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Regulation (EC) No 853/2004 of the European Parliament and of the CouncilShow full title

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

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  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Scope

    2. Article 2.Definitions

  3. CHAPTER II FOOD BUSINESS OPERATORS' OBLIGATIONS

    1. Article 3.General obligations

    2. Article 4.Registration and approval of establishments

    3. Article 5.Health and identification marking

    4. Article 6.Products of animal origin from outside the Community

  4. CHAPTER III TRADE

    1. Article 7.Documents

    2. Article 8.Special guarantees

  5. CHAPTER IV FINAL PROVISIONS

    1. Article 9.Transitional measures of general scope designed to amend non-essential elements...

    2. Article 10.Amendment and adaptation of Annexes II and III

    3. Article 11.Specific decisions

    4. Article 12.Committee procedure

    5. Article 13.Consultation of the European Food Safety Authority

    6. Article 14.Report to the European Parliament and to the Council

    7. Article 15.This Regulation shall enter into force on the 20th day...

  6. Signature

    1. ANNEX I

      DEFINITIONS

      1. For the purpose of this Regulation:

      2. 1. MEAT

        1. 1.1. ‘Meat’ means edible parts of the animals referred to in...

        2. 1.2. ‘Domestic ungulates’ means domestic bovine (including Bubalus and Bison species),...

        3. 1.3. ‘Poultry’ means farmed birds, including birds that are not considered...

        4. 1.4. ‘Lagomorphs’ means rabbits, hares and rodents.

        5. 1.5. ‘Wild game’ means:

        6. 1.6. ‘Farmed game’ means farmed ratites and farmed land mammals other...

        7. 1.7. ‘Small wild game’ means wild game birds and lagomorphs living...

        8. 1.8. ‘Large wild game’ means wild land mammals living freely in...

        9. 1.9. ‘Carcase’ means the body of an animal after slaughter and...

        10. 1.10. ‘Fresh meat’ means meat that has not undergone any preserving...

        11. 1.11. ‘Offal’ means fresh meat other than that of the carcase,...

        12. 1.12. ‘Viscera’ means the organs of the thoracic, abdominal and pelvic...

        13. 1.13. ‘Minced meat’ means boned meat that has been minced into...

        14. 1.14. ‘Mechanically separated meat’ or ‘MSM’ means the product obtained by...

        15. 1.15. ‘Meat preparations’ means fresh meat, including meat that has been...

        16. 1.16. ‘Slaughterhouse’ means an establishment used for slaughtering and dressing animals,...

        17. 1.17. ‘Cutting plant’ means an establishment used for boning and/or cutting...

        18. 1.18. ‘Game-handling establishment’ means any establishment in which game and game...

      3. 2. LIVE BIVALVE MOLLUSCS

        1. 2.1. ‘Bivalve molluscs’ means filter-feeding lamellibranch molluscs.

        2. 2.2. ‘Marine biotoxins’ means poisonous substances accumulated by bivalve molluscs, in...

        3. 2.3. ‘Conditioning’ means the storage of live bivalve molluscs coming from...

        4. 2.4. ‘Gatherer’ means any natural or legal person who collects live...

        5. 2.5. ‘Production area’ means any sea, estuarine or lagoon area, containing...

        6. 2.6. ‘Relaying area’ means any sea, estuarine or lagoon area with...

        7. 2.7. ‘Dispatch centre’ means any on-shore or off-shore establishment for the...

        8. 2.8. ‘Purification centre’ means an establishment with tanks fed by clean...

        9. 2.9. ‘Relaying’ means the transfer of live bivalve molluscs to sea,...

      4. 3. FISHERY PRODUCTS

        1. 3.1. ‘Fishery products’ means all seawater or freshwater animals (except for...

        2. 3.2. ‘Factory vessel’ means any vessel on board which fishery products...

        3. 3.3. ‘Freezer vessel’ means any vessel on board which freezing of...

        4. 3.4. ‘Mechanically separated fishery product’ means any product obtained by removing...

        5. 3.5. ‘Fresh fishery products’ means unprocessed fishery products, whether whole or...

        6. 3.6. ‘Prepared fishery products’ means unprocessed fishery products that have undergone...

      5. 4. MILK

        1. 4.1. ‘Raw milk’ means milk produced by the secretion of the...

        2. 4.2. ‘Milk production holding’ means an establishment where one or more...

      6. 5. EGGS

        1. 5.1. ‘Eggs’ means eggs in shell — other than broken, incubated...

        2. 5.2. ‘Liquid egg’ means unprocessed egg contents after removal of the...

        3. 5.3. ‘Cracked eggs’ means eggs with damaged shell and intact membranes....

        4. 5.4. ‘Packing centre’ means an establishment where eggs are graded by...

      7. 6. FROGS' LEGS AND SNAILS

        1. 6.1. ‘Frogs' legs’ means the posterior part of the body divided...

        2. 6.2. ‘Snails’ means terrestrial gastropods of the species Helix pomatiaLinné, Helix...

      8. 7. PROCESSED PRODUCTS

        1. 7.1. ‘Meat products’ means processed products resulting from the processing of...

        2. 7.2. ‘Dairy products’ means processed products resulting from the processing of...

        3. 7.3. ‘Egg products’ means processed products resulting from the processing of...

        4. 7.4. ‘Processed fishery products’ means processed products resulting from the processing...

        5. 7.5. ‘Rendered animal fat’ means fat derived from rendering meat, including...

        6. 7.6. ‘Greaves’ means the protein-containing residue of rendering, after partial separation...

        7. 7.7. ‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by...

        8. 7.8. ‘Collagen’ means the protein-based product derived from animal bones, hides,...

        9. 7.9. ‘Treated stomachs, bladders and intestines’ means stomachs, bladders and intestines...

      9. 8. OTHER DEFINITIONS

        1. 8.1. ‘Products of animal origin’ means:

        2. 8.2. ‘Wholesale market’ means a food business that includes several separate...

    2. ANNEX II

      REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN

      1. SECTION I: IDENTIFICATION MARKING

        1. A. APPLICATION OF THE IDENTIFICATION MARK

        2. B. FORM OF THE IDENTIFICATION MARK

        3. C. METHOD OF MARKING

      2. SECTION II: OBJECTIVES OF HACCP-BASED PROCEDURES

      3. SECTION III: FOOD CHAIN INFORMATION

    3. ANNEX III

      SPECIFIC REQUIREMENTS

      1. SECTION I: MEAT OF DOMESTIC UNGULATES

        1. CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

        2. CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES

        3. CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS

        4. CHAPTER IV: SLAUGHTER HYGIENE

        5. CHAPTER V: HYGIENE DURING CUTTING AND BONING

        6. CHAPTER VI: EMERGENCY SLAUGHTER OUTSIDE THE SLAUGHTERHOUSE

        7. CHAPTER VII: STORAGE AND TRANSPORT

      2. SECTION II: MEAT FROM POULTRY AND LAGOMORPHS

        1. CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

        2. CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES

        3. CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS

        4. CHAPTER IV: SLAUGHTER HYGIENE

        5. CHAPTER V: HYGIENE DURING AND AFTER CUTTING AND BONING

        6. CHAPTER VI: SLAUGHTER ON THE FARM

        7. CHAPTER VII: WATER RETENTION AGENTS

      3. SECTION III: MEAT OF FARMED GAME

      4. SECTION IV: WILD GAME MEAT

        1. CHAPTER I: TRAINING OF HUNTERS IN HEALTH AND HYGIENE

        2. CHAPTER II: HANDLING OF LARGE WILD GAME

        3. CHAPTER III: HANDLING OF SMALL WILD GAME

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

        1. CHAPTER I: REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS

        2. CHAPTER II: REQUIREMENTS FOR RAW MATERIAL

        3. CHAPTER III: HYGIENE DURING AND AFTER PRODUCTION

        4. CHAPTER IV: LABELLING

      6. SECTION VI: MEAT PRODUCTS

      7. SECTION VII: LIVE BIVALVE MOLLUSCS

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

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

          1. A. REQUIREMENTS FOR PRODUCTION AREAS

          2. B. REQUIREMENTS FOR HARVESTING AND HANDLING FOLLOWING HARVESTING

          3. C. REQUIREMENTS FOR RELAYING LIVE BIVALVE MOLLUSCS

        3. CHAPTER III: STRUCTURAL REQUIREMENTS FOR DISPATCH AND PURIFICATION CENTRES

        4. CHAPTER IV: HYGIENE REQUIREMENTS FOR PURIFICATION AND DISPATCH CENTRES

          1. A. REQUIREMENTS FOR PURIFICATION CENTRES

          2. B. REQUIREMENTS FOR DISPATCH CENTRES

        5. CHAPTER V: HEALTH STANDARDS FOR LIVE BIVALVE MOLLUSCS

        6. CHAPTER VI: WRAPPING AND PACKAGING OF LIVE BIVALVE MOLLUSCS

        7. CHAPTER VII: IDENTIFICATION MARKING AND LABELLING

        8. CHAPTER VIII: OTHER REQUIREMENTS

        9. CHAPTER IX: SPECIFIC REQUIREMENTS FOR PECTINIDAE HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS

      8. SECTION VIII: FISHERY PRODUCTS

        1. CHAPTER I: REQUIREMENTS FOR VESSELS

          1. I. STRUCTURAL AND EQUIPMENT REQUIREMENTS

            1. A. Requirements for all vessels

            2. B. Requirements for vessels designed and equipped to preserve fresh fishery...

            3. C. Requirements for freezer vessels

            4. D. Requirements for factory vessels

          2. II. HYGIENE REQUIREMENTS

        2. CHAPTER II: REQUIREMENTS DURING AND AFTER LANDING

        3. CHAPTER III: REQUIREMENTS FOR ESTABLISHMENTS, INCLUDING VESSELS, HANDLING FISHERY PRODUCTS

          1. A. REQUIREMENTS FOR FRESH FISHERY PRODUCTS

          2. B. REQUIREMENTS FOR FROZEN PRODUCTS

          3. C. REQUIREMENTS FOR MECHANICALLY SEPARATED FISHERY PRODUCTS

          4. D. REQUIREMENTS CONCERNING PARASITES

          5. E. REQUIREMENTS FOR FISH OIL FOR HUMAN CONSUMPTION

        4. CHAPTER IV: REQUIREMENTS FOR CERTAIN PROCESSED FISHERY PRODUCTS

          1. A. REQUIREMENTS FOR COOKING OF CRUSTACEANS AND MOLLUSCS

            1. 1. Rapid cooling must follow cooking. If no other method of...

            2. 2. Shelling or shucking must be carried out hygienically, avoiding contamination...

            3. 3. After shelling or shucking, cooked products must be frozen immediately,...

          2. B. REQUIREMENTS FOR FISH OIL INTENDED FOR HUMAN CONSUMPTION

            1. 1. Raw materials used in the preparation of fish oil for...

            2. 2. The production process for fish oil must ensure that all...

            3. 3. Provided that the raw materials and the production process comply...

            4. 4. Pending the establishment of specific Community legislation food business operators...

        5. CHAPTER V: HEALTH STANDARDS FOR FISHERY PRODUCTS

          1. A. ORGANOLEPTIC PROPERTIES OF FISHERY PRODUCTS

          2. B. HISTAMINE

          3. C. TOTAL VOLATILE NITROGEN

          4. D. PARASITES

          5. E. TOXINS HARMFUL TO HUMAN HEALTH

        6. CHAPTER VI: WRAPPING AND PACKAGING OF FISHERY PRODUCTS

        7. CHAPTER VII: STORAGE OF FISHERY PRODUCTS

        8. CHAPTER VIII: TRANSPORT OF FISHERY PRODUCTS

      9. SECTION IX: RAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM-BASED PRODUCTS

        1. CHAPTER I: RAW MILK AND COLOSTRUM — PRIMARY PRODUCTION

          1. I. HEALTH REQUIREMENTS FOR RAW MILK AND COLOSTRUM PRODUCTION

            1. 1. Raw milk and colostrum must come from animals:

            2. 2. In particular, as regards brucellosis, raw milk and colostrum must...

            3. 3. However, raw milk from animals that does not meet the...

            4. 4. Raw milk and colostrum from any animal not complying with...

            5. 5. The isolation of animals that are infected, or suspected of...

          2. II. HYGIENE ON MILK AND COLOSTRUM PRODUCTION HOLDINGS

            1. A. Requirements for premises and equipment

              1. 1. Milking equipment and premises where milk and colostrum are stored,...

              2. 2. Premises for the storage of milk and colostrum must be...

              3. 3. Surfaces of equipment that are intended to come into contact...

              4. 4. After use, such surfaces must be cleaned and, where necessary,...

            2. B. Hygiene during milking, collection and transport

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

              2. 2. Immediately after milking, milk and colostrum must be held in...

              3. 3. During transport the cold chain must be maintained and, on...

              4. 4. Food business operators need not comply with the temperature requirements...

            3. C. Staff hygiene

              1. 1. Persons performing milking and/or handling raw milk and colostrum must...

              2. 2. Persons performing milking must maintain a high degree of personal...

          3. III. CRITERIA FOR RAW MILK AND COLOSTRUM

            1. 1. The following criteria for raw milk apply pending the establishment...

            2. 2. A representative number of samples of raw milk and colostrum...

            3. 3. Food business operators must initiate procedures to ensure that raw...

            4. 4. Without prejudice to Directive 96/23/EC, food business operators must initiate...

            5. 5. When raw milk fails to comply with point 3 or...

        2. CHAPTER II: REQUIREMENTS CONCERNING DAIRY AND COLOSTRUM-BASED PRODUCTS

          1. I. TEMPERATURE REQUIREMENTS

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

            2. 2. However, food business operators may keep milk and colostrum at...

          2. II. REQUIREMENTS FOR HEAT TREATMENT

            1. 1. When raw milk, colostrum, dairy or colostrum-based products undergo heat...

            2. 2. When considering whether to subject raw milk and colostrum to...

          3. III. CRITERIA FOR RAW COWS' MILK

            1. 1. Food business operators manufacturing dairy products must initiate procedures to...

            2. 2. When milk fails to meet the criteria laid down in...

        3. CHAPTER III: WRAPPING AND PACKAGING

        4. CHAPTER IV: LABELLING

          1. 1. In addition to the requirements of Directive 2000/13/EC, except in...

          2. 2. The requirements of paragraph 1 apply to products destined for...

        5. CHAPTER V: IDENTIFICATION MARKING

      10. SECTION X: EGGS AND EGG PRODUCTS

        1. CHAPTER I: EGGS

        2. CHAPTER II: EGG PRODUCTS

          1. I. REQUIREMENTS FOR ESTABLISHMENTS

          2. II. RAW MATERIALS FOR THE MANUFACTURE OF EGG PRODUCTS

          3. III. SPECIAL HYGIENE REQUIREMENTS FOR THE MANUFACTURE OF EGG PRODUCTS

          4. IV. ANALYTICAL SPECIFICATIONS

          5. V. LABELLING AND IDENTIFICATION MARKING

      11. SECTION XI: FROGS' LEGS AND SNAILS

      12. SECTION XII: RENDERED ANIMAL FATS AND GREAVES

        1. CHAPTER I: REQUIREMENTS APPLICABLE TO ESTABLISHMENTS COLLECTING OR PROCESSING RAW MATERIALS

        2. CHAPTER II: HYGIENE REQUIREMENTS FOR THE PREPARATION OF RENDERED ANIMAL FAT AND GREAVES

      13. SECTION XIII: TREATED STOMACHS, BLADDERS AND INTESTINES

      14. SECTION XIV: GELATINE

        1. CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

        2. CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

        3. CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF GELATINE

          1. 1. The production process for gelatine must ensure that:

          2. 2. A food business operator may produce and store both gelatine...

        4. CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

        5. CHAPTER V: LABELLING

      15. SECTION XV: COLLAGEN

        1. CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

        2. CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

        3. CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF COLLAGEN

        4. CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

        5. CHAPTER V: LABELLING

      16. Appendix to ANNEX III

        1. MODEL DOCUMENT TO ACCOMPANY RAW MATERIAL DESTINED FOR THE PRODUCTION...

          1. I. Identification of raw material

          2. II. Origin of raw material

          3. III. Destination of raw material

          4. IV. Means of transport: …

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