CELEX: 51990PC0648
Language: en
Date: 1990-12-18
Title: PROPOSAL FOR A COUNCIL DECISION AMENDING DECISION 89/657/EEC ESTABLISHING AN ACTION PROGRAMME TO PROMOTE INNOVATION IN THE FIELD OF VOCATIONAL TRAINING RESULTING FROM TECHNOLOGICAL CHANGE IN THE COMMUNITY ( EUROTECNET ) AND DECISION 90/267/EEC ESTABLISHING AN ACTION PROGRAMME FOR THE DEVELOPMENT OF CONTINUING VOCATIONAL TRAINING IN THE EUROPEAN COMMUNITY ( FORCE ) IN ORDER TO ESTABLISH THE ADVISORY COMMITTEE FOR CONTINUING EDUCATION AND TRAINING EMBRACING FORCE AND EUROTECNET

COMMISSION OF THE EUROPEAN COMMUNITIES
                                      C0MC89) 648 final
                                      Brussels, 31 January 1990
                          Proposal for a
                    COUNCIL REGULATION (EEC)
    laying down the health conditions for the production and
       the placing on the market of live bivalve molluscs
                  (presented by the Commission)
 ---pagebreak---                                                                C0M(89)648 final
                                       - 2 -
                              EXPLANATORY MEMORANDUM
 With the adoption of the Single European Act, the Community has embarked upon
 a programme to eliminate all controls at frontiers.  The programme to achieve
 this undertaking in set out in the Commissions White Paper of June 1985, and
 includes the elimination of barriors to trade related to health problems in
 the fisherios sector.
This proposal aims in particular to lay down the health conditions for the
 production and the placing on the market of live bivalve molluscs (mussels,
oysters, carpet shells otc.) which, because of their particular way of
 production and consumption, need special attention.
It defines therefore the obligations to be respected by both professionals and
the competent authorities, and lays down the measures to be taken to ensure
that the final product is safe for human consumption.   This implies a
surveillance of the harvesting areas, the obligation to submit the molluscs to
a purification process, relaying or processing in certain circumstances, a
contrôle of the final product etc.
Provision is made for Community checks in the Member States so as to ensure
the uniform application of the said requirements.   This must also allow to
reinforce the confidence of the Member States in each others inspection
systems which is necessary to ensure a proper functioning of an internal
market without frontiers.
The proposal covers the placing on the market in the whole of the Community
and lays down a procedure to ensure that products originating from third
countries are produced and placed on the market under conditions which are
equivalent to those applied in the Community.
For certain applicatory decisions to be taken, the Commission opted for the
Regulatory Committee procedure.   This choice, which is justified in this case
by a desire not to disrupt the management process in the health sector, is
without prejudice to the Commission's preference for the Advisory Committee
procedure.
 ---pagebreak---                                           3 -
                                   PROPOSAL FOR A
                                COUNCIL REGULATION
               laying down the health conditions for the production
              and the placing on the market of live bivalve molluscs
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and
 in particular Article 43 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas, in order to ensure the smooth operation of the Common market and more
in particular the common organization of the market in products of fisheries,
it is essential that the placing on the market of live bivalve molluscs should
no longer be hindered by disparities existing in the Member States in respect
of health requirements; whereas this will enable the production and the
placing on the market to be better harmonized and bring about competition on
equal terms while assuring consumers of a quality product;
Whereas Council Directive 79/923/EEC of 30 October 1979 on the quality of
shellfish waters(1) lays down that it is necessary to establish the health
requirements to be observed for shellfish products;
Whereas requirements should be laid down for all stages during harvesting,
handling, storage, transport and distribution of live bivalve molluscs in
order to safeguard the public health of consumers; whereas these requirements
shall apply equally to echinoderms and tunicates;
(1) OJ No L 281, 10.11.1979, p. 47
 ---pagebreak---                                        - 4 -
Whereas it is important, would a health problem occur after the placing on the
market of live bivalve molluscs to be able to trace back the establishment of
 dispatch and the harvesting area of origin; whereas it is therefore necessary
 to introduce a registration and labeling system which will enable to follow
 the flow of a batch after harvesting;
Whereas it is important that the public health standards for the final product
must be specified; whereas, however, scientific and technological knowledge is
not always advanced enough to lay down definitive solutions for certain health
problems and that it is therefore necessary, in order to guarantee optimal
protection of public health, to fix a Community system to ensure rapid
adoption and where necessary improvement of the health standards to safeguard
from virus contamination or other hazards to human health;
Whereas live bivalve molluscs obtained from harvesting areas which do not
permit direct, safe consumption may be rendered safe by submitting them to a
purification process or by relaying in clean water over a longer period;
whereas it is therefore necessary to define harvesting areas from which
molluscs can be gathered for direct human consumption, or from which they have
to be purified or relayed;
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 the competent authorities must by carrying
out checks and inspections ensure that producers comply with those health
requirements; whereas the competent authorities must in particular submit
harvesting areas to a regular control to ensure that molluscs from these
harvesting areas do not contain microorganisms and toxic substances in
quantities which are considered to be dangerous to human health;
Whereas control measures organised on a Community level must be introduced to
guarantee the uniform application in all Member States of the standards laid
down in this Regulation;
 ---pagebreak---                                         - 5
Whereas in the context of trade between the Member States, the rules laid down
 in Council Directive               , concerning veterinary checks in
 intra-Community trade, with a view to the realisation of the internal market
 (1) should be applied;
Whereas live bivalve molluscs produced in a third country and intended to be
 placed on the market in the Community must not qualify for more favourable
conditions than those applied in Lhe Community; whereas provision munt. bo mado
 for a Community procedure for Inspecting Lhe conditions in third countries of
 the production and the placing on the market in order to allow the Community
to apply a common import regime based on terms of equivalence;
Whereas it is possible that, due to some particular situations, some establish
ments in function before 1 January 1992 will not be able to fulfil all the
rules laid down in this Regulation; whereas it is opportune to settle the
matter of granting limited and temporary derogations for those establishments
in the general framework laid down in Council Decision .../.../EEC [on the
granting of temporary limited derogations from specific Community health rules
on the production and marketing of products of animal origin] (2);
Whereas it is appropriate to emphasize that any exceptions from the health
rules laid down in this Regulation are without prejudice to the submission of
all operations of production and placing on the market of live bivalve
molluscs to the general hoalth rulos laid down by Council Regulation (EEC)
No .../... [laying down general health rules applicable to the production and
placing on the market of products of animal origin and specific health rules
applicable to certain products of animal origin] (3);
Whereas the Commission should be entrusted with the task of adopting certain
measures for implementing this Regulation; whereas to that end, procedures
should be laid down introducing close and effective cooperation between the
Commission and the Member States within the Standing Veterinary Committee;
HAS ADOPTED THIS REGULATION :
(1) COM(88)383 Final of July 1988
(2) OJ No L
(3) OJ No L
 ---pagebreak---                            CHAPTER I : GENERAL PROVISIONS
                                     Article 1
 This Regulation lays down the health conditions for the production and the
 placing on the market of live bivalve molluscs which are destined for
 immediate human consumption or for further processing before consumption.
 This Regulation applies mutatis mutandis also to echinoderms and tunlcates.
                                    . Article 2
For the purpose of this Regulation, the following definitions shall apply :
1) Bivalve molluscs : Lamellibranch molluscs which are filter-feeders and may
    be eaten raw or partially cooked, and are normally consumed whole including
    the viscera or after removal of selected parts of the viscera.
2) Marine biotoxins : poisonous substances accumulated by bivalve molluscs
    feeding on plankton containing toxin.
3) Clean seawater : seawater or estuary water which is free from
    microbiological contamination and toxic and objectionable substances
    occuring naturally or after discharge in the environment such as those
    listed in the Annex to Directive 79/923/EEC, in such quantities as may
    adversely affect the health quality of bivalve molluscs or to impair their
    taste and which is to be used under the conditions laid down in this
    Regulation.
4) Competent authority : the department designated by the Member State
    concerned to monitor the implementation of this Regulation.
5) Conditioning : the temporary wet storage of live bivalve molluscs, whose
    quality does not indicate need for relaying or treatment in a purification
    plant, in tanks or any other installation containing clean seawater or in
    natural sites to remove sand, mud or slime and to improve product
    palatability.
6) Gatherer : any physical or legal person or legal entity who collects live
    bivalve molluscs by any means from a harvesting area for the purpose of
   handling and the placing on the market.
 ---pagebreak---                                        - 7-
 7)  Harvesting area : sea, estuarine or lagoon areas with sites of relaid 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.
8)   Establishment : any on shore or off shore construction or area in which
     live bivalve molluscs are handlod and stored after harvesting and before
     placing on the market.
9)   Purification : the process of holding contaminated live bivalve molluscs
     in clean seawater for a time sufficient to permit removal of
    microbiological contamination through normal filter-feeding processes so
    making them suitable for human consumption.
10) Expedition center : an establishment for the reception, conditioning,
    washing, cleaning, calibration and wrapping of live bivalve molluscs which
    conform to the requirements of this Regulation.
11) Purification plant : an establishment where live bivalve molluscs ace kept
    for purification under suitable conditions using clean seawater or
    seawater which is treated to remove contamination so causing the reduction
    of harmful microorganisms to an acceptable level.
12) Relaying : transfer of live bivalve molluscs to suitable natural oea or
    estuarine areas under the supervision of the competent authority in order
    for purification to occur.   It does not include the specific operation of
    transferring bivalve molluscs to more suitable areas for further growth or
    fattening.
13) 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 air.
14) Wrapping : an operation whereby live bivalve molluscs are protected from
    shock and desiccation by placing them in packaging material adequate for
    that purpose.
 ---pagebreak---                                             - 8 -
     15) Consignment : quantity of live bivalve molluscs handled in an expedition
         center or treated in a purification plant and subsequently bound for one
         or more customers.
     16) Batch : quantity of live bivalve molluscs collected from a harvesting area
         and subsequently destined for delivery to an approved expedition center,
         purification plant, relaying area or processing establishment as
         appropriate.
    17) Placing on the market : the holding or displaying for 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
         in the Community.
    18) Importation : the introduction of live bivalve molluscs into the territory
         of the Community from third countries.
    19) Faecal coliform : facultative, aerobic, gram-negative, non-sporeforming,
         cytochrome oxidase negative, rod-shaped bacteria that are able to ferment
         lactose with gas production in the presence of bile salts, or other
         surface active agents with similar growth-inhibiting properties, at 44*C +
         0.2*C within 24h at least.
    20) E. coll : faecal coliforms which also form indole from tryptophan at 44*C
         +0.2*C within 24h.
                     CHAPTER II : PROVISIONS FOR COMMUNITY PRODUCTION
                                         Article 3
    1. The placing on the market of live bivalve molluscs for immediate human
       consumption shall be subject to the following conditions:
       a) they must originate from harvesting areas which comply with the
           requirements laid down in Chapter I of the Annex;
       b) they must have been collected and transported from the harvesting area
           to an expedition centre or purification plant under the conditions laid
           down in Chapter II of the Annex;
(2)
 ---pagebreak---                                          9 -
     c) where provided for in this Regulation, they must have been relayed in
        suitable sites approved for that purpose and complying with the
        conditions laid down in Chapter III of the Annex;
     d) they must havo been handled hygienically, and where appropriate, they
        must have been purified in establishments approved for that purpose and
        complying with Lho requirements of Chapter IV;
     e) they must comply with the criteria set out in Chapter V of the Annex;
     f) health controls must have been carried out in accordance with
        Chapter VI of the Annex;
    g) they must have been appropriately wrapped in accordance with
        Chapter VII of the Annex;
    h) they must have been stored and transported under satisfactory hygiene
        conditions in accordance with Chapters VIII and IX of the Annex;
     i) they must bear a health mark as provided for in Chapter X of the Annex.
2.  Live bivalve molluscs intended for further processing must comply with the
    relevant requirements of paragraph 1, and be processed in conformity with
    the requirements of Council Regulation (EEC) No          laying down the
    health conditions for the production and the placing on the market of
    fishery products (1).
                                     Article 4
Persons handling live bivalve molluscs during their production and placing on
the market shall adopt all measures necessary to comply with the requirements
of this Regulation.
Persons who operate establishments shall in particular ensure that :
- adequate numbers of samples for laboratory examination are taken and
  analysed in order to establish an historical record of the sanitary quality
  of the live bivalve molluscs both before and after handling at an expedition
  center or 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 competent authority.
(1)
 ---pagebreak---                                           10
                                      Article 5
 1. a) The competent authorities shall draw up a list of their approved
        expedition centers and purification plants, each of which shall have an
        official number.
        The competent authority shall approve such centers or plants only where
        they can be sure that they meet the requirements of this Regulation.
       Member States shall withdraw approval if the requirements cease to be
       met.
    b) The inspection and monitoring of these establishments shall be carried
       out regularly on the responsibility of the competent authority, which
       shall at all times have free access to all parts of the establishments,
        in order to ensure compliance with the requirements of this Regulation.
       If such inspections reveal that not all the requirements of this
       Regulation are being met, the competent authority shall take the
       appropriate action.
2. a) The competent authorities shall establish a list of harvesting areas
       with indication of their location and bounderies from which live bivalve
       molluscs may be taken in conformity with this Regulation, and in
       particular, with Chapter I of the Annex.
       This list must be communicated to those affected by this Regulation such
       as harvesters and operators of purification plants and expendition
       centers.
   b) The monitoring of the harvesting areas shall be carried out on the
       responsibility of the competent authority in accordance with the
       requirements of this Regulation.
       If such monitoring reveals that the requirements of this Regulation are
       not being met, the competent authority shall close the harvesting area
       concerned until the situation has been restored.
3. The competent authorities concerned shall take all measures necessary to
   take account of the results referred to in Article 6(1).
 ---pagebreak---                                        - 11
                                     Article 6
 1. Experts from the Commission may make on-the-spot checks in so far as is
    necessary to ensure the uniform application of this Regulation.   They may
    check whether establishments and harvesting sites are in effect complying
    with tho requirements of this Regulation.   A Member State in whose
    territory a check is being carried out shall give all necessary assistance
    to the exports in carrying out their duties.   The Commission shall inform
    the Mombor States of tho results of such chocks.
2. The general provisions for implomonting paragraph 1 shall be determined in
    accordance with the procedure laid down in Article 16.   If necessary, and
    in accordance with the same procedure, a code shall be established
    containing the rules to be followed for the purpose of the checks provided
    for in paragraph 1.
3. The Commission, in accordance with the procedure laid down in Article 16,
    may draw up recommendations containing guidelines on good manufacturing
    practices applicable at the different stages of production and placing on
    the market.
                                     Article 7
The rules laid down in Diroctive               , [concerning veterinary controls
in intra-Communlty trade, with a view to the realisation of the internal
market], shall apply, in particular with respect to the organisation of the
checks carried out by the Member State of destination, and the subsequent
action and the safeguard measures to be applied.
However, the definitions to be applied are the ones laid down in this
Regulation.
 ---pagebreak---                                        - 12 -
                    CHAPTER III : IMPORTS FROM THIRD COUNTRIES
                                     Article 8
Provisions applied to imports of live bivalve molluscs from third countries
shall be equivalent to those governing the placing on the market of Community
products.
                                    Article 9
In order to ensure the uniform application of the provision laid down in
Article 8, the following procedure shall apply :
1. Inspections shall be carried out on the spot by experts of the Commission
   and the Member States to verify wether the conditions of production and
   placing on the market can be considered as being equivalent to those
   applied in the Community.
   The experts from 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.
   These inspections shall be made on behalf of the Community, which shall
   bear the cost of any expenditure in this connection.
   The frequency and the procedure for these inspections shall be determined
   in accordance with the procedure laid down in Article 16.
2. In deciding wether the conditions of production and placing on the market
   of live bivalve molluscs in a third country can be deemed equivalent to
   those of the Community, particular account shall be taken of :
   a) the legislation of the third country;
   b) the organisation of the competent authority of the third country and of
      its inspection services, the powers of such services and the supervision
      to which they are subject, as well as their facilities for monitoring
      the implementation of their legislation;
   c) the actual health conditions during the production and placing on the
      market of live bivalve molluscs and in particular the surveillance of
      harvesting areas in relation to microbiological and environmental
      contamination, and to the presence of marine biotoxins;
 ---pagebreak---                                         13
   d) the regularity and the rapidity of the information by the third country
       on the presence of plankton containing toxin in the harvesting areas;
   e) the assurances a third country can give on the compliance of the
      molluscs with the standards laid down in Chapter V of the Annex.
3. The Commission, following the procedure laid down in Article 14 shall
   decide on :
   a) the third countries fulfilling the conditions of equivalence referred to
      in paragraph 2;
   b) for each third country, the conditions for the importation of live
      bivalve molluscs.   These conditions may include in particular :
      i)    the supplying of a health certificate which must accompany
            consignments when forwarded to the Community,
      ii)   the definition of the harvesting areas from which live bivalve
            molluscs may be collected and imported,
      iii) the obligation of immedate information to the Community on every
            possible change of the approval of harvesting areas,
      iv)   possibly the mandatory purification after arrival at the territory
            of the Community.
c) a list of establishments from which the importation of live bivalve
   molluscs is authorized.   For that purpose, one or more lists of such
   establishments shall be established.   An establishment may not appear on a
   list unless it is officially approved by the competent authority of the
   third country exporting to the Community.   Such approval shall be subject
   to observance of the following requirements :
     compliance with requirements equivalent to those laid down in this
     Regulation,
     supervision by an official inspection sorvico of tho third country.
 ---pagebreak---                                       - 14 -
4. The Decisions referred to in point 3 may be modified or supplemented in
    accordance with the procedure laid down in Article 15.
    These Decisions and the amendments thereto shall be published in tho
    Official Journal of the European Communities, series L.
                                    Article 10
Should an inspection as referred to in Article 9(1) bring to 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 import conditions
or to suspend the importation from a particular establishment, harvesting area
or from a part or the whole of the third country concerned.
A final decision shall be taken in accordance with the procedure provided for
in Article 15.
                                    Article 11
1. The rules laid down in Council Regulation (EEC) No           , laying down
   the principles relating to the organisation of health controls for products
   arising from third countries with a view to the completion of the internal
   market (1) will apply.
2. The importation of live bivalve molluscs shall be prohibited if the
   conditions laid down in this Regulation have not been observed, and in
   particular when it is ascertained that :
   - the consignment does not comply with the conditions for importation laid
      down for the third country concerned;
   - the consignment constitutes a hazard to human health.
(1)
 ---pagebreak---                                        - 15 -
                                     Article 12
 1. If a disease capable of being conveyed to humans by live bivalve molluscs
    and therefore liable to be a serious hazard to public health, breaks out or
    spreads in a third country or if other considerations of public health so
    warrant, the Commission acting in accordance with the procedure laid down
    in Article 15, or a Member State may prohibit or subject to specific
    conditions the importation of those live bivalve molluscs directly or
    indirectly from the whole or part of the territory of the third country.
2. Measures taken by the Member States under paragraph 1 and withdrawal of
    such measures, shall be notified immediately to the other Member States and
    the Commission, together with the reasons therefor.
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 15.
4. The Commission shall monitor the situation and, in accordance with the
    procedure laid down in Article 15, shall amend or repeal the decisions
    referred to in paragraphs 1 and 3, having regard to such situation.
                           CHAPTER IV : FINAL PROVISIONS
                                    Article 13
The Annex to this Regulation shall be amended in accordance with the procedure
laid down in Article 14.
                                    Article 14
1. Where the procedure laid down in this Article is to be applied, the matter
   shall be referred forthwith to the Standing Veterinary Committee set up by
   the Council Decision 68/361/EECU) (hereinafter called "the Committee)
   by its chairman on his initiative or at the request of a Member State.
(1)
 ---pagebreak---                                               16
    2. The representative of the Commission shall submit to the committee a draft
        of the measures to be taken.   The committee shall deliver its opinion on
        the draft within a time limit which the chairman may lay down according to
        the urgency of the matter.   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 roquired to adopt on a proposal from tho Commission. Tho
        votes of the represent ativeu of Un» Member States within the committ.e shall
        be weighted in the manner 3ot out in that Article.   The chairman shall not
        vote.
        The Commission shall adopt the measure envisaged if they are in accordance
        with the opinion of the Committee.
        If the measures envisaged are not in accordance with the opinion of the
        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.  The Council shall act by a qualified majority.
        If, on the expiry of a period of three months from the date of referral to
        the Council, the Council has not acted, the proposed measures shall be
        adopted by the Commission.
                                         Article 15
    1. Where the procedure laid down in this Article is to be applied, the
       chairman shall rc»for tho mattor without, delay on his own initiative or at
       the request of a Member State to the Committee.
    2. The representative of the Commission shall submit to the committee a draft
       of the measures to be taken.    The committee shall deliver its opinion on
       the draft within two days.    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 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.
       The Commission shall adopt the measures envisaged if they are in accordance
       with the opinion of the committee.
13)
 ---pagebreak---                                           17
     If the measures envisaged are not in accordance with the opinion of the
     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.  The Council shall act by a qualified majority.
     If, on the expiry of a period of fifteon working days from the date of
     referral to the Council, the Council has not acted, the proposed measures
     shall be adopted by the Commission.
                                     Article 16
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 Committee a draft of
the measures to be taken.    The Committee shall deliver its opinion on the
draft within a time-limit which the Chairman may lay down according to the
urgency of the matter, if necessary by taking a vote.
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.
The Commission shall take the utmost account of the opinion doiivorod by the
Committee.    It shall inform the Committee of the mannor in which its opinion
liHti boon taken Into account.
                                     Article _17
This Regulation shull enter into force on 1 January 199T.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
Done at Brussels,                                       For the Council
 ---pagebreak---                                          18  -
                                     A N N E X
                                     CHAPTER I
                          CONDITIONS FOR HARVESTING AREAS
 1. 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 relaying or after processing 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.  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 g of flesh or 4.600 E. Coli per 100 g of flesh in 95 %
       of samples.  After purification, relaying or processing, the
       requirements set out in Chapter V shall be met.
    c) can be collected but only placed on the market after relaying over a
       long period or after relaying combined with purification to meet the
       requirements under (a). Processing of these molluscs by a heat
       treatment sufficient to kill micro organisms 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 out 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 centers.
 ---pagebreak---                                       -- 19
                                    CHAPTER II
                 REQUIREMENTS FOR HARVESTING AND TRANSPORTATION
            OF BATCHES TO AN EXPEDITION CENTER 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 relaying.
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 center, purification plant or relaying site, the means of
   transport must be equiped in such a way as to ensure the best survival
   conditions possible, and in particular must they comply with the
   requirements laid down in Chapter IX, point 2.
 ---pagebreak---                                        - 20 -
 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, relaying site or processing plant is
     issued by the competont 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, relaying 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 center, purification plant relaying
    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 center, purification plant, relaying 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---                                           21 -
                                     CHAPTER III
                    CONDITIONS FOR RELAYING LIVE BIVALVE MOLLUSCS
 The following conditions must be mot :
 1. live bivalve molluscs must be gathered and transported in accordance with
     the requirements of Chaptor II;
2. techniques for handling live bivalve molluscs destined for relaying must
    permit the resumption of filter feeding activity after immersion in natural
    waters;
3. live bivalve molluscs must not be relaid at a density which does not permit
    purification;
4. live bivalve molluscs must be immersed in seawater at the relaying 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 relaying* must, where necessary,
    be determined and announced by the competent authority for each species of
    live bivalve mollusc and approved relay site;
6. sites for relaying live bivalve molluscs must be approved by the competent
    authority.   The boundaries of the sites must be clearly identified;
7. sites within a relaying area must be woll separated to prevent mixing of
    batches;
8. permanent records of the source of live bivalve molluscs, relaying period,
    relaying site and subsequent destination of the batch after relaying must
    be maintained by tho operators of relaying sites for inspection by the
    competent authority;
 ---pagebreak---                                          22
    after harvesting from the relaying site, the batches must during transport
   from the relaying site to the approved expedition center, purification
   plant or processing plant be accompanied by the registration document
   referred to in Chaptor II, point 6, except in the case where tho samo staff
   is operating both the relaying site and the expedition center, 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 spaco to allow for aatlal'actory performance of all
          operations;
 ---pagebreak---                                          23 -
       d) durable walls which are easy to clean;
       e) adequate natural or artificial lighting.
    2. Access to an appropriate numbor of changing rooms, wash basins and
       lavatories; there must be a sufficient numbor 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 80/7 78/EEC of 15 July 1980 relating the quality of water
       intended for human consumption (1) 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 resists corrosion.
(1) OJ No L 229, 30.08.1980, p 11.
 ---pagebreak---                                        - 24 -
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 illlness 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
       then 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.
 ---pagebreak---                                         25 -
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 impermoable surface and be
         easy to clean by scrubbing or use of pressurised 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 sea water 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 sea water per hour and per tonne of live bivalve molluscs
        treated.
     4. Clean sea water must be used for purifying live bivalve molluscs; the
        distance between the sea water intake point and the waste water
        outlets must be sufficient to avoid contamination; the procedure for
        sanitizing the sea water 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.
    5. Operation of the purification system must be in accordance with
        instructions issued by the competent authority to ensure that live
        bivalve molluscs rapidly rosume filter feeding activity, removo sewago
        contamination, do not bocomo rocontaminated and are able to remain
        alive in a suitable condition after purification for wrapping, storage
        and transport before placing on the market.
 ---pagebreak---                                  - 26 -
 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 tho
    moment when water is drained away before removal from the said
     system.  The establishment operator must tako account of the data
     relating to the raw materials (the type of bivalve mollusc, its area
    of origin, microbe content, otc.) 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.
 ---pagebreak---                                   27 -
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 tosts 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 conters 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.
 ---pagebreak---                                          28
IV. REQUIREMENTS FOR EXPEDITION CENTERS
    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;
       d) procedures for calibration of live shellfish must not result in
           additional contamination of the product or in any changes affecting
           the ability of the product to be transported and stored after
           wrapping.
       e) any washing or cleaning of live bivalve molluscs must be carried out
           using pressurised clean seawater or potable water - cleaning water
           may not be recycled.
    2. Expedition centers 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, relaying site or
       purification plant.
    3. The expedition centers must have their own laboratory or secure the
       services of a laboratory equiped 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 requirements is invalid if the expedition centers get
       their molluscs from a purification plant where they have been examined
       after purification.
 ---pagebreak---                                          29 -
                                     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 g 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 g 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 (ADD, 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 g 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.
 ---pagebreak---                                       - 30 -
Examinations for checking the compliance with the requirements of this Chapter
must be carried out in accordance with proven methods which are scientifically
recognised.
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-Shelfish Poisson (NSP), this shall be done applying the same
procedure.
                                   CHAPTER VI
               PUBLIC HEALTH CONTROL AND SUPERVISION OF PRODUCTION
A public 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 include :
1. Periodic supervision of live bivalve mollusc relaying and harvesting areas
   in order :
   a) to avoid any abuse of the origin and destination of the live bivalve
      molluscs;
   b) to check the microbiological quality of the live bivalve molluscs in
      relation to the area of harvesting as laid down in Chapter I;
   c) to check the possible presence of toxin-producing plankton.
 ---pagebreak---                                          31 -
    For that purpose, sampling plans shall be established by the competent
    authorities for checking at regular intervals or on a case-by-case basis in
    the situation of irregular periods of harvesting.
    Sampling plans must in particular take account of :
    a) likely variations in faecal contamination at each harvesting area;
    b) possible variations of the presence of plankton containing marine
       biotoxins; the sampling must be designed as follows :
       (i)   surveillance : periodic sampling organised to detect changes in
             the composition of the plankton containing toxins and the
             geographical distribution thereof.  Information leading to a
             suspicion of accumulation of toxins in muscle flesh must be
             followed by
       (ii)  intensive sampling :
             - control of the plankton in the growing and fishing waters by
               increasing the number of sampling points and the number of
               samples and
             - toxicity tests on molluscs from the affected zone and most
               susceptible to the contamination.
             This intensive sampling plan must be continued until the results
             of toxicity tests permit again the placing on the market of the
             molluscs;
   c) possible contamination of the molluscs in the harvesting area.
       If the result of a sampling plan shows that the placing on the market of
       live bivalve molluscs may constitute a hazard to human health, the
       competent authority shall close the harvesting area untill the situation
       has been restored.
2. Laboratory tests in order to check the respect of the requirements for the
   end product as laid down in Chapter V of this Annex.
   There shall in particular be established a control system to verify that
   the level of marine biotoxins do not exceed the safe levels required by
   this Regulation.
 ---pagebreak---                                       - 32
3. An inspection at regular intervals of establishments.  These inspections
   shall include in particular checks :
   a) to verify whether the approval conditions are still being complied with;
   b) on the cleanliness of the premises, facilities, equipment and of staff
      hygiene;
   c) to verify whether the live bivalve molluscs are handled and treated
      correctly;
   d) on the correct application and functioning of purification or
      conditioning systems;
   e) of the record books referred to in Chapter IV under III, 12;
   f) the correct use of health marks.
   These checks may include the taking of samples for laboratory tests; the
   results of these tests shall be notified to the persons responsible for the
   establishments.
4. Checks on the storage and transport conditions of the consignments of live
   bivalve molluscs.
                                   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.
 ---pagebreak---                                           33
 2. Oysters must be wrapped with the concave shell downwards.
 3. All wrappings of live bivalve molluscs must be sealed and remain sealed
     from tho expedition centre until delivery to the consumer or retailer.
                                    CHAPTKR 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 center except in the case of
    retail sale at the expedition centre.
                                     CHAPTER IX
                        TRANSPORT FROM THE EXPEDITION CENTER
1. Consignments of live bivalve molluscs destined for human consumption must
    be transported wrapped as a sealed parcel from the expedition center 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 :
 ---pagebreak---                                          34
    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 bo sultubly equipped to provide efficient protection of tho
       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 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 sea water.
                                     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 center.
   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
                                                    D         89/395/EEC (2),
   the mark must contain the following information :
(1) OJ No L 33, 08.02.19/9, p. 1
(2) OJ No L 186, 30.06.1989, p. 17
 ---pagebreak---                                         35
   - the country of dispatch,
     species of bivalve mollusc (common name and scientific name)
   - the identification of the expedition center 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.
 ---pagebreak---                                           - 36 -
 F I N A N C I A L   STATEMENT          concerning :
 Draft proposal for a Council Regulation concerning the health conditions governing
 the production and the placing on the market of live bivalve molluscs
 1. BUDGET HEADING:               Item:                    Title:
     III B                        382 (1)                  Inspection in Agriculture
2. LEGAL BASIS: Article 43 of the Treaty
3. CLASSIFICATION : Non-compulsory expenditure
4. PURPOSE/DESCRIPTION OF THE MEASURE:
    Verification of the application of the Regulation (Art. 6 and 9)
T!    METHOD OF CALCULATION:
5.1.Form of expenditure: Mission expenses
5.2.Community contribution: 100 %
5.3.Calculation:
      300 mission days per year at ECU 170 per day (currant cost of inspection)
      ECU 51.000 per year
T.    FINANCIAL IMPLICATION AS REGARDS OPERATING APPROPRIATIONS
6.1.Schedule of appropriations (m ECU):
          Year
          1991
          1992
          1993                              0,051
          1994                             0,051
          1995                              0,051
          following years
          Total                             0.153
6.2.Financing during current year: NIL
7. OBSERVATIONS:
     (1) When the preliminary draft budget is prepared, an examination will be made to
         see where this category of expenditure is to be charged in the budget.
    This proposal also calls for 3 additional A7/6 posts.
    Staff requirements set out above must be met by redeployment within the Commission
    or by the budget procedure for the year concerned.
 ---pagebreak---                                  - 37 -
                     STATEMENT OF IMPACT ON BUSINESS
NAME OF THE PROPOSAL
Draft proposal for a Council Regulation on the health conditions
affecting the production and the placing on the market of live bivalve
moi(uses.
OBJECTIVES
The proposal outlines the health requirements to be respected by
Industry and commerce, as well as by the competent authorities during
production, handling, storage and distribution of          live bivalve
mo I I uses.
These requirements replace the different health conditions at present
applied by the Member States and will help to bring about a single
market.
IMPACT ON BUSINESS
The national rules of the Member States as regards health problems
related to live bivalve molluscs are not always on an equivalent level
or are conceived in a different manner.
Live bivalve mol lues are extremely sensitive as far as health risks are
concerned. The creation of a single market where bivalve molluscs are
allowed to be moved freely requires a harmonisation of the conditions
for production and marketing, based on a high level of protection.
This will Inevitably require for a certain number of mainly small
enterprises an effort in order to adapt to the proposed rules as far as
upgrading of premises and control procedures are concerned. It Is also
likely that, In order to meet the proposed standards, a number of
establishments which are situated In zones where the quality of coastal
waters is not satisfactory will need to provide for purification
equipment.
In order to allow smooth adaptation to the proposed rules and in order
to limit possible influence on business, transitional periods are
proposed for certain requirements.
 ---pagebreak---                                   - 38 -
Member States will  also be allowed, under the conditions set out In
Council Decision              laying down the conditions for granting
derogations to the Community health requirements for the production and
the placing on the market of products of animal o r i g i n ^ ) , to submit
to the Commission  requests  for dorogatlons  to the proposed      rules  If
those are well grounded and documented.
It must be further emphasized that the Community Is prepared to assist
the Member States in achieving higher health standards. For that
purpose, the Commission has submitted to the Council a proposal for a
Regulation on the Improvement of the conditions under which fishery
products and aquaculture products are processed and marketed [COM (89)
187 final] < 2 >.
It must also be carried In mind that Member States are already bound to
respect certain standards for the shellfish waters by virtue of
Directive 79/923/EEC on the quality required of shellfish w a t e r s ^ 3 ) .
The respect of these standards will to a large extend help to achieve
the product standards as envisaged In the present proposal.
Furthermore, free trade will be ensured once consignments comply with
the proposed standards: this will be without doubt to the benefit of
enterprIses.
<1> O.J. n°
(2) O.J. n° C 143 of 09.06.89, p. 6
<3> O.J. n° L 281 of 10.11.79, p. 47
 ---pagebreak---                                                                       ISSN 0254-1475
                                                               COM(89) 648 final
                                                      DOCUMENTS
EN                                                                      03 04 05
                                 Catalogue number : CB-CO-90-057-EN-C
                                                             ISBN 92-77-57297-3
Office for Official Publications of the European Communities
L-2985 Luxembourg