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THE NEW REGULATION (EU) 2016/425

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The experience accumulated since 1989 in the application of the 89/686/EEC directive on PPE (Personal Protective Equipment) has demonstrated some inadequacies and inconsistencies. The new regulation (EU) 2016/425 was therefore drafted to introduce the necessary corrections and replace the old directive. Unlike a directive, a regulation does not need to be acknowledged and implemented in the legislation of each EU member state. It therefore has the advantage of being identical and immediately applicable inall countries of the European Union.

What are the main changes?
The regulation includes changes and clarifications concerning:
- the roles of the various economic operators involved (manufacturers, distributors, importers and authorised representatives);
- the applicable requirements for certification processes with notified bodies;
- the requirements related to monitoring on the market and production controls.
It also defines new obligations concerning marking and user instruction manuals. Last, but not least, it requires the manufacturers to review PPE certification every 5 years.

What are the consequences for retailers?
A transition period is defined for the switch from the directive to the regulation. Therefore:
- the devices certified in accordance with the old directive and already placed on the market can be sold in the European Union until 21 April 2023;
- the devices certified in accordance with the new regulation can already be sold from 21 April 2018.

What are the consequences for companies and users?
The products certified in accordance with the old directive and purchased prior to 21 April 2023 can be used for the entire life cycle specified in the product instruction manual.

How can you recognise a product certified under the old directive?
The instruction manual indicates conformity to directive 89/686/EEC.

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How can you recognise a product certified in accordance with the new regulation?
If the product is certified in accordance with the new regulation, the instruction manual indicates:
- conformity with regulation (EU) 2016/425;
- the risks the PPE is intended to protect against;
- the website URL where the EU declaration of conformity can be downloaded.

What is the progress of conformity with the new regulation concerning CAMP, CAMP Safety and CASSIN Personal Protective Equipment?
C.A.M.P. has followed the drafting of the regulation from the start and took steps immediately to implement the necessary measures on its products. A vast amount of PPE already complies with the new regulation and C.A.M.P.'s goal is to have all of their equipment in compliance by 21 April 2019. All of the EU declarations of conformity will be available in 30 languages on the website www.camp.it by said date.

Go HERE to download the document in pdf format.