EN Official Journal of the European Union C 451/76

Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council on personal protective equipment

COM(2014) 186 final — 2014/0108 (COD)

(2014/C 451/12)

Rapporteur: Ms Butaud-Stubbs

On 2 April 2014 and 24 April 2014 respectively, the European Parliament and the Council decided to consult the European Economic and Social Committee, under Article 114 of the Treaty on the Functioning of the European Union, on the:

Proposal for a Regulation of the European Parliament and of the Council on personal protective equipment.

COM(2014) 186 final — 2014/0108 (COD).

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 23 June 2014.

At its 500th plenary session, held on 9 and 10 July 2014 (meeting of 9 July), the European Economic and Social Committee adopted the following opinion with 191 votes in favour and two abstentions.

1. Conclusions and recommendations

1.1 The EESC supports the European Commission's aim of replacing the 1989 directive on personal protective equipment, i.e. ‘any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards’ (PPE Directive) by a regulation in order to ensure uniform and compulsory application in all the Member States.

1.2 The EESC feels that most of the proposed changes are positive: — alignment of product legislation with a common framework, — clarification of the responsibilities of all private- and public- sector operators involved in procedures to verify PPE compliance with the requirements set out in the proposal for a regulation and its annexes, — introduction of two new categories of PPE: made-to-measure and individually adapted PPE, — the new period of five years for the validity of certificates of conformity.

1.3 However, the EESC questions whether some of the proposed changes are necessary: — inclusion of products for private use providing protection against heat, damp and water, — the variety of language requirements for different types of information that have to be communicated,

1.4 The EESC also considers that PPE use should be integrated into a general policy on risk prevention at work. In particular, such a policy could cover the following aspects: — accurately identifying risk factors, — adapting work stations in order to reduce exposure to risks, — changing the way in which work is organised, — training employees in risk prevention, ergonomics, and the wearing and use of PPE.

1.5 Indeed, all of these objectives are central to the new 2014-2020 strategic European framework on health and safety at work adopted on 6 June 2014, and it would be good if the proposal for a Regulation set out in COM(2014) 186 final mentioned this. It should be remembered that 3 million employees were victims of a serious accident at their workplace in 2013.

1.6 It is also a pity that there is no discussion at all of the economic aspects of the growing European PPE market, estimated at EUR 10 billion in 2010. This is a technologically innovative (new fibres, smart textiles, nanomaterials, etc.) market geared not only to meeting protection needs but also social expectations that equipment must be comfortable, easy to walk in, light and aesthetically appealing.

1.7 The EESC is also disappointed that PPE maintenance, checking and review procedures do not take account of the case of PPE used by several persons or second-hand PPE.

2. Content of the proposal for a regulation

2.1 Strong points and limitations of the 1989 directive

2.1.1 The proposal for a regulation of the European Parliament and the Council is based on Article 114 TFEU with the objective of overcoming shortcomings in the functioning of the internal market for personal protective equipment.

2.1.2 Directive 89/686/EEC on personal protective equipment was adopted on 21 December 1989 and became fully applicable as from 1 July 1995.

2.1.3 The directive defines PPE as ‘any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards’.

2.1.4 It describes the essential safety requirements which PPE has to meet before being put on the market and freely circulating on the Single Market. PPE must be designed and manufactured in compliance with the requirements of the directive. Manufacturers must affix the CE marking and provide users with instructions for storage, use, cleaning, maintenance, servicing and disinfection of the PPE.

2.1.5 Since 1995, there have been certain difficulties in connection with implementing the directive: — differences of interpretation in national transposals of the directive, leading to fragmentation of the Single Market, — poor understanding among manufacturers and notified authorities of certain provisions, — exclusion of certain categories of PPE, not always for obvious reasons (a given item is considered to be PPE when used by a professional (e.g. gloves used for dishwashing in a restaurant) but not by a private individual).

2.1.6 Furthermore, the European Commission has set itself the objective of simplification, and would like to align the 1989 directive with the new legislative framework establishing a common foundation for EU product harmonisation legislation.

2.2 Content of the proposal for a regulation

2.2.1 Revised scope of application

2.2.1.1 PPE designed and manufactured for private use against heat, damp and water in non-extreme conditions is now included (e.g. dishwashing gloves, oven gloves, rubber boots). At the same time, safety helmets for users of two- or three-wheeled motor vehicles are now excluded, as they fall within the scope of a UN Economic Commission for Europe regulation.

2.2.2 Alignment with the usual provisions of EU product harmonisation legislation

2.2.2.1 The obligations of all economic operators concerned — manufacturers, agents, importers and distributors — are defined in line with the provisions of EU product harmonisation legislation. Indeed, since 2008 the new legislative framework has been a cross-sectoral Internal Market instrument, intended to make EU product safety legislation (Regulation (EC) No 765/2008 on accreditation and market surveillance and Decision No 768/2008/EC establishing a common framework for the marketing of products) more effective.

2.2.3 Compliance evaluation procedures reorganised according to class of risk

2.2.3.1 PPE is divided into three risk categories, each with its own specific certification procedure.

Risk categories Certification procedures Examples Category I Minimal risks, arising from superficial mechanical injury, contact with water or hot surfaces (not exceeding 50 oC), exposure to sunlight and to atmospheric conditions that are not of an extreme nature Self-certification Internal production control (module A — Annex IV) Dishwashing gloves, oven gloves, sunglasses, etc. Category II PPE protecting users against risks other than minimal (Category I) and very serious (Category III) Made-to-measure PPE unless intended for protection from minimal risks EU type-examination (module B — Annex V) Conformity to type based on internal production control (Module C — Annex VI) Safety helmets, high-visibility clothing, etc. Category III Very serious risks, arising from harmful substances, aggressive chemicals, ionising radiation, high-temperature environments (over 100 oC), low-temperature environments (less than 50 oC), falling from a height, electric shocks and live working, drowning, cuts by chainsaws, high-pressure cutting, bullet wounds or knife stabs, harmful noise, etc. EU type-examination (Module B — Annex V) + complementary procedure with involvement of a notified body: — either conformity to type based on product verification (Module F — Annex VII), — or conformity to type based on quality assurance of the production process (module D — Annex VIII) — Number of the notified body Respiratory protection equipment, PPE to prevent falling from a height, etc.

2.2.3.2 Some new risks have been added to Category III, such as risk of injury from knife stabs and harmful noise.

2.2.3.3 It is unclear how individually adapted PPE as defined in Article 3 is to be dealt with: what risk category does it relate to, and therefore which certification procedure is applicable?

2.2.4 Limiting the validity of the certificate of conformity to 5 years

2.2.4.1 This is a major change made in response to requests by inspection authorities in some Member States which had detected PPE on their markets with certificates remaining valid despite major changes to standards (for example in the case of lifejackets).

2.2.5 Clarifying basic health and safety requirements

2.2.5.1 The regulation deletes sections with requirements relating to three types of risks which have been found to be either irrelevant or confusing:

— protection against mechanical vibration (section 3.1.3),

— protection against the harmful effects of noise (section 3.5),

— protection against non-ionising radiation (section 3.9.1).

2.2.6 Closer supervision of notified bodies

2.2.6.1 Member States are to be given stronger supervisory powers over notified bodies. They can object to notification of bodies which have not been active for several years, which are unlikely to have sufficient human and technical resources to issue certificates, or which have issued certificates of conformity for non-compliant PPE in the past.

2.2.7 A transition period after entry into force

2.2.7.1 There is a two-year period after the regulation enters into force to allow manufacturers, notified bodies and Member States time to adapt to the new requirements.

3. General comments

3.1 Is it feasible to include PPE for private use providing protection against minor risks such as water or damp? How will consumers be made aware of this? It might make sense to specify the conditions for CE marking (legibility, format, etc.), for example in line with the existing specifications for labelling, composition and maintenance instructions for textiles in all private-use PPE for sale, hire or loan. Will these new requirements mean higher prices?

3.2 It is a pity that the text fails to mention technological progress, a particular feature of the sector in areas such as textile fibres and materials (Teflon, latex, neoprene, nitrile, etc.), coating and filtration technology, as well as integrated micro-electronic sensors able to transmit information or energy (smart textiles) enabling superior risk protection performance.

3.3 Nor is there any mention of this market's potential for European PPE sectors (textiles, clothing, footwear, accessories), despite the fact that in 2007 the European Commission identified it as a lead industrial market.

3.4 In addition, the proposal for a regulation does not sufficiently address human aspects. PPE use should ideally be preceded by employee information and training sessions in order to raise awareness of risk, usage requirements, instructions and essential information. Pilot and test periods are also needed to adapt PPE to user morphology and work-stations (Annex II, Article 1.3 to be completed, above all on the basis of input from national experience).

3.5 It is true that all of these aspects are relevant to the proposal for a Directive on health and safety of 12 June 1989 (89/391/EEC), intended to improve health and safety at work, which sets out employers' obligations together with employees' rights and duties.

3.6 PPE policy is part of a general policy on reducing exposure to risks at company or sector level. Such a policy should build on accurate identification of risk factors, listing the steps needed to reduce or eliminate such factors, such as considering the option of air filtration systems before using respiratory equipment. Collective risk-prevention solutions should always be considered before resorting to individual protection solutions.

3.7 Risk evaluation should always be carried out in partnership with a company's in-house stakeholders such as staff representatives, staff representation bodies, health and safety committees, etc., as well as external partners such as occupational medicine specialists, consultants and public authorities responsible for improving working conditions.

3.8 Particular attention should be paid to PPE maintenance, checking and review procedures to ensure that this equipment provides the highest possible level of protection from the risks which they were designed for. Maintenance includes inspection, care, cleaning, repair and suitable storage.

3.9 The proposal for a regulation only partially addresses cases of exposure to multiple risks.

3.10 It does not cover the issue of PPE used by several different people (e.g. safety helmets on building sites). Hygiene specifications should be defined.

3.11 Nor does the proposal for a regulation discuss the issue of persons whose capacity to wear PPE is limited — for medical reasons, in the case of some employees. In such rare but genuinely existing cases, how do employers meet their obligation to ensure general safety? e.g. assigning the employee concerned to another post, workstation adaptation.

3.12 The case of second-hand PPE is not dealt with in the text, even though according to certain national sources this market is flourishing, in particular for Category I equipment, due to the economic crisis which has severely affected the sectors where PPE is used most intensively (construction, public works, transport, etc.).

4. Specific comments

4.1 Text of the proposal for a regulation, recital 24: setting the period of validity of PPE certificates of conformity at a maximum of five years makes it possible to ensure that examinations are carried out on the basis of the latest scientific knowledge available, which fits in fully with the prevention and worker health and safety improvement goals targeted by framework directive 89/391 of 12 June 1989. A simplified procedure is envisaged for cases in which standards have not significantly changed.

4.2 Article 3: it would be useful to add definitions here of ‘second-hand PPE’, the ‘market surveillance authorities’ mentioned in articles 11 and 13, and the ‘notifying authorities’ responsible at national level for notification of the bodies authorised to carry out checks on PPE compliance.

4.3 Article 8.3: the requirement to keep technical documentation for 10 years seems excessive, especially given that the certificate of conformity is only valid for five years. Why not set the same five-year validity period for both?

4.4 Articles 8.3, 8.7 and 8.10, Article 9.2 a), Article 10.3, 10.4 and 10.7, Article 11.2, Article 13, Article 15.1, Article 15 (15.2 and 15.3) and Annex II, point 2.12 set different language requirements for the various documents relating to PPE and their compliance with the applicable procedures.

— The text mentions ‘a language which can be easily understood by end-users’, which is an expression from ECJ case law, but is rather subjective.

— The language issue is also mentioned in point 2.12 of Annex II: ‘The identification markings (...) must be written in the official language(s) of the Member State where the equipment is to be used’.

— whereas in Article 15 (15.2 and 15.3) we have ‘the official language(s) of the Member State of destination’, which from a legal point of view is the most precise wording.

The EESC understands the reasons behind the decision to have three separate sets of language requirements, but for the sake of simplification suggests that only the wording of the third option should be used.

4.5 Article 15.3: the expression ‘continuously updated’ is liable to be interpreted in different ways at national level. Why not specify this, for example by having annual updating?

4.6 Article 42: the proposed period of two years after entry into force is certainly short in view of the numerous changes that will have to be made, especially in Member States with weaker administrative structures (re-notification of all notified bodies throughout the 28 Member States, changing the validity period of certificates of conformity), but necessary in respect of prevention and working condition improvement goals, particularly as regards the reduction of accidents at work.