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 functions 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 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 except a 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.
It should also be noted that 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.
In February 2022, the European Commission released its first ever standardization strategy, which sets out a series of long-term changes to the EU’s standardization framework in an effort to “strengthen the EU’s global competitiveness.” The implementation of the strategy entails a shift towards the politicization of standards setting in the EU, through the creation of a High-Level Forum, which aims to ensure that standardization work carried out by CEN, CENELEC, and ETSI is better aligned with the Commission’s political priorities. The Commission has also proposed a change to Regulation 1025/2012 (the Standards Regulation), which will result in a change in ETSI’s governance rules, limiting the role of third-country companies when responding to standardization requests made by the European Commission. While large firms with resources may be able to mitigate this shift, smaller companies may find it more difficult to voice their concerns.
The United States continues to engage in active dialogue with the European Commission on the implementation of its standardization strategy as well as on areas of potential standards cooperation within the context of the Trade and Technology Council and welcomes the opportunity to hear from all U.S. stakeholders, but especially SMEs, involved in global standards development.
(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 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 range from self-certification, type examination and production quality control system certification to full quality assurance system certification. In the case of CE Mark 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 of 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 Organisations (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, case law and studies by committees. It also lists the standards reference numbers linked to legislation (known as a Harmonized Standard).
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.
Proposed 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 of 2002. This Regulation introduced mandatory traceability throughout the feed and food chain as of Jan 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.