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The difficulties of Regulating Markets and Risks in Europe through Notified Bodies

Published online by Cambridge University Press:  20 January 2017

Jean-Pierre Galland
Jean-Pierre Galland*
Affiliation:
Ecole des Ponts ParisTech, Marne la Vallée
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Abstract

Although scholars have described and commented on the European New Approach to standardisation principles, they have paid much less attention to the ways in which this innovative process and its follow-on, i.e. the Global Approach, have been implemented. In many cases, this comes through the day-to-day activity of a very specific population of European experts, the notified bodies. Notified bodies, whose role it is to certify that products, for a given sector, comply with the essential safety requirements set out in the corresponding directive, originate from the Member States, but also compete against each other within a European certification market. This article examines the technical and political difficulties encountered by the Commission and the Member States in ensuring both the independence and the competences of these certifiers. It describes and questions the organisational architecture devised in response to these problems.

Type
Research Article
Information
European Journal of Risk Regulation , Volume 4 , Issue 3 , September 2013 , pp. 365 - 373
Copyright
Copyright © Cambridge University Press 2013

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References

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8 The author conducted a series of interviews (6) in June 2012 with notified bodies and other actors of European standardisation.

9 This was the case from the first New Approach Directives (“Toys”, 1988; “Pressure equipments”, 1987; “Construction products”, 1989)

10 Council resolution of May 28, 1989 on a global approach to assessing conformity, OJ 1990, 010, pp 0001-0002.

11 It is thus desired that notified bodies should themselves be accredited under international standard ISO 45000, which assesses the quality of inspection bodies.

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16 The European Commission's NANDO (New Approach Notified and Designated Organisations) website, <http://ec.europa.eu/enterprise/newapproach/nando> (last accessed on 5 August 2013).

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18 Ibid. (appendix)

19 Thus in France, many notified bodies have “association 1901” (non-profit) status, which says nothing about the nature of the associates.

20 Infra, part 3.

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23 Decision of the European Parliament and Council on a common framework for the sale of products, replacing Council decision 93/465, Annex 1, Article R17, Requirements applicable to notified bodies, 768/2008/CE.

24 Ibid.

25 Ibid.

26 EC, Framework for coordination and cooperation between notified bodies, Member States and the European Commission under the community harmonisation Directives based on the New Approach and the Global Approach, CERTIF 94/6 Rev.6, February 20, 1998.

27 Ibid.

28 Ibid.

29 EC, Code of Conduct for the functioning of the system of notified bodies, CERTIF 97/1 Rev. 3, July 17, 1998.

30 Communication from the Commission to the Council and European Parliament. Enhancing the Implementation of New Approach Directives, 7/05/2003, COM (2003) 240 final

31 Ibid.

32 Draft regulation by the Parliament and Council, 14/02/2007, COM (2007) 37 final.

33 Regulation (EC) of the European Parliament and Council setting out the requirements for the accreditation and market surveillance relating to the marketing of products and repealing Council regulation (CE) No. 339/93, July 9, 2008, 765/2008.

34 Article 4. In France for example, COFRAC, the French Accreditation Committee, had been set up in 1994, and similar committees or bodies had also been set up in other Member States in the 1990s and 2000s. On this question, it would seem that the European contribution was essentially to extend this innovation to all the Member States.

35 For this purpose, moreover, a European cooperation for Accreditation (EA) was set up.

36 Jacques McMillan, “La ‘certification’, la reconnaissance mutuelle et le marché unique”, Revue du Marché Européen (1991), pp. 181–211.

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