Overview

Products tested and certified to U.S. standards are likely to require re-testing and re-certification for EU requirements because of the EU’s different approaches to health, safety, and environmental concerns. While harmonization of EU legislation can facilitate access to the EU Single Market, regulations and technical standards in the EU often differ from those in the United States. 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.

EU standards were harmonized across the 27 EU member states and European Economic Area countries to allow for the free flow of goods. Relevant standard authorities include:

• European Committee for Electrotechnical Standardization (CENELEC),
• European Telecommunications Standards Institute (ETSI), and
• European Committee for Standardization (CEN), handling of all other standards.

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

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

Standards

The Spanish Standards Association and Certification Associations, originally known as AENOR (Asociación Española de Normalización y Certificación), was split in early 2017 into two separate legal entities:

• Asociación Española de Normalización (UNE), the parent body, is responsible for developing standards and cooperation projects. UNE participates in international and European standardization bodies.
• AENOR, the Spanish benchmark certification agency, responsible for conformity assessment and the promotion of Spanish standards, training, information services, the sale of standards and other commercial activities. 

Entidad Nacional de Acreditación (ENAC), is the national accreditation entity and officially recognizes the technical competence of the conformity assessment entities in Spain.  ENAC and AENOR are the major entities for conformity assessment in Spain. ENAC establishes the criteria and grants permits to the authorized certification labs. 

Testing, Inspection, and Certification

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, from design to production, and to facilitate acceptance of the final product. EU product legislation gives manufacturers some choice regarding conformity assessments, depending on the level of risk involved in the use of their product. These conformity assessments range from: self-certification type examinations and production quality control systems, to full quality assurance systems. Conformity assessment bodies in individual member states are listed in NANDO, the European Commission’s website for relevant standard authorities. Conformity assessment bodies include:

• Laboratories
• Inspection bodies
• Certification bodies
• Environmental verifiers

At the national level, most Spanish ministries, as well as autonomous communities and local governments, use ENAC accreditations.

ENAC was nominated by the Ministry of Agriculture, Fisheries, and Food as the body in charge of checking compliance with the principles of good laboratory practices (GLP) by testing labs engaging in studies of phytosanitary products, such as pesticides, insecticides, and fungicides.

There are several voluntary conformity assessment programs to promote market acceptance of the final product, including:

• CEN’s Keymark and CEN workshop agreements (CWA) certification rules and
• CENELEC voluntary standards.

Publication of Technical Regulations

In Spain, the official state record is the Boletín Oficial del Estado (BOE). An English version can be viewed on the website. BOE publishes a monthly list of all new technical regulations approved by the Spanish Ministry of Industry, Trade, and Tourism, plus amendments or other changes to technical regulations. However, the full text of the documents with the technical regulations does not appear in the BOE and can be requested through AENOR.

Both AENOR and ENAC have newsletters and publications that provide a broad range of information on developments in these areas.

The Official Journal is the official record of the EU. It is published daily on the internet and consists of two series covering draft and adopted legislation, as well as case law, studies by committees, and more. It also lists the standards reference numbers linked to legislation.

National technical regulations can be found under Summaries of EU legislation on the EU´s Commission’s website to allow other countries and interested parties to comment.

Certain products are subject to specific technical regulations, including:

• 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 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.

Contact Information

• ENAC

Calle Serrano 240 - Planta 3

28016 Madrid

Tel: (+34) 914 573 289

E-mail: enac@enac.es

• AENOR

Calle Génova 6

28004 Madrid

Tel: (+34) 914 326 000/(+34) 902 102 201

E-mail: info@aenor.com

The Standards Attaché for the European Union is in Brussels: Jim Curtis (Jim.Curtis@trade.gov).

Use ePing to review proposed technical regulations and conformity assessment procedures. 

The ePing SPS&TBT platform (https://epingalert.org/), or “ePing”, provides access to notifications made by World Trade Organization (WTO) Members under the Agreements on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT), distributed by the WTO from January 16, 1995 to present.  ePing is available to all stakeholders free of charge and does not require registration unless the user wishes to receive customized e-mail alerts.  Use it to browse notifications on past as well as new draft and updated product regulations, food safety and animal and plant health standards and regulations, find information on trade concerns discussed in the WTO SPS and TBT Committees, locate information on SPS/TBT Enquiry Points and notification authorities, and to follow and review current and past notifications concerning regulatory actions on products, packaging, labeling, food safety and animal and plant health measures in markets of interest. 

Notify U.S., operated and maintained by the National Institute of Standards and Technology (NIST) since 2003 to distribute and provide access to notifications (and associated draft texts) made under the WTO TBT Agreement for US stakeholders, has reached its end of life. Per obligation under the TBT Agreement, each WTO Member operates a national TBT (and an SPS) Enquiry Point.  National TBT Enquiry Points are authorized to accept comments and official communications from other national TBT Enquiry Points, which are NOT part of the WTO or the WTO Secretariat.  All comment submissions from U.S. stakeholders, including businesses, trade associations, U.S domiciled standards development organizations and conformity assessment bodies, consumers, or U.S. government agencies on notifications to the WTO TBT Committee should be sent directly to the USA WTO TBT Inquiry Point.  Refer to the comment guidance at https://tsapps.nist.gov/notifyus/data/guidance/guidance.cfm for further information. This guidance is provided to assist U.S. stakeholders in the preparation and submission of comments in response to notifications of proposed foreign technical regulations and conformity assessment procedures.

Article with a video on CE Mark: https://www.trade.gov/ce-marking.