Explanatory Memorandum to COM(2014)186 - Personal protective equipment - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2014)186 - Personal protective equipment. |
|---|---|
| source | COM(2014)186  |
| date | 27-03-2014 |
Directive 89/686/EEC on personal protective equipment was adopted on 21 December 1989 and became fully applicable as from 1 July 1995.
Directive 89/686/EEC (PPE Directive) ensures the free movement of personal protective equipment (PPE). It has contributed considerably to the completion and operation of the Single Market with regard to PPE. It permits the free movement of PPE covered by its scope in Europe while ensuring a high level of protection for its user.
The PPE Directive sets out basic requirements, that PPE must comply with in order to be made available on the EU market. PPE must be designed and manufactured in compliance with the provisions of the Directive. Manufacturers must also affix the CE marking and provide users with instructions for storage, use, cleaning, maintenance, servicing and disinfection of the PPE.
The PPE Directive is based on Article 114 of the Treaty on the Functioning of the European Union and is one of the first harmonisation Directives based on the “New Approach” principles, according to which manufacturers must ensure compliance of their products with the essential health and safety requirements provided for in the legislative instrument. The essential requirements are performance based, without imposing specific technical solutions or specifications.
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”. It also covers “interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment” and “any system placed on the market in conjunction with PPE for its connection to another external, additional device”. Examples of PPE are safety helmets, ear muffs, safety shoes, life jackets but also bicycle helmets, sunglasses and high-visibility vests.
Certain types of PPE are excluded from the scope of the PPE Directive, namely PPE specifically designed and manufactured for use by armed forces or in the maintenance of law and order, PPE for self-defence, PPE designed and manufactured for private use against atmospheric conditions, damp, water and heat, PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time and helmets and visors intended for users of two- or three-wheeled motor vehicles.
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. Furthermore some provisions of the PPE Directive should be made clearer and simpler.
This proposal intends to replace Directive 89/686/EEC on personal protective equipment by a Regulation, in line with the Commission’s simplification objectives.
The overall objectives of this initiative are to better protect the health and safety of PPE users, to ensure a level playing field for PPE economic operators within the internal market and simplify the European regulatory environment in the field of PPE. 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).
More specifically, it is proposed to slightly enlarge the scope of the current PPE Directive by removing the exclusions of products for private use providing protection against heat, damp and water. Experience with the implementation and enforcement of the PPE Directive showed that these exclusions were no longer justified. In order to improve the health and safety of the users, the requirements of the PPE Directive and hence of this proposal should apply to these products. Clarifications were introduced in order to reduce interpretation, e. g. concerning provisions for made-to-measure and individually adapted PPE. The list of the products subject to the most stringent conformity assessment procedure was revised in order to remove inconsistencies. Documentary requirements were changed in order to improve the work of the market surveillance authorities and minor changes to three essential health and safety requirements were introduced in order to remove sources of confusion.
The proposal also intends to align the PPE Directive to the NLF Decision. Many of the general problems identified at horizontal level have also been observed in the context of implementing the PPE Directive (PPE placed on the market that does not ensure an adequate level of protection, problems with the quality of the services delivered by some notified bodies, different practices in the Member States as regards the evaluation and monitoring of notified bodies). A number of manufacturers are also faced with the problem of the legal framework being complex and sometimes inconsistent. The alignment of the PPE Directive with the NLF responds to the political commitment laid down in Article 2 of the NLF Decision.
The NLF Decision sets out a common framework for EU product harmonisation legislation. This framework consists of the provisions which are commonly used in EU product legislation (e.g. definitions, obligations of economic operators, notified bodies, safeguard mechanisms, etc.). These common provisions have been reinforced to ensure that the legislation can be applied and enforced more effectively in practice. New elements, such as obligations of importers, have been introduced, which are crucial for improving the safety of products on the market.
The Commission has already proposed the alignment of nine Directives to the NLF Decision within an NLF implementation package adopted on 21 November 2011.
In view of ensuring consistency across Union harmonisation legislation for industrial products, in accordance with the political commitment resulting from the adoption of the NLF Decision and the legal obligation provided for in Article 2 of the NLF Decision, it is necessary that this proposal is in line with the provisions of the NLF Decision.
The proposal takes into account Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council.
The proposal also takes into account the proposal of the Commission of 13 February 2013 for a Regulation on market surveillance of products, which intends to set out a single legal instrument on the market surveillance activities in the field of non-food goods, consumer or non-consumer products and products covered or not by Union harmonisation legislation. The proposal merges the rules on market surveillance of Directive 2001/95/EC on general product safety[5], Regulation (EC) 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and of sector-specific harmonisation legislation in order to increase the effectiveness of market surveillance activities within the Union. The proposed Regulation on market surveillance of products contains also the relevant provisions on market surveillance and safeguard clauses. Therefore, provisions in existing sector specific harmonisation legislation that relate to market surveillance and safeguard clauses should be removed from that harmonisation legislation. The overacting objective of the proposed Regulation is to simplify the Union market surveillance framework fundamentally so that it works better for its main users: market surveillance authorities and economic operators. The current PPE Directive provides for a safeguard clause procedure. In line with the framework intended to be established by the proposed Regulation on market surveillance of products, this proposal for a Regulation on PPE does not include the provisions on market surveillance and safeguard clause procedures for PPE provided for in the NLF Decision. However, in order to ensure legal clarity, it makes a reference to the proposed Regulation on market surveillance of products.
This initiative is in line with the Single Market Act[7], which stressed the need to restore consumer confidence in the quality of products on the market and the importance of reinforcing market surveillance.
Furthermore it supports the Commission’s policy on Better Regulation and simplification of the regulatory environment.
This proposal does not change the relationship to the Directive 89/656/EEC[8] of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 of Directive 89/391/EEC).
Contents
- RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- General context, reasons for and objectives of this proposal
- Consistency with other policies and objectives of the Union
- Consultation of interested parties
- Collection and use of expertise - Impact assessment
- 3.1. Scope and definitions
- 3.2. Making available on the market, free movement, obligations of economic operators, CE marking
- 3.3. Notified bodies
- 3.4. Categories and Conformity assessment
- 3.5. Essential health and safety requirements
- 3.6. Implementing acts
- 3.7. Delegated acts
- 3.8. Final provisions
- 3.10. Union competence, legal basis, subsidiarity principle and legal form
- Subsidiarity principle
- Proportionality
- Legislative technique used
- 5. OPTIONAL ELEMENTS
- European Economic Area
The revision of the PPE Directive has been discussed with all stakeholders, including Member States, manufacturers' federations, notified bodies and representatives from standardisation. The consultation included meetings for a selected group of experts as well as consultation of the PPE Working Group as well as the PPE AdCo Group of market surveillance authorities.
While the success of the Directive is generally recognised a broad consensus exists among the Member States and other stakeholders that some improvements can be made, contributing to an even more effective protection of the health of the users and to a more efficient functioning of the PPE legislation including more effective market surveillance. Most of the proposed improvements result from the day to day experience of Member States authorities and other stakeholders with the enforcement and implementation of the PPE legislation and are not directly related to accidents.
From April to June 2011 a public consultation collected views and opinions of relevant stakeholders and citizens on the various issues that the revision of the PPE Directive might address. Overall 77 responses were received, 74 from the 27 Member States (authorities, enterprises, notified bodies, trade associations, individual citizens), 2 from an EFTA country and 1 from overseas. The replies provided the Commission services with a broader view on the identified policy needs and as such confirmed the envisaged approaches[9].
In general all stakeholders expressed support for the initiative. Both authorities and industry consider that the PPE legislation needs to be simplified and clarified. There is unanimity on the need to improve market surveillance and the system for assessing and monitoring notified bodies.
There is also unanimity on the need to align the PPE Directive to the NLF and thus to improve the existing general regulatory framework. Authorities fully support the exercise because it will strengthen the existing system and improve cooperation at EU level. Industry expects a more level playing field resulting from more effective actions against products that do not comply with the legislation, as well as a simplification effect from the alignment of legislation.
Furthermore Member States and stakeholders expressed their support for:
– The extension of the product coverage of the PPE Directive;
– The addition of some types of PPE to the list of products subject to the most stringent conformity assessment procedure;
– The change of three basic health and safety requirements; and
– The change of the requirements to the technical file, the validity and content of the EC type-examination certificate, and the EC Declaration of Conformity.
An impact assessment on the revision of the PPE Directive has been conducted. The impact assessment sets out extensively the different options of revision of the sector related aspects of the PPE Directive.
With regard to the NLF alignment aspects, the impact assessment report for the revision of the PPE Directive refers to the general impact assessment conducted in the framework of the NLF Implementation package of 21 November 2011[10].
In particular, the modifications due to the alignment to the NLF Decision and their impacts are expected to be the same as for the nine product harmonisation Directives included in the Alignment Package.
The Impact Assessment Report on this Alignment Package has already examined in depth the different options, which are exactly the same with regard to the PPE Directive. The Report contained also an analysis of the impacts resulting from the legislative alignment to the provisions of the NLF Decision.
Therefore, the Impact Assessment Report on the revision of the PPE Directive did not examine those aspects and it focussed on specific issues relating to the PPE Directive as well as on the ways to address them.
An external study launched and completed in 2010[11] to complement he results of the consultation .The study provides an overview of the structure of the PPE market as well as it assesses the impacts of the proposed measures.
In 2012 another complementary study was carried out. It focused on analysing the competitiveness impacts of the envisaged changes[12].
Based on the information collected, the impact assessment carried out by the Commission examined and compared three options with regard to problems and issues relating to the PPE Directive.
Option 1 – “Do nothing” - No changes to the existing situation
This option proposes no changes to the PPE Directive.
Option 2 – Intervention by non-legislative measures
Option 2 considers voluntary measures to resolve the identified issues, e.g., guidance documents containing a commonly agreed interpretation of the PPE Directive.
Option 3 – Intervention by legislative measures
This option consists in modifying the PPE Directive.
Option 3 was found to be the preferred option because:
– it is considered more effective than option 2: due to the lack of enforceability of option 2 it is questionable that the positive impacts would materialise under that option;
– it leads to an improved level of protection of the health and safety of the users in a framework of legal certainty;
– it ensures a more effective work of the market surveillance authorities and consequently reduces the non-compliant products and creates a more level playing field;
– it does not entail significant costs for economic operators and notified bodies; for manufacturers of products that are not yet covered by the PPE Directive the cost will be higher but only affect those manufacturers that do not meet the basic requirements at the moment; however, those products are manufactured in mass production resulting in a low impact on cost per unit;
– it will strengthen the competitiveness of European enterprises as a result of guaranteeing a level playing field for the economic operators and will lead to a better protection of the users of PPE;
– options 1 and 2 do not provide answers to legal inconsistencies or ambiguities and therefore will not lead to a better implementation of the PPE Directive.
The scope of the proposed Regulation is enlarged compared to the scope of Directive 89/686/EEC. The exclusions of PPE designed and manufactured for private use against heat, damp and water, set out in Annex I of 89/686/EEC, are removed. These products are included in the scope of the proposed Regulation.
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”.
Additionally, the general definitions of the NLF Decision have been inserted.
3.2. 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.
The proposal 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.
Proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and for the confidence of all interested parties in the New Approach system.
Therefore, in line with the NLF Decision, 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.
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. The risks belonging to each category are set out in Annex I. Made-to-measure PPE is defined as category II.
The conformity assessment procedures to be followed depend on the category of the PPE.
The proposed Regulation changes the category of a few types of PPE compared to Directive 89/686/EEC. 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 is listed under category III and subject to the most stringent conformity assessment procedure.
The proposal keeps the applicable conformity assessment procedures provided for under Directive 89/686/EEC. It however updates the corresponding modules in line with the NLF Decision.
In module B, EU type-examination, additional requirements are introduced concerning the minimum content and the length of validity of the EU type-examination certificates. The module provides for a procedure for a review of the certificate.
Module B also requires particular steps for individually adapted PPE and made-to-measure PPE.
The proposed Regulation changes marginally three essential health and safety requirements (EHSR) set out in Annex II. EHSR 3.1.3, 3.5, and 3.9.1 are changed in order to remove requirements shown to be impracticable or that create confusion.
The proposal empowers the Commission to adopt, where appropriate, implementing acts to ensure the uniform application of this Regulation in respect of notified bodies that do not meet or no longer meet the requirements for their notification.
Those implementing acts will be adopted in accordance with the provisions on implementing acts laid down in Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers.
The proposal empowers the Commission to 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.
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. This will ensure that by the date of application of the proposed Regulation, sufficient notified bodies will have been designated in accordance with the new rules so as to avoid problems with production continuity and market supply.
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.
Directive 89/686/EEC will be repealed and replaced by the proposed Regulation.
Legal basis
The proposal is based on Article 114 of the Treaty on the Functioning of the European Union.
The subsidiarity principle arises in particular with regard to the newly added provisions aiming at the improvement of effective enforcement of Directive 89/686/EEC, namely, the economic operators’ obligations, the traceability provisions, the provisions on the assessment and notification of conformity assessment bodies.
Experience with the enforcement of the legislation has shown that measures taken at national level have led to divergent approaches and to a different treatment of economic operators inside the EU, which undermines the objectives of Directive 89/686/EEC. If actions are taken at national level to address the problems, this risks creating obstacles to the free movement of goods. Furthermore action at national level is limited to the territorial competence of a Member State. Coordinated action at EU level can much better achieve the objectives set, and will in particular render market surveillance more effective. Hence it is more appropriate to take action at EU level.
In accordance with the principle of proportionality, the proposed modifications do not go beyond what is necessary to achieve the objectives set.
The new or modified obligations do not impose unnecessary burdens and costs on industry - especially on small and medium sized enterprises - or administrations. Where modifications have been identified to have negative impacts, the analysis of the impacts of the option serves to provide the most proportionate response to the problems identified. A number of modifications concern the improvement of clarity of the existing Directive without introducing new requirements that entail added cost.
The proposal takes the form of a Regulation.
The proposed change from a Directive to a Regulation takes into account the Commission’s general objective to simplify the regulatory environment and the need to ensure a uniform implementation throughout the Union of the proposed legislation.
The use of a Regulation does not conflict with the subsidiarity principle. This legislation is based on Article 114 TFEU with the objective of ensuring the proper functioning of the internal market for personal protective equipment. To achieve this objective, the PPE Directive 89/686/EEC is a total harmonisation directive. Member States are not allowed to impose more stringent or additional requirements in their national legislation for the placing on the market of PPE. In particular, the mandatory essential health and safety requirements for products and the conformity assessment procedures to be followed by manufacturers must be identical in all of the Member States. Given this level of harmonisation, which is necessary to avoid obstacles to the free movement of PPE, Member States have almost no flexibility in transposing the Directive into their national law and its content is in many cases reproduced word for word in the national transposition legislation.
The same applies to the new provisions that will be integrated into the text following the alignment to the NLF Decision No 768/2008/EC. These provisions lay down requirements, obligations and procedures for the manufacturers, importers and distributors of PPE and for the notified bodies that carry out the conformity assessment procedures. All of these provisions are clear and sufficiently precise to be applied directly by the actors concerned.
The obligations set by the legislation for the Member States, such as the obligation to assess, appoint and notify the conformity assessment bodies are, in any case, not transposed as such into national law but implemented by the Member States by means of the necessary regulatory and administrative arrangements. This will not change when the obligations concerned are set out in a Regulation.
The change from a Directive to a Regulation will not lead to any change in the regulatory approach. The characteristics of the New Approach will be fully preserved, in particular the flexibility given to manufacturers in the choice of the means employed to comply with the essential requirements (harmonised standards or other technical specifications) and in the choice of the procedure used to demonstrate compliance from among the available conformity assessment procedures. The existing mechanisms supporting the implementation of the legislation (standardisation process, working groups, market surveillance, administrative cooperation (AdCo), and the development of guidance documents…) will not be affected by the nature of the legal instrument and will continue to operate in the same manner under the Regulation as they currently do under the Directive.
Finally, the use of Regulations in the area of internal market legislation, in accordance also with the preference expressed by stakeholders, avoids the risk of ‘gold plating’. It also allows manufacturers to work directly with the Regulation text instead of needing to identify and examine 28 transposition laws.
On this basis, it is considered that the choice of a Regulation is the most appropriate solution for all involved parties as it will allow a more rapid and coherent application of the proposed legislation and will establish a clearer regulatory environment for economic operators.
This proposal does not have any implication for the EU budget.
Repeal of existing legislation
The adoption of the proposal will lead to repeal of Directive 89/686/EEC.
The proposal concerns the EEA and should therefore be extended to the European Economic Area.