Overview

Products tested and certified in the United States to American 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. 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. Information on the harmonization of the EU legislation including agricultural standards, and standards organizations like CENELEC (European Committee for Electrotechnical Standardization), ETSI (European Telecommunications Standards Institute), and CEN (European Committee for Standardization, handling of all other standards) can be found using the link below.

While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that regulations (mandatory) and technical standard (voluntary) might also function as barriers to trade if U.S. standards are different from those of the EU.

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 homologation and promotes certification and normalization for industrial products and processes and quality control procedures.

Standards

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

• UNE, the parent body, responsible for developing standards and cooperation projects.
• 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. UNE participates in international and European standardization bodies. 

ENAC (Entidad Nacional de Acreditación), 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, to facilitate acceptance of the final product. EU product legislation gives manufacturers some choice with regard to conformity assessments, depending on the level of risk involved in the use of their product. These range from self-certification, type examination and production quality control system, to full quality assurance system. Conformity assessment bodies in individual member states are listed in NANDO, the European Commission’s website. 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 Practice (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.

• CEN’s certification systems are the Keymark, the CENCER mark, and CEN workshop agreements (CWA) Certification Rules.
• CENELEC has its own initiative.
• ETSI does not offer conformity assessment services.

Publication of Technical Regulations

In Spain, the Spanish National Gazette 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 gazette 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.

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 91 457 32 89

E-mail: enac@enac.es

 

• AENOR:

Calle Génova 6

28004 Madrid

Tel: +34 91 432 6000/ +34 902 102 201

E-mail: info@aenor.com

The Standards Attaché for the European Union is in Brussels:
Jim Courtis

Jim.Courtis@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 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.