Nařízení Komise v přenesené pravomoci (EU) 2023/119 ze dne 9. listopadu 2022, kterým se mění nařízení v přenesené pravomoci (EU) 2020/692, kterým se doplňuje nařízení Evropského parlamentu a Rady (EU) 2016/429, pokud jde o pravidla pro vstup zásilek některých zvířat, zárodečných produktů a produktů živočišného původu do Unie a jejich přemísťování a manipulaci s nimi po vstupu (Text s významem pro EHP)

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THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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)OJ L 84, 31.3.2016, p. 1 . , and in particular Articles 3(5), 234(2), 237(4) and 239(2) thereof,

OJ L 84, 31.3.2016, p. 1 .

(1) Commission Delegated Regulation (EU) 2020/692Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379 ). supplements the animal health rules laid down in Regulation (EU) 2016/429 as regards the entry into the Union and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin.

(2) The application of the rules laid down in Delegated Regulation (EU) 2020/692 concerning aquatic animals and their products, has indicated that greater clarity is required concerning which commodities are excluded from the scope of that Delegated Regulation. In particular, it should be clarified that wild aquatic animals and products of animal origin from those wild aquatic animals which are landed from fishing vessels and which enter the food chain intended for direct human consumption are excluded from the scope of that Regulation. In addition, it should be clarified that products of animal origin from aquatic animals other than live aquatic animals, which are not intended for further processing in the Union, are excluded from the scope of Delegated Regulation (EU) 2020/692. Article 1(6) of Delegated Regulation (EU) 2020/692 should be amended accordingly.

(3) Several Member States and stakeholders have indicated that following recent developments and specialisations in the germinal products sector, the definition of embryo collection teams in Article 2 of Delegated Regulation (EU) 2020/692 should also include those teams which only collect and handle unfertilised oocytes. That definition should therefore be amended to cover such teams.

(4) In addition, for the purpose of the specific requirements for equine animals as regards African horse sickness and Venezuelan equine encephalomyelitis set out in Annex XI, points 2.1 and 2.2, to Delegated Regulation (EU) 2020/692, it is necessary to lay down a definition of a vector-protected establishment in Article 2 of that Delegated Regulation. There is already a definition of vector-protected establishment in Article 2 of Commission Delegated Regulation (EU) 2020/689Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211 ). in the context of infection with bluetongue virus (serotypes 1-24).vector-protected establishment in Article 2 of Delegated Regulation (EU) 2020/692, for the purpose of African horse sickness and Venezuelan equine encephalomyelitis, should be consistent with the definition of the vector-protected establishment in Article 2 of Delegated Regulation (EU) 2020/689. Article 2 of Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.

(5) Article 3(5) of Regulation (EU) 2016/429 provides that movements of pet animals, other than non-commercial movements, are to comply with the animal health requirements laid down in Parts IV and V thereof. Article 3(5) of that Regulation also empowers the Commission to lay down rules concerning the adaptions that are necessary in order to ensure that Parts IV and V thereof are correctly applied to pet animals, in particular to take account of the fact that pet animals are kept in households by pet keepers. Accordingly, it is necessary to adapt the general requirements regarding the means of transport of terrestrial animals laid down in Article 17 of Delegated Regulation (EU) 2020/692 and the requirements on the movement and handling of terrestrial animals after their entry into the Union laid down in Article 19 of that Delegated Regulation to pet animals kept in households. Articles 17 and 19 of Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.

(6) Article 21(1), point (b) of Delegated Regulation (EU) 2020/692 provides that consignments of ungulates, other than equine animals, are only to be permitted to enter the Union, if the animals of the consignment were individually identified prior to being dispatched from the establishment of origin, by a physical means of identification with a visible, legible and indelible display of, amongst others, the code of the exporting country in accordance with ISO Standard 3166 in the format of two-letter code. It is necessary to provide for a derogation from that requirement in order for the Member States to permit the entry into the Union of such ungulates identified by a physical means of identification displaying the code of the exporting country different from the code conforming to ISO Standard 3166. Such a derogation should only be granted by the Commission and upon request by a third country or territory concerned.

(7) Article 38(2) of Delegated Regulation (EU) 2020/692 provides that, following an outbreak of highly pathogenic avian influenza in a third country or territory, or zone thereof previously considered as free of that disease, that third country or territory, or zone thereof, is again to be considered as free from highly pathogenic avian influenza, when, after a stamping out policy and an adequate cleaning and disinfection has been carried out on all previously infected establishments, the competent authority of the third country or territory has carried out a surveillance programme during a period of at least 3 months following the completion of the stamping out policy and cleaning and disinfection. However, that time frame is not consistent with the one applicable following outbreaks of highly pathogenic avian influenza in a Member State. Therefore, Article 38(2) of Delegated Regulation (EU) 2020/692 should be amended accordingly.

(8) Article 53, point (a), of Delegated Regulation (EU) 2020/692 provides that consignments of captive birds are only to be permitted to enter the Union if the animals in the consignment are identified with an individual identification number, which contains, inter alia, the code of the third country or territory of origin conforming with ISO Standard 3166 in the format of two-letter. As some birds are validly identified in the third countries or territories which are not the third countries or territories from where the birds enter into the Union or with an individual identification number including the code of the third country or territory of origin in the format of three-letter conforming with ISO Standard 3166, Delegated Regulation (EU) 2020/692 should be amended accordingly.

(9) Article 73 of Delegated Regulation (EU) 2020/692 lays down the requirements for the dispatch of dogs, cats and ferrets to the Union. It does not provide for an approval obligation for shelters where consignments of dogs, cats and ferrets are dispatched to the Union, whereas Commission Delegated Regulation (EU) 2020/688Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (OJ L 174, 3.6.2020, p. 140 ). provides for

(10) Article 79 of Delegated Regulation (EU) 2020/692 provides that consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine animals are only be permitted to enter the Union if they were collected from animals which come from third countries or territories which comply with the animal health requirements laid down in Article 22 thereof. Article 22 of that Delegated Regulation provides such consignments are only to be permitted to enter the Union if they comply, inter alia, with the prohibition on the vaccination of donor bovine, porcine, ovine and caprine animals against, among others, foot-and-mouth disease. However, Commission Delegated Regulation (EU) 2020/686Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (OJ L 174, 3.6.2020, p. 1 ). , as well as relevant international standards of the World Organisation for Animal Health (WOAH) allow vaccination of bovine, porcine, ovine and caprine animals against foot-and-mouth disease under certain conditions. Therefore, Article 79 of Delegated Regulation (EU) 2020/692 should be amended to provide for a derogation for such vaccination and to align that Article with comparable rules applicable within the Union as well as with international standards.

(11) Article 117 of Delegated Regulation (EU) 2020/692 lays down animal health requirements for the entry into the Union of consignments of germinal products of certain animals intended for confined establishments. Since the date of application of Delegated Regulation (EU) 2020/692 several Member States and stakeholders have questioned the proportionality of those requirements in light of the specificities of those consignments and the differences in related risks to animal health. Therefore, it is appropriate to amend that Article to provide more flexibility for the Member States to manage the risks under their particular circumstances and depending on the animal species concerned while taking into account of the Union lists of authorised third countries, territories or zones thereof laid down by Commission Implementing Regulation (EU) 2021/404Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council (OJ L 114, 31.3.2021, p. 1 ). .

(12) Article 124, point (c)(i), of Delegated Regulation (EU) 2020/692 provides that consignments of fresh meat of kept animals, except those kept as farmed game that have been killed on-the-spot, are only permitted to enter the Union if the fresh meat of the consignment has been obtained from kept animals which, during the transport to the slaughterhouse, did not pass through a third country or territory, or zone thereof, not listed for the entry into the Union of the particular species and category of fresh meat. However, as regards consignments of poultry, compliance with that requirement would in certain cases require the use of less direct roads, affecting normal trade patterns in a disproportionate manner, and also extending the travel time. To resolve this issue while ensuring the application of risk mitigation measures to prevent the spread of diseases, a derogation from that requirement, subject to certain conditions, should be introduced into Delegated Regulation (EU) 2020/692.

(13) Article 150 of Delegated Regulation (EU) 2020/692 lays down requirements for the entry into the Union of consignments of meat products as regards the establishment of origin of the animals from which the fresh meat used for the production thereof was obtained. That provision should be amended to refer to the date of slaughter or killing of the animals instead of the dispatch to the Union of the consignment in order to better link the potential animal health risks to specific products in the consignment.

(14) Article 156 of Delegated Regulation (EU) 2020/692 lays down requirements for the entry into the Union of consignments of dairy products not subject to a risk-mitigating treatment and produced only from raw milk. That provision should be amended to allow the entry into the Union of dairy products produced from dairy products not subject to a risk-mitigating treatment subject to compliance with certain conditions, as the risk is similar.

(15) Article 163 of Delegated Regulation (EU) 2020/692 derogates from Article 3, points (a)(i) and (c)(i), thereof and lays down specific requirements for shelf-stable composite products. That provision should be amended to allow the sourcing of the dairy products from Member States and treated dairy products from third countries or territories, or zones thereof authorised for the entry into the Union of raw milk for the production of shelf-stable composite products. Moreover, the requirements concerning shelf-stable composite products referred to in Article 163(3) should be clarified.

(16) Article 12(2) of Regulation (EU) 2016/429 provides that aquatic animal health professionals may undertake activities assigned to veterinarians under that Regulation, provided they are authorised to do so by the Member State concerned, under national law. In certain third countries and territories, clinical inspections of aquatic animals prior to export to the Union, have in the past, been carried out by aquatic animal health professionals, in addition to veterinarians. It is therefore appropriate to amend Article 166 of Delegated Regulation (EU) 2020/692 to permit aquatic animal health professionals to perform clinical inspections prior to export to the Union, provided they are authorised to do so, under the law of the exporting third country or territory.

(17) Certain aquatic animals are packaged and labelled for human consumption in accordance with Regulation (EC) No 853/2004 of the European Parliament and of the CouncilRegulation (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 ). , before they enter the Union. Such aquatic animals present a lower risk for the spread of disease than other aquatic animals which enter the Union, and which are not packaged and labelled in the same way. It is therefore appropriate to amend Article 167, point (a), of Delegated Regulation (EU) 2020/692 to exempt the live aquatic animals which are referred to in Article 172, points (d), (e) and (f), of the same Regulation, from the requirement to be dispatched directly from their place of origin to the Union. This amendment would allow such commodities to be kept in an approved cold store for example, en route from their place of origin in a third country or territory, to their place of destination in the Union. A similar exemption should also apply to Article 174(1), point (a), of Delegated Regulation (EU) 2020/692 concerning the handling after entry into the Union of certain products of animal origin from aquatic animals, other than live aquatic animals. Those Articles should therefore be amended accordingly.

(18) Also due to the lower risk of the spread of disease associated with those commodities, consignments of the aquatic animals which are referred to in Article 172, points (d), (e) and (f), of Delegated Regulation (EU) 2020/692, should be exempted from the requirement to be accompanied by a declaration, which is signed by the master of a vessel in which such consignments have been transported, when they enter the Union. Article 168 of that Regulation should therefore, be amended accordingly.

(19) Regulation (EU) 2016/429 provides that Member States may take national measures concerning a disease other than a listed disease referred to in Article 9(1), point (d), of Regulation (EU) 2016/429 subject to certain conditions. Where such measures concern movements of aquatic animals and products of animal origin from aquatic animals between Member States, they are required to be approved in accordance with Article 226(3) of that Regulation. Such measures may apply to listed diseases, which are category E diseases as defined in Commission Implementing Regulation (EU) 2018/1882Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21 ). , and to non-listed diseases. Title 2 of Part V of Delegated Regulation (EU) 2020/692 should therefore, be amended to clarify that national measures, which have been approved in accordance with Article 226(3) of Regulation (EU) 2016/429, apply not only to non-listed diseases, but also to category E diseases.

(20) A cross referencing error has been detected in Article 170(1), point (a)(iv), of Delegated Regulation (EU) 2020/692. That Article should therefore be corrected by removing the reference to Article 176 and replacing it by a reference to Article 175 of that Regulation.

(21) Article 178 of Delegated Regulation (EU) 2020/692 lays down the special requirements for the entry into the Union of ungulates, poultry and aquatic animals originating from and returning to the Union following a refusal of entry by a third country or territory. Article 179 of that Regulation lays down the special requirements for the entry into the Union of animals other than ungulates, poultry and aquatic animals originating from and returning to the Union

(22) Annex VIII, point 4, to Delegated Regulation (EU) 2020/692 lays down minimum periods without a reported case or outbreak of certain diseases in the establishment of origin for equine animals. That point omits an option where movement restrictions may be lifted by the competent authority in the case where the 30-day period has elapsed after the last animal of a listed species on the establishment was either killed and destroyed or slaughtered, and the premises in the establishment were cleaned and disinfected. That option is available in the case of movements between Member States of equine animals in accordance with Article 22 of Delegated Regulation (EU) 2020/688 for establishments where surra, dourine or equine infectious anaemia has been reported. At the same time, model animal health certificates laid down in Annex II, Chapters 12 to 18, to Commission Implementing Regulation (EU) 2021/403Commission Implementing Regulation (EU) 2021/403 of 24 March 2021 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates and model animal health/official certificates, for the entry into the Union and movements between Member States of consignments of certain categories of terrestrial animals and germinal products thereof, official certification regarding such certificates and repealing Decision 2010/470/EU (OJ L 113, 31.3.2021, p. 1 ). already include that option of the 30-day period without a reported case of surra, dourine or equine infectious anaemia in the establishment of origin for equine animals. Therefore, it is necessary to align Annex VIII, point 4, to Delegated Regulation (EU) 2020/692. Annex VIII to Delegated Regulation (EU) 2020/692 should be aligned accordingly.

(23) Annex X, point 1, to Delegated Regulation (EU) 2020/692 lays down specific requirements for the entry into the Union of ovine animals as regards infection with Brucella as referred to in Article 24(5) of that Delegated Regulation. The requirements concerning a residency period in the establishment of origin should be aligned to those referred to in Article 11, point (b)(iii), of that Delegated Regulation and the relevant entry as regards ovine animals in the table in Annex III to that Delegated Regulation. Annex X to Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.

(24) Annex XI, point 2.1, to Delegated Regulation (EU) 2020/692 lays down specific requirements for African horse sickness to be fulfilled by equine animals entering the Union from third countries or territories, or zones thereof, assigned to a sanitary group E or F. The animals are required to have been kept in isolation in vector-protected facilities for a particular period. It is necessary to align the term vector-protected facility, reserved for a confined establishment as referred to in Article 34 of Delegated Regulation (EU) 2020/692, with the term vector-protected establishment, defined in Article 2 to that Delegated Regulation. Annex XI to Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.

(25) Annex XI, point 2.2, to Delegated Regulation (EU) 2020/692 lays down specific requirements for Venezuelan equine encephalomyelitis to be fulfilled by equine animals entering the Union from third countries or territories, or zones thereof, assigned to a sanitary group C or D. The animals are required to have been kept in a vector-protected quarantine for a particular period. It is necessary to align the term vector-protected quarantine with the term vector-protected establishment, defined in Article 2 to that Delegated Regulation. Annex XI to Delegated Regulation (EU) 2020/692 should therefore be amended accordingly.

(26) In addition, minimum criteria for granting a status of a vector-protected establishment by the competent authority should be specified. It is therefore necessary to laid down those criteria in Annex XI to Delegated Regulation (EU) 2020/692. Those criteria should be consistent with the criteria provided for in Annex V, Part II, Chapter 3, to Delegated Regulation (EU) 2020/689 and in Article 12.1.10, point 1, of the Terrestrial Animal Health Code of the World Organisation for Animal Health (WOAH). Annex XI to Delegated Regulation (EU) 2020/692 should be amended accordingly.

(27) Annex XXI to Delegated Regulation (EU) 2020/692, point 2(b), specifies the timeframe during which the treatment against infestation with Echinoccocus multilocularis is to be administered. That time frame has proven difficult to comply with. A certain degree of flexibility may be provided without increasing the risks to public or animal health. Annex XXI to Delegated Regulation (EU) 2020/692 should therefore be amended accordingly,

Delegated Regulation (EU) 2020/692 is corrected as follows:

Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379 ).

Article 2 Article 2 Correction to Delegated Regulation (EU) 2020/692

Article 3 Article 3 Entry into force

in Article 170(1), point (a)(iv), is replaced by the following: (iv) diseases for which certain Member States have taken the national measures referred to in Article 175 of this Regulation, when a consignment contains relevant species listed in Annex XXIX hereto and it is destined for a Member State, zone or compartment which is listed in Annex I or II to Commission Implementing Decision (EU) 2021/260Commission Implementing Decision (EU) 2021/260 of 11 February 2021 approving national measures designed to limit the impact of certain diseases of aquatic animals in accordance with Article 226(3) of Regulation (EU) 2016/429 of the European Parliament and of the Council and repealing Commission Decision 2010/221/EU (OJ L 59, 19.2.2021, p. 1 ). ;

(iv) diseases for which certain Member States have taken the national measures referred to in Article 175 of this Regulation, when a consignment contains relevant species listed in Annex XXIX hereto and it is destined for a Member State, zone or compartment which is listed in Annex I or II to Commission Implementing Decision (EU) 2021/260Commission Implementing Decision (EU) 2021/260 of 11 February 2021 approving national measures designed to limit the impact of certain diseases of aquatic animals in accordance with Article 226(3) of Regulation (EU) 2016/429 of the European Parliament and of the Council and repealing Commission Decision 2010/221/EU (OJ L 59, 19.2.2021, p. 1 ).

Article 79 Article 79 The third country or territory of origin or zone thereof 1.Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine animals shall only be permitted to enter the Union if they were collected or produced from animals in third countries or territories, or zones thereof, which comply with the animal health requirements laid down in Article 22. 2.By way of derogation from paragraph 1 of this Article, in connection with the animal health requirement laid down in Article 22(4), point (a), consignments of semen, oocytes and embryos of bovine, porcine, ovine, and caprine animals may be permitted to enter the Union if they were collected or produced in third countries or territories where vaccination against foot and mouth disease has been carried out, provided that they were collected from animals in accordance with the animal health requirements laid down in Annex II, Part 5, Chapter I, point 3 or 4, to Delegated Regulation (EU) 2020/686.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (OJ L 174, 3.6.2020, p. 211 ).

Article 117 Article 117 Requirements for the entry into the Union of consignments of germinal products of animals other than those referred to in Article 1(4), point (a) and (b), intended for confined establishments

Article 150 Article 150 The establishment of origin of the animals from which the fresh meat was obtained

Article 156 Article 156 Dairy products not subject to a risk-mitigating treatment

Article 163 Article 163 Specific requirements for shelf-stable composite products 1.By way of derogation from Article 3, point (c)(i), consignments of composite products that do not contain meat products, except gelatine and collagen, or colostrum-based products, and that have been treated to become shelf-stable at ambient temperature, shall be permitted to enter the Union accompanied by a declaration, as provided for in paragraph 2 of this Article, if they contain: (a) dairy products that comply with one of the following conditions:(i) they have not undergone a risk-mitigating treatment provided for in Annex XXVII, provided that the dairy products have been obtained either in the Union or in a third country or territory, or zone thereof, listed for the entry into the Union of dairy products without undergoing a specific risk-mitigating treatment, in accordance with Article 156, and the third country or territory, or zone thereof, where the composite product is produced, if different, is also listed for entry into the Union of those products without the requirement to apply a specific risk-mitigating treatment;(ii) they have undergone a risk-mitigating treatment provided for in column A or B of Annex XXVII, relevant for the species of origin of the milk, provided that they have been obtained either in the Union, or in a third country or territory, or zone thereof, listed for entry into the Union of dairy products without undergoing a specific risk-mitigating treatment, in accordance with Article 156, or of dairy products that have undergone a specific risk-mitigating treatment, in accordance with Article 157; and the third country or territory, or zone thereof, where the composite product is produced, if different, is also listed for entry into the Union of those products if they have undergone a specific risk-mitigating treatment;(iii) they have undergone a risk-mitigating treatment at least equivalent to those referred to in column B of Annex XXVII, regardless of the species of origin of the milk, if the dairy products do not comply with all the requirements provided for in (i) or (ii) of this point or they have been obtained either in the Union, or in a third country or territory, or zone thereof, which is not authorised for the entry into the Union of dairy products but is authorised for the entry into the Union of other products of animal origin in accordance with this Regulation; (b) egg products that have undergone a risk-mitigating treatment equivalent to those set out in Annex XXVIII. 2.The declaration referred to in paragraph 1 shall: (a) only accompany consignments of composite products where the final destination of the composite products is in the Union;(b) be issued by the operator responsible of the entry into the Union of the consignment of composite products, attesting that the composite products in the consignment comply with the requirements laid down in paragraph 1. 3.By way of derogation from of Article 3, point (a)(i), the composite products containing dairy products referred to in paragraph 1, point (a)(iii), of this Article, and the composite products containing egg products that have been treated to become shelf-stable at ambient temperature shall be permitted to enter the Union if they come from a third country or territory, or zone thereof which is not specifically listed for the entry into the Union of those products of animal origin but is listed for the entry into the Union of either: (a) meat products, dairy products or egg products; or(b) fishery products in accordance with Article 127 of Regulation (EU) 2017/625

Article 178 Article 178 Special requirements for entry into the Union of ungulates, poultry, captive birds and aquatic animals originating from, and returning to the Union following a refusal of entry by a third country or territory 1.Consignments of ungulates, poultry, captive birds and aquatic animals originating from and returning to the Union following a refusal of entry by the competent authority of a third country or territory shall only be permitted to re-enter the Union if the following requirements are fulfilled:

Article 179 Article 179 Special requirements for the entry into the Union of animals other than ungulates, poultry, captive birds and aquatic animals originating from, and returning to the Union following a refusal of entry by a third country or territory 1.Consignments of animals other than ungulates, poultry, captive birds and aquatic animals originating from and returning to the Union following a refusal of entry by the competent authority of a third country or territory shall only be permitted to re-enter the Union if the animals of the consignment are accompanied by the following documents:

Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (OJ L 174, 3.6.2020, p. 140 ).

Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (OJ L 174, 3.6.2020, p. 1 ).

Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council (OJ L 114, 31.3.2021, 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 ).

Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (OJ L 308, 4.12.2018, p. 21 ).

Commission Implementing Regulation (EU) 2021/403 of 24 March 2021 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates and model animal health/official certificates, for the entry into the Union and movements between Member States of consignments of certain categories of terrestrial animals and germinal products thereof, official certification regarding such certificates and repealing Decision 2010/470/EU (OJ L 113, 31.3.2021, p. 1 ).

Commission Implementing Decision (EU) 2021/260 of 11 February 2021 approving national measures designed to limit the impact of certain diseases of aquatic animals in accordance with Article 226(3) of Regulation (EU) 2016/429 of the European Parliament and of the Council and repealing Commission Decision 2010/221/EU (OJ L 59, 19.2.2021, p. 1 ).;

Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine animals shall only be permitted to enter the Union if they were collected or produced from animals in third countries or territories, or zones thereof, which comply with the animal health requirements laid down in Article 22.

By way of derogation from paragraph 1 of this Article, in connection with the animal health requirement laid down in Article 22(4), point (a), consignments of semen, oocytes and embryos of bovine, porcine, ovine, and caprine animals may be permitted to enter the Union if they were collected or produced in third countries or territories where vaccination against foot and mouth disease has been carried out, provided that they were collected from animals in accordance with the animal health requirements laid down in Annex II, Part 5, Chapter I, point 3 or 4, to Delegated Regulation (EU) 2020/686.

Consignments of semen, oocytes and embryos of animals other than those referred to in Article 1(4), point (a) and (b), intended for a confined establishment located in the Union may be permitted to enter the Union provided that:

(a) an assessment has been carried out by the competent authority of the Member State of destination of the risks that the entry of those germinal products may present for the Union;

(b) the donor animals of those germinal products originate from a third country or territory, or zone thereof, authorised for the entry into the Union of the particular species and category of animals either by Commission Implementing Regulation (EU) 2021/404Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council (OJ L 114, 31.3.2021, p. 1 ). , or pursuant to Article 230(2) of Regulation (EU) 2016/429, by the Member State of destination, depending on the species in question;

(c) the donor animals of those germinal products originate from an establishment in the third country or territory, or zone thereof of origin, which is included in a list established by the competent authority of the Member State of destination from which the entry of animals of specific species into the Union may be authorised;

(d) the germinal products are destined to a confined establishment in the Union, which is approved in accordance with Article 95 of Regulation (EU) 2016/429;

(e) the germinal products are transported directly to the confined establishment referred to in point (d).

Consignments of meat products shall only be permitted to enter the Union if they have been processed from fresh meat which originates from animals coming from an establishment, or, in the case of wild animals, from a place in and around which, in an area of a 10 km radius, including, where appropriate, the territory of a neighbouring country, none of the listed diseases, relevant for the species of origin of the meat products in accordance with the list set out in Annex I, has been reported during the period of 30 days prior to the date of slaughter or killing of the animals.

Consignments of dairy products originating from a third country or territory, or zone thereof, which is listed for entry into the Union of raw milk shall be permitted to enter the Union without having undergone a specific risk-mitigating treatment provided for in Annex XXVII, if the dairy products of the consignment comply with following requirements:

(a) the raw milk or dairy product therefrom, from which they were processed, were obtained from animals of the species Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedarius ;

(b) the raw milk or dairy product therefrom, used for the processing of the dairy products complied with the relevant general animal health requirements for the entry into the Union of products of animal origin laid down in Articles 3 to 10 and the specific animal health requirements for the entry into the Union of raw milk laid down in Articles 153 and 154, and therefore was eligible for entry into the Union and it originates from one of the following:(i) a listed third country or territory, or zone thereof, where the dairy products were processed;(ii) a third country or territory, or zone thereof, other than a listed third country or territory, or zone thereof, where the dairy products were processed and which is authorised for entry into the Union of raw milk; or(iii) a Member State.

(i) a listed third country or territory, or zone thereof, where the dairy products were processed;

(ii) a third country or territory, or zone thereof, other than a listed third country or territory, or zone thereof, where the dairy products were processed and which is authorised for entry into the Union of raw milk; or

(iii) a Member State.

By way of derogation from Article 3, point (c)(i), consignments of composite products that do not contain meat products, except gelatine and collagen, or colostrum-based products, and that have been treated to become shelf-stable at ambient temperature, shall be permitted to enter the Union accompanied by a declaration, as provided for in paragraph 2 of this Article, if they contain:

(a) dairy products that comply with one of the following conditions:(i) they have not undergone a risk-mitigating treatment provided for in Annex XXVII, provided that the dairy products have been obtained either in the Union or in a third country or territory, or zone thereof, listed for the entry into the Union of dairy products without undergoing a specific risk-mitigating treatment, in accordance with Article 156, and the third country or territory, or zone thereof, where the composite product is produced, if different, is also listed for entry into the Union of those products without the requirement to apply a specific risk-mitigating treatment;(ii) they have undergone a risk-mitigating treatment provided for in column A or B of Annex XXVII, relevant for the species of origin of the milk, provided that they have been obtained either in the Union, or in a third country or territory, or zone thereof, listed for entry into the Union of dairy products without undergoing a specific risk-mitigating treatment, in accordance with Article 156, or of dairy products that have undergone a specific risk-mitigating treatment, in accordance with Article 157; and the third country or territory, or zone thereof, where the composite product is produced, if different, is also listed for entry into the Union of those products if they have undergone a specific risk-mitigating treatment;(iii) they have undergone a risk-mitigating treatment at least equivalent to those referred to in column B of Annex XXVII, regardless of the species of origin of the milk, if the dairy products do not comply with all the requirements provided for in (i) or (ii) of this point or they have been obtained either in the Union, or in a third country or territory, or zone thereof, which is not authorised for the entry into the Union of dairy products but is authorised for the entry into the Union of other products of animal origin in accordance with this Regulation;

(i) they have not undergone a risk-mitigating treatment provided for in Annex XXVII, provided that the dairy products have been obtained either in the Union or in a third country or territory, or zone thereof, listed for the entry into the Union of dairy products without undergoing a specific risk-mitigating treatment, in accordance with Article 156, and the third country or territory, or zone thereof, where the composite product is produced, if different, is also listed for entry into the Union of those products without the requirement to apply a specific risk-mitigating treatment;

(ii) they have undergone a risk-mitigating treatment provided for in column A or B of Annex XXVII, relevant for the species of origin of the milk, provided that they have been obtained either in the Union, or in a third country or territory, or zone thereof, listed for entry into the Union of dairy products without undergoing a specific risk-mitigating treatment, in accordance with Article 156, or of dairy products that have undergone a specific risk-mitigating treatment, in accordance with Article 157; and the third country or territory, or zone thereof, where the composite product is produced, if different, is also listed for entry into the Union of those products if they have undergone a specific risk-mitigating treatment;

(iii) they have undergone a risk-mitigating treatment at least equivalent to those referred to in column B of Annex XXVII, regardless of the species of origin of the milk, if the dairy products do not comply with all the requirements provided for in (i) or (ii) of this point or they have been obtained either in the Union, or in a third country or territory, or zone thereof, which is not authorised for the entry into the Union of dairy products but is authorised for the entry into the Union of other products of animal origin in accordance with this Regulation;

(b) egg products that have undergone a risk-mitigating treatment equivalent to those set out in Annex XXVIII.

The declaration referred to in paragraph 1 shall:

(a) only accompany consignments of composite products where the final destination of the composite products is in the Union;

(b) be issued by the operator responsible of the entry into the Union of the consignment of composite products, attesting that the composite products in the consignment comply with the requirements laid down in paragraph 1.

By way of derogation from of Article 3, point (a)(i), the composite products containing dairy products referred to in paragraph 1, point (a)(iii), of this Article, and the composite products containing egg products that have been treated to become shelf-stable at ambient temperature shall be permitted to enter the Union if they come from a third country or territory, or zone thereof which is not specifically listed for the entry into the Union of those products of animal origin but is listed for the entry into the Union of either:

(a) meat products, dairy products or egg products; or

(b) fishery products in accordance with Article 127 of Regulation (EU) 2017/625

Consignments of ungulates, poultry, captive birds and aquatic animals originating from and returning to the Union following a refusal of entry by the competent authority of a third country or territory shall only be permitted to re-enter the Union if the following requirements are fulfilled:

Consignments of animals other than ungulates, poultry, captive birds and aquatic animals originating from and returning to the Union following a refusal of entry by the competent authority of a third country or territory shall only be permitted to re-enter the Union if the animals of the consignment are accompanied by the following documents:

HAS ADOPTED THIS REGULATION: