The PPE Directive was one of the first New Approach Directives and was over 20 years old. In order to reflect current technologies and processes for developing and bringing PPE to the market, it needed to be updated. As well as reflecting new technology, the new Regulation has been shaped to enhance consumer safety and ensure fair competition between companies. It is also important to bring it in line with other Directives that have undergone a revision in recent years.
The changes also meant that the old Directive was re-implemented as a Regulation rather than remain in its outdated status. This meant that the new Regulation did not have to be transposed into each Member State’s national law. (A Directive is a legislative act that sets out an objective that all EU countries must achieve by a given date. However, it is up to the individual countries to decide how this is done. In contrast a Regulation is a binding legislative act, and it must be applied in its entirety across the EU without the need for separate national legislation.)
Obligations on Distributors in the PPE Regulation (EU) 2016/425
The PPE Regulation places responsibilities on distributors some of which are;
- When making PPE available on the market, distributors shall act with due care in relation to the requirements of this Regulation
- Before making PPE available on the market, distributors shall verify that it bears the CE marking, is accompanied by the required instructions in a language which can be understood by end-users in the country which PPE is to be made available
- Distributors shall ensure that, while the PPE is under their responsibility, storage or transport conditions do not jeopardise its conformity
- Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with this Regulation shall withdraw it or to recall it
Furthermore, where the PPE presents a risk, distributors shall immediately inform the competent national authorities giving details, in particular, of the non-conformity and of any corrective measures taken.