Directives decision at last!
15 October 2015
SGS Baseefa Technical Manager Ron Sinclair MBE is 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, as well as the Cenelec TC31 committee. Here he looks at the likely effect on manufacturers of the new ATEX Directive 2014/34/EU.
Ron Sinclair MBE
After a wait of nearly 18 months, on September 30 we eventually had a decision from the European Commission about the only issue that will seriously affect most manufacturers when the new ATEX Directive 2014/34/EU replaces 94/9/EC on April 20, 2016.
Of all the questions we receive from our customers, one has predominated: “How do we deal with the transition between the directives in our Declarations of Conformity (DoCs)”? And for many manufacturers, that is the only question that really needs to concern them.
According to the strict interpretation of the wording of the new directive, a DoC issued with a product dispatched on April 19 must refer only to 94/9/EC, but the DoC issued with the same product dispatched on April 20 must refer only to 2014/34/EU. This is clearly a logistical nightmare for those packing and warehousing product.
The same problem did not occur when 94/9/EC was introduced, as there was an overlap of seven years during which the manufacturer could continue fulfilling the requirements of the much older ATEX Directives or issue a DoC to the new directive, before the date of compulsory application on July 1, 2003.
So what is the solution? The Commission have consulted across all the directives coming into force at this time and have eventually arrived at what seems to be an all- too-obvious answer.
Applicable from the date of the workshop (i.e. from September 30 onwards) manufacturers may make a declaration using the format prescribed in 2014/34/EU (which is slightly different from that in 94/9/EC) using the following, or very similar, format:
Declaration of Conformity Number xxxxxx
This Declaration is valid for directive 94/9/EC until April 19, 2016
This Declaration is valid for directive 2014/34/EU from April 20,2016
The Commission also confirmed that, although the wording in the new directive is not as clear as in the old directive, it remains the intention that if a non-harmonised standard is used to support claims of compliance with the Essential Health and Safety Requirements (EHSRs), then the Declaration should, in short form, explain why the standard is being used.
A typical explanation might be: “A check between the current harmonised standard, and the standard listed has confirmed that none of the changes materially affect this equipment”. Such a statement could easily be made, for example, if the equipment was an electric motor and the only changes in the standard affected luminaires. The full details would be retained in the Technical File.
And to set everyone’s mind at rest, the following is a confirmation of what you do not need to do. The new directive makes it clear that any documents (other than the DoC) existing prior to April 20, 2016 and relating to 94/9/EC can be used exactly as if they referred to 2014/34/EU.
Therefore all existing EC-Type Examination Certificates that were valid to support 94/9/EC on April 19, 2016 can be used to support 2014/34/EU from April 20, 2016 onwards. There is no need to have the documents re-issued.
When the time comes to have a certificate up-issued or supplemented because of a change in the product, the new document will refer to the new directive but can continue to carry the same base certificate number that the previous versions carried. Obviously, if the manufacturer prefers to have a new number, the opportunity could be taken to start with a fresh set of documentation. No doubt, after a few years, market pressure may push manufacturers into considering a new certificate, but this should certainly not happen in the short term.
All existing Quality Assurance Notifications (QANs) remain valid and need only be replaced in the normal time frame for renewal (normally every three years).
All standards harmonised on April 19 for 94/9/EC will become harmonised for 2014/34/EU before April 20. The Commission have indicated they propose to issue two identical lists – one for each directive – in the Official Journal, probably sometime in March 2016.
But there is one area affecting some manufacturers that has been tightened up. In the simple situation of a manufacturer selling to the end-user/purchaser, there is no change. However, if a manufacturer outside the EU sells into the EU via an importer or agent, the importer and agent are now identified as significant economic operators and have acquired a number of responsibilities.
Essentially, they have responsibilities for document retention (10 years, as for the manufacturer) and in the case of the importer, their name and address must appear on the marking plate, alongside that of the manufacturer. They may also acquire responsibilities for translation of documents. As this will affect only a small number of manufacturers, I don’t propose to give further details here, but I specifically recommend anyone in that position to carefully read the text of the new directive.
The full texts of both directives, along with other useful information, are freely available at http://ec.europa.eu/growth/sectors/mechanical-engineering/atex/