Food and Agricultural Import Regulations and Standards

An Expert's View about Agriculture and Animal Husbandry in Spain

Posted on: 24 Nov 2012

This report is an update of SP1126 and outlines the applicable legislation regarding the export of U.S. food products to Spain.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 10/31/2012 GAIN Report Number: SP1231 Spain Food and Agricultural Import Regulations and Standards - Narrative FAIRS Country Report Approved By: Robert Hanson Agricultural Counselor Prepared By: Marta Guerrero Agricultural Specialist Report Highlights: Spain is a member of the European Union (EU) and it follows EU directives and regulations. This report is an update of SP1126 and outlines the applicable legislation regarding the export of U.S. food products to Spain, particularly those rules that differ from EU legislation. This report should be read in conjunction with the EU-27 Food and Agricultural Import Regulations and Standards Report. Table of Contents Section I. Food Laws: ................................................................................................................... 3 Section II. Labeling Requirements:............................................................................................. 4 Section III. Packaging and Container Regulations: .................................................................. 6 Section IV. Food Additives Regulations: .................................................................................... 6 Section V. Pesticides and Other Contaminants: ........................................................................ 6 Section VI. Other Regulations and Requirements: ................................................................... 7 Section VII. Other Specific Standards: ....................................................................................... 9 Section VIII. Copyright and/or Trademark Laws: ................................................................. 13 Section IX. Import Procedures: ................................................................................................. 14 Appendix I. Government Regulatory Agency Contacts:......................................................... 16 Appendix II. Other Import Specialist Contacts: ...................................................................... 20 DISCLAIMER: This report was prepared by the Office of Agricultural Affairs of the USDA/Foreign Agricultural Service in Madrid, Spain for U.S. exporters of domestic food and agricultural products. While every possible care was taken in the preparation of this report, information provided may not be completely accurate either because policies have changed since its preparation, or because clear and consistent information regarding these policies was not available. It is highly recommended that U.S. exporters verify the full set of import requirements with their foreign customers, who are normally best equipped to research such matters with local authorities, before any goods are shipped. FINAL CUSTOMS CLEARANCE APPROVAL OF ANY PRODUCT IS SUBJECT TO THE IMPORTING COUNTRY’S RULES AND REGULATIONS AS INTERPRETED BY BORDER OFFICIALS AT THE TIME OF PRODUCT ENTRY. FAIRS Country Report Page 2 out of 21 Section I. Food Laws: Spain is a member of the EU since 1986. As a member of the European Union (EU), Spain follows all EU directives, regulations, and obligations where available. While EU Regulations are binding and directly applicable to the Member States, EU Directives have to be transposed into National law. EU Decisions are binding and directly applicable to whom they are addressed. This report outlines the applicable legislation regarding the export of U.S. food products to Spain, particularly those rules that differ from EU legislation or regulation. Exporters should be aware that when EU-wide legislation is incomplete, absent or there is room for interpretation, Spanish laws apply and imported product must meet existing Spanish requirements. For detailed information on EU Food and Agricultural Import Regulations and Standards (FAIRS), see reports produced by the U.S. Mission to the EU in Brussels, Belgium which can be accessed from their website: http://www.usda-eu.org/ . Food and beverage products originating in the United States do not require any special Spanish permits and are not subject to special rules or regulations regarding retail sale in Spain. However, all products must comply with the generally applied rules and regulations required for any food and beverage product sold within the EU market. Spain’s food regulations apply to both domestically produced and imported food products. Spanish Food law At the EU level, Regulation (EC) 178/2002 sets out general principles and objectives in food law. In Spain, the Food Safety and Nutrition Law (Law 17/2011) published in July 2011, outlines the basic Spanish food and feed regulations. This law is based in EU Regulations and Directives and includes the traditional food safety aspects of detection and removal of physical, chemical and biological hazards as well as other less conventional issues such as obesity prevention and food advertising rules. It applies to domestically produced and imported products. The Spanish Food Safety and Nutrition Law establishes basic definitions, goals and principles for food safety. It also defines procedural rules, coordination mechanisms between the different public administrations with responsibilities in official food control. It sets out general food safety and health protection rules, regulates inspection, detention and seizure rules of suspect food and classifies breaches. Spain has a decentralized system for testing and controlling the feed and food chain. While the central government has total oversight over the controls carried out in customs, the autonomous communities establish their own monitoring and sampling plans throughout the food and feed chain coordinated by national authorities. Sampling plans are based on risk assessment and sampling is primarily done at the FAIRS Country Report Page 3 out of 21 wholesale and the processing level. Relevant Competent Authorities In Spain, the Ministry of Health, Social Services and Gender Equality (MSSSI) controls agricultural product imports intended for human consumption; while the Ministry of Agriculture, Food and Environment (MAGRAMA) controls imports of animal feed/ingredients and live animals not intended for direct human consumption. Food Safety is the responsibility of the Spanish Food and Safety and Nutrition Agency (AESAN), ascribed to the MSSSI that coordinates the food chain control. AESAN was established as an independent agency and it is also responsible for risk management. Within the MAGRAMA, the Sub directorate General for Livestock Resources coordinates the National plan in feedstuffs. Contact data for the above mentioned departments can be found in Appendix I. Please note: The following products sourced in the United States and imported into the EU must originate from an EU-approved U.S. establishment - red meat, meat products, farmed and wild game meat, ratites, milk and milk products, seafood, bovine embryos and semen, porcine and equine semen, gelatin and animal casings. Section II. Labeling Requirements: At the EU level, general rules on the labeling, presentation and advertising of foodstuffs are laid down by Regulation (EC) 1169/2011. This regulation consolidates general labeling requirements in a single text. Spain applies EU-harmonized legislation to: General Labeling Requirements Nutritional Labeling Product-Specific Labeling The U.S. standard label does not comply with EU labeling requirements. General Labeling Requirements In Spain, Royal Decree 1334/1999 as amended regulates food labeling by transposing EU Directives 79/112/CEE and 2000/13/CE. FAIRS Country Report Page 4 out of 21 Information required includes: Product name List of ingredients and quantity of certain ingredients or category of ingredients Alcoholic content when it is over 1.2% in volume Net weight in packaged products Expiration date Storage and use conditions Use instructions when essential to make a proper use the product Company identification: name and address of the manufacturer or packer or seller established within the European Union Batch information Country of Origin Misleading labeling attributing properties that the foodstuff does not have is not accepted. The Government of Spain permits multi-language labeling and stickers; however, one of the languages must be Spanish. U.S. food manufacturers or exporters are encouraged to contact their potential importer to learn the labeling requirements applicable. For detailed information on the EU-harmonized labeling legislation, please consult the EU-27 FAIRS Report well as the USEU website section on labeling. Detailed information on labeling can be found in the USEU report on New EU food labeling rules that will apply from December 13, 2014. Nutritional Labeling Royal Decree 930/1992, as amended by Royal Decrees 2180/2004 and 1669/2009 transposes EU Directive 90/496/CEE regulates nutritional labeling for foodstuffs. For further details please see the EU Food and Agricultural Import Regulations and Standards (FAIRS). More information (in Spanish language) can be found in AESAN’s website. Product-Specific Labeling For a number of products, specific labeling requirements have been established in addition to the general requirements described above. More details on above products can be found in Section VII. FAIRS Country Report Page 5 out of 21 Section III. Packaging and Container Regulations: Spain applies EU-harmonized legislation to packaging and containers There are two EU Directives related to the making-up by weight or by volume of certain prepackaged products (Council Directive 76/211/EEC) and laying down rules on nominal quantities for pre-packed products (Directive 2007/45/EC) that were transposed into Spain’s National Law by Royal Decree 1801/2008. While Spain participates in the preparation of European legislation on materials in contact with food. At the EU level material in contact with foodstuffs are regulated by EU Regulations directly applicable in all member states. For more detailed information on the EU’s harmonized legislation on packaging and container regulations, please consult the EU-27 FAIRS Report as well as the USEU website section on packaging. Section IV. Food Additives Regulations: Spain applies EU-harmonized legislation regarding food additives. For detailed information on the EU- harmonized legislation on food additive regulations, please consult the EU-27 FAIRS Report as well as the USEU website section on additives. Section V. Pesticides and Other Contaminants: Tolerance for pesticide residues were harmonized in the EU in 2008. Spain strictly adheres to EU- harmonized legislation on pesticides and contaminants. The complete list of MRLs, and commodity combinations allowed in the EU can be obtained from the Commission’s webpage. When a pesticide is not listed under the EU harmonized MRL list, an authorization request can be submitted to the Spanish administration. (Ministry of Agriculture, Food and Environment. Subdirección General de de Sanidad e Higiene Vegetal y Forestal). For application of an import tolerance for a non-yet regulated substance in Spain contact: FAIRS Country Report Page 6 out of 21 Subdirección General de de Sanidad e Higiene Vegetal y Forestal C/Alfonso XII, 62 28014 Madrid. sgmpagri@magrama.es The request form is available in the Ministry’s website. For detailed information on EU-harmonized legislation on pesticide and contaminant regulations, please consult the EU-27 FAIRS Report as well as the USEU website section on pesticides. Private Industry Standards While the official standards are set by the public administration, the large majority of food retailers require certification of good agricultural practices. The private certification schemes include not only stricter limits for MRL but also with other additional requirement. The most widely used schemes in Spain include AENOR, Globalgap, BRC, IFS and Q+S. Voluntary Aflatoxin Sampling Plan for Almonds The Spain is a major import market for tree nuts and the United States is the primary supplier to Spain. As of September 1, 2007, the EU implemented Special Import Conditions (European Commission Decision 2007/563/EC), which called for mandatory testing of California almonds imported to EU member countries. The California almond industry and the USDA developed a Voluntary Aflatoxin Sampling Plan (VASP) comparable to the EU sampling procedures so that almonds can be uniformly tested before they are shipped to the EU. In March 2012, the European Commission implemented the Regulation 274/2012, amending Commission Regulation 1152/2009, imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins. Regulation 274/2012 states that it is appropriate to repeal the transitional provision for foodstuffs imported from the United States of America, which are not covered by the Voluntary Aflatoxin Sampling Plan (VASP), as sufficient time has been provided to operators in the United States of America to implement the Voluntary Aflatoxin Sampling Plan. Almonds with a VASP certificate are subject to random testing while almonds without this certificate are subject to being rejected. Regulation 1152/2009 introduced the use of a Common Entry Document (CED), similar to the Common Veterinary Entry Document (CVED) used for veterinary products. Starting January 1, 2010, the importer has to provide prior notification to the competent authorities at the designated port of entry for the goods covered by the regulation at least one working day prior to the arrival of the goods, using the CED. The CED was published in Annex II of the Regulation 669/2009. FAIRS Country Report Page 7 out of 21 Provisions for methods of sampling and analysis for the official control of mycotoxins including aflatoxins are laid down in Commission Regulation 401/2006 as amended by Commission Regulation 178/2010. As of March 13, 2010, sampling under the VASP is performed on the basis of a 2x10 kg sample, in accordance with the new EU sampling legislation. For additional information see Annex VII B of the EU guidance document. For additional information on the VASP program check the Almond Board of California website. Commission Regulation (EU) No 165/2010 increased the maximum aflatoxin levels for almonds and pistachios, as well as apricot kernels, hazelnuts and Brazil nuts, bringing them in line with the Codex Alimentarius levels for tree nuts adopted in July 2008. As a result of both new EU regulations, EU aflatoxin levels are in line with existing Codex maximum aflatoxin levels and sampling plans. However, EU legislation has more extensive product coverage and also includes separate maximum limits for aflatoxin B1. The new levels, effective on March 9, 2010, changes to maximum tolerance for aflatoxin to the following: Ready-to-Eat (RTE) For Further Processing (FFP) Almonds 10 ppb total /8 ppb B1 15 ppb total/12 ppb B1 Hazelnuts, Brazil Nuts 10 ppb total/5 ppb B1 15 ppb total/8 ppb B1 Pistachios 10 ppb total/8 ppb B1 15 ppb total/12 ppb B1 For more information, see the E50018 GAIN report Section VI. Other Regulations and Requirements: The Spanish Government applies EU-harmonized legislation for other related regulations and requirements including product inspection, registration and certification. For detailed information on certification, please see the USEU certification site or consult the following websites: Certificates for Plant Products Certificates for Animal Products Certificates for Processed Foods Please note: Council Directive 2000/29/EC, harmonizes the importation requirements of plants and plant products into the EU. Phytosanitary certificates, issued by an APHIS inspector, are required to accompany all plant and plant products entering the EU. Your nearest APHIS Export Certification FAIRS Country Report Page 8 out of 21 Specialist can be found in this link. For detailed information on specific certificates to export to Spain please consult the latest version of Spain’s FAIRS Certificate report (SP1226). Section VII. Other Specific Standards: For detailed information on the EU-harmonized legislation on other specific standards, please consult the EU-27 FAIRS Report. Genetically Modified Foods and Feeds There are two relevant Authorities that weigh-in on Spain’s biotechnology decision making process, which are the National Biosafety Commission (CNB) and the Inter-ministerial Council for GMOs (CIOMG). The CNB takes a scientific approach, whereas CIOMG’s approach is technical. Both bodies are ascribed to the Ministry of Agriculture, Food and Environment. For more information, please see Spain’s Biotech Annual Report. Spain has a decentralized system for testing and controlling unauthorized presence of GMO in the feed and food chain. While the central government has a total control over the controls carried out in customs, the 17 autonomous communities establish their own monitoring and sampling plans throughout the food and feed chain coordinated by national authorities. Sampling plans are based on risk assessment. Sampling is primarily done at the wholesale and the processing level. Novel Foods The Novel Food Regulation (EC) 258/1997 lays down detailed rules for the authorization of novel foods and novel food ingredients, including foods derived from, containing, or consisting of GMOs. It defines novel foods as foods and food ingredients that were not used to a significant degree in the EU before May 15, 1997. The EU catalogue on Novel Foods can be consulted in the EU Commission’s website. This catalogue provides information on whether or not a product would require authorization under the Novel Food Regulation. The list of novel food applications, authorizations, rejections and withdrawals can be also found in the Commission’s website. Experts belonging to AESAN (Spanish Food Safety and Nutrition Agency) participate in the EU decision making process by attending the discussions in the Novel Food Working Group. New authorizations can be submitted to Member State’s competent authorities. A summary on the FAIRS Country Report Page 9 out of 21 authorization process when submitted to the Spanish competent authorities can be found in the link (Spanish language only). Fortified Foods European Parliament and Council Regulation 1925/2006 establishes an EU-wide regulatory framework for the addition of vitamins and mineral and of certain other substances such as herbal extracts to foods. It lists the vitamins and minerals that may be added to foods and sets criteria for setting maximum and minimum levels. The use of vitamins and minerals not included in the annexes to Regulation 1925/2006 is not allowed. However, Member States may provide for a temporary derogation (until January 19, 2014) for vitamins and minerals not included in the annexes. Such derogations should be obtained from the competent authorities in the individual Member States. In Spain, AESAN, Spain’s Food Safety and Nutrition Agency, is the competent authority to grant this temporary derogation. Requests should be submitted to: Ministerio de Sanidad y Servicios Sociales e Igualdad Agencia Española de Seguridad Alimentaria y Nutrición (AESAN) Dirección Ejecutiva C/ Alcalá, 56 28071 Madrid Tel.: +34-91-338-0585 Fax: +34-91-227-0073 E-mail: aesande@msssi.es Foodstuffs for Particular Nutritional Uses Specific directives on foods and beverages for athletes or on foods intended for diabetics are still subject to Member State legislation. The introduction of foodstuffs intended for particular nutritional uses for which no specific rules are set must be notified to the Member State where the food is sold. Spain’s competent authority is AESAN. Notification should be addressed to: Agencia Española de Seguridad Alimentaria y Nutrición (AESAN) Dirección Ejecutiva C/ Alcalá, 56 28071 Madrid Tel.: +34-91-338-0585 Fax: +34-91-227-0073 E-mail: aesande@msssi.es FAIRS Country Report Page 10 out of 21 Wine, Beer and Other Alcoholic Beverages Rules on oenological practices, designations of origin and labeling, originally established are described in the Single CMO (Council Regulation 1234/2007). Also Commission Regulation 606/2009, amended by Commission Regulation 53/2011, lays down detailed rules for permitted oenological practices. For detailed information on labeling rules, see GAIN Report E49061 “New EU wine labeling rules”. The “Agreement between the United States and the European Community on Trade in Wine” addresses a number of issues, such as labeling and certification. Information on the simplified EU import certificate form can be obtained from the Alcohol and Tobacco Tax and Trade Bureau. Information on the US-EU Wine Agreement can also be obtained from the U.S. Dept. of the Treasury - Alcohol and Tobacco Tax and Trade Bureau. Organic Foods On February 15, 2012, the European Union and the United States announced that beginning June 1st, 2012 their respective countries’ certified organic products will be recognized. All products traded under the agreement must be accompanied by an organic export certificate. More information about this partnership can be found on the USDA Organics Home Page for International Agreements. Vertical Legislation (Breakfast Directives) Directive 2001/112/EC amended by Directive 2012/12/EU regulates to fruit juices and certain similar products intended for human consumption. Key amendments which affect to the fruit juice labeling rules include orange juice, nutrition claims, mixed juices and sugars and sweeteners. While Directive 2012/12/EC remains pending of being transposed to national law, Royal Decree 1050/2003 transposed Directive 2001/122/EC. More information about EU fruit juice labeling requirements can be found in the GAIN Report E70022. Beef Labeling Regulation (EC) 1825/2000 as amended by Regulation (EC) 275/2007 regulates compulsory beef labeling. Other relevant pieces of regulation on the issue include Regulation 361/2008 and Regulation 566/2008. Egg Labeling FAIRS Country Report Page 11 out of 21 Commission Regulation 589/2008 lays down detailed rules for implementing Council Regulation 1234/2007 ("Single CMO”) as regards marketing standards for eggs. Frozen Foods Council Directive 89/108/EEC sets rules for quick-frozen foodstuffs and for their packaging and labeling. This Directive is transposed into National Law by Royal Decree 1109/1991 as amended. Quick-frozen foodstuffs sold to the final consumer should carry the following additional labeling indications: the product name with the indication “quick-frozen”; the date of minimum shelf life; the period during which the purchaser may store the product; the storage temperature and/or type of storage equipment required; batch identification; a clear indication of the type “do not re-freeze after defrosting”. Food Irradiation Harmonization of EU rules on food irradiation has been slow and only a few products have so far received EU- wide approval. Framework Directive 1999/2/EC outlines the marketing, labeling, import and control procedures and technical aspects of food irradiation. Irradiated foods must be labeled "irradiated" or "treated with ionizing radiation". Implementing Directive 1999/3/EC establishes a Community list of foods and food ingredients authorized for irradiation treatment. The list contains only one food category: "dried aromatic herbs, spices and vegetable seasonings". Until the EU positive list is expanded, national authorizations continue to apply. Fruits and Vegetables Commission Regulation 543/2011 lays down detailed rules for the implementation of Article 113 of the Single CMO. This regulation sets out general marketing standards and specific marketing standards for 10 products: apples, citrus fruit, kiwi fruit, lettuces, peaches and nectarines, pears, strawberries, sweet peppers, table grapes and tomatoes. Fruit and vegetables not covered by a specific standard must conform to the general marketing standard. Products that are in conformity with any applicable standards adopted by the United Nations Economic Commission for Europe (UNECE) will be considered as conforming to the general marketing standard. Marketing standards include criteria such as quality, size, labeling, packaging and presentation. Marketing standards apply at all marketing stages including imports. Imports into the EU of fresh fruit and vegetables are checked for compliance with EU-harmonized marketing standards and include criteria such as quality, size, labeling, packaging and presentation. Only fruits and vegetables destined for the food industry are not required to conform to the marketing standards provided they are clearly FAIRS Country Report Page 12 out of 21 market accordingly. Seafood NOAA (National Marine Fisheries Service) of the U.S. Department of Commerce is the unique competent authority for the certification of fishery and aquaculture products intended for the EU. More detailed information can be found in the Guide: “How to export Seafood to the European Union”. Pet Food European Parliament and Council Regulation 767/2009 sets out new rules for the labeling and marketing of feed and pet food. More information about EU pet food labeling requirements can be found in the GAIN Report E50060. Section VIII. Copyright and/or Trademark Laws: The regulations and standards covered under this section have been harmonized with the European Union requirements. However, the EU-harmonized trademark regulation did not replace the existing laws at the Member State level. Both systems coexist. For detailed information on EU-harmonized legislation, please consult the EU-27 FAIRS Report. Also please refer to Council Regulation 207/2009, which created a single, unitary trademark registration system for the entire European Community. Applications for registering under the Community Trademark Register must be submitted to the Spanish based Office for Harmonization in the Internal Market (See contact data in Appendix I). For detailed information on the EU-harmonized legislation on copyright and/or trademark laws, please consult the EU-27 FAIRS Report as well as the USEU website. At the Member State level, the Spanish Office for Patents and Trademarks, ascribed to the Ministry of Industry, Energy and Tourism, is the public body responsible for the registration and granting the different types of Industrial Property ranking from industrial property titles, including brands and commercial names (or distinctive signs), inventions, and industrial designs. In Spain the legal basis for trademarks is laid down by National Law 17/2001. The trademark protection is granted for 10 years after which it can be renewed. Requests should be addressed to the Spanish Office for Patents and Trademarks (See contact data in Appendix I). In addition, Spain is a member of the World Intellectual Property international Organization (WIPO), a signatory to the Paris Convention for the Protection of Industrial Property, and a party to the Madrid FAIRS Country Report Page 13 out of 21 Agreement on International Registration of Trademarks and Prevention of the Use of False Origins. Both the Trademark and the Intellectual Property Laws address protection of brand names and trademarks. Designation of Origin and Geographical Indications Council Regulation 510/2006 lays down the rules on the protection of designation of origin and geographical indications for agricultural products intended for human consumption (except wine and spirit drinks which are covered by separate legislation). Commission Regulation 1898/2006 established detailed rules for the implementation of Regulation 510/2006. Under these regulations, third country operators can also submit registration applications directly to the Commission and can object directly to new registrations. Guidelines for the registration of GIs by third country producers are published on the Commission’s website. Lists of protected names by country, product type, registered name and name applied for are available through the Commission’s online “DOOR” (Database of Origin and Registration) database. Section IX. Import Procedures: As a member of the European Union (EU), Spain follows all EU directives, regulations, and obligations where available. Since the EU is a customs union, all Member States apply the same import duties on goods imported from outside the EU based on tariff classification of goods and the customs value. Once import goods are cleared in one Member State, they can be moved freely throughout the EU territory. EU’s applicable duties information can be found in the on-line customs data base. It is possible to obtain Binding Tariff Information (BTI) from a Member State Customs Authority. In the case of Spain, Agencia Tributaria, ascribed to the Ministry for the Treasury and Public Administration, is the responsible entity. Contact data for Agencia Tributaria can be found in Appendix I. Other taxes applicable to agricultural products include the Value Added Tax (VAT) and inspection fees which are not harmonized throughout the EU. A list of VAT rates applicable in the different Member States can be found in the link. Spain announced in early July 2012 the increase of the standard VAT rate from 18 percent to 21% percent, which is effective since September 1, 2012. Reduced rates applicable to passenger transport, hotel and restaurant services will increase from 8 to 10 percent. The super-reduced tax for certain food products that include basic food items such as bread and grains, milk, cheese, eggs, fruits and vegetables, pulses and tubers FAIRS Country Report Page 14 out of 21 will stay at 4 percent. Some goods on the reduced VAT rates have been re-caged at the higher standard VAT rate. As an example, ornamental plants and flowers VAT will increase from 8 percent to 21 percent, which represents a 13 points increase all at once. Animal products are subject to inspection fees. The information on the inspection fees payment process for plant and animal products can be consulted in the Ministry of Finance and Public Administration website (only available in Spanish language). Import Documentation and Process The following documents are required for ocean or air cargo shipments of food products into Spain: Bill of Lading and/or Airway Bill Commercial Invoice Phytosanitary Certificate and/or Health Certificate when applicable See “SECTION VI. Other Regulations and Requirements” Import Certificate Most food products require an Import Certificate issued by the competent Spanish authorities. This certificate must be obtained by a registered importer as it is intended for tariff classification purposes. The import process requires: Pre announcement by Common (veterinary) Entry Document (CVED or CED) Documentary Check Identity Check Physical check Agricultural products are examined when they enter Spain by the Spanish Border Inspection Posts. There are a number of border inspections points in Spain that carry out plant health inspection and veterinary inspection points for animal products intended for human consumption and animal products not intended for human consumption. Contact data for each of them can be found in the links. Competent authorities on certificates vary depending on the type of products. While the Ministry of Social Services and Gender Equality (MSSSI) is responsible for of products intended for human consumption, the Ministry of Agriculture, Food and Environment (MAGRAMA) is responsible for agricultural products for purposes other than human consumption. Goods are only released for free circulation within the EU once the documentary and analytical requirements are checked and the import duty and other taxes that may be due are paid. Information on import duties can be consulted in the EU on-line customs data base. FAIRS Country Report Page 15 out of 21 U.S. exporters interested in introducing a product into the Spanish market should obtain local representation and/or a local importer/distributor to gain knowledge of the market, up-to-date information and guidance on trade laws and business practices, sales contacts, and market development expertise. As local importers have primary responsible to the Spanish Government for imported food products entering Spanish territory, they are in the best position to provide guidance to U.S. exporters through the market-entry process. For additional information on the Spanish Market, please consult the latest Spain’s Exporters Guide. Temporary Entry Temporary entry may be permitted for goods in transit (up to 24 months), manufacturing for re-export, and/or for temporary storage. Generally, the exporter must pay normally applied import duties and VAT, which are then reimbursed upon re-export of the merchandise to a destination outside of the EU. Samples and Advertising Material Spain grants duty free entry to giveaway samples if properly labeled. Samples are, however, subject to the same import documentation requirements that apply to normal commercial imports. They also require a nominal value for customs declaration purposes on the commercial invoice which must carry the statement “Samples without Commercial Value.” For detailed information on the procedure to import samples without commercial value to Spain please consult the Spain’s latest FAIRS Certificate report (SP1226). Appendix I. Government Regulatory Agency Contacts: Ministry of Health and Social Services and Gender Equality Imported Foodstuffs, Contaminations and Compound Residues, Health Certification, Port Inspection and EU Alerts Ministerio de Sanidad y Servicios Sociales e Igualdad Subdirección General de Sanidad Exterior Paseo del Prado, 18 y 20 28014 Madrid Tel.: +34-91-596-1000 Fax: +34-91-596-4480 Website link E-mail : saniext@msssi.es Ministry of Health and Social Services and Gender Equality Spanish Food Safety and Nutrition Agency FAIRS Country Report Page 16 out of 21 Ministerio de Sanidad y Servicios Sociales e Igualdad Agencia Española de Seguridad Alimentaria y Nutrición (AESAN) C/ Alcalá, 56 28071 Madrid Tel.: +34-91-338-0392 Fax: +34-91-338-0378 Website link E-mail: informacionaesan@msssi.es Ministry of Agriculture, Food and Environment Plant Health Unit - Inspection and Certification Ministerio de Agricultura, Alimentación y Medio Ambiente Subdirección General de Acuerdos Sanitarios y Control en Frontera C/ Alfonso XII, 62 28071 Madrid Tel.: +34-91-347-8241 Fax: +34-91-347-8248 Website link Email: sgsveget@magrama.es Ministry of Agriculture, Food and Environment Animal Health Unit - Inspection and Certification Ministerio de Agricultura, Alimentación y Medio Ambiente Subdirección General de Acuerdos Sanitarios y Control en Frontera C/ Alfonso XII, 62 28071 Madrid Tel.: +34-91-347-8241 Fax: +34-91-347-8248 Website link Email: sgsveget@magrama.es Ministry of Agriculture, Food and Environment Planting Seeds and Nursery Products (import requirements, seed registration and certification, and commercial seed catalogs) Ministerio de Agricultura, Alimentación y Medio Ambiente Subdirección General de Medios de Producción Agrícolas y Oficina Española de Variedades Vegetales C/ Alfonso XII, 62 28071 Madrid Tel.: +34-91-347-6659 FAIRS Country Report Page 17 out of 21 Fax: +34-91-347-6703 Website link Email: oevv@magrama.es Ministry of Agriculture, Food and Environment Pesticides, Registration and MRL Establishment Ministerio de Agricultura, Alimentación y Medio Ambiente Subdirección General de Sanidad e Higiene Vegetal y Forestal C/ Alfonso XII, 62 28071 Madrid Tel.: +34-91-347-4058 Fax: +34-91-347-8316 Website link Email: sgmpagri@magrama.es Ministry of Agriculture, Food and Environment Organic Farming Ministerio de Agricultura, Alimentación y Medio Ambiente Subdirección General de Calidad Diferenciada y Agricultura Ecológica C/ Alfonso XII, 62 28071 Madrid Tel.: +34-91-347-5397 Fax: +34-91-347-5410 Website link Email: sgcdae@magrama.es Spanish Patent and Trademark Office Oficina Española de Patentes y Marcas Paseo de la Castellana, 75 28046 Madrid Tel.: +34-902 157 530 Website link E-mail: informacion@oepm.es EU Trademark Register Office for Harmonization in the Internal Market Avenida de Europa, 4 03008 Alicante Tel.: +34-96-513-9100 FAIRS Country Report Page 18 out of 21 Fax: +34-96-513-1344 Website link E-mail: information@oami.europa.eu Ministry for the Treasury and Public Administration Ministerio de Hacienda y Administraciones Públicas Agencia Tributaria - Departamento de Aduanas e Impuestos Especiales C/ Guzmán El Bueno, 132 28003 Madrid Tel.: +34 91 582 6805 Website: www.aeat.es Ministry for the Treasury and Public Administration – Binding Tariff Information Ministerio de Hacienda y Administraciones Públicas Agencia Tributaria - Departamento de Aduanas e Impuestos Especiales Subdirección de Gestión Aduanera - Servicio de Arancel Avda. Llano Castellano, 17 28071 Madrid Ministry for the Treasury and Public Administration Ministerio de Hacienda y Administraciones Públicas Laboratorio Central de Aduanas - Customs Central Laboratory Calle Navaluenga, 2 A 28035 Madrid Tel.: +34 91 376 80 00 WTO Inquiry Post a. For technical regulations: Ministry of Economy and Competitiveness Ministerio de Economía y Competitividad Secretaría de Estado de Comercio Exterior Subdirección General de Certificación y Asistencia Técnica de Comercio Exterior Paseo de la Castellana, 162, 6a planta 28046 Madrid Tel: +34 91 349 37 59 Fax: +34 91 349 37 77 E-mail: sgsoivre.sscc@comercio.mineco.es Website link FAIRS Country Report Page 19 out of 21 Ministry of Economy and Competitiveness Ministerio de Economía y Competitividad Secretaría de Estado de Comercio Exterior Subdirección General de Comercio Exterior de Productos Agroalimentarios Paseo de la Castellana, 162, 6a planta 28046 Madrid Tel: +34 91 349 37 80 Fax: +34 91 349 38 06 E-mail: sgagro.sscc@comercio.mineco.es Website link a. For standards: Spanish Association for Standardization and Certification Asociación Española de Normalización y Certificación (AENOR) Calle Génova n° 6 28004 Madrid Tel: (+34 91) 432 5965 Fax: (+34 91) 310 45 96 E-mail: info@aenor.es Website link European Union – Delegation of the European Union to the United States 2300 M Street NW, Washington, DC 20037 Tel.: (202) 862-9500 Fax: (202) 429-1766 United States Mission to the European Union Office of Agricultural Affairs 27 Boulevard du Regent 1000 Brussels Belgium Tel.: +32-2-508 2760 Fax: +32-2-511 0918 E-mail: AgUSEUBrussels@fas.usda.gov Website link Appendix II. Other Import Specialist Contacts: FAIRS Country Report Page 20 out of 21 The USDA’s Foreign Agricultural Service Office for Spain and Portugal, located in Madrid, can also assist U.S. exporters in obtaining specific national legislation on all food product directives. You may contact us at the following address: Foreign Agricultural Service Office of Agricultural Affairs American Embassy Madrid C/ Serrano, 75 – Box 20 28006 Madrid Spain Tel.: +34-91-587-2555 Fax: +34-91-587-2556 Email: AgMadrid@fas.usda.gov Website link FAIRS Country Report Page 21 out of 21
Posted: 24 November 2012

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