(1)

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 (4) 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.

(2)

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.

(3)

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.

(4)

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

(5)

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.

(6)

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.

(7)

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.

(8)

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.

(9)

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.

(10)

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.

(11)

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 (5), as well as the definitions laid down in Commission Implementing Regulation (EU) No 208/2013 (6) and Commission Delegated Regulation (EU) 2019/625 (7).

(12)

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.

(13)

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.

(14)

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 (8) 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.

(15)

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.

(16)

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.

(17)

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.

(18)

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.

(19)

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 (9), 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.

(20)

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.

(21)

Commission Implementing Regulation (EU) 2019/628 (10) 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.

(22)

Given that the rules laid down in Commission Regulation (EC) No 599/2004 (11) and Commission Implementing Regulation (EU) No 636/2014 (12) and Commission Decisions 2000/572/EC (13), 2003/779/EC (14) and 2007/240/EC (15) are now included in this Regulation those legal acts should be repealed.

(23)

Regulation (EC) No 882/2004 of the European Parliament and of the Council (16) repeals Council Directive 95/53/EC (17). Commission Directive 98/68/EC (18) 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.

(24)

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 (19) and Implementing Regulation (EU) 2019/628 before the date of application of this Regulation.

(25)

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

(26)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

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

(2)

‘frogs' legs’ means frogs’ legs as defined in point 6.1 of Annex I to Regulation (EC) No 853/2004 and frogs’ legs of the genus Pelophylax from the family of Ranidae, and the genera Limnonectes, Fejervarya and Hoplobatrachus from the family of Dicroglossidae;

(3)

‘snails’ means snails as defined in point 6.2 of Annex I to Regulation (EC) No 853/2004 and any other snails of the families of Helicidae, Hygromiidae or Sphincterochilidae;

(4)

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

(5)

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

(6)

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

(7)

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

(8)

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

(9)

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

(10)

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

(11)

‘sprouts’ means sprouts as defined in point (a) of the first paragraph of Article 2 of Implementing Regulation (EU) No 208/2013.

(a)

BOV drawn up in accordance with the model set out in Chapter 1 of Annex III, for fresh meat intended for human consumption, excluding mechanically separated meat, of domestic bovine animals;

(b)

OVI drawn up in accordance with the model set out in Chapter 2 of Annex III, for fresh meat intended for human consumption, excluding mechanically separated meat, of domestic ovine and caprine animals;

(c)

POR drawn up in accordance with the model set out in Chapter 3 of Annex III, for fresh meat intended for human consumption, excluding mechanically separated meat, of domestic porcine animals;

(d)

EQU drawn up in accordance with the model set out in Chapter 4 of Annex III, for fresh meat intended for human consumption, excluding minced meat and mechanically separated meat, of domestic solipeds (Equus caballus, Equus asinus and their cross-breeds);

(e)

RUF drawn up in accordance with the model set out in Chapter 5 of Annex III, for fresh meat intended for human consumption, excluding offal, minced meat and mechanically separated meat, of animals of the family Bovidae (other than domestic bovine, ovine and caprine animals), camelid animals and cervid animals kept as farmed game;

(f)

RUW drawn up in accordance with the model set out in Chapter 6 of Annex III, for fresh meat intended for human consumption, excluding offal, minced meat and mechanically separated meat, of wild animals of the family Bovidae (other than domestic bovine, ovine and caprine animals), wild camelid animals and wild cervid animals;

(g)

SUF drawn up in accordance with the model set out in Chapter 7 of Annex III, for fresh meat intended for human consumption, excluding offal, minced meat and mechanically separated meat, of animals kept as farmed game of wild breeds of porcine animals and animals of the family Tayassuidae;

(h)

SUW drawn up in accordance with the model set out in Chapter 8 of Annex III, for fresh meat intended for human consumption, excluding offal, minced meat and mechanically separated meat, of wild animals of wild breeds of porcine animals and animals of the family Tayassuidae;

(i)

EQW drawn up in accordance with the model set out in Chapter 9 of Annex III, for fresh meat intended for human consumption, excluding offal, minced meat and mechanically separated meat, of wild game solipeds belonging to the subgenus Hippotigris (zebra);

(j)

RUM-MSM drawn up in accordance with the model set out in Chapter 10 of Annex III, for mechanically separated meat, intended for human consumption, of domestic ruminants;

(k)

SUI-MSM drawn up in accordance with the model set out in Chapter 11 of Annex III, for mechanically separated meat, intended for human consumption, of domestic porcine animals;

(l)

NZ-TRANSIT-SG drawn up in accordance with the model set out in Chapter 12 of Annex III, for fresh meat intended for human consumption originating from New Zealand transiting through Singapore with unloading, possible storage and reloading before entry into the Union.

(a)

POU drawn up in accordance with the model set out in Chapter 13 of Annex III, for fresh meat intended for human consumption, excluding minced meat and mechanically separated meat, of poultry other than ratites;

(b)

POU-MI/MSM drawn up in accordance with the model set out in Chapter 14 of Annex III, for minced meat and mechanically separated meat, intended for human consumption, of poultry other than ratites;

(c)

RAT drawn up in accordance with the model set out in Chapter 15 of Annex III, for fresh meat intended for human consumption, excluding minced meat and mechanically separated meat, of ratites;

(d)

RAT-MI/MSM drawn up in accordance with the model set out in Chapter 16 of Annex III, for minced meat and mechanically separated meat, intended for human consumption, of ratites;

(e)

GBM drawn up in accordance with the model set out in Chapter 17 of Annex III, for fresh meat intended for human consumption, excluding minced meat and mechanically separated meat, of game birds;

(f)

GBM-MI/MSM drawn up in accordance with the model set out in Chapter 18 of Annex III, for minced meat and mechanically separated meat, intended for human consumption, of game birds;

(g)

E drawn up in accordance with the model set out in Chapter 19 of Annex III, for eggs intended for human consumption;

(h)

EP drawn up in accordance with the model set out in Chapter 20 of Annex III, for egg products intended for human consumption.

(a)

WL drawn up in accordance with the model set out in Chapter 21 of Annex III, for fresh meat intended for human consumption of wild leporidae (rabbits and hares), excluding minced meat, mechanically separated meat and offal except for unskinned and uneviscerated leporidae;

(b)

WM drawn up in accordance with the model set out in Chapter 22 of Annex III, for fresh meat intended for human consumption, excluding offal, minced meat and mechanically separated meat, of wild land mammals other than ungulates and leporidae;

(c)

RM drawn up in accordance with the model set out in Chapter 23 of Annex III, for fresh meat intended for human consumption, excluding minced meat and mechanically separated meat, of farmed rabbits.

(a)

MPNT drawn up in accordance with the model set out in Chapter 25 of Annex III, for meat products intended for human consumption, including rendered animal fats and greaves, meat extracts and treated stomachs, bladders and intestines, others than casings, that are not required to undergo a specific risk-mitigating treatment;

(b)

MPST drawn up in accordance with the model set out in Chapter 26 of Annex III, for meat products intended for human consumption, including rendered animal fats and greaves, meat extracts and treated stomachs, bladders and intestines, others than casings, that are required to undergo a specific risk-mitigating treatment.

(a)

MILK-RM drawn up in accordance with the model set out in Chapter 33 of Annex III, for raw milk intended for human consumption;

(b)

MILK-RMP/NT drawn up in accordance with the model set out in Chapter 34 of Annex III, for dairy products intended for human consumption derived from raw milk or that are not required to undergo a specific risk-mitigating treatment;

(c)

DAIRY-PRODUCTS-PT drawn up in accordance with the model set out in Chapter 35 of Annex III, for dairy products intended for human consumption that are required to undergo a pasteurization treatment;

(d)

DAIRY-PRODUCTS-ST drawn up in accordance with the model set out in Chapter 36 of Annex III, for dairy products intended for human consumption that are required to undergo a specific risk-mitigating treatment other than pasteurization;

(e)

COLOSTRUM drawn up in accordance with the model set out in Chapter 37 of Annex III, for colostrum intended for human consumption;

(f)

COLOSTRUM-BP drawn up in accordance with the model set out in Chapter 38 of Annex III, for colostrum-based products intended for human consumption.

(a)

the model set out in Chapter 1 of Annex IV, for live animals transported to the slaughterhouse;

(b)

the model set out in Chapter 2 of Annex IV, for poultry intended for the production of ‘foie gras’ and for delayed eviscerated poultry;

(c)

the model set out in Chapter 3 of Annex IV, for farmed game and domestic bovine, porcine and equine animals, slaughtered at the holding of provenance in accordance with point 3 of Section III of Annex III to Regulation (EC) No 853/2004 and Article 6(3) of Delegated Regulation (EU) 2019/624;

(d)

the model set out in Chapter 4 of Annex IV, for farmed game slaughtered at the holding of provenance in accordance with point 3(a) of Section III of Annex III to Regulation (EC) No 853/2004 and Article 6(4) of Delegated Regulation (EU) 2019/624.