Personal protective equipment (PPE) are products that the user can wear or hold, to be protected against risks either at work, at home or whilst engaging in leisure activities. Statistics on fatal and major work accidents underline the importance of protection and prevention, for which personal protective equipment plays an important role.
EU legislation and PPE
Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment (the PPE regulation) covers the design, manufacture and marketing of personal protective equipment. It defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation.
As legislation based on the 'new approach' aligned to the new legislative framework policy, manufacturers or their authorised representative in the EU must comply with the essential health and safety requirements of the PPE regulation, directly or by using harmonised European standards. The latter confer presumption of conformity to legal requirements. Further explanations on the different elements of the new legislative framework can be found on the ‘Blue Guide on the implementation of the product rules’.
The PPE regulation guidelines (4th edition - October 2024) (5 MB) aim to facilitate a common understanding and implementation of the PPE regulation.
Relevant information
- Minutes of the PPE working group meetings (4 MB) from 2002 onwards
- Standardisation for PPE: consolidated lists of references of harmonised European standards under the PPE regulation
- Notified bodies for PPE
- List of bodies notified under Regulation (EU) 2016/425 on personal protective equipment (NANDO information system)
- European coordination of notified bodies - Horizontal Committee of Notified Bodies (HCNB) for PPE
Technical secretariat: Abertech, email: info
abertech [dot] it (info[at]abertech[dot]it)
- Report on the exercise of the power to adopt delegated acts
- Placing on the market of products subject to conformity assessment B+C2
'Recommendation for use' (RfU) sheets
These 'technical sheets for coordination' report the common position of the notified bodies for PPE endorsed by the PPE committee working group
- Horizontal recommendation for use sheets (RfUs) (16 MB)
- Vertical recommendation for use sheets (RfUs) (5 MB)
PPE and COVID-19
Since the beginning of the pandemic, we've monitored the supply chain of key PPE products used for COVID-19. Initially, the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs focused on securing a stable supply and increasing essential PPE availability. Commission Recommendation (EU) 2020/403 on COVID-related conformity assessment and market surveillance procedures helped increase the availability of PPE products in the short term, benefitting healthcare workers and other first-line responders.
Based on information from EU country authorities and economic operators, the supply of PPE to the EU currently appears stable without shortages such as the ones in the first half of 2020.
The Commission will continue to monitor the supply of critical PPE in the EU. However, in this stable situation, only CE-marked products that have gone through the standard conformity assessment procedures should circulate in the internal market. To ensure legal certainty, the Commission adopted Recommendation (EU) 2021/1433 on conformity assessment and market surveillance procedures related to COVID-19. It sets out deadlines for putting products on the market, their use, and authorisation under derogatory procedures.
Unregulated certificates warning
Unregulated certificates, which are often called ‘voluntary certificates’ besides other names, are often issued for some products covered by EU harmonisation legislation by certification bodies not acting in their capacity as notified bodies under EU law. These practices are misleading since only notified bodies may issue certificates of compliance for harmonised products and only in the area for which they are notified. For example, if a body is notified to issue certificates for machinery, it should not issue certificates (voluntary or other) for non-machinery products (such as personal protective equipment – masks).
Please note that, under EU law, voluntary or other additional certificates are not a recognised means to prove compliance. Consequently, they have no value in the case of checks by market surveillance authorities or customs. However, an exception arises in instances where voluntary certification is outlined in specific legislation. In such cases, while the certificate is not obligatory, it must adhere to explicit requirements if chosen to be acquired.
Voluntary certificates can create the impression that the product conforms with applicable EU harmonisation legislation, although such certificates are not issued by an authorised body.
Voluntary certificates must not be confused with third-party conformity assessment certification by notified bodies within the area for of competence for which they are notified, due to the use of terms such as ‘certification’ or ‘independent third party’ or the presence of the CE marking on the certificate.
CE marking can only be affixed after testing the product and performing the conformity assessment procedure prescribed by the applicable EU harmonisation legislation. It is not acceptable for voluntary certificates to bear a CE marking.