BE SAFE. WE CARE.

THE PPE Regulation (EU) 2016/425

The new Regulation (EU) 2016/425 on personal protective equipment (PPE), which entered into force on 20th April 2016, replaces Directive 89/686/EEC, which is repealed with effect from 21st April 2018. The regulation is binding in all respects and represents directly applicable law throughout the EU. It sets down requirements and specifications for the manufacture and provision of PPE in accordance with the new regulation.

ECONOMIC OPERATORS

MANUFACTURER:

Any natural or legal person established within the Union who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark.
 

AUTHORISED REPRESENTATIVE:

Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks.
 

IMPORTER:

Any natural or legal person established within the Union who places PPE from a third country on the Union market.
 

DISTRIBUTOR:

Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market.

PLACING ON THE MARKET

The placing on the market of PPE is the first making available of PPE on the Union market.
 

MAKING AVAILABLE ON THE MARKET

The making available on the market of PPE means any supply of PPE for distribution or use on the Union market in the course of a commercial activity, e.g. via a distributor, whether in return for payment or free of charge.
 

CASES IN WHICH OBLIGATIONS OF MANUFACTURERS APPLY TO IMPORTERS AND DISTRIBUTORS

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and he shall be subject to the obligations of the manufacturer where he places PPE on the market under his name or trademark or modifies PPE already placed on the market in such a way that compliance with this Regulation may be affected. (e.g. by the application of emblems that do not conform to the standard)


Each economic operator must, on request, designate the upstream and downstream economic operators for the market surveillance authorities and retain the relevant documents for 10 years.

OBLIGATIONS FOR THOSE WHO PLACE GOODS ON THE MARKET

(E.G. MANUFACTURERS)

Those who place goods on the market are obliged to indicate the risk against which the PPE is intended to provide protection and the harmonised EU standards applied, including the date of issue of the standard. In addition, each PPE product must be accompanied by the relevant declaration of conformity or the declaration of conformity must be available for download on the Internet.

This information, including the Internet link, can be found at HB in the manufacturer’s information (see Fig.).

THE NEW OBLIGATIONS FOR THOSE WHO MAKE GOODS AVAILABLE ON THE MARKET

(E.G. DISTRIBUTORS)

When making PPE available on the market, distributors shall act with due care in relation to the requirements of this Regulation.

This means:

They must verify that the necessary manufacturer’s documentation and markings are affixed to the product or accompany it, e.g.:

  • CE marking
  • Manufacturer’s information (in a language easily understood by consumers and users of PPE in accordance with the decision of the Member State)
  • Declaration of conformity or link to a website where this is easily accessible
  • Manufacturer marking

INFORMATION OBLIGATION FOR DISTRIBUTORS

Distributors have a duty to inform manufacturers, importers and market surveillance authorities if the PPE presents a risk to health and safety. Where a distributor considers or has reason to believe that PPE that he has made available on the market does not comply with this Regulation, he must ensure that all appropriate corrective action to bring the PPE (back) into compliance, to withdraw the PPE from the market, or to recall it is taken.

HB PROTECTIVE WEAR

All PPE products from HB Protective Wear naturally bear the CE marking. It can be found on the sewn-in labels in all HB PPE garments or, if the type of PPE does not permit this, on the packaging or as printing or a sticker on the product.

At HB, a production order number is printed onto each label to identify each garment, enabling all information on the manufacture of each individual HB garment to be reliably traced.

HB Protective Wear has been manufacturing its products since 2017 in such a way that they meet the requirements of the new PPE regulation. For example, the information required since 21st April 2018, such as the issue date of the standard, the manufacturer’s full address and the CE marking, can already be found on the labels of all HB PPE garments.

TIMELINE

20.04.2016

Entry into force of the new Regulation (EU) 2016/425

21.04.2018

THE NEW REGULATION (EU) 2016/425 IS VALID.

Repeal of Directive 89/686/EEC
Start of the transitional provisions (Article 47 PPE Regulation): 

  • Certification and placing on the market of PPE products on the basis of the new Regulation (EU) 2016/425 are now possible.
  • The placing on the market of PPE products certified on the basis of Directive 89/686/EEC is still permitted.
21.04.2019

End of transitional provisions: 

  • Only PPE products in accordance with the requirements of Regulation (EU) 2016/425 may be placed on the market. 
  • The placing on the market of products with a certificate in accordance with Directive 89/686/EEC is only permitted if these fulfil the substantive requirements of Regulation (EU) 2016/425 (e.g. declaration of conformity, product marking and traceability). 

Products can be made available on the market for an unlimited period of time. 

21.04.2023

Maximum validity of ‘EC type-examination certificates and approval decisions’ issued under Directive 89/686/EEC unless they expire before that date. 

Errors and omissions excepted.