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.

---

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.

---

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

Top
 

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

Top

• 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; regard