ECEXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT - Main contents

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dossier	SEC(2011)1375 - Accompanying document to10 PROPOSALS TO ALIGN PRODUCT HARMONISATION DIRECTIVES TO DECISION No 768/2008/ECEXECUTIVE SUMMARY ...
document	SEC(2011)1375
date	November 21, 2011

Annexes I, II and III. However, Community legislation may depart from those general principles and reference provisions if that is appropriate on account of the specificities of the sector concerned, especially if comprehensive legal systems are already in place."

6Examples of individual alignments that are being carried out together with the revision of sector-specific elements (e.g. product requirements or testing methods) are the Recreational Craft Directive, the Directive on Personal Protective Equipment or the R&TTE Directive.

7Quote from questionnaire reply: “Expert estimations say that fulfilling the safety and administrative provisions required by our regulations can add up to a fifth of total manufacturing costs. In the absence of efficient enforcement mechanisms some manufacturers might be tempted to "take the easy way" and to market non-compliant products.”

8These bodies are conformity assessment bodies, which test, inspect and certify products. They are called “notified bodies”, because they are notified by the Member States to the Commission.

9In the electro-technical sector the role of notified bodies is different. For instance under EMC Directive recourse to notified bodies in the conformity assessment procedure is voluntary.

10It this respect, it is important to note that existing guidance contained in the so-called "Blue Guide" (Guide to the implementation of directives based on the New Approach and the Global Approach, European Commission, September 1999), already points to the responsibilities of the economic operators that are then clarified by Decision No 768/2008/EC. However as the Blue Guide is not binding, it has not been sufficient to address the issues identified.

1158-78% of economic operators, 72-78% of notified bodies 58-62% of authorities and about 72-79% of users participating in the consultation (excluding the measuring instrument sector).

12These are 1) EN 45011:1998, General requirements for bodies operating product certification systems; 2) EN ISO/IEC 17020:2004, General criteria for the operation of various types of bodies performing inspection; 3) EN ISO/IEC 17021:2006, Conformity assessment – Requirements for bodies providing audit and certification of management systems; 4) EN ISO/IEC 17024:2003, Conformity assessment – General requirements for bodies operating certification of persons; 5) EN ISO/IEC 17025:2005, Conformity assessment – General requirements for the competence of testing and calibration laboratories.

13See Article 40 of Regulation (EC) No 765/2008.

14 http://ec.europa.eu/enterprise/newapproach/nando/