ANNEX VISupplementary provisions
ANNEX VI Appendix 6 of Annex 11 to the Agricultural Agreement shall be replaced by the following: ‘Appendix 6 Animal products CHAPTER I Sectors where recognition of equivalence is mutual “Animal products for human consumption” The definitions of Regulation (EC) No 853/2004 shall apply mutatis mutandis . Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. Exports from the European Union to Switzerland and exports from Switzerland to the European Union Trade conditions Equivalence European Union Switzerland Animal health 1. Fresh meat including minced meat, meat preparations, meat products, unprocessed fats and rendered fats Domestic ungulates Domestic solipeds Directive 64/432/EEC Directive 2002/99/EC ( *1 ) Regulation (EC) No 999/2001 Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes ( 1 ) 2. Farmed game meat, meat preparations and meat products Farmed land mammals other than those cited above Directive 64/432/EEC Directive 92/118/EEC ( *2 ) Directive 2002/99/EC Regulation (EC) No 999/2001 Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes Farmed ratites Lagomorphs Directive 92/118/EEC Directive 2002/99/EC Yes 3. Wild game meat, meat preparations and meat products Wild ungulates Lagomorphs Other land mammals Feathered wild game Directive 2002/99/EC Regulation (EC) No 999/2001 Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes 4. Fresh poultry meat, meat preparations, meat products, fats and rendered fats Poultry Directive 92/118/EEC Directive 2002/99/EC Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes 5. Stomachs, bladders and intestines Cattle Sheep and goats Swine Directive 64/432/EEC Directive 92/118/EEC Directive 2002/99/EC Regulation (EC) No 999/2001 Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes ( 1 ) 6. Bone and bone products Domestic ungulates Domestic solipeds Other farmed or wild land mammals Poultry, ratites and feathered wild game Directive 64/432/EEC Directive 92/118/EEC Directive 2002/99/EC Regulation (EC) No 999/2001 Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401) Yes ( 1 ) 7. Processed animal proteins, blood and blood products Domestic ungulates Domestic solipeds Other farmed or wild land mammals Poultry, ratites and feathered wild game Directive 64/432/EEC Directive 92/118/EEC Directive 2002/99/EC Regulation (EC) No 999/2001 Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes ( 1 ) 8. Gelatine and collagen Directive 2002/99/EC Regulation (EC) No 999/2001 Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes ( 1 ) 9. Milk and milk products Directive 64/432/EEC Directive 2002/99/EC Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes 10. Eggs and egg products Directive 2002/99/EC Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes 11. Fishery products, bivalve molluscs, echinoderms, tunicates and marine gastropods Directive 2006/88/EC Directive 2002/99/EC Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes 12. Honey Directive 92/118/EEC Directive 2002/99/EC Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes 13. Snails and frogs' legs Directive 92/118/EEC Directive 2002/99/EC Law of 1 July 1966 on epizootic diseases (LFE; RS 916.40); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Yes Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014. Exports from the European Union to Switzerland and exports from Switzerland to the European Union Trade conditions Equivalence European Union Switzerland Public health 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 147, 31.5.2001, p. 1 ). Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( OJ L 139, 30.4.2004, p. 1 ). Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( OJ L 139, 30.4.2004, p. 55 ). Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption ( OJ L 139, 30.4.2004, p. 206 ): 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 ). Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs ( OJ L 338, 22.12.2005, p. 1 ). Federal Law of 9 October 1992 on foodstuffs and consumer products (LDAL; RS 817.0); Ordinance of 23 April 2008 on animal protection (OPAn; RS 455.1); Ordinance of 16 November 2011 concerning the basic training, training leading to qualifications and ongoing training of persons working in the Public Veterinary Service (RS 916.402); Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); Ordinance of 23 November 2005 on primary production (OPPr; RS 916.020); Ordinance of 23 November 2005 on the slaughter of livestock and the checking of meat (OabCV; RS 817.190); Ordinance of 23 November 2005 on foodstuffs and consumer products (ODAlOUs; RS 817.02); DFI Ordinance of 23 November 2005 on the implementation of foodstuffs legislation (RS 817.025.21). DEFR Ordinance of 23 November 2005 on hygiene in primary production (OHyPPr; RS916.020.1); DFI Ordinance of 23 November 2005 on hygiene (OhyG; RS 817.024.1); DFI Ordinance of 23 November 2005 on hygiene during the slaughter of livestock (OHyAb; RS817.190.1); DFI Ordinance of 23 November 2005 on foodstuffs of animal origin (RS 817.022.108). Yes, subject to special conditions Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) 854/2004 ( OJ L 338, 22.12.2005, p. 27 ). Commission Regulation (EC) No 2075/2005 of 5 December 2005 laying down specific rules on official controls for Trichinella in meat ( OJ L 338, 22.12.2005, p. 60 ). Protection of animals Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing ( OJ L 303, 18.11.2009, p. 1 ). Federal Law of 16 December 2005 on animal protection (LPA; RS 455); Ordinance of 23 April 2008 on animal protection (OPAn; RS 455.1); OVF Ordinance of 12 August 2010 on the protection of animals at the time of slaughter (OPAnAb; RS455.110.2); Ordinance of 23 November 2005 on the slaughter of livestock and the checking of meat (OabCV; RS 817.190); Yes, subject to special conditions Special conditions (1) Animal products intended for human consumption which are traded between the Member States of the European Union and Switzerland shall be moved only under the same conditions as animal products intended for human consumption which are traded between the Member States of the European Union, also as regards animal protection at the time of slaughter. Where necessary, these products are accompanied by the health certificates required for trade between the Member States of the European Union or defined in this Annex and available in the TRACES system. (2) Switzerland will draw up a list of its establishments approved in accordance with Article 31 (registration/approval of establishments) of Regulation (EC) No 882/2004. (3) For its imports, Switzerland shall apply the same provisions as those applicable at Union level. (4) The competent authorities of Switzerland may not make use of the exemption from the Trichinella examination as provided for in Article 3(2) of Regulation (EC) No 2075/2005. Where this exemption is used, the competent authorities of Switzerland undertake to notify the Commission by written procedure of the list of regions where the risk of Trichinella in domestic swine is officially recognised as negligible. The Member States of the European Union shall have three months from receipt of the notification to send written comments to the Commission. If the Commission or a Member State of the European Union raises no objections, the region is recognised as a region presenting a negligible Trichinella risk, and domestic swine coming from that region shall be exempted from examination for Trichinella at the time of slaughter. The provisions of Article 3(3) of Regulation (EC) No 2075/2005 shall apply mutatis mutandis . (5) The detection methods described in Chapters I and II of Annex I to Regulation (EC) No 2075/2005 shall be used in Switzerland for the Trichinella examinations. However, no use shall be made of the trichinoscopic examination described in Chapter III of Annex I to Regulation (EC) No 2075/2005. (6) The competent authorities of Switzerland may derogate from the Trichinella examination of carcasses and meat of domestic swine kept for fattening and slaughter in low-capacity slaughter establishments. This provision shall apply until 31 December 2016. Pursuant to the provisions of Article 8(3) of the DFI Ordinance of 23 November 2005 on hygiene during the slaughter of livestock (OHyAb; RS 817.190.1) and Article 9(8) of the DFI Ordinance of 23 November 2005 on foodstuffs of animal origin (RS 817.022.108), these carcasses and meat of domestic swine kept for fattening and slaughter as well as meat preparations, meat products and derived processed products thereof shall be marked with a special health stamp in accordance with the model specified in the last subparagraph of Annex 9 to the DFI Ordinance of 23 November 2005 on hygiene during the slaughter of livestock. These products may not be traded with the Member States of the European Union, in accordance with the provisions of Article 9 a of the DFI Ordinance on foodstuffs of animal origin of 23 November 2005. (7) Carcasses and meat of domestic swine kept for slaughter which are traded between the Member States of the European Union and Switzerland from: — holdings recognised as free from Trichinella by the competent authorities of the Member States of the European Union; — regions where the risk of Trichinella in domestic swine is officially recognised as negligible; and for which the Trichinella examination has not been carried out pursuant to the provisions of Article 3 of Regulation (EC) No 2075/2005, shall move only under the same conditions as those traded between the Member States of the European Union. (8) Pursuant to the provisions of Article 2 of the Ordinance on hygiene (RS 817.024.1), the competent authorities of Switzerland may in particular cases allow exceptions to Articles 8, 10 and 14 of the Ordinance on hygiene: (a) to meet the needs of establishments located in mountainous regions, pursuant to the Federal Law of 6 October 2006 on regional policy (RS 901.0) and the ordinance of 28 November on regional policy (RS 901.021). The competent authorities of Switzerland undertake to notify the Commission by written procedure of such adjustments. This notification shall: — provide a detailed description of the provisions for which the competent authorities of Switzerland consider that an adjustment is necessary, and indicates the nature of the adjustment in question; — describe the foodstuffs and establishments concerned; — explain the grounds for the adjustment (including, where appropriate, the provision of a summary of the risk analysis carried out and indicating any measure needed to ensure that the adjustment does not compromise the objectives of the Ordinance on hygiene (OHyg; RS 817.024.1); — give any other relevant information. The Commission and the Member States of the European Union shall have three months from the receipt of the notification to submit their written observations. If necessary, the Joint Veterinary Committee will be convened. (b) for the production of foods with traditional characteristics. The competent authorities of Switzerland undertake to notify the Commission by written procedure of such adjustments at the latest twelve months after the individual or general derogations have been granted. Each notification shall: — provide a short description of the requirements that have been adapted; — describe the foodstuffs and establishments concerned, and — give any other relevant information. (9) The Commission shall inform Switzerland of the derogations and adjustments applied in the Member States of the European Union under Article 13 of Regulation (EC) No 852/2004, Article 10 of Regulation (EC) No 853/2004, Article 13 of Regulation (EC) No 854/2003 and Article 7 of Regulation (EC) No 2074/2005. (10) Under Article 179 d 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. (11) The EU reference laboratories for residues of veterinary medicines and contaminants in food of animal origin are as follows: (a) For the residues listed in Annex I, Group A (1), (2), (3) and (4), Group B (2)(d) and Group B (3)(d) to Directive 96/23/EC ( 1 ) : RIKILT – Institute for Food Safety, part of Wageningen UR P.O. Box 230 6700 AE Wageningen Netherlands (b) For the residues listed in Annex I, Group B (1) and B (3)(e) to Directive 96/23/EC, and carbadox and olaquindox Laboratoires d'études et de recherches sur les médicaments vétérinaires et les désinfectants ANSES – Laboratoire de Fougères 35306 Fougères cedex France (c) For the residues listed in Annex I, Group A (5) and Group B (2)(a), (b) and (e) to Directive 96/23/EC Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Diedersdorfer Weg, 1 D-12277 Berlin Germany (d) For the residues listed in Annex I, Group B(3)(c) to Directive 96/23/EC Istituto Superiore di Sanità (ISS) Viale Regina Elena, 299 00161 Rome Italy Switzerland shall pay the costs for which it is liable for operations carried out by the laboratories in the above capacity. The competences and tasks of these laboratories are laid down in Title III and Annex VII of Regulation (EC) No 882/2004. (12) Pending recognition of the alignment of European Union legislation and the Swiss legislation, for exports to the European Union, Switzerland shall monitor compliance with the acts listed below and their implementing texts: 1. Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food ( OJ L 37, 13.2.1993, p. 1 ); 2. Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC ( OJ L 267, 2.10.2012, p. 1 ); 3. Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock farming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC ( OJ L 125, 23.5.1996, p. 3 ); 4. Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC ( OJ L 125, 23.5.1996, p. 10 ); 5. Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation ( OJ L 66, 13.3.1999, p. 16 ); 6. Directive 1999/3/EC of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising radiation ( OJ L 66, 13.3.1999, p. 24 ); 7. Commission Decision 2002/840/EC of 23 October 2002 adopting the list of approved facilities in third countries for the irradiation of foods ( OJ L 287, 25.10.2002, p. 40 ); 8. Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods ( OJ L 309, 26.11.2003, p. 1 ); 9. Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs ( OJ L 364, 20.12.2006, p. 5 ); 10. Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 ( OJ L 354, 31.12.2008, p. 7 ); 11. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ( OJ L 354, 31.12.2008, p. 16 ); 12. Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC ( OJ L 354, 31.12.2008, p. 34 ); 13. Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( OJ L 83, 22.3.2012, p. 1 ); 14. Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients ( OJ L 141, 6.6.2009, p. 3 ); 15. Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( OJ L 152, 16.6.2009, p. 11 ). “Animal by-products not intended for human consumption” Exports from the European Union to Switzerland and exports from Switzerland to the European Union Trade conditions Equivalence European Union ( *3 ) Switzerland ( *3 ) Yes, subject to special conditions 1. 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 147, 31.5.2001, p. 1 ). 2. 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 (Animal by-products Regulation) ( OJ L 300, 14.11.2009, p. 1 ). 3. 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 ). 1. Ordinance of 23 November 2005 on the slaughter of livestock and the checking of meat (OAbCV; RS 817.190); 2. DFI Ordinance of 23 November 2005 on hygiene during the slaughter of livestock (OHyAb; RS 817.190.1); 3. Ordinance of 27 June 1995 on epizootic diseases (OFE; RS 916.401); 4. Ordinance of 18 April 2007 on the import, transit and export of animals and animal products (OITE; RS 916.443.10); 5. Ordinance of 25 May 2011 on the disposal of animal by-products (OESPA; RS 916.441.22). Special conditions For its imports, Switzerland applies the same provisions as those under Articles 25 to 28 and 30 to 31 and Annexes XIV and XV (certificates) to Regulation (EU) No 142/2011, in accordance with Articles 41 and 42 of Regulation (EC) No 1069/2009. Trade in Category 1 and Category 2 materials shall be governed by Article 48 of Regulation (EC) No 1069/2009. Category 3 materials traded between the Member States of the European Union and Switzerland shall be accompanied by the commercial documents and health certificates provided for in Chapter III of Annex VIII to Regulation (EU) No 142/2011, in accordance with Article 17 of Regulation (EU) No 142/2011 and with Articles 21 and 48 of Regulation (EC) No 1069/2009. Pursuant to Title II, Chapter I, Section 2 of Regulation (EC) No 1069/2009 and Chapter IV and Annex IX to Regulation (EU) No 142/2011, Switzerland shall draw up the list of its corresponding establishments. CHAPTER II Sectors other than those covered by Chapter I Exports from the European Union to Switzerland and exports from Switzerland to the European Union These exports shall be subject to the same conditions as intra-Union trade. However, if relevant, a certificate attesting compliance with those conditions shall be issued by the competent authorities to accompany consignments. If necessary, models for certificates shall be discussed in the Joint Veterinary Committee.’. ( *1 ) Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ( OJ L 18, 23.1.2003, p. 11 ). ( *2 ) Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC ( OJ L 62, 15.3.1993, p.49 ). ( 1 ) The recognition of similarities in legislation governing the monitoring of TSEs in ovine and caprine animals will be reconsidered by the Joint Veterinary Committee. ( 1 ) + Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC ( OJ L 125, 23.5.1996, p. 10 ). ( *3 ) Unless indicated otherwise, any reference to an act shall mean that act as amended before 31 December 2014.