Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 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, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (Text with EEA relevance)

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 laying down specific hygiene rules for food of animal origin^f1, and in particular point (a) of Article 7(2) 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’)^f2, and in particular Articles 168(4), 224(4), 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) No 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)^f3, and in particular the first paragraph of Article 90 and Article 126(3) thereof,

Whereas:

Regulation (EU) 2016/429 lays down rules on animal diseases that are transmissible to animals or to humans, including requirements for official animal health certification for various movements of animals, germinal products and products of animal origin. Those requirements, inter alia for movements of certain live aquatic animals and products of animal origin for human consumption, are further specified in Commission Delegated Regulation (EU) 2020/692^f4 pursuant to Regulation (EU) 2016/429. It also empowers the Commission to adopt implementing acts laying down rules for model forms of those animal health certificates, as well rules concerning the information to be contained in certain documents and declarations required for the entry into the Union of such consignments. In addition, that Regulation empowers the Commission to lay down special rules concerning model forms of animal health certificates, declarations and other documents for animals, germinal products and products of animal origin. Regulation (EU) 2016/429 also provides that animal health certificates may include other information required under other Union legislation.

Delegated Regulation (EU) 2020/692 lays down supplementing animal health requirements for entry into the Union of consignments of certain animals, including live aquatic animals, germinal products and products of animal origin. In particular, in accordance with that Regulation, such consignments shall be accompanied by the animal health certificate, and if provided in that Regulation, by declaration or other documents. Those Delegated Regulations provide the requirements which animals and goods for human consumption have to comply with when entering the Union.

Article 168(1) and (3) of Regulation (EU) 2016/429 lays down rules as regards information in the animal health certificate required to accompany movements within a Member State or from one Member State to another Member State of consignments of products of animal origin from terrestrial animals, and empowers the Commission to adopt delegated acts supplementing these rules. Therefore, models of animal health certificates for such movements of products of animal origin produced or processed in establishments, food businesses or zones subject to emergency measures or movement restrictions should be set out by this Regulation.

Article 224(4) of Regulation (EU) 2016/429 empowers the Commission to lay down rules on model forms of animal health certificates.

In addition, Article 238(3) of Regulation (EU) 2016/429 empowers the Commission to lay down by means of implementing acts, rules concerning the contents and the format of models of animal health certificates, declarations and other documents for the entry into the Union of animals, germinal products and products of animal origin.

Article 239(3) of Regulation (EU) 2016/429 empowers the Commission to lay down by means of implementing acts, rules concerning the contents and the format of models of animal health certificates, declarations and other documents for the entry into the Union of animals, germinal products and products of animal origin for which the Union is not the final destination.

In order to provide for legal clarity and consistency of the rules on animals and goods for human consumption, models of official certificates containing the animal health requirements for such movements of certain live aquatic animals and products of animal origin should be set out by this Regulation.

Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities performed by the competent authorities of the Member States to ensure compliance with the rules referred to in Article 1(2) of that Regulation, among others, rules on food safety at all stages of production, processing and distribution and animal health and welfare requirements and animal by-products. That Regulation provides for certain rules on official certification when the rules referred to in Article 1(2) or Article 126(2)(c) of that Regulation require the issuance of official certificates. In the absence of more specific rules in Regulation (EU) 2016/429, those rules on official certification apply to the certificates set out in this Regulation.

In particular, point (a) of the first paragraph of Article 90 of Regulation (EU) 2017/625 empowers the Commission to lay down by means of implementing acts, rules concerning model official certificates, for the issuance of such certificates.

The rules referred to in Article 1(2) of Regulation (EU) 2017/625 include animal health requirements, but also, inter alia, rules in the area of food safety and animal welfare. In the interests of legal clarity, and in order to minimise administrative burden during the issuance of certificates, this Regulation should include animal health certificates, to be signed by the official veterinarian, official certificates to be signed by the certifying officer and animal health/ official certificates, to be signed by the official veterinarian or certifying officer, with respect to particular commodities.

In addition, this Regulation should have regard to certain definitions laid down in other Union acts, such as definitions laid down in Annex I to Regulation (EC) No 853/2004 and Part IX of Annex II to Regulation (EU) No 1308/2013 of the European Parliament and of the Council^f5, as well as the definitions laid down in Commission Implementing Regulation (EU) No 208/2013^f6 and Commission Delegated Regulation (EU) 2019/625^f7.

Regulation (EU) 2016/429 aims at reducing the administrative burden in relation to certification and notification by using information technology as far as possible for multiple purposes. In addition, that Regulation lays down certain rules regarding the possibility for electronic animal health certificates to accompany certain consignments instead of animal health certificates issued on paper. Regulation (EU) 2017/625 lays down that consignments of animals and goods are to be accompanied by an official certificate issued either on paper or in electronic form. In addition, Article 90(f) of that Regulation empowers the Commission, by means of implementing acts, to lay down rules for the issuance of electronic certificates and for the use of electronic signatures. Therefore, it is appropriate to establish common requirements as regards issuance of certificates in both forms in addition to the requirements laid down in Articles 150 and 217 of Regulation (EU) 2016/429 and in Chapter VII of Title II of Regulation (EU) 2017/625.

To facilitate official controls at the border control posts of entry into the Union, the requirements for certificates for the entry into the Union should include linguistic requirements.

Regulation (EU) 2017/625 provides that the Information Management System for Official Controls (IMSOC) is to allow for the production, handling and transmission of official certificates, including in electronic form. Commission Implementing Regulation (EU) 2019/1715^f8 provides that the Trade Control and Expert System (TRACES) is the IMSOC component enabling certificates to be produced electronically, thus preventing possible fraudulent or deceptive practices in respect of animal health, official certificates or animal health/official certificates. To this end, this Regulation should lay down standard models for official certificates that are compatible with TRACES.

Point (c) of the first paragraph of Article 90 of Regulation (EU) 2017/625 empowers the Commission to lay down by means of implementing acts rules concerning the procedures to be followed for the issuance of replacement certificates. Therefore, it is appropriate to establish common requirements as regards the replacement of certificates and these common requirements, which should apply to animal health certificates, to be signed by the official veterinarian, official certificates to be signed by the certifying officer and animal health/official certificates, to be signed by the official veterinarian or certifying officer, should be set out in this Regulation.

To avoid misuse and abuse, it is important to lay down rules concerning the cases where a replacement certificate may be issued and the requirements that such certificates need to meet. These cases should be limited to administrative errors and to cases where the initial certificate has been damaged or lost.

Article 237(1)(a) of Regulation (EU) 2016/429 provides that the Member States shall only permit the entry into the Union of consignments of animals, germinal products and products of animal origin if they are accompanied by an animal health certificate, unless a derogation is provided for in Article 237(4)(a) of that Regulation. Article 126(2)(c) of Regulation (EU) 2017/625 establishes the requirement that consignments of certain animals and goods entering the Union are to be accompanied by an official certificate, an official attestation or any other evidence that the consignments comply with the relevant requirements established by the rules referred to in Article 1(2) of that Regulation.

In this regard, Delegated Regulation (EU) 2019/625 provides for a list of goods and animals intended for human consumption, in particular products of animal origin, live insects, sprouts for human consumption and seeds intended for the production of sprouts for human consumption, that need to be accompanied by an official certificate upon the entry into the Union. To facilitate official controls upon the entry into the Union of consignments of products of animal origin, live insects, sprouts for human consumption and seeds intended for the production of sprouts for human consumption, model official certificates should be laid down for such goods and animals intended for human consumption.

Point (e) of the first paragraph of Article 90 of Regulation (EU) 2017/625 empowers the Commission to adopt, by means of implementing acts, rules concerning the format of documents that are to accompany animals and goods after official controls have been performed. In accordance with Article 5(2)(f) of Commission Delegated Regulation (EU) 2019/624^f9, health certificates are to accompany animals to the slaughterhouse after ante-mortem inspection has been carried out at the holding of provenance. The format of such certificates should therefore be laid down in this Regulation.

In the case of emergency slaughter outside the slaughterhouse of certain categories of animals, it is appropriate for reasons of harmonisation and clarity, to lay down a model certificate in this Regulation for the declaration to be issued by the official veterinarian in accordance with point (6) of Chapter VI of Section I of Annex III to Regulation (EC) No 853/2004.

Commission Implementing Regulation (EU) 2019/628^f10 lays down, inter alia, supplementing rules for the uniform application of Articles 88 and 89 of Regulation (EU) 2017/625 and sets out model official certificates listed therein. However, Regulation (EU) 2016/429 repeals certain legal acts mentioned in that Implementing Regulation. Therefore, for reasons of harmonisation and clarity, in order to avoid duplication of rules, the model certificates laid down in Implementing Regulation (EU) 2019/628 should be replaced by the certificates laid down in this Regulation and Implementing Regulation (EU) 2019/628 should be repealed.

Given that the rules laid down in Commission Regulation (EC) No 599/2004^f11 and Commission Implementing Regulation (EU) No 636/2014^f12 and Commission Decisions 2000/572/EC^f13, 2003/779/EC^f14 and 2007/240/EC^f15 are now included in this Regulation those legal acts should be repealed.

Regulation (EC) No 882/2004 of the European Parliament and of the Council^f16 repeals Council Directive 95/53/EC^f17. Commission Directive 98/68/EC^f18 laid down the standard document for the introduction of feedingstuffs from third countries and for checks on such feedingstuffs at the external border. Since in accordance with Regulation (EU) 2017/625, systematic mandatory checks of feedingstuffs at border control posts of entry into the Union are no longer required, the entry document established by Commission Directive 98/68/EC is devoid of purpose.

It is appropriate to introduce a transitional period to take into account the specific situation of competent authorities in third countries that need to make the necessary arrangements to ensure compliance with this Regulation and the specific situation of shipments of consignments of animals and goods accompanied by certificates issued in accordance with Commission Regulation (EU) No 28/2012^f19 and Implementing Regulation (EU) 2019/628 before the date of application of this Regulation.

As Regulation (EU) 2016/429 applies with effect from 21 April 2021, this Regulation should also apply from that date.

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: