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The revision of Directive 89/686/EEC relating to the manufacture and marketing of personal protective equipment (PPE) is entering its final phase, and a publication is expected in the first half of 2016.
The revised document was approved at first reading by the European Parliament on 20 January 2016. It is expected to soon be approved by the European Commission for publication.
What will be the main changes made by the revision of the Directive?
First, the Directive becomes a Regulation. This means that the text will be directly applicable to economic operators (manufacturers, representatives, importers and distributors, and the inspection authorities), without requiring transposition into national law.
As a reminder, the PPE 89/686/EEC Directive is applicable exclusively to European Union Member States. It must therefore be transposed into national law to become applicable to the aforementioned economic operators. The absence of transposition due to the use of a Regulation could therefore correspond to a desire for simplification of the (European and national) legislation and for harmonization between Member States.
Secondly, economic operators’ obligations will be better defined. Thus, in addition to manufacturers and representatives, allowance is made for the role of importers and distributors, whose scope of responsibility is clarified. They are no longer “simply” considered as manufacturers, as was suggested by the 1989 Directive. But they have different constraints, more in line with their role regarding product access to the European internal market.
The product verification procedures, for their part, remain unchanged. However, the “EC type examination certificates” (ATEX ECs) issued by the notified bodies (in charge of inspection of the product validation/verification procedures) will become EU type examination certificates, but in particular they will have a period of validity limited to five years, renewable.
This arrangement is already applicable within the framework of other directives such as the Machinery Directive, where specific procedures were put in place by the European Coordination of Notified Bodies to facilitate renewals. Similar measures could therefore be put in place. For the renewal of an ATEX EC, there would be no need to redo all the tests for a given product, but checks would be performed to make sure that changes in state-of-the-art practice and/or the product do not jeopardize users’ safety.
The definition of each category of PPE will be better specified in this Regulation: the definition for each category will be based on the risk for which the PPE must provide protection, and not on its type (respiratory protection device, equipment for operations in hot atmospheres, etc.).
Finally, the essential health and safety requirements are on the whole unchanged, and only a few marginal clarifications are expected.
Overall, this revision of the PPE Directive is unlikely to radically change the procedures for manufacturing “safe” equipment, but provides clarifications and removes certain ambiguities.