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PPE Regulation (EU) 2016/425 - A guide 

Regulation (EU) 2016/425 on personal protective equipment (PPE), which came into force on 20 April 2016, has been in force since 21 April 2018, replacing Directive 89/686/EEC and is directly applicable law throughout the EU. The regulation brings together all the requirements that must be met for the manufacture and provision of PPE, leaving no individual EU country more room for interpretation. The scope of the regulation has not changed significantly compared to the old directive. It continues to cover all equipment and means developed and manufactured to protect people from various risks. You can find more information on risk categories 1 - 3 of protective equipment in our blog ‘Risk assessment when selecting PPE’. 

We would like to give you an overview of what is changing for providers of personal protective equipment and how we as PPE manufacturers are dealing with this new regulation. Please also note the new scopes and product categories of the regulation: For example, items such as oven gloves now also count as PPE and earplugs are subordinate to product category III.

A woman and a man in protective clothing work on a photovoltaic system.

The economic operators 

Every economic operator in the PPE supply chain is obliged to know both the upstream and downstream economic operators and to keep the corresponding documents for 10 years. The economic operators are defined as providers (e.g. distributors or textile service companies) or distributors (e.g. manufacturers, authorised representatives and importers). 

Providers, such as distributors and textile service companies: The making available of PPE includes any supply of PPE for distribution or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge. A supplier is subject to the obligations of a manufacturer if he places PPE on the market under his own name or trade mark or modifies PPE already placed on the market in such a way that compliance with the Regulation may be affected (e.g. by affixing logos). 

Placers on the market, such as manufacturers, authorised representatives and importers: Placing PPE on the market involves making PPE available on the EU market for the first time. 

  • Manufacturer: someone who manufactures PPE or has it developed or manufactured and markets it under their name or brand. 
  • Authorised representative: someone who has received a written mandate from a manufacturer to carry out certain tasks on their behalf. 
  • Importer: someone who places PPE from a third country on the EU market for the first time.

Pictogram for weather protection.

Timeline PPE Regulation (EU) 2016/425 

21.04.2018 
The new Regulation (EU) 2016/425 is valid. Start of the transitional regime: 
  • All economic operators must fulfil their obligations under the Regulation.
  • Certification in accordance with the new regulation is only now possible. 
  •  PPE products certified in accordance with Directive 89/686/EEC may continue to be placed on the market. 

21.04.2019 
End of the transitional regulation: 
  • All documents accompanying PPE articles must now comply with the content of the new regulation. This means that distributors must have updated all documents. However, recertification in accordance with the new regulation is not mandatory. 
  • Products certified in accordance with Directive 89/686/EEC may no longer be placed on the market if the content of their accompanying documents does not comply with the new regulation. 
  • Making available on the market is possible indefinitely 

From 21.04.2023 
  • The validity of all EC type-examination certificates issued in accordance with Directive 89/686/EEC expires. 
  • However, products certified in accordance with Directive 89/686/EEC may continue to be made available by distributors or textile service companies.
Road builders lay a cable and wear orange high-visibility clothing.

The obligations for you as a provider 

These obligations apply to you if you are a retailer or textile service provider, for example:

  • Inform: Consider the regulation with due diligence 
  • Check: Check whether the manufacturer has drawn up the required documents and attached them to the product, such as manufacturer information (in the relevant official language), declaration of conformity, manufacturer's labelling, CE marking. 
  • Ensure: Ensure that the respective protective effect is not impaired during storage. BP offers individual packaging for each PPE product as well as UV protective packaging for high-visibility products. 
  • Support: Obligation to co-operate with market surveillance.

A man wears a weather protection jacket in accordance with en343. Snow and a wind turbine can be seen in the background.

The obligations for us as a distributor 

These obligations apply to manufacturers. As a distributor, we are obliged to describe all the risks that the PPE product protects against and to refer to the harmonised EU standards applied with the date of issue. In addition, the required declaration of conformity must at least be available as a download link on every PPE product. 

Our manufacturer information is available for all this information and is always an integral part of every BP® PPE product. As a distributor, we are also obliged to guarantee traceability through labelling. Therefore, all manufacturer information such as type, batch or serial number is permanently attached to every BP® PPE product. 

Furthermore: BP retains all technical documentation, declarations of conformity and information on who PPE was sold to for 10 years. We also have a duty to support market surveillance through our co-operation. 

And: If BP products are found to be non-compliant, BP is obliged to implement the prescribed corrective measures and inform all economic operators involved. 

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You want to equip an entire team or company with PPE and need support in selecting and compiling protective clothing that conforms to standards?
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