Regulations

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Regulation (EU) PPE 2016/425 

Methods and times of application: 

Regulation (EU) 2016/425 entered into force on 20 April 2016 and is applied from 21 April 2018.
For 2019, the new regulations started leaving Directive 89/686 alive, which was definitively repealed on April 21, 2019.
In this transition year, the companies were able to indiscriminately market products that comply with the Directive or comply with the Regulation. (NDR - By placing on the market it is intended the first making available of the PPE on the European market = time when the goods are cleared through customs)
At the end of this transitional period, PPE placed on the market will have to respect only the Regulation.
This does not mean, however, that they will not be able to circulate on the market PPE that meet the requirements of the previous legislation: Article 47.1 of the Regulation (EU) specifies, in fact, that product certifications placed on the market on a date prior to April 21, 2019 and issued in accordance with the provisions of the Directive, remain valid until April 21, 2023, unless they expire sooner.
At the end of this period it will be necessary to proceed with a new certification compliant with the Regulation.

All the products that will already be present in the distribution chain (or already made available on the market, therefore present in any EU warehouse regardless of whether it is a distributor, wholesaler or retailer), can be marketed until the natural expiry of the PPE (if indicated ) or the relevant EC certification certificate and, if the certificate does not show the expiry date, until the last date of 21/04/2023 (the last validity date of all the EC certification certificates according to EEC Directive 89/686).

Remember that under the new Regulation end users are not considered economic operators, therefore they can continue to use PPE certified according to the old Directive 89/686 EEC even after this date (21/04/2023) and until the expiration of the device if and where indicated by the manufacturer.

 

Main changes in the Regulation with respect to the repealed Directive:

  • PPE classification is now carried out by risk categories and no longer by product;
  • The classification of some product categories has been changed;
  • Hearing protection, now classified as (risk of) "harmful noise", will go from Category II to Category III;
  • Each product must be accompanied by the EU declaration of conformity (or by a link to the page on which this declaration is available);
  • The technical documentation and the EU declaration of conformity must be kept for a period of 10 years from the date of placing on the market of the PPE;
  • Newly issued certificates have a validity period/expiration date of 5 years;
  • The obligations of economic operators in the supply and distribution chain have been outlined.

 

HERE ARE SOME QUESTIONS AND ANSWERS TO THE MOST COMMON DOUBTS ABOUT THE REGULATION TRANSITION PERIOD:

Q. I am a user: with the new EU Regulation 2016/425 how long can I continue to use PPE certified with the old EEC Directive 89/686?

A: PPE purchased and certified with the old EEC Directive 89/686 may continue to be used until the natural expiration of the device if and where indicated by the manufacturer if necessary.

Q. I am a distributor: with the new EU Regulation 2016/425 until when can I continue to sell PPE certified with the old EEC Directive 89/686?

A: to answer this question it is necessary to reiterate these two definitions: - “making available on the market”: the supply of PPE for distribution or use on the EU market in the context of a commercial activity (distributors) - "Placing on the market": the first making available of a PPE on the EU market (manufacturers and importers)