Personal Protective Equipment: Impact Assessment and Proposal for a Regulation

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1 Personal Protective Equipment: Impact Assessment and Proposal for a Regulation Luis Filipe Girão European Commission DG Enterprise and Industry Unit F5 Engineering Industries ppe@ec.europa.eu entr-engineering-industries@ec.europa.eu

2 Impact Assessment: review process 2010: launch external study 2011 (April-June): launch public consultation : discussions within the PPE Directive Working Group, including participation of standardisation organisations, notified bodies, industry and consumers representatives 2012: complementary study (focused on analysing the competitiveness impacts of the envisaged changes) 2013 (19 June): opinion of the Commission Impact Assessment Board 2014 (27 March): formal adoption of the Commission Proposal for a Regulation of the European Parliament and of the Council on personal protective equipment

3 Impact Assessment: main issues A. Alignment to the New Legislative Framework (NLF) Regulation (EC) No 765/2008 and Decision 768/2008/EC: simplification and harmonisation of current legislation especially regarding definitions, obligations of economic operators, conformity assessment, notified bodies etc. Many of the general problems identified by the NLF, observed also in the context of implementing the PPE Directive: level of protection, notified bodies, etc. Need to carry out the alignment to the NLF for the PPE Directive too, as for other European harmonisation legislation to ensure better overall coherence of EU product legislation

4 Impact Assessment: main issues B. Extension of the product coverage Products on the market providing for a protective function to the user, but not covered by the PPE Directive when designed for private use e.g. oven gloves, dish-washing gloves When intended for professional use, the same type of products is subject to the PPE Directive More potentially exposition to injuries and problems to Market Surveillance authorities Need to apply similar health and safety requirements to similar products

5 Impact Assessment: main issues C. Inconsistency in classification of PPE PPE certification classification: Category I, II and III The list of PPE subject to the most stringent conformity assessment procedure (Category III) misses PPE that fits the definition of Category III, i.e. PPE designed to protect against serious risks Need to add some types of PPE to the list of products of Category III: life jackets, bullet-resistant and knife stab-resistant PPE and PPE for protection against cutting by hand-held chain saws, against high pressure cutting and against noise

6 Impact Assessment: main issues D. Change of three basic health and safety requirements (BHSR) Three requirements of the PPE Directive (Annex II) have shown to be impracticable or confusing: - BHSR for protection against mechanical vibrations - BHSR 3.5 for protection against harmful effects of noise - BHSR for protection against non-ionizing radiation Need to adapt requirements to prevent possible partiality, irrelevance and sources of confusion for manufacturers

7 Impact Assessment: main issues E. Change of the requirements to specific documents in the PPE Directive Unclear and ineffective requirements for the validity and content of: - the Technical File - the EC Type-examination Certificate - the EC Declaration of Conformity Need to change the requirements to improve clarity and manageability of such documents

8 Impact Assessment: policy options and preferred solution Policy options considered for each respective problem: - the "Do nothing" as baseline option - the "Soft law" option as non-legislative alternative, including changes in guidance texts - the "Legislative" option including changes in the legal text Preferred solution: the "Legislative" option for all the problems - Legislative measures deliver the most positive impact and fully met the specific objectives, providing for improvement of the health and safety, legal certainty, consistency in the requirements and the best improvement of the market surveillance work

9 Regulation as the legal instrument chosen Proposal to change the Directive into a Regulation: - Simplification: no need of 28 national transposition acts; a single text throughout the EU for all the economic operators - Legal certainty: keep total harmonisation, avoid the risk of "gold plating" in the area of internal market legislation - No conflict with the subsidiarity principle (Art. 114 TFUE) - No change in the regulatory approach: full preservation of the characteristics of the New Approach

10 Legislative Proposal: structure in Chapters and Annexes Keeping the structure of a typical internal market harmonisation legislation, with 7 Chapters (42 Articles) and 11 Annexes: Chapter I - General provisions Chapter II - Obligations of economic operators Chapter III - Conformity of the PPE Chapter IV - Conformity assessment Chapter V - Notification of conformity assessment bodies Chapter VI - Delegated and implementing acts Chapter VII - Final and transitional provisions Annex I - Risk Categories for PPE Annex II - Essential health and safety requirements Annex III - Technical documentation for PPE Annex IV to VIII - Modules A, B, C, F and D Annex IX and X - EU declaration of conformity Annex XI - Correlation table

11 Legislative proposal: main changes Alignment with NLF Decision 768/2008/EC on a common framework for the marketing of products, including: - the definitions set out in chapter R1 of Decision 768/2008/EC - the obligations of economic operators (manufacturers, importers, distributors) set out in chapter R2 of Decision 768/2008/EC - the obligations for the notification of conformity assessment bodies set out in chapter R4 of Decision 768/2008/EC - the modules for conformity assessment set out in Annex II of Decision 768/2008/EC

12 Legislative proposal: main changes Article 2 - Scope: - The scope is enlarged, including PPE designed and manufactured for private use protecting against heat, damp and water (e.g. oven gloves, dishwashing gloves); the relevant exclusions are removed - The other existing exclusions are kept, clarifying those regarding head, face or eye protection equipment for users of two- and three wheeled motor vehicles, which are subject to the relevant UNECE legislation

13 Legislative proposal: main changes Article 3 - Definitions: - NLF general definitions - Two specific definitions added: "Individually adapted PPE" and "Madeto-measure PPE" individually adapted PPE means PPE produced in series where each item is manufactured to fit an individual user made-to-measure PPE means PPE produced as a single unit to accommodate the special needs of an individual user according to a basic model, following the instructions of the designer of that basic model and respecting the range of permissible variations Individually adapted PPE are e.g. custom moulded ear-plugs (most parts are produced in series) Made to measure PPE are e.g. orthopaedic safety shoes, which are unique products based on a basic model

14 Legislative proposal: main changes Article 5 - Essential health and safety requirements: - EHSRs: "Essential" instead of "Basic" - Set out in Annex II Annex II - Essential health and safety requirements: - Editorial changes - Some technical changes in EHSRs 3.1.3, 3.5 and 3.9.1

15 Legislative proposal: main changes Articles 8 to 13 - Obligations of economic operators: - Mainly taken from NLF Decision 768/2008/EC for Manufacturers, Authorised Representatives, Importers and Distributors - The manufacturer of PPE must draw up a technical documentation - PPE must be accompanied by a copy of the EU Declaration of Conformity (DoC) or a simplified DoC, according to Annex IX or X respectively - Art. 8(4): Manufacturers shall ensure that procedures are in place for series production to remain in conformity with the PPE Regulation. Changes in the design or characteristics of the PPE and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account

16 Legislative proposal: main changes Article 17 - Risk Categories of PPE: - PPE Categories in the legal text: PPE shall be classified into the risk categories set out in Annex I Annex I - Risk Categories of PPE: - Simplification: only risk-based definitions and exclusive lists of risks. PPE intended to protect users against: o o o Minimal risks: Category I Other risks than Categories I and III and made-to-measure PPE: Category II Very serious risks: Category III. Some risks added, more types of PPE are subject to the most stringent conformity assessment procedure: drowning, cuts by hand held chain-saws, highpressure cutting, bullet wounds or knife stabs, harmful noise (h-l)

17 Legislative proposal: main changes Article 18 - Conformity assessment procedures: - The conformity assessment procedures to be followed (Annexes IV to VIII) depend on the Category of PPE (Annex I) - Update of the modules of the applicable conformity assessment procedures in line with the NLF Decision 768/2008/EC Annex III - Technical documentation for PPE: - Combination of NLF (modules) and the PPE Directive 89/686/EEC - No difference for categories - Made-to-measure PPE: instructions of the designer Annexes IV to VIII - Modules A, B, C, F and D: - Module B, EU Type-examination: additional requirements on the minimum content and validity of the EU Type-examination certificate (5 years); procedure for a review of the certificate; procedures for individually adapted and made-to-measure PPE

18 Legislative proposal: main changes Articles 19 to 35 - Notification of conformity assessment bodies: - Requirements for national authorities responsible for conformity assessment bodies (Notified Bodies), in line with the NLF Decision 768/2008/EC - Article 30: Challenge to the competence of notified bodies (3) Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including the withdrawal of the notification if necessary

19 Legislative proposal: main changes Articles 36 to 38 - Delegated and Implementing Acts: - The Commission is empowered to: o adopt implementing acts to ensure the uniform application of the PPE Regulation in respect of Notified Bodies that do not meet or no longer meet the requirements for their notification o adopt delegated acts in order to modify the category of a specific risk to take into account the progress of technical knowledge or new scientific evidence. So, Category changes by amending Annex I will not require to undergo a full revision procedure - A specific PPE Committee is established according to Regulation (EU) No 182/2011

20 Legislative proposal: main changes Articles 39 to 42 - Final and transitional provisions: - The current PPE Directive 89/686/EEC will be repealed and replaced by the PPE Regulation - Specific transitional provisions for products manufactured and certificates issued under the PPE Directive 89/686/EEC - Transitional period: the PPE Regulation will become applicable two years after its entry into force - But: provisions on Notified Bodies shall apply already six months after the entry into force of the PPE Regulation

21 Thank you for your attention! Contact: European Commission DG Enterprise and Industry Unit F5 Engineering Industries