How to Export Seafood to the EU

An Expert's View about Aquaculture in Bulgaria

Posted on: 29 Nov 2012

Given the complexity of the EU legislation, this report provides an overview of key EU legislation governing trade in edible seafood products.

European Union: How to Export Seafood to the How to Export Seafood to the EU Page 1 of 27 European Union – November 2012 Update Stéphane Vrignaud NOAA Fisheries November 2012 Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 2 of 27 TABLE OF CONTENTS I. Introduction ............................................................................................................................ 3 A) Scope of the Report: ......................................................................................................... 3 B) Background: ...................................................................................................................... 3 C) The Institutions: ................................................................................................................ 3 D) What are the different measures? ................................................................................... 4 II. How Fishery Policies are Handled at the EU Level ............................................................ 5 III. The Common Organization of the Market in Fishery and Aquaculture Products .......... 6 IV. Exporting Seafood to the EU ............................................................................................... 7 A) General provisions: .......................................................................................................... 7 V. Food and Feed Hygiene Legislation .................................................................................. 11 A) Food Hygiene: ................................................................................................................. 11 B) Subsequent Regulations: ................................................................................................ 12 C) Feed Hygiene: .................................................................................................................. 13 D) Food and Feed Controls: ................................................................................................ 13 VI. Which Certificate For Which Product? ............................................................................. 13 A) Fishery Products: ............................................................................................................ 13 B) Aquaculture products: .................................................................................................... 13 C) Live Bivalve Mollusks: ..................................................................................................... 14 VII. Fishmeal – Fish oil ............................................................................................................ 14 VIII. Duties and trade measures ............................................................................................. 15 A) Background: .................................................................................................................... 15 IX. How do I label my seafood product? ................................................................................ 17 A) Legislative background: ................................................................................................. 17 B) Specific Labeling Examples: ........................................................................................... 19 X. Other legislation .................................................................................................................. 21 XI. Illegal, Unreported, and Unregulated (IUU) Legislation ................................................. 23 XII. Points of contact ............................................................................................................... 24 Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 3 of 27 I. Introduction A) Scope of the Report: Given the complexity of the EU legislation, this report provides an overview of key EU legislation governing trade in edible seafood products. It does not intend to answer all questions; additional comments or concerns should be addressed to specific competent authorities (see Points of Contacts at the end of the report). B) Background: Twenty-seven countries compose the European Union (E.U.). The current Member States (MS) are: Austria, Belgium, Bulgaria, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Romania, Spain, Sweden, the United Kingdom, Latvia, Lithuania, Estonia, Poland, Malta, Cyprus, Hungary, Slovenia, Slovakia and the Czech Republic. The EU population is approximately 500 million people since the accession of Bulgaria and Romania on January 1, 2007. The decision to integrate Turkey is still being discussed. C) The Institutions: The EU has seven different institutions that function in many ways as the different branches of the US government: The European Commission is the EU executive body. It has three main tasks: to initiate EU policies, to act as the guardian of EU treaties and to supervise implementation of EU law. The Commission is divided in 32 directorates general (DG), of which DG Mare and DG Sanco share responsibility for food safety consumer policy and public health protection. A college of 27 Commissioners named by their national governments but should be independent, heads the Commission. The Council of the EU consists of Ministers from the National Governments from each EU Member States. Each Member State holds the rotating presidency of the Council for six months. The Council and the European Parliament share the responsibility for passing laws and making policy decisions. It also bears the responsibility for what the EU in the fields of Common Foreign and Security Policy and EU action on several justice and freedom issues. 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, or COREPER. The European Council is made up of the heads of state from each Member State. They hold regularly scheduled meetings. This Council is responsible for defining the general political direction and priorities of the EU. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 4 of 27 In addition to the Heads of State, there is a semi-permanent President who serves a two and half year term and the rotating President of the Council. While the European Council has no formal legislative power, it is an institution that deals with major issues and any decisions made by it are "a major impetus in defining the general political guidelines of the European Union." The Council meets at least twice every six months The European Parliament (EP) is elected every five years by the people of Europe to represent their interests. The core mission of the European Parliament is to pass European laws. It shares this responsibility with the Council of the EU. Proposals for new laws are generated by the European Commission. The EP has the power to dismiss the College of the European Commission. The European Parliament has gained authority over time, culminating with the Lisbon Treaty’s “co-decision” authority as well as budget oversight of the European Commission. The European Court of Justice rules on disputes involving interpretation and application of the EU treaties and legislation. It makes sure that EU law is interpreted and applied in the same way in all MS. The Court is located in Luxemburg and has one judge from each MS. The European Central Bank has gained greater prominence during the Euro Zone crisis and the Court of Auditors audits EU finances; its role is to improve EU financial management and report on the use of public funds. D) What are the different 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 each MS has the ability to choose how it is to be implemented. In practice, the Commission will issue approved implementing legislation after a Directive is adopted, known as Implementing Measures. Usually, the Commission works with the Member States regarding the details of the implementing measures in order to ensure correct implementation of the referred Directive. This is an important point, as businesses affected by a Directive have to take into account the national implementing legislation as well as the Directive. All Directives include a date by which Member States must transpose it into their National legislation. In case of Member State non-implementation, the Directive remains the legal framework for adjudication. The Commission can act against Member States that have not implemented the Directive on time. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 5 of 27 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. Example: Commission Decision 95/328 laying down certain transitional measures concerning the certification of fishery products from third countries in order to facilitate the switch over 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. II. How Fishery Policies are Handled at the EU Level DG Mare is responsible for negotiating international fishing agreements, resources management, aquaculture, fleet management, and the Common Fishery Policy (CFP). It also proposes tariff reductions, tariff suspensions and import quotas. It supports DG Trade, part of which is the EU equivalent to the Office of the US Trade Representative for WTO matters. Some species are subject to trade restrictions under the Convention on International Trade of Endangered Species, which is the responsibility of DG Environment. DG Mare and DG Environment work together closely due to the current status of worldwide fish resources. Fishery products are also subject to measures introduced by DG Agriculture and DG Internal Market, and are supervised by DG Sanco. DG Agriculture is responsible for the Common Agricultural Policy (CAP) and all “vertical” measures on raw material. These DGs initiate proposals on all EU 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. Together with DG Sanco, they propose legislation on additives, microbiological criteria, colorings, antibiotics, and labeling. All those texts refer to “foodstuffs.” DG Sanco oversees 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), which is based in Ireland. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 6 of 27 The FVO principal activities are to monitor the observance of food hygiene, veterinary, and plant health legislation within the European Union, and to help promote confidence in Europe’s food safety to consumers. The FVO is responsible for auditing Member States’ competent authorities and to inspect third countries for compliance and/or equivalency to EU legislation. The European Food Safety Authority (EFSA) was created on January 28, 2002. EFSA covers risk assessment as well as risk communications. The relevant EU institutions maintain risk management responsibility for the EU. The primary EU laws that impact US seafood exports are: the Common Fisheries Policy (CFP) and the Food Hygiene Legislation. The CFP establishes a legal framework for the regulation of fisheries and aquaculture activities. It has a direct impact on the EU’s production capacity through fleet and quotas management. Therefore, it can directly affect imports of seafood from third countries such as the US. The Food Hygiene Legislation is the EU’s instrument that guarantees safe food to European consumers. It makes sure that “domestically made” as well as imported food complies with the EU’s minimum hygiene standards. III. The Common Organization of the Market in Fishery and Aquaculture Products The Common Organization of the Market in Fishery and Aquaculture Products was first introduced in 1970, and then reviewed in 1993 and amended in 2000 (Council Regulation 104/2000). Its purpose is to stabilize the market, to guarantee a steady supply of quality products, to ensure reasonable prices for consumers and support fishermen’s incomes. 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 imports. Producers’ organizations (associations to which fishermen belong on a voluntary basis), are officially recognized and 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 ensure that fishing quotas are respected. Interbranch Organizations and Agreements are aimed at facilitating a total integration of the sector (from producer to 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. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 7 of 27 Trade with third countries in order to ensure an adequate supply to the EU, in this case, specifically fishery and aquaculture products, intended for the processing industry, the EU adopts a series of regulations providing reduced duty rates, quotas, and autonomous suspensions for specified products. IV. Exporting Seafood to the EU A) General provisions: As a general principle, seafood is exported to the EU from only approved countries and from approved establishments, e.g., processing plants, factory or freezing vessels, brokers. Aquaculture products, including live bivalve mollusks, may be exported from only approved establishments from approved production zones or areas. Since 2006, the US Seafood Inspection System has been recognized by the EU as an equivalent of the European Seafood Inspection System. This status does not apply yet to the export of live bivalve mollusks and their derived fishery products - scallops. This mutual recognition facilitates seafood trade between the US and the EU. Furthermore, it creates a framework under which Member States cannot impose national requirements on US seafood exporters on top of EU harmonized legislation. However, differences of interpretation among member states can lead to delays at border inspection posts. B) List of Countries: Commission Decision 2006/766/EC is the list of countries and territories from which imports of fishery products and bivalve mollusks, echinoderms, tunicates and marine gastropods are permitted. One may note that the US does not appear in the list of countries authorized to export bivalve mollusks, echinoderms, tunicates and marine gastropods. This means that, unlike fishery products, the US inspection system for shellfish has not been recognized as equivalent to the EU’s inspection system. The US and the EU are currently negotiating a veterinary equivalency agreement but lack of progress from both sides has led the EU to adopt a ban of all US shellfish per Commission Decision 2009/951. However, article 1, paragraph 2 of the Decision 2006/766/EC, mentioned above, indicates that any third country, not listed in the Decision can export adductor muscles of wild Pectinidae completely separated from the viscera and gonads. In other words, the EU accepts “roe-off” scallops from the US, provided that they are caught wild. In this case, a regular health certificate for fishery products is required. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 8 of 27 C) Approved Establishments US operators that wish to export seafood to the EU must be approved by and registered with their National competent authority. The Food & Drug Administration (FDA) is the US agency responsible for the approval of seafood establishments. Once they are approved, US exporters are included on the FDA list, which is updated every quarter. This FDA list is then sent to the EU for validation. The process can take up to three months. The list of FDA District Offices in charge of the approval process can be found at: Important Notice: US exporters MUST NOT send shipments to the EU before the EU list is published and is in force within the EU. D) Certification Each shipment of seafood products must be accompanied by both a Sanitary and since January 1, 2010, a Catch Certificate. You will find a separate chapter on the Catch Certificate in this report. Important Notice: Effective June 2009, the US Department of Commerce, NOAA/National Marine Fisheries Service, is the U.S. agency responsible for the certification of fishery and aquaculture products intended for the EU. A Health Certificate may be issued for goods produced by different establishments, but can only be made to one consignee. A Health Certificate may be issued for several containers of the same product considered to be a single lot. US exporters should pay specific attention to the fact that Health Certificates must be issued and signed by U.S.D.C.-NOAA before the shipment leaves the U.S. In other words, bills of lading should always be dated the day of, or after issuance of the Health Certificate. The Health Certificate must define the lot. Therefore, a rejection at the point of entry will include all goods covered by the same Health Certificate, even if only a part of it presents a sanitary or documentary problem. It is acceptable to list fresh and/or live products on the same Health Certificate. However, frozen products must be listed in a separate Health Certificate. Instructions regarding the language of Health Certificates can be found at the end of Regulation 1663/2006, noted in chapter III. In summary, Health Certificates must be issued in one of the official languages of the country of entry into the EU territory, and if necessary, in the language of the country of destination. However, a Member State may consent to the use of one of the 23 official EU languages other than its own. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 9 of 27 In practice, the Border Inspection Post (BIP) at the first point of entry into the EU conducts the documentary check and issues a Common Veterinary Entry Document (CVED) in conformity with Commission Decision 2003/279/EC (last amended by Commission Regulation 36/2004). This CVED must be: 1) Either in the language or one of the languages of the border inspection post, where the products are entering into the EU and 2) Either in the language or one of the languages of the destination country. Important Notice: Effective April 1, 2007, Switzerland adopted EU sanitary legislation regarding import requirements for fishery products. Therefore, US seafood shipments must be accompanied by the same Health Certificate as required by any EU member state. A Health Certificate intended for Switzerland may be in French or English. E) Import controls: Principles for veterinary checks are laid down in Council Directive 97/78/EC, Council Directive 2002/99/EC, Regulations 882/2004 and 854/2004. Inspections of consignments originating from third countries must be carried out on all consignments, at the first point of entry into the EU territory and at approved border inspection posts. Import controls are done in three consecutive steps: 1. Documentary check: examination of the Health Certificate; 2. Identity check: visual inspection to confirm consistency between documents and products, verification for the presence of required sanitary marks - country of origin, approval number; and 3. Physical check: check on the product itself, organoleptic control, packaging, temperature. This may include sampling and laboratory testing. Products imported from “harmonized” countries, such as the US, are subject to the documentary, identity and physical checks at the approved border inspection post at the first point of entry into the EU territory. When a consignment satisfies EU requirements, it can be marketed freely in all EU Member States. While 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 percent 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. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 10 of 27 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 an “import license” from their Customs Authorities before the import process occurs. European border inspection posts may randomly conduct specific analysis on shipment being presented to them for clearance. The analyses can target residues, heavy metals or other contaminants. During random tests, shipments may be cleared and delivered to EU customers. However, if the tests reveal any contamination, the US establishment that sent the shipment in question will be put on “reinforced control status.” This status is then communicated to all Member States as well as to the European Commission through the Rapid Alert System. When an establishment is on reinforced control status, its ten next consecutive shipments, regardless of size, to any EU country, will be automatically tested. The products will be detained at the border inspection posts until results are received. After ten shipments without negative results, the establishment in question is lifted from the reinforced control list. The exporter may also choose to stop sending shipments to the EU for a three month period. This period is equivalent to the ten consecutive shipments rule. If a shipment is refused for non-compliance with EU legislation, the responsible party of the shipment has three options: 1. Destroy the products in question; 2. Re-dispatch these products to a non-EU country; or 3. Return the products to the originating country It is important to note that Regulation 882/2004 (Article 21) imposes a number of conditions for the two last options noted above: 1. The destination has been agreed with the EU based food business operator, i.e., consignee; 2. The consignee must inform the competent authority of the third country of origin or third country of destination, if different, of the reasons and circumstances that prevented sales of the food within the EU; 3. And, when the third country of destination is not the third country of origin, the competent authority of the third country of destination must signal its preparedness to accept the consignment. F) Triangular trade: Triangular trade occurs when US products are shipped from the US to other third (Non EU) countries for storage before being re-exported to the European Union at a later date. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 11 of 27 EU sanitary legislation requires: 1) The shipment must be stored in an EU-approved facility in the third country; 2) At the time of re-export to the EU, must be accompanied by a Sanitary Certificate from the last country of dispatch, even if the products were not further processed in that country. This second certificate must be based on the first certificate that was issued by the US responsible agency when the shipment departed the US. The two sanitary documents to provide to EU border inspection post in that case are the following: 1) From the US to country of storage: US certificate (EU type or not) with final destination the country of storage AND 2) From the country of storage: EU certificate with final destination in the EU. V. Food and Feed Hygiene Legislation Hygiene is part of the European policy on food safety, which also takes into account other sanitation aspects such as materials in contact with food, labeling, chemical substances, e.g., additives and food colorants, and ionization of foodstuffs, contaminants and residues. While this Hygiene Package tends to simplify the previous very complex legislation, it also introduces the concept of “responsibility” for the food and feed operators throughout the entire food chain, in other words, “from farm to fork.” This report summarizes this new legislation specifically addressing fishery products and bivalve mollusks. A) Food Hygiene: The Hygiene Package sets clear and strict rules on the sanitary conditions of foodstuffs, specific sanitation rules for food of animal origin, and specific rules for controls on products of animal origin intended for human consumption. While there are general rules for all food, there are specific measures that apply to fishery products and bivalve mollusks. Under this updated legislation, imported products will be required to meet the same standards as EU products. The Hygiene Package is divided into 5 Regulations and Directives: Hygiene 1: European Parliament and Council Regulation 852/2004 on the sanitation of foodstuffs. It includes general and technical requirements for primary production, including HACCP. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 12 of 27 Hygiene 2: European Parliament and Council Regulation 853/2004 are specific sanitary rules for food of animal origin. Specifically, Annex I - definition, and Annex III Section VII & VIII -bivalve mollusks and fishery products. This Regulation has been amended by Regulation 1662/2006. The last amendment modifies the conditions for exports of fishmeal into the EU. Hygiene 3: Regulation 854/2004 sets specific rules for the organization of official controls on products of animal origin that are intended for human consumption. Specifically, Chapter III, Annexes II, III and VI. This Regulation has been amended by Regulation 1663/2006. It modifies point 2 of annex VI of Regulation 854/2004 regarding the languages of Health Certificates. Hygiene 4: Council Directive 2002/99/EC are health rules governing the production, processing, distribution and importation of products of animal origin. Hygiene 5: Council Directive 2004/41/EC repeals the 17 previously existing Directives. B) Subsequent Regulations: U.S. exporters should be aware that Member States have adopted additional measures that are specific and must be followed in addition to the requirements of the Hygiene Package. Microbiological Criteria for Foodstuffs: These criteria are fundamental for a comprehensive food sanitation framework. Regulation 2073/2005 last amended by Regulation 1441/2007, introduces new criteria for certain food borne bacteria, their toxins and metabolites, such as salmonella, histamine and listeria. These criteria are applicable to products during their entire shelf life. In addition, the Regulation sets down certain sanitation criteria regarding the production process. Implementation Measures: Implementing rules concerning the Hygiene Package (Commission Regulation 2074/2005) include certificates for certain products and testing methods for marine biotoxins. Implementing measures, described in Regulation 1664/2006, and subsequent Regulation 1250/2008, amending Regulation 2074/2005, have been in place since May 1, 2007. These measures include new certificates for fishery products and live bivalve mollusks. These certificates do not apply to U.S fishery products and apply only partially for live bivalve mollusks. Chapter IV of this report will guide you on the correct certificate to use while exporting fishery products to the EU. Implications for Third Countries Exporting to the EU: The Commission developed a Guidance Document that addresses the key questions related to EU imports requirements. Food business operators will find the necessary information they need as to the consequences of this new regime on their activity. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 13 of 27 C) Feed Hygiene: Contaminated feed has been responsible for many food crises. Council Regulation 183/2005 aims at ensuring the safety of feed at all stages, including primary production. Effective January 1, 2006, it includes mandatory registration of feed growers, processors, packers and distributors with their competent authority. Note: in the U.S. it is FDA and NOAA. However, in the absence of specific implementing rules concerning third countries, the existing rules on EU imports continue to apply. Questions & Answers on Feed Hygiene. D) Food and Feed Controls: The Food and Feed Regulation on Official Controls - Council Regulation 882/2004 – execute a harmonized EU controls systems that includes: food and feed safety, animal health and welfare standards. Third countries have to guarantee that products intended for the EU market meet the necessary standards. This section does not include animal welfare controls except when there are explicit animal welfare provisions in specific bilateral agreements, which is not the case for the US. Questions & Answers on Food Controls. VI. Which Certificate For Which Product? A) Fishery Products: Effective June 15, 2011, shipments of fishery and aquaculture products must be accompanied by a Health Certificate. (U.S. exporters should consult the NOAA Seafood Inspection Program web site.) This Health Certificate is mandated by Commission Decision 2006/199/EC -for the public health part - and Regulation 1250/2008. This Health Certificate is valid for both fishery and aquaculture products. Processed mollusks as well as frozen scallops are considered as fishery product and must have a Health Certificate. B) Aquaculture products: The EU legislation regarding aquaculture products is the following: Commission Decision 2003/858/EC sets specific animal health conditions and certification requirements for imports of live fish, their eggs and gametes intended for farming. It also includes conditions for live fish of aquaculture origin and products thereof intended for human consumption; as amended by Commission Decision 2004/454/EC. This Decision has been partially repealed by Regulation 1664/2006. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 14 of 27 Commission Decision 2003/804/EC sets specific animal health conditions and certification requirements for imports of mollusks, their eggs and gametes, for further growth, fattening, relaying or human consumption; as amended by Commission Decision 2004/319/EC, Commission Decision 2004/609/EC, Commission Decision 2004/623/EC and Commission Decision 2005/409/EC. These three last amendments are of particular interest to US exporters. According to Commission Decision 2004/609/EC, the US is authorized to exports mollusks, from aquaculture, not only for human consumption (2004/319/EC) but also for further growth, fattening or relaying. However, Commission Decision 2005/409/EC reduced the number of US regions from which the export of live mollusks for further growth, fattening, or relaying and for further processing before human consumption. Click on Commission Decision 2005/409/EC for a list of the US regions. As indicated in the previous chapter, these specific products cannot be exported to the EU until further notice. Commission Decision 2004/623/EC eliminates the need for a NOAA Animal Health attestation but the NOAA Public Health attestation requirement continues for mollusks intended for direct human consumption, under some labeling conditions. C) Live Bivalve Mollusks: Effective July 1, 2010, per Commission Decision 2009/951, imports of US bivalve mollusks, in whatever form, are not permitted into the EU. Trade will resume once the US and the EU will have reached a veterinary equivalency agreement. VII. Fishmeal – Fish oil A) Fishmeal: A certificate “for processed animal protein not intended for human consumption”, according to the model listed in Regulation 1069/2009 and its implementing Regulation 142/2011 (Chapter 1 certificate), must accompany US exports of fishmeal. For U.S. exporters, NOAA issues this certificate. All exports of fishmeal must come from EU - approved establishments. The list of US approved animal by-products establishments can be found through the link: B) Fish oil: Effective April 30, 2009, the amended Hygiene Legislation requires that fish oil intended for human consumption must meet the requirements for “regular” fishery products. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 15 of 27 As such, shipments of U.S. fish oil must come from EU-approved establishments and accompanied by the same Public Health Certificate as the one used for fishery products. For a complete overview of fish oil import requirements into the EU, see link below: Shipments of fish oil not intended for human consumption are controlled by a different set of legislation and must be accompanied by a certificate according to the model described in Regulation 142/2011 -Chapter 9 certificate- mentioned above. VIII. Duties and trade measures A) Background: All EU fish tariffs were consolidated under the Tokyo Round of GATT. The overall average of EU duties for Chapters 3, 1604 and 1605 is 17.2%, one of the highest in the world. The tariff range is from 0%, live eels, to 25%, canned mackerel, bonito and anchovies. The main legislation covering tariffs is Commission Regulation 1006/2011. However, the EU 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 according to different categories, e.g., sensitive, semi-sensitive and very sensitive. The ANDEAN Group, intended to help those countries combat drugs, enjoys duty-free rate on most of Chapter 3 lines. “Access to Markets” for “Access to Resources” is the preferred EU strategy for fish trade negotiations. Some advantages are so granted, product-by- product, following signatures of fishing agreements. For example, Argentina: reduced duty for hake fillets; Morocco: duty-free imports of canned sardines. Recognizing the needs of its processing industry, the EU unilaterally reduces duties for certain portions of its imports using two annual mechanisms, suspensions and autonomous quotas. Most of the products concerned must be further processed within the EU. For a better impact, reduced duties must be requested first by the European importer. Suspensions, set on a yearly basis, provide better access for raw material needed by the EU industry on an unlimited basis, e.g., Alaskan Pollack fillets blocks, hard fish roes. Applied duties may be a full suspension - duty-free or a reduced duty. Autonomous quotas (Council Regulation 1062/20009 ) are opened on an annual basis. Each product or group of products is subject to 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 a compromise is reached usually at the Ministerial level. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 16 of 27 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 previous year landing prices, the EU fixes minimum prices on a yearly basis for a wide range of species. Depending on those prices, several aids are calculated to Producers Organizations (POs) such as withdrawal prices and carry-over aids. B) Tariff suspensions: Council Regulation 1255/96/EC, most recently amended by Council Regulation 1344/2011, covers tariffs 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 a given product 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 when the importer cannot access the quota, and must pay a 15% duty; $110 when the importer can access the quota and will pay a 5% duty. Tariff suspensions are considered during October each year and in December for autonomous quotas. During these months, the EC consults with the 27 Member States, to discuss and receive the needs of each Member States’ fisheries industry. The needs requests are summarized and a proposal is sent to all Member States and relevant EU institutions to be discussed in various committees. It is impossible to request a suspension 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. 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. In December 1999, the EU Fisheries Council adopted the final text for the renewal of the EU Common Organization of Markets for Fish and Fishery Products (2000/104/EC). Some products, e.g., surimi, Alaskan Pollock fillets and meat blocks, are considered essential to the EU processing industry in order to remain competitive, will enjoy total or partial suspension of customs duties. It is important to note that the European Commission wants to get rid of suspensions. A proposal is currently under discussion and may lead to the suppression of suspensions by January 2013. For other products, e.g., H&G cod, tuna loins, herring flaps, pluri-annual autonomous quotas at a reduced duty rate were decided for the period 2010-2012. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 17 of 27 On a more global scale, the US Government continues to negotiate with the EU for a “zero for zero” approach to tariffs in the fisheries sector. Unfortunately, the slow progresses of current Doha negotiations do not predict a rapid agreement on this issue. For any questions on a specific tariff rate, you may consult the following web site: =0&redirectionDate=20110203 IX. How do I label my seafood product? A) Legislative background: Various crises within the food chain, such as Foot and Mouth disease, BSSE, and heavy metals have reinforced the critical need for information, communication and transparency for consumers from the producers, processors, and marketers. The three main Regulations with respect to labeling are: Council Directive 2000/13/EC (last amended by Directive 2003/89/EC on ingredients present in foodstuffs). Commission Regulation 2065/2001/EC primarily targeting retail products. But additional Regulations are expected in the context of “Public safety” and “Organic Food.” Directive 2003/89, in force since November 2005, imposes the labeling of potential allergens. “Fish and products thereof” and “crustaceans and products thereof” that were included on the list of potential allergens have been removed from this list per Commission Directive 2007/68/EC. Food manufacturers must indicate the source allergen on the label, if it is used as an ingredient at any level in pre-packed foods. Directive 2006/142/EC adds “mollusks and products thereof” to the list of potential allergens. All new EU Regulations are based on ensuring the consumer’s confidence and safety in such a way that “the consumer will not be misled by any product or packaging.” For sanitary purposes and to allow traceability of seafood products, the EU legislation requests that all outer and inner packages bear at least: 1. The country of origin, 2. The commercial denomination of the products and 3. The approval number of the establishment of origin. Per Regulation 853/2004 (Annex II, point 7), requires that products intended for the ultimate consumer such as canned products, must include the FDA approval number of the US packer/processor/manufacturer as well as their address or that of the EU seller. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 18 of 27 However, US exporters will pay specific attention to article 5 of Commission Decision 2006/199 regarding products in bulk and intended for further processing which introduces derogation to this rule. Finally, Regulation 853/2004, Annex II, paragraph 11 allows for a minimal labeling instead of normal labeling requirements: “For products of animal origin that are placed in transport containers or large packages and are intended for further processing, handling, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging.” Those two items must be written or printed “indelibly.” The most desirable way would be to have them pre-printed on packages/cartons. In instances where stick-on labels may be used, they must not be easily destructible or removable. Labels must be in a language “easily understandable” by users and at least in one of the official languages of the country of final destination (distribution). Labels may be in several languages. Commission Regulation 2001/2065/EC imposes specific requirements for the labeling of fishery and aquaculture products intended for the retail sector. This Regulation only concerns products from Chapter 3 of the Tariff Harmonized System, and not products from Chapter 16, for example, canned products. 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 required by your client. Each Member State has established a list of applicable commercial names. These lists are visible on DG Mare’s website:  The production method, e.g., aquaculture or fishery product. The appropriate language is: “caught in...”; “caught in fresh water;” “farmed;” or “cultivated.” However, it is a Member States decision 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, which is taken from the FAO list, Annex of the above Regulation. However, only the general area must be mentioned, e.g., Pacific Ocean. The FAO Area code is voluntary. Products caught in fresh water require a reference to the Member State or third country of origin of these products. Farmed products must reference the Member State or third country, in which the product underwent final stage of development. Operators may well choose to provide additional information on the area. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 19 of 27 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. A new requirement regarding labeling of frozen food is in place since July 1, 2012. The intention of Regulation 16/2012 is to ensure that the information on the date of production and freezing is provided to the food business operator to whom the food is supplied and not to the consumers. Point 3 of Regulation (EU) no 16/2012 stipulates that the information must be available in an appropriate form which is up to the choice of the supplier. This does not imply that it has to be done through labeling or through the certificates. In practice, the information may be made available on the commercial document, catch certificate or in any other appropriate document that is sent to the next Food Business Operator in the chain. According to the interpretation of the European Commission the document containing the requested information does not necessarily need to be presented at the BIPs since the control of the proper fulfillment of the rules will be carried out on a more general basis such as an audit by the Food and Veterinary Office. Other sets of Regulations regarding ingredients, allergens and guidelines for the implementation of labeling legislation can be downloaded from DG SANCO’s website at: m B) Specific Labeling Examples: 1- Fresh, Chilled Products:  Species  Country of origin -roman letters, min. 2 cm.  Presentation - whole, gutted, fillet, etc.  Best before date - not mandatory per EU legislation, but requested by most Member States.  Freshness grade and size category - for species with common standards, min 5 cm.  Net weight in kilograms (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. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 20 of 27 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 - unless it is only fish.  Date of minimum durability -month/year- or “Best Before” date, o  Special storage conditions - to be maintained at - 18 C.  Instructions for use - if not obvious, incl. “Do Not Freeze Again Once Thawed.”  Name and address of the manufacturer or of the EU seller.  “FDA approval #” of the packer -CFN or FEI - or processor.  Lot # - It must begin by “L” or the world “LOT.” Not always mandatory. The lot # is defined by the processor in order to trace a product history in case of problem. It can be the production date. For example: L8110B15 may mean L = Lot 8 = 1998 110 = day of production B15 = production line number 3- For Deep-Frozen Foods: The previously mentioned requirements apply in addition to the following requirements:  Freezing date.  Storage conditions and maximum period of storage: o Between 0 and 5 C: 1 day o ”*”, or between -5 and 0 C: 1 week o ”**”, or between -12 and -6 C: 1 month o ”***”, or at least at -18 C: up to the best before date. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 21 of 27 4- 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 #. 5- Canned Products:  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 an EU seller.  ”FDA approval #” of the packer or manufacturer/processor. It is important to note that some Member States as well as countries that are part of the European Economic Area (EEA) may have additional requirements in terms of labeling of seafood. For further information on labeling, contact our office at the US Mission to the European Union. X. Other legislation In addition to the above-mentioned legislation, the EU sets various requirements for a wide range of issues. This includes legislation on: Additives, colorings, flavorings and sweeteners allowed within the EU. Per Directive 95/2/EEC, additives such as STP - E338 to E 450 - are not allowed in fresh scallops, only in frozen and deep frozen scallops. Traceability of foodstuffs. Contaminants. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 22 of 27 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. Wood packing materials: In 2004, the EU adopted Commission Directive 2004/102/EC for protective measures against the introduction into the EU of organisms harmful to plants or plants products and against their spread within the EU. On January 17, 2006, the European Union Standing Committee on Plant Health (SCPH) voted to delay until January 1, 2009, the requirement that imported wood packaging material (WPM) be debarked. After further review, the debarking requirement was postponed again to July 1, 2009. For more information on this specific subject, consult the following web site: Sport caught fish: Commission Regulation 2006/2009 sets up the weight limit under which there is no need for health certificate for the import of fish for personal consumption. This limit has been raised from 1 kg to 20 kg. Article 2, paragraph c. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 23 of 27 XI. Illegal, Unreported, and Unregulated (IUU) Legislation In 2008, the EU adopted Council Regulation (EC) 1005/2008 aiming at eliminating Illegal, Unreported & Unregulated (IUU) fishing. Effective January 1, 2010, all third countries wishing to export seafood to the EU must provide a Catch Certificate. This document requirement is in addition to all other sanitary documentation This Regulation has been amended by Regulation 86/2010 and Regulation 202/2011. These last Regulations amend the list of products excluded by the scope of the catch certification system and identified specific agreements between the EC and third countries, including the U.S. Implementing measures, as well as the list of products excluded by the IUU legislation, the list of competent Member States (MS) authorities and FAQs can be found through the EC- DG Mare web site below: NOAA signed an agreement with the EC that stipulates a U.S. specific catch certificate. NOAA is responsible for the issuance of both Sanitary and Catch Certificates. Exporters will find all necessary information regarding these catch certificates, as well as FAQs on the NOAA SIP web site. For any problems at EU border inspection posts or questions regarding the IUU Legislation please contact: Mr. Stéphane Vrignaud NOAA Fisheries US Mission to the EU Tel: (011) 322 811 5831 Fax: (011) 322 811 5151 Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 24 of 27 XII. Points of contact N.O.A.A. – National Marine Fisheries Service Phone (301) 427-8300 Seafood Inspection Program Timothy Hansen Robert Downs Regional Offices: North-East: Inspection Steve Ross Phone (978) 281-9228 Fax (978) 281-9134 South-East: Inspection Monty Berg Phone (727) 570-5383 Fax (727) 570-5387 South-West: Inspection Laurice Churchill Phone (562) 388-7346 Fax (562) 388-7353 North-West: Inspection Eric Staiger Phone (206) 526-4259 Fax (206) 526-4264 Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 25 of 27 Food and Drug Administration (FDA): Center for Food Safety and Applied Nutrition Phone (202) 418-3160 Office of Seafood (Washington, DC): Fax (202) 418-3196 Johnny Braddy Bruce Wilson Regional Offices: click on the hyperlink. Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 26 of 27 Useful links EU List of US FDA approved seafood producers/freezing & factory vessels/cold storage: FDA list of approved shellfish growers/shuckers/packers: FDA list of approved shellfish production areas: EU Official Journal: DG SANCO - EU food safety legislation: EU Tariffs database: DG Mare: European Food Safety Authority (EFSA) The European Free Trade Association UK Department for Environment Food and Rural Affairs Let us help you export. The U.S. Commercial Service — Your global business partner. 800-USA-TRADE How to Export Seafood to the EU Page 27 of 27 For More Information The U.S. Commercial Service at the U.S. Mission to the European Union, can be contacted via email at: Stephane Vrignaud, at Stephane.vrignaud@; Phone: +32(2) 811-5831; Fax: +32(2) 811 5151; or visit our website: The U.S. Commercial Service – Your Global Business Partner With its network of offices across the United States and in more than 80 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting Comments and Suggestions We welcome your comments and suggestions regarding this market research. You can e-mail us your comments/suggestions to: Please include the name of the applicable market research in your message. We greatly appreciate your feedback. Disclaimer: The information provided in this report is intended to be of assistance to U.S. exporters. While we make every effort to ensure its accuracy, neither the United States government nor any of its employees make any representation as to the accuracy or completeness of the information in this or any other United States government document. Readers are advised to independently verify any information prior to reliance thereon. The information provided in this report does not constitute legal advice. The U.S. Commercial Service reference to or inclusion of material by a non-U.S. Government entity in this document is for informational purposes only and does not constitute an endorsement by the U.S. Commercial Service of the entity, its materials, or its products or services. 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Posted: 29 November 2012