Regulation 2016/425 - Personal protective equipment - Main contents
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official title
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| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2016/425 |
| Original proposal | COM(2014)186  |
| CELEX number i | 32016R0425 |
| Document | 09-03-2016; Date of signature |
|---|---|
| Publication in Official Journal | 31-03-2016; OJ L 81 p. 51-98 |
| Signature | 09-03-2016 |
| Effect | 20-04-2016; Entry into force Date pub. +20 See Art 48.1 21-10-2016; Application Partial application See Art 48.2 21-03-2018; Application Partial application See Art 48.2 21-04-2018; Application See Art 48.2 |
| Deadline | 21-03-2018; See Art 45.1 |
| End of validity | 31-12-9999 |
31.3.2016 |
EN |
Official Journal of the European Union |
L 81/51 |
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
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
Council Directive 89/686/EEC (3) was adopted in the context of establishing the internal market, in order to harmonise health and safety requirements for personal protective equipment (PPE) in all Member States and to remove obstacles to trade in PPE between Member States. |
(2) |
Directive 89/686/EEC is based on the ‘new approach’ principles, as set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (4). Thus, it sets only the essential requirements applying to PPE, whereas technical details are adopted by the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (5). Conformity with the harmonised standards so set, the reference numbers of which are published in the Official Journal of the European Union, provides a presumption of conformity with the requirements of Directive 89/686/EEC. Experience has shown that those basic principles have worked well in that sector and should be maintained and even further promoted. |
(3) |
Experience with the application of Directive 89/686/EEC has shown inadequacies and inconsistencies in the product coverage and conformity assessment procedures. In order to take account of that experience and to provide clarification in relation to the framework within which products covered by this Regulation may be made available on the market, certain aspects of Directive 89/686/EEC should be revised and enhanced. |
(4) |
Since the scope, the essential health and safety requirements and conformity assessment procedures have to be identical in all the Member States there is almost no flexibility in transposing a directive based on the new approach principles into national law. Directive 89/686/EEC should therefore be replaced by a regulation, which is the appropriate legal instrument for imposing clear and detailed rules which do not give room for divergent transposition by Member States. |
(5) |
Regulation (EC) No 765/2008 of the European Parliament and of the Council (6) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. |
(6) |
Decision No 768/2008/EC of the European Parliament and of the Council (7) lays down common principles and reference provisions intended to apply across sectoral legislation. In order to ensure consistency with other sectoral product legislation, it is appropriate to align certain provisions of this Regulation to that Decision, in so far as sectoral specificities do not require a different solution. Therefore, certain definitions, the general obligations of economic operators, the presumption of conformity, EU declaration of conformity, rules on CE marking, requirements for conformity assessment bodies and notification procedures, the conformity assessment procedures and the provisions concerning procedures to... |
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