REGULATION (EU) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC
This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the 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.
1.This Regulation applies to PPE.
2.This Regulation does not apply to PPE:
(a) specifically designed for use by the armed forces or in the maintenance of law and order; (b) designed to be used for self-defence, with the exception of PPE intended for sporting activities;
(c) designed for private use to protect against:
(i) atmospheric conditions that are not of an extreme nature,
(ii) damp and water during dishwashing;
(d) for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
(e) 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 of PPE
‘personal protective equipment’ (PPE) means:
(a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;
(b) interchangeable components for equipment referred to in point (a) which are essential for its protective function;
(c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;
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.
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.
Risk categories of PPE
The PPE shall be classified according to the risk categories set out in Annex I.
Conformity assessment procedures
The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows:
(a) Category I: internal production control (module A) set out in Annex IV;
(b) Category II: EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI;
(c) Category III: EU type-examination (module B) set out in Annex V, and either of the following:
(i) conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII;
(ii) conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.
By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.
Annex I Risk categories of PPE
ANNEX II ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
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