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

• (f) special equipment for pumping waste or fishery products that are unfit for human consumption either directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to cleaning, separate areas must be allocated for that purpose;

• (g) equipment providing a supply of potable water or pressurised clean seawater. The seawater intake must be situated in a position where it is not possible for the water being taken in to be affected by discharges into the sea of waste water, waste and engine coolant outlets;

• (h) a suitable number of changing rooms, wash basins and toilets, the latter not opening directly onto areas where fishery products are prepared, processed or stored. The wash basins must be equipped with appliances for washing and drying the hands that comply with hygiene requirements; the wash-basin taps must not be hand-operable.

2

Areas used for the preparation and processing or freezing/quick-freezing of fishery products must have—

• (a) a non-slip floor that is also easy to clean and disinfect and equipped for easy drainage of water. Structures and fixtures must have limber holes that are large enough not to be obstructed by fish waste and to allow water to drain freely;

• (b) walls and ceilings that are easy to clean, particularly where there are pipes, chains or electricity conduits;

• (c) the hydraulic circuits must be arranged or protected in such a way as to ensure that it is not possible for any leakage of oil to contaminate fishery products;

• (d) adequate ventilation and, where necessary, proper vapour extraction;

• (e) adequate lighting;

• (f) appliances for cleaning and disinfecting tools, equipment and fittings;

• (g) appliances for cleaning and disinfecting the hands with taps that are not hand-operable and with single use towels.

3

Equipment and tools such as cutting benches, containers, conveyors, gutting or filleting machines etc. must be resistant to seawater corrosion, easy to clean and disinfect and well-maintained.

4

Factory vessels which freeze fishery products must have—

• (a) a refrigeration plant sufficiently powerful to lower the temperature rapidly so as to achieve a core temperature that complies with the specifications of these Regulations;

• (b) refrigeration plants sufficiently powerful to keep fishery products in the storage holds at a temperature that complies with the specifications of these Regulations. The storage holds must be equipped with a temperature recording system placed so that it can easily be consulted.

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

1

A qualified person on board the factory vessel must be responsible for applying good fishery products manufacturing practices. That person shall have the authority to ensure that the provisions of these Regulations are applied and shall make available to inspectors the programme for inspecting and checking critical points as applied on board, a register containing that person’s comments and the temperature recordings that may be required.

2

The general conditions of hygiene applicable to areas and equipment shall be those laid down in Section IIA of Chapter III.

3

The general conditions of hygiene applicable to staff shall be those laid down in Section IIB of Chapter III.

4

Heading, gutting and filleting must be carried out under the conditions of hygiene laid down in paragraphs 2 to 4 of Section I of Chapter IV.

5

On-board processing of fishery products must be carried out under the conditions of hygiene laid down in paragraphs 2 and 3 of Section II, Section IV and Section V of Chapter IV.

6

Fishery products must be wrapped and packaged under the conditions of hygiene laid down in Chapter VI.

7

On-board storage of fishery products must be carried out under the conditions of hygiene laid down in paragraphs 1 and 2 of Chapter VIII.

8

• (1) Subject to sub-paragraph (2), any on-board processing (in particular any cooking) of shrimps or molluscs must be undertaken in accordance with such of—

• (a) the approved treatments set out in Commission Decision 93/25/EEC approving certain treatments to inhibit the development of pathogenic micro-organisms in bivalve molluscs and marine gastropods; and

• (b) the standards and other obligations set out in Commission Decision 93/51/EEC on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish,

as are appropriate in the particular circumstances of the case.

• (2) For the purposes of Commission Decision 93/51/EEC—

• (a) the reference in article 2 to a processing plant shall be treated as if it were a reference to a factory vessel;

• (b) the reference in article 3(1) to the requirements of article 6 of the Council Directive shall be treated as if it were a reference to regulation 28; and

• (c) the reference to competent authorities in the first indented paragraph of article 3(2) shall be treated as a reference to the food authority which approved the factory vessel in question.

CHAPTER II — REQUIREMENTS DURING AND AFTER LANDING

1

Unloading and landing equipment must be constructed of material which is easy to clean and disinfect and must be kept in a good state of repair and cleanliness.

2

During unloading and landing, contamination of fishery products must be avoided. It must in particular be ensured that—

• unloading and landing operations proceed rapidly;

• fishery products are placed without unnecessary delay in a protected environment at the temperature required on the basis of the nature of the product and, where necessary, in ice in transport, storage or market facilities, or in an establishment;

• equipment and handling practices that cause unnecessary damage to the edible parts of the fishery products are not authorised.

3

Parts of auction or wholesale markets where fishery products are displayed for sale must—

• (a) be covered and have walls which are easy to clean;

• (b) have waterproof flooring which is easy to wash and disinfect and laid in such a way as to facilitate the drainage of water and have a hygienic waste water disposal system;

• (c) be equipped with sanitary facilities with an appropriate number of wash basins and flush lavatories. Wash basins shall be supplied with materials for cleaning the hands and single use hand towels;

• (d) be well lit to facilitate the inspection of fishery products provided for in Chapter V;

• (e) when they are used for display or storage of fishery products, not be used for other purposes; vehicles emitting exhaust fumes which may impair the quality of the fishery products must not be admitted to markets; undesirable animals must not be admitted;

• (f) be cleaned regularly and at least after each sale, crates must, after each sale, be cleaned and rinsed inside and outside with potable water or clean seawater, where required, they must be disinfected;

• (g) have displayed in a prominent position signs prohibiting smoking, spitting, eating and drinking;

• (h) be closeable and be kept closed when the competent authority considers it necessary;

• (i) have facilities to provide adequate water supplies satisfying the conditions laid down in paragraph 7 of Section I of Chapter III;

• (j) have special watertight receptacles made of corrosion-resistant materials for fishery products which are unfit for human consumption;

• (k) in so far as they do not have their own premises on-the-spot or in the immediate vicinity on the basis of the quantities displayed for sale, have, for the purposes of the competent authority, an adequately equipped lockable room and the equipment necessary for carrying out inspections.

4

After lending or, where appropriate, after first sale, fishery products must be transported without delay under the conditions laid down in Chapter VIII to their place of destination.

5

However, if the conditions laid down in paragraph 4 are not fulfilled, the markets in which fishery products may be stored before being displayed for sale or after being sold and pending transport to their place of destination must have sufficiently large cold rooms which satisfy the conditions laid down in paragraph 3 of Section I of Chapter III. In such cases, fishery products must be stored at a temperature approaching that of melting ice.

6

The general conditions of hygiene laid down in Section II of Chapter III—with the exception of paragraph 1(a) of Section IIB—shall apply mutatis mutandis to the markets in which fishery products are displayed for sale or stored.

7

The wholesale markets in which fishery products are displayed for sale or stored shall be subject to the same conditions as those laid down in paragraphs 3 and 5 of this Chapter and to those set out in paragraphs 4, 10 and 11 of Section I of Chapter III. The general conditions of hygiene laid down in Section II of Chapter III shall apply mutatis mutandis to wholesale markets.

CHAPTER III — GENERAL CONDITIONS FOR ESTABLISHMENTS ON LAND

Section I. — General conditions relating to premises and equipment

Each establishment shall afford at least the following facilities—

1

working areas of sufficient size for work to be carried out under adequate hygienic conditions. Their design and layout shall be such as to preclude contamination of the product and keep quite separate the clean and contaminated parts of the building;

2

in areas where products are handled, prepared and processed—

• (a) waterproof flooring which is easy to clean and disinfect and laid down in such a way as to facilitate the drainage of the water or provided with equipment to remove water;

• (b) walls which have smooth surfaces and are easy to clean, durable and impermeable;

• (c) ceilings or roof linings which are easy to clean;

• (d) doors in durable materials which are easy to clean;

• (e) adequate ventilation and, where necessary, good steam and water-vapour extraction facilities;

• (f) adequate natural or artificial lighting;

• (g) an adequate number of facilities for cleaning and disinfecting hands. In work rooms and lavatories, taps must not be hand-operable. These facilities must be provided with single use hand towels;

• (h) facilities for cleaning plant, equipment and utensils;

3

in cold rooms where fishery products are stored—

• the provisions set out under paragraph 2(a), (b), (c), (d) and (f);

• where necessary, a sufficiently powerful refrigeration plant to keep products at temperatures prescribed in these Regulations;

4

appropriate facilities for protection against pests such as insects, rodents, birds etc.;

5

instruments and working equipment such as cutting tables, containers, conveyor belts and knives made of corrosion-resistant materials, easy to clean and disinfect;

6

special watertight, corrosion-resistant containers for fishery products not intended for human consumption and premises for the storage of such containers if they are not emptied at least at the end of each working day;

7

facilities to provide adequate supplies of potable water, or alternatively of clean seawater or seawater treated by an appropriate system, under pressure and in sufficient quantity. However, by way of exception, a supply of non-potable water is permissible for the production of steam, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the products. Non-potable water pipes must be clearly distinguishable from those used for potable water or clean seawater;

8

hygienic waste water disposal system;

9

an adequate number of changing-rooms with smooth, water-proof, washable walls and floor, wash basins and flush lavatories. The latter may not open directly onto the work rooms. The wash basins must have materials for cleaning the hands and disposable towels; the wash basin taps must not be hand-operable;

10

if the volume of products treated requires regular or permanent presence an adequately equipped lockable room for the exclusive use of the inspection service;

11

adequate facilities for cleaning and disinfecting means of transport. However, such facilities are not compulsory if there is a requirement for the means of transport to be cleaned and disinfected at facilities officially authorised by the food authority;

12

establishments keeping live animals such as crustaceans and fish must have appropriate fittings ensuring the best survival conditions provided with water of a quality such that no harmful organisms or substances are transferred to the animals.

Section II — General conditions of hygiene

1

Floors, walls and partitions, ceilings and roof linings, equipment and instruments used for working on fishery products must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the products.

2

Rodents, insects and other vermin must be systematically exterminated in the premises or on the equipment; rodenticides, insecticides, disinfectants and any other potentially toxic substances must be stored in premises or cupboards which can be locked; their use must not present any risk of contamination of the products.

3

Working areas, instruments and working equipment must be used only for work on fishery products. However, following authorization by the food authority they may be used at the same time or other times for work on other foodstuffs.

4

Potable water or clean seawater must be used for all purposes. However, by way of an exception, non-potable water may be used for steam production, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the products.

5

Detergents, disinfectants and similar substances must be acceptable to the food authority and used in such a way that they do not have adverse effects on the machinery, equipment and products.

1

The highest possible standard of cleanliness is required of staff. More specifically—

• (a) staff must wear suitable clean working clothes and headgear which completely encloses the hair. This applies particularly to persons handling exposed fishery products;

• (b) staff assigned to the handling and preparation of fishery products must be required to wash their hands at least each time work is resumed; wounds to the hands must be covered by a waterproof dressing;

• (c) smoking, spitting, eating and drinking in work and storage premises of fishery products must be prohibited.

2

The employer shall take all the requisite measures to prevent persons liable to contaminate fishery products from working on and handling them, until there is evidence that such persons can do so without risk. When recruited, any person working on and handling fishery products shall be required to prove, by a medical certificate, that there is no impediment to such employment.

CHAPTER IV — SPECIAL CONDITIONS FOR HANDLING FISHERY PRODUCTS ON SHORE

Section I — Conditions for fresh products

1

Where chilled, unpackaged products are not dispatched, prepared or processed immediately after reaching the establishment, they must be stored or displayed under ice in the establishment’s cold room. Re-icing must be carried out as often as is necessary; the ice used, with or without salt, must be made from potable water or clean seawater and be stored under hygienic conditions in receptacles provided for the purpose; such receptacles must be kept clean and in a good state of repair. Pre-packed fresh products must be chilled with ice or mechanical refrigeration plant creating similar temperature conditions.

2

If they are not carried out on board, operations such as heading and gutting must be carried out hygienically. The products must be washed thoroughly with potable water or clean seawater immediately after such operations.

3

Operations such as filleting and slicing must be carried out in such a way as to avoid the contamination or spoilage of fillets and slices, and in a place other than that used for heading and gutting operations. Fillets and slices must not remain on work tables any longer than is necessary for their preparation and must be protected from contamination by appropriate packaging. Fillets and slices to be sold fresh must be chilled as quickly as possible after preparation.

4

Guts and parts that may constitute a danger to public health must be separated from and removed from the vicinity of products intended for human consumption.

5

Containers used for the dispatch or storage of fresh fishery products must be designed in such a way as to ensure both their protection from contamination and their preservation under sufficiently hygienic conditions and, more particularly, they must provide adequate drainage of melt water.

6

Unless special facilities are provided for the continuous disposal of waste, the latter must be placed in leakproof, covered containers which are easy to clean and disinfect. Waste must not be allowed to accumulate in working areas. It must be removed either continuously or as soon as the containers are full and at least at the end of each working day in the containers or to the premises referred to in paragraph 6 of Section I of Chapter III. The containers, receptacles and/or premises set aside for waste must always be thoroughly cleaned and, if appropriate, disinfected after use. Waste stored there must not constitute a source of contamination for the establishment or of pollution of its surroundings.

Section II — Conditions for frozen products

1

Plants must have—

• (a) freezing equipment sufficiently powerful to achieve a rapid reduction in the temperature so that the temperature laid down in these Regulations can be obtained in the product;

• (b) freezing equipment sufficiently powerful to keep products in storage rooms at a temperature not exceeding those laid down in these Regulations, whatever the ambient temperature may be,

however, for technical reasons related to the method of freezing and to the handling of such products, for whole fish frozen in brine and intended for canning, higher temperatures than those laid down in these Regulations are acceptable, although they may not exceed −9°C.

2

Fresh products to be frozen or quick-frozen must comply with the requirements of Section I of this Chapter.

3

• (1) Storage rooms must have a temperature recording device in a place where it can easily be read. The temperature sensor of the recorder must be located in the area furthest away from the cold source, i.e. where the temperature in the storage room is the highest.

• (2) Temperature charts must be available for inspection by the supervisory authorities at least during the period in which the products are stored.

Section III — Conditions for thawing products

Establishments that carry out thawing operations must comply with the following requirements—

1

fishery products must be thawed under hygienic conditions; their contamination must be avoided and there must be adequate drainage for any melt water produced. During thawing, the temperature of the products must not increase excessively;

2

after thawing, fishery products must be handled in accordance with the requirements of these Regulations. When they are prepared or processed, these operations must be carried out without delay. If they are put directly onto the market, particulars as to the thawed state of the fish must be clearly marked on the packaging in accordance with the Food Labelling Regulations 1996.

Section IV — Conditions for processed products

1

Fresh, frozen and thawed products used for processing must comply with the requirements set out in Sections I, II or III of this Chapter.

2

• (1) Where the processing treatment is carried out to inhibit the development of pathogenic micro-organisms, or if it is a significant factor in the preservation of the product, the treatment must be a scientific process which produces safe food, or in the case of a treatment of products referred to in Parts II and III of Chapter I of Schedule 2 which have not been relayed or purified, such treatment must be a form of treatment mentioned in the Annex to Commission Decision 93/25/EEC approving certain treatments to inhibit the development of pathogenic micro-organ isms in bivalve molluscs and marine gastropods.

2

The person responsible for an establishment must keep a register of the processing carried out. Depending on the type of process employed, details such as heating time and temperature, salt content, pH, water content, etc. must be monitored and controlled. Records must be kept at least for the expected storage life of the products and be available to the food authority.

3

For products which are preserved for a limited period by a treatment such as salting, smoking, drying or marinading, the appropriate conditions for storage must be clearly marked on the packaging, in accordance with the Food Labelling Regulations 1996.

Canning

4

In the case of fishery products which have been subjected to sterilisation in hermetically sealed containers—

• (a) the water used for the preparation of cans must be potable water;

• (b) the process used for the heat treatment must be appropriate, having regard to such major criteria as the heating time, temperature, filling, size of containers etc., a record of which must be kept; the heat treatment must be capable of destroying or inactivating pathogenic organisms and the spores of pathogenic micro-organisms. The heating equipment must be fitted with devices for verifying whether the containers have in fact undergone appropriate heat treatment. Potable water must be used to cool containers after heat treatment, without prejudice to the presence of any chemical additives used in accordance with good technological practice to prevent corrosion of the equipment and containers;

• (c) further checks must be carried out at random by the manufacturer to ensure that the processed products have undergone appropriate heat treatment, viz—

• incubation tests: incubation must be carried out at 37°C for seven days or at 35°C for ten days, or at any other equivalent combination;

• microbiological examination of contents and containers in the establishment’s laboratory or in a laboratory recognised by the food authority;

• (d) samples must be taken of production each day at predetermined intervals, to ensure the efficacy of sealing or of any other method of hermetic closure. For that purpose, appropriate equipment must be available for the examination of cross-sections of the can-seams;

• (e) checks are carried out in order to ensure that containers are not damaged;

• (f) all containers which have undergone heat treatment under practically identical conditions must be given a batch identification mark, in accordance with the Food (Lot Marking) Regulations 1996⁷².

Smoking

5

Smoking must be carried out in separate premises or a special place equipped, if necessary, with a ventilation system to prevent the smoke and heat from the combustion from affecting other premises or places where fishery products are prepared, processed or stored—

• (a) materials used to produce smoke for the smoking of fish must be stored away from the place of smoking and must be used in such a way that they do not contaminate the products;

• (b) materials used to produce smoke by burning wood that has been painted, varnished, glued or has undergone any chemical preservation treatment must be prohibited;

• (c) after smoking, products must be cooled rapidly to the temperature required for their preservation before being packaged.

Salting

6

As regards salting—

• (a) salting operations must take place in different premises and sufficiently removed from the premises where the other operations are carried out;

• (b) salt used in the treatment of fishery products must be clean and stored in such a way as to preclude contamination. It must not be re-used;

• (c) any container used for salting or brining must be constructed in such a way as to preclude contamination during the salting or brining process;

• (d) containers or areas used for salting or brining must be cleaned before use.

Cooked crustacean and molluscan shellfish

7

Crustaceans and molluscan shellfish must be cooked as follows—

• (a) any cooking must be followed by rapid cooling. Water used for this purpose must be potable water or clean seawater. If no other method of preservation is used, cooling must continue until the temperature approaching that of melting ice is reached;

• (b) shelling or shucking must be carried out under hygienic conditions avoiding the contamination of the product. Where such operations are done by hand, workers must pay particular attention to the washing of their hands and all working surfaces must be cleaned thoroughly. If machines are used, they must be cleaned at frequent intervals and disinfected after each working day. After shelling or shucking, cooked products must immediately be frozen or kept chilled at a temperature which will preclude the growth of pathogens, and be stored in appropriate premises;

• (c) every manufacturer must carry out microbiological checks at regular intervals, complying with the standards and other obligations set out in Commission Decision 93/51/EEC on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish, but for the purposes of that Commission Decision—

• (i) the reference in article 3(1) to the requirements of article 6 of the Council Directive shall be treated as if it were a reference to regulation 28, and

• (ii) the reference in the first indented paragraph of article 3(2) to competent authorities shall be treated as a reference to the food authority which approved the establishment in question.

Mechanically recovered fish flesh

8

The mechanical recovery of fish flesh must be carried out under the following conditions—

• (a) mechanical recovery of gutted fish must take place without undue delay after filleting, using raw materials free of guts. Where whole fish are used, they must be gutted and washed beforehand;

• (b) the machinery must be cleaned at frequent intervals and at least every two hours;

• (c) after recovery, mechanically recovered flesh must be frozen as quickly as possible or incorporated in a product intended for freezing or stabilising treatment.

Section V — Conditions concerning parasites

1

• (1) During production and before they are released for human consumption, fish and fish products must be subject to a visual inspection for the purpose of detecting and removing any parasites that are visible.

• (2) Fish or parts of fish which are obviously infested with parasites, and which are removed, must not be placed on the market for human consumption.

• (3) This inspection must be carried out in accordance with the rules set out in the Commission Decision 93/140/EEC laying down the detailed rules relating to the visual inspection for the purpose of detecting parasites in fishery products, but for the purposes of that Commission Decision—

• (a) the competent authority to which article 4 of that Decision refers is the food authority; and

• (b) the provisions referred to in that article (the provisions in accordance with which a sampling plan must be drawn up) are those specified in regulation 28(4).

2

The fish and fish products referred to in paragraph 1(1) of this Section which are to be consumed as they are must, in addition, be subjected to freezing at a temperature of not more than −20°C in all parts of the product for not less than 24 hours. Products subjected to this freezing process must be either raw or finished.

3

Fish and fish products which are subject to the conditions in paragraph 2 are—

• (a) fish to be consumed raw or almost raw, e.g. raw herring `maatje';

• (b) the following species, if they are to undergo a cold smoking process at which the internal temperature of the fish is less than 60°C—

• herring;

• mackerel;

• sprat;

• (wild) Atlantic and Pacific salmon;

• (c) marinated and/or salted herring where this process is insufficient to kill the larvae of nematodes.

4

Manufacturers must ensure that fish and fish products listed in paragraph 3, or the raw materials for use in their manufacture, are subjected to the treatment described in paragraph 2 prior to their release for consumption.

5

The fishery products listed in paragraph 3 must, when they are placed on the market, be accompanied by a document from the manufacturer stating the type of process they have undergone.

CHAPTER V — HEALTH CONTROL AND MONITORING OF PRODUCTION CONDITIONS

Section I — General monitoring

Each food authority shall establish the following arrangements in order to establish whether the requirements laid down in the Regulations are complied with, and such arrangements will include, in particular—

1

a check on the fishing vessels, on the understanding that such a check may be carried out during the stay in port;

2

a check on the conditions of landing and first sale;

3

an inspection at regular intervals of establishments and factory vessels (wherever registered) to check in particular—

• (a) whether the conditions for approval (where applicable) are still fulfilled;

• (b) whether the fishery products are handled correctly;

• (c) the cleanliness of the premises, facilities and instruments and staff hygiene;

• (d) whether any necessary identification marks are put on correctly;

4

an inspection of the wholesale and auction markets;

5

a check on storage and transport conditions.

Section II — Special Checks

Organoleptic checks

1

• (1) Without prejudice to the derogations provided for by Council Regulation (EEC) No. 103/76⁷³ laying down common marketing standards for certain fresh or chilled fish, as amended⁷⁴, each batch of fishery products must be submitted for inspection by the food authority at the time of landing or before first sale to check whether they are fit for human consumption. This inspection comprises an organoleptic check carried out by sampling.

• (2) Fishery products complying, as far as the freshness criteria are concerned, with the common marketing standards already laid down pursuant to article 2 of Council Regulation (EEC) No. 3759/92⁷⁵ on the common organisation of the market in fishery products, as amended⁷⁶, are considered to fulfil the organoleptic requirements necessary for compliance with the provisions of these Regulations.

• (3) The organoleptic examinations must be repeated after the first sale of fishery products, if it is found that the requirements of these Regulations have not been complied with or when considered necessary. After the first sale, fishery products must at least comply with the minimum freshness requirements of Regulation (EEC) No. 3687/91⁷⁷, as amended.

• (4) If the organoleptic examination reveals that the fishery products are not fit for human consumption, measures must be taken to withdraw them from the market and denature in such a way that they cannot be re-used for human consumption.

• (5) If the organoleptic examination reveals any doubt as to the freshness of the fishery products, use may be made of chemical checks or microbiological analysis.

Parasite checks

2

• (1) Before they are released for human consumption, fish and fish products must be subject to a visual inspection on behalf of the food authority, by way of sample, for the purpose of detecting any parasites that are visible.

• (2) Fish or parts of fish which are obviously infested with parasites must not be placed on the market for human consumption.

Chemical checks

3A

When the chemical checks are to be carried out by the food authority samples must be taken and subjected to laboratory analysis for the control of the following parameters—

• (a) TVB-N (Total Volatile Basic-Nitrogen), in respect of which—

• (i) the following TVB-N limits must not be exceeded—

• 25 milligrams of nitrogen per 100 grams of flesh for the following species: Sebastes spp.; Helicolenus dactylopterus; Sebastichthys capensis;

• 30 milligrams of nitrogen per 100 grams of flesh for the following species: all species belonging to the Pleuronectidae family (with the exception of halibut: Hippoglossus spp.);

• 35 milligrams of nitrogen per 100 grams of flesh for the following species: Salmo salar; species belonging to the Merlucciidae family; species belonging to the Gadidae family;

• (ii) the reference method to be used for checking the TVB-N limit is the method involving distillation of an extract deproteinized by perchloric acid as set out in Annexes II and III of Commission Decision 95/149/EC of 8th March 1995⁷⁸ (“the Decision”) read together with article 3 of the Decision;

• (iii) the routine methods which may be used to check the TVB-N limit are those specified in article 2(3) of the Decision;

• (iv) the sample must consist of about 100 grams of flesh, taken from at least 3 different points and mixed together by grinding;

• (b) TMA-N (Trimethylamine-Nitrogen);

• (c) Histamine, in respect of which—

• (i) nine samples must be taken from each batch; these must fulfil the following requirements—

• the mean value must not exceed 100 parts per million (“ppm”);

• two samples may have a value of more than 100 ppm but less than 200 ppm;

• no sample may have a value exceeding 200 ppm;

• (ii) these limits apply only to fish species of the following families: Scombridae, Clupeidae, Engraulidae and Coryphaenidae; however, fish belonging to these families which have undergone enzyme ripening treatment in brine may have higher histamine levels but not more than twice the above values; examinations must be carried out in accordance with reliable, scientifically recognised methods, such as high-performance liquid chromatography (HPLC).

Contaminants present in the aquatic environment

3B

• (1) Without prejudice to the Community rules concerning water protection and management, and in particular those concerning pollution of the aquatic environment, fishery products must not contain in their edible parts contaminants present in the aquatic environment such as heavy metals and organochlorinated substances at such a level that the calculated dietary intake exceeds the acceptable daily or weekly intake for humans.

• (2) The Ministers shall establish a monitoring system to check the levels of such contamination of fishery products.

Microbiological analyses

4

• (1) Subject to sub-paragraph (2), the microbiological standards applicable to the production of cooked crustaceans and molluscan shellfish are those set out in Commission Decision 93/51/EEC on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish.

• (2) For the purposes of sub-paragraph (1), the reference in article 2 of Commission Decision 93/51/EEC to a processing plant shall be treated as if it were a reference to an approved establishment or factory vessel.

5

• (1) The sampling programme to be established in accordance with article 3 of Commission Decision 93/51/EEC, as provided for in—

• (a) paragraph 8(1)(b) of Section II of Chapter I; and

• (b) paragraph 7(c) of Section IV of Chapter IV,

shall be monitored by the food authority which approved the establishment or factory vessel in question.

• (2) For the purposes of sub-paragraph (1)—

• (a) the reference in article 3(1) of Commission Decision 93/51/EEC to the requirements of article 6 of the Fishery Products Directive shall be treated as if it were a reference to the requirements of regulation 28; and

• (b) the reference in the first indented paragraph of article 3(2) of that Commission Decision of competent authorities shall be treated as if it were a reference to the food authority mentioned in sub-paragraph (1).

CHAPTER VI — PACKAGING

1

Packaging must be carried out under satisfactory conditions of hygiene, to preclude contamination of the fishery products.

2

Packaging materials and products liable to enter into contact with fishery products must comply with all the rules of hygiene, and in particular—

• they must not be such as to impair the organoleptic characteristics of the fishery product;

• they must not be capable of transmitting to the fishery products substances harmful to human health;

• they must be strong enough to protect the fishery products adequately.

3

With the exception of certain containers made of impervious, smooth and corrosion-resist ant material which are easy to clean and disinfect, which may be re-used after cleaning and disinfecting, packaging materials may not be re-used. Packaging materials used for fresh fishery products which are held under ice must provide adequate drainage for melt water.

4

Unused packaging materials must be stored in places away from the production area and be protected from dust and contamination.

CHAPTER VII — IDENTIFICATION MARKS

PART I — PRODUCTS PREPARED ON OR AFTER 29 APRIL 1998

1

This Part of this Chapter shall apply to all products other than those which were prepared before these Regulations come into force and in respect of which the conditions set out in Part II of this Chapter are satisfied.

2

• (1) Without prejudice to the provisions of the Food Labelling Regulations 1996, it must be possible to trace for inspection purposes the establishment of dispatch of consignments of fishery products, by means either of the labelling or of the accompanying documents. For that purpose, the following information must appear on the packaging or, in the case of a non-packaged product, in the accompanying documents—

• the country of dispatch, which may be written out in full or shown as an abbreviation, using capital letters, e.g. for the member States of the European Community, one of the following:

• B—DK—D—EL—E—F—IRL—I—L—NL—P—UK—AT—FI—SE;

• identification of— the establishment or factory vessel by its official approval number, in the case of marketing from a freezer vessel covered by, as respects Great Britain, paragraph 7 of Part II of Schedule 4 or, as respects any other part of the European Economic Area, point 7 of Annex II to the Fishing Vessels Directive, the identification number of the vessel, or the registered wholesale or auction market by its registration number, from which the products were dispatched;

• one of the following abbreviations:

• CE—EC—EG—EK—EF—EY.

• (2) All the letters and figures must be fully legible and grouped together on the packaging in a place where they are visible from the outside without any need to open the packaging.

PART II — PRODUCTS PREPARED BEFORE 29 APRIL 1998

1

This Part of this Chapter applies to products which were prepared before these Regulations come into force and in respect of which the conditions set out Part I of this Chapter are not satisfied, but only if the conditions set out in this Part of this Chapter are satisfied in relation to those products.

2

Without prejudice to the requirements of the Food Labelling Regulations 1996, it must be possible to trace for inspection purposes the establishment of dispatch of consignments of fishery products, by means of either labelling or the accompanying documents. For that purpose, in respect of each consignment of fishery products the following information must appear on the packaging or in the accompanying documents—

• the country of dispatch;

• identification of the establishment or factory vessel of dispatch by its approval number or, in the case of separate registering of auction or wholesale markets, the registration number of the auction or wholesale market.

CHAPTER VIII — STORAGE AND TRANSPORT

1

Fishery products must, during storage and transport, be kept at the temperatures laid down in these Regulations, and in particular—

• (a) fresh or thawed fishery products and cooked and chilled crustacean and molluscan shellfish products must be kept at a temperature approaching that of melting ice;

• (b) frozen fishery products, with the exception of frozen fish in brine intended for the manufacture of canned foods, must be kept at an even temperature of −18°C or less in all parts of the product, after temperature stabilisation, and allowing for the possibility of brief upward fluctuations of not more than 3°C, during transport.

2

Where frozen fishery products are transported from a cold storage plant to an approved establishment to be thawed on arrival for the purposes of either preparation or processing and where the distance to be covered does not exceed 50 km or, if the distance is greater, the anticipated duration of the journey is less than one hour, the food authority may grant a derogation from the conditions laid down in paragraph 1(b).

3

Products may not be stored or transported with other products which may contaminate them or affect their hygiene, unless they are packaged in such a way as to provide satisfactory protection.

4

Vehicles used for the transport of fishery products must be constructed and equipped in such a way that the temperatures laid down in these Regulations can be maintained throughout the period of transport. If ice is used to chill the fishery products, adequate drainage must be provided in order to ensure that water from melted ice does not stay in contact with the products. The inside surfaces of the means of transport must be finished in such a way that they do not adversely affect the fishery products. They must be smooth and easy to clean and disinfect.

5

Means of transport used for fishery products may not be used for transporting other products likely to impair or contaminate fishery products, except where the fishery products can be safeguarded against contamination by such transport being thoroughly cleaned and disinfected immediately prior to each occasion it is used for fishery products.

6

Fishery products may not be transported in a vehicle or container which is not clean or which should have been disinfected.

7

The transport conditions of fishery products to be placed on the market alive must not adversely affect the fishery products.

SCHEDULE 4 — HYGIENE CONDITIONS FOR FISHING VESSELS (BASED ON THE CORRE SPONDING PROVISIONS OF THE ANNEXES TO THE FISHING VESSELS DIRECTIVE)

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

1

The sections of vessels or the containers reserved for the storage of fishery products must not contain objects or products liable to transmit harmful properties or abnormal characteristics to the foodstuffs. These sections or containers must be so designed as to allow them to be cleaned easily and to ensure that melt water cannot remain in contact with the fishery products.

2

When used, the sections of vessels or the containers reserved for the storage of fishery products must be completely clean and, in particular, must not be capable of being contaminated by the fuel used for the propulsion of the vessel or by bilge water.

3

As soon as they are taken on board, the fishery products must be protected from contamination and from the effects of the sun or any other source of heat. When they are washed, the water used must be either fresh water complying with the parameters set out in—

• (a) in England and Wales, Tables B and C of Schedule 2 to the Water Supply (Water Quality) Regulations 1989⁷⁹; or

• (b) in Scotland, Tables B and C of Schedule 2 to the Water Supply (Water Quality) (Scotland) Regulations 1990⁸⁰,

or clean seawater, so as not to impair their quality or wholesomeness.

4

The fishery products shall be handled and stored in such a way as to prevent bruising. The use of spiked instruments shall be tolerated for the moving of large fish or fish which might injure the handler, provided the flesh of these products is not damaged.

5

Fishery products other than those kept alive must undergo cold treatment as soon as possible after loading. However, in the case of fishing vessels where cooling is not possible from a practicable point of view, the fishery products must not be kept on board for more than 8 hours.

6

Ice used for the chilling of products must be made from potable water or clean seawater. Before use, it must be stored under conditions which prevent its contamination.

7

After the fishery products have been unloaded, the containers, equipment and sections of vessels which are directly in contact with the fishery products must be cleaned with potable water or clean seawater.

8

Where fish is headed and/or gutted on board, such operations must be carried out hygienically and the products must be washed immediately and thoroughly with potable water or clean seawater. The viscera and parts which may pose a threat to public health must be removed and set apart from products intended for human consumption. Livers and roes intended for human consumption must be refrigerated or frozen.

9

Equipment used for gutting, heading and the removal of fins, and containers and equipment in contact with the fishery products, must be made of or coated with a material which is waterproof, resistant to decay, smooth and easy to clean and disinfect. When used they must be completely clean.

10

Staff assigned to the handling of fishery products shall be required to maintain a high standard of cleanliness for themselves and their clothes.

PART II — Additional hygiene conditions applicable to article 1.2 fishing vessels

1

Fishing vessels must be equipped with holds, tanks or containers for the storage of refrigerated or frozen fishery products at the temperature laid down by these Regulations. These holds shall be separated from the machinery space and the quarters reserved for the crew by partitions which are sufficiently impervious to prevent any contamination of the stored fishery products.

2

The inside surface of the holds, tanks or containers shall be waterproof and easy to wash and disinfect. It shall consist of a smooth material or, failing that, smooth paint maintained in good condition, not being capable of transmitting to the fishery products substances harmful to human health.

3

The holds shall be designed to ensure that melt water cannot remain in contact with the fishery products.

4

Containers used for the storage of products must ensure their preservation under satisfactory conditions of hygiene and, in particular, allow drainage of melt water. When used they must be completely clean.

5

The working decks, the equipment and the holds, tanks and containers shall be cleaned each time they are used. Potable water or clean seawater shall be used for this purpose. Disinfection, the removal of insects or rat extermination shall be carried out whenever necessary.

6

Cleaning products, disinfectants, insecticides and all potentially toxic substances shall be stored in locked premises or cupboards. Their use must not present any risk of contamination of the fishery products.

7

If fishery products are frozen on board, this operation must be carried out in accordance with the conditions laid down in paragraphs 1 and 3 of Section II of Chapter IV of Schedule 3. Where freezing in brine is used, the brine shall not be a source of contamination for the fish.

8

Vessels equipped for chilling of fishery products in cooled seawater, either chilled by ice (CSW) or refrigerated by mechanical means (RSW), shall comply with the following requirements—

• (a) tanks must be equipped with adequate seawater filling and drainage installations and must incorporate devices for achieving uniform temperature throughout the tanks;

• (b) tanks must have a means of recording temperature connected to a temperature sensor positioned in the section of the tank where temperatures are highest;

• (c) the operation of the tank or container system must secure a chilling rate which ensures the mix of fish and seawater reaches 3°C at the most 6 hours after loading and 0°C at the most after 16 hours;

• (d) after each unloading, the tanks, circulation systems and containers must be completely emptied and thoroughly cleaned using potable water or clean seawater. They should only be filled with clean seawater;

• (e) the date and the number of the tank must be clearly indicated on the temperature recordings which must be kept available for the control authorities.

SCHEDULE 5 — REVOCATIONS

Column (1)	Column (2)	Column (3)
The Food Safety (Fishery Products) (Derogations) Regulations 1992	S.I. 1992/1507	The whole Regulations
The Food Safety (Live Bivalve Molluscs) (Derogations) Regulations 1992	S.I. 1992/1508	The whole Regulations
The Food Safety (Fishery Products) Regulations 1992	S.I. 1992/3163	The whole Regulations
The Food Safety (Live Bivalve Molluscs and Other Shellfish) Regulations 1992	S.I. 1992/3164	The whole Regulations
The Food Safety (Fishery Products on Fishing Vessels) Regulations 1992	S.I. 1992/3165	The whole Regulations
The Food Safety (Live Bivalve Molluscs and Other Shellfish) (Import Conditions and Miscellaneous Amendments) Regulations 1994	S.I. 1994/2782	The whole Regulations
The Food Safety (Fishery Products) (Import Conditions and Miscellaneous Amendments) Regulations 1994	S.I. 1994/2783	The whole Regulations
The Food Safety (General Food Hygiene) Regulations 1995	S.I. 1995/1763	Paragraphs 3 to 7 of Schedule 2
The Food Safety (Fishery Products and Live Bivalve Molluscs and Other Shellfish) (Miscellaneous Amendments) Regulations 1996	S.I. 1996/1547	The whole Regulations
The Products of Animal Origin (Import and Export) Regulations 1996	S.I. 1996/3124	Paragraphs 4 and 5 of Schedule 6

Signed

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

Explanatory note

(This note is not part of the Regulations)

These Regulations consolidate with amendments the regulations which were made to give effect to the provisions of Council Directive 91/492/EEC laying down the health conditions for the production and placing on the market of live bivalve molluscs, as adapted for the purposes of the EEA Agreement and as amended, and Council Directive 91/493/EEC laying down the health conditions for the production and placing on the market of fishery products, as adapted and as amended, together with a number of Commission Decisions made under these two Council Directives. These Regulations also consolidate with amendments the regulations which were made to give effect to the provisions of Council Directive 92/48/EEC laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with article 3.1(a)(i) of Council Directive 91/493/EEC, and to the measures set out in paragraph 1 of Section II of Chapter III of the Annex to Council Directive 85/73/EEC on the financing of veterinary inspections and controls covered by Directives 89/662/EEC, 90/425/EEC, 90/675/EEC and 91/496/EEC, which is annexed to Council Directive 96/43/EC amending and consolidating Directive 85/73/EEC in order to ensure financing of veterinary inspections and controls on live animals and certain animal products and amending Directives 90/675/EEC and 91/496/EEC (OJ No. L162, 1.7.96, p.1). In addition, these Regulations give effect to the amendments made by Council Directive 95/71/EC to the Annex to Directive 91/493/EEC (health conditions for the production and placing on the market of fishery products; see Schedule 3 to these Regulations).

The Regulations are made under the Food Safety Act 1990, except for Part V which is made under section 2(2) of the European Communities Act 1972. Part V implements the amendments made by Council Directive 96/43/EC to which reference is made above.

Part I of the Regulations contains general provisions relating to citation, commencement and interpretation (regulations 1 and 2).

Part II contains the provisions relating to the production and placing on the market of live shellfish (defined as live bivalve molluscs, echinoderms, tunicates and marine gastropods, and so excluding crustaceans) in Great Britain. The Ministers have the power to designate certain areas as designated production areas for live bivalve molluscs; relaying areas (areas where bivalve molluscs may be relaid after harvesting to remove contamination) are designated by food authorities (regulation 3). The Ministers may also designate certain areas as prohibited areas for live shellfish production of various kinds (regulation 4) and food authorities may make temporary prohibitions concerning layings (regulation 7). Collecting shellfish from areas subject to a relevant prohibition is an offence (regulation 8). The Ministers may vary and revoke their designations of production and prohibited areas, and food authorities may vary and revoke their designations of relaying areas (regulation 5). The Ministers have an obligation to keep an up-to-date list of designated production and relaying areas (regulation 6).

Part II also contains special requirements relating to the harvesting, transporting and relaying of live shellfish (regulation 9), and to the operation of dispatch and purification centres, which need to be approved by the local food authority (regulations 10 to 13). There are also special rules for the variation and revocation of approvals of such centres (regulation 14 and 15).

Part II also contains special rules for the wrapping, unwrapping, repackaging, storage and transportation of live shellfish within Great Britain (regulations 16 to 18), and detailed obligations relating to the placing on the market of live shellfish (regulation 19). There is, however, an exemption scheme from most of the requirements of this Part which relates to local sales of small quantities of live shellfish (regulation 20).

Part III of the Regulations deals with the production and placing on the market of fishery products. There is a registration scheme for fishing vessels on board which shrimps and molluscs are cooked, there are hygiene rules for all fishing vessels, and there are special additional rules for certain longer range vessels (regulations 21 and 22). Factory vessels and establishments on land which are involved in the production of fishery products both have to be approved by the local food authority (regulations 23 and 24), and their proprietors have to comply with various specified requirements (regulation 28). Masters of third country factory vessels also have an additional obligation to give the food authority at their port of arrival at least 24 hours notice before they arrive (regulation 29). Auction and wholesale markets also have to be registered, again by the food authority (regulations 25 and 26), and their proprietors also have to comply with certain specified requirements (regulation 30). Provision is also made for appeals against decisions to refuse to approve or register, or to grant approvals but only subject to conditions (regulation 27), and there are procedures (including appeals procedures) relating to the variation and revocation of approvals and the cancellation of market registrations (regulations 31 and 32).

Part III also contains a special rule relating to the timing of gutting of fishery products (regulation 33), and rules relating to the packaging, storage and transportation of fishery products within Great Britain (regulations 34 and 35). There are also detailed obligations relating to the placing on the market of all types of fishery products (regulation 36), with special additional rules relating to the placing on the market of aquaculture products (regulation 37), processed shellfish (regulation 38) and live fish and other aquatic animals (regulation 39). There is, however, a prohibition on selling or supplying in the course of a business certain poisonous fishery products (regulation 40). As with live shellfish, there is an exemption scheme from most of the requirements of this Part which relates essentially to local sales of small quantities of products (regulation 41).

Part IV of the Regulation deals with the import conditions for fishery products and live shellfish (regulations 42 to 45), but there is an exemption from this Part for certain private consignments (regulation 46).

Part V deals with inspection charges for third country direct landings (products landed from third country vessels which have or had not been on land prior to their importation into the European Community). The charge is paid by the first purchaser to the vendor, and an equivalent amount is then passed by the vendor to the food authority (regulations 48 and 49). Some reductions are available in relation to part of this charge where checks are facilitated by specified factors (regulation 50). The vendor is also under an obligation to make a written return in respect of his weekly sales (regulation 51).

Part VI contains more general provisions. These include provisions relating to the health control responsibilities of the Ministers and food authorities (regulation 52), enforcement responsibilities (regulations 54 and 56), certification of shellfish and fishery products as failing to comply with food safety requirements (regulation 57), amendments to other Regulations (regulation 58), and revocations (regulation 59). Regulation 59 also contains a transitional provision.

An assessment of the cost to business of complying with these Regulations has been prepared and copies may be obtained from the Department of Health, Room 501A, Skipton House, 80 London Road, London SE1 6LW, or the Scottish Office Agriculture, Environment and Fisheries Department, Room 358, Pentland House, 47 Robb’s Loan, Edinburgh EH14 1TW. A copy has also been placed in the library of each of the Houses of Parliament.

Footnotes