Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (Text with EEA relevance.)

TITLE I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

This Regulation lays down uniform practical arrangements for the performance of official controls and actions in relation to the production of products of animal origin intended for human consumption. These official controls and actions shall be performed by the competent authorities taking into account the requirements of Article 18(2), (3) and (5) of Regulation (EU) 2017/625 and Delegated Regulation (EU) 2019/624.

The specific rules cover:

(a) specific requirements and uniform minimum frequency of official controls on any product of animal origin, as regards audits and identification marking;

(b) specific requirements and uniform minimum frequency of official controls on fresh meat, including specific requirements for audits and specific tasks as regards controls on fresh meat;

(c) measures to be taken in cases of non-compliance of fresh meat with Union requirements for the protection of human health and animal health and welfare;

(d) technical requirements and practical arrangements as regards the health mark referred to in Article 5 of Regulation (EC) No 853/2004;

(e) specific requirements and uniform minimum frequency of official controls on milk, colostrum, dairy products and colostrum-based products;

(f) conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs, including decisions to be taken after monitoring classified production and relaying areas;

(g) specific requirements and uniform minimum frequency of official controls on fishery products.

Article 2

Definitions

The following definitions shall apply for the purpose of this Regulation:

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

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

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

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

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

(6) ‘relaying area’ means relaying area as defined in point 2.6 of Annex I of Regulation (EC) No 853/2004;

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

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

(9) ‘establishment’ means an establishment as defined in Article 2(1)(c) of Regulation (EC) No 852/2004;

(10) ‘food business operator’ means a food business operator as defined in Article 3(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (¹);

(11) ‘microbiological criterion’ means microbiological criterion as defined in Article 2(b) of Regulation (EC) No 2073/2005;

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

(13) ‘traceability’ means traceability as defined in Article 3(15) of Regulation (EC) No 178/2002;

(14) ‘specified risk material’ means specified risk material as defined in Article 3(1)(g) of Regulation (EC) No 999/2001;

(15) ‘contamination’ means contamination as defined in Article 2(1)(f) of Regulation (EC) No 852/2004;

(16) ‘holding of provenance’ means a holding of provenance as defined in point 2 of Article 2 of Delegated Regulation (EU) 2019/624;

(17) ‘primary production’ means primary production as defined in Article 3(17) of Regulation (EC) No 178/2002;

(18) ‘domestic ungulates’ means domestic ungulates as defined in point 1.2 of Annex I of Regulation (EC) No 853/2004;

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

(20) ‘large wild game’ means large wild game as defined in point 1.8 of Annex I to Regulation (EC) No 853/2004;

(21) ‘flock’ means a flock as defined in Article 2(3)(b) of Regulation (EC) No 2160/2003;

(22) ‘lagomorphs’ means lagomorphs as defined in point 1.4 of Annex I of Regulation (EC) No 853/2004;

(23) ‘carcase’ means a carcase as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004;

(24) ‘offal’ means offal as defined in point 1.11 of Annex I to Regulation (EC) No 853/2004;

(25) ‘low-capacity slaughterhouse’ means a low-capacity slaughterhouse as defined in Article 2(17) of Delegated Regulation (EU) 2019/624;

(26) ‘low-capacity game-handling establishment’ means a game-handling establishment as defined in Article 2(18) of Delegated Regulation (EU) 2019/624;

(27) ‘livestock unit’ means a livestock unit as defined in Article 17(6) of Regulation (EC) No 1099/2009;

(28) ‘small wild game’ means small wild game as defined in point 1.7 of Annex I of Regulation (EC) No 853/2004;

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

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

(31) ‘viscera’ means viscera as defined in point 1.12 of Annex I of Regulation (EC) No 853/2004;

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

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

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

(35) ‘milk production holding’ means a milk production holding as defined in point 4.2 of Annex I of Regulation (EC) No 853/2004;

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

(37) ‘purification centre’ means a purification centre as defined in point 2.8 of Annex I to Regulation (EC) No 853/2004;

(38) ‘marine biotoxins’ means marine biotoxins as defined in point 2.2 of Annex I to Regulation (EC) No 853/2004;

(39) ‘stages of production, processing and distribution’ means stages of production, processing and distribution as defined in Article 3(16) of Regulation (EC) No 178/2002;

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

(41) ‘placing on the market’ means placing on the market as defined in Article 3(8) of Regulation (EC) No 178/2002;

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

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

(44) ‘reptiles’ means reptiles as defined in point 15 of Article 2 of Commission Delegated Regulation (EU) 2019/625 (²);

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

(46) ‘fresh fishery products’ means fresh fishery products as defined in point 3.5 of Annex I to Regulation (EC) No 853/2004;

(47) ‘prepared fishery products’ means prepared fishery products as defined in point 3.6 of Annex I to Regulation (EC) No 853/2004;

(48) ‘processed fishery products’ means processed fishery products as defined in point 7.4 of Annex I to Regulation (EC) No 853/2004.

TITLE II

SPECIFIC REQUIREMENTS FOR THE PERFORMANCE OF OFFICIAL CONTROLS AND THE UNIFORM MINIMUM FREQUENCY FOR OFFICIAL CONTROLS ON PRODUCTS OF ANIMAL ORIGIN

CHAPTER I

Specific requirements for audits by the competent authorities in establishments handling products of animal origin

Article 3

Requirements subject to auditing

When auditing good hygiene practices in establishments, the competent authorities shall verify that food business operators handling products of animal origin apply procedures continuously and properly concerning at least the following:

(a) the design and maintenance of premises and equipment;

(b) pre-operational, operational and post-operational hygiene;

(c) personal hygiene;

(d) training in hygiene and in work procedures;

(e) pest control;

(f) water quality;

(g) temperature control;

(h) controls on animals or food entering and leaving the establishment, and any accompanying documentation.

They shall, in particular, determine whether the procedures guarantee, to the extent possible, that products of animal origin:

(a) comply with Article 3 of Regulation (EC) No 2073/2005 as regards microbiological criteria;

(b) comply with Union legislation on: — the monitoring of chemical residues, in accordance with Council Directive 96/23/EC and Commission Decision 97/747/EC (³); — maximum residue limits for pharmacologically active substances, in accordance with Commission Regulation (EU) No 37/2010 (⁴) and Commission Implementing Regulation (EU) 2018/470 (⁵); — prohibited and unauthorised substances, in accordance with Commission Regulation (EU) No 37/2010, Council Directive 96/22/EC (⁶), Commission Decision 2005/34/EC (⁷); — contaminants, in accordance with Regulations (EC) No 1881/2006 and (EC) No 124/2009 setting maximum levels for certain contaminants in food; — pesticide residues, in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council (⁸);

(c) do not contain physical hazards, such as foreign bodies.

When carrying out auditing tasks, the competent authorities shall take special care:

(a) to determine whether staff and staff activities in the establishment at all stages of the production process comply with the requirements, as regards hygienic practices and HACCP laid down in Article 3 of Regulation (EC) No 2073/2005, Articles 4 and 5 of Regulation (EC) No 852/2004 and Article 3(1) of Regulation (EC) No 853/2004. To complement the audit, the competent authorities may carry out performance tests, in order to ascertain that staff are sufficiently skilled;

(b) to verify the food business operator's relevant records;

(c) to take samples for laboratory analysis where necessary;

(d) to document elements taken into account and the findings of the audit.

Article 4

Nature and frequency of auditing

The nature and frequency of auditing tasks in respect of individual establishments shall depend on the assessed risk. To this end, the competent authorities shall regularly assess:

(a) human and, where appropriate, animal health risks;

(b) in the case of slaughterhouses, animal welfare aspects;

(c) the type and throughput of the processes carried out;

(d) the food business operator's past record as regards compliance with food law.

CHAPTER II

Specific requirements for identification marking

Article 5

Compliance with the requirements of Regulation (EC) No 853/2004 concerning the application of identification marks shall be verified in all establishments approved in accordance with that Regulation, in addition to verification of compliance with other traceability requirements in accordance with Article 18 of Regulation (EC) No 178/2002.

CHAPTER III

Scientific and technological developments

Article 6

The Member States shall inform the Commission and other Member States on scientific and technological developments, as referred to in Article 16(2)(b) of Regulation (EU) 2017/625 for consideration and further action as appropriate.

TITLE III

SPECIFIC REQUIREMENTS FOR THE PERFORMANCE OF OFFICIAL CONTROLS AND THE UNIFORM MINIMUM FREQUENCY FOR OFFICIAL CONTROLS ON FRESH MEAT

CHAPTER I

Audits

Article 7

Additional requirements for audits in establishments handling fresh meat

When carrying out audits of HACCP-based procedures, the competent authorities shall check that due regard is given to the procedures set out in Section II of Annex II to Regulation (EC) No 853/2004 and that the food business operators' procedures guarantee, to the extent possible, that fresh meat:

(a) does not contain pathological abnormalities or changes;

(b) does not bear (i) faecal contamination; or, (ii) any other contamination considered to pose an unacceptable human health risk;

(c) complies with the microbiological criteria in Article 3 of Regulation (EC) No 2073/2005;

(d) does not contain specified risk material, in accordance with the requirements in Regulation (EC) No 999/2001.

CHAPTER II

Official controls on fresh meat

Article 8

Relevance of audit results

When carrying out official controls in accordance with this Chapter, the official veterinarian shall take into account the results of the audits carried out in accordance with Chapter I. Where appropriate, the official veterinarian shall target official controls to deficiencies detected during previous audits.

Section 1

Checks of documents

Article 9

Obligations of the competent authorities as regards checks of documents other than the checks of the food chain information referred to in Article 10(1)

The competent authorities shall perform the necessary checks of documents to verify that:

(a) the food chain information is consistently and effectively communicated between the food business operator who raised or kept the animals before dispatch and the operator of the slaughterhouse or game-handling establishment;

(b) the food chain information is valid and reliable;

(c) feedback of relevant information to the holding of provenance, if applicable, is provided in accordance with Article 39(5).

Article 10

Obligations of the official veterinarian as regards checks of documents

Section 2

Ante-mortem inspection

Article 11

Requirements as regards ante-mortem inspection at the slaughterhouse

Ante-mortem inspections shall determine whether, as regards the particular animal inspected, there is any sign:

(a) that the health and welfare of the animal has been compromised;

(b) of any condition, abnormalities or disease that make the fresh meat unfit for human consumption or that might adversely affect animal health, paying particular attention to the detection of zoonotic diseases and animal diseases for which animal health rules are laid down in Regulation (EU) 2016/429;

(c) of the use of prohibited or unauthorised substances, misuse of veterinary medicinal products or the presence of chemical residues or contaminants.

Section 3

Post-mortem inspection

Article 12

Requirements for post-mortem inspection

Subject to the derogation stipulated in Point 4 of Chapter II of Section IV to Annex III of Regulation (EC) No 853/2004, carcases and accompanying offals, shall be subjected to post-mortem inspection:

(a) without delay after slaughter, or

(b) as soon as possible after arrival at the game-handling establishment.

The competent authorities shall:

(a) check all external surfaces, including those of body cavities of carcases, as well as offal;

(b) pay particular attention to the detection of zoonotic diseases and animal diseases for which animal health rules are laid down in Regulation (EU) 2016/429.

Article 13

Derogation on the timing of post-mortem inspection

By way of derogation from Article 12(1), the competent authorities may allow that, when neither the official veterinarian nor the official auxiliary are present in the game-handling establishment or slaughterhouse during slaughter and dressing, the post-mortem inspection is delayed by a maximum period of 24 hours from slaughter or arrival in the game-handling establishment, provided that:

(a) the animals concerned are slaughtered in a low-capacity slaughterhouse or handled in a low-capacity game-handling establishment that slaughters or handles: (i) fewer than 1 000 livestock units per year; or (ii) fewer than 150 000 poultry, lagomorphs and small wild game per year;

(b) sufficient facilities exist within an establishment to store the fresh meat and offal so that they can be examined;

(c) the post-mortem inspection is carried out by the official veterinarian.

The competent authorities may increase the thresholds laid down in point (a) (i) and (ii) of paragraph 1 ensuring that the derogation is applied in the smallest slaughterhouses and game-handling establishments complying with the definition of low-capacity slaughterhouse or low-capacity game-handling establishment and provided that the combined annual production of these establishments does not exceed 5 % of the total amount of fresh meat produced in a Member State:

(a) for the species concerned;

(b) or for all ungulates together;

(c) of all poultry together; or,

(d) of all birds and lagomorphs together.

In such case, the competent authorities shall notify this derogation and the evidence to support it in accordance with the procedure laid down in Directive (EU) 2015/1535 of the European Parliament and of the Council (¹⁰);

Article 14

Additional examination requirements for post-mortem inspection

Additional examinations, such as palpation and incision of parts of the carcase and offal, and laboratory tests, shall be carried out if needed to:

(a) reach a definitive diagnosis of a suspected hazard; or

(b) detect the presence of: (i) an animal disease for which animal health rules are laid down in Regulation (EU) 2016/429; (ii) chemical residues or contaminants as referred to in Directive 96/23/EC and Decision 97/747/EC, especially: — chemical residues in excess of the levels laid down in Regulations (EU) No 37/2010 and (EC) No 396/2005; — contaminants exceeding the maximum levels laid down in Regulations (EC) No 1881/2006 and (EC) No 124/2009; or — residues of substances that are prohibited or unauthorised in accordance with Regulation (EU) No 37/2010 or Directive 96/22/EC; (iii) non-compliance with the microbiological criteria referred to in Article 3(1)(b) of Regulation (EC) No 2073/2005 or the possible presence of other microbiological hazards that would make the fresh meat unfit for human consumption; (iv) other factors that might require the fresh meat to be declared unfit for human consumption or restrictions to be placed on its use.

Article 15

Requirements for post-mortem inspection of domestic solipeds, bovine animals over eight months old and domestic swine more than five weeks old, and large wild game

Article 16

Additional requirements for post-mortem inspection in cases of emergency slaughter

In the event of emergency slaughter, the carcase shall be subjected to post-mortem inspection as soon as possible in accordance with Articles 12, 13, 14 and 15 before it is released for human consumption.

Article 17

Practical arrangements for post-mortem inspection of domestic bovine animals, domestic sheep and goats, domestic solipeds and domestic swine