Latest update: 28/11/2023

Guide to application of Regulation EU 2016/425 on personal protective equipment

The PPE Regulation Guidelines have been issued by the EU Commission to further explain the content and procedures of Regulation (EU) 2016/425 regarding the placing on the market of personal protective equipment (PPE).

Legislative background
The guide is a manual for all parties and stakeholders affected by Regulation (EU) 2016/425 such as Member States’ competent authorities, manufacturers, trade associations and notified bodies. The Regulation contains provisions on the design and marketing of PPE. The Regulation sets out the rules for manufacturers and lays down essential health and safety requirements. The requirements are further specified by European harmonised standards. The CE marking signifies that the PPE satisfies the essential health and safety requirements. Directive 89/656/EEC stipulates minimum requirements for PPE used by workers at work and specifies employers' obligations.

Content of the guide
The guide follows the structure of the Regulation and provides for each part of the legal text explanations provided by sectorial experts. In addition, the appendix of the guide contains further information concerning categorisation of PPE, according to the level of risk the intended user is protected against. PPE are divided into three categories. Category III includes PPE that protect against the most serious risks. 

PPE and COVID-19 pandemic
During the COVID-19 pandemic efforts were made to increase the manufacturing and distribution capacity especially with regard to face masks. The EU Commission has issued additional guidance for manufacturers, namely the guide Conformity assessment procedures for protective equipment. It details applicable EU legal frameworks (PPE Regulation and Regulation (EU) 2017/745 on medical devices) and steps that manufacturers need to take to place their products on the EU market. The EU Commission has also issued a recommendation on this topic: Commission Recommendation (EU) 2021/1433 of 1 September 2021 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.

Publication details
Published by: EU Commission, DG Internal Market, Industry, Entrepreneurship and SMEs
Publication date: October 2023 (3rd edition)
Number of pages: 176 pp.

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