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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 by the European Parliament 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 in all countries of the European Union.

What is the progress of conformity with the new regulation concerning CAMP, CAMP Safety and CASSIN Personal Protective Equipment?
C.A.M.P. followed the drafting of the regulation from the very beginning and immediately started to implement the required action in order to offer its own clients products which were compliant to the new regulation. Thanks to our fast reaction we hereby inform you that all the PPE produced by C.A.M.P. from 21 April, 2019 is compliant to the new regulation. More specifically, we are pleased to announce that the greatest majority of C.A.M.P.'s devices produced since mid 2018 are already compliant to the new regulation, therefore for months now our warehouses have been delivering compliant PPEs. For an extremely limited number of products our warehouses offer stock compliant to Directive 89/686/EEC, which is salable up until 21 April, 2023 and usable till the end of its declared lifetime. In terms of the new EU Declarations of Conformity, these are already available at the website www.camp.it in 30 languages.

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 (manufactured and warehoused by the manufacturer before 21 April, 2019) 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 (beginning of transitional period).
From the above it can be deduced that the first expiry of 21 April, 2019 is tied to production by manufacturers and has no special importance for retailers. Despite this fact, the choice of buying products from a manufacturer like C.A.M.P., who has been updating its own stock of products compliant to the new regulation for a year now, is certainly quite advantageous.

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.

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.
For PPE produced by C.A.M.P., the new manuals clearly indicate compliance to the new EU regulation on the cover. For a limited number of products, on the other hand, the old manual was updated with an additional card which illustrates the information required by the new regulation.

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What is the EU Declaration of Conformity and why is it required?
The EU Declaration of conformity certifies that the main applicable health and safety requirements have been observed, therefore it's an official document where the manufacturer is responsible for the PPE compliance to the requirements established by the new regulation. The EU declaration of conformity is required to prove PPE compliance and is sent to distributors, retailers, users and must be supplied upon request by the competent authorities. The EU declaration of conformity is drawn up:
- based on a EU Examination Certificate in compliance with Module B of the new Regulation (EU) 2016/425, issued by a notified accredited body. Or based on a former EC Examination Certificate in accordance with article 10 of the old Directive 89/686/EEC: this is possible only in case the EC certificate is still valid, the product has not been changed after certification and in the meantime there were no amendments to the EN standards.
- Only for PPEs of the 3rd category (e.g. all fall-arrest products for industry and mountaineering), based on a certificate to guarantee quality of the production process (Module D) or an official control at casual intervals (Module C2). This second certification is important to guarantee the continuity of the production quality and is indicated by the number which follows the CE marking on the device. For the greatest majority of all products manufactured by C.A.M.P. this number is 0123 and refers to the notified body TUV SUD which guarantees the quality of the production process with Module D.
Both the EU examination certificates and those which guarantee quality of the production process are not documents which need to be disclosed to customers: the manufacturer must make these available, on the other hand, upon request by the competent authorities.

How to download the new EU Declarations of Conformity?
C.A.M.P. has developed an innovative electronic system which allows user to search and download the EU Declarations of Conformity at the website www.camp.it. These declarations are available in 30 languages. It is possible to download the most updated declaration directly from the page of each product.

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Alternatively, it is possible to access the complete archive of all declarations of conformity through the special link found at the bottom of the homepage Outdoor and Safety.

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After accessing the archive it is possible to search for the declaration with a free search (by entering the article code or the name of the product), through the sales category of the product or simply by entering the bar-code number found on each product. The archive has all the versions of the declarations with relative validity dates.

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Go HERE to download the document in pdf format.