Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998 (S.R. No. 207 of 1998)

Statutory Rule 1998 No. 207 Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998 © Crown Copyright All Crown copyrights are reserved. The text is reproducible in all media and formats and without restriction provided that the text is reproduced accurately; is not used in a misleading manner; and is accompanied by the following acknowledgment: Crown copyright 1998 with the permission of the Controller of Her Majesty's Stationery Office It should be noted that the right to reproduce the text of Statutory Rules of Northern Ireland does not extend to the Royal Arms and the Government Printer imprints. The text of this Internet version of the Statutory Rule has been prepared to reflect the text as it was Made. The authoritative version is the Government Printer for Northern Ireland copy published by The Stationery Office Limited as the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998, ISBN 0 337 93148 8, £8.70 sterling. STATUTORY RULES OF NORTHERN IRELAND 1998 No. 207 FOOD Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998 Made 8th June 1998 Coming into operation 27th July 1998 ARRANGEMENT OF REGULATIONS Part I General 1. Citation and commencement 2. Interpretation Part II Production and Placing on the Market of Live Shellfish 3. Designation of areas as designated bivalve production areas 4. Designation of areas as prohibited areas for live shellfish production 5. Alterations to designated areas 6. Lists of designated production and relaying areas 7. Temporary prohibition orders concerning production areas 8. Collecting live shellfish from prohibited areas 9. Requirement relating to the harvesting, transporting and relaying of live shellfish 10. Requirement for the approval of dispatch or purification centres 11. Approval of dispatch or purification centres 12. Appeals against a refusal to grant an approval or against any conditions or limitations in approvals 13. Obligations on food business proprietors operating dispatch or purification centres 14. Variation of approvals for dispatch or purification centres 15. Revocation of approvals for dispatch or purification centres 16. Wrapping of live shellfish 17. Storage and transportation of live shellfish after dispatch 18. Splitting consignments of live shellfish 19. Placing live shellfish on the market 20. Direct transfers of live shellfish on local markets Part III Production and Placing on the Market of Fishery Products 21. Registration of fishing vessels on board which shrimps or molluscs are cooked 22. Hygiene conditions for fishing vessels 23. Operation of a factory vessel or fishery products establishment without an approval 24. Approval of factory vessels and fishery products establishments 25. Requirement for the registration of auction or wholesale markets 26. Registration of auction and wholesale markets 27. Appeals against decisions under this Part to refuse to register or grant an approval or against any conditions or limitations in such approvals 28. Obligations upon food business proprietors operating establishments and factory vessels 29. Notice of arrival obligation for masters of third country vessels 30. Obligations upon food business proprietors operating auction or wholesale markets 31. Variation of approvals for factory vessels or establishments 32. Revocation of approvals for factory vessels or establishments and cancellation of market registrations 33. Gutting of fishery products 34. Packaging of fishery products 35. Storage and transportation of fishery products 36. Placing of fishery products on the market 37. Placing aquaculture products on the market 38. Placing processed shellfish on the market 39. Fishery products to be placed on the market alive 40. Prohibition on placing certain fishery products on the market 41. Direct transfers of fishery products on local markets Part IV Import Conditions for Fishery Products and Live Shellfish 42. General restriction on importing fishery products 43. Additional conditions relating to certain third country imports of fishery products 44. General restriction on importing live shellfish 45. Additional conditions relating to certain third country imports of live shellfish 46. Exemption for private consignments Part V Hygiene Inspection Charges for Direct Landings from Third Country Vessels 47. Interpretation of Part V 48. Charge in respect of official checks on third country direct landings 49. Sum payable by vendors to district councils 50. The reducible element of the charge 51. Collection and remittance arrangements Part VI Enforcement, Penalties and Revocations 52. Functions of the Department and district councils 53. Offences and penalties 54. Enforcement of Parts II and III 55. Application of provisions of the Order for the purposes of Parts II and III 56. Enforcement of Part IV 57. Food treated as failing to comply with food safety requirements 58. Amendment of other Regulations 59. Revocations and transitional provision SCHEDULES SCHEDULE 1 Imports Part I Approved import conditions for fishery products Part II Approved import conditions for live shellfish Part III The Fishery Products Decisions Part IV Applicable requirements relating to imported fishery products Part V Applicable requirements relating to imported live shellfish SCHEDULE 2 Production and placing on the market; conditions for live shellfish Chapter I Conditions for production areas Chapter II Requirements for harvesting and transportation of batches to a dispatch or purification centre, relaying area or processing plant Chapter III Conditions for relaying live bivalve molluscs Chapter IV Conditions for the approval of dispatch or purification centres Chapter V Requirements concerning live shellfish Chapter VI Public health control and monitoring of production Chapter VII Wrapping Chapter VIII Preservation and storage Chapter IX Transport from the dispatch centre Chapter X Marking of consignments SCHEDULE 3 Production and placing on the market; conditions for fishery products Chapter I Conditions applicable to factory vessels Chapter II Requirements during and after landing Chapter III General conditions for establishments on land Chapter IV Special conditions for handling fishery products on shore Chapter V Health control and monitoring of production conditions Chapter VI Packaging Chapter VII Identification marks Chapter VIII Storage and transport SCHEDULE 4 Hygiene requirements relating to fishing vessels Part I General hygiene conditions Part II Additional hygiene conditions SCHEDULE 5 Revocations Explanatory Note Statutory Rule 1998 No. 207 Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998 back to previous page The Department of Health and Social Services for Northern Ireland in exercise of the powers conferred on it by Articles 15(1), 16(1), 17(1)(c), 25(1)(b) and (3), 26(3), 47(2) and 48(2) of, and paragraphs 2(2), 5(1) and (2), 6(1) and 7(1) of Schedule 1 to, the Food Safety (Northern Ireland) Order 1991[1], and, being a designated Department[2] for the purposes of section 2(2) of the European Communities Act 1972[3] in relation to the common agricultural policy of the European Community, in exercise of the powers conferred on it by the said section 2(2), and in each case in exercise of all other powers respectively enabling it in that behalf and after consultation (so far as is required by Article 47(3) of the said Order) with such organisations as appear to it to be representative of interests likely to be substantially affected by these Regulations, hereby makes the following Regulations Part I General Citation and commencement 1. These Regulations may be cited as the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998 and shall come into operation on 27th July 1998. Interpretation 2. - (1) In these Regulations "another EEA State" means an EEA State other than the United Kingdom; "approved import conditions for fishery products" means the conditions for the importation of fishery products which are laid down in any Commission Decision listed in Part I of Schedule 1; "approved import conditions for live shellfish" means the conditions for the importation of live shellfish which are laid down in any Commission Decision listed in Part II of Schedule 1; "approved relaying area" means a relaying area which, if situated (or treated as situated[4]) in part of Northern Ireland, is designated as a relaying area in accordance with regulation 3(2) by a district council for any area within its district; "aquaculture products" means (a) all fishery products born and raised in controlled conditions until placed on the market as a foodstuff; and (b) all seawater fish, freshwater fish or crustaceans caught in their natural environment when juvenile and kept until they reach the desired commercial size for human consumption, other than fish or crustaceans of commercial size caught in their natural environment and kept alive to be sold at a later date, if they are merely kept alive without any attempt being made to increase their size or weight; "auction or wholesale market" means any premises where the display and sale by wholesale of fishery products, but no other activities associated with the production and placing on the market of fishery products, takes place; "batch" means, with regard to (a) fishery products, a quantity of fishery products obtained under practically identical circumstances; (b) live shellfish, a quantity of live shellfish collected from a production area and subsequently intended for delivery to an approved dispatch centre, purification centre, relaying area or processing plant; "bivalve molluscs" means filter-feeding lamellibranch molluscs; "chilling" means the process of cooling fishery products to a temperature approaching that of melting ice; "clean seawater" means, with regard to the production of (a) fishery products for human consumption, seawater or briny water which is free from any microbiological contamination, harmful substances or toxic marine plankton in such quantities as may effect the health quality of fishery products, and which is used under the conditions laid down in these Regulations; (b) live shellfish for human consumption, seawater or brackish water which is to be used under the conditions laid down in these Regulations and which is free from microbiological contamination and toxic and objectionable substances occurring naturally or after discharge in the environment such as those listed in the Annex to Council Directive 79/923/EEC[5], in such quantities as may adversely affect the health quality of shellfish or impair their taste; "conditioning" means the storage of live shellfish in tanks or any other installation containing clean seawater or in natural sites to remove sand, mud or slime; "consignment", except in the expression "private consignment", means, with regard to (a) fishery products, a quantity of such products bound for one or more customers in the country of destination and conveyed at any one time by one means of transport only; (b) live shellfish, a quantity of such shellfish handled in a dispatch centre or treated in a purification centre and subsequently intended for one or more customers; "designated bivalve production area" means an area of seawaters or brackish waters designated by the Department in accordance with regulation 3(1) as an area from which live bivalve molluscs may be taken; "dispatch centre" means any on-shore installation for the reception, conditioning, washing, cleaning, grading and wrapping of live shellfish fit for human consumption; "E coli" means faecal coliforms which also form indole from tryptophan at 44°C plus or minus 0.2°C within 24 hours; "EEA Agreement" means the Agreement of the European Economic Area signed at Oporto on 2nd May 1992[6] as adjusted by the Protocol signed at Brussels on 17th March 1993[7]; "EEA State" means a State which is a Contracting Party to the EEA Agreement; "establishment" means, with regard to the production of fishery products for human consumption, any premises where fishery products are prepared, processed, chilled, frozen, packaged or stored, other than (a) cold stores where only the handling of wrapped products takes place; or (b) auction or wholesale markets where only display and sale by wholesale takes place; "factory vessel" means any vessel on which fishery products undergo one or more of the following operations - filleting, slicing, skinning, mincing, freezing or processing - followed by packaging, but the following are not deemed to be factory vessels (a) fishing vessels in which only shrimps and molluscs are cooked on board; and (b) fishing vessels on board which only freezing is carried out; "faecal coliforms" means facultative, aerobic, gram-negative, non sporeforming, cytochrome oxidase negative, rod-shaped bacteria that are able to ferment lactose with gas production in the presence of bile salts, or other surface active agents with similar growth-inhibiting properties, at 44°C plus or minus 0.2°C within 24 hours; "fishery products" means (a) all seawater or freshwater animals, including their roes; and (b) parts of such animals, except in circumstances where they (i) are combined (in whatever way) with other foodstuffs, and (ii) comprise less than 10% of the total weight of the combined foodstuffs, but excluding aquatic mammals, frogs and aquatic animals covered by Community acts other than the Fishery Products Directive, and parts of such mammals, frogs and aquatic animals; "the Fishery Products Decisions" means the Commission Decisions listed in Part III of Schedule 1; "the Fishery Products Directive" means Council Directive 91/493/EEC[8] of 22nd July 1991 laying down the health conditions for the production and placing on the market of fishery products, as adapted for the purposes of the EEA Agreement[9] and as amended[10]; "the Fishing Vessels Directive" means Council Directive 92/48/EEC[11] of 16th June 1992 laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with article 3(1)(a)(i) of the Fishery Products Directive; "fresh products" means any fishery products whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, which have not undergone any treatment to ensure preservation other than chilling; "frozen products" means fishery products which have undergone a freezing process; "gatherer" means any person who collects live shellfish by any means from a production area for the purposes of handling and placing on the market; "the Health Checks Decision" means Commission Decision 94/356/EC[12] of 20th May 1994 laying down detailed rules for the application of the Fishery Products Directive as regards own health checks on fishery products; "healthmark" means a healthmark which is in accordance with (a) Chapter X of Schedule 2; (b) any law in force in another EEA State, Great Britain, the Isle of Man or the Channel Islands which is intended to give effect to the results to be achieved by Chapter X of the Annex to the Live Bivalve Molluscs Directive; or (c) any approved import conditions for live shellfish; "imported" means imported into Northern Ireland, but only if the product in question was not imported from another part of the United Kingdom or the Channel Islands or the Isle of Man; "laying" means a foreshore, bed, pond, pit, ledge, float or similar place, including a relaying area, where live shellfish are liable to be gathered, harvested or deposited; "the Live Bivalve Molluscs Directive" means Council Directive 91/492/EEC[13] of 15th July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs, as adapted for the purposes of the EEA Agreement[14] and as amended[15]; "marine biotoxins" means poisonous substances accumulated by bivalve molluscs feeding on plankton containing toxins; "means of transport" means those parts set aside for goods in automobile vehicles (which include trailers), rail vehicles, aircraft or vessels, and containers for transport by land, sea or air; "movement document" means (a) in relation to any batch of live shellfish transported from a production area to (i) an approved relaying area situated or treated as situated in Northern Ireland, (ii) a dispatch centre or purification centre approved in accordance with Part II, or (iii) a processing plant in Northern Ireland, a movement document which meets the requirements of paragraph 6(4) and (5) of Chapter II of Schedule 2; (b) in relation to any batch of live shellfish transported from a production area to (i) an approved relaying area in Great Britain, the Channel Islands or the Isle of Man, or (ii) a dispatch centre or purification centre approved in accordance with any law in force in Great Britain, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved in relation to the approval of dispatch and purification centres by the Live Bivalve Molluscs Directive, or (iii) a processing plant in Great Britain, the Channel Islands or the Isle of Man, a movement document which meets the requirements of any law in force in Great Britain, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by paragraph 6 of Chapter II of the Annex to the Live Bivalve Molluscs Directive; (c) in relation to any batch of live shellfish in transit from a production area to (i) a relaying area, (ii) a dispatch or purification centre, or (iii) a processing plant; which is situated elsewhere, a movement document which meets the requirements of paragraph 6(4) and (5) of Chapter II of Schedule 2; "the Order" means the Food Safety (Northern Ireland) Order 1991; "packaging" means, in relation to fishery products, the procedure for protecting fishery products by a wrapper, a container or any other suitable device; "permanent transport authorisation" means a written authorisation which has been (a) issued by a district council and which meets the requirements of paragraph 6(8) of Chapter II of Schedule 2; (b) granted by a competent authority in Great Britain, the Channel Islands or the Isle of Man and which meets the requirements of any law in force in those territories which is intended to give effect to the results to be achieved by the final unnumbered paragraph of paragraph 6 of Chapter II of the Annex to the Live Bivalve Molluscs Directive; "placing on the market" means, with regard to (a) fishery products, the holding or displaying for sale, offering for sale, selling, delivering or any other form of placing on the market in the European Community, except for (i) retail sale (which includes retail sales to catering businesses and sales by catering businesses), and (ii) direct transfers on local markets of small quantities by fishermen to retailers or consumers in the circumstances specified in regulation 41; and (b) live shellfish, the holding or displaying for sale, offering for sale, selling, delivering or any other form of placing on the market of live shellfish for human consumption either raw or for the purposes of processing in the European Community, except for direct transfers on local markets of small quantities by coastal fishermen to retailers or consumers in the circumstances specified in regulation 20; "potable water" has the same meaning as in the Food Safety (General Food Hygiene) Regulations (Northern Ireland) 1995[16]; "preserve" means the process whereby products are packaged in hermetically sealed containers and subjected to heat treatment to the extent that any micro-organisms that might proliferate are destroyed or inactivated, irrespective of the temperature at which the product is to be stored; "private consignment" means a quantity of fishery products or live shellfish which is (a) imported solely as trade samples; or (b) not being imported by way of trade, and which (i) forms part of a traveller's personal luggage, or (ii) has been sent to an individual in Northern Ireland; "private laying" means a laying where live shellfish are usually harvested or deposited by the owner or by a tenant of the laying ; "processed" means (a) except in relation to shellfish, having undergone a chemical or physical process such as heating, smoking, salting, dehydration or marinating of chilled or frozen products, or a combination of these various processes; (b) in relation to shellfish, any process or any combination of processes such as those referred to in sub-paragraph (a), unless as a result of that process or combination of processes the shellfish remain alive; "production area" means any sea, estuarine or lagoon area containing natural deposits of shellfish or sites used for the cultivation of shellfish (including relaying areas) from which live shellfish are taken; "purification centre" means an establishment with tanks fed by naturally clean seawater or seawater which has been cleaned by appropriate treatment, in which live bivalve molluscs are placed for the time necessary to remove microbiological contamination, so making them fit for human consumption; "relaying" means an operation whereby live bivalve molluscs are transferred to a sea, lagoon or estuarine area in order to remove contamination, but does not include a transfer to an area more suitable for further growth or fattening; "relaying area" means any sea, lagoon or estuarine area with boundaries clearly marked and indicated by buoys, posts or any other fixed means which is used exclusively for the natural purification of live bivalve molluscs; "shellfish" means only bivalve molluscs, echinoderms, tunicates and marine gastropods; "tenant", in relation to a private laying, includes any person authorised by the owner or by any other holder of an interest in the laying to harvest from or deposit at that laying; "third country" means any country or territory which is not part of the European Economic Area; "wrapping" means, in relation to live shellfish, any operation whereby live shellfish are placed in packaging material adequate for the purpose. (2) As respects any Commission Decision listed in Part I or II of Schedule 1 ("a listed Decision"), where the European Commission publishes in an amending Decision (a) a revised list of approved establishments, dispatch centres, purification centres, factory vessels, freezer vessels or production areas which is to replace a list annexed to or contained in an Annex to a listed Decision; or (b) any revision of an existing list of approved establishments, dispatch centres, purification centres, factory vessels, freezer vessels or production areas which is for incorporation into a list contained in an Annex to a listed Decision, the listed Decision shall be read subject to the changes contained in the amending Decision. (3) The Interpretation Act (Northern Ireland) 1954[17] shall apply to these Regulations as it applies to a Measure of the Northern Ireland Assembly. Notes: [1] S.I. 1991/762 (N.I. 7) as amended by S.I. 1996/1633 (N.I. 12). See Article 2(2) for the definitions of "the Department concerned" and "regulations"back [2] S.I. 1972/1811back [3] 1972 c. 68back [4] See regulation 55(4)back [5] O.J. No. L281, 10.11.79, p. 47; this Directive was last amended by Council Directive 91/692/EEC (O.J. No. L377, 31.12.91, p. 48)back [6] O.J. No. L1, 3.1.94, p. 3back [7] O.J. No. L1, 3.1.94, p. 572back [8] O.J. No. L268, 24.9.91, p. 15back [9] See paragraph 24 of the basics texts in Annex I to the EEA Agreementback [10] Council Directive 91/493/EEC was last amended by Council Directive 95/71/EC (O.J. No. L332, 30.12.95, p. 40)back [11] O.J. No. L187, 7.7.92, p. 41back [12] O.J. No. L156, 23.6.94, p. 50back [13] O.J. No. L268, 24.9.91, p. 1back [14] See paragraph 25 of the basic texts in Annex 1 to the EEA Agreementback [15] Council Directive 91/492/EEC was last amended by the last sub paragraph of point 8 of Chapter V of the Annex to the Act of Accession of Austria, Finland and Swedenback [16] S.R. 1995 No. 360; as amended by S.R. 1996 No. 286back [17] 1954 c. 33 (N.I.)back Part II Production and Placing on the Market of Live Shellfish Designation of areas as designated bivalve production areas 3. - (1) The Department shall designate sea waters and brackish waters from which live bivalve molluscs may be taken in accordance with the requirements of this Part and shall specify as respects each area of water designated by it whether it is (a) a class A area from which live bivalve molluscs can be gathered as specified in Part I of Chapter I of Schedule 2; (b) a class B area from which live bivalve molluscs can be gathered as specified in Part II of Chapter I of Schedule 2; (c) a class C area from which live bivalve molluscs can be gathered as specified in Part III of Chapter I of Schedule 2, and any such designation may be subject to such limitation, condition or restriction as appears to the Department to be called for by article 5(2) of the Live Bivalve Molluscs Directive. (2) Each district council shall, wherever possible, designate as a relaying area any area within its district which (a) fulfils the conditions required for designation as a class A or class B area specified in paragraph 1(a) and (b); and (b) in its opinion is suitable for the relaying of live bivalve molluscs if the conditions specified in Parts II and III of Chapter I of Schedule 2 and in Chapter III of Schedule 2 are satisfied, and, where the Department has notified the district council that specified conditions relating to the matters mentioned in Chapter III of Schedule 2 should be complied with as respects the operation of the relaying area, the district council shall make that designation subject to those conditions. (3) The district council shall notify the Department of any designation made under paragraph (2) and of its terms. Designation of areas as prohibited areas for live shellfish production 4. The Department may at any time designate any area as an area unsuitable, for health reasons, for the production or harvesting of (a) live bivalve molluscs; (b) live echinoderms, tunicates and marine gastropods; (c) live shellfish, and any such area shall be designated, as appropriate, as a "designated prohibited area for live bivalve mollusc production", a "designated prohibited area for live echinoderm, tunicate and marine gastropod production" or a "designated prohibited area for live shellfish production". Alterations to designated areas 5. - (1) The Department may in appropriate circumstances and at any time (a) vary the boundary of any area designated under regulation 3(1) or 4; (b) impose any limitation, restriction or condition on the use of any area designated under regulation 3(1) or 4; (c) alter the class of any designated bivalve production area or any area within a designated bivalve production area; (d) revoke the designation of a designated bivalve production area, if the area is no longer suitable for the gathering of live bivalve molluscs; (e) vary or revoke the designation of any area designated under regulation 4. (2) A district council may at any time (a) in appropriate circumstances, vary the designation of a relaying area made under regulation 3(2); (b) if a relaying area designated in accordance with regulation 3(2) is no longer suitable for the relaying of live bivalve molluscs, revoke the designation of that relaying area, and shall communicate any such variation or revocation to the Department. Lists of designated production and relaying areas 6. - (1) The Department shall maintain and publish (a) a list of designated bivalve production areas; and (b) a list of any areas which district councils have designated as suitable for the relaying of live bivalve molluscs, and amendments to these lists shall be published from time to time. (2) The Department shall send a copy of the lists mentioned in paragraph (1), and any amendments to them to (a) each district council; (b) trade associations which appear to it to represent the interests of food businesses who are likely to be directly affected by this Part. (3) Each district council shall take such action as it considers sufficient to bring any part of the lists mentioned in paragraph (1) which relates to its district to the attention of any harvester, handler or operator of a dispatch centre or purification centre who is carrying out commercial operations with respect to live bivalve molluscs in its district. Temporary prohibition orders concerning production areas 7. - (1) Subject to paragraph (4), a district council may, if it is satisfied that the consumption of live shellfish taken from a production area situated in its district is likely to cause a risk to public health, make a temporary prohibition order prohibiting the collecting of any live shellfish from that area. (2) A temporary prohibition order shall cease to have effect at the expiration of a period of 28 days after it was made, unless earlier revoked by the district council making the order. (3) Forthwith after making such an order, a district council shall (a) in the case of a private laying, refer the matter to the Department and serve a notice on every owner and tenant of the laying whose name and address can with reasonable diligence be ascertained containing the following information (i) the reasons for the district council making the order, and (ii) any action which the district council is requesting the Department to take pursuant to regulation 4 or 5(1), and in particular the detail or any proposed conditions or restrictions; (b) in the case of any other production area, affix notices in the vicinity of the area and take any other steps it considers appropriate to bring the order to the attention of those affected, and in either case send a copy of the order and notice to the Department. (4) A district council shall not make a temporary prohibition order in respect of any production area if it has made such an order in respect of that area within the preceding 28 days, unless the Department gives consent to such action. Collecting live shellfish from prohibited areas 8. No person shall collect (a) live bivalve molluscs from a designated prohibited area for live bivalve mollusc production; (b) live echinoderms, tunicates or marine gastropods from a designated prohibited area for live echinoderm, tunicate and marine gastropod production; (c) live shellfish from (i) a designated prohibited area for live shellfish production, or (ii) a laying which is the subject of a temporary prohibition order made by a district council under regulation 7. Requirements relating to the harvesting, transporting and relaying of live shellfish 9. No person shall (a) harvest or transport from a production area to a dispatch centre or processing plant any live echinoderms, tunicates or marine gastropods otherwise than in accordance with Chapter II of Schedule 2; (b) harvest or transport from a production area to a relaying area, dispatch centre, purification centre or processing plant any live bivalve molluscs otherwise than in accordance with Chapter II of Schedule 2; or (c) relay any live bivalve molluscs otherwise than at a designated relaying area and in accordance with the applicable conditions for relaying in Chapter III of Schedule 2, if they are intended for placing on the market for human consumption. Requirement for the approval of dispatch or purification centres 10. No person shall operate a dispatch centre or purification centre unless it has been approved by the district council for the district in which the centre is situated. Approval of dispatch or purification centres 11. - (1) An application for an approval for a dispatch centre or purification centre shall be made to the district council for the district in which the centre is situated. (2) An application pursuant to paragraph (1) shall be (a) made in writing; and (b) accompanied by such supplementary information, documents, plans and diagrams as are necessary to enable the district council to determine the application. (3) An approval in respect of a dispatch centre may only be granted if the district council is satisfied that it meets such of the conditions set out in Sections I, II and IV of Chapter IV of Schedule 2 as apply to it. (4) An approval in respect of a purification centre may only be granted if the district council is satisfied that it meets (a) such of the conditions set out in Sections I, II and III of Chapter IV of Schedule 2 as apply to it; and (b) any additional conditions of which the district council has been notified by the Department pursuant to paragraph (5). (5) An approval for a dispatch centre or purification centre under this regulation may be granted subject to limitations as to the particular activities approved, the method of operation approved and the intensity of use approved, and where the Department notifies the district council that specified conditions for the operation of a purification centre relating to matters mentioned in Chapter IV of Schedule 2 should be complied with, the district council shall give its approval subject to those conditions. (6) The district council shall give written notification to each person who makes an application pursuant to paragraph (1) of the result of his application and, in the case of refusal, of the reasons for that refusal. (7) If an application pursuant to paragraph (1) is approved, the district council shall (a) designate the dispatch centre or purification centre with a unique approval number; and (b) notify the Department of the approval and the approval number allocated. Appeals against a refusal to grant an approval or against any conditions or limitations in approvals 12. - (1) A person who is aggrieved by a decision taken by the district council (a) to refuse to grant an approval for a dispatch centre or purification centre; or (b) to impose any limitation or condition in an approval granted for a dispatch centre or purification centre, may appeal to a court of summary jurisdiction and Article 37(2) to (3) of the Order shall apply in relation to such an appeal as it applies in relation to an appeal under Article 37(1)(c) of the Order. (2) Where an appeal against (a) a limitation as to the particular activities approved, the method of operation approved or the intensity of use approved; or (b) a condition notified to the district council by the Department in accordance with regulation 11(5), is brought in accordance with paragraph (1)(b), the appellant may continue to operate the dispatch centre or the purification centre, as the case may be, free of the limitation or condition which is being appealed against while the appeal is pending, and an appeal shall be regarded as pending for these purposes until it is finally disposed of, is struck out for want of prosecution or is withdrawn. (3) Where an appeal is brought in accordance with paragraph (1)(b) against a condition notified to the district council by the Department in accordance with regulation 11(5), the district council shall inform the Department that such an appeal has been brought. (4) Where an appeal is brought in accordance with paragraph (1), the court may (a) affirm any decision to refuse an approval; (b) grant the approval either in its original form or with such modifications as the court may in the circumstances think fit; (c) remit the matter to the district council with the court's opinion on it; or (d) make such other order in relation to the matter as the court thinks fit. Obligations on food business proprietors operating dispatch or purification centres 13. A food business proprietor who is operating a dispatch centre or purification centre at which live shellfish which are intended for placing on the market are handled shall ensure that (a) the requirements of the approval for his centre and of the applicable provisions of Chapter IV of Schedule 2 are complied with as respects his centre; (b) regular microbiological checks are carried out on (i) those of his shellfish which he is required to check for microbiological contamination in order to comply with the requirements set out in Chapter IV of Schedule 2, and (ii) if he is a purification centre proprietor, the water for use in the purification system at his centre, by or in laboratories which meet the applicable requirements of Chapter IV of Schedule 2; and (c) the results of the checks mentioned in sub-paragraph (b)(i) are recorded in a historical record which, in relation to each production area from which the shellfish were taken, gives details of the health quality of the shellfish from that area both before and after handling at the centre. Variation of approvals for dispatch or purification centres 14. - (1) A person may at any time apply to the district council for the council to vary or revoke any term or limitation in any approval for a dispatch centre or purification centre granted to him, and subject to paragraph (2), the district council may, in appropriate circumstances, vary any such term or limitation. (2) A district council may vary or revoke any additional condition of which it has been notified by the Department pursuant to regulation 11(5) only with the consent of the Department. (3) Any person who is aggrieved by a decision of a district council to refuse to vary any term or limitation of any approval for a dispatch centre or purification centre may appeal to a court of summary jurisdiction and Article 37(2) to (3) of the Order shall apply in relation to such an appeal as it applies in relation to an appeal under Article 37(1)(c) of the Order. (4) Where an appeal is brought in accordance with paragraph (3) against a refusal to vary a condition notified to the district council by the Department in accordance with regulation 11(5), the district council shall inform the Department that such an appeal has been brought. (5) Where an appeal is brought in accordance with paragraph (3), the court may (a) affirm any decision to refuse to vary the term or limitation in the approval; (b) vary the term or limitation in the approval; (a) (b) Species Maximum amount Cockles 25.0 tonnes Oysters 5.0 tonnes King Scallops 5.0 tonnes Queen Scallops 10.0 tonnes Mussels 20.0 tonnes Other Live Bivalve Molluscs 10.0 tonnes Marine Gastropods 20.0 tonnes Part III Production and Placing on the Market of Fishery Products Registration of fishing vessels on board which shrimps or molluscs are cooked 21. - (1) A person operating a fishing vessel on board which shrimps and molluscs are, for the purposes of a food business, processed by cooking shall, unless such processing is to be supplemented subsequently by cooking, comply with paragraphs (2) and (4). (2) The person operating the fishing vessel to which paragraph (1) applies shall, prior to engaging for the first time in such cooking, give notice in writing of his intention to do so to the district council for the area in which the vessel is based and shall at the same time supply that council with the following information (a) the name of the vessel; (b) the usual place of landing of the processed products; (c) the name and address of the owner of the vessel, and (d) any changes to the information originally supplied under sub paragraphs (a) to (c). (3) Each district council shall maintain a register of all the information supplied pursuant to paragraph (2). (4) Any processing of shrimps or molluscs by cooking on board a fishing vessel shall be carried out in accordance with the requirements of (a) paragraph 5 of Section I of Chapter III of Schedule 3; and (b) paragraph 7 of Section IV of Chapter IV of Schedule 3. Hygiene conditions for fishing vessels 22. - (1) A food business proprietor who is operating a fishing vessel on board which fishery products which are intended for placing on the market for human consumption are handled shall ensure that the applicable provisions of Part I of Schedule 4 are complied with as respects his vessel. (2) A food business proprietor who is operating a fishing vessel (a) which is designed and equipped to preserve fishery products on board under satisfactory conditions for more than 24 hours, other than those equipped for keeping fish and shellfish alive without other means of conservation on board; and (b) on board which fishery products which are intended for placing on the market for human consumption are handled, shall also ensure that the applicable provisions of Part II of Schedule 4 are complied with as respects his vessel. (3) Ship owners, or their representatives, who are operating a fishing vessel (a) which is designed and equipped to preserve fishery products on board under satisfactory conditions for more than 24 hours, other than those equipped for keeping fish and shellfish alive without other means of conservation on board; and (b) on board which fishery products which are intended for placing on the market for human consumption are handled, shall take all the measures necessary to prevent persons liable to contaminate fishery products from working on and handling them, until there is evidence that such persons can do so without risk. (4) The Department shall keep up-to-date for control purposes a list of the vessels equipped in accordance with paragraphs 7 and 8 of Part II of Schedule 4, with the exception however of vessels equipped with removable containers which, without prejudice to paragraph 5 of Part II of Schedule 4, are not engaged regularly in preserving fish in chilled seawater. Operation of a factory vessel or fishery products establishment without an approval 23. - (1) No person shall operate a fishery products establishment unless it has been approved by the district council for the district in which it is situated. (2) No person shall operate a United Kingdom, Channel Islands or Isle of Man factory vessel unless it has been approved (a) by the district council for the area which includes the place at which the vessel usually lands fishery products in Northern Ireland; or (b) in accordance with any law in force in Great Britain, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved in relation to the approval of factory vessels by the Fishery Products Directive. Approval of factory vessels and fishery products establishments 24. - (1) An application for an approval for a factory vessel or fishery products establishment shall be made to (a) in the case of a fishery products establishment, the district council for the district in which the establishment is situated; and (b) in the case of a factory vessel, the district council for the district which includes the place at which the vessel usually lands fishery products in Northern Ireland. (2) An application pursuant to paragraph (1) shall be (a) made in writing; and (b) accompanied by such supplementary information, documents, plans and diagrams as are necessary to enable the district council to determine the application. (3) An approval in respect of a factory vessel may only be granted if the district council is satisfied that it meets such of the conditions set out in Chapters I and II of Schedule 3 as apply to it. (4) An approval in respect of a fishery products establishment may only be granted if the district council is satisfied that it meets such of the conditions set out in Chapters III and IV of Schedule 3 as apply to it. (5) An approval in respect of a factory vessel or fishery products establishment under this regulation may be granted subject to limitations as to the particular activities approved, the method of operation approved and the intensity of use approved. (6) The district council shall give written notification to each person who makes an application pursuant to paragraph (1) of the result of the application and, in the case of refusal, of the reasons for that refusal. (7) If an application pursuant to paragraph (1) is granted, the district council shall (a) designate the fishery products establishment or factory vessel with a unique approval number; and (b) notify the Department of the granting of the approval and the number allocated under sub-paragraph (a). Requirement for the registration of auction or wholesale markets 25. No person shall operate an auction or wholesale market unless that market has been registered with the district council for the district in which it is situated. Registration of auction and wholesale markets 26. - (1) An application for registration for an auction or wholesale market shall be made to the district council for the district in which it is situated. (2) An application pursuant to paragraph (1) shall be (a) made in writing; and (b) accompanied by such supplementary information, documents, plans and diagrams as are necessary to enable the district council to determine the application. (3) An auction or wholesale market may only be registered if the district council is satisfied that it meets such of the conditions set out in Chapters II and III of Schedule 3 as apply to it. (4) The district council shall give written notification to each person who makes an application pursuant to paragraph (1) of the result of the application and, in the case of refusal, of the reasons for that refusal. (5) If an application pursuant to paragraph (1) is granted, the district council shall (a) designate the market with a unique registration number; and (b) notify the Department of the registration and the registration number allocated under sub-paragraph (a). Appeals against decisions under this Part to refuse to register or to grant an approval or against any conditions or limitations in such approvals 27. - (1) A person who is aggrieved by a decision taken by a district council (a) to refuse to grant an approval for a factory vessel or fishery products establishment; (b) to impose any limitation or condition in an approval granted for a factory vessel or fishery products establishment; or (c) to refuse to register an auction or wholesale market, may appeal to a court of summary jurisdiction, and Article 37(2) to (3) of the Order shall apply in relation to such an appeal as it applies in relation to an appeal under Article 37(1)(c) of the Order. (2) Where an appeal against a limitation as to the particular activities approved, the method of operation approved or the intensity of use approved is brought in accordance with paragraph (1)(b), the appellant may continue to operate the factory vessel or fishery products establishment free of the limitation which is being appealed against while the appeal is pending, and an appeal shall be regarded as pending for these purposes until it is finally disposed of, is struck out for want of prosecution or is withdrawn. (3) Where an appeal is brought in accordance with paragraph (1), the court may (a) affirm any decision to refuse to grant an approval or to register; (b) grant an application for registration; (c) grant an approval either in its original form or with such modifications as the court may in the circumstances think fit; (d) remit the matter to the district council with the court's opinion on it; or (e) make such other order in relation to the matter as the court thinks fit. Obligations upon food business proprietors operating establishments and factory vessels 28. - (1) A food business proprietor who is operating a fishery products establishment or United Kingdom, Channel Islands or Isle of Man factory vessel approved in either case under regulation 24 shall ensure that, as respects that establishment or vessel, the requirements of that approval are complied with. (2) A food business proprietor who is operating a factory vessel on board which fishery products which are intended for placing on the market for human consumption are handled shall ensure that the applicable provisions of Chapters I and II of Schedule 3 are complied with as respects his vessel. (3) A food business proprietor who is operating an establishment at which fishery products which are intended for placing on the market for human consumption are handled shall ensure that the applicable provisions of Chapters III and IV of Schedule 3 are complied with as respects his establishment. (4) A food business proprietor who is operating a factory vessel or fishery products establishment shall carry out checks at his vessel or establishment based on the following principles (a) identification of points critical to ensuring safe and hygienic production in his vessel or establishment on the basis of the manufacturing processes used, and for these purposes a critical point is any point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels; (b) establishment and implementation of methods for monitoring and checking such critical points; (c) taking samples for analysis in a laboratory which the appropriate district council considers suitable for the purpose of checking (i) cleaning and disinfection methods, and (ii) compliance with the standards established by this Part, and in deciding whether it considers a laboratory to be suitable, the appropriate district council shall have regard to any relevant guidance issued by the Department; (d) keeping a written record or a record registered in an indelible fashion of the preceding points which shall be made available to the appropriate district council on request, and that record shall (i) satisfy any applicable requirements of article 6.2 of the Health Checks Decision, and (ii) include results of the different checks for a period going back at least 2 years, and in the course of so doing, he shall have regard to any relevant recommendations in the Annex to the Health Checks Decision. (5) A food business proprietor to whom this regulation applies shall ensure that all staff involved in checks under paragraph (4) receive adequate training in order to participate effectively in their implementation. (6) If the results of checks under paragraph (4) reveal a serious health risk or suggest one might exist, the food business proprietor shall immediately notify the appropriate district council of that risk or possible risk and shall confirm such notification in writing within 48 hours. (7) In this regulation, "appropriate district council" in relation to a factory vessel means the district council for the district which includes the place at which that vessel usually lands fishery products in Northern Ireland and in relation to a fishery products establishment means the district council for the district in which that establishment is situated. Notice of arrival obligation for masters of third country vessels 29. The master of a factory vessel of a third country shall, before landing any fishery products in Northern Ireland which are for placing on the market, give the district council for the district in which the place at which he intends to land those fishery products is situated notice of arrival of at least 24 hours. Obligations upon food business proprietors operating auction or wholesale markets 30. A food business proprietor who is operating an auction or wholesale market at which fishery products which are intended for placing on the market for human consumption are handled shall ensure that the applicable provisions of Chapters II and III of Schedule 3 are complied with as respects his market. Variation of approvals for factory vessels or establishments 31. - (1) A person may at any time apply to the district council which granted an approval under regulation 24 for it to vary any term or limitation in any approval for a factory vessel or fishery products establishment so granted to him, and the district council may vary any such term or limitation. (2) Any person who is aggrieved by a decision of a district council to refuse to vary a term or limitation in any approval for a factory vessel or fishery products establishment may appeal to a court of summary jurisdiction, and Article 37(2) to (3) of the Order shall apply in relation to such an appeal as it applies in relation to any appeal under Article 37(1)(c) of the Order. (3) Where an appeal is brought in accordance with paragraph (2), the court may (a) affirm any decision to refuse to vary the term or limitation in the approval; (b) vary the term or limitation in the approval; (c) remit the matter to the district council with the court's opinion on it; or (d) make such other order in relation to the matter as the court thinks fit. Revocation of approvals for factory vessels or establishments and cancellation of market registrations 32. - (1) A district council may revoke an approval of an establishment or a factory vessel which it granted under regulation 24 if, after inspection of or any inquiry into the method of operation of the establishment or vessel, it is satisfied that (a) there has been a serious (on animal or public health grounds) and manifest breach of the conditions or limitations subject to which the approval was granted or of the applicable provisions of Chapters I to IV of Schedule 3; (b) the food business proprietor who is operating the establishment or vessel is either unable or not prepared to ensure that the breach is remedied; and (c) there is in force in relation to that establishment or vessel (i) a prohibition order under Article 10 of the Order, or (ii) an emergency prohibition order under Article 11 of the Order, and as a consequence of the order, commercial operations with regard to fishery products which are for placing on the market for human (a) (b) Species Maximum amount Cockles 25.0 tonnes Oysters 5.0 tonnes King Scallops 5.0 tonnes Queen Scallops 10.0 tonnes Mussels 20.0 tonnes Other Bivalve Molluscs 10.0 tonnes Marine Gastropods 20.0 tonnes Part IV Import Conditions for Fishery Products and Live Shellfish General restriction on importing fishery products 42. Subject to regulation 46, no person shall import any fishery products which are for human consumption unless they are products in respect of which (a) the applicable requirements of the Fishery Products Directive, the Fishing Vessels Directive, the Live Bivalve Molluscs Directive and the Fishery Products Decisions are satisfied (the requirements of these Directives and Decisions which are capable of being applicable in these circumstances are those mentioned in Part IV of Schedule 1); and (b) any additional conditions imposed under regulation 43 are satisfied. Additional conditions relating to certain third country imports of fishery products 43. - (1) Subject to paragraph (4) and regulation 46, no person shall import any fishery products which are for human consumption (a) from a third country; (b) from another country or territory within the European Community if those fishery products do not originate from within the European Economic Area[1], except where those products were in free circulation in that country or territory within the European Community; (c) from an EEA State which is not also a member State of the European Community, except where those fishery products originate from within the European Economic Area, unless the conditions specified in paragraph (2) or alternatively, if those fishery products originate in a country in respect of which the European Commission has adopted approved import conditions for fishery products and those fishery products fall within the scope of those approved import conditions, paragraph (3) are satisfied in relation to those fishery products which he imports. (2) The conditions in paragraph (2) referred to in paragraph (1) are that the fishery products (a) if dispatched to Northern Ireland from their country of origin (i) before the relevant date (aa) have their country of origin shown clearly on their labelling; and (bb) are only to be marketed in the United Kingdom, the Channel Islands or the Isle of Man, or in another EEA State according to the derogation mentioned in article 3.2 of Commission Decision 97/296/EC[2] drawing up the list of third countries from which the import of fishery products is authorised for human consumption, (ii) on or after the relevant date, originate in one of the third countries listed in Part II of the Annex to Commission Decision 97/296/EC; (b) come from an approved establishment or vessel inspected by a competent authority of the State of origin of those products; (c) comprise or are part of a consignment which is accompanied by a numbered, original, duly completed health certificate which (i) comprises a single sheet of paper, (ii) is drawn up in English and, if necessary, in an official language of the country or territory for which those fishery products are destined, (iii) contains the information mentioned in the specimen health certificate set out in the Annex to Commission Decision 95/328/EC[3] of 25th July 1995 establishing health certification for fishery products from third countries which are not yet covered by a specific decision, and (iv) contains the health attestation mentioned in that specimen health certificate, duly signed and dated by an official inspector duly appointed by the competent authority of the State of origin of those products; and (d) if they are or include processed shellfish, the processed shellfish (or parts thereof) originate in one of the third countries listed in the Annex to Commission Decision 97/20/EC establishing the list of third countries fulfilling the equivalence conditions for the production and placing on the market of bivalve molluscs, echinoderms, tunicates and marine gastropods[4], but this sub-paragraph shall not apply to adductor muscles, completely separated from viscera and gonads, of wild pectinidae. (3) The conditions in paragraph (3) referred to in paragraph (1) are that a person importing fishery products in circumstances where those products (a) originate in a third country in respect of which the European Commission has adopted approved import conditions for fishery products; and (b) fall within the scope of those improved import conditions, shall import those products in accordance with those approved import conditions. (4) Fishery products which (a) originate in a third country; (b) were caught in their natural environment; and (c) have not or had not been on land prior to their importation into the European Community; need not be accompanied by any health certificate which would otherwise be required under paragraph (2) or (3). (5) In paragraph (2), "the relevant date" means the date on which the derogation mentioned in article 3.2 of Commission Decision 97/296/EC comes to an end or, if that date is deferred, the deferred date. General restriction on importing live shellfish 44. - (1) Subject to paragraph (2) and regulation 46, no person shall import any live shellfish which are for human consumption, unless (without prejudice to any restrictions imposed under the Risk of Infection (Oysters) Order (Northern Ireland) 1973[5] or the Fish Health Regulations (Northern Ireland) 1993[6] (a) they are products in respect of which the applicable requirements of the Live Bivalve Molluscs Directive are satisfied (the requirements of this Directive which are capable of being applicable in these circumstances are those mentioned in Part V of Schedule 1); and (b) any additional conditions imposed under regulation 45 are satisfied, in relation to those live shellfish which he imports. (2) Live bivalve molluscs belonging to the species Acanthocardia tuberculatum may be imported from Spain which were harvested from production areas where the paralytic shellfish poison level in the edible parts of those molluscs is higher than 80 micrograms per 100 grams but lower than 300 micrograms per 100 grams, but only if the conditions set out in articles 2 and 3 of Commission Decision 96/77/EC[7] of 18th January 1996 establishing the conditions for the harvesting and processing of certain bivalve molluscs coming from areas where the paralytic shellfish poison level exceeds the limit laid down by the Live Bivalve Molluscs Directive are satisfied in relation to those molluscs which are imported from such production areas. Additional conditions relating to certain third country imports of live shellfish 45. - (1) Subject to regulation 46, no person shall import any live shellfish which are for human consumption (a) from a third country; (b) from another country or territory within the European Community if those live shellfish do not originate from within the European Economic Area[8], except where those live shellfish were in free circulation in that country or territory within the European Community; (c) from an EEA State which is not also a member State of the European Community, except where those live shellfish originate from within the European Economic Area, unless the conditions specified in paragraph (2) or alternatively, if those live shellfish originate in a country in respect of which the European Commission has adopted approved import conditions for live shellfish and those live shellfish fall within the scope of those approved import conditions, paragraph (3) are satisfied in relation to those live shellfish which he imports. (2) The conditions in paragraph (2) referred to in paragraph (1) are that (a) the live shellfish originate in one of the third countries listed in the Annex to Commission Decision 97/20/EC establishing the list of third countries fulfilling the equivalence conditions for the production and placing on the market of bivalve molluscs, echinoderms, tunicates and marine gastropods; (b) the live shellfish shall have been harvested from a production area checked and approved by the competent authority of the State of origin of those shellfish; (c) if the live shellfish are for immediate human consumption, those live shellfish comprise or are part of a consignment which is accompanied by a numbered, original, duly completed health certificate which (i) comprises a single sheet of paper, (ii) is drawn up in English and, if necessary, in an official language of the country or territory for which those live shellfish are destined, (iii) contains the information mentioned in the specimen health certificate set out in Annex I to Commission Decision 96/333/EC[9] establishing health certification of live bivalve molluscs, echinoderms, tunicates and marine gastropods from third countries which are not covered by a specific decision, and (iv) contains the health attestation mentioned in that specimen health certificate, duly signed and dated (all of which shall be in a colour different from that of the other printing on the certificate) by an official inspector duly appointed by the competent authority of the State of origin of those shellfish; (d) if the live shellfish are for purification in an approved purification centre, for relaying at a designated relaying area or for processing at an approved establishment, those live shellfish comprise or are part of a consignment which is accompanied by a numbered, original, duly completed health certificate which (i) comprises of a single sheet of paper, (ii) is drawn up in English and, if necessary, in an official language of the country or territory for which those live shellfish are destined, (iii) contains the information mentioned in the specimen health certificate set out in Annex II to Commission Decision 96/333/EC, and (iv) contains the health attestation mentioned in that specimen health certificate, duly signed, stamped and dated (all of which shall be in a colour different from that of the other printing on the certificate) by an official inspector duly appointed by the competent authority of the State of origin of those live shellfish. (3) The conditions in paragraph (3) referred to in paragraph (1) are that a person importing live shellfish in circumstances where those live shellfish (a) originate in a third country in respect of which the European Commission has adopted approved import conditions for live shellfish; and (b) fall within the scope of those approved import conditions, shall import those live shellfish in accordance with those approved import conditions. Exemption for private consignments 46. This Part shall not apply to a person importing a private consignment (a) from a country or territory within the European Community, unless that consignment is a consignment of trade samples which weighs more than 10 kilograms; or (b) from any other country or territory, if that consignment weighs 1 kilogram or less. Part V Inspection Charges for Direct Landings from Third Country Vessels Interpretation of Part V 47. - (1) In this Part "chargeable transaction" shall be construed in accordance with regulation 48(1); "ECU" means European Currency Unit, and any reference in this Part to a specified number of ECU shall be taken to be a reference to the sterling equivalent of that number of ECU; "reducible element" shall be construed in accordance with regulation 50(1); "relevant fishery products" means imported fishery products which (a) originate in a country or territory which is not part of the customs territory of the European Community other than Greenland; (b) were caught in their natural environment; (c) have not or had not been on land prior to their importation or proposed importation into the European Community; (d) are or will be landed in Northern Ireland; and (e) are intended for placing on the market for human consumption; "third country direct landings charge" shall be construed in accordance with regulation 48(1); "vendor" includes an agent selling fishery products on behalf of the owner or master of a fishing vessel. (2) The sterling equivalent of any amount expressed in this Part as a number of ECU shall be converted to sterling at the official rate, which is published annually in the C Series of the Official Journal of the European Communities normally on the first working day of the month of September. Charge in respect of official checks on third country direct landings 48. - (1) When any relevant fishery products are sold for the first time in Northern Ireland (referred to in this Part as a "chargeable transaction"), the vendor of those products shall include in the price which the first purchaser is required to pay for them an amount referred to in this Part as the "third country direct landings charge". (2) Subject to regulation 50, the amount of the third country direct landings charge shall be (a) in respect of allaying the expenditure incurred in carrying out the checks mentioned in Section II of Chapter V of Schedule 3 (special checks), ECU 1 per tonne of relevant fishery products for the first 50 tonnes and ECU 0.5 per tonne thereafter, except that any charge in respect of (i) herring of the species Clupea harengus, (ii) sardines of the species Sardina pilchardus, (iii) mackerel of the species Scomber scrombus or Scomber japonicus, (iv) horse mackerel, (v) anchovies, (vi) picarels of the species Maena smaris, shall not exceed ECU 50 per consignment unloaded, if the expenditure actually incurred does not exceed that amount; and (b) in respect of allaying the expenditure incurred in carrying out checks on vessels and on conditions of landing, ECU 1 per tonne, and the vendor of the products to which the amount relates shall be entitled to recover the amount from the first purchaser as a civil debt. Sum payable by vendors to district councils 49. - (1) Subject to paragraph (2), a sum equal to the amount of any third country direct landings charge which a vendor is required to include in the purchase price of any relevant fishery products shall be payable by him to the district council for the district in which the chargeable transaction takes place. (2) If the chargeable transaction takes place before the fishery products are landed in Northern Ireland, a sum equal to the amount of any third country direct landings charge which a vendor is required to include in the purchase price shall be payable by him to the district council responsible for carrying out the checks provided for in Section II of Chapter V of Schedule 3 in respect of those products. (3) Any sum payable to a district council under this regulation shall be recoverable as a civil debt. The reducible element of the charge 50. - (1) A vendor who enters into a chargeable transaction may, with the consent of the district council for the district in which the chargeable transaction takes place, reduce by such amount as the district council considers reasonable the part of the third country direct landings charge which is calculated in accordance with regulation 48(2)(a) (referred to in this Part as "the reducible element") in circumstances where any of the checks mentioned in Section II of Chapter V of Schedule 3 are or were facilitated by one or more of the following factors (a) the fish are or were graded for freshness and/or size in accordance with relevant national or Community rules; (b) the first sale transactions are or were grouped together, in particular at an auction or wholesale market, except that the reducible element shall not be reduced by more than 55% of the total amount that the reducible element would be, if it were not reduced. (2) A vendor who considers that in respect of a chargeable transaction a district council has unreasonably refused to consent (a) to a reduction in the reducible element of the third country direct landings charge; or (b) to a reduction in the reducible element of that charge by a larger amount than the amount by which the district council has agreed that the reducible element of the charge may be reduced, may appeal against the district council's decision to a court of summary jurisdiction, and Article 37(2) to (3) of the Order shall apply in relation to such an appeal as it applies in relation to an appeal under Article 37(1)(c) of the Order. (3) On an appeal, the court may (a) confirm the decision of the district council; (b) reduce the amount of the reducible element of the charge to the level it thinks fit, except that the court shall not reduce the reducible element by an amount which results in a total reduction of more than 55% of the total amount that the reducible element would be, if it were not reduced. (4) Pending the outcome of the appeal (a) the original amount of the third country direct landings charge shall remain payable by the first purchaser to the vendor; and (b) a sum equal to the original amount of that charge shall remain payable by the vendor to the district council, but if after the court's decision the amount of the charge needs to be recalculated, the new amount of the charge, and the sum equal to that new amount which is payable to the district council, shall have effect from the date on which the original amount was payable. (5) If, as a result of the recalculation of the amount of a third country direct landings charge by a court, a vendor of relevant fishery products has made an over-payment to a district council in respect of a sum payable under this Part, the district council shall reimburse to the vendor an amount equal to that overpayment. Collection and remittance arrangements 51. - (1) A vendor who has entered into a chargeable transaction shall within seven days after the end of the week during which the chargeable transaction took place make a return to the district council for the district in which the chargeable transaction took place, which shall include the following information (a) the date of the chargeable transaction; (b) a description of the fishery products sold (sufficient for the purposes of identifying whether any of the products fall into one of the categories listed in regulation 48(2)(a)); (c) the net weight of each description of fishery products sold; (d) the purchaser; (e) the amount of the third country direct landings charge; (f) the amount of any reduction in the reducible element of the third country direct landings charge; and (g) the place of landing of the fishery products sold and the country or territory in which the products originate[1]. (2) In any case where, in respect of any relevant fishery products (a) the district council responsible for checks on vessels and on conditions of landing ("the general monitoring council"); or (b) the district council responsible for the checks provided for in Section II of Chapter V of Schedule 3 ("the special checks council"), is different from the district council to which the first vendor of the products is required to pay a sum equal to the amount of the third country direct landings charge ("the recipient council"), the recipient council shall remit to the general monitoring council or, as the case may be, the special checks council a sum equal to any amount received from the vendor which is referable to checks for which the general monitoring council or, as the case may be, the special checks council is responsible. Notes: [1] See Council Regulation (EEC) No. 2193/92 establishing the Community Customs Code (O.J. No. L302, 19.10.92, p. 1), Title II, Chapter 2 (Origin of Goods)back Part VI Enforcement, Penalties and Revocations Functions of the Department and district councils 52. - (1) Subject to paragraph (2)(b), the Department shall perform the functions assigned to it by Chapters III and VI of Schedule 2. (2) Each district council shall perform (a) the functions assigned to it by Chapters III and VI of Schedule 2; and (b) any function of the Department specified in paragraph 1 of Chapter VI of Schedule 2 which the Department requires the district council to undertake on its behalf. (3) The Department and district councils shall perform the functions assigned to them by Chapter V of Schedule 3. Offences and penalties 53. - (1) If a person contravenes any provision of regulations 8 to 10, 13, 16 to 19(1), 21(1), (2) and (4), 22(1) to (3), 23, 25, 28 to 30, or 33 to 40, he shall be guilty of an offence, and subject to paragraph (2) shall be liable (a) on summary conviction, to a fine not exceeding the statutory maximum; (b) on conviction on indictment, to a fine or imprisonment for a term not exceeding 2 years or both. (2) Any person who (a) without reasonable cause, fails to give any person acting on behalf of a district council in matters arising under Part V any assistance or information which that person may reasonably require of him in connection with such matters; or (b) in purported compliance with any such requirement as is mentioned in sub-paragraph (a) intentionally or recklessly furnishes information which is false or misleading in a material particular, shall be guilty of an offence, and shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale. Enforcement of Parts II and III 54. Except where otherwise specified, each district council shall enforce and execute Parts II and III within its district. Application of provisions of the Order for the purposes of Parts II and III 55. - (1) The following provisions of the Order shall apply for the purposes of Parts II and III as they apply for the purposes of Articles 7, 13 and 14 of the Order, and a reference in them to the Order shall for the purposes of Parts II and III be construed as a reference to these Regulations (a) Article 4 (presumptions that food intended for human consumption); (b) Article 19 (offences due to fault of another person); (c) Article 20 (defence of due diligence); (d) Article 30(8) (which relates to documentary evidence); (e) Article 34 (obstruction, etc., of officers); (f) Article 35 (time limit for prosecutions). (2) Article 26(2) of the Order (discharge of duties of district councils by the Department concerned) shall apply as respects functions imposed on district councils under these Regulations as it does as respects a duty imposed on a district council by Article 26(1) of the Order. (3) Article 33 of the Order (powers of entry) shall apply for the purposes of Parts II and III as though (a) any reference to premises included a reference to a fishing vessel, a factory vessel or any vessel used for transporting live shellfish to a relaying area or dispatch centre or purification centre (in so far as it does not already do so); and (b) any reference to an occupier included a reference to the master or other person in charge of a vessel mentioned in sub-paragraph (a) (in so far as it does not already do so). (4) Article 2(6) of the Order (territorial waters) shall apply for the purposes of Parts II and III as it applies for the purposes of the Order. Enforcement of Part IV 56. For the purposes of the Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998[1] (in this paragraph referred to as "the Import and Export Regulations") (a) the conditions set out in Part IV shall be treated as animal and public health requirements; and (b) those conditions shall be enforced as animal and public health requirements (i) by a district council or the Department of Agriculture for Northern Ireland (or by an authorised officer of a district council or of that Department), whichever has the responsibility under the Import and Export Regulations for enforcing animal and public health requirements in the particular circumstances of the case, (ii) in accordance with the procedures set out in the Import and Export Regulations, and (iii) subject to the penalties and other sanctions set out in the Import and Export Regulations. Food treated as failing to comply with food safety requirements 57. - (1) A district council may certify any fishery products or live shellfish in respect of which any applicable requirements of Part II or III are not met as being a food or food source which fails to comply with these Regulations. (2) Any fishery products or live shellfish which in accordance with paragraph (1) are certified as being a food or food source which fails to comply with these Regulations may be treated for the purpose of Article 8 of the Order as failing to comply with food safety requirements. Amendment of other Regulations 58. - (1) After sub-paragraph (h) of paragraph (2) of regulation 3 of the Food Premises (Registration) Regulations (Northern Ireland) 1992[2] there shall be inserted " (i) as a dispatch centre, purification centre, factory vessel or fishery products establishment which is approved under, or an auction or wholesale market which is registered under, the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998.". (2) Regulation 3(2) of the Food Safety (General Food Hygiene) Regulations (Northern Ireland) 1995[3] shall be amended as follows (a) sub-paragraphs (a) to (e) shall be omitted; and (b) after sub-paragraph (l) there shall be inserted " (m) the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998.". (3) Regulation 3 of the Food Safety (Temperature Control) Regulations (Northern Ireland) 1995[4] shall be amended as follows (a) paragraph (2)(a) to (e) shall be omitted; (b) in paragraph (2), after sub-paragraph (k) there shall be inserted " (l) the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998."; (c) in paragraph (3), for the words from "regulated by" to "unless," there shall be substituted "regulated by Part III of the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland 1998, unless,". (4) The Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998 shall be amended as follows (a) in regulation 2(1) (i) the definitions of "bivalve molluscs" and "other shell fish" shall be omitted; (ii) for the definition of "fishery products" there shall be substituted " "fishery products" has the same meaning as in the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998;", and (iii) after the definition of "importer" there shall be inserted " "live shellfish" has the same meaning as in the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998;"; (b) in each of the following provisions (i) regulation 20(1), (ii) regulation 21(1) and (2), (iii) regulation 22(b) and (c), (iv) regulation 23(3), and (v) regulation 24(3), "bivalve molluscs or other" shall be omitted; and (c) in Schedule 2 (i) paragraphs 1 and 2 shall be omitted; and (ii) after paragraph 5 there shall be inserted " 6. The Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998 (S.R. 1998 No. 207).". Revocations and transitional provision 59. - (1) The Regulations specified in column (1) of Schedule 5 are hereby revoked to the extent specified in column (3) of that Schedule. (2) Any premises (which includes vessels) recognised immediately before the commencement of these Regulations as registered or approved by a district council in accordance with any of the Regulations revoked by paragraph (1) shall be treated as registered or (as the case may be) approved in accordance with and for the purposes of these Regulations. Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on L.S. W. B. Smith Assistant Secretary 8th June 1998. Notes: [1] S.R. 1998 No. 45back [2] S.R. 1992 No. 167, as amended by S.R. 1993 No. 423, S.R. 1994 No. 346, S.R. 1995 No. 201 and S.R. 1997 Nos. 493, 494, 495 and 496back [3] S.R. 1995 No. 360, as amended by S.R. 1996 No. 286 and S.R. 1997 Nos. 493, 494, 495 and 496back [4] S.R. 1995 No. 377, as amended by S.R. 1996 No. 383 and S.R. 1997 Nos. 493, 494 and 495back SCHEDULES SCHEDULE 1 Regulations 2(1) and (2), 42(a) and 44(1)(a) Imports Part I Approved Import Conditions for Fishery Products 1. Commission Decision 93/436/EEC laying down special import conditions governing imports of fishery products originating in Chile[1]. 2. Commission Decision 93/437/EEC laying down special import conditions governing imports of fishery products originating in Argentina[2]. 3. Commission Decision 93/494/EEC laying down special conditions governing imports of fishery products originating in the Faroe Islands[3]. 4. Commission Decision 93/495/EEC laying down special conditions governing imports of fishery products originating in Canada[4]. 5. Commission Decision 94/198/EC laying down special conditions governing the import of fishery and aquaculture products originating in Brazil[5]. 6. Commission Decision 94/200/EC laying down special conditions governing the import of fishery and aquaculture products originating in Ecuador[6]. 7. Commission Decision 94/269/EC laying down special conditions governing imports of fishery and aquaculture products originating in Columbia[7]. 8. Commission Decision 94/323/EC laying down special conditions governing imports of fishery products originating in Singapore[8]. 9. Commission Decision 94/324/EC laying down special conditions governing imports of fishery and aquaculture products originating in Indonesia[9]. 10. Commission Decision 94/325/EC laying down special conditions governing imports of fishery and aquaculture products originating in Thailand[10]. 11. Commission Decision 94/448/EC laying down special conditions governing imports of fishery and aquaculture products originating in New Zealand[11]. 12. Commission Decision 94/766/EC laying down special conditions governing imports of fishery and aquaculture products originating in Taiwan[12]. 13. Commission Decision 94/778/EC laying down special conditions for the import of frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Turkey[13]. 14. Commission Decision 95/30/EC laying down special conditions governing imports of fishery and aquaculture products originating in Morocco[14]. 15. Commission Decision 95/90/EC laying down special conditions governing imports of fishery and aquaculture products originating in Albania[15]. 16. Commission Decision 95/173/EC laying down special conditions governing imports of fishery and aquaculture products originating in Peru[16]. 17. Commission Decision 95/190/EC laying down special conditions governing imports of fishery and aquaculture products originating in the Philippines[17]. 18. Commission Decision 95/454/EC laying down special conditions governing imports of fishery and aquaculture products originating in the Republic of Korea[18]. 19. Commission Decision 95/538/EC laying down special conditions governing the import of fishery and aquaculture products originating in Japan[19]. 20. Commission Decision 96/355/EC laying down special conditions governing the import of fishery and aquaculture products originating in Senegal[20]. 21. Commission Decision 96/356/EC laying down special conditions governing the import of fishery and aquaculture products originating in Gambia[21]. 22. Commission Decision 96/425/EC laying down special conditions governing the import of fishery and aquaculture products originating in Mauritania[22]. 23. Commission Decision 96/606/EC laying down special conditions governing the import of fishery and aquaculture products originating in Uruguay[23]. 24. Commission Decision 96/607/EC laying down special conditions governing the import of fishery and aquaculture products originating in South Africa[24]. 25. Commission Decision 96/608/EC laying down special conditions governing the import of fishery and aquaculture products originating in Malaysia[25]. 26. Commission Decision 96/609/EC laying down special conditions governing the import of fishery and aquaculture products originating in the Ivory Coast[26]. Part II Approved Import Conditions for Live Shellfish 1. Commission Decision 93/387/EEC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Morocco[27]. 2. Commission Decision 94/777/EC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Turkey[28]. 3. Commission Decision 95/174/EC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Peru[29]. 4. Commission Decision 95/453/EC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in the Republic of Korea[30]. 5. Commission Decision 96/675/EC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Chile[31]. Part III The Fishery Products Decisions 1. Commission Decision 93/25/EEC approving certain treatments to inhibit the development of pathogenic micro-organisms in bivalve molluscs and marine gastropods[32]. 2. Commission Decision 93/51/EEC on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish[33]. 3. Commission Decision 93/140/EEC laying down the detailed rules relating to the visual inspection for the purpose of detecting parasites in fishery products[34]. 4. Commission Decision 93/351/EEC determining analysis methods, sampling plans and maximum limits for mercury in fishery products[35]. 5. The Health Checks Decision. 6. Commission Decision 95/149/EC fixing the total volatile basic nitrogen (TVB-N) limit values for certain categories of fishery products and specifying the analysis methods to be used[36]. Part IV Applicable Requirements Relating to Imported Fishery Products As respects imported fishery products, the requirements of the Fishery Products Directive, the Fishing Vessels Directive, the Live Bivalve Molluscs Directive and the Fishery Products Decisions which are capable of being applicable are (a) in relation to fishery products other than aquaculture products or processed bivalve molluscs, echinoderms, tunicates or marine gastropods, those set out in (i) articles 3.1(a) to (g), 3.2, 4, 5 and 6.1 of the Fishery Products Directive, (ii) article 1 of the Fishery Vessels Directive, (iii) articles 1 to 4 of Commission Decision 93/51/EEC, (iv) articles 2 to 4 of Commission Decision 93/140/EEC, (v) articles 1 to 3 of Commission Decision 93/351/EEC, (vi) articles 1.3 and 6.2 of the Health Checks Decision, and (vii) articles 1 and 2 of Commission Decision 95/149/EC; (b) in relation to fishery products which are aquaculture products, those set out in (i) articles 3.1(c) to (g), 3.3, 4, 5 and 6.1 of the Fishery Products Directive, (ii) articles 1 to 4 of Commission Decision 93/51/EEC, (iii) articles 2 to 4 of Commission Decision 93/140/EEC, (iv) articles 1 to 3 of Commission Decision 93/351/EEC, (v) articles 1.3 and 6.2 of the Health Checks Decision, and (vi) articles 1 and 2 of Commission Decision 95/149/EC; (c) in relation to fishery products which are processed bivalve molluscs, echinoderms, tunicates or marine gastropods, those set out in (i) articles 3.1(a) and (c) to (g), 3.4, 5 and 6.1 of the Fishery Products Directive, (ii) article 3.1(a) to (i) and 3.2 (as read with article 1) and article 4 of the Live Bivalve Molluscs Directive, (iii) article 1 of Commission Decision 93/25/EEC, (iv) articles 1 to 4 of Commission Decision 93/51/EEC, (v) article 2 of Commission Decision 93/140/EEC, (vi) articles 1 to 3 of Commission Decision 93/351/EEC, and (vii) articles 1.3 and 6.2 of the Health Checks Decision. Part V Applicable Requirements Relating to Imported Live Shellfish As respects imported live shellfish, the requirements of the Live Bivalve Molluscs Directive which are capable of being applicable are those set out in article 3.1(a) to (i) and 3.2 (read with article 1) and article 4. Notes: [1] O.J. No. L202, 12.8.93, p. 31; amended by Commission Decision 93/620/EC (O.J. No. L297, 2.12.93, p. 31), Commission Decision 94/188/EC (O.J. No. L89, 6.4.94, p. 21), Commission Decision 94/675/EC (O.J. No. L268, 19.10.94, p. 22, and a corrigendum in O.J. No. L298, 19.11.94, p. 49), Commission Decision 95/164/EC (O.J. No. L108, 13.5.95, p. 174), Commission Decision 96/31/EC (O.J. No. L9, 12.1.96, p. 6), Commission Decision 96/220/EC (O.J. No. L74, 22.3.96, p. 75) and Commission Decision 96/674/EC (O.J. No. L313, 3.12.96, p. 29)back [2] O.J. No. L202, 12.8.93, p. 42; amended by Commission Decision 93/525/EEC (O.J. No. L252, 9.10.93, p. 30), Commission Decision 94/341/EC (O.J. No. L151, 17.6.94, p. 41), Commission Decision 95/299/EC (O.J. No. L184, 3.8.95, p. 49), Commission Decision 96/31/EC, Commission Decision 96/262/EC (O.J. No. L89, 10.4.96, p. 36) and Commission Decision 97/276/EC (O.J. No. L108, 25.4.97, p. 53)back [3] O.J. No. L232, 15.9.93, p. 37; amended by Commission Decision 95/151/EC (O.J. No. L100, 3.5.95, p. 22) and Commission Decision 96/31/EC.back [4] O.J. No. L232, 15.9.93, p. 43; amended by Commission Decision 93/606/EEC (O.J. No. L289, 24.11.93, p. 26), Commission Decision 94/287/EC (O.J. No. L122, 17.5.94, p. 38), Commission Decision 94/674/EC (O.J. No. L267, 18.10.94, p. 15), Commission Decision 94/989/EC (O.J. No. L378, 31.12.94, p. 64), Commission Decision 95/351/EC (O.J. No. L203, 29.8.95, p. 13), Commission Decision 95/549/EC (O.J. No. L310, 22.12.95, p. 74) and Commission Decision 96/31/EC.back [5] O.J. No. L93, 12.4.94, p. 26; amended by Commission Decision 96/31/EC and Commission Decision 96/193/EC (O.J. No. L61, 12.3.96, p. 43)back [6] O.J. No. L93, 12.4.94, p. 34; amended by Commission Decision 94/840/EC (O.J. No. L352, 31.12.94, p. 21), Commission Decision 95/177/EC (O.J. No. L117, 24.5.95, p. 42) and Commission Decision 96/31/ECback [7] O.J. No. L115, 6.5.94, p. 38; amended by Commission Decision 94/469/EC (O.J. No. L194, 29.7.94, p. 85), Commission Decision 95/332/EC (O.J. No. L192, 15.8.95, p. 30) and Commission Decision 96/31/ECback [8] O.J. No. L145, 10.6.94, p. 19; amended by Commission Decision 96/31/ECback [9] O.J. No. L145, 10.6.94, p. 23; amended by Commission Decision 95/34/EC (O.J. No. L44, 26.2.95, p. 67) and Commission Decision 96/31/ECback [10] O.J. No. L145, 10.6.94, p. 30; amended by Commission Decision 94/704/EC (O.J. No. L285, 4.11.94, p. 28), Commission Decision 95/178/EC (O.J. No. L117, 24.5.95, p. 35) and Commission Decision 96/31/ECback [11] O.J. No. L184, 20.7.94, p. 16; amended by Commission Decision 94/705/EC (O.J. No. L285, 4.11.94, p. 33), Commission Decision 95/179/EC (O.J. No. L117, 24.5.95, p. 40), Commission Decision 95/310/EC (O.J. No. L186, 5.8.95, p. 70), Commission Decision 96/31/EC and Commission Decision 96/254/EC (O.J. No. L86, 4.4.96, p. 75)back [12] O.J. No. L305, 30.11.94, p. 31; amended by Commission Decision 96/31/EC and Commission Decision 96/255/EC. (O.J. No. L86, 4.4.96, p. 81).back [13] O.J. No. L312, 6.12.94, p. 40; amended by Commission Decision 96/31/ECback [14] O.J. No. L42, 24.2.95, p. 32; amended by Commission Decision 95/298/EC (O.J. No. L184, 3.8.95, p. 48) and Commission Decision 96/459/EC (O.J. No. L191, 1.8.96, p. 48)back [15] O.J. No. L70, 30.3.95, p. 27; amended by Commission Decision 95/235/EC (O.J. No. L156, 7.7.95, p. 82)back [16] O.J. No. L116, 23.5.95, p. 41; amended by Commission Decision 95/311/EC (O.J. No. L186, 5.8.95, p. 78)back [17] O.J. No. L123, 3.6.95, p. 20; amended by Commission Decision 96/256/EC (O.J. No. L86, 4.4.96, p. 83)back [18] O.J. No. L264, 7.11.95, p. 37back [19] O.J. No. L304, 16.12.95, p. 52back [20] O.J. No. L137, 8.6.96, p. 24back [21] O.J. No. L137, 8.6.96, p. 31back [22] O.J. No. L175, 13.7.96 p. 27back [23] O.J. No. L269, 22.10.96, p. 18back [24] O.J. No. L269, 22.10.96, p. 23back [25] O.J. No. L269, 22.10.96, p. 32back [26] O.J. No. L269, 22.10.96, p. 37back [27] O.J. No. L166, 8.7.93, p. 40; amended by Commission Decision 93/530/EEC (O.J. No. L258, 16.10.93, p. 32); Commission Decision 94/767/EC (O.J. No. L305, 30.11.94, p. 36) and Commission Decision 96/31/ECback [28] O.J. No. L312, 6.12.94, p. 35; amended by Commission Decision 95/275/EC (O.J. No. L167, 18.7.95, p. 26) and Commission Decision 96/31/ECback [29] O.J. No. L116, 23.5.95, p. 47back [30] O.J. No. L264, 7.11.95, p. 35back [31] O.J. No. L313, 3.12.96, p. 38back [32] O.J. No. L16, 25.1.93, p. 22; amended by Commission Decision 97/275/EC (O.J. No. L108, 25.4.97 p. 52)back [33] O.J. No. L13, 21.1.93, p. 11back [34] O.J. No. L56, 9.3.93, p. 42back [35] O.J. No. L144, 16.6.93, p. 23back [36] O.J. No. L97, 29.4.95, p. 84back SCHEDULE 2 Regulations 2(1), 3(1) and (2), 9, 11(3) to (5), 13, 15 to 20 and 52 Production and placing on the market Conditions for live shellfish (Based on the corresponding provisions of the Annex to the Live Bivalve Molluscs Directive) Chapter I Conditions for Production Areas Part I Class A Areas Areas to be designated class A areas 1. An area from which live bivalve molluscs can be gathered for direct human consumption provided such molluscs satisfy the requirements specified in Chapter V. Part II Class B Areas Areas to be designated class B areas 2. An area from which live bivalve molluscs may be gathered but only placed on the market for human consumption (a) after treatment in a purification centre or after relaying (followed, where necessary, by treatment in a purification centre); or (b) after heat treatment by an approved process in an approved establishment. Conditions in relation to a class B area 3. Prior to relaying, treatment in a purification centre or heat treatment, the live bivalve molluscs from these areas must not exceed in 90% of samples the limits of (a) a five-tube, three-dilution MPN-test of 6,000 faecal coliforms per 100 grams of flesh; or Movement Document No. Issued by: Date of Issue: Name of gatherer Signature of gatherer District council for the district where shellfish landed Address of gatherer Date of gathering Location of production area and, if live bivalve molluscs, class of production area (A, B or C) Name of shellfish species being moved (common and scientific) and quantity of shellfish being moved Place of destination, including (if applicable) approval number Date of receipt Place of receipt REMINDER - This document is to be kept by the person receiving the shellfish for a period of not less than 60 days. (5) Each movement document must be numbered permanently in sequence by the district council. (6) Each district council shall keep a register indicating the number of each movement document together with the name of the person collecting the live shellfish and of the person to whom the document was issued. (7) The person receiving a movement document for each batch of live shellfish shall put on it the date the batch was received by either a dispatch centre, purification centre, relaying area or processing plant and shall keep it available for inspection for a period of at least 60 days. (8) If gathering is or is to be carried out by a person employed by the person who operates the dispatch centre, purification centre, relaying area or processing plant of destination, the district council may, if satisfied that the gatherer will comply with the requirements of Part II concerning gathering and handling, issue to the gatherer a permanent transport authorisation (which may be withdrawn at any time) absolving the gatherer from the requirement to use movement documents for transfers from a production area specified in that authorisation to a dispatch centre, purification centre, relaying area, or processing plant specified in that authorisation. 7. If a production or relaying area is closed temporarily, pursuant to regulation 7, the district council shall refrain from issuing further movement documents and permanent transport authorisations for that area and the district council may suspend the validity of any such documentations or authorisations already issued for the area. Chapter III Conditions for Relaying Live Bivalve Molluscs The following conditions must be met 1. live bivalve molluscs must be gathered and transported, under the supervision of the district council, in accordance with the requirements of Chapter II; 2. techniques for handling live bivalve molluscs intended for relaying must permit the resumption of filter-feeding activity after immersion in natural waters; 3. live bivalve molluscs must not be relaid at a density which does not permit purification; 4. live bivalve molluscs must be immersed in sea water at the relaying area for an appropriate period which must exceed the time taken for levels of faecal bacteria to become reduced to the levels permitted by these Regulations and in particular either the standards specified in Chapter V or the standards in Part 2 of Chapter I where relaying is to be followed by purification; Country of dispatch Approval number of dispatch centre Species consigned (scientific name) Species consigned (common name) Day and month of wrapping [EITHER 'WARNING: THESE ANIMALS MUST BE ALIVE WHEN SOLD' OR DATE OF DURABILITY] 2. - (1) The healthmark may be (a) printed on the wrapping material; (b) affixed as a separate label to the wrapping material; (c) put inside the wrapping; or (d) of a twist-tie or staple design. (2) A self-adhesive healthmark must not be used, unless it is not detachable. (3) All types of healthmark must be for single use only and are not transferable. 3. The healthmark must be durable and waterproof, and the information presented must be legible, indelible and in easily decipherable characters. 4. Where a person repackages any live shellfish in accordance with paragraph 3 of Chapter VII, the healthmark provided on the new wrapping shall be in the form set out in paragraph 1, except that it shall also contain (a) if the live shellfish originate (i) in the European Economic Area or in a third country in respect of which the European Commission has adopted import conditions for live shellfish, the approval number of the original dispatch centre, or (ii) in a third country in respect of which the European Commission has not adopted approved import conditions for live shellfish, the original dispatch details; and (b) if the consignment was unwrapped (i) at a registered market, the registration number of the market where the consignment was unwrapped, or (ii) elsewhere than at a registered market, the full name and address of the person repackaging the consignment. Notes: [1] S.R. 1996 No. 383back SCHEDULE 3 Regulations 21(4), 24(3) and(4), 26(3), 28(2) and (3), 30, 32(1)(a) and (2)(a), 34 to 36, 48(2), 49(2), 51(2)(b) and 52(3) Production and placing on the market Conditions for fishery products (Based on the corresponding provisions of the Annex to the Fishery Products Directive) Chapter I Conditions Applicable to Factory Vessels Section I Conditions concerning design and equipment 1. The minimum requirements for factory vessels are as follows (a) a reception area set aside for taking fishery products on board, designed and arranged into pounds or pens that are large enough to allow each successive catch to be separated. The reception area and its movable parts must be easy to clean. It must be designed in such a way as to protect the products from the sun or the elements and from any source of dirt or contamination; (b) a system for conveying fishery products from the reception area to the work area that conforms with rules of hygiene; (c) work areas that are large enough for the preparation and processing of fishery products in proper conditions of hygiene. They must be designed and arranged in such a way as to prevent any contamination of the products; (d) storage areas for the finished products that are large enough and designed so that they are easy to clean. If a waste processing unit operates on board, a separate hold must be designated for the storage of these by products; (e) a place for storing packaging materials that is separate from the product preparation and processing areas; (f) special equipment for pumping waste or fishery products that are unfit for human consumption either directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to cleaning, separate areas must be allocated for that purpose; (g) equipment providing a supply of potable water or pressurised clean seawater. The seawater intake must be situated in a position where it is not possible for the water being taken in to be affected by discharges into the sea of waste water, waste and engine coolant outlets; (h) a suitable number of changing rooms, wash basins and toilets, the latter not opening directly onto areas where fishery products are prepared, processed or stored. The wash basins must be equipped with appliances for washing and drying hands that comply with hygiene requirements; the wash-basin taps must not be hand operable. 2. Areas used for the preparation and processing or freezing/quick-freezing of fishery products must have (a) a non-slip floor that is also easy to clean and disinfect and equipped for easy drainage of water. Structures and fixtures must have limber holes that are large enough not to be obstructed by fish waste and to allow water to drain freely; (b) walls and ceilings that are easy to clean, particularly where there are pipes, chains or electricity conduits; (c) the hydraulic circuits must be arranged or protected in such a way as to ensure that it is not possible for any leakage of oil to contaminate fishery products; (d) adequate ventilation and, where necessary, proper vapour extraction; (e) adequate lighting; (f) appliances for cleaning and disinfecting tools, equipment and fittings; (g) appliances for cleaning and disinfecting the hands with taps that are not hand-operable and with single use towels. 3. Equipment and tools such as cutting benches, containers, conveyors, gutting or filleting machines etc. must be resistant to seawater corrosion, easy to clean and disinfect and well-maintained. 4. Factory vessels which freeze fishery products must have (a) a refrigeration plant sufficiently powerful to lower the temperature rapidly so as to achieve a core temperature that complies with the specifications of these Regulations; (b) refrigeration plants sufficiently powerful to keep fishery products in the storage holds at a temperature that complies with the specifications of these Regulations. The storage holds must be equipped with a temperature recording system placed so that it can easily be consulted. Section II Conditions of hygiene relating to on-board handling and storage of fishery produts 1. A qualified person on board the factory vessel must be responsible for applying good fishery products manufacturing practices. That person shall have the authority to ensure that the provisions of these Regulations are applied and shall make available to inspectors the programme for inspecting and checking critical points as applied on board, a register containing that persons comments and the temperature recordings that may be required. 2. The general conditions of hygiene applicable to areas and equipment shall be those laid down in Section IIA of Chapter III. 3. The general conditions of hygiene applicable to staff shall be those laid down in Section IIB of Chapter III. 4. Heading, gutting and filleting must be carried out under the conditions of hygiene laid down in paragraphs (2) to (4) of Section I of Chapter IV. 5. On-board processing of fishery products must be carried out under the conditions of hygiene laid down in paragraphs 2 and 3 of Section II, Section IV and Section V of Chapter IV. 6. Fishery products must be wrapped and packaged under the conditions laid down in Chapter VI. 7. On-board storage of fishery products must be carried out under the conditions of hygiene laid down in paragraphs 1 and 2 of Chapter VIII. 8. - (1) Subject to sub-paragraph (2), any on-board processing (in particular any cooking) of shrimps or molluscs must be undertaken in accordance with such of (a) the approved treatments set out in Commission Decision 93/25/EEC approving certain treatments to inhibit the development of pathogenic micro-organisms in bivalve molluscs and marine gastropods; and (b) the standards and other obligations set out in Commission Decision 93/51/EEC on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish, as are appropriate in the particular circumstances of the case. (2) For the purposes of Commission Decision 93/51/EEC (a) the reference in article 2 to a processing plant shall be treated as if it were a reference to a factory vessel; (b) the reference in article 3(1) to the requirements of article 6 of the Council Directive shall be treated as if it were a reference to regulation 28; and (c) the reference to competent authorities in the first indented paragraph of article 3(2) shall be treated as a reference to the district council which approved the factory vessel in question. Chapter II Requirements During and After Landing 1. Unloading and landing equipment must be constructed of material which is easy to clean and disinfect and must be kept in a good state of repair and cleanliness. 2. During unloading and landing, contamination of fishery products must be avoided. It must in particular be ensured that unloading and landing operations proceed rapidly; fishery products are placed without unnecessary delay in a protected environment at the temperature required on the basis of the nature of the product and, where necessary, in ice in transport, storage or market facilities, or in an establishment; equipment and handling practices that cause unnecessary damage to the edible parts of the fishery products are not authorised. 3. Parts of auction or wholesale markets where fishery products are displayed for sale must (a) be covered and have walls which are easy to clean; (b) have waterproof flooring which is easy to wash and disinfect and laid in such a way as to facilitate the drainage of water and have a hygienic waste water disposal system; (c) be equipped with sanitary facilities with an appropriate number of wash basins and flush lavatories. Wash basins shall be supplied with materials for cleaning the hands and single use hand towels; (d) be well lit to facilitate the inspection of fishery products provided for in Chapter V; (e) when they are used for display or storage of fishery products, not be used for other purposes; vehicles emitting exhaust fumes which may impair the quality of the fishery products must not be admitted to markets; undesirable animals must not be admitted; (f) be cleaned regularly and at least after each sale, crates must, after each sale, be cleaned and rinsed inside and outside with potable water or clean seawater, where required, they must be disinfected; (g) have displayed in a prominent position signs prohibiting smoking, spitting, eating and drinking; (h) be closable and be kept closed when the district council considers it necessary; (i) have facilities to provide adequate water supplies satisfying the conditions laid down in paragraph 7 of Section I of Chapter III; (j) have special watertight receptacles made of corrosion-resistant materials for fishery products which are unfit for human consumption; (k) in so far as they do not have their own premises on-the-spot or in the immediate vicinity on the basis of the quantities displayed for sale, have, for the purposes of the district council, an adequately equipped lockable room and the equipment necessary for carrying out inspections. 4. After landing or, where appropriate, after first sale, fishery products must be transported without delay under the conditions laid down in Chapter VIII to their place of destination. 5. However, if the conditions laid down in paragraph 4 are not fulfilled, the markets in which fishery products may be stored before being displayed for sale or after being sold and pending transport to their place of destination must have sufficiently large cold rooms which satisfy the conditions laid down in paragraph 3 of Section I of Chapter III. In such cases, fishery products must be stored at a temperature approaching that of melting ice. 6. The general conditions of hygiene laid down in Section II of Chapter III with the exception of paragraph 1(a) of Section IIB - shall apply mutatis mutandis to the markets in which fishery products are displayed for sale or stored. 7. The wholesale markets in which fishery products are displayed for sale or stored shall be subject to the same conditions as those laid down in paragraphs 3 and 5 of this Chapter and to those set out in paragraphs 4, 10 and 11 of Section I of Chapter III. The general conditions of hygiene laid down in Section II of Chapter III shall apply mutatis mutandis to wholesale markets. Chapter III General Conditions for Establishments on Land Section I General conditions relating to premises and equipment Each establishment shall afford at least the following facilities 1. working areas of sufficient size for work to be carried out under adequate hygienic conditions. Their design and layout shall be such as to preclude contamination of the product and keep quite separate the clean and contaminated parts of the building; 2. in areas where products are handled, prepared and processed (a) waterproof flooring which is easy to clean and disinfect and laid down in such a way as to facilitate the drainage of water or provided with equipment to remove water; (b) walls which have smooth surfaces and are easy to clean, durable and impermeable; (c) ceiling or roof linings which are easy to clean; (d) doors in durable materials which are easy to clean; (e) adequate ventilation and, where necessary, good steam and water vapour extraction facilities; (f) adequate natural or artificial lighting; (g) an adequate number of facilities for cleaning and disinfecting hands. In work rooms and lavatories, taps must not be hand-operable. These facilities must be provided with single use hand towels; (h) facilities for cleaning plant, equipment and utensils; 3. in cold rooms where fishery products are stored the provisions set out under paragraph 2(a), (b), (c), (d) and (f); where necessary, a sufficiently powerful refrigeration plant to keep products at temperatures prescribed in these Regulations; 4. appropriate facilities for protection against pests such as insects, rodents, birds etc.; 5. instruments and working equipment such as cutting tables, containers, conveyor belts and knives made of corrosion-resistant materials, easy to clean and disinfect; 6. special watertight, corrosion-resistant containers for fishery products not intended for human consumption and premises for the storage of such containers if they are not emptied at least at the end of each working day; 7. facilities to provide adequate supplies of potable water, or alternatively of clean seawater or seawater treated by an appropriate system, under pressure and in sufficient quantity. However, by way of exception, a supply of non potable water is permissible for the production of steam, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the products. Non-potable water pipes must be clearly distinguishable from those used for potable water or clean seawater; 8. hygienic waste water disposal system; 9. an adequate number of changing-rooms with smooth, water-proof, washable walls and floor, wash basins and flush lavatories. The latter may not open directly onto the work rooms. The wash basins must have materials for cleaning the hands and disposable towels; the wash basin taps must not be hand-operable; 10. if the volume of products treated requires regular or permanent presence an adequately equipped lockable room for the exclusive use of the inspection service; 11. adequate facilities for cleaning and disinfecting means of transport. However, such facilities are not compulsory if there is a requirement for the means of transport to be cleaned and disinfected at facilities officially authorised by the district council; 12. establishments keeping live animals such as crustaceans and fish must have appropriate fittings ensuring the best survival conditions provided with water of a quality such that no harmful organisms or substances are transferred to the animals. Section II General conditions of hygiene A. General conditions of hygiene applicable to premises and equipment 1. Floors, walls and partitions, ceilings and roof linings, equipment and instruments used for working on fishery products must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the products. 2. Rodents, insects and other vermin must be systematically exterminated in the premises or on the equipment; rodenticides, insecticides, disinfectants and any other potentially toxic substances must be stored in premises or cupboards which can be locked; their use must not present any risk of contamination of the products. 3. Working areas, instruments and working equipment must be used only for work on fishery products. However, following authorisation by the district council they may be used at the same time or other times for work on other foodstuffs. 4. Potable water or clean seawater must be used for all purposes. However, by way of an exception, non-potable water may be used for steam production, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the products. 5. Detergents, disinfectants and similar substances must be acceptable to the district council and used in such a way that they do not have adverse effects on the machinery, equipment and products. B. General conditions of hygiene applicable to staff 1. The highest possible standard of cleanliness is required of staff. More specifically (a) staff must wear suitable clean working clothes and headgear which completely encloses the hair. This applies particularly to persons handling exposed fishery products; (b) staff assigned to the handling and preparation of fishery products must be required to wash their hands at least each time work is resumed; wounds to the hands must be covered by a waterproof dressing; (c) smoking, spitting, eating and drinking in work and storage premises of fishery products must be prohibited. 2. The employer shall take all the requisite measures to prevent persons liable to contaminate fishery products from working on and handling them, until there is evidence that such persons can do so without risk. When recruited, any person working on and handling fishery products shall be required to prove, by a medical certificate, that there is no impediment to such employment. Chapter IV Special Conditions for Handling Fishery Products on Shore Section I Conditions for fresh products 1. Where chilled, unpackaged products are not dispatched, prepared or processed immediately after reaching the establishment, they must be stored or displayed under ice in the establishment's cold room. Re-icing must be carried out as often as is necessary; the ice used, with or without salt, must be made from potable water or clean seawater and be stored under hygienic conditions in receptacles provided for the purpose; such receptacles must be kept clean and in a good state of repair. Prepacked fresh products must be chilled with ice or mechanical refrigeration plant creating similar temperature conditions. 2. If they are not carried out on board, operations such as heading and gutting must be carried out hygienically. The products must be washed thoroughly with potable water or clean seawater immediately after such operations. 3. Operations such as filleting and slicing must be carried out in such a way as to avoid contamination or spoilage of fillets and slices, and in a place other than that used for heading and gutting operations. Fillets and slices must not remain on work tables any longer than is necessary for their preparation and must be protected from contamination by appropriate packaging. Fillets and slices to be sold fresh must be chilled as quickly as possible after preparation. 4. Guts and parts that may constitute a danger to public health must be separated from and removed from the vicinity of products intended for human consumption. 5. Containers used for the dispatch or storage of fresh fishery products must be designed in such a way as to ensure both their protection from contamination and their preservation under sufficiently hygienic conditions and, more particularly, they must provide adequate drainage of melt water. 6. Unless special facilities are provided for the continuous disposal of waste, the latter must be placed in leakproof, covered containers which are easy to clean and disinfect. Waste must not be allowed to accumulate in working areas. It must be removed either continuously or as soon as the containers are full and at least at the end of each working day in the containers or to the premises referred to in paragraph 6 of Section I of Chapter III. The containers, receptacles and/or premises set aside for waste must always be thoroughly cleaned and, if appropriate, disinfected after use. Waste stored there must not constitute a source of contamination for the establishment or of pollution of its surroundings. Section II Conditions for frozen products 1. Plants must have (a) freezing equipment sufficiently powerful to achieve a rapid reduction in the temperature so that the temperature laid down in these Regulations can be obtained in the product; (b) freezing equipment sufficiently powerful to keep products in storage rooms at a temperature not exceeding those laid down in these Regulations, whatever the ambient temperature may be, however, for technical reasons related to the method of freezing and to the handling of such products, for whole fish frozen in brine and intended for canning, higher temperatures than those laid down in these Regulations are acceptable, although they may not exceed -9°C. 2. Fresh products to be frozen or quick-frozen must comply with the requirements of Section I of this Chapter. 3. - (1) Storage rooms must have a temperature recording device in a place where it can easily be read. The temperature sensor of the recorder must be located in the area furthest away from the cold source, ie where the temperature in the storage room is the highest. (2) Temperature charts must be available for inspection by the supervisory authorities at least during the period in which the products are stored. Section III Conditions for thawing products Establishments that carry out thawing operations must comply with the following requirements 1. fishery products must be thawed under hygienic conditions; their contamination must be avoided and there must be adequate drainage for any melt water produced. During thawing, the temperature of the products must not increase excessively; 2. after thawing, fishery products must be handled in accordance with the requirements of these Regulations. When they are prepared or processed, these operations must be carried out without delay. If they are put directly onto the market, particulars as to the thawed state of the fish must be clearly marked on the packaging in accordance with the Food Labelling Regulations (Northern Ireland) 1996. Section IV Conditions for processed products 1. Fresh, frozen and thawed products used for processing must comply with the requirements set out in Sections I, II or III of this Chapter. 2. - (1) Where the processing treatment is carried out to inhibit the development of pathogenic micro-organisms, or if it is a significant factor in the preservation of the product, the treatment must be a scientific process which produces safe food, or in the case of a treatment of products referred to in Parts II and III of Chapter I of Schedule 2 which have not been relayed or purified, such treatment must be a form of treatment mentioned in the Annex to Commission Decision 93/25/EEC approving certain treatments to inhibit the development of pathogenic micro-organisms in bivalve molluscs and marine gastropods. (2) The person responsible for an establishment must keep a register of the processing carried out. Depending on the type of process employed, details such as heating time and temperature, salt content, pH, water content, etc. must be monitored and controlled. Records must be kept at least for the expected storage life of the products and be available to the district council. 3. For products which are preserved for a limited period by a treatment such as salting, smoking, drying or marinading, the appropriate conditions for storage must be clearly marked on the packaging, in accordance with the Food Labelling Regulations (Northern Ireland) 1996. Canning 4. In the case of fishery products which have been subjected to sterilisation in hermetically sealed containers (a) the water used for the preparation of cans must be potable water; (b) the process used for the heat treatment must be appropriate, having regard to such major criteria as the heating time, temperature, filling, size of containers etc., a record of which must be kept; the heat treatment must be capable of destroying or inactivating pathogenic organisms and the spores of pathogenic micro-organisms. The heating equipment must be fitted with devices for verifying whether the containers have in fact undergone appropriate heat treatment. Potable water must be used to cool containers after heat treatment, without prejudice to the presence of any chemical additives used in accordance with good technological practice to prevent corrosion of the equipment and containers; (c) further checks must be carried out at random by the manufacturer to ensure that the processed products have undergone appropriate heat treatment, namely incubation tests: incubation must be carried out at 37°C for seven days or at 35°C for ten days, or at any other equivalent combination; - microbiological examination of contents and containers in the establishment's laboratory or in such laboratory as the district council considers suitable; (d) samples must be taken of production each day at predetermined intervals, to ensure the efficacy of sealing or of any other method of hermetic closure. For that purpose, appropriate equipment must be available for the examination of cross-sections of can-seams; (e) checks are carried out in order to ensure that containers are not damaged; (f) all containers which have undergone heat treatment under practically identical conditions must be given a batch identification mark, in accordance with the Food (Lot Marking) Regulations (Northern Ireland) 1996[1]. Smoking 5. Smoking must be carried out in separate premises or a special place equipped, if necessary, with a ventilation system to prevent smoke and heat from the combustion from affecting other premises or places where fishery products are prepared, processed or stored (a) materials used to produce smoke for the smoking of fish must be stored away from the place of smoking and must be used in such a way that they do not contaminate the products; (b) materials used to produce smoke by burning wood that has been painted, varnished, glued or has undergone any chemical preservation treatment must be prohibited; (c) after smoking, products must be cooled rapidly to the temperature required for their preservation before being packaged. Salting 6. As regards salting (a) salting operations must take place in different premises and sufficiently removed from the premises where the other operations are carried out; (b) salt used in the treatment of fishery products must be clean and stored in such a way as to preclude contamination. It must not be reused; (c) any container used for salting or brining must be constructed in such a way as to preclude contamination during the salting or brining process; (d) containers or areas used for salting or brining must be cleaned before use. Cooked crustacean and molluscan shellfish 7. Crustacean and molluscan shellfish must be cooked as follows (a) any cooking must be followed by rapid cooling. Water used for this purpose must be potable water or clean seawater. If no other method of preservation is used, cooling must continue until the temperature approaching that of melting ice is reached; (b) shelling or shucking must be carried out under hygienic conditions avoiding the contamination of the product. Where such operations are done by hand, workers must pay particular attention to the washing of their hands and all working surfaces must be cleaned thoroughly. If machines are used, they must be cleaned at frequent intervals and disinfected after each working day. After shelling or shucking, cooked products must immediately be frozen or kept chilled at a temperature which will preclude the growth of pathogens, and be stored in appropriate premises; (c) every manufacturer must carry out microbiological checks at regular intervals, complying with the standards and other obligations set out in Commission Decision 93/51/EEC on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish, but for the purposes of that Commission Decision (i) the reference in article 3(1) to the requirements of article 6 to the Council Directive shall be treated as if it were a reference to regulation 28, and (ii) the reference in the first indented paragraph of article 3(2) to competent authorities shall be treated as a reference to the district council which approved the establishment in question. Mechanically recovered fish flesh 8. The mechanical recovery of fish flesh must be carried out under the following conditions (a) mechanical recovery of gutted fish must take place without due delay after filleting, using raw materials free of guts. Where whole fish are used, they must be gutted and washed beforehand; (b) the machinery must be cleaned at frequent intervals and at least every two hours; (c) after recovery, mechanically recovered flesh must be frozen as quickly as possible or incorporated in a product intended for freezing or stabilising treatment. Section V Conditions concerning parasites 1. - (1) During production and before they are released for human consumption, fish and fish products must be subject to a visual inspection for the purpose of detecting and removing any parasites that are visible. (2) Fish or parts of fish which are obviously infested with parasites, and which are removed, must not be placed on the market for human consumption. (3) This inspection must be carried out in accordance with the rules set out in the Commission Decision 93/140/EEC laying down the detailed rules relating to the visual inspection for the purpose of detecting parasites in fishery products, but for the purposes of that Commission Decision (a) the competent authority to which article 4 of that Decision refers is the district council; and (b) the provisions referred to in that article (the provisions in accordance with which a sampling plan must be drawn up) are those specified in regulation 28(4). 2. The fish and fish products referred to in paragraph 1(1) of this Section which are to be consumed as they are must, in addition, be subjected to freezing at a temperature of not more than -20°C in all parts of the product for not less than 24 hours. Products subjected to this freezing process must be either raw or finished. 3. Fish and fish products which are subject to the conditions in paragraph 2 are (a) fish to be consumed raw or almost raw, eg raw herring 'maatje'; (b) the following species, if they are to undergo a cold smoking process at which the internal temperature of the fish is less than 60°C herring; - mackerel; - sprat; - (wild) Atlantic and Pacific salmon; (c) marinated and/or salted herring where this process is insufficient to kill the larvae or nematodes. 4. Manufacturers must ensure that fish and fish products listed in paragraph 3, or the raw materials for use in their manufacture, are subjected to the treatment described in paragraph 2 prior to their release for consumption. 5. The fishery products listed in paragraph 3 must, when they are placed on the market, be accompanied by a document from the manufacturer stating the type of process they have undergone. Chapter V Health Control and Monitoring of Production Conditions Section I General monitoring Each district council shall establish the following arrangements in order to establish whether the requirements laid down in the Regulations are complied with, and such arrangements will include, in particular 1. a check on the fishing vessels, on the understanding that such a check may be carried out during the stay in port; 2. a check on the conditions of landing and first sale; 3. an inspection at regular intervals of establishments and factory vessels (wherever registered) to check in particular (a) whether the conditions for approval (where applicable) are still fulfilled; (b) whether the fishery products are handled correctly; (c) the cleanliness of the premises, facilities and instruments and staff hygiene; (d) whether any necessary identification marks are put on correctly; 4. an inspection of the wholesale and auction markets; 5. a check on storage and transport conditions. Section II Special checks Organoleptic checks 1. - (1) Without prejudice to the derogations provided for by Council Regulation (EEC) No. 103/76[2] laying down common marketing standards for certain fresh or chilled fish, as amended[3], each batch of fishery products must be submitted for inspection by the district council at the time of landing or before first sale to check whether they are fit for human consumption. This inspection comprises an organoleptic check carried out by sampling. (2) Fishery products complying, as far as the freshness criteria are concerned, with the common marketing standards already laid down pursuant to article 2 of Council Regulation (EEC) No. 3759/92[4] on the common organisation of the market in fishery products, as amended[5], are considered to fulfil the organoleptic requirements necessary for compliance with the provisions of these Regulations. (3) The organoleptic examinations must be repeated after the first sale of fishery products, if it is found that the requirements of these Regulations have not been complied with or when considered necessary. After the first sale, fishery products must at least comply with the minimum freshness requirements of Regulation (EEC) No. 3687/91[6], as amended. (4) If the organoleptic examination reveals that the fishery products are not fit for human consumption, measures must be taken to withdraw them from the market and denature in such a way that they cannot be re-used for human consumption. (5) If the organoleptic examination reveals any doubt as to the freshness of the fishery products, use may be made of chemical checks or microbiological analysis. Parasite checks 2. - (1) Before they are released for human consumption, fish and fish products must be subject to visual inspection on behalf of the district council by way of sample, for the purpose of detecting any parasites that are visible. (2) Fish or parts of fish which are obviously infested with parasites must not be placed on the market for human consumption. Chemical checks 3A. When chemical checks are to be carried out by the district council samples must be taken and subjected to laboratory analysis for the control of the following parameters (a) TVB-N (Total Volatile Basic-Nitrogen), in respect of which (i) the following TVB-N limits must not be exceeded 25 milligrams of nitrogen per 100 grams of flesh for the following species: Sebastes spp.; Helicolenus dactylopterus; Sebastichthys capensis; 30 milligrams of nitrogen per 100 grams of flesh for the following species all species belonging to the Pleuronectidae family (with the exception of halibut: Hippoglossus spp.); 35 milligrams of nitrogen per 100 grams of flesh for the following species Salmo salar; species belonging to the Merlucciidae family; species belonging to the Gadidae family; (ii) the reference method to be used for checking the TVB-N limit is the method involving distillation of an extract deproteinised by perchloric acid as set out in Annexes II and III of Commission Decision 95/149/EC of 8th March 1995[7] ("the Decision") read together with article 3 of the Decision; (iii) the routine methods which may be used to check the TVB-N limit are those specified in article 2(3) of the Decision; (iv) the sample must consist of about 100 grams of flesh, taken from at least 3 different points and mixed together by grinding; (b) TMA-N (Trimethylamine-Nitrogen); (c) Histamine, in respect of which (i) nine samples must be taken from each batch; these must fulfil the following requirements the mean value must not exceed 100 parts per million ("ppm"); two samples may have a value of more than 100 ppm but less than 200 ppm; - no sample may have a value exceeding 200 ppm;(ii) these limits apply only to fish species of the following families: Scombridae, Clupeidae, Engraulidae and Coryphaenidae; however, fish belonging to these families which have undergone enzyme ripening treatment in brine may have higher histamine levels but not more than twice the above values; examinations must be carried out in accordance with reliable, scientifically recognised methods, such as high-performance liquid chromatography (HPLC). Contaminants present in the aquatic environment 3B. - (1) Without prejudice to the Community rules concerning water protection and management, and in particular those concerning pollution of the aquatic environment, fishery products must not contain in their edible parts contaminants present in the aquatic environment such as heavy metals and organochlorinated substances at such a level that the calculated dietary intake exceeds the acceptable daily or weekly intake for humans. (2) The Department shall establish a monitoring system to check the levels of such contamination of fishery products. Microbiological analyses 4. - (1) Subject to sub-paragraph (2), the microbiological standards applicable to the production of cooked crustaceans and molluscan shellfish are those set out in Commission Decision 93/51/EEC on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish. (2) For the purposes of sub-paragraph (1), the reference in article 2 of Commission Decision 93/51/EEC to a processing plant shall be treated as if it were a reference to an approved establishment or factory vessel. 5. - (1) The sampling programme to be established in accordance with article 3 of Commission Decision 93/51/EEC, as provided for in (a) paragraph 8(1)(b) of Section II of Chapter I; and (b) paragraph 7(c) of Section IV of Chapter IV, shall be monitored by the district council which approved the establishment or factory vessel in question. (2) For the purposes of sub-paragraph (1) (a) the reference in article 3(1) of Commission Decision 93/51/EEC to the requirements of article 6 of the Fishery Products Directive shall be treated as if it were a reference to the requirements of regulation 28; and (b) the reference in the first indented paragraph of article 3(2) of that Commission Decision to competent authorities shall be treated as if it were a reference to the district council mentioned in sub-paragraph (1). Chapter VI Packaging 1. Packaging must be carried out under satisfactory conditions of hygiene, to preclude contamination of the fishery products. 2. Packaging materials and products liable to enter into contact with fishery products must comply with all the rules of hygiene, and in particular they must not be such as to impair the organoleptic characteristics of the fishery products; they must not be capable of transmitting to the fishery products substances harmful to human health; they must be strong enough to protect the fishery products adequately. 3. With the exception of certain containers made of impervious, smooth and corrosion-resistant material which are easy to clean and disinfect, which may be re-used after cleaning and disinfecting, packaging materials may not be re used. Packaging materials used for fresh fishery products which are held under ice must provide adequate drainage for melt water. 4. Unused packaging materials must be stored in places away from the production area and be protected from dust and contamination. Chapter VII Identification Marks Part I Products Prepared on or After 27th July 1998 1. This Part of this Chapter shall apply to all products other than those which were prepared before these Regulations come into force and in respect of which the conditions set out in Part II of this Chapter are satisfied. 2. - (1) Without prejudice to the provisions of the Food Labelling Regulations (Northern Ireland) 1996 it must be possible to trace for inspection purposes the establishment of dispatch of consignments of fishery products, by means either of the labelling or of the accompanying documents. For that purpose, the following information must appear on the packaging or, in the case of a non-packaged product, in the accompanying documents the country of dispatch, which may be written out in full or shown as an abbreviation, using capital letters, eg for the member States of the European Community, one of the following B - DK - D - EL - E - F - IRL - I - L - NL - P - UK - AT - FI - SE; identification of (i) the establishment or factory vessel by its official approval number, (ii) in the case of marketing from a freezer vessel covered by, as respects Northern Ireland, paragraph 7 of Part II of Schedule 4 or, as respects any other part of the European Economic Area, point 7 of Annex II to the Fishing Vessels Directive, the identification number of the vessel, or (iii) the registered wholesale or auction market by its registration number, from which the products were dispatched; one of the following abbreviations CE - EC - EG - EK - EF - EY. (2) All the letters and figures must be fully legible and grouped together on the packaging in a place where they are visible from the outside without any need to open the packaging. Part II Products Prepared Before 27th July 1998 1. This Part of this Chapter applies to products which were prepared before these Regulations come into force and in respect of which the conditions set out in Part I of this Chapter are not satisfied, but only if the conditions set out in this Part of this Chapter are satisfied in relation to those products. 2. Without prejudice to the requirements of the Food Labelling Regulations (Northern Ireland) 1996, it must be possible to trace for inspection purposes the establishment of dispatch of consignments of fishery products, by means either of the labelling or of the accompanying documents. For that purpose, in respect of each consignment of fishery products the following information must appear on the packaging or in the accompanying documents the country of dispatch; identification of the establishment or factory vessel of dispatch by its approval number or, in the case of separate registering of auction or wholesale markets, the registration number of the auction or wholesale market. Chapter VIII Storage and Transport 1. Fishery products must, during storage and transport, be kept at the temperatures laid down in these Regulations, and in particular (a) fresh or thawed fishery products and cooked and chilled crustacean and molluscan shellfish products must be kept at a temperature approaching that of melting ice; (b) frozen fishery products, with the exception of frozen fish in brine intended for the manufacture of canned foods, must be kept at an even temperature of -18°C or less in all parts of the product, after temperature stabilisation, and allowing for the possibility of brief upward fluctuations of not more than 3°C, during transport. 2. Where frozen fishery products are transported from a cold storage plant to an approved establishment to be thawed on arrival for the purposes of either preparation or processing and where the distance to be covered does not exceed 50 km or, if the distance is greater, the anticipated duration of the journey is less than one hour, the district council may grant a derogation from the conditions laid down in paragraph 1(b). 3. Products may not be stored or transported with other products which may contaminate them or affect their hygiene, unless they are packaged in such a way as to provide satisfactory protection. 4. Vehicles used for the transport of fishery products must be constructed and equipped in such a way that the temperatures laid down in these Regulations can be maintained throughout the period of transport. If ice is used to chill fishery products, adequate drainage must be provided in order to ensure that water from melted ice does not stay in contact with the products. The inside surfaces of the means of transport must be finished in such a way that they do not adversely affect the fishery products. They must be smooth and easy to clean and disinfect. 5. Means of transport used for fishery products may not be used for transporting other products likely to impair or contaminate fishery products, except where the fishery products can be safeguarded against contamination by such transport being thoroughly cleaned and disinfected immediately prior to each occasion it is used for fishery products. 6. Fishery products may not be transported in a vehicle or container which is not clean or which should have been disinfected. 7. The transport conditions of fishery products to be placed on the market alive must not adversely affect the fishery products. Notes: [1] S.R. 1996 No. 384back [2] O.J. No. L20, 28.1.76, p. 29back [3] The Regulation was last amended by Council Regulation (EEC) No. 1935/93 (O.J. No. L176, 20.7.93, p. 1)back [4] O.J. No. L388, 31.12.92, p. 10back [5] The Regulation was last amended by Council Regulation (EC) No. 3318/94 (O.J. No. L350, 31.12.94, p. 15)back [6] O.J. No. L354, 23.12.91, p 1back [7] O.J. No. L97, 29.4.95, p. 84back SCHEDULE 4 Regulations 22(1), (2) and (4), and 36(1)(a)(i) Hygiene Conditions for Fishing Vessels (Based on the corresponding provisions of the Annexes to the Fishery Products Directive) Part I General Hygiene Conditions Applicable to Fishery Products on board Fishing Vessels 1. The section of vessels or the containers reserved for the storage of fishery products must not contain objects or products liable to transmit harmful properties or abnormal characteristics to the foodstuffs. These sections or containers must be so designed as to allow them to be cleaned easily and to ensure that melt water cannot remain in contact with the fishery products. 2. When used, the sections of vessels or the containers reserved for the storage of fishery products must be completely clean and, in particular, must not be capable of being contaminated by the fuel used for the propulsion of the vessel or by bilge water. 3. As soon as they are taken on board, the fishery products must be protected from contamination and from the effects of the sun or any other source of heat. When they are washed, the water used must be either fresh water complying with the parameters set out in Tables B and C of Schedule 1 to the Water Quality Regulations (Northern Ireland) 1994[1] or clean seawater, so as not to impair their quality or wholesomeness. 4. The fishery products shall be handled and stored in such a way as to prevent bruising. The use of spiked instruments shall be tolerated for the moving of large fish or fish which might injure the handler, provided the flesh of these products is not damaged. 5. Fishery products other than those kept alive must undergo cold treatment as soon as possible after loading. However, in the case of fishing vessels where cooling is not possible from a practicable point of view, the fishery products must not be kept on board for more than 8 hours. 6. Ice used for the chilling of products must be made from potable water or clean seawater. Before use, it must be stored under conditions which prevent its contamination. 7. After the fishery products have been unloaded, the containers, equipment and sections of vessels which are directly in contact with the fishery products must be cleaned with potable water or clean seawater. 8. Where fish is headed and/or gutted on board, such operations must be carried out hygienically and the products must be washed immediately and thoroughly with potable water or clean seawater. The viscera and parts which may pose a threat to public health must be removed and set apart from products intended for human consumption. Livers and roes intended for human consumption must be refrigerated or frozen. 9. Equipment used for gutting, heading and the removal of fins, and containers and equipment in contact with the fishery products, must be made of or coated with material which is waterproof, resistant to decay, smooth and easy to clean and disinfect. When used they must be completely clean. 10. Staff assigned to the handling of fishery products shall be required to maintain a high standard of cleanliness for themselves and their clothes. Part II Additional Hygiene Conditions Applicable to Article 1.2 Fishing Vessels 1. Fishing vessels must be equipped with holds, tanks or containers for the storage of refrigerated or frozen fishery products at the temperature laid down by these Regulations. These holds shall be separated from the machinery space and the quarters reserved for the crew by partitions which are sufficiently impervious to prevent any contamination of the stored fishery products. 2. The inside surface of the holds, tanks or containers shall be waterproof and easy to wash and disinfect. It shall consist of a smooth material or, failing that, smooth paint maintained in good condition, not being capable of transmitting to the fishery products substances harmful to human health. 3. The holds shall be designed to ensure that melt water cannot remain in contact with the fishery products. 4. Containers used for the storage of products must ensure their preservation under satisfactory conditions of hygiene and, in particular, allow drainage of melt water. When used they must be completely clean. 5. The working decks, the equipment and the holds, tanks and containers shall be cleaned each time they are used. Potable water or clean seawater shall be used for this purpose. Disinfection, the removal of insects or rat extermination shall be carried out whenever necessary. 6. Cleaning products, disinfectants, insecticides and all potentially toxic substances shall be stored in locked premises or cupboards. Their use must not present any risk of contamination of the fishery products. 7. If fishery products are frozen on board, this operation must be carried out in accordance with the conditions laid down in paragraphs 1 and 3 of Section II of Chapter IV of Schedule 3. Where freezing in brine is used, the brine shall not be a source of contamination for the fish. 8. Vessels equipped for chilling of fishery products in cooled seawater, either chilled by ice (CSW) or refrigerated by mechanical means (RSW), shall comply with the following requirements (a) tanks must be equipped with adequate seawater filling and drainage installations and must incorporate devices for achieving uniform temperature throughout the tanks; (b) tanks must have a means of recording temperature connected to a temperature sensor positioned in the section of the tank where temperatures are highest; (c) the operation of the tank or container system must secure a chilling rate which ensures the mix of fish and seawater reaches 3°C at the most 6 hours after loading and 0°C at the most after 16 hours; (d) after each unloading, the tanks, circulation systems and containers must be completely emptied and thoroughly cleaned using potable water or clean seawater. They should only be filled with clean seawater; (e) the date and the number of the tank must be clearly indicated on the temperature recordings which must be kept available for the control authorities. Notes: [1] S.R. 1994 No. 221back SCHEDULE 5 Regulation 59(1) Revocations Column (1) Column (2) Column (3) Food Safety (Live Bivalve Molluscs) (Derogations) Regulations (Northern Ireland) 1992 S.R. 1992 No. 295 The whole Regulations Food Safety (Fishery Products) (Derogations) Regulations (Northern Ireland) 1992 S.R. 1992 No. 296 The whole Regulations Food Safety (Fishery Products) Regulations (Northern Ireland) 1993 S.R. 1993 No. 51 The whole Regulations Food Safety (Live Bivalve Molluscs and Other Shellfish) Regulations (Northern Ireland) 1993 S.R. 1993 No. 52 The whole Regulations Food Safety (Fishery Products on Fishing Vessels) Regulations (Northern Ireland) 1993 S.R. 1993 No. 53 The whole Regulations Food Safety (Live Bivalve Molluscs and Other Shellfish) (Import Conditions and Miscellaneous Amendments) Regulations (Northern Ireland) 1995 S.R. 1995 No. 112 The whole Regulations Food Safety (Fishery Products) (Import Conditions and Miscellaneous Amendments) Regulations (Northern Ireland) 1995 S.R. 1995 No. 113 The whole Regulations Food Safety (General Food Hygiene) Regulations (Northern Ireland) 1995 S.R. 1995 No. 360 Paragraphs 2 to 6 of Schedule 2 Food Safety (Fishery Products and Live Bivalve Molluscs and Other Shellfish) (Miscellaneous Amendments) Regulations (Northern Ireland) 1996 S.R. 1996 No. 264 The whole Regulations EXPLANATORY NOTE (This note is not part of the Regulations.) These Regulations consolidate with amendments the Regulations which were made to give effect to the provisions of Council Directive 91/492/EEC laying down the health conditions for the production and placing on the market of live bivalve molluscs, as adapted for the purposes of the EEA Agreement and as amended, and Council Directive 91/493/EEC laying down the health conditions for the production and placing on the market of fishery products, as adapted and as amended, together with a number of Commission Decisions made under these two Council Directives. These Regulations also consolidate with amendments the Regulations which were made to give effect to the provisions of Council Directive 92/48/EEC laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with article 3.1.(a)(i) of Council Directive 91/493/EEC, and to the measures set out in paragraph 1 of Section II of Chapter III of the Annex to Council Directive 85/73/EEC on the financing of veterinary inspections and controls covered by Directives 89/662/EEC, 90/425/EEC, 90/675/EEC and 91/496/EEC, which is annexed to Council Directive 96/43/EC amending and consolidating Directive 85/73/EEC in order to ensure financing of veterinary inspections and controls on live animals and certain animal products and amending Directives 90/675/EEC and 91/496/EEC (O.J. No. L162, 1.7.96, p. 1). In addition, these Regulations give effect to the amendments made by Council Directive 95/71/EC to the Annex to Directive 91/493/EEC (health conditions for the production and placing on the market of fishery products: see Schedule 3 to these Regulations). The Regulations are made under the Food Safety (Northern Ireland) Order 1991, except for Part V which is made under section 2(2) of the European Communities Act 1972. Part V implements the amendments made by Council Directive 96/43/EC to which reference is made above. Part I of the Regulations contains general provisions relating to citation, commencement and interpretation (regulations 1 and 2). Part II contains the provisions relating to the production and placing on the market of live shellfish (defined as live bivalve molluscs, echinoderms, tunicates and marine gastropods, and so excluding crustaceans). The Department has the power to designate certain areas as designated production areas for live bivalve molluscs; relaying areas (areas where live bivalve molluscs may be relaid after harvesting to remove contamination) are designated by district councils (regulation 3). The Department may also designate certain areas as prohibited areas for live shellfish production of various kinds (regulation 4), and district councils may make temporary prohibitions concerning layings (regulation 7). Collecting shellfish from areas subject to a relevant prohibition is an offence (regulation 8). The Department may vary and revoke its designations of production and prohibited areas, and district councils may vary and revoke their designations of relaying areas (regulation 5). The Department has an obligation to keep an up-to-date list of designated production and relaying areas (regulation 6). Part II also contains special requirements relating to the harvesting, transporting and relaying of live shellfish (regulation 9), and to the operation of dispatch and purification centres, which need to be approved by the local district council (regulations 10 to 13). There are also special rules for the variation and revocation of approvals of such centres (regulations 14 and 15). Part II also contains special rules for the wrapping, unwrapping, repackaging, storage and transportation of live shellfish (regulations 16 to 18), and detailed obligations relating to the placing on the market of live shellfish (regulation 19). There is, however, an exemption scheme from most of the requirements of this Part which relates to local sales of small quantities of live shellfish (regulation 20). Part III of the Regulations deals with the production and placing on the market of fishery products. There is a registration scheme for fishing vessels on board which shrimps and molluscs are cooked, there are hygiene rules for all fishing vessels, and there are special additional rules for certain longer range vessels (regulations 21 and 22). Factory vessels and establishments on land which are involved in the production of fishery products both have to be approved by the local district council (regulations 23 and 24), and their proprietors have to comply with various specified requirements (regulation 28). Masters of third country factory vessels also have an additional obligation to give the district council at their port of arrival at least 24 hours notice before they arrive (regulation 29). Auction and wholesale markets also have to be registered, again by the district council (regulations 25 and 26), and their proprietors also have to comply with certain specified requirements (regulation 30). Provision is also made for appeals against decisions to refuse to approve or register, or to grant approvals but only subject to conditions (regulations 27), and there are procedures (including appeals procedures) relating to the variation and revocation of approvals and cancellation of market registrations (regulations 31 and 32). Part III also contains a special rule relating to the timing of gutting of fishery products (regulation 33), and rules relating to the packaging, storage and transportation of fishery products (regulations 34 and 35). There are also detailed obligations relating to the placing on the market of all types of fishery products (regulation 36), with special additional rules relating to the placing on the market of aquaculture products (regulation 37), processed shellfish (regulation 38) and live fish and other aquatic animals (regulation 39). There is, however, a prohibition on selling or supplying in the course of business certain poisonous fishery products (regulation 40). As with live shellfish, there is an exemption scheme from most of the requirements of this Part which relates essentially to local sales of small quantities of products (regulation 41). Part IV of the Regulations deals with the import conditions for fishery products and live shellfish (regulations 42 to 45), but there is an exemption from this Part for certain private consignments (regulation 46). Part V deals with the inspection charges for third country direct landings (products landed from third country vessels which have or had not been on land prior to their importation into the European Community). The charge is paid by the first purchaser to the vendor, and an equivalent amount is then passed by the vendor to the district council (regulations 48 and 49). Some reductions are available in relation to part of this charge where checks are facilitated by specified factors (regulation 50). The vendor is also under an obligation to make a written return in respect of his weekly sales (regulation 51). Part VI contains more general provisions. These include provisions relating to the health control responsibilities of the Department and district councils (regulation 52), enforcement responsibilities (regulations 54 and 56), certification of shellfish and fishery products as failing to comply with food safety requirements (regulation 57), amendments to other Regulations (regulation 58), and revocations (regulation 59). Regulation 59 also contains a transitional provision. Notes: [1] See sections 1(5) and 10(2)(b) of the Fishery Limits Act 1976 (c. 86 Notes: [1] See protocol 4 (on rules of origin) annexed to the EEA Agreement, as amended by the Decision of the EEA Joint Committee No. 6/94 amending protocol 4 to the EEA Agreement (O.J. No. L95, 14.4.94, p. 22)back [2] O.J. No. L122, 14.5.97, p. 21back [3] O.J. No. L191, 12.8.95, p. 32back [4] O.J. No. L6, 10.1.97, p. 46back [5] S.R. & O. (N.I.) 1973 No. 392back [6] S.R. 1993 No. 306, as amended by S.R. 1995 No. 174back [7] O.J. No. L15, 20.1.96, p. 46back [8] See protocol 4 (on rules of origin) annexed to the EEA Agreement, as amended by the Decision of the EEA Joint Committee No. 6/94 amending protocol 4 to the EEA Agreement (O.J. No. L95, 14.4.94, p. 22back [9] O.J. No. L127, 25.5.96, p. 33back ISBN 0 337 93148 8