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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 (Text with EEA relevance.)

Type Implementing Regulation

Publication 2019-05-17

Last updated 2026-07-19

State In force

Department European Commission, SANTE

Source EUR-Lex

articles 76

Reform history JSON API

Measures in cases of non-compliance with requirements for live animals

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.

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.

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.

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.

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.

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.

Article 44

Measures in cases of non-compliance with requirements for animal welfare

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 and 19 of Regulation (EC) No 1099/2009, the official veterinarian shall verify that the food business operator immediately takes the necessary corrective measures and prevents recurrence.

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.

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

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.

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.

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:

(a) 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;

(b) 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;

(d) results from the trimming of sticking points;

(e) derives from animals affected by animal diseases for which animal health rules are laid down in, or are adopted on the basis of, Part III, Title II, or Article 259, of Regulation (EU) 2016/429, in particular derives from animals affected by animal diseases for which animal health rules are laid down in Commission Delegated Regulation (EU) 2020/687 ([^E0014]), except if it is obtained in conformity with the specific requirements provided for in Regulation (EU) 2016/429 and in Delegated Regulation (EU) 2020/687; 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;

(f) derives from animals affected by a generalised disease, such as generalised septicaemia, pyaemia, toxaemia or viraemia;

(g) 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;

(h) exhibits parasitic infestation, unless otherwise provided for in the requirements on the official controls for cysticercosis provided for in Article 30;

(i) 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;

(j) 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;

(k) has been treated illegally with decontaminating substances;

(l) has been treated illegally with ionising radiation or UV-radiation;

(m) contains foreign bodies, except, in the case of wild game, material used to hunt the animal;

(n) exceeds maximum permitted radioactivity levels laid down under Union legislation or, in the absence of Union legislation, under national rules;

(o) indicates pathological or organoleptic changes, in particular a pronounced sexual odour or insufficient bleeding (except for wild game);

(p) derives from emaciated animals;

(q) 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;

(r) shows soiling, faecal or other contamination;

(s) 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;

(t) 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;

(u) 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:

(a) 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

(b) if the competent authorities consider that good hygiene practices are jeopardised.

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.

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:

(a) that have undergone emergency slaughter outside the slaughterhouse; or

(b) 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 supervise health marking and the marks used.

The official veterinarian shall ensure, in particular, that:

(a) 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;

(b) 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 or game-handling establishment into half carcases or quarters, or half carcases are cut into three pieces, each piece bears a health mark.

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

The requirements on the form of the health mark in Annex II of this Regulation may be replaced by the requirements for a special health mark laid down on the basis of Article 67, second subparagraph, point (a), Article 71(3) or (4), or Article 259 of Regulation (EU) 2016/429.

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.

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:

(a) the health status of the animals;

(b) the absence of the use of prohibited or unauthorised pharmacologically active substances; and

(c) 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.

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.

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.

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.

Article 50

Control of milk and colostrum

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.

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:

(a) delivery of raw milk and colostrum from the production holding is suspended, or

(b) 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.

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.

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

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.

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.

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.

CHAPTER I Specific requirements for the classification of production and relaying areas for live bivalve molluscs

Article 53

Requirements for Class A areas

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

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.

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.

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

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.

Article 54

Requirements for Class B areas

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.

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

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

Article 55

Requirements for Class C areas

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.

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

Article 56

Sanitary survey requirements

The competent authorities shall carry out a sanitary survey:

— before classifying a new production or relaying area not yet classified;

— where monitoring data collected in accordance with Article 59, or any other information, may indicate to the competent Authorities material changes in the environmental conditions of the already classified production and relaying areas, which may significantly and persistently affect the results of the previous sanitary survey.

The sanitary survey shall include:

(a) an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area;

(b) 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.;

(c) determination of the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area.

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.

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:

(a) that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;

(b) the microbiological quality of live bivalve molluscs in relation to the classified production and relaying areas;

(c) for the presence of toxin-producing plankton in production and relaying waters and marine biotoxins in live bivalve molluscs;

(d) for the presence of chemical contaminants in live bivalve molluscs.

Article 60

Recognised methods for the detection of marine biotoxins in live bivalve molluscs

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.

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.

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.

Article 61

Sampling plans

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.

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

(a) the likely variation in faecal contamination;

(b) 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:

(a) 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;

(b) 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:

(a) 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;

(b) the sampling frequency shall be increased where such an assessment suggests that weekly sampling would not be sufficient.

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.

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.

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.

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.

CHAPTER III Management of classified production and relaying areas after monitoring

Article 62

Decisions following monitoring

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.

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:

(a) 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;

(b) the live bivalve molluscs concerned are subjected to appropriate restrictive measures such as purification, relaying or processing.

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.

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.

Article 63

Re-opening of production areas

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.

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.

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

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.

Article 64

Control system

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.

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.

Article 65

Decision by the competent authorities

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).

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.

CHAPTER IV Other requirements

Article 66

Recording and exchange of information

The competent authorities shall:

(a) 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;

(b) 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) a regular check on the hygiene conditions of landing and first sale;

(b) regular inspections of vessels and establishments on land, including fish auctions and wholesale markets, in particular to check:
(i) whether the conditions for approval are still fulfilled;
(ii) whether the fishery products are handled correctly;
(iii) compliance with hygiene and temperature requirements;
(iv) the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene;

Article 68

Site of official controls

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.

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.

Article 69

Approval of factory, freezer or reefer vessels

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.

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.

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.

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:

(a) organoleptic examinations;

(b) freshness indicators;

(d) residues and contaminants;

(e) microbiological checks;

(f) parasites;

(g) poisonous fishery products.

Article 71

Decisions after controls

The competent authorities shall declare fishery products unfit for human consumption if:

(a) 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;

(b) 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;

(c) they derive from:
(i) poisonous fish;
(ii) fishery products not complying with the requirements on marine biotoxins;
(iii) 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

(d) 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

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 29 to Annex III to Implementing Regulation (EU) 2020/2235.

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.

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.

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

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:

1. Articles 5, 6b and 6c are deleted.

1. In Annex I, Section II and the Appendix are deleted.

1. In Annex II, Section II is deleted.

1. Annexes III and V are deleted.

1. Annex VIa is deleted.

1. 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 ([^E0015])

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 ([^E0016]))

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 ([^E0017])

3.4. Other results

3.5. Welfare findings

1. Additional information

1. Contact details of slaughterhouse or game-handling establishment (approval number)

Name

Full address

Telephone number

Electronic address if available

1. Official veterinarian (print name)

Signature and stamp

1. Date

1. 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:

(a) 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 ([^E0018]), 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);

(b) the approval number of the slaughterhouse or game-handling establishment;

(c) (when the mark is applied in an establishment located in the Union) the abbreviations EC, EU, EL, UE, EE, AE, ES or EÚ. Those abbreviations must not appear on marks applied on meat imported into the Union from slaughterhouses or game-handling establishments 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:

1. EN ISO 4833-1 for the plate count at 30 °C;

1. EN ISO 13366-1 for the somatic cell count.

B.The use of alternative analytical methods is acceptable:

1. 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.

1. 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

A. 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 ([^E0019]) or any other internationally recognised validated method not entailing the use of a live animal.

B. The abovementioned methods shall determine at least the following compounds:
(a) 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);
(b) 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);
(c) Toxins decarbamoyl dcSTX, dcNeoSTX, decarbamoylgonyautoxin-2 and -3 (isomers determined together).

B.1. 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;

B.2. 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 ([^E0020]);

C. 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:

(a) okadaic acid group toxins: OA, DTX1 and DTX2, including their esters (DTX3);

(d) 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:

(a) either alone or combined they can detect at least the analogues identified in Part A; more appropriate criteria shall be defined where necessary;

(b) 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;

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 ([^E0021]).

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:

— maximum residue limits for pharmacologically active substances, in accordance with Regulations (EU) No 37/2010 and (EU) No 2018/470;

— prohibited and non-authorised substances, in accordance with Regulation (EU) No 37/2010, Directive 96/22/EC and Decision 2005/34/EC;

— contaminants, in accordance with Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in food; and

— pesticide residues, in accordance with Regulation (EC) No 396/2005.

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:

1. fishery products derived from poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae;

1. 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;

1. 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:

(a) 25 mg of nitrogen/100 g of flesh for the species referred to in point 1 of Part B of this Chapter;

(b) 30 mg of nitrogen/100 g of flesh for the species referred to in point 2 of Part B of this Chapter;

(d) 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:

(a) microdiffusion method described by Conway and Byrne (1933);

(b) direct distillation method described by Antonacopoulos (1968);

(c) 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:

1. Sebastes spp., Helicolenus dactylopterus, Sebastichthys capensis;

1. species belonging to the Pleuronectidae family (with the exception of halibut: Hippoglossus spp.);

1. 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:

(a) perchloric acid solution = 6 g/100 ml;

(b) sodium hydroxide solution = 20 g/100 ml;

(c) 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);

(d) boric acid solution = 3 g/100 ml;

(e) silicone anti-foaming agent;

(f) phenolphtalein solution = 1 g/100 ml 95 % ethanol;

(g) 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.

1. 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;

(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.

1. 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.

1. 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:

Image omitted; see official source

where:


V1	=	volume of 0,01 mol hydrochloric acid standard solution in ml for sample;

---	---	---
V0	=	volume of 0,01 mol hydrochloric acid standard solution in ml for blank;

---	---	---
M	=	mass of sample in g.

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

Image omitted; see official source

Text of image

Sample extract

Steam injection tube

Distillation tube

Steam generator

Flask or breaker

(Boric acid)

End of condenser

Cool water

Cooler

[^E0001]: 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).

[^E0002]: 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).

[^E0003]: 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).

[^E0004]: 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).

[^E0005]: 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).

[^E0006]: 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).

[^E0007]: 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).

[^E0008]: 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).

[^E0009]: 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).

[^E0010]: 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).

[^E0011]: Commission Implementing Regulation (EU) 2021/620 of 15 April 2021 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of the disease-free and non-vaccination status of certain Member States or zones or compartments thereof as regards certain listed diseases and the approval of eradication programmes for those listed diseases (OJ L 131, 16.4.2021, p. 78, ELI: http://data.europa.eu/eli/reg_impl/2021/620/oj).

[^E0012]: If all are negative, 95 % statistical certainty is provided that the prevalence is below 6 %.

[^E0013]: Commission Implementing Regulation (EU) 2020/2002 of 7 December 2020 laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to Union notification and Union reporting of listed diseases, to formats and procedures for submission and reporting of Union surveillance programmes and of eradication programmes and for application for recognition of disease-free status, and to the computerised information system (OJ L 412, 8.12.2020, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2020/2002/oj).

[^E0014]: Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64, ELI: http://data.europa.eu/eli/reg_del/2020/687/oj.).

[^E0015]: Microbiological, chemical, serological, etc. (include results as attached).

[^E0016]: 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.

[^E0017]: Microbiological, chemical, serological, etc. (include results as attached).

[^E0018]: 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.

[^E0019]: Determination of saxitoxin-group toxins in shellfish – HPLC method using pre-column derivatization with peroxide or periodate oxidation.

[^E0021]: 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).

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