Describes the country's standards landscape, identifies the national standards and accreditation bodies, and lists the main national testing organization(s) and conformity assessment bodies.
Products tested and certified in the United States to American standards are likely to require re-testing and re-certification for EU requirements as a result 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.
European Union standards were harmonized across the 28 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 European Union.
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.
Spanish Standards are developed by UNE (previously known as AENOR), the Spanish Standards Association.
Testing, inspection, and certification
The Spanish Standards Association & Certification Associations was originally known as AENOR (Asociación Española de Normalización y Certificación). In early 2017, the organization was split into separate legal entities, UNE and AENOR, with UNE becoming the parent body. UNE is responsible for developing standards and cooperation projects, while AENOR, the Spanish benchmark certification agency, is 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, is the National Accreditation Entity and officially recognizes the technical competence of the conformity assessment entities in Spain. A detailed breakdown of Conformity Assessment (see Conformity Assessment, next section) bodies:
- 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.
and AENOR (Spanish Certification Association) are the major entities for conformity assessment in Spain. ENAC establishes the criteria and grants permits to the authorized certification labs.
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.
To promote market acceptance of the final product, there are a number of voluntary conformity assessment programs. 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.
To sell products on the EU market as well as in Norway, Liechtenstein and Iceland, U.S. exporters are required to 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.
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 then 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, or when U.S. companies lack the benefit of some sort of European presence to assist in or handle the process. As market surveillance was found lacking, the EU adopted the New Legislative Framework, which went into force in 2010. This framework is similar to a blueprint for all CE marking legislation, harmonizing definitions, responsibilities, European accreditation and market surveillance.
The CE Mark is primarily for the benefit of the national control authorities of the member states, and its use simplifies the task of essential market surveillance of regulated products.
The 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 (which the manufacturer or authorized agent must be able to provide at any time, together with the product's technical file), or the documents accompanying the product.
Publication of technical regulations
In Spain, the Spanish National Gazette is the Boletín Oficial del Estado (BOE). An English version of the website can be viewed. 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.
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 lists the standards reference numbers linked to legislation.
National technical regulations are published on the 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 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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NIST Notify U.S. Service
Members of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to notify to the WTO proposed technical regulations and conformity assessment procedures that could affect trade. Notify U.S. (www.nist.gov/notifyus) is a free, web-based e-mail registration service that captures and makes available for review and comment key information on draft regulations and conformity assessment procedures. Users receive customized e-mail alerts when new notifications are added by selected country or countries and industry sector(s) of interest and can also request full texts of regulations. This service and its associated web site are managed and operated by the USA WTO TBT Inquiry Point housed within the National Institute of Standards and Technology, part of the U.S. Department of Commerce.