Legal act: 
Regulation (EU) 2016/425

Consolidated act:
31/03/2016 (Languages available: FR, NL, SL, SV)

Scope

This Regulation contains the requirements for the design and manufacture of personal protective equipment (PPE) to be made available on the EU market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the Union.

This Regulation does not apply to PPE:

1. specifically designed for use by the armed forces or in the maintenance of law and order;
2. designed to be used for self-defence, with the exception of PPE intended for sporting activities;
3. designed for private use to protect against:
   1. atmospheric conditions that are not of an extreme nature,
   2. damp and water during dishwashing;
4. for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
5. for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.

Definitions

Making available on the market means any supply of PPE for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

Placing on the market means the first making available of PPE on the Union market.

Importer means any natural or legal person established within the Union who places PPE from a third country on the Union market.

Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes PPE available on the market.

Withdrawal means any measure aimed at preventing PPE in the supply chain from being made available on the market.

Article 15 - EU declaration of conformity

1. The EU declaration of conformity shall state that the fulfilment of the applicable essential health and safety requirements set out in Annex II has been demonstrated.
2. The EU declaration of conformity shall have the model structure set out in Annex IX, shall contain the elements specified in the relevant modules set out in Annexes IV, VI, VII and VIII and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the PPE is placed or made available on the market.
3. Where PPE is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the PPE with the requirements laid down in this Regulation.

Article 16 - General principles of the CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 17 - Rules and conditions for affixing the CE marking

1. The CE marking shall be affixed visibly, legibly and indelibly to the PPE. Where that is not possible or not warranted on account of the nature of the PPE, it shall be affixed to the packaging and to the documents accompanying the PPE.
2. The CE marking shall be affixed before the PPE is placed on the market.
3. For category III PPE, the CE marking shall be followed by the identification number of the notified body involved in the procedure set out in Annex VII or VIII. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
4. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or other marking indicating the risk against which the PPE is intended to protect.
5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

Application of the regulation

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