CELEX: 51989PC0645
Language: en
Date: 1990-01-31
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) LAYING DOWN THE HEALTH CONDITIONS FOR THE PRODUCTION AND THE PLACING ON THE MARKET OF FISHERY PRODUCTS

No C 84/58                               Official Journal of the European Communities                                    2. 4. 90
              Proposal for a Council Regulation (EEC) laying down the health conditions for the production and the
                                            placing on the market of fishery products
                                                       COM(89) 645 final
                                     (Submitted by the Commission on 12 February 1990)
                                                          (90/C 84/05)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                            Whereas it is appropriate to apply by analogy certain
                                                                    marketing standards which are laid down pursuant to
                                                                    Article 2 of Regulation (EEC) No 3796/81, in order to fix
Having regard to the Treaty establishing the European               the health quality of these products;
Economic Community, and in particular Article 43
thereof,
                                                                    Whereas it is the responsibility primarily of the fisheries
                                                                    industry to ensure that fishery products meet the health
Having regard to the proposal from the Commission,                  requirements laid down in this Regulation;
Having regard to the opinion of the European Parliament,            Whereas the competent authorities of the Member States
                                                                    must by carrying out checks and inspections ensure that
                                                                    producers and manufacturers comply with the health
Having regard to the opinion of the Economic and Social             requirements;
Committee,
                                                                    Whereas Community control measures should be introduced
Whereas, in order to ensure the smooth operation of the             to guarantee the uniform application in all Member States of
common market and more especially of the common                     the standards laid down in this Regulation;
organization of the market in fishery products established by
Council Regulation (EEC) No 3796/81 (*), as last amended
                                                                    Whereas, in order to ensure a smooth functioning of the
by Regulation (EEC) No 1495/89 ( 2 ), it is essential that the
                                                                    internal market, the measures should apply in an identical
marketing of fish and fish products should not be hindered by
                                                                    manner to trade within the Member States and to trade
disparities existing in the Member States in respect of health
                                                                    between the Member States;
requirements; whereas this will enable marketing to be better
harmonized and bring about competition on equal terms;
                                                                    Whereas in the context of intra-Community trade, the rules
                                                                    laid down in Council Directive No . . ., concerning
Whereas the European Parliament in its resolution . . . of 17       veterinary controls in intra-Community trade ( 4 ), with a
March 1989 (3) requested the Commission to come forward             view to the completion of the internal market should apply to
with comprehensive proposals on the hygienic production             fishery products;
and placing on the market of fishery products, including
solutions for the problem of nematodes;
                                                                    Whereas fishery products from third countries intended to be
                                                                    placed on the market of the Community must not qualify for
Whereas fishery products freshly caught are in principle free       more favourable arrangements than those applied in the
of contamination with microorganisms, whereas however               Community; whereas provision should therefore be made for
contamination and subsequent decomposition may occur                a Community procedure for the inspection in third countries
when handled and treated improperly;                                of the conditions of production and placing on the market in
                                                                    order to decide on imports in terms of equivalence;
Whereas fishery products may pose particular health threats
such as the presence of nematodes, the presence of naturally        Whereas the essential requirements laid down in this
occuring toxins, or the presence of histamine due to                Regulation may need further specification; whereas this can
decomposition;                                                      be achieved by the establishment of rules of good
                                                                    manufacturing practice in the form of a recommendation;
Whereas therefore the essential requirements should be laid
down for the correct hygienic handling of fresh and processed       Whereas it is possible that, because of particular
fishery products at all stages of production and during             circumstances, some establishments already operating before
storage and transport;                                              1992 will be unable to comply with all of the measures laid
                                                                    down in this Regulation; whereas it is therefore necessary to
                                                                    settle the question of granting limited or temporary
(') OJ No L 379, 31. 12. 1981, p. 1.
(2) OJ NoL 148, 1. 6. 1989, p. 1.
(3) OJ No L 96, 17. 4. 1989, p. 199.                                («) OJ No L . . .
 ---pagebreak--- 2. 4. 90                                   Official Journal of the European Communities                                 No C 84/59
derogations in the general context of Council Decision                     date are not included if they are merely kept alive
. . . / . . ./EEC of . . . on the conditions for granting                  without any attempt being made to increase their size or
temporary, limited derogations from specific Community                     weight;
health rules on the production and marketing of products of
animal origin ( J );                                                    3.  'fresh products': fishery products whether whole or
                                                                           prepared, including products packaged under vacuum
Whereas it is necessary to stress that excluding certain                   or in a controlled atmosphere, which have not been
activities from the scope of this Regulation or the possible               submitted to any treatment to ensure preservation other
grant of derogations from the rules laid down in this                      than chilling;
Regulation is without prejudice to the requirement that all
production and placing on the market of products of animal
origin conform to the general health rules laid down by                 4.  'prepared products': fishery products having undergone
Council Regulation (EEC) No . . . / . . . of . . . laying down             an operation affecting their physical wholeness such as
general health rules applicable to the production and placing              gutting, heading, slicing, filleting, chopping etc.;
on the market of products of animal origin and specific health
rules applicable to certain products of animal origin (2);              5. 'processed products': fishery products which have been
                                                                           submitted to a chemical or physical process such as the
Whereas the Commission should be entrusted with the task                   heating, smoking, salting, dehydration or marinating
of adopting certain measures for implementing this                         etc. of fresh products, whether or not associated with
Regulation; whereas, to that end, procedures should be laid                other foodstuffs, or to a combination of these various
down introducing close and effective cooperation between                   processes;
the Commission and the Member States within the Standing
Veterinary Committee,                                                   6.  frozen products': means fishery products which have
                                                                           been submitted to a freezing process to reach a core
                                                                           temperature of -18 °C or lower;
HAS ADOPTED THIS REGULATION:
                                                                        7.  'quick-frozen products': fishery products complying
                                                                           with the requirements laid down in Council Directive
                                                                           89/108/EEC on the approximation of the laws of the
                                                                           Member States relating to quick-frozen foodstuffs for
                                                                           human consumption (3);
                            CHAPTER I
                        General provisions                              8. 'packaging': the procedure of protecting fishery
                                                                           products by a wrapper, a container or any suitable
                                                                           device;
                             Article 1
                                                                        9. 'consignment': the quantity of fishery products bound
This Regulation lays down the health conditions for the                    for one or more customers in the country of
production and the placing on the market of fishery products               destination;
for human consumption.
                                                                      10.   'means of transport': those parts set aside for goods in
                                                                           automobile vehicles, rail vehicles and aircraft, the holds
                                                                           of vessels, and containers for transport by land, sea or
                             Article 2
                                                                           air;
For the purposes of this Regulation, the following definitions
shall apply:                                                          11.   'batch': a quantity of fishery products obtained under
                                                                           the same conditions and during the same working
  1. 'fishery products': all seawater or freshwater animals or             period;
         parts thereof, including their roes, excluding aquatic
         mammals, frogs and aquatic animals covered by other          12.   'competent authority': the department designated by
         Community acts;                                                   the Member State concerned to monitor the
                                                                           implementation of this Regulation;
2 . 'aquaculture products': all fishery products born and
         raised under controlled circumstances until placed on        13.   'establishment': the premises authorized for the
         the market as a foodstuff, and also fresh or seawater             handling and packing of fresh or processed products;
         fish or crustaceans captured in their natural
         environment when juvenile and kept until they reach
         the desired commercial size for human consumption.           14. 'placing on the market': the holding or displaying for
         Fish and crustaceans of commercial size caught in their           sale, offering for sale, selling, delivering or any other
         natural surroundings and kept alive to be sold at a later         form of placing on the market in the Community,
                                                                           excluding retail sale;
0) OJ No L . . .
(*) OJ No L . . .                                                     (3) OJ No L 40, 11. 2. 1989, p. 34.
 ---pagebreak--- No C 84/60                               Official Journal of the European Communities                                    2. 4. 90
15.   'importation': the introduction into the territory of the     3. a) The placing on the market of live bivalve molluscs
      Community of fishery products from third countries;                    shall be subject to the requirements laid down in
                                                                             Council Regulation (EEC) No . . . concerning the
16. 'clean seawater': sea or estuary water which is free from                health conditions governing the production and the
      the microbiological contamination and objectionable                    placing on the market of live bivalve molluscs (*).
      substances in such quantities as may adversely affect the
      health quality of fishery products and which is used              b) When processed, bivalve molluscs must in addition
      under the conditions laid down in this Regulation.                     satisfy the requirements laid down under 1 (c)
                                                                             to (g).
                                                                                                Article 4
                         CHAPTER II
                                                                    Fishery products to be placed on the market alive shall at all
            Provisions for Community production                     times be kept under the most suitable survival conditions.
                           Article 3                                                            Article S
1.     The placing on the market of fishery products caught         The placing on the market of the following products shall be
wild shall be subject to the following conditions:                  forbidden:
(a) They shall have been caught and handled on board                1. Poisonous fish of the following families: Tetra-
     vessels in accordance with the conditions laid down                odontidae, Molidae, Diodontidae, Canthigasteridae.
     pursuant to Article 2 of Regulation (EEC) No
     3796/81.                                                       2. Fish containing biotoxines such as ciguatera toxins.
     Factory vessels, preparing and processing or freezing
     fishery products on board, shall comply with                   Detailed provisions concerning the species covered by this
     requirements to be established in accordance with the          Article and concerning methods of analysis will be laid down
     procedure laid down in Article 17;                             in accordance with the procedure prescribed in Article 17.
(b) During and after landing they shall be handled in
     accordance with the requirements laid down in
     Chapter I of the Annex;                                                                    Article 6
(c) They shall, where necessary, have been packed,                  Persons responsible for the protection and the placing on the
     prepared, processed, frozen, defrosted or stored               market of fishery products shall adopt all measures necessary
     hygienically in establishments approved in accordance          to comply with the requirements of this Regulation. They
     with Article 7(1), having regard to the requirements           shall accordingly institute checks to ensure:
     laid down in Chapters II and III of the Annex;
                                                                    — the cleanliness of vessels and establishments,
(d) They shall have undergone a health check in accordance
     with the requirements laid down in Chapter IV of the           — the correct handling of products at all stages during
     Annex;                                                             production,
(e) They shall have been appropriately packaged in                  — preparation, processing, storage and transport,
     accordance with Chapter V of the Annex;
                                                                    and, where       necessary,   take   samples for   laboratory
(f)  They shall have been labelled in accordance with               analysis.
     Chapter VI of the Annex;
(g) They shall have been stored and transported under
     satisfactory conditions of hygiene, in accordance with                                     Article 7
     Chaper VII of the Annex;
                                                                    1.    The competent authorities shall draw up a list of their
2.     The placing on the market of aquaculture products            approved establishments, each of which shall have an official
shall be subject to the following conditions:                       number.
(a) They shall have been slaughtered under hygienic
     conditions. They shall not be soiled with earth, slime or      The competent authorities shall approve establishments only
     faeces. If not processed immediately after having been         where they can be sure that they meet the requirements of this
     slaughtered, they shall be kept refrigerated;                  Regulation. Member States shall withdraw approval if the
                                                                    requirements cease to be met.
(b) They shall further comply with the requirements laid
     down under 1 (b) to (g).                                       (>) OJ No L . . .
 ---pagebreak--- 2. 4. 90                                   Official Journal of the European Communities                                  No C 84/61
If a check has been made in accordance with Article 8, the             Direct landings of fishery products in the territory of the
competent authorities concerned shall take account of the              Community by third country vessels shall be subject to the
conclusion resulting therefrom. The other Member States                requirements laid down for landings by Community
and the Commission shall be informed in the event of                   vessels.
approval being withdrawn.
2.     The inspection and monitoring of establishments shall
be carried out regularly on the responsibility of the                                             Article 11
competent authority, which shall at all times have free access
to all parts of establishments, in order to ensure compliance
                                                                       1.     The Commission, in accordance with the procedure
 with the requirements of this Regulation.
                                                                      laid down in Article 17, shall for each third country lay down
                                                                      the conditions for the importation of fishery products. These
If such inspections reveal that not all the requirements of this
                                                                       conditions may include in particular:
Regulation are being met, the competent authority shall take
the appropriate action.                                                (a) the frequency and the nature of the physical checks to be
                                                                           carried out in conformity with Council Regulation
3.     Paragraphs 1 and 2 shall also apply in respect of
                                                                            (EEC) No . . . laying down the principles relating to the
factory vessels.
                                                                           organization of health controls for products arising
                                                                            from third countries with a view to the completion of the
                                                                           internal market ( J ); this frequency shall be fixed in the
                           Article 8                                       light of the guarantees a third country can offer in
                                                                           relation with the checks carried at the place of origin;
1.     Experts from the Commission may make on-the-spot
                                                                           these physical checks must ensure that imported fishery
checks, in so far as this is necessary to ensure the uniform
                                                                           products are fit for human consumption, do not
application of this Regulation. They may in particular verify
                                                                           represent a hazard to human health and comply with the
whether establishments are in effect complying with the
                                                                           requirements of this Regulation, in particular those laid
requirements of this Regulation.
                                                                           down in point IV of Chapter III and point II of
                                                                           Chapter IV of the Annex;
A Member State in whose territory a check is being carried
out shall give all necessary assistance to the experts in
                                                                      (b) the production of a health certificate which must
carrying out their duties. The Commission shall inform the
                                                                            accompany consignments when forwarded to the
Member States of the results of the investigations.
                                                                            Community;
2.     The general provisions for implementing paragraph 1
                                                                      (c) the placing of a mark identifying the fishery products, in
shall be determined in accordance with the procedure laid
                                                                           particular with the approval number of the
down in Article 19. If necessary, and in accordance with the
                                                                           establishment of expedition;
same procedure, a code shall be established containing the
rules to be followed for the purpose of the checks provided           (d) drawing up a list of establishments and factory vessels
for in paragraph 1.                                                        from which the importation of fishery products is
                                                                           authorized;
                           Article 9
                                                                      2.     The conditions referred to in paragraph 1 (a), (b) and
The rules laid down in Directive . . ., (concerning veterinary        (c) may be amended in accordance with the procedure laid
checks in intra-Community trade, with a view to the                   down in Article 18.
completion of the internal market), shall apply, in particular
with respect to the organization of the checks carried out by         The conditions referred to in paragraph 1 (d) may be
the Member State of destination and subsequent action, and            amended by the Commission, which shall inform the
the safeguard clause shall be applied.                                Member States thereof.
However, the definitions given in this Regulation shall               3.     In order to allow decisions on the import conditions to
apply.                                                                be taken, and in order to be informed about the conditions of
                                                                      production, storage and expedition of fishery products for
                                                                      consignment to the Community, inspections may be carried
                                                                      out on the spot by experts from the Commission and the
                                                                      Member States.
                         CHAPTER HI
                 Imports from third countries                         The experts of the Member States who are to be entrusted
                                                                      with these inspections shall be appointed by the Commission
                                                                      acting on a proposal from the Member States.
                          Article 10
                                                                      These inspections shall be made on behalf of the Community,
Provisions applied to imports of fishery products from third          which shall bear any expenditure incurred.
countries shall be equivalent to those governing the placing
on the market of Community products.                                  (>) OJ No L . . .
 ---pagebreak--- No C 84/62                                Official Journal of the European Communities                                       2. 4. 90
The frequency and the procedure for these inspections shall                                   CHAPTER IV
be determined in accordance with the procedure laid down in
Article 19. The decisions taken to that effect, and in                                      Final provisions
particular those concerning visits to establishments must, for
each third country, be based on the health situation
found.
                                                                                                Article 15
                                                                     The Annex to this Regulation shall be amended in
                           Article 12                                accordance with the procedure laid down in Article 17, in
                                                                     particular with a view to adapting; to take account of
                                                                     scientific and technological progress.
Should an inspection referred to in Article 11 (3) bring to
light serious facts which may render the placing on the
market of fishery products for human consumption unsafe,
the Commission shall immediately inform the Member States                                       Article 16
and forthwith adopt a decision to change the import
conditions or to suspend the importation from a particular           The Commission, in accordance with the procedure laid
establishment or from a part or the whole of the third country       down in Article 19 may draw up recommendations
concerned.                                                           containing guidelines on good manufacturing practice at the
                                                                     different stages of production and placing on the market.
A decision shall be taken according to the procedure
provided for in Article 18.
                                                                                                Article 1 7
                                                                     1.     Where the procedure laid down in this Article is to be
                           Article 13                                applied, the matter shall be referred forthwith to the Standing
                                                                     Veterinary Committee set up by the Council Decision
The importation of fishery products is not allowed if the            68/361 /EEC (a) (hereinafter called 'the Committee') by its
conditions laid down in this Regulation have not been                Chairman on his initiative or at the request of a Member
observed, and in particular when it is ascertained that:             State.
— the consignment does not comply with the conditions for            2.     The representative of the Commission shall submit to
    importation laid down for the third country                      the Committee a draft of the measure to be taken. The
    concerned;                                                       Committee shall deliver its opinion on the draft within a time
                                                                     limit to be determined by the Chairman in relation to the
— the consignment constitutes a hazard to human health.              urgency of the matter to be considered. The opinion shall be
                                                                     delivered by the majority laid down in Article 148 (2) of the
                                                                     Treaty in the case of decisions which the Council is required
                                                                     to adopt on a proposal from the Commission. The votes of
                           Article 14
                                                                     the representatives of the Member States within the
                                                                     Committee shall be weighted in the manner set out in that
1.     If a disease capable of being conveyed to humans by           Article. The Chairman shall not vote.
fishery products and therefore liable to be a serious hazard to
public health, breaks out or spreads in a third country or if        The Commission shall adopt the measures envisaged if they
other considerations of public health so warrant, the                are in accordance with the opinion of the Committee.
Commission acting in accordance with the procedure laid
down in Article 18 or a Member State, may prohibit or                If the measures envisaged are not in accordance with the
subject to specific conditions the importation of those fishery      opinion of the Committee, or if no opinion is delivered, the
products directly or indirectly from the whole or part of the        Commission shall, without delay, submit to the Council a
territory of the third country.                                      proposal relating to the measures to be taken.
2.     Measures taken by the Member States under                     The Council shall act by a qualified majority.
paragraph 1 and withdrawal of such measures, shall be
notified immediately to the other Member States and the              If, within three months from the date on which the proposal
Commission, together with the reasons therefor.                      was put to it, the Council has not acted, the proposed
                                                                     measures shall be adopted by the Commission.
3.     The Commission shall as soon as possible appraise the
situation and take the requisite decisions in accordance with
the procedure laid down in Article 18.                                                          Article 18
4.     The Commission shall monitor the situation and, in            1.     Where the procedure laid down in this Article is to be
accordance with the procedure laid down in Article 18, shall         applied, the Chairman shall refer the matter without delay on
amend or revoke the decisions referred to in paragraphs 1
and 3, having regard to such situation.                              (') OJNoL . . .
 ---pagebreak--- 2. 4. 90                                      Official Journal of the European Communities                                      No C 84/63
his own initiative or at the request of a Member State to the                                        Article 19
Committee.
                                                                          Where the procedure laid down in this Article is to be
                                                                          applied, the following rules shall apply.
2.     The representative of the Commission shall submit to
the Committee a draft of the measures to be taken. The
                                                                          The representative of the Commission shall submit to the
Committee shall deliver its opinion on the draft within two
                                                                          Committee a draft of the measures to be taken. The
days. The opinion shall be delivered by the majority laid
                                                                          Committee shall deliver its opinion on the draft within a
down in Article 148 (2) of the Treaty in the case of decisions
                                                                          time-limit which the Chairman may lay down according to
which the Council is required to adopt on a proposal from the
                                                                          the urgency of the matter, if necessary by taking a vote.
Commission. The votes of the representatives of the Member
States within the Committee shall be weighted in the manner
                                                                          The opinion shall be recorded in the minutes; in addition,
set out in that Article. The Chairman shall not vote.
                                                                          each Member State shall have the right to ask to have its
                                                                          position recorded in the minutes.
The Commission shall adopt the measures envisaged if they
are in accordance with the opinion of the Committee.                      The Commission shall take the utmost account of the
                                                                          opinion delivered by the Committee. It shall inform the
                                                                          Committee of the manner in which its opinion has been taken
If the measures are not in accordance with the opinion of the             into account.
Committee, or if no opinion is delivered, the Commission
shall, without delay, submit to the Council a proposal
relating to the measures to be taken.
                                                                                                     Article 20
The Council shall act by a qualified majority.                            This Regulation shall enter into force on 1 January 1993.
If, on expiry of a period of fifteen working days from the date
of referral to the Council, the Council has not acted, the                This Regulation shall be binding in its entirety and directly
proposed measures shall be adopted by the Commission.                     applicable in all the Member States.
                                                                    ANNEX
                                                                 CHAPTER I
                                            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.
               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 the protected environment of transport, storage
                       or market facilities, or in an establishment,
                   — equipment and practices that cause unnecessary damage to the edible parts of the fishery products are not
                       used.
               3. Markets where fishery products are displayed for sale or stored must:
                   (a) 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 the water;
                   (c) be equipped with sanitary facilities with an appropriate number of wash basins and flush lavoratories.
                        Wash basins shall be supplied with materials for cleaning the hands and disposable hand towels;
 ---pagebreak--- No C 84/64                                  Official Journal of the European Communities                                           2. 4. 90
                (d) be well lit to facilitate the inspection of fishery products;
                (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 may not be admitted to
                     markets; undesirable animals must not be admitted;
                (f)  be cleaned regularly and at least after each sale; crates must, after each sale, be cleaned and rinsed inside
                     and outside with drinking water or clean seawater; where required, they must be disinfected;
                (g) have displayed in a prominent position signs prohibiting smoking and spitting.
           4. After landing or, where appropriate, after first sale, fishery products must be transported without delay, under
                appropriate conditions, to their place of destination.
                                                                CHAPTER II
                                   GENERAL CONDITIONS FOR ESTABLISHMENTS ON SHORE
            I. General conditions relating to premises and equipment
                Establishments shall afford at least the following facilities:
                  1. Working areas of adequate size for work to be carried out under hygienic conditions. Their design and
                     layout shall be such as to preclude contamination of the product.
                  2. In areas where products are handled, prepared and processed:
                     (a) waterproof flooring which is easy to clean and disinfect and laid down in such a way as to facilitate
                          the drainage of the water or provided with equipment to remove water;
                     (b) walls which are easy to clean, durable and impermeable;
                     (c) ceilings or roof linings which are easy to clean;
                     (d) doors in durable materials;
                     (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; taps must not be hand operated;
                          these facilities must be provided with hand towels which can be used once only;
                     (h) facilities for cleaning plant, equipment and utensils.
                  3. In cold rooms where fishery products are stored:
                     — the provisions set out under point 2 (a), (b), (c) and (d),
                     — where necessary, a sufficiently powerful refrigeration plant to keep products at temperatures
                         prescribed in this Regulation.
                  4. Appropriate facilities for protection against pests such as insects, rodents, 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, or premises for such products, if the quantities thereof so require.
                  7. Facilities to provide adequate supplies of drinking water within the meaning of Directive 80/778/EEC
                     relating to the quality of water intended for human consumption ( 1 ), or alternatively of clean seawater or
                     seawater treated by an appropriate system, under pressure and in sufficient quantity. However, by way of
                     exception, a supply of non-drinking water is permissible for the production of steam, fire-fighting and the
                     cooling of refrigeration equipment, provided that the pipes installed for the purpose preclude the use of
                     such water for other purposes and present no risk of contamination of the products. Non-drinking water
                     pipes must be clearly distinguished from those used for drinking water or clean seawater.
                  8. A hygienic waste water disposal system.
           (') OJ No L 229, 30. 8. 1980, p. 11.
 ---pagebreak---                                   Official Journal of the European Communities                                            No C 84/65
       9. An adequate number of changing-rooms with smooth, water-proof, washable walls and floors, 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 towels which can be used once only; the wash basin taps must
            not be hand-operable.
     10. 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 officially
            authorized facilities.
     11. Establishments keeping live animals such as lobsters or eels 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.
II. General hygiene conditions
A. General conditions of hygiene applicable to premises and equipment
     1. Floors, walls and partitions, ceilings or 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 any other vermin must be systematically exterminated; rodenticides, insecticides,
         disinfectants and any other potentially toxic substances must be stored in premises or cupboards which can
         be locked. Their use must not present any risk of contamination of the products.
    3. Working areas, instruments and working equipment must be used only for work on fishery products.
         However, following authorization by the competent authority they may be used at any time for work on
         other foodstuffs.
    4. Drinking water or clean seawater must be used for all purposes; however, by way of an exception,
         non-drinking water may be used for steam production, fire-fighting and the cooling of refrigeration
         equipment, provided that the pipes installed for the purpose preclude the use of such water for other
         purposes and present no risk of contamination of the products.
    5. Detergents, disinfectants and similar substances must be 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 the staff. More specifically:
         (a) staff must wear suitable clean working clothes and headgear. This applies particularly to persons
               handling exposed fishery products;
         (b) staff assigned to the handling and preparation of the fishery products must be required to wash their
               hands at least each time work is resumed;
         (c) smoking, spitting, eating and drinking in work and storage premises 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.
                                                     CHAPTER HI
                 SPECIAL CONDITIONS FOR HANDLING FISHERY PRODUCTS ON SHORE
  I. Conditions for fresh products
      1. Where fresh products are not dispatched, prepared or processed within a reasonable time after landing,
           they must be stored under ice in the establishment's cold room. Re-icing must be carried out as often as is
           necessary; ice used for re-icing must be made from drinking water or clean seawater and be stored under
           hygienic conditions in receptacles provided for the purpose; such receptacles must be kept clean and in a
           good state of repair. Prepacked fresh products must be chilled with ice or mechanical refrigeration plant
           creating similar temperature conditions.
      2. Heading and gutting operations must be carried out hygienically; the products must be washed thoroughly
           with drinking water or clean seawater immediately after such operations;
 ---pagebreak--- No C 84/66                                 Official Journal of the European Communities                                             2. 4. 90
                 3. Operations such as filleting and slicing must be carried out in such a way as to avoid the contamination or
                    spoilage of fillets and slices, especially during heading and gutting operations. Fillets^and slices to be sold
                    fresh must be chilled as quickly as possible after preparation;
                 4. 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.
                 5. 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. These must be removed at least at the end of each working day to a premises
                    or an area designated for the purpose. Containers must always be thoroughly cleaned and disinfected after
                    use.
             II. Conditions for frozen and quick frozen products
                 1. Plants must have:
                    (a) freezing equipment sufficiently powerful to achieve a rapid reduction in the temperature so as to allow
                          that the temperatures referred to in this Regulation are obtained in the products;
                    (b) freezing equipment sufficiently powerful to keep products in storage rooms at a temperature not
                          exceeding those laid down in this Regulation, whatever the ambient temperature may be.
                    However, for tunny fish frozen in brine and intended for canning, higher temperatures than the ones laid
                    down in this Regulation are acceptable for technical reasons related to the method of freezing and to the
                    handling oi such products.
                 2. Fresh products to be frozen or quick-frozen must comply with the requirements of section I of this
                    Chapter.
                 3. Storage rooms must have a temperature recording device in a place where it can easily be read. The
                    temperature sensor of the recorder must be located in the area furthest away from the cold source, i.e.
                    where the temperature in the storage room is the highest.
                    Temperature charts must be available for inspection by the supervisory authorities at least during the
                    period for which the products are stored.
                 4. Fishery products must be thawed under hygienic conditions: their contamination must be avoided and
                    there must be adequate drainage for any drip produced.
                    During thawing, the temperature of the products must not increase excessively.
                    After thawing, fishery products must be handled in accordance with the requirement of this Regulation.
                    When they are prepared or processed, these must be carried out without delay.
           III. Conditions for processed products
                 1. Fresh or frozen products used for processing must comply with the requirements of sections I or II of this
                    Chapter.
                 2. Where the processing treatment is carried out for the destruction of pathogenic microorganisms, or if it is a
                    significant factor in the preservation of the product, the treatment process must be monitored and
                    controlled and be subject to approval by the competent authority. In particular heating time and
                    temperature, salt content, pH, water content, etc. must be monitored and controlled. Records must be
                    kept at least for the expected storage life of the products and be available to the competent
                    authority.
                 3. For products which are preserved for a limited period by a treatment such as salting, smoking, drying or
                    marinading, the appropriate conditions for storage must be clearly marked on the packaging, in
                    conformity with Council Directive 79/112/EEC on the approximation of the laws of the Member States
                    relating to the labelling, presentation and advertising of foodstuffs, as last amended by Directive
                    89/395/EEC( 1 )-
                    In addition, the following conditions must be complied with:
           (') OJ No L 180, 30. 6. 1989, p. 17.
 ---pagebreak--- ^ ^ 0                             C^t^c^]o^rnaio^rri^^^ror^c^nCornrnnn^n^                                           ^oC^B^
      ^t  C^m^
         In the case of fishery products which have been subjected to stabilizing heat treatment in hermetically
         sealed containers
         m^ the process used for the heat treatment must be appropriate, having regard to such ma^or criteria as
              the heating time,temperature,filling,size of contamersetc,arecordofwhichmust be kept,the heat
              treatment must be capable of destroying all pathogenic and spoilage organisms and the spores of
              pathogenicmicroorgamsms Theheatmg equipment must be fitted with devicesfor monitoring
              whether the containers have in fact undergone appropriate heat treatment,
         ^b^ further checks must be carnedout at random by the manufacturer to ensure that the processed
               products have undergone appropriate heat treatment viz
               — incubation tests for that purpose, establishmentsmusthave facilities fortheincubationof
                  samples of canned fishery products a t r B ^ e for seven days or at e^^^e for ten days^
               — microbiological examination of contents and containers in the estabhshment^slaboratory or in
                  anotherapprovedlaboratorv,
         ^0 samples must be taken of production each day at predetermined intervals, to ensure the efficacy of
              sealing, for that purpose, appropriate equipment must be available for the examination of
              crosssectionsofthecanseams,
         ^    checks are carried out in order to ensure that containers are not damaged,
         ^    all containers which have undergone heat treatment in a single batch must be given a batch
              identification mark
         m^ sawdust used in the smoking of fish must be stored away from the area used for smoking andmust be
              used in s u c h a w a y so as to preclude contamination of the products
         d^   The use of sawdust made from wood treated with preservatives is prohibited
         ^    ^fter smoking, products must be cooled rapidly prior to packaging
         m^ ^alt used in the treatment of fishery products must be cleaned and stored in suchaway as to preclude
              contamination
         ^    ^ny contamerusedforsaltingmustbeconstructedin suchaway as to precludecontammation during
              the salting process
         ^    eontamersorareas used for salting must be cleaned betore use
         shellfish and molluscs must be cooked as follows
         ea^ any cookmgmust be followed by rapid cooling, waterusedforthispurposemustbedrmkingwater or
              clean seawater,
         ^b^ shelling or shuckingmustbecarned out underhygienicconditionsavoidmgthe contamination of the
              product ^ h e r e such operations are done by hand,workers must pay particular attentionto the
              washing of their hands and all working surfaces must be cleaned thoroughly tfmachmes are used,
              they must be cleaned at frequent intervals
              ^fter shelling or shucking,precooked shellfish must immediately be frozenorkept chilled a t a
              temperature which will preclude the growth of pathogens, and be stored in appropriate
              premises
      ^    ^vf^^^^^yr^o^r^^^^^
         The mechanical recovery of fish flesh must be carried out under the following conditions
         m^ Mechanical recovery of gutted fish must take place immediately after filleting ^ h e r e whole fish are
              used, they must be gutted and washed beforehand
         ^    The machinery must be cleaned at frequent intervals and at least every two hours
         ^    Mechanically recovered flesh must be frozen immediately after recovery or incorporated in suitably
              stabilized or frozen products
 ---pagebreak--- No C 84/68                                 Official Journal of the European Communities                                          2. 4. 90
           IV. Conditions concerning nematodes
                1. Before distribution, the fish and fishery products listed under 2 and to be consumed as such, must be
                    subject to:
                    (a) a visual inspection carried out during their processing in accordance with a sampling scheme to be
                         established in accordance with the procedure laid down in Article 17, for the purpose of detecting
                         nematodes and removing any that are visible;
                    (b) freezing of either the finished or raw product at a temperature of not more than -20 °C in all parts of
                         the product for not less than 24 hours.
                2. List of fish and fishery products covered by paragraph 1.
                    (a) fish to be consumed raw or almost raw e.g. raw herring;
                    (b) the following products if they are to be subjected to a cold smoking process at which the internal
                         temperature of the fish is less than 60 °C:
                         — herring,
                         — mackerel,
                         — sprat,
                         — Atlantic and Pacific (wild) salmon.
                    (c) Marinated or salted herring where this process is insufficient to destroy the larvae of nematodes.
                    This list may be amended in accordance with the procedure laid down in Article 17. In accordance with the
                    same procedure, criteria will be laid down which must ensure adequate definition of the processes which
                    are insufficient to destroy nematodes.
                3. Manufacturers must ensure that fish and fishery products listed under 2 or the raw materials for use in their
                    manufacture are subjected to the treatment described in 1 (b) prior to their release for consumption.
                4. The fishery products listed under 2 must, when they are placed on the market, be accompanied by a
                    document certifying that they have been properly treated.
                                                              CHAPTER IV
                                    HEALTH CONTROL AND SUPERVISION OF PRODUCTION
            I. General supervision
               Arrangements for supervision must be made by the competent authorities, in order to establish whether the
               requirements laid down in this Regulation are complied with. Such arrangements will include:
               1. a check on the vessels;
               2. a check on the conditions of landing and first sale;
               3. an inspection at regular intervals of establishments to check:
                   (a) whether the conditions for approval 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 labels are put on correctly.
               4. checks on storage and transport conditions.
           II. Special checks
               1. Sensory checks
                   Fishery products must be subjected to an inspection by the competent authority at the time of landing or
                   before first sale to check whether they are fit for human consumption. This inspection comprises a sensory
                   check.
 ---pagebreak--- 2. 4. 90                                  Official Journal of the European Communities                                            No C 84/69
                 Fishery products complying as far as the freshness criteria are concerned with the common marketing
                 standards already laid down in accordance with Article 2 of Council Regulation (EEC) No 3796/81 are
                 considered to fulfil the sensory requirements necessary for the respect of this Regulation.
                 The Commission may, by the procedure referred to in Article 19, in cases where it is necessary, lay down
                 specific sensory requirements for fishery products not harmonized under Council Regulation (EEC) No
                 3796/81.
                 The sensory check is repeated after first sale of fishery products, if it is found that the requirements of this
                 Regulation have not been complied with or when considered necessary. After first sale, fishery products
                 must at least comply with the minimum freshness requirements of forementioned Regulation. If the sensory
                 examination reveals that the fishery products are not fit for human consumption, they must be withdrawn
                 from the market and denaturated in such a way that they cannot be used for human consumption.
             2. Chemical checks
                 A. If the sensory examination reveals any doubt as to the freshness of the fishery products, samples shall be
                     taken and subjected to laboratory analysis for the control of the following parameters:
                     (a) TVB-N (total volatile basic nitrogen) and TMA-N (trimethylamine-nitrogen)
                           Controls for the determination of the levels of these parameters are carried out in order to obtain
                           guidance: increased levels must not automatically induce withdrawal of the fishery products, but
                           must lead to an enquiry in order to detect the reason for the increased values.
                     b) Histamine
                          Nine samples shall be taken from each batch. These must fulfil the following requirements:
                          — the mean value must not exceed 100 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.
                          These limits may only apply to fish species of the following families:
                          Scombridae and Clupeidae. Examinations must be carried out in accordance with proven
                          scientifically recognized methods, such as high performance liquid chromatography (HPLC).
                 B. Contaminants from the aquatic environment
                     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 from the aquatic environment such as heavy metals and
                     organochlorinated substances at such a level that the calculated dietary intake exceeds the acceptable
                     daily intake (ADI).
                    A monitoring system must be established by the Member States for checking the level of contamination
                     of fishery products with contaminants.
                    The Commission, following the procedure laid down in Article 17,
                    (a) shall modify or complete the requirements laid down for the chemical analysis with a view to adapt
                          them to technological and scientific progress;
                    (b) shall lay down the methods of analysis to be used for checking the chemical parameters, as well as
                           the sampling plans;
                    (c) shall lay down the acceptable levels for the chemical parameters.
             3. Microbiological analyses
                In accordance with the procedure laid down in Article 17, microbiological criteria, including sampling
                plans and methods of analysis, can be laid down when there is a need to protect public health.
                                                            CHAPTER V
                                                   WRAPPING AND PACKAGING
         1. Packaging must be carried out under satisfactory conditions of hygiene, to preclude contamination of the
            fishery products.
         2. Packaging materials 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,
 ---pagebreak--- No C 84/70                                   Official Journal of the European Communities                                       2. 4. 90
                — 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 special containers made of impervious, smooth and corrosion resistant material
                easy to clean and disinfect, which may be re-used after cleaning and disinfecting, packaging materials may not
                be re-used. Packaging used for fresh fishery products held under ice must provide adequate drainage for melt
                water.
           4. Unused packaging materials must be stored in an area away from the production area and be protected from
                dust and contamination.
                                                              CHAPTER VI
                                                               LABELLING
           Without prejudice to the requirements laid down in Council Directive 79/112/EEC ( ! ), on the approximation of
           the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs as last amended
           by Directive 89/395/EEC ( 2 ), it must be possible to trace back for inspection purposes the establishment of
           dispatch of consignments of fishery products, by means of either labelling or the accompanying documents. For
           that purpose, the following information must appear on the packaging or in the accompanying documents:
           — the country of dispatch,
           — particulars of the establishment of dispatch, including its official approval number.
                                                              CHAPTER VII
                                                       STORAGE AND TRANSPORT
           1. Fishery products must at all times during storage and transport be kept at the temperatures laid down in this
                Regulation and in particular:
                — fresh fishery products must be kept at the temperature of melting ice,
                — frozen fishery products must be kept at a temperature below -18 °C,
                — processed products must be kept at the temperatures specified by the manufacturer.
           2. No other products which may contaminate or affect the hygiene of fishery products may be stored with them,
                unless the fishery products are packaged.
           3. Vehicules used for the transport of fishery products must be constructed and equipped in such a way that the
                temperatures laid down in this Regulation can be maintained throughout the period of transport. If ice is used
                to chill the 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.
           4. Means of transport used for fishery products may not be used for transporting other products likely to impair
                or contaminate fishery products, either simultaneously or at different times.
           5. Fishery products may not be transported in a vehicle or container which is not clean and where necessary, has
                not been disinfected.
           6. The transport conditions of fishery products to be placed on the market alive must not adversely affect the
               products.
           (') OJ No L 3 3 , 8. 2. 1979, p. 1.
           (2) OJ No L 186, 30. 6. 1989, p. 17.