INTRODUCTION	3- 91/493: How to handle fishery products to be placed on the market?
Background	3.1- General provisions
The Common Fisheries Policy	3.2- Imports
Scope	4- 91/492: How to handle live bivalve mollusks to be placed on the market?
1. How the European Union makes law: an outline	4.1- General Provisions
1.1- What are the different stages for a proposal to become a law?	4.2- Imports
1.2- What are the different types of measures?	4.3- Member States requirements
1.3- Who makes proposals in the European Commission?	5- Duties and Trade measures
2- The Common Organization of the Market in Fishery and Aquaculture Products	6 - Labeling
2.1- The key elements of the E.U. market organization	7- Other legislation
2.2- The Commission is reviewing the Common Market Organ.	POINTS OF CONTACTS
Directive 91/493 Council directive of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products      (91/493/EEC Articles)	Directive 91/492 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)
Article 1   Article 6     Article 11 Article16 Article 2   Article 7     Article 12 Article17  Article 3   Article 8   Article 13   Article18 Article 4   Article 9     Article 14 Article19 Article 5   Article 10   Article 15	Article 1   Article 5      Article 9Article 13  Article 2   Article 6      Article 10Article 14    Article 3   Article 7      Article 11Article 15   Article 4    Article 8      Article 12Article 16
Annex to Directive 91/493	Annex to Directive 91/492
Chapter I       - Conditions applicable to factory vessels	Chapter I       - Conditions for production areas
Chapter II    - Requirements during and after landing	Chapter II     -  Requirements for Harvesting  & transportation of  batches to a dispatch or purification centre,relaying area or processing plant
Chapter III   -General conditions for establishments on landings	Chapter III    - Conditions for relaying live bivalve molluscs
Chapter IV   -  Special conditions for handling fishery products on shore	Chapter IV   -  Conditions for the approval of dispatch or purification centres
Chapter V    - Health control and monitoring of production conditions	Chapter V      - Requirements concerning live bivalve molluscs
Chapter VI   - Packaging	Chapter VI     - Public health control and monitoring of production
Chapter VII  - Identification marks	Chapter VII   - Wrapping
Chapter VIII - Storage and transport	Chapter VIII - Preservation and storage
	Chapter IX    - Transport from the dispatch centre
	Chapter X     - Marking of consignments

INTRODUCTION

Background

The European Union (E.U.) is made up of 15 countries. The current Member States are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom. The E.U. population is approximately 370 million people. Several Eastern European countries are already candidates to join the Union in the next decade. These countries are Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia, Slovenia and Turkey. January 1, 2003 will be the earliest date of entrance of candidate countries into the E.U.

The E.U. has four different institutions that function in many ways as the different branches of the U.S. government. These institutions are the European Commission, the Council of Ministers, the European Parliament, and the European Court of Justice.
 

• The European Commission is the E.U. executive body. It has three main tasks: to initiate E.U. policies, to act as the guardian of E.U. treaties (Rome, Maastricht and Amsterdam), and to supervise implementation of E.U. law. The Commission is divided in 24 directorates general (DG), of which DG XIV looks after fisheries, DG VI is in charge of agriculture and sanitary legislation, and DG XXIV for consumer policy and public health protection. A college of 20 Commissioners, named by their national governments but supposedly independent,  heads the Mission.
•                                                                                                                                                                                                                                                                                                                       The Council of Ministers is made up of government representatives from the 15 Member States. Each Member State is in his turn president of the Council for six months. The Ministers represent their individual country, and so defend their national interests. They are responsible for determining E.U. policies and to vote legislation. The Council has working parties and permanent or special committees consisting of representatives from Member States. The best known is the Committee of Permanent Representatives of the Member States, the COREPER.

• The European Parliament gained power over time. From an advisory-only body, it can now veto legislation in certain areas such as consumer protection, health, environment or the single market. It has 626 members, elected for five years.

• The European Court of Justice rules on disputes involving interpretation and application of the E.U. treaties and legislation.

The Common Fisheries PolicyTop

Fishing and aquaculture are important economic activities in the European Union, even if their contribution to the Gross National Product of Member States generally represents less than one percent. However, those sectors can provide more than 10 percent of all jobs in certain zones, such the Atlantic coast of Spain or Scotland.

With a production of approximatly 7.8 million tons of fish (including catches for the fish meal industry), the E.U. is the world's largest fishing power after China and Peru. However being one of the largest markets, the E.U. has a trade deficit of some 2.5 million tons of seafood products, worth about USD 7.5 billion.

The Common Fisheries Policy (CFP) is the E.U.'s instrument for the management of fisheries and aquaculture. Justification for the Community's involvement in fisheries is perfectly clear being based on Articles 38 and 39 of the Treaty of Rome signed in 1957. It means there must be common rules adopted at Community level and implemented in all Member States, covering all aspects of the fishing industry from the sea to the consumer.

It was only in 1970 that the first common measures were taken. Rules were set for access to fishing grounds, for a common market and for a structural policy to coordinate the modernization of fishing vessels, port infrastructures and processing plants. It was agreed that, in principle, all fishers should have equal access to all waters under the Community jurisdiction. However, a coastal band was reserved for local fishers and those who traditionally fished those areas. In 1976, Member States followed the worldwide movement to extend their rights from 12 to 200 miles. The change in the international access to fishing grounds really gave impetus to build the actual CFP, born after difficult negotiations in 1983.

The CFP deals with the biological, social and economic dimensions of fisheries. To integrate those multiple areas, it relies on five instruments:

-The policy and conservation management of resources (allocations of TACs and quotas, restructuration plans, technical measures on fishing gears...).
- The structural policy for fisheries (modernization of the fleet, adaptation of activity vis a vis depletion of resources).
- The Common Organization of the Markets (prices of withdrawal, distinction between fishery products and aquaculture products, quality strategies...).
- The International relations (participation of the EU in several international and regional conventions, fisheries agreement with third countries).
- The monitoring and inspection policy (of growing importance within the CFP framework).

The Agenda 2000 has introduced new guidelines for a better CFP, where concepts such as "responsible fishing" and "sustainable development" have been constantly reminded.
In March 2001, the Commission published a "Green Paper" intending to reform the CFP. The overall objective of this future Common Fishery Policy would be to reduce the European fleet and developing its aquaculture industry while paying more attention to environmental and consumer protection.
The new CFP is to be effective by January 2003 but given the strong objections from the Member States towards the Commision's proposals, it seems that the first semester 2003 is a better schedule for the CFP's implementation.

 Scope

 Top

Given the complexity of the E.U. legislation, this report provides an overview of key E.U. legislation
governing trade in edible seafood products.  It does not intend to answer all questions, any
additional comments or concerns should be addressed to competent authorities (see Points of  Contacts).

1. How the European Union makes law: an outlineTop
 

1.1- What are the different stages for a proposal to become a law?

The European Commission (which has both executive and administrative roles) initiates and drafts proposals which it submits to the European Council (whose members represent the government of the Member States, normally at ministerial level). Proposals are drafted after consultation with the relevant Commission services, management and advisory committees (such as the Scientific, Technical and Economic Committee on Fisheries, the STECF). Once the proposal is completed, it is presented to the 20 Commissioners (one of them being in charge of Fisheries).

If adopted, the proposal is sent to the Council, where it is examined by the relevant working groups and committees. Depending on the nature of the proposal, the Council may consult the European Parliament (which is elected by the citizens of the Union), the Economic and Social Committee (which consists of representatives from employer organizations, trade unions, and other interest groups) and/or the Committee of Regions (which represents regional interests).

If the COREPER agrees with the proposal, it is passed at the next Council meeting without discussion as a so-called "A Point". However, if there is no agreement, the proposal is discussed at a Council meeting in order to find a compromise. If an agreement is found, it becomes a law. Otherwise, the Commission has to decide to maintain its proposal, to amend it or to withdraw it.

The European Commission can take some measures in specific areas. The proposal is anyway discussed by Member States representatives in various committees. If Member States support the proposal, it becomes a law.

1.2- What are the different types of measures?

Regulations: a regulation is a law that is binding and directly applicable in all Member States without any implementing national legislation. Both the Council and the Commission can adopt regulations.

Example: Council Regulation (EC) No 1093/94 of 6 May 1994 setting the terms under which fishing vessels of a third country may land directly and market their catches at Community ports.

Directives: a directive is a law binding on the Member States as to the result to be achieved, but the choice of method is their own. In practice, national implementing legislation in form deemed appropriate in each Member State is necessary in most cases. This is an important point, as businesses affected by a directive have to take account of the national implementing legislation as well as the directive. All directives set a date by which Member States have to transpose it in national legislation. After that date, in case of non-implementation, the directive should remain the basis in case of dispute. The Commission can act against Member States that have not implemented the directive in time. Since 1995, the European Parliament may have with the Council a co-decision role.

Example: Council Directive 91/493 laying down the health conditions for the production and the placing on the market of fishery products.

Decisions: a decision is binding entirely on those to whom it is addressed. No national implementing legislation is required. Both the Council and the Commission can adopt decisions. Since 1995, the European Parliament can be associated to the adoption process on a limited number of issues.

Example: Commission Decision 95/328 laying down certain transitional measures concerning the certification of fishery products from third countries in order to facilitate the switchover to the arrangements laid down in Council Directive 91/493/EEC.

Recommendations: a recommendation has no binding effect (it is not a law). Both the Council and the Commission can adopt recommendations.

Example: Commission Recommendation 92/540 concerning a coordinated program for the official control of foodstuffs for 1993.

1.3- Who makes proposals in the European Commission?

The European Commission is now composed of 24 Directorates General (DG).

DG  FISHERIES  handles negotiations of International fishing agreements, resources management, aquaculture,  fleet management, and makes the Common Fishery Policy (CFP). It also makes proposals for tariff reduction, tariff suspensions and import quotas. It act as aid to DG TRADE,  part of which is the E.U. equivalent to the Office of the U.S. Trade Representative) for WTO matters.
Some species are subject to trade restrictions under the Convention on International Trade of Endangered Species which is covered by DG ENVIRONMENT. So DG FISHERIES and DG ENVIRONMENT are working closer and closer due to the current status of worldwide fish resources.

But fishery products are also subject to measures taken by DG AGRICULTURE and DG INTERNAL MARKET , and to the supervision of DG HEALTH and CONSUMER PROTECTION (SANCO). DG AGRICULTURE handles the Common Agricultural Policy (CAP) and all "vertical" measures on raw material. They make proposals on all E.U. measures concerning sanitary legislation and inspection, by type of products (beef, pork, poultry, vegetables, seafood, etc).

DG INTERNAL MARKET  deals with "horizontal" measures for processed products. They make legislation on additives, colorings, antibiotics, and labeling. All those texts refer to "foodstuffs".

DG SANCO is in charge of all scientific committees that advise DG INTERNAL MARKET and DG AGRICULTURE on matters concerning consumer health. DG SANCO includes also the Food and Veterinary Office (FVO based in Dublin, Ireland). The FVO principal missions are to monitor the observance of food hygiene, veterinary and plant health legislation within the European Union, and to contribute towards the maintenance of confidence in the safety of foods offered to European consumers. The FVO is responsible for auditing Member States' competent authorities, and to inspect third countries for compliance and/or equivalency to E.U. legislation.

2- The Common Organization of the Market in Fishery and Aquaculture Products Top

The Common Organization of the Market in Fishery and Aquaculture Products was first introduced in 1970, then reviewed in 1993 and amended in 2000 (Council Regulation 104/2000 of 17 December 1999). Its purpose is to stabilize the market, guarantee a steady supply of quality products, ensure reasonable prices for consumers and support fishermen's incomes.

2.1- The key elements of the E.U. market organization

The five components of the Common Organization of the Markets are:

• Marketing standards and consumer information for fresh products for quality, grades, packaging and labeling for domestic production as well as for imports.
• Producers' organizations (associations to which fishermen belong on a voluntary basis), officially recognized, they are set up to help stabilize markets fluctuations. Their role is to protect fishermen from sudden changes by adjusting supply to demand. They also help to improve product quality, and to make sure that fishing quotas are respected.
• Interbranch Organizations and Agreements aiming at facilitating a total integration of the sector (from the producer to the consumer).
• Prices and Intervention by which certain species cannot be sold below a given price. Financial support is available to producers' organizations to withdraw fish from the market when products reach the floor price. They can be stored to be sold when market improves, or they can be processed.
• Trade with third countries in order to insure an adequate supply to the Community market of raw material intended for the processing industry (tarriffs, customs duties, autonomous quotas).

2.2- The Commission is reviewing the Common Market Organization

Resource depletion, overcapacity of the European fleet, a fishery sector with a fragile economic viabilty: all those preceding factors were already in everyone's mind while reforming the Common Fishery Policy in 1983.
Unfortunatly, the E.U. must now acknowledge the failure of the current CFP in solving these "internal" weaknesses.
Furthermore, there are "external" challenges that make this reform even more necessary: the future enlargement of the EU with countries which have a strong aquaculture background, the emergence of developing countries in the fishing sector, the changes in consumer trends and needs (following the BSE crisis, the foot & mouth disease, asking for quality and traceability...), the globalization of the economy.
For all these reasons, the new CFP has to be ambitious in its way to maintain a viable fishing fleet as well as a competitive processing industry.

That is why the Commission has published a "Green Paper" (March 2001) which summarizes the core principles of the future CFP:
 

• To establish responsible and sustainable fisheries that ensure healthy marine ecosystems maintaining the quality, diversity and availability of marine resources and habitats.
• To contribute, through appropriate fisheries management action, to achieve the environmental objectives set out in Article 174 of the Treaty. appropriate measures to reduce the negative environmental impact of other human activities, such as maritime transport, oiling and dredging should be envisaged as complement to fisheries policy measures.
• To integrate health requirements into the CFP in order to protect public and animal health and safety, and to endure the stable supply of the European market at prices reasonable for the consumer.
• To bring fleet capacity into line as soon as possible with the availability and sustainability of the resources.
• To promote better governance by putting in place more transparent, accountable and flexible management and decision-making processes which involve stakeholders also at the regional and local levels and ensure that emergencies and conservation problems of a local nature are adequacy addressed.
• To ensure effective enforcement of CFP rules through transparent arrangements which can guarantee a level playing-field across the Union.
• To secure an economically viable and self-sufficient fisheries and aquaculture sector which can be competitive in a globalized economy.
• To address the problem of structural adjustment that will result from a commitment to sustainable fisheries.
• To promote the responsible and rational exploitation of fishery resources in international waters and to develop partnership with third countries in a manner coherent with Community development policy.
• To improve the quality and amount of relevant data to support decision-making and to promote multidisciplinary scientific research which will allow for obtaining timely and qualitative scientific information and advice on fisheries, associated ecosystems and relevant environmental factors.

3- 91/493: How to handle fishery products to be placed on the market? Top
 

3.1- General provisions

EC Directive 91/493/EEC is the main text for fish and fishery products. It concerns both domestic (E.U.) and third countries (non-E.U.) production. It defines EC standards for handling, processing, storing and transporting fish.

It must be noted that processed bivalve mollusks (as well as tunicates, marine gastropods and echinoderms) are subject to both Directive 91/492 and Directive 91/493.

Directive 91/493 lays down rules on conditions applicable to factory vessels, to on-shore plants, to packaging, to storage and transport. Provisions, that may require more details, are set concerning own-checks, parasites (all visible parasites must be removed), organoleptic, chemical and microbiological checks.

Other texts must be considered as complements to Directive 91/493 and 91/492:

• Directive 92/48 concerning minimum hygiene rules on board fishing vessels;
• Decision 94/356 to implement an own-check system (HACCP);
• Decision 93/140 concerning parasites (visual inspection, non-destructive method);
• Decision 93/351 concerning the maximum level of mercury;
• Directive 95/71/EC modifying the annex of the Directive 91/493;
• Decision 95/149 fixing TVB-N level for certain species;
• Decision 93/51 fixing microbiological criteria for cooked crustaceans and molluscs;
• Regulation 2001/466/EC setting maximum levels for certain contaminants in foodstuffs, last amended by Commission Regulations 2001/2375/EC and 2002/221/EC;
• Directive 2001/22/EC laying down the sampling methods and the methods of analyzing for the official control of the level of lead, cadmiun, mercury and 3-MCPD in foodstuffs;
• Directive 2001/13/EC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs;
• Decision 2001/183/EC laying down the sampling plans and diagnostic methods for the detection and confirmation of certain fish diseases and repealing Decision 92/532.
• Commission Decision 2002/225/EC laying down detailed rules for the implementation of Council Directive 91/492/CEE as regards the maximum level and the methods of analysis of ertain marine biotoxins in bivalve molluscs, echinoderms, tunicates and marine gastropods.
• Commission Decision 2002/226/EC establishing special health checks for the harvesting and processing of certain bivalve molluscs with a level of Amnesic Shellfish Poison (ASP) exceeding the limits laid down by Council Directive 91/492/CEE.
• Commission Regulation 2001/2065/EC laying down detailed rules for the application of Council Regulation 104/2000/EC as regards informing consumers about fishery and aquaculture products.

3.2- Imports

Even if the production and placing on the market of shellfish, fishery and aquaculture products are subject to E.U. Directives 91/492 and 91/493, those products remain in the so-called "non-harmonized products" category. It means that national rules can be applied in addition to the E.U. legislation.

3.2.1- Harmonized and Non-Harmonized countries

Third (non-E.U.) countries are classified into two categories (see lists below).  Particular account is taken of the third country legislation; of the organization and powers of the third country competent authority and inspection services; the actual health conditions.

Countries (+ Norway and Iceland as members of the European Economic Area) included in List 1 are "harmonized" or "approved" countries. It means that their legislation requirements are at least equivalent to those governing the E.U. domestic production, and that an E.U. inspection team has audited the competent authority, which satisfied E.U. requirements. A specific decision has been adopted for each of those countries fixing specific import conditions, including the official recognition of the competent authority, a specific model of health certificate and a list of approved establishments.

List 2 includes third countries that gave, at least on paper, enough guarantees concerning their inspection system and their legal sanitary requirements. But those countries have not yet been visited by an E.U. team of inspectors to audit the competent authority.  After that date, imports from non-approved countries will be banned. This list of countries, of which the United States is one, constitutes the so-called "pre-listed" or "pre-harmonized" group. Products imported from those countries may be subject to additional national legislation. Some Member States may request lists of approved establishments. A list may be fully accepted by one Member State, and partially rejected by another one.
The US is one of the countries scheduled to be part of list 1 by the end of 2003.

All other countries not mentioned in either List 1 or 2 cannot export any fish and fishery products to the European Union. If a third country, not listed in List 1 or 2, wants to export fish and fishery products to the E.U., it has first to contact the European Commission to provide information on its legal system concerning controls on seafood establishments. Discussions and negotiations may lead to an official visit of the country by a team of E.U. inspectors that will propose to approve or not that country.
 

3.2.2- Import controls

Principles for veterinary checks are laid down in Directive 97/78. Inspections of consignments originating from third countries must be carried out on all consignments, at the first point of entry into the E.U. territory and in approved border inspection posts.

Import controls are done in three consecutive steps:

- documentary check: examination of the health certificate;

- identity check: visual inspection to confirm consistency between documents and products, verification for the presence of required sanitary marks (country of origin, approval number);

- physical check: check on the product itself (organoleptic control, packaging, temperature), it may include sampling and laboratory testing.

Each shipment must be accompanied by a sanitary certificate following the model drawn up by E.U. Decision 2001/65/EC for fishery and aquaculture products and 1996/333/Ec for shellfish(see below). A certificate may be issued for goods produced in different establishments, but can only be made to one consignee. A certificate may be issued for several containers of the same product considered to be a single lot.

It must be noted that a certificate defines a lot; therefore a rejection may be decided for all goods covered by the same certificate, even if only a part of it presents a sanitary or documentary problem.

The certificate must be issued in one of the official languages of the country of entry into the E.U. territory, and if necessary in the language of the country of destination. In practice, the veterinary office of the point of entry into the E.U. does the documentary check and issues an "Annex B" which as to be in the language of the country of destination.

In the United States, both the Food and Drug Administration and the US Department of Commerce (National Marine Fisheries Service) have the authority to issue certificates for export to the E.U.

Each import control (one certificate = one control) is subject to inspection fees.

In the case of processed food containing animal products (surimi for example), the European importer must have a "import licence" from the Customs Authorities before the import process occures.

Products imported from "harmonized" countries are subject to the documentary, identity and physical checks at the approved border inspection post at the first point of entry into the E.U. territory. When such a consignment satisfies E.U. requirements, it is then considered as an E.U. product. That is to say that if a consignment can be marketed in one Member State, it can be marketed in all the others without being subject to non-harmonized rules.

If the documentary and the identity checks must be performed on all consignments, the frequency of physical checks is reduced for products from "harmonized" countries from a theoretical 100 per cent to a theoretical 20 percent for fish products in hermetically sealed containers, for fresh and frozen fish, for dry and/or salted products, to 50 percent for other fishery products and for bivalve mollusks.

The "China Case":

The European Union has adopted on January 30, 2002, the Decision 2002/69/EC concerning certain protective measures with regards to the products of animal origin imported from China. This ban is the consequence of an inspection conducted in China that revealed a very poor residue inspection system on the one hand, and of the presence of antibiotic (Chloramphenicol) in shrimps imported from teh Chinese territory on the other hand.

As a consequence:

• All seafood products coming from China are concerned by this ban except fish catched, frozen, packed "on board" and landed within the Community territory. this derogation doesn't apply to crustaceans.
• US products exported to China for processing are also concerned by this ban.
• All Aquaculture products coming from China are prohibited within the EU.

The Commission reviewed its ban on July 2002 and authorized certain species to enter the EU Territory under very strict conditions.
20% of all shipments coming from China are subject to tests and analysis in order to detect the presence of antibiotics such as Chloramphenicol and Nitrofurans. These tests are to the expenses of the exporter/importer and lead to a 2 to 3 weeks delay.
The list of products of animal origin intended for human consumption or animal feed use authorized to be imported into the Community, subject to a chemical test under the conditions of Article 3 of Decision 2002/69/EC (last amended by Decision 2002/573/EC), is as follow:

1. Entire fish, fish de-headed and gutted, and fish fillets from the following species caught at sea:
- Alaska Pollack (Theragra chalcogramma)
- Cod (Gadus spp.)
- Redfish (Sebastes spp.)
- Blue Whiting (Micromesistius poutassou)
- Halibut (Reinhardtius spp.)
- Haddock (Melanogrammus aeglefinus)
- Herring (Clupea spp.)
- Yellowfin sole (Limanda spp.)
- Cephalopods (Sepiidae, Sepiolidae, Loliginidae, Ommastrephidae, Octopodidae)
- Plaice (Pleuronectes platessa)
- Pacific Salmon (Oncorhynchus keta, O. kisutch, O. nerka, O. gorbuscha)

2.Fillets of salmon (Salmon salar)

3. Casings'

This list is dated from July 2002 and may be subject to changes in function of the review of the Decision.

3.2.3- Member States

France:
In 1979, France published a decree setting microbiological criteria for food products. Those criteria are considered to be guidelines only, but may be interpreted in a stricter manner leading to rejection of products.
In case of serious sanitary problems, the establishment of origin may be subject to systematic controls. Veterinary authorities block products until results of laboratory tests are known. Three consecutive shipments must have good results in order to have this measure lifted.

Germany:
For animal welfare reasons, German authorities prohibit the importation of live eels if not packed in a "sufficient" volume of water. However, glass-eels may be transported in a moist atmosphere.

Spain:
Strict limits of copper and cadmium are set for cephalopods, respectively 20 and 1 ppm.
 
 

Top

Last Updated on 08/07/2002
By NMFS
Email: Stephane.vrignaud@mail.doc.gov
Top

I. Countries and territories covered by a specific decision under Council Directive 91/493/EC

(1) Authorized only for imports of live crayfish (Astacus leptodactylus) intended for direct human consumption
(2) Authorized only for import of fresh fish
(3) Authorized only for imports of caviar
(4) Authorized only for import of fishery products caught frozen and packed in their final packaging at sea
(5) Authorized only for import of live animals for direct human consumption
(6) Authorized only for imports of non-processed and non-prepared fresh aquaculture products.

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4- 91/492: How to handle live bivalve mollusks to be placed on the market?

4.1- General Provisions

EC Directive 91/492/EEC is the main legislation concerning live bivalve mollusks, tunicates, marine gastropods and echinoderms (named bivalve hereafter). It defines conditions for placing those live animals on the market for immediate consumption. It also set criteria concerning production areas, harvesting and transportation, relaying and purification.

In general terms, the E.U. and the U.S. legislation are very similar when defining several categories of production areas. The main difference remains in the method of control to qualify those areas. The E.U. requests tests to be performed on animal flesh, where the United States relies on water tests.

E.U. officials unofficially state that both methods appear to be in good correlation for bivalve mollusks such oysters and mussels. Results differ for clams in general.
 

4.2- Imports

As for fish and fishery products, live and processed bivalve mollusks can be imported only from approved countries. Right now two lists exist with "harmonized" and "pre-approved" countries (see below).

A health certificate that may be obtained from the Food and Drug Administration or the US Department of Commerce (National Marine Fisheries Service) must accompany each consignment. Certificates will be delivered only for products originated from U.S. establishments listed in the FDA Interstate Certified Shellfish Shippers List.

As for fish and fishery products, the certificate must be at least in one of the official languages of the country of entry into the European Union.

Scallops are an exception. Directive 91/492 concern only farmed scallops. Wild-caught Pectinidae may be imported from any country that is authorized to export fish and fishery products. In this case, they must be processed (at least frozen, shelled) and roe-off. Live and roe-on wild-caught scallops, and all type of farmed scallops must be imported only from countries approved or pre-approved for bivalve mollusks.
 

4.3- Member States requirements

Top

For non-harmonized countries, of which the United States is one, E.U. Member States may or may not accept live bivalve mollusks to be imported for immediate human consumption.

As of August 2002, the following Member States have indicated their national requirements:

France:
Live bivalve mollusks must be imported in closed packages that may be sold as such to retailers. The French measure is intended to prohibit the relaying of imported mollusks in their coastal area to avoid development of "exotic" diseases. It is advisable to use packaging of less than 15 kg. The so-called "Reshippers", according to FDA definition, can not be listed in Part II of the certificate, as they are not considered as the establishment of origin.

Italy:
Italian authorities made clear that no live bivalve mollusks will be accepted on the Italian territory unless the country of origin has been approved by the European Commission (List I).

Spain:
Spain prohibits the imports of live bivalve molluscs from the US. Only frozen and/or processed bivalve molluscs are authorized (Royal Decree 2/2001 of May 24, 2001)

The other twelve Member States do not have any particular requirements or prohibitions.

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Example Health Certificate

Last Updated on 04/17/2000
By NMFS
Email: Eric.Fleury@mail.doc.gov

 I. Third Countries which have been the subject of a specific decision under Council Directive 91/492/EC

                                        (1) Only for marine gastropods

II. Third Countries which may be the subject of a provisional decision based on Council Decision 95/408/EC

(1) (only for products sterilized or heat-treated under the conditions laid down in Commission Decision 93/25/EEC)

5- Duties and Trade measures

All E.U. fish tariffs have been consolidated in the GATT agreement of the Tokyo Round.  The overall average of E.U. duties for Chapters 3, 1604 and 1605 is 17.2%, one of the highest in the world. The tariff range goes from 0% (live eels) to 25% (canned mackerel, bonito and anchovies).

However, the E.U. provides different mechanisms to reduce duties. It claims that its overall tariff average is then reduced to around 3 to 4%.
 

• An overall duty-free scheme applies to Africa-Caribbean-Pacific (ACP) countries, signatories of the Lomé Convention, for all seafood products.
• The Generalized System of Preferences (GSP), which applies to developing countries, covers all seafood products of Chapter 3. Products are classified as non-sensitive, semi-sensitive, sensitive and very sensitive. Reduced duties are 0%, 35%, 70% and 85%, respectively, of the conventional rate. Products, for which no sensitivity has been defined, are not entitled to reduced duties under the GSP.    It is important to note that Russia, Thailand and South Korea in particular do not enjoy GSP privileges.
• The ANDEAN group, meant to help those countries to combat drugs, enjoys duty-free rate on most of Chapter 3 lines.
• "Access to markets" for "Access to Resources" is the preferred E.U. strategy of fish trade negotiations. Some advantages are so granted, product by product, following signatures of fishing agreements (Argentina: reduced duty for hake fillets; Morocco: duty-free imports of canned sardines...)
• All eastern countries (candidates for future accession to the EU) have recently signed Agreements on the progresive elimination of customs duties for fishery products (i.e. 0% duty rate by 2004 at the latest).

 

Otherwise, a number of GATT-bound Tariff-Rate-Quotas has been negotiated over the years.

Recognizing the needs of its processing industry, the E.U. unilaterally reduce duties for certain portions of its imports using two yearly mechanisms, suspensions and autonomous quotas. Most of the products concerned must be further processed within the E.U.
For a better impact, reduced duties must be requested first by the European importer.

Suspensions (see below), set on a yearly basis, provide better access for raw material needed by the E.U. industry on an unlimited basis (Alaskan pollack fillets blocks, hard fish roes). Applied duties may be a full suspension (duty-free) or a reduced duty. Many products are subject to a reference price.

Autonomous quotas (see below) are opened on a yearly basis (from April 1 until December 31). Each product (or group of products) is subject a quantitative limit. The quota remains opened until the limit is reached. Quantities and reduced duties may change every year depending on Member States' demands (following national industry requirements) and the compromise reached usually at ministerial level. Most products are also subject to reference prices.

The system of reference prices is based on an essential part of the CFP, the support of fishermen's incomes. Based on past years landing prices, the E.U. fixes on a yearly basis minimum prices for a wide range of species. Depending on those prices are calculated several aids to Producers Organizations (POs) like withdrawal prices, carry-over aids.
 

Tariff Suspensions

To be entitled to a tariff suspension or reduction, importers must buy the concerned product at a "free-at-frontier" price (C&F) higher than the reference price. Otherwise, products may be imported, but the full conventional rate applies. For example, an autonomous quota is opened for product A with a reduced duty of 5% instead of the conventional 15%, subject to the respect of a reference price of $100. If the C&F price paid by the importer is:

• $ 95: the importer cannot access the quota, and must pay a 15% duty;

• $ 110: the importer can access the quota and will pay a 5% duty.

In October for suspensions, and December for autonomous quotas, the European Commission consults the fifteen Member States to know about the needs of each national industry.  Summing the different needs, a proposal is sent to all governments to be discussed in various committees. A decision has to be made for the December (suspensions) and April (autonomous quotas) Fisheries Councils of Ministers.

It is impossible to request a suspension at once for a product not yet entitled to a reduced duty. But a product may be moved from the list of autonomous quotas to the list of suspensions, or quantities of a quota may be increased and its duty further reduced. It is also possible to open new autonomous quotas.

To attain such goals, it is imperative to get European buyers involved. Showing their needs and the importance of imports for their supplies, the concerned European industry can request to the E.U. Commission, through their government, a reduced duty for a certain amount. Without the E.U. industry involvement, no proposals can be made.

Once a reduced duty has been obtained, the product can be petitioned for a move to a suspension of the tariff.  However, the move from reductions to suspension is difficult to obtain.

The EU Fisheries Council of December 1999 finally decided on the final text for the renewal of the EU Common Organization of Markets for fish and fishery products (2000/104/EC). Some products (surimi, Alaskan pollock fillets and meat blocks) considered as essential to the EU processing industry to remain competitive will enjoy total or partial suspension of customs duties. For some other products (H&G cod, tuna loins, herring flaps), pluri-annual autonomous quotas at a reduced duty rate have been decided for the period 2001-2003.
The current discussions that follow the Doha Talks are good opportunity for the US to ask again for a complete elimination of customs duties for fishery products.

2001 E.U. AUTONOMOUS SUSPENSIONS (Council Regulation 2002/1120/EC)

2000 Autonomous Quotas (January 1 - December 31) and WTO (Annex 7) quotas

Council Decision 2803/2000 and 2031/2001 (annex 7)

 Official Journal L331 of 12/14/00 and OJ 10/23/2001

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Product description	Quantity (tons)	Duty rate (%)
Cod livers (Gadus morhua, ogac and macrocephalus), for processing	300	0
Cod (Gadus morhua, ogac and macrocephalus) salted but not dried, for processing (quota period 1/1/01-12/31/03)	10,000	0
Squid (Ommastrephes spp, Nototodarus spp, Sepioteuthis spp, Illex spp) tubes, frozen, for processing (quota period 1/1/01-12/31/03)	11,000	3.5
Squid (Ommastrephes spp, Nototodarus spp, Sepioteuthis spp,Illex spp), frozen whole, tentacles and fins, for processing (quota period 1/1/01-12/31/03)	500	3
Herrings, whole or fillets,including flaps, fresh, chilled or frozen (quota period 11/1/01 - 12/31/01, 11/1/02-12/31/02, 11/1/03-12/31/03)	20,000	0
Tuna loins, for processing (quota period 1/1/01-12/31/03)	4,000	6
Herring, spice/vinegar cured, in brine preserved in barrels of at least 70 kg net drained weight, for processing (quota period 1/1/01-12/31/03)	5,000	6
Shrimps and prawns of the species Pandalus borealis, cooked and peeled, for processing (quota period 1/1/01-12/31/03)	5,000	6
Tunas (of the genus Thunnus) and fish of the genus Euthunnus	17, 250	0
Herrings	34,000	0
Siver Hake (merlucius bilinearis)	2,000	8
Fish of the genus Coregonus	1,000	5.5
Fish of the genus Allocyttus and of the species Pseudocyttus maculatus	200	0
Cod of the species Gadus morhua and Gadus ogac Fish of the species Boregadus saida	25,000	0
Shrimps of the species Pandalus borealis, shelled, boiled, frozen, but not further prepared	500	0
Freshwater crayfish, cooked in dill, frozen	3,000	0

Autonomous Duty Suspensions from January 2001(104/2000/EC)

Autonomous quotas for 2001, 2002 and 2003

6 - Labeling

The two main Regulations with respect to labeling are the Council Regulation 2000/104/EC and the Council Directive 2000/13/EC. But additional Regulations are expected in the context of  "Public safety" and "Organic Food".
Foot and Mouth disease, BSE crisis, Heavy metals...All these preceding crisis have reinforced the critical need for information, communication and transparency towards consumers. All new EU Regulation is (and will be) based on consumer confidence and safety in such a way that "the consumer will not be misleaded by any product or packaging".

For sanitary purposes, and especially to allow traceability of seafood products, the EU legislation requests that all packages bear the country of origin and the approval number of the establishment of origin. Those two items must be written or printed "indelibly". The most desirable way would be to have them pre-printed on packages/cartons. In cases where stick-on labels may be used, they must not be easily destructible when attempts are made to remove them, i.e. tear into small pieces.
Labels must be in a language "easily understandable" by users. National legislation may ask for the official language(s). It is always better to use that official one. Labels may be in several languages.

Since january 1 2002, the Commission Regulation 2001/2065/EC imposes new requirements for the labeling of fishery and aquaculture products intended to the retail sector. This Regulation only concerns products from Chapter 3 of the Tariff Harmonized System, and not products from Chapter 16 (canned products for instance).
Three sets of information are now compulsory on the label of any fishery and aquaculture products on sales at retailers:

• The Commercial name of the species (the Latin name is not compulsory on the label except if your client requires it). Each Member State has established a list of commercial names applicable. These lists are visible on the EU web site.
• The production method (aquaculture or fishery product). The proper language to use is "caught in...", "caught in fresh water", "farmed" or "cultivated". However Member States may decide whether this information is required when the commercial designation and the area of capture make it obvious that the fish was caught at sea.
• The catch area. Products caught at sea have to show the area of capture (taken from the FAO list, Annex of the above Regulation). However, only the general area has to be mentioned (Pacific ocean for example) and not the Area codes. Products caught in fresh water requires a reference to the Member State or third country of origin of these products. As for farmed products, the reference is to the Member State or third country in which the product undergoes the final stage of development. Perators may wel choose to provide additional information on the area.

To ensure a perfect traceability at all stages of the marketing process, fisheries and aquaculture products have to be accompanied by a document indicating the information described above as well as the Latin name of the products. The document concerned can be the invoice.

6.1- Fresh, chilled products

• species
• country of origin (roman letters, min. 2 cm)
• presentation (whole, gutted, fillet, etc)
• freshness grade and size category (for species with common standards, min 5 cm)
• net weight in kg (except for standard boxes, average net weight is enough)
• date of grading and dispatch
• name and address (city + state) + "FDA approval #" of processor/packer

Freshness grading is only for whole/gutted fresh fish.

6.2- Frozen products

• species followed by the word "frozen"
• country of origin
• presentation (may be included with the name of the species)
• net weight in kg
• list of ingredients (except if fish only)
• date of minimum durability (month/year) or " best before" date (cf  Directive 2000/13/EC)
• special storage conditions (to be maintained at - 18^o C)
• instructions for use (if not obvious), incl. "do not freeze again once thawed"
• name and address of the manufacturer, or of a seller in the EC
• "FDA approval #" of the packer (CFN)
• lot # (it must begin by "L" or the world "LOT") (not always mandatory).
• The lot # is defined by the processor in order to be able to trace a product history in case of problem.  It can be the production date.

 
Example: L8110B15 may mean: L = Lot
                                                          8 = 1998
                                                         110 = day of production 110
                                                         B15 = production line
 

For deep-frozen foods:

Storage conditions and maximum period of storage:

between 0 and 5 ^oC : 1 day
"*", or between -5 and 0 ^oC : 1 week
"**", or between -12 and -6 ^oC : 1 month
"***", or at least at -18 ^oC : up to the best before date.

For frozen goods, the following mentions are not mandatory:

• storage conditions
• "do not refreeze once thawed"
• lot #

6.3- Live bivalve mollusks

• species (common name and Latin name)
• country of dispatch
• date of wrapping (at least day and month)
• date of durability or "these animals must be alive when sold"
• net weight (kg)
• identification of the dispatch center by its approval number
• name and address (city + state) of packer + "FDA approval #" (Interstate Certified Shellfish Shipper #)

6.4- Canned products

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• name of product
• country of origin
• net weight in grams (or liter for liquid products)
• net drained weight (in case of solid packed in a usually-not-consumed liquid)
• list of ingredients (added water is an ingredient)
• date of minimum durability (year)
• any special storage conditions or conditions of use
• instructions for use (if not obvious)
• name and address of the manufacturer, or of a seller established within the E.U.

"FDA approval #" of the packer (CFN)

7- Other legislation

Besides the above-mentioned legislation, the E.U. sets various requirements for a wide range of issues. It includes legislation on:

• Additives, colorings and sweeteners allowed to be used.
• Packaging materials regarding their stability to not transfer substances to foodstuffs in quantities that may be harmful to human health, or change organoleptic properties; regarding waste standardizing information systems for recycling to contribute to environmental protection.
• Commission Decision 2001/219/EC on temporary emergency measures in respect of wood packing comprised in whole or in part of non-manufactured coniferous wood origniating in Canada, China, Japan and the US.
• Measurement units: the enforcement of E.U. directive on metric labeling only (no imperial measures could be used as dual labeling) is postponed to year 2010.

All EU Regulations can be find on the following website:
www.europa.eu.int

POINTS OF CONTACTS

N.O.A.A. – National Marine Fisheries Service

 
 

Office of Industry and Trade (Silver Spring, MD):	Phone (301) 713 2379  Fax (301) 713 2384
Linda Chaves	Linda.Chaves@noaa.gov
Jerome Erbacher	Jerome.Erbacher@noaa.gov
Robert Nordstrom	Robert.Nordstrom@noaa.gov
Greg Schneider	Greg.Schneider@noaa.gov

Inspection Service (Silver Spring, MD):	Phone (301) 713 2355  Fax (301) 713 1081
Richard Cano – Richard.Cano@noaa.gov	Kenneth Aadsen – Kenneth.Aadsen@noaa.gov

Regional Offices:
North-East:  Trade	Inspection
– NMFS Headquarters - Phone (301) 723 2379 - fax (301) 713 2384	– David Moisan – Phone (978) 281 9292 - fax (978) 281 9134
South-East:   Trade	Inspection
– Bill Antozzi - Phone (727) 570 -5335 - fax (727) 570 5300	– Robert J. Buckley – Phone (727) 570 5383 - fax (727) 570 5387
- South-West: Trade	Inspection
– Sonee Sonu – Phone (562) 980 4030 - fax (562) 980 4047	– Eric Staiger – Phone (323) 526 7412 – fax (323) 526 7417
- North-West: Trade	Inspection
– Steve Freese - Phone (206) 526 3117 - fax (206) 526 6544  – Rick Ranta – Phone (206) 526 6114	Phone (206) 526 4259 - fax (206) 526 4264

European office	Phone +32 2 508 2842   Fax +32 2 513 1228
– Stéphane Vrignaud	Stephane.Vrignaud@mail.doc.gov

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Directive 91/493  Top

Council directive 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 put 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:

 
 

Batch	Fishery products	Preserve
Chilling	Fresh products	Prepared products
Clean seawater	Frozen products	Processed products
Competent authority	Importation
Consignment	Means of transport
Establishment	Packaging
Factory vessel	Placing on the market

 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;
TOC Article 2

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;
TOC Article 2

3. 'chilling' means the process of cooling fishery products to a temperature approaching that of melting ice;
TOC Article 2

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;
TOC Article 2

5. 'prepared products' means any fishery product which has undergone an operation affecting its anatomical wholeness, such as gutting, heading, slicing, filleting, chopping, etc.;
TOC Article 2

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;
TOC Article 2

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;
TOC Article 2

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;
TOC Article 2

9. 'packaging' means the procedure of protecting fishery products by a wrapper, a container or any other suitable device;
TOC Article 2

10. 'batch' means the quantity of fishery products obtained under practically identical circumstances;
TOC Article 2

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;
TOC Article 2

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;
TOC Article 2

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;
TOC Article 2

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;
TOC Article 2

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;
TOC Article 2

16. 'importation' means the introduction into the territory of the Community of fishery products from third countries;
TOC Article 2

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;
TOC Article 2
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.

TOC Article 2

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) and 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:

Table of Contents

• 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 1shall 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 auctions 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. Table of Contents
 

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.
For the Council
the president P. Dankert

____________________________
Notes:

(1) OJ no C 66, 11. 3. 1988, p. 2; OJ no C 282, 8. 11. 1989, p. 7 and OJ no C 84, 2. 4. 1990, p. 56.
(2) OJ no C 96, 17. 4. 1989, p. 29 and OJ no C 183, 15. 7. 1991.
(3) OJ no C 134, 24.5. 1988, p. 31 and OJ no C 332, 31. 12. 1990, p. 59.
(4) OJ no L 379, 31.12. 1981, p. 1.
(5) OJ no L 282, 2. 10. 1989, p. 1.
(6) OJ no C 96, 17. 4.1989, p. 199.
(7) OJ no L 395, 30. 12. 1989, p. 13.
(8) OJ no L 373, 31. 12.1990, p. 1.
(9) see page 1 of this Official Journal.
(10) OJ no L 8, 11. 1.1990, p. 70.
(11) OJ no L 255, 18. 10. 1968, p. 23.

Directive 91/493 AnnexTop
 
 

Chapter I - Conditions applicable to factory vessels

Chapter II - Requirements during and after landing

Chapter III - General conditions for establishments on land

Chapter IV - Special conditions for handling fishery products on shore

Chapter V - Health control and monitoring of production conditions

Chapter VI - Packaging

Chapter VII -  Identification marks

Chapter VIII -Storage and transport

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  Chapter I - Conditions applicable to factory vessels

I. Conditions concerning design and equipment

1. The minimum requirements for factory vessels are as follows:

(a) a reception area set aside for taking fishery products on board, designed and arranged into pounds or pens that are large enough to allow each successive catch to be separated. The reception area and its movable parts must be easy to clean. It must be designed in such a way as to protect the products from the sun or the elements and from any source of dirt or contamination;

(b) a system for conveying fishery products from the reception area to the work area that conforms with rules of hygiene;

(c) work areas that are large enough for the preparation and processing of fishery products in proper conditions of hygiene. They must be designed and arranged in such a way as to prevent any contamination of the products;

(d) storage areas for the finished products that are large enough and designed so that they are easy to clean. If a waste processing unit operates on board, a separate hold must be designated for the storage of these by-products;

(e) a place for storing packaging materials that is separate from the product preparation and processing areas;

(f) special equipment for pumping waste or fishery products that are unfit for human consumption either directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to cleaning, separate areas must be allocated for that purpose;

(g) equipment providing a supply of potable water within the meaning of Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption (¹) or pressurized clean seawater. The seawater intake must be situated in a position where it is not possible for the water being taken in to be affected by discharges into the sea of waste water, waste and engine coolant outlets;

(h) a suitable number of changing rooms, wash basins and toilets, the latter not opening directly onto areas where fishery products are prepared, processed or stored. The wash basins must be equipped with appliances for washing and drying the hands that comply with hygiene requirements; the wash-basin taps must not be hand-operable.

2. Areas used for the preparation and processing or freezing/quick-freezing of fishery products must have:

(a) a non-slip floor that is also easy to clean and disinfect and equipped for easy drainage of water. Structures and fixtures must have limber holds that are large enough not to be obstructed by fish waste and to allow water to drain freely;

(b) walls and ceilings that are easy to clean, particularly where there are pipes, chains or electricity conduits;

(c) the hydraulic circuits must be arranged or protected in such a way as to ensure that it is not possible for any leakage of oil to contaminate fishery products;

(d) adequate ventilation and, where necessary, proper vapour extraction;

(e) adequate lighting;

(f) appliances for cleaning and disinfecting tools, equipment and fittings;

(g) appliances for cleaning and disinfecting the hands with taps that are not hand-operable and with single use towels.

 3. Equipment and tools such as cutting benches, containers, conveyors, gutting or filleting machines, etc., must be resistant to seawater corrosion, easy to clean and disinfect and well-maintained.

4. Factory vessels which freeze fishery products must have:

(a) a refrigeration plant sufficiently powerful to lower the temperature rapidly so as to achieve a core temperature that complies with the specifications of this Directive;

(b) refrigeration plants sufficiently powerful to keep fishery products in the storage holds at a temperature that complies with the specifications of this Directive. The storage holds must be equipped with a temperature recording system placed so that it can easily be consulted.
___________________________

Notes (¹) OJ no L 229, 30. 9.1980, p. 11. Directive last amended by the 1985 act of accession (OJ no L 302, 15. 11. 1985, p. 218).

II. Conditions of hygiene relating to on-board handling and storage of fishery products

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1. A qualified person on board the factory vessel must be responsible for applying good fishery products manufacturing practices. That person shall have the authority to ensure that the provisions of this Directive are applied and shall make available to inspectors the programme for inspecting and checking critical points as applied on board, a register containing that person's comments and the temperature recordings that may be required.

2. The general conditions of hygiene applicable to areas and equipment shall be those laid down in Chapter III, Section II (a), of this Annex.

3. The general conditions of hygiene applicable to staff shall be those laid down in Chapter III, Section II (b), of this Annex.

4. Heading, gutting and filleting must be carried out under the conditions of hygiene laid down in Chapter IV, Section I (2), (3) and (4) of this Annex.

5. On-board processing of fishery products must be carried out under the conditions of hygiene laid down in Chapter IV, Sections III, IV and V of this Annex.

6. Fishery products must be wrapped and packaged under the conditions of hygiene laid down in Chapter VI of this Annex.

7. On-board storage of fishery products must be carried out under the conditions of hygiene laid down in Chapter VIII, points 1 and 2, of this Annex.
 

Directive 91/493 Annex

Chapter II - Requirements during and after landing

1. Unloading and landing equipment must be constructed of material which is easy to clean and disinfect and must be kept in a good state of repair and cleanliness.

2. During unloading and landing, contamination of fishery products must be avoided. It must in particular be ensured that:

- unloading and landing operations proceed rapidly;

- fishery products are placed without unnecessary delay in a protected environment at the temperature required on the basis of the nature of the product and, where necessary, in ice in transport, storage or market facilities, or in an establishment;

- equipment and handling practices that cause unnecessary damage to the edible parts of the fishery products are not authorized.
 

3. Parts of auction or wholesale markets where fishery products are displayed for sale must:

(a) be covered and have walls which are easy to clean;

(b) have waterproof flooring which is easy to wash and disinfect and laid in such a way as to facilitate the drainage of water and have a hygienic waste water disposal system;

(c) be equipped with sanitary facilities with an appropriate number of wash basins and flush lavatories. Wash basins shall be supplied with materials for cleaning the hands and single use hand towels;

(d) be well lit to facilitate the inspection of fishery products provided for in Chapter V of this Annex;

(e) when they are used for display or storage of fishery products, not be used for other purposes; vehicles emitting exhaust fumes which may impair the quality of the fishery products not be admitted to markets; undesirable animals must not be admitted;

(f) be cleaned regularly and at least after each sale; crates must, after each sale, be cleaned and rinsed inside and outside with drinking water or clean seawater; where required, they must be disinfected;

(g) have displayed in a prominent position signs prohibiting smoking, spitting, eating and drinking;

(h) be closeable and be kept closed when the competent authority considers it necessary;

(i) have facilities to provide adequate water supplies satisfying the conditions laid down in Chapter III, Section I, point 7 of this Annex;

(j) have special watertight receptacles made of corrosion-resistant materials for fishery products which are unfit for human consumption;

(k) insofar as they do not have their own premises on-the-spot or in the immediate vicinity on the basis of the quantities displayed for sale, have, for the purposes of the competent authority, an adequately equipped lockable room and the equipment necessary for carrying out inspections.

4. After landing or, where appropriate, after first sale, fishery products must be transported without delay, under the conditions laid down in Chapter VIII, of this Annex, to their place of destination.

5. However, if the conditions laid down in point 4 are not fulfilled, the markets in which fishery products may be stored before being displayed for sale or after being sold and pending transport to their place of destination must have sufficiently large cold rooms which satisfy the conditions laid down in Chapter III, Section I, point 3 of this Annex. In such cases, fishery products must be stored at a temperature approaching that of melting ice.

6. The general conditions of hygiene laid down in Chapter III, Section II - with the exception of point b 1(a) - of this Annex shall apply mutatis mutandis to the markets in which fishery products are displayed for sale or stored.

7. The wholesale markets in which fishery products are displayed for sale or stored shall be subject to the same conditions as those laid down in points 3 and 5 of this Chapter and to those set out in points 4, 10 and 11 of Chapter III, Section I of this Annex.

The general conditions of hygiene laid down in Chapter III, Section II of this Annex shall apply mutatis mutandis to wholesale markets.

Directive 91/493 Annex

Chapter III - General conditions for establishments on land

I. General conditions relating to premises and equipment

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Establishment shall afford at least the following facilities:

1. working areas of sufficient size for work to be carried out under adequate hygienic conditions. Their design and layout shall be such as to preclude contamination of the product and keep quite separate the clean and contaminated parts of the building;

2. in areas where products are handled, prepared and processed:

(a) waterproof flooring which is easy to clean and disinfect and laid down in such a way as to facilitate the drainage of the water or provided with equipment to remove water;

(b) walls which have smooth surfaces and are easy to clean, durable and impermeable;

(c) ceilings or roof linings which are easy to clean;

(d) doors in durable materials which are easy to clean;

(e) adequate ventilation and, where necessary, good steam and water-vapour extraction facilities;

(f) adequate natural or artificial lighting;

(g) an adequate number of facilities for cleaning and disinfecting hands. In work rooms and lavatories taps must not be hand-operable. These facilities must be provided with single use hand towels;

(h) facilities for cleaning plant, equipment and utensils;
 

3. in cold rooms where fishery products are stored:

- the provisions set out under point 2 (a), (b), (c), (d) and (f);

- where necessary, a sufficiently powerful refrigeration plant to keep products at temperatures prescribed in this Directive;
 

4. appropriate facilities for protection against pests such as insects, rodents, birds, etc.;

5. instruments and working equipment such as cutting tables, containers, conveyor belts and knives made of corrosion-resistant materials, easy to clean and disinfect;

6. special watertight, corrosion-resistant containers for fishery products not intended for human consumption and premises for the storage of such containers if they are not emptied at least at the end of each working day;

7. facilities to provide adequate supplies of drinking water within the meaning of Directive 80/778/EEC, or alternatively of clean seawater or seawater treated by an appropriate system, under pressure and in sufficient quantity. However, by way of exception, a supply of non-drinking water is permissible for the production of steam, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the products. Non-drinking-water pipes must be clearly distinguished from those used for drinking water or clean seawater;

8. hygienic waste water disposal system;

9. an adequate number of changing-rooms with smooth, water-proof, washable walls and floors, wash basins and flush lavatories. The latter may not open directly onto the work rooms. The wash basins must have materials for cleaning the hands and disposable towels; the wash basin taps must not be hand-operable;

10. if the volume of products treated requires regular or permanent presence an adequately equipped lockable room for the exclusive use of the inspection service;

11. adequate facilities for cleaning and disinfecting means of transport. However, such facilities are not compulsory if there is a requirement for the means of transport to be cleaned and disinfected at facilities officially authorized by the competent authority;

12. establishments keeping live animals such as crustaceans and fish must have appropriate fittings ensuring the best survival conditions provided with water of a quality such that no harmful organisms or substances are transferred to the animals.
 

II. General conditions of hygiene

A. General conditions of hygiene applicable to premises and equipment

1. Floors, walls and partitions, ceilings or roof linings, equipment and instruments used for working on fishery products must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the products.

2. Rodents, insects and any other vermin must be systematically exterminated in the premises or on the equipment; rodenticides, insecticides, disinfectants and any other potentially toxic substances must be stored in premises or cupboards which can be locked; their use must not present any risk of contamination of the products.

3. Working areas, instruments and working equipment must be used only for work on fishery products. However, following authorization by the competent authority they may be used at the same time or other times for work on other foodstuffs.

4. Drinking water, within the meaning of Directive 80/778/EEC, or clean seawater must be used for all purposes. However, by way of an exception, non-drinking waster may be used for steam production, fire-fighting and the cooling of refrigeration equipment, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the products.

5. Detergents, disinfectants and similar substances must be approved by the competent authority and used in such a way that they do not have adverse effects on the machinery, equipment and products.
 

B. General conditions of hygiene applicable to staff

1. The highest possible standard of cleanliness is required of staff. More specifically:

(a) staff must wear suitable clean working clothes and headgear which completely encloses the hair. This applies particularly to persons handling exposed fishery products;

(b) staff assigned to the handling and preparation of fishery products must be required to wash their hand at least each time work is resumed; wounds to the hands must be covered by a waterproof dressing;

(c) smoking, spitting, eating and drinking in work and storage premises of fishery products must be prohibited.

2. The employer shall take all the requisite measures to prevent persons liable to contaminate fishery products from working on and handling them, until there is evidence that such persons can do so without risk.

When recruited, any person working on and handling fishery products shall be required to prove, by a medical certificate, that there is no impediment to such employment. The medical supervision of such a person shall be governed by the national legislation in force in the Member State concerned or in the case of third countries by specific guarantees to be fixed under the procedure set out in article 15.

Directive 91/493 Annex

Chapter IV - Special conditions for handling fishery products on shore

I. Conditions for fresh products

1. Where chilled, unpackaged products are not dispatched, prepared or processed immediately after reaching the establishment, they must be stored or displayed under ice in the establishment's cold room. Re-icing must be carried out as often as is necessary; the ice used, with or without salt, must be made from drinking water or clean seawater and be stored under hygienic conditions in receptacles provided for the purpose; such receptacles must be kept clean and in a good state of repair. Prepacked fresh products must be chilled with ice or mechanical refrigeration plant creating similar temperature conditions.

2. If they are not carried out on board, operations such as heading and gutting must be carried out hygienically. The products must be washed thoroughly with drinking water or clean seawater immediately after such operations.

3. Operations such as filleting and slicing must be carried out in such a way as to avoid the contamination or spoilage of fillets and slices, and in a place other than that used for heading and gutting operations. Fillets and slices must not remain on work tables any longer than is necessary for their preparation. Fillets and slices to be sold fresh must be chilled as quickly as possible after preparation.

4. Guts and parts that may constitute a danger to public health must be separated from and removed from the vicinity of products intended for human consumption.

5. Containers used for the dispatch or storage of fresh fishery products must be designed in such a way as to ensure both their protection from contamination and their preservation under sufficiently hygienic conditions and, more particularly, they must provide adequate drainage of melt water.

6. Unless special facilities are provided for the continuous disposal of waste, the latter must be placed in leakproof, covered containers which are easy to clean and disinfect. Waste must not be allowed to accumulate in working areas. it must be removed either continuously or as soon as the containers are full and at least at the end of each working day in the containers or to the premises referred to in Chapter III, Section I, paragraph 6 of this Annex. The containers, receptacles and/or premises set aside for waste must always be thoroughly cleaned and, if appropriate, disinfected after use. Waste stored there must not constitute a source of contamination for the establishment or of pollution of its surroundings.
TOC Chapter IV
 

II. Conditions for frozen products

1. Plants must have:

(a) freezing equipment sufficiently powerful to achieve a rapid reduction in the temperature so that the temperatures laid down to in this Directive can be obtained in the product;

(b) freezing equipment sufficiently powerful to keep products in storage rooms at a temperature not exceeding those laid down in this Directive, whatever the ambient temperature may be.

However, for technical reasons related to the method of freezing and to the handling of such products, for whole fish frozen in brine and intended for canning, higher temperatures than those laid down in this Directive are acceptable although they may not exceed -9 ^oC.

2. Fresh products to be frozen or quick-frozen must comply with the requirements of Section I of this Chapter.

3. Storage rooms must have a temperature-recording device in a place where it can easily be read. The temperature sensor of the recorder must be located in the area furthest away from the cold source, i.e. where the temperature in the storage room is the highest.

Temperature charts must be available for inspection by the supervisory authorities at least during the period in which the products are stored.
TOC Chapter IV
 

III. Conditions for thawing products

Establishments that carry out thawing operations must comply with the following requirements:

1. fishery products must be thawed under hygienic conditions; their contamination must be avoided and there must be adequate drainage for any melt water produced.

During thawing, the temperature of the products must not increase excessively;

2. after thawing, fishery products must be handled in accordance with the requirements of this Directive. When they are prepared or processed, these operations must be carried out without delay. If they are put directly onto the market, particulars as to the thawed state of the fish must be clearly marked on the packaging in accordance with article 5 (3) 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 (¹).
TOC Chapter IV
 

IV. Conditions for processed products

1. Fresh, frozen and thawed products used for processing must comply with the requirements of Sections I or II of this Chapter.

2. Where the processing treatment is carried out to inhibit the development of pathogenic micro-organisms, or if it is a significant factor in the preservation of the product, the treatment must be scientifically recognized by the law in force, or in the case of a treatment of products referred to in Chapter I Section 1 (b) and (c) of Directive 91/492/EEC which have not been relayed or purified, such treatment must be approved, in accordance with the procedure laid down in article 15 of this Directive, within four months of receipt of a request from a member state.

The person responsible for an establishment must keep a register of the processing carried out. Depending on the type of process employed, heating time and temperature, salt content, pH, water content, etc., must be monitored and controlled. Records must be kept at least for the expected storage life of the products and be available to the competent authority.
TOC Chapter IV
 

3. For products which are preserved for a limited period by a treatment such as salting, smoking, drying or marinating, the  In addition, the following conditions shall be complied with.

appropriate conditions for storage must be clearly marked on the packaging, in accordance with Directive 79/112/EEC.
TOC Chapter IV
_______________________________

Notes (¹) OJ no L 33, 8. 2. 1979, p. 1. Directive last amended by Directive 91/72/EEC (OJ no L 42, 16. 1. 1991, p. 22).

4. Canning

In the case of fishery products which have been subjected to sterilization in hermetically sealed containers:
 

(a) the water used for the preparation of cans must be drinking water;

(b) the process used for the heat treatment must be appropriate, having regard to such major criteria as the heating time, temperature, filling, size of containers, etc., a record of which must be kept; the heat treatment must be capable of destroying or inactivating pathogenic organisms and the spores of pathogenic micro-organisms. The heating equipment must be fitted with devices for verifying whether the containers have in fact undergone appropriate heat treatment. Drinking water must be used to cool containers after heat treatment, without prejudice to the presence of any chemical additives used in accordance with good technological practice to prevent corrosion of the equipment and containers;

(c) further checks must be carried out at random by the manufacturer to ensure that the processed products have undergone appropriate heat treatment, viz.:

- incubation tests: incubation must be carried out at 37 ^oC for seven days or at 35 ^oC for ten days, or at any other equivalent combination;

- microbiological examination of contents and containers in the establishment's laboratory or in another approved laboratory;

(d) samples must be taken of production each day at predetermined intervals, to ensure the efficacy of sealing. For that purpose, appropriate equipment must be available for the examination of cross-Sections of the can-seams;

(e) checks are carried out in order to ensure that containers are not damaged;

(f) all containers which have undergone heat treatment under practically identical conditions must be given a batch identification mark, in accordance with Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (¹).
 TOC Chapter IV

5. Smoking
Smoking must be carried out in separate premises or a special place equipped, if necessary, with a ventilation system to prevent the smoke and heat from the combustion from affecting other premises or places where fishery products are prepared, processed or stored.

(a) Materials used to produce smoke for the smoking of fish must be stored away from the place of smoking and must be used in such a way that they do not contaminate the products.

(b) Materials used to produce smoke by burning wood that has been painted, varnished, glued or has undergone any chemical preservation treatment must be prohibited.

(c) After smoking, products must be cooled rapidly to the temperature required for their preservation before being packaged.
TOC Chapter IV

6. Salting

(a) Salting operations must take place in different premises and sufficiently removed from the premises where the other operations are carried out.

(b) salt used in the treatment of fishery products must be clean and stored in such a way as to preclude contamination. It must not be re-used.

(c) any container used for salting or brining must be constructed in such a way as to preclude contamination during the salting or brining process.

(d) containers or areas used for salting or brining must be cleaned before use.
TOC Chapter IV

 7. Cooked crustacean and molluscan shellfish products

Crustaceans and molluscan shellfish must be cooked as follows:

(a) any cooking must be followed by rapid cooling. Water used for this purpose must be drinking water or clean seawater. If no other method of preservation is used, cooling must continue until the temperature approaching that of melting ice is reached;

(b) shelling or shucking must be carried out under hygienic conditions avoiding the contamination of the product. Where such operations are done by hand, workers must pay particular attention to the washing of their hands and all working surfaces must be cleaned thoroughly. If machines are used, they must be cleaned at frequent intervals and disinfected after each working day.
After shelling or shucking, cooked products must immediately be frozen or kept chilled at a temperature which will preclude the growth of pathogens, and be stored in appropriate premises;

(c) every manufacturer must carry out micro-biological checks on his production at regular intervals, complying with the standards to be fixed in accordance with Chapter V, Section 4 of this Annex.

(d) appropriate conditions for storage must be clearly marked on the packaging, in accordance with Directive 79/112/EEC.
TOC Chapter IV

8. Mechanically recovered fish flesh
The mechanical recovery of fish flesh must be carried out under the following conditions:

(a) mechanical recovery of gutted fish must take place without undue delay after filleting, using raw materials free of guts. Where whole fish are used, they must be gutted and washed beforehand;

(b) the machinery must be cleaned at frequent intervals and at least every two hours;

(c) after recovery, mechanically recovered flesh must be frozen as quickly as possible or incorporated in a product intended for freezing or stabilizing treatment.
TOC Chapter IV
_______________________________

Notes
(¹) OJ no L 186, 30. 6. 1989, p. 21.
(¹) OJ no L 33, 8. 2. 1979, p. 1. Directive last amended by Directive 91/72/EEC (OJ no L 42, 16. 1. 1991, p. 22).

V. Conditions concerning parasites

1. During production and before they are released for human consumption, fish and fish products must be subject to a visual inspection for the purpose of detecting and removing any parasites that are visible.

Fish or parts of fish which are obviously infested with parasites, and which are removed, must not be placed on the market for human consumption.

The detailed rules for this inspection shall be adopted in accordance with the procedure laid down in article 15 of this Directive, on a proposal from the Commission to be submitted before 1 October 1992.

TOC Chapter IV

2. The fish and fish products referred to in point 3 which are to be consumed as they are must, in addition, be subjected to freezing at a temperature of not more than -20 ^oC in all parts of the product for not less than 24 hours. Products subjected to this freezing process must be either raw or finished.
TOC Chapter IV

3. Fish and products subject to the conditions in point 2:

 (a) fish to be consumed raw or almost raw, e.g. raw herring 'maatje';

(b) the following species, if they are to undergo a cold smoking process at which the internal temperature of the fish is less than 60 ^oC:
- herring,
- mackerel,
- sprat,
- (wild) atlantic and pacific salmon;

(c) marinated and/or salted herring where this process is insufficient to destroy the larvae of nematodes.

This list may be amended, in the light of scientific data, in accordance with the procedure laid down in article 15 of this Directive. in accordance with the same procedure, criteria will be laid down which must enable the processes which are deemed sufficient or insufficient to destroy nematodes to be defined.
TOC Chapter IV

4. Manufacturers must ensure that fish and fish products listed in point 3 or the raw materials for use in their manufacture are subjected to the treatment described in point 2, prior to their release for consumption.
TOC Chapter IV

5. The fishery products listed in point 3 must, when they are placed on the market, be accompanied by a document from the manufacturer stating the type of process they have undergone.
TOC Chapter IV

Directive 91/493 Annex

Chapter V - Health control and monitoring of production conditions

I. General monitoring

Arrangements for checking and monitoring must be made by the competent authorities in order to establish whether the requirements laid down in this Directive are complied with.

Such arrangements will include, in particular:

1. a check on the fishing vessels, on the understanding that such a check may be carried out during the stay in port;

2. a check on the conditions of landing and first sale;

3. an inspection at regular intervals of establishments to check, in particular:

(a) whether the conditions for approval are still fulfilled;

(b) whether the fishery products are handled correctly;

(c) the cleanliness of the premises, facilities and instruments and staff hygiene;

(d) whether identification marks are put on correctly;

4. an inspection of the wholesale and auction markets;

5. a check on storage and transport conditions.
TOC Chapter V

II. Special checks

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Organoleptic checks

2. Parasite checks

3. Chemicals checks

4. Microbiological analyses

1. Organoleptic checks

Without prejudice to the derogations provided for by Council Regulation (EEC) no 103/76 of 19

January 1976 laying down common marketing standards for certain fresh or chilled fish (¹), each batch of fishery products must be submitted for inspection by the competent authority at the time of landing or before first sale to check whether they are fit for human consumption. This inspection comprises an organoleptic check carried out by sampling.

Fishery products complying, as far as the freshness criteria are concerned, with the common marketing standards already laid down pursuant to article 2 of regulation (EEC) no 3796/81 are considered to fulfil the organoleptic requirements necessary for compliance with the provisions of this Directive.

The Commission may, where necessary, in accordance with the procedure referred to in article 15 of this Directive, lay down specific organoleptic requirements for fishery products not harmonized under regulation (EEC) no 3796/81.

The organoleptic examination must be repeated after the first sale of fishery products, if it is found that the requirements of this Directive have not been complied with or when considered necessary. After the first sale, fishery products must at least comply with the minimum freshness requirements of the aforementioned regulation.

If the organoleptic examination reveals that the fishery products are not fit for human consumption, measures must be taken to withdraw them from the market and denature in such a way that they cannot be re-used for human consumption.

If the organoleptic examination reveals any doubt as to the freshness of the fishery products, use may be made of chemical checks or microbiological analyses.
TOC II
TOC Chapter V

2. Parasite checks

 Before they are released for human consumption, fish and fish products must be subject to a visual inspection, by way of sample, for the purpose of detecting any parasites that are visible.

Fish or parts of fish which are obviously infested with parasites, and which are removed, must not be placed on the market for human consumption.

The detailed rules for this inspection shall be established in accordance with the procedure laid down in article 15.
TOC II
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(¹) OJ no L 20, 28. 1. 1976, p. 29. Regulation last amended by regulation (EEC) no 33/89 (OJ no L 5, 7. 1. 1989, p. 18).

3. Chemicals checks

A. Samples must be taken and subjected to laboratory analysis for the control of the following parameters:

(a) TVB-N (Total Volatile Basic Nitrogen) and TMA-N (Trimethylamine-Nitrogen)

The levels of these parameters must be specified for each category of species in accordance with the procedure laid down in article 15 of this Directive.

(b) Histamine

Nine samples must be taken from each batch. These must fulfil the following requirements:

- the mean value must not exceed 100 ppm;

- two samples may have a value of more than 100 ppm but less than 200 ppm;

- no sample may have a value exceeding 200 ppm.

These limits apply only to fish species of the following families: Scombridae and Clupeidae. However, fish belonging to these families which have undergone enzyme ripening treatment in brine may have higher histamine levels but not more than twice the above values. Examinations must be carried out in accordance with reliable, scientifically recognized methods, such as high-performance liquid chromatography (HPLC).

B. Contaminants present in the aquatic environment

Without prejudice to the Community rules concerning water protection and management, and in particular those concerning pollution of the aquatic environment, fishery products must not contain in their edible parts contaminants present in the aquatic environment such as heavy metals and organochlorinated substances at such a level that the calculated dietary intake exceeds the acceptable daily or weekly intake for humans.

A monitoring system must be established by the member states to check the level of contamination of fishery products.

C. In accordance with the procedure laid down in article 15 of this Directive, the following shall be decided on by not later than 31 December 1992:

(a) the methods of analysis to be used to check the chemical parameters, as well as the sampling plans;

(b) the acceptable levels for the chemical parameters.
TOC II

4. Microbiological analyses

In accordance with the procedure laid down in article 15 of this Directive, microbiological criteria, including sampling plans and methods of analysis, may be laid down when there is a need to protect public health. The Commission will to this end submit appropriate proposals for measures by 1 October 1992.
TOC II
TOC Chapter V

Directive 91/493 Annex

Chapter VI - Packaging

1. Packaging must be carried out under satisfactory conditions of hygiene, to preclude contamination of the fishery products.

2. Packaging materials and products liable to enter into contact with fishery products must comply with all the rules of hygiene, and in particular:

- they must not be such as to impair the organoleptic characteristics of the fishery products;

- they must not be capable of transmitting to the fishery products substances harmful to human health;

- they must be strong enough to protect the fishery products adequately.

3. With the exception of certain containers made of impervious, smooth and corrosion-resistant material which are easy to clean and disinfect, which may be re-used after cleaning and disinfecting, packaging materials may not be re-used. Packaging materials used for fresh products held under ice must provide adequate drainage for melt water.

4. Unused packaging materials must be stored in premises away from the production area and be protected from dust and contamination.

Directive 91/493Annex

Chapter VII - Identification marks

Without prejudice to the requirements laid down in Directive 79/112/EEC, it must be possible to trace for inspection purposes the establishment of dispatch of consignments of fishery products, by means of either labelling or the accompanying documents. For that purpose, the following information must appear on the packaging or in the accompanying documents:

- the country of dispatch;

- identification of the establishment by its official approval number or, in the case of separate registering of auction or wholesale markets as laid down in article 7 (1), third subparagraph of this Directive, the registration number of the auction or wholesale market.

Directive 91/493 Annex

Chapter VIII - Storage and transport

- fresh or thawed fishery products and cooked and chilled crustacean and molluscan shellfish products must be kept at the temperature of melting ice;

- frozen fishery products, with the exception of frozen fish in brine intended for the manufacture of canned foods, must be kept at an even temperature of -18 ^oC or less in all parts of the product, allowing for the possibility of brief upward fluctuations of not more than 3 ^oC, during transport;

- processed products must be kept at the temperatures specified by the manufacturer, when the circumstances so require, prescribed in accordance with the procedure laid down in article 15 of this Directive.
 

2. Where frozen fishery products are transported from a cold-storage plant to an approved establishment to be thawed on arrival for the purposes of preparation and/or processing and where the distance to be covered is short, not exceeding 50 km or one hour's journey, thecompetent authority may grant a derogation from the conditions laid down in point 1, second indent.

3. Products may not be stored or transported with other products which may contaminate them or affect their hygiene, unless they are packaged in such a way as to provide satisfactory protection.

4. Vehicles used for the transport of fishery products must be constructed and equipped in such a way that the temperatures laid down in this Directive can be maintained throughout the period of transport. If ice is used to chill the products, adequate drainage must be provided in order to ensure that water from melted ice does not stay in contact with the products. The inside surfaces of the means of transport must be finished in such a way that they do not adversely affect the fishery products. They must be smooth and easy to clean and disinfect.

5. Means of transport used for fishery products may not be used for transporting other products likely to impair or contaminate fishery products, except where the fishery products can be guaranteed uncontaminated as a result of such transport being thoroughly cleaned and disinfected.

6. Fishery products may not be transported in a vehicle or container which is not clean or which should have been disinfected.

7. The transport conditions of fishery products to be placed on the market alive must not adversely affect the products.

Directive 91/492

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)

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Chapter I -General provisions

Chapter II - Provisions for community production

Chapter III - Imports from third countries

Chapter IV - Final provisions

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:

Directive 91/492 Chapter I -General provisions

Article 1
Table of Contents

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
Table of Contents

 
 

For the purposes of this Directive, the following definitions shall apply:
batch	gatherer
bivalve molluscs	importation
marine biotoxins	means of transport
clean sea water	placing on the market
competent authority	production area
conditioning	purification centre
consignment	relaying
dispatch centre	relaying area
E. Coli	wrapping
faecal coliform

1. 'bivalve molluscs' means filter-feeding lamellibranch molluscs;
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2. 'marine biotoxins' means poisonous substances accumulated by bivalve molluscs feeding on plankton containing toxin;
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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;
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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;
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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;
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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;
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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;
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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;
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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;
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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;
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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;
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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;
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13. 'wrapping' means an operation whereby live bivalve molluscs are placed in packaging material adequate for the purpose;
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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;
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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;
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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;
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17. 'importation' means the introduction of live bivalve molluscs into the territory of the community from third countries;
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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-inhibitingproperties, at 44 ^o ± 0,2 ^oC within 24 hours at least;
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19. 'E. Coli' means faecal coliforms which also form indole from tryptophan at 44 ^o ± 0,2 ^oC within 24 hours.
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Directive 91/492 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 (¹);

(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 Chapter 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'.

Directive 91/492 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.

Directive 91/492 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

For the Council
The president P.Bukman
______________________

Notes:
(1) OJ no C 84, 2. 4. 1990, p. 29.
(2) OJ no C 183, 15. 7. 1991.
(3) OJ no C 332, 31. 12. 1990, p. 1.
(4) OJ no L 379, 31. 12. 1981, p. 1.
(5) OJ no L 282, 2. 10. 1989, p. 1.
(6) OJ no L 281, 10. 11. 1979, p. 47.
(7) OJ no L 373, 31. 12. 1990, p. 1.
(8) OJ no L 395, 30. 12. 1989, p. 13.
(9) OJ no L 33, 8. 2. 1979, p. 1.
(10) OJ no L 42, 16. 1. 1991, p. 27.
(11) see page 15 of this Official Journal.

Directive 91/492 ANNEX

 Directive 91/492 ANNEX

Chapter I - Conditions for production areas

1. The location and the boundaries of production 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 must meet the requirements set out in chapter V of this Directive;

(b) can be collected but only placed on the market for human consumption after treatment in a purification centre, after relaying. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three-dilution mpn-test of 6 000 faecal coliforms per 100 g of flesh or 4

600 E. Coli per 100 g of flesh in 90 % of samples. After purification or relaying, all the requirements set out in chapter V of this Annex must be met;

(c) can be collected but placed on the market only after relaying over a long period (at least two months), whether or not combined with purification, or after intensive purification for a period to be fixed in accordance with the procedure provided for in article 12 of this Directive, so as to meet the requirements under (a). Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three-dilution mpn-test of 60 000 faecal coliforms per 100 g of flesh.
 

2. Any change in the demarcation of production areas and the temporary or definitive closure thereof must be immediately announced by the competent authority to those affected by this Directive and in particular to producers and operators of purification and dispatch centres.

Directive 91/492 ANNEX

Chapter II - Requirements for harvesting and transportation of batches to a dispatch or purification centre, relaying area or processing 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 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 in the quality of the product, nor in any changes significantly affecting their ability to be treated by purification, processing or relaying.

4. Live bivalve molluscs must not be re-immersed in water which could cause additional contamination between harvesting and landing.

5. The means of transport used for transporting live bivalve molluscs must be used under conditions which protect the latter from 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 a dispatch centre, purification centre, relaying area or processing plant, the means of transport must be equipped in such a way as to ensure the best survival conditions possible, and in particular must comply with the requirements laid down in chapter ix, section 2 of this Annex.

6. A registration document for the identification of batches of live bivalve molluscs during transport from the production area to a dispatch centre, purification centre, relaying area or processing plant is issued by the competent authority upon request by the gatherer. For each batch, the gatherer must complete legibly and indelibly the relevant sections of the registration document which must contain the following information:

- the gatherer's identity and signature,

- the date of harvesting,

- the location of the production area in as precise detail as is practicable,

- the shellfish species and quantity indicated in as precise detail as is practical,

- the approval number and place of destination for wrapping, relaying, purification or processing.

The registration documents must be numbered permanently in sequence. The competent authority must keep a register indicating numbers of registration documents together with the names of the persons collecting live bivalve molluscs and to whom the documents were issued. The registration document for each batch of live bivalve molluscs must be date-stamped upon delivery of a batch to a dispatch centre, purification centre, relaying area or processing plant and must be kept by operators of such centres, areas or establishments for at least 60 days.

However, if gathering is carried out by the same staff operating the dispatch centre, purification centre, relaying area or processing plant of destination, the registration document may be replaced by a permanent transport authorization granted by the competent authority.

7. If a production or relaying area is closed temporarily, the competent authority must refrain from issuing registration documents for that area and immediately suspend the validity of all registration documents already issued.

Directive 91/492 ANNEX

Chapter III - Conditions for relaying live bivalve molluscs

1. live bivalve molluscs must be gathered and transported in accordance with the requirements of chapter II of this Annex;

2. techniques for handling live bivalve molluscs intended 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 area for an appropriate period which must exceed the time taken for levels of faecal bacteria to become reduced to the levels permitted by this Directive taking account of the fact that the standards of chapter V of this Annex must be met;

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 relaying area;

6. areas for relaying live bivalve molluscs must be approved by the competent authority. The boundaries of the sites must be clearly identified by buoys, poles or other fixed means; there must be a minimum distance of 300 metres between relaying areas, and also between relaying areas and production areas;

7. sites within a relaying area must be well separated to prevent mixing of batches; the 'all in, all out' system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed;

8. permanent records of the source of live bivalve molluscs, relaying periods, relaying areas and subsequent destination of the batch after relaying must be kept by the operators of relaying areas for inspection by the competent authority;

9. after harvesting from the relaying area, batches must, during transport from the relaying area to the approved dispatch centre, purification centre or processing plant, be accompanied by the registration document referred to in chapter II, section 6 of this Annex, except in the case where the same staff operates both the relaying area and the dispatch centre, purification centre or processing plant.

Directive 91/492 ANNEX

Chapter IV - Conditions for the approval of dispatch or purification centres

Back  Chapter contents

I. General conditions relating to premises and equipment
II. General Hygiene Requirements
III. Requirements for Purification Centres
IV. Requirements for dispatch centres

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   I. General conditions relating to premises and equipment

Chapter Contents

Centres must not be located in areas which are close to 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.

Centres must have at least:

1. on premises where live bivalve molluscs are handled or stored:
 

(a) buildings or facilities of sound construction, designed and maintained adequately for the purpose of preventing contamination of live bivalve molluscs by 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 drainage;

(c) adequate working space to allow for satisfactory performance of all operations;

(d) durable walls which are easy to clean;

(e) adequate natural or artificial lighting;

2. access to an appropriate number of changing rooms, wash basins and lavatories; there must be a sufficient number of wash basins close to the lavatories;

3. adequate equipment for washing tools, containers and equipment;

4. facilities for the supply and, where appropriate, storage of exclusively potable water within the meaning of Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption (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 direct contact with live bivalve molluscs or be used for cleaning or disinfecting containers, plant or equipment which come into contact with 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 corrosion-resistant material which is easy to wash and clean repeatedly.

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II. General Hygiene Requirements Chapter Contents
A high degree of cleanliness and hygiene must 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, gloves which are suitable for the work in which the person is engaged;

2. Staff are obliged to refrain from personal behaviour, such as spitting, which could result in contamination of live bivalve molluscs; any person suffering from an illness which can be transmitted by live bivalve molluscs must be temporarily prohibited, until recovery, from working with or handling these 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 handling live bivalve molluscs must 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 and at such other times as may be appropriate;

5. Premises, instruments and equipment must not be used for purposes other than the handling of live bivalve molluscs without authorization by the competent authority;

6. Waste products must be stored hygienically in a separate area and, where appropriate, in covered containers suitable for the purpose intended. Waste material must be removed from the vicinity of the establishment at appropriate intervals;

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.
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(¹) OJ no L 229, 30. 8. 1980, p. 11. Directive last amended by the 1985 Act of accession (OJ no L 302, 15. 11. 1985, p. 218).

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III. Requirements for Purification CentresChapter Contents
In addition to the requirements under sections I and II, the following conditions must be met:

1. the floors and walls of the purification tanks and any water storage containers must have a smooth, hard and impermeable surface and be easy to clean by scrubbing or use of pressurized water. The base of the purification tanks must be sufficiently sloped and be equipped with drainage 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 tanks 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 tanks must be supplied with a sufficient flow of sea water per hour and per tonne of live bivalve molluscs treated;

4. clean sea water or sea water cleaned by treatment 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; if treatment of the sea water is necessary, the process shall be authorized once its effectiveness has been verified by the competent authority; potable water used to prepare sea water from its major constituent chemicals must comply with the requirements laid down in Directive 80/778/EEC;

5. operation of the purification system must allow live bivalve molluscs to rapidly resume filter feeding activity, remove sewage contamination, not to become recontaminated and be able to remain alive in a suitable condition after purification for wrapping, storage and transport before being placed on the market;

6. the quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre; the live bivalve molluscs must be continuously purified for a period sufficient to allow the microbiological standards laid down in chapter V of this Annex to be met. This period starts from the moment at which the live bivalve molluscs in the purification tanks are adequately covered by the water until the moment when they are removed.

The purification centre must take account of the data relating to the raw materials (the type of bivalve mollusc, its area of origin, microbe content, etc.) in case it is necessary to extend the purification period so as to ensure that the live bivalve molluscs meet the bacteriological requirements of chapter V of this Annex;

7. should a purification tank contain several batches of molluscs, they must be of the same species and come from the same production area or different areas conforming to the same health conditions. The length of the treatment must be based on the time required by the batch needing the longest period of purification;

8. containers used to hold live bivalve molluscs in purification systems must have a construction which allows sea water to flow through; the depth of layers of live bivalve molluscs should not impede the opening of shells during purification;

9. no crustaceans, fish or other marine species must be kept in a purification tank in which live bivalve molluscs are undergoing purification;

10. after completion of purification, the shells of live bivalve molluscs must be washed thoroughly by hosing with potable water or clean sea water; this may take place in the purification tank if necessary; the washing water must not be recirculated;

11. purification centres must have their own laboratories or secure the services of a laboratory equipped with the necessary facilities for checking the efficiency of purification by use of microbiological specifications. Laboratory facilities outside the centres must be recognized by the competent authority;

12. purification centres must regularly keep a record of the following data:

- results of microbiological tests on purification system water entering the purification tanks;
- results of microbiological tests on unpurified live bivalve molluscs;
- results of microbiological tests on purified live bivalve molluscs;
- dates and quantities of live bivalve molluscs delivered to the purification centre and corresponding registration document numbers;
- 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 centres must accept only those batches of live molluscs which are accompanied by the registration document referred to in chapter II of this Annex;

Purification centres dispatching batches of live bivalve molluscs to dispatch centres must provide the registration document referred to in chapter II, section 6 of this Annex.

14. every package containing purified live bivalve molluscs must be provided with a label certifying that all molluscs have been purified.

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IV. Requirements for dispatch centres Chapter Contents

1. In addition to the requirements under sections I and II, the following conditions must be met:

(a) conditioning must not cause any contamination of the product; conditioning facilities must be used in accordance with procedures recognized by the competent authorities, with special regard to the bacteriological and chemical quality of the sea water used in those facilities;

(b) equipment and containers in the conditioning facilities must not constitute a source of contamination;

(c) procedures for calibration of live bivalve molluscs 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;

(d) any washing or cleaning of live bivalve molluscs must be carried out using pressurized clean sea water or potable water; cleaning water may not be recycled.
 

2. Dispatch centres must accept only those batches of live bivalve molluscs which are accompanied by the registration document referred to in chapter II, section 6 of this Annex and coming from an approved production area, relaying area or purification centre.

3. Dispatch centres must have their own laboratories or secure the services of a laboratory equipped with the necessary facilities for checking, inter alia, whether the molluscs comply with the microbiological standards of chapter V of this Annex. Laboratory facilities outside the centres must be recognized by the competent authority.

However, these requirements do not apply to dispatch centres obtaining their molluscs exclusively and directly from a purification centre where they have been examined after purification.

4. Dispatch centres must keep the following data at the disposal of the competent authority:

- results of microbiological tests on live bivalve molluscs from an approved production area or relaying area;

- dates and quantities of live bivalve molluscs delivered to the dispatch centre and corresponding registration document numbers;

- dispatch details.

These data must be classified chronologically and preserved for a period to be laid down by the competent authority, but not less than three months.

5. Dispatch centres situated aboard vessels shall be subject to the conditions laid down in point 1 (b), (c) and (d) and in points 3 and 4. The conditions laid down in points I and II shall apply mutatis mutandis to such dispatch centres although special conditions may be laid down in accordance with the procedure laid down in article 12 of this Directive.
Chapter Contents

Directive 91/492 ANNEX

Chapter V - Requirements concerning live bivalve molluscs

 Live bivalve molluscs intended for immediate human consumption must 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 must contain less than 300 faecal coliforms or less than 230 E. Coli per 100 g of mollusc flesh and intravalvular liquid based on a five-tube, three-dilution mpn-test or any other bacteriological procedure shown to be of equivalent accuracy.

3. they must not contain salmonella in 25 g of mollusc flesh.

4. They must not contain 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 permissible daily intake (pdi), or that the taste of the molluscs may be impaired.

In accordance with the procedure laid down in article 12 of this Directive, the Commission shall determine the testing methods for checking the chemical criteria and the limit values applicable.

5. The upper limits as regards the radionuclide contents must not exceed the limits for foodstuffs as laid down by the community.

6. The total paralytic shellfish poison (PSP) content in the edible parts of molluscs (the whole body or any part edible separately) must not exceed 80 microgrammes per 100 g of mollusc flesh in accordance with the biological testing method - in association if necessary with a chemical method for detection of saxitoxin - or any other method recognized in accordance with the procedure laid down in article 12 of this Directive.

If the results are challenged, the reference method shall be the biological method.

7. The customary biological testing methods must not give a positive result to the presence of diarrhetic shellfish poison (DSP) in the edible parts of molluscs (the whole body or any part edible separately).

8. In the absence of routine virus testing procedures and the establishment of virological standards, health checks must be based on faecal bacteria counts.

Examinations for checking compliance with the requirements of this chapter must be carried out in accordance with proven methods which are scientifically recognized.

For the uniform application of this Directive sampling plans as well as the methods and analytical tolerances to be applied in order to check compliance with the requirements of this chapter must be established in accordance with the procedure laid down in article 12 of this Directive.

The effectiveness of the faecal indicator bacteria and their numerical limits as well as the other parameters laid down in this chapter must be kept under constant review and, where scientific evidence proves the need to do so, be revised following the procedure laid down in article 12 of this Directive.

When there is scientific evidence indicating the need to introduce other health checks or to amend the parameters in this chapter for the purpose of protecting public health, such measures must be adopted in accordance with the procedure laid down in article 12.

Directive 91/492 ANNEX

Chapter VI - Public health control and monitoring of production

A public health control system must be established by the competent authority in order to verify whether the requirements laid down in this Directive are complied with. This control system must include:

1. periodic monitoring of live bivalve molluscs relaying and production areas in order to:

(a) avoid any malpractice with regard to the origin and destination of the live bivalve molluscs;

(b) check the microbiological quality of the live bivalve molluscs in relation to the production and relaying areas;

(c) check the possible presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs;

(d) check the possible presence of chemical contaminants, the maximum authorized level of which will be fixed, in accordance with the procedure laid down in article 12 of this Directive, by 31 December 1992.

For the purposes of points (c) and (d), sampling plans must be established by the competent authorities for checking such possible presence at regular intervals or on a case-by-case basis in the event of irregular periods of harvesting.

2. Sampling plans as provided for in point 1, must in particular take account of:

(a) likely variations in faecal contamination at each production and relaying area;

(b) possible variations in production at relaying areas in the presence of plankton containing marine biotoxins. The sampling must be carried out as follows:

(i) monitoring: periodic sampling organized 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 mollusc flesh must be followed by intensive sampling;

(ii) intensive sampling:

- monitoring plankton in the growing and fishing waters by increasing the number of sampling points and the number of samples, and

- toxicity tests using the molluscs from the affected area which are most susceptible to contamination. Placing on the market of molluscs from that area may not be re-authorized until new sampling has provided satisfactory toxicity test
 

(c) possible contamination of the molluscs in the production and relaying area;

If the result of a sampling plan shows that placing on the market of live bivalve molluscs may constitute a hazard to human health, the competent authority must close the production area, as regards molluscs concerned, until the situation has been restored.

3. Laboratory tests in order to check compliance with the requirements for the end product as laid down in chapter V of this Annex.  A control system must be established to verify that the level of marine biotoxins does not exceed safety limits.

4. An inspection of establishments at regular intervals.

These inspections must 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 on 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) on the ledger books referred to in chapter IV section III, 12 of this Annex,

(f) on the correct use of health marks.

These checks may include the taking of samples for laboratory tests; the results of these tests are notified to the persons responsible for the establishments.

5. Checks on the storage and transport conditions for consignments of live bivalve molluscs.

Directive 91/492 ANNEX

Chapter VII - Wrapping

1. Live bivalve molluscs must be wrapped under satisfactory conditions of hygiene.
The wrapping material or container must:

- not impair the organoleptic characteristics of the live bivalve molluscs,

- not be capable of transmitting substances harmful to human health to the live bivalve molluscs,

- be strong enough to give adequate protection to the live bivalve molluscs.

2. Oysters must be wrapped with the concave shell downwards.

3. All wrappings of live bivalve molluscs must be sealed and remain sealed from the dispatch centre until delivery to the consumer or retailer.

Directive 91/492 ANNEX

Chapter VIII - Preservation and storage

1. In any storing rooms, live bivalve molluscs must be kept at a temperature which does not adversely affect their quality and viability; the wrapping must not come into contact with the floor of the store room, but must be placed on a clean, raised surface.

2. reimmersion in or spraying with water of live bivalve molluscs must not take place after they have been wrapped and have left the dispatch centre except in the case of retail sale at the dispatch centre.

Directive 91/492 ANNEX

Chapter IX - Transport from the dispatch centre

1. Consignments of live bivalve molluscs intended for human consumption must be transported wrapped as sealed parcels from the dispatch centre until offered for sale to the consumer or retailer.

2. The means of transport used for consignments of live bivalve molluscs must have the following characteristics:

(a) their interior walls and any other parts which might come into contact with the live bivalve molluscs must be made of corrosion-resistant materials; the walls must be smooth and easy to clean;

(b) they must be suitably equipped to provide efficient protection of the live bivalve molluscs against extremes of hot and cold, contamination with dirt or dust, and damage to the shells from vibration and abrasion;

(c) the live bivalve molluscs must not be transported with other products which might contaminate them.

3. Live bivalve molluscs must be transported and distributed using closed vehicles or containers which maintain the product at a temperature which does not adversely affect their quality and viability.

The parcels containing live bivalve molluscs must not be transported in direct contact with the floor of the vehicle or container but must be supported on raised surfaces or by some other means which prevents contact.

Where ice is used in transporting consignments of live bivalve molluscs, it must have been made from potable water or clean sea water.

Directive 91/492 ANNEX

Chapter X - Marking of consignments

1. All parcels in a consignment of live bivalve molluscs must be provided with a health mark so that the original dispatch centre may be identified at all times during transport and distribution until retail sale. Without prejudice to Directive 79/112/EEC, the mark must contain the following information:
 

- the country of dispatch,

- the species of bivalve mollusc (common name and scientific name),

- the identification of the dispatch centre by the approval number issued by the competent authority,

- the date of wrapping, comprising at least the day and the month.

By way of derogation from Directive 79/112/EEC the date of durability may be replaced by the entry 'these animals must be alive when sold'.

2. The health mark may be printed on the wrapping material or be put on a separate label which is then affixed to the wrapping material or put inside the wrapping. It may also be of a twist-tie or staple design; self-adhesive health marks must not be used, unless they are not detachable. All types of health mark must be for single use only and may not be transferred.

3. The health mark must be durable and waterproof, and the information presented must be legible, indelible and in easily decipherable characters.

4. The health mark attached to consignments of live bivalve molluscs which are not wrapped in individual consumer-size parcels must be kept for at least 60 days by the retailer after splitting up the contents of the consignment.