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Massimiliano Vurro

Impacts of the European Legislative Framework on product compliance

Product compliance matters!

In July 2008 the New Legislative Framework (NLF) was  adopted in the form of Regulation (EC) 765/2008 and Decision 2008/768/EC.

Regulation (EC) 765/2008 which will come into force on January 1st, 2010 in all Member States of the European Economic Area (EEA) as a step forward to boost the role of market surveillance and custom controls.

Regulation (EC) No 765/2008 and Decision No 768/2008/EC bring together, in the New Legislative Framework, all the elements required for a comprehensive regulatory framework to operate effectively for the safety and compliance of industrial products with the requirements adopted to protect the various public interests and for the proper functioning of the single market.

Main elements of the framework are:

  • overall coherence and consistency,
  • notification process,
  • accreditation,
  • conformity assessment procedures (modules),
  • CE marking and market surveillance

Regulation (EC) No 765/2008 imposes clear obligations on Member States who do not have to transpose its provisions. Its provisions are directly applicable to the Member States, to all the economic operators’ concerned (manufacturers, distributors, importers) and to conformity assessment bodies and accreditation bodies. Economic operators have not only obligations but direct rights that they can enforce through the national courts against both national authorities and other economic operators for non-respect of the provisions of the Regulation.

In the presence of other EU legislation, the Regulation applies first and foremost:
a) on the basis of being directly applicable i.e. national authorities and economic operators must apply the provisions of the Regulation as such (most of the other legislation is contained in directives) and
b) on the basis of the lex specialis rule i.e. whenever a matter is regulated by two rules, the more specific one should be applied first.

In the absence of more specific legislation on the issues covered by its provisions, Regulation (EC) No 765/2008 will apply at the same time, with, and as a complement to, existing legislation. Where existing legislation contains similar provisions as the Regulation, the corresponding provisions will have to be examined on a one to one basis to determine which is the most specific.

ecision No 768/2008/EC is what is referred to as a sui generis decision, meaning that it has no addressees and therefore is neither directly nor indirectly applicable. It constitutes a political commitment on the part of the three EU institutions, European Parliament, Council and Commission.

This means that for its provisions to apply in Union law, they have to be either referred to expressis verbis (expressly) in future legislation or integrated into it. The three institutions have indeed committed themselves to adhere to and to have recourse as systematically as possible to its provisions when drawing up product related legislation.