Trade Regulations and Standards in Spain

A Hot Tip about Trade Agreements in Spain

Posted on: 1 Mar 2010

Import Tariffs

Import tariffs do not apply within EU-member states as of January 1, 2003. Thirdcountry goods, including those from the United States, are charged the EU's Common External Tariff. U.S. goods are taxed according to the standard EU duty rate. Since 1988, Spain has used the Harmonized System of tariff nomenclature for applying duties. Spain has been a World Trade Organization member since 1995.

 

For agricultural products, import documentation and tariffs are similar to those of other EU countries. While some agricultural commodities, such as soybeans, sunflower seeds, corn by-products and lumber, are tariff free or subject to minimal tariffs, the great majority of food and agricultural products covered by the EU's Common Agricultural Policy (CAP) are subject to high tariffs, tariff rate quotas, and /or variable import levies which significantly restrict access to the Spanish market.

 

Spanish customs values shipments at C.I.F. prices. For U.S. products, the tariff rate averages five percent. A registered customs agent must clear all shipments through customs. Usually, total costs to clear customs are between 20 to 30 percent of the shipment's C.I.F. value. This estimate includes tariffs, 16 percent value added tax (VAT), plus customs agent and handling fees. Total costs are lower for goods assessed at lower VAT levels (i.e. foodstuffs).

 

Trade Barriers

American businesses complain about very few trade barriers. However, biotech corn still cannot be sold in Spain. Agricultural biotechnology companies could lose sales of biotech seeds if the government approves a proposed coexistence decree mandating a 220-meter distance between biotech, organic and conventional crops. Meanwhile, the debate continues on the coexistence decree. The first draft was published in 2004 and with each successive successful year, the “case” for a government-imposed decree becomes increasingly more difficult, unless forced politically via an internal domestic Government decision/agreement or an unequivocal EC-mandated requirement.

 

American construction firms note that they have not been able to win public-sector construction contracts in Spain, although they have not alleged systematic discrimination against them. Spanish counterparts have recently won several large public-sector construction contracts in the United States, which has prompted usually very competitive American companies to ask why they are not similarly successful in the Spanish market. The United States and the EU are committed to ongoing cooperation aimed at reducing or eliminating barriers to trade and investment.

 

The U.S. and the E.U. agreed at their April 30, 2007 summit to establish a Transatlantic Economic Council (TEC) to encourage greater transatlantic economic cooperation, especially in the regulatory area. Spain provides input into EU policymaking on this initiative.

 

In May 1999, the Spanish Parliament adopted legislation that incorporated the EU Television without Frontiers Directive and revised the 1994 Spanish law on television broadcasting. The 1999 law explicitly requires television operators to reserve 51 percent of their annual broadcast time for European audiovisual productions. It also created an “investment quota,” obliging television operators to devote five percent of their annual earnings to finance European feature-length films and films for European television.

 

This investment quota was further defined in new July 2001 legislation – 60 percent of the investment quota must be spent on audiovisual productions in one of Spain’s official languages. A campaign promise of the current Socialist government was further reform of Spain’s public television stations, including the remote possibility of privatization.

 

Legislation affecting cinema productions includes setting film screen quotas. Spanish movie theatres are required to show at a minimum one day of European films for every three days of films from third countries. In July 2001, the Spanish Parliament adopted new legislation that maintains the film screen quotas. This legislation indicated the possible elimination of screen quotas within five years. However, a new draft Film Law currently being considered by parliament maintains screen quotas.

 

Import Requirements and Documentation

Import Licenses

The Integrated Tariff of the Community, referred to as TARIC (acronym for "Tarif Intégré de la Communauté"), includes rules applying to specific products being imported into the customs territory of the EU or, in some cases, when exported from it. To determine if a license is required for a particular product, check the TARIC.

 

The TARIC can be searched by country of origin, Harmonized System (HS) Code, and product description on the interactive website of the Directorate-General for Taxation and the Customs Union. The TARIC is updated daily.

 

It is important to note that the World Customs Organization has released the third update to the HS Code. There are major production classification revisions to chapters 84 and 85. This affects not just the EU, but also all 121 contracting parties to the HS starting January 2007.

 

Many EU member states maintain their own list of goods subject to import licensing.

 

While Spain does not enforce any quotas on U.S.-origin manufactured products, it still requires import documents, which are described below. None of the following documents constitutes a trade barrier for U.S.-origin goods.

 

Import Authorization: (Autorización Administrativa de Importación, AAI) is used to control imports subject to quotas. Although there are no quotas against U.S. goods, this document may still be required if part of the shipment contains goods produced or manufactured in a third country. For U.S.-origin goods, the document is used essentially for statistical purposes or national security.

 

Prior notice of imports: (Notificación previa de importación) is used for merchandise that circulates in the EU Customs Union Area, but is controlled for statistical purposes. The importer must obtain the document and present it to the General Register.

 

Importers may apply for import licenses at the Register of Spain's Secretariat of Commerce or at any of its regional offices. A commercial invoice that includes freight and insurance, C.I.F. price, net and gross weight, and an invoice number must accompany the license application. Customs accepts commercial invoices by fax. The license, once granted, is normally valid for six months, but may be extended if adequately justified.

 

Goods shipped to a Spanish customs area without proper import licenses or declarations are usually subject to considerable delay and may run up substantial demurrage charges. Prior to making shipments, U.S. exporters should ensure that the importing party has obtained the necessary licenses. Also, U.S. exporters should have their importer confirm with Spanish customs whether any product approvals or other special certificates will be required for the shipment to pass customs.

 

Fines and Penalties

Regulations establish fines for actions delaying normal customs procedure. Fines are not very large, usually between Euros 30 and 60.

 

Import Documentation

Non-agricultural Documentation

 

The official model for written declarations to customs under "normal procedure" is the Single Administrative Document (SAD). European Free Trade Association (EFTA) countries including Norway, Iceland, Switzerland, and Liechtenstein also use the SAD. Goods brought into the customs territory of the Community are, from the time of entry, subject to customs supervision until customs formalities are completed.

 

Goods presented to customs are covered by a summary declaration, which is lodged once the goods have been presented to customs.

 

The summary declaration is to be lodged by:

• the person who brought the goods into the customs territory of the Community or by any person who assumes responsibility for carriage of the goods following such entry; or

• the person in whose name the person referred to above acted.

Non-EU goods presented to customs must be assigned a customs-approved treatment or use authorized for such non-Community goods. Where goods are covered by a summary declaration, the formalities for them to be assigned a customs-approved treatment or use must be carried out:

• 45 days from the date on which the summary declaration is lodged in the case of goods carried by sea;

• 20 days from the date on which the summary declaration is lodged in the case of goods carried other than by sea.

 

Where circumstances so warrant, the customs authorities may set a shorter period or authorize an extension of the period.

 

Batteries

New EU battery rules came into force on 26 September 2006 following the publication of a revised Directive on batteries and accumulators and waste batteries and accumulators (Directive 2006/66). The new Directive applies to all batteries and accumulators put on the EU market, including automotive, industrial and portable batteries. It aims to protect the environment by restricting the sale of batteries and accumulators that contain mercury or cadmium (with an exemption for emergency and alarm systems, medical equipment and cordless power tools) and by promoting a high level of collection and recycling.

 

Responsibility is placed on producers to finance the costs associated with collection, treatment, and recycling of used batteries and accumulators. The Directive also includes provisions on labeling of batteries and their removability from equipment. EU member states must incorporate the EU Directive into their national law by September 26, 2008.

 

Chemicals

REACH is a major reform of EU chemicals policy that was adopted at EU level in December 2006. REACH became national law in the 27 EU member states on the 1st of June 2007. REACH stands for the "Registration, Evaluation and Authorization of Chemicals". REACH requires all chemicals produced or imported into the EU in volumes greater than one ton per year to be registered with the central European Chemicals Agency (ECHA), with information on their properties, uses and safe handling. Most chemicals currently imported into the EU are eligible for pre-registration that provides ECHA with basic information on the substance and allows the continued imports until a later registration deadline. ECHA will accept pre-registrations from June 1, 2008 until December 1, 2008. U.S. companies should take advantage of the pre-registration period if possible. The full registration period for pre-registered chemicals ranges from 3 to 11 years depending on the volume of the substance and its hazardous properties. Substances not pre-registered must be registered to stay on the market. Chemicals of very high concern, like carcinogens, need an authorization for use in the EU.

 

Virtually every industrial sector, from automobiles to textiles, may be affected by the new policy. U.S. exporters to Europe should carefully consider this piece of EU environmental legislation.

 

WEEE & RoHS

EU rules on waste electrical and electronic equipment (WEEE), while not requiring specific customs or import paperwork, may require U.S. exporters to register products with a national WEEE authority, or arrange for this to be done by a local partner. Similarly, related rules for WEEE restricting the use of the hazardous substances (RoHS) lead, cadmium, mercury, hexavalent chromium, PBBs, and PBDEs, do not entail customs or importation paperwork. However, U.S. exporters may be asked by a European RoHS enforcement authority or by a customer to provide evidence of due diligence in compliance with the substance bans on a case-by-case basis.

 

Several forms of documentation may be required for shipments to Spain. Exporters are required to present one commercial invoice, one bill of lading and three copies of a certificate of origin for all shipments. Other certificates are necessary for exporting pharmaceutical goods, perishable foods, live animals and some medical goods.

 

Pharmaceutical Certificates: These certificates are required by Spanish customs for drugs and certain sanitary items. A standard analysis bulletin issued by the manufacturer, listing the product composition, is acceptable for customs purposes.

 

Other certificates: Ocean-going vessels require a certificate of compliance from the Marine Authority (Ministry of Transport) to bring ships into Spain. In order to acquire this certificate, the manufacturer has to demonstrate the sea-worthiness of the vessels. The National Marine Manufacturers Association issues a sea-worthiness affidavit that is accepted by the Spanish authorities for the certificate of compliance.

 

Agricultural Documentation - Sanitary-Phytosanitary Certificate: Phytosanitary certificates established at the EU level are required for importation of living plant material, including plants, plant products and seeds.

 

Sanitary certificates are required to import animals, meat products, marine mammals, fish, crustaceans, or molluscs and parts thereof. In addition, U.S. exports of these animals and/or products must originate from plants and regions included in EU lists of establishments/regions approved for export to the EU. This applies regardless of whether the product is for human consumption, for pharmaceutical use, or strictly for non-human use (e.g., veterinary biological, animal feeds, fertilizers, research). Many of these certificates are uniform throughout the EU, but the harmonization process has not yet been finalized.

 

Since April 2006, the EU has accepted the U.S. seafood inspection system as equivalent to the European. A specific public health certificate must accompany U.S. seafood shipments. Commission Decision 2006/199/EC place specific conditions on imports of fishery products from the U.S. Sanitary certificates for shellfish are required for gastropods, bivalve molluscs, tunicates and echinoderms. Sanitary certificates are issued by the FDA and the U.S. Department of Commerce, NOAA- National Marine Fisheries Service (NMFS/USDC). However, as of June 17, 2009, the FDA will stop issuing health certificates for fishery products intended for the EU.

 

NOAA-NMFS will remain the sole competent authority for the certification of fishery and aquaculture products, including live bivalve mollusks.

 

Since May 1, 2007, with the implementation of the second Hygiene Package, aquaculture products coming from the United States must be accompanied by a public health certificate according to Commission Decision 2006/199/EC and the animal health attestation included in the new fishery products certificate covered by Regulation (EC) 1664/2006. This animal health attestation is not required in the case of live bivalve molluscs intended for immediate human consumption (retail).

 

Legislation is currently under review at the European Commission. For further information, please contact the NOAA Fisheries office at the U.S. Mission to the EU.

 

A new EU law on hygiene of foodstuffs and food of animal origin, which simplifies existing rules and guarantees safer food, has been in force since January 1, 2006. To facilitate the implementation of the revised rules, the Commission published these implementing measures and transitional arrangements:

• Commission Regulation 2073/2005, updated by Commission Regulation 1441/2007

• Commission Regulation 20074/2005

• Commission Regulation 2076/2005

 

A second set of new hygiene laws were put in place as of May 1, 2007. They greatly modify import requirements for animal and animal products.

 

U.S. Export Controls

In general, exports of U.S.-made products to Spain are not subject to specific requirements. However, certain aerospace/defense items require export licenses if they are considered "dual use type of equipment" with defense or military use. The Department of Commerce's Bureau of Industry and Security (BIS) issues export licenses . If an application is approved, the company will receive a license number and expiration date to use on export documents. A BIS-issued license is usually valid for 2 years.

 

For normal deliveries of U.S. goods to Spain, Spanish authorities only require regular documentation (bill of loading, copy of invoice, certificate of origin, copies of documents related to payment and insurance). Customs agents for U.S. firms should help their clients in the process of including all relevant documents in the delivery.

 

Spain was a member of COCOM from 1985, and now participates in the Wassenaar Arrangement that replaced COCOM. Spain is also a member of the Australian Group for Chemical Products Controls, the Missile Technology Control Regime (MTCR) and is a signatory of the Chemical Weapons Convention that became effective in 1995.

 

Temporary Entry

The Spanish re-export system is regulated by Order of July 24, 1987, and conforms to EU regulations. Re-export inquiries must be addressed to the Port's Customs Director. Re-exports of U.S. goods from Spain follow the same procedures as exportation of Spanish products. Goods re-exported to other EU member states are subject to statistical surveillance.

 

Re-exports to outside the EU and not covered by specific EU regulations are exported with an accompanying Customs Export Declaration at the exit point. A limited number of goods require a Prior Notice of Export.

 

Exporters of high-technology goods subject to U.S. export control procedures must ensure that Spanish clients and subsidiaries are aware of U.S. export controls.

There are four types of procedures for handling the re-export of goods:

• Temporary Imports: Goods imported for a limited time period under an ATA (international customs document for temporary duty-free imports) carnet. A bank guarantee in the form of a bond equivalent to duties owed must be provided to customs, which will be refunded once the goods leave the country.

• Temporary Admission: Goods that will be incorporated into a final product for export. The same procedure used for temporary imports applies for re-export.

• Replacement Goods: Companies with continuing needs for primary materials, commodities, or intermediates can request prior approval for replacement goods after the second year of operation. They must deposit a bond with customs on the compensatory tax only. Replacements for defective goods destroyed under customs supervision are also admitted duty-free, but require extensive supporting documentation.

• Drawback: Duties are paid simultaneously with a presentation of a list of products to be re-exported in the future. Later, a rebate is given upon customs clearance out of Spain.

 

Companies are advised to use the carnet procedure to temporarily bring goods into Spain for demonstration purposes without paying duties or posting bond. The carnet must be presented to the customs authorities whenever entering or leaving the country. Consumable items and give-away samples are not included under carnet procedures.

 

ATA carnets are predominantly used for commercial samples, tools of trade, advertising material or cinematographic, audio-visual, medical, scientific or other professional equipment that will be imported for a period of less than a year. The ATA carnet allows exporters to avoid normal customs clearance formalities. The carnet also provides a financial guarantee to foreign customs officials so that if the goods are not re-exported, the duty will be paid. A bond equivalent to the duty is charged.

 

The ATA carnet is used internationally and should be distinguished from the EU carnet, sometimes referred to as the ESC carnet. Introduced in 1985, the EU carnet is used for the temporary movement of certain goods, usually equipment and working materials, between EU countries. Unlike the ATA carnet, it does not require the posting of a bond. Information on carnet applications is available from all U.S. Export Assistance Centers, most U.S. Chambers of Commerce and authorized export insurance companies.

 

Advertising material, catalogs, price lists and similar printed items are admitted duty free. However, to avoid problems, such items should always be labelled, "no value." Otherwise, a customs duty is likely to be levied on the sample.

 

As a signatory to the International Convention to Facilitate the Importation of Commercial Samples and Advertising Matter, Spain admits samples of negligible value duty free. Items of commercial value not covered under carnet procedures can be imported by companies for up to a year upon payment of a bond. Upon presentation of the customs receipt and at re-export, the deposit is refunded.

 

Business visitors entering with commercial samples should bring letters from their companies attesting to their status, identifying the samples and certifying that the samples are not for sale.

 

Prohibited and Restricted Imports

Spanish regulations ban the import of illicit narcotics and drugs. There are also very restrictive regulations for imports of explosives, firearms, defense equipment and material, tobacco and gambling material. Furthermore, the government highly restricts the import of many types of pharmaceutical products.

 

EU regulations on hormones ban most U.S. beef and beef products from entry into the EU, and preclude the importation of certain live cattle. The United States successfully challenged the EU hormone ban at the World Trade Organization, but the EU has not yet opened its market to hormone-treated beef. The EC has instead opened a quota for the import of hormone-free U.S. beef. However, because the quota is so small and because the EC only permits 1/12th of the quota to enter monthly, U.S. exporters have not been able to take advantage of this very limited entry point into the European market.

 

Standards

Overview

Products tested and certified in the United States to American standards are likely to have to be retested and re-certified to EU requirements as a result of the EU’s different approach to the protection of the health and safety of consumers and the environment. Where products are not regulated by specific EU technical legislation, they are always subject to the EU’s General Product Safety Directive as well as to possible additional national requirements.

 

European Union standards created under the New Approach are harmonized across the 27 EU Member states and European Economic Area countries to allow for the free flow of goods. A feature of the New Approach is CE marking. While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that Regulations and technical standards might also function as barriers to trade if U.S. standards are different from those of the European Union.

 

The European Union is currently undertaking a major revision of the New Approach that will enhance some aspects, especially in market surveillance.

 

 

Some recent changes include:

*Units of Measurement: On December 16, 2008, the European Parliament (EP) voted in favor of adoption of the common position which amends the existing "metrics only" legislation (80/181/EEC). The amendment indefinitely extends the use of supplementary units of measurement, such as pounds and inches. Expectations are that the final text of the adopted directive amending 80/181/EEC will be published in the Official Journal in February 2009 following formal notification of the Council/Coreper.

*Energy-Using Products (EUP): On December 17, 2008, the Commission adopted and published the first implementing measure on standby energy consumption. The measure, one of many to come under the energy-using products directive 2005/23/EC, affects a broad range of household and office appliances such as television and computers. Manufacturers will have to lower their product's energy consumption in standby mode to a certain watt level in two stages. By 2020, the Commission estimates an energy reduction by 73% as a result of the measure.

*New Toy Safety Directive Adopted: On December 18, 2008, the European Parliament adopted the new toy safety directive which strengthens existing safety, labeling and market surveillance requirements. The new directive bans use of certain carcinogenic substances as well as some toxic heavy metals. Any potential hazard has to be clearly labeled in order to warn children and adults. In addition, the new directive enhances the obligations of importers and distributors who will be required to verify compliance.

 

Agricultural Standards The establishment of harmonized EU rules and standards in the food sector has been ongoing for several decades, but it took until January 2002 for the publication of an EU general food law establishing general principles. This Regulation introduced mandatory traceability of the feed and food chain as of Jan 1, 2005.

 

Spanish requirements for certification and testing standards have gradually adopted EU directives. A product that meets the standards and certification requirements of any other EU country can be imported and sold in Spain without further testing.

 

The Ministry of Industry processes applications for homologation, and promotes certification and normalization for industrial products and processes and quality control procedures.

 

Standards Organizations

EU standards setting is based on consensus initiated by industry or mandated by the European Commission and carried out by independent standards bodies, acting at the national, European or international level. There is strong encouragement for nongovernmental organizations, such as environmental and consumer groups, to actively participate in European standardization.

 

Many standards in the EU are adopted from international standards bodies such as the International Standards Organization (ISO). The drafting of specific EU standards is handled by three European standards organizations:

-CENELEC, European Committee for Electrotechnical Standardization

-ETSI, European Telecommunications Standards Institute

-CEN, European Committee for Standardization, handling all other standards

 

Standards are created or modified by experts in Technical Committees or Working Groups. The members of CEN and CENELEC are the national standards bodies of the member states, which have "mirror committees" that monitor and participate in ongoing European standardization. Individual member states’ standards bodies sell CEN and CENELEC standards. ETSI is different in that it allows direct participation in its technical committees from non-EU companies that have interests in Europe and gives away its individual standards at no charge on its website. In addition to the three standardsdeveloping organizations, the European Commission plays an important role in standardization through its funding of participation in the standardization process by small- and medium-sized companies and non-governmental organizations such as environmental and consumer groups. The Commission also provides money to standards bodies when it mandates standards development to the European Standards Organization for harmonized standards that will be linked to EU technical regulations.

 

Due to the EU’s vigorous promotion of its regulatory and standards system as well as its generous funding for its business development, the EU standards regime is wide and deep - extending well beyond EU political borders to include affiliate members (countries which are hopeful of becoming full members in the future) such as Albania, Bulgaria, Croatia, FYR of Macedonia, and Turkey. Another category, called "partner standardization bodies" includes the standards organizations of Bosnia and Herzegovina, Egypt, Serbia and Montenegro, Russia, Tunisia, the Ukraine and Australia, which are not likely to join the EU or CEN any time soon, but have an interest in participating in specific CEN technical committees. They pay a fee for full participation in certain technical committees and agree to implement the committee’s adopted standards as national standards. Many other countries are targets of the EU’s extensive technical assistance program, which is aimed at exporting EU standards and technical regulations to developing countries, especially in the Mediterranean and Balkan countries, Africa, as well as smaller programs for China and Latin America.

 

To know what CEN and CENELEC have in the pipeline for future standardization, it is best to visit their websites. CEN’s "business domain" page provides an overview by sector and/or technical committee whereas CENELEC offers the possibility to search its database.

 

With the need to adapt more quickly to market needs, European standards organizations have been looking for "new deliverables" which are standard-like products delivered in a shorter timeframe. While few of these "new deliverables" have been linked to EU regulations, expectations are that they will eventually serve as the basis for EU-wide standards

 

Conformity Assessment

Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU legislation. The purpose of conformity assessment is to ensure consistency of compliance during all stages of the production process to facilitate acceptance of the final product. EU product legislation gives manufacturers some choice with regard to conformity assessment, depending on the level of risk involved in the use of a product. These range from self-certification, type examination and production quality control systems, to full quality assurance systems. To promote market acceptance of the final product, there are a number of voluntary conformity assessment programs. Conformity assessment bodies in individual Member States are available in a list published by the European Commission.

 

CEN’s certification systems are the Keymark, the CENCER mark, and the European Standard Agreement Group. CENELEC has its own initiative. ETSI does not offer conformity assessment services.

 

ENAC (Entidad Nacional de Acreditación – National Accreditation Entity) and AENOR (Spanish Standards & Certification Association) are the major entities for conformity assessment in Spain. ENAC establishes the criteria and grants permits to the authorized certification labs.

 

Product Certification

To sell products in the EU market of 27 member states as well as Norway, Liechtenstein and Iceland, U.S. exporters must apply CE marking whenever their product is covered by specific product legislation. CE marking product legislation offers manufacturers a number of choices and requires decisions to determine which safety/health concerns need to be addressed, which conformity assessment module is best suited to the manufacturing process, and whether or not to use EU-wide harmonized standards. There is no easy way for U.S. exporters to understand and go through the process of CE marking, but this section provides some background and clarification.

 

Products manufactured to standards adopted by CEN, CENELEC and ETSI and published in the Official Journal as harmonized standards are presumed to conform to the requirements of EU Directives. The manufacturer then applies the CE marking and issues a declaration of conformity. With these, the product will be allowed to circulate freely within the EU. A manufacturer can choose not to use the harmonized EU standards, but still must demonstrate that the product meets the essential safety and performance requirements. Trade barriers occur when design, rather than performance, standards are developed by the relevant European standardization organization, and when U.S. companies do not have access to the standardization process through a European presence.

 

CE marking addresses itself primarily to the national control authorities of the member states, and its use simplifies the task of essential market surveillance of regulated products. Although CE marking is intended primarily for inspection purposes by member state inspectors, the consumer may well perceive it as a quality mark.

 

CE marking is not intended to include detailed technical information on the product, but there must be enough information to enable the inspector to trace the product back to the manufacturer or the authorized EU representative. This detailed information should not appear next to the CE marking, but rather on the declaration of conformity, the certificate of conformity (which the manufacturer or authorized agent must be able to provide at any time, together with the product's technical file), or documents accompanying the product.

 

Spain has established specific certification requirements for certain products. This certification procedure is referred to as "homologation" and requires product testing by approved laboratories. Local homologation requirements and testing standards have adapted Spanish legislation to EU directives.

 

At present, there are no requirements for either ISO 9000 certification or its EU equivalent. Nonetheless, demand is growing for companies that meet these standards as a guarantee of quality in product and manufacturing processes.

 

Accreditation

Competent authorities have officially accredited independent certification bodies, known as notified bodies, to test and certify to EU requirements. However, under U.S.-EU Mutual Recognition Agreements (MRAs), notified bodies based in the United States and referred to as conformity assessment bodies are allowed to test in the United States to EU specifications, and vice versa. The costs are significantly lower, helping make U.S. products more competitive. At this time, U.S.-EU MRAs cover the following sectors: EMC (in force), RTTE (in force), medical devices (in transition), pharmaceutical (on hold), recreational craft (in force) and marine equipment (in force). The U.S. Department of Commerce, National Institute of Standards and Technology (NIST), has a link on its website to American and European Conformity Assessment bodies operating under a mutual recognition agreement

 

Accreditation is handled at Member State level. Membership in European Accreditation is open to nationally recognized accreditation bodies in countries in the European geographical area that can demonstrate that they operate an accreditation system compatible with EN45003 or ISO/IEC Guide 58.

 

In Spain, ENAC keeps an updated list of accredited labs on its website in the "Accredited Bodies" section, indicating the types of testing and calibration that they perform.

 

Labeling and Marking

Manufacturers should be mindful that, in addition to EU mandatory and voluntary schemes, national voluntary labeling schemes might still apply. These schemes may be highly appreciated by consumers, and thus, become unavoidable for marketing purposes.

 

All labels require metric units, although dual labeling will also be accepted until end of December 2009. The use of language on labels has been the subject of a Commission Communication, which encourages multilingual information, while preserving the right of member states to require the use of language of the country of consumption.

 

The EU has mandated that certain products be sold in standardized quantities. Council Directive 80/232/EC provides permissible ranges of nominal quantities, container capacities and volumes for a variety of products. This legislation is currently being reviewed in an effort to simplify it.

 

 

The Eco-label EU legislation revised in 2000 distinguishes environmentally friendly products and services through a voluntary labeling scheme called the Eco-label. Currently, the scheme applies to 7 product groups: cleaning products, appliances, paper products, clothing, lubricants, home and garden products and tourism services. The symbol, a green flower, is a voluntary mark. The Eco-label is awarded to producers who can show that their product is less harmful to the environment than such similar products. This “green label” encourages consumers to buy green products. However, the scheme does not establish ecological standards that manufacturers are required to meet to place a product on the market. Products without the EU Eco-label can still enter the EU as long as they meet the existing health, safety, and environmental standards and Regulations.

 

The EU Eco-label is a costly scheme (up to EUR 1,300 – USD 1,793 for registration and up to EUR 25,000 – USD 34,482 per year for the use of the label, with a reduction of 25 percent for small and mid-sized enterprises) and has therefore not been widely used so far. However, the Eco-label can be a good marketing tool and, given the growing demand for green products in Europe, it is likely that the Eco-label will become more and more a reference for green consumers.

 

In June 2005, the European Commission tabled a Communication designed to launch a debate on the best way ahead regarding the eco-labeling of fisheries products. This initiative follows the growing interest by environmental Non-Governmental Organizations and increased public interest in food products associated with considerations related to environmental sustainability. A number of eco-labeling schemes have already been established with regard to fisheries products and other initiatives are being developed. It is not always easy to establish how reliable eco-labeling claims are. International guidelines on eco-labeling have recently been adopted by the Food and Agriculture Organization (FAO) and discussions on these issues and their potential effects on free trade areas are progressing in other international organizations such as the World Trade Organization (WTO)

 

Companies selling a broad range of electrical goods in Europe are required to comply with the Waste Electrical and Electronic Equipment Directive (WEEE), and since July 2006 they need to conform to the Restriction of Use of certain Hazardous Substances Directive (RoHS). One of the requirements is that electrical goods be marked so that consumers do not put them in with municipal waste.

 

Manufacturers and distributors should be aware of specific requirements regarding the labeling and traceability of foodstuffs, including seafood, which are covered by several EU Regulations:

• Regulation 178/2002/EC

• Directive 2000/13/EC, last amended by Directive 2003/89/EC as regards indication of the ingredients present in foodstuffs.

• Commission Directive 2005/26/EC.

• Council Regulation 104/2000/EC (seafood)

• Commission Regulation 2065/2001/EC (seafood, only for retail channels) In view of the complexity and rapid change in marking, labeling and testing requirements in Spain, U.S. exporters are advised to request pertinent instructions from their importers prior to shipment.

 

Basic labelling requirements apply in certain product categories:

• Electrical products that operate in a range of 50 to 1,000 volts alternating current or 75 to 1,500 volt direct current must comply with the EU lowvoltage directive. There are three accepted forms of proof of conformity with this regulation: a mark issued by an authorized EU agency, a certificate issued by an approved EU authority or a declaration issued by the manufacturer, which can self-certify the product.

• Used equipment: Spain now allows the entry of used equipment, material and goods subject to the same standards concerning safety as new imports in the same product category.

• Foodstuffs: The Directorate General of Health implements human consumption standards for the preparation, residue content and storage media for virtually all foodstuffs. Labeling must conform to EU requirements and must be in Spanish.

• Food and Animal Feed: New EU legislation requiring labeling and traceability in food and animal feed came into effect on April 18, 2004. As of this date, all genetically modified organism- (GMO) containing products must be labelled “contains GMOs”. “Traceability” through the production chain is required by the new legislation. The GMO content of products must be documented along the production chain and kept on file for five years.

• Agricultural products: Labeling requirements are fully harmonized with the EU labeling system and labels must be in Spanish.

• Textiles: Customs and point-of-sale regulations require that all textile goods and ready-made clothing have a Spanish label. Standard Spanish textile nomenclature and content requirements must be stated on the label.

 

Requirements relating to textile content, labeling and packaging are specific and extensive.

• Drugs, Pharmaceuticals and Cosmetics: These goods are subject to technical inspection and registration by the Directorate General of Health prior to entry. There are also detailed marking and labelling requirements, somewhat similar to those for foodstuffs, which include detailed chemical composition.

• Fertilizers and Fungicides: Imported fertilizers must be registered with the local Ministry of Agriculture. Inspection and analysis will be performed prior to customs clearance. The Ministry of Agriculture must approve all printed advertising and publicity materials, and labels must be in Spanish and include detailed precautions.

• Firearms: The Spanish government must clear all firearms, which must bear stamps of certifications.

• Motor Vehicles: Each vehicle will be inspected for engraved serial numbers on both the engine and chassis. If both of these are not present, Spanish customs levies a special charge for stamping the number.

• Tires and Tubes: All tires and inner tubes must be marked with serial numbers.

 

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Posted: 01 March 2010

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