Anxious Wait on European Accreditation Law

15 May 2009

It was back in July 2008 that the EU Parliament adopted Regulation 765/08 which deals with "Accreditation and Market Surveillance". This established a legal framework for the provision of accreditation services, including rules on the organization and operation of accreditation of conformity assessment bodies in both the voluntary and regulated sectors. It becomes law on January 1st, 2010. In short, it's the biggest ever shake-up of accreditation practice and undermines numerous agreements that have, until now, been its foundation.

An aspect that has caused much concern amongst accredited organizations is Article 7.1 about so-called cross-frontier accreditation.This says that it will only be permissible to gain accreditation from the (one and only) national accreditation body for the country in which the applicant is "established". The move to having only a single accreditation authority in each country is, in itself, a significant change in some countries such as Germany.

Pressure from objectors has led European Commission (EC) acknowledgement of the need to agree the meaning of "established" but the current intent is, for example, that test/calibration labs in France will no longer be able to choose to be accredited by a foreign national accreditation body (NAB). Similarly, a product or quality certification body with offices across Europe will be forced to seek accreditation in each and every country. Opponents say this will be inefficient, increase costs and may actually be counter-productive by reducing availability of accredited services. Furthermore, forcing multinational organizations to obtain local accreditations in each country in which it operates is incongruous with one of the Regulations stated aims -- the so-called Recital 19 -- which is to avoid multiple accreditations.

There was a "frank exchange of views" on this matter during a public meeting in London late last year. Responding to feedback that removal of choice was anti-competitive, a spokesman from the EC explained that because the new NABs are government-sponsored (in terms of legal authority rather than financially) they are outside the EU's anti-monopoly rules. Forcing organizations to seek accreditation locally was, she went on, exactly what the Member States had intended. In doing this, their purpose was to protect and promote development of the NABs. Noting the fact that the word "customer" does not appear even once in the Regulation, more than one angry delegate drew attention to the apparent lack of thought given to customers' wishes; whether those were customers of the new NABs (that is, those who are accredited) or the end-users of accredited services.

Europe's Senior Officials Group on Standardization (SOGS) met in Brussels last month and it had been hoped that they would provide strong direction to the Commission in resolving the interpretation issue. The responsible department of the British government (DIUS) sent a detailed proposal of how the Article should be implemented and seeking support from other Member States to put pressure on the Commission. The Commission tabled comments received from other Member States but despite key countries supporting the British view, the Commission didn’t consider it an urgent issue and wants further feedback for review at the next SOGS meeting in June. The Commission has set a deadline for completion of the consultation by end-August, expecting to give formal guidance by year-end. The Commission reasserted its position that while the Regulation applies from 1 January 2010 they will take a relaxed view on this particular aspect and will not take action against those [NABs] who then appear to be in contravention.

Accredited bodies that are particularly affected by Article 7.1 now have an anxious wait until a decision is announced, during which time plans for their business future will be in a state of limbo.

• EU Regulation 765/08 (via the UK DIUS)

SOGS is an ad hoc expert forum for the Member States' public authorities and the European Commission services but doesn’t have legal status. Its role is to act as an informal consultation body and to enable information flow on issues of policy concerning standardization and conformity assessment (including accreditation, market surveillance and other New Approach issues).