Requirements for personal protective equipment
Personal protective equipment must comply with the requirements imposed on them in the relevant legislation and standards.
Manufacturers (Manufacturer's obligations page on tukes.fi), importers and distributors are, in relation to their respective roles in the supply chain, responsible for the compliance of PPE that is placed on the market, i.e. put on sale and distribution. More information on the obligations of the manufacturers, importers and distributors can be found in the Personal Protective Equipment Regulation.
Personal protective equipment (PPE) refers to devices, equipment and protective clothing designed to be worn or held by a person for protection against one or more risks to that person's health or safety. Examples of PPE include
- respiratory protective devices
- hearing protectors
- safety goggles
- life jackets
- motorcyclists’ protective equipment, such as protective clothing against abrasion and impacts, back and limb joint protectors, gloves and footwear
- clothing and equipment intended to signal the presence of the user with their visibility, such as reflective vests and reflectors for pedestrians.
PPE is covered by the EU Personal Protective Equipment Regulation that replaced the earlier Personal Protective Equipment Directive. Information on the transitional periods can be found on page Transitional periods.
PPE is classified into three risk categories depending on the seriousness of risks the PPE in question protects against. More information on the risk categories of PPE can be found on page Risk categories of Personal Protective Equipment.
More information on the application of the Personal Protective Equipment Regulation and PPE classification can be found in the PPE Guidelines, guide to application of the PPE Regulation.
Tukes supervises the safety of PPE intended for consumer use. The safety of PPE intended for professional use is supervised by the occupational safety and health authorities.
Health and safety requirements
The manufacturer must ensure that PPE complies with the relevant health and safety requirements (Personal Protective Equipment Regulation (EU) 2016/425, Annex II). The requirements are met if PPE is designed, manufactured and equipped in accordance with the relevant harmonised standards.
Where a PPE product does not have a harmonised standard setting out the requirements and test methods applicable to it, the manufacturer must provide detailed information in the technical documentation of the product concerned as to how the health and safety requirements for that PPE have been met.
More information on the position of standards in demonstrating compliance can be found on page The position of standards in demonstrating compliance.
The PPE manufacturer must prepare the technical documentation (Personal Protective Equipment Regulation (EU) 2016/425, Annex III). The technical documentation includes information on the model, manufacturing and operation of the product, as well as on how the manufacturer has ensured the conformity of the PPE with the applicable requirements.
The manufacturer must keep the technical documentation for 10 years after the PPE has been placed on the market.
The importer must ensure that the manufacturer has prepared the technical documentation and that the documentation is kept available for authorities.
Markings and operating instructions
PPE must bear
- a type, batch or serial number or other element
- the name, registered trade name or trademark and postal address of the manufacturer
- the name, registered trade name or trademark and postal address of the importer.
If these markings cannot be placed on the PPE, the required information must be provided on the packaging or in a document accompanying the PPE.
The PPE must be accompanied by operating instructions, in Finland in Finnish and Swedish. The operating instructions must contain the following:
- instructions for use, storage and servicing of the PPE
- class of protection
- instructions for accessories
- the contact details and identification number of the notified body which carried out the PPE model's type examination
- the name and address of the manufacturer.
More detailed information on the requirements for PPE markings and instructions can be found in Annex II of the Personal Protective Equipment Regulation and in the standards applying to PPE.
Conformity assessment procedure
The manufacturer is responsible for the conformity assessment for the PPE during the design and manufacturing stages.
If the importer or distributor puts PPE on sale under its own trade name or trademark, the obligations of the manufacturer apply to the importer or distributor. In this case, the importer or distributor must apply for a parallel EU type-examination certificate for the PPE. The importer must apply for the EU type-examination certificate together with the original manufacturer.
The conformity assessment procedures are determined by the risk category of the PPE:
- Category I:
- internal production control, module A
- Category II:
- EU type examination, module B, and conformity to type based on internal production control, module C
- Category III:
- EU type examination, module B, and either conformity to type based on internal production control plus supervised product checks at random intervals, module C2, or conformity to type based on quality assurance of the production process, module D.
More information on the conformity assessment procedures and the modules applied can be found in Annexes IV to VIII of the Personal Protective Equipment Regulation.
In the EU type examination, a notified body assesses the technical design of the PPE and the conformity of a specimen of the PPE. The notified body issues an EU type-examination certificate for PPE that meets the relevant requirements
Notified bodies are inspection bodies approved and supervised by EU Member States. These bodies are authorised to carry out EU type examinations or otherwise verify that a product complies with the relevant requirements. Information on the notified bodies can be found on the NANDO website of the European Commission.
The maximum period of validity of an EU type-examination certificate is 5 years. The manufacturer must ask the notified body to review the EU type-examination certificate if
- the manufacturer has modified the product
- changes in the state of the art, such as a new standard version, have taken place
- at the latest, before the date of expiry of the certificate.
EU Declaration of Conformity
The manufacturer draws up the EU Declaration of Conformity before placing the PPE on the market. Placing on the market means the first making available of PPE on the EU market. More detailed information on the contents of the EU Declaration of Conformity can be found on the EU Declaration of Conformity page and in Annex IX of the EU Personal Protective Equipment Regulation.
The EU Declaration of Conformity must accompany the PPE or, alternatively, the manufacturer must include the following information in the operating instructions:
- references to the Personal Protective Equipment Regulation and, where appropriate, other EU legislation
- details of the notified bodies involved in the conformity assessment
- references to the relevant harmonised standards
- the internet address where the EU Declaration of Conformity can be accessed
The EU Declaration of Conformity must be in the languages required by the relevant Member State, in Finland in Finnish and Swedish.
PPE placed on the market in the European Economic Area must bear the CE marking. The manufacturer affixes the CE marking to the PPE.
General information on the CE marking can be found on page CE marking (CE marking page on tukes.fi).
The CE marking must be affixed to each item of PPE. The CE marking must be affixed visibly, legibly and indelibly to the PPE. If the marking cannot be placed on the PPE on the account of the properties of the PPE, the CE marking can be affixed to the packaging or accompanying documents.
For risk category III PPE, the CE marking must include the four-digit identification number of the PPE's notified body.