On 27th March 2014 The European Commission proposed to replace Directive 89/686/EEC on the safety of Personal Protective Equipments by a directly applicable Regulation COM (2014) 186, with the aim of simplifying the process of placing PPE equipments on the European Market.
The proposal is part of the European Commission initiative to simplify and align the legal requirements applying to industrial products marketed in the EU, by eliminating conflicting or overlapping requirements for products governed by more than one piece of legislation.
NEW Requirements ?
While the EC proposal will need to complete the legislative procedure of being adopted by the European Union institutions (EU Parliament & the Council of the EU) – some of the new requirements will surely form part of the final text.
The proposed New Requirements include:
- New definitions of PPE categories, and re-classification of some type of equipments;
- Updated conformity assessment procedures;
- Extension to PPE for private use for protection against heat, damp and water;
- Clear obligations on manufacturers, importers, distributors & authorized representatives;
Impact on the Authorized Representative
Proposal COM (2014) 186 provides the following definition (Article 3.7) for the authorized representative – ‘authorised representative’ means any natural or legal person established within the
Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
According to the Proposal, the mandate with the authorized representative must allow him to do at least the following (Article 9):
- Keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for at least 10 years after the PPE has been placed on the market;
- Further to a reasoned request from a national market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the PPE;
- Cooperate with the national market surveillance authorities, at their request, on any action taken to eliminate the risks posed by PPE covered by the authorized representative’s mandate.
Future Expectations
The change from a Directive to a Regulation will mean that the law will no longer be subject to national transposition. However, being a Regulation would not lead to any change in the regulatory approach.
The characteristics of the New Approach will be fully preserved, in particular the flexibility given to manufacturers in the choice of the means employed towards compliance with theessential requirements (harmonized standards or other technical specifications) and in the choice of the procedure used to demonstrate compliance from among the available conformity assessment procedures.
If you would like to know more on the new PPE Regulation, please do not hesitate to contact us.