13 July 2012
It is now inevitable. We will have a new ATEX Directive with a new number, replacing 94/9/EC. The UK had fought to keep the original number, to minimise costs for both manufacturers and Notified Bodies, but that battle appears to have been lost. So we have to put up with the extra cost. But what do we gain?
The first point to emphasise is that the New Legislative Framework (NLF) affecting all the so-called new approach directives comes about as a result of the European Commission at last realising that the directives are failing to achieve their main purpose. In particular, the introduction to the new proposals refers to:
* the presence of non-compliant or dangerous products on the market, and consequently a certain lack of trust in CE Marking
* competitive disadvantages for economic operators complying with the legislation as opposed to those circumventing the rules
* unequal treatment in the case of non-compliant products and distortion of competition among economic operators due to different enforcement practices
* differing practices in the designation of conformity assessment bodies by national authorities, and
* problems with the quality of certain Notified Bodies.
Clearly there is still work to be done,but most people will be glad to see the attempt to find a level playing field for manufacturers and Notified Bodies, as well as an increase in the level of market surveillance across Europe.
But what does it mean for current â€œgoodâ€� manufacturers and current â€œgoodâ€� Notified Bodies. The simple, and welcome, answer is: â€œNot a lotâ€�.
In terms of Notified Bodies, the real change is that notification must in future normally be based on accreditation. If accreditation is not involved, the basis for notification must be circulated to all other member states to allow for objections. This is a very significant step forward. Even though not all accreditation bodies are equal, we can no longer have a body notified purely for political reasons, without some form of independent scrutiny.
For manufacturers, the good news is that there are no changes in the Essential Health and Safety Requirements (EHSRs) of the directive, and although the words have changed (for alignment purposes across all the directives), there are no changes in principle affecting the conformity assessment modules.
There are changes affecting certificates (which become EU-Type Examination Certificates, rather than EC-Type Examination Certificates) and the Declaration of Conformity (where the original Annex X disappears and is replaced by reference to a separate document covering declarations for all directives. I will cover this in more detail in a later article).
There are a number of other changes of no direct interest to the manufacturer, but regulations have been added which affect importers and distributors.
Importers are given specific duties to verify that the manufacturer has complied with the relevant provisions of the directive, that the products are correctly marked, and that all documentation is present. They must also be capable of sourcing declarations and technical files, to make available to â€œauthoritiesâ€� on request. The importerâ€™s name and address must also be added to the product (or in some cases, the packaging). Distributors have a subset of the importersâ€™ duties, and importers and distributors must keep records for a minimum period of 10 years, as is currently the case for manufacturers.
But I save the best, and most important, bit for last. Article 10, Paragraph 2 of the new draft directive says: Certificates of Conformity issued pursuant to Article 8 of Directive 94/9/EC shall be valid under this Directive.
Provided this statement remains in the final text, all existing EC-type examination certificates remain valid for the future, and there is no question of the need for such documents to be re-issued.
In this regular column for HazardEx, Ron Sinclair MBE keeps readers up to date in developments in standards and aspects of IECEx schemes. He is General Manager of SGS Baseefa and chairman of BSI Committee EXL/31, responsible for the UK input to both European and International standards for Electrical Equipment for use in potentially explosive atmospheres. He is chairman of Cenelec TC31 and has chaired ExTAG, the Test and Assessment Group of the IECEx International Certification Scheme. And represents electrical standardisation interests at the European Commissionâ€™s ATEX Standing Committee.
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