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Update to PPE Regulation (EU) 2016/425

Recent refinements to the new European PPE legislation.

by Peter Doughty

Image © Sophiejames | Dreamstime

As mentioned in the article 'New European PPE Regulation (EU) 2016/425', we intend to keep readers updated with any developments relating to the new PPE Regulation (EU) 2016/425. There are now two significant differences in interpretation that we consider should be reported.

Firstly, with regard to when Notified Bodies such as SATRA will be able to issue EU type-examination certificates under the regulation, it had previously been presumed that nothing could be issued until after the full application of the regulation on 21st April 2018. However, a new document released by the Commission states that Notified Bodies are entitled to issue an EU-type examination certificate or other certificates before the full application of the regulation, that is, before 21st April 2018. It is important to highlight that those certificates will be valid only for products placed on the market as from 21st April 2018 under Regulation (EU) 2016/425 (see table 1).

Table 1: Regulation (EU) 2016/425 –
Current interpretation of transition period
Directive 89/686/CEE Regulation (EU) 2016/425

to 21 April 2023

  
to 21 April 2019 End of validity for all EC-type certificates and decisions made according to the Directive (Article 47 paragraph 2)
to 21 April 2018 End of possibility to place on the market PPE with a Certificate according to the Directive (Article 47 paragraph 1)
Directive withdrawal
– Regulation application

PPE
Category l

 Only PPE made according to the Directive may be placed and made available on the market Placing on the market of PPE made according to the Directive or the Regulation is possible Only PPE made according to the Regulation may be placed on the market
PPE made according to the Directive or the Regulation may be made available on the market
PPE
Category ll		 Only PPE made according to the Directive may be placed and made available on the market Placing on the market of PPE made according to the Directive or the Regulation is possible Only PPE made according to the Regulation may be placed on the market
PPE may be made available on the market according to the Directive or the Regulation
PPE Category lll Only PPE made according to the Directive may be placed and made available on the market Placing on the market of PPE made according to the Directive or the Regulation is possible Only PPE made according to the Regulation may be placed on the market. Production control only according to Regulation (Modules C2 and D)
PPE may be made available on the market according to the Directive or the Regulation
PPE that moves from Category ll to Category lll May be placed and made available on the market as Category II PPE if made according to the Directive PPE made according to the Directive may be placed on the market as Category II. PPE made according to the Regulation may be placed on the market as Category III Only PPE made according to the Regulation may be placed on the market as Category III
PPE made according to the Directive may be made available on the market as Category II. PPE made according to the Regulation may be made available on the market as Category III

Production control only according to Regulation (Modules C2 and D) for those with EU Certificate

This effectively provides for an extension to the current transition period for the review work to be carried out and certificates to be issued by the Notified Bodies. However, to issue a certificate, the Notified Body will also need to have had their notification scope extended to cover the regulation. If all goes to schedule, SATRA hopes to be notified under the regulation by the third quarter of this year. Members are therefore encouraged to contact us and start the review process as soon as possible.

Selling PPE footwear

The second difference is that previously it had been reported that PPE footwear certified to the current directive could not be 'made available'* after 21st April 2023. More recent information, though, would suggest that there is no deadline for such product in the supply chain, and it can remain in distribution or retail outlets indefinitely. The only consideration is that the product was compliant with all relevant legislation at the time that it was 'placed on the market'*. The chart on the opposite page shows an updated timeline that has been revised to take account of this second point.

*See the article 'New European PPE Regulation (EU) 2016/425' for a simplified definition of these two terms.

How can we help?

Please email ppe@satra.com for assistance to ensure that your products will meet the new legislative requirements.

Publishing Data

This article was originally published on page 34 of the April 2017 issue of SATRA Bulletin.

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