1.   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:

2.   When auditing procedures based on hazard analysis and critical control points (HACCP), as laid down in Article 5 of Regulation (EC) No 852/2004, the competent authorities shall verify that food business operators handling products of animal origin apply such procedures continuously and properly.

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

4.   Where a food business operator uses procedures set out in guides to the application of HACCP-based principles, in accordance with Article 5(5) of Regulation (EC) No 852/2004, the audit shall cover the correct use of those guides.

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

1.   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:

2.   Where food business operators in the food chain take additional measures to guarantee food safety by implementing integrated systems, private control systems or independent third-party certification, or by other means, and where these measures are documented and animals covered by such schemes are clearly identifiable, the competent authorities may take such measures into account when carrying out audits to review good hygiene practices and the HACCP-based procedures.

1.   In addition to the requirements for audits laid down in Articles 3 and 4, the competent authorities shall, when carrying out an audit in establishments handling fresh meat, verify continuous compliance with food business operators' own procedures concerning the collection, transport, storage and handling of fresh meat, and the use or disposal of animal by-products, including specified risk material, for which they are responsible.

2.   In the course of audits in slaughterhouses, the competent authorities shall verify the evaluation of food chain information, as laid down in Section III of Annex II to Regulation (EC) No 853/2004.

3.   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:

1.   The competent authorities shall inform the food business operator of the holding of provenance of the minimum elements of food chain information to be supplied to the slaughterhouse operator in accordance with Section III of Annex II to Regulation (EC) No 853/2004.

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

3.   Where animals are dispatched for slaughter to another Member State, the competent authorities at the holding of provenance and the place of slaughter shall cooperate to ensure that the food chain information provided by the food business operator of the holding of provenance is easily accessible to the slaughterhouse operator receiving it.

1.   The official veterinarian shall verify the results of the checks and evaluations of food chain information provided by the slaughterhouse operator in accordance with Section III of Annex II to Regulation (EC) No 853/2004. The official veterinarian shall take those checks and evaluations into account when carrying out ante-mortem and post-mortem inspections, together with any other relevant information from the records of the animals' holding of provenance.

2.   When carrying out ante-mortem and post-mortem inspections, the official veterinarian shall take into account official certificates provided for in accordance with Article 29 of Commission Implementing Regulation (EU) 2019/628 (38), and any declarations by veterinarians carrying out official controls or other checks at the level of primary production.

3.   In the case of the emergency slaughter of domestic ungulates outside the slaughterhouse, the official veterinarian at the slaughterhouse shall examine the certification provided for in accordance with Article 29 of Implementing Regulation (EU) 2019/628 and issued by the official veterinarian who carried out the ante-mortem inspection in accordance with point 6 of Chapter VI of Section I of Annex III to Regulation (EC) No 853/2004 and any other relevant information provided by the food business operator.

4.   In the case of large wild game, the official veterinarian at the game-handling establishment shall examine and take into account the declaration accompanying the body of the animal, as issued by a trained person in accordance with point 4(a) of Chapter II of Section IV of Annex III to Regulation (EC) No 853/2004.

1.   All animals shall be subjected to ante-mortem inspection before slaughter. However, inspection can be limited to a representative sample of birds from each flock and a representative sample of lagomorphs from each holding of provenance of lagomorphs.

2.   Ante-mortem inspection shall take place within 24 hours of arrival of the animals at the slaughterhouse and less than 24 hours before slaughter. The official veterinarian may require an additional ante-mortem inspection at any other time.

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

4.   Ante-mortem inspection shall include verification of food business operators' compliance with their obligation to ensure that animals have a clean hide, skin or fleece, so as to avoid any unacceptable risk of contamination of the fresh meat during slaughter.

5.   The official veterinarian shall carry out a clinical inspection of all animals that the food business operator or an official auxiliary may have put aside for a more thorough ante-mortem inspection.

6.   Where the ante-mortem inspection is carried out at the holding of provenance in accordance with Article 5 of Delegated Regulation (EU) 2019/624, the official veterinarian at the slaughterhouse shall carry out ante-mortem inspection only when and to the extent specified.

1.   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:

2.   The competent authorities may require the food business operator to provide special technical facilities and sufficient space to check offal.

3.   The competent authorities shall:

4.   The speed of the slaughter line and the number of inspection staff present shall be such as to allow for proper inspection.

1.   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:

2.   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:

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 (39);

3.   For the purpose of point (a) (i) of paragraph 1, the conversion rates laid down in Article 17(6) of Regulation (EC) No 1099/2009 shall be used. However in case of ovine and caprine animals and small (< 100 kg life weight) Cervidae a conversion rate of 0,05 livestock units, and in case of other large game a conversion rate of 0,2 livestock units shall be used.

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

2.   During the post-mortem inspection, precautions shall be taken to ensure that contamination of fresh meat by actions such as palpation, cutting or incision is kept to a minimum.

1.   The requirements in this Article shall apply in addition to the requirements in Articles 12 and 14.

2.   The official veterinarian shall require that carcases of domestic solipeds, bovine animals over eight months old and domestic swine more than five weeks old are submitted for post-mortem inspection split lengthways into half carcases down the spinal column.

3.   If the post-mortem inspection so necessitates, the official veterinarian may require any head or any carcase to be split lengthways. However, to take account of particular eating habits, technological developments or specific sanitary situations, the official veterinarian may authorise the submission for post-mortem inspection of carcases of domestic solipeds, bovine animals more than eight months old and domestic swine more than five weeks old that are not split in half.

4.   In low-capacity slaughterhouses or low-capacity game-handling establishments handling fewer than 1 000 livestock units per year, the official veterinarian may, for sanitary reasons, authorise the cutting into quarter carcases of adult domestic solipeds, adult bovine animals and adult large wild game before post-mortem inspection.

1.   Carcases and offal of the following bovine animals shall undergo the post-mortem inspection procedures laid down in paragraph 2:

2.   The post-mortem inspection procedures shall include at least a visual inspection of the following:

3.   The official veterinarian shall proceed with the following post-mortem inspection procedures 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:

1.   Carcases and offal of bovine animals other than those referred to in Article 18(1) shall undergo the following post-mortem inspection procedures:

2.   The official veterinarian shall proceed with the following post-mortem inspection procedures 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:

1.   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:

2.   The official veterinarian shall proceed with the following post-mortem inspection procedures 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:

1.   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:

2.   The official veterinarian shall proceed with the following post-mortem inspection procedures 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:

1.   Carcases and offal of domestic solipeds shall undergo the following post-mortem inspection procedures:

2.   The official veterinarian shall proceed with the following post-mortem inspection procedures 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:

1.   Carcases and offal of domestic swine shall undergo the following post-mortem inspection procedures:

2.   The official veterinarian shall proceed with the following post-mortem inspection procedures 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:

1.   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:

2.   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:

3.   In case of poultry reared for the production of foie gras and delayed eviscerated poultry obtained at the holding of provenance in accordance with Points 8 and 9 of Chapter VI to Section II of Annex III to Regulation (EC) No 853/2004, post-mortem inspection shall take place at the cutting plant where such carcases are transported directly from the holding of provenance.

1.   The following post-mortem inspection procedures shall apply to farmed game:

2.   Where the animals have been slaughtered outside the slaughterhouse, the official veterinarian at the slaughterhouse shall verify the certificate.

1.   The official veterinarian shall verify that a health certificate conforming to the specimen set out in the Annex to Regulation (EU) No 636/2014, or the declaration(s) in accordance with point 8(b) of Chapter II of Section IV of Annex III to Regulation (EC) No 853/2004, accompanies unskinned large wild game transported to the game-handling establishment from the territory of another Member State. The official veterinarian shall take into account the content of that certificate or declaration(s).

2.   During post-mortem inspection, the official veterinarian shall carry out:

3.   Where the official veterinarian so requires, the vertebral column and the head shall be split lengthwise.

4.   In the case of small wild game not eviscerated immediately after killing, the official veterinarian shall carry out a post-mortem inspection on a representative sample of animals from the same source. Where inspection reveals a disease transmissible to humans or any of the characteristics listed in point (e) in paragraph 2, the official veterinarian shall carry out more checks on the entire batch to determine whether it shall be declared unfit for human consumption or whether each carcase shall be inspected individually.

5.   The official veterinarian may perform any further cuts and inspections of the relevant parts of the animals that are necessary to reach a final diagnosis. If an assessment cannot be made on the basis of the practical arrangements in paragraph 2, additional investigations shall be carried out in a laboratory.

6.   In addition to the cases provided for in Article 45, meat presenting during post-mortem inspection any of the characteristics listed in point (e) in paragraph 2 shall be declared unfit for human consumption.

1.   In addition to the requirements of Regulation (EC) No 999/2001 concerning the official controls to be carried out in relation to TSEs, the official veterinarian shall check the removal, separation and, where appropriate, marking of specified risk material also in accordance with the rules laid down in Article 8(1) of that Regulation and in Article 12 of Regulation (EC) No 1069/2009 on animal by-products.

2.   The official veterinarian shall ensure that the food business operator takes all necessary measures to avoid contaminating meat with specified risk material during slaughter, including stunning. This includes the removal of specified risk material.

1.   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:

2.   Meat infected with cysticerci shall be declared unfit for human consumption. However, where the animal is not generally infected with cysticercus, the parts not infected may be declared fit for human consumption after having undergone a cold treatment.

1.   Carcases of Suidae, solipeds and other species susceptible to Trichinella shall be examined for Trichinella in accordance with Regulation (EU) 2015/1375 unless one of the derogations set out in Article 3 of that Regulation applies.

2.   Meat from animals infected with trichinae shall be declared unfit for human consumption.

1.   Fresh meat of solipeds shall be placed on the market only if it was produced from solipeds kept for at least 90 days prior to the date of slaughter in a Member State or in a third country or region thereof from which it is authorised to bring solipeds into the Union.

2.   In the case of solipeds originating from a Member State or third country or region thereof not meeting the World Organisation for Animal Health criteria for a glanders-free country, solipeds shall be inspected for glanders by a careful examination of the mucous membranes of the trachea, larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising the nasal septum.

3.   Meat produced from solipeds in which glanders has been diagnosed shall be declared unfit for human consumption.

1.   Where animals have reacted positively or inconclusively to tuberculin, or there are other grounds for suspecting infection, they shall be slaughtered separately from other animals, taking precautions to avoid the risk of contamination of other carcases, the slaughter line and staff present in the slaughterhouse.

2.   All meat from animals in which post-mortem inspection has revealed localised lesions similar to tuberculoid lesions in a number of organs or a number of areas of the carcase shall be declared unfit for human consumption. However, where a tuberculoid lesion has been found in the lymph nodes of only one organ or part of the carcase, only the affected organ or part of the carcase and the associated lymph nodes shall be declared unfit for human consumption.

1.   Where animals have reacted positively or inconclusively to a brucellosis test, or there are other grounds for suspecting infection, they shall be slaughtered separately from other animals, taking precautions to avoid the risk of contamination of other carcases, the slaughter line and staff present in the slaughterhouse.

2.   Meat from animals in which post-mortem inspection has revealed lesions indicating acute brucellosis shall be declared unfit for human consumption. In the case of animals reacting positively or inconclusively to a brucellosis test, the udder, genital tract and blood shall be declared unfit for human consumption even if no such lesion is found.

1.   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:

2.   Where the food business operator fails on several occasions to comply with the process hygiene criterion, the competent authorities shall require it to submit an action plan and shall strictly supervise its outcome.

3.   The total number and the number of Salmonella-positive samples, differentiating between samples taken under points (a), (b) and (c) in paragraph 1, when applied, shall be reported in accordance with Article 9(1) of Directive 2003/99/EC.

1.   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:

2.   Where the food business operator fails on several occasions to comply with the process hygiene criterion, the competent authorities shall require it to submit an action plan and shall strictly supervise its outcome.

3.   The total number and the number of Campylobacter samples with more than 1 000 cfu/g, differentiating between samples taken under points (a) and (b) in paragraph 1, when applied, shall be reported in accordance with Article 9(1) of Directive 2003/99/EC.

1.   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:

2.   The official veterinarian shall ensure that any additional laboratory testing deemed necessary for the fulfilment the obligations under Article 18(2) of Regulation (EU) 2017/625 takes place as required.

1.   The official veterinarian shall record and evaluate the results of official controls carried out in accordance with Articles 7 to Article 38.

2.   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:

3.   The competent authorities shall enter the results of official controls in relevant databases, at least where the collection of such information is required under Article 4 of Directive 2003/99/EC, Article 8 of Council Directive 64/432/EEC (41) and Annex III to Directive 2007/43/EC.

4.   Where the official veterinarian, while carrying out ante-mortem or post-mortem inspection or any other official control, suspects the presence of an animal disease for which animal health rules are laid down in Regulation (EU) 2016/429, he/she shall notify the competent authorities. The official veterinarian and competent authorities, within their respective areas of competence, shall take all necessary measures and precautions to prevent the possible spread of the disease agent.

5.   The official veterinarian may use the model document in Annex I for the purpose of communicating the relevant results of ante-mortem and post-mortem inspections to the holding of provenance where the animals were kept before slaughter.

6.   Where the animals were kept on a holding of provenance in another Member State, the competent authorities of the Member State in which they were slaughtered shall communicate the relevant results of ante-mortem and post-mortem inspections to the competent authorities in the Member State of provenance. They shall use the model document in Annex I in the official languages of both Member States involved or in a language agreed between both Member States.

1.   The official veterinarian shall ensure that animals are not slaughtered unless the slaughterhouse operator has been provided with, checked and evaluated relevant food chain information in accordance with Article 9(2)(a) and (b).

2.   By way of derogation from paragraph 1, the official veterinarian may allow animals to undergo slaughter in the slaughterhouse if the relevant food chain information is not available. In such cases, the information shall be supplied before the meat is declared fit for human consumption and carcases and related offal shall be stored separately from other meat pending that declaration.

3.   Where relevant food chain information is not available within 24 hours of an animal's arrival at the slaughterhouse, the official veterinarian shall declare all meat from the animal unfit for human consumption. If the animal has not yet been slaughtered, it shall be killed separately from other animals taking all necessary precautions to safeguard animal and human health.

1.   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:

2.   If the animals are already present at the slaughterhouse, they shall be killed separately and declared unfit for human consumption, taking precautions to safeguard animal and human health. Where the official veterinarian considers it necessary, official controls shall be carried out on the holding of provenance.

1.   The competent authorities shall take appropriate action if they discover that the accompanying records, documentation or other information do not correspond to the true situation of the holding of provenance or the true condition of the animals, or aim deliberately to mislead the official veterinarian.

2.   They shall take action against the food business operator responsible for the holding of provenance of the animals, or any other person involved, including the slaughterhouse operator. In particular, this action may consist of extra controls. The food business operator responsible for the holding of provenance or any other person involved shall bear the costs of such extra controls.

1.   The official veterinarian shall verify the food business operator's compliance with its duty under point 3 in Chapter IV of Section I of Annex III to Regulation (EC) No 853/2004 to ensure that animals accepted for slaughter for human consumption are properly identified. The official veterinarian shall ensure that animals whose identity is not ascertainable are killed separately and declared unfit for human consumption. Where the official veterinarian considers it necessary, official controls shall be carried out on the holding of provenance.

2.   The official veterinarian shall ensure that animals subject to an unacceptable risk of contamination of the meat during slaughter, as laid down in Article 11(4), are not slaughtered for human consumption unless they are cleaned beforehand.

3.   The official veterinarian shall ensure that animals with a disease or condition that may be transmitted to animals or humans handling or eating the meat and, in general, animals showing clinical signs of systemic disease or emaciation, or any other condition rendering meat unfit for human consumption, are not slaughtered for human consumption. Such animals shall be killed separately under such conditions that other animals or carcases cannot be contaminated, and declared unfit for human consumption.

4.   The official veterinarian shall defer the slaughter of animals suspected of having a disease or condition that may adversely affect human or animal health. Such animals shall undergo detailed ante-mortem examination by the official veterinarian in order to make a diagnosis. In addition, the official veterinarian may decide that sampling and laboratory examinations must take place to supplement post-mortem inspection. If necessary to avoid contamination of other meat, the animals shall be slaughtered separately or at the end of normal slaughtering, taking all other necessary precautions.

5.   The official veterinarian shall ensure that animals that might contain residues of prohibited or unauthorised pharmacologically active substances or residues of authorised pharmacologically active substances, pesticides or contaminants in excess of the levels laid down in accordance with Union legislation, are dealt with in accordance with Articles 16 to 19 of Directive 96/23/EC.

6.   The official veterinarian shall impose the conditions under which animals shall be dealt with under a specific scheme for the eradication or control of a specific disease, such as brucellosis or tuberculosis, or zoonotic agents such as salmonella, under his/her direct supervision. The competent authorities shall determine the conditions under which such animals may be slaughtered. These conditions shall be designed to minimise the contamination of other animals and the meat of other 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.

1.   In cases of non-compliance with the rules concerning the protection of animals at the time of slaughter or killing laid down in Articles 3 to 9 and Articles 14 to 17, 19 and 22 of Council Regulation (EC) No 1099/2009, the official veterinarian shall verify that the food business operator immediately takes the necessary corrective measures and prevents recurrence.

2.   The official veterinarian shall take a proportionate and stepped approach to enforcement action, ranging from issuing directions to slowing down and stopping production, depending on the nature and gravity of the problem.

3.   Where appropriate, the official veterinarian shall inform other competent authorities of welfare problems.

4.   Where the official veterinarian discovers non-compliance with the rules concerning the protection of animals during transport laid down in Regulation (EC) No 1/2005, he/she shall take the requisite measures in accordance with the relevant Union legislation.

5.   Where an official auxiliary carries out checks on animal welfare and those checks identify non-compliance with the rules on the protection of animals, he/she shall immediately inform the official veterinarian. If necessary in urgent cases, he/she shall take the necessary measures referred to in paragraphs 1 to 4 pending the arrival of the official veterinarian.

1.   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:

2.   In such cases, the competent authorities shall increase the intensity of inspection until such time as they are satisfied that the food business operator has regained control of the process.

1.   The official veterinarian shall supervise health marking and the marks used.

2.   The official veterinarian shall ensure, in particular, that:

3.   The competent authorities shall ensure that the practical arrangements for the health mark are applied in accordance with Annex II.

4.   The competent authorities shall ensure that meat from unskinned wild game does not bear a health mark until, after skinning in a game-handling establishment, it has undergone post-mortem inspection and been declared fit for human consumption.

1.   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:

2.   The official controls referred to in paragraph 1 may take place at the occasion of veterinary checks carried out pursuant to Union provisions on animal or human health or animal welfare.

3.   If there are grounds for suspecting that the health requirements referred to in paragraph 1 are not being complied with, the official veterinarian shall check the general health status of the animals.

4.   Milk and colostrum production holdings shall undergo official controls by the competent authorities to verify that hygiene requirements laid down in Part II of Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 are being complied with. These controls may involve inspections and the monitoring of controls carried out by professional organisations. If it is demonstrated that the hygiene is inadequate, the competent authorities shall verify that appropriate steps are taken to correct the situation.

1.   In the case of raw milk and colostrum, the competent authorities shall monitor the checks carried out in accordance with Part III of Chapter I, Section IX of Annex III to Regulation (EC) No 853/2004. When testing is used, the competent authorities shall use the analytical methods set out in Annex III to this Regulation to check compliance with the limits laid down for raw milk and colostrum in Part III of Chapter I, Section IX of Annex III to Regulation (EC) No 853/2004.

2.   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:

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.

3.   The competent authorities shall use the analytical methods set out in Annex III of this Regulation to verify appropriate application of a pasteurisation process to dairy products as referred to in Part II of Chapter II, Section IX of Annex III to Regulation (EC) No 853/2004.

1.   The competent authorities shall fix the location and boundaries of the production and relaying areas that they classify in accordance with Article 18(6) of Regulation (EU) 2017/625. They may, where appropriate, do so in cooperation with the food business operator.

2.   The competent authorities shall classify production and relaying areas from which they authorise the harvesting of live bivalve molluscs as Class A, Class B and Class C areas according to the level of faecal contamination. They may, where appropriate, do so in cooperation with the food business operator.

3.   In order to classify production and relaying areas, the competent authorities shall fix a review period for sampling data from each production and relaying area in order to determine compliance with the standards referred to in Articles 53, 54 and 55.

1.   The competent authorities may classify as Class A areas those from which live bivalve molluscs may be collected for direct human consumption.

2.   Live bivalve molluscs placed on the market from such areas shall meet the health standards for live bivalve molluscs set out in Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004.

3.   Samples of live bivalve molluscs from Class A areas shall not exceed, in 80 % of samples collected during the review period, 230 E. coli per 100 g of flesh and intravalvular liquid.

4.   The remaining 20 % of samples shall not exceed 700 E. coli per 100 g of flesh and intravalvular liquid.

5.   When evaluating the results for the fixed review period for maintenance of a Class A area, the competent authorities may, on the basis of a risk assessment based on an investigation, decide to disregard an anomalous result exceeding the level of 700 E. coli per 100 g of flesh and intravalvular liquid.

1.   The competent authorities may classify as Class B areas those from which live bivalve molluscs may be collected and placed on the market for human consumption only after treatment in a purification centre or after relaying so as to meet the health standards referred to in Article 53.

2.   Live bivalve molluscs from Class B areas shall not exceed, in 90 % of the samples, 4 600E. coli per 100 g of flesh and intravalvular liquid.

3.   The remaining 10 % of samples shall not exceed 46 000E. coli per 100 g of flesh and intravalvular liquid.

1.   The competent authorities may classify as Class C areas those from which live bivalve molluscs may be collected and placed on the market only after relaying over a long period so as to meet the health standards referred to in Article 53.

2.   Live bivalve molluscs from Class C areas shall not exceed 46 000E. coli per 100 g of flesh and intravalvular liquid.

1.   Before classifying a production or relaying area, the competent authorities shall carry out a sanitary survey that includes:

2.   The competent authorities shall carry out a sanitary survey fulfilling the requirements set out in paragraph 1 in all classified production and relaying areas, unless carried out previously.

3.   The competent authorities may be assisted by other official bodies or food business operators under conditions established by the competent authorities in relation to the performance of this survey.

1.   The competent authorities shall use the analytical methods laid down in Annex V to check compliance with the limits laid down in point 2 of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004 and, where appropriate, to verify compliance by food business operators. Food business operators shall use these methods where appropriate.

2.   In accordance with Article 4 of Directive 2010/63/EU, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used where possible, instead of a procedure as defined in Article 3(1) of that Directive.

3.   In accordance with Article 4 of Directive 2010/63/EU, elements of replacement, refinement and reduction must be taken into account when biological methods are used.

1.   For the purposes of the checks provided for in points (b), (c) and (d) of Article 59, the competent authorities shall draw up sampling plans providing for such checks to take place at regular intervals, or on a case-by-case basis if harvesting periods are irregular. The geographical distribution of the sampling points and the sampling frequency shall ensure that the results of the analysis are representative of the classified production and relaying area concerned.

2.   Sampling plans to check the microbiological quality of live bivalve molluscs shall take particular account of:

3.   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:

4.   The sampling frequency for toxin analysis in live bivalve molluscs shall be weekly during harvesting periods, except when:

5.   The risk assessment referred to in paragraph 4 shall be reviewed periodically in order to assess the risk of toxins occurring in the live bivalve molluscs from these areas.

6.   Where knowledge of toxin accumulation rates is available for a group of species growing in the same classified production or relaying area, the species with the highest rate may be used as an indicator species. This will allow the exploitation of all species in the group if toxin levels in the indicator species are below the regulatory limits. Where toxin levels in the indicator species are above the regulatory limits, the harvesting of the other species may be allowed only if further analysis of the other species shows toxin levels below the limits.

7.   With regard to the monitoring of plankton, the samples shall be representative of the water column in the classified production or relaying area and provide information on the presence of toxic species and on population trends. If any changes in toxic populations that may lead to toxin accumulation are detected, the sampling frequency for live bivalve molluscs shall be increased or precautionary closures of the areas established until results of toxin analysis are obtained.

8.   Sampling plans to check for the presence of chemical contaminants shall enable the detection of any overshooting of the levels laid down in Regulation (EC) No 1881/2006.

1.   Where the results of the monitoring provided for in Article 59 indicate that the health standards for live bivalve molluscs are not met or that there may otherwise be a risk to human health, the competent authorities shall close the classified production or relaying area concerned, preventing the harvesting of live bivalve molluscs. However, they may reclassify a production or relaying area as being of Class B or C if it meets the relevant criteria set out in Articles 54 and 55 and presents no other risk to human health.

2.   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:

3.   The accompanying registration document, as referred to in Chapter I of Section VII of Annex III to Regulation (EC) No 853/2004, shall include all the information concerning the application of paragraph 2.

4.   The competent authorities shall establish the conditions under which paragraph 2 can be availed of in order to ensure, for the production area concerned, maintenance of the compliance with the criteria established in Article 53.

1.   The competent authorities may re-open a closed production or relaying area only if the health standards for live bivalve molluscs comply once again with the relevant requirements of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004 and present no other risk to human health.

2.   Where the competent authorities have closed a production or relaying area because of the presence of plankton or levels of toxins in live bivalve molluscs that exceed the regulatory limit for marine biotoxins laid down in point 2 of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004, they may re-open it only if at least two consecutive analytical results separated by at least 48 hours are below the regulatory limit.

3.   When deciding whether to re-open a production or relaying area, the competent authorities may take account of information on phytoplankton trends.

4.   Where there are robust data on the dynamic of the toxicity for a given area, and provided that recent data on decreasing trends of toxicity are available, the competent authorities may decide to re-open an area with results below the regulatory limit in point 2 of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004 obtained from a single sampling.

1.   The competent authorities shall set up a control system to ensure that products of animal origin harmful to human health are not placed on the market. The control system shall comprise laboratory tests to verify food business operators' compliance with the requirements for the end product, including live bivalve molluscs and any products derived from them, at all stages of production, processing and distribution.

2.   This control system shall verify, where applicable, that the levels of marine biotoxins and contaminants do not exceed safety limits and that the microbiological quality of the molluscs does not constitute a hazard to human health.

1.   The competent authorities shall act promptly where a production area must be closed or reclassified, or may be re-opened, or where live bivalve molluscs are subject to the application of measures as referred to in Article 62(2).

2.   When deciding on the classification, reclassification, opening or closure of production areas in accordance with Articles 52, 62 and 63, competent authorities may take into account the results of checks carried out by food business operators or organisations representing food business operators, only if the laboratory carrying out the analysis is designated by the competent authorities, and the sampling and analysis are performed in accordance with a protocol agreed upon jointly by the competent authorities and food business operators or organisation concerned.

1.   The competent authorities shall carry out official controls on vessels when these call at a port in a Member State. These controls shall concern all vessels landing fishery products at EU ports, irrespective of flag.

2.   Flag state competent authorities may carry out official controls on vessels under their flag while the vessel is at sea or in a port in another Member State or a third country.

1.   Where a factory, freezer or reefer vessel flying the flag of a Member State is inspected with a view to granting approval of the vessel, the competent authorities of the flag Member State shall carry out official controls in accordance with Article 148 of Regulation (EU) 2017/625, particularly the time limits referred to in Article 148(4). If necessary, they may inspect the vessel while it is at sea or in a port in another Member State or a third country.

2.   Where the competent authorities of the flag Member State have granted the vessel conditional approval in accordance with Article 148 of Regulation (EU) 2017/625, they may authorise the competent authorities of another Member State, or of a third country to carry out follow-up controls with a view to granting full approval, prolonging conditional approval or keeping approval under review, provided that, in the case of a third country, such country appears on a list of third countries from which imports of fishery products are permitted pursuant to Article 127 of Regulation (EU) 2017/625. If necessary, these competent authorities may inspect the vessel while it is at sea or in a port in another Member State or third country.

3.   Where the competent authorities of a Member State authorise the competent authorities of another Member State or of a third country to carry out controls on their behalf in accordance with this Article, the two competent authorities shall agree on the conditions governing such controls. These conditions shall ensure, in particular, that the competent authorities of the flag Member State receive reports on the results of the controls and on any suspected non-compliance without delay, so as to enable them to take the necessary measures.

1.   Fishery products intended for human consumption caught by vessels flying the flag of a Member State, unloaded, with or without storage, in third countries listed as provided for in Article 126(2)(a) of Regulation (EU) 2017/625 before entering the Union by a different means of transportation, shall be accompanied by a health certificate issued by the competent authorities of that third country and completed in accordance with the model health certificate set out in Chapter B of Part II to Annex III to Implementing Regulation (EU) 2019/628.

2.   If the fishery products referred to in paragraph 1 are unloaded and transported to a storage facility located in the third country referred to in that paragraph, that storage facility shall appear in a list as provided for in Article 5 of Delegated Regulation (EU) 2019/625.

3.   If the fishery products referred to in paragraph 1 are loaded in a vessel flying the flag of a third country, that third country shall be listed as provided for in Article 3 of Delegated Regulation (EU) 2019/625 and the vessel shall appear in a list as provided for in Article 5 of Delegated Regulation (EU) 2019/625.

4.   Container vessels used to transport containerised fishery products are excluded from this requirement.