The Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998

1. Introductory Text

2. PART I GENERAL

   1. 1. Citation and commencement

   2. 2. Interpretation

3. PART II PRODUCTION AND PLACING ON THE MARKET OF LIVE SHELLFISH

   1. 3. Designation of areas as designated bivalve production areas

   2. 4. Designation of areas as prohibited areas for live shellfish production

   3. 5. Alterations to designated areas

   4. 6. Lists of designated production and relaying areas

   5. 7. Temporary prohibition orders concerning production areas

   6. 8. Collecting live shellfish from prohibited areas

   7. 9. Requirements relating to the harvesting, transporting and relaying of live shellfish

   8. 10. Requirement for the approval of dispatch or purification centres

   9. 11. Approval of dispatch or purification centres

   10. 12. Appeals against a refusal to grant an approval or against any conditions or limitation in approvals

   11. 13. Obligations on food business proprietors operating dispatch or purification centres

   12. 14. Variation of approvals for dispatch or purification centres

   13. 15. Revocation of approvals for dispatch or purification centres

   14. 16. Wrapping of live shellfish

   15. 17. Storage and transportation of live shellfish after dispatch

   16. 18. Splitting consignments of live shellfish

   17. 19. Placing liv shellfish on the market

   18. 20. Direct transfers of live shellfish on local markets

4. PART III PRODUCTION AND PLACING ON THE MARKET OF FISHERY PRODUCTS

   1. 21. Registration of fishing vessels on board which shrimps or molluscs are cooked

   2. 22. Hygiene conditions for fishing vessels

   3. 23. Operation of a factory vessel or fishery products establishment without an approval

   4. 24. Approval of factory vessels and fishery products establishments

   5. 25. Requirement for the registration of auction or wholesale markets

   6. 26. Registration of auction and wholesale markets

   7. 27. Appeals against decisions under this Part to refuse to register or to grant an approval or against any conditions or limitations in such approvals

   8. 28. Obligations upon food business proprietors operating establishments and factory vessels

   9. 29. Notice of arrival obligation for masters of third country factory vessels

   10. 30. Obligations upon food business proprietors operating auction or wholesale markets

   11. 31. Variation of approvals for factory vessels or establishments

   12. 32. Revocation of approvals for factory vessels or establishments and cancellation of market registrations

   13. 33. Gutting of fishery products

   14. 34. Packaging of fishery products

   15. 35. Storage and transportation of fishery products

   16. 36. Placing fishery products on the market

   17. 37. Placing aquaculture products on the market

   18. 38. Placing processed shellfish on the market

   19. 39. Fishery products to be placed on the market alive

   20. 40. Prohibition on placing certain fishery products on the market

   21. 41. Direct transfers of fishery products on local markets

5. PART IV IMPORT CONDITIONS FOR FISHERY PRODUCTS AND LIVE SHELLFISH

   1. 42. General restriction on importing fishery products

   2. 43. Additional conditions relating to certain third country imports of fishery products

   3. 44. General restriction on importing live shellfish

   4. 45. Additional conditions relating to certain third country imports of live shellfish

   5. 46. Exemption for private consignments

6. PART V INSPECTION CHARGES FOR DIRECT LANDINGS FROM THIRD COUNTRY VESSELS

   1. 47. Interpretation of Part V

   2. 48. Charge in respect of official checks on third country direct landings

   3. 49. Sum payable by vendors to food authorities

   4. 50. The reducible element of the charge

   5. 51. Collection and remittance arrangements

7. PART VI ENFORCEMENT, PENALTIES AND REVOCATIONS

   1. 52. Functions of the Ministers and food authorities

   2. 53. Offences and penalties

   3. 54. Enforcement of Parts II and III

   4. 55. Application of provisions of the Act for the purposes of Parts II and III

   5. 56. Enforcement of Part IV

   6. 57. Food treated as failing to comply with food safety requirements

   7. 58. Amendment of other Regulations

   8. 59. Revocations and transitional provision

8. Signature

9. 1. SCHEDULE 1

      IMPORTS

      1. PART I APPROVED IMPORT CONDITIONS FOR FISHERY PRODUCTS

         1. 1. Commission Decision 93/436/EEC laying down special import conditions governing imports...

         2. 2. Commission Decision 93/437/EEC laying down special import conditions governing imports...

         3. 3. Commission Decision 93/494/EEC laying down special conditions governing imports of...

         4. 4. Commission Decision 93/495/EEC laying down special conditions governing imports of...

         5. 5. Commission Decision 94/198/EC laying down special conditions governing the import...

         6. 6. Commission Decision 94/200/EC laying down special conditions governing the import...

         7. 7. Commission Decision 94/269/EC laying down special conditions governing imports of...

         8. 8. Commission Decision 94/323/EC laying down special conditions governing imports of...

         9. 9. Commission Decision 94/324/EC laying down special conditions governing imports of...

         10. 10. Commission Decision 94/325/EC laying down special conditions governing imports of...

         11. 11. Commission Decision 94/448/EC laying down special conditions governing imports of...

         12. 12. Commission Decision 94/766/EC laying down special conditions governing the import...

         13. 13. Commission Decision 94/778/EC laying down special conditions for the import...

         14. 14. Commission Decision 95/30/EC laying down special conditions governing imports of...

         15. 15. Commission Decision 95/90/EC laying down special conditions governing the import...

         16. 16. Commission Decision 95/173/EC laying down special conditions governing imports of...

         17. 17. Commission Decision 95/190/EC laying down special conditions governing imports of...

         18. 18. Commission Decision 95/454/EC laying down special conditions governing imports of...

         19. 19. Commission Decision 95/538/EC laying down special conditions governing the import...

         20. 20. Commission Decision 96/355/EC laying down special conditions governing the import...

         21. 21. Commission Decision 96/356/EC laying down special conditions governing the import...

         22. 22. Commission Decision 96/425/EC laying down special conditions governing the import...

         23. 23. Commission Decision 96/606/EC laying down special conditions governing the import...

         24. 24. Commission Decision 96/607/EC laying down special conditions governing the import...

         25. 25. Commission Decision 96/608/EC laying down special conditions governing the import...

         26. 26. Commission Decision 96/609/EC laying down special conditions governing the import...

      2. PART II APPROVED IMPORT CONDITIONS FOR LIVE SHELLFISH

         1. 1. Commission Decision 93/387/EEC laying down special conditions for the import...

         2. 2. Commission Decision 94/777/EC laying down special conditions for the import...

         3. 3. Commission Decision 95/174/EC laying down special conditions for the import...

         4. 4. Commission Decision 95/453/EC laying down special conditions for the import...

         5. 5. Commission Decision 96/675/EC laying down special conditions for the import...

      3. PART III THE FISHERY PRODUCTS DECISIONS

         1. 1. Commission Decision 93/25/EEC approving certain treatments to inhibit the development...

         2. 2. Commission Decision 93/51/EEC on the microbiological criteria applicable to the...

         3. 3. Commission Decision 93/140/EEC laying down the detailed rules relating to...

         4. 4. Commission Decision 93/351/EEC determining analysis methods, sampling plans and maximum...

         5. 5. The Health Checks Decision.

         6. 6. Commission Decision 95/149/EC fixing the total volatile basic nitrogen (TVB-N)...

      4. PART IV APPLICABLE REQUIREMENTS RELATING TO IMPORTED FISHERY PROD UCTS

      5. PART V APPLICABLE REQUIREMENTS RELATING TO IMPORTED LIVE SHELLFISH

   2. SCHEDULE 2

      PRODUCTION AND PLACING ON THE MARKET CONDITIONS FOR LIVE SHELLFISH

      1. CHAPTER I CONDITIONS FOR PRODUCTION AREAS

         1. PART 1 CLASS A AREAS

            1. 1. Areas to be designated class A areas

         2. PART 2 CLASS B AREAS

            1. 2. Areas to be designated class B areas

            2. 3. Conditions in relation to a class B area

            3. 4. After any necessary relaying, purification and treatment, the live bivalve...

         3. PART 3 CLASS C AREAS

            1. 5. Areas to be designated class C areas

            2. 6. Conditions in relation to a class C area

            3. 7. After any necessary relaying, purification and treatment, the live bivalve...

      2. CHAPTER II REQUIREMENTS FOR HARVESTING AND TRANSPORTATION OF BATCHES TO A DISPATCH OR PURIFICATION CENTRE, RELAYING AREA OR PROCESSING PLANT

         1. 1. Harvesting techniques must not cause excessive damage to the shells...

         2. 2. Live shellfish must be adequately protected from crushing, abrasion or...

         3. 3. Techniques for harvesting, transporting, landing and handling live shellfish must...

         4. 4. Live shellfish must not be re-immersed in water which could...

         5. 5. (1) The means of transport used for transporting live shellfish...

         6. 6. (1) A movement document, as prescribed in this paragraph, for...

         7. 7. If a production or relaying area is closed temporarily, pursuant...

      3. CHAPTER III CONDITIONS FOR RELAYING LIVE BIVALVE MOLLUSCS

         1. 1. live bivalve molluscs must be gathered and transported, under the...

         2. 2. techniques for handling live bivalve molluscs intended for relaying must...

         3. 3. live bivalve molluscs must not be relaid at a density...

         4. 4. live bivalve molluscs must be immersed in seawater at the...

         5. 5. the minimum water temperature for effective relaying must, where necessary,...

         6. 6. the boundaries of the sites must be physically delineated by...

         7. 7. sites within a relaying area must be well separated to...

         8. 8. permanent records of the source of live bivalve molluscs, relaying...

         9. 9. after harvesting from the relaying area, batches must, during transport...

      4. CHAPTER IV CONDITIONS FOR THE APPROVAL OF DISPATCH OR PURIFICATION CEN TRES

         1. Section I General conditions relating to premises and equipment

            1. 1. on premises where live shellfish are handled or stored—

            2. 2. access to an appropriate number of changing rooms, wash basins...

            3. 3. adequate equipment for washing tools, containers and equipment;

            4. 4. facilities for the supply and, where appropriate, storage of exclusively...

            5. 5. equipment and instruments or their surfaces which are intended to...

         2. Section II General hygiene requirements

            1. 1. staff who treat or handle live shellfish must in particular...

            2. 2. staff are obliged to refrain from personal behaviour, such as...

            3. 3. any rodents, insects or other vermin found must be destroyed...

            4. 4. premises, equipment and instruments used for handling live shellfish must...

            5. 5. premises, instruments and equipment must not be used for purposes...

            6. 6. waste products must be stored hygienically in a separate area...

            7. 7. the finished products must be stored under cover and must...

         3. Section III Requirements for purification centres

            1. 1. the floors and walls of the purification tanks and any...

            2. 2. live bivalve molluscs must be washed free of mud with...

            3. 3. the purification tanks must be supplied with a sufficient flow...

            4. 4. clean seawater or seawater cleaned by treatment must be used...

            5. 5. operation of the purification system must allow live bivalve molluscs...

            6. 6. the quantity of live bivalve molluscs to be purified must...

            7. 7. should a purification tank contain several batches of molluscs, they...

            8. 8. containers used to hold live bivalve molluscs in purification systems...

            9. 9. no crustaceans, fish or other marine species must be kept...

            10. 10. after completion of purification, the shells of live bivalve molluscs...

            11. 11. purification centres must have their own laboratories or secure the...

            12. 12. purification centres must regularly keep a record of the following...

            13. 13. purification centres must accept only those batches of live bivalve...

            14. 14. every package containing purified live bivalve molluscs must be provided...

         4. Section IV Requirements for dispatch centres

            1. 1. In addition to the requirements under Sections I and II,...

            2. 2. Dispatch centres must accept only those batches of live shellfish...

            3. 3. Dispatch centres must have their own laboratories or secure the...

            4. 4. Dispatch centres must keep the following data at the disposal...

            5. 5. Dispatch centres situated aboard vessels shall be subject to the...

      5. CHAPTER V REQUIREMENTS CONCERNING LIVE SHELLFISH

         1. 1. the possession of visual characteristics associated with freshness and viability,...

         2. 2. they must contain less than 300 faecal coliforms or less...

         3. 3. they must not contain salmonella in 25 grams of mollusc...

         4. 4. they must not contain toxic or objectionable compounds occurring naturally...

         5. 5. the upper limits as regards the radionuclide contents must not...

         6. 6. the total Paralytic Shellfish Poison (PSP) content in the edible...

         7. 7. the customary biological testing methods must not give a positive...

         8. 8. in the absence of routine virus testing procedures and the...

      6. CHAPTER VI PUBLIC HEALTH CONTROL AND MONITORING OF PRODUCTION

         1. 1. The Ministers shall undertake, or may require food authorities to...

         2. 2. A food authority shall undertake periodic monitoring of live bivalve...

         3. 3. (1) Sampling plans for the purposes of paragraphs 1 and...

         4. 4. (1) Laboratory tests shall be carried out by the food...

         5. 5. (1) A food authority shall inspect establishments at regular intervals...

         6. 6. A food authority shall check on the storage and transport...

      7. CHAPTER VII WRAPPING

         1. 1. (1) Live shellfish must be wrapped under satisfactory conditions of...

         2. 2. Oysters must be wrapped with the concave shell downwards.

         3. 3. All wrappings of live shellfish must be sealed and remain...

      8. CHAPTER VIII PRESERVATION AND STORAGE

         1. 1. In any storing rooms, live shellfish must be kept at...

         2. 2. Re-immersion in or spraying with water of live shellfish must...

      9. CHAPTER IX TRANSPORT FROM THE DISPATCH CENTRE

         1. 1. Except where paragraph 3 of Chapter VII applies, consignments of...

         2. 2. The means of transport used for consignments of live shellfish...

         3. 3. Live shellfish must be transported and distributed using closed vehicles...

         4. 4. The parcels containing live shellfish must not be transported in...

         5. 5. Where ice is used in transporting consignments of live shellfish,...

      10. CHAPTER X MARKING OF CONSIGNMENTS

          1. 1. Without prejudice to the requirements of the Food Labelling Regulations...

          2. 2. (1) The healthmark may be— (a) printed on the wrapping...

          3. 3. The healthmark must be durable and waterproof, and the information...

          4. 4. Where a person repackages any live shellfish in accordance with...

   3. SCHEDULE 3

      PRODUCTION AND PLACING ON THE MARKET CONDITIONS FOR FISHERY PRODUCTS

      1. CHAPTER I CONDITIONS APPLICABLE TO FACTORY VESSELS

         1. Section I Conditions concerning design and equipment

            1. 1. The minimum requirements for factory vessels are as follows—

            2. 2. Areas used for the preparation and processing or freezing/quick-freezing of...

            3. 3. Equipment and tools such as cutting benches, containers, conveyors, gutting...

            4. 4. Factory vessels which freeze fishery products must have—

         2. Section II Conditions of hygiene relating to on-board handling and storage of fishery products

            1. 1. A qualified person on board the factory vessel must be...

            2. 2. The general conditions of hygiene applicable to areas and equipment...

            3. 3. The general conditions of hygiene applicable to staff shall be...

            4. 4. Heading, gutting and filleting must be carried out under the...

            5. 5. On-board processing of fishery products must be carried out under...

            6. 6. Fishery products must be wrapped and packaged under the conditions...

            7. 7. On-board storage of fishery products must be carried out under...

            8. 8. (1) Subject to sub-paragraph (2), any on-board processing (in particular...

      2. CHAPTER II REQUIREMENTS DURING AND AFTER LANDING

         1. 1. Unloading and landing equipment must be constructed of material which...

         2. 2. During unloading and landing, contamination of fishery products must be...

         3. 3. Parts of auction or wholesale markets where fishery products are...

         4. 4. After lending or, where appropriate, after first sale, fishery products...

         5. 5. However, if the conditions laid down in paragraph 4 are...

         6. 6. The general conditions of hygiene laid down in Section II...

         7. 7. The wholesale markets in which fishery products are displayed for...

      3. CHAPTER III GENERAL CONDITIONS FOR ESTABLISHMENTS ON LAND

         1. Section I. General conditions relating to premises and equipment

            1. 1. working areas of sufficient size for work to be carried...

            2. 2. in areas where products are handled, prepared and processed—

            3. 3. in cold rooms where fishery products are stored— the provisions...

            4. 4. appropriate facilities for protection against pests such as insects, rodents,...

            5. 5. instruments and working equipment such as cutting tables, containers, conveyor...

            6. 6. special watertight, corrosion-resistant containers for fishery products not intended for...

            7. 7. facilities to provide adequate supplies of potable water, or alternatively...

            8. 8. hygienic waste water disposal system;

            9. 9. an adequate number of changing-rooms with smooth, water-proof, washable walls...

            10. 10. if the volume of products treated requires regular or permanent...

            11. 11. adequate facilities for cleaning and disinfecting means of transport. However,...

            12. 12. establishments keeping live animals such as crustaceans and fish must...

         2. Section II General conditions of hygiene

            1. A.

               General conditions of hygiene applicable to premises and equipment

               1. 1. Floors, walls and partitions, ceilings and roof linings, equipment and...

               2. 2. Rodents, insects and other vermin must be systematically exterminated in...

               3. 3. Working areas, instruments and working equipment must be used only...

               4. 4. Potable water or clean seawater must be used for all...

               5. 5. Detergents, disinfectants and similar substances must be acceptable to the...

            2. B.

               General conditions of hygiene applicable to staff

               1. 1. The highest possible standard of cleanliness is required of staff....

               2. 2. The employer shall take all the requisite measures to prevent...

      4. CHAPTER IV SPECIAL CONDITIONS FOR HANDLING FISHERY PRODUCTS ON SHORE

         1. Section I Conditions for fresh products

            1. 1. Where chilled, unpackaged products are not dispatched, prepared or processed...

            2. 2. If they are not carried out on board, operations such...

            3. 3. Operations such as filleting and slicing must be carried out...

            4. 4. Guts and parts that may constitute a danger to public...

            5. 5. Containers used for the dispatch or storage of fresh fishery...

            6. 6. Unless special facilities are provided for the continuous disposal of...

         2. Section II Conditions for frozen products

            1. 1. Plants must have— (a) freezing equipment sufficiently powerful to achieve...

            2. 2. Fresh products to be frozen or quick-frozen must comply with...

            3. 3. (1) Storage rooms must have a temperature recording device in...

         3. Section III Conditions for thawing products

            1. 1. fishery products must be thawed under hygienic conditions; their contamination...

            2. 2. after thawing, fishery products must be handled in accordance with...

         4. Section IV Conditions for processed products

            1. 1. Fresh, frozen and thawed products used for processing must comply...

            2. 2. (1) Where the processing treatment is carried out to inhibit...

            3. (2). The person responsible for an establishment must keep a register...

            4. 3. For products which are preserved for a limited period by...

            5. 4. Canning

            6. 5. Smoking

            7. 6. Salting

            8. 7. Cooked crustacean and molluscan shellfish

            9. 8. Mechanically recovered fish flesh

         5. Section V Conditions concerning parasites

            1. 1. (1) During production and before they are released for human...

            2. 2. The fish and fish products referred to in paragraph 1(1)...

            3. 3. Fish and fish products which are subject to the conditions...

            4. 4. Manufacturers must ensure that fish and fish products listed in...

            5. 5. The fishery products listed in paragraph 3 must, when they...

      5. CHAPTER V HEALTH CONTROL AND MONITORING OF PRODUCTION CONDITIONS

         1. Section I General monitoring

            1. 1. a check on the fishing vessels, on the understanding that...

            2. 2. a check on the conditions of landing and first sale;...

            3. 3. an inspection at regular intervals of establishments and factory vessels...

            4. 4. an inspection of the wholesale and auction markets;

            5. 5. a check on storage and transport conditions.

         2. Section II Special Checks

            1. 1. Organoleptic checks

            2. 2. Parasite checks

            3. 3A. Chemical checks

            4. 3B. Contaminants present in the aquatic environment

            5. 4. Microbiological analyses

            6. 5. (1) The sampling programme to be established in accordance with...

      6. CHAPTER VI PACKAGING

         1. 1. Packaging must be carried out under satisfactory conditions of hygiene,...

         2. 2. Packaging materials and products liable to enter into contact with...

         3. 3. With the exception of certain containers made of impervious, smooth...

         4. 4. Unused packaging materials must be stored in places away from...

      7. CHAPTER VII IDENTIFICATION MARKS

         1. PART I PRODUCTS PREPARED ON OR AFTER 29 APRIL 1998

            1. 1. This Part of this Chapter shall apply to all products...

            2. 2. (1) Without prejudice to the provisions of the Food Labelling...

      8. PART II PRODUCTS PREPARED BEFORE 29 APRIL 1998

         1. 1. This Part of this Chapter applies to products which were...

         2. 2. Without prejudice to the requirements of the Food Labelling Regulations...

      9. CHAPTER VIII STORAGE AND TRANSPORT

         1. 1. Fishery products must, during storage and transport, be kept at...

         2. 2. Where frozen fishery products are transported from a cold storage...

         3. 3. Products may not be stored or transported with other products...

         4. 4. Vehicles used for the transport of fishery products must be...

         5. 5. Means of transport used for fishery products may not be...

         6. 6. Fishery products may not be transported in a vehicle or...

         7. 7. The transport conditions of fishery products to be placed on...

   4. SCHEDULE 4

      HYGIENE CONDITIONS FOR FISHING VESSELS (BASED ON THE CORRE SPONDING PROVISIONS OF THE ANNEXES TO THE FISHING VESSELS DIRECTIVE)

      1. PART I General hygiene conditions applicable to fishery products on board fishing vessels

         1. 1. The sections of vessels or the containers reserved for the...

         2. 2. When used, the sections of vessels or the containers reserved...

         3. 3. As soon as they are taken on board, the fishery...

         4. 4. The fishery products shall be handled and stored in such...

         5. 5. Fishery products other than those kept alive must undergo cold...

         6. 6. Ice used for the chilling of products must be made...

         7. 7. After the fishery products have been unloaded, the containers, equipment...

         8. 8. Where fish is headed and/or gutted on board, such operations...

         9. 9. Equipment used for gutting, heading and the removal of fins,...

         10. 10. Staff assigned to the handling of fishery products shall be...

      2. PART II Additional hygiene conditions applicable to article 1.2 fishing vessels

         1. 1. Fishing vessels must be equipped with holds, tanks or containers...

         2. 2. The inside surface of the holds, tanks or containers shall...

         3. 3. The holds shall be designed to ensure that melt water...

         4. 4. Containers used for the storage of products must ensure their...

         5. 5. The working decks, the equipment and the holds, tanks and...

         6. 6. Cleaning products, disinfectants, insecticides and all potentially toxic substances shall...

         7. 7. If fishery products are frozen on board, this operation must...

         8. 8. Vessels equipped for chilling of fishery products in cooled seawater,...

   5. SCHEDULE 5

      REVOCATIONS

10. Explanatory Note