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

(a)a reception area set aside for taking fishery products on board, designed and arranged into pounds or pens that are large enough to allow each successive catch to be separated. The reception area and its movable parts must be easy to clean. It must be designed in such a way as to protect the products from the sun or the elements and from any source of dirt or contamination;

(b)a system for conveying fishery products from the reception area to the work area that conforms with rules of hygiene;

(c)work areas that are large enough for the preparation and processing of fishery products in proper conditions of hygiene. They must be designed and arranged in such a way as to prevent any contamination of the products;

(d)storage areas for the finished products that are large enough and designed so that they are easy to clean. If a waste processing unit operates on board, a separate hold must be designated for the storage of these by-products;

(e)a place for storing packaging materials that is separate from the product preparation and processing areas;

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

(g)equipment providing a supply of potable water within the meaning of Council Directive 80/778/EEC of 15th July 1980(5) relating to the quality of water intended for human consumption 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 holds that are large enough not 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 the Directive;

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

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 the Directive 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 Chapter III, Section IIA, of the Annex.

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

4. Heading, gutting and filleting must be carried out under the conditions of hygiene laid down in Chapter IV, Section 1(2), (3) and (4) of the Annex.

5. On-board processing of fishery products must be carried out under the conditions of hygiene laid down in Chapter IV, Sections III, IV and V of the Annex.

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

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

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 of the Annex;

(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 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 drinking 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 Chapter III, Section I, point 7 of the Annex;

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

5. However, if the conditions laid down in point 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 Chapter III, Section I, point 3 of the Annex. 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 Chapter III, Section II-with the exception of point B 1(a)-of the Annex shall apply mutatis mutandisto 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 points 3 and 5 of this Chapter and to those set out in points 4, 10 and 11 of Chapter III, Section I of the Annex. The general conditions of hygiene laid down in Chapter III, Section II of the Annex shall apply mutatis mutandis to wholesale markets.

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 point 2(a), (b), (c), (d) and (f);

- where necessary, a sufficiently powerful refrigeration plant to keep products at temperatures prescribed in the Directive;

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 drinking water within the meaning of Directive 80/778/EEC, 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-drinking 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-drinking-water pipes must be clearly distinguishable from those used for drinking 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 competent 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.

A. General conditions of hygiene applicable to premises and equipment

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

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

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

4. Drinking water, within the meaning of Directive 80/778/EEC, or clean seawater must be used for all purposes. However, by way of an exception, non-drinking 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 approved by the competent authority and used in such a way that they do not have adverse effects on the machinery, equipment and products.

B. General conditions of hygiene applicable to staff

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

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

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

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

2. The employer shall take all the requisite measures to prevent persons liable to contaminate fishery products from working on and handling them, until there is evidence that such persons can do so without risk. When recruited, any person working on and handling fishery products shall be required to prove, by a medical certificate, that there is no impediment to such employment. The medical supervision of such a person shall be governed by the national legislation in force in the Member State concerned or in the case of third countries by specific guarantees to be fixed under the procedure set out in Article 15 of the Directive.

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 drinking water or clean seawater and be stored under hygienic conditions in receptacles provided for the purpose; such receptacles must be kept clean and in a good state of repair. Prepacked fresh products must be chilled with ice or mechanical refrigeration plant creating similar temperature conditions.

2. If they are not carried out on board, operations such as heading and gutting must be carried out hygienically. The products must be washed thoroughly with drinking 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. 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 Chapter III, Section I, point 6 of the Annex. 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.

1. Plants must have:

(a)freezing equipment sufficiently powerful to achieve a rapid reduction in the temperature so that the temperature laid down to in the Directive 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 the Directive, 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 the Directive 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. 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.

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

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 the Directive. 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 Article 5(3) of Council Directive 79/112/EEC of 18th December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(6).

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

2. 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 scientifically recognised by the law in force, or in the case of a treatment of products referred to in Chapter I Section 1(b) and (c) of Directive 91/492/EEC(7) which have not been relayed or purified, such treatment must be approved, in accordance with the procedure laid down in Article 15 of this Directive, within four months of receipt of a request from a Member State.

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 competent 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 Directive 79/112/EEC.

In addition, the following conditions shall be complied with.

4. Canning

In the case of fishery products which have been subjected to sterilization in hermetically sealed containers:

(a)the water used for the preparation of cans must be drinking 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. Drinking 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 another approved laboratory;

(d)samples must be taken of production each day at predetermined intervals, to ensure the efficacy of sealing. 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 Council Directive 89/396/EEC of 14th June 1989 on indications or marks identifying the lot to which a foodstuff belongs(8).

5. Smoking

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.

6. 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.

7. Cooked crustacean and molluscan shellfish products

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 drinking 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 micro-biological checks on his production at regular intervals, complying with the standards to be fixed in accordance with Chapter V, Section 4 of the Annex.

8. Mechanically recovered fish flesh

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, mechnically recovered flesh must be frozen as quickly as possible or incorporated in a product intended for freezing or stabilizing treatment.

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.

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.

The detailed rules for this inspection shall be adopted in accordance with the procedure laid down in Article 15 of the Directive, on a proposal from the Commission to be submitted before 1 October 1992.

2. The fish and fish products referred to in point 3 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 products subject to the conditions in point 2:

(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 destroy the larvae of nematodes.

This list may be amended, in the light of scientific data, in accordance with the procedure laid down in Article 15 of the Directive. In accordance with the same procedure, criteria will be laid down which must enable the processes which are deemed sufficient or insufficient to destroy nematodes to be defined.

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

5. The fishery products listed in point 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.