The ‘Product’ of change
06 January 2016
SGS Baseefa Technical Manager Ron Sinclair MBE, chairman of BSI Committee EXL/31, Cenelec TC31 and the IECEx Service Facility Certification Committee, adds to his previous comments about the likely effect on manufacturers when 2014/34/EU is introduced.
I have previously indicated that when 2014/34/EU replaces 94/9/EC and is implemented on April 20, there will be little for most manufacturers to worry about. I fully stand by that statement, but I thought it was important to clarify a few details.
The first major change is that the new directive introduces the term “Product”, and lists “Equipment and Protective Systems”, “Safety, Controlling and Regulating Devices” and “Components” as types of product which require slightly different forms of consideration. This allows clarification later in the document where the term “Product” can now be used to shorten the text if the requirement applies to all sub-categories.
Where the product is manufactured outside the EU and sold through a distributor based in the EU, that distributor gains additional responsibilities, particularly in relation to making documentation available for a minimum of 10 years after the last product is sold. The distributor would be expected to hold copies of Declarations of Conformity but, provided he could prove an arrangement with the manufacturer to make all documentation available via the distributor on request, this would satisfy the requirement.
The name and address of the distributor must also be added to the marking of the product, in order to confirm that they can act for the manufacturer in matters of accessibility of documentation. It is also foreseen that the distributor may play an active part in ensuring that instructions for use are provided in the relevant community language.
There is, however, no added restriction requiring an overseas manufacturer to employ such a distributor or agent. As at present, such a manufacturer is entitled to sell directly to a customer within the EU. In this respect, ATEX is slightly more relaxed than some of the other directives, which require a definite address in the EU where the documentation is held available.
The European Commission has also clarified issues regarding the signing of the Declaration of Conformity.
There has been a wrong interpretation made by some manufacturers previously that, because the wording of Annex X to 94/9/EC refers to “identification of the empowered signatory”, an actual signature is not required. The Commission has now put this beyond doubt by stating that an actual signature is required, accompanied by the name and role of the person signing on behalf of the company.
Where the original declaration is provided only in the manufacturer’s language, the importer or distributor would become liable for translation into the local language. The person signing on behalf of the importer or distributor would be identified, and a copy of the original, untranslated, declaration (complete with original signature) appended.
The reference to a single declaration covering all applicable directives has also caused confusion. The Commission has clarified that the preference would be for an actual single document giving the relevant information required by all applicable directives. However, it has also said that a dossier, containing individual declarations for each directive, could be considered as a single document.
It remains a concern that, although the Declaration of Conformity is the top document in terms of demonstration of compliance, a typical purchaser will often place more emphasis on the Type Examination Certificate, alone, and fail to follow through by looking at the declaration, which may contain more up-to-date information. It is the declaration which brings together both the Type Examination activity and the Production activity, and both aspects are equally important in ensuring that a product is compliant.
The ATEX Notified Bodies Group has been active in preparing the wording for the new certificates to be issued according to the new directive. Although, as clearly specified in 2014/34/EU, certificates issued in accordance with 94/9/EC remain valid, as if issued to the new directive, any supplementary certification must be issued by the Notified Body acting in its appointed role for 2014/34/EU.
Because this might cause confusion in the market place, a form of words has been agreed to appear on all such certificates, fully explaining how an EU-Type Examination supplementary certificate can be issued to an EC-Type Examination certificate, retaining the base number that existed for the original certificate.
The last thing that the Commission wants to encourage is a lot of activity in having products issued with brand new certificates when there is no technical justification for so doing. In the course of time, the market place will probably expect that new certificates are issued, relating only to the current directive. But the best route is for this to happen naturally, as significant, rather than minor, changes are made to the product.
One final point. In my previous article I slightly jumped the gun in explaining how the Commission was recommending wording for Declarations of Conformity to refer to both directives, to cover the overlapping period. My original suggestion is perfectly valid, but the Commission has now released its own (slightly different) preferred form of wording:
The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: Directive 94/9/EC (until April 19th, 2016) and Directive 2014/34/EU (from April 20th, 2016)