Regulation (EU) 2016/425 (Personal Protective Equipment)

Scope

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

For the purposes of this Regulation, the following definitions apply:
(1)    ‘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;

(2)    ‘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;
(3)    ‘placing on the market’ means the first making available of PPE on the Union market;
(4)    ‘manufacturer’ means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;
(5)    ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
(6)    ‘importer’ means any natural or legal person established within the Union who places PPE from a third country on the Union market;
(7)    ‘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;
(8)    ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
(9)    ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by PPE;
(10)    ‘harmonised standard’ means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
(11)    ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
(12)    ‘national accreditation body’ means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
(13)    ‘conformity assessment’ means the process demonstrating whether the essential health and safety requirements of this Regulation relating to PPE have been fulfilled;
(14)    ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
(15)    ‘recall’ means any measure aimed at achieving the return of PPE that has already been made available to the end-user;
(16)    ‘withdrawal’ means any measure aimed at preventing PPE in the supply chain from being made available on the market;
(17)    ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;
(18)    ‘CE marking’ means a marking by which the manufacturer indicates that PPE is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.