Products tested and certified in the United States to U.S. standards will most likely need to be retested and re-certified to EU requirements as a result of the EU’s different 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 subject to the EU’s General Product Safety Directive, as well as possible additional national requirements.
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 European Union.
Agricultural standards are set in the EU by a general food law establishing general principles. This set of regulations has required mandatory traceability throughout the feed and food chain since 2005.
EVS (a non-profit association recognized by the Government of Estonia as the national standards body for Estonia) started its operations as provided by the Technical Regulations and Standards Act in 2000. EVS has exclusive rights for sale of ISO, CEN, BSI, DIN, SFS and GOST standards in Estonia. EVS also has a sales agreement with IHS Nordic.
EU standards setting is a process based on consensus initiated by industry or mandated by the European Commission and carried out by independent standards bodies, acting at the national, European or international level. There is strong encouragement for non-governmental organizations, such as environmental and consumer groups, to actively participate in European standardization.
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)
Conformity assessment is a mandatory step for manufacturers in the process of complying with specific EU legislation. The purpose of conformity assessment is to ensure consistency of compliance during all stages of the production process to facilitate acceptance of the final product. EU product legislation gives manufacturers options with conformity assessment approach, including self-certification, type examination and production quality control systems, to full quality assurance systems, depending on the level of risk involved in the use of their product. Conformity assessment bodies in Estonia can be found in this list by the European Commission.
Testing, Inspection and Certification
To sell products in EU Member States, 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 several choices and requires decisions to determine which safety or health concerns need to be addressed, which conformity assessment module is best suited to the manufacturing process, and whether to use EU-wide harmonized standards.
Publication of Technical Regulations
The Consumer Protection and Technical Regulatory Authority is responsible for market regulations in Estonia.
The EU Technical Regulation Information System (TRIS) tracks new draft regulations.
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.