Overview
Products tested and certified in the United States to U.S. regulations and standards will probably 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 always subject to the EU’s General Product Safety Directive as well as to possible additional national requirements. For further information on EU regulations pertaining to standards, please refer to Doing Business in the European Union: 2022 Country Commercial Guide for U.S. Companies.
Agricultural Standards
The establishment of harmonized EU rules and standards in the food sector has been ongoing for several decades. In January 2002, the EU publicized 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 EU regulations pertaining to agricultural standards, please refer to the Foreign Agricultural Service’s U.S.-EU website. Information on Czech agricultural standards that are not yet harmonized at the EU level and exporter guides providing sector specific information, are available on the Foreign Agricultural Service’s website.
Standards
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. For further information on EU regulations pertaining to standards, please refer to Doing Business in the European Union: 2022 Country Commercial Guide for U.S. Companies.
Conformity Assessment is a mandatory step for the manufacturer in the process of complying with specific EU harmonized 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. For further information on EU testing, inspection and certification, please refer to Doing Business in the European Union: 2022 Country Commercial Guide for U.S. Companies.
Publication of Technical Regulations
The Official Journal of the EU is the official publication of the European Union. It is published daily on the internet 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.
National technical regulations are published on the Commission’s website to allow other countries and interested parties to comment.
National Institute of Standards and Technology’s (NIST) Notify U.S. Service
Members of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to notify to the WTO proposed technical regulations and conformity assessment procedures that could affect trade. Notify U.S. is a free, web-based e-mail registration service that captures and makes available for review and comment key information on draft regulations and conformity assessment procedures. Users receive customized e-mail alerts when new notifications are added by selected country(ies) and industry sector(s) of interest and can also request full texts of regulations. This service and its associated web site are managed and operated by the USA WTO TBT Inquiry Point housed within the National Institute of Standards and Technology, part of the U.S. Department of Commerce.
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 World Trade Organization (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. This guidance is provided to assist U.S. stakeholders in the preparation and submission of comments in response to notifications of proposed foreign technical regulations and conformity assessment procedures.
For EU CCG: Include reference to article with a video on CE Mark: https://www.trade.gov/ce-marking