Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

• 2a. For the purposes of this point, ‘dry-ageing’ means the storage of fresh meat in aerobic conditions of hanging carcasses or cuts either unpacked or packed in bags permeable to water vapour in a refrigerated room or cabinet and left to age for several weeks at controlled environmental conditions of temperature, relative humidity and airflow. Before placing on the market or freezing, bovine meat subject to dry-ageing must be stored at a surface temperature of – 0,5 to 3,0 °C, with a relative humidity of a maximum of 85 % and an airflow of 0,2 to 0,5 m/s in a dedicated room or cabinet for a maximum of 35 days starting at the end of the stabilisation period upon slaughter. However, food business operators may apply other combinations of surface temperature, relative humidity, airflow and time, or do dry-ageing of meat of other species, if they demonstrate to the satisfaction of the competent authority that equivalent guarantees are provided on the safety of the meat. In addition, the following specific measures shall be applied:
• (i) the dry-ageing shall start immediately after the stabilisation period upon slaughter and unduly delayed cutting and/or transport to an establishment carrying out the dry-ageing;
• (ii) the meat shall not be loaded into the room or the cabinet until the temperature and relative humidity referred to in the second subparagraph have been achieved;
• (iii) the meat shall be hanged from the bone or, if using a shelf, sufficient perforation to facilitate air flow with regular turning using hygienic methods must be ensured;
• (iv) a higher airflow may be applied at the start of the dry-ageing process to facilitate early crust development and reduce the surface water activity;
• (v) thermometers, relative humidity probes and other equipment to accurately monitor and facilitate control of room or cabinet conditions must be used;
• (vi) air leaving the evaporator, returning to the evaporator and coming in contact with the beef must be filtered or UV treated;
• (vii) when the crust is trimmed, such trimming shall be carried out in a hygienic manner.

• 1. Meat must attain the temperature specified in point 1 before transport, and remain at that temperature during transport. However, following points (a) and (b) shall apply.
• (a) Transport of meat for the production of specific products may take place before the temperature specified in point 1 is attained if the competent authority so authorises, provided that:
• (i) such transport takes place in accordance with the requirements that the competent authorities of origin and destination specify in respect of transport from one given establishment to another;
• (ii) the meat leaves the slaughterhouse, or a cutting room on the same site as the slaughter premises, immediately and transport takes no more than 2 hours; and,
• (iii) such transport is justified for technological reasons.
• (b) Transport of carcases, half carcases, quarters, or half carcases cut into three wholesale cuts of ovine and caprine animals, bovine animals and porcine animals may commence before the temperature specified in point 1 is attained, provided that all of the following conditions are fulfilled:
• (i) the temperature is monitored and recorded within the framework of procedures based on the HACCP principles;
• (ii) food business operators dispatching and transporting the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts have received documented authorisation from the competent authority at the place of departure to make use of this derogation;
• (iii) the vehicle transporting the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts are fitted with an instrument that monitors and records air temperatures to which the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts are subjected in such a way that competent authorities are enabled to verify compliance with the time and temperature conditions set out in point (viii);
• (iv) per transport, the vehicle transporting the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts collects meat from a maximum of three slaughterhouses or from one cold store collecting directly from slaughterhouses; all the requirements laid down in this point (b) shall apply to all loads of carcases, half carcases, quarters, or half carcases cut into three wholesale cuts dispatched from the slaughterhouse and cold store collecting from the above mentioned slaughterhouse;
• (v) carcases, half carcases, quarters, or half carcases cut into three wholesale cuts must have a core temperature of 15 °C at the start of the transport if they are to be transported in the same compartment as meat which meets the temperature requirement set out in point 1 for offal and 7 °C for other meat;
• (vi) a declaration by the food business operator accompanies the consignment; that declaration must state the duration of chilling before the first loading, the time at which the first loading of the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts was started, the surface temperature at that time, the maximum transportation air temperature to which the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts may be subjected, the maximum transport time permitted, the date of authorisation and the name of the competent authority authorising the transport in accordance with point (ii);
• (vii) the food business operator of destination must notify the competent authority before receiving for the first time carcases, half carcases, quarters, or half carcases cut into three wholesale cuts, not attaining the temperature referred to in point 1 before the start of transport;
• (viii) the meat must be transported in accordance with the following parameters:
• — For a maximum transport time ([^E0015]) of six hours: Species Surface temperature [^E0016] Maximum time to chill to surface temperature [^E0017] Maximum transportation air temperature [^E0018] Maximum daily mean carcase aerobic colony count [^E0019] Ovine and caprine animals 7 °C 8 hours 6 °C log10 3,5 cfu/cm² Bovine animals 20 hours log10 3,5 cfu/cm² Porcine animals 16 hours log10 4 cfu/cm² (¹) Maximum surface temperature allowed at loading and thereafter measures at the thickest part of the carcase, half carcases, quarters, or half carcases cut into three wholesale cuts. (²) Maximum time allowed from the moment of killing until the reaching of the maximum surface temperature allowed at loading. (³) The maximum air temperature to which the meat is allowed to be subjected from the moment loading begins, and throughout the whole duration of the transport. (⁴) Slaughterhouse maximum daily mean carcase aerobic colony count using a rolling window of 10 weeks, allowed for carcases of the relevant species, as assessed by the operator to the satisfaction of the competent authority, according to the sampling and testing procedures laid out in points 2.1.1, 2.1.2 of Chapter 2, and point 3.2 of Chapter 3, of Annex I to Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1). The maximum transport time may be extended to 30 hours if a core temperature below 15 °C is reached before the start of the transport.
• — For a maximum transport time (15)  of 60 hours: Species Surface temperature [^E0020] Maximum time to chill to surface temperature [^E0021] Core temperature [^E0022] Maximum transportation air temperature [^E0023] Maximum daily mean carcase aerobic colony count [^E0024] Ovine and caprine animals 4 °C 12 hours 15 °C 3 °C log10 3 cfu/cm² Bovine animals 24 hours (¹) Maximum surface temperature allowed at loading and thereafter measures at the thickest part of the carcase, half carcases, quarters, or half carcases cut into three wholesale cuts. (²) Maximum time allowed from the moment of killing until the reaching of the maximum surface temperature allowed at loading. (³) The maximum core temperature of the meat allowed at the time of loading, and thereafter. (⁴) The maximum air temperature to which the meat is allowed to be subjected from the moment loading begins, and throughout the whole duration of the transport. (⁵) Slaughterhouse maximum daily mean carcase aerobic colony count using a rolling window of 10 weeks, allowed for carcases of the relevant species, as assessed by the operator to the satisfaction of the competent authority, according to the sampling and testing procedures laid out in points 2.1.1, 2.1.2 of Chapter 2, and point 3.2 of Chapter 3, of Annex I to Regulation (EC) No 2073/2005.
• (ix) methods for measuring the surface temperature shall be validated and the following method shall be used as reference method:
• — a thermometer calibrated in accordance with the latest version of ISO 13485 shall be used;
• — the sensor shall be penetrated perpendicularly in the thickest part at a depth of 0,5 to 1 cm of the external part of either: (a) the shoulder; or (b) the leg for bovine, ovine and caprine animals or of the ham, or the internal surface of the ham in the middle upper part for porcine animals;
• — five temperature measurements shall be carried out as follows: Image omitted; see official source
• — at least one of the five measurements must be below the surface temperature requirements laid down in point (viii).

• 1. Meat intended for freezing must be frozen without undue delay, taking into account where necessary a stabilisation period before freezing. However, food business operators carrying out a retail activity may freeze meat in view of its redistribution for the purpose of food donations in accordance with the following conditions:
• (i) in the case of meat for which a ‘use by’ date is applied in accordance with Article 24 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council ([^E0025]), before the expiry of that date;
• (ii) without undue delay to a temperature of – 18 °C or lower;
• (iii) ensuring that the date of freezing is documented and provided either on the label or by other means;
• (iv) excluding meat that has been frozen before (defrosted meat); and,
• (v) in accordance with any condition laid down by the competent authorities for freezing and further use as food.

• 1. Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat.

SECTION II:   MEAT FROM POULTRY AND LAGOMORPHS

CHAPTER I:   TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

Food business operators transporting live animals to slaughterhouses must ensure compliance with the following requirements.

• 1. During collection and transport, animals must be handled carefully without causing unnecessary distress.

• 1. Animals showing symptoms of disease or originating in flocks known to be contaminated with agents of public-health importance may only be transported to the slaughterhouse when permitted by the competent authority.

• 1. Crates for delivering animals to the slaughterhouse and modules, where used, must be made of non-corrodible material and be easy to clean and disinfect. Immediately after emptying and, if necessary, before re-use, all equipment used for collecting and delivering live animals must be cleaned, washed and disinfected.

CHAPTER II:   REQUIREMENTS FOR SLAUGHTERHOUSES

Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which poultry or lagomorphs are slaughtered meet the requirements laid down in the following points 1 to 7. Mobile partial slaughterhouses must operate in cooperation with complementary permanent slaughtering facilities in order to constitute a complete slaughterhouse complying with the requirements laid down in the following points 1 to 7. Mobile partial slaughterhouses may operate with several complementary slaughtering facilities, thus constituting several slaughterhouses.

• 1. They must have a room or covered space for the reception of the animals and for their inspection before slaughter.

• 1. To avoid contaminating meat, they must:
• (a) have a sufficient number of rooms, appropriate to the operations being carried out;
• (b) have a separate room for evisceration and further dressing, including the addition of seasonings to whole poultry carcases, unless the competent authority authorises separation in time of these operations within a specific slaughterhouse on a case-by-case basis;
• (c) ensure separation in space or time of the following operations:
• (i) stunning and bleeding;
• (ii) plucking or skinning, and any scalding; and
• (iii) dispatching meat;
• (d) have installations that prevent contact between the meat and the floors, walls and fixtures; and
• (e) have slaughter lines (where operated) that are designed to allow a constant progress of the slaughter process and to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination.

• 1. They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

• 1. The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to prevent the spread of contamination.

• 1. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the storage of meat declared unfit for human consumption.

• 1. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of:
• (a) transport equipment such as crates; and
• (b) means of transport. These places and facilities are not compulsory for (b) if officially authorised places and facilities exist nearby.

• 1. They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the veterinary service.

CHAPTER III:   REQUIREMENTS FOR CUTTING PLANTS

• 1.Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs:

• (a) are constructed so as to avoid contamination of meat, in particular by:
• (i) allowing constant progress of the operations; or
• (ii) ensuring separation between the different production batches;

• (b) have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat;

• (c) have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

• (d) have equipment for washing hands used by staff handling exposed meat with taps designed to prevent the spread of contamination; and

• (e) have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

• 2.If the following operations are undertaken in a cutting plant:

• (a) the evisceration of geese and ducks reared for the production of ‘foie gras’, which have been stunned, bled and plucked on the fattening farm; or

• (b) the evisceration of delayed eviscerated poultry,

• food business operators must ensure that separate rooms are available for that purpose.

CHAPTER IV:   SLAUGHTER HYGIENE

Food business operators operating slaughterhouses in which poultry or lagomorphs are slaughtered must ensure compliance with the following requirements.

• 1. • (a) Meat from animals other than those referred to in (b) must not be used for human consumption if they die otherwise than by being slaughtered in the slaughterhouse.
• (b) Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:
• (i) delayed eviscerated poultry, geese and ducks reared for the production of ‘foie gras’ and birds that are not considered as domestic but which are farmed as domestic animals, if slaughtered at the farm in accordance with Chapter VI;
• (ii) farmed game slaughtered at the place of production in accordance with Section III; and
• (iii) small wild game in accordance with Section IV, Chapter III.

• 1. Slaughterhouse operators must follow the instructions of the competent authority to ensure that ante-mortem inspection is carried out under suitable conditions.

• 1. Where establishments are approved for the slaughter of different animal species or for the handling of farmed ratites and small wild game, precautions must be taken to prevent cross contamination by separation either in time or in space of the operations carried out on the different species. Separate facilities for the reception and storage of carcases of farmed ratites slaughtered at the farm and for small wild game must be available.

• 1. Animals brought into the slaughter room must be slaughtered without undue delay.

• 1. Stunning, bleeding, skinning or plucking, evisceration and other dressing must be carried out without undue delay in such a way that contamination of the meat is avoided. In particular, measures must be taken to prevent the spillage of digestive tract contents during evisceration.

• 1. Slaughterhouse operators must follow the instructions of the competent authority to ensure that the post-mortem inspection is carried out under suitable conditions, and in particular that slaughtered animals can be inspected properly.

• 1. After post-mortem inspection:
• (a) parts unfit for human consumption must be removed as soon as possible from the clean sector of the establishment;
• (b) meat detained or declared unfit for human consumption and inedible by-products must not come into contact with meat declared fit for human consumption; and
• (c) viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely, if possible, and as soon as possible, unless otherwise authorised by the competent authority.

• 1. After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4 °C as soon as possible, unless the meat is cut while warm.

• 1. When carcases are subjected to an immersion chilling process, account must be taken of the following.
• (a) Every precaution must be taken to avoid contamination of carcases, taking into account parameters such as carcase weight, water temperature, volume and direction of water flow and chilling time.
• (b) Equipment must be entirely emptied, cleaned and disinfected whenever this is necessary and at least once a day.

• 1. Sick or suspect animals, and animals slaughtered in application of disease eradication or control programmes, must not be slaughtered in the establishment except when permitted by the competent authority. In that event, slaughter must be performed under official supervision and steps taken to prevent contamination; the premises must be cleaned and disinfected before being used again.

CHAPTER V:   HYGIENE DURING AND AFTER CUTTING AND BONING

Food business operators must ensure that cutting and boning of meat of poultry and lagomorphs takes place in accordance with the following requirements.

• 1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that:
• (a) meat intended for cutting is brought into the workrooms progressively as needed;
• (b) during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the temperature of the meat is maintained at not more than 4 °C by means of an ambient temperature of 12 °C or an alternative system having an equivalent effect; and
• (c) where the premises are approved for the cutting of meat of different animal species, precautions are taken to avoid cross-contamination, where necessary by separation of the operations on the different species in either space or time.

• 1. However, meat may be boned and cut prior to reaching the temperature referred to in point 1(b) when the cutting room is on the same site as the slaughter premises, provided that it is transferred to the cutting room either:
• (a) directly from the slaughter premises; or
• (b) after a waiting period in a chilling or refrigerating room.

• 1. As soon as the meat is cut and, where appropriate, packaged, it must be chilled to a temperature of not more than 4 °C.

• 1. Meat must attain a temperature of not more than 4 °C before transport, and be maintained at that temperature during transport. However, if the competent authority so authorises, livers for the production of foie gras may be transported at a temperature of more than 4 °C, provided that:
• (a) such transport takes place in accordance with the requirements that the competent authority specifies in respect of transport from one given establishment to another; and
• (b) the meat leaves the slaughterhouse, or a cutting room immediately and transport takes no more than two hours.

• 1. Meat intended for freezing must be frozen without undue delay. However, food business operators carrying out a retail activity may freeze meat in view of its redistribution for the purpose of food donations in accordance with the following conditions:
• (i) in the case of meat for which a ‘use by’ date is applied in accordance with Article 24 of Regulation (EU) No 1169/2011, before the expiry of that date;
• (ii) without undue delay to a temperature of – 18 °C or lower;
• (iii) ensuring that the date of freezing is documented and provided either on the label or by other means;
• (iv) excluding meat that has been frozen before (defrosted meat); and,
• (v) in accordance with any condition laid down by the competent authorities for freezing and further use as food.

• 1. Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at different times or in such a way that the packaging material and the manner of storage or transport cannot be a source of contamination for the meat.

CHAPTER VI:   SLAUGHTER ON THE FARM

Food business operators may slaughter poultry referred to in Chapter IV, point 1(b)(i), on the farm only with the authorisation of the competent authority and in compliance with the following requirements.

• 1. The farm must undergo regular veterinary inspection.

• 1. The food business operator must inform the competent authority in advance of the date and time of slaughter.

• 1. The holding must have facilities for concentrating the birds to allow an ante-mortem inspection of the group to be made.

• 1. The holding must have premises suitable for the hygienic slaughter and further handling of the birds.

• 1. Animal welfare requirements must be complied with.

• 1. In addition to the food chain information to be submitted in accordance with Section III of Annex II to this Regulation, the animal health certificate set out in Chapter 2 of Annex IV to Implementing Regulation (EU) 2020/2235 must accompany the slaughtered animal to the slaughterhouse or cutting plant, or be sent in advance in any format.

• 1. In the case of poultry reared for the production of ‘foie gras’, the uneviscerated birds must be transported immediately and, if necessary, refrigerated to a slaughterhouse or cutting plant. They must be eviscerated within 24 hours of slaughter under the supervision of the competent authority.

• 1. Delayed eviscerated poultry obtained at the farm of production may be kept for up to 15 days at a temperature of not more than 4 °C. It must then be eviscerated in a slaughterhouse or in a cutting plant located in the same Member State as the farm of production.

CHAPTER VII:   WATER RETENTION AGENTS

Food business operators shall ensure that poultrymeat that has been treated specifically to promote water retention is not placed on the market as fresh meat but as meat preparations or used for the production of processed products.

SECTION III:   MEAT OF FARMED GAME

• 1.The provisions of Section I apply to the production and placing on the market of meat from even-toed farmed game mammals, unless the competent authority considers them inappropriate.

• 2.The provisions of Section II apply to the production and placing on the market of meat from ratites. However, those of Section I apply where the competent authority considers them appropriate. Appropriate facilities must be provided, adapted to the size of the animals.

• 3.Notwithstanding points 1 and 2, food business operators may slaughter farmed ratites and farmed ungulates referred to in point 1 at the place of origin with the authorisation of the competent authority if:

• (a) the animals cannot be transported, to avoid any risk for the handler or to protect the welfare of the animals;

• (b) the herd undergoes regular veterinary inspection;

• (c) the owner of the animals submits a request;

• (d) the competent authority is informed in advance of the date and time of slaughter of the animals;

• (e) the holding has procedures for concentrating the animals to allow an ante-mortem inspection of the group to be made;

• (f) the holding has facilities suitable for the slaughter, bleeding and, where ratites are to be plucked, plucking of the animals;

• (g) animal welfare requirements are complied with;

• (h) slaughtered and bled animals are transported to the slaughterhouse or to a game-handling establishment, as appropriate, hygienically and without undue delay. If transport takes more than two hours, the animals must be refrigerated; where climatic conditions so permit, active chilling shall not be required. Evisceration may take place on the spot, under the supervision of the official veterinarian;

• (j) the health certificate set out in Chapter 3 of Annex IV to Implementing Regulation (EU) 2020/2235, issued and signed by the official veterinarian, attesting to a favourable result of the ante-mortem inspection, correct slaughter and bleeding and the date and time of slaughter, must accompany the slaughtered animal to the slaughterhouse or to a game-handling establishment, as appropriate, or must be sent in advance in any format.

• 3aBy way of derogation from point 3(j), the competent authority may authorise that the attestation of the correct slaughter and bleeding and of the date and time of slaughter be included only in the food chain information in accordance with Section III to Annex II of this Regulation provided that:

• (a) the holding is not situated in a restricted zone defined in Article 4(41) of Regulation (EU) 2016/429;

• (b) the food business operator has demonstrated the appropriate level of competence to slaughter animals without causing the animals any avoidable pain, distress or suffering in accordance with Article 7(2) of Regulation (EC) No 1099/2009 and without prejudice to Article 12 of that Regulation.

• 4.Food business operators may also slaughter bison on the farm in accordance with point 3 in exceptional circumstances.

SECTION IV:   WILD GAME MEAT

For the purpose of this Section, ‘collection centre’ means an establishment used to store the bodies and viscera of wild game before their transport to a game handling establishment.

CHAPTER I:   TRAINING OF HUNTERS IN HEALTH AND HYGIENE

• 1.Persons who hunt wild game with a view to placing it on the market for human consumption must have sufficient knowledge of the pathology of wild game, and of the production and handling of wild game and wild game meat after hunting, to undertake an initial examination of wild game on the spot.

• 2.It is however enough if at least one person of a hunting team has the knowledge referred to in point 1. References in this Section to a ‘trained person’ are references to that person.

• 3.The trained person could also be the gamekeeper or the game manager if he or she is part of the hunting team or located in the immediate vicinity of where hunting is taking place. In the latter case, the hunter must present the wild game to the gamekeeper or game manager and inform them of any abnormal behaviour observed before killing.

• 4.Training must be provided to the satisfaction of the competent authority to enable hunters to become trained persons. It should cover at least the following subjects:

• (a) the normal anatomy, physiology and behaviour of wild game;

• (b) abnormal behaviour and pathological changes in wild game due to diseases, environmental contamination or other factors which may affect human health after consumption;

• (c) the hygiene rules and proper techniques for the handling, transportation, evisceration, etc. of wild game animals after killing; and

• (d) legislation and administrative provisions on the animal and public health and hygiene conditions governing the placing on the market of wild game.

• 5.The competent authority should encourage hunters' organisations to provide such training.

CHAPTER II:   HANDLING OF LARGE WILD GAME

• 1.After killing, large wild game must have their stomachs and intestines removed as soon as possible and, if necessary, be bled.

• 2.The trained person must carry out an examination of the body, and of any viscera removed, to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing.

• 3.Meat of large wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 2. The viscera must accompany the body as specified in point 4. The viscera must be identifiable as belonging to a given animal.

• 1. (a) If no abnormal characteristics are found during the examination referred to in point 2, no abnormal behaviour was observed before killing, and there is no suspicion of environmental contamination, the trained person must attach to the animal body a numbered declaration stating this. This declaration must also indicate the date, time and place of killing. The declaration need not be attached to the animal body and may cover more than one animal body, provided that each animal body is appropriately identified and the declaration bears an indication of the identification number of each animal body covered by it, with the corresponding date, time and place of killing. All animal bodies covered by a single declaration may only be sent to a single game-handling establishment. The head and the viscera need not accompany the body to the game-handling establishment, except in the case of species susceptible to trichinosis (porcine animals, solipeds and others), whose heads (except for tusks) and diaphragm must accompany the body. However, the competent authority may authorise that heads of animals susceptible to Trichinella infestation be sent to a technical plant for the production of game trophies, which has been approved in accordance with Article 18 of Regulation (EC) No 1774/2002. The technical plant shall be indicated in the declaration of the trained person. A copy of that declaration shall be sent to the technical plant. Where the results of the Trichinella examination of the carcase are positive, the competent authority shall carry out an official check to verify the proper handling of the head in the technical plant. However, hunters must comply with any additional requirements imposed in the Member State where hunting takes place, in particular to permit the monitoring of certain residues and substances in accordance with Directive 96/23/EC.

(b) In other circumstances, the head (except for tusks, antlers and horns) and all the viscera except for the stomach and intestines must accompany the body. The trained person who carried out the examination must inform the competent authority of the abnormal characteristics, abnormal behaviour or suspicion of environmental contamination that prevented him or her from making a declaration in accordance with (a);

(c) If no trained person is available to carry out the examination referred to in point 2 in a particular case, the head, except for tusks, antlers and horns, and all the viscera, except for the stomach and the intestines, must accompany the body which must be transported to a game handling-establishment as soon as possible after killing.

• 5.Chilling must begin within a reasonable period of time after killing and achieve a temperature throughout the meat of not more than 7 °C. Where climatic conditions so permit, active chilling is not necessary.

• 6.During transport to the game-handling establishment, heaping must be avoided.

• 7.Large wild game delivered to a game-handling establishment must be presented to the competent authority for inspection.

• 8.In addition, unskinned large wild game:

• (a) may be skinned and placed on the market only if:
• (i) before skinning, it is stored and handled separately from other food and it is not frozen;
• (ii) after skinning, it undergoes a final inspection in a game-handling establishment in accordance with Regulation (EC) No 854/2004;

• (b) may be sent to a game handling establishment in another Member State only if, during transport to that game-handling establishment, it is accompanied by an official certificate set out in Chapter 2 of Annex II to Implementing Regulation (EU) 2020/2235 issued and signed by an official veterinarian, attesting that the requirements set out in point 4 of this Chapter as regards the availability of a declaration, when relevant, and the accompaniment of relevant parts of the body, have been complied with. In case the game handling establishment, close to the hunting area, is in another Member State, transport to this game handling establishment need not be accompanied by the certificate but by the declaration of the trained person referred to in point 2 to comply with Article 3(1) of Directive 89/662/EEC, taking into account the animal health status of the Member State of origin.

• 9.The rules laid down in Section I, Chapter V, apply to the cutting and boning of large wild game.

• 10.The bodies and viscera of large wild game may be transported to and stored in a collection centre before being sent to a game handling establishment provided that:

• (a) the collection centre is either:
• (1) registered with the competent authority as a food business carrying out primary production as referred to in Article 4(2)(a) when only receiving bodies as first collection centre, or
• (2) approved by the competent authority as a food business in accordance with Article 4(2) when receiving bodies from other collection centres;

• (b) if the animals are eviscerated, their heaping is prohibited during transport to and storage in the collection centre;

• (c) killed animals are transported to the collection centre hygienically and without delay;

• (d) the temperature conditions laid down in point 5 are complied with;

• (e) storage time is kept to the minimum possible;

• (f) no other handling takes place on the bodies and viscera of the large wild game; however the examination by a trained person and the removal of viscera may take place under the conditions laid down in points 2, 3 and 4.

CHAPTER III:   HANDLING OF SMALL WILD GAME

• 1.The trained person must carry out an examination to identify any characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as possible after killing.

• 2.If abnormal characteristics are found during the examination, abnormal behaviour was observed before killing, or environmental contamination is suspected, the trained person must inform the competent authority.

• 3.Meat of small wild game may be placed on the market only if the body is transported to a game-handling establishment as soon as possible after the examination referred to in point 1 or, if no trained person is available to carry out that examination in a particular case, as soon as possible after killing

• 4.Chilling must begin within a reasonable period of time of killing and achieve a temperature throughout the meat of not more than 4 °C. Where climatic conditions so permit, active chilling is not necessary.

• 5.Evisceration must be carried out, or completed, without undue delay upon arrival at the game -handling establishment, unless the competent authority permits otherwise.

• 6.Small wild game delivered to a game-handling establishment must be presented to the competent authority for inspection.

• 7.The rules laid down in Section II, Chapter V, apply to the cutting and boning of small wild game.

• 8.The bodies, including viscera, of small wild game may be transported to and stored in a collection centre before being sent to a game handling establishment provided that:

• (a) the collection centre is either:
• (1) registered with the competent authority as a food business carrying out primary production as referred to in Article 4(2)(a) when only receiving bodies as first collection centre, or
• (2) approved by the competent authority as a food business in accordance with Article 4(2) when receiving bodies from other collection centres;

• (b) if the animals are eviscerated, their heaping is prohibited during transport to and storage in the collection centre;

• (c) killed animals are transported to the collection centre hygienically and without delay;

• (d) the temperature conditions laid down in point 4 are complied with;

• (e) storage time is kept to the minimum possible;

• (f) no other handling takes place on the bodies, including viscera, of the small wild game; however the examination by a trained person and the removal of viscera may take place under the conditions laid down in points 1 and 2.

SECTION V:   MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY SEPARATED MEAT (MSM)

CHAPTER I:   REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS

Food business operators operating establishments producing minced meat, meat preparations or MSM must ensure that they:

• 1. are constructed so as to avoid contamination of meat and products, in particular by:
• (a) allowing constant progress of the operations; or
• (b) ensuring separation between the different production batches;

• 1. have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contamination for the meat or products;

• 1. have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III;

• 1. have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination; and

• 1. have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect.

CHAPTER II:   REQUIREMENTS FOR RAW MATERIAL

Food business operators producing minced meat, meat preparations or MSM must ensure that the raw materials used satisfy the following requirements.

• 1. The raw material used to prepare minced meat must meet the following requirements.
• (a) It must comply with the requirements for fresh meat;
• (b) It must derive from skeletal muscle, including adherent fatty tissues;
• (c) It must not derive from:
• (i) scrap cuttings and scrap trimmings (other than whole muscle cuttings);
• (ii) MSM;
• (iii) meat containing bone fragments or skin; or
• (iv) meat of the head with the exception of the masseters, the non-muscular part of the linea alba, the region of the carpus and the tarsus, bone scrapings and the muscles of the diaphragm (unless the serosa has been removed).

• 1. The following raw material may be used to prepare meat preparations:
• (a) fresh meat;
• (b) meat meeting the requirements of point 1; and
• (c) if the meat preparation is clearly not intended to be consumed without first undergoing heat treatment:
• (i) meat derived from the mincing or fragmentation of meat meeting the requirements of point 1 other than point 1(c)(i); and
• (ii) MSM meeting the requirements of Chapter III, point 3(d).

• 1. The raw material used to produce MSM must meet the following requirements.
• (a) It must comply with the requirements for fresh meat;
• (b) The following material must not be used to produce MSM:
• (i) for poultry, the feet, neckskin and head; and
• (ii) for other animals, the bones of the head, feet, tails, femur, tibia, fibula, humerus, radius and ulna.

CHAPTER III:   HYGIENE DURING AND AFTER PRODUCTION

Food business operators producing minced meat, meat preparations or MSM must ensure compliance with the following requirements.

• 1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is:
• (a) at a temperature of not more than 4 °C for poultry, 3 °C for offal and 7 °C for other meat; and
• (b) brought into the preparation room progressively as needed.

• 1. The following requirements apply to the production of minced meat and meat preparations.
• (a) Unless the competent authority authorises boning immediately before mincing, frozen or deep-frozen meat used for the preparation of minced meat or meat preparations must be boned before freezing. It may be stored only for a limited period.
• (b) When prepared from chilled meat, minced meat must be prepared:
• (i) in the case of poultry, within no more than three days of their slaughter;
• (ii) in the case of animal other than poultry, within no more than six days of their slaughter; or
• (iii) within no more than 15 days from the slaughter of the animals in the case of boned, vacuum-packed beef and veal.
• (c) Immediately after production, minced meat and meat preparations must be wrapped or packaged and be:
• (i) chilled to an internal temperature of not more than 2 °C for minced meat and 4 °C for meat preparations; or
• (ii) frozen to an internal temperature of not more than -18 °C. These temperature conditions must be maintained during storage and transport.

• 1. The following requirements apply to the production and use of MSM produced using techniques that do not alter the structure of the bones used in the production of MSM and the calcium content of which is not significantly higher than that of minced meat.
• (a) Raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than five days old. However, poultry carcases must be no more than three days old.
• (b) Mechanical separation must take place immediately after deboning.
• (c) If not used immediately after being obtained, MSM must be wrapped or packaged and then chilled to a temperature of not more than 2 °C or frozen to an internal temperature of not more than –18 °C. These temperature requirements must be maintained during storage and transport.
• (d) If the food business operator has carried out analyses demonstrating that MSM complies with the microbiological criteria for minced meat adopted in accordance with Regulation (EC) No 852/2004 it may be used in meat preparations that are clearly not intended to be consumed without first undergoing heat treatment and in meat products.
• (e) MSM not shown to comply with the criteria referred to in (d) may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation.

• 1. The following requirements apply to the production and use of MSM produced using techniques other than those mentioned in point 3.
• (a) Raw material for deboning from an on-site slaughterhouse must be no more than seven days old; otherwise, raw material for deboning must be no more than five days old. However, poultry carcases must be no more than three days old.
• (b) If mechanical separation does not take place immediately after deboning the flesh-bearing bones must be stored and transported at a temperature of not more than 2 °C or, if frozen, at a temperature of not more than -18 °C.
• (c) Flesh-bearing bones obtained from frozen carcases must not be refrozen.
• (d) If not used within one hour of being obtained, MSM must be chilled immediately to a temperature of not more than 2 °C.
• (e) If, after chilling, MSM is not processed within 24 hours, it must be frozen within 12 hours of production and reach an internal temperature of not more than –18 °C within six hours.
• (f) Frozen MSM must be wrapped or packaged before storage or transport, must not be stored for more than three months and must be maintained at a temperature of not more than –18 °C during storage and transport.
• (g) MSM may be used only to manufacture heat-treated meat products in establishments approved in accordance with this Regulation.

• 1. Minced meat, meat preparations and MSM must not be re-frozen after thawing.

• 1. Meat preparations subjected to dry-ageing, shall comply with the requirements laid down in Section I, Chapter VII, point 2a of this Annex III.

CHAPTER IV:   LABELLING

• 1.In addition to the requirements of Directive 2000/13/EC ([^E0026]), food business operators must ensure compliance with the requirement of point 2 if, and to the extent that, national rules in the Member State in the territory of which the product is placed on the market so require.

• 2.Packages intended for supply to the final consumer containing minced meat from poultry or solipeds or meat preparations containing MSM must bear a notice indicating that such products should be cooked before consumption.

SECTION VI:   MEAT PRODUCTS

• 1.Food business operators must ensure that the following items are not used in the preparation of meat products:

• (a) genital organs of either female or male animals, except testicles;

• (b) urinary organs, except the kidneys and the bladder;

• (c) the cartilage of the larynx, the trachea and the extra-lobular bronchi;

• (d) eyes and eyelids;

• (e) the external auditory meatus;

• (f) horn tissue; and

• (g) in poultry, the head — except the comb and the ears, the wattles and caruncles — the oesophagus, the crop, the intestines and the genital organs.

• 2.All meat, including minced meat and meat preparations, used to produce meat product must meet the requirements for fresh meat. However, minced meat and meat preparations used to produce meat products need not satisfy other specific requirements of Section V.

SECTION VII:   LIVE BIVALVE MOLLUSCS

• 1.This Section applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to live echinoderms, live tunicates and live marine gastropods. The provisions on the classification of production areas set out in Chapter II, Part A, of that Section do not apply to marine gastropods and to echinoderms which are not filter feeders.

• 1a.For the purpose of this Section, ‘intermediary operator’ means a food business operator, including traders, other than the first supplier, with or without premises, who carries out its activities between production areas, relaying areas or any establishments.

• 2.Chapters I to VIII apply to animals harvested from production areas that the competent authority has classified in accordance with Regulation (EC) No 854/2004. Chapter IX applies to pectinidae harvested outside those areas.

• 3.Chapters V, VI, VIII and IX, and point 3 of Chapter VII, apply to retail.

• 4.The requirements of this Section supplement those laid down in Regulation (EC) No 852/2004:

• (a) In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre, they supplement the requirements of Annex I to that Regulation.

• (b) In the case of other operations, they supplement the requirements of Annex II to that Regulation.

CHAPTER I:   GENERAL REQUIREMENTS FOR THE PLACING ON THE MARKET OF LIVE BIVALVE MOLLUSCS

• 1.Live bivalve molluscs may not be placed on the market for retail sale otherwise than via a dispatch centre, where an identification mark must be applied in accordance with Chapter VII.

• 2.Food business operators may accept batches of live bivalve molluscs only if the documentary requirements set out in points 3 to 7 have been complied with.

• 3.Whenever a food business operator moves a batch of live bivalve molluscs between production areas, relaying areas or any establishments, a registration document must accompany the batch.

• 4.The registration document must be in at least one official language of the Member State in which the receiving establishment is located and contain at least the information specified below.

• (a) In the case of a batch of live bivalve molluscs sent from a production area, the registration document must contain at least the following information:
• (i) the gatherer's identity and address;
• (ii) the date of harvesting;
• (iii) the location of the production area described in as precise detail as is practicable or by a code number;
• (iv) the health status of the production area;
• (v) the shellfish species and quantity; and
• (vi) the destination of the batch.

• (b) In the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain at least the information referred to in (a) and the following information:
• (i) the location of the relaying area; and
• (ii) the duration of relaying.

• (c) In the case of a batch of live bivalve molluscs sent from a purification centre, the registration document must contain at least the information referred to in (a) and the following information:
• (i) the address of the purification centre;
• (ii) the duration of purification; and
• (iii) the dates on which the batch entered and left the purification centre.

• (d) Where a batch of live bivalve molluscs is sent by an intermediary operator, a new registration document, filled-in by the intermediary operator, must accompany the batch. The registration document must contain at least the information referred to in points (a), (b) and (c) and the following information:
• (i) the name and address of the intermediary operator;
• (ii) in the case of conditioning or in the case of re-immersion for storing purpose, the date of starting, the date of end and the place of the conditioning or the re-immersion;
• (iii) if a conditioning in a natural site was carried out, the intermediary operator must confirm that the natural site where the conditioning took place was classified at the time of conditioning as an class A production area open for harvest;
• (iv) if a re-immersion in natural site was carried out, the intermediary operator must confirm that the natural site where the re-immersion took place was classified at the time of re-immersion with the same classification of the production area where the live bivalve molluscs were harvested.
• (v) if a re-immersion was carried out in an establishment, the intermediary operator must confirm that the establishment was approved at the time of the re-immersion. The re-immersion shall not cause additional contamination to the live bivalve molluscs.
• (vi) in the case of grouping, the species, the date when the grouping started, the date of the end of the grouping, the status of the area where the live bivalve molluscs were harvested, and the batch of the grouping, that always consists of the same species, captured on the same date, and in the same production area.

• 5.Food business operators sending batches of live bivalve molluscs must complete the relevant sections of the registration document so that they are easy to read and cannot be altered. Food business operators receiving batches must date-stamp the document on receipt of the batch or record the date of receipt in another manner.

• 6.Food business operators must keep a copy of the registration document relating to each batch sent and received for at least twelve months after its dispatch or receipt (or such longer period as the competent authority may specify).

• 7.However, if:

• (a) the staff gathering live bivalve molluscs also operate the dispatch centre, purification centre, relaying area or processing establishment receiving the live bivalve molluscs; and

• (b) a single competent authority supervises all the establishments concerned,

• registration documents are not necessary if that competent authority so permits.

• 8.Intermediary operators must be:

• (a) registered with the competent authority as a food business carrying out primary production as referred to in Article 4(2)(a) if they do not have premises or if they have premises where they only handle, wash and store at ambient temperature live bivalve molluscs, without grouping nor conditioning, or

• (b) approved by the competent authority as a food business operator in accordance with Article 4(2) if, in addition to carrying out the activities referred to in point (a), they have a cold store or they group or split batches of live bivalve molluscs or they carry out conditioning or re-immersion.

• 9.Intermediary operators may receive live bivalve molluscs from production areas classified as A, B or C, from relaying areas or from other intermediary operators. Intermediary operators can send live bivalve molluscs:

• (a) from class A production areas to dispatch centres or another intermediary operator;

• (b) from class B production areas only to purification centres, processing establishments or to another intermediary operator;

• (c) from class C production areas to processing establishments or to another intermediary operator with premises.

CHAPTER II:   HYGIENE REQUIREMENTS FOR THE PRODUCTION AND HARVESTING OF LIVE BIVALVE MOLLUSCS

A. REQUIREMENTS FOR PRODUCTION AREAS

• 1.Gatherers may only harvest live bivalve molluscs from production areas with fixed locations and boundaries that the competent authority has classified — where appropriate, in cooperation with food business operators — as being of class A, B or C in accordance with Regulation (EC) No 854/2004.

• 2.Food business operators may place live bivalve molluscs collected from class A production areas on the market for direct human consumption only if they meet the requirements of Chapter V.

• 3.Food business operators may place live bivalve molluscs collected from class B production areas on the market for human consumption only after treatment in a purification centre or after relaying.

• 4.Food business operators may place live bivalve molluscs collected from class C production areas on the market for human consumption only after relaying over a long period in accordance with Part C of this Chapter.

• 5.After purification or relaying, live bivalve molluscs from class B or C production areas must meet all of the requirements of Chapter V. However, live bivalve molluscs from such areas that have not been submitted for purification or relaying may be sent to a processing establishment, where they must undergo treatment to eliminate pathogenic micro-organisms (where appropriate, after removal of sand, mud or slime in the same or another establishment). The permitted treatment methods are:

• (a) sterilisation in hermetically sealed containers; and

• (b) heat treatments involving:
• (i) immersion in boiling water for the period required to raise the internal temperature of the mollusc flesh to not less than 90 °C and maintenance of this minimum temperature for a period of not less than 90 seconds;
• (ii) cooking for three to five minutes in an enclosed space where the temperature is between 120 and 160 °C and the pressure is between 2 and 5 kg/cm², followed by shelling and freezing of the flesh to a core temperature of – 20 °C; and
• (iii) steaming under pressure in an enclosed space satisfying the requirements relating to cooking time and the internal temperature of the mollusc flesh mentioned under (i). A validated methodology must be used. Procedures based on the HACCP principles must be in place to verify the uniform distribution of heat.

• 6.Food business operators must not produce live bivalve molluscs in, or harvest them from, areas that the competent authority has not classified, or which are unsuitable for health reasons. Food business operators must take account of any relevant information concerning areas' suitability for production and harvesting, including information obtained from own-checks and the competent authority. They must use this information, particularly information on environmental and weather conditions, to determine the appropriate treatment to apply to harvested batches.

B. REQUIREMENTS FOR HARVESTING AND HANDLING FOLLOWING HARVESTING

Food business operators harvesting live bivalve molluscs, or handling them immediately after harvesting, must ensure compliance with the following requirements.

• 1. Harvesting techniques and further handling must not cause additional contamination or excessive damage to the shells or tissues of the live bivalve molluscs or result in changes significantly affecting their suitability for treatment by purification, processing or relaying. Food business operators must in particular:
• (a) adequately protect live bivalve molluscs from crushing, abrasion or vibration;
• (b) not expose live bivalve molluscs to extreme temperatures;
• (c) not re-immerse live bivalve molluscs in water that could cause additional contamination; and
• (d) if carrying out conditioning in natural sites, use only areas that the competent authority has classified as being of class A.

• 1. Means of transport must permit adequate drainage, be equipped to ensure the best survival conditions possible and provide efficient protection against contamination.

C. REQUIREMENTS FOR RELAYING LIVE BIVALVE MOLLUSCS

Food business operators relaying live bivalve molluscs must ensure compliance with the following requirements.

• 1. Food business operators may use only those areas that the competent authority has approved for relaying live bivalve molluscs. Buoys, poles or other fixed means must clearly identify the boundaries of the sites. There must be a minimum distance between relaying areas, and also between relaying areas and production areas, so as to minimise any risk of the spread of contamination.

• 1. Conditions for relaying must ensure optimal conditions for purification. In particular, food business operators must:
• (a) use techniques for handling live bivalve molluscs intended for relaying that permit the resumption of filter-feeding activity after immersion in natural waters;
• (b) not relay live bivalve molluscs at a density that prevents purification;
• (c) immerse live bivalve molluscs in seawater at the relaying area for an appropriate period, fixed depending on the water temperature, which period must be of at least two months' duration unless the competent authority agrees to a shorter period on the basis of the food business operator's risk analysis; and
• (d) ensure sufficient separation of sites within a relaying area to prevent mixing of batches; the ‘all in, all out’ system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed.

• 1. Food business operators managing relaying areas must keep permanent records of the source of live bivalve molluscs, relaying periods, relaying areas used and the subsequent destination of the batch after relaying, for inspection by the competent authority.

CHAPTER III:   STRUCTURAL REQUIREMENTS FOR DISPATCH AND PURIFICATION CENTRES

• 1.The location of premises on land must not be subject to flooding by ordinary high tides or run-off from surrounding areas.

• 2.Tanks and water storage containers must meet the following requirements:

• (a) Internal surfaces must be smooth, durable, impermeable and easy to clean.

• (b) They must be constructed so as to allow complete draining of water.

• (c) Any water intake must be situated in a position that avoids contamination of the water supply.

• 3.In addition, in purification centres, purification tanks must be suitable for the volume and type of products to be purified.

CHAPTER IV:   HYGIENE REQUIREMENTS FOR PURIFICATION AND DISPATCH CENTRES

A. REQUIREMENTS FOR PURIFICATION CENTRES

Food business operators purifying live bivalve molluscs must ensure compliance with the following requirements.

• 1. Before purification commences, live bivalve molluscs must be free of mud and accumulated debris and washed if necessary, using clean water.

• 1. Operation of the purification system must allow live bivalve molluscs rapidly to resume and to maintain filter-feeding activity, to eliminate sewage contamination, not to become re-contaminated and to be able to remain alive in a suitable condition after purification for wrapping, storage and transport before being placed on the market.

• 1. The quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre. The live bivalve molluscs must be continuously purified for a period sufficient to achieve compliance with allow the health standards of Chapter V and microbiological criteria adopted in accordance with Regulation (EC) No 852/2004.

• 1. Should a purification tank contain several batches of live bivalve molluscs, they must be of the same species and the length of the treatment must be based on the time required by the batch needing the longest period of purification.

• 1. Containers used to hold live bivalve molluscs in purification systems must have a construction that allows clean seawater to flow through. The depth of layers of live bivalve molluscs must not impede the opening of shells during purification.

• 1. No crustaceans, fish or other marine species may be kept in a purification tank in which live bivalve molluscs are undergoing purification.

• 1. Every package containing purified live bivalve molluscs sent to a dispatch centre must be provided with a label certifying that all molluscs have been purified.

B. REQUIREMENTS FOR DISPATCH CENTRES

Food business operators operating dispatch centres must ensure compliance with the following requirements.

• 1. Handling of live bivalve molluscs, particularly conditioning, calibration, wrapping and packing, must not cause contamination of the product or affect the viability of the molluscs.

• 1. Before dispatch, the shells of live bivalve molluscs must be washed thoroughly with clean water.

• 1. Live bivalve molluscs must come from:
• (a) a class A production area;
• (b) a relaying area;
• (c) a purification centre; or
• (d) another dispatch centre.

• 1. The requirements laid down in points 1 and 2 also apply to dispatch centres situated on board vessels. Molluscs handled in such centres must come from a class A production area or a relaying area.

CHAPTER V:   HEALTH STANDARDS FOR LIVE BIVALVE MOLLUSCS

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC) No 852/2004, food business operators must ensure that live bivalve molluscs placed on the market for human consumption meet the standards laid down in this Chapter.

• 1. They must have organoleptic characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion and normal amounts of intravalvular liquid.

• 1. They must not contain marine biotoxins in total quantities (measured in the whole body or any part edible separately) that exceed the following limits:
• (a) for paralytic shellfish poison (PSP), 800 micrograms of saxitoxin equivalents diHCl per kilogram;
• (b) for amnesic shellfish poison (ASP), 20 milligrams of domoic acid per kilogram;
• (c) for okadaic acid and dinophysistoxins together 160 micrograms of okadaic acid equivalents per kilogram;
• (d) for yessotoxins, 3,75 milligrams of yessotoxin equivalent per kilogram; and
• (e) for azaspiracids, 160 micrograms of azaspiracid equivalents per kilogram.

CHAPTER VI:   WRAPPING AND PACKAGING OF LIVE BIVALVE MOLLUSCS

• 1.Oysters must be wrapped or packaged with the concave shell downwards.

• 2.All packages of live bivalve molluscs leaving dispatch centres or destined for another dispatch centre, must be closed. Packages of live bivalve molluscs, intended for direct retail sale, must remain closed until they are presented for sale to the final consumer.

CHAPTER VII:   IDENTIFICATION MARKING AND LABELLING

• 1.The label, including the identification mark, must be waterproof.

• 2.In addition to the general requirements for identification marks contained in Annex II, Section I, the following information must be present on the label:

• (a) the species of bivalve mollusc (common name and scientific name); and

• (b) the date of packaging, comprising at least the day and the month.

• By way of derogation from Directive 2000/13/EC, the date of minimum durability may be replaced by the entry ‘these animals must be alive when sold’.

• 3.The retailer must keep the label attached to the packaging of live bivalve molluscs that are not in individual consumer-size packages for at least 60 days after splitting up the contents.

CHAPTER VIII:   OTHER REQUIREMENTS

• 1.Food business operators storing and transporting live bivalve molluscs must ensure that they are kept at a temperature that does not adversely affect food safety or their viability.

• 2.Live bivalve molluscs must not be re-immersed in, or sprayed with, water after they have been packaged for retail sale and left the dispatch centre.

CHAPTER IX:   SPECIFIC REQUIREMENTS FOR PECTINIDAE, MARINE GASTROPODS AND ECHINODERMS WHICH ARE NOT FILTER FEEDERS HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS

Food business operators harvesting pectinidae, marine gastropods and echinoderms which are not filter feeders, outside classified production areas or handling such pectinidae, and/or such marine gastropods and/or echinoderms must comply with the following requirements:

• 1. Pectinidae, marine gastropods and echinoderms which are not filter feeders, must not be placed on the market unless they are harvested and handled in accordance with Part B of Chapter II and meet the standards laid down in Chapter V, as demonstrated by a system of own checks by the food business operators operating a fish auction, a dispatch centre or a processing establishment;

• 1. In addition to point 1, where data from official monitoring programmes enable the competent authority to classify fishing grounds – where appropriate, in cooperation with food business operators – the provisions of Part A of Chapter II apply by analogy to pectinidae;

• 1. Pectinidae, marine gastropods and echinoderms which are not filter feeders, must not be placed on the market for human consumption otherwise than via a fish auction, a dispatch centre or a processing establishment. When they handle pectinidae and/or such marine gastropods, and/or echinoderms food business operators operating such establishments must inform the competent authority and, as regards dispatch centres, comply with the relevant requirements of Chapters III and IV;

• 1. Food business operators handling pectinidae, marine gastropods and echinoderms which are not filter feeders, must comply with the following requirements:
• (a) with the documentary requirements of Chapter I, points 3 to 7, where applicable. In this case, the registration document must clearly indicate the location of the area, indicating the system used to describe the coordinates, where the live pectinidae and/or live marine gastropods and/or live echinoderms were harvested; or
• (b) with the requirements of Chapter VI, point 2, concerning the closing of all packages of live pectinidae, live marine gastropods and live echinoderms dispatched for retail sale and Chapter VII concerning identification marking and labelling.

CHAPTER X:   MODEL OF REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS, LIVE TUNICATES AND LIVE MARINE GASTROPODS