BETA

Awaiting Parliament 1st reading / single reading / budget 1st stage



Activites

  • 2016/01/20 Vote in plenary scheduled
  • 2016/01/19 Debate scheduled
  • 2015/04/30 Committee report tabled for plenary, 1st reading/single reading
    • A8-0148/2015 summary
  • 2015/04/23 Committee decision to open interinstitutional negotiations with report adopted in committee
  • 2015/04/23 Vote in committee, 1st reading/single reading
  • #3353
  • 2014/12/04 Council Meeting
  • 2014/10/20 Committee referral announced in Parliament, 1st reading/single reading
  • 2014/04/02 Committee referral announced in Parliament, 1st reading/single reading
  • 2014/03/27 Legislative proposal published
    • COM(2014)0186 summary
    • DG {'url': 'http://ec.europa.eu/enterprise/', 'title': 'Enterprise and Industry'}, TAJANI Antonio

Documents

  • Legislative proposal published: COM(2014)0186
  • Debate in Council: 3353
  • Committee report tabled for plenary, 1st reading/single reading: A8-0148/2015
AmendmentsDossier
209 2014/0108(COD)
2015/03/03 IMCO 92 amendments...
source: 549.462
2015/03/04 EMPL 117 amendments...
source: 549.449

History

(these mark the time of scraping, not the official date of the change)

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2.10.03 Standardisation, EC standards and trademark, certification, compliance
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2015-10-27T00:00:00
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  • 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.

    Excluded from the scope of the legislation are PPE:

    • 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):

    Manufacturers should:

    • 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 classes of protection provided by the PPE is available electronically or upon request.

    Manufacturers should include with the EPP either the simplified EU declaration of conformity or include in the instructions or information leaflet the web site address where the EU declaration of conformity might be seen.

    Importers should:

    • indicate, on the PPE their contact details in the official language or languages of the Member State(s) in which the PPE is to be marketed;
    • ensure that PPE is accompanied by the instructions and safety information in a language which can be easily understood by consumers;
    • with regard to the risks presented by PPE, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.

    Members stressed that importers and distributors should immediately inform the manufacturer and the competent national authorities if they have reason to believe that PPE that they have placed on the market is not in conformity with the Regulation.

    Examination certificate: the PPE should be examined on the basis of the latest scientific evidence. The maximum period of validity of the EU type-examination certificate should be five years and a process for reviewing the certificate should be provided. Following a positive review, a renewed certificate may continue to be valid for further periods, each of which should be for a maximum of five years.

    Presumption of conformity: unless otherwise provided for by Union harmonisation legislation, the withdrawal of a harmonised standard shall not invalidate existing certificates issued by notified bodies. Products produced in accordance with the existing certificate shall still benefit from continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies.

    CE marking: the CE marking and, where applicable, the identification number of the notified body may be accompanied by a pictogram or other marking indicating the risk against which the PPE is intended to protect. 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.

    Notification of conformity assessment bodies: accreditation should be the general rule for notified bodies. Members also stipulated that:

    • Member States must notify manufacturers if a notified body has ceased activity;
    • any appeal procedure must be transparent and accessible.

    Market surveillance: noting that the existing PPE legislation is in need of updating in line with the New Legislative Framework (NLF) on regulation of goods, Members introduced a new Chapter that will take into account: the requirements of the market surveillance regulation when the latter has been finalised; Union market surveillance and control of products entering the Union market; procedure applicable to PPE presenting a risk at national level, safeguard measures, etc.

    Requirements for employers: Members clarified the requirements for employers who provide PPE to their employees. Accordingly, employers shall provide PPE that complies with the relevant Union provisions on design and manufacture with respect to safety and health.

activities/5/docs
  • url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2015-0148&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A8-0148/2015
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CELEX:52014PC0186:EN
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CELEX:52014PC0186:EN
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  • PURPOSE: 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 PPE Directive applies to PPE that is defined as “any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards”.

    While the directive has successfully achieved its objectives in creating a single market and ensuring a high level of protection for users of PPE, certain problems have been encountered in its implementation. These concern products on the market that do not ensure an adequate level of protection, diverging approaches of the notified bodies, the effectiveness of the market surveillance as well as risks related to protective equipment which is currently not covered by the PPE Directive.

    The proposal modifies and clarifies a number of the provisions of the existing Directive and aligns it with the provisions of Decision No 768/2008/EC establishing a common framework for the marketing of products (NLF Decision). The Commission has already proposed the alignment of nine Directives to the NLF Decision within an NLF implementation package adopted on 21 November 2011.

    IMPACT ASSESSMENT: the preferred option consists of amending the PPE Directive as it: (i) lead to an improved level of protection of the health and safety of the users; (ii) ensures a more effective work of the market surveillance authorities and consequently reduces the non-compliant products; (iii) does not entail significant costs for economic operators and notified bodies.

    CONTENT: this proposal intends to replace Directive 89/686/EEC on personal protective equipment by a Regulation. Its general objectives are to ensure a high level of protection of human health and safety whilst guaranteeing fair competition for economic operators on the Union market and simplifying the regulatory environment in this area.

    The proposal also clarifies a number of provisions of the existing Directive and aligns it with those of the Decision No 768/2008/EC establishing a common framework for the marketing of products (decision on the new legislative framework).

    Scope: the Commission proposes to enlarge the scope of the current PPE Directive by deleting the exclusions of PPE designed and manufactured for private use against heat, damp and water. The proposal keeps the other existing exclusions and clarifies that it does not apply to PPE for head, face or eye protection, subject to the relevant UNECE Regulation, of users of two- or three-wheeled motor vehicles.

    Two PPE specific definitions have been added in order to clarify the applicable conformity assessment procedures: “Individually adapted PPE” and “Made-to-measure PPE”.

    Making available on the market, free movement, obligations of economic operators, CE marking: the proposal:

    • contains the typical provisions for product-related Union harmonisation legislation and sets out the obligations of the relevant economic operators (manufacturers, authorised representatives, importers and distributors), in accordance with the NLF Decision;
    • obliges the manufacturer of PPE to draw up a technical documentation and to ensure that the PPE is accompanied by a copy of the EU declaration of conformity or a simplified EU declaration of conformity.

    Notified bodies: the proposal sets out requirements for national authorities responsible for conformity assessment bodies (notified bodies). It leaves the ultimate responsibility for designating and monitoring notified bodies with the individual Member State.

    Categories and Conformity assessment: the proposal simplifies the definition of the categories of PPE. The category only depends on the risk against which the PPE is intended to protect. Provisions are set out for made-to-measure PPE. PPE intended to protect the user against drowning, cuts by hand-held chain-saws, high-pressure cutting, bullet wounds or knife stabs, and harmful noise are subject to the most stringent conformity assessment procedure.

    Minor amendments have been made which change marginally three essential health and safety requirements (EHSR) in order to remove requirements shown to be impracticable or that create confusion.

    Application: the proposed Regulation will become applicable two years after its entry into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements. However, the designation of notified bodies pursuant to the new requirements and process needs to start shortly after the entry into force of this Regulation.

    Transitional provisions are foreseen for products manufactured and the certificates issued by notified bodies under Directive 89/686/EEC so as to allow stocks to be absorbed and ensure a smooth transition to the new requirements.

    DELEGATED ACTS: this proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.

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  • body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL
  • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
  • body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
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EMPL
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  • date: 2014-03-27T00:00:00 docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2014&nu_doc=0186 celexid: CELEX:52014PC0186:EN type: Legislative proposal published title: COM(2014)0186 body: EC type: Legislative proposal published commission: DG: url: http://ec.europa.eu/enterprise/ title: Enterprise and Industry Commissioner: TAJANI Antonio
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committees
  • body: EP responsible: False committee_full: Employment and Social Affairs committee: EMPL
  • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
  • body: EP responsible: True committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
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European Commission
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Repealing Directive 89/686/EEC
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Legislation
title
Personal protective equipment
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COD - Ordinary legislative procedure (ex-codecision procedure)
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