Food and Agricultural Import Regulations and Standards

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

Posted on: 30 Dec 2011

This report is an update of SP1022 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: 12/16/2011 GAIN Report Number: SP1125 Spain Food and Agricultural Import Regulations and Standards - Narrative FAIRS Country Report Approved By: Robert Hanson Agricultural Attaché Prepared By: Marta Guerrero Agricultural Specialist Report Highlights: This report is an update of SP1022 and outlines the applicable legislation regarding the export of U.S. food products to Spain, particularly those rules that differ from EU legislation or regulation. This report should be read in conjunction with the EU-27 Food and Agricultural Import Regulations and Standards Report, available at http://www.fas.usda.gov/posthome/useu/fairs.html. TABLE OF CONTENTS SECTION I. FOOD LAWS SECTION II. LABELING REQUIREMENTS SECTION III. PACKAGING AND CONTAINER REGULATIONS SECTION IV. FOOD ADDITIVES REGULATIONS SECTION V. PESTICIDES AND OTHER CONTAMINANTS SECTION VI. OTHER REGULATIONS AND REQUIREMENTS SECTION VII. OTHER SPECIFIC STANDARDS SECTION VIII. COPYRIGHT AND/OR TRADEMARK LAWS SECTION IX. IMPORT PROCEDURES APPENDIX I – GOVERNMENT REGULATORY AGENCY CONTACTS APPENDIX II – OTHER IMPORT SPECIALIST CONTACTS 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 11 Section I. Food Laws: As a member of the European Union (EU), Spain follows all EU directives, regulations, and obligations where available. 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. 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, available at http://www.fas.usda.gov/posthome/useu/usda.html as well as at http://gain.fas.usda.gov/Pages/Default.aspx. Food laws of individual member states have mostly been fully harmonized into EU law. However, it is important to note that when EU-wide legislation is incomplete or absent, Spanish laws apply and imported product must meet existing Spanish requirements. 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. 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 obesity prevention and food advertising rules. The Spanish Food Safety and Nutrition Law established 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 defines 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 wholesale and the processing level. In Spain, the Ministry of Health, Social Welfare and Gender Equality (MSPSI) controls agricultural imports intended for human consumption; while the Ministry of Environment and Rural and Marine Affairs (MARM) controls imports of animal feed/ingredients and live animals. Food Safety is the responsibility of the Spanish Food and Safety and Nutrition Agency (AESAN), ascribed to the MSPSI that coordinates the food chain control. AESAN was established as an independent agency and it is also responsible for risk management. Within the MARM, the Sub directorate General for Animal Feed and Resources Preservation coordinates the National plan in feedstuffs. FAIRS Country Report Page 3 out of 11 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: Spain applies EU-harmonized legislation to: General Labeling Requirements Nutritional Labeling Product-Specific Labeling GMO and Novel Foods Labeling The Government of Spain permits multi-language labeling and stickers; however, one of the languages must be Spanish. For detailed information on the EU-harmonized labeling legislation, please consult the EU-27 FAIRS Report http://www.fas.usda.gov/posthome/useu/fairs.htmlwell as the USEU website http://www.fas.usda.gov/posthome/useu/label.html. Section III. Packaging and Container Regulations: Spain applies EU-harmonized legislation to packaging and containers. For detailed information on the EU’s harmonized legislation on packaging and container regulations, please consult the EU-27 FAIRS Report http://www.fas.usda.gov/posthome/useu/fairs.html as well as the USEU website http://www.fas.usda.gov/posthome/useu/packaging.html. 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: http://www.fas.usda.gov/posthome/useu/fairs.html as well as the USEU website http://www.fas.usda.gov/posthome/useu/additive.html. Section V. Pesticides and Other Contaminants: Spain strictly adheres to EU-harmonized legislation on pesticides and contaminants; however, where the EU does not have a maximum residue level (MRL) for a given pesticide or specific contaminant, Spain’s national limits are applied. The complete list of MRLs, and commodity combinations allowed in the EU can be obtained from the Commission’s webpage at http://ec.europa.eu/food/plant/protection/pesticides/index_en.htm An European database on MRLs is available at: FAIRS Country Report Page 4 out of 11 http://ec.europa.eu/food/plant/protection/pesticides/database_pesticide_en.htm However, where the EU does not have a Maximum Residue Level (MRL) for a given pesticide or specific contaminant, Spain’s national limits are applied. When a pesticide is not listed under the EU harmonized MRL list, it will likely be subject to Spanish legislation as listed in the following Ministry of Environment and Rural and Marine Affairs (Subdirección General de Medios de Producción) link: http://www.marm.es/es/agricultura/temas/medios-de-produccion/productos-fitosanitarios/fitos.asp For detailed information on EU-harmonized legislation on pesticide and contaminant regulations, please consult the EU-27 FAIRS Report http://www.fas.usda.gov/posthome/useu/fairs.html as well as the USEU website http://www.fas.usda.gov/posthome/useu/pesticides.html. 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. 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 consult the following websites: Certificates for Plant Products - http://www.fas.usda.gov/posthome/useu/plantcertif.html Certificates for Animal Products - http://www.fas.usda.gov/posthome/useu/certification.html Certificates for Processed Foods - http://www.fas.usda.gov/posthome/useu/foodcertif.html 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 Specialist can be found at: http://www.aphis.usda.gov/import_export/plants/plant_exports/ecs/index.shtml For detailed information on specific certificates to export to Spain please consult the latest version of Spain’s FAIRS Certificate report at: http://gain.fas.usda.gov/Pages/Default.aspx FAIRS Country Report Page 5 out of 11 Section VII. Other Specific Standards: For detailed information on the EU-harmonized legislation on other specific standards, please consult the EU-27 FAIRS Report. Detailed information may also be obtained at the following links: A. GMOs B. Novel Foods C. Fortified Foods D. Dietetic or Special Use Foods E. Wine, Beer and Other Alcoholic Beverages F. Organic Foods G. Vertical Legislation (Breakfast Directives) H. Beef Labeling I. Egg Labeling J. Frozen Foods K. Irradiated Foods L. Fruits and Vegetables M. Seafood N. Pet Food Section VIII. Copyright and/or Trademark Laws: The Spanish Office for Patents and Trademarks, ascribed to the Ministry of Industry, Tourism and Trade, 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 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 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. The regulations and standards covered under this section have been harmonized with the European Union requirements. For detailed information on EU-harmonized legislation on pesticide and contaminant regulations, 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. 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 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 at: http://ec.europa.eu/agriculture/quality/schemes/index_en.htm FAIRS Country Report Page 6 out of 11 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. 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 http://www.fas.usda.gov/posthome/useu/GI.html . Section IX. Import Procedures: First Steps to Enter the Spanish Market As a member of the European Union (EU), Spain follows all EU directives, regulations, and obligations where available. All EU 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. However, 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 see Spain’s Exporters Guide. Import Documentation 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 the importer as it is intended for tariff classification purposes. 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. FAIRS Country Report Page 7 out of 11 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 commercial samples without commercial value to Spain please consult the Spain’s latest FAIRS Certificate report at: http://gain.fas.usda.gov/Pages/Default.aspx. Appendix I. Government Regulatory Agency Contacts: Ministry of Health and Social Welfare Imported Foodstuffs, Contaminations and Compound Residues, Health Certification, Port Inspection and EU Alerts Ministerio de Sanidad y Política Social Subdirección General de Sanidad Exterior Paseo del Prado, 18 y 20 28014 Madrid Tel.: +34-91-596-1000 Fax: +34-91-596-4480 Website: http://www.mspsi.es E-mail : saniext@mspsi.es Ministry of Health and Social Welfare and Gender Equality Spanish Food Safety and Nutrition Agency Ministerio de Sanidad, Política Social 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: http://www.aesan.mspsi.es E-mail: informacionaesan@mspsi.es Ministry of Environment and Rural and Marine Affairs Plant Health Unit - Inspection and Certification Ministerio de Medio Ambiente y Medio Rural y Marino 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: http://www.marm.es/app/CPRP/CPRP1.aspx Email: sgsveget@mapa.es FAIRS Country Report Page 8 out of 11 Ministry of Environment and Rural and Marine Affairs Animal Health Unit - Inspection and Certification Ministerio de Medio Ambiente y Medio Rural y Marino 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: http://cexgan.mapa.es/Modulos/Default.aspx Email: sgsveget@mapa.es Ministry of Environment and Rural and Marine Affairs Planting Seeds and Nursery Products (import requirements, seed registration and certification, and commercial seed catalogs) Ministerio de Medio Ambiente y Medio Rural y Marino Oficina Española de Variedades Vegetales C/ Alfonso XII, 62 28071 Madrid Tel.: +34-91-347-6659 Fax: +34-91-347-6703 Website: http://www.marm.es/es/agricultura/temas/medios-de-produccion/semillas-y-plantas-de- vivero/ Email: oevv@marm.es Ministry of Environment and Rural and Marine Affairs Pesticides, Registration and MRL Establishment Ministerio de Medio Ambiente y Medio Rural y Marino Subdirección General de Medios de Producción C/ Alfonso XII, 62 28071 Madrid Tel.: +34-91-347-4058 Fax: +34-91-347-4087 Website: http://www.marm.es/es/agricultura/temas/medios-de-produccion/productos- fitosanitarios/fitos.asp Spanish Patent and Trademark Office Oficina Española de Patentes y Marcas Paseo de la Castellana, 75 28046 Madrid Tel.: +34-902 157 530 Website: http://www.oepm.es/es/index.html E-mail: informacion@oepm.es EU Trademark Register Office for Harmonization in the Internal Market FAIRS Country Report Page 9 out of 11 Avenida de Europa, 4 03008 Alicante Tel.: +34-96-513-9100 Fax: +34-96-513-1344 Website: http://oami.europa.eu/ows/rw/pages/index.en.do E-mail: information@oami.europa.eu Ministry of Economy and Finance Customs and Duties Ministerio de Economía y Hacienda Departamento de Aduanas e Impuestos Especiales C/ Guzmán El Bueno, 132 28003 Madrid Tel.: +34-91-582-6805 Website: www.aeat.es WTO Inquiry Post a. For technical regulations: Ministry of Industry, Tourism and Trade Ministerio de Industria, Turismo y Comercio Secretaría de Estado de Comercio Exterior Subdirección General 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@mcx.es Website: www.mcx.es/sgcomex/Soivre/Obstaculos.htm 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: http://www.aenor.es European Union – Delegation of the European Union to the United States 2300 M Street NW, Washington, DC 20037 Tel.: (202) 862-9500 FAIRS Country Report Page 10 out of 11 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 Website: http://www.fas.usda.gov/posthome/useu/about.html E-mail: AgUSEUBrussels@fas.usda.gov Appendix II. Other Import Specialist Contacts: 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 Website: http://madrid.usembassy.gov/about-us/fas.html Email: AgMadrid@fas.usda.gov FAIRS Country Report Page 11 out of 11
Posted: 30 December 2011

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