At the workshop that it held in Brussels on 16 November, the European Commission confirmed the worst scenario that could be imagined: all personal protective equipment (PPE) manufactured after 21 April 2019 will have to be in conformity with the 2016/425 Regulation, even that having a valid EC type examination certificate in accordance with the 89/686/EEC directive.
In other words, the transition period provided for by the Regulation will cause a disruption of the market, between manufacturers who will have to re-certify all their product ranges and notified bodies which will probably be unable to cope with the influx of applications.
This is because the transition period as defined (Article 47) is to be understood as follows:
- It is possible to place on the market (series of) products in conformity with the directive, for which there exists a valid certificate (ATEX EC), until 21 April 2019. So any PPE, in the sense of an individual product, in conformity with the directive will no longer be able to be placed on the market as of 21 April 2019, even if there exists a valid ATEX EC.
- For manufacturers, this means that the production of PPE in accordance with the directive will no longer be possible after 21 April 2019, or even earlier, because allowance must be made for the time to market (transport of goods, customs authorities, etc.). The declarations of conformity referring to an ATEX EC shall be produced in accordance with the directive. A declaration of conformity performed in accordance with the directive may not refer to an ATEX EC or a decision established in accordance with the Regulation.
- The delivery of products in conformity with the directive is possible so long as the EC type examination certificates, and where applicable the decisions of approval of the inspection of PPE manufactured as indicated in Article 11 of the directive, are valid, and at the latest until 21 April 2023.
- As of 21 April 2019, only PPE complying with the Regulation may be placed on the market. The certificates (ATEX EU) and the approval decisions may refer only to the Regulation. An EU declaration of conformity referring to the Regulation shall be established.
Note that the French Ministries of Labour, Agriculture and Industry, together with Eurogip and the French notified bodies, will coordinate with one another to help get through this difficult transition stage.
To find out more, please write to Pierre Belingard, EUROGIP