COUNCIL DIRETTIVE of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (91/493/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 proposals from the Commission (1),
Having regard to the opinions of the European Parliament (2),
Having regard to the opinions of the Economic and Social Committee (3),
Whereas, with a view to achieving the internal market and more especially to ensuring 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 marketing of fish and fish products 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, whilst ensuring quality products for the consumer;
Whereas the European Parliament in its legislative resolution of 17 March 1989 (6) requested the Commission to come forward with comprehensive proposals on the hygienic production and placing on the market of fishery products, including solutions for the problem of nematodes;
Whereas fishery products freshly caught are in principle free of contamination with micro-organisms; whereas however contamination and subsequent decomposition may occur when handled and treated unhygienically;
Whereas therefore the essential requirements should be laid down for the correct hygienic handling of fresh and processed
fishery products at all stages of production and during storage and transport;
Whereas it is appropriate to apply by analogy certain marketing standards which are laid down pursuant to
Article 2
of Regulation (EEC) No 3796/81, in order to fix the health quality of these products;
Whereas it is the responsibility primarily of the fisheries industry to ensure that fishery products meet the health requirements laid down in this Directive;
Whereas the competent authorities of the Member States must, by carrying out checks and inspections, ensure that producers and manufacturers comply with the said requirements;
Whereas Community control measures should be introduced to guarantee the uniform application in all Member States of the standards laid down in this Directive;
Whereas, in order to ensure the smooth operation of the internal market, the measures should apply in an identical manner to trade within the Member States and to trade between the Member States;
Whereas in the context of intra-Community trade, 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 (7) as amended by Directive 90/675/EEC (8) apply to fishery products;
Whereas fishery products from third countries intended to be placed on the market of the Community must not qualify for more favourable arrangements than those applied in the Community; whereas provision should therefore be made for a Community procedure for the inspection in third countries of the conditions of production and placing on the market in order to permit the application of a common import system based on conditions of equivalence;
Whereas the products in question are subject to the rules concerning checks and to safeguard measures covered 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;
Whereas, so that account may be taken of particular circumstances, derogations should be granted to some establishments already operating before 1 January 1993 so as to allow them to adapt to all the requirements laid down in this Directive;
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;
Whereas the essential requirements laid down in this Directive may need further specification,
HAS ADOPTED THIS DIRECTIVE
CHAPTER I General provisions
Article 1
This Directive lays down the health conditions for the production and the placing on the market of fishery products for human consumption.
Article 2
For the purposes of this Directive, the following definitions shall apply:
1. 'fishery products' means all seawater or freshwater animals or parts thereof, including their roes, excluding aquatic mammals, frogs and aquatic animals covered by other Community acts;
2. 'aquaculture products' means all fishery products born and raised in controlled conditions until placed on the market as a foodstuff. However seawater or freshwater fish or crustaceans caught in their natural environment when juvenile and kept until they reach the desired commercial size for human consumption are also considered to be aquaculture products. Fish and crustaceans of commercial size caught in their natural environment and kept alive to be sold at a later date are not considered to be aquaculture products if they are merely kept alive without any attempt being made to increase their size or weight;
3. 'chilling' means the process of cooling fishery products to a temperature approaching that of melting ice;
4. 'fresh products' means any fishery product whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, which have not undergone any treatment to ensure preservation other than chilling;
5. 'prepared products' means any fishery product which has undergone an operation affecting its anatomical wholeness, such as gutting, heading, slicing, filleting, chopping, etc.;
6. 'processed products' means any fishery product which has undergone a chemical or physical process such
as the heating, smoking, salting, dehydration or marinating, etc., of chilled or frozen products, whether or not associated with other foodstuffs, or a combination of these various processes;
7. 'preserve' means the process whereby products are packaged in hermetically sealed containers and subjected to heat treatment to the extent that any micro-organisms that might proliferate are destroyed or inactivated, irrespective of the temperature at which the product is to be stored;
8. 'frozen products' means any fishery product which
has undergone a freezing process to reach a core temperature of -18 oC or lower after temperature stabilization;
9. 'packaging' means the procedure of protecting fishery products by a wrapper, a container or any other suitable device;
10. 'batch' means the quantity of fishery products obtained under practically identical circumstances;
11. 'consignment' means the quantity of fishery products bound for one or more customers in the country of destination and conveyed by one means of transport only;
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. '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;
14. 'establishment' means any premises where fishery products are prepared, processed, chilled, frozen, packaged or stored. Auction and wholesale markets in which only display and sale by wholesale takes place are not deemed to be establishments;
15. '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 in the Community, excluding retail sales and direct transfers on local markets of small quantities by fishermen to retailers or consumers, which must be subject to the health checks laid down by national rules for checking the retail trade;
16. 'importation' means the introduction into the territory of the Community of fishery products from third countries;
17. 'clean seawater' means seawater or briny water which is free from microbiological contamination, harmful substances and/or toxic marine plankton in such quantities as may affect the health quality of fishery products and which is used under the conditions laid down in this Directive;
18. 'factory vessel' means any vessel on which fishery products undergo one or more of the following operations followed by packaging: filleting, slicing, skinning, mincing, freezing or processing.
The following are not deemed to be 'factory vessels':
- fishing vessels in which only shrimps and molluscs are cooked on board;
- fishing vessels on board which only freezing is carried out.
Article 3
1. The placing on the market of fishery products caught in their natural environment shall be subject to the following conditions:
(a) they must have:
(i) been caught and where appropriate handled for bleeding, heading, gutting and the removal of fins, chilled or frozen, on board vessels in accordance with hygiene rules to be established by the Council acting by a qualified majority on a proposal from the Commission. The Commission shall submit proposals to that effect before 1 October 1992;
(ii)
where appropriate, been handled in factory vessels approved in accordance with Article 7, and in accordance with the requirements of Chapter I of the Annex.
The cooking of shrimps and molluscs on board must comply with the provisions of Chapter III, section I(5), or Chapter IV, section IV(7), of the Annex. Such vessels shall be specifically registered by the competent authorities;
(b)
during and after landing they must have been handled in accordance with Chapter II of the Annex;
(c)
they must have been handled and, where appropriate, packaged, prepared, processed, frozen, defrosted or stored hygienically in establishments approved in accordance with Article 7, in compliance with the requirements of Chapters III and IV of the Annex.
The competent authority may, notwithstanding Chapter II, section 2 of the Annex, authorize the transfer of fishery products ex quay into containers for immediate delivery to an approved establishment or registered auction or wholesale market to be checked there;
(d)
they must have undergone a health check in accordance with Chapter V of the Annex;
(e)
they must have been appropriately packaged in accordance with Chapter VI of the Annex;
(f)
they must have been given an identification mark in accordance with Chapter VII of the Annex;
(g)
they must have been stored and transported under satisfactory conditions of hygiene, in accordance with Chapter VIII of the Annex.
2. Where gutting is possible from a technical and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or landed.
3. The placing on the market of aquaculture products shall be subject to the following conditions:
(a)
they must have been slaughtered under appropriate conditions of hygiene. They must not be soiled with earth, slime or faeces. If not processed immediately after having been slaughtered, they must be kept chilled;
(b)
they must, in addition, comply with the requirements laid down under 1 (c) to (g).
4. (a) The placing on the market of live bivalve molluscs shall be subject to the requirements laid down in Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs (9).
(b)
When processed, bivalve molluscs must, in addition to the requirements in point (a), satisfy those of paragraph 1 (c) to (g).
Article 4
Fishery products to be placed on the market alive shall at all times be kept under the most suitable survival conditions.
Article 5
The placing on the market of the following products shall be forbidden:
- poisonous fish of the following families: Tetraodontidae, Molidae, Diodontidae, Canthigasteridae,
- fishery products containing biotoxins such as ciguatera toxins or muscle-paralysing toxins.
Detailed requirements concerning the species covered by this Article and concerning methods of analysis shall be laid down in accordance with the procedure prescribed in Article 15.
Article 6
1. Member States shall ensure that persons responsible for establishment take all necessary measures, so that, at all stages of the production of fishery products, the specifications of this Directive are complied with.
To that end, the said persons responsible must carry out their own checks based on the following principles;
- identification of critical points in their establishment on the basis of the manufacturing processes used;
- establishment and implementation of methods for monitoring and checking such critical points;
- taking samples for analysis in an approved laboratory by the competent authority for the purpose of checking cleaning and disinfection methods and for the purpose of checking compliance with the standards established by this Directive;
- keeping a written record or a record registered in an indelible fashion of the preceding points with a view to submitting them to the competent authority. The results of the different checks and tests will in particular be kept for a period of at least two years.
2. If the results of own checks or any information at the disposal of the persons responsible referred to in paragraph 1 reveal the risk of a health risk or suggest one might exist and without prejudice to the measures laid down in the fourth subparagraph of Article 3 (1) of Directive 89/662/EEC, the appropriate measures shall be taken, under official supervision.
3. Rules for the application of the second subparagraph of paragraph 1 shall be established in accordance with the procedure laid down in Article 15.
Article 7
1. The competent authorities shall approve establishments once they have verified that these establishments meet the requirements of this Directive, with regard to the nature of the activities they carry out. The approval must be renewed if an establishment decides to carry out activities other than those for which it has received approval.
The competent authorities shall take the necessary measures if the requirements cease to be met. To this end, they shall take particular account of the conclusions of any check carried out in accordance with Article 8.
The competent authority shall register those auction and wholesale markets which are not subject to approval after verifying that such installations comply with the provisions of this Directive.
2. However, subject to the express condition that products coming from factory-vessels and establishments,
auction and wholesale markets meet the hygiene standards set by this Directive, Member States may, for the requirements relating to equipment and structures laid down in Chapters I to IV to the Annex, grant to factory-vessels and establishments, auction and wholesale markets a further period expiring on 31 December 1995 within which to comply with the conditions of approval set out in Chapter IX. Such derogations may be granted only to factory-vessels and establishments, auction and wholesale markets, already operating on 31 December 1991, which have, before 1 July 1992, submitted a duly justified 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 them 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.
3. The competent authorities shall draw up a list of their approved establishments, each of which shall have an official number.
Each Member State shall notify the Commission of its list of approved establishments and of any subsequent amendment thereof. The Commission shall forward this information to the other Member States.
4. The inspection and monitoring of establishments shall be carried out regularly under the responsibility of the competent authority, which shall at all times have free access to all parts of establishments, in order to ensure compliance with the requirements 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.
5. Paragraphs 1, 3 and 4 shall also apply in respect of factory vessels.
6. Paragraphs 3 and 4 shall also apply to wholesale and auction markets.
Article 8
1. Experts from the Commission may, in cooperation with the competent authorities of the Member States, make on-the-spot checks insofar as this is necessary to ensure the uniform application of this Directive. They may in particular verify whether establishments 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 the investigations.
2. The arrangements for implementing paragraph 1 shall be adopted in accordance with the procedure laid down in Article 15.
Article 9
1. The rules laid down in Directive 89/662/EEC, as regards fishery products intended for human consumption, shall apply, in particular as regards the organization of and the action to be taken following the inspections to be carried out by the Member States of destination, and the protective 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 91/493/EEC of 22 July 1991 laying down the health conditions for the production and placing on the market of fishery products (OJ No L 268, 24. 9. 1991, p. 15);'
(b) In Annex B the following indent shall be deleted:
'- fishery products intended for human consumption'.
CHAPTER II Imports from third countries
Article 10
Provisions applied to imports of fishery products from third countries shall be at least equivalent to those governing the production and placing on the market of Community products.
Fishery products caught in their natural environment by a fishing vessel flying the flag of a third country must undergo the checks laid down in Article 18 (3) of Directive 90/675/EEC.
Article 11
1. For each third country or group of third countries, fishery products must fulfil the specific import conditions fixed in accordance with the procedure laid down in Article 15, depending on the health situation in the third country concerned.
2. In order to allow the import conditions to be fixed, and in order to verify the conditions of production, storage and dispatch of fishery products for consignment to the Community, inspections may be carried out on the spot by experts from the Commission and the Member States.
The experts of the Member States who are to be entrusted with these inspections shall be appointed by the Commission acting on a proposal from the Member States.
These inspections shall be made on behalf of the Community, which shall bear any expenditure incurred.
The frequency of and procedure for these inspections shall be determined in accordance with the procedure laid down in Article 15.
3. When fixing the import conditions of fishery products referred to in paragraph 1, 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 effectively verifying the implementation of their legislation in force;
(c)
the actual health conditions during the production, storage and dispatch of fishery products intended for the Community;
(d)
the assurances which a third country can give on the compliance with the standards laid down in Chapter V of the Annex.
4. The import conditions referred to in paragraph 1 shall include:
(a)
the procedure for obtaining a health certificate which must accompany consignments when forwarded to the Community;
(b)
the placing of a mark identifying the fishery products,
in particular with the approval number of the establishment of origin, except in the case of frozen fishery products, landed immediately for canning and bearing the certificate provided for under (a);
(c)
drawing up a list of approved establishments and auction or wholesale markets registered and approved by the Commission in accordance with the procedure laid down in Article 15;
For that purpose, one or more lists of such establishments shall draw up on the basis of a communication from the competent authorities of the third country to the Commission. 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.
5. The conditions referred to in paragraph 4 (a) and (b) may be modified in accordance with the procedure laid down in Article 15.
The list referred to in paragraph 4 (c) may be amended by the Commission, in accordance with the rules established by Commission Decision 90/13/EEC (10).
6. To deal with specific situations and in accordance with the procedure laid down in Article 15, imports may be authorized direct from an establishment or factory vessel of a third country where the latter is unable to provide the guarantees laid down in paragraph 3, provided that the establishment or factory vessel in question has received special approval following an inspection carried out in accordance with paragraph (2). The authorization decision shall fix the specific import conditions to be followed for products coming from that establishment or factory vessel.
7. Pending the fixing of the import conditions referred to in paragraph 1, the Member States shall ensure that the conditions applied to imports of fishery products from third countries shall be at least equivalent to those governing
the production and placing on the market of Community products.
Article 12
1. The rules and principles laid down by Directive 90/675/EEC shall apply, notably as regards the organization of and follow up to the inspections to be carried out by the Member States.
2. Without prejudice to compliance with the rules and principles referred to in paragraph 1 of this Article and pending implementation of the decisions provided for in Article 8 (3) and Article 30 of Directive 90/675/EEC, and in Article 11 of this Directive the relevant national rules for applying Article 8 (1) and (2) of the said Directive shall continue to apply.
CHAPTER III Final provisions
Article 13
The Annexes shall be amended by the Council, acting by a qualified majority on a proposal from the Commission.
Article 14
The Commission, after consulting the Member States, shall by 1 July 1992 submit a report to the Council concerning the minimum structural and equipment requirements to be met by small establishments which distribute on the local market and are situated in regions subject to particular supply constraints, together with any proposals, on which the
Council, acting under the voting procedure laid down in Article 43 of the Treaty, shall act before 31 December 1992.
Article 15
1. Where the procedure laid down in this Article is to be followed, the Chairman shall refer the matter to the Standing Veterinary Committee set up by Decision 68/361/EEC (11) 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 16
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 15 for a period of two years.
Article 17
The provisions of this Directive shall be re-examined before
1 January 1998 by the Council, acting on proposals from the Commission, on the basis of experience gained.
Article 18
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 19
This Directive is addressed to the Member States.
Done at Brussels, 22 July 1991.