Describes standards, identifies the national standards, accreditation bodies, and lists the national testing organization(s) and conformity assessment bodies.
The Malta Competition and Consumer Affairs Authority (MCCAA) has the primary role to coordinate the application of international standards in Malta and to enforce standards specific to the local market, such as those governing Maltese lace and filigree work. Manufacturers who test and certify products in the United States usually must re-test and re-certify them in the EU due to the EU’s different approach to the protection of the health, safety, 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.
Key Link: mccaa.org.mt/
EU standards setting is a process based on consensus that is initiated by industry or mandated by the European Commission and carried out by independent standards bodies, acting at the national, European, or international level. Experts in Technical Committees or Working Groups create standards. Non-governmental organizations, such as environmental and consumer groups, actively participate in European standardization.
Many standards in the EU are adopted from international standards bodies, such as the International Standards Organization (ISO). Three European standards organizations draft EU standards:
- European Committee for Standardization (CEN)
- European Committee for Electrotechnical Standardization (CENELEC)
- European Telecommunications Standards Institute (ETSI)
The European Commission also plays an important role in standardization through its funding of the participation in the process of small- and medium-sized companies and non-governmental organizations, such as environmental and consumer groups. The Commission provides money to the standards bodies when it mandates standards development to the European Standards Organization for harmonized standards that will be linked to EU technical legislation.
Key Link: Standardization Policy
The 2002 EU food law introduced mandatory traceability throughout the feed and food chain as of January 1, 2005. For specific information on agricultural standards and import regulations, please refer to the Foreign Agricultural Service’s website (https://www.usda-eu.org/).
There are also export guides to import regulations and standards available on the Foreign Agricultural Service’s website.
Testing, Inspection and Certification
The MCCAA oversees conformity assessments in Malta. Manufacturers need conformity assessments to ensure consistency of compliance with standards during all stages, from design to production to facilitate acceptance of the final product.
EU product legislation gives manufacturers some choice regarding conformity assessments, 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 a full quality assurance system. Conformity assessment bodies in individual Member States are listed in the New Approach Notification and Designated Organizations (NANDO) information system. To promote market acceptance of the final product, there are a number of voluntary conformity assessment programs. While CEN offers a certification service known as the “Keymark,” neither CENELEC nor ETSI offers conformity assessment services.
All products sold in Malta that may pose a health or safety risk bear a CE marking. A manufacturer uses the CE marking as a declaration that the product’s design and manufacture meet all requirements of EU directives. Examples of products that should have a CE mark include toys, medical devices, safety devices, low voltage equipment, and pressure protective equipment.
If EU product legislation applies to a U.S. product, the U.S. exporter must apply CE marking in order to sell the product in the EU market.
The EU presumes that products manufactured to standards adopted by CEN, CENELEC, or ETSI, and referenced in the Official Journal as harmonized standards conform to the requirements of EU Directives. The manufacturer then applies the CE marking and issues a declaration of conformity, which allows the product 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, and 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.
Competent national authorities have officially accredited independent test and certification laboratories, known as notified bodies, to test and certify products 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.
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. (https://tsapps.nist.gov/notifyus/data/index/index.cfm) 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 procedur3es. Users receive customized e-mail alerts when new notifications are added by selected country or countries 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.”
Publication of Technical Regulations
Local newspapers and MCCAA’s web site publish proposed and final technical regulations (mccaa.org.mt/). The Commission publishes national technical regulations on its website to allow other countries and interested parties to comment (https://mccaa.org.mt/)
The EU publishes information about legislation and other information about the adoption or interpretation of laws in its Official Journal (eur-lex.europa.eu/oj/direct-access.html?locale=en). It also lists the standards reference numbers linked to legislation https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en).
Proposed EU member state technical regulations are published on the Commission’s website to allow other countries and interested parties to comment.
Frequently Asked Questions:
- Where do I find EU product legislation?
Under industry sectors on https://ec.europa.eu/growth/sectors_en
- Where can I find European (EN) standards?
- In the event that I need the services of a test laboratory – EU notified body, U.S. based subcontractor or conformity assessment body - where do I obtain a list?
Jim Curtis, Standards Attaché
Tel: +32 2 811 42 44
Gordon Gillerman Standards Coordination Office 100 Bureau Dr.
Mail Stop 2100
Gaithersburg, Maryland 20899
Tel: (301) 975-4000
Rue de la Science 23
B – 1040 Brussels, Belgium
Rue de la Science 23
B – 1040 Brussels, Belgium
Route des Lucioles 650
F-06560 Valbonne France