End of transition period for directive 94/9/EC - drafts questions and answers
At the ATEX Standing Committee held on 29 June 2001 the European Commission made it absolutely clear that there will be no extension to the transition period over that already prescribed. As stated, all products falling within scope of Directive 94/9/EC ("the ATEX Directive") will have to comply from the 1 July 2003.
It was considered by a number of Member States that further guidance might be required for those manufacturing spare parts held in stock purchased during the transitional period for use after this period ends.
On the basis of a number of questions presented, the following interpretations were discussed by the Committee.
The European Commission has issued guidance, ("the Blue Guide") on the interpretation of new approach Directives, of which the ATEX Directive is one. This may be helpful in interpreting the ATEX Directive, although definitive interpretation is for a court, ultimately the European Court of Justice. The Blue Guide formed the basis for the Standing Committee's discussions on this issue.
Q1 - What is meant by "Ready for Use", as used in the Blue Guide? The Blue Guide states that certain products that can be put into service after the end of the transitional period if ready for use at the time they are placed on the market. However most spare parts will require some work to install them. (ref. The Blue Guide, p.20)
Each spare part must be considered in its own circumstances and it is difficult to generalise out of context. However, for spare parts which are not equipment, a protective system, a component or a device according to Article 1 of the ATEX Directive the answer is provided for at Chapter 7 of the Commission's Guidance notes to the Directive, the ATEX Guidelines, 2001 Edition. Spare parts that are not equipment, protective systems, components or devices, as defined in the ATEX Directive, are not subject to the ATEX Directive. Therefore, there is nothing in the ATEX Directive to prevent them from being placed on the market any time after the end of the transitional period.
Spare parts which are equipment, a protective system, a component or a device according to Article 1 of the ATEX Directive will have to comply with the ATEX Directive when placed on the market after the end of the transitional period.
Generally, repaired products, which are within the scope of the ATEX Directive, need not be assessed against the requirements of the ATEX Directive after repair, as a repair does not substantially modify the product.
The Standing Committee considered that, although each case must be assessed on it own merits, in general terms "Ready for use" means the ability to be incorporated or installed without a change to the performance or safety characteristics as originally anticipated by the manufacturer.
Q2 - Can there be some relaxation on the use of safe but non-compliant spares that may be held by end-users for use during the foreseeable life of the equipment/ assembly?
In general, equipment, protective systems, components and safety devices, as defined in Article 1of the ATEX Directive which are spare parts and which are held by the end-user are likely to have been have been placed on the market already.
If the above spare parts were placed on the market prior to the end of the transition period and they were ready for use at that time then, according to the Blue Guide, they can be first used after the end of the transition period. Whether a product is ready for use must be assessed on a case by case basis and any subsequent alteration of the product would have to be taken into account in considering whether it was ready for use when placed on the market.
However, there may be spare parts falling within the scope of the ATEX Directive, which may be held by an end-user that may not have already been placed on the market. This is the case for equipment, protective systems or devices that are manufactured by the user for own use. In these circumstances the spare part will need to comply with the requirements of the ATEX Directive when it is first put into service.
Q3 - Can the installing of a spare part allow the freedom to ensure the overall continuing integrity of the system by using non-compliant parts subject only to the requirement to provide a satisfactory risk assessment under the relevant "Use" Directive?
The consequences of installing each spare part must be assessed individually. However, in general, equipment, protective systems, components or devices, as defined in the ATEX Directive, which are intended to be integrated into an installation will inevitably be placed on the market and/or put into service and consequently will have to comply with the requirements of the ATEX Directive at that time.
Q4 - After the end of the transitional period, will manufacturers be able to sell non- compliant stock to the owners of relevant installations, which are not in scope of the ATEX Directive? This would mean that these installations would only be subject to the relevant "Use" Directive (92/91/EEC, 92/104/EC or 1999/92/EC), requiring only an overall risk assessment?
See answer to Q3 above. If this stock represents equipment, protective systems, components or devices as defined in the ATEX Directive it must comply with the requirements of the ATEX Directive when placed on the market.
In respect of the second question installations are not covered by the ATEX Directive but are covered by the relevant "Use" Directive.
Q5.1 - Distributors are those in the distribution chain who are neither manufacturers nor end-users. At the end of June 2003 they may be holding stock which has been "placed on the market" but is not in the hands of end-users. This equipment may already meet national health and safety requirements applicable at the relevant date.
The circumstances of each piece of stock would have to be examined individually.
However, such stock would already have been placed on the market before end of the transitional period and would have complied with the relevant national health and safety provisions at that time, therefore such stock did not need to comply with the requirements of the ATEX Directive at that time. As regards putting into service the following approach could be considered:
- For spare parts see A2;
- In other cases (e.g. where the safety characteristics are altered through the nature of the installation) the obligation for compliance with the requirements of the ATEX Directive is unavoidable.
Q5.2 - Distributors who are part of the commercial chain of the manufacturer
It is clear from 5.1 that, on a case-by-case basis, equipment sold down the distribution chain may be considered to be placed on the market. However, there are cases when the distribution chain is part of the commercial chain of the manufacturer rather than a separate organisation. Footnote 31 of the Commission's "Guide to the New and Global Approach" recognises this situation and makes it clear that equipment moving down this type of distribution chain could also be considered as having been placed on the market. However, market surveillance authorities would need to ensure that a "transaction" had taken place even if the equipment was not as such "sold".
This evidently needs to be considered by the market surveillance authorities of the Member States on a case-by-case basis. In effect, there is a general burden of proof on the manufacturer to show that the equipment has been given to the authorised representative distributor with the real intention of distribution and use rather than a mechanism of treatment of stocks.
Q6 - Who will become responsible for the purpose of the assessment of remaining stock against the requirements of the ATEX Directive after 1 July 2003, the distributor or the end-user?
The circumstances of each situation will have to be examined individually.
However, according to general principles of New Approach, the manufacturer would be responsible for conformity assessment (assisted by a notified body, if required). Further information is provided at Chapter 3 of the Blue Guide. The responsibilities on the manufacturer or his authorised representative undertaking the conformity assessment of products are laid down in the Annexes to the ATEX Directive.
Q7 - Products manufactured for "Own Use" are subject to the ATEX Directive, but will they be required to CE mark them and hold a signed DOC, in addition to the technical construction file?
Generally, though each case must be examined individually, persons manufacturing for own use will be putting the equipment, protective systems or devices into service and will be subject to those requirements of the ATEX Directive, which are placed on any other manufacturer.