FOOD PART I GENERAL Citation and commencement 1 These Regulations may be cited as the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998 and shall come into force on 29th April 1998. Interpretation 2 1 In these Regulations, unless the context otherwise requires— “ the Act ” means the Food Safety Act 1990; “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 ) in part of Great Britain, is designated as a relaying area in accordance with regulation 3(2) by the food authority for that part of Great Britain; “aquaculture products” means— all fishery products born and raised in controlled conditions until placed on the market as a foodstuff; and 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— fishery products, a quantity of fishery products obtained under practically identical circumstances; 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— 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 affect the health quality of fishery products, and which is used under the conditions laid down in these Regulations; 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 , 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— 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; 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 Ministers in accordance with regulation 3(1) as an area from which live bivalve molluscs may be taken; “dispatch centre” means any on-shore or off-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; “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— cold stores where only the handling of wrapped products takes place; or auction or wholesale markets where only display and sale by wholesale takes place; “ EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993 ; “EEA State” means a State which is a Contracting Party to the EEA Agreement; “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— fishing vessels in which only shrimps and molluscs are cooked on board; and fishing vessels on board which only freezing is carried out; “faecal coliform” means facultative, aerobic, gram-negative, non-sporeforming, cy tochrome 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— all seawater or freshwater animals, including their roes; and parts of such animals, except in circumstances where they— are combined (in whatever way) with other foodstuffs, and 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 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 and as amended ; “the Fishing Vessels Directive” means Council Directive 92/48/EEC 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; “food authority” means— with regard to England— as respects the Isles of Scilly, the Council of the Isles of Scilly, as respects the City of London (including the Temples), the Common Council, as respects any other part of England— if it is situated in a port health district, the port health authority for that district, or if it is not situated in a port health district, the London borough, district council or unitary authority in whose area that part is situated; as respects any part of Wales— if it is situated in a port health district, the port health authority for that district, or if it is not situated in a port health district, the county or county borough council in whose area that part is situated; as respects any part of Scotland— if it is situated in the district of a port local authority or joint port local authority, the port local authority or joint port local authority for that district, or if it is not situated in the district of a port local authority or joint port local authority, the council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 in whose area that part is situated; “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 natural or legal 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 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 (as the context requires) is in accordance with— Chapter X of Schedule 2; any law in force in another EEA State, Northern Ireland, 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 any approved imported conditions for live shellfish; “imported” means imported into Great Britain, but only if the product in question was not imported from another part of the British Islands ; “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 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 and as amended ; “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 includes trailers), rail vehicles, aircraft or vessels, and containers for transport by land, sea or air; “movement document” means— in relation to any batch of live shellfish transported from a production area to— an approved relaying area in Great Britain, a dispatch or purification centre approved in accordance with Part II of these Regulations, or a processing plant in Great Britain, a movement document which meets the requirements of paragraph 6(4) and (5) of Chapter II of Schedule 2; in relation to any batch of live shellfish transported from a production area to— an approved relaying area in Northern Ireland, the Channel Islands or the Isle of Man, a dispatch or purification centre approved in accordance with any law in force in Northern Ireland, 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 a processing plant in Northern Ireland, the Channel Islands or the Isle of Man, a movement document which meets the requirements of any law in force in Northern Ireland, 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; in relation to any batch of live shellfish in transit from a production area to— a relaying area, a dispatch or purification centre, or 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; “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 authorization” means a written authorization which has been— issued by a food authority and which meets the requirements of paragraph 6(8) of Chapter II of Schedule 2; granted by a competent authority in Northern Ireland, 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— 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— retail sales (which includes retail sales to catering businesses and sales by catering businesses), and direct transfers on local markets of small quantities by fishermen to retailers or consumers in the circumstances specified in regulation 41; and 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 1995 ; “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 is— imported solely as trade samples; or not being imported by way of trade, and which— forms part of a traveller’s personal luggage, or has been sent to a person, other than a body of persons corporate or unincorporate, in Great Britain; “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— except in relation to shellfish, having undergone a chemical or physical process such as the heating, smoking, salting, dehydration or marinating of chilled or frozen products, or a combination of these various processes; in relation to shellfish, any process or any combination of processes such as those referred to in sub-paragraph (a) above, 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; “Sea Fisheries Committee” means a local fisheries committee for a sea fisheries district constituted under the Sea Fisheries Regulation Act 1966 ; “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; “unitary authority” means an authority in England which is the sole principal council for its local government 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 In these Regulations, unless the context otherwise requires, a reference— a to a numbered Part is to the Part of these Regulations bearing that number; b to a numbered regulation or Schedule is to the regulation in or Schedule to these Regulations bearing that number; c in a Schedule to a numbered Chapter is to the Chapter of that Schedule bearing that number; d in a regulation or Chapter of a Schedule to a numbered or lettered paragraph is to the paragraph in that regulation or Chapter bearing that number or letter; e in a paragraph to a lettered or numbered sub-paragraph is to the sub-paragraph in that paragraph bearing that letter or number. PART II PRODUCTION AND PLACING ON THE MARKET OF LIVE SHELLFISH Designation of areas as designated bivalve production areas 3 1 The Ministers 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 them whether it is— a a class A area from which live bivalve molluscs can be gathered as specified in Part 1 of Chapter I of Schedule 2; b a class B area from which live bivalve molluscs can be gathered as specified in Part 2 of Chapter I of Schedule 2; c a class C area from which live bivalve molluscs can be gathered as specified in Part 3 of Chapter I of Schedule 2, and any such designation may be subject to such limitation, condition or restriction as appears to the Ministers to be called for by article 5(2) of the Live Bivalve Molluscs Directive. 2 Each food authority shall, wherever possible, designate as a relaying area any area within their district which— a fulfils the conditions required for designation as a class A or B area specified in paragraph (1)(a) and (b); and b in their opinion is suitable for the relaying of live bivalve molluscs if the conditions specified in Parts 2 and 3 of Chapter I of Schedule 2 and in Chapter III of Schedule 2 are satisfied, and, where the Ministers have notified the food authority 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 food authority shall make that designation subject to those conditions. 3 The food authority shall notify the Ministers of any designation made under paragraph (2) and of its terms. Designation of areas as prohibited areas for live shellfish production 4 The Ministers may at any time designate any area as an area unsuitable, for health reasons, for the production or collection 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 Ministers 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 food authority 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 Ministers. Lists of designated production and relaying areas 6 1 The Ministers shall maintain and publish— a a list of designated bivalve production areas; and b a list of any areas which food authorities 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 Ministers shall send a copy of the lists mentioned in paragraph (1), and any amendments to them to— a each food authority; b trade associations which appear to them to represent the interests of food businesses which are likely to be directly affected by this Part of these Regulations. 3 Each food authority shall take such action as they consider sufficient to bring any part of the lists mentioned in paragraph (1) which relates to their area to the attention of any harvester, handler or operator of a dispatch or purification centre who is carrying out commercial operations with respect to live bivalve molluscs in their area. Temporary prohibition orders concerning production areas 7 1 Subject to paragraph (4), a food authority may, if it is satisfied that the consumption of live shellfish taken from a production area 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 food authority making the order. 3 Forthwith after making such an order, a food authority shall— a in the case of a private laying, refer the matter to the Ministers 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 food authority making the order, and ii any action which the food authority is requesting the Ministers to take pursuant to regulation 4 or 5(1), and in particular the detail of 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 Ministers and to any Sea Fisheries Committee in whose district the production area is situated. 4 A food authority shall not make a temporary prohibition order in respect of any production area if they have made such an order in respect of that area within the preceding 28 days, unless the Ministers give 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. 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 or purification centre unless it has been approved by the food authority for the area in which the centre is situated. Approval of dispatch or purification centres 11 1 An application for an approval for a dispatch or purification centre shall be made to the food authority for the area 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 food authority to determine the application. 3 An approval in respect of a dispatch centre may only be granted if the food authority 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 food authority 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 food authority has been notified by the Ministers pursuant to paragraph (5). 5 An approval for a dispatch or purification centre under this regulation may be granted subject to limitations as to the particular activities approved, the method of operation approved and intensity of use approved, and where the Ministers notify the food authority 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 food authority shall give their approval subject to those conditions. 6 The food authority shall give written notification to each person who makes an application pursuant to paragraph (1) of the result of their application and, in the case of refusal, of the reasons for that refusal. 7 If an application pursuant to paragraph (1) is approved, the food authority shall— a designate the dispatch or purification centre with a unique approval number; and b notify the Secretary of State of the approval and the approval number allocated. Appeals against a refusal to grant an approval or against any conditions or limitation in approvals 12 1 A person who is aggrieved by a decision taken by a food authority— a to refuse to grant an approval for a dispatch or purification centre; or b to impose any limitation or condition in an approval granted for a dispatch or purification centre, may appeal to a magistrates' court or, in Scotland, to the sheriff, and section 37(3) to (6) of the Act shall apply in relation to such an appeal as it applies in relation to an appeal under section 37(1)(c). 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 food authority by the Ministers in accordance with regulation 11(5), is brought in accordance with paragraph (1)(b), the appellant may continue to operate the centre 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 food authority by the Ministers in accordance with regulation 11(5), the food authority shall inform the Ministers 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 food authority 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 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 this 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 area from which the shellfish come, 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 a food authority for the authority to vary or revoke any term or limitation in any approval for a dispatch or purification centre granted to him, and subject to paragraph (2), the food authority may, in appropriate circumstances, vary any such term or limitation. 2 A food authority may only vary or revoke any additional condition of which the food authority has been notified by the Ministers pursuant to regulation 11(5) with the consent of the Ministers. 3 Any person who is aggrieved by a decision of a food authority to refuse to vary any term or limitation of any approval for a dispatch or purification centre may appeal to a magistrates' court or, in Scotland, to the sheriff, and section 37(3) to (6) of the Act shall apply in relation to such an appeal as it applies in relation to an appeal under section 37(1)(c) of the Act. 4 Where an appeal is brought in accordance with paragraph (3) against a refusal to vary a condition notified to the food authority by the Ministers in accordance with regulation 11(5), the food authority shall inform the Ministers 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; c remit the matter to the food authority 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 dispatch or purification centres 15 1 A food authority may revoke an approval of a dispatch or purification centre situated in its area if, after inspection of or any inquiry into the method of operation of the centre, they are 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 Chapter IV of Schedule 2; b the food business proprietor who is operating the centre is either unable or not prepared to ensure that the breach is remedied; and c there is in force in relation to that dispatch or purification centre— i a prohibition order under section 11 of the Act, or ii an emergency prohibition order under section 12 of that Act, and as a consequence of the order, commercial operations with regard to live shellfish which are for placing on the market for human consumption may not be carried out at that dispatch or purification centre. 2 A proprietor who is aggrieved by a decision to revoke an approval for a dispatch or purification centre may appeal to a magistrates' court or, in Scotland, to the sheriff, and section 37(3) to (6) of the Act shall apply in relation to such an appeal as it applies in relation to an appeal under section 37(1)(c) of the Act. 3 A revocation under this regulation shall take effect— a immediately after the time for appealing against it has elapsed; or b if an appeal is brought, immediately after the appeal is finally disposed of, struck out for want of prosecution or withdrawn, and when a food authority informs the food business proprietor who is operating a dispatch or purification centre of a decision to revoke the approval for the centre, they shall explain to the proprietor in writing when the revocation will take effect (including when it will take effect if an appeal is brought). Wrapping of live shellfish 16 A proprietor of a food business in the course of which live shellfish which are intended for placing on the market for human consumption are wrapped or repackaged shall ensure that the wrapping or repackaging of such shellfish is in accordance with the applicable requirements of those set out in Chapter VII of Schedule 2. Storage and transportation of live shellfish after dispatch 17 A proprietor of a food business in the course of which live shellfish which are intended for placing on the market for human consumption are stored or transported after they have left a dispatch or purification centre, shall ensure that such shellfish are stored and transported in accordance with the applicable requirements of those set out in Chapters VIII and IX of Schedule 2. Splitting consignments of live shellfish 18 1 A person other than the final consumer who splits the contents of a consignment of live shellfish which are not wrapped in individual consumer-sized parcels shall keep— a any healthmark which is attached to the consignment; or b a copy of any certificate required in accordance with regulation 45(2) which accompanied that consignment, for a period of not less than 60 days from the date of the splitting of the contents of that consignment. 2 A person who repackages a consignment of live shellfish in accordance with paragraph 3 of Chapter VII of Schedule 2 shall keep the original healthmark (if one was required) which was attached to the consignment for a period of not less than 60 days from the date of the splitting of the contents of that consignment. Placing liv shellfish on the market 19 1 Subject to paragraphs (2) to (4), no person shall place on the market for immediate human consumption any live shellfish, unless— a they originate, if they are live bivalve molluscs, from a bivalve production area which— i has been designated a class A area, a class B area or a class C area in accordance with regulation 3(1), and any condition or limitation specified in Chapter I of Schedule 2 in relation to that class of area has been complied with, ii has been identified, pursuant to any law in force in Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by Chapter I of the Annex to the Live Bivalve Molluscs Directive, as an area from which bivalve molluscs may be collected, and any condition or limitation derived from that Chapter which relates to that production area has been complied with, or iii if they are imported for relaying, was of the same standard as an area designated as a class B area or a class C area in accordance with regulation 3(1)(b) or (c), and any condition or limitation specified in Chapter I of Schedule 2 for that production area has been complied with; b they have been harvested, kept and transported to any approved dispatch centre, approved purification centre or approved relaying area to which they are thereafter transferred in accordance with the applicable requirements of— i Chapter II of Schedule 2, or ii any law in force in Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by Chapter II of the Annex to the Live Bivalve Molluscs Directive, accompanied by a valid movement document or a valid permanent transport authorisation; c if they are live bivalve molluscs, they have, where necessary, been relaid in accordance with— i Chapter III of Schedule 2, or ii any law in force in Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by Chapter III of the Live Bivalve Molluscs Directive; d they have been handled hygienically and, if they are live bivalve molluscs, they have, where appropriate, been purified at a purification centre which has been approved in accordance with— i regulation 11, or ii any law in force in Northern Ireland, 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 purification centres by the Live Bivalve Molluscs Directive; e they are as specified in Chapter V of Schedule 2; f they have been wrapped in accordance with the applicable requirements of Chapter VII of Schedule 2; g they have been stored and transported in accordance with the applicable requirements of Chapter VIII of Schedule 2; h they comprise or form part of a consignment which bears a healthmark— i unless head (ii) or (iii) applies, which is in accordance with Chapter X of Schedule 2, ii which, if they comprise or form part of a consignment which has been given a healthmark in accordance with any law in force in another EEA State, Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by Chapter X of the Annex to the Live Bivalve Molluscs Directive, is in accordance with that law, iii which, if they comprise or form part of a consignment from a third country in respect of which the European Commission has adopted approved import conditions, is in accordance with those approved import conditions, but a healthmark is not required in relation to live shellfish which originate from a third country in respect of which the European Commission has not adopted approved import conditions, unless those live shellfish have been repackaged in accordance with paragraph 3 of Chapter VII of Schedule 2; i if they are imported live shellfish, prior to importation such of the requirements specified in regulations 44 and 45 as are applicable to his case are satisfied in relation to those live shellfish which he places on the market. 2 Paragraph (1)(a) shall not apply to— a pectinidae, unless they are aquaculture products; or b any imported live bivalve molluscs, unless they were harvested from seawaters or brackish waters within British fishery limits . 3 Paragraph (1)(b) and (c) shall not apply to imported live shellfish, unless their country of dispatch is part of the British Islands. 4 Paragraph (1)(h)(ii) to (iii) shall not apply in circumstances where, in Great Britain, a person repackages live shellfish from a country or territory other than Great Britain in accordance with paragraph 3 of Chapter VII of Schedule 2. Direct transfers of live shellfish on local markets 20 1 Regulations 9, 16, 17 and 19 shall not apply to a direct transfer to a retailer or final consumer in the United Kingdom of a small quantity of— a live bivalve molluscs gathered from a class A designated bivalve production area; or b live echinoderms, tunicates or marine gastropods, which are as specified in Chapter V of Schedule 2 by a coastal fisherman who is part of the direct transfers scheme. 2 A coastal fisherman is part of the direct transfers scheme for the purposes of paragraph (1) if, prior to gathering live shellfish for the first time in any calender year in the district of a food authority, he notifies the food authority of his intention to do so and supplies them with the following information— a his name, address and telephone number; b the address where he keeps the equipment he uses for gathering; c the intended place of landing of gathered live shellfish; d the address where he intends to put the gathered live shellfish when landed; e if applicable, the name, address and approval number of any dispatch or purification centre to which he intends to send live shellfish after gathering, and if he notifies the food authority of any changes to the information originally supplied. 3 For the purposes of paragraph (1) a “small quantity” means an amount which comprises part of the coastal fisherman’s annual allowance. 4 For the purposes of paragraph (3), a coastal fisherman’s annual allowance is a total amount of not more than 25 tonnes of live shellfish in a calendar year, and although that total amount may comprise of amounts of one or more species, in that total amount the amount of any species listed in column (a) of the table below shall not exceed the maximum amount for that species mentioned in column (b) of that table— Table (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 or 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 shall, prior to engaging for the first time in such cooking, notify the food authority for the area in which the vessel is based in writing of his intention to do so, and shall at the same time supply the authority 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 he shall notify the food authority in writing of any changes to the information originally supplied. 3 Each food authority shall maintain a register of all the information supplied pursuant to paragraph (2). 4 Any cooking on board a fishing vessel of shrimps or molluscs shall be 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 Ministers 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 food authority for the area in which it is situated. 2 No person shall operate a British Islands factory vessel unless it has been approved— a by the food authority for the area which includes the place at which the vessel usually lands fishery products in Great Britain; or b in accordance with any law in force in Northern Ireland, 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 an establishment, the food authority in whose area the establishment is situated; and b in the case of a factory vessel, the food authority for the area which includes the place at which the vessel usually lands fishery products in Great Britain. 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 food authority to determine the application. 3 An approval in respect of a factory vessel may only be granted if the food authority 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 food authority 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 for a factory vessel or 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 food authority 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 approved, the food authority shall— a designate the establishment or vessel with a unique approval number; and b notify the Secretary of State of the approval and the approval number allocated. 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 food authority in whose area 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 food authority in whose area 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 food authority to determine the application. 3 An auction or wholesale market may only be registered if the food authority 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 food authority 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 accepted, the food authority shall— a designate the market with a unique registration number; and b notify the Secretary of State of the registration and the registration number allocated. 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 food authority— 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 magistrates' court or, in Scotland, to the sheriff, and section 37(3) to (6) of the Act shall apply in relation to such an appeal as it applies in relation to an appeal under section 37(1)(c) of the Act. 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 establishment or vessel 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 an approval or to register; b accept an application to register; 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 food authority 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 an approved fishery products establishment or an approved British Islands factory vessel shall ensure that, as respects his establishment or vessel, the requirements of the approval for his establishment or vessel 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 recognised by the food authority for the purpose of checking— i cleaning and disinfection methods, and ii compliance with the standards established by this Part of these Regulations, and in deciding whether or not to recognise a laboratory, food authorities shall have regard to any relevant guidance issued by the Ministers; d keeping a written record or a record registered in an indelible fashion of the preceding points which shall be made available to the food authority 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 The proprietor 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 the proprietor’s checks under paragraph (4) reveal a serious health risk or suggest one might exist, the proprietor shall immediately notify the food authority of that risk or possible risk and such notification shall be confirmed in writing by the proprietor within 48 hours. Notice of arrival obligation for masters of third country factory vessels 29 The master of a factory vessel of a third country shall, before landing any fishery products in Great Britain which are for placing on the market, give the food authority for the port at which he intends to land those fishery products 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 a food authority for it to vary any term or limitation in any approval for a factory vessel or fishery products establishment granted to him, and the food authority may vary any such term or limitation. 2 Any person who is aggrieved by a decision of a food authority to refuse to vary a term or limitation in any approval for a factory vessel or fishery products establishment may appeal to a magistrates' court or, in Scotland, to the sheriff, and section 37(3) to (6) of the Act shall apply in relation to such an appeal as it applies in relation to any appeal under section 37(1)(c) of the Act. 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 food authority 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 food authority may revoke an approval of an establishment situated in its area or a factory vessel which they approved if, after inspection of or any inquiry into the method of operation of the establishment or vessel, they are 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 section 11 of the Act, or ii an emergency prohibition order under section 12 of the Act, and as a consequence of the order, commercial operations with regard to fishery products which are for placing on the market for human consumption may not be carried out at that establishment or on board that vessel. 2 A food authority may cancel the registration of an auction or wholesale market situated in their area if, after inspection of or any inquiry into the method of operation of the market, they are satisfied that— a there has been a serious (on animal or public health grounds) and manifest breach of the applicable provisions of Chapter II or III of Schedule 3; b the food business proprietor who is operating the market is either unable or not prepared to ensure that the breach is remedied; and c there is in force in relation to that market— i a prohibition order under section 11 of the Act, or ii an emergency prohibition order under section 12 of the Act, and as a consequence of the order, commercial operations with regard to fishery products which are for placing on the market for human consumption may not be carried out at that market. 3 A proprietor who is aggrieved by a decision to revoke an approval for a factory vessel or a fishery products establishment or cancel the registration of an auction or wholesale market may appeal to a magistrates' court or, in Scotland, to the sheriff, and section 37(3) to (6) of the Act shall apply in relation to such an appeal as it applies in relation to an appeal under section 37(1)(c) of the Act. 4 A revocation or cancellation under this regulation shall take effect— a after the time for appealing against it has elapsed; or b if an appeal is brought, after the appeal is finally disposed of, struck out for want of prosecution or withdrawn, and when a food authority informs a food business proprietor operating a factory vessel or fishery products establishment of a decision to revoke the approval for the vessel or establishment or a food business proprietor operating an auction or wholesale market of a decision to cancel the registration of that market, they shall explain to the proprietor in writing when the revocation or cancellation will take effect (including when it will take effect if an appeal is brought). Gutting of fishery products 33 Where gutting of a fishery product which is intended for placing on the market for human consumption is possible from a technical and commercial standpoint, a food business proprietor who has control over the timing of the gutting of the product shall ensure that it is carried out as soon as possible after the product has been caught or landed. Packaging of fishery products 34 A proprietor of a food business in the course of which fishery products which are intended for placing on the market for human consumption are packaged shall ensure that the packaging of such products is in accordance with the applicable requirements of those set out in Chapter VI of Schedule 3. Storage and transportation of fishery products 35 A proprietor of a food business in the course of which fishery products which are intended for placing on the market for human consumption are stored or transported shall ensure that such products are stored, except at cold stores where only the handling of wrapped products takes place, and transported in accordance with any applicable requirements of those set out in Chapter VIII of Schedule 3. Placing fishery products on the market 36 1 Subject to paragraph (2), no person shall place on the market for human consumption any fishery products, unless— a if they have been handled on board a British Islands fishing vessel, the applicable requirements of— i Schedule 4, or ii any law in force in Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by the Fishing Vessels Directive, have been satisfied in relation to those fishery products; b if they have been handled on board a British Islands factory vessel, the applicable requirements of— i Chapter I of Schedule 3, or ii any law in force in Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by Chapter I of the Annex to the Fishery Products Directive, have been satisfied in relation to those fishery products; c if they were landed in the British Islands, during and after landing the applicable requirements of— i Chapter II of Schedule 3, or ii any law in force in Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by Chapter II of the Annex to the Fishery Products Directive, have been satisfied in relation to those fishery products; d where gutting of those fishery products is or was possible from a technical and commercial viewpoint, gutting was carried out as quickly as possible after the products were caught or landed; e at an establishment on land in the British Islands, they have been handled and, where appropriate, packaged, prepared, processed, frozen, defrosted, stored hygienically and inspected in accordance with the applicable requirements of— i Chapters III and IV of Schedule 3, or ii any law in force in Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by Chapters III and IV of the Annex to the Fishery Products Directive; f they— i in Great Britain, have been subject to such of the health control and monitoring of production conditions described in Chapter V of Schedule 3 as is appropriate in the particular circumstances of the case, or ii in Northern Ireland, the Channel Islands or the Isle of Man, have been subject to such of the health control and monitoring of production conditions described in Chapter V of the Annex to the Fishery Products Directive, as provided for in any law in force in Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by that Chapter, as is appropriate in the particular circumstances of the case, unless the competent authority authorised the transfer of those fishery products ex quay to an approved establishment or registered auction or wholesale market to be checked there, in which case a check on the conditions of landing is not required; g they have been appropriately packaged in accordance with Chapter VI of Schedule 3; h they comprise or form part of a consignment which bears an identification mark— i unless head (ii) or (iii) applies, which is in accordance with Chapter VII of Schedule 3, ii which, if they comprise or form part of a consignment which has been given an identification mark in accordance with any law in force in another EEA State, Northern Ireland, the Channel Islands or the Isle of Man which is intended to give effect to the results to be achieved by Chapter VII of the Annex to the Fishery Products Directive, is in accordance with that law, iii which, if those fishery products originate in a country in respect of which the European Commission has adopted approved import conditions for fishery products, is in accordance with those approved import conditions, but an identification mark is not required in relation to any fishery products which have been landed in a third country in respect of which the European Commission has not adopted any approved import conditions; i except at cold stores where only the handling of packaged products takes place, they have been stored and transported in accordance with Chapter VIII of Schedule 3; j if they are imported products, prior to importation the requirements specified in regulations 42 and 43 which are applicable to his case are satisfied in relation to those fishery products; k any additional requirements in regulations 37 and 38 which are applicable to his case are satisfied in relation to those fishery products. 2 Paragraph (1)(a) to (c) shall not apply to aquaculture products. Placing aquaculture products on the market 37 No person shall place fishery products which are aquaculture products on the market for human consumption, unless— a they have been slaughtered under appropriate conditions of hygiene; b they have not been soiled with earth, slime or faeces; c if they were not processed immediately after being slaughtered, they have been kept chilled. Placing processed shellfish on the market 38 1 Subject to paragraphs (2) and (3), no person shall place fishery products which are processed shellfish on the market for human consumption unless, prior to processing, there were satisfied in relation to those processed shellfish those of the requirements of regulation 19 to which those products would have been subject if, when they were processed, they had instead been kept for placing on the market as live shellfish. 2 For the purposes of paragraph (1), regulation 19 shall apply as if, where reference is made in regulation 19(1)(b) to transportation to an approved dispatch centre, reference had also been made to transportation to a processing plant, and the requirements in relation to movement documents and permanent transport authorizations set out in regulation 19(1)(b). 3 Paragraph (1) shall not apply to imported fishery products which were processed before they were imported. Fishery products to be placed on the market alive 39 A person with control over the survival conditions of a fishery product for human consumption which is to be placed on the market alive shall ensure that it is at all times kept under the most suitable survival conditions. Prohibition on placing certain fishery products on the market 40 No person shall sell, supply in the course of a food business or place on the market for human consumption— a poisonous fish of any of the following families: Tetraodontidae, Molidae, Diodontidae, and Canthigasteridae; or b fishery products containing biotoxins such as ciguatera toxins or muscle-paralysing toxins. Direct transfers of fishery products on local markets 41 1 Regulations 33 to 39 shall not apply to a direct transfer to a retailer or final consumer in the United Kingdom of a small quantity of fishery products by a fisherman. 2 For the purposes of paragraph (1), a “small quantity” means an amount which comprises part of the fisherman’s annual allowance. 3 For the purposes of paragraph (2), a fisherman’s annual allowance is a total amount of not more than 25 tonnes of fishery products in a calendar year, and although the total amount may comprise of amounts of one or more species, in that total amount the amount of processed shellfish of any species listed in column (a) of the table below shall not exceed the maximum amount for that species mentioned in column (b) of that table— Table (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 , 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 Great Britain from their country of origin— i before 22nd April 1998— aa have their country of origin shown clearly on their labelling, and bb are only to be marketed in the British Islands or in an EEA State other than the United Kingdom according to the derogation mentioned in article 3.2 of Commission Decision 97/296/EC drawing up the list of third countries from which the import of fishery products is authorised for human consumption, ii on or after 22nd April 1998, 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 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 , but this 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 approved 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 (1) 22nd April 1998 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 Fish Health Regulations 1992 or the Shellfish and Specified Fish (Third Country Imports) Order 1992 )— 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 these 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 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 , 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 direct 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 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, 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 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 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, unless the context otherwise requires— “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— originate in a country or territory which is not part of the customs territory of the European Community other than Greenland; were caught in their natural environment; have not or had not been on land prior to their importation or proposed importation into the European Community; are or will be landed in Great Britain; and 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 Great Britain (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 scombrus 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 actual costs do 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 food authorities 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 food authority in whose area the chargeable transaction takes place. 2 If the chargeable transaction takes place before the fishery products are landed in Great Britain, 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 food authority responsible for the checks provided for in Section II of Chapter V of Schedule 3 in respect of those products. 3 Any sum payable to a food authority 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 food authority for the area where the chargeable transaction takes place, reduce by such amount as the food authority 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 hereafter 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 food authority has unreasonably refused to consent— a to a reduction in the reducible element of the charge; or b to a reduction in the reducible element of the charge by a larger amount than the amount by which the food authority has agreed that the reducible element of the charge may be reduced, may appeal against the food authority’s decision to a magistrates' court or, in Scotland, to the sheriff, and section 37(3) to (6) of the Act shall apply in relation to such an appeal as it applies in relation to an appeal under section 37(1)(c) of the Act. 3 On an appeal, the court may— a confirm the decision of the food authority; 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 charge shall remain payable by the first purchaser to the vendor; and b a sum equal to the original amount of the charge shall remain payable by the vendor to the food authority, 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 food authority, shall have effect from the date on which the original charge was made. 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 overpayment to a food authority in respect of a sum payable under this Part, the food authority shall reimburse the vendor as appropriate. 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 food authority in respect of the chargeable transaction, and he shall include in that return 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(1)(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 charge; and g the place of landing of the fishery products sold and the country or territory in which the products originate . 2 In any case where, in respect of any relevant fishery products— a the food authority responsible for checks on vessels and on conditions of landing (“the general monitoring authority”); or b the food authority responsible for the checks provided for in Section II of Chapter V of Schedule 3 (“the special checks authority”), is different from the food authority 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 authority”), the recipient authority shall remit to the general monitoring authority or, as the case may be, the special checks authority a sum equal to any amount received from the vendor which is referable to checks for which the general monitoring authority or, as the case may be, the special checks authority is responsible. PART VI ENFORCEMENT, PENALTIES AND REVOCATIONS Functions of the Ministers and food authorities 52 1 Subject to paragraph (2)(b), the Ministers shall perform the functions assigned to them by Chapters III and VI of Schedule 2. 2 Each food authority shall perform— a the functions assigned to them by Chapters III and VI of Schedule 2; and b any function of the Ministers specified in paragraph 1 of Chapter VI of Schedule 2 which the Ministers require the food authority to undertake on their behalf. 3 The Ministers and food authorities 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 against these Regulations. 2 Subject to paragraph (3), a person guilty of an offence against these Regulations 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. 3 Any person who— a without reasonable cause, fails to give any person acting on behalf of a food authority 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. 4 A food authority in England or Wales may institute proceedings under paragraph (3). Enforcement of Parts II and III 54 Except where otherwise specified, each food authority shall enforce and execute Parts II and III within their area. Application of provisions of the Act for the purposes of Parts II and III 55 1 The following provisions of the Act shall apply for the purposes of Parts II and III as they apply for the purposes of sections 8, 14 and 15 of the Act, and unless the context otherwise requires, a reference in them to the Act shall for the purposes of Parts II and III be construed as a reference to these Regulations— a section 3 (presumptions that food intended for human consumption); b section 20 (offences due to fault of another person); c section 21 (defence of due diligence); d section 30(8) (which relates to documentary evidence); e section 33 (obstruction etc. of officers); f section 34 (time limit for prosecutions); g section 36 (offences by body corporate), subject to the following modifications— i after the words “body corporate”, at the three places where they occur in section 36(1) of the Act, there shall be inserted the words “or Scottish partnership”, and ii for the word “secretary” there shall be substituted the words “secretary, partner”; h section 44 (protection of officers acting in good faith). 2 Section 6(3) of the Act (discharge of duties of food authorities by Ministers) shall apply as respects functions imposed on food authorities under Parts II and III as it does as respects a duty imposed on a food authority by section 6(2) of the Act. 3 Section 32 of the Act (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 the transporting of live shellfish to a relaying area or dispatch or purification centre (in so far as it does not already do so); b and 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 Section 58(1) of the Act (territorial waters and continental shelf) shall apply for the purposes of Parts II and III as it applies for the purposes of the Act. Enforcement of Part IV 56 For the purposes of the Products of Animal Origin (Import and Export) Regulations 1996 (in this paragraph referred to as “the Import and Export Regulations”)— a the conditions set out in Part IV shall be treated as health conditions (whether or not they are health conditions as defined in the Import and Export Regulations); and b those conditions shall be enforced as health conditions— i by a local authority or the Minister (or by an authorised officer of the local authority or the Minister), which ever has the responsibility under the Import and Export Regulations for enforcing health conditions 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 food authority 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 section 9 of the Act 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 1991 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 1998. unless . 2 Regulation 3(2) of the Food Safety (General Food Hygiene) Regulations 1995 shall be amended as follows— a sub-paragraphs (a) to (e) shall be omitted; and b after sub-paragraph (m) there shall be inserted the following paragraph— n the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998. . 3 Regulation 3 of the Food Safety (Temperature Control) Regulations 1995 shall be amended as follows— a paragraph (2)(a) to (e) shall be omitted; b in paragraph (2), after sub-paragraph (l) there shall be inserted the following sub-paragraph— m the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998. ; c in paragraph (3), for the words from “regulated by” to “unless,” there shall be substituted the words “regulated by Part III of the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998, unless,”. 4 The Products of Animal Origin (Import and Export) Regulations 1996 shall be amended as follows— a in regulation 1(2)— i the definitions of “bivalve molluscs” and “other shellfish” shall be omitted, ii in the definition of “fishery products”, for the words “Food Safety (Fishery Products) Regulations 1992” there shall be inserted the words “Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998”, and iii after the definition of “import” there shall be inserted the following definition— “live shellfish” has the same meaning as in the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998; ; b in each of the following provisions— i regulation 21(1), ii regulation 22(1), iii regulation 23(b) and (c), iv regulation 24(3), and v regulation 25(3), the words “bivalve molluscs or other” shall be omitted and c in Schedule 2 for paragraphs 1 to 4 there shall be substituted the following paragraph The Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations 1998 . 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 Schedule 5. 2 Any premises (which includes vessels) recognised immediately before these Regulations come into force as registered or approved by a food authority 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. Jeff Rooker Minister of State Ministry of Agriculture, Fisheries and Food 6th April 1998 Signed by authority of the Secretary of State for Health Tessa Jowell Minister for Public Health Department of Health 6th April 1998 Win Griffiths Parliamentary Under Secretary of State Welsh Office 6th April 1998 Sam Galbraith Parliamentary Under Secretary of State Scottish Office 6th April 1998