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 likely have to 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. For more information about the NLF, go to: http://ec.europa.eu/growth/single-market/goods/new-legislative-framework
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 website at: www.usda-eu.org
There are also export guides to import regulations and standards available on the Foreign Agricultural Service’s website: www.usda-eu.org/trade-with-the-eu/eu-import-rules/certification/fairs-export-certificate-report
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 can be found in Romanian at http://www.asro.ro/?page_id=443
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:
1. CENELEC, European Committee for Electrotechnical Standardization: www.cenelec.eu
2. ETSI, European Telecommunications Standards Institute: www.etsi.org
3. CEN, European Committee for Standardization, handling all other standards: www.cen.eu/cen/pages/default.aspx
Address: Str. Mendeleev nr. 21 – 25, 010362 Bucureşti
Email: firstname.lastname@example.org; email@example.com
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: http://ec.europa.eu/growth/tools-databases/nando
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”: www.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:
RENAR/Romanian Association for Accreditation
Phone: + 40 21 402 04 71
Fax: + 40 21 402 04 89
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: www.eur-lex.europa.eu/JOIndex.do?ihmlang=en
National technical Regulations are published on the Commission’s website: www.ec.europa.eu/growth/tools-databases/tris/en to allow other countries and interested parties to comment.
NIST Notify U.S. Service
Member countries of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to report to the WTO all proposed technical regulations that could affect trade with other Member countries. Notify U.S. is a free, web-based e-mail subscription service that offers an opportunity to review and comment on proposed foreign technical regulations that can affect your access to international markets. Register online at Internet URL: www.nist.gov
The U.S. Commercial Service at the United States Mission to the European Union