Explanatory Memorandum to COM(2011)772 - Harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres - Main contents
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| dossier | COM(2011)772 - Harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially ... |
|---|---|
| source | COM(2011)772  |
| date | 21-11-2011 |
This proposal is presented in the framework of the implementation of the “goods package” adopted in 2008. It is part of a package of proposals aligning ten product directives to Decision No 768/2008/EC establishing a common framework for the marketing of products.
Union (EU) harmonisation legislation ensuring the free movement of products has contributed considerably to the completion and operation of the Single Market. It is based on a high level of protection and provides economic operators with the means to demonstrate conformity, thus ensuring free movement through trust in the products.
Directive 94/9/EC (the ATEX Directive) is an example of that Union harmonisation legislation, ensuring the free movement of products. It sets out the essential health and safety requirements that products must comply with in order to be made available on the EU market. Manufacturers must demonstrate that a product has been designed and manufactured in compliance with the essential health and safety requirements and affix the CE marking.
Experience with the implementation of Union harmonisation legislation has shown – on a cross-sector scale - certain weaknesses and inconsistencies in the implementation and enforcement of this legislation, leading to
– the presence of non-compliant or dangerous products on the market and consequently a certain lack of trust in CE marking,
– competitive disadvantages for economic operators complying with the legislation as opposed to those circumventing the rules,
– unequal treatment in the case of non-compliant products and distortion of competition amongst economic operators due to different enforcement practices,
– differing practices in the designation of conformity assessment bodies by national authorities, and
– problems with the quality of certain notified bodies.
Furthermore the regulatory environment has become more and more complex, as frequently several pieces of legislation apply simultaneously to one and the same product. Inconsistencies in these pieces of legislation make it increasingly difficult for economic operators and authorities to correctly interpret and apply that legislation.
To remedy these horizontal shortcomings in Union harmonisation legislation observed across several industrial sectors, the 'New Legislative Framework' was adopted in 2008 as part of the goods package. Its objective is to strengthen and complete the existing rules and to improve practical aspects of their application and enforcement. The New Legislative Framework (NLF) consists of two complementary instruments, 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.
The NLF Regulation has introduced rules on accreditation (a tool for the evaluation of competence of conformity assessment bodies) and requirements for the organisation and performance of market surveillance and controls of products from third countries. Since 1 January 2010 these rules apply directly in all Member States.
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 directives can be applied and enforced more effectively in practice. New elements, such as obligations on importers, have been introduced, which are crucial for improving the safety of products on the market.
The provisions of the NLF Decision and those of the NLF Regulation are complementary and closely interlinked. The NLF Decision contains the corresponding obligations for economic operators and notified bodies allowing market surveillance authorities and authorities responsible for notified bodies to properly perform the tasks imposed on them by the NLF Regulation and to ensure an effective and consistent enforcement of EU product legislation.
However, unlike the NLF Regulation, the provisions of the NLF Decision are not directly applicable. To ensure that all economic sectors subject to Union harmonisation legislation benefit from the improvements of the NLF, the provisions of the NLF Decision need to be integrated into the existing product legislation.
A survey after the adoption of the goods package in 2008 showed that a majority of Union harmonisation legislation on products was due to be revised within the following 3 years, not only to address the problems observed throughout all sectors but also for sector-specific reasons. Any such revision would automatically include an alignment of the legislation concerned to the NLF Decision since Parliament, Council and Commission have committed themselves to use its provisions as much as possible in future legislation on products in order to further the utmost coherence of the regulatory framework.
For a number of other Union harmonisation directives, including Directive 94/9/EC, no revision for sector-specific problems had been envisaged within this timeframe. To ensure that the problems in relation to non-compliance and notified bodies are nevertheless addressed in these sectors, and for the sake of consistency of the overall regulatory environment on products, it was decided to align these directives within a package to the provisions of the NLF Decision.
This initiative is in line with the Single Market Act, which has 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.
Consultation of interested parties
The alignment of the ATEX Directive 94/9/EC to the NLF Decision has been discussed with national experts responsible for the implementation of this Directive, the notified body group, the administrative cooperation group as well as the representatives of industry associations in the relevant experts working group.
From June to October 2010 a public consultation was organised that comprised all the sectors involved in this initiative. It consisted of four targeted questionnaires for economic operators, authorities, notified bodies and users and the Commission services received 300 replies. The results are published at ec.europa.eu/enterprise/policies
In addition to the general consultation a specific SME consultation was carried out. 603 SMEs were consulted through the Enterprise Europe Network in May/June 2010. The results are available at ec.europa.eu/enterprise/policies
The consultation process revealed widespread support for the initiative. There is unanimity on the need to improve market surveillance and the system for assessing and monitoring Notified Bodies. 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. Certain concerns were expressed on some obligations which are, however, indispensable for increasing the efficiency of market surveillance. These measures will not entail significant costs for industry, and the benefits resulting from improved market surveillance should by far outweigh the costs.
The impact assessment for this implementation package has largely built on the impact assessment carried out for the New Legislative Framework. In addition to the expertise collected and analysed in that context, further consultation of sector-specific experts and interest groups, as well as horizontal experts active in the area of technical harmonisation, conformity assessment, accreditation and market surveillance, has taken place.
External expertise was used to obtain some basic data on certain sectors: for the ATEX sector, the study 'Market description, competitiveness analysis in the field of products and protective systems intended for use in potentially explosive atmospheres', available on ec.europa.eu/enterprise/sectors/mechanical/files
Based on the information collected, the Commission carried out an impact assessment which examined and compared three options.
Option 1 – No changes to the current situation
This option proposes no changes to the current directive and relies exclusively on certain improvements that can be expected from the NLF Regulation.
Option 2 – Alignment to the NLF Decision by non-legislative measures
Option 2 considers the possibility of encouraging a voluntary alignment to the provisions set out in the NLF Decision by, e.g., presenting them as best practices in guidance documents.
Option 3 – Alignment to NLF Decision by legislative measures
This option consists in integrating the provisions of the NLF Decision into the existing directives.
– it will improve the competitiveness of companies and notified bodies taking their obligations seriously, as opposed to those cheating on the system;
– it will improve the functioning of the internal market by ensuring equal treatment of all economic operators, notably importers and distributors, as well as notified bodies;
– it does not entail significant costs for economic operators and notified bodies; for those who are already acting responsibly, no extra costs or only negligible costs are expected;
– 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;
– options 1 and 2 do not provide answers to the problem of inconsistencies in the regulatory framework and therefore have no positive impact on the simplification of the regulatory environment.
The proposal introduces harmonised definitions of terms which are commonly used throughout Union harmonisation legislation and should therefore be given a consistent meaning throughout that legislation.
The proposal clarifies the obligations of manufacturers and authorised representatives and introduces obligations for importers and distributors. Importers must verify that the manufacturer has carried out the applicable conformity assessment procedure and has drawn up a technical documentation. They must also make sure with the manufacturer that this technical documentation can be made available to authorities upon request. Furthermore importers must verify that the products are correctly marked and accompanied by the required documents, instructions and safety information. They must keep a copy of the Declaration of conformity and indicate their name and address on the product, or where this is not possible on the packaging or the accompanying documentation. Distributors must verify that the product bears the CE marking, the name of the manufacturer and of the importer, if relevant, and that it is accompanied by the required documentation and instructions.
Importers and distributors must cooperate with market surveillance authorities and take appropriate actions when they have supplied non-compliant products.
Enhanced traceability obligations are introduced for all economic operators. Products have to bear the manufacturer’s name and address and a number allowing to identify and link the product to its technical documentation. When a product is imported the importer’s name and address must also be on the product. Furthermore every economic operator must be able to identify towards authorities the economic operator who has supplied him with a product or to whom he has supplied a product.
Compliance with harmonised standards provides a presumption of conformity with the essential requirements. On 1 June 2011 the Commission adopted a proposal for a Regulation on European Standardisation that sets out a horizontal legal framework for European standardisation. The proposal for the Regulation contains inter alia provisions on standardisation requests from the Commission to the European Standardisation Organisations, on the procedure for objections to harmonised standards and on stakeholder participation in the standardisation process. Consequently the provisions of Directive 94/9/EC which cover the same aspects have been deleted in this proposal for reasons of legal certainty.
The provisions conferring presumption of conformity to harmonised standards have been modified to clarify the extent of the presumption of conformity when standards only partially cover the essential requirements.
Directive 94/9/EC has selected the appropriate conformity assessment procedures which manufacturers have to apply in order to demonstrate that their products comply with the essential health and safety requirements. The proposal aligns these procedures to their updated versions set out in the NLF Decision. Sector specific elements of the procedures have been maintained.
General principles of the CE marking are set out in Article 30 of Regulation 765/2008, while the detailed provisions on the affixing of the CE marking and the specific marking of explosion protection to products have been inserted in this proposal.
The proposal reinforces the notification criteria for notified bodies. It clarifies that subsidiaries or subcontractors must also comply with the notification requirements. Specific requirements for notifying authorities are introduced, and the procedure for notification of notified bodies is revised. The competence of a notified body must be demonstrated by an accreditation certificate. Where accreditation has not been used to evaluate the competence of a notified body, the notification must comprise the documentation demonstrating how the competence of that body has been evaluated. Member States will have the possibility to object to a notification.
The proposal revises the existing safeguard clause procedure. It introduces a phase of information exchange between Member States, and specifies the steps to be taken by the authorities concerned, when a non-compliant product is found. A real safeguard clause procedure – leading to a Decision at Commission level on whether a measure is justified or not – is only launched when another Member State objects to a measure taken against a product. Where there is no disagreement on the restrictive measure taken, all Member States must take the appropriate action on their territory.
The provisions on the operation of standing committees have to be adapted to the new rules on delegated acts laid down in Article 290 of the Treaty on the Functioning of the EU and to the new 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[3].
Directive 94/9/EC provided for a standing committee. As this committee is not involved in the adoption of implementing acts provided for in Article 291 of the Treaty on the Functioning of the EU, and no need to adopt implementing acts appears under the new Directive, therefore this provision has been deleted in the proposal.
The Commission will set up an expert working group in accordance with the Communication from the President to the Commission - Framework for Commission expert groups: horizontal rules and public register (C(2010) 7649 final), that will carry out the tasks of the standing committee provided for in Directive 94/9/EC, to examine any question relating to the application of the Directive.
Contents
- legal elements of the proposal
- budgetary implications
- General context, reasons for and objectives of this proposal
- Consistency with other policies and objectives of the Union
- 2. consultation of interested parties and impact assessment
- Collection and use of expertise
- Impact assessment
- Option 3 was found to be the preferred option because
- 3. Main elements of the proposal 3.1. Horizontal definitions
- 3.2. Obligations of economic operators and traceability requirements
- 3.3. Harmonised standards
- 3.4. Conformity assessment and CE marking
- 3.5. Notified Bodies
- 3.6. Market surveillance and the safeguard clause procedure
- 3.7. Comitology and Delegated acts
- Legal basis
- Subsidiarity principle
- Proportionality
- Legislative technique used
- 6. additional information
- European Economic Area
The proposal is based on Article 114 of the Treaty on the Functioning of the European Union.
The internal market is a competence that is shared between the Union and the Member States. The subsidiarity principle arises in particular with regard to the newly added provisions aiming at the improvement of effective enforcement of Directive 94/9/EC, namely, the importer and distributor obligations, the traceability provisions, the provisions on the assessment and notification of notified bodies, and the enhanced cooperation obligations in the context of the revised market surveillance and safeguard procedures.
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 objective of this directive. 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. In view of the increasing internationalisation of trade, the number of cross-border cases is constantly rising. 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.
As regards the problem of inconsistencies throughout the directives, this is a problem which can only be solved by the EU legislator.
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 alignment to the NLF Decision requires a number of substantive amendments to the provisions of Directive 94/9/EC. To ensure the readability of the amended text the technique of recasting has been chosen in line with the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts.
The changes made to the provisions of Directive 94/9/EC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, notified bodies, the safeguard clause procedure and the conformity assessment procedures.
The proposal does not change the scope of Directive and the essential health and safety requirements.
This proposal does not have any implications for the EU budget.
Repeal of existing legislation
The adoption of the proposal will lead to repeal of Directive 94/9/EC.
The proposal concerns the EEA and should therefore be extended to the European Economic Area.
ê 94/9/EC (adapted)