Malta - Standards for TradeMalta - Standards for Trade
Overview
Manufacturers who test and certify products in the United States usually must retest and re-certify them in the EU due to the EU’s different approach to health, safety, and the environment. While harmonization of EU legislation can facilitate access to the EU Single Market, standards could also function as barriers to trade if U.S. standards are different from those of the EU.
Standards
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:
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.
When products are not regulated by specific EU technical legislation, they are subject to the EU’s General Product Safety Directive and possible additional national requirements. For more information, go to NLF.
The primary role of the Malta Competition and Consumer Affairs Authority (MCCAA) is 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.
Key Link: Standardization Policy
Agricultural Stamdards
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.
Testing, inspection and certification
Conformity Assessment
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.
Product Certification
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, 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. The NLF framework serves as a blueprint for all CE marking legislation, harmonizing definitions, responsibilities, European accreditation, and market surveillance.
The CE marking need not 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.
Accreditation
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 (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.
Publication of technical regulations
Local newspapers and MCCAA’s web site publish proposed and final technical regulations . The Commission publishes national technical regulations on its website to allow other countries and interested parties to comment (ec.europa.eu/growth/tools-databases/tris/en/).
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.
National Institute of Standards and Technology’s (NIST) Notify U.S. Service
As a member of the World Trade Organization (WTO), Malta must notify the WTO of 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 (www.nist.gov/notifyus). Users receive customized e-mail alerts when selected countries add new notifications about industry sectors of interest. USA WTO TBT Inquiry Point, which is housed within the National Institute of Standards and Technology and part of the U.S. Department of Commerce, manages this service and its associated web site.
Contact information
U.S. Embassy Valletta
Maria Cassar
Commercial /Economic Specialist
Tel: +356 2561 4120
cassarm@state.gov
National Institute of Standards & Technology
Dr. George W. Arnold
Director
Standards Coordination Office
100 Bureau Dr.
Mail Stop 2100
Gaithersburg, Maryland 20899
Tel: (301) 975-5627
Website: www.nist.gov/director/sco/index.cfm
CEN – European Committee for Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: 32.2.550.08.11
Fax: 32.2.550.08.19
Website: www.cen.eu
CENELEC – European Committee for Electrotechnical Standardization
Avenue Marnix 17
B – 1000 Brussels, Belgium
Tel: 32.2.519.68.71
Fax: 32.2.519.69.19
Website: www.cenelec.eu
ETSI - European Telecommunications Standards Institute
Route des Lucioles 650
F – 06921 Sophia Antipolis Cedex, France
Tel: 33.4.92.94.42.00
Fax: 33.4.93.65.47.16
Website: www.etsi.org
SBS – Small Business Standards
4, Rue Jacques de Lalaing
B-1040 Brussels
Tel: +32.2.285.07.27
Fax : +32-2/230.78.61
Website: sbs-sme.eu
ANEC - European Association for the Co-ordination of Consumer Representation in Standardization
Avenue de Tervuren 32, Box 27
B – 1040 Brussels, Belgium
Tel: 32.2.743.24.70
Fax: 32.2.706.54.30
Website: www.anec.org
ECOS – European Environmental Citizens Organization for Standardization
Rue d’Edimbourg 26
B – 1050 Brussels, Belgium
Tel: 32.2.894.46.68
Fax: 32.2.894.46.10
Website: www.ecostandard.org
EOTA – European Organization for Technical Assessment (for construction products)
Avenue des Arts 40
B – 1040 Brussels, Belgium
Tel: 32.2.502.69.00
Fax: 32.2.502.38.14
Website: www.eota.eu