Regulations and use of PPE

Did you know that the use of PPE (personal protective equipment) is mandatory for more than 40% of workers in different sectors? Mandatory for 80% of workers operating in the construction sector, 60% of workers in the industrial sector and 58% in the agricultural sector.

However, it is surprising that approximately 10% of workers admit that they do not use them. This data is spine-chilling, since not using the appropriate PPE is accountable for almost 10% of fatal accidents, a figure that could be reduced if protective equipment were used properly.

Most of the accidents are recorded in workers under 25 years of age, temporary workers, the self-employed and companies that have less than 10 workers on their workforce.

Personal protective equipment: use of PPE

When we talk about the use of PPE, we refer to personal protective equipment that has been designed and manufactured to be worn or held by a person to protect against one or more risks that threaten their health or safety. It can be private or professional use. This is important to highlight, since PPE is also used in sports or DIY. It is also important to highlight and it has become clear during the COVID 19 pandemic, that PPE can also be medical devices and thus have dual certification or dual use.

Personal protective equipment

Documentary obligations of economic operators

As stated in Articles 8 to 13 of the Regulation, the documentary obligations of economic operators basically come from Decision 768/2008 for manufacturers, authorized representatives, importers, and distributors. Which are?

  • The PPE must be accompanied by the EU Type Certificate, the EU Declaration of Conformity (Annex IX)
  • They must keep the technical documentation for 10 years after the PPE was put on the market
  • Internal production control
  • Identification of PPE (traceability)


The manufacturer will assess the level of risk for which the PPE will offer protection and will consider the anticipated and reasonably foreseeable risks.

The PPE must comply with the Health and Safety Requirements of the applicable legislation (EU Regulation 2016/425). Their compliance will be evaluated through the established conformity assessment processes.

The manufacturer must present with each protective equipment:

  • EU Type Certificate
  • CE marking and other markings
  • EU declaration of conformity
  • Information brochure
  • Traceability: They will identify the PPE with its type, batch, or serial number. They will be identified with their name or brand and contact postal address.

Authorized representative

It is the natural or legal person, established in the Union, who has received a written mandate from the manufacturer to perform specific tasks on its behalf:

  • Request to conduct conformity assessment
  • Maintain EU declaration of conformity and technical documentation
  • Cooperate with national authorities


The importer is the natural or legal person, established in the Union, who places PPE from a third country on the Union market. Your responsibilities are based on those of the manufacturer. You must ensure that only PPE compliant with the required documentation is placed on the market, which must be identified with your name and brand and contact address.


A distributor is the natural or legal person, different from the other operators (manufacturer or importer) that markets the PPE in the Union. You must ensure that it bears the CE marking and that it is accompanied by the necessary documentation. The manufacturer and / or importer should have indicated their name and address.

What should the user know about the use of PPE?

  1. Product information
  2. Product safety

What will the PPE wear according to Regulation 2016/425?

  1. Identification of the manufacturer and importer
  2. Declaration of conformity accessible
  3. Same CE marking

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