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

(Text with EEA relevance)

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’) (1), and in particular Article 230(1) thereof,

Whereas:

(1) Regulation (EU) 2016/429 lays down, inter alia, the animal health requirements for the entry into the Union of consignments of animals, germinal products and products of animal origin, and it applies from 21 April 2021. One of those animal health requirements is that those consignments must come from a third country or territory, or zone or compartment thereof, in accordance with Article 230(1) of that Regulation.

(2) Commission Delegated Regulation (EU) 2020/692 (2) supplements Regulation (EU) 2016/429 as regards the animal health requirements for the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories or zones thereof, or compartments thereof in the case of aquaculture animals. Point (a) of Article 3 of Delegated Regulation (EU) 2020/692 provides that consignments of animals, germinal products and products of animal origin falling within its scope may only be permitted to enter into the Union if they come from a third country or territory, or zone or compartment thereof, listed for the particular species and categories of animals, germinal products and products of animal origin in accordance with the animal health requirements laid down in that Delegated Regulation.

(3) This Regulation should therefore establish the lists of third countries, territories or zones thereof, or compartments thereof in the case of aquaculture animals, from which the entry into the Union of the species and categories of animals, germinal products and products of animal origin falling within the scope of Delegated Regulation (EU) 2020/692 should be permitted, in accordance with the criteria laid down in Article 230(1) of Regulation (EU) 2016/429.

(4) Currently, the lists of third countries and territories or zones thereof from which the entry into the Union of specific species and categories of animals, germinal products and products of animal origin is permitted, are laid down in several Commission acts. Firstly, lists are laid down in Commission Decision 2007/777/EC (3), Commission Regulation (EC) No 798/2008 (4), Commission Regulation (EC) No 119/2009 (5), Commission Regulation (EU) No 206/2010 (6), Commission Regulation (EU) No 605/2010 (7), Commission Implementing Regulation (EU) No 139/2013 (8) and Commission Implementing Regulation (EU) 2016/759 (9), all of which are repealed by Delegated Regulation (EU) 2020/692 with effect from 21 April 2021. In addition, other lists are laid down in Commission Decision 2006/168/EC (10), Commission Decision 2008/636/EC (11), Commission Regulation (EC) No 1251/2008 (12), Commission Decision 2010/472/EU (13), Commission Implementing Decision 2011/630/EU (14), Commission Implementing Decision 2012/137/EU (15), Commission Implementing Regulation (EU) 2018/659 and Commission Implementing Decision (EU) 2019/294 (16), all of which are repealed by this Implementing Regulation.

(5) Under the new animal health framework, established by Regulation (EU) 2016/429, it is appropriate to combine in a single Commission act a complete set of lists of third countries, territories or zones thereof authorised on the basis of animal health requirements for the entry into the Union of consignments of the animals, germinal products and products of animal origin falling with the scope of Delegated Regulation (EU) 2020/692. This is in line with the approach adopted by Delegated Regulation (EU) 2020/692, where the animal health requirements for the entry into the Union of those consignments are laid down in a single Commission act. In addition, it provides for more consistency and transparency of Union legislation.

(6) For that reason, Decisions 2006/168/EC, 2008/636/EC, Regulation (EC) No 1251/2008, Decision 2010/472/EU, Implementing Decisions 2011/630/EU and 2012/137/EU, Implementing Regulation (EU) 2018/659 and Implementing Decision (EU) 2019/294 should be repealed from 21 April 2021. This Regulation should therefore establish new lists of third countries and territories or zones thereof which will replace the current lists of third countries and territories or zones or compartments thereof from which the entry into the Union of consignments of animals, germinal products and products of animal origin is permitted. The current lists are drawn up with regard to both animal health and food safety, where relevant. The new lists, however, should be drawn up separately on the basis of in particular the animal health requirements provided for Regulation (EU) 2016/429 and the food safety requirements provided for in Regulation (EU) 2017/625.

(7) In certain cases, only certain zones or compartments of a third country or territory comply with all the criteria laid down in Article 230(1) of Regulation (EU) 2016/429 and the relevant animal health requirements laid down in Delegated Regulation (EU) 2020/692. In such cases, entry into the Union of certain species and categories of animals, germinal products and products of animal origin should only be permitted if they come from such zones or compartments of the third country or territory. This Regulation should therefore clearly specify in each list the zone(s), or compartment(s) in the case of aquaculture animals, of the third countries or territories which comply with those animal health requirements.

(8) Point (c) of Article 231 of Regulation (EU) 2016/429 provides that the lists laid down by the Commission pursuant to Article 230(1) of that Regulation should also specify the specific conditions and animal health guarantees concerning listed diseases to be complied by the third countries or territories. This Regulation should therefore provide, where relevant, for such specific conditions and animal health guarantees, taking into account the specific animal health situation of the third country or territory of origin or zone thereof, or compartment thereof in the case of aquaculture animals, and the specific species and categories of animals, germinal products and products of animal origin concerned.

(9) Part VI of Delegated Regulation (EU) 2020/692 sets out special rules for the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin for which the Union is not the final destination, and of consignments of certain species and categories of animals, germinal products and products of animal origin originating in and returning to the Union. In particular, that Regulation provides for the possibility to authorise the entry into the Union of such consignments which do not comply with all the relevant animal health requirements subject to the fulfilment of specific conditions. This Regulation should therefore lay down the specific animal health conditions that such consignments should comply with for entry into Union.

(10) Pursuant to the EEA Agreement, the EEA EFTA States are not third countries when trading with the EU Member States in areas governed by the EEA Agreement.

(11) As the rules laid down in this Regulation are to be applied in tandem with the rules laid down in Regulation (EU) 2016/429 and in Delegated Regulation (EU) 2020/692, this Regulation should also apply from 21 April 2021.

(12) 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 Subject matter and scope This Regulation lays down the lists of third countries, territories or zones thereof, or compartments thereof in the case of aquaculture animals, from which the entry into the Union of consignments of the species and categories of animals, germinal products and products of animal origin falling within the scope of Delegated Regulation (EU) 2020/692 is to be permitted. The lists and certain general rules concerning the lists are set out in Annexes I to XXII to this Regulation. It also lays down specific conditions and animal health guarantees for the entry into the Union of certain consignments and specifies the model animal health certificates to be used by the third country or territory of origin of the consignments.

Article 2 Definitions For the purpose of this Regulation, the definitions laid down in Article 2 of Delegated Regulation (EU) 2020/692 apply.

Article 3 Lists of third countries, territories or zones or compartments thereof from which the entry into the Union of animals, germinal products and products of animal origin shall be permitted 1. The competent authority shall only permit the entry into the Union of consignments of the species and categories of animals, germinal products and products of animal origin falling within the scope of Delegated Regulation (EU) 2020/692 only if the third country or territory of origin of the consignment, or zone or compartment thereof, is listed for the specific species and category of animals, germinal products or products of animal origin and the consignment is accompanied by the animal health certificate required to accompany consignments of such species and categories in the table set up in Part 1 of: (a) Annex II for ungulates other than: (i) equine animals; (ii) ungulates intended for confined establishments; (b) Annex III for ungulates intended for confined establishments; (c) Annex IV for equine animals; (d) Annex V for poultry and germinal products of poultry; (e) Annex VI for captive birds and germinal products of captive birds; (f) Annex VII for queen honeybees and bumble bees; (g) Annex VIII for dogs, cats and ferrets; (h) Annex IX for germinal products of bovine animals; (i) Annex X for germinal products of ovine and caprine animals; (j) Annex XI for germinal products of porcine animals; (k) Annex XII for germinal products of equine animals (l) Annex XIII for fresh meat of ungulates; (m) Annex XIV for fresh meat of poultry and game birds; (n) Annex XV for meat products from ungulates, poultry and game birds as follows: (i) Section A of Part 1 for meat products which have undergone the non-specific risk mitigating treatment A or treatments B, C or D for meat products, (in accordance with Annex XXVI to Delegated Regulation (EU) 2020/692); (ii) Section B of Part 1 for biltong/jerky type products from ungulates, poultry and game birds; (o) Annex XVI for casings; (p) Annex XVII for milk, colostrum and colostrum-based products and dairy products derived from raw milk and dairy products not required to undergo specific risk-mitigating treatment against foot and mouth; (q) Annex XVIII for dairy products required to undergo a specific risk-mitigating treatment against foot and mouth; (r) Annex XIX for eggs and egg products; (s) Annex XX for products of animal origin intended for personal use; (t) Annex XXI for aquatic animals of listed species intended for aquaculture establishments, release into the wild or other purposes other than direct human consumption, as well as certain aquatic animals of listed species and products of animal origin from those listed species which are intended for human consumption. 2. The competent authority shall only permit the entry into the Union of consignments of animals, germinal products and products of animal origin from the third countries, territories or zones thereof listed in the table set out in Part 1 of Annex XXII if they: (a) are consignments of the species and categories of animals, germinal products or products of animal origin referred to in column 3 of that table and the Union is not their final destination; or (b) are consignments of the species and categories of animals, germinal products or products of animal origin referred to in column 4 of that table and originated in and are being returned to the Union after transiting through a third country or territory.

Article 4 Specific conditions and animal health guarantees for the entry into the Union of animals, germinal products and products of animal origin Member States shall only permit the entry into the Union of the consignments falling within the scope of Delegated Regulation (EU) 2020/692, if those consignments fulfil, where applicable, the specific conditions and animal health guarantees set out in the relevant Annex for the specific species and categories of animals, germinal products and products of animal origin and for the third country, territory or zone thereof, or compartment thereof in the case of aquaculture animals.

Article 5 Repeals The following acts are repealed as from 21 April 2021: — Commission Decision 2006/168/EC; — Commission Decision 2008/636/EC; — Commission Decision 2010/472/EU; — Commission Implementing Decision 2011/630/EU; — Commission Implementing Decision 2012/137/EU; — Commission Implementing Regulation (EU) 2018/659; — Commission Implementing Decision (EU) 2019/294; — Commission Decision 2000/585/EC.

Article 6 Transitional provisions Consignments of animals, germinal products and products of animal origin from third countries, territories or zones thereof authorised for entry into the Union pursuant the following Commission acts, and accompanied by the appropriate certificate issued in accordance with those Commission acts, shall be permitted for entry into the Union until 20 October 2021 provided that the certificate was signed by the person authorised to sign the certificate in accordance with those Commission acts before 21 August 2021: — Commission Decision 2006/168/EC; — Commission Decision 2007/777/EC; — Commission Regulation (EC) No 798/2008; — Commission Decision 2008/636/EC; — Commission Regulation (EC) No 1251/2008; — Commission Regulation (EU) No 206/2010; — Commission Regulation (EU) No 605/2010; — Commission Decision 2010/472/EU; — Commission Implementing Decision 2011/630/EU; — Commission Regulation (EU) No 28/2012; — Commission Implementing Decision 2012/137/EU; — Commission Implementing Regulation (EU) No 139/2013; — Commission Implementing Regulation (EU) 2016/759; — Commission Implementing Regulation (EU) 2018/659; — Commission Implementing Decision (EU) 2019/294.

Article 7 Entry into force and application This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 21 April 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 March 2021. For the Commission The President Ursula VON DER LEYEN

(1) 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).

(2) 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).

(3) 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).

(4) 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)

(5) Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12).

(6) 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).

(7) Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption (OJ L 175, 10.7.2010, p. 1).

(8) Commission Implementing Regulation (EU) No 139/2013 of 7 January 2013 laying down animal health conditions for imports of certain birds into the Union and the quarantine conditions thereof (OJ L 47, 20.2.2013, p. 1).

(9) 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 (OJ L 126, 14.5.2016, p. 13).

(10) Commission Decision 2006/168/EC of 4 January 2006 establishing the animal health and veterinary certification requirements for imports into the Community of bovine embryos and repealing Decision 2005/217/EC (OJ L 57, 28.2.2006, p. 19).

(11) Commission Decision 2008/636/EC of 22 July 2008 establishing the list of third countries from which Member States authorise imports of ova and embryos of the porcine species (OJ L 206, 2.8.2008, p. 32)

(12) Commission Regulation (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species (OJ L 337, 16.12.2008, p. 41).

(13) Commission Decision 2010/472/EU of 26 August 2010 on imports of semen, ova and embryos of animals of the ovine and caprine species into the Union (OJ L 228, 31.8.2010, p. 74).

(14) Commission Implementing Decision 2011/630/EU of 20 September 2011 on imports into the Union of semen of domestic animals of the bovine species (OJ L 247, 24.9.2011, p. 32).

(15) Commission Implementing Decision 2012/137/EU of 1 March 2012 on imports into the Union of semen of domestic animals of the porcine species (OJ L 64, 3.3.2012, p. 29).

(16) Commission Implementing Decision (EU) 2019/294 of 18 February 2019 laying down the list of territories and third countries authorised for imports into the Union of dogs, cats and ferrets and the model animal health certificate for such imports (OJ L 48, 20.2.2019, p. 41).