New EU Legal Framework

New Package of measures for enhancing trade of products, published in the Official Journal of the European Union (L218 Volume 51, 13.08.2008), include: 

- Decision No. 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on common framework for the marketing of products, and repealing Council Decision 93/465 EEC,
- Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, and
- Regulation (EC) No. 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC.

Decision No. 768/2008/EC provides a legal framework and observance of principles of future harmonisation of sectoral legislation and technical requirements for specific products, obligations of manufacturers, authorised representatives, importers or distributers, and conformity assessment procedures and modules, rules and conditions for the use of CE marking, requirements for authorisation (designation/notification) of bodies to assess the conformance of products with all the requirements from specific EU directives, criteria to be met by national notification bodies, and the rules for notifying the EU Commission thereof.

Regulation (EC) No. 765/2008 establishes for the first time a common legal framework for the provision of accreditation services across Europe. The Regulation covers the operation of accreditation in support of voluntary conformity assessment as well as conformity assessment required by legislation. Under the Regulation, EU Member States are required to appoint a single national accreditation body for these activities. In order to reach a higher level of consistency as regards the performance of accreditation services in Europe, this Regulation defines general requirements for national accreditation bodies the operation of which is supervised by the competent authorities in the EU Member States. Thus, the national accreditation bodies shall:

  • be independent from the conformity assessment bodies they accredit,
  • be objective and impartial,
  • have competent staff,
  • operate on a non-profit basis,
  • refrain from providing services provided by CABs,
  • not be in competition with other national accreditation bodies.

Furthermore, this Regulation prescribes that the European co-operation for Accreditation (EA) has been established as the official European accreditation infrastructure. National accreditation bodies must become EA members and participate in the peer evaluation process carried out by the EA to confirm conformance with the legal requirements. With that end in view Article 5 of the Law on Accreditation (Official Gazette of the RS No. 73/2010) prescribes that “The Accreditation Body of Serbia is the sole accreditation body in the Republic of Serbia that is hereby delegated the performance of the accreditation activities”.

Rules and procedures applied by the competent authorities when making decisions that can limit the free trade in products lawfully marketed in another Member State are laid down in Regulation (EC) No. 764/2008.

Mutual recognition principle implies the following: products lawfully marketed in one Member State cannot be prevented from entering the market of another Member State due to differences in national regulations. The only exception that is allowed refers to general interest such as health, consumers or environment and therefore implies strict observance of the requirements of Regulation (EC) No. 764/2008.
 

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