PPE Regulation 2016/425 – end of transition period

As of 21 April 2019, only Personal Protective Equipment in conformity with PPE Regulation 2016/425 can be placed on the market as foreseen by the transitional period (article 47) of the PPE Regulation.

Therefore, it will be no longer possible to place on the market  products in compliance with the Directive 89/686/EEC, while they will  made available until the expiration date of corresponding EC-type  examination certificate (no later than 21st April 2023).

On this last aspect, as from 21 April 2019, the Notified Bodies must  assess only the compliance of equipment with the PPE Regulation.

The European Commission has published a guidance to clarify the concept of “placing on the market’ and product in stocks during the transitional period from the PPE Directive to the PPE Regulation.

This guidance will definitely help the manufacturer to prove that  products, designed and manufactured according to the PPE Directive, have  been legally placed on the market before 21 April 2019-  even if not  yet physically presented on the market.

According to that, products in compliance with the PPE Directive which are in the warehouse of the manufacturer, can be considered as already placed on the market before 21 April 2019 in the case that these products have been offered for sale:

  • in product catalogues;
  • on websites;
  • in the manufacturer’s own store(s) and/or online store;
  • by verbal contact between central warehouse and subsidiary company’s warehouse (only if they are two different legal entities);
  • by verbal contract between a parent company and a subsidiary company  as business operations within a corporate group (only if they are two  different legal entities).

In case of a verbal contract, the economic operator needs to provide documentary evidence such as shipment information.

If you wish to receive more regulatory updates concerning the EU and legislation on products, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU legislation, will gladly answer any question you may have and assist you in safeguarding and achieving your products’ compliance.

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Floriana Dibitetto