Describes standards, identifies the national standards, accreditation bodies, and lists the national testing organization(s) and conformity assessment bodies.
Products tested and certified in the United States by U.S. regulations to U.S. standards are likely to have to be retested and re-certified to EU requirements as a result of the European Union’s differing 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 General Product Safety Directive as well as to possible additional national requirements.
While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that regulations, which are mandatory, and technical standards, which are voluntary, might also function as barriers to trade when U.S. standards differ from those of the European Union, which is often the case. For more on how the EU standards and regulatory system function as a barrier to trade, see page 177 in the National Trade Estimate maintained by the Office of the United States Trade Representative.
In general, the harmonization of EU standards has greatly simplified technical regulations amongst EU Member States. Prior to harmonization, each country in the European Union developed its own standards through its national standards body, leading to differing and conflicting standards, laws, and conformity assessment procedures. Thus, it became necessary to create a new, integrated, European system of standardization. The new system provided for three EU standards bodies to create standards on a Europe-wide level: The European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute (ETSI).
CEN activities cover a broad range of areas and CENELEC addresses electrotechnical standards, while ETSI specializes in telecommunications. CEN and CENELEC’s principal members are Member State national standards bodies. ETSI’s membership has a broader range of interested parties. These three are the only recognized bodies where a Harmonized European Standard (EN) can be developed. When the development of a European Harmonized Standard begins in one of these organizations, development of a national standard must stop. Harmonized Standards are standards that support European legislation. They have been mandated by the European Commission, have been developed by the European Standards Bodies above, address essential health and safety requirements, and notification of their development has been published in the Official Journal of the European Union.
Technically, the use of a Harmonized Standard is voluntary. A manufacturer can elect to use a Harmonized Standard or decide to use a non-Harmonized Standard (e.g., a standard developed by one of the many standards development organizations based in the United States) to meet essential requirements. However, when using a Harmonized Standard, the manufacturer is presumed to be in conformity with the law (Presumption of Conformity). EU harmonized standards that confer presumption of conformity are listed in the directive or regulation usually in Annex Z or ZZ. On the contrary, using a standard that is not a Harmonized Standard will impose additional responsibilities. The use of anything but an EU Harmonized Standard places a burden of proof upon the manufacturer that the product meets the essential requirements. This proof may be provided by the manufacturer’s technical file, by the employment of a third party (e.g., consultant or testing house), or by a combination of the two.
In addition to the three EU standards developing organizations, the European Commission funds the participation of small- and medium-sized EU companies and non-governmental EU organizations, such as environmental, labor and consumer groups, in the standardization process. The Commission also provides money to the European standards bodies when it mandates standards development for harmonized standards that will be linked to EU legislation. The Commission requests CEN/CENELEC or TSI to develop standards.
There are also several European Standards (ENs) developed by CEN, CENELEC, and ETSI that are not mandated by the Commission and that do not necessarily define essential requirements. In theory, their use is voluntary. They may define other characteristics, such as durability, appearance, quality levels, or even cultural preferences. They may be test methods or measurement guides. These European Standards often have the advantage of recognition in the European marketplace. A standard that does not emanate from one of the European standards bodies is not always recognized by insurers, lending institutions, retailers, developers, market surveillance organizations, conformity assessment bodies, and consumers, and may hinder acceptance of the product in the marketplace, particularly when a well-known European Standard already exists for the same product.
Finally, given the European Union’s vigorous promotion of its regulatory and standards system, as well as its generous funding for its development, the European Union’s standards regime extends well beyond the European Union’s borders to include affiliate members (countries which are hopeful of becoming full members in the future). Another category, called “companion standardization body” includes the standards organization of Morocco, Israel, Kazakhstan, and Australia, among others, which are not likely to become a CEN member or affiliate for political and geographical reasons.
(Future standardization activities can be viewed on the CEN and CENELEC’s work plan. Other than their respective annual work plans, CEN’s “what we do” page provides an overview of standards activities by subject. Both CEN and CENELEC offer the possibility to search their respective database. ETSI’s webpage links to ongoing activities.)
Testing, Inspection and Certification
Conformity Assessment is the demonstration that specified requirements relating to a product, process, system, or group are fulfilled. Conformity assessment can include: The supplier’s declaration of conformity, different types of sampling and testing, inspection, certification, management system assessment and registration, the accreditation of the competence of those activities, and the recognition of an accreditation program’s capability. Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU harmonized legislation. As mentioned above under CE marking, EU harmonized product legislation gives manufacturers some choice regarding conformity assessment, depending on the level of risk involved in the use of their product. Certification for defined lesser risk products can be done by the manufacturer themselves by building a technical file in many cases. Higher risk products will need third party testing through accredited testing labs. Types of compliance certification ranges from self-certification, type examination and production quality control system certification, to full quality assurance system certification. In the case of CE marking directives or regulations, each directive or regulation stipulates the processes which can be used for which products. This is usually found in an annex and called a module.
Modules vary in complexity. For example, Module A permits the manufacturer to assume total responsibility for conformity assessment. If the product is manufactured to Harmonized Standards, and if the risk is not unusually high (as in most machinery, for example), the manufacturer may rely on internal manufacturing checks. The manufacturer would compile a technical file, issue a Declaration of Conformity to the appropriate directives, and if appropriate, apply the CE marking, and places the product on the market. Modules for higher risk products, for example, a medical device, could call for a type examination of the product and a production quality assurance system that conforms to the standard or a complete quality management system and conforms to accepted standards (e.g., ISO 9001 or EN 29001). These modules may call for the involvement of third-party testing and assessment for a Declaration of Conformity. In the European Union, these third parties are designated by Member States’ authorities, accepted by the European Commission, and are called Notified Bodies. Each directive provides the module choices available, but there are no choices beyond the modules specified.
When third party testing is required, that testing must be done by accredited member state organizations called Notified Bodies, which must be domiciled in a Member State. The official list of approved Notified Bodies for each EU harmonized directive or regulation is found on the New Approach Notified and Designated Organizations (NANDO) Information System page on the EU Commission website.
The only exceptions to this EU-domiciled rule are U.S.-based organizations and test labs for products covered under U.S.-EU mutual recognition agreements for certain types of marine equipment, products under the electromagnetic compatibility mutual recognition agreement, and the radio equipment mutual recognition agreement.
In addition, to promote market acceptance for products in the European Union, there are several voluntary conformity assessment programs. CEN and CENELEC’s certification system are known as the Keymark. ETSI does not offer conformity assessment services.
Publication of Technical Regulations
The Official Journal of the European Union is the official publication of the European Union. It is published daily on the European Commission’s EUR-Lex webpage and consists of two series covering adopted legislation, as well as case law and studies by committees. It also lists the standards reference numbers linked to legislation (known as a Harmonized Standard).
National Institute of Standards and Technology’s Notify U.S. Service
Members of the World Trade Organization, such as the European Union, are required under the Agreement on Technical Barriers to Trade to notify the WTO proposed technical regulations and conformity assessment procedures that could affect trade. Notify U.S. is a free registration service that captures and makes available for review and comment key information on draft regulations and conformity assessment procedures. Users receive customized alerts when new notifications are added by a selected country or countries and industry sectors of interest and they can request full texts of regulations.
Proposed EU Member State technical regulations are published on the Commission’s website to allow other countries and interested parties to comment.
The establishment of harmonized EU rules and standards in the food sector has been ongoing for several decades, and the EU publicized a law establishing the general principles of EU food law in January 2002. This regulation introduced mandatory traceability throughout the feed and food chain as of January 1, 2005. For specific information on agricultural standards, please refer to the Foreign Agricultural Service’s website.
There are also export guides to import regulations and standards available on the Foreign Agricultural Service’s website.