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

Regulations 2(1) and (2), 42(a) and 44(1)(a)

SCHEDULE 1 Imports

Part I Approved Import Conditions for Fishery Products

1.  Commission Decision 93/436/EEC laying down special import conditions governing imports of fishery products originating in Chile(1).

2.  Commission Decision 93/437/EEC laying down special import conditions governing imports of fishery products originating in Argentina(2).

3.  Commission Decision 93/494/EEC laying down special conditions governing imports of fishery products originating in the Faroe Islands(3).

4.  Commission Decision 93/495/EEC laying down special conditions governing imports of fishery products originating in Canada(4).

5.  Commission Decision 94/198/EC laying down special conditions governing the import of fishery and aquaculture products originating in Brazil(5).

6.  Commission Decision 94/200/EC laying down special conditions governing the import of fishery and aquaculture products originating in Ecuador(6).

7.  Commission Decision 94/269/EC laying down special conditions governing imports of fishery and aquaculture products originating in Columbia(7).

8.  Commission Decision 94/323/EC laying down special conditions governing imports of fishery products originating in Singapore(8).

9.  Commission Decision 94/324/EC laying down special conditions governing imports of fishery and aquaculture products originating in Indonesia(9).

10.  Commission Decision 94/325/EC laying down special conditions governing imports of fishery and aquaculture products originating in Thailand(10).

11.  Commission Decision 94/448/EC laying down special conditions governing imports of fishery and aquaculture products originating in New Zealand(11).

12.  Commission Decision 94/766/EC laying down special conditions governing imports of fishery and aquaculture products originating in Taiwan(12).

13.  Commission Decision 94/778/EC laying down special conditions for the import of frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Turkey(13).

14.  Commission Decision 95/30/EC laying down special conditions governing imports of fishery and aquaculture products originating in Morocco(14).

15.  Commission Decision 95/90/EC laying down special conditions governing imports of fishery and aquaculture products originating in Albania(15).

16.  Commission Decision 95/173/EC laying down special conditions governing imports of fishery and aquaculture products originating in Peru(16).

17.  Commission Decision 95/190/EC laying down special conditions governing imports of fishery and aquaculture products originating in the Philippines(17).

18.  Commission Decision 95/454/EC laying down special conditions governing imports of fishery and aquaculture products originating in the Republic of Korea(18).

19.  Commission Decision 95/538/EC laying down special conditions governing the import of fishery and aquaculture products originating in Japan(19).

20.  Commission Decision 96/355/EC laying down special conditions governing the import of fishery and aquaculture products originating in Senegal(20).

21.  Commission Decision 96/356/EC laying down special conditions governing the import of fishery and aquaculture products originating in Gambia(21).

22.  Commission Decision 96/425/EC laying down special conditions governing the import of fishery and aquaculture products originating in Mauritania(22).

23.  Commission Decision 96/606/EC laying down special conditions governing the import of fishery and aquaculture products originating in Uruguay(23).

24.  Commission Decision 96/607/EC laying down special conditions governing the import of fishery and aquaculture products originating in South Africa(24).

25.  Commission Decision 96/608/EC laying down special conditions governing the import of fishery and aquaculture products originating in Malaysia(25).

26.  Commission Decision 96/609/EC laying down special conditions governing the import of fishery and aquaculture products originating in the Ivory Coast(26).

Part II Approved Import Conditions for Live Shellfish

1.  Commission Decision 93/387/EEC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Morocco(27).

2.  Commission Decision 94/777/EC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Turkey(28).

3.  Commission Decision 95/174/EC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Peru(29).

4.  Commission Decision 95/453/EC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in the Republic of Korea(30).

5.  Commission Decision 96/675/EC laying down special conditions for the import of live bivalve molluscs, echinoderms, tunicates and marine gastropods originating in Chile(31).

Part III The Fishery Products Decisions

1.  Commission Decision 93/25/EEC approving certain treatments to inhibit the development of pathogenic micro-organisms in bivalve molluscs and marine gastropods(32).

2.  Commission Decision 93/51/EEC on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish(33).

3.  Commission Decision 93/140/EEC laying down the detailed rules relating to the visual inspection for the purpose of detecting parasites in fishery products(34).

4.  Commission Decision 93/351/EEC determining analysis methods, sampling plans and maximum limits for mercury in fishery products(35).

5.  The Health Checks Decision.

6.  Commission Decision 95/149/EC fixing the total volatile basic nitrogen (TVB-N) limit values for certain categories of fishery products and specifying the analysis methods to be used(36).

Part IV Applicable Requirements Relating to Imported Fishery Products

As respects imported fishery products, the requirements of the Fishery Products Directive, the Fishing Vessels Directive, the Live Bivalve Molluscs Directive and the Fishery Products Decisions which are capable of being applicable are—

(a) in relation to fishery products other than aquaculture products or processed bivalve molluscs, echinoderms, tunicates or marine gastropods, those set out in—

(i) articles 3.1(a) to (g), 3.2, 4, 5 and 6.1 of the Fishery Products Directive,

(ii) article 1 of the Fishery Vessels Directive,

(iii) articles 1 to 4 of Commission Decision 93/51/EEC,

(iv) articles 2 to 4 of Commission Decision 93/140/EEC,

(v) articles 1 to 3 of Commission Decision 93/351/EEC,

(vi) articles 1.3 and 6.2 of the Health Checks Decision, and

(vii) articles 1 and 2 of Commission Decision 95/149/EC;

(b) in relation to fishery products which are aquaculture products, those set out in—

(i) articles 3.1(c) to (g), 3.3, 4, 5 and 6.1 of the Fishery Products Directive,

(ii) articles 1 to 4 of Commission Decision 93/51/EEC,

(iii) articles 2 to 4 of Commission Decision 93/140/EEC,

(iv) articles 1 to 3 of Commission Decision 93/351/EEC,

(v) articles 1.3 and 6.2 of the Health Checks Decision, and

(vi) articles 1 and 2 of Commission Decision 95/149/EC;

(c) in relation to fishery products which are processed bivalve molluscs, echinoderms, tunicates or marine gastropods, those set out in—

(i) articles 3.1(a) and (c) to (g), 3.4, 5 and 6.1 of the Fishery Products Directive,

(ii) article 3.1(a) to (i) and 3.2 (as read with article 1) and article 4 of the Live Bivalve Molluscs Directive,

(iii) article 1 of Commission Decision 93/25/EEC,

(iv) articles 1 to 4 of Commission Decision 93/51/EEC,

(v) article 2 of Commission Decision 93/140/EEC,

(vi) articles 1 to 3 of Commission Decision 93/351/EEC, and

(vii) articles 1.3 and 6.2 of the Health Checks Decision.

Part V Applicable Requirements Relating to Imported Live Shellfish

As respects imported live shellfish, the requirements of the Live Bivalve Molluscs Directive which are capable of being applicable are those set out in article 3.1(a) to (i) and 3.2 (read with article 1) and article 4.

Regulations 2(1), 3(1) and (2), 9, 11(3) to (5), 13, 15 to 20 and 52

SCHEDULE 2 Production and placing on the marketConditions for live shellfish

Chapter I Conditions for Production Areas

Part I Class A Areas

Areas to be designated class A areas

1.  An area from which live bivalve molluscs can be gathered for direct human consumption provided such molluscs satisfy the requirements specified in Chapter V.

Part II Class B Areas

Areas to be designated class B areas

2.  An area from which live bivalve molluscs may be gathered but only placed on the market for human consumption—

(a) after treatment in a purification centre or after relaying (followed, where necessary, by treatment in a purification centre); or

(b) after heat treatment by an approved process in an approved establishment.

Conditions in relation to a class B area

3.  Prior to relaying, treatment in a purification centre or heat treatment, the live bivalve molluscs from these areas must not exceed in 90% of samples the limits of—

(a) a five-tube, three-dilution MPN-test of 6,000 faecal coliforms per 100 grams of flesh; or

(b) 4,600 E. coli per 100 grams of flesh.

4.  After any necessary relaying, purification and treatment, the live bivalve molluscs must satisfy the requirements of Chapter V.

Part III Class C Areas

Areas to be designated class C areas

5.  An area from which live bivalve molluscs can be gathered but placed on the market for direct human consumption only after—

(a) a relaying period of at least 2 months, followed, where necessary, by treatment in a purification centre; or

(b) heat treatment by an approved process in an approved establishment.

Conditions in relation to a class C area

6.  The live bivalve molluscs from these areas must not, prior to relaying and any periods of purification or heat treatment, exceed the limits of—

(a) a five-tube, three-dilution MPN-test of 60,000 faecal coliforms per 100 grams of flesh; or

(b) 46,000 E. coli per 100 grams of flesh.

7.  After any necessary relaying, purification and treatment, the live bivalve molluscs must satisfy the requirements of Chapter V.

Chapter II Requirements for Harvesting and Transportation of Batches to a Dispatch or Purification Centre, Relaying Area or Processing Plant

1.  Harvesting techniques must not cause excessive damage to the shells or tissue of live shellfish.

2.  Live shellfish must be adequately protected from crushing, abrasion or vibration after harvesting and must not be exposed to extremes of hot or cold temperature.

3.  Techniques for harvesting, transporting, landing and handling live shellfish must not result in additional contamination of the product, nor in a significant reduction in the quality of the product, nor in any changes significantly affecting their ability to be treated by purification, processing or relaying.

4.  Live shellfish must not be re-immersed in water which could cause additional contamination between harvesting and landing.

5.—(1) The means of transport used for transporting live shellfish must be used under conditions which protect the latter from additional contamination and crushing of shells, and must permit adequate drainage and cleaning.

(2) In the event of bulk transport over long distances of live shellfish to a dispatch centre, purification centre, relaying area or processing plant, the means of transport must be equipped in such a way as to ensure the best survival conditions possible, and in particular must comply with the requirements laid down in paragraph 2 of Chapter IX.

6.—(1) A movement document, as prescribed in this paragraph, for the identification of each batch of live shellfish during the transport from the production area to a dispatch centre, purification centre, relaying area or processing plant shall be issued by the district council on request, to the gatherer for completion by the gatherer in respect of each batch in a way which is both legible and indelible.

(2) The gatherer shall ensure the completed movement document accompanies each batch at all times.

(3) If a batch in respect of which a movement document has been issued is split for any reason, the person having control of the original batch at the time of splitting shall ensure that the information accompanying the original batch accompanies each sub-batch in the same form as the movement document together with the full name and address of the person splitting the batch.

(4) A movement document shall be in the following form—

(5) Each movement document must be numbered permanently in sequence by the district council.

(6) Each district council shall keep a register indicating the number of each movement document together with the name of the person collecting the live shellfish and of the person to whom the document was issued.

(7) The person receiving a movement document for each batch of live shellfish shall put on it the date the batch was received by either a dispatch centre, purification centre, relaying area or processing plant and shall keep it available for inspection for a period of at least 60 days.

(8) If gathering is or is to be carried out by a person employed by the person who operates the dispatch centre, purification centre, relaying area or processing plant of destination, the district council may, if satisfied that the gatherer will comply with the requirements of Part II concerning gathering and handling, issue to the gatherer a permanent transport authorisation (which may be withdrawn at any time) absolving the gatherer from the requirement to use movement documents for transfers from a production area specified in that authorisation to a dispatch centre, purification centre, relaying area, or processing plant specified in that authorisation.

7.  If a production or relaying area is closed temporarily, pursuant to regulation 7, the district council shall refrain from issuing further movement documents and permanent transport authorisations for that area and the district council may suspend the validity of any such documentations or authorisations already issued for the area.

Chapter III Conditions for Relaying Live Bivalve Molluscs

The following conditions must be met—

1.  live bivalve molluscs must be gathered and transported, under the supervision of the district council, in accordance with the requirements of Chapter II;

2.  techniques for handling live bivalve molluscs intended for relaying must permit the resumption of filter-feeding activity after immersion in natural waters;

3.  live bivalve molluscs must not be relaid at a density which does not permit purification;

4.  live bivalve molluscs must be immersed in sea water at the relaying area for an appropriate period which must exceed the time taken for levels of faecal bacteria to become reduced to the levels permitted by these Regulations and in particular either the standards specified in Chapter V or the standards in Part 2 of Chapter I where relaying is to be followed by purification;

5.  the minimum water temperature for effective relaying must, where necessary, be determined for each species of live bivalve molluscs and each approved relaying area, by the Department and the district council for the district where the laying is situated, acting jointly, and be announced by the district council;

6.  the boundaries of the sites must be physically delineated by buoys, poles or any other fixed means; there must be a minimum distance of 300 meters between relaying areas, and also between relaying areas and production areas;

7.  sites within a relaying area must be well separated to prevent mixing of batches; the ‘all in, all out’ system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed;

8.  permanent records of the source of live bivalve molluscs, relaying periods, relaying areas and subsequent destination of the batch after relaying must be kept by the operators of relaying areas for inspection by the district council;

9.  after harvesting from the relaying area, batches must, during transport from the relaying area to the approved dispatch centre, purification centre or processing plant, be accompanied by the movement document referred to in paragraph 6 of Chapter II, unless a permanent transport authorisation has been issued by a district council.

Chapter IV Conditions for the Approval of Dispatch or Purification Centres

Section I— General conditions relating to premises and equipment

Centres must not be located in areas which are close to objectionable odours, smoke, dust and other contaminants. The location must not be subject to flooding by ordinary high tides or run-off from surrounding areas.

Centres must have at least—

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

(a) buildings or facilities of sound construction, designed and maintained adequately for the purpose of preventing contamination of live bivalve molluscs by any type of waste, dirty water, fumes, dirt or by the presence of rodents or other animals;

(b) flooring which is easy to keep clean and is laid in such a way as to facilitate drainage;

(c) adequate working space to allow for satisfactory performance of all operations;

(d) durable walls which are easy to clean;

(e) adequate natural or artificial lighting;

2.  access to an appropriate number of changing rooms, wash basins and lavatories; there must be a sufficient number of wash basins close to the lavatories;

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

4.  facilities for the supply and, where appropriate, storage of exclusively potable water or facilities for the supply of clean seawater. Facilities supplying non-potable water may be authorised. The water concerned may not come into direct contact with live shellfish or be used for cleaning or disinfecting containers, plant or equipment which come into contact with live shellfish. Pipes and outlets carrying non-potable water must be clearly distinguished from those carrying potable water;

5.  equipment and instruments or their surfaces which are intended to come into contact with live shellfish must be made of corrosion-resistant material which is easy to wash and clean repeatedly.

Section II— General hygiene requirements

A high degree of cleanliness and hygiene must be required of staff, premises, equipment and working conditions—

1.  staff who treat or handle live shellfish must in particular wear clean working clothes and, where appropriate, gloves which are suitable for the work in which the person is engaged;

2.  staff are obliged to refrain from personal behaviour, such as spitting, which could result in contamination of live shellfish; any person suffering from an illness which can be transmitted by live shellfish must be temporarily prohibited, until recovery, from working with or handling these products;

3.  any rodents, insects or other vermin found must be destroyed and further infestation prevented. Domestic animals must not enter the facilities;

4.  premises, equipment and instruments used for handling live shellfish must be kept clean and in a good state of repair; equipment and instruments must be thoroughly cleaned at the end of the day’s works and at such other times as may be appropriate;

5.  premises, instruments and equipment must not be used for purposes other than the handling of live shellfish without authorisation by the district council;

6.  waste products must be stored hygienically in a separate area and, where appropriate, in covered containers suitable for the purpose intended. Waste material must be removed from the vicinity of the establishment at appropriate intervals;

7.  the finished products must be stored under cover and must be kept away from the areas where animals other than live bivalve molluscs, echinoderms, tunicates or marine gastropods—such as crustaceans—are handled.

Section III— Requirements for purification centres

In addition to the requirements under Sections I and II, the following conditions must be met—

1.  the floors and walls of the purification tanks and any water storage containers must have a smooth, hard and impermeable surface and be easy to clean by scrubbing or use of pressurised water. The base of the purification tanks must be sufficiently sloped and be equipped with drainage sufficient for the volume of work;

2.  live bivalve molluscs must be washed free of mud with pressurised clean seawater or potable water before purification. The initial washing may also be carried out in the purification tanks before purification commences, the drainage pipes being kept open during the entire initial washing and sufficient time being allowed thereafter for the system to be flushed clean before the purification process begins;

3.  the purification tanks must be supplied with a sufficient flow of seawater per hour and per tonne of live bivalve molluscs treated;

4.  clean seawater or seawater cleaned by treatment must be used for purifying live bivalve molluscs; the distance between the seawater intake point and the waste water outlets must be sufficient to avoid contamination; if treatment of the seawater is necessary, the process shall be authorised once its effectiveness has been verified by the Department; water used to prepare seawater from its major constituent chemicals must be potable water;

5.  operation of the purification system must allow live bivalve molluscs to rapidly resume filter feeding activity, remove sewage contamination, not to become recontaminated and be able to remain alive in a suitable condition after purification for wrapping, storage and transport before being placed on the market;

6.  the quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre; the live bivalve molluscs must be continuously purified for a period sufficient to allow the microbiological standards laid down in Chapter V to be met. This period starts from the moment at which the live bivalve molluscs in the purification tanks are adequately covered by the water until the moment when they are removed. The purification centre must take account of the data relating to the raw materials (the type of bivalve molluscs, its area of origin, microbe content, etc.) in case it is necessary to extend the purification period so as to ensure that the live bivalve molluscs meet the bacteriological requirements of Chapter V;

7.  should a purification tank contain several batches of molluscs, they must be of the same species and come from the same production area or different areas conforming to the same health conditions. The length of the treatment must be based on the time required by the batch needing the longest period of purification;

8.  containers used to hold live bivalve molluscs in purification systems must have a construction which allows seawater to flow through; the depth of layers of live bivalve molluscs should not impede the opening of shells during purification;

9.  no crustaceans, fish or other marine species must be kept in a purification tank in which live bivalve molluscs are undergoing purification;

10.  after completion of purification, the shells of live bivalve molluscs must be washed thoroughly by hosing with potable water or clean seawater; this may take place in a purification tank if necessary; the washing water must not be recirculated;

11.  purification centres must have their own laboratories or secure the services of a laboratory equipped with the necessary facilities for checking the efficiency of purification by use of microbiological specifications. Laboratory facilities outside the centres must be acceptable to the district council;

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

• results of microbiological tests on purification system water entering the purification tanks;

• results of microbiological tests on unpurified live bivalve molluscs;

• results of microbiological tests on purified live bivalve molluscs;

• dates and quantities of live bivalve molluscs delivered to the purification centre and corresponding movement document numbers;

• the times of filling and emptying of purification systems (purification times);

• dispatch details of consignments after purification;

these records must be completed and accurate, legible and recorded in a permanent ledger book which must be available for inspection by the district council or a person authorised by the Department;

13.  purification centres must accept only those batches of live bivalve molluscs which are accompanied by a movement document or permanent transport authorisation. Purification centres dispatching batches of live bivalve molluscs to dispatch centres must provide a movement document or permanent transport authorisation;

14.  every package containing purified live bivalve molluscs must be provided with a label certifying that all molluscs have been purified.

Section IV— Requirements for dispatch centres

1.  In addition to the requirements under Sections I and II, the following conditions must be met—

(a) conditioning must not cause any contamination of the product, conditioning facilities must be used in accordance with procedures recognised by the Department with special regard to the bacteriological and chemical quality of seawater used in those facilities;

(b) equipment and containers in the conditioning facilities must not constitute a source of contamination;

(c) procedures for calibration of live shellfish must not result in additional contamination of the product or in any changes affecting the ability of the product to be transported and stored after wrapping;

(d) any washing or cleaning of live shellfish must be carried out using pressurised clean seawater or potable water; cleaning water may not be recycled.

2.  Dispatch centres must accept only those batches of live shellfish which are accompanied by the movement document referred to in paragraph 6 of Chapter II, and coming from an approved production area, relaying area or purification centre.

3.  Dispatch centres must have their own laboratories or secure the services of a laboratory equipped with the necessary facilities for checking inter alia, whether the shellfish comply with the microbiological standards of Chapter V. Laboratory facilities outside the centre must be acceptable to the district council. However, these requirements do not apply to dispatch centres obtaining molluscs exclusively and directly from a purification centre where they have been examined after purification.

4.  Dispatch centres must keep the following data at the disposal of the district council—

• results of microbiological tests on live bivalve molluscs from an approved production area or relaying area;

• dates and quantities of live shellfish delivered to the dispatch centre and corresponding movement document numbers;

• dispatch details.

These data must be classified chronologically and preserved for a period to be laid down by the district council but not less than three months.

5.  Dispatch centres situated aboard vessels shall be subject to the conditions laid down in paragraphs 1(b), (c) and (d) and in paragraphs 3 and 4. The conditions laid down in Sections I and II shall apply mutatis mutandis to such dispatch centres although special conditions may be laid down in accordance with the procedure laid down in article 12 of the Live Bivalve Molluscs Directive.

Chapter V Requirements concerning Live Shellfish

Live shellfish intended for immediate human consumption must comply with the following requirements—

1.  the possession of visual characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion, and normal amounts of intravalvular liquid;

2.  they must contain less than 300 faecal coliforms or less than 230 E. coli per 100 grams of mollusc flesh and intravalvular liquid based on a five-tube, three-dilution MPN-test or any other bacteriological procedure shown to be of equivalent accuracy;

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

4.  they must not contain toxic or objectionable compounds occurring naturally or added to the environment such as those listed in the Annex to Directive 79/923/EEC in such quantities that the calculated dietary intake exceeds the permissible daily intake (PDI) or that the taste of the molluscs may be impaired;

5.  the upper limits as regards the radionuclide contents must not be excessive;

6.  the total Paralytic Shellfish Poison (PSP) content in the edible parts of molluscs that is the whole body or any part edible separately must not exceed 80 micrograms per 100 grams of mollusc flesh in accordance with the biological testing method — in association if necessary with a chemical method for detection of Saxitoxin. If the results of such tests are challenged, the reference method shall be the biological method;

7.  the customary biological testing methods must not give a positive result to the presence of Diarrhetic Shellfish Poison (DSP) in the edible parts of molluscs that is the whole body or any part edible separately;

8.  in the absence of routine virus testing procedures and the establishment of virological standards, health checks must be based on faecal bacteria counts.

Any examination for checking compliance with the requirements of this Chapter must be carried out in accordance with methods which may from time to time be approved for the purpose of these Regulations by the Department.

Chapter VI Public Health Control and Monitoring of Production

1.  The Department shall undertake, or may require district councils to undertake on its behalf, the periodic monitoring of bivalve molluscs relaying and production areas to determine—

(a) whether toxin producing plankton are present in production and relaying waters or biotoxins are present in live bivalve molluscs; and

(b) whether chemical or microbiological contaminants are present.

2.  A district council shall undertake periodic monitoring of live bivalve molluscs relaying and production areas in order to—

(a) preclude any malpractice with regard to the origin and destination of the live bivalve molluscs;

(b) determine the microbiological quality of the live bivalve molluscs in relation to the production and relaying areas.

3.—(1) Sampling plans for the purposes of paragraphs 1 and 2 of this Chapter shall in particular take account of—

(a) likely variations in faecal contamination at each production and relaying area;

(b) possible variations in production and relaying areas in the presence of plankton containing marine biotoxins;

(c) possible contamination of the molluscs in the production and relaying area.

(2) Sampling plans referred to in sub-paragraph (1)(b) shall be carried out as follows—

(a) in relation to monitoring, periodic sampling shall be organised to detect changes in the composition of the plankton containing toxins and the geographical distribution of the plankton;

(b) where periodic sampling leads to a suspicion of accumulation of toxins in mollusc flesh, intensive sampling shall be carried out and molluscs from the relevant area shall not be placed on the market until new sampling has provided satisfactory toxicity test results;

(c) where intensive sampling is to be carried out, it shall consist of—

(i) monitoring plankton in the growing and fishing waters by increasing the number of sampling points and the number of samples, and

(ii) the carrying out of toxicity tests using the molluscs from the affected area which are most susceptible to contamination.

4.—(1) Laboratory tests shall be carried out by or on behalf of the district council to check compliance with the requirements for the end product as laid down in Chapter V.

(2) A control system shall be established by the district council to verify that the level of marine biotoxins does not exceed safety limits.

5.—(1) A district council shall inspect establishments at regular intervals and those inspections shall include, in particular, checks—

(a) to determine whether the approval conditions are still being complied with;

(b) on the cleanliness of the premises, facilities, equipment and on staff hygiene;

(c) to determine whether the live shellfish are handled and treated correctly;

(d) on the correct application and functioning of purification or conditioning systems;

(e) on the ledger books referred to in paragraph 12 of Section III of Chapter IV;

(f) on the correct use of healthmarks.

(2) The checks referred to in sub-paragraph (1) may include the taking of samples for laboratory tests.

(3) The results of such tests must be notified to the persons responsible for the establishments.

6.  A district council shall check on the storage and transport conditions for consignments of live shellfish.

Chapter VII Wrapping

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

(2) The wrapping material or container of such molluscs or shellfish shall—

(a) not impair the organoleptic characteristics of the live shellfish;

(b) not be capable of transmitting substances harmful to human health to the live shellfish;

(c) be strong enough to give adequate protection to the live shellfish.

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

3.  All wrappings of live shellfish must be sealed and remain sealed from the dispatch centre until delivery to the consumer or retailer, but wrappings may be unwrapped and repackaged provided that—

(a) the person who unwraps the product keeps records of the origin of all live shellfish received and of the place of dispatch;

(b) live shellfish from different dispatch centres are not mixed when repackaged; and

(c) a healthmark is provided on the new packaging which is in accordance with Chapter X.

Chapter VIII Preservation and Storage

1.  In any storing rooms, live shellfish must be kept at a temperature which does not adversely affect their quality and viability; the wrapping must not come into contact with the floor of the store room, but must be placed on a clean, raised surface.

2.  Re-immersion in or spraying with water of live shellfish must not take place after they have been wrapped and have left the dispatch centre except in the case of retail sale at the dispatch centre.

Chapter IX Transport from the Dispatch Centre

1.  Except where paragraph 3 of Chapter VII applies, consignments of live shellfish intended for human consumption must be transported wrapped in sealed parcels from the dispatch centre until offered for sale to the consumer or retailer.

2.  The means of transport used for consignments of live shellfish must have the following characteristics—

(a) their interior walls and any other parts which might come into contact with the live shellfish must be made of corrosion-resistant materials, and the walls must be smooth and easy to clean;

(b) they must be suitably equipped to provide efficient protection of the live shellfish against extremes of heat and cold, contamination with dirt or dust, and damage to the shells from vibration and abrasion;

(c) the live shellfish must not be transported with other products which might contaminate them.

3.  Live shellfish must be transported and distributed using closed vehicles or containers which maintain the product at a temperature which does not adversely affect quality and viability.

4.  The parcels containing live shellfish must not be transported in direct contact with the floor of the vehicle or container but must be supported on raised surfaces or by some other means which prevents such contact.

5.  Where ice is used in transporting consignments of live shellfish, it must have been made from potable water or clean seawater.

Chapter X Marking of Consignments

1.  Without prejudice to the requirements of the Food Labelling Regulations (Northern Ireland) 1996(37) and subject to paragraph 4, all parcels in a consignment of live shellfish shall be provided with a healthmark so that the original dispatch centre may be identified at all times during transport and distribution until retail sale, and the healthmark shall be in the following form—

2.—(1) The healthmark may be—

(a) printed on the wrapping material;

(b) affixed as a separate label to the wrapping material;

(c) put inside the wrapping; or

(d) of a twist-tie or staple design.

(2) A self-adhesive healthmark must not be used, unless it is not detachable.

(3) All types of healthmark must be for single use only and are not transferable.

3.  The healthmark must be durable and waterproof, and the information presented must be legible, indelible and in easily decipherable characters.

4.  Where a person repackages any live shellfish in accordance with paragraph 3 of Chapter VII, the healthmark provided on the new wrapping shall be in the form set out in paragraph 1, except that it shall also contain—

(a) if the live shellfish originate—

(i) in the European Economic Area or in a third country in respect of which the European Commission has adopted import conditions for live shellfish, the approval number of the original dispatch centre, or

(ii) in a third country in respect of which the European Commission has not adopted approved import conditions for live shellfish, the original dispatch details; and

(b) if the consignment was unwrapped—

(i) at a registered market, the registration number of the market where the consignment was unwrapped, or

(ii) elsewhere than at a registered market, the full name and address of the person repackaging the consignment.

Regulations 21(4), 24(3) and(4), 26(3), 28(2) and (3), 30, 32(1)(a) and (2)(a), 34 to 36, 48(2), 49(2), 51(2)(b) and 52(3)

SCHEDULE 3 Production and placing on the marketConditions for fishery products

Chapter I Conditions Applicable to Factory Vessels

Section I— Conditions concerning design and equipment

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(e) adequate lighting;

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

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

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

4.  Factory vessels which freeze fishery products must have—

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

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

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

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

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

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

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

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

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

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

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

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

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

as are appropriate in the particular circumstances of the case.

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

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

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

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

Chapter II Requirements During and After Landing

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

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

• unloading and landing operations proceed rapidly;

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

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

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

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

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

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

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

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

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

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

(h) be closable and be kept closed when the district council considers it necessary;

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

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

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

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

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

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

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

Chapter III General Conditions for Establishments on Land

Section I— General conditions relating to premises and equipment

Each establishment shall afford at least the following facilities—

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

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

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

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

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

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

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

(f) adequate natural or artificial lighting;

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

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

3.  in cold rooms where fishery products are stored—

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

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

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

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

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

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

8.  hygienic waste water disposal system;

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

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

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

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

Section II— General conditions of hygiene

A. General conditions of hygiene applicable to premises and equipment

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

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

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

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

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

B. General conditions of hygiene applicable to staff

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

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

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

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

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

Chapter IV Special Conditions for Handling Fishery Products on Shore

Section I— Conditions for fresh products

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

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

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

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

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

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

Section II— Conditions for frozen products

1.  Plants must have—

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

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

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

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

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

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

Section III— Conditions for thawing products

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

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

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

Section IV— Conditions for processed products

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

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

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

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

Canning

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

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

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

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

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

• microbiological examination of contents and containers in the establishment’s laboratory or in such laboratory as the district council considers suitable;

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

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

(f) all containers which have undergone heat treatment under practically identical conditions must be given a batch identification mark, in accordance with the Food (Lot Marking) Regulations (Northern Ireland) 1996(38).

Smoking

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

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

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

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

Salting

6.  As regards salting—

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

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

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

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

Cooked crustacean and molluscan shellfish

7.  Crustacean and molluscan shellfish must be cooked as follows—

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

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

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

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

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

Mechanically recovered fish flesh

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

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

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

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

Section V— Conditions concerning parasites

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

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

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

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

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

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

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

(a) fish to be consumed raw or almost raw, eg raw herring ‘maatje’;

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

• herring;

• mackerel;

• sprat;

• (wild) Atlantic and Pacific salmon;

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

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

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

Chapter V Health Control and Monitoring of Production Conditions

Section I— General monitoring

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

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

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

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

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

(b) whether the fishery products are handled correctly;

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

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

4.  an inspection of the wholesale and auction markets;

5.  a check on storage and transport conditions.

Section II— Special checks

Organoleptic checks

1.—(1) Without prejudice to the derogations provided for by Council Regulation (EEC) No. 103/76(39) laying down common marketing standards for certain fresh or chilled fish, as amended(40), each batch of fishery products must be submitted for inspection by the district council at the time of landing or before first sale to check whether they are fit for human consumption. This inspection comprises an organoleptic check carried out by sampling.

(2) Fishery products complying, as far as the freshness criteria are concerned, with the common marketing standards already laid down pursuant to article 2 of Council Regulation (EEC) No. 3759/92(41) on the common organisation of the market in fishery products, as amended(42), are considered to fulfil the organoleptic requirements necessary for compliance with the provisions of these Regulations.

(3) The organoleptic examinations must be repeated after the first sale of fishery products, if it is found that the requirements of these Regulations have not been complied with or when considered necessary. After the first sale, fishery products must at least comply with the minimum freshness requirements of Regulation (EEC) No. 3687/91(43), as amended.

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

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

Parasite checks

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

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

Chemical checks

3A.  When chemical checks are to be carried out by the district council samples must be taken and subjected to laboratory analysis for the control of the following parameters—

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

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

• 25 milligrams of nitrogen per 100 grams of flesh for the following species:

  • Sebastes spp.;

  • Helicolenus dactylopterus;

  • Sebastichthys capensis;

• 30 milligrams of nitrogen per 100 grams of flesh for the following species

  • all species belonging to the Pleuronectidae family (with the exception of halibut: Hippoglossus spp.);

• 35 milligrams of nitrogen per 100 grams of flesh for the following species

  • Salmo salar;

  • species belonging to the Merlucciidae family;

  • species belonging to the Gadidae family;

(ii) the reference method to be used for checking the TVB-N limit is the method involving distillation of an extract deproteinised by perchloric acid as set out in Annexes II and III of Commission Decision 95/149/EC of 8th March 1995(44) (“the Decision”) read together with article 3 of the Decision;

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

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

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

(c) Histamine, in respect of which—

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

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

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

• no sample may have a value exceeding 200 ppm;

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

Contaminants present in the aquatic environment

3B.—(1) Without prejudice to the Community rules concerning water protection and management, and in particular those concerning pollution of the aquatic environment, fishery products must not contain in their edible parts contaminants present in the aquatic environment such as heavy metals and organochlorinated substances at such a level that the calculated dietary intake exceeds the acceptable daily or weekly intake for humans.

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

Microbiological analyses

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

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

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

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

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

shall be monitored by the district council which approved the establishment or factory vessel in question.

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

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

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

Chapter VI Packaging

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

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

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

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

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

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

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

Chapter VII Identification Marks

Part I Products Prepared on or After 27th July 1998

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

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

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

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

• identification of—

  (i)

  the establishment or factory vessel by its official approval number,

  (ii)

  in the case of marketing from a freezer vessel covered by, as respects Northern Ireland, paragraph 7 of Part II of Schedule 4 or, as respects any other part of the European Economic Area, point 7 of Annex II to the Fishing Vessels Directive, the identification number of the vessel, or

  (iii)

  the registered wholesale or auction market by its registration number,

  from which the products were dispatched;

• one of the following abbreviations—

  • CE—EC—EG—EK—EF—EY.

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

Part II Products Prepared Before 27th July 1998

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

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

• the country of dispatch;

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

Chapter VIII Storage and Transport

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

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

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

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

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

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

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

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

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

Regulations 22(1), (2) and (4), and 36(1)(a)(i)

SCHEDULE 4 Hygiene Conditions for Fishing Vessels

Part I General Hygiene Conditions Applicable to Fishery Products on board Fishing Vessels

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

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

3.  As soon as they are taken on board, the fishery products must be protected from contamination and from the effects of the sun or any other source of heat. When they are washed, the water used must be either fresh water complying with the parameters set out in Tables B and C of Schedule 1 to the Water Quality Regulations (Northern Ireland) 1994(45) or clean seawater, so as not to impair their quality or wholesomeness.

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

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

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

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

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

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

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

Part II Additional Hygiene Conditions Applicable to Article 1.2 Fishing Vessels

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

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

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

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

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

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

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

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

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

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

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

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

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

Regulation 59(1)

SCHEDULE 5 Revocations

Column (1)	Column (2)	Column (3)
Food Safety (Live Bivalve Molluscs) (Derogations) Regulations (Northern Ireland) 1992	S.R. 1992 No. 295	The whole Regulations
Food Safety (Fishery Products) (Derogations) Regulations (Northern Ireland) 1992	S.R. 1992 No. 296	The whole Regulations
Food Safety (Fishery Products) Regulations (Northern Ireland) 1993	S.R. 1993 No. 51	The whole Regulations
Food Safety (Live Bivalve Molluscs and Other Shellfish) Regulations (Northern Ireland) 1993	S.R. 1993 No. 52	The whole Regulations
Food Safety (Fishery Products on Fishing Vessels) Regulations (Northern Ireland) 1993	S.R. 1993 No. 53	The whole Regulations
Food Safety (Live Bivalve Molluscs and Other Shellfish) (Import Conditions and Miscellaneous Amendments) Regulations (Northern Ireland) 1995	S.R. 1995 No. 112	The whole Regulations
Food Safety (Fishery Products) (Import Conditions and Miscellaneous Amendments) Regulations (Northern Ireland) 1995	S.R. 1995 No. 113	The whole Regulations
Food Safety (General Food Hygiene) Regulations (Northern Ireland) 1995	S.R. 1995 No. 360	Paragraphs 2 to 6 of Schedule 2
Food Safety (Fishery Products and Live Bivalve Molluscs and Other Shellfish) (Miscellaneous Amendments) Regulations (Northern Ireland) 1996	S.R. 1996 No. 264	The whole Regulations

(1)

O.J. No. L202, 12.8.93, p. 31; amended by Commission Decision 93/620/EC (O.J. No. L297, 2.12.93, p. 31), Commission Decision 94/188/EC (O.J. No. L89, 6.4.94, p. 21), Commission Decision 94/675/EC (O.J. No. L268, 19.10.94, p. 22, and a corrigendum in O.J. No. L298, 19.11.94, p. 49), Commission Decision 95/164/EC (O.J. No. L108, 13.5.95, p. 174), Commission Decision 96/31/EC (O.J. No. L9, 12.1.96, p. 6), Commission Decision 96/220/EC (O.J. No. L74, 22.3.96, p. 75) and Commission Decision 96/674/EC (O.J. No. L313, 3.12.96, p. 29)

(2)

O.J. No. L202, 12.8.93, p. 42; amended by Commission Decision 93/525/EEC (O.J. No. L252, 9.10.93, p. 30), Commission Decision 94/341/EC (O.J. No. L151, 17.6.94, p. 41), Commission Decision 95/299/EC (O.J. No. L184, 3.8.95, p. 49), Commission Decision 96/31/EC, Commission Decision 96/262/EC (O.J. No. L89, 10.4.96, p. 36) and Commission Decision 97/276/EC (O.J. No. L108, 25.4.97, p. 53)

(3)

O.J. No. L232, 15.9.93, p. 37; amended by Commission Decision 95/151/EC (O.J. No. L100, 3.5.95, p. 22) and Commission Decision 96/31/EC.

(4)

O.J. No. L232, 15.9.93, p. 43; amended by Commission Decision 93/606/EEC (O.J. No. L289, 24.11.93, p. 26), Commission Decision 94/287/EC (O.J. No. L122, 17.5.94, p. 38), Commission Decision 94/674/EC (O.J. No. L267, 18.10.94, p. 15), Commission Decision 94/989/EC (O.J. No. L378, 31.12.94, p. 64), Commission Decision 95/351/EC (O.J. No. L203, 29.8.95, p. 13), Commission Decision 95/549/EC (O.J. No. L310, 22.12.95, p. 74) and Commission Decision 96/31/EC.

(5)

O.J. No. L93, 12.4.94, p. 26; amended by Commission Decision 96/31/EC and Commission Decision 96/193/EC (O.J. No. L61, 12.3.96, p. 43)

(6)

O.J. No. L93, 12.4.94, p. 34; amended by Commission Decision 94/840/EC (O.J. No. L352, 31.12.94, p. 21), Commission Decision 95/177/EC (O.J. No. L117, 24.5.95, p. 42) and Commission Decision 96/31/EC

(7)

O.J. No. L115, 6.5.94, p. 38; amended by Commission Decision 94/469/EC (O.J. No. L194, 29.7.94, p. 85), Commission Decision 95/332/EC (O.J. No. L192, 15.8.95, p. 30) and Commission Decision 96/31/EC

(8)

O.J. No. L145, 10.6.94, p. 19; amended by Commission Decision 96/31/EC

(9)

O.J. No. L145, 10.6.94, p. 23; amended by Commission Decision 95/34/EC (O.J. No. L44, 26.2.95, p. 67) and Commission Decision 96/31/EC

(10)

O.J. No. L145, 10.6.94, p. 30; amended by Commission Decision 94/704/EC (O.J. No. L285, 4.11.94, p. 28), Commission Decision 95/178/EC (O.J. No. L117, 24.5.95, p. 35) and Commission Decision 96/31/EC

(11)

O.J. No. L184, 20.7.94, p. 16; amended by Commission Decision 94/705/EC (O.J. No. L285, 4.11.94, p. 33), Commission Decision 95/179/EC (O.J. No. L117, 24.5.95, p. 40), Commission Decision 95/310/EC (O.J. No. L186, 5.8.95, p. 70), Commission Decision 96/31/EC and Commission Decision 96/254/EC (O.J. No. L86, 4.4.96, p. 75)

(12)

O.J. No. L305, 30.11.94, p. 31; amended by Commission Decision 96/31/EC and Commission Decision 96/255/EC. (O.J. No. L86, 4.4.96, p. 81).

(13)

O.J. No. L312, 6.12.94, p. 40; amended by Commission Decision 96/31/EC

(14)

O.J. No. L42, 24.2.95, p. 32; amended by Commission Decision 95/298/EC (O.J. No. L184, 3.8.95, p. 48) and Commission Decision 96/459/EC (O.J. No. L191, 1.8.96, p. 48)

(15)

O.J. No. L70, 30.3.95, p. 27; amended by Commission Decision 95/235/EC (O.J. No. L156, 7.7.95, p. 82)

(16)

O.J. No. L116, 23.5.95, p. 41; amended by Commission Decision 95/311/EC (O.J. No. L186, 5.8.95, p. 78)

(17)

O.J. No. L123, 3.6.95, p. 20; amended by Commission Decision 96/256/EC (O.J. No. L86, 4.4.96, p. 83)

(18)

O.J. No. L264, 7.11.95, p. 37

(19)

O.J. No. L304, 16.12.95, p. 52

(20)

O.J. No. L137, 8.6.96, p. 24

(21)

O.J. No. L137, 8.6.96, p. 31

(22)

O.J. No. L175, 13.7.96 p. 27

(23)

O.J. No. L269, 22.10.96, p. 18

(24)

O.J. No. L269, 22.10.96, p. 23

(25)

O.J. No. L269, 22.10.96, p. 32

(26)

O.J. No. L269, 22.10.96, p. 37

(27)

O.J. No. L166, 8.7.93, p. 40; amended by Commission Decision 93/530/EEC (O.J. No. L258, 16.10.93, p. 32); Commission Decision 94/767/EC (O.J. No. L305, 30.11.94, p. 36) and Commission Decision 96/31/EC

(28)

O.J. No. L312, 6.12.94, p. 35; amended by Commission Decision 95/275/EC (O.J. No. L167, 18.7.95, p. 26) and Commission Decision 96/31/EC

(29)

O.J. No. L116, 23.5.95, p. 47

(30)

O.J. No. L264, 7.11.95, p. 35

(31)

O.J. No. L313, 3.12.96, p. 38

(32)

O.J. No. L16, 25.1.93, p. 22; amended by Commission Decision 97/275/EC (O.J. No. L108, 25.4.97 p. 52)

(33)

O.J. No. L13, 21.1.93, p. 11

(34)

O.J. No. L56, 9.3.93, p. 42

(35)

O.J. No. L144, 16.6.93, p. 23

(36)

O.J. No. L97, 29.4.95, p. 84

(37)

S.R. 1996 No. 383

(38)

S.R. 1996 No. 384

(39)

O.J. No. L20, 28.1.76, p. 29

(40)

The Regulation was last amended by Council Regulation (EEC) No. 1935/93 (O.J. No. L176, 20.7.93, p. 1)

(41)

O.J. No. L388, 31.12.92, p. 10

(42)

The Regulation was last amended by Council Regulation (EC) No. 3318/94 (O.J. No. L350, 31.12.94, p. 15)

(43)

O.J. No. L354, 23.12.91, p 1

(44)

O.J. No. L97, 29.4.95, p. 84

(45)

S.R. 1994 No. 221