What is the New Approach?

Council Resolution 85/C 136/01

Adopted by the European Council on May 7, 1985, the "new approach to technical harmonization and standards" was an attempt to move away from a broken regulatory system of proliferating directives for each separate product that were excessively technical and unable to adapt to commercial innovation in a timely manner.

Directives following the new approach should cover broad product categories or families of products to avoid the unnecessary proliferation of directives.

Directives following the new approach should state only the essential  requirements for public safety (as opposed to the manufacturing specifications for products). For example, RoHS restricts the amount of lead in electrical products but does not specify how the reduction is to be accomplished.

Independent European Standards Organizations (ESO) with representatives from all interested parties (public authorities, industry, users, consumers and unions) and recognized technical expertise for their industries should develop the technical specifications (standards) needed for product compliance.

Harmonized standards are agreed-upon European standards applicable throughout the EU. They replace a system of national standards for each Member State which restrict the free movement of goods across national borders.

Products manufactured in conformity with ESO harmonized standards are presumed to conform with the directive's essential requirements.

Harmonized standards are voluntary, and manufacturers do not have to follow the standard, in which case, they have the burden of proof that the product conforms to the directive.

Conformity may be demonstrated by (1) marks and certificates of conformity, (2) third party testing or (3) declarations of conformity issued by the manufacturer in conjunction with a manufacturing surveillance system.

Notified bodies which have been accredited by their respective Member States may issue marks & certificates of conformity for products that they have tested according to recognized international practices, such as ISO guidelines.

Three non-profit European Standards Organizations (ESO) produce harmonized standards for the EU. Published standards may be purchased from their websites.

The NANDO Information System (i.e. New Approach Notified and Designated Organizations) provides an online searchable database of all notified bodies which have been accredited by Member States or by countries with whom the EU has mutual recognition agreements. It is available at http://ec.europa.eu/enterprise/newapproach/nando. Searches may be conducted by location of the conformity assessment body (CAB), the name and number of the directive for which it is accredited, or by the type of CAB.

In July 2008, the New Approach was modernized as the New Legislative Framework (NLF). New requirements for accreditation and market surveillance by Member States was included in Regulation (EC) 765/2008. A "toolkit" for drafting future product safety legislation, including 16 conformity assessment modules, was included in Decision 768/2008/EC.

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