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 to American standards likely must be retested and re-certified to EU requirements as a result of the EU’s 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 EU’s General Product Safety Directive as well as to possible additional national requirements.
EU legislation and standards created under the New Approach are harmonized across the member states and European Economic Area countries to allow for the free flow of goods. A feature of the New Approach is CE marking.
The concept of New Approach legislation is slowly disappearing as the New Legislative Framework (NLF), which entered into force in January 2010, was put in place to serve as a blueprint for existing and future CE marking legislation. Existing legislation has been reviewed to bring them in line with the NLF concepts, which means that new requirements and reference numbers will have to be used as of 2016, new requirements will have to be addressed, and new reference numbers will have to be used on declarations of conformity. The date of applicability depends on the product category. For example, the new Electromagnetic Compatibility Directive (2014/30/EU) replaced the existing law and became applicable on April 20th, 2016.
While harmonization of EU legislation can facilitate access to the EU Single Market, manufacturers should be aware that regulations (mandatory) and technical standards (voluntary) might also function as barriers to trade if U.S. standards are different from those of the EU. Note more information about the NLF.
The establishment of harmonized EU rules and standards in the food sector has been ongoing for several decades, but it took until January 2002 for the publication of a general food law establishing the general principles of EU food law. 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 EU website.
There are also export guides to import regulations and standards available on the Foreign Agricultural Service’s website.
National Standardization Body (ASRO)
ASRO is the Romanian national institution for standardization. It is a national private legal entity of public interest, non-governmental and apolitical, set up as a national standards body. ASRO is a full member of CEN, CENELEC, ISO, and IEC, and it is an observer member of ETSI. ASRO’s main duties include establishing the principles and methodologies of national standardization, developing, and approving national standards, and participating in European and international standardization activities. In addition, the institution is responsible for providing information to the public in the field of standardization, as well as publishing and disseminating standards.
The National Standardization Program is the annual working plan of the national standardization body covering the list of topics to be developed. Details included in the 2016 National Work Program in Romanian at the official website.
Many standards in the EU are adopted from international standards bodies such as the International Standards Organization (ISO). The drafting of specific EU standards is handled by three European standards organizations:
- European Committee for Electrotechnical Standardization – CENELEC
- European Telecommunications Standards Institute - ETSI
- European Committee for Standardization - CEN handling all other standards:
National Standardization Body – ASRO
Address: 238th, Mihai Eminescu Str., Sector 2, Bucharest – 020085, Romania
Phone: +4 021 316 3292
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 regarding conformity assessment, 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 Romania are listed in NANDO, the European Commission’s website.
Products manufactured to standards adopted by CEN, CENELEC or ETSI, and referenced 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, and when U.S. companies do not have access to the standardization process through a European presence.
The CE marking addresses itself primarily to the national control authorities of the member states, and its use simplifies the task of essential market surveillance of regulated products. As market surveillance was found lacking, the EU adopted the New Legislative Framework, which went into force in 2010. As mentioned before, this framework is like a blueprint for all CE marking legislation, harmonizing definitions, responsibilities, European accreditation, and market surveillance.
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 local contact established in the EU. 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.
Independent test and certification laboratories, known as notified bodies, have been officially accredited by competent national authorities to test and certify to EU requirements.
“European Accreditation” (https://european-accreditation.org/) is an organization representing nationally recognized accreditation bodies. Membership is open to nationally recognized accreditation bodies in countries in the European geographical area that can demonstrate that they operate an accreditation system compatible to appropriate EN and ISO/IEC standards. For Romania, the accreditation body is:
Romanian Association for Accreditation - RENAR
Phone: + 40 21 402 04 71
Publication of technical regulations
The Official Journal is the official publication of the EU. It is published daily on the internet and consists of two series covering adopted legislation as well as case law, studies by committees, and more.
National Technical Regulations are published on the Commission’s website to allow other countries and interested parties to comment.
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.
U.S. Commercial Service at the U.S. Mission to the European Union.