Regulation (EU) 2016/425 on personal protective equipment

What it is

to lay down requirements for the design and manufacture of personal protective equipment (PPE) in order to ensure the health and safety protection of users and rules on its free movement in the Union. PROPOSED ACT: Regulation of the European Parliament and the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Directive 89/686/EEC on personal protective equipment was adopted on 21 December 1989 and became fully applicable as from 1 July 1995. It sets out basic requirements that PPE must comply with in order to be made available on the EU market. The Committee on the Internal Market and Consumer Protection adopted the report by Vicky FORD (ECR, UK) on the proposal for a regulation of the European Parliament and of the Council on personal protective equipment. The committee recommended that Parliament’s position adopted at first reading following the ordinary legislative procedure should amend the Commission proposal as follows: Purpose and scope : the Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is being made available on the market in order to ensure the protection of users and rules on its free movement in the Union. Amendments aiming to include in the scope of the Regulation equipment to protect against oxygen deficiency (e.g. diving equipment), chemicals, biological agents and radiation/radioactive contamination, laser radiation and radioactive contamination, and explosive fragments are now inserted into Annex I, Category III. designed to be used for self-defence, with the exception of PPE intended for sporting activities; intended for private use to protect against: (i) damp and water not of an extreme nature; (ii) heat, for which the economic operator does not explicitly describe and market the products as having a protective function; in the form of clothing intended for private use, with reflective or fluorescent garments which are exclusively included for reasons of design or decoration, and for which the economic operator does not describe and market the products as having a protective function; designed and placed on the market as artisanal products which are decorative in nature. Definitions: Members wanted to see more specific technical provisions, regarding: connection systems as items essential to the PPE's function; adding a definition of 'demonstration' and 'field test' and permitting field testing to take place. Field tests should not be designed to test the protection performance of the PPE but to evaluate other non-protective aspects such as comfort, ergonomics and design. Obligations of economic operators (manufacturers, importers, distributors): keep the technical documentation and the EU declaration of conformity for at least five years after the PPE has been placed on the market (rather than 10 years as proposed by the Commission); ensure that instructions , as well as any labelling, are clear, understandable and intelligible; ensure that performance as recorded during relevant technical tests to check the levels of…

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