Ensuring safe personal protective equipment for users

Regulation (EU) 2016/425 — safe personal protective equipment

It lays down requirements for the design and manufacture of personal protective equipment* (PPE).
These aim to ensure the health and safety of users and to allow the equipment to be sold and used throughout the European Union (EU).
It replaces earlier legislation (Council Directive 89/686/EEC).

Key Points

Personal protective equipment may only be sold and used if it:
complies with the regulation, when properly maintained and used for its intended purpose, especially the Annex II setting out the essential health and safety requirements;
does not endanger the health or safety of people, pets or property.

Manufacturers must:
ensure PPE items are designed and made according to the legislation;
subject each PPE to the relevant conformity assessment procedure;
keep relevant technical documentation and the EU conformity declaration for 10 years;
carry out sample testing of PPE and, if necessary, keep a register of complaints, non-conforming PPE and PPE recalls;
give details, such as the registered trade name and their postal address, on PPE packaging or accompanying documents;
provide easily understood instructions for use and safety instructions;
inform national authorities immediately where the PPE presents a risk.

Obligations are placed on importers and distributors to ensure that the PPE satisfies the EU’s standards.

Different conformity assessment procedures are carried out by national conformity assessment bodies depending on which of the 3 categories of risk the PPE is intended to protect users against:
category I — minimal risks;
category II — risks not included in categories I or III;
category III — very serious risks such as death or irreversible damage to health.
EU countries inform the European Commission of the various bodies which are authorised to carry out the conformity assessment tests.

The Commission organises exchange of experience between national authorities.

The legislation does not apply to personal protective equipment used:
by the armed forces or for the maintenance of law and order;
for self-defence, except for sporting activities;
privately to protect against weather conditions that are not extreme; damp and water during dishwashing;
on seagoing vessels or aircraft subject to the relevant international treaties;
by drivers and passengers of motorcycles and mopeds (protective helmets and visors).
EU countries must have penalties in place for any violations of the law by 21 March 2018.

Application & Background

It applies from 21 April 2018, apart from certain articles dealing largely with notification bodies and procedures. These apply from 21 October 2016.

For more information, see:

‘Personal protective equipment (PPE)’ on the European Commission’s website.
Following the COVID-19 outbreak and introducing measures to cope with the impact of the crisis, the European Commission adopted:

Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
Commission Implementing Decision (EU) 2020/668 of 18 May 2020 on the harmonised standards for personal protective equipment drafted in support of Regulation (EU) 2016/425 of the European Parliament and of the Council


Personal protective equipment: equipment designed and manufactured to be worn or held by a person to protect them against one or more risks to their health and safety.


Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, pp. 51–98)


Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, pp. 18–38)

Successive amendments to Directive 89/686/EEC have been incorporated in the basic text. This consolidated version is of documentary value only


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