Commission Implementing Regulation (EU) 2016/759
of 28 April 2016
drawing up lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC
(Text with EEA relevance)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 and in particular Articles 8(1) and 9(4) thereof,
OJ L 18, 23.1.2003, p. 11.
Having regard to 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, and in particular Article 11(1) thereof,
OJ L 139, 30.4.2004, p. 206.
Whereas:
(1) Regulation (EC) No 854/2004 requires products of animal origin to be imported only from a third country or a part of third country that appears on a list drawn up in accordance with that Regulation.
(2) Commission Decision 2003/812/EC draws up lists of third countries from which Member States are to authorise imports of certain products for human consumption subject to Council Directive 92/118/EEC. Those lists include a list of third countries or parts of third countries from which imports of gelatine intended for human consumption are authorised. However, there is no list which covers collagen, or raw materials for the production of gelatine and collagen, for human consumption. It is appropriate to draw up such lists.
Commission Decision 2003/812/EC of 17 November 2003 drawing up lists of third countries from which Member States are to authorise imports of certain products for human consumption subject to Council Directive 92/118/EEC (OJ L 305, 22.11.2003, p. 17).
Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and import 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, Directive 90/425/EEC (OJ L 62, 15.3.1993, p. 49).
(3) In accordance with Regulation (EC) No 853/2004 of the European Parliament and of the Council, food business operators importing products of animal origin are to ensure that the documents accompanying the consignment meet the requirements of Article 14 of Regulation (EC) No 854/2004. Commission Regulation (EC) No 2074/2005 lays down model certificates for imports of certain products of animal origin intended for human consumption. Those model certificates include outdated references to previous legislation that need to be updated.
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).
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) No 854/2004 (OJ L 338, 22.12.2005, p. 27).
(4) Third countries, parts of third countries and territories listed in Annex II to Commission Decision 2006/766/EC, in Part 1 of Annex I to Commission Regulation (EC) No 798/2008, in Part 1 of Annex I to Commission Regulation (EC) No 119/2009 or in Part 1 of Annex II to Commission Regulation (EU) No 206/2010 meet the Union requirements with regard to imports of fresh meat and certain fishery products. Those lists could also be used for imports of raw materials for the production of gelatine and collagen. However, less strict requirements should apply if those raw materials have been subjected to certain treatments as provided for in Sections XIV and XV of Annex III to Regulation (EC) No 853/2004.
Commission Decision 2006/766/EC of 6 November 2006 establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted (OJ L 320, 18.11.2006, p. 53).
Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).
Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for import into, or transit through, the Community of meat and wild leporidae, of certain wild land mammals and farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12).
Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1).
(5) Raw materials for the production of gelatine and collagen, whether or not treated, introduced into the Union for transit to a third country, pose a negligible risk to public health. Such raw materials, even when treated, should, however, comply with the relevant animal health requirements. Accordingly, a list of third countries, parts of third countries and territories should be drawn up and model certificates for transit, and storage before transit, of raw materials and treated raw materials for the production of gelatine and collagen should be laid down.
(6) Due to the geographical situation of Kaliningrad, specific animal health conditions should be laid down for transit via the Union of consignments of raw materials and treated raw materials for the production of gelatine or collagen to and from Russia, which only concern transit through Latvia, Lithuania and Poland.
(7) In the interest of clarity and simplification of Union legislation, and without prejudice to Commission Decision 2003/863/EC, the lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction of frogs' legs, snails, gelatine, collagen, raw materials and treated raw materials for the production of gelatine and collagen, and honey, royal jelly and other products of apiculture for human consumption, and the model certificates for those products, should be set out in an Annex to this Regulation. Consequently, the corresponding existing certificates should be deleted from Annex VI to Regulation (EC) No 2074/2005.
Commission Decision 2003/863/EC of 2 December 2003 on health certificates for the importation of animal products from the United States of America (OJ L 325, 12.12.2003, p. 46).
(8) In order to ensure the safety of certain highly refined products of animal origin, specific requirements have been inserted in Annex III to Regulation (EC) No 853/2004. Therefore it is appropriate to draw up the list of countries from which those products may be imported and lay down a model certificate for those products.
(9) As the lists of third countries, parts of third countries and territories from which Member States are to authorise imports of furred farm game meat products and feathered farm game meat products and leporidae (rabbit and hare) meat and their meat products have been laid down in Commission Decision 2007/777/EC and in Regulation (EC) No 119/2009 respectively, Decision 2003/812/EC becomes redundant and should be repealed.
Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC (OJ L 312, 30.11.2007, p. 49).
(10) It is appropriate to introduce a transitional period to allow Member States and food business operators to adapt to the new requirements laid down in this Regulation.
(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:

CHAPTER 1 IMPORTS OF CERTAIN PRODUCTS OF ANIMAL ORIGIN

Article 1 Lists of third countries, parts of third countries and territories
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deleted by Commission Implementing Regulation (EU) 2019/626 of 5 March 2019 concerning lists of third countries or regions thereof authorised for the entry into the European Union of certain animals and goods intended for human consumption, amending Implementing Regulation (EU) 2016/759 as regards these lists (Text with EEA relevance), Art. 22 (with Art. 24)

Article 2 Model certificates
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deleted by Commission Implementing Regulation (EU) 2019/628 of 8 April 2019 concerning model official certificates for certain animals and goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates (Text with EEA relevance).

CHAPTER 2 TRANSIT OF CERTAIN PRODUCTS OF ANIMAL ORIGIN

Article 3 Lists of third countries, parts of third countries and territories
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 3 omitted (31.12.2020) by virtue of S.I. 2019/640, reg. 53B (with reg. 53G) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 9(15))

Article 4 Model certificate
1. The model certificate for the transit through Great Britain of raw materials and treated raw materials for the production of gelatine and collagen intended for human consumption bound for a third country, either by immediate transit or after storage in Great Britain, must be in the form published by the appropriate authority from time to time on its website.
The appropriate authority may from time to time publish on its website guidance on the completion of the model certificate.
References in other legislation which, on or after IP completion day, forms part of assimilated law to the model official certificate set out in Annex 3 to this Regulation are to be read as references to the form of certificate referred to in the first sentence of this Article.
Art. 4(1) substituted (31.12.2020) by S.I. 2019/640, reg. 53C(a) (with reg. 53G) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 9(15))
Word in Art. 4(1) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 23
2. Electronic certification and other systems harmonised in Great Britain may be used.
Words in Art. 4(2) substituted (31.12.2020) by S.I. 2019/640, reg. 53C(b) (with reg. 53G) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 9(15))

Article 5 Derogation for transit through Latvia, Lithuania and Poland
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 5 omitted (31.12.2020) by virtue of S.I. 2019/640, reg. 53D (with reg. 53G) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 9(15))

CHAPTER 3 FINAL PROVISIONS

Article 6 Amendment
Annex VI to Regulation (EC) No 2074/2005 is amended as follows:
(1) in Section I, Chapters I, II, III and VI are deleted;
(2) Appendices I, II, III and VI are deleted.

Article 7 Repeal
Decision 2003/812/EC is repealed.

Article 8 Transitional provisions
Consignments of products of animal origin in respect of which the relevant certificates have been issued in accordance with Regulation (EC) No 2074/2005 may continue to be introduced into the Union provided that the certificate was signed before 3 December 2016.

Article 9 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
...
Words in Signature omitted (31.12.2020) by virtue of S.I. 2019/640, reg. 53E (with reg. 53G) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 9(15))

ANNEX I Lists of third countries, parts of third countries and territories as referred to in Article 1

PART I FROGS' LEGS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART II SNAILS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART III GELATINE AND COLLAGEN INTENDED FOR HUMAN CONSUMPTION

SECTION A Gelatine and collagen derived from bovine, ovine, caprine, porcine and equine animals, both farmed and wild
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION B Gelatine and collagen derived from poultry including ratites and feathered game
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION C Gelatine and collagen derived from fishery products
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION D Gelatine and collagen derived from leporidae and from wild land mammals not referred to in Section A
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART IV RAW MATERIALS FOR THE PRODUCTION OF GELATINE AND COLLAGEN INTENDED FOR HUMAN CONSUMPTION

SECTION A Raw materials from bovine, ovine, caprine, porcine and equine animals, both farmed and wild
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION B Raw materials from poultry including ratites and feathered game
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION C Raw materials from fishery products
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION D Raw materials from leporidae and from wild land mammals not referred to in Section A
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART V TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE AND COLLAGEN INTENDED FOR HUMAN CONSUMPTION

SECTION A Treated raw materials from bovine, ovine, caprine, porcine and equine animals, both farmed and wild
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION B Treated raw materials from poultry including ratites and feathered game
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION C Treated raw materials from fishery products
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION D Treated raw materials from leporidae and wild land mammals not referred to in Section A
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION E Treated raw materials referred to in Annex III to Regulation (EC) No 853/2004, Section XIV, Chapter I point 4(b)(iii) and Section XV, Chapter I, point 4(b)(iii)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART VI HONEY, ROYAL JELLY AND OTHER PRODUCTS OF APICULTURE INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART VII HIGHLY REFINED CHONDROITIN SULPHATE, HYALURONIC ACID, OTHER HYDROLYSED CARTILAGE PRODUCTS, CHITOSAN, GLUCOSAMINE, RENNET, ISINGLASS AND AMINO ACIDS FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ANNEX II Model certificates as referred to in Article 2

PART I MODEL CERTIFICATE FOR IMPORTS OF CHILLED, FROZEN OR PREPARED FROGS' LEGS INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART II MODEL CERTIFICATE FOR IMPORTS OF CHILLED, FROZEN, SHELLED, COOKED, PREPARED OR PRESERVED SNAILS INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART III MODEL CERTIFICATE FOR IMPORTS OF GELATINE INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART IV MODEL CERTIFICATE FOR IMPORTS OF COLLAGEN INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART V MODEL CERTIFICATE FOR IMPORTS OF RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART VI MODEL CERTIFICATE FOR IMPORTS OF TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART VII MODEL CERTIFICATE FOR IMPORTS OF HONEY, ROYAL JELLY AND OTHER APICULTURE PRODUCTS INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART VIII MODEL CERTIFICATE FOR IMPORTS OF HIGHLY REFINED CHONDROITIN SULPHATE, HYALURONIC ACID, OTHER HYDROLYSED CARTILAGE PRODUCTS, CHITOSAN, GLUCOSAMINE, RENNET, ISINGLASS AND AMINO ACIDS INTENDED FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ANNEX III MODEL CERTIFICATE FOR THE TRANSIT THROUGH THE UNION, IMMEDIATE TRANSIT OR AFTER STORAGE, FOR RAW MATERIALS OR TREATED RAW MATERIALS FOR THE PRODUCTION OF GELATINE/COLLAGEN FOR HUMAN CONSUMPTION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annexes 3, 4 omitted (31.12.2020) by virtue of S.I. 2019/640, reg. 53F (with reg. 53G) (as inserted by The Food and Feed Hygiene and Safety (Miscellaneous Amendments etc.) (EU Exit) Regulations 2020 (S.I. 2020/1504), regs. 1(2), 9(15))

ANNEX IV EXPLANATORY NOTES FOR COMPLETING THE CERTIFICATES
(referred to in Articles 2(1) and 4(1))
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annex 1 (in so far as still in force): power to amend conferred (31.12.2020) by The Trade in Animals and Animal Products (Legislative Functions) and Veterinary Surgeons (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1225), regs. 1(3), 16; 2020 c. 1, Sch. 5 para. 1(1)