Regulation (EU) 2016/425 lays down requirements for designing and manufacturing products that users can wear or hold for protection against certain risks either at work, at home, or while engaging in leisure activities. This group of products is called personal protective equipment (PPE), and it includes face masks, gloves, goggles, face shields, garments, etc.


When making PPE available on the EU market, economic operators (e.g. manufacturers, distributors and importers) must ensure that their products are labelled correctly and meet all essential requirements of the EU Regulation. In this regard, the following information must be clearly and durably marked on the smallest commercially available packaging:

  • The name or trademark of the product's manufacturer or supplier
  • The type, batch or serial number of the product
  • The CE marking symbol
  • Where applicable, the identification number of the EU notified body involved in the production control phase
  • Where applicable, the appropriate classification (e.g. face masks – FFP1, FFP2 or FFP3)
  • Indication of whether the product is reusable or non-reusable
  • Where applicable, the number and year of publication of the relevant EN standard
  • The year of the end of shelf life
  • The sentence 'see information supplied by the manufacturer.'
  • The manufacturer's recommended conditions of storage
  • If applicable, the contact details of the EU authorised representative.

In Addition, economic operators must ensure that the product's surface is clearly and durably marked with the following:

  • The CE marking symbol
  • Where applicable, the identification number of the EU notified body
  • The name or trademark of the product's manufacturer or supplier
  • Where applicable, the appropriate classification of the product
  • The type, batch or serial number of the product 
  • If appropriate, the number and year of publication of the relevant EN standard.

If the size of the PPE does not allow for indicating all the above, economic operators must provide the required information on the packaging or in a document accompanying the PPE. Furthermore, the required information must be at least in the destination country's official language(s) and accompany every commercially available package regardless of its dimensions.