All “New Approach” European Directives require products placed on the market to be accompanied by a “Declaration of Conformity” with the directive.
It is important to note that the declaration is made on the day the product is placed on the market. Each individual example of a product is treated separately in a legal sense, so the declaration must relate to the way the directive is implemented on the date the individual product is placed on the market. Although the directive itself may not change, the new approach allows related aspects, such as harmonized standards, to change. It is not always easy for the manufacturer to follow such second level changes and to calculate the impact on his declaration over the lifespan of a particular product range.
The purpose of this paper is to outline responsibilities in this area and to indicate where information is available that will help a manufacturer keep his declarations up to date in the most cost effective manner.
Although what follows is applicable in principle to all the new approach directives, it is described solely in relation to the ATEX Directive 94/9/EC.
Annex X of the directive lists exactly what must be included in the declaration :
1. The name or identification mark and the address of the manufacturer or his authorized representative established within the Community;
2. A description of the equipment, protective system, or device referred to in Article 1 (2);
3. All relevant provisions fulfilled by the equipment, protective system, or device referred to in Article 1 (2);
4. Where appropriate, the name, identification number and address of the notified body and the number of the EC-type-examination certificate;
5. Where appropriate, reference to the harmonized standards;
6. Where appropriate, the standards and technical specifications which have been used;
7. Where appropriate, references to other Community Directives which have been applied;
8. Identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his authorized representative established within the Community.
Annex II of the directive “The Essential Health and Safety Requirements” (EHSRs) has the following statement right up front :
Technological knowledge, which can change rapidly, must be taken into account as far as possible and be utilized immediately.
It therefore follows that a manufacturer must keep himself aware of changes in technological knowledge and any impact that this may have on the continuing validity of the form of a declaration. Fortunately we have a fairly common understanding of “Current Technological Knowledge”, based on the European standards that have been given “Harmonised” status for the directive by having their number published in the Official Journal of the European Communities (OJEC).
Particularly, the declaration is required to list the use of harmonized standards (5) and other standards (6) separately.
It therefore follows that, throughout the lifetime of a product range, the relevant declaration may have to change up to twice in respect of each standard listed; if it had not been harmonised when the product range was launched, it subsequently became harmonized, and then ceased to be harmonised while the product range was still being manufactured.
This may sound far fetched but, as an example, consider a Category 3G product where EN 50021 has been used as the basis of conformity.
a) The product range was first manufactured in 2000 and the declaration relied on referencing EN 50021: 1999 as “state of the art” for Category 3G electrical equipment, although it was not yet harmonised.
b) EN 50021:1999 was harmonised in 2001.
c) EN 50021:1999 will cease to have harmonised status in 2006.
The move from (a) to (b) is a comparatively simple clerical exercise, merely requiring an editorial reworking of the declaration. The move from (b) to (c) is not so simple.
The essence of the directive is compliance with the EHSRs at the time the individual product is placed on the market. If the reason that the standard ceases to be harmonized is that it no longer fulfils the criteria of being based on current technological knowledge, then it cannot stand alone as justification of compliance. In such a case, the whole set of technical documentation for the product needs to be reviewed and a new justification of compliance prepared.
It may be that changes in the standard, brought about by revision or replacement, do not impinge on the particular product (changes applicable to electric motors, for example, do not impinge on luminaires made to the same standard), in which case a straightforward statement to this effect will be sufficient justification for continuing to use the de-harmonised standard.
However, if the replacement standard has more stringent technical requirements applicable to the product, it will be necessary to prove compliance to those new requirements or to prepare a very careful technical justification as to why the updated requirement should not apply to the product.
The reason EN 50021:1999 will de-harmonised in 2006 is because it has already been replaced by EN 60079-15:2003 and Cenelec Standards Committee TC31 agreed that EN 50021:1999 should be withdrawn in 2006, allowing the normal three year overlap. De-harmonisation normally follows automatically.
Although there are many detailed differences between EN 50021 and EN 60079-15, the one major difference affecting virtually every product is that the standard impact test level has been doubled from 3.5J to 7J. (The other impact levels, e.g. applicable to transparent parts, have also increased.)
Does this mean every product requires a new type test ? Possibly, yes. Possibly, no.
The existing test report will give details of the test performed. It may well be that if the product has been certified by a body which is aware of developments in the standards, the test will already have been done at the enhanced level, in order to “future proof” the certification. Relief all round.
The existing report may give justification for “deeming” compliance with the impact test, rather than performing it. This is often done with thick cast iron constructions. A new justification for “deeming” compliance at the higher impact level will be required.
If all else fails, it will be necessary to do the test !
Once the technical justification is sorted out, the necessary compliance modules of the directive have to be followed.
It is not often that a new standard doubles a test requirement, but extra requirements are often introduced. For example, as EN 60079-7 replaces EN 50019 (ceasing harmonised status in 2006), proof will be needed for the new terminal pull test on plastic bodied terminal blocks.
In the future, as we move from one edition of an EN 60079 series standard to another, life will be simpler as the IEC published version of the standard carries a list of the major differences. So far, Cenelec has deleted this information from the standard when published as an EN. However, the IEC has been very kind to us and the information can be downloaded free from the IEC Webstore (www.webstore.iec.ch) as part of the service designed to encourage the direct purchase of the IEC version of the standard.
So where do the responsibilities lie ? Baseefa has always accepted the previously stated view of the UK DTI and the European Commission that Declarations of Conformity are a purely legal matter for the manufacturer and that Notified Bodies are solely responsible for providing the compliance confirmation in accordance with the modules of the directive. However, over the last year, it has been suggested that Notified Bodies might have a legal responsibility to inform manufacturers of relevant changes to standards and how they impinge on the declaration for particular certified products. This was roundly rejected by all the European Notified Bodies at their meeting in Brussels in November. The cost of putting a foolproof system in place to monitor all certificates on behalf of manufacturers would be prohibitively expensive. It also begs the question about responsibilities in respect of equipment declared in accordance with the “Internal Control of Production” module, where there is no Notified Body involvement.
It seems likely that a compromise will be worked out, whereby during the QA procedures the responsible Notified Body will check that the manufacturer understands his responsibility and has a procedure in place to allow him to be aware of changes in the standards that affect his products.
The initial key to this is to maintain a watching brief on the OJEC to have current awareness of the harmonization status of each applicable standard. This is not always so easy to do direct from the source, but the information is available in pre-digested form from the European Commission ATEX web site.
However, once a change in status is determined, what happens next ? The one constant source of information is a Notified Body involved in the standards making process. The Notified Body will know the details of the changes and be able to give advice as to how they apply to a particular product. All Notified Bodies should normally try and be as helpful as possible. This is part of the duty of care they have to their customers and a totally different matter from a legal imposition placed on them by the European Commission. In a sensible world, the manufacturer will accept that he has prime legal responsibility, but will rely on the Notified Body for advice and assistance.
