland Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (OJ L 316, 1.12.2001, p. 5). 1. Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40), and in particular Articles1 to 10b thereof (objectives, measures against highly contagious epizootic diseases) and 57 (technical implementation provisions, international collaboration); 2. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 2 (highly contagious epizootic diseases), 40 to 47 (disposal of animal byproducts), 49 (handling micro-organisms that are pathogenic for animals), 73 and 74 (cleaning and disinfection), 77 to 98 (common provisions concerning highly contagious epizootic diseases) and 116 to 121 (detection of swine fever at slaughter, specific measures to combat swine fever) thereof; 3. Ordinance of 28 June 2000 on the organisation of the Département fédéral de l'intérieur (Org DFI; RS 172.212.1), in particular Article 12 thereof (reference laboratory); 4. Ordinance of 25 May 2011 on the disposal of animal by-products (OESPA; RS 916.441.22). B. IMPLEMENTING ARRANGEMENTS 1. The Commission and the Federal Food Safety and Veterinary Office shall notify each other of any intention to carry out emergency vaccinations. Consultations shall be held as soon as possible within the Joint Veterinary Committee. 2. If necessary, pursuant to Article 117(5) of the Ordinance on epizootic diseases, the Federal Food Safety and Veterinary Office shall lay down technical implementing rules on the marking and treatment of meat coming from protection and surveillance zones. 3. Pursuant to Article 121 of the Ordinance on epizootic diseases, Switzerland has a plan to eradicate classical swine fever in wild pigs in accordance with Articles 15 and 16 of Directive 2001/89/EC. 4. Pursuant to Article 97 of the Ordinance on epizootic diseases, Switzerland has established a contingency plan, which is published on the website of the Federal Food Safety and Veterinary Office. 5. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 21 of Directive 2001/89/EC and Article 57 of the Law on epizootic diseases. 6. If necessary, pursuant to Article 89(2) of the Ordinance on epizootic diseases, the Federal Food Safety and Veterinary Office shall lay down technical implementing rules on serological checks on pigs in protection and surveillance zones in accordance with Chapter IV of the Annex to Commission Decision 2002/106/EC (3). 7. The joint reference laboratory for classical swine fever shall be the: Institut für Virologie der Tierärztlichen Hochschule Hannover, 15 Bünteweg 17, 30559 Hannover, Germany. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in Annex IV to Directive 2001/89/EC. III. African swine fever A. LEGISLATION (4) European Union Switzerland Council Directive 2002/60/EC of 27 June 2002 laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever (OJ L 192, 20.7.2002, p. 27). 1. Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40) and in particular Articles 1 to 10b thereof (objectives, measures against highly contagious epizootic diseases) and 57 (technical implementation provisions, international collaboration); 2. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 2 (highly contagious epizootic diseases), 40 and 47 (disposal of animal by-products), 49 (handling micro-organisms that are pathogenic for animals), 73 and 74 (cleaning and disinfection), 77 to 98 (common provisions concerning highly contagious epizootic diseases) and 116 to 121 (detection of swine fever at slaughter, specific measures to combat swine fever) thereof; 3. Ordinance of 28 June 2000 on the organisation of the Département fédéral de l'intérieur (Org DFI; RS 172.212.1), in particular Article 12 thereof (reference laboratory); 4. Ordinance of 25 May 2011 on the disposal of animal by-products (OESPA; RS 916.441.22). B. IMPLEMENTING ARRANGEMENTS 1. The EU reference laboratory for African swine fever is the: Centro de Investigación en Sanidad Animal, 28130 Valdeolmos, Madrid, Spain. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in Annex V to Directive 2002/60/EC. 2. Pursuant to Article 97 of the Ordinance on epizootic diseases, Switzerland has established a contingency plan, which is published on the website of the Federal Food Safety and Veterinary Office. 3. If necessary, pursuant to Article 89(2) of the Ordinance on epizootic diseases, the Federal Food Safety and Veterinary Office shall lay down technical implementing rules in accordance with the provisions of Commission Decision 2003/422/EC (5) concerning the diagnosis of African swine fever. 4. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 20 of Directive 2002/60/EC and Article 57 of the Law on epizootic diseases. IV. African horse sickness A. LEGISLATION (6) European Union Switzerland Council Directive 92/35/EEC of 29 April 1992 laying down control rules and measures to combat African horse sickness (OJ L 157, 10.6.1992, p. 19). 1. Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40) and in particular Articles 1 to 10b thereof (objectives, measures against highly contagious epizootic diseases) and 57 (technical implementation provisions, international collaboration); 2. Ordinance on epizootic diseases of 27 June 1995 (OFE; RS 916.401), in particular Articles 2 (highly contagious epizootic diseases), 49 (handling micro-organisms that are pathogenic for animals), 73 and 74 (cleaning and disinfection), 77 to 98 (common provisions concerning highly contagious epizootic diseases), 112 to 112f (specific measures concerning African horse sickness); 3. Ordinance of 28 June 2000 on the organisation of the Département fédéral de l'intérieur (Org DFI; RS 172.212.1), in particular Article 12 thereof (reference laboratory); 4. Ordinance of 25 May 2011 on the disposal of animal by-products (OESPA; RS 916.441.22). B. IMPLEMENTING ARRANGEMENTS 1. Where an epizootic disease of particular severity develops in Switzerland, the Joint Veterinary Committee shall meet to consider the situation. The competent Swiss authorities undertake to implement the measures found necessary in the light of that examination. 2. The joint reference laboratory for African horse sickness shall be the: Laboratorio de Sanidad y Producción Animal, Ministerio de Agricultura, Pesca y Alimentación, 28110 Algete, Madrid, Spain. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in Annex III to Directive 92/35/EEC. 3. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 16 of Directive 92/35/EEC and Article 57 of the Law on epizootic diseases. 4. Pursuant to Article 97 of the Ordinance on epizootic diseases, Switzerland has established a contingency plan, which is published on the website of the Federal Food Safety and Veterinary Office. V. Avian influenza A. LEGISLATION (7) European Union Switzerland Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (OJ L 10, 14.1.2006, p. 16). 1. Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40), and in particular Articles 1 to 10b thereof (objectives, measures against highly contagious epizootic diseases) and 57 (technical implementation provisions, international collaboration); 2. Ordinance on epizootic diseases of 27 June 1995 (OFE; RS 916.401), in particular Articles 2 (highly contagious epizootic diseases), 49 (handling micro-organisms that are pathogenic for animals), 73 and 74 (cleaning and disinfection), 77 to 98 (common provisions concerning highly contagious epizootic diseases), and 122 to 122f (specific measures concerning avian influenza) thereof; 3. Ordinance of 28 June 2000 on the organisation of the Département fédéral de l'intérieur (Org DFI; RS 172.212.1), in particular Article 12 (reference laboratory). B. IMPLEMENTING ARRANGEMENTS 1. The EU reference laboratory for avian influenza is the: Animal Health and Veterinary Laboratory Agency AHVLA Corporate Headquarters (Weybridge), Woodham Lane, New Haw, Addlestone, Surrey, KT15 3NB, United Kingdom. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in point 2 of Annex VII to Directive 2005/94/EC. 2. Pursuant to Article 97 of the Ordinance on epizootic diseases, Switzerland has established a contingency plan, which is published on the website of the Federal Food Safety and Veterinary Office. 3. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 60 of Directive 2005/94/EC and Article 57 of the Law on epizootic diseases. VI. Newcastle disease A. LEGISLATION (8) European Union Switzerland Council Directive 92/66/EEC of 14 July 1992 introducing Community measures for the control of Newcastle disease (OJ L 260, 5.9.1992, p. 1). 1. Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40), and in particular Articles 1 to 10b (objectives, measures against highly contagious epizootic diseases) and 57 (technical implementation provisions, international collaboration) thereof; 2. Ordinance of 27 June 1995 on epizootic diseases (LFE; RS 916.401), and in particular Articles 2 (highly contagious epizootic diseases), 40 to 47 (elimination of animal by-products), 49 (handling of micro-organisms which are pathogenic for animals), 73 and 74 (cleaning and disinfection), 77 to 98 (common provisions concerning highly contagious diseases), 123 to 125 (specific measures concerning Newcastle disease); 3. Ordinance of 28 June 2000 on the organisation of the Département fédéral de l'intérieur (Org DFI; RS 172.212.1), in particular Article 12 thereof (reference laboratory); 4. Ordinance of 25 May 2011 on the disposal of animal by-products (OESPA; RS 916.441.22). B. IMPLEMENTING ARRANGEMENTS 1. The EU reference laboratory for Newcastle disease is the: Animal Health and Veterinary Laboratory Agency AHVLA Corporate Headquarters (Weybridge), Woodham Lane, New Haw, Addlestone, Surrey, KT15 3NB, United Kingdom. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in Annex V to Directive 92/66/EEC. 2. Pursuant to Article 97 of the Ordinance on epizootic diseases, Switzerland has established a contingency plan, which is published on the website of the Federal Food Safety and Veterinary Office. 3. The information provided for in Articles 17 and 19 of Directive 92/66/EEC shall be the responsibility of the Joint Veterinary Committee. 4. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 22 of Directive 92/66/EEC and Article 57 of the Law on epizootic diseases. VII. Diseases affecting fish and molluscs A. LEGISLATION (9) European Union Switzerland Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14). 1. Act of 1 July 1966 on epizootic diseases (LFE; RS 916.40), in particular Articles 1 to 10 (measures against epizootic diseases) and 57 (technical implementing provisions, international cooperation); 2. Ordinance on epizootic diseases of 27 June 1995 (OFE; RS 916.401), in particular Articles 3 and 5 (epizootic diseases concerned), 21 to 23 (registration of fish breeding units, monitoring of staff and other obligations, health monitoring), 61 (obligations of leasers of fishing rights and of bodies responsible for monitoring fishing), 62 to 76 (general measures for combating disease), and 277 to 290 (common and specific measures relating to fish diseases, diagnostic laboratory). B. IMPLEMENTING ARRANGEMENTS 1. Flat oyster farming is not currently practised in Switzerland. Should cases of bonamiosis or marteiliosis appear, the Federal Food Safety and Veterinary Office undertakes to adopt the necessary emergency measures in accordance with the EU rules on the basis of Article 57 of the Act on epizootic diseases. 2. With a view to combating diseases affecting fish and molluscs, Switzerland shall apply the Ordinance on epizootic diseases, in particular Articles 61 (obligations of leasers of fishing rights and of bodies responsible for monitoring fishing), 62 to 76 (general measures for combating disease), 277 to 290 (specific measures relating to fish diseases, diagnostic laboratory) and 291 (epizootic diseases to be monitored). 3. The European Union reference laboratory for crustacean diseases shall be the Centre for Environment, Fisheries & Aquaculture Science (CEFAS), Weymouth Laboratory, United Kingdom. The European Union reference laboratory for fish diseases shall be the National Veterinary Institute, Technical University of Denmark, Hangøvej 2, 8200 Århus, Denmark. The European Union reference laboratory for mollusc diseases shall be the Laboratoire IFREMER, BP 133, 17390 La Tremblade, France. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratories in the above capacity. The functions and tasks of the laboratories shall be as laid down in Part I of Annex VI to Directive 2006/88/EC. 4. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 58 of Directive 2006/88/EC and Article 57 of the Law on epizootic diseases. VIII. Transmissible spongiform encephalopathies A. LEGISLATION (10) European Union Switzerland 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 (OJ L 47, 31.5.2001, p. 1). 1. Ordinance of 23 April 2008 on animal protection (OPAn; RS 455.1), in particular Article 184 thereof (stunning procedures); 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10); 3. Law of 9 October 1992 on foodstuffs and consumer products (LDAl; RS 817.0), and in particular Articles 24 (Inspection and sampling) and 40 (Inspection of foodstuffs); 4. DFI Ordinance of 23 November 2005 on foodstuffs of animal origin (RS 817.022.108), and in particular Articles 4 and 7 thereof (parts of the carcass which may not be used); 5. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 6 (definitions and abbreviations), 34 (patents), 61 (obligation to report), 130 (surveillance of Swiss livestock), 175 to 181 (transmissible spongiform encephalopathies), 297 (internal implementation), 301 (duties of the canton veterinarian), 302 (official veterinarian) and 312 (diagnostic laboratories); 6. DFER Ordinance of 26 October 2011 on the Catalogue of feeding stuffs (OLALA; RS 916.307.1), and in particular Article 21 (tolerance, sampling, methods of analysis and transport), Annex 1.2, No 15 (land animal products), No 16 (fish, other marine animals, their products and by-products), and Annex 4.1 (substances the bringing into circulation and use of which are restricted or prohibited); 7. Ordinance of 25 May 2011 on the disposal of animal by-products (OESPA; RS 916.441.22). B. IMPLEMENTING ARRANGEMENTS 1. The EU reference laboratory for transmissible spongiform encephalopathies (TSEs) is the: Animal Health and Veterinary Laboratory Agency AHVLA Corporate Headquarters (Weybridge), Woodham Lane, New Haw, Addlestone, Surrey, KT15 3NB, United Kingdom. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in Chapter B of Annex X to Regulation (EC) No 999/2001. 2. Pursuant to Article 57 of the Law on epizootic diseases, Switzerland has established an emergency plan for implementing measures to combat TSEs. 3. Under Article 12 of Regulation (EC) No 999/2001, any animal suspected of being infected by a TSE in the Member States of the European Union shall be placed under an official movement restriction until the results of a clinical and epidemiological examination carried out by the competent authority are known, or killed for the purposes of laboratory examination under official control. In accordance with Articles 179b and 180a of the Ordinance on epizootic diseases, Switzerland has banned the slaughter of animals suspected of being infected by a TSE. Suspect animals must be killed without spilling blood and incinerated, and their brains must be analysed in the Swiss reference laboratory for TSEs. Under Article 10 of the Ordinance on epizootic diseases, Switzerland has introduced a uniform identification system for bovine animals 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 females or BSE confirmed bovine animals. Pursuant to Article 179c of the Ordinance on epizootic diseases, Switzerland slaughters animals infected with BSE, at the latest by the end of the production phase, all animals of the bovine species born between one year before and one year after the birth of the contaminated animal and which, over this period of time, were part of the herd, and all the direct descendants of the contaminated cows born in the two years which preceded the diagnosis. 4. Pursuant to Article 180b of the Ordinance on epizootic diseases, Switzerland slaughters animals infected with scrapie, their dams and the direct descendants of contaminated dams, as well as all the other sheep and goats in the herd, with the exception of: — sheep carrying at least one ARR allele and no VRQ allele; and — animals less than two months old which are intended solely for slaughter. The head and organs of the abdominal cavity of these animals are disposed of in accordance with the provisions of the Ordinance on the disposal of animal by-products. By way of exception, in the case of breeds which are low in number, the herd does not have to be slaughtered. In this case, the herd is placed under official veterinary surveillance for a period of two years during which a clinical examination of the animals in the herd is carried out twice a year. If during this period animals are presented for slaughter, their heads, including tonsils, are subjected to an analysis by the Swiss reference laboratory for TSEs. These measures are reviewed according to the findings from animal health monitoring. In particular, the monitoring period is extended if a new case of the disease is detected in the herd. In the event of a confirmed case of BSE in a sheep or goat, Switzerland undertakes to apply the measures laid down in Annex VII to Regulation (EC) No 999/2001. 5. Under Article 7 of Regulation (EC) No 999/2001, the Member States of the European Union prohibit the feeding of processed animal proteins to farmed animals which are kept, fattened or bred for the production of food. There is a total prohibition on feeding proteins derived from animals to ruminants in the Member States of the European Union. Under Article 27 of the Ordinance on the elimination of animal by-products (OESPA), Switzerland has introduced a total prohibition on the feeding of animal protein to farmed animals. 6. Under Article 6 of Regulation (EC) No 999/2001 and in accordance with Chapter A of Annex III to that Regulation, the Member States of the European Union are to introduce an annual BSE monitoring programme. This plan includes a rapid BSE test for all cattle more than 24 months old subject to emergency slaughter, animals which have died on the farm or were found to be ill during the ante mortem inspection and all animals more than 30 months old slaughtered for human consumption. The rapid BSE tests used by Switzerland are listed in Chapter C of Annex X to Regulation (EC) No 999/2001. Pursuant to Article 176 of the Ordinance on epizootic diseases, Switzerland carries out an obligatory rapid BSE test on all cattle older than 48 months that have died or been killed for reasons other than slaughter, been taken diseased to the slaughterhouse or have suffered an accident. 7. Under Article 6 of Regulation (EC) No 999/2001 and in accordance with Chapter A of Annex III to that Regulation, the Member States of the European Union are to introduce an annual monitoring programme for scrapie. Pursuant to the provisions of Article 177 of the Ordinance on epizootic diseases, Switzerland has introduced a TSE monitoring programme for ovine and caprine animals more than 12 months old. Animals which are subject to emergency slaughter, have died on the farm or have been found to be ill during the ante mortem inspection and all animals slaughtered for human consumption were examined over the period from June 2004 to July 2005. As all the samples tested negative for BSE, samples for monitoring purposes are taken from clinical suspect animals, animals subject to emergency slaughter and animals which died on the farm. The recognition of similarities in legislation governing the monitoring of TSEs in ovine and caprine animals will be reconsidered by the Joint Veterinary Committee. 8. The Joint Veterinary Committee is responsible for providing the information required in Article 6 and Chapter B of Annex III and in Annex IV (3.III) to Regulation (EC) No 999/2001. 9. On-the-spot inspections are carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 21 of Regulation (EC) No 999/2001 and Article 57 of the Law on epizootic diseases. C. ADDITIONAL INFORMATION 1. From 1 January 2003, and pursuant to the Ordinance of 10 November 2004 on the allocation of contributions to cover the costs of eliminating animal waste (RS 916.407), Switzerland has introduced a financial incentive for farms on which bovine animals are born and slaughterhouses where they are slaughtered, provided they comply with the procedures for declaring animal movements as provided for in the legislation in force. 2. Under Article 8 of Regulation (EC) No 999/2001 and in accordance with point 1 of Annex XI to that Regulation, the Member States of the European Union are to remove and destroy specified risk materials (SRMs). The list of SRMs removed from bovine animals comprises the skull, excluding the mandible but including the brain and eyes, and the spinal cord of bovine animals aged over 12 months; the spinal column, excluding the vertebrae of the tail, the spinous and transversal processes of the cervical and lumbar vertebrae and the median sacral crest and the wings of the sacrum, but including the dorsal root ganglia and spinal cord of bovine animals aged over 24 months; the tonsils, the intestines from the duodenum to the rectum and the mesentery of bovine animals of all ages. The list of SRMs removed from ovine and caprine animals comprises 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. Under Article 179d of the Ordinance on epizootic diseases and Article 4 of the Ordinance on foodstuffs of animal origin, Switzerland has introduced a policy of removing SRMs from the animal and human food chains. The list of SRMs removed from bovine animals comprises in particular the spinal column of animals aged over 30 months, and the tonsils, intestines from the duodenum to the rectum, and mesentery of animals of all ages. Under Article 180c of the Ordinance on epizootic diseases and Article 4 of the Ordinance on foodstuffs of animal origin, Switzerland has introduced a policy of removing SRMs from the animal and human food chains. The list of SRMs removed from ovine and caprine animals includes in particular the brain in the cranial cavity, the spinal cord with the dura mater and the tonsils of animals aged over 12 months or which have a permanent incisor erupted through the gum, and the spleen and ileum of animals of all ages. 3. Regulation (EC) No 1069/2009 of the European Parliament and of the Council (11) and Commission Regulation (EU) No 142/2011 (12) lay down health rules concerning animal by-products not intended for human consumption in the Member States of the European Union. Under Article 22 of the Ordinance on the elimination of animal by-products, Switzerland is to incinerate category 1 animal by-products, including specified risk materials and animals which have died on the farm. IX. Bluetongue A. LEGISLATION (13) European Union Switzerland Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue (OJ L 327, 22.12.2000, p. 74). 1. Act of 1 July 1966 on epizootic diseases (LFE; RS 916.40), and in particular Articles 1 to 10 thereof (objectives, measures against highly contagious epizootic diseases) and 57 (technical implementation provisions, international collaboration); 2. Ordinance on epizootic diseases of 27 June 1995 (OFE; RS 916.401), in particular Articles 2 (highly contagious epizootic diseases), 73 and 74 (cleaning and disinfection), 77 to 98 (common provisions concerning highly contagious epizootic diseases), 239a to 239h (specific measures concerning bluetongue); 3. Ordinance of 28 June 2000 on the organisation of the Département fédéral de l'intérieur (Org DFI; RS 172.212.1), in particular Article 12 thereof (reference laboratory). B. IMPLEMENTING ARRANGEMENTS 1. The EU reference laboratory for bluetongue is: The Pirbright Institute, Pirbright Laboratory, Ash Road, Pirbright, Surrey, GU24 0NF, United Kingdom. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in Chapter B of Annex II to Directive 2000/75/EC. 2. Pursuant to Article 97 of the Ordinance on epizootic diseases, Switzerland has established a contingency plan, which is published on the website of the Federal Food Safety and Veterinary Office. 3. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 17 of Directive 2000/75/EC and Article 57 of the Law on epizootic diseases. X. Zoonoses A. LEGISLATION (14) European Union Switzerland 1. Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1); 2. Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31). 1. Act of 1 July 1966 on epizootic diseases (LFE; RS 916.40); 2. Ordinance on epizootic diseases of 27 June 1995 (OFE; RS 916.401), and in particular Articles 291a to 291e (special provisions on zoonoses); 3. Law of 9 October 1992 on foodstuffs and consumer products (LDAl; RS 817.0); 4. Ordinance of 23 November 2005 on foodstuffs and consumer products (ODAlOUs; RS 817.02); 5. Ordinance of the DFI of 23 November 2005 on hygiene (OHyg; RS 817.024.1); 6. Federal Law of 18 December 1970 on protection against infectious diseases in humans (Epidemics Law, RS 818.101); 7. Ordinance of 13 January 1999 on the declaration of infectious diseases in humans (Declaration ordinance; RS 818.141.1). B. IMPLEMENTING ARRANGEMENTS 1. The EU reference laboratories are the following: — EU reference laboratory for the analysis and testing of zoonoses (salmonella): Rijksinstituut voor Volksgezondheid en Milieuhygiëne (RIVM) 3720 BA Bilthoven Netherlands — EU reference laboratory for the monitoring of marine biotoxins: Agencia Española de Seguridad Alimentaria (AESA): 36200 Vigo Spain — EU reference laboratory for monitoring the viral and bacteriological contamination of bivalve molluscs: The laboratory of the Centre for Environment, Fisheries and Aquaculture Science (CEFAS), Weymouth Dorset DT4 8UB United Kingdom — EU reference laboratory for Listeria monocytogenes: AFSSA – Laboratoire d'études et de recherches sur la qualité des aliments et sur les procédés agroalimentaires (LERQAP) 94700 Maisons-Alfort France — EU reference laboratory for Coagulase positive Staphylococci, including Staphylococccus aureus: AFSSA – Laboratoire d'études et de recherches sur la qualité des aliments et sur les procédés agroalimentaires (LERQAP) 94700 Maisons-Alfort France — EU reference laboratory for Escherichia coli, including Verotoxigenic E. coli (VTEC): Istituto Superiore di Sanità (ISS) 00161 Rome Italy — EU reference laboratory for Campylobacter: Statens Veterinärmedicinska Anstalt (SVA) 751 89 Uppsala Sweden — EU reference laboratory for parasites (in particular Trichinella, Echinococcus and Anisakis): Istituto Superiore di Sanità (ISS) 00161 Rome Italy — EU reference laboratory for antimicrobial resistance: Danmarks Fødevareforskning (DFVF) 1790 Copenhagen V Denmark 2. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratories in the above capacity. The functions and tasks of these laboratories shall be as laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council (15). 3. Switzerland shall transmit to the Commission every year by the end of May a report on trends and sources of zoonoses, zoonotic agents and antimicrobial resistance, covering the data collected pursuant to Articles 4, 7 and 8 of Directive 2003/99/EC during the previous year. This report shall also include the information referred to in Article 3(2)(b) of Regulation (EC) No 2160/2003. This report shall be sent by the Commission to the European Food Safety Authority with a view to the publication of the summary report concerning the trends and sources of zoonoses, zoonotic agents and antimicrobial resistance in the European Union. XI. Other diseases A. LEGISLATION (16) European Union Switzerland Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease (OJ L 62, 15.3.1993, p. 69). 1. Act of 1 July 1966 on epizootic diseases (LFE; RS 916.40), and in particular Articles 1 to 10 thereof (objectives, measures against highly contagious epizootic diseases) and 57 (technical implementation provisions, international collaboration); 2. Ordinance on epizootic diseases of 27 June 1995 (OFE; RS 916.401), in particular Articles 2 (highly contagious epizootic diseases), 49 (handling micro-organisms that are pathogenic for animals), 73 and 74 (cleaning and disinfection), 77 to 98 (common provisions concerning highly contagious epizootic diseases), 104 to 105 (specific measures concerning swine vesicular disease); 3. Ordinance of 28 June 2000 on the organisation of the Département fédéral de l'intérieur (Org DFI; RS 172.212.1), in particular Article 12 thereof (reference laboratory). B. IMPLEMENTING ARRANGEMENTS 1. In cases as referred to in Article 6 of Directive 92/119/EEC, the information shall be submitted to the Joint Veterinary Committee. 2. The joint reference laboratory for swine vesicular disease shall be: The Pirbright Institute, Pirbright Laboratory, Ash Road, Pirbright, Surrey, GU24 0NF, United Kingdom. Switzerland shall pay the costs for which it is liable for operations carried out by the laboratory in that capacity. The functions and tasks of the laboratory shall be as laid down in Annex III to Directive 92/119/EEC. 3. Pursuant to Article 97 of the Ordinance on epizootic diseases, Switzerland has established an emergency plan. This emergency plan is the subject of a technical implementation regulation No 95/65 issued by the Federal Food Safety and Veterinary Office. 4. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 22 of Directive 92/119/EEC and Article 57 of the Law on epizootic diseases. XII. Notification of diseases A. LEGISLATION (17) European Union Switzerland Council Directive 82/894/EEC of 21 December 1982 on the notification of animal diseases within the Community (OJ L 378, 31.12.1982, p. 58). 1. Act of 1 July 1966 on epizootic diseases (LFE; RS 916.40), in particular Articles 11 (diligence obligation and reporting obligation) and 57 (technical implementation provisions, international collaboration); 2. Ordinance on epizootic diseases of 27 June 1995 (OFE; RS 916.401), and in particular Articles 2 to 5 (targeted diseases), 59 to 65 and 291 (reporting obligation, notification), 292 to 299 (surveillance, implementation, administrative support) thereof. B. IMPLEMENTING ARRANGEMENTS The Commission, in cooperation with the Federal Food Safety and Veterinary Office, shall integrate Switzerland into the animal disease notification system provided for in Directive 82/894/EEC.’. (1) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (2) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (3) Commission Decision 2002/106/EC of 1 February 2002 approving a Diagnostic Manual establishing diagnostic procedures, sampling methods and criteria for evaluation of the laboratory tests for the confirmation of classical swine fever (OJ L 39, 9.2.2002, p. 71). (4) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (5) Commission Decision 2003/422/EC of 26 May 2003 approving an African swine fever diagnostic manual (OJ L 143, 11.6.2003, p. 35). (6) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (7) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (8) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (9) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (10) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (11) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1.) (12) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1). (13) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (14) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (15) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). (16) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (17) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014.

ANNEX II Appendix 2 of Annex 11 to the Agricultural Agreement shall be replaced by the following: ‘Appendix 2 Animal health: Trade and placing on the market I. Bovine animals and swine A. LEGISLATION (1) European Union Switzerland Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ L 121, 29.7.1964, p. 1977). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 27 to 31 (markets, exhibitions), 34 to 37b (trade), 73 and 74 (cleaning and disinfection), 116 to 121 (African swine fever), 135 to 141 (Aujeszky's disease), 150 to 157 (bovine brucellosis), 158 to 165 (tuberculosis), 166 to 169 (enzootic bovine leucosis), 170 to 174 (IBR/IPV), 175 to 181 (spongiform encephalopathies), 186 to 189 (bovine genital infections), 207 to 211 (porcine brucellosis), 301 (approval of holdings, insemination and semen storage centres, embryo transfer units, markets and other similar establishments or events) thereof; 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10). B. IMPLEMENTING ARRANGEMENTS 1. Pursuant to Article 301(1)(i) of the Ordinance on epizootic diseases, the cantonal veterinarian shall authorise holdings, markets and other similar establishments or events as defined in Article 2 of Directive 64/432/EEC. For the purposes of this Annex, in accordance with Articles 11, 12 and 13 of Directive 64/432/EEC, Switzerland shall draw up a list of its approved assembly centres, transporters and traders. 2. The information provided for in Article 11(3) of Directive 64/432/EEC shall be submitted to the Joint Veterinary Committee. 3. For the purposes of this Annex, Switzerland is recognised as fulfilling the conditions laid down in Point 7 of Part II of Annex A to Directive 64/432/EEC as regards bovine brucellosis. In order to maintain its status as having an officially brucellosis-free bovine herd, Switzerland undertakes to meet the following conditions: (a) any animal of the bovine species suspected of being infected with brucellosis shall be reported to the competent authorities and the animal concerned shall undergo the official tests for brucellosis, comprising at least two serological tests with complement fixation and a microbiological examination of suitable samples taken in cases of abortion; (b) until such time as suspicion of the disease is lifted, i.e. when the tests provided for in point (a) have produced negative results, the officially brucellosis-free status of the herd to which the animal (or animals) of the bovine species suspected of infection belongs shall be suspended. Detailed information concerning herds testing positive and an epidemiological report shall be submitted to the Joint Veterinary Committee. If any of the conditions laid down in Point 7 of Part II of Annex A to Directive 64/432/EEC is not fulfilled by Switzerland, the Federal Food Safety and Veterinary Office shall immediately notify the Commission. The situation shall be considered within the Joint Veterinary Committee with a view to reviewing this paragraph. 4. For the purposes of this Annex, Switzerland is recognised as fulfilling the conditions laid down in point 4 of Part I of Annex A to Directive 64/432/EEC as regards bovine tuberculosis. In order to maintain its status as having an officially tuberculosis-free bovine herd, Switzerland undertakes to meet the following conditions: (a) an identification system shall be introduced allowing each bovine animal to be traced back to its herd of origin; (b) all slaughtered animals shall undergo a post mortem inspection carried out by an official veterinarian; (c) any suspected cases of tuberculosis in live, dead or slaughtered animals shall be reported to the competent authorities; (d) in each case the competent authorities shall carry out the investigations necessary to establish whether the suspected disease is present, including upstream research on herds of origin and transit herds; where lesions suspected to have been caused by tuberculosis are discovered during an autopsy or at the time of slaughter, the competent authorities shall have a laboratory examination conducted on the lesions; (e) the officially tuberculosis-free status of the herds of origin and transit herds to which the bovine animal suspected of infection belong shall be suspended until clinical, laboratory or tuberculin tests have confirmed that no bovine tuberculosis is present; (f) where tuberculin, clinical or laboratory tests confirm that tuberculosis is present, the officially tuberculosis-free status of the herds of origin and transit herds shall be withdrawn; (g) officially tuberculosis-free status shall not be established until all the animals suspected of being infected have been removed from the herd, the premises and equipment have been disinfected, and all the remaining animals aged over six weeks have reacted negatively to at least two official intradermal injections of tuberculin pursuant to Annex B to Directive 64/432/EEC, the first being carried out at least six months after the infected animal has left the herd and the second at least six months after the first. Detailed information on the infected herds and an epidemiological report shall be submitted to the Joint Veterinary Committee. If any of the conditions laid down in the first subparagraph of point 4 of Part II of Annex A to Directive 64/432/EEC is not fulfilled by Switzerland, the Federal Food Safety and Veterinary Office shall immediately notify the Commission. The situation shall be considered within the Joint Veterinary Committee with a view to reviewing this paragraph. 5. For the purposes of this Annex, Switzerland is recognised as fulfilling the conditions laid down in Section F of Chapter I of Annex D to Directive 64/432/EEC as regards enzootic bovine leucosis. In order to maintain its status as having an officially enzootic bovine leucosis-free herd, Switzerland undertakes to meet the following conditions: (a) the Swiss herd must be monitored by sampling. The size of the sample shall be such that it can be declared with 99 % reliability that less than 0.2 % of herds are infected with enzootic bovine leucosis; (b) all slaughtered animals shall undergo a post mortem inspection carried out by an official veterinarian; (c) any suspected cases of enzootic bovine leucosis found in clinical examinations, autopsies or checks on meat shall be reported to the competent authorities; (d) where enzootic bovine leucosis is suspected or found to be present, the officially leucosis-free status of the herd shall be suspended until the isolation period is terminated; (e) the isolation period shall be terminated when, after the infected animals and, where appropriate, their calves have been eliminated, two serological examinations carried out at an interval of at least 90 days have produced negative results. If enzootic bovine leucosis has been found in 0.2 % of herds, the Federal Food Safety and Veterinary Office shall immediately notify the Commission. The situation shall be considered within the Joint Veterinary Committee with a view to reviewing this paragraph. 6. For the purposes of this Annex, Switzerland is recognised as officially free from infectious bovine rhinotracheitis. In order to maintain that status, Switzerland undertakes to meet the following conditions: (a) the Swiss herd must be monitored by sampling. The size of the sample shall be such that it can be declared with 99 % reliability that less than 0.2 % of herds are infected with infectious bovine rhinotracheitis; (b) breeding bulls aged over 24 months shall undergo an annual serological examination; (c) any suspected cases of infectious bovine rhinotracheitis shall be reported to the competent authorities and the animals concerned shall undergo official tests for infectious bovine rhinotracheitis, comprising virological or serological tests; (d) where infectious bovine rhinotracheitis is suspected or found to be present, the officially infection-free status of the herd shall be suspended until the isolation period is terminated; (e) the isolation period shall be terminated when a serological examination carried out at least 30 days after the infected animals have been eliminated produces negative results. By virtue of the recognised status of Switzerland, Decision 2004/558/EC (2) shall apply mutatis mutandis. The Federal Food Safety and Veterinary Office shall immediately notify the Commission of any change in the conditions on which recognition of that status is based. The situation shall be considered within the Joint Veterinary Committee with a view to reviewing this paragraph. 7. For the purposes of this Annex, Switzerland is recognised as officially free from Aujeszky's disease. In order to maintain that status, Switzerland undertakes to meet the following conditions: (a) the Swiss herd must be monitored by sampling. The size of the sample shall be such that it can be declared with 99 % reliability that less than 0.2 % of herds are infected with Aujeszky's disease; (b) any suspected cases of Aujeszky's disease shall be reported to the competent authorities and the animals concerned shall undergo official tests for Aujeszky's disease including virological or serological tests; (c) where Aujeszky's disease is suspected or found to be present, the officially infection-free status of the herd shall be suspended until the isolation period is terminated; (d) Isolation shall be terminated when, after the infected animals have been eliminated, two serological examinations of all breeding animals and a representative number of fattening animals carried out at an interval of least 21 days have produced negative results. By virtue of the recognised status of Switzerland, Commission Decision 2008/185/EC (3) shall apply mutatis mutandis. The Federal Food Safety and Veterinary Office shall immediately notify the Commission of any change in the conditions on which recognition of that status is based. The situation shall be considered within the Joint Veterinary Committee with a view to reviewing this paragraph. 8. The question of possible additional guarantees concerning transmissible gastroenteritis of pigs (TGE) and porcine reproductive and respiratory syndrome (PRRS) shall be considered as soon as possible by the Joint Veterinary Committee. The Commission shall inform the Federal Food Safety and Veterinary Office of any developments. 9. In Switzerland the Institute for Veterinary Bacteriology of the University of Zurich is responsible for the official testing of tuberculins within the meaning of point 4 of Annex B to Directive 64/432/EEC. 10. The Centre for Zoonotic Diseases, Bacterial Diseases and Antimicrobial Resistance (ZOBA) shall be responsible for the official testing of antigens (brucellosis) in Switzerland in accordance with point 4 of Annex C to Directive 64/432/EEC. 11. Bovine animals and swine traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the models set out in Annex F to Directive 64/432/EEC. The following adaptations shall apply: — Model 1: in section C, the certifications are adapted as follows: — in point 4, relating to the additional guarantees, the following shall be added to the indents: — “disease: infectious bovine rhinotracheitis, — in accordance with Commission Decision 2004/558/EC, which shall apply mutatis mutandis;”. — Model 2: in section C, the certifications are adapted as follows: — in point 4, relating to the additional guarantees, the following shall be added to the indents: — 'disease: Aujeszky's, — in accordance with Commission Decision 2008/185/EC, which shall apply mutatis mutandis;'. 12. For the purposes of applying this Annex, bovine animals traded between the Member States of the European Union and Switzerland shall be accompanied by additional health certificates containing the following health declarations: — Bovine animals: — 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 born during the two years preceding the diagnosis; — do not come from herds where a suspected case of BSE is under investigation; — were born after 1 June 2001. II. Sheep and goats A. LEGISLATION (4) European Union Switzerland Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 27 to 31 (markets, exhibitions), 34 to 37b (trade), 73 and 74 (cleaning and disinfection), 142 to 149 (rabies), 158 to 165 (tuberculosis), 180 to 180c (scrapie), 190 to 195 (ovine and caprine brucellosis), 196 to 199 (contagious agalactia), 217 to 221 (caprine arthritis/encephalitis), 233 to 236 (brucellosis in rams) and 301 (approval of holdings, insemination and semen storage centres, embryo transfer units, markets and other similar establishments or events) thereof; 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10). B. IMPLEMENTING ARRANGEMENTS 1. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 11 of Directive 91/68/EC and Article 57 of the Law on epizootic diseases. Should ovine and caprine brucellosis appear or reappear, Switzerland shall inform the Joint Veterinary Committee so that the necessary measures can be taken in line with developments in the situation. 2. For the purposes of this Annex, Switzerland is recognised as officially free from ovine and caprine brucellosis. In order to maintain that status, Switzerland undertakes to implement the measures provided for in point 2 of Section II of Chapter 1 of Annex A to Directive 91/68/EEC. 3. Ovine and caprine animals traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the models set out in Annex E to Directive 91/68/EEC. III. Equidae A. LEGISLATION (5) European Union Switzerland Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (OJ L 192, 23.7.2010, p. 1). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 112 to 112f (African horse disease), 204 to 206 (dourine, encephalomyelitis, infectious anaemia, glanders), and 240 to 244 (contagious equine metritis) thereof; 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10). B. IMPLEMENTING ARRANGEMENTS 1. For the purposes of Article 3 of Directive 2009/156/EC, information shall be submitted to the Joint Veterinary Committee. 2. For the purposes of Article 6 of Directive 2009/156/EC, information shall be submitted to the Joint Veterinary Committee. 3. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 10 of Directive 2009/156/EC and Article 57 of the Law on epizootic diseases. 4. Annexes II and III to Directive 2009/156/EEC shall apply mutatis mutandis to Switzerland. IV. Poultry and hatching eggs A. LEGISLATION (6) European Union Switzerland Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (OJ L 343, 22.12.2009, p. 74). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 25 (transport), 122 to 125 (avian influenza and Newcastle disease), 255 to 261 (Salmonella spp.) and 262 to 265 (avian infectious laryngotracheitis) thereof; 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10). B. IMPLEMENTING ARRANGEMENTS 1. In application of Article 3 of Directive 2009/158/EC, it is recognised that Switzerland has a plan setting out the measures it intends to implement for the approval of its establishments. 2. For the purposes of Article 4 of Directive 2009/158/EC, the national reference laboratory for Switzerland shall be the Institute for Veterinary Bacteriology of the University of Bern. 3. The requirement concerning eggs held prior to consignment in point (a)(i) of Article 8(1) of Directive 2009/158/EC shall apply mutatis mutandis to Switzerland. 4. For consignments of hatching eggs to the European Union, the Swiss authorities undertake to comply with the rules on marking laid down in Commission Regulation (EEC) No 617/2008 (7). 5. The holding requirement specified in point (a) of Article 10 of Directive 2009/158/EC shall apply mutatis mutandis to Switzerland. 6. The holding requirement specified in point (a) of Article 11 of Directive 2009/158/EC shall apply mutatis mutandis to Switzerland. 7. The holding requirement in point (a) of Article 14(2) of Directive 2009/158/EC shall apply mutatis mutandis to Switzerland. 8. For the purposes of this Annex, Switzerland is recognised as meeting the requirements of Article 15(2) of Directive 2009/158/EC with regard to Newcastle disease and therefore shall have the status of not vaccinating against Newcastle disease. The Federal Food Safety and Veterinary Office shall immediately notify the Commission of any change in the conditions on which recognition of that status is based. The situation shall be considered within the Joint Veterinary Committee with a view to reviewing this paragraph. 9. The references to the name of the Member State of the European Union in Article 18 of Directive 2009/158/EC shall apply mutatis mutandis to Switzerland. 10. Poultry and hatching eggs traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the models set out in Annex IV to Directive 2009/158/EC. 11. In the case of consignments from Switzerland to Finland or Sweden, the Swiss authorities undertake to supply the guarantees concerning salmonella required under EU legislation. V. Aquaculture animals and products A. LEGISLATION (8) European Union Switzerland Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), in particular Articles 3 and 5 (epizootic diseases concerned), 21 to 23 (registration of fish breeding units, monitoring of staff and other obligations, health monitoring), 61 (obligations of leasers of fishing rights and of bodies responsible for monitoring fishing), 62 to 76 (general measures for combating disease), 277 to 290 (joint and specific measures relating to fish diseases, diagnostic laboratory); 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10); 3. Ordinance of 18 April 2007 on the import and transit of animals by air from third countries (OITA; RS 916.443.12). B. IMPLEMENTING ARRANGEMENTS 1. For the purposes of this Annex, Switzerland is recognised as officially free from infectious salmon anaemia and infections with Marteilia refringens and Bonamia ostreae. 2. The Joint Veterinary Committee shall decide on any application of Articles 29, 40, 41, 43, 44 and 50 of Directive 2006/88/EC. 3. The animal health conditions for the placing on the market of ornamental aquatic animals, aquaculture animals intended for farming, including relaying areas, put and take fisheries and open ornamental facilities, and restocking, and aquaculture animals and products thereof intended for human consumption are laid down in Articles 4 to 9 of Commission Regulation (EC) No 1251/2008 (9). 4. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 58 of Directive 2006/88/EC and Article 57 of the Law on epizootic diseases. VI. Bovine embryos A. LEGISLATION (10) European Union Switzerland Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 56 to 58a (embryo transfer) thereof; 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10). B. IMPLEMENTING ARRANGEMENTS 1. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 15 of Directive 89/556/EC and Article 57 of the Law on epizootic diseases. 2. Bovine embryos traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the models set out in Annex C to Directive 89/556/EEC. VII. Bovine semen A. LEGISLATION (11) European Union Switzerland Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species (OJ L 194, 22.7.1988, p. 10). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 51 to 55a (artificial insemination) thereof; 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10). B. IMPLEMENTING ARRANGEMENTS 1. For the purposes of Article 4(2) of Directive 88/407/EEC, it is noted that in Switzerland all centres keep only animals giving a negative reaction to the serum neutralisation test or the Elisa test. 2. The information provided for in Article 5(2) of Directive 88/407/EEC shall be submitted to the Joint Veterinary Committee. 3. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 16 of Directive 88/407/EC and Article 57 of the Law on epizootic diseases. 4. Bovine semen traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the model set out in Annex D to Directive 88/407/EEC. VIII. Porcine semen A. LEGISLATION (12) European Union Switzerland Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species (OJ L 224, 18.8.1990, p. 62). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 51 to 55a (artificial insemination) thereof; 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10). B. IMPLEMENTING ARRANGEMENTS 1. The information provided for in Article 5(2) of Directive 90/429/EEC shall be submitted to the Joint Veterinary Committee. 2. On-the-spot inspections shall be carried out under the responsibility of the Joint Veterinary Committee in accordance in particular with Article 16 of Directive 90/429/EC and Article 57 of the Law on epizootic diseases. 3. Porcine semen traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the model set out in Annex D to Directive 90/429/EEC. IX. Other species A. LEGISLATION (13) European Union Switzerland 1. Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54); 2. Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178, 28.6.2013, p. 1). 1. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401), and in particular Articles 51 to 55a (artificial insemination) and 56 to 58a (embryo transfer) thereof; 2. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE: RS 916.443.10); 3. Ordinance of 28 November 2014 on the importation, the transit and exportation of pet animals (OITE-AC; RS 916.443.14). B. IMPLEMENTING ARRANGEMENTS 1. For the purposes of this Annex, this point shall cover trade in live animals not subject to parts I to V of this Appendix, and in semen, ova and embryos not subject to parts VI to VIII of this Appendix. 2. The European Union and Switzerland undertake not to ban or restrict trade in the live animals, semen, ova and embryos as referred to in point 1 for animal-health reasons other than those resulting from the application of this Annex, and in particular any safeguard measures taken pursuant to Article 20 thereof. 3. Ungulates of species other than those referred to in parts I, II and III of this Appendix which are traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the model set out in the first section of Part I of Annex E to Directive 92/65/EEC, bearing the declaration provided for in point 1(e) of Article 6(A) of Directive 92/65/EEC. 4. Lagomorphs traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the model set out in part 1 of Annex E to Directive 92/65/EEC, bearing where necessary the declaration provided for in the second subparagraph of Article 9(2) of Directive 92/65/EEC. The declaration may be adapted by the Swiss authorities to include in full the requirements of Article 9 of Directive 92/65/CEE. 5. The information provided for in the third subparagraph of Article 9(2) of Directive 92/65/EEC shall be submitted to the Joint Veterinary Committee. 6. Consignments of cats and dogs from the European Union to Switzerland shall be subject to the requirements of Article 10(2) of Directive 92/65/EEC. The identification system shall be the one provided for in Regulation (EU) No 576/2013. The passport to be used shall be the one provided for in Part 3 of Annex II to Implementing Regulation (EU) No 577/2013 (14). The validity of the anti-rabies vaccination, and if relevant the re-vaccination, is defined in Annex III to Regulation (EU) No 576/2013. 7. Semen, ova and embryos of the ovine or caprine species traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates as provided for by Commission Decision 2010/470/EU (15). 8. Semen of the equine species traded between the Member States of the European Union and Switzerland shall be accompanied by the health certificate provided for in Decision 2010/470/EU. 9. Ova and embryos of the equine species traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with Decision 2010/470/EU. 10. Ova and embryos of the porcine species traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with Decision 2010/470/EU. 11. Colonies of bees (hives or queens with attendants) traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the model set out in Part II of Annex E to Directive 92/65/EEC. 12. Animals, semen, embryos and ova from bodies, institutes or centres approved in accordance with Annex C to Directive 92/65/EEC traded between the Member States of the European Union and Switzerland shall be accompanied by health certificates in accordance with the model set out in Part III of Annex E to Directive 92/65/EEC. 13. For the purposes of Article 24 of Directive 92/65/EEC, the information provided for in paragraph 2 of that Article shall be submitted to the Joint Veterinary Committee. X. Non-commercial movements of pet animals A. LEGISLATION (16) European Union Switzerland Regulation (EU) No 576/2013 of the European Parliament and of the Council of 12 June 2013 on the non-commercial movement of pet animals and repealing Regulation (EC) No 998/2003 (OJ L 178, 28.6.2013, p. 1). Ordinance of 28 November 2014 on the importation, transit and exportation of pet animals (OITE-AC; RS 916.443.14). B. IMPLEMENTING ARRANGEMENTS 1. The identification system shall be the one provided for in Regulation (EC) No 576/2013. 2. The validity of the anti-rabies vaccination, and if relevant the re-vaccination, is defined in Annex III to Regulation (EU) No 576/2013. 3. The model passport to be used is that provided for in Part 3 of Annex III to Regulation (EU) No 577/2013. The additional requirements relating to this passport are laid down in Part 4 of Annex III to Regulation (EU) No 577/2013. 4. For the purposes of this Appendix, the provisions of Chapter II of Regulation (EU) No 576/2013 shall apply mutatis mutandis to the non-commercial movement of pet animals between the Member States of the European Union and Switzerland. Documentary and identity checks that have to be carried out for non-commercial movements of pet animals to Switzerland from a Member State of the European Union shall be carried out in line with Article 33 of Regulation (EU) No 576/2013.’. (1) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (2) Commission Decision 2004/558/EC of 15 July 2004 implementing Council Directive 64/432/EEC as regards additional guarantees for intra-Community trade in bovine animals relating to infectious bovine rhinotracheitis and the approval of the eradication programmes presented by certain Member States (OJ L 249, 23.7.2004, p. 20). (3) Commission Decision 2008/185/EC of 21 February 2008 on additional guarantees in intra-Community trade of pigs relating to Aujeszky's disease and criteria to provide information on this disease (OJ L 59, 4.3.2008, p. 19). (4) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (5) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (6) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (7) Commission Regulation (EC) No 617/2008 of 27 June 2008 laying down detailed rules for implementing Council Regulation (EC) No 1234/2007 as regards marketing standards for eggs for hatching and farmyard poultry chicks (OJ L 168, 28.6.2008, p. 5). (8) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (9) Commission Regulation (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species (OJ L 337, 16.12.2008, p. 41). (10) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (11) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (12) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (13) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. (14) Commission Implementing Regulation (EU) No 577/2013 of 28 June 2013 on the model identification documents for the non-commercial movement of dogs, cats and ferrets, the establishment of lists of territories and third countries and the format, layout and language requirements of the declarations attesting compliance with certain conditions provided for in Regulation (EU) No 576/2013 of the European Parliament and of the Council (OJ L 178, 28.6.2013, p. 109). (15) Commission Decision 2010/470/EU of 26 August 2010 laying down model health certificates for trade within the Union in semen, ova and embryos of animals of the equine, ovine and caprine species and in ova and embryos of animals of the porcine species (OJ L 228, 31.08.2010, p. 15). (16) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014.

ANNEX VII Appendix 7 of Annex 11 to the Agricultural Agreement shall be replaced by the following: ‘Appendix 7 Competent Authorities PART A Switzerland Health and veterinary monitoring competences shall be shared between the authorities of the individual Cantons and those of Federal Food Safety and Veterinary Office. The following provisions shall apply: — for exports to the European Union, the Cantons shall be responsible for monitoring compliance with production conditions and requirements, and in particular statutory inspections and the issuing of health certificates attesting to compliance with the standards and requirements laid down, — the Federal Food Safety and Veterinary Office shall be responsible for overall coordination, audits of inspection systems and the necessary legislative action to ensure uniform application of standards and requirements within the Swiss market. It shall also be responsible for imports of foodstuffs of animal origin and other animal products from third countries. It shall also draw up authorisations for the export of Category 1 and 2 animal by-products to the European Union. PART B European Union Responsibility shall be shared between the national services in the individual Member States of the European Union and the European Commission. The following provisions shall apply: — for exports to Switzerland, the Member Statesof the European Union shall be responsible for monitoring compliance with production conditions and requirements, and in particular statutory inspections and the issuing of health certificates attesting to compliance with the standards and requirements laid down, — theEuropean Commission shall be responsible for overall coordination, audits of inspection systems and the necessary legislative action to ensure uniform application of standards and requirements within the Single Market.’.