THE NEW PPE REGULATION 2016/425 DATED MARCH 9, 2016 WILL BE APPLICABLE ON THIS COMING APRIL 21 

What is the situation for the PPEs that are in the stock of the manufacturer on April 21, 2019 and that are in compliance with the PPE Directive 89/686/CEE?

A text of the European commission, available on the Europa website (https://ec.europa.eu/docsroom/documents/34622 - in English only), clarifies the situation very clearly. 

 

As a summary of the document 34622 dated 27/03/2019:

“Despite being in the stock of the manufacturer, individual product items of personal protective equipment can be considered as “placed on the market” when they are effectively offered for distribution, consumption or use.

[…] The offer or the transaction must refer to a quantifiable lot of product items which have been already manufactured. 

[…] Products in compliance with the PPE Directive which are in the warehouse of the manufacturer, can be considered as already placed on the market before 21 April 2019 in the case that these products have been offered for sale in product catalogues, or on websites, or in the manufacturer’s own store(s) and/or online store. Therefore, these products in compliance with the PPE Directive already placed on the market before 21 April 2019 can continue to be made available on the market after 20 April 2019. 

The manufacturer must be able to provide, on a case-by-case basis, the adequate proofs (documentation, justification, traceability) to demonstrate that products that have been designed and manufactured according to the PPE Directive have been legally placed on the market before 21 April 2019.”

What does it mean for you?

Since January 2019, the PPEs we manufacture are in conformity with the new PPE regulation and can be placed on the market in compliance with the new regulation. 

  • If you have in stock products of this kind, you are already in tune with the new regulation.

Of course, we still have in stock PPEs that were manufactured in conformity with the European directive (manufacturing date prior or equal to January 2019). As confirmed by the European commission, these PPEs in stock in our warehouse are considered as placed on the market and can thus be sold after April 21, 2019. 

  • If you have in stock products of this kind, everything is alright, they have been placed on the market before April 21, 2019 (by KRATOS SAFETY) and you have made them available on the market.

These products (manufactured before April 21, 2019) can be made available until April 2023 (end of validity of the EC-type examination certificates). 

It should be noted that they can be made available by you or another distributor.

  • Finally, in order to be totally exhaustive about the subject, the PPEs that have been manufactured before April 21, 2019 and used by end-users don’t have any date of validity. The validity of use only depends on the result of the mandatory periodic inspections and the information on the User Instruction manual.

Definitions as per the EU Regulation 2016/425:

  • Placing on the market: the first making available of PPE on the Union market.
  • Making available on the market: any supply of PPE for distribution or use on the Union market in the course of a commercial activity.