COUNCIL DIRECTIVE of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs (91/492/EEC)
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 (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas, with a view to achieving the internal market and more especially to ensure the smooth operation of the common organization of the market in fishery products established by Regulation (EEC) No 3796/81 (4) as last amended by Regulation (EEC) No 2886/89 (5), 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 production and placing on the market to be better harmonized and bring about competition on equal terms while ensuring quality products for the consumer.
Whereas Council Directive 79/923/EEC of 30 October 1979 on the quality required of shellfish waters (6) lays down that it is necessary to establish the health requirements to be observed for shellfish products;
Whereas these 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, tunicates and marine gastropods;
Whereas it is important, should 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 labelling system which will enable the route of a batch after harvesting to be followed;
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 whereas it is therefore necessary, in order to guarantee optimal protection of public health, to set up a Community system to ensure rapid adoption and where necessary reinforcement of the health standards to safeguard human health from virus contamination or other hazards;
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 relatively long period; whereas it is therefore necessary to define production areas from which molluscs can bet gathered for direct human consumption, or from which they have to be purified or relayed;
Whereas it is primarily 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 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 organized on a Community level must be introduced to guarantee the uniform application in all Member States of the standards laid down in this Directive;
Whereas the rules, principles and safeguard measures established by Council Directive 90/675/EEC of 10 December 1990 laying down the principles governing the organization of veterinary checks on products entering the Community from third countries (7), should apply to the case in question;
Whereas in the context of trade between the Member States, the rules laid down in Council Directive 89/662/EEC of
11 December 1989 concerning veterinary checks in intra-Community trade, with a view to the completion of the internal market (8) as amended by Directive 90/675/EEC should also 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 the Community; whereas provision must be made for a Community procedure for checking the conditions in third countries of production and of the placing on the market, in order to allow the Community to apply a common import system based on conditions of equivalence;
Whereas, so that account may be taken of particular circumstances, derogations should be granted to certain establishments already operating before 1 January 1993 so as to allow them to adapt to all the requirements laid down in this Directive;
Whereas, in the case of living animals that are edible whilst they are alive, a derogation should be made, with regard to the durability date, to the rules of Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale (9) as last amended by Directive 91/72/EEC (10);
Whereas provision should be made for the possibility of adopting transitional measures in order to cover the absence of certain implementing rules;
Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; 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 DIRECTIVE:
CHAPTER I General provisions
Article 1
This Directive lays down health conditions for the production and placing on the market of live bivalve molluscs which are intended for immediate human consumption or for further processing before consumption.
With the exception of the provisions on purification, this Directive applies to echinoderms, tunicates and marine gastropods.
Article 2
For the purposes of this Directive, the following definitions shall apply:
1. 'bivalve molluscs' means filter-feeding lamellibranch molluscs;
2. 'marine biotoxins' means poisonous substances accumulated by bivalve molluscs feeding on plankton containing toxin;
3. 'clean sea water' means sea water or brackish water which is to be used under the conditions laid down in this Directive and which is free from microbiological contamination and toxic and objectionable substances occurring 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;
4. 'competent authority' means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence;
5. 'conditioning' means the storage of live bivalve molluscs, whose quality does not indicate the need for relaying or treatment in a purification plant, in tanks or any other installation containing clean sea water or in natural sites to remove sand, mud or slime;
6. 'gatherer' means any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market;
7. 'production area' means any sea, estuarine or lagoon area containing natural deposits of bivalve molluscs or sites used for cultivation of bivalve molluscs from which live bivalve molluscs are taken;
8. 'relaying area' means any sea, estuarine or lagoon area approved by the competent authority, with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs;
9. 'dispatch centre' means any approved on-shore or off-shore installation for the reception, conditioning, washing, cleaning, grading and wrapping of live bivalve molluscs fit for human consumption;
10. 'purification centre' means an approved establishment with tanks fed by naturally clean sea water or sea water that has been cleaned by appropriate treatment, in which live bivalve molluscs are placed for the time necessary to remove microbiological contamination, so making them fit for human consumption;
11. 'relaying' means an operation whereby live bivalve molluscs are transferred to approved sea or lagoon areas or approved estuarine areas under the supervision of the competent authority for the time necessary to remove contamination. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening;
12. 'means of transport' means 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;
13. 'wrapping' means an operation whereby live bivalve molluscs are placed in packaging material adequate for the purpose;
14. 'consignment' means a quantity of live bivalve molluscs handled in a dispatch centre or treated in a purification centre and subsequently intended for one or more customers;
15. 'batch' means a quantity of live bivalve molluscs collected from a production area and subsequently intended for delivery to an approved dispatch centre, purification centre, relaying area or processing plant as appropriate;
16. 'placing on the market' means 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 for the purpose of processing in the Community, excluding the direct transfer on the local market in small quantities by the coastal fisherman to the retailer or the consumer which must be subject to the health checks laid down by national rules for checking on retail business;
17. 'importation' means the introduction of live bivalve molluscs into the territory of the Community from third countries;
18. 'faecal coliform' means 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 oC p 0,2 oC within 24 hours at least;
19. 'E. coli' means faecal coliforms which also form indole from tryptophan at 44 oC p 0,2 oC within 24 hours.
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 production areas which comply with the requirements laid down in Chapter I of the Annex; however, in the case of pectinidae, this provision shall apply only to aquaculture products as defined in Article 2 (2) of Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and placing on the market of fishery products (;);
(b) they must have been harvested and transported from the production area to a dispatch centre, purification centre, relaying area or processing plant under the conditions laid down in Chapter II of the Annex;
(c) where provided for in this Directive, they must have been relaid in suitable areas approved for that purpose and complying with the conditions laid down in Chapter III of the Annex;
(d) they must have been handled hygienically, and where appropriate, they must have been purified in establishments approved for that purpose and complying with the requirements of Chaper IV of the Annex;
(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 conditions of hygiene 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 accordance with the requirements of Council Directive 91/493/EEC.
Article 4
Member States shall ensure that 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 Directive.
Persons responsible for dispatch and purification centres shall in particular ensure that:
- representative numbers of samples for laboratory examination are regularly taken and analysed in order to establish an historical record on the basis of the areas where batches come from and of the health quality of the live bivalve molluscs both before and after handling at a dispatch centre or purification centre.
- a register is kept for the permanent record of the results of the various checks and kept for presentation to the competent authority.
Article 5
1. (a) The competent authority shall approve dispatch centres and purification centres once it is satisfied that they meet the requirements of this Directive. The competent authority shall take the necessary measures if the requirements cease to be met. In so doing, it shall take account of, in particular, the outcome of any check carried out in accordance with Article 6 (1).
However, subject to the express condition that live molluscs coming from such centres meet the hygiene standards set by this Directive, Member States may, for the requirements relating to equipment and structures laid down in Chapter IV of the Annex, to be specified before 1 October 1991 in accordance with the procedure laid down in Article 12, grant to dispatch and purification centres, a further period expiring on 31 December 1995 within which to comply with the conditions of the approval set out in the abovementioned Chapter. Such derogations may be granted only to establishments, already operating on 31 December 1991, which have, before 1 July 1992, submitted a duly substantiated application for derogation to the competent national authority. This application must be accompanied by a work plan and programme indicating the period within which it would be possible for the establishments to comply with the requirements in question. Where financial assistance is requested from the Community, only requests in respect of projects complying with the requirements of this Directive can be accepted.
The competent authority shall draw up a list of approved dispatch centres and purification centres, each of which shall have an official number.
The list of approved dispatch centres and purification centres, and any subsequent amendments thereto, must be communicated by each Member State to the Commission, which shall pass such information on to the other Member States.
(b) The inspection and monitoring of these centres shall be carried out regularly under the responsibility of the competent authority, which shall have free access to all parts of the centres, in order to ensure compliance with the provisions of this Directive.
If such inspections and monitoring reveal that the requirements of this Directive are not being met, the competent authority shall take appropriate action.
2. (a) The competent authority shall establish a list of production and relaying areas, with an indication of their location and boundaries, from which live bivalve molluscs may be taken in accordance with the requirements of this Directive and, in particular, with Chapter I of the Annex.
This list must be communicated to those affected by this Directive, such as gatherers and operators of purification centres and dispatch centres.
. (b) The monitoring of the production and relaying areas shall be carried out under the responsibility of the competent authority in accordance with the requirements of this Directive.
If such monitoring reveals that the requirements of this Directive are no longer being met, the competent authority shall close the production or relaying area concerned until the situation has been restored to normal.
3. The competent authority may prohibit any production and harvesting of bivalve molluscs in areas considered unsuitable for these activities for health reasons.
Article 6
1. Experts from the Commission may, in cooperation with the competent authorities of the Member States, make on-the-spot checks insofar as is necessary to ensure the uniform application of this Directive. They may, in particular, check whether centres, production and relaying areas are in effect complying with the requirements of this Directive. A Member State in whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member States of the results of such checks.
2. The arrangements for implementing paragraph 1 shall be adopted in accordance with the procedure laid down in Article 12.
3. The Commission, may draw up recommendations containing guidelines on good manufacturing practices applicable at the different stages of production and placing on the market.
Article 7
1. The rules laid down in Directive 89/662/EEC as regards live bivalve molluscs, echinoderms, tunicates and marine gastropods intended for human consumption, shall apply, in particular as regards the organization of and the action to be taken following the checks to be carried out by the Member State of destination, and the safeguard measures to be implemented.
2. Directive 89/662/EEC shall be amended as follows:
(a) In Annex A, the following indent shall be added:
'- Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and placing on the market of live bivalve molluscs, (OJ No L 268, 24. 9. 1991, p. 1.);
(b) in Annex B, the following indent shall be deleted:
'- live bivalve molluscs intended for human consumption'.
CHAPTER III Imports from third countries
Article 8
Provisions applied to imports of live bivalve molluscs from third countries shall be at least equivalent to those governing the production and placing on the market of Community products.
Article 9
In order to ensure the uniform application of the requirement imposed in Article 8, the following procedure shall apply:
1. inspections shall be carried out on the spot by experts from the Commission and the Member States to verify whether 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 12;
2. in deciding whether 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 organization 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 in force;
(c) the actual health conditions during the production and placing on the market of live bivalve molluscs and in particular the monitoring of production areas in relation to microbiological and environmental contamination, and to the presence of marine biotoxins;
(d) the regularity and the rapidity of the information provided by the third country on the presence of plankton containing toxin in the production areas and, in particular, of species not occurring in Community waters, and risks that such presence may signify for the Community;
(e) the assurances which a third country can give on the compliance with the standards laid down in Chapter V of the Annex;
3. the Commission, following the procedure laid down in Article 12, shall decide on:
(a) the list of third countries fulfilling the conditions of equivalence referred to in paragraph 2;
(b) for each third country, the specific conditions for the importation of live bivalve molluscs. These conditions must include:
(i) the procedure for obtaining a health certificate which must accompany consignments when forwarded to the Community;
(ii) the demarcation of the production areas from which live bivalve molluscs may be harvested and imported;
(iii) the obligation to notify the Community of any possible change in the approval of production areas;
(iv) any purification after arrival in 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 Directive,
- monitoring by an official inspection service of the third country;
4. the decisions referred to in paragraph 3 may be amended in accordance with the procedure laid down in Article 12.
These decisions and the amendments thereto shall be published in the Official Journal of the European Communities, L series;
5. pending the decisions referred to in paragraph 3, the conditions which Member States shall apply to imports
of live bivalve molluscs from third countries shall be at least equivalent to those governing the production and placing on the market of Community products.
Article 10
The rules and principles laid down in Directive 90/675/EEC shall apply, with particular reference to the organization of and follow up to the inspections to be carried out by
the Member States and the safeguard measures to be
implemented.
Without prejudice to compliance with the rule and principles referred to in the first subparagraph of this Article and pending implementation of the decisions provided for in Article 8 (3) and Article 30 of Directive 90/675/EEC, the relevant national rules for applying Article 8 (1) and (2) of the said Directive shall continue to apply.
CHAPTER IV Final provisions
Article 11
The chapters of the Annex may be amended by the Council, acting by a qualified majority on a proposal from the Commission.
The Commission shall, before 1 January 1994, submit to the Council, after receiving the opinion of the Scientific Veterinary Committee, a report on Chapters I and V of the Annex, accompanied by any proposed amendments to those Chapters.
Article 12
1. Where the procedure laid down in this Article is to
be followed, the Chairman shall refer the matter to the
Standing Veterinary Committee hereafter referred to as the committee, either on his own initiative or at the request of a Member State.
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 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.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
. (b) 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 save where the Council has decided against the said measures by a simple majority.
Article 13
In order to take into account the possible failure to take a decision on the detailed rules for applying this Directive by
1 January 1993, necessary transitional measures may be adopted in accordance with the procedure laid down in Article 12 for a period of two years.
Article 14
The Commission shall, after consulting the Member States, submit, before 1 July 1992, a report to the Council on the minimum requirements to be met with regard to structure and equipment by small dispatch centres or by small establishments ensuring distribution on the local market and situated in areas subject to particular constraints with respect to their supply, possibly accompanied by proposals, on which the Council will take a decision, acting in accordance with the voting procedure laid down in Article 43 of the Treaty, before 31 December 1992.
The provisions of this Directive shall be re-examined before 1 January 1998 by the Council, acting on a Commission proposal, in the light of the experience gained.
Article 15
The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 1993. They shall notify the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 16
This Directive is addressed to the Member States.
Done at Brussels, 15 July 1991.