(a) primary production for private domestic use;

(b) the domestic preparation, handling or storage of food for private domestic consumption;

(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;

(d) the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat;

(e) hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer.

(a) Unless expressly indicated to the contrary, this Regulation shall not apply to retail.

(b) However, this Regulation shall apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless:

(c) Member States may adopt national measures to apply the requirements of this Regulation to retail establishments situated on their territory to which it would not apply pursuant to subparagraphs (a) or (b).

(a) relevant animal and public health rules, including more stringent rules laid down for the prevention, control and eradication of certain transmissible spongiform encephalopathies;

(b) animal welfare requirements;

and

(c) requirements concerning the identification of animals and the traceability of products of animal origin.

1. the definitions laid down in Regulation (EC) No 178/2002;

2. the definitions laid down in Regulation (EC) No 852/2004;

3. the definitions laid down in Annex I;

and

4. any technical definitions contained in Annexes II and III.

(a) that meet the relevant requirements of Regulation (EC) No 852/2004, those of Annexes II and III of this Regulation and other relevant requirements of food law;

and

(b) that the competent authority has registered or, where required in accordance with paragraph 2, approved.

(a) primary production;

(b) transport operations;

(c) the storage of products not requiring temperature-controlled storage conditions;

or

(d) retail operations other than those to which this Regulation applies pursuant to Article 1(5)(b).

(a) granted the establishment approval to operate following an on-site visit;

or

(b) provided the establishment with conditional approval.

(a) is subject to approval in accordance with paragraph 2 and placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation;

or

(b) is of a type in respect of which there was no requirement for approval before the application of this Regulation.

(a) a health mark applied in accordance with Regulation (EC) No 854/2004;

or

(b) when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation.

(a) the third country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No 854/2004, of third countries from which imports of that product are permitted;

(c) the product satisfies:

and

(d) the requirements of Article 14 of Regulation (EC) No 854/2004 concerning certificates and documents are satisfied, when applicable.

(a) products are made available for control upon importation in accordance with Directive 97/78/EC ( 20 );

(b) importation complies with the requirements of Directive 2002/99/EC ( 21 );

and

(c) operations under their control that take place after importation are carried out in accordance with the requirements of Annex III.

(a) model documents may be established;

and

(b) provision may be made for the use of electronic documents.

(a) meat from bovine and porcine animals, including minced meat but excluding meat preparations and MSM;

(b) meat from poultry of the following species: domestic fowl, turkeys, guinea-fowl, ducks and geese, including minced meat but excluding meat preparations and MSM;

and

(c) eggs.

(a) In the case of meat from bovine and porcine animals and meat from poultry, samples of consignments shall have been taken in the dispatching establishment and been subjected to a microbiological test with negative results in accordance with Community legislation.

(b) In the case of eggs, packing centres shall provide a guarantee that consignments originate from flocks that have been subjected to a microbiological test with negative results in accordance with Community legislation.

(c) In the case of meat from bovine and porcine animals, the test provided for in subparagraph (a) need not be carried out for consignments intended for an establishment for the purposes of pasteurisation, sterilisation or treatment having a similar effect. In the case of eggs, the test provided for in subparagraph (b) need not be carried out for consignments intended for the manufacture of processed products by a process that guarantees the elimination of salmonella.

(d) The tests provided for in subparagraphs (a) and (b) need not be carried out for foodstuffs originating in an establishment that is subject to a control programme recognised, in respect of the food of animal origin concerned and in accordance with the procedure referred to in Article 12(2), as equivalent to that approved for Sweden and Finland.

(e) In the case of meat from bovine and porcine animals and meat from poultry, a trade document or certificate conforming to a model laid down by Community legislation shall accompany the food and state that:

(f) In the case of eggs, a certificate stating that the tests referred to in subparagraph (b) have been carried out with negative results, or that the eggs are destined to be used in the manner referred to in subparagraph (c), must accompany consignments.

(a) The requirements of paragraphs 1 and 2 may be updated by the Commission, in particular to take account of changes in Member States’ control programmes or of the adoption of microbiological criteria in accordance with Regulation (EC) No 852/2004. Those measures, designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).

(b) In accordance with the regulatory procedure referred to in Article 12(2), the rules laid down in paragraph 2 of this Article in respect of any of the foodstuffs referred to in paragraph 1 of this Article may be extended, in whole or in part, to any Member State, or any region of a Member State, that has a control programme recognised as equivalent to that approved for Sweden and Finland in respect of the food of animal origin concerned.

(a) the development of guides to good practice;

(b) the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No 852/2004;

(c) the technological developments and their practical consequences and consumer expectations with regard to food composition;

(d) scientific advice, particularly new risk assessments;

(e) microbiological and temperature criteria for foodstuffs;

(f) changes in patterns of consumption.

(a) The national measures referred to in paragraph 3 shall have the aim of:

(b) In other cases, they shall apply only to the construction, layout and equipment of establishments.

(a) provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought;

(b) describe the foodstuffs and establishments concerned;

(c) explain the reasons for the adaptation, including, where relevant, by providing a summary of the hazard analysis carried out and any measures to be taken to ensure that the adaptation will not compromise the objectives of this Regulation;

and

(d) give any other relevant information.

(a) in compliance with a decision adopted in accordance with paragraph 6;

(b) if, one month after the expiry of the period referred to in paragraph 6, the Commission has not informed Member States that it has received written comments or that it intends to propose the adoption of a decision in accordance with paragraph 6;

or

(c) in accordance with paragraph 8.

(a) prohibiting or restricting the placing on the market within its territory of raw milk or raw cream intended for direct human consumption;

or

(b) permitting the use, with the authorisation of the competent authority, of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards plate count and somatic cell count of the manufacture of cheeses with an ageing or ripening period of at least 60 days, and dairy products obtained in connection with the manufacture of such cheeses, provided that this does not prejudice the achievement of the objectives of this Regulation.

1. to lay down rules for the transport of meat while it is warm;

2. to specify, in respect of MSM, which calcium content is not significantly higher than that of minced meat;

3. to lay down other treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying;

4. to specify recognised testing methods for marine biotoxins;

5. to lay down additional health standards for live bivalve molluscs in cooperation with the relevant Community Reference Laboratory, including:

6. to lay down health standards or checks, where there is scientific evidence indicating that they are necessary to protect public health;

7. to extend Annex III, Section VII, Chapter IX, to live bivalve molluscs other than pectinidae;

8. to specify criteria for determining when epidemiological data indicate that a fishing ground does not present a health hazard with regard to the presence of parasites and, consequently, for determining when the competent authority may authorise food business operators not to freeze fishery products in accordance with Annex III, Section VIII, Chapter III, Part D;

9. to lay down freshness criteria and limits with regard to histamine and total volatile nitrogen for fisheries products;

10. to permit the use for the manufacture of certain dairy products of raw milk not meeting the criteria laid down in Annex III, Section IX, as regards its plate count and somatic cell count;

11. without prejudice to Directive 96/23/EC ( 22 ), to fix a maximum permitted value for the combined total of residues of antibiotic substances in raw milk;

and

12. to approve equivalent processes for the production of gelatine or collagen.

(a) Regulation (EC) No 852/2004;

(b) Regulation (EC) No 854/2004;

and

(c) Directive 2004/41/EC.

1.1. ‘Meat’ means edible parts of the animals referred to in points 1.2 to 1.8, including blood.

1.2. ‘Domestic ungulates’ means domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds.

1.3. ‘Poultry’ means farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites.

1.4. ‘Lagomorphs’ means rabbits, hares and rodents.

1.5. ‘Wild game’ means:

1.6. ‘Farmed game’ means farmed ratites and farmed land mammals other than those referred to in point 1.2.

1.7. ‘Small wild game’ means wild game birds and lagomorphs living freely in the wild.

1.8. ‘Large wild game’ means wild land mammals living freely in the wild that do not fall within the definition of small wild game.

1.9. ‘Carcase’ means the body of an animal after slaughter and dressing.

1.10. ‘Fresh meat’ means meat that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere.

1.11. ‘Offal’ means fresh meat other than that of the carcase, including viscera and blood.

1.12. ‘Viscera’ means the organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus and, in birds, the crop.

1.13. ‘Minced meat’ means boned meat that has been minced into fragments and contains less than 1 % salt.

1.14. ‘Mechanically separated meat’ or ‘MSM’ means the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle fibre structure.

1.15. ‘Meat preparations’ means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat.

1.16. ‘Slaughterhouse’ means an establishment used for slaughtering and dressing animals, the meat of which is intended for human consumption.

1.17. ‘Cutting plant’ means an establishment used for boning and/or cutting up meat.

1.18. ‘Game-handling establishment’ means any establishment in which game and game meat obtained after hunting are prepared for placing on the market.

2.1. ‘Bivalve molluscs’ means filter-feeding lamellibranch molluscs.

2.2. ‘Marine biotoxins’ means poisonous substances accumulated by bivalve molluscs, in particular as a result of feeding on plankton containing toxins.

2.3. ‘Conditioning’ means the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before wrapping or packaging.

2.4. ‘Gatherer’ means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market.

2.5. ‘Production area’ means any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken.

2.6. ‘Relaying area’ means any sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs.

2.7. ‘Dispatch centre’ means any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption.

2.8. ‘Purification centre’ means an establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption.

2.9. ‘Relaying’ means the transfer of live bivalve molluscs to sea, lagoon or estuarine areas for the time necessary to reduce contamination to make them fit for human consumption. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening.

3.1. ‘Fishery products’ means all seawater or freshwater animals (except for live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including all edible forms, parts and products of such animals.

3.2. ‘Factory vessel’ means any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing.

3.3. ‘Freezer vessel’ means any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging.

3.4. ‘Mechanically separated fishery product’ means any product obtained by removing flesh from fishery products using mechanical means resulting in the loss or modification of the flesh structure.

3.5. ‘Fresh fishery products’ means unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preservation other than chilling.

3.6. ‘Prepared fishery products’ means unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping.

4.1. ‘Raw milk’ means milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40 °C or undergone any treatment that has an equivalent effect.

4.2. ‘Milk production holding’ means an establishment where one or more farmed animals are kept to produce milk with a view to placing it on the market as food.

5.1. ‘Eggs’ means eggs in shell — other than broken, incubated or cooked eggs — that are produced by farmed birds and are fit for direct human consumption or for the preparation of egg products.

5.2. ‘Liquid egg’ means unprocessed egg contents after removal of the shell.

5.3. ‘Cracked eggs’ means eggs with damaged shell and intact membranes.

5.4. ‘Packing centre’ means an establishment where eggs are graded by quality and weight.

6.1. ‘Frogs' legs’ means the posterior part of the body divided by a transverse cut behind the front limbs, eviscerated and skinned, of the species RNA (family Ranidae).

6.2. ‘Snails’ means terrestrial gastropods of the species Helix pomatiaLinné, Helix aspersaMuller, Helix lucorum and species of the family Achatinidae.

7.1. ‘Meat products’ means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat.

7.2. ‘Dairy products’ means processed products resulting from the processing of raw milk or from the further processing of such processed products.

7.3. ‘Egg products’ means processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products.

7.4. ‘Processed fishery products’ means processed products resulting from the processing of fishery products or from the further processing of such processed products.

7.5. ‘Rendered animal fat’ means fat derived from rendering meat, including bones, and intended for human consumption.

7.6. ‘Greaves’ means the protein-containing residue of rendering, after partial separation of fat and water.

7.7. ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals.

7.8. ‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of this Regulation.

7.9. ‘Treated stomachs, bladders and intestines’ means stomachs, bladders and intestines that have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning.

8.1. ‘Products of animal origin’ means:

8.2. ‘Wholesale market’ means a food business that includes several separate units which share common installations and sections where foodstuffs are sold to food business operators.

1. The identification mark must be applied before the product leaves the establishment of production.

2. However, when a product's packaging and/or wrapping is removed or it is further processed in another establishment, a new mark must be applied to the product. In such cases, the new mark must indicate the approval number of the establishment where these operations take place.

3. An identification mark is not necessary on packs of eggs when a packing centre code is applied in accordance with Part A of Annex XIV to Council Regulation (EC) No 1234/2007 ( 23 ).

4. Food business operators must, in accordance with Article 18 of Regulation (EC) No 178/2002, have in place systems and procedures to identify food business operators from whom they have received and to whom they have delivered products of animal origin.

5. The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities.

6. The mark must indicate the name of the country in which the establishment is located, which may be written out in full or shown as a two-letter code in accordance with the relevant ISO standard.

In the case of Member States, however, these codes are BE, BG, CZ, DK, DE, EE, GR, ES, FR, HR, IE, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, SI, SK, FI, RO, SE and UK.

7. The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food.

8. When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK, EO, EY, ES, EÜ, EK, EB, EZ or WE.

Those abbreviations must not be included in marks applied on products imported into the Community from establishments located outside the Community.

9. The mark may, depending on the presentation of different products of animal origin, be applied directly to the product, the wrapping or the packaging, or be printed on a label affixed to the product, the wrapping or the packaging. The mark may also be an irremovable tag made of a resistant material.

10. In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary, however, if the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the label may be affixed to the wrapping.

11. For products of animal origin that are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging.

12. In the case of liquid, granulate and powdered products of animal origin carried in bulk, and fishery products carried in bulk, an identification mark is not necessary if accompanying documentation contains the information specified in points 6, 7 and, where appropriate, 8.

13. When products of animal origin are placed in a package destined for direct supply to the final consumer, it is sufficient to apply the mark to the exterior of that package only.

14. When the mark is applied directly to products of animal origin, the colours used must be authorised in accordance with Community rules on the use of colouring substances in foodstuffs.

1. Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in accordance with the general requirements of Article 5 of Regulation (EC) No 852/2004 meet the requirements that the hazard analysis shows to be necessary and the specific requirements listed in point 2.

2. The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises:

3. In the event of failure to comply with any of the requirements listed under point 2, the food business operator must notify the official veterinarian and take appropriate measures.

1. Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested, and been provided with, relevant food chain information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No 852/2004.

2. Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals at the slaughterhouse, except in the circumstances mentioned in point 7.

3. The relevant food chain information referred to in point 1 is to cover, in particular:

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5. Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant food chain information must make it available to the official veterinarian without delay and, except in the circumstances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem inspection of the animal concerned.

6. If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits.

7. If the competent authority so permits and provided it does not jeopardise the objectives of this Regulation, food chain information may arrive less than 24 hours before the arrival of the animals of all species to which it relates at the slaughterhouse or accompany these animals to the slaughterhouse.

However, any item of food chain information, knowledge of which may result in serious disruption of the slaughterhouse activity, is to be made available to the food business operator operating the slaughterhouse in sufficient time before the animals arrive at the slaughterhouse, in order for that food business operator to plan the slaughterhouse activity accordingly.

The food business operator operating the slaughterhouse must evaluate the relevant information and must submit the food chain information received to the official veterinarian. The slaughter or dressing of the animals may not take place until the official veterinarian so permits.

8. Food business operators must check passports accompanying domestic solipeds to ensure that the animal is intended for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the official veterinarian.

1. For the purposes of this Section, ‘date of production’ means:

2. Until the stage at which a food is labelled in accordance with Directive 2000/13/EC or used for further processing, food business operators must ensure that in the case of frozen food of animal origin intended for human consumption, the following information is made available to the food business operator to whom the food is supplied and, upon request, to the competent authority:

Where a food is made from a batch of raw materials with different dates of production and of freezing, the oldest dates of production and/or of freezing, as appropriate, must be made available.

3. The appropriate form in which the information must be made available is up to the choice of the supplier of the frozen food, as long as the information requested in paragraph 2 will be clearly and unequivocally available to and retrievable by the business operator to whom the food is supplied.

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

2. Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public health importance may only be transported to the slaughterhouse when the competent authority so permits.

2. To avoid contaminating meat, they must:

3. 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.

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

5. 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.

6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of transport for livestock. However, slaughterhouses need not have these places and facilities if the competent authority so permits and official authorised places and facilities exist nearby.

7. They must have lockable facilities reserved for the slaughter of sick and suspect animals. This is not essential if this slaughter takes place in other establishments authorised by the competent authority for this purpose, or at the end of the normal slaughter period.

8. If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that purpose.

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

1. are constructed so as to avoid contamination of meat, in particular by:

2. 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;

3. have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

4. have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff engaged in handling exposed meat; and

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

1. After arrival in the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, where required for welfare reasons, animals must be given a resting period before slaughter.

3. The animals or, where appropriate, each batch of animals sent for slaughter must be identified so that their origin can be traced.

4. Animals must be clean.

5. Slaughterhouse operators must follow the instructions of the veterinarian appointed by the competent authority in accordance with Regulation (EC) No 854/2004 to ensure that ante-mortem inspection of every animal to be slaughtered is carried out under suitable conditions.

6. Animals brought into the slaughter hall must be slaughtered without undue delay.

7. Stunning, bleeding, skinning, evisceration and other dressing must be carried out without undue delay and in a manner that avoids contaminating the meat. In particular:

8. Carcases and other parts of the body intended for human consumption must be completely skinned, except in the case of porcine animals, the heads of ovine and caprine animals and calves, the muzzle and lips of bovine animals and the feet of bovine, ovine and caprine animals. Heads, including muzzle and lips, and feet must be handled in such a way as to avoid contamination.

9. When not skinned, porcine animals must have their bristles removed immediately. The risk of contamination of the meat with scalding water must be minimised. Only approved additives may be used for this operation. Porcine animals must be thoroughly rinsed afterwards with potable water.

10. The carcases must not contain visible faecal contamination. Any visible contamination must be removed without delay by trimming or alternative means having an equivalent effect.

11. Carcases and offal must not come into contact with floors, walls or work stands.

12. Slaughterhouse operators must follow the instructions of the competent authority to ensure that post-mortem inspection of all slaughtered animals is carried out under suitable conditions in accordance with Regulation (EC) No 854/2004.

13. Until post-mortem inspection is completed, parts of a slaughtered animal subject to such inspection must:

However, provided that it shows no pathological lesion, the penis may be discarded immediately.

14. Both kidneys must be removed from their fatty covering. In the case of bovine and porcine animals, and solipeds, the peri-renal capsule must also be removed.

15. If the blood or other offal of several animals is collected in the same container before completion of post-mortem inspection, the entire contents must be declared unfit for human consumption if the carcase of one or more of the animals concerned has been declared unfit for human consumption.

16. After post-mortem inspection:

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17. After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the requirements laid down in Chapter VII.

18. When destined for further handling:

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

20. If the slaughterhouse does not have lockable facilities reserved for the slaughter of sick or suspect animals, the facilities used to slaughter such animals must be cleaned, washed and disinfected under official supervision before the slaughter of other animals is resumed.

1. Carcases of domestic ungulates may be cut into half-carcases or quarters, and half carcases into no more than three wholesale cuts, in slaughterhouses. Further cutting and boning must be carried out in a cutting plant.

2. 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:

3. However, meat may be boned and cut before it reaches the temperature referred to in point 2(b) in accordance with Chapter VII, point 3.

4. Meat may also be boned and cut prior to reaching the temperature referred to in point 2(b) when the cutting room is on the same site as the slaughter premises. In this case, the meat must be transferred to the cutting room either directly from the slaughter premises or after a waiting period in a chilling or refrigerating room. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 2(b).

1. An otherwise healthy animal must have suffered an accident that prevented its transport to the slaughterhouse for welfare reasons.

2. A veterinarian must carry out an ante-mortem inspection of the animal.

3. The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay. Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal.

4. If more than two hours elapse between slaughter and arrival at the slaughterhouse, the animal must be refrigerated. Where climatic conditions so permit, active chilling is not necessary.

5. A declaration by the food business operator who reared the animal, stating the identity of the animal and indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, must accompany the slaughtered animal to the slaughterhouse.

6. A declaration issued by the veterinarian recording the favourable outcome of the ante-mortem inspection, the date and time of, and reason for, emergency slaughter, and the nature of any treatment administered by the veterinarian to the animal, must accompany the slaughtered animal to the slaughterhouse.

7. The slaughtered animal must be fit for human consumption following post-mortem inspection carried out in the slaughterhouse in accordance with Regulation (EC) No 854/2004, including any additional tests required in the case of emergency slaughter.

8. Food business operators must follow any instructions that the official veterinarian may give after post-mortem inspection concerning the use of the meat.

2. Meat must attain the temperature specified in point 1 and remain at that temperature during storage.

3. Meat must attain the temperature specified in point 1 before transport, and remain at that temperature during transport. However, transport may also take place if the competent authority so authorises to enable the production of specific products, provided that:

4. Meat intended for freezing must be frozen without undue delay, taking into account where necessary a stabilisation period before freezing.

5. 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.

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

2. 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.

3. 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.

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

2. To avoid contaminating meat, they must:

3. 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.

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

5. 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.

6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of:

These places and facilities are not compulsory for (b) if officially authorised places and facilities exist nearby.

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

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

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

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

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

3. 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.

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

5. 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.

6. 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.

7. After post-mortem inspection:

8. 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.

9. When carcases are subjected to an immersion chilling process, account must be taken of the following.

10. 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.

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:

2. 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:

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

4. 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:

5. Meat derived from poultry and lagomorphs intended for freezing must be frozen without undue delay.

6. 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.

1. The farm must undergo regular veterinary inspection.

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

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

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

5. Animal welfare requirements must be complied with.

6. The slaughtered birds must be accompanied to the slaughterhouse by a declaration by the food business operator who reared the animal indicating any veterinary products or other treatments administered to the animal, dates of administration and withdrawal periods, and the date and time of slaughter.

7. The slaughtered animal must be accompanied to the slaughterhouse by a certificate issued by the official veterinarian or approved veterinarian in accordance with Regulation (EC) No 854/2004.

8. 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.

9. 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.

1. The provisions of Section I apply to the production and placing on the market of meat from even-toed farmed game mammals (Cervidae and Suidae), 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:

3a. By 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 declaration by the food business operator referred to in point 3(i), provided that:

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

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:

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

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.

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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:

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

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.

1. are constructed so as to avoid contamination of meat and products, in particular by:

2. 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;

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

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

and

5. 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 raw material used to prepare minced meat must meet the following requirements.

2. The following raw material may be used to prepare meat preparations:

3. The raw material used to produce MSM must meet 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:

2. The following requirements apply to the production of minced meat and meat preparations.

3. 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.

4. The following requirements apply to the production and use of MSM produced using techniques other than those mentioned in point 3.

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

1. In addition to the requirements of Directive 2000/13/EC ( 26 ), 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.

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

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.

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. Provisions on classification of production areas set out in Chapter II part A of that Section do not apply to marine gastropods which are not filter feeders.

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:

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 establishments, up to and including the arrival of the batch at a dispatch centre or processing establishment, 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.

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:

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

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:

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.

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:

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

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.

2. Conditions for relaying must ensure optimal conditions for purification. In particular, food business operators must:

3. 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.

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:

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

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

2. 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.

3. 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.

4. 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.

5. 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.

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

7. 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.

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.

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

3. Live bivalve molluscs must come from:

4. 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.

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.

2. They must not contain marine biotoxins in total quantities (measured in the whole body or any part edible separately) that exceed the following limits:

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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.

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:

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.

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.

1. Pectinidae and marine gastropods, which are not filter feeders, may not be placed on the market unless they are harvested and handled in accordance with Chapter II, Part B, and meet the standards laid down in Chapter V, as proved by a system of own-checks.

2. In addition, 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 Chapter II, Part A, apply by analogy to pectinidae

3. Pectinidae and marine gastropods, which are not filter feeders, may 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, 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.

4. Food business operators handling pectinidae and live marine gastropods, which are not filter feeders, must comply:

1. This Section does not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods if they are still alive when placed on the market. With the exception of Chapters I and II, it applies to such animals when not placed on the market live, in which case they must have been obtained in accordance with Section VII.

It applies to thawed unprocessed fishery products and fresh fishery products to which food additives have been added in accordance with the appropriate Union legislation.

2. Chapter III, Parts A, C and D, Chapter IV, Part A and Chapter V apply to retail.

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

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By way of derogation from point (a), point 7 of Part A of Annex I to Regulation (EC) No 852/2004 may not apply to operators engaged in small-scale coastal fishing within the meaning of Article 26(1) of Council Regulation (EC) No 1198/2006 ( 27 ), and carrying out their activities only for short periods of less than 24 hours.

4. In relation to fishery products:

1. vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, comply with the structural and equipment requirements laid down in Part I;

and

2. operations carried out on board vessels take place in accordance with the rules laid down in Part II.

1. Vessels must be designed and constructed so as not to cause contamination of the products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances.

2. Surfaces with which fishery products come into contact must be of suitable corrosion-resistant material that is smooth and easy to clean. Surface coatings must be durable and non-toxic.

3. Equipment and material used for working on fishery products must be made of corrosion-resistant material that is easy to clean and disinfect.

4. When vessels have a water intake for water used with fishery products, it must be situated in a position that avoids contamination of the water supply.

1. Vessels designed and equipped to preserve fishery products for more than 24 hours must be equipped with holds, tanks or containers for the storage of fishery products at the temperatures laid down in Chapter VII.

2. Holds must be separated from the engine compartments and from the crew quarters by partitions which are sufficient to prevent any contamination of the stored fishery products. Holds and containers used for the storage of fishery products must ensure their preservation under satisfactory conditions of hygiene and, where necessary, ensure that melt water does not remain in contact with the products.

3. In vessels equipped for chilling fishery products in cooled clean seawater, tanks must incorporate devices for achieving a uniform temperature throughout the tanks. Such devices must achieve a chilling rate that ensures that the mix of fish and clean seawater reaches not more than 3 °C six hours after loading and not more than 0 °C after 16 hours and allow the monitoring and, where necessary, recording of temperatures.

1. have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature of not more than -18 °C;

2. have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more than -18 °C. Storage holds must be equipped with a temperature-recording device in a place where it can be easily read. The temperature sensor of the reader must be situated in the area where the temperature in the hold is the highest;

and

3. meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid down in Part B, point 2.

1. Factory vessels must have at least:

2. However, factory vessels on board which crustaceans and molluscs are cooked, chilled and wrapped, need not meet the requirements of point 1 if no other form of handling or processing takes place on board such vessels.

3. Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid down in Part C, points 1 and 2.

1. When in use, the parts of vessels or containers set aside for the storage of fishery products must be kept clean and maintained in good repair and condition. In particular, they must not be contaminated by fuel or bilge water.

2. As soon as possible after they are taken on board, fishery products must be protected from contamination and from the effects of the sun or any other source of heat. ►M6  ————— ◄

3. Fishery products must be handled and stored so as to prevent bruising. Handlers may use spiked instruments to move large fish or fish which might injure them, provided that the flesh of the products suffers no damage.

4. Fishery products other than those kept alive must undergo chilling as soon as possible after loading. However, when chilling is not possible, fishery products must be landed as soon as possible.

6. Where fish are headed and/or gutted on board, such operations must be carried out hygienically as soon as possible after capture, and the products must be washed immediately and thoroughly. In that event, the viscera and parts that may constitute a danger to public health must be removed as soon as possible and kept apart from products intended for human consumption. Livers and roes intended for human consumption must be preserved under ice, at a temperature approaching that of melting ice, or be frozen.

7. Where freezing in brine of whole fish intended for canning is practised, a temperature of not more than – 9 °C must be achieved for the product. The brine must not be a source of contamination for the fish.

1. Food business operators responsible for the unloading and landing of fishery products must:

2. Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are displayed for sale must ensure compliance with the following requirements.

3. When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice.

4. Food business operators must cooperate with relevant competent authorities so as to permit them to carry out official controls in accordance with Regulation (EC) No 854/2004, in particular as regards any notification procedures for the landing of fishery products that the competent authority of the Member State the flag of which the vessel is flying or the competent authority of the Member State where the fishery products are landed might consider necessary.

1. Where chilled, unpackaged products are not distributed, dispatched, prepared or processed immediately after reaching an establishment on land, they must be stored under ice in appropriate facilities. Re-icing must be carried out as often as necessary. Packaged fresh fishery products must be chilled to a temperature approaching that of melting ice.

2. Operations such as heading and gutting must be carried out hygienically. Where gutting is possible from a technical and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or landed. The products must be washed thoroughly immediately after these operations.

3. Operations such as filleting and cutting must be carried out so as to avoid contamination or spoilage of fillets and slices. Fillets and slices must not remain on the worktables beyond the time necessary for their preparation. Fillets and slices must be wrapped and, where necessary, packaged and must be chilled as quickly as possible after their preparation.

4. Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must ensure that melt water does not remain in contact with the products.

5. Whole and gutted fresh fishery products may be transported and stored in cooled water on board vessels. They may also continue to be transported in cooled water after landing, and be transported from aquaculture establishments, until they arrive at the first establishment on land carrying out any activity other than transport or sorting.

1. The raw materials used must satisfy the following requirements.

2. The manufacturing process must satisfy the following requirements:

1. Food business operators placing on the market the following fishery products derived from finfish or cephalopod molluscs:

must ensure that the raw material or finished product undergo a freezing treatment in order to kill viable parasites that may be a risk to the health of the consumer.

2. For parasites other than trematodes the freezing treatment must consist of lowering the temperature in all parts of the product to at least:

3. Food business operators need not carry out the freezing treatment set out in point 1 for fishery products:

1. Rapid cooling must follow cooking. If no other method of preservation is used, cooling must continue until a temperature approaching that of melting ice is reached.

2. Shelling or shucking must be carried out hygienically, avoiding contamination of the product. Where such operations are done by hand, workers must pay particular attention to washing their hands.

3. After shelling or shucking, cooked products must be frozen immediately, or be chilled as soon as possible to the temperature set out in Chapter VII.

1. Raw materials used in the preparation of fish oil for human consumption must:

By way of derogation from point 1(d), the food business operator may refrain from chilling the fishery products when whole fishery products are used directly in the preparation of fish oil for human consumption, and the raw material is processed within 36 hours after loading, provided that the freshness criteria are met and the total volatile basic nitrogen (TVB-N) value of the unprocessed fishery products do not exceed the limits set out in point 1 of Chapter I of Section II of Annex II to Commission Regulation (EC) No 2074/2005 ( 28 ).

2. The production process for fish oil must ensure that all raw material intended for the production of crude fish oil is subject to a treatment including, where relevant, heating, pressing, separation, centrifugation, processing, refining and purification steps before being placed on the market for the final consumer.

3. Provided that the raw materials and the production process comply with the requirements applying to fish oil intended for human consumption a food business operator may produce and store both fish oil for human consumption and fish oil and fish meal not intended for human consumption in the same establishment.

4. Pending the establishment of specific Community legislation food business operators must ensure compliance with national rules for fish oil being placed on the market for the final consumer.

1. Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae.

Fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, may only be placed on the market in wrapped/packaged form and must be appropriately labelled to provide information to the consumer on preparation/cooking methods and on the risk related to the presence of substances with adverse gastrointestinal effects.

The scientific name of the fishery products must accompany the common name on the label.

2. Fishery products containing biotoxins such as ciguatoxin or muscle-paralysing toxins must not be placed on the market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII and comply with the standards laid down in Chapter V, point 2, of that section.

1. Receptacles in which fresh fishery products are kept under ice must be water-resistant and ensure that melt-water does not remain in contact with the products.

2. Frozen blocks prepared on board vessels must be adequately wrapped before landing.

3. When fishery products are wrapped on board fishing vessels, food business operators must ensure that wrapping material:

1. Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice.

2. Frozen fishery products must be kept at a temperature of not more than – 18 °C in all parts of the product; however, whole fish initially frozen in brine intended for the manufacture of canned food may be kept at a temperature of not more than – 9 °C.

3. Fishery products kept alive must be kept at a temperature and in a manner that does not adversely affect food safety or their viability.

1. During transport, fishery products must be maintained at the required temperature. In particular:

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2. Food business operators need not comply with point 1(b) when frozen fishery products are transported from a cold store to an approved establishment to be thawed on arrival for the purposes of preparation and/or processing, if the journey is short and the competent authority so permits.

3. If fishery products are kept under ice, melt water must not remain in contact with the products.

4. Fishery products to be placed on the market live must be transported in such a way as not adversely to affect food safety or their viability.

1. ‘Colostrum’ means the fluid secreted by the mammary glands of milk-producing animals up to three to five days post parturition that is rich in antibodies and minerals, and precedes the production of raw milk.

2. ‘Colostrum-based products’ means processed products resulting from the processing of colostrum or from the further processing of such processed products.

1. Raw milk and colostrum must come from animals:

3. However, raw milk from animals that does not meet the requirements of point 2 may be used with the authorisation of the competent authority:

4. Raw milk and colostrum from any animal not complying with the appropriate requirements of points 1 to 3, and in particular, any animal showing individually a positive reaction to the prophylactic tests vis-à-vis tuberculosis or brucellosis as laid down in Directive 64/432/EEC and Directive 91/68/EEC, must not be used for human consumption.

5. The isolation of animals that are infected, or suspected of being infected, with any of the diseases referred to in point 1 or 2 must be effective to avoid any adverse effect on other animals' milk and colostrum.

1. Milking equipment and premises where milk and colostrum are stored, handled or cooled must be located and constructed so as to limit the risk of contamination of milk and colostrum.

2. Premises for the storage of milk and colostrum must be protected against vermin, have adequate separation from premises where animals are housed and, where necessary to meet the requirements laid down in Part B, have suitable refrigeration equipment.

3. Surfaces of equipment that are intended to come into contact with milk and colostrum (utensils, containers, tanks, etc. intended for milking, collection or transport) must be easy to clean and, where necessary, disinfect and must be maintained in a sound condition. This requires the use of smooth, washable and non-toxic materials.

4. After use, such surfaces must be cleaned and, where necessary, disinfected. After each journey, or after each series of journeys when the period of time between unloading and the following loading is very short, but in all cases at least once a day, containers and tanks used for the transport of milk and colostrum must be cleaned and disinfected in an appropriate manner before re-use.

1. Milking must be carried out hygienically, ensuring in particular:

2. Immediately after milking, milk and colostrum must be held in a clean place designed and equipped to avoid contamination.

3. During transport the cold chain must be maintained and, on arrival at the establishment of destination, the temperature of the milk and the colostrum must not be more than 10 oC.

4. Food business operators need not comply with the temperature requirements laid down in points 2 and 3 if the milk meets the criteria provided for in Part III and either:

1. Persons performing milking and/or handling raw milk and colostrum must wear suitable clean clothes.

2. Persons performing milking must maintain a high degree of personal cleanliness. Suitable facilities must be available near the place of milking to enable persons performing milking and handling raw milk and colostrum to wash their hands and arms.

2. A representative number of samples of raw milk and colostrum collected from milk production holdings taken by random sampling must be checked for compliance with points 3 and 4 in case of raw milk and with the existing national criteria referred to in point 1(b) in case of colostrum. The checks may be carried out by, or on behalf of:

4. Without prejudice to Directive 96/23/EC, food business operators must initiate procedures to ensure that raw milk is not placed on the market if either:

5. When raw milk fails to comply with point 3 or 4, the food business operator must inform the competent authority and take measures to correct the situation.

1. Food business operators must ensure that, upon acceptance at a processing establishment,

and kept at that temperature until processed.

2. However, food business operators may keep milk and colostrum at a higher temperature if:

1. When raw milk, colostrum, dairy or colostrum-based products undergo heat treatment, food business operators must ensure that this satisfies the requirements laid down in Chapter XI of Annex II to Regulation (EC) No 852/2004. In particular, they shall ensure, when using the following processes, that they comply with the specifications mentioned:

such that the products show, where applicable, a negative reaction to an alkaline phosphatase test immediately after such treatment.

2. When considering whether to subject raw milk and colostrum to heat treatment, food business operators must:

1. Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before being heat treated and if its period of acceptance specified in the HACCP-based procedures is exceeded:

2. When milk fails to meet the criteria laid down in paragraph 1, the food business operator must inform the competent authority and take measures to correct the situation.

1. In addition to the requirements of Directive 2000/13/EC, except in the cases envisaged in Article 13(4) and (5) of that Directive, labelling must clearly show:

2. The requirements of paragraph 1 apply to products destined for retail trade. The term ‘labelling’ includes any packaging, document, notice, label, ring or collar accompanying or referring to such products.

1. rather than indicating the approval number of the establishment, the identification mark may include a reference to where on the wrapping or packaging the approval number of the establishment is indicated;

2. in the case of the reusable bottles, the identification mark may indicate only the initials of the consigning country and the approval number of the establishment.

1. At the producer's premises, and until sale to the consumer, eggs must be kept clean, dry, free of extraneous odour, effectively protected from shocks and out of direct sunshine.

2. Eggs must be stored and transported until sale to the final consumer at a temperature, preferably constant, that is best suited to assure optimal conservation of their hygiene properties, unless the competent authority imposes national temperature requirements for egg storage facilities and for vehicles transporting eggs between such storage facilities.

3. Eggs must be delivered to the consumer within a maximum time limit of 21 days of laying.

1. washing, drying and disinfecting dirty eggs, where carried out;

2. breaking eggs, collecting their contents and removing parts of shells and membranes;

and

3. operations other than those referred to in points 1 and 2.

1. The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks. However, cracked eggs may be used for the manufacture of liquid egg or egg products if the establishment of production or a packing centre delivers them directly to an establishment approved for the manufacture of liquid egg or a processing establishment, where they must be broken as soon as possible.

2. Liquid egg obtained in an establishment approved for that purpose may be used as raw material. Liquid egg must be obtained in accordance with the requirements of points 1, 2, 3, 4 and 7 of Part III.

1. Eggs must not be broken unless they are clean and dry.

2. Eggs must be broken in a manner that minimises contamination, in particular by ensuring adequate separation from other operations. Cracked eggs must be processed as soon as possible.

3. Eggs other than those of hens, turkeys or guinea fowl must be handled and processed separately. All equipment must be cleaned and disinfected before processing of hens', turkeys' and guinea fowls' eggs is resumed.

4. Egg contents may not be obtained by the centrifuging or crushing of eggs, nor may centrifuging be used to obtain the remains of egg whites from empty shells for human consumption.

5. After breaking, each particle of the liquid egg must undergo processing as quickly as possible to eliminate microbiological hazards or to reduce them to an acceptable level. A batch that has been insufficiently processed may immediately undergo processing again in the same establishment if this processing renders it fit for human consumption. Where a batch is found to be unfit for human consumption, it must be denatured to ensure that it is not used for human consumption.

6. Processing is not required for egg white intended for the manufacture of dried or crystallised albumin destined subsequently to undergo heat treatment.

7. If processing is not carried out immediately after breaking, liquid egg must be stored either frozen or at a temperature of not more than 4 °C. The storage period before processing at 4 °C must not exceed 48 hours. However, these requirements do not apply to products to be de-sugared, if de-sugaring process is performed as soon as possible.

8. Products that have not been stabilised so as to be kept at room temperature must be cooled to not more than 4 °C. Products for freezing must be frozen immediately after processing.

1. The concentration of 3-OH-butyric acid must not exceed 10 mg/kg in the dry matter of the unmodified egg product.

2. The lactic acid content of raw material used to manufacture egg products must not exceed 1 g/kg of dry matter. However, for fermented products, this value must be the one recorded before the fermentation process.

3. The quantity of eggshell remains, egg membranes and any other particles in the processed egg product must not exceed 100 mg/kg of egg product.

1. In addition to the general requirements for identification marking laid down in Annex II, Section I, consignments of egg products, destined not for retail but for use as an ingredient in the manufacture of another product, must have a label giving the temperature at which the egg products must be maintained and the period during which conservation may thus be assured.

2. In the case of liquid egg, the label referred to in point 1 must also bear the words: ‘non-pasteurised liquid egg — to be treated at place of destination’ and indicate the date and hour of breaking.

1. Frogs and snails must be killed in an establishment constructed, laid out and equipped for that purpose.

2. Establishment in which frogs' legs are prepared must have a room reserved for the storage and washing of live frogs, and for their slaughter and bleeding. This room must be physically separate from the preparation room.

3. Frogs and snails that die otherwise than by being killed in the establishment must not be prepared for human consumption.

4. Frogs and snails must be subjected to an organoleptic examination carried out by sampling. If that examination indicates that they might present a hazard, they must not be used for human consumption.

5. Immediately following preparation, frogs' legs must be washed fully with running potable water and immediately chilled to a temperature approaching that of melting ice, frozen or processed.

6. After killing, snails' hepato-pancreas must, if it might present a hazard, be removed and not be used for human consumption.

1. Centres for the collection of raw materials and further transport to processing establishments must be equipped with facilities for the storage of raw materials at a temperature of not more than 7 °C.

2. Each processing establishment must have:

3. However, the refrigeration facilities required under points 1 and 2(a) are not necessary if the arrangements for the supply of raw materials ensure that they are never stored or transported without active refrigeration otherwise than as provided for in Chapter II, point 1(d).

1. Raw materials must:

2. During rendering the use of solvents is prohibited.

3. When the fat for refining meets the standards laid down in point 4, rendered animal fat prepared in accordance with points 1 and 2 may be refined in the same establishment or in another establishment with a view to improving its physico-chemical quality.

4. Rendered animal fat, depending on type, must meet the following standards:

5. Greaves intended for human consumption must be stored in accordance with the following temperature requirements.

1. Animal intestines, bladders and stomachs may be placed on the market only if:

2. Treated stomachs, bladders and intestines that cannot be kept at ambient temperature must be stored chilled using facilities intended for that purpose until their dispatch. In particular, products that are not salted or dried must be kept at a temperature of not more than 3 °C.

1. Food business operators manufacturing gelatine must ensure compliance with the requirements of this section.

2. For the purpose of this section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

1. For the production of gelatine intended for use in food, the following raw materials may be used:

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2. The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

3. Raw materials listed in point 1(a) to (e) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-mortem and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption.

4. Raw materials must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation.

5. Collection centres and tanneries may also supply raw material for the production of gelatine intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.

1. In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the gelatine-processing establishment.

2. Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature.

1. The production process for gelatine must ensure that:

2. A food business operator may produce and store both gelatine intended for human consumption and gelatine not intended for human consumption in the same establishment provided that the raw materials and the production process comply with the requirements applying to gelatine intended for human consumption.

1. Food business operators manufacturing collagen must ensure compliance with the requirements of this section.

2. For the purpose of this section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

1. For the production of collagen intended for use in food, the following raw materials may be used:

2. The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

3. Raw materials listed in point 1(a) to (d) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption.

4. Raw materials must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation.

5. Collection centres and tanneries may also supply raw material for the production of collagen intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.

1. In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the collagen-processing establishment.

2. Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature.

1. The production process for collagen must ensure that:

2. After having been subjected to the process referred to in point 1, collagen may undergo a drying process.

3. A food business operator may produce and store both collagen intended for human consumption and collagen not intended for human consumption in the same establishment provided that the raw materials and the production process comply with the requirements applying to collagen intended for human consumption.