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

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

THE EUROPEAN COMMISSION,

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

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)(1), and in particular points (a), (c) and (e) of the first paragraph of Articles 90 and 126(3) thereof,

Whereas:

  1. Regulation (EU) 2017/625 lays down rules for official controls and other control activities performed by the competent authorities of the Member States in order to verify compliance with Union legislation in the area of, among others, food safety at all stages of the production, processing and distribution process. In particular, it provides for official certification when considered appropriate to ensure compliance with EU rules on animals and goods.

  2. Point (a) of the first paragraph of Article 90 of Regulation (EU) 2017/625 empowers the Commission to adopt, by means of implementing acts, rules concerning model official certificates and rules for the issuance of such certificates, where requirements are not laid down in the rules referred to in Article 1(2) of that Regulation.

  3. Consignments of animals and goods shall be accompanied by an official certificate issued either on paper or in electronic form. Therefore, it is appropriate to establish common requirements as regards issuance of official certificates in both cases in addition to the requirements laid down in Chapter VII of Title II of Regulation (EU) 2017/625.

  4. Model certificates are included in the electronic system Traces, set up by Commission Decision 2003/623/EC(2), to facilitate and accelerate administrative procedures at Union borders and to enable electronic communication between the competent authorities which helps preventing possible fraudulent or deceptive practices in respect of the official certificates.

  5. Since 2003, computer technology has evolved considerably and the Traces system has been modified to improve the quality, processing and secure exchange of data. As a result, the format of the model certificates and the notes on their completion laid down in this Regulation should be adapted to the Traces system, for example by reflecting the use of multiple Combined Nomenclature (CN) codes or providing traceability for triangular trade, where the country of dispatch is not the country of origin of the consignment.

  6. In accordance with Article 133(4) of Regulation (EU) 2017/625, the Traces system is to be integrated into the Information Management System for Official Controls (IMSOC). The model health certificates laid down in this Regulation should therefore be adapted to IMSOC.

  7. 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.

  8. To avoid misuse and abuse, it is important to define the cases where a replacement certificate may be issued and the requirements that need to be met by such certificates. In particular, these cases should be limited to obvious administrative errors, such as transposed numbers in the container number or seal number, spelling errors in addresses or in product descriptions.

  9. Article 126(2)(c) of Regulation (EU) 2017/625 establishes the requirement that consignments of certain animals and goods are to be accompanied by an official certificate, an official attestation or any other evidence that the consignment complies with the applicable rules referred to in Article 1(2) of that Regulation.

  10. Commission Delegated Regulation (EU) 2019/625(3) provides for a list of goods and animals intended for human consumption, in particular products of animal origin, live insects and sprouts and seeds intended for the production of sprouts, that need to be accompanied by an official certificate upon the entry into the Union if intended for placing on the market. To facilitate official controls upon the entry into the Union, model official certificates should be laid down for such goods and animals intended for human consumption in accordance with Point (a) of the first paragraph of Article 90 and Article 126(3) of Regulation (EU) 2017/625.

  11. Model certificates required for public health reasons are currently laid down in various legal acts. It is appropriate to consolidate these model certificates in one single legal act by making cross-references to them.

  12. With respect to certification of certain products of animal origin for animal health reasons, common model certificates are used. The requirements for certification for animal health reasons should be revised by 21 April 2021, which is the date of application of Regulation (EU) 2016/429 of the European Parliament and of the Council(4). The common model certificates should be maintained until that revision.

  13. For reasons of harmonisation and clarity, model certificates currently laid down in Commission Regulation (EC) No 2074/2005(5), Commission Regulation (EU) No 211/2013(6) and Commission Implementing Regulation (EU) 2016/759(7) should be incorporated into this Regulation. As a result, Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 should be amended accordingly and Regulation (EU) No 211/2013 should be repealed.

  14. To facilitate the verification of compliance with EU requirements, it seems appropriate to introduce additional new model health certificates for the entry of rendered animal fats and greaves, insects and reptile meat intended for placing on the market. Such model certificates also make it easier for competent authorities in third countries to understand EU requirements and therefore facilitate the entry of animal fats and greaves, insects and reptile meat into the Union.

  15. 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 or goods after official controls have been performed. In accordance with Article 5 of Commission Delegated Regulation (EU) 2019/624(8), such health certificates are to accompany animals to the slaughterhouse after ante-mortem inspection has been carried at the holding of provenance. The format of such certificates should therefore be laid down in this Regulation.

  16. In the case of emergency slaughter outside the slaughterhouse, 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 of Regulation (EC) No 853/2004 of the European Parliament and of the Council(9).

  17. As Regulation (EU) 2017/625 applies with effect from 14 December 2019, this Regulation should also apply from that date.

  18. It is appropriate to introduce a transitional period to take into account the consignments of animals and goods shipped and certified, if required, before the date of application of this Regulation.

  19. 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

1.

This Regulation lays down:

  1. rules for the uniform application of Articles 88 and 89 of Regulation (EU) 2017/625 as regards the signature and issuance of official certificates and the guarantees of reliability for official certificates, in order to comply with the requirements of Article 126(2)(c) of that Regulation;

  2. requirements for model official certificates which are not submitted in IMSOC;

  3. requirements for model official certificates which are submitted in IMSOC;

  4. requirements for replacement certificates.

2.

This Regulation also sets out:

  1. model official certificates for the entry into the Union of animals, products of animal origin, composite products, germinal products and animal by-products and notes for its completion;

  2. specific model official certificates for the entry into the Union of the following animals and goods intended for human consumption and placing on the market:

    1. products of animal origin for which such certificate is required in accordance with Article 13 of Delegated Regulation (EU) 2019/625;

    2. live insects;

    3. sprouts and seeds intended for the production of sprouts;

  3. model official certificates in the case of ante-mortem inspection at the holding of provenance or in the case of emergency slaughter outside the slaughterhouse.

Article 2 Definitions

For the purpose of this Regulation, the following definitions shall apply:

  1. ‘placing on the market’ means placing on the market as defined in point (8) of Article 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(10);

  2. ‘sprouts’ means sprouts as defined in point (a) of Article 2 of Commission Implementing Regulation (EU) No 208/2013(11);

  3. ‘slaughterhouse’ means a slaughterhouse as defined in point 1.16 of Annex I to Regulation (EC) No 853/2004;

  4. ‘fresh meat’ means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) No 853/2004;

  5. ‘meat’ means meat as defined in point 1.1 of Annex I to Regulation (EC) No 853/2004;

  6. ‘poultry’ means poultry as defined in point 1.3 of Annex I to Regulation (EC) No 853/2004;

  7. ‘wild game’ means wild game as defined in point 1.5 of Annex I to Regulation (EC) No 853/2004;

  8. ‘eggs’ means eggs as defined in point 5.1 of Annex I to Regulation (EC) No 853/2004;

  9. ‘egg products’ means egg products as defined in point 7.3 of Annex I to Regulation (EC) No 853/2004;

  10. ‘meat preparations’ means meat preparations as defined in point 1.15 of Annex I to Regulation (EC) No 853/2004;

  11. ‘meat products’ means meat products as defined in point 7.1 of Annex I to Regulation (EC) No 853/2004;

  12. ‘treated stomachs, bladders and intestines’ means treated stomachs, bladders and intestines as defined in point 7.9 of Annex I to Regulation (EC) No 853/2004;

  13. ‘bivalve molluscs’ means bivalve molluscs as defined in point 2.1 of Annex I to Regulation (EC) No 853/2004;

  14. ‘fishery products’ means fishery products as defined in point 3.1 of Annex I to Regulation (EC) No 853/2004;

  15. ‘raw milk’ means raw milk as defined in point 4.1 of Annex I to Regulation (EC) No 853/2004;

  16. ‘dairy products’ means dairy products as defined in point 7.2. of Annex I to Regulation (EC) No 853/2004;

  17. ‘colostrum’ means colostrum as defined in point 1 of Section IX of Annex III of Regulation (EC) No 853/2004;

  18. ‘colostrum-based products’ means colostrum-based products as defined in points 2 of Section IX of Annex III of Regulation (EC) No 853/2004;

  19. ‘frogs’ legs' means frogs' legs as defined in point 6.1 of Annex I to Regulation (EC) No 853/2004;

  20. ‘snails’ means snails as defined in point 6.2 of Annex I to Regulation (EC) No 853/2004;

  21. ‘rendered animal fat’ means rendered animal fat defined in point 7.5 of Annex I to Regulation (EC) No 853/2004;

  22. ‘greaves’ means greaves as defined in point 7.6 of Annex I to Regulation (EC) No 853/2004;

  23. ‘gelatine’ means gelatine as defined in point 7.7 of Annex I to Regulation (EC) No 853/2004;

  24. ‘collagen’ means collagen as defined in point 7.8 of Annex I to Regulation (EC) No 853/2004;

  25. ‘honey’ means honey as defined in point 1 of Part IX of Annex II to Regulation (EU) No 1308/2013 of the European Parliament and of the Council(12);

  26. ‘apiculture products’ means apiculture products as defined in point 2 of Part IX of Annex II to Regulation (EU) No 1308/2013;

  27. ‘reptile meat’ means reptile meat as defined in point (16) of Article 2 of Delegated Regulation (EU) 2019/625;

  28. ‘insects’ means insects as defined in point (17) of Article 2 of Delegated Regulation (EU) 2019/625;

  29. ‘reefer vessel’ means a reefer vessel as defined in point (26) of Article 2 of Delegated Regulation (EU) 2019/625;

  30. ‘freezer vessel’ means a freezer vessel as defined in point 3.3 of Annex I to Regulation (EC) No 853/2004;

  31. ‘factory vessel’ means a factory vessel as defined in point 3.2 of Annex I to Regulation (EC) No 853/2004;

  32. ‘production area’ means a production area as defined in point 2.5 of Annex I to Regulation (EC) No 853/2004;

  33. ‘dispatch centre’ means a dispatch centre as defined in point 2.7 of Annex I to Regulation (EC) No 853/2004;

  34. ‘mechanically separated meat’ means mechanically separated meat as defined in point 1.14 of Annex I to Regulation (EC) No 853/2004;

  35. ‘game-handling establishment’ means a game-handling establishment as defined in point 1.18 of Annex I to Regulation (EC) No 853/2004;

  36. ‘cutting plant’ means a cutting plant as defined in point 1.17 of Annex I to Regulation (EC) No 853/2004;

  37. ‘farmed game’ means farmed game as defined in point 1.6 of Annex I to Regulation (EC) No 853/2004.

Article 3 Requirements for model official certificates not submitted in IMSOC

The model official certificates for those animals, products of animal origin, composite products, germinal products, animal by-products, sprouts and seeds intended for the production of sprouts originating from third countries or regions thereof which are required by Union legislation for the entry into the Union and are not submitted in IMSOC, shall meet the following requirements:

  1. In addition to the signature of the certifying officer, the certificate shall bear an official stamp. The colour of signature shall be different to the colour of the printing. This requirement also applies to stamps other than those embossed or watermarked.

  2. Where the model certificate contains statements, the statements which are not relevant shall be crossed out, initialled and stamped by the certifying officer, or completely removed from the certificate.

  3. The certificate shall consist of:

    1. a single sheet of paper; or

    2. several sheets of paper where all sheets are indivisible and constitute an integral whole; or

    3. a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence.

  4. Where the certificate consists of a sequence of pages, each page shall indicate the unique code as referred to in Article 89(1)(a) of Regulation (EU) 2017/625 and bear the signature of the certifying officer and the official stamp.

  5. The certificate shall be issued before the consignment to which it relates leaves the control of the competent authorities of the third country issuing the certificate.

Article 4 Requirements for model official certificates submitted in IMSOC

1.

The model official certificates for the entry into the Union of animals, products of animal origin, composite products, germinal products and animal by-products originating from third countries or regions thereof, submitted in IMSOC, shall be based on the model official certificate laid down in Annex I.

2.

Part II of the model official certificates referred to in paragraph 1 shall include the specific health guarantees and the information as required in Part II of the relevant model official certificates for those animals, products of animal origin, composite products, germinal products and animal by-products originating from third countries or regions thereof which are required by Union legislation for the entry into the Union.

3.

The official certificate shall be submitted in IMSOC before the consignment to which it relates leaves the control of the competent authorities of the third country issuing the certificate.

4.

The requirements laid down in this Article shall not affect the nature, content and format of the official certificates or attestations referred to in Article 73(2)(b) and (c) and Article 129(2)(a) of Regulation (EU) 2017/625.

Article 5 Replacement certificates

Article 6 Notes on the completion of model official certificates

Article 7 Model official certificates for the entry into the Union for placing on the market of fresh meat of ungulates

Article 8 Model official certificates for the entry into the Union for placing on the market of meat of poultry, ratites and wild game birds, eggs and egg products

Article 9 Model official certificates for the entry into the Union for placing on the market of meat of wild leporidae, of certain wild land mammals and of farmed rabbits

Article 10 Model official certificate for the entry into the Union for placing on the market of meat preparations

Article 11 Model official certificates for the entry into the Union for placing on the market of certain meat products and treated stomachs, bladders and intestines

Article 12 Model official certificates for the entry into the Union for placing on the market of live bivalve molluscs, echinoderms, tunicates and marine gastropods

Article 13 Model official certificates for the entry into the Union for placing on the market of fishery products

Article 14 Model official certificates for the entry into the Union for placing on the market of raw milk, colostrum, dairy products and colostrum-based products

Article 15 Model official certificate for the entry into the Union for placing on the market of chilled, frozen or prepared frogs' legs intended for human consumption

Article 16 Model official certificate for the entry into the Union for placing on the market of chilled, frozen, shelled, cooked, prepared or preserved snails intended for human consumption

Article 17 Model official certificate for the entry into the Union for placing on the market of rendered animal fats and greaves intended for human consumption

Article 18 Model official certificate for the entry into the Union for placing on the market of gelatine intended for human consumption

Article 19 Model official certificate for the entry into the Union for placing on the market of collagen intended for human consumption

Article 20 Model official certificate for the entry into the Union for placing on the market of raw materials for the production of gelatine and collagen intended for human consumption

Article 21 Model official certificate for the entry into the Union for placing on the market of treated raw materials for the production of gelatine and collagen intended for human consumption

Article 22 Model official certificate for the entry into the Union for placing on the market of honey and other apiculture products intended for human consumption

Article 23 Model official certificate for the entry into the Union for placing on the market of highly refined chondroitin sulphate, hyaluronic acid, other hydrolysed cartilage products, chitosan, glucosamine, rennet, isinglass and amino acids intended for human consumption

Article 24 Model official certificate for the entry into the Union for placing on the market of reptile meat intended for human consumption

Article 25 Model official certificate for the entry into the Union for placing on the market of insects intended for human consumption

Article 26 Model official certificate for the entry into the Union for placing on the market of other products of animal origin intended for human consumption and not covered by Articles 7 to 25

Article 27 Model official certificate for the entry into the Union for placing on the market of sprouts and seeds intended for the production of sprouts

Article 28 Model official certificates in case of ante-mortem inspection at the holding of provenance

Article 29 Model official certificate in case of emergency slaughter outside the slaughterhouse

Article 30 Amendments to Regulation (EC) No 2074/2005

Article 31 Amendments to Implementing Regulation (EU) 2016/759

Article 32 Repeal

Article 33 Transitional provisions

Article 34 Entry into force and application

ANNEX I

ANNEX II

ANNEX III

ANNEX IV

ANNEX V

ANNEX VI