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Document 02019R0627-20230109
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)Text with EEA relevance
Consolidated text: 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)Text with EEA relevance
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)Text with EEA relevance
02019R0627 — EN — 09.01.2023 — 003.001
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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 (OJ L 131 17.5.2019, p. 51) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2020/2108 of 16 December 2020 |
L 427 |
1 |
17.12.2020 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2021/1709 of 23 September 2021 |
L 339 |
84 |
24.9.2021 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2022/2503 of 19 December 2022 |
L 325 |
58 |
20.12.2022 |
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Corrected by:
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:
specific requirements and uniform minimum frequency of official controls on any product of animal origin, as regards audits and identification marking;
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;
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;
technical requirements and practical arrangements as regards the health mark referred to in Article 5 of Regulation (EC) No 853/2004;
specific requirements and uniform minimum frequency of official controls on milk, colostrum, dairy products and colostrum-based products;
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;
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:
‘fresh meat’ means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) No 853/2004;
‘colostrum’ means colostrum as defined in point 1 of Section IX of Annex III of Regulation (EC) No 853/2004;
‘dairy products’ means dairy products as defined in point 7.2. of Annex I to Regulation (EC) No 853/2004;
‘colostrum-based products’ means colostrum-based products as defined in point 2 of Section IX of Annex III of Regulation (EC) No 853/2004;
‘production area’ means a production area as defined in point 2.5 of Annex I of Regulation (EC) No 853/2004;
‘relaying area’ means relaying area as defined in point 2.6 of Annex I of Regulation (EC) No 853/2004;
‘bivalve molluscs’ means bivalve molluscs as defined in point 2.1 of Annex I of Regulation (EC) No 853/2004;
‘fishery products’ means fishery products as defined in point 3.1 of Annex I to Regulation (EC) No 853/2004;
‘establishment’ means an establishment as defined in Article 2(1)(c) of Regulation (EC) No 852/2004;
‘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 );
‘microbiological criterion’ means microbiological criterion as defined in Article 2(b) of Regulation (EC) No 2073/2005;
‘slaughterhouse’ means slaughterhouse as defined in point 1.16 of Annex I of Regulation (EC) No 853/2004;
‘traceability’ means traceability as defined in Article 3(15) of Regulation (EC) No 178/2002;
‘specified risk material’ means specified risk material as defined in Article 3(1)(g) of Regulation (EC) No 999/2001;
‘contamination’ means contamination as defined in Article 2(1)(f) of Regulation (EC) No 852/2004;
‘holding of provenance’ means a holding of provenance as defined in point 2 of Article 2 of Delegated Regulation (EU) 2019/624;
‘primary production’ means primary production as defined in Article 3(17) of Regulation (EC) No 178/2002;
‘domestic ungulates’ means domestic ungulates as defined in point 1.2 of Annex I of Regulation (EC) No 853/2004;
‘game-handling establishment’ means a game-handling establishment as defined in point 1.18 of Annex I of Regulation (EC) No 853/2004;
‘large wild game’ means large wild game as defined in point 1.8 of Annex I to Regulation (EC) No 853/2004;
‘flock’ means a flock as defined in Article 2(3)(b) of Regulation (EC) No 2160/2003;
‘lagomorphs’ means lagomorphs as defined in point 1.4 of Annex I of Regulation (EC) No 853/2004;
‘carcase’ means a carcase as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004;
‘offal’ means offal as defined in point 1.11 of Annex I to Regulation (EC) No 853/2004;
‘low-capacity slaughterhouse’ means a low-capacity slaughterhouse as defined in Article 2(17) of Delegated Regulation (EU) 2019/624;
‘low-capacity game-handling establishment’ means a game-handling establishment as defined in Article 2(18) of Delegated Regulation (EU) 2019/624;
‘livestock unit’ means a livestock unit as defined in Article 17(6) of Regulation (EC) No 1099/2009;
‘small wild game’ means small wild game as defined in point 1.7 of Annex I of Regulation (EC) No 853/2004;
‘poultry’ means poultry as defined in point 1.3 of Annex I of Regulation (EC) No 853/2004;
‘cutting plant’ means a cutting plant as defined in point 1.17 of Annex I of Regulation (EC) No 853/2004;
‘viscera’ means viscera as defined in point 1.12 of Annex I of Regulation (EC) No 853/2004;
‘meat’ means meat as defined in point 1.1 of Annex I of Regulation (EC) No 853/2004;
‘farmed game’ means farmed game as defined in point 1.6 of Annex I of Regulation (EC) No 853/2004;
‘wild game’ means wild game as defined in point 1.5 of Annex I to Regulation (EC) No 853/2004;
‘milk production holding’ means a milk production holding as defined in point 4.2 of Annex I of Regulation (EC) No 853/2004;
‘raw milk’ means raw milk as defined in point 4.1 of Annex I to Regulation (EC) No 853/2004;
‘purification centre’ means a purification centre as defined in point 2.8 of Annex I to Regulation (EC) No 853/2004;
‘marine biotoxins’ means marine biotoxins as defined in point 2.2 of Annex I to Regulation (EC) No 853/2004;
‘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;
‘dispatch centre’ means a dispatch centre as defined in point 2.7 of Annex I of Regulation (EC) No 853/2004;
‘placing on the market’ means placing on the market as defined in Article 3(8) of Regulation (EC) No 178/2002;
‘factory vessel’ means factory vessel as defined in point 3.2 of Annex I to Regulation (EC) No 853/2004;
‘freezer vessel’ means freezer vessel as defined in point 3.3 of Annex I to Regulation (EC) No 853/2004;
‘reptiles’ means reptiles as defined in point 15 of Article 2 of Commission Delegated Regulation (EU) 2019/625 ( 2 );
‘reptile meat’ means reptile meat as defined in point 16 of Article 2 of Delegated Regulation (EU) 2019/625;
‘fresh fishery products’ means fresh fishery products as defined in point 3.5 of Annex I to Regulation (EC) No 853/2004;
‘prepared fishery products’ means prepared fishery products as defined in point 3.6 of Annex I to Regulation (EC) No 853/2004;
‘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:
the design and maintenance of premises and equipment;
pre-operational, operational and post-operational hygiene;
personal hygiene;
training in hygiene and in work procedures;
pest control;
water quality;
temperature control;
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:
comply with Article 3 of Regulation (EC) No 2073/2005 as regards microbiological criteria;
comply with Union legislation on:
do not contain physical hazards, such as foreign bodies.
When carrying out auditing tasks, the competent authorities shall take special care:
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;
to verify the food business operator's relevant records;
to take samples for laboratory analysis where necessary;
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:
human and, where appropriate, animal health risks;
in the case of slaughterhouses, animal welfare aspects;
the type and throughput of the processes carried out;
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:
does not contain pathological abnormalities or changes;
does not bear
faecal contamination; or,
any other contamination considered to pose an unacceptable human health risk;
complies with the microbiological criteria in Article 3 of Regulation (EC) No 2073/2005;
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.
Article 9
Obligations of the competent authorities as regards checks of documents
The competent authorities shall perform the necessary checks of documents to verify that:
the food chain information is consistently and effectively communicated between the food business operator who raised or kept the animals before dispatch and the slaughterhouse operator;
the food chain information is valid and reliable;
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
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:
that the health and welfare of the animal has been compromised;
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;
of the use of prohibited or unauthorised substances, misuse of veterinary medicinal products or the presence of chemical residues or contaminants.
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:
without delay after slaughter, or
as soon as possible after arrival at the game-handling establishment.
The competent authorities shall:
check all external surfaces, including those of body cavities of carcases, as well as offal;
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:
the animals concerned are slaughtered in a low-capacity slaughterhouse or handled in a low-capacity game-handling establishment that slaughters or handles:
fewer than 1 000 livestock units per year; or
fewer than 150 000 poultry, lagomorphs and small wild game per year;
sufficient facilities exist within an establishment to store the fresh meat and offal so that they can be examined;
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:
for the species concerned;
or for all ungulates together;
of all poultry together; or,
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:
reach a definitive diagnosis of a suspected hazard; or
detect the presence of:
an animal disease for which animal health rules are laid down in Regulation (EU) 2016/429;
chemical residues or contaminants as referred to in Directive 96/23/EC and Decision 97/747/EC, especially:
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;
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
Where the post-mortem inspection is performed by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian in accordance with Article 18(2)(c) of Regulation (EU) 2017/625 and Article 7 of Delegated Regulation (EU) 2019/624, the competent authorities shall ensure that the practical arrangements laid down in the following Articles 18 to 24 are complied with in the cases of domestic bovine animals, domestic sheep and goats, domestic solipeds and domestic swine in addition to the requirements laid down in Articles 12, 14 and 15.
Article 18
Young bovine animals
Carcases and offal of the following bovine animals shall undergo the post-mortem inspection procedures laid down in paragraph 2:
animals under eight months old; and,
animals under 20 months old if reared without access to pasture land during their whole life in an officially tuberculosis-free Member State or region of a Member State in accordance with Article 1 of Decision 2003/467/EC.
The post-mortem inspection procedures shall include at least a visual inspection of the following:
the head and throat; together with palpation and examination of the retropharyngeal lymph nodes (Lnn. retropharyngiales), however, in order to ensure the surveillance of the officially tuberculosis free status, Member States may decide to carry out further investigations; inspection of the mouth and fauces;
the lungs, trachea and oesophagus; palpation of the lungs; palpation and examination of the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales);
the pericardium and heart;
the diaphragm;
the liver and the hepatic and pancreatic lymph nodes, (Lnn. portales);
the gastro-intestinal tract, the mesentery and gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales);
the spleen;
the kidneys;
the pleura and peritoneum;
the umbilical region and the joints of young animals.
►M2 Post-mortem inspection procedures shall be carried out in accordance with Article 18(2)(c) of Regulation (EU) 2017/625 and Article 7 and 8 of Regulation (EU) 2019/624, using incision and palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or animal welfare indicated in accordance with Article 24: ◄
incision of the retropharyngeal lymph nodes (Lnn. retropharyngiales); palpation of the tongue;
incision of the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales); lengthwise opening of the trachea and the main branches of the bronchi; the lungs shall be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;
lengthways incision of the heart so as to open the ventricles and cut through the interventricular septum;
incision of the gastric and mesenteric lymph nodes;
palpation of the spleen;
incision of the kidneys and the renal lymph nodes (Lnn. renales);
palpation of the umbilical region and the joints. The umbilical region shall be incised and the joints opened; the synovial fluid must be examined.
Article 19
Other bovine animals
Carcases and offal of bovine animals other than those referred to in Article 18(1) shall undergo the following post-mortem inspection procedures:
a visual inspection of the head and throat; incision and examination of the retropharyngeal lymph nodes (Lnn. retropharyngiales); examination of the external masseters, in which two incisions shall be made parallel to the mandible, and the internal masseters (internal pterygoid muscles), which shall be incised along one plane. The tongue shall be freed to permit a detailed visual inspection of the mouth and the fauces;
an inspection of the trachea and oesophagus; visual inspection and palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales);
a visual inspection of the pericardium and heart, the latter being incised lengthways so as to open the ventricles and cut through the interventricular septum;
a visual inspection of the diaphragm;
a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales);
a visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales); palpation of the gastric and mesenteric lymph nodes;
a visual inspection of the spleen;
a visual inspection of the kidneys;
a visual inspection of the pleura and the peritoneum;
a visual inspection of the genital organs (except for the penis, if already discarded);
a visual inspection of the udder and its lymph nodes (Lnn. supramammarii).
►M2 Post-mortem inspection procedures shall be carried out in accordance with Article 18(2)(c) of Regulation (EU) 2017/625 and Article 7 and 8 of Regulation (EU) 2019/624, using incision and palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or animal welfare indicated in accordance with Article 24: ◄
an incision and examination of the sub-maxillary and parotid lymph nodes (Lnn. mandibulares and parotidei); palpation of the tongue and the fauces;
►M2 an incision of the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales); ◄ lengthwise opening of the trachea and the main branches of the bronchi; the lungs shall be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;
a palpation of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales); incision of the gastric surface of the liver and at the base of the caudate lobe to examine the bile ducts;
an incision of the gastric and mesenteric lymph nodes;
a palpation of the spleen;
an incision of the kidneys and the renal lymph nodes (Lnn. renales);
a palpation and incision of the udder and its lymph nodes (Lnn. supramammarii) in cows. Each half of the udder shall be opened by a long, deep incision as far as the lactiferous sinuses (sinus lactiferes) and the lymph nodes of the udder shall be incised, except where the udder is excluded from human consumption.
Article 20
Young domestic sheep and goats and sheep with no eruption of permanent incisors
Carcases and offal of sheep not having any permanent incisor erupted or less than 12 months of age, and goats less than six months of age, shall undergo the following post-mortem inspection procedures:
a visual inspection of the head, including the throat, mouth, tongue and parotid and retropharyngeal lymph nodes. These examinations are not necessary if the competent authorities are able to guarantee that the head, including the tongue and the brains, will be excluded from human consumption;
a visual inspection of the lungs, trachea and oesophagus and the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales);
a visual inspection of the pericardium and heart;
a visual inspection of the diaphragm;
a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales);
a visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales);
a visual inspection of the spleen;
a visual inspection of the kidneys;
a visual inspection of the pleura and peritoneum;
a visual inspection of the umbilical region and joints.
►M2 Post-mortem inspection procedures shall be carried out in accordance with Article 18(2)(c) of Regulation (EU) 2017/625 and Article 7 and 8 of Regulation (EU) 2019/624, using incision and palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or animal welfare indicated in accordance with Article 24: ◄
a palpation of the throat, mouth, tongue and parotid lymph nodes. Unless animal-health rules provide otherwise, these examinations are not necessary if the competent authorities are able to guarantee that the head, including the tongue and the brains, will be excluded from human consumption;
a palpation of the lungs; incision of the lungs, trachea, oesophagus, bronchial and mediastinal lymph nodes;
an incision of the heart;
a palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts;
a palpation of the spleen;
an incision of the kidneys and the renal lymph nodes (Lnn. renales);
a palpation of the umbilical region and joints; the umbilical region shall be incised and the joints opened; the synovial fluid shall be examined.
Article 21
Other domestic sheep and goats
Carcases and offal of sheep having a permanent incisor erupted or 12 months of age or more, and goats six months of age or more, shall undergo the following post-mortem inspection procedures:
a visual inspection of the head, including the throat, mouth, tongue and parotid lymph nodes and palpation of the retropharyngeal lymph nodes. These examinations are not necessary if the competent authorities are able to guarantee that the head, including the tongue and the brains, will be excluded from human consumption;
a visual inspection of the lungs, trachea and oesophagus; palpation of the lungs, the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales);
a visual inspection of the pericardium and heart;
a visual inspection of the diaphragm;
a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales); palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts;
a visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales);
a visual inspection of the spleen;
a visual inspection of the kidneys;
a visual inspection of the pleura and peritoneum;
a visual inspection of the genital organs (except for the penis, if already discarded);
a visual inspection of the udder and its lymph nodes.
►M2 Post-mortem inspection procedures shall be carried out in accordance with Article 18(2)(c) of Regulation (EU) 2017/625 and Article 7 and 8 of Regulation (EU) 2019/624, using incision and palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or animal welfare indicated in accordance with Article 24: ◄
a palpation of the throat, mouth, tongue and parotid lymph nodes. Unless animal-health rules provide otherwise, these examinations are not necessary if the competent authorities are able to guarantee that the head, including the tongue and the brains, will be excluded from human consumption;
an incision of the lungs, trachea, oesophagus and the bronchial and mediastinal lymph nodes;
an incision of the heart;
a palpation of the spleen;
an incision of the kidneys and the renal lymph nodes (Lnn. renales).
Article 22
Domestic solipeds
Carcases and offal of domestic solipeds shall undergo the following post-mortem inspection procedures:
a visual inspection of the head and, after freeing the tongue, the throat; the tongue shall be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually examined;
a visual inspection of the lungs, trachea, oesophagus and the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales);
a visual inspection of the pericardium and the heart;
a visual inspection of the diaphragm;
a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn portales);
a visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales);
a visual inspection of the spleen;
a visual inspection of the kidneys;
a visual inspection of the pleura and peritoneum;
a visual inspection of the genital organs of stallions (except for the penis, if already discarded) and mares;
a visual inspection of the udder and its lymph nodes (Lnn. supramammarii);
a visual inspection of the umbilical region and joints of young animals;
examination of the muscles and lymph nodes (Lnn. subrhomboidei) of the shoulders beneath the scapular cartilage after loosening the attachment of one shoulder, in the case grey horses, in order to inspect for melanosis and melanomata. The kidneys shall be exposed.
►M2 Post-mortem inspection procedures shall be carried out in accordance with Article 18(2)(c) of Regulation (EU) 2017/625 and Article 7 and 8 of Regulation (EU) 2019/624, using incision and palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or animal welfare indicated in accordance with Article 24: ◄
a palpation and incision of the sub-maxillary, retropharyngeal and parotid lymph nodes (Lnn. retropharyngiales, mandibulares and parotidei); palpation of the tongue;
a palpation of the lungs; palpation and incision of the bronchial and mediastinal lymph nodes. The trachea and the main branches of the bronchi shall be opened lengthwise and the lungs shall be incised in their posterior third, perpendicular to their main axes; however, these incisions are not necessary where the lungs are excluded from human consumption;
an incision of the heart lengthwise, so as to open the ventricles and cut through the interventricular septum;
a palpation and incision of the liver and the hepatic and pancreatic lymph nodes, (Lnn. portales);
an incision of the gastric and mesenteric lymph nodes;
a palpation of the spleen;
a palpation of the kidneys and incision of the kidneys and the renal lymph nodes (Lnn. renales);
an incision of the supramammary lymph nodes;
a palpation of the umbilical region and joints of young animals. In cases of doubt, the umbilical region shall be incised and the joints opened; the synovial fluid must be examined;
an incision through the entire kidney in grey horses.
Article 23
Domestic swine
Carcases and offal of domestic swine shall undergo the following post-mortem inspection procedures:
a visual inspection of the head and throat;
a visual inspection of the mouth, fauces and tongue;
a visual inspection of the lungs, trachea and oesophagus;
a visual inspection of the pericardium and heart;
a visual inspection of the diaphragm;
a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales); visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales and caudales);
a visual inspection of the spleen; visual inspection of the kidneys; visual inspection of the pleura and peritoneum;
a visual inspection of the genital organs (except for the penis, if already discarded);
a visual inspection of the udder and its lymph nodes (Lnn. supramammarii);
a visual inspection of the umbilical region and joints of young animals.
►M2 Post-mortem inspection procedures shall be carried out in accordance with Article 18(2)(c) of Regulation (EU) 2017/625 and Article 7 and 8 of Regulation (EU) 2019/624, using incision and palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or animal welfare indicated in accordance with Article 24: ◄
an incision and examination of the submaxillary lymph nodes (Lnn. mandibulares);
a palpation of the lungs and the bronchial and mediastinal lymph nodes (Lnn. bifurcationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi shall be opened lengthwise and the lungs shall be incised in their posterior third, perpendicular to their main axes; those incisions are not necessary where the lungs are excluded from human consumption;
an incision of the heart lengthwise so as to open the ventricles and cut through the interventricular septum;
a palpation of the liver and its lymph nodes;
a palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;
a palpation of the spleen;
an incision of the kidneys and the renal lymph nodes (Lnn. renales);
an incision of the supramammary lymph nodes;
a palpation of the umbilical region and joints of young animals and, if necessary, incision of the umbilical region and opening of the joints.
Article 24
Indications of a possible risks to human health, animal health or animal welfare in domestic bovine animals, domestic sheep and goats, domestic solipeds and domestic swine
The additional post-mortem inspection procedures referred to in Articles 18(3), 19(2), 20(2), 21(2), 22(2) and 23(2) shall be carried out using incision and palpation of the carcase and offal, where, in the opinion of the official veterinarian, a possible risk to human health, animal health or animal welfare is indicated by one of the following:
the checks and analysis of the checks of documents carried out in accordance with Articles 9 and 10;
the findings of the ante-mortem inspection carried out in accordance with Article 11;
the results of the verifications of compliance with animal welfare rules carried out in accordance with Article 38;
the findings of post-mortem inspection carried out in accordance with Articles 12 to 24;
additional epidemiological data or other data from the holding of provenance of the animals.
Article 25
Practical arrangements for post-mortem inspection of poultry
All poultry shall undergo post-mortem inspection which may include the assistance of slaughterhouse staff in accordance with Article 18(3) of Regulation (EU) 2017/625. The official veterinarian or official auxiliary, in accordance with Article 18(2)(c) of that Regulation shall personally carry out the following checks:
daily inspection of the viscera and body cavities of a representative sample of each flock;
a detailed inspection of a random sample of parts of birds or entire birds declared unfit for human consumption following post-mortem inspection from each flock;
any further investigations necessary where there is reason to suspect that the meat from the birds concerned could be unfit for human consumption.
By way of derogation from paragraph 1, the competent authorities may decide that only a representative sample of poultry from each flock undergoes post-mortem inspection if:
food business operators have a system in place to the satisfaction of the official veterinarian, that allows the detection and the separation of birds with abnormalities, contamination or defects;
the slaughterhouse has a longstanding history of compliance with the requirements as regards:
general and specific requirements in accordance with Article 4 of Regulation (EC) No 852/2004, including the microbiological criteria applicable to Point 1.28 and 2.1.5 of Annex I to Regulation (EC) No 2073/2005;
procedures based on the HACCP principles in accordance with Article 5 of Regulation (EC) No 852/2004; and
specific hygiene rules in accordance with Article 5 and Section II of Annex III to Regulation (EC) No 853/2004;
no abnormalities that may indicate a serious problem for human or animal health that may indicate the need for measures laid down in Articles 40 to 44, have been found during ante-mortem inspection or verification of food chain information.
Article 26
Practical arrangements for post-mortem inspection of farmed lagomorphs
The practical arrangements for post-mortem inspection in poultry in accordance with Article 25, shall apply to farmed lagomorphs. The provisions applicable to a single poultry flock in Article 25 shall apply to farmed lagomorphs slaughtered the same day from a single holding of provenance.
Article 27
Practical arrangements for post-mortem inspection of farmed game
The following post-mortem inspection procedures shall apply to farmed game:
in the case of small (< 100 kg) Cervidae, the post-mortem procedures for ovine animals laid down in Article 21, however in the case of reindeer the post-mortem procedures for ovine animals laid down in Article 20 shall be used and the tongue may be used for human consumption without inspection of the head;
in the case of game of the family Suidae, the post-mortem procedures for domestic swine laid down in Article 23;
in the case of other game ungulates, not covered by points (a) and (b) the post-mortem procedures for bovine animals laid down in Article 19;
in the case of ratites, the post-mortem procedures for poultry laid down in Article 25(1).
Article 28
Practical arrangements for post-mortem inspection of wild game
During post-mortem inspection, the official veterinarian shall carry out:
a visual inspection of the carcase, its cavities and, where appropriate, organs with a view to:
detecting any abnormalities not resulting from the hunting process. For this purpose, the diagnosis may be based on any information that the trained person has provided concerning the behaviour of the animal before killing;
checking that death was not due to reasons other than hunting;
an investigation of organoleptic abnormalities;
palpation and incisions of organs, where appropriate;
where there are serious grounds for suspecting the presence of residues or contaminants, an analysis by sampling of residues not resulting from the hunting process, including environmental contaminants. Where a more extensive inspection is made on the basis of such suspicions, the veterinarian shall wait until that inspection has been concluded before assessing all the wild game killed during a specific hunt, or those parts suspected of showing the same abnormalities;
examination for characteristics indicating that the meat presents a health risk, including:
abnormal behaviour or disturbance of the general condition of the live animal, as reported by the hunter;
the generalised presence of tumours or abscesses affecting different internal organs or muscles;
arthritis, orchitis, pathological changes in the liver or the spleen, inflammation of the intestines or the umbilical region;
the presence of foreign bodies not resulting from the hunting process in the body cavities, stomach, intestines or urine, where the pleura or peritoneum are discoloured (when relevant viscera are present);
the presence of parasites;
formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal organs (when these viscera are present);
significant abnormalities of colour, consistency or odour of muscle tissue or organs;
aged open fractures;
emaciation and/or general or localised oedema;
recent pleural or peritoneal adhesions;
other obvious extensive changes, such as putrefaction.
Article 29
Practical arrangements for official controls for transmissible spongiform encephalopathies (TSEs)
Article 30
Practical arrangements for official controls for cysticercosis during post-mortem inspection in domestic bovine animals and Suidae
The post-mortem inspection procedures described in Articles 18, 19 and 23 shall be the minimum requirements for the examination for cysticercosis in bovine animals and Suidae (domestic swine, farmed game and wild game). In the case of bovine animals referred to in Article 19, the competent authorities may decide that incision of the masseters at post-mortem inspection is not compulsory if:
a specific serological test is used;
the animals have been raised on a holding of provenance officially certified to be free of cysticercosis; or,
the prevalence of the source population or in a well-defined subpopulation is below one in a million, has been demonstrated with 95 % certainty or no cases have been detected in all slaughtered animals in the past five years (or two years where supported and justified by the competent authorities' risk analysis) based on data from reporting carried out in accordance with Article 9(1) of Directive 2003/99/EC.
Article 31
Practical arrangements for official controls for Trichinella during post-mortem inspection
Article 32
Practical arrangements for official controls for glanders during post-mortem inspection of solipeds
Article 33
Practical arrangements for official controls for tuberculosis during post-mortem inspection
Article 34
Practical arrangements for official controls for brucellosis during post-mortem inspection
Article 35
Practical arrangements for official controls for Salmonella
The competent authorities shall verify the correct implementation by food business operators of points 2.1.3, 2.1.4 and 2.1.5 of Chapter 2 of Annex I of Regulation (EC) No 2073/2005 by applying one or more of the following measures:
official sampling using the same method and sampling area as food business operators. At least 49 random samples ( 11 ) shall be taken in each slaughterhouse each year. This number of samples may be reduced in small slaughterhouses based on a risk evaluation;
collecting all information on the total number and the number of Salmonella-positive samples taken by food business operators in accordance with Article 5 of Regulation (EC) No 2073/2005, in the framework of points 2.1.3, 2.1.4 and 2.1.5 of Chapter 2 of Annex I thereto;
collecting all information on the total number and the number of Salmonella-positive samples taken in the framework of national control programmes in Member States or regions of Member States for which special guarantees have been approved in accordance with Article 8 of Regulation (EC) No 853/2004 as regards ruminant, equine, swine and poultry production.
Article 36
Practical arrangements for official controls for Campylobacter
The competent authorities shall verify the correct implementation by food business operators of point 2.1.9 (process hygiene criterion for Campylobacter on carcases of broilers) of Chapter 2 of Annex I of Regulation (EC) No 2073/2005 by applying the following measures:
official sampling using the same method and sampling area as food business operators. At least 49 random samples shall be taken in each slaughterhouse each year. This number of samples may be reduced in small slaughterhouses based on a risk evaluation; or
collecting all information on the total number and the number of Campylobacter samples with more than 1 000 cfu/g taken by food business operators in accordance with Article 5 of Regulation (EC) No 2073/2005, in the framework of point 2.1.9 of Chapter 2 of Annex I thereto.
Article 37
Specific requirements as regards laboratory tests
When performing laboratory tests in accordance with Article 18(2)(d)(ii) and (iv) of Regulation (EU) 2017/625, the official veterinarian shall ensure that, when sampling takes place, samples are appropriately identified and handled and sent to the appropriate laboratory in the framework of:
the monitoring and control of zoonoses and zoonotic agents;
the annual programme for the monitoring of TSEs in accordance with Article 6 of Regulation (EC) No 999/2001;
the detection of pharmacologically active substances or products either prohibited or unauthorised, and controls for regulated pharmacologically active substances, pesticides, feed additives and contaminants exceeding applicable maximum Union limits, in particular in the framework of the national plans for the detection of residues or substances referred to in Article 110(2) of Regulation (EU) 2017/625 and in Article 5 of Directive 96/23/EC;
the detection of animal diseases for which animal health rules are laid down in Regulation (EU) 2016/429.
Article 38
Official controls on animal welfare at transport and slaughter
The official veterinarian shall verify compliance with the rules concerning the protection of animals during transport in accordance with Regulation (EC) No 1/2005 and at the time of slaughter in accordance with Regulation (EC) No 1099/2009 and national rules on animal welfare.
CHAPTER III
Communication of inspection results and measures to be taken by competent authorities in cases of specific non-compliance with requirements for fresh meat and for animal welfare
Article 39
Measures concerning the communication of the results of official controls
The following actions shall be taken by the official veterinarian where inspections reveal the presence of any disease or condition that might affect human or animal health, or compromise animal welfare:
the official veterinarian shall inform the slaughterhouse operator;
where the problem referred to in this paragraph arose during primary production and relates to human health, animal health, animal welfare or residues of veterinary medicinal products, unauthorised or prohibited substances, pesticide residues, feed additives or contaminants, the official veterinarian shall inform:
the veterinarian attending the holding of provenance;
the official veterinarian who carried out any ante-mortem inspection at the holding of provenance, where different from (i);
the food business operator responsible for the holding of provenance (provided that such information would not prejudice subsequent legal proceedings); and,
the competent authorities responsible for supervising the holding of provenance or the hunting area;
where the animals concerned were raised in another country, the official veterinarian shall ensure that the country's competent authorities are informed.
Article 40
Measures in cases of non-compliance with requirements for food chain information
Article 41
Measures in cases of non-compliance recorded in food chain information
The official veterinarian shall verify that the slaughterhouse operator does not accept animals for slaughter when the food chain information or any other accompanying records, documentation or information shows that:
the animals come from a holding of provenance or an area subject to a movement prohibition or other restriction for reasons of animal or human health;
rules on the use of veterinary medicinal products have not been complied with, animals have been treated with prohibited or unauthorised substances, or the legal limits for chemical residues or contaminants have not been complied with; or
any other condition which might adversely affect human or animal health is present.
Article 42
Measures in cases of misleading food chain information
Article 43
Measures in cases of non-compliance with requirements for live animals
As a rule, animals that are presented to a slaughterhouse for slaughter shall be slaughtered there. However, in exceptional circumstances, such as a serious breakdown of the slaughter facilities, the official veterinarian may allow direct movements to another slaughterhouse.
Where non-compliance which results in a risk to animal or human health, or animal welfare, is detected during ante-mortem inspection at the holding of provenance, the official veterinarian shall not allow the animals to be transported to the slaughterhouse and the relevant measures regarding the communication of inspection results in accordance with Article 39(2)(b)(i) and (iii) shall apply.
Article 44
Measures in cases of non-compliance with requirements for animal welfare
Article 45
Measures in cases of non-compliance with requirements for fresh meat
The official veterinarian shall declare fresh meat unfit for human consumption if it:
derives from animals that have not undergone ante-mortem inspection in accordance with Article 18(2)(a) or (b) of Regulation (EU) 2017/625, except for wild game and stray reindeer referred to in Article 12(1)(b) of Delegated Regulation (EU) 2019/624;
derives from animals whose offal has not undergone post-mortem inspection in accordance with Article 18(2)(c) of Regulation (EU) 2017/625, except in case of viscera of large wild game that do not need to accompany the body to a game-handling establishment in accordance with point 4 of Chapter II of Section IV in Annex III of Regulation (EC) No 853/2004;
derives from animals that are dead before slaughter, stillborn, unborn or slaughtered under the age of seven days;
results from the trimming of sticking points;
derives from animals affected by animal diseases for which animal health rules are laid down in the Union legislation listed in Annex I to Directive 2002/99/EC, except if it is obtained in conformity with the specific requirements provided for in that Directive; this exception shall not apply if otherwise provided for in the requirements on the official controls of tuberculosis and brucellosis provided for in Articles 33 and 34 of this Regulation;
derives from animals affected by a generalised disease, such as generalised septicaemia, pyaemia, toxaemia or viraemia;
is not in conformity with the food safety criteria laid down in Chapter I of Annex I to Regulation (EC) No 2073/2005 for determining whether food may be placed on the market;
exhibits parasitic infestation, unless otherwise provided for in the requirements on the official controls for cysticercosis provided for in Article 30;
contains chemical residues or contaminants in excess of the levels laid down in Regulations (EU) No 37/2010, (EC) No 396/2005, (EC) No 1881/2006 and (EC) No 124/2009 or residues of substances that are prohibited or unauthorised under Regulation (EU) No 37/2010 or Directive 96/22/EC;
consists of the liver and kidneys of animals more than two years old from regions where implementation of plans approved in accordance with Article 5 of Directive 96/23/EC has revealed the generalised presence of heavy metals in the environment;
has been treated illegally with decontaminating substances;
has been treated illegally with ionising radiation or UV-radiation;
contains foreign bodies, except, in the case of wild game, material used to hunt the animal;
exceeds maximum permitted radioactivity levels laid down under Union legislation or, in the absence of Union legislation, under national rules;
indicates pathological or organoleptic changes, in particular a pronounced sexual odour or insufficient bleeding (except for wild game);
derives from emaciated animals;
contains specified risk material unless removal is allowed in another establishment in accordance with Point 4.3 of Annex V to Regulation (EC) No 999/2001 and the fresh meat remains under the control of the competent authorities;
shows soiling, faecal or other contamination;
consists of blood that may constitute a risk to human or animal health owing to the health status of any animal from which it derives or contamination arising during the slaughter process;
in the opinion of the official veterinarian, after examination of all the relevant information, may constitute a risk to human or animal health or is for any other reason not suitable for human consumption;
gives rise to specific hazards in accordance with Articles 29 to 36.
Article 46
Measures in cases of non-compliance with requirements on good hygiene practices
The competent authorities may instruct the food business operator to take immediate corrective action, including a reduction in the speed of slaughter, where this is considered necessary by the official present in the following cases:
where contamination is detected on external surfaces of a carcase or its cavities and the food business operator does not take appropriate action to rectify the situation; or
if the competent authorities consider that good hygiene practices are jeopardised.
CHAPTER IV
Restrictions
Article 47
Restrictions for certain fresh meat
The official veterinarian may impose requirements concerning the use of fresh meat derived from animals:
that have undergone emergency slaughter outside the slaughterhouse; or
from flocks where a treatment of the meat is applied in accordance with Part E of Annex II to Regulation (EC) No 2160/2003 before the meat is placed on the market.
CHAPTER V
Health marking of meat fit for human consumption after ante-mortem and post-mortem inspection
Article 48
Technical requirements of the health mark and practical arrangements for its application
The official veterinarian shall ensure, in particular, that:
the health mark is applied only to domestic ungulates and farmed game mammals other than lagomorphs, having undergone ante-mortem and post-mortem inspection, and large wild game having undergone post mortem inspection, in accordance with Article 18(2)(a), (b) and (c) of Regulation (EU) 2017/625, where there are no grounds for declaring the meat unfit for human consumption. However, the mark may be applied before the results of any examination for Trichinella and/or TSE testing are available, in accordance with the provisions laid down respectively in Article 4(3) of Implementing Regulation (EU) 2015/1375 and in Chapter A of Annex III to Regulation (EC) No 999/2001, points 6.2 and 6.3 of point I and points 7.2 and 7.3 of point II;
the health mark is applied on the external surface of the carcase, by stamping in ink or hot branding, in such a manner that, if carcases are cut in the slaughterhouse into half carcases or quarters, or half carcases are cut into three pieces, each piece bears a health mark.
TITLE IV
SPECIFIC REQUIREMENTS AND UNIFORM MINIMUM FREQUENCY OF OFFICIAL CONTROLS WITH RESPECT TO RAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM-BASED PRODUCTS, AS NECESSARY TO RESPOND TO RECOGNISED UNIFORM HAZARDS AND RISKS
Article 49
Control of milk and colostrum production holdings
The official veterinarian shall verify that the health requirements for raw milk and colostrum production as laid down in Part I of Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 are complied with. In particular, the official veterinarian shall verify:
the health status of the animals;
the absence of the use of prohibited or unauthorised pharmacologically active substances; and
that the possible presence of residues of authorised pharmacologically active substances, pesticides or contaminants does not exceed the levels laid down in Regulations (EU) No 37/2010, (EC) No 396/2005 or (EC) No 1881/2006.
Article 50
Control of milk and colostrum
If the food business operator of the production holding has not corrected the situation within three months of the first notification to the competent authorities of non-compliance with the plate count and/or somatic cell count criteria for raw milk and colostrum, the competent authorities shall verify that:
delivery of raw milk and colostrum from the production holding is suspended, or
the raw milk and colostrum is subjected to requirements concerning its treatment and use necessary to protect human health in accordance with a specific authorisation of, or general instructions from the competent authorities.
This suspension or these requirements shall remain in place by the competent authorities until the food business operator has proved that the raw milk and colostrum again comply with the criteria.
TITLE V
SPECIFIC REQUIREMENTS FOR OFFICIAL CONTROLS CONCERNING LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AND RELAYING AREAS
Article 51
Exclusion
This Title applies to live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods. This Title does not apply to non-filter feeder live marine gastropods and to non-filter feeder live echinoderms.
Article 52
Classification of production and relaying areas for live bivalve molluscs
CHAPTER I
Specific requirements for the classification of production and relaying areas for live bivalve molluscs
Article 53
Requirements for Class A areas
Article 54
Requirements for Class B areas
Article 55
Requirements for Class C areas
Article 56
Sanitary survey requirements
Before classifying a production or relaying area, the competent authorities shall carry out a sanitary survey that includes:
an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area;
an examination of the quantities of organic pollutants released during the different periods of the year, according to the seasonal variations of human and animal populations in the catchment area, rainfall readings, waste-water treatment, etc.;
determination of the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area.
Article 57
Monitoring programme
The competent authorities shall establish a monitoring programme for live bivalve mollusc production areas that is based on an examination of the sanitary survey referred to in Article 56. The number of samples, geographical distribution of sampling points and sampling frequency for the programme shall ensure that the results of the analysis are representative of the area in question.
Article 58
The competent authorities shall establish a procedure to ensure that the sanitary survey referred to in Article 56 and the monitoring programme referred to in Article 57 are representative of the area considered.
CHAPTER II
Conditions for the monitoring of classified production and relaying areas for live bivalve molluscs
Article 59
Monitoring of classified production and relaying areas
The competent authorities shall periodically monitor production and relaying areas classified in accordance with Article 18(6) of Regulation (EU) 2017/625 in order to check:
that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;
the microbiological quality of live bivalve molluscs in relation to the classified production and relaying areas;
for the presence of toxin-producing plankton in production and relaying waters and marine biotoxins in live bivalve molluscs;
for the presence of chemical contaminants in live bivalve molluscs.
Article 60
Recognised methods for the detection of marine biotoxins in live bivalve molluscs
Article 61
Sampling plans
Sampling plans to check the microbiological quality of live bivalve molluscs shall take particular account of:
the likely variation in faecal contamination;
the parameters referred to in Article 56(1).
Sampling plans to check for the presence of toxin-producing plankton in the water in classified production and relaying areas and for marine biotoxins in live bivalve molluscs shall take particular account of possible variations in the presence of plankton containing marine biotoxins. Sampling shall comprise:
periodic sampling to detect changes in the composition of plankton containing toxins and their geographical distribution. Results suggesting an accumulation of toxins in live bivalve mollusc flesh shall be followed by intensive sampling;
periodic toxicity tests using live bivalve molluscs from the affected area most susceptible to contamination.
The sampling frequency for toxin analysis in live bivalve molluscs shall be weekly during harvesting periods, except when:
the sampling frequency may be reduced in specific classified relaying or production areas, or for specific types of live bivalve mollusc, if a risk assessment of toxins or phytoplankton occurrence suggests a very low risk of toxic episodes;
the sampling frequency shall be increased where such an assessment suggests that weekly sampling would not be sufficient.
CHAPTER III
Management of classified production and relaying areas after monitoring
Article 62
Decisions following monitoring
Where the results of microbiological monitoring show that the health standards for live bivalve molluscs referred to in Article 53 not met, competent authorities may, on the basis of a risk assessment, and only on a temporary and non-recurring basis, permit continued harvesting without closure or reclassification subject to the following conditions:
the classified production area concerned and all approved establishments receiving live bivalve molluscs from it are under the official control of the same competent authorities;
the live bivalve molluscs concerned are subjected to appropriate restrictive measures such as purification, relaying or processing.
Article 63
Re-opening of production areas
Article 64
Control system
Article 65
Decision by the competent authorities
CHAPTER IV
Other requirements
Article 66
Recording and exchange of information
The competent authorities shall:
establish and keep up to date a list of classified production and relaying areas, with details of their location, and boundaries, as well as the Class in which the area is classified, from which live bivalve molluscs may be taken in accordance with the requirements of Article 52. This list shall be communicated to interested parties affected by this Regulation, such as producers, gatherers and operators of purification centres and dispatch centres;
►C1 immediately inform the interested parties such as producers, gatherers and operators of purification centres and dispatch centres, of any change to the location, boundaries or Class of a production area, of its temporary or final closure, or of the application of measures as referred to in Article 62(2). ◄
TITLE VI
SPECIFIC REQUIREMENTS AND UNIFORM MINIMUM FREQUENCY OF OFFICIAL CONTROLS WITH RESPECT TO FISHERY PRODUCTS
Article 67
Official controls on production and placing on the market
Official controls on the production and placing on the market of fishery products shall include verification of compliance with the requirements set out in Section VIII of Annex III to Regulation (EC) No 853/2004, in particular:
a regular check on the hygiene conditions of landing and first sale;
regular inspections of vessels and establishments on land, including fish auctions and wholesale markets, in particular to check:
whether the conditions for approval are still fulfilled;
whether the fishery products are handled correctly;
compliance with hygiene and temperature requirements;
the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene;
checks on storage and transport conditions.
Article 68
Site of official controls
Article 69
Approval of factory, freezer or reefer vessels
Article 70
Official controls of fishery products
Official controls of fishery products shall include at least the practical arrangements laid down in Annex VI as regards:
organoleptic examinations;
freshness indicators;
histamine;
residues and contaminants;
microbiological checks;
parasites;
poisonous fishery products.
Article 71
Decisions after controls
The competent authorities shall declare fishery products unfit for human consumption if:
official controls carried out in accordance with Article 70 reveal they are not in compliance with organoleptic, chemical, physical or microbiological requirements or requirements for parasites as established in Section VIII of Annex III to Regulation (EC) No 853/2004 or Regulation (EC) No 2073/2005;
they contain in their edible parts chemical residues or contaminants in excess of the levels laid down in Regulations (EU) No 37/2010, (EC) No 396/2005, (EC) No 1881/2006, or residues of substances that are prohibited or unauthorised in accordance with Regulation (EU) No 37/2010 or Directive 96/22/EC, or are not in compliance with any other relevant Union legislation on pharmacologically active substances;
they derive from:
poisonous fish;
fishery products not complying with the requirements on marine biotoxins;
live bivalve molluscs, echinoderms, tunicates or marine gastropods containing marine biotoxins in total quantities exceeding the limits referred to in Regulation (EC) No 853/2004; or
the competent authorities consider that they may constitute a risk to human or animal health or are for any other reason not suitable for human consumption.
Article 72
Requirements concerning the official controls on fishery products caught by vessels flying the flag of Member States entering the Union after being transferred in third countries with or without storage
TITLE VII
SPECIFIC REQUIREMENTS FOR THE PERFORMANCE OF OFFICIAL CONTROLS AND UNIFORM MINIMUM FREQUENCY FOR OFFICIAL CONTROLS ON REPTILE MEAT
Article 73
Ante-mortem and post-mortem inspection of reptiles
Article 11 shall apply to the ante-mortem inspection of reptiles.
Articles 12, 13 and 14 shall apply to the post-mortem inspection of reptiles. For the purpose of Article 13 (a)(i), a reptile will be considered as 0,5 livestock units.
TITLE VIII
FINAL PROVISIONS
Article 74
Amendments to Regulation (EC) No 2074/2005
Regulation (EC) No 2074/2005 is amended as follows:
Articles 5, 6b and 6c are deleted.
In Annex I, Section II and the Appendix are deleted.
In Annex II, Section II is deleted.
Annexes III and V are deleted.
Annex VIa is deleted.
Annex VIb and its Appendix are deleted.
Article 75
Entry in force and application
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
It shall apply from 14 December 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
MODEL DOCUMENT FOR COMMUNICATION WITH THE HOLDING OF PROVENANCE IN ACCORDANCE WITH ARTICLE 39(5)
1. Identification details
1.1. Holding of provenance (owner or manager)
Name/number
Full address
Telephone number
Electronic address if available
1.2. Identification numbers of … [please specify] or attach list
Total number of animals (by species)
Identification problems (if any)
|
1.3. |
Herd/flock/cage identification number (if applicable) |
|
1.4. |
Animal species |
|
1.5. |
Reference number of health certificate (if applicable) |
2. Ante-mortem findings
2.1. Welfare
Number of animals affected
Type/class/age
Observations
|
2.2. |
Animals were delivered dirty |
|
2.3. |
Clinical findings of disease Number of animals affected Type/class/age Observations Date of inspection |
|
2.4. |
Laboratory results ( 13 ) |
3. Post-mortem findings
3.1. Macroscopic findings
Number of animals affected
Type/class/age
Organ or site of animal(s) affected
Date of slaughter
3.2. Disease (codes may be used ( 14 ))
Number of animals affected
Type/class/age
Organ or site of the animal(s) affected
Partially or totally condemned carcase (give reason)
Date of slaughter
|
3.3. |
Laboratory results ( 15 ) |
|
3.4. |
Other results |
|
3.5. |
Welfare findings |
|
4. |
Additional information |
|
5. |
Contact details of slaughterhouse (approval number)
Name Full address Telephone number Electronic address if available |
|
6. |
Official veterinarian (print name)
Signature and stamp |
|
7. |
Date |
|
8. |
Number of pages attached to this form: |
ANNEX II
PRACTICAL ARRANGEMENTS FOR THE HEALTH MARK IN ACCORDANCE WITH ARTICLE 48
1. The health mark must be an oval mark at least 6,5 cm wide by 4,5 cm high bearing the following information in perfectly legible characters:
the name of the country in which the establishment is located, which may be written out in full in capitals or shown as a two-letter code in accordance with the relevant ISO code. In the case of Member States ( 16 ), however, these codes are BE, BG, CZ, DK, DE, EE, IE, GR, ES, FR, HR, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, RO, SI, SK, FI, SE and UK(NI);
the approval number of the slaughterhouse; and
(when the mark is applied in an establishment located in the Union) the abbreviation CE, EC, EF, EG, EK, EO, EY, ES, EÜ, EB, EZ, KE or WE. Those abbreviations must not appear on marks applied on meat imported into the Union from slaughterhouses located outside the Union.
2. Letters must be at least 0,8 cm high and figures at least 1 cm high. The dimensions of the characters and the mark may be reduced for the health marking of lamb, kids and piglets.
3. The ink used for health marking must be authorised in accordance with Union rules on the use of colouring substances in foodstuffs.
4. The health mark may also include an indication of the official veterinarian who carried out the health inspection of the meat.
ANNEX III
TESTING METHODS FOR RAW MILK AND HEAT-TREATED COW'S MILK IN ACCORDANCE WITH ARTICLE 50
CHAPTER I
DETERMINATION OF PLATE COUNT AND SOMATIC CELL COUNT
A. When verifying compliance with the criteria laid down in Part III of Section IX, Chapter I of Annex III to Regulation (EC) No 853/2004, the following standards must be applied as reference methods:
EN ISO 4833-1 for the plate count at 30 °C;
EN ISO 13366-1 for the somatic cell count.
B. The use of alternative analytical methods is acceptable:
for the plate count at 30 °C, where the methods are validated against the reference method mentioned in point 1 of Part A in accordance with the protocol set out in standard EN ISO 16140-2, supplemented by standard EN ISO 16297 for the specific case of plate count in raw milk.
In particular, the conversion relationship between an alternative method and the reference method mentioned in point 1 of Part A is established according to standard EN ISO 21187.
for the somatic cell count, where the methods are validated against the reference method mentioned in point 2 of Part A in accordance with the protocol set out in standard ISO 8196-3 and operated in accordance with standard EN ISO 13366-2 or other similar internationally accepted protocols.
CHAPTER II
DETERMINATION OF ALKALINE PHOSPHATASE ACTIVITY IN COW'S MILK
A. To determine alkaline phosphatase activity in pasteurised cow's milk, standard EN ISO 11816-1 must be applied as the reference method.
B. The alkaline phosphatase activity in pasteurised cow's milk is expressed as milli units of enzyme activity per litre (mU/l). A unit of alkaline phosphatase activity is the amount of alkaline phosphatase enzyme that catalyses the transformation of 1 micromole of substrate per minute.
C. An alkaline phosphatase test is considered to give a negative result if the measured activity in cow's milk is not higher than 350 mU/l.
D. The use of alternative analytical methods is acceptable where they are validated against the reference methods mentioned in Part A in accordance with internationally accepted protocols and rules of good laboratory practices.
ANNEX IV
REFERENCE TESTING METHOD FOR ANALYSIS OF E. COLI IN LIVE BIVALVE MOLLUSCS FOR CLASSIFICATION OF PRODUCTION AND RELAYING AREAS IN ACCORDANCE WITH ARTICLE 52(2)
The reference method for analysis of E. coli in live bivalve molluscs shall be the detection and ‘most probable number’ (MPN) technique specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in ISO 16140.
ANNEX V
RECOGNISED METHODS FOR THE DETECTION OF MARINE BIOTOXINS IN ACCORDANCE WITH ARTICLE 60
CHAPTER I
PARALYTIC SHELLFISH POISON DETECTION METHOD
The paralytic shellfish poisoning (PSP) toxins content of the whole body or any part edible separately of bivalve molluscs shall be determined using the method described in the Standard EN 14526 ( 17 ) or any other internationally recognised validated method not entailing the use of a live animal.
The abovementioned methods shall determine at least the following compounds:
Toxins Carbamate STX, NeoSTX, gonyautoxin 1 and 4 (GTX1 and GTX4 isomers determined together) and gonyautoxin 2 and 3 (GTX2 and GTX3 isomers determined together);
Toxins N-sulfo-carbamoyl (B1), gonyautoxin-6 (B2), N-sulfocarbamoyl-gonyautoxin 1 and 2 (C1 and C2 isomers determined together), N-sulfocarbamoyl-gonyautoxin 3 and 4 (C3 and C4 isomers determined together);
Toxins decarbamoyl dcSTX, dcNeoSTX, decarbamoylgonyautoxin-2 and -3 (isomers determined together).
If new analogues of the above toxins, for which a toxicity equivalent factor (TEF) has been established, appear, they shall be included in the analysis;
Total toxicity will be expressed in μg STX 2HCL equivalents/Kg and shall be calculated using TEFs as recommended in the most recent EFSA opinion or FAO OMS report, upon proposal of the European Reference Laboratory for marine biotoxins and its National Reference Laboratories network and acceptance by the European Commission. The TEFs used will be published in the European Reference Laboratory for marine biotoxins website ( 18 );
If the results are challenged, the reference method shall be the method described in the Standard EN 14526 as referred in Part A.
CHAPTER II
AMNESIC SHELLFISH POISON DETECTION METHOD
A. The amnesic shellfish poisoning (ASP) toxins content of the entire body or any part edible separately of bivalve molluscs shall be determined using the high-performance liquid chromatography with ultraviolet detection (HPLC/UV) method or any other internationally recognised validated method.
B. However, for screening purposes, AOAC official method 2006.02, as published in AOAC International Journal 90, 1011-1027 (ASP enzyme-linked immunosorbent assay (ELISA) method), or any other internationally recognised validated method may also be used.
C. If the results are challenged, the reference method shall be the HPLC/UV method.
CHAPTER III
LIPOPHILIC TOXIN DETECTION METHODS
A. The reference method for the detection of marine toxins as referred to in points (c), (d) and (e) in Chapter V(2) of Section VII of Annex III to Regulation (EC) No 853/2004 shall be the EU reference laboratory liquid chromatography-mass spectrometry/mass spectrometry (EURL LC-MS/MS) method. This method shall determine at least the following compounds:
okadaic acid group toxins: OA, DTX1 and DTX2, including their esters (DTX3);
▼M2 —————
yessotoxins group toxins: YTX, 45 OH YTX, homo YTX and 45 OH homo YTX;
azaspiracids group toxins: AZA 1, AZA 2 and AZA 3.
If new analogues of the above toxins appear, for which a toxicity equivalent factor (TEF) has been established, they shall be included in the analysis.
Total toxicity equivalence shall be calculated using TEFs as recommended by the European Food Safety Authority (EFSA) in Journal (2008) 589, 1-62 or any updated EFSA advice.
B. Methods other than those referred to in Part A, such as the LC-MS method, HPLC with appropriate detection, immunoassays and functional assays, such as the phosphatase inhibition assay, may be used as alternatives to, or as well as, the EURL LC-MS/MS method, provided that:
either alone or combined they can detect at least the analogues identified in Part A; more appropriate criteria shall be defined where necessary;
they meet the method performance criteria stipulated by the EURL LC-MS/MS method. Such methods must be intra-laboratory validated and successfully tested under a recognised proficiency test scheme. The European Reference Laboratory for marine biotoxins shall support activities toward inter-laboratory validation of the technique to allow for formal standardisation;
their implementation provides an equivalent level of public health protection.
CHAPTER IV
DETECTION OF NEW OR EMERGING MARINE TOXINS
Chemical methods, alternative methods with appropriate detection, or the mouse bioassay can be used during the periodic monitoring of production areas and relaying areas for detecting new or emerging marine toxins on the basis of the national control programmes elaborated by the Member States.
ANNEX VI
PRACTICAL ARRANGEMENTS FOR OFFICIAL CONTROLS ON FISHERY PRODUCTS IN ACCORDANCE WITH ARTICLE 70
CHAPTER I
GENERAL PROVISIONS
A. Organoleptic examinations
Random organoleptic controls shall be carried out at all stages of production, processing and distribution. One aim of the controls is to verify compliance with the freshness criteria established in accordance with this Regulation. In particular, this includes verifying, at all stages of production, processing and distribution, that fishery products at least meet the baselines of freshness criteria established in accordance with Council Regulation (EC) No 2406/96 ( 19 ).
B. Freshness indicators
When the organoleptic examination gives rise to any doubt as to the freshness of the fishery products, samples may be taken and subjected to laboratory tests to determine the levels of total volatile basic nitrogen (TVB-N) and trimethylamine nitrogen (TMA-N) in accordance with the technical arrangements in Chapter II.
When the organoleptic examination gives rise to any doubt that previously frozen fish is commercially presented as fresh, samples may be taken for verification purposes and subjected to laboratory tests such as the Hydroxyacyl-coenzyme A dehydrogenase (HADH) test, histology, ultraviolet–visible–near–infrared (UV-VIS/NIR) spectroscopy and hyperspectral imaging.
The competent authorities shall use the criteria laid down in this Regulation.
When the organoleptic examination gives cause to suspect the presence of other conditions that may affect human health, appropriate samples shall be taken for verification purposes.
C. Histamine
Random testing for histamine shall be carried out to verify compliance with the permitted levels laid down in Regulation (EC) No 2073/2005.
D. Residues and contaminants
Monitoring arrangements shall be established in accordance with Directive 96/23/EC and Decision 97/747/EC to control compliance with the EU legislation on:
For wild caught fishery products monitoring arrangements shall be established to control compliance with the EU legislation on contaminants, in accordance with Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in food.
E. Microbiological checks
Where necessary, microbiological controls shall be performed in accordance with the relevant rules and criteria laid down in Regulation (EC) No 2073/2005.
F. Parasites
Risk-based testing shall take place to verify compliance with Part D of Chapter III of Section VIII of Annex III to Regulation (EC) No 853/2004 and Section I of Annex II to Regulation (EC) No 2074/2005.
G. Poisonous fishery products
Controls shall take place to ensure that:
fishery products derived from poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae;
fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, may be placed on the market only in wrapped/packaged form and are appropriately labelled to inform the consumer about preparation/cooking methods and the risk related to the presence of substances with adverse gastrointestinal effects. The scientific names of the fishery products and the common names shall appear on the label;
fishery products containing biotoxins such as ciguatera or other toxins dangerous to human health are not placed on the market. However, fishery products derived from live bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII of Annex III to Regulation (EC) No 853/2004 and comply with the standards laid down in point 2 of Chapter V of that Section.
CHAPTER II
CONTROLS ON TOTAL VOLATILE BASIC NITROGEN (TVB-N)
A. TVB-N limit values for certain categories of fishery products and analysis methods to be used
1. Unprocessed fishery products shall be regarded as unfit for human consumption where organoleptic assessment has raised doubts as to their freshness and chemical checks reveal that the following TVB-N limits are exceeded:
25 mg of nitrogen/100 g of flesh for the species referred to in point 1 of Part B of this Chapter;
30 mg of nitrogen/100 g of flesh for the species referred to in point 2 of Part B of this Chapter;
35 mg of nitrogen/100 g of flesh for the species referred to in point 3 of Part B of this Chapter;
60 mg of nitrogen/100 g of whole fishery product used directly for the preparation of fish oil for human consumption, as referred to in the second paragraph of point 1 of Chapter IV.B of Section VIII of Annex III to Regulation (EC) No 853/2004; however, where the raw material complies with points (a), (b) and (c) of the first paragraph of that point, Member States may set limits at a higher level for certain species pending the establishment of specific Union legislation.
The reference method to be used for checking the TVB-N limits involves distilling an extract deproteinised by perchloric acid as set out in Part C below.
2. Distillation as referred to in point 1 shall be performed using apparatus which complies with the diagram in Part D below.
3. The routine methods that may be used to check the TVB-N limit are as follows:
microdiffusion method described by Conway and Byrne (1933);
direct distillation method described by Antonacopoulos (1968);
distillation of an extract deproteinised by trichloracetic acid (Codex Alimentarius Committee on Fish and Fishery Products, 1968).
4. The sample shall consist of about 100 g of flesh, taken from at least three different points and mixed together by grinding.
Member States shall recommend that official laboratories use, as a matter of routine, the methods referred to above. Where the results are dubious or in the event of dispute regarding the results of analysis performed by one of the routine methods, only the reference method may be used to check the results.
B. Species categories for which TVB-N limit values are fixed
TVB-N limit values are fixed for the following species categories:
Sebastes spp., Helicolenus dactylopterus, Sebastichthys capensis;
species belonging to the Pleuronectidae family (with the exception of halibut: Hippoglossus spp.);
Salmo salar, species belonging to the Merlucciidae family, species belonging to the Gadidae family.
C. Reference procedure for determining the concentration of TVB-N in fish and fishery products
1. Purpose and area of application
This method describes a reference procedure for identifying the nitrogen concentration of TVB-N in fish and fishery products. The procedure is applicable at TVB-N concentrations of 5 mg/100 g to at least 100 mg/100 g.
2. Definitions
‘TVB-N concentration’ means the nitrogen content of volatile nitrogenous bases as determined by the reference procedure described.
‘Solution’ means an aqueous solution as follows:
perchloric acid solution = 6 g/100 ml;
sodium hydroxide solution = 20 g/100 ml;
hydrochloric acid standard solution 0,05 mol/l (0,05 N). When using an automatic distillation apparatus, titration must take place with a hydrochloric acid standard solution of 0,01 mol/l (0,01 N);
boric acid solution = 3 g/100 ml;
silicone anti-foaming agent;
phenolphtalein solution = 1 g/100 ml 95 % ethanol;
indicator solution (Tashiro mixed indicator) = 2 g methyl-red and 1 g methylene-blue dissolved in 1 000 ml 95 % ethanol.
3. Brief description
The volatile nitrogenous bases are extracted from a sample using a solution of 0,6 mol/l perchloric acid. After alkalinisation, the extract undergoes steam distillation and the volatile base components are absorbed by an acid receiver. The TVB-N concentration is determined by titration of the absorbed bases. The concentration is expressed in mg/100 g.
4. Chemicals
Unless otherwise indicated, reagent-grade chemicals shall be used. The water used shall be either distilled or demineralised and of at least the same purity.
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5. |
The following instruments and accessories shall be used:
(a)
a meat grinder to produce a sufficiently homogenous fish mince;
(b)
high-speed blender with a speed of 8 000 to 45 000 revolutions/min;
(c)
fluted filter, diameter 150 mm, quick-filtering;
(d)
burette, 5 ml, graduated to 0,01 ml;
(e)
apparatus for steam distillation. The apparatus must be able to regulate various amounts of steam and produce a constant amount of steam over a given period of time. It must ensure that, during the addition of alkalising substances, the resulting free bases cannot escape. |
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6. |
Execution of the reference procedure When working with perchloric acid, which is strongly corrosive, necessary caution and preventive measures shall be taken. The samples shall be prepared as soon as possible after their arrival, in accordance with the following instructions:
(a)
Preparing the sample The sample to be analysed is ground carefully using a meat grinder as described in point 5(a). An amount of 10 g ± 0,1 g of the ground sample is weighed out into a suitable container. This is mixed with 90,0 ml perchloric acid solution, homogenised for two minutes with a blender as described in point 5(b), and then filtered. The extract thereby obtained can be kept for at least seven days at a temperature of between approximately 2 °C and 6 °C;
(b)
Steam distillation 50,0 ml of the extract obtained in accordance with point (a) is put into an apparatus for steam distillation as described in point 5(e). For a later check on the extract's alkalinisation, several drops of phenolphtalein solution are added. After adding a few drops of silicone anti-foaming agent, 6,5 ml of sodium hydroxide solution is added to the extract and steam distillation begins immediately. The steam distillation is regulated so that around 100 ml of distillate is produced in 10 minutes. The distillation outflow tube is submerged in a receiver with 100 ml boric acid solution, to which three to five drops of the indicator solution have been added. After exactly 10 minutes, distillation is ended. The distillation outflow tube is removed from the receiver and washed out with water. The volatile bases contained in the receiver solution are determined by titration with hydrochloric acid standard solution. The pH of the end point must be 5,0 ± 0,1;
(c)
Titration Duplicate analyses are required. The applied method is correct if the difference between the duplicates is not greater than 2 mg/100 g;
(d)
Blank A blind test is carried out as described in point (b). Instead of the extract, 50,0 ml perchloric acid solution is used. |
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7. |
Calculation of TVB-N concentration By titration of the receiver solution with hydrochloric acid standard solution, the TVB-N concentration is calculated using the following equation:
where:
In addition, the following is required:
(a)
duplicate analyses. The applied method is correct if the difference between duplicates is not greater than 2 mg/100 g;
(b)
equipment check. The equipment is checked by distilling solutions of NH4Cl equivalent to 50 mg TVB-N/100 g;
(c)
standard deviations. The standard deviation for repeatability Sr = 1,20 mg/100 g and the standard deviation for reproducibility SR = 2,50 mg/100 g are calculated. |
D. TVB-N steam distillation apparatus
( 1 ) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
( 2 ) Commission Delegated Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of certain animals and goods intended for human consumption (see page 18 of this Official Journal).
( 3 ) Commission Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products (OJ L 303, 6.11.1997, p. 12).
( 4 ) Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
( 5 ) Commission Implementing Regulation (EU) 2018/470 of 21 March 2018 on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC (OJ L 79, 22.3.2018, p. 16).
( 6 ) Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock farming of certain substances having a hormonal or thyrostatic action and of β-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, p. 3).
( 7 ) Commission Decision 2005/34/EC of 11 January 2005 laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries (OJ L 16, 20.1.2005, p. 61).
( 8 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
►M3 ( 9 ) 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 (OJ L 442, 30.12.2020, p. 1). ◄
( 10 ) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
( 11 ) If all are negative, 95 % statistical certainty is provided that the prevalence is below 6 %.
( 12 ) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ L 121, 29.7.1964, p. 1977).
( 13 ) Microbiological, chemical, serological, etc. (include results as attached).
( 14 ) The competent authorities may introduce the following codes: code A for OIE-listed diseases; codes B100 and B200 for welfare issues and C100 to C290 for decisions concerning meat. The coding system can, if necessary, include further subdivisions (e.g. C141 for a mild generalised disease, C142 for a more severe disease, etc.). If codes are used, they must be readily available to the food business operator with a suitable explanation of their meaning.
( 15 ) Microbiological, chemical, serological, etc. (include results as attached).
( 16 ) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex, references to Member States include the United Kingdom in respect of Northern Ireland.
( 17 ) Determination of saxitoxin-group toxins in shellfish – HPLC method using pre-column derivatization with peroxide or periodate oxidation.
( 18 ) http://www.aecosan.msssi.gob.es/en/CRLMB/web/home.html
( 19 ) Council Regulation (EC) No 2406/96 of 26 November 1996 laying down common marketing standards for certain fishery products (OJ L 334, 23.12.1996, p. 1).