Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 on laying specific hygiene rules for food of animal originnote, and in particular Article 7(2), point (a), thereof,Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’)note, and in particular Articles 238(3) and 239(3) thereof,Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)note, and in particular Article 90, first paragraph, point (a) and Article 126(3) thereof,Whereas:
(1)Commission Implementing Regulation (EU) 2020/2235note lays down rules regarding model certificates for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods. In particular, Annexes III and IV to Implementing Regulation (EU) 2020/2235 lay down model certificates for the entry into the Union of consignments of certain products of animal origin and certain composite products for human consumption and for certain movements of animals in the case of ante-mortem inspection at the holding of provenance or in the case of emergency slaughter outside the slaughterhouse.
(2)Article 19 of Implementing Regulation (EU) 2020/2235 provides that the official certificate to be used for the entry into the Union of gelatine intended for human consumption is to correspond to the model set out in Chapter 41 of Annex III to that Implementing Regulation. Article 21(3) of Commission Delegated Regulation (EU) 2022/2292note establishes that no official certificate is necessary for the entry into the Union of certain gelatine capsules, where they are not derived from ruminant bones. It is therefore necessary to amend Article 19 of Implementing Regulation (EU) 2020/2235 and the title of the corresponding model in Annex III to Implementing Regulation (EU) 2020/2235 accordingly.
(3)Commission Implementing Regulation (EU) 2022/2504note amended the title of the model official certificate for the entry into the Union of highly refined products intended for human consumption set out in Chapter 46 of Annex III to Implementing Regulation (EU) 2020/2235. That new title should also be reflected in Article 24 of Implementing Regulation (EU) 2020/2235. It is therefore necessary to amend that Article accordingly.
(4)Chapter C of Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Councilnote requires the presentation of an animal health certificate at the entry into the Union of consignments of gelatine or collagen derived from bovine, ovine or caprine products other than hides and skins. This requirement applies to gelatine or collagen present in composite products, such as gelatine capsules, where the gelatine or collagen is derived from ruminant bones. However, Article 28 of Implementing Regulation (EU) 2020/2235 and the model animal health/official certificate for the entry of certain composite products (model COMP) in Chapter 50 of Annex III to Implementing Regulation (EU) 2020/2235 exclude from certification composite products containing gelatine or collagen. This creates ambiguity regarding certification requirements and the model certificate to be used for the entry of consignments of composite products containing gelatine or collagen. Article 28 of Implementing Regulation (EU) 2020/2235 and the model COMP in Chapter 50 of Annex III to that Implementing Regulation should therefore be amended in order to require the use of that model certificate for the entry of composite products containing gelatine or collagen, where the gelatine or collagen is derived from ruminant bones.
(5)Transit through the Union represents a lower risk than entry into the Union. Article 30 of Implementing Regulation (EU) 2020/2235, and the title of Chapter 52 of Annex III to that Implementing Regulation should be amended to avoid that stricter rules apply to transit of certain composite products than to entry into the Union by introducing the same exclusions.
(6)Articles 4, 5 and 6 of Commission Delegated Regulation (EU) 2019/624note refer to the model health certificates for live animals transported to the slaughterhouse in the case of ante-mortem inspection at the holding of provenance, for poultry reared for the production of foie gras and delayed eviscerated poultry slaughtered at the holding of provenance, for domestic bovine and porcine animals, domestic solipeds and farmed game, slaughtered at the holding of provenance, and for emergency slaughter outside the slaughterhouse. Articles 31 and 32 of Implementing Regulation (EU) 2020/2235 refer to the same certificates as ‘model animal health certificates’. However, the model health certificates referred to in Articles 4, 5 and 6 of Delegated Regulation (EU) 2019/624 do not contain animal health certifications. Therefore, and for consistency of wording, Articles 31 and 32 of Implementing Regulation (EU) 2020/2235 and Annex IV to that Implementing Regulation should be amended accordingly.
(7)Article 6(2) of Delegated Regulation (EU) 2019/624 provides that a relevant certificate is to accompany the uneviscerated carcasses of poultry to the slaughterhouse or cutting plant or be sent in advance in any format. It is necessary to include the term ‘cutting plant’ in the model health certificate for poultry reared for the production of foie gras and delayed eviscerated poultry slaughtered at the holding of provenance set out in Chapter 2 of Annex IV to Implementing Regulation (EU) 2020/2235 to align that model health certificate with Article 6(2) of Delegated Regulation (EU) 2019/624.
(8)Commission Delegated Regulation (EU) 2024/1141note amended Section I, Chapter VIa, of Annex III to Regulation (EC) No 853/2004 allowing slaughter at the holding of provenance of ovine and caprine animals under certain conditions. Therefore, it is necessary to reflect that amendment in Article 31 of Implementing Regulation (EU) 2020/2235 and in the model health certificate for farmed game, domestic bovine, porcine and equine animals slaughtered at the holding of provenance set out in Chapter 3 of Annex IV to Implementing Regulation (EU) 2020/2235.
(9)Delegated Regulation (EU) 2024/1141 amended Section III, point 3, of Annex III to Regulation (EC) No 853/2004 authorising game-handling establishments to receive and handle farmed ratites and farmed ungulates when having appropriate facilities to hygienically handle farmed game slaughtered on the farm. Therefore, it is necessary to reflect that possibility in the model health certificates for farmed game, domestic bovine, porcine and equine animals slaughtered at the holding of provenance set out in Chapters 3 and 4 of Annex IV to Implementing Regulation (EU) 2020/2235.
(10)The verification of food chain information referred to in Section III of Annex II to Regulation (EC) No 853/2004 is part of an ante-mortem inspection defined in Article 17, point (c), of Regulation (EU) 2017/625. The certification of the verification of food chain information should therefore be included in the model health certificates set out in Annex IV to Implementing Regulation (EU) 2020/2235 in case of slaughter and ante-mortem inspection at the holding of provenance.
(11)Implementing Regulation (EU) 2020/2235 should therefore be amended accordingly.
(12)In order to avoid any disruption to trade as regards the entry into the Union of consignments of certain composite products intended for human consumption referred to in Article 28 of Implementing Regulation (EU) 2020/2235, the use of animal health/official certificates issued in accordance with Implementing Regulation (EU) 2020/2235, as applicable prior to the amendments made by this Regulation, should continue to be authorised during a transitional period subject to certain conditions.
(13)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:
Article 1#
Implementing Regulation (EU) 2020/2235 is amended as follows:
(1)Article 19 is replaced by the following:‘Article 19Model official certificate for the entry into the Union of gelatine intended for human consumption other than gelatine capsules not derived from ruminant bonesThe official certificate referred to in Article 1(3), point (b)(i) to be used for the entry into the Union of gelatine intended for human consumption other than gelatine capsules not derived from ruminant bones shall correspond to the model GEL drawn up in accordance with the model set out in Chapter 41 of Annex III.’;
(2)Article 24 is replaced by the following:‘Article 24Model official certificate for the entry into the Union of highly refined products as described in Section XVI of Annex III to Regulation (EC) No 853/2004, intended for human consumptionThe official certificate referred to in Article 1(3), point (b)(i) to be used for the entry into the Union of highly refined products as described in Section XVI of Annex III to Regulation (EC) No 853/2004, intended for human consumption, shall correspond to the model HRP drawn up in accordance with the model set out in Chapter 46 of Annex III.’;
(3)Article 28 is replaced by the following:‘Article 28Model animal health/official certificate for the entry into the Union of non-shelf-stable composite products intended for human consumption and shelf-stable composite products intended for human consumption and containing any quantity of meat products except gelatine not derived from ruminant bones, collagen not derived from ruminant bones and highly refined products, and any quantity of colostrum-based products1.The animal health/official certificate referred to in Article 1(3), point (b)(i) to be used for the entry into the Union of non-shelf-stable composite products intended for human consumption shall correspond to the model COMP drawn up in accordance with the model set out in Chapter 50 of Annex III.2.The certification requirement referred to in paragraph 1 shall also apply to the entry into the Union of shelf-stable composite products intended for human consumption and containing:
(a)any quantity of meat products except gelatine not derived from ruminant bones, collagen not derived from ruminant bones and highly refined products; or,
(b)any quantity of colostrum-based products.’
;
(4)Article 30 is replaced by the following:‘Article 30Model animal health certificate for the transit through the Union to a third country either by immediate transit or after storage in the Union of non-shelf-stable composite products intended for human consumption and shelf-stable composite products intended for human consumption and containing any quantity of meat products except gelatine, collagen and highly refined products, and any quantity of colostrum-based products1.The animal health certificate referred to in Article 1(3), point (d) to be used for the transit through the Union to a third country either by immediate transit or after storage in the Union of non-shelf-stable composite products intended for human consumption shall correspond to the model TRANSIT-COMP drawn up in accordance with the model set out in Chapter 52 of Annex III.2.The certification requirement referred to in paragraph 1 shall also apply to the transit through the Union to a third country either by immediate transit or after storage in the Union of shelf-stable composite products intended for human consumption and containing:
(5)Articles 31 and 32 are replaced by the following:‘Article 31Model health certificate in the case of ante-mortem inspection at the holding of provenanceThe health certificate referred to in Article 1(3), point (e) to be used in the case of ante-mortem inspection at the holding of provenance in accordance with Articles 5 and 6 of Delegated Regulation (EU) 2019/624 shall correspond to one of the following models, depending on the species and categories of products concerned:
(a)the model set out in Chapter 1 of Annex IV, for live animals transported to the slaughterhouse in the case of ante-mortem inspection at the holding of provenance in accordance with Article 5(2), point (f), of Delegated Regulation (EU) 2019/624;
(b)the model set out in Chapter 2 of Annex IV, for poultry reared for the production of foie gras and delayed eviscerated poultry slaughtered at the holding of provenance in accordance with Article 6(2) of Delegated Regulation (EU) 2019/624;
(c)the model set out in Chapter 3 of Annex IV, for domestic bovine, porcine, ovine and caprine animals, domestic solipeds and farmed game, slaughtered at the holding of provenance in accordance with Section I, Chapter VIa and Section III, point 3, of Annex III to Regulation (EC) No 853/2004 and Article 6(3) of Delegated Regulation (EU) 2019/624;
(d)the model set out in Chapter 4 of Annex IV, for farmed game slaughtered at the holding of provenance in accordance with Section III, point 3a, of Annex III to Regulation (EC) No 853/2004 and Article 6(4) of Delegated Regulation (EU) 2019/624.
Article 32Model health certificate in the case of emergency slaughter outside the slaughterhouseThe health certificate referred to in Article 1(3), point (e) to be used in the case of emergency slaughter outside the slaughterhouse in accordance with Article 4 of Delegated Regulation (EU) 2019/624 shall correspond to the model set out in Chapter 5 of Annex IV.’;
(a)any quantity of meat products except gelatine, collagen and highly refined products;
(b)any quantity of colostrum-based products.’
;
(6)Annexes III and IV to Implementing Regulation (EU) 2020/2235 are amended in accordance with the Annex to this Regulation.
Article 2#
For a transitional period until 29 April 2025, consignments of certain composite products intended for human consumption referred to in Article 28 of Implementing Regulation (EU) 2020/2235, accompanied by the appropriate animal health/official certificate issued in accordance with the model set out in Chapter 50 of Annex III to Implementing Regulation (EU) 2020/2235, as applicable before the amendments made to that Implementing Regulation by this Regulation, shall continue to be authorised for the entry into the Union provided that the certificate was issued no later than 29 January 2025.
Article 3#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Annex IV
Chapter 1:Model health certificate for live animals transported to the slaughterhouse in the case of ante-mortem inspection at the holding of provenance in accordance with Article 5(2), point (f), of Delegated Regulation (EU) 2019/624
Chapter 2:Model health certificate for poultry reared for the production of foie gras and delayed eviscerated poultry slaughtered at the holding of provenance in accordance with Article 6(2) of Delegated Regulation (EU) 2019/624
Chapter 3:Model health certificate for domestic bovine, porcine, ovine and caprine animals, domestic solipeds and farmed game, slaughtered at the holding of provenance in accordance with Section I, Chapter VIa and Section III, point 3, of Annex III to Regulation (EC) No 853/2004 and Article 6(3) of Delegated Regulation (EU) 2019/624
Chapter 4:Model health certificate for farmed game slaughtered at the holding of provenance in accordance with Section III, point 3a, of Annex III to Regulation (EC) No 853/2004 and Article 6(4) of Delegated Regulation (EU) 2019/624
Chapter 5:Model health certificate in the case of emergency slaughter outside the slaughterhouse in accordance with Article 4 of Delegated Regulation (EU) 2019/624
Annex IV contains the following model health certificates:
Chapter 1 — model health certificate for live animals transported to the slaughterhouse in the case of ante-mortem inspection at the holding of provenance in accordance with article 5(2), point (f), of delegated regulation (eu) 2019/624
1.Identification of the animalsSpecies: …Number of animals: …Identification mark: …Owner of the animals: ……
2.Provenance of the animalsAddress of the holding of provenance: …Identification of house *: …
3.Destination of the animalsThe animals will be transported to the following slaughterhouse: ……by the following means of transport: …
4.Other relevant information…
5.DeclarationI, the undersigned, declare that:
(a)the animals described in point 1 were examined before slaughter at the above-mentioned holding of provenance at … (time) on … (date) and were found to be fit for slaughter;
(b)the following observations on the health and welfare of these animals were made: …;
(c)the records and documentation concerning these animals satisfied the legal requirements and did not prohibit their slaughter;
(d)I verified the food chain information.
Name of the official veterinarian: …
No: …
Done at: …,
(Place)
on: …
(Date)
Stamp
…
(Signature of the official veterinarian)
*optional
Chapter 2 — model health certificate for poultry reared for the production of foie gras and delayed eviscerated poultry slaughtered at the holding of provenance in accordance with article 6(2) of delegated regulation (eu) 2019/624
1.Identification of uneviscerated carcassesSpecies: …Number of animals: …Owner of the animals: ……
2.Provenance of uneviscerated carcassesAddress of the holding of provenance: …
3.Destination of uneviscerated carcassesThe uneviscerated carcasses will be transported to the following slaughterhouse or cutting plant: ……by the following means of transport …
4.DeclarationI, the undersigned, declare that:
(a)the uneviscerated carcasses described in point 1 are of the birds which were examined before slaughter at the above-mentioned holding of provenance at … (time) on … (date) and found to be fit for slaughter;
(b)the following observations on the health and welfare of these birds were made: …;
(c)the records and documentation concerning these birds satisfied the legal requirements and did not prohibit their slaughter;
(d)I verified the food chain information.
Name of the official veterinarian: …
No: …
Done at: …,
(Place)
on: …
(Date)
Stamp
…
(Signature of the official veterinarian)
Chapter 3 — model health certificate for domestic bovine, porcine, ovine and caprine animals, domestic solipeds and farmed game, slaughtered at the holding of provenance in accordance with section I, chapter via and section III, point 3, of annex III to regulation (ec) no 853/2004 and article 6(3) of delegated regulation (eu) 2019/624
1.Identification of the animalsSpecies: …Number of animals: …Identification mark: …Owner of the animals: …
2.Provenance of the animalsAddress of the holding of provenance: …Identification of house *: …
3.Destination of the animalsThe animals will be transported to the following slaughterhouse or, in the case of farmed game, alternatively to the following game-handling establishment: ……by the following means of transport: …
4.Other relevant information…
5.DeclarationI, the undersigned, declare that:
(a)the animals described in point 1 were examined before slaughter at the holding of provenance referred to in point 2 at … (time) on … (date) and were found to be fit for slaughter;
(b)they were slaughtered at the holding of provenance at … (time) on … (date) and the slaughter and bleeding were carried out correctly;
(c)the following observations on the health and welfare of these animals were made: …;
(d)the records and documentation concerning these animals satisfied the legal requirements and did not prohibit their slaughter;
(e)I verified the food chain information.
Name of the official veterinarian: …
No: …
Done at: …,
(Place)
on: …
(Date)
Stamp
…
(Signature of the official veterinarian)
*optional
Chapter 4 — model health certificate for farmed game slaughtered at the holding of provenance in accordance with section III, point 3A, of annex III to regulation (ec) no 853/2004 and article 6(4) of delegated regulation (eu) 2019/624
1.Identification of the animalsSpecies: …Number of animals: …Identification mark: …Owner of the animals: …
2.Provenance of the animalsAddress of the holding of provenance: …Identification of house *: …
3.Destination of the animalsThe animals will be transported to the following slaughterhouse or game-handling establishment: ……by the following means of transport: …
4.Other relevant information…
5.DeclarationI, the undersigned, declare that:
(a)the animals described in point 1 were examined before slaughter at the holding of provenance referred to in point 2 at … (time) on … (date) and were found to be fit for slaughter;
(b)the following observations on the health and welfare of these animals were made: …;
(c)the records and documentation concerning these animals satisfied the legal requirements and did not prohibit their slaughter;
(d)I verified the food chain information.
Name of the official veterinarian: …
No: …
Done at: …,
(Place)
on: …
(Date)
Stamp
…
(Signature of the official veterinarian)
*optional
Chapter 5 — model health certificate in the case of emergency slaughter outside the slaughterhouse in accordance with article 4 of delegated regulation (eu) 2019/624
1.Identification of the animalsSpecies: …Number of animals: …Identification mark: …Owner of the animals: …
2.Place of emergency slaughterAddress: …Identification of house *: …
3.Destination of the animalsThe animals will be transported to the following slaughterhouse: ……by the following means of transport: …
4.Other relevant information…
5.DeclarationI, the undersigned, declare that:
(a)the animals described in point 1 were examined before slaughter at the location referred to in point 2 at … (time) on … (date) and were found to be fit for slaughter;
(b)they were slaughtered at … (time) on … (date) and the slaughter and bleeding were carried out correctly;
(c)the following was the reason for the emergency slaughter: ……;
(d)the following observations on the health and welfare of these animals were made: ……;
(e)I verified the food chain information.Done at: …,(Place)on: …(Date)Stamp…(Signature of the official veterinarian)
Name of the official veterinarian: …
No: …
*optional.
(1)Annex III is amended as follows:
(a)in the table, the list of model certificates is amended as follows:
(i)the entry for ‘GEL’ is replaced by the following:GEL | Chapter 41: Model official certificate for the entry into the Union of gelatine intended for human consumption other than gelatine capsules not derived from ruminant bones
(ii)the entry for ‘COMP’ is replaced by the following:COMP | Chapter 50: Model animal health/official certificate for the entry into the Union of non-shelf-stable composite products intended for human consumption and shelf-stable composite products intended for human consumption and containing any quantity of meat products except gelatine not derived from ruminant bones, collagen not derived from ruminant bones and highly refined products, and any quantity of colostrum-based products
(iii)the entry for ‘TRANSIT-COMP’ is replaced by the following:TRANSIT-COMP | Chapter 52: Model animal health certificate for the transit through the Union to a third country either by immediate transit or after storage in the Union of non-shelf-stable composite products intended for human consumption and shelf-stable composite products intended for human consumption and containing any quantity of meat products except gelatine, collagen and highly refined products, and any quantity of colostrum-based products
(b)the title of Chapter 41 is replaced by the following:‘CHAPTER 41MODEL OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF GELATINE INTENDED FOR HUMAN CONSUMPTION OTHER THAN GELATINE CAPSULES NOT DERIVED FROM RUMINANT BONES (MODEL GEL)’;
(c)Chapter 50 is replaced by the following:‘CHAPTER 50MODEL ANIMAL HEALTH/OFFICIAL CERTIFICATE FOR THE ENTRY INTO THE UNION OF NON-SHELF-STABLE COMPOSITE PRODUCTS INTENDED FOR HUMAN CONSUMPTION AND SHELF-STABLE COMPOSITE PRODUCTS INTENDED FOR HUMAN CONSUMPTION AND CONTAINING ANY QUANTITY OF MEAT PRODUCTS EXCEPT GELATINE NOT DERIVED FROM RUMINANT BONES, COLLAGEN NOT DERIVED FROM RUMINANT BONES AND HIGHLY REFINED PRODUCTS, AND ANY QUANTITY OF COLOSTRUM-BASED PRODUCTS (MODEL COMP)’
(d)the title of Chapter 52 is replaced by the following:‘CHAPTER 52MODEL ANIMAL HEALTH CERTIFICATE FOR THE TRANSIT THROUGH THE UNION TO A THIRD COUNTRY EITHER BY IMMEDIATE TRANSIT OR AFTER STORAGE IN THE UNION OF NON-SHELF-STABLE COMPOSITE PRODUCTS INTENDED FOR HUMAN CONSUMPTION AND SHELF-STABLE COMPOSITE PRODUCTS INTENDED FOR HUMAN CONSUMPTION AND CONTAINING ANY QUANTITY OF MEAT PRODUCTS EXCEPT GELATINE, COLLAGEN AND HIGHLY REFINED PRODUCTS, AND ANY QUANTITY OF COLOSTRUM-BASED PRODUCTS (MODEL TRANSIT-COMP)’;
(2)Annex IV is replaced by the following:‘’
Annexes III and IV to Implementing Regulation (EU) 2020/2235 are amended as follows:
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