The Council Resolution of 1985 on the New Approach to technical harmonization and standardization, which established the following principles, implemented a new regulatory technique and strategy.
- Legislative harmonization is limited to essential requirements that products placed on the Community market must meet, if they are to benefit from free movement within the Community.
- The technical specifications of products meeting the essential requirements set out in the directives are laid down in harmonized standards.
- Application of harmonized or other standards remains voluntary, and the manufacturer may always apply other technical specifications to meet the requirements.
- Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the corresponding essential requirements.
The operation of the New Approach requires that the standards offer a guaranteed level of protection with regard to the essential requirements established by the directives, and that the national authorities carry out their responsibilities for the protection of safety or other interests covered by the directive. Further, a safeguard clause procedure is necessary to allow the possibility of contesting the conformity of a product, or failures or shortcomings of harmonized standards.
Since the New Approach calls for essential requirements to be harmonized and made mandatory by directives, this approach is appropriate only where it is genuinely possible to distinguish between essential requirements and technical specifications. Further, a wide range of products has to be sufficiently homogenous, or a horizontal hazard identifiable, to allow common essential requirements. The product area or hazard concerned must also be suitable for standardization.
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