Explanatory Memorandum to COM(2013)471 - Harmonisation of the laws of the Member States relating to making available on the market of pressure equipment (Recast) - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)471 - Harmonisation of the laws of the Member States relating to making available on the market of pressure equipment (Recast). |
|---|---|
| source | COM(2013)471  |
| date | 28-06-2013 |
This proposal intends to align Directive 97/23/EC on pressure equipment to the ‘goods package’ adopted in 2008 and in particular to Decision No 768/2008/EC establishing a common framework for the marketing of products. It also intends to align Directive 97/23/EC to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures i.
a) Alignment to Decision No 768/2008/EC:
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 97/23/EC is an example of that Union harmonisation legislation, ensuring the free movement of pressure equipment. It sets out essential safety requirements that pressure equipment and assemblies must comply with in order to be made available on the EU market. Manufacturers must demonstrate that pressure equipment has been designed and manufactured in compliance with the essential 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;
– 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 (hereinafter NLF Decision).
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.
The Commission has already proposed the alignment of nine other Directives to the NLF Decision within an NLF implementation package adopted on 21 November 2011 i.
In view of ensuring consistency across Union harmonisation legislation for industrial products, it is necessary to align Directive 97/23/EC to the provisions of the NLF Decision.
The proposal also takes into account the proposal of the Commission of 13 February 2013 for a Regulation on market surveillance of products i.
b) Alignment to Regulation (EC) No 1272/2008:
Regulation (EC) No 1272/2008 (hereinafter CLP Regulation), implements within the Union the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) that has been adopted at the international level, within the structure of the United Nations.
Directive 97/23/EC provides, in Article 9, for a classification of pressure equipment in categories, according to the ascending level of risk due to pressure. While the classification of pressure equipment under the Directive is mainly based on the total energetic content (pressure and volume of the pressure equipment), it is also influenced by the classification (dangerous or not) of the fluid it contains.
The classification of pressure equipment into categories is directly related to the conformity assessment procedure applied in order to verify the conformity of the pressure equipment to the essential requirements of Directive 97/23/EC. In particular, the conformity assessment procedure to be applied is determined by the category, as defined in Article 9, in which the equipment is classified.
The classification of the fluids contained in the pressure equipment for the purposes of the classification of the pressure equipment in view of its conformity assessment, is based on Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances i.
According to Article 9 of Directive 97/23/EC, the ‘fluids’ are divided into two groups. Group 1 comprises the following ‘dangerous fluids’[5], as classified on the basis of their intrinsic properties and the degree and specific nature of the hazards involved in Directive 67/548/EEC: explosive, extremely flammable, highly flammable, flammable, very toxic, toxic and oxidising. Group 2 comprises all other fluids not referred to in Directive 97/23/EC as ‘dangerous’.
To take account of the pressure hazards associated with dangerous fluids, the conformity assessment requirements of Directive 97/23/EC are more stringent for pressure equipment containing Group 1 fluids than for pressure equipment containing Group 2 fluids.
According to Regulation (EC) No 1272/2008, Directive 67/548/EEC will be repealed on 1 June 2015 and replaced by the Regulation. That Regulation introduces new hazard classes and categories only partially corresponding to those used under the current provisions.
The fluid classification criteria of Directive 97/23/EC must therefore be aligned to the classification criteria of Regulation (EC) No 1272/2008 until 1 June 2015, while maintaining the existing levels of protection of the Directive.
The alignment of Directive 97/23/EC to the CLP Regulation requires therefore redefining what constitutes a ‘dangerous fluid’ in the terms of the new classification introduced by the Regulation.
The need to align the fluid classification criteria of Directive 97/23/EC to the CLP Regulation is therefore a direct consequence of implementing the CLP Regulation in the Union, which requires all downstream legislation to be aligned to the CLP Regulation at the latest by the date on which Directive 67/548/EEC will be repealed (1 June 2015).
Although the two classification systems provided by the CLP Regulation and Directive 67/548/EEC are similar, there is no perfect match. Some substances are classified differently under the CLP Regulation than under Directive 67/548/EEC due to changes in the classification criteria or cut-off values. A change in the classification of the fluid (substance or preparation) contained in the pressure equipment may therefore result in a change of the classification of the pressure equipment itself (categories of pressure equipment).
Directive 97/23/EC provides for four categories of pressure equipment, according to the ascending pressure related hazard. For each category of pressure equipment, the Directive provides for a set of conformity assessment procedures. Pressure equipment must be subject to one of the conformity assessment procedures which may be chosen by the manufacturer among those laid down for the category in which the pressure equipment is classified. The manufacturer may also choose to apply one of the procedures which apply to a higher category, if available.
The change in category under Directive 97/23/EC is having an impact only on the conformity assessment procedure and not on the design or manufacturing of the pressure equipment itself. If pressure equipment is classified in a higher category due to the fluid it contains, it may result in a more demanding and more expensive conformity assessment procedure.
As the current provision[6] related to the classification of pressure equipment based also on the characteristics of the fluid it contains is considered satisfactory, Directive 97/23/EC should be aligned to the CLP Regulation while maintaining the current scope in relation to the hazards due to the fluids. The new classification of the fluids should therefore match as close as possible the current classification based on Directive 67/548/EEC.
The proposed alignment is therefore a technical alignment primarily designed to minimize the impact of the changes in the classification system of the fluids introduced by the CLP Regulation on the classification of the pressure equipment itself.
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.
Consultation of interested parties
a) The alignment of Directive 97/23/EC to the NLF Decision has been discussed with national experts responsible for the implementation of the Directive, the conformity assessment bodies’ forum, the administrative cooperation group on market surveillance as well as in bilateral contacts with industry associations.
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, conformity assessment 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 conformity assessment 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.
b) The alignment of Directive 97/23/EC to the CLP Regulation has been discussed with national experts responsible for the implementation of the Directive, the conformity assessment bodies’ forum, the administrative cooperation group as well as in bilateral contacts with industry associations.
An impact assessment study on the alignment of Directive 97/23/EC to the CLP Regulation was conducted in 2012.
In the context of this study, a survey was organised amongst key stakeholders. The Commission organised a workshop on 7 November 2012 in order to collect further information and to allow direct interaction with stakeholders. The workshop was attended by representatives of national authorities, user and manufacturer associations, conformity assessment bodies, standardisers and experts in the field of the CLP Regulation.
a) Impact assessment concerning the alignment to the NLF Decision
In addition to the general impact assessment for the New Legislative Framework, an impact assessment was conducted for the NLF implementation package adopted in November 2011. That impact assessment covered also the alignment of Directive 97/23/EC to the NLF Decision and was largely built on the general impact assessment carried out for the New Legislative Framework. In addition to the expertise collected and analysed in that context, further consultation of the 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.
Based on the information collected, the Commission carried out an impact assessment which examined and compared three options.
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 the NLF Decision by legislative measures
This option consists in integrating the provisions of the NLF Decision into Directive 97/23/EC.
Option 3 was found to be the preferred option because:
– it will improve the competitiveness of companies and conformity assessment bodies taking their obligations seriously;
– it will improve the functioning of the internal market by ensuring equal treatment of all economic operators, notably importers and distributors, as well as conformity assessment bodies;
– it does not entail significant costs for economic operators and conformity assessment 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.
As outlined above in option 3, the alignment of Directive 97/23/EC to the NLF Decision will lead to a better implementation of the Directive.
The proposal includes:
· Measures to address the problem of non-compliance by clarifying the obligations of economic operators and requiring enhanced traceability requirements.
· Measures intended to ensure the quality of work done by conformity assessment bodies by reinforcing the notification requirements, revised notification process, specifying requirements for notifying authorities and more stringent information obligations.
· Measures intended to ensure greater consistency amongst Directives by aligning commonly used definitions and terminology and aligning the conformity assessment procedures.
The impact of these measures will lead to strengthening the competitiveness of European enterprises as a result of guaranteeing a level playing field for the economic operators.
The alignment of Directive 97/23/EC to the CLP Regulation is a direct consequence of implementing the CLP Regulation in the Union.
In particular, the classification of hazardous substances and mixtures is regulated at European level by the CLP Regulation which transposes the international Global Harmonised System (GHS) in the EU.
Therefore, the objective of the alignment of Directive 97/23/EC to the CLP Regulation is to ensure legal coherence. Such an alignment requires only the modification of Article 9 i of Directive 97/23/EC.
A non-alignment to the CLP Regulation would lead to legal uncertainty as from 1 June 2015, when Directive 67/548/EEC will be repealed, because, as from this date, there would be no legal basis for the classification of pressure equipment based on the fluid it contains.
The evaluation study of Directive 97/23/EC completed in November 2012, concluded that there is no urgent need for a full revision of Directive 97/23/EC. Better implementation of the Directive can be achieved by introducing the NLF provisions and by complementary measures such as improving the market surveillance. Additional studies should be conducted before preparing a full revision of the Directive, analysing e.g. issues related to the scope, technical provisions related to the essential safety requirements, etc… It also confirmed that the current classification mechanism of the pressure equipment provided for by the Directive and based also on the classification of the fluid is satisfactory.
The proposed alignment options are the result of a technical mapping of the current hazard classes of dangerous substances and preparations provided for by Directive 97/23/EC and based on Directive 67/548/EEC to the hazard classes for the classification of substances and mixtures classified as hazardous in accordance with the CLP Regulation. This technical mapping results to minimal changes to the existing classification system of pressure equipment provided for by Directive 97/23/EC.
Similar to the current provisions of Directive 97/23/EC, the proposal should therefore address the physical and health hazards due to the fluids contained in the pressure equipment, as far as relevant for the classification of pressure equipment in view of its conformity assessment.
For most pressure equipment there will be no change of the classification of the equipment due to the alignment to the CLP Regulation.
The best possible mapping between Directive 67/548/EEC and the CLP Regulation should be envisaged reducing the impact of this change to the minimum. The technical detail of the alignment and the options chosen on how to modify Article 9 i of Directive 97/23/EC could lead to increasing or reducing the number of substances or mixtures included in Group 1 of Directive 97/23/EC (the group which imposes more demanding requirements with regard to the conformity assessment procedures).
The impact of the various options has been analysed in an impact assessment study on the alignment of Directive 97/23/EC to the CLP Regulation, finalised in February 2013.
It results from the analysis that whilst there will be changes in the terminology used to identify the hazards, only a small number of fluids will be classified in a different group under Directive 97/23/EC possibly leading to a different classification of the pressure equipment itself.
A possible change in the classification of the fluids under Directive 97/23/EC does not always necessarily result in a different classification of the pressure equipment itself since such classification of the equipment depends not only on the nature of the fluid but also on the total energetic content (based on the pressure and the volume of the equipment).
In particular, the transition from Directive 67/548/EEC to the CLP Regulation for physical hazards is reasonably smooth as there is a good matching between that Directive and the new classification under the CLP Regulation. Only for a few substances the classification will change because the CLP Regulation introduces new cut-off values for the flammability criteria.
The transition from Directive 67/548/EEC to the CLP Regulation for the health hazards is more complex as the boundaries of some categories do not always align with those of Directive 67/548/EEC, as the CLP Regulation introduces also new hazard classes and categories.
In particular, the hazard classes and categories related to acute toxicity have been analysed more in detail with regard to their potential safety and economic impact.
With regard to the hazard classes for acute toxicity, the findings can be summarized as follows:
- the inclusion of the fluids that are classified under the hazard classes acute oral toxicity category 1 and 2 in Group 1 under Directive 97/23/EC will lead to a decrease in the number of fluids (in the meaning of substances or preparations) in Group 1. This option is supported by the fact that the oral take-up of substances or mixtures due to failure of pressure equipment cannot be excluded but the risk is very limited. This option would therefore not cause an unacceptable safety risk. However, the inclusion of acute oral toxicity category 3 would lead to a substantial increase in the number of fluids in Group 1, possibly resulting in a higher category of the equipment which may lead to an increase of the costs of the conformity assessment, without a substantial gain in the level of safety.
- the inclusion of the fluids that are classified under the hazard classes acute dermal toxicity category 1 and 2 will lead to a small decrease in the number of fluids (in the meaning of substances or preparations) in Group 1 under Directive 97/23/EC. This option is supported by the fact that dermal contact with substances or mixtures due to failure of pressure equipment cannot be excluded but the risk is rather limited and would not cause an unacceptable safety risk. However, the inclusion of acute dermal toxicity category 3 would lead to a relatively small increase in the number of fluids in Group 1, without a substantial gain in the level of safety.
- the inclusion of the fluids that are classified under the hazard classes acute toxicity inhalation category 3 in addition to category 1 and 2 will lead to an increase of fluids (in the meaning of substances or preparations) in Group 1 under Directive 97/23/EC which is justified given the risk that might exist due to small leakages of fluids in the pressure equipment.
In summary, for most of the fluids used in pressure equipment, there will be no change in the classification of the equipment due to the alignment to the CLP Regulation. For a limited number of fluids, used in a limited number of applications, the alignment to the CLP Regulation may lead to a different classification of the equipment and may influence the cost for the conformity assessment process.
The impact assessment study concluded that the impact of the proposed alignment would be limited and in particular that the overall economic impact will be low considering that the proposed alignment options are aiming at the best possible mapping between the current classification (based on Directive 67/548/EEC) and the future one (based on the CLP Regulation).
Based on the number of substances that would be subject to a different classification and the proportion of manufacturers that would be affected, the impact assessment study estimates the overall costs of aligning Directive 97/23/EC to the CLP Regulation to be of the order of 8,5 million euros per year. The cost is due to the changes in the alignment for the health hazard classes.
However, looking at the current compliance costs, and according to the impact assessment study, the total average cost of the conformity assessment for the pressure equipment covered by Directive 97/23/EC is estimated at 236,3 million euros per year.
Therefore, the incremental cost due to the alignment of Directive 97/23/EC to the CLP Regulation is low compared to the total cost for conformity assessment. However, the implementation of the CLP Regulation in the Union is mandatory and the cost cannot be avoided.
The impact assessment study is available at: ec.europa.eu/enterprise/sectors/pressure-and-gas
On the basis of the above, the Commission concluded that:
a) There is no alternative course of action because all downstream legislation which is using classification of chemical substances has to be aligned to the CLP Regulation, which is the European Union initiative transposing the international Global Harmonised System (GHS) in the EU. The current legal basis for the classification of substances and preparations, referred to in Article 9(2.1) of Directive 97/23/EC, namely Directive 67/548/EEC, will be repealed on 1 June 2015. By that time, Directive 97/23/EC should be modified and refer to the CLP Regulation for the purpose of the classification of pressure equipment within its scope. The proposed alignment is therefore a technical alignment which is primarily designed to minimize the impact of the changes in the classification system of the pressure equipment itself and to guarantee legal certainty as from 1 June 2015.
b) The impact assessment study did not identify significant economic or health related impacts.
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 pressure equipment is correctly marked and accompanied by the 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 pressure equipment 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 pressure equipment.
Enhanced traceability obligations are introduced for all economic operators. Pressure equipment has to bear the manufacturer’s name and address and a number allowing to identify and link the pressure equipment to its technical documentation. When pressure equipment is imported the importer’s name and address must also be on the pressure equipment. Furthermore every economic operator must be able to identify towards authorities the economic operator who has supplied him with pressure equipment or to whom he has supplied pressure equipment.
Compliance with harmonised standards provides for a presumption of conformity with the essential requirements. 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[8] sets out a horizontal legal framework for European standardisation. The Regulation contains inter alia provisions on standardisation requests from the Commission to the European Standardisation Organisation, on the procedure for objections to harmonised standards and on stakeholder participation in the standardisation process. Consequently, it repealed Article 6 of Directive 97/23/EC covering the same aspects. The provision conferring presumption of conformity to harmonised standards has been modified to clarify the extent of the presumption of conformity when standards only partially cover the essential requirements.
Directive 97/23/EC has selected the appropriate conformity assessment procedures which manufacturers have to apply in order to demonstrate that their pressure equipment complies with the essential safety requirements. The proposal aligns these procedures to their updated versions set out in the NLF Decision.
General principles of the CE marking are set out in Article 30 of Regulation (EC) No 765/2008, while the detailed provisions on the affixing of the CE marking to pressure equipment have been inserted in this proposal.
The proposal reinforces the notification criteria for conformity assessment bodies, namely notified bodies but also recognised third-party organisations and user inspectorates. 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 and user inspectorates and for designation of recognised third-party organisations is revised. The competence of conformity assessment bodies must be demonstrated by an accreditation certificate. Where accreditation has not been used to evaluate the competence of a conformity assessment 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.
On 13 February 2013, the Commission adopted a proposal 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 i, Regulation (EC) No 765/2008 and sector- specific harmonisation legislation in order to increase the effectiveness of market surveillance activities within the Union. The proposed Regulation covers also the reference provisions on market surveillance and safeguard clauses contained in the NLF Decision. Therefore, provisions in existing Union harmonisation legislation that relate to market surveillance and safeguard clauses should be removed from that harmonisation legislation.
The overarching 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. This will result in a better implementation of the market surveillance rules across Member States, providing better protection for consumers and other users, reduced administrative burdens and enhanced information and work-sharing between market surveillance authorities.
In this framework, the proposed Regulation will lead to a better implementation of Directive 97/23/EC, which covers consumer and non-consumer products, and to an improved competitiveness framework in the internal market.
On this basis, the proposal does not include provisions on market surveillance and safeguard clause procedures, but in order to ensure legal clarity, it makes a reference to the proposed Regulation on market surveillance of products.
The proposal modifies Article 9 i of Directive 97/23/EC so as to align, for purposes related to the conformity assessment of the pressure equipment, the current classification of fluids contained in the equipment and which is based on the classification of dangerous substances and preparations provided for by Directive 67/548/EEC, to the new classification of hazardous substances and mixtures provided for by the CLP Regulation.
The provisions on the operation of the Committee on Pressure Equipment have been 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[10].
Contents
- 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
- 2. CONSULTATION OF THE INTERESTED PARTIES AND IMPACT ASSESSMENT
- Collection and use of expertise - Impact assessment
- Option 1 - No changes to the current situation
- b) Impact assessment concerning the alignment to the CLP Regulation
- 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. Conformity assessment bodies
- 3.6. Market surveillance and the safeguard clause procedure
- 3.7. Classification of pressure equipment
- 3.8. 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 97/23/EC, namely, the importer and distributor obligations, the traceability provisions, the provisions on the assessment and notification of conformity assessment 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 modifications to be proposed will not go beyond what is necessary to achieve the objectives set.
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 and to the CLP Regulation requires a number of substantive amendments to the provisions of Directive 97/23/EC. To ensure the readability of the amended text the technique of recasting has been chosen in line with the Inter-institutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts[11].
The changes made to the provisions of Directive 97/23/EC concern: the definitions, the obligations of economic operators, the presumption of conformity provided by harmonised standards, the declaration of conformity, CE marking, conformity assessment bodies, the safeguard clause procedure, the conformity assessment procedures and the classification of the fluids.
The proposal does not change the scope of Directive 97/23/EC and the essential 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 97/23/EC as from 1 June 2015.
In particular, in order to ensure the simultaneous and coherent implementation of the alignment of Directive 97/23/EC to Decision 768/2008/EC and to Regulation (EC) No 1272/2008, the proposal provides that the new Directive will apply as from 1 June 2015.
The proposal concerns the EEA and should therefore be extended to the European Economic Area.
ê 97/23/EC (adapted)