CELEX: 51989PC0648
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 LIVE BIVALVE MOLLUSCS

2. 4. 90                                   Official Journal of the European Communities                                    No C 84/29
                Proposal for a Council Regulation (EEC) laying down the health conditions for the production and the
                                            placing on the market of live bivalve molluscs
                                                          COM(89) 648 final
                                         (Submitted by the Commission on 6 February 1990)
                                                             (90/C 84/03)
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,                               from virus contamination or other hazards to human
                                                                       health;
 Having regard to the Treaty establishing the European
 Economic Community, and in particular Article 43                      Whereas live bivalve molluscs obtained from harvesting
 thereof,                                                               areas which do not permit direct, safe consumption may be
                                                                       rendered safe by submitting them to a purification process or
 Having regard to the proposal from the Commission,                     by re-laying in clean water over a longer period; whereas it is
                                                                       therefore necessary to define harvesting areas from which
 Having regard to the opinion of the European Parliament,              molluscs can be gathered for direct human consumption, or
                                                                        from which they have to be purified or re-layed;
 Having regard to the opinion of the Economic and Social
 Committee,                                                            Whereas it is the responsibility of the producers to ensure that
                                                                       the bivalve molluscs are produced and placed on the market
                                                                       in compliance with the health requirements prescribed;
 Whereas, in order to ensure the smooth operation of the               whereas the competent authorities must by carrying out
 common market and more in particular the common                       checks and inspections ensure that producers comply with
 organization of the market in products of fisheries, it is            those health requirements; whereas the competent
 essential that the placing on the market of live bivalve              authorities must in particular submit harvesting areas to a
 molluscs should no longer be hindered by disparities existing         regular control to ensure that molluscs from these harvesting
 in the Member States in respect of health requirements;               areas do not contain microorganisms and toxic substances in
 whereas this will enable the production and the placing on            quantities which are considered to be dangerous to human
 the market to be better harmonized and bring about                    health;
 competition on equal terms while assuring consumers of a
 quality product;
                                                                       Whereas control measures organized on a Community level
                                                                       must be introduced to guarantee the uniform application in
 Whereas Council Directive 79/923/EEC of 30 October
                                                                       all Member States of the standards laid down in this
 1979 on the quality of shellfish waters (1) lays down that it is
                                                                       Regulation;
 necessary to establish the health requirements to be observed
 for shellfish products;
                                                                       Whereas in the context of trade between the Member States,
Whereas requirements should be laid down for all stages                the rules laid down in Council Directive . . ., concerning
 during harvesting, handling, storage, transport and                   veterinary checks in intra-Community trade, with a view to
 distribution of live bivalve molluscs in order to safeguard the       the realization of the internal market (2) should be
public health of consumers; whereas these requirements shall           applied;
 apply equally to echinoderms and tunicates;
                                                                       Whereas live bivalve molluscs produced in a third country
Whereas it is important, would a health problem occur after            and intended to be placed on the market in the Community
the placing on the market of live bivalve molluscs to be able to       must not qualify for more favourable conditions than those
trace back the establishment of dispatch and the harvesting            applied in the Community; whereas provision must be made
area of origin; whereas it is therefore necessary to introduce a       for a Community procedure for inspecting the conditions in
registration and labeling system which will enable to follow           third countries of the production and the placing on the
the flow of a batch after harvesting;                                  market in order to allow the Community to apply a common
                                                                       import regime based on terms of equivalence;
Whereas it is important that the public health standards for
the final product must be specified; whereas, however,                 Whereas it is possible that, due to some particular situations,
scientific and technological knowledge is not always                   some establishments in function before 1 January 1992 will
advanced enough to lay down definitive solutions for certain           not be able to fulfil all the rules laid down in this Regulation;
health problems and that it is therefore necessary, in order to       whereas it is opportune to settle the matter of granting
guarantee optimal protection of public health, to fix a                limited and temporary derogations for those establishments
Community system to ensure rapid adoption and where                    in the general framework laid down in Council Decision
necessary improvement of the health standards to safeguard             . . . / . . ./EEC (on the granting of temporary limited
(M OJ No L 281, 10. 11. 1979, p. 47.                                   (2) COM(88) 383 final of July 1988.
 ---pagebreak--- No C 84/30                                Official Journal of the European Communities                                      2. 4. 90
derogations from specific Community health rules on the                   molluscs or impair their taste and which is to be used
production and marketing of products of animal                            under the conditions laid down in this Regulation.
origin)! 1 );
                                                                       4. Competent authority: the department designated by the
Whereas it is appropriate to emphasize that any exceptions                Member       State    concerned      to    monitor     the
from the health rules laid down in this Regulation are                    implementation of this Regulation.
without prejudice to the submission of all operations of
                                                                       5. Conditioning: the temporary wet storage of live bivalve
production and placing on the market of live bivalve molluscs
                                                                          molluscs, whose quality does not indicate need for
to the general health rules laid down by Council Regulation
                                                                          re-laying or treatment in a purification plant, in tanks
(EEC) No . . . / . . . (laying down general health rules
                                                                          or any other installation containing clean seawater or in
applicable to the production and placing on the market of
                                                                          natural sites to remove sand, mud or slime and to
products of animal origin and specific health rules applicable
                                                                          improve product palatability.
to certain products of animal origin) (2);
                                                                       6. Gatherer: any physical or legal person or legal entity
Whereas the Commission should be entrusted with the task
                                                                          who collects live bivalve molluscs by any means from a
of adopting certain measures for implementing this                        harvesting area for the purpose of handling and the
Regulation; whereas to that end, procedures should be laid                placing on the market.
down introducing close and effective cooperation between
the Commission and the Member States within the Standing               7. Harvesting area: sea, estuarine or lagoon areas with
Veterinary Committee,                                                     sites of re-laid beds or natural deposits of bivalve
                                                                          molluscs, or those sites used for cultivation of bivalve
                                                                          molluscs from which live bivalve molluscs are taken for
                                                                          their placing on the market.
HAS ADOPTED THIS REGULATION:
                                                                       8. Establishment: any on-shore or off-shore construction
                                                                          or area in which live bivalve molluscs are handled and
                                                                          stored after harvesting and before placing on the
                            CHAPTER I                                     market.
                        General Provisions                             9. Purification: the process of holding contaminated live
                                                                          bivalve molluscs in clean seawater for a time sufficient
                                                                          to permit removal of microbiological contamination
                              Article 1                                   through normal filter-feeding processes so making them
                                                                          suitable for human consumption.
This Regulation lays down the health conditions         for the
                                                                     10. Expedition centre: an establishment for the reception,
production and the placing on the market of live         bivalve
                                                                          conditioning, washing, cleaning, calibration and
molluscs which are destined for immediate                human
                                                                          wrapping of live bivalve molluscs which conform to the
consumption          or   for     further  processing     before
                                                                          requirements of this Regulation.
consumption.
                                                                     11. Purification plant: an establishment where live bivalve
This Regulation applies mutatis            mutandis    also   to           molluscs are kept for purification under suitable
echinoderms and tunicates.                                                 conditions using clean seawater or seawater which is
                                                                          treated to remove contamination so causing the
                                                                           reduction of harmful microorganisms to an acceptable
                              Article 2                                    level.
For the purpose of this Regulation, the following definitions         12. Re-laying: transfer of live bivalve molluscs to suitable
 shall apply:                                                              natural sea or estuarine areas under the supervision of
                                                                           the competent authority in order for purification to
   1. Bivalve molluscs: Lamellibranch molluscs which are                   occur. It does not include the specific operation of
       filter-feeders and may be eaten raw or partially cooked,            transferring bivalve molluscs to more suitable areas for
       and are normally consumed whole including the viscera               further growth or fattening.
       or after removal of selected parts of the viscera.
                                                                      13. Means of transport: those parts set aside for goods in
   2. Marine biotoxins: poisonous substances accumulated
                                                                           automobile vehicles, rail vehicles and aircraft, the holds
       by bivalve molluscs feeding on plankton containing
                                                                           of vessels and containers for transport by land, sea or
       toxin.
                                                                           air.
   3. Clean seawater: seawater or estuary water which is free
       from microbiological contamination and toxic and               14.   Wrapping: an operation whereby live bivalve molluscs
       objectionable substances occurring naturally or after               are protected from shock and desiccation by placing
       discharge in the environment such as those listed in the            them in packaging material adequate for that
       Annex to Directive 79/923/EEC, in such quantities as                purpose.
       may adversely affect the health quality of bivalve
                                                                      15. Consignment: quantity of live bivalve molluscs handled
 (') O J N o L . . .                                                       in an expedition center or treated in a purification plant
 H OJ No L . . .                                                            and subsequently bound for one or more customers.
 ---pagebreak--- 2. 4. 90                                   Official Journal of the European Communities                                 No C 84/31
16. Batch: quantity of live bivalve molluscs collected from a         2.     Live bivalve molluscs intended for further processing
      harvesting area and subsequently destined for delivery          must comply with the relevant requirements of paragraph 1,
      to an approved expedition center, purification plant,           and be processed in conformity with the requirements of
      re-laying area or processing establishment as                   Council Regulation (EEC) No . . . laying down the health
      appropriate.                                                    conditions for the production and the placing on the market
17. Placing on the market: the holding or displaying for              of fishery products (1).
      sale, offering for sale, selling, delivering or any other
      form of placing on the market of live bivalve molluscs
      for human consumption either raw or after processing
                                                                                                  Article 4
      in the Community.
18. Importation: the introduction of live bivalve molluscs            Persons handling live bivalve molluscs during their
      into the territory of the Community from third                  production and placing on the market shall adopt all
      countries.                                                      measures necessary to comply with the requirements of this
19. Faecal coliform: facultative, aerobic, gram-negative,             Regulation.
      non-sporeforming, cytochrome oxidase negative,
      rod-shaped bacteria that are able to ferment lactose            Persons who operate establishments shall in particular ensure
      with gas production in the presence of bile salts, or           that:
      other     surface    active     agents     with    similar
      growth-inhibiting properties, at 44 °C + 0 , 2 ° C              — adequate numbers of samples for laboratory examination
      within 24 hours at least.                                           are taken and analyzed in order to establish an historical
                                                                          record of the sanitary quality of the live bivalve molluscs
20. E. coli: faecal coliforms which also form indole from                 both before and after handling at an expedition centre or
      tryptophan at 44 °C ± 0,2 °C within 24 hours.                       at a purification plant,
                                                                      — a register is kept for the permanent record of the results of
                                                                          the various health checks and kept for presentation to the
                          CHAPTER II                                      competent authority.
            Provisions for Community production
                           Article 3                                                              Article 5
1.     The placing on the market of live bivalve molluscs for
immediate human consumption shall be subject to the                   1. (a) The competent authorities shall draw up a list of
following conditions:                                                          their approved expedition centres and purification
                                                                               plants, each of which shall have an official
(a) they must originate from harvesting areas which comply                     number.
     with the requirements laid down in Chapter I of the
                                                                               The competent authority shall approve such centres
     Annex;
                                                                               or plants only where they can be sure that they meet
(b) they must have been collected and transported from the                     the requirements of this Regulation. Member States
     harvesting area to an expedition centre or purification                   shall withdraw approval if the requirements cease to
     plant under the conditions laid down in Chapter II of the                 be met.
     Annex;
                                                                          (b) The inspection and monitoring of these
(c) where provided for in this Regulation, they must have
                                                                               establishments shall be carried out regularly on the
     been re-layed in suitable sites approved for that purpose
                                                                               responsibility of the competent authority, which
     and complying with the conditions laid down in
                                                                               shall at all times have free access to all parts of the
     Chapter III of the Annex;
                                                                               establishments, in order to ensure compliance with
(d) they must have been handled hygienically, and where                        the requirements of this Regulation.
     appropriate, they must have been purified in
                                                                               If such inspections reveal that not all the
     establishments approved for that purpose and
                                                                               requirements of this Regulation are being met, the
     complying with the requirements of Chapter IV;
                                                                               competent authority shall take the appropriate
(e) they must comply with the criteria set out in Chapter V                    action.
     of the Annex;
(f)  health controls must have been carried out in                    2. (a) The competent authorities shall establish a list of
     accordance with Chapter VI of the Annex;                                  harvesting areas with indication of their location and
                                                                               boundaries from which live bivalve molluscs may be
(g) they must have been appropriately wrapped                 in
                                                                               taken in conformity with this Regulation, and in
     accordance with Chapter VII of the Annex;
                                                                               particular, with Chapter I of the Annex.
(h) they must have been stored and transported under
                                                                               This list must be communicated to those affected by
     satisfactory hygiene conditions in accordance with
                                                                               this Regulation such as harvesters and operators of
     Chapters VIII and IX of the Annex;
                                                                               purification plants and expedition centres.
(i)  they must bear a health mark as provided for in
     Chapter X of the Annex.                                          i1) OJNoL
 ---pagebreak--- No C 84/32                                Official Journal of the European Communities                                        2. 4. 90
    (b) The monitoring of the harvesting areas shall be                                         Article 9
         carried out on the responsibility of the competent
         authority in accordance with the requirements of this       In order to ensure the uniform application of the provision
         Regulation.                                                 laid down in Article 8, the following procedure shall
         If such monitoring reveals that the requirements of         apply:
         this Regulation are not being met, the competent
         authority shall close the harvesting area concerned         1. Inspections shall be carried out on the spot by experts of
         until the situation has been restored.                          the Commission and the Member States to verify
                                                                         whether the conditions of production and placing on the
3. The competent authorities concerned shall take all                    market can be considered as being equivalent to those
    measures necessary to take account of the results referred           applied in the Community.
    to in Article 6 (1).
                                                                         The experts from the Member States who are to be
                                                                         entrusted with these inspections shall be appointed by the
                            Article 6                                    Commission, acting on a proposal from the Member
                                                                         States.
1.     Experts from the Commission may make on-the-spot
checks in so far as is necessary to ensure the uniform                   These inspections shall be made on behalf of the
application of this Regulation. They may check whether                   Community, which shall bear the cost of any expenditure
establishments and harvesting sites are in effect complying              in this connection.
with the requirements of this Regulation. A Member State in
whose territory a check is being carried out shall give all              The frequency and the procedure for these inspections
necessary assistance to the experts in carrying out their                shall be determined in accordance with the procedure
duties. The Commission shall inform the Member States of                 laid down in Article 16.
the results of such checks.
                                                                     2. In deciding whether the conditions of production and
2.     The general provisions for implementing paragraph 1               placing on the market of live bivalve molluscs in a third
shall be determined in accordance with the procedure laid                country can be deemed equivalent to those of the
down in Article 16. If necessary, and in accordance with the             Community, particular account shall be taken of:
same procedure, a code shall be established containing the
rules to be followed for the purpose of the checks provided              (a) the legislation of the third country;
for in paragraph 1.
                                                                         (b) the organization of the competent authority of the
3.     The Commission, in accordance with the procedure                       third country and of its inspection services, the
laid down in Article 16, may draw up recommendations                          powers of such services and the supervision to which
containing guidelines on good manufacturing practices                         they are subject, as well as their facilities for
applicable at the different stages of production and placing                  monitoring      the    implementation        of    their
on the market.                                                                legislation;
                                                                         (c) the actual health conditions during the production
                           Article 7                                          and placing on the market of live bivalve molluscs
                                                                              and in particular the surveillance of harvesting areas
The rules laid down in Directive . . ., (concerning veterinary                in relation to microbiological and environmental
controls in intra-Community trade, with a view to the                         contamination, and to the presence of marine
realization of the internal market) (*), shall apply, in                      biotoxins;
particular with respect to the organization of the checks
carried out by the Member State of destination, and the                  (d) the regularity and the rapidity of the information by
subsequent action and the safeguard measures to be                            the third country on the presence of plankton
applied.                                                                      containing toxin in the harvesting areas;
However, the definitions to be applied are the ones laid down            (e) the assurances a third country can give on the
in this Regulation.                                                           compliance of the molluscs with the standards laid
                                                                              down in Chapter V of the Annex.
                                                                         The Commission, following the procedure laid down in
                          CHAPTER HI                                     Article 14 shall decide on:
                 Imports from third countries                            (a) the third countries fulfilling the conditions of
                                                                              equivalence referred to in paragraph 2;
                            Article 8                                    (b) for each third country, the conditions for the
                                                                              importation of live bivalve molluscs. These
Provisions applied to imports of live bivalve molluscs from                   conditions may include in particular:
third countries shall be equivalent to those governing the
                                                                                (i) the supplying of a health certificate which must
placing on the market of Community products.
                                                                                    accompany consignments when forwarded to
    OJ No L .                                                                       the Community;
 ---pagebreak--- 2. 4. 90                                     Official Journal of the European Communities                                 No C 84/33
          (ii) the definition of the harvesting areas from                                         Article 12
               which live bivalve molluscs may be collected
               and imported;                                            1.     Ha disease capable of being conveyed to humans by
         (iii) the obligation of immediate information to the           live bivalve molluscs and therefore liable to be a serious
               Community on every possible change of the                hazard to public health, breaks out or spreads in a third
               approval of harvesting areas;                            country or if other considerations of public health so
         (iv) possibly the mandatory purification after                 warrant, the Commission acting in accordance with the
               arrival at the territory of the Community.               procedure laid down in Article 15, or a Member State may
                                                                        prohibit or subject to specific conditions the importation of
     (c) a list of establishments from which the importation            those live bivalve molluscs directly or indirectly from the
         of live bivalve molluscs is authorized. For that               whole or part of the territory of the third country.
         purpose, one or more lists of such establishments
         shall be established. An establishment may not                 2.     Measures taken by the Member States under
         appear on a list unless it is officially approved by the       paragraph 1 and withdrawal of such measures, shall be
         competent authority of the third country exporting             notified immediately to the other Member States and the
         to the Community. Such approval shall be subject to            Commission, together with the reasons therefor.
         observance of the following requirements:
         — compliance with requirements equivalent to                   3.     The Commission shall as soon as possible appraise the
              those laid down in this Regulation,                       situation and take the requisite decisions in accordance with
         — supervision by an official inspection service of             the procedure laid down in Article 15.
              the third country.
                                                                        4.     The Commission shall monitor the situation and, in
4. The Decisions referred to in point 3 may be modified or              accordance with the procedure laid down in Article 15, shall
     supplemented in accordance with the procedure laid                 amend or repeal the decisions referred to in paragraphs 1 and
     down in Article 15.                                                3, having regard to such situation.
     These Decisions and the amendments thereto shall be
    published in the Official journal of the European
     Communities, series L.
                            Article 10                                                           CHAPTER IV
Should an inspection as referred to in Article 9(1) bring to                                   Final Provisions
light serious facts which may render the placing on the
market of live bivalve molluscs unsafe for human
consumption, the Commission shall immediately inform the
Member States and forthwith adopt a decision to change the                                         Article 13
import conditions or to suspend the importation from a
particular establishment, harvesting area or from a part or             The Annex to this Regulation shall be amended in
the whole of the third country concerned.                               accordance with the procedure laid down in Article 14.
A final decision shall be taken in accordance with the
procedure provided for in Article 15.
                                                                                                   Article 14
                            Article 11
                                                                        1.     Where the procedure laid down in this Article is to be
                                                                        applied, the matter shall be referred forthwith to the Standing
1.     The rules laid down in Council Regulation (EEC)
                                                                        Veterinary Committee set up by the Council Decision
No . . ., laying down the principles relating to the
                                                                        68/361/EEC (2) (hereinafter called 'the Committee') by its
organization of health controls for products arising from
                                                                        Chairman on his initiative or at the request of a Member
third countries with a view to the completion of the internal
                                                                        State.
market 0) will apply.
2.     The importation of live bivalve molluscs shall be                2.     The representative of the Commission shall submit to
prohibited if the conditions laid down in this Regulation have          the Committee a draft of the measures to be taken. The
not been observed, and in particular when it is ascertained             Committee shall deliver its opinion on the draft within a time
that:                                                                   limit which the Chairman may lay down according to the
                                                                        urgency of the matter. The opinion shall be delivered by the
— the consignment does not comply with the conditions for               majority laid down in Article 148 (2) of the Treaty in the case
    importation laid down for the third country                         of decisions which the Council is required to adopt on a
    concerned,                                                          proposal from the Commission. The votes of the
— the consignment constitutes a hazard to human health.                 representatives of the Member States within the committee
                                                                        shall be weighted in the manner set out in that Article. The
(i) OJ No L . . .                                                       Chairman shall not vote.
 ---pagebreak--- No C 84/34                                    Official Journal of the European Communities                                         2. 4. 90
The Commission shall adopt the measure envisaged if they                   Commission shall, without delay, submit to the Council a
are in accordance with the opinion of the Committee.                       proposal relating to the measures to be taken. The Council
                                                                           shall act by a qualified majority.
If the measures envisaged are not in accordance with the
opinion of the Committee, or if no opinion is delivered, the               If, on the expiry of a period of fifteen working days from the
Commission shall, without delay, submit to the Council a                   date of referral to the Council, the Council has not acted, the
proposal relating to the measures to be taken. The Council                 proposed measures shall be adopted by the Commission.
shall act by a qualified majority.
If, on the expiry of a period of three months from the date of                                           Article 16
referral to the Council, the Council has not acted, the
proposed measures shall be adopted by the Commission.                      Where the procedure laid down in this Article is to be
                                                                           applied, the following rules shall apply.
                                                                           The representative of the Commission shall submit to the
                            Article IS                                     Committee a draft of the measures to be taken. The
                                                                           Committee shall deliver its opinion on the draft within a
 1.    Where the procedure laid down in this Article is to be              time-limit which the Chairman may lay down according to
applied, the Chairman shall refer the matter without delay on              the urgency of the matter, if necessary by taking a vote.
his own initiative or at the request of a Member State to the
Committee.                                                                 The opinion shall be recorded in the minutes; in addition,
                                                                           each Member State shall have the right to ask to have its
                                                                           position recorded in the minutes.
2.     The representative of the Commission shall submit to
the Committee a draft of the measures to be taken. The
                                                                           The Commission shall take the utmost account of the
Committee shall deliver its opinion on the draft within two
                                                                           opinion delivered by the Committee. It shall inform the
days. The opinion shall be delivered by the majority laid
                                                                           Committee of the manner in which its opinion has been taken
down in Article 148 (2) of the Treaty in the case of decisions
                                                                           into account.
which the Council is required to adopt on a proposal from the
Commission. The votes of the representatives of the Member
States within the Committee shall be weighted in the manner
set out in that Article. The Chairman shall not vote.                                                    Article 17
The Commission shall adopt the measures envisaged if they                  This Regulation shall enter into force on 1 January 1993.
are in accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the                   This Regulation shall be binding in its entirety and directly
opinion of the Committee, or if no opinion is delivered, the               applicable in all Member States.
                                                                    ANNEX
                                                                  CHAPTER I
                                                 CONDITIONS FOR HARVESTING AREAS
                  The location and the boundaries of harvesting areas must be fixed by the competent authority in such a way as
                  to identify the areas from which live bivalve molluscs:
                  (a) can be collected for direct human consumption; live bivalve molluscs taken from these areas shall meet the
                       requirements set out in Chapter V;
                  (b) can be collected but only placed on the market after treatment in a purification system, after re-laying or
                       after processing by a heat treatment sufficient to kill microorganisms as described in Chapter HI,
                       Section III, 4 of the Annex to Regulation (EEC) No . . . (') concerning the health conditions governing the
                       production and the placing on the market of fishery products. Live bivalve molluscs from these areas must
                       not exceed the limits of a 5-tube-3-dilution MPN-test of 6 000 faecal coliforms per 100 grams of flesh or
              («) OJNoL...
 ---pagebreak--- 2. 4. 90                               Official Journal of the European Communities                                            No C 84/35
                  4 600 E. Coli per 100 grams of flesh in 95 % of samples. After purification, re-laying or processing, the
                  requirements set out in Chapter V shall be met;
            (c) can be collected but only placed on the market after re-laying over a long period or after re-laying
                  combined with purification to meet the requirements under (a). Processing of these molluscs by a heat
                  treatment sufficient to kill microorganisms as described in Chapter III, Section III, 4 of the Annex to
                  Regulation (EEC) No . . . concerning the health conditions governing the production and the placing on
                  the market of fishery products may be carried our if the limits laid down under (b) are met.
         2. Any change in the delimitation of harvesting areas and the temporary or definite closure thereof shall be
            immediately announced by the competent authorities to those affected by this Regulation and in particular to
            producers and operators of purification plants and expedition centres.
                                                            CHAPTER II
         REQUIREMENTS FOR HARVESTING AND TRANSPORTATION OF BATCHES TO AN EXPEDITION
                                              CENTRE OR PURIFICATION PLANT
         1. Harvesting techniques must not cause excessive damage to the shells or tissues of live bivalve molluscs.
         2. Live bivalve molluscs must be adequately protected from excessive 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 bivalve molluscs must not result in
            additional contamination of the product, nor in a significant reduction of the keeping quality of the product,
            nor in any changes significantly affecting the ability to be treated by purification or processing or
            re-laying.
         4. Live bivalve molluscs must not be reimmersed in water which could have additional contamination between
            harvesting and landing onshore.
         5. Means of transport used for transporting live bivalve molluscs must be used under conditions which protect
            against additional contamination and crushing of shells. They must permit adequate drainage and
            cleaning.
            In the event of bulk transport over long distances of live bivalve molluscs to an expedition centre, purification
            plant or re-laying site, the means of transport must be equiped in such a way as to ensure the best survival
            conditions possible, and in particular they must comply with the requirements laid down in Chapter IX,
            point 2.
         6. A registration document for the identification of batches of live bivalve molluscs during transport from the
            harvesting area to an approved expedition centre, purification plant, re-laying site or processing plant is issued
            by the competent authority upon request of the gatherer. For each batch, the gatherer must complete the
            relevant sections of the registration document legibly and indelibly and which must contain the following
            information:
            — the gatherer's identity and signature,
            — the date of harvesting,
            — the location of the harvesting area in as precise detail as is practicable,
            — the shellfish species and quantity in as precise detail as is practicable,
            — the approval number and place of destination for wrapping, re-laying or purification or processing.
            The registration documents must be permanently and sequentially numbered. The competent authority shall
            keep a register indicating the number of the registration documents together with the names of the persons
            collecting live bivalve molluscs to whom they have been issued. The registration document for each batch of
            live bivalve molluscs must be date-stamped upon delivery of a batch to an expedition centre, purification plant,
            re-laying site or processing plant and must be kept available by operators of these sites or establishments for at
            least 60 days.
            However, if the gathering is carried out by the same person operating the expedition centre, purification plant,
            re-laying site or processing plant of destination, the registration document may be replaced by a permanent
            derogation granted by the competent authority.
         7. In case any harvesting area is closed temporarily, the competent authority shall refrain from issuing
            registration documents for that area and immediately suspend the validity of all registration documents already-
            issued.
 ---pagebreak--- No C 84/36                                Official Journal of the European Communities                                           2. 4. 90
                                                               CHAPTER III
                                   CONDITIONS FOR RE-LAYING LIVE BIVALVE MOLLUSCS
           The following conditions must be met:
           1. live bivalve molluscs must be gathered and transported in accordance with the requirements of
               Chapter II;
           2. techniques for handling live bivalve molluscs destined for re-laying must permit the resumption of filter-feeding
               activity after immersion in natural waters;
           3. live bivalve molluscs must not be re-laid at a density which does not permit purification;
           4. live bivalve molluscs must be immersed in seawater at the re-laying site for an appropriate period which must
               exceed the time taken for levels of faecal bacteria to become reduced to the levels permitted in this Regulation,
               and taking into account that the standards of Chapter V have to be compted with;
           5. the minimum water temperature for effective re-laying must, where necessary, be determined and announced
               by the competent authority for each species of live bivalve molluscs and approved re-lay site;
           6. sites for re-laying live bivalve molluscs must be approved by the competent authority. The boundaries of the
               sites must be clearly identified;
           7. sites within a re-laying area must be well separated to prevent mixing of batches;
           8. permanent records of the source of live bivalve molluscs, re-laying period, re-laying site and subsequent
               destination of the batch after re-laying must be maintained by the operators of re-laying sites for inspection by
               the competent authority;
           9. after harvesting from the re-laying site, the batches must during transport from the re-laying site to the
               approved expedition centre, purification plant or processing plant be accompanied by the registration
               document referred to in Chapter II, point 6, except in the case where the same staff is operating both the
               re-laying site and the expedition centre, purification plant or processing plant.
                                                              CHAPTER IV
                                   CONDITIONS FOR THE APPROVAL OF ESTABLISHMENTS
            I. General conditions relating to premises and equipment
                Establishments must be located in areas which are free from 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.
                Establishments must have at least:
                1. In areas where live bivalve molluscs are handled or stored:
                    (a) buildings or facilities of sound construction and designed and maintained adequately for the purpose
                         of preventing contamination of live bivalve molluscs with 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 adequate 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.
 ---pagebreak--- 2. 4. 90                                  Official Journal of the European Communities                                           No C 84/37
               2. Access to an appropriate number of changing rooms, wash basins and lavatories; there must be a sufficient
                   number of hand wash basins close to the lavatories.
               3. Adequate equipment for washing tools, containers and equipment.
               4. Facilities for the supply and, where appropriate, adequate storage and distribution of exclusively potable
                   water within the meaning of Council Directive 80/778/EEC of 15 July 1980 relating to the quality of
                   water intended for human consumption (') or facilities for the supply of clean sea water.
                   Facilities supplying non-potable water may be authorized. The water concerned may not come into
                   contact with live bivalve molluscs or be used for cleaning or disinfecting containers, plant or equipment
                   which come into contact with the live bivalve molluscs. 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 bivalve
                   molluscs must be made of material which is easy to wash and clean repeatedly and resist corrosion.
           II. General hygiene requirements
               A high degree of cleanliness and hygiene shall be required of staff, premises, equipment and working
               conditions:
               1. Staff who treat or handle live bivalve molluscs must in particular wear clean working clothes and, where
                   appropriate, clean gloves which are suitable for the work in which the person is engaged.
               2. It is forbidden for staff to apply types of personal behaviour, such as spitting, which could result in
                   contamination of live bivalve molluscs; any person suffering from an illness which can be transmitted by
                   live bivalve molluscs must be temporarily prohibited, until recovery, from working with or handling
                   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 production of live bivalve molluscs shall be kept clean and
                   in a good state of repair; equipment and instruments must be thoroughly cleaned at the end of the day's
                   work or at such other times as may be appropriate.
               5. Premises, instruments and equipment must not be used for purposes other than the production of live
                   bivalve molluscs unless authorization by the competent authority.
               6. Waste products must be stored hygienically in a separate area and, where appropriate, in covered
                   receptacles suitable for the purpose intended. Waste material must be removed from the vicinity of the
                   establishment at suitable periods.
               7. The finished products must be stored under cover and must be kept away from the areas where animals
                   other than live bivalve molluscs, such as crustaceans are handled.
         III. Requirements for purification plants
               In addition to the requirements under I and II, the following conditions must be met:
                 1. The floors and walls of the purification system and any water storage containers must have a smooth,
                     hard and impermeable surface and be easy to clean by scrubbing or use of pressurized water. The base of
                     the purification system must be sufficiently sloped and be equipped with drains sufficient for the volume
                     of work.
                2. Live bivalve molluscs must be washed free of mud with pressurized clean seawater or potable water
                     before purification. The initial washing may also be carried out in the purification system 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 system must be supplied with sufficient seawater or flow of seawater per hour and per
                     tonne of live bivalve molluscs treated.
                4. Clean seawater 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; the procedure for sanitizing
                     the seawater shall be authorized once its effectiveness has been verified by the competent authority;
                     potable water used to prepare seawater from its major constituent chemicals shall conform to the
                     meaning of Council Directive 80/778/EEC.
         (') OJ No L 229, 30. 8. 1980, p. 11.
 ---pagebreak--- N o C 84/38                                Official Journal of the European Communities                                             2. 4. 90
                 5. Operation of the purification system must be in accordance with instructions issued by the competent
                    authority to ensure that live bivalve molluscs rapidly resume filter-feeding activity, remove sewage
                    contamination, do not become recontaminated and are able to remain alive in a suitable condition after
                    purification for wrapping, storage and transport before placing on the market.
                 6. The quantity of live bivalve molluscs shall not exceed the capacity of the purification system; 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 system are adequately covered by the water until the moment when water is
                    drained away before removal from the said system. The establishment operator 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. A purification tank shall not contain more than one batch of molluscs during the period of
                    purification.
                 8. Containers used to hold live bivalve molluscs in purification system must have a mesh-type construction
                    which allows seawater to flow through; the depth of layers of live bivalve molluscs should not impair the
                    opening of shells during purification; containers of live bivalve molluscs should be placed at densities
                    recommended by the competent authorities.
                 9. No crustaceans, fish or other marine species must be kept in a purification system in which live bivalve
                    molluscs are undergoing purification.
                10. After completion of purification, the shells of live bivalve molluscs can be washed thoroughly by hosing
                    with potable water or clean seawater, this may take place in the purification system if necessary, the
                    washing water must not be recirculated.
                11. The purification plants must have their own laboratory or secure the services, or access to data of, a
                    laboratory equipped with the necessary facilities for checking the efficiency of purification by use of
                    microbiological specifications. Laboratory facilities must be approved by the competent authority.
                12. Purification plants must regularly keep 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,
                    — date and quantity of live bivalve molluscs delivered to the purification plant and appropriate
                        registration document number,
                    — the times of filling and emptying of purification systems (purification times),
                    — dispatch details of consignments after purification.
                    These records must be complete and accurate, legible and recorded in a permanent ledger book which
                    must be available for inspection by the competent authority.
                13. Purification plants must only accept batches of live molluscs which are accompanied by the registration
                    document referred to in Chapter II;
                    purification establishments dispatching batches of live bivalve molluscs to expedition centres must
                    provide for the registration document referred to in Chapter II, point 6.
                14. Every package containing purified live bivalve molluscs must be provided with a label certifying that all
                    molluscs have been purified.
            IV. Requirements for expedition centres
                1. In addition to meeting the requirements under I and II, the following conditions must be met:
                   (a) conditioning must not cause any deleterious microbiological contamination of the product;
                   (b) instructions for the use of conditioning facilities shall be issued by the competent authority and will
                        have special regard to the bacteriological and chemical quality of the seawater used in the
                        facilities;
                   (c) equipment and containers in the conditioning facilities do not constitute a source of
                       contamination;
 ---pagebreak--- 2. 4. 90                                Official Journal of the European Communities                                            No C 84/39
                  (d) procedures for calibration of live shellfish must not result in additional contamination of the product
                       or in any changes afecting the ability of the product to be transported and stored after
                       wrapping;
                  (e) any washing or cleaning of live bivalve molluscs must be carried out using pressurized clean seawater
                       or potable water — cleaning water may not be recycled.
               2. Expedition centres must only accept batches of live shellfish which are accompanied by the registration of
                  documents referred to in Chapter II, point 6 and coming from an approved harvesting area, re-laying site
                  or purification plant.
               3. The expedition centres must have their own laboratory or secure the services of a laboratory equipped
                  with the necessary facilities for checking if the molluscs comply with the microbiological standards of
                  Chapter V. Laboratory facilities must be approved by the competent authority.
                  However, this requirement is invalid if the expedition centres get their molluscs from a purification plant
                  where they have been examined after purification.
                                                             CHAPTER V
                                REQUIREMENTS CONCERNING LIVE BIVALVE MOLLUSCS
         Live bivalve molluscs destined for immediate human consumption shall 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 shall contain less than 300 faecal coliforms or less than 230 E. Coli per 100 grams of mollusc flesh and
             intravalvular liquid based on a 5-tube, 3 dilution MPN-test or any other bacteriological procedure shown to be
             equivalent in degree of precision.
         3. Absence of salmonella in 25 grams mollusc flesh.
         4. Live bivalve molluscs are not contaminated with 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 acceptable daily intake (ADI), or that the taste of the molluscs is
             impaired.
         5. The upper limits as regards the radionuclide contents shall not exceed the limits for foodstuffs as laid down by
             the Community.
         6. The total Paralytic Shellfish Poison (PSP) content shall not exceed 80 micrograms per 100 grams of mollusc
             flesh.
         7. The Diarrhetic Shellfish Poison (DSP) content of the flesh shall not exceed levels which may be considered
             dangerous to human health.
         8. In the absence of routine virus testing procedures and establishment of virological standards sanitary
             evaluation must use counts of faecal bacteria.
             Examinations for checking the compliance with the requirements of this Chapter must be carried out in
             accordance with proven methods which are scientifically recognized.
             Where necessary for the uniform application of this Regulation, sampling plans as well as the methods and
             analytical tolerances to be applied in order to check compliance with the requirements of this Chapter shall be
             established in accordance with the procedure laid down in Article 14.
             The effectiveness of the faecal indicator bacteria and their numerical limits as well as the other parameters laid
             down in this Chapter shall constantly be kept under review and, where scientific evidence proves the need to do
             so, be revised following the procedure laid down in Article 15.
             When there is scientific evidence indicating the need to introduce other parameters to safeguard public health
             such as the possible contamination with Neurotoxin-Shellfish Poison (NSP), this shal be done applying the
             same procedure.
 ---pagebreak--- ^oC^^O                                 COtnci^l]ourn^otrric^nro^^nCornrnuninc^                                                ^^ ^0
                                                          Ct^A^T8^Vl
                           ^U8L^^^ALT^^O^T^^LA^O^U^^V^^
       Apublic health control system shall be established by the competent authorities in order to verify whether the
       requirements laid down in this regulation are complied with. This control system shall included
       L   periodic supervision oflive bivalve molluscs relaying and harvesting areas in order.
           ^a^ to avoid any abuse of the origin and destination of the live bivalve molluscs^
           d^    to check the microbiological quality ofthe live bivalve molluscs in relation to the area ofharvestmg as laid
                 down in Chapters
           ^    to check the possible presence of to^mDproducing plankton
           f^or that purposed sampling plans shall be established by the competent authorities for checking at regular
           intervals or onacaseby^case basis in the situation of irregular periods of harvesting.
           sampling plans must in particular take account of^
           ^    likely variations in faecal contamination at each harvesting area^
           ^     possible variations of the presenceofplanktoncontaimngmarmebioto^ins^ the sampling must be
                 designed as follows^
                  ^ ^ ^ ^ B ^ ^ ^ . penodicsamplingorgam^edtodetectchangesin thecomposition of theplankton
                      containing toxins and the geographical distribution thereof. Information leading toasuspicion of
                      accummulation of toxins in muscle flesh must be followed by
                      — control of the plankton in the growing and fishing waters by increasing the number of sampling
                          points and the number of samples^ and
                      — tonicity tests on molluscs from the affected ^one and most susceptible to the contamination.
                      This intensive sampling plan must be continued until the results of tonicity tests permit again the
                     placing on the market of the molluscs^
           ^    possible contamination of the molluscs in the harvesting area.If the result ofasampling plan shows that
                the placing on themarketoflivebivalvemolluscs may constituteaha^ard to humanhealth^thecompetent
                authority shall close the harvesting area until the situation has been restored.
       2. Laboratory tests inorder to check the respectof the requirementsfor the e n d p r o d u c t a s l a i d d o w n i n
           ChapterVofthisAnne^.
           There shall in particular be establishedacontrol system to verify that the level of marine bioto^ms do not
           exceed the safe levels required by this regulation.
       3. An inspection at regular intervals of establishments. These inspections shall include in particular checks^
           ^     to verify whether the approval conditions are still being complied with^
           ^    on the cleanliness of the premises^ facilities^ equipment and of staff hygienes
           ^    to verify whether the live bivalve molluscs are handled and treated correctly^
           ^    on the correct application and functioning of purification or conditioning systems^
           ^     of the record books referred to in Chapter i V u n d e r t t p f ^
           ^    the correct use of health marks.
           Thesechecksmaymcludethetakingofsamples for laboratorytests^theresultsofthesetestsshall be notified to
           the persons responsible for the establishments.
       ^. Checks on the storage and transport conditions of the consignments of live bivalve molluscs.
 ---pagebreak--- 2. 4. 90                               Official Journal of the European Communities                                          No C 84/41
                                                          CHAPTER VII
                                                           WRAPPING
         1. Live bivalve molluscs shall be wrapped under satisfactory hygiene conditions.
            The wrapping material or container must:
            — not impair the organoleptic characteristics of the live bivalve molluscs,
            — must not be capable of transmitting substances which are harmful to human health to the live bivalve
                molluscs,
            — be strong enough to give adequate protection to the live bivalve molluscs.
         2. Oysters must be wrapped with the concave shell downwards.
         3. All wrappings of live bivalve molluscs must be sealed and remain sealed from the expedition centre until
            delivery to the consumer or retailer.
                                                         CHAPTER VIII
                                               PRESERVATION AND STORAGE
         1. In any storing rooms, live bivalve molluscs 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. Reimmersion of live bivalve molluscs in seawater must not take place after being wrapped and having left the
            expedition centre except in the case of retail sale at the expedition centre.
                                                          CHAPTER IX
                                      TRANSPORT FROM THE EXPEDITION CENTRE
         1. Consignments of live bivalve molluscs destined for human consumption must be transported wrapped as a
            sealed parcel from the expedition centre up to the time of being offered for immediate sale to the consumer or
            retailer.
         2. The means of transport used for consignments of live bivalve molluscs must have the following
            characteristics:
            (a) their interior walls and any other parts which might come into contact with the live bivalve molluscs must
                 be made of corrosion-resistant materials; the walls must be smooth and easy to clean;
            (b) they must be suitably equipped to provide efficient protection of the live bivalve molluscs against extremes
                 of hot and cold, contamination with dirt or dust, and damage to the shells from vibration and
                 abrasion;
            (c) the live bivalve molluscs must not be transported with other products which might contaminate
                 them.
         3. Consignments of live bivalve molluscs must be transported and distributed using closed vehicles or containers
            which maintain the product at a temperature which does not adversely affect their quality and viability.
            The parcels containing live bivalve molluscs 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
            contact.
            Where ice is used in transporting consignments of live bivalve molluscs, it must have been made from potable
            water or clean seawater.
 ---pagebreak--- No C 84/42                                    Official Journal of the European Communities                                               2 . 4 . 90
                                                                 CHAPTER X
                                                      MARKING OF CONSIGNMENTS
              1. All parcels in a consignment of live bivalve molluscs must be provided with a health mark so enabling at all
                  times during transport and distribution until retail, the identification of their original expedition centre.
                  Without prejudice to Council Directive 79/112/EEC on the approximation of laws of the Member States
                  relating to the labelling, presentation and advertising of foodstuffs^), as last amended by Directive
                   89/395/EEC ( 2 ), the mark must contain the following information:
                  — the country of dispatch,
                  — species of bivalve mollusc (common name and scientific name),
                  — the identification of the expedition centre by the approval number granted by the competent
                      authority,
                  — the date of wrapping.
              2. The health mark may be printed on the wrapping material or be put on a separate tag which is then fixed on the
                  wrapping material or put inside the wrapping. They may also be of a twist-tie or staple design; self-adhesive
                  health marks must not be used. All types of health marks must be designed for single use and be not
                  transferable.
              3. The health mark must be durable and waterproof and the information presented as legible, indelible and in
                  easily decipherable characters.
              4. The health mark attached to consignments of live bivalve molluscs which are not wrapped as consumer size
                  parcels must be kept for at least 60 days by the retailer after splitting up the content of the consignment.
              H OJ No L 3 3 , 8. 2. 1979, p. 1.
              (2) OJ No L 186, 30. 6. 1989, p. 17.
              Proposal for a Council Regulation (EEC) concerning the animal health conditions governing the
                                     placing on the market of aquaculture animals and products
                                                             COM(89)   655     final
                                          (Submitted    by the Commission     on 9 February      1990)
                                                                (90/C 84/04)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                                  Whereas the breeding and rearing of aquaculture animals,
                                                                           and the placing on the market of aquaculture animals and
Having regard to the Treaty establishing the European                     products constitutes a source of income for persons working
Economic C o m m u n i t y , and in particular Article 43                 in the fisheries sector;
thereof,
                                                                          Whereas, in order to ensure the rational development of this
                                                                           sector and to increase productivity, health rules for this
Having regard to the proposal from the Commission,                         sector must be laid d o w n at C o m m u n i t y level;
Having regard to the opinion of the European Parliament,                  Whereas in this context it is necessary to contribute to the
                                                                          completion of the internal m a r k e t , avoiding the spread of
                                                                           contagious diseases;
Having regard to the opinion of the Economic and Social
Committee,                                                                Whereas the animal health situation for aquaculture animals
                                                                           is not the same t h r o u g h o u t the territory of the C o m m u n i t y ,
Whereas aquaculture animals and products are included in                   whereas reference must therefore be m a d e to zones when
the list in Annex II to the Treaty;                                       dealing with parts of the C o m m u n i t y ;