What is the New Legislative Framework?

Regulation (EC) 765/2008
Decision 768/2008/EC

The EU's New Legislative Framework (NLF) is the modernization of its New Approach to technical harmonization. Under the New Approach, directives specify only the "essential elements" for safe products; optional technical requirements for compliance are specified in the  "harmonized standards" developed by non-profit European standards organizations (ESO).

Adopted July 9, 2008 and effective January 1, 2010, Regulation (EC) 765/2008 requires Member States to establish accreditation and market surveillance systems under rules designed to increase product compliance and promote uniformity among the Member States.

Each Member State must appoint a single national accreditation body (NAB) responsible for accrediting all "conformity assessment bodies" operating within its borders. NABs must not offer conformity assessment services themselves, they must be not-for-profit, and they must be audited annually.

The national accreditation bodies must be members of the European cooperation for Accreditation (EA) which is to coordinate a rigorous and transparent system of peer review.

Conformity assessment bodies (CAB) are third-party organizations who perform testing and inspection of manufacturing products and processes for the purpose of certifying conformity with specified requirements (such as an EU directive or an international standard)

While CABs must be accredited by the national accreditation body (NAB) for the Member State in which they are established, a single accreditation is good for the whole EU territory.

Each Member State must carry out market surveillance activities (such as documentary checks and sample testing) on an adequate scale, based upon established principles of risk assessment, complaints and other information. Also included is the right to enter the manufacturer/importer/distributor's place of business and request additional documentation of compliance.

Market surveillance is required for all products covered by EU "harmonization" legislation, except for these products which are specifically excluded: food, feed, living plants and animals, products of human origin, products of plants and animals relating directly to their future reproduction.

Member states should pay particular attention to enforcing the compliance of imported products. Customs authorities must carry out checks at external borders on an adequate scale.

Member States may order recall or destruction of products that present a serious risk.

The CE mark may be affixed to products only when its use is required by specific EU legislation and only by the manufacturer of the product. Member States must ensure the correct application of the CE mark and provide penalties for its misuse.

Also adopted July 9, 2008, Decision 768/2008/EC provides an extensive legislative "toolkit" to be used in drafting future directives. Annex II contains 16 different modules for conformity assessment. Variables include manufacturer declaration of conformity with either the essential requirements or an approved type (standard); tests on specific aspects of the product or random checks on the final product; product testing by accredited in-house body or a third party "notified body" (i.e. CAB accredited for this requirement); ISO certified quality system for design, production and/or final inspection/testing.

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