EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

General context, reasons for and objectives of this proposal

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[1].

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[2].

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[3].

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[4].

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.

Consistency with other policies and objectives of the Union

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.

2. CONSULTATION OF THE INTERESTED PARTIES AND IMPACT ASSESSMENT

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:

http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/new-legislative-framework/index_en.htm

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 http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf

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.

Collection and use of expertise - Impact assessment

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.

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 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.

b) Impact assessment concerning the alignment to the CLP Regulation

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(2) 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(2) 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: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/index_en.htm

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.

3. Main elements of the proposal

3.1. Horizontal definitions

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.

3.2. Obligations of economic operators and traceability requirements

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.

3.3. Harmonised standards

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.

3.4. Conformity assessment and CE marking

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.

3.5. Conformity assessment bodies

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.

3.6. Market surveillance and the safeguard clause procedure

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[9], 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.

3.7. Classification of pressure equipment

The proposal modifies Article 9(2) 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.

3.8. Comitology and delegated acts

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].

4. legal elements of the proposal

Legal basis

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union.

Subsidiarity principle

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.

Proportionality

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.

Legislative technique used

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.

5. BUDGETARY IMPLICATION

This proposal does not have any implications for the EU budget.

6. ADDITIONAL INFORMATION

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.

European Economic Area

The proposal concerns the EEA and should therefore be extended to the European Economic Area.

ê 97/23/EC (adapted)

2013/0221 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the approximation Ö harmonisation Õ of the laws of the Member States concerning Ö relating to making available on the market of Õ pressure equipment

(Recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community Ö on Functioning of the European Union Õ and in particular Article 100a Ö 114 Õ thereof,

Having regard to the proposals from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the Opinion of the European Economic and Social Committee[12],

Acting in accordance with the ordinary legislative procedure,

Whereas:

ò new

(1) Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment[13] has been substantially amended several times. Since further amendments are to be made, it should be recast in the interests of clarity.

(2) Regulation (EC) No 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 repealing Regulation (EEC) No 339/93[14] lays down rules on the accreditation of conformity assessment bodies [provides a framework for the market surveillance of products and for controls on products from third countries,] and lays down the general principles of the CE marking.

(3) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93/465/EEC[15] lays down a common framework of general principles and reference provisions intended to apply across the legislation harmonising the conditions for the marketing of products in order to provide a coherent basis for revision or recasts of that legislation. Directive 97/23/EC should therefore be adapted to that Decision.

ê 97/23/EC recital 1 (adapted)

Whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;

ê 97/23/EC recital 2

Whereas there are differences in the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety and protection of health of persons and, where appropriate, domestic animals or property, where pressure equipment not covered by present Community legislation is concerned; whereas the certification and inspection procedures for such equipment differ from one Member State to another; whereas such disparities may well constitute barriers to trade within the Community;

ê 97/23/EC recital 3

Whereas the harmonization of national legislation is the only means of removing these barriers to free trade; whereas this objective cannot be achieved satisfactorily by the individual Member States; whereas this Directive only lays down indispensable requirements for the free circulation of the equipment to which it is applicable;

ê 97/23/EC recital 4 (adapted)

(4) Whereas equipment subject to a pressure of not more than 0,5 bar does not pose a significant hazard due to pressure; whereas there should not therefore be any obstacle to its free movement within the Community; This Directive applies Ö should apply Õ to equipment subject to a maximum allowable pressure PS exceeding Ö greater than Õ 0,5 bar. Ö Equipment subject to a pressure of not more than 0,5 bar does not pose a significant risk due to pressure. Therefore, there should not be any obstacle to its free movement within the Union. Õ

ê 97/23/EC recital 5 (adapted)

(5) This Directive relates also Ö should also apply Õ to assemblies composed of several pieces of pressure equipment assembled to constitute an integrated and functional whole. These Ö Those Õ assemblies may range from simple assemblies such as pressure cookers to complex assemblies such as water tube boilers. If the manufacturer of an assembly intends it to be placed Ö place it Õ on the market and put Ö it Õ into service as an assembly - and not in the form of its constituent non-assembled elements - that assembly must conform to Ö should comply with Õ this Directive. On the other hand Ö However Õ, this Directive does not cover Ö should not apply to Õ the assembly of pressure equipment on the site and under the responsibility of the user, as in the case of industrial installations.

ê 97/23/EC recital 6 (adapted)

(6) This Directive harmonises Ö should harmonise Õ national provisions on hazards Ö risks Õ due to pressure. The other hazards Ö risks Õ which this equipment may present accordingly may fall within the scope of other Directives dealing with such hazards Ö those risks Õ.

(7) However, Ö some Õ pressure equipment may be included among products Ö is Õ covered by other Directives based on Article 100a Ö 114 Õ of the Treaty. The provisions laid down in some of those Directives deal Ö also Õ with the hazard Ö risk Õ due to pressure. Those provisions Ö Directives Õ are considered adequate to provide appropriate protection where the hazard Ö risk Õ due to pressure associated with such equipment remains small. Therefore, there are grounds for excluding such equipment Ö should be excluded Õ from the scope of this Directive.

ê 97/23/EC recital 7 (adapted)

ð new

(8) For Ö some Õ pressure equipment covered by international Conventions, Ö agreements for its international transport, national Õ transport and pressure hazards Ö risks Õ are due to be dealt with as soon as possible by forthcoming Community Ö Union Õ Directives based on such Conventions Ö agreements Õ or by supplements to existing Directives ð by extending the application of those agreements to national transport, in order to ensure the free movement of such dangerous goods whilst enhancing transport safety ï. Such equipment ð which is covered by Directive 2008/68/EC of the European Parliament and of the Council of 29 September 2008 on the inland transport of dangerous goods[16] and by Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC[17] ï is accordingly Ö should be Õ excluded from the scope of this Directive.

ê 97/23/EC recital 8 (adapted)

(9) Certain types of pressure equipment, although subject to a maximum allowable pressure PS higher Ö greater Õ than 0,5 bar, do not present any significant hazard Ö risk Õ due to pressure, and therefore the freedom of Ö free Õ movement of such equipment in the Community Ö Union Õ should not be hindered if it has been legally manufactured or placed on the market in a Member Stat. It is not necessary in order to ensure free movement of such equipment to include it in the scope of this Directive. Consequently it is Ö should be Õ expressly excluded from its scope.

ê 97/23/EC recital 9 (adapted)

(10) Other pressure equipment subject to a maximum allowable pressure higher Ö greater Õ than 0,5 bar and presenting a significant hazard Ö risk Õ due to pressure, but in respect of which free movement and an appropriate level of safety are guaranteed, is Ö should be Õ excluded from the scope of this Directive. Such exclusions should, however, be regularly reviewed in order to ascertain whether it is necessary to take action at Union level.

ê 97/23/EC recital 10

Whereas regulations to remove technical barriers to trade must follow the new approach provided for in the Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards[18], which requires a definition of the essential requirements regarding safety and other requirements of society without reducing existing, justified levels of protection within the Member States; whereas that Resolution provides that a very large number of products be covered by a single Directive in order to avoid frequent amendments and the proliferation of Directives;

ê 97/23/EC recital 11

Whereas the existing Community Directives on the approximation of the laws of the Member States relating to pressure equipment have made positive steps towards removing barriers to trade in this area; whereas those Directives cover that sector only to a minor extent; whereas Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of the Member States relating to simple pressure vessels[19] is the first case of application of the new approach to the sector of pressure equipment; whereas the present Directive will not apply to the area covered by Directive 87/404/EEC; whereas, no later than three years after the present Directive enters into force, a review will be carried out of the application of Directive 87/404/EEC in order to ascertain the need for the integration thereof into the present Directive;

ê 97/23/EC recital 12

Whereas the framework Directive, Council Directive 76/767/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to common provisions for pressure vessels and methods for inspecting them[20] is optional; whereas it provides for a procedure for the bilateral recognition of testing and certification of pressure equipment which did not operate satisfactorily and which therefore must be replaced by effective Community measures;

ê 97/23/EC recital 13 (adapted)

(11) The scope of this Directive must Ö should Õ be based on a general definition of the term «pressure equipment» so as to allow for the technical development of products.

ê 97/23/EC recital 14 (adapted)

(12) Compliance with the essential safety requirements is necessary in order to ensure the safety of pressure equipment. Those requirements have been Ö should be Õ subdivided into general and specific requirements which must Ö that need to Õ be met by pressure equipment. In particular the specific requirements are intended to Ö should Õ take account of particular types of pressure equipment. Certain types of pressure equipment in categories III and IV must Ö should Õ be subject to a final assessment comprising final inspection and proof tests.

ê 97/23/EC recital 15 (adapted)

(13) Member States should be in a position to allow the showing at trade fairs of pressure equipment which is not yet in conformity with the requirements of this Directive. During demonstrations, appropriate safety measures must Ö should Õ be taken in accordance with the general safety rules of the Member State concerned to ensure the safety of persons.

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(14) Directive 97/23/EC provides for a classification of pressure equipment in categories, according to the ascending level of risk due to pressure. This includes the classification of the fluid contained in the pressure equipment as dangerous or not, according to 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[21]. On 1 June 2015 Directive 67/548/EEC is to be repealed and replaced by 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[22], which implements in the Union the Globally Harmonised System of Classification and Labelling of Chemicals that has been adopted at international level, within the United Nations (UN) structure. Regulation (EC) No 1272/2008 introduces new hazard classes and categories only partially corresponding to those provided for by Directive 67/548/EEC. Directive 97/23/EC should therefore be aligned to Regulation (EC) No 1272/2008 while maintaining the existing levels of protection of that Directive.

(15) Economic operators should be responsible for the compliance of pressure equipment with the requirements of this Directive, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety and the protection of users, and to guarantee fair competition on the Union market.

(16) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market pressure equipment which is in conformity with this Directive. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.

(17) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the complete conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.

(18) In order to facilitate the communication between economic operators, national market surveillance authorities and consumers, Member States should encourage economic operators to indicate a website address in addition to the postal address.

(19) It is necessary to ensure that pressure equipment from third countries entering the Union market complies with the requirements of this Directive, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to that pressure equipment. Provision should therefore be made for importers to make sure that the pressure equipment they place on the market complies with the requirements of this Directive and that they do not place on the market pressure equipment which does not comply with such requirements or presents a risk. Provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that marking of pressure equipment and documentation drawn up by manufacturers are available for inspection by the national authorities.

(20) The distributor makes pressure equipment available on the market after it has been placed on the market by the manufacturer or the importer and should act with due care to ensure that its handling of the pressure equipment does not adversely affect the compliance of the equipment with the requirements of this Directive.

(21) When placing pressure equipment on the market, every importer should indicate on the pressure equipment his name and the postal address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the pressure equipment does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the equipment.

(22) Any economic operator that either places pressure equipment on the market under its own name or trademark or modifies pressure equipment in such a way that compliance with the requirements of this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

(23) Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the pressure equipment concerned.

(24) Ensuring traceability of pressure equipment throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities' task of tracing economic operators who made non-compliant pressure equipment available on the market.

(25) When keeping the information required under this Directive for the identification of economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with a pressure equipment or to whom they have supplied a pressure equipment.

(26) This Directive should be limited to the expression of the essential safety requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for presumption of conformity for pressure equipment which is in conformity with harmonised standards that are adopted in accordance with 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[23] for the purpose of expressing detailed technical specifications of those requirements, especially with regard to the design, manufacture and testing of pressure equipment.

(27) Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy requirements of this Directive.

ê 97/23/EC recital 16

Whereas in order to ease the task of demonstrating compliance with the essential requirements, standards harmonized at European level are useful, especially with regard to the design, manufacture and testing of pressure equipment, compliance with which enables a product to be presumed to meet the said essential requirements; whereas standards harmonized at European level are drawn up by private bodies and must retain their non-mandatory status; whereas, for this purpose, the European Committee for Standardization (CEN) and the European Committee for Electro-technical Standardization (Cenelec) are recognized as being the bodies that are competent to adopt harmonized standards that follow the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984;

ê 97/23/EC recital 17

Whereas, for the purposes of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted by one or other of those bodies, or by both, at the request of the Commission pursuant to Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations[24] and in accordance with the general guidelines referred to above; whereas, in relation to standardization, it would be advisable for the Commission to be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the Committee will, if necessary, consult technical experts;

ê 97/23/EC recital 18 (adapted)

ð new

(28) Manufacturing of pressure equipment calls for the utilisation of safe materials. In the absence of harmonised standards, it is useful to define the characteristics of the materials intended for repeated use Ö should be established. Those characteristics should be Õ . This definition is established by European approvals for materials, such approvals being issued by one of the notified bodies specifically designated for that task. The materials conforming to the European approvals shall be presumed to satisfy Ö should benefit from presumption of conformity with Õ the essential ð safety ï requirements of this Directive.

ê 97/23/EC recital 19 (adapted)

ð new

(29) In view of the nature of the hazards Ö risks Õ involved in the use of pressure equipment ð and in order to enable economic operators to demonstrate and the competent authorities to ensure that pressure equipment made available on the market conforms to the essential safety requirements, ï it is necessary to establish ð provide for conformity assessment ï procedures for assessing compliance with the basic requirements of the Directives. These procedures must Ö should Õ be devised in the light of the level of danger which is inherent in the pressure equipment. Therefore, for each category of pressure equipment there must Ö should Õ be an adequate procedure or a choice between different procedures of equivalent stringency. whereas the procedures adopted are as required by Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization Directives[25]; ð Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules. ï The details added to these Ö those Õ procedures are justified by the nature of the verification required for pressure equipment.

ê 97/23/EC recital 20 (adapted)

(30) Member States should be in a position to authorize user inspectorates to carry out certain tasks for conformity assessment in the framework of this Directive. For that purpose this Directive Ö should Õ sets out criteria for the authorizsation of user inspectorates by Member States.

ê 97/23/EC recital 21 (adapted)

(31) Under the conditions laid down by this Directive, certain procedures for conformity assessment may require Ö it should be possible for Õ each item to be inspected and tested by a notified body or a user inspectorate as part of the final assessment of the pressure equipment. In other cases provision should be made to ensure that the final assessment may be monitored by a notified body by means of unexpected visits.

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(32) Manufacturers should draw up an EU declaration of conformity to provide information required under this Directive on the conformity of the pressure equipment with the requirements of this Directive and of other relevant Union harmonisation legislation.

(33) To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a ‘single EU declaration of conformity’.

ê 97/23/EC recital 22 (adapted)

ð new

(34) Pressure equipment will Ö should Õ, as a general rule, bear the CE marking. affixed either by the manufacturer or by his authorized representative established within the Community; whereas the CE marking means that the pressure equipment complies with the provisions of this Directive and those of other applicable Community directives on CE marking; ð The CE marking, indicating the conformity of pressure equipment, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship to other markings are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in this Directive. ï

(35) For pressure equipment defined in this Directive which presents only a minor pressure hazard Ö risk Õ and for which certification procedures are therefore not justified, the CE marking will Ö should Õ not be affixed.

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(36) The conformity assessment procedures set out in this Directive require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.

(37) Experience has shown that the criteria set out in Directive 97/23/EC that conformity assessment bodies have to fulfil to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of these bodies throughout the Union. It is, however, essential that all conformity assessment bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.

(38) In order to ensure a consistent level of conformity assessment quality, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of conformity assessment bodies.

(39) If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards, it should be presumed to comply with the corresponding requirements set out in this Directive.

(40) The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.

(41) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in conformity certificates, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.

(42) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the pressure equipment to be placed on the Union market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.

(43) It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.

(44) Since conformity assessment bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.

(45) In the interests of competitiveness, it is crucial that conformity assessment bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between conformity assessment bodies.

(46) Member States should take all appropriate measures to ensure that pressure equipment may be placed on the market only if, when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen, they do not endanger the health and safety of persons. Pressure equipment should be considered as non-compliant with the essential safety requirements laid down in this Directive only under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour.

ê 97/23/EC recital 23

Whereas it is appropriate that the Member States, as provided for by Article 100a of the Treaty, may take provisional measures to limit or prohibit the placing on the market, putting into service and use of pressure equipment in cases where it presents a particular risk to the safety of persons and, where appropriate, domestic animals or property, provided that the measures are subject to a Community control procedure;

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(47) Regulation (EU) No […/…] [on market surveillance of products] providing for a single Union legal instrument relating to market surveillance of products, applies to pressure equipment.

ê 97/23/EC recital 24

Whereas the addressees of any decision taken under this Directive must be aware of the reasons behind that decision and the means of appeal open to them;

ê 97/23/EC recital 25

Whereas it is necessary to lay down a transitional arrangement enabling pressure equipment manufactured in compliance with the national regulations in force on the date of entry into force of this Directive to be marketed and put into service;

ê 97/23/EC recital 26

Whereas the requirements laid down in the Annexes should be made as clear as possible so as to allow all users, including small and medium-sized enterprises (SMEs), to comply with them easily;

ê 97/23/EC recital 27

Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994[26];

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(48) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred to the Commission. Those powers should be exercised in accordance with 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[27].

(49) The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification.

(50) The examination procedure should be used for the adoption of implementing acts with respect to European approvals for materials presenting shortcomings and whose references were already published in the Official Journal of the European Union, given that such decisions could have consequences on the presumption of conformity with the applicable essential requirements.

(51) In order to take into account the technical developments in pressure equipment technology, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amendments to classification of pressure equipment. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

(52) The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(53) Directive 97/23/EC provides for a transitional arrangement enabling pressure equipment and assemblies which comply with the national regulations in force on the date of application of Directive 97/23/EC to be put into service. For reasons of legal certainty, it is necessary to include that transitional arrangement also in this Directive.

(54) It is necessary to provide for transitional arrangements that allow the making available on the market and the putting into service of pressure equipment which complies with Directive 97/23/EC.

(55) Member States should lay down rules on penalties applicable to infringements of the provisions of national law adopted pursuant to this Directive and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive.

(56) Since the objective of this Directive, namely to ensure that pressure equipment on the market fulfils the requirements providing a high level of protection of health and safety of users and protection of domestic animals or property while guaranteeing the functioning of the internal market cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(57) The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive change as compared with Directive 97/23/EC. The obligation to transpose the provisions which are unchanged arises under Directive 97/23/EC.

(58) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of Directive 97/23/EC set out in Part B of Annex V,

ê 97/23/EC (adapted)

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

Ö GENERAL PROVISIONS Õ

Article 1

Scope and definitions

1. This Directive applies Ö shall apply Õ to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.

32. The following are excluded from the scope of Tthis Directive Ö shall not apply to Õ :

ê 97/23/EC (adapted)

3.1.(a) pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation (onshore or offshore) starting from and including the last isolation device located within the confines of the installation, including all the annexed equipment designed specifically for pipelines;, Tthis exclusion does Ö shall Õ not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;

3.2.(b) networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;

ê 97/23/EC (adapted)

3.3.(c) equipment Ö simple pressure vessels Õ covered by Directive 87/404/EEC 2009/105/EC of the European Parliament and of the Council[28] on simple pressure vessels;

3.4.(d) equipment Ö aerosol dispensers Õ covered by Council Directive 75/324/EEC[29] of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers;

3.5.(e) equipment intended for the functioning of vehicles defined by the following Directives and their Annexes:

ê 97/23/EC (adapted)

(i) Directive 70/156/EEC of 6 February 1970 2007/46/EC of the European Parliament and of the Council[30] on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles,;

(ii) Directive 74/150/EEC 2003/37/EC of the European Parliament and of the Council[31] 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units,;

(iii) Directive 92/61/EEC 2002/24/EC of the European Parliament and of the Council[32] 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles;

3.6.(f) equipment classified as no higher than category I under Article 9 of this Directive and covered by one of the following Directives:

(i) Directive 89/392/EEC 2006/42/EC of the European Parliament and of the Council[33] 14 June 1989 on the approximation of the laws of the Member States relating to machinery,;

(ii) Directive 95/16/EC of 29 June 1995 the European Parliament and of the Council[34] on the approximation of the laws of the Member States relating to lifts,;

(iii) Directive 73/23/EEC 2006/95/EC of the European Parliament and of the Council[35] 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits,;

(iv) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices[36],;

(v) Directive 90/396/EEC 2009/142/EC of the European Parliament and of the Council[37] 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels,;

(vi) Directive 94/9/EC of the European Parliament and of the Council[38] of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres;

3.7.(g) equipment covered by Article 223 Ö 346 Õ (1) (b) of the Treaty;

3.8.(h) items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;

3.9.(i) well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and/or control well pressure;, Tthis Ö shall Õ comprises the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;

3.10.(j) equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor;, Ssuch equipment may include:

(i) engines including turbines and internal combustion engines;

(ii) steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;.

3.11.(k) blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-melting, de-gassing and casting of steel and non-ferrous metals;

3.12.(l) enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;

3.13.(m) pressurized pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;

3.14.(n) ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;

3.15.(o) pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;

3.16.(p) exhaust and inlet silencers;

3.17.(q) bottles or cans for carbonated drinks for final consumption;

3.18.(r) vessels designed for the transport and distribution of drinks having a PS·V of not more than 500 bar·L and a maximum allowable pressure not exceeding 7 bar;

ê 97/23/EC (adapted)

3.19.(s) equipment covered by Ö Directive 2008/68/EC and Directive 2010/35/EU and equipment covered by Õ ADR[39], the RID[40], the Ö International Maritime Dangerous Goods Code Õ (IMDG)[41] and the Ö Convention on International Civil Aviation Õ (ICAO Convention)[42];

ê 97/23/EC

3.20.(t) radiators and pipes in warm water heating systems;

3.21.(u) vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.

ê 97/23/EC (adapted)

Article 2

Ö Definitions Õ

For the purposes of this Directive Ö the following definitions apply Õ :

2.1.(1) ‘Ppressure equipment’ means vessels, piping, safety accessories and pressure accessories., Ö including, Õ Wwhere applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifting lugs, etc.;

ê 97/23/EC

2.1.1.(2) ‘Vvessel’ means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment;, Aa vessel may be composed of more than one chamber.;

2.1.2.(3) ‘Ppiping’ means piping components intended for the transport of fluids, when connected together for integration into a pressure system;, Ppiping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate;, Hheat exchangers consisting of pipes for the purpose of cooling or heating air shall be considered as piping.;

ê 97/23/EC (adapted)

2.1.3.(4) ‘Ssafety accessories’ means devices designed to protect pressure equipment against the allowable limits being exceeded., Such devices include Ö including Õ devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and «safety related measurement control and regulation (SRMCR)» devices.;

ê 97/23/EC

2.1.4.(5) ‘Ppressure accessories’ means devices with an operational function and having pressure-bearing housings.;

2.1.5.(6) ‘Aassemblies’ means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.;

2.2.(7) ‘Ppressure» means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is designated by a negative value.;

2.3.(8) ‘Mmaximum allowable pressure PS’ means the maximum pressure for which the equipment is designed, as specified by the manufacturer.,

ê 97/23/EC (adapted)

It is Ö and Õ defined at a location specified by the manufacturer Ö him, being either Õ . This must be the location of Ö the Õ connection of protective and/or limiting devices, or the top of equipment or, if not appropriate, any point specified.

ê 97/23/EC

2.4.(9) ‘Mmaximum/minimum allowable temperature TS’ means the maximum/minimum temperatures for which the equipment is designed, as specified by the manufacturer.;

2.5.(10) ‘Vvolume (V)’ means the internal volume of a chamber, including the volume of nozzles to the first connection or weld and excluding the volume of permanent internal parts.;

2.6.(11) ‘Nnominal size (DN)’ means a numerical designation of size which is common to all components in a piping system other than components indicated by outside diameters or by thread size;, Iit is a convenient round number for reference purposes and is only loosely related to manufacturing dimensions;, Tthe nominal size is designated by DN followed by a number.;

2.7.(12) ‘Ffluids’ means gases, liquids and vapours in pure phase as well as mixtures thereof. A fluid may contain a suspension of solids.;

2.8.(13) ‘Ppermanent joints’ means joints which cannot be disconnected except by destructive methods.;

2.9.(14) ‘European approval for materials’ means a technical document defining the characteristics of materials intended for repeated use in the manufacture of pressure equipment which are not covered by any harmonised standard.;

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(15) ‘making available on the market’ means any supply of pressure equipment for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(16) ‘placing on the market’ means the first making available of pressure equipment on the Union market;

(17) ‘manufacturer’ means any natural or legal person who manufactures pressure equipment or has such equipment designed or manufactured, and markets that product under his name or trademark;

(18) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

(19) ‘importer’ means any natural or legal person established within the Union who places pressure equipment from a third country on the Union market;

(20) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes pressure equipment available on the market;

(21) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(22) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by pressure equipment, process or service;

(23) ‘harmonised standard’ means harmonised standard as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012;

(24) ‘accreditation’ means accreditation as defined in Article 2(10) of Regulation (EC) No 765/2008;

(25) ‘national accreditation body’ means national accreditation body as defined in Article 2(11) of Regulation (EC) No 765/2008;

(26) ‘conformity assessment’ means the process demonstrating whether the requirements of this Directive relating to pressure equipment, process, service, or a system have been fulfilled;

(27) ‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

(28) ‘recall’ means any measure aimed at achieving the return of pressure equipment that has already been made available to the user;

(29) ‘withdrawal’ means any measure aimed at preventing pressure equipment in the supply chain from being made available on the market;

(30) ‘CE marking’ means a marking by which the manufacturer indicates that the pressure equipment and/or the assembly is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;

(31) ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products.

ê 97/23/EC (adapted)

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Article 23

Market surveillance Ö Making available on the market and putting into service Õ

1. Member States shall take all appropriate measures to ensure that the pressure equipment and the assemblies referred to in Article 1 may be placed ð made available ï on the market and put into service only if, when properly installed and maintained and used for their intended purpose, they do not endanger the health and safety of persons and, where appropriate, domestic animals or property ð they satisfy the requirements of this Directive ï .

2. The provisions of Tthis Directive shall not affect Member States' entitlement to lay down, with due regard to the provisions of the Treaty, such requirements as they may deem necessary to ensure that persons and, in particular, workers are protected during use of the pressure equipment or assemblies in question provided that this does not mean modifications to such equipment or assemblies in a way not specified in this Directive.

3. At trade fairs, exhibitions, demonstrations, etc., Ö and other similar events, Õ Member States shall not prevent the showing of pressure equipment or assemblies as defined in Article 1 not in conformity Ö which do not comply Õ with the provisions of this Directive, provided that a visible sign clearly indicates their non-conformity and their non-availability for sale until Ö they are Õ brought into conformity by the manufacturer or by his authorized representative established within the Community. During demonstrations, appropriate safety measures shall be taken in accordance with any requirements laid down by the competent authority of the Member State concerned in order to ensure the safety of persons.

Article 34

Technical requirements

1. The Ö following Õ pressure equipment referred to in 1.1, 1.2, 1.3 and 1.4 must satisfy the essential Ö safety Õ requirements set out in Annex I:

ê 97/23/EC

è1 Corrigendum 97/23/EC

1.1.(a) Vvessels, except those referred to in 1.2 point (b) for:

(ai) gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure, (1013 mbar) within the following limits:

– for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 25 bar·L, or with a pressure PS greater than 200 bar (Annex II, table 1),;

– for fluids in Group 2, with a volume greater than 1 L and a product of PS and V is greater than 50 bar·L, or with a pressure PS greater than 1000 bar, and all portable extinguishers and bottles for breathing apparatus (Annex II, table 2);

(bii) liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal atmospheric pressure (1013 mbar) within the following limits:

– for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 200 bar·L, or with a pressure PS greater than 500 bar (Annex II, table 3),;

– for fluids in Group 2 with a pressure PS greater than 10 bar and a product of PS and V greater than 10000 bar·L, or with a pressure PS greater than 1000 bar (Annex II, table 4).

1.2.(b) Ffired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or super-heated water at temperatures higher than è1 110 °C ç having a volume greater than 2 L, and all pressure cookers (Annex II, table 5).

1.3.(c) Ppiping intended for:

(ai) gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1013 mbar) within the following limits:

– for fluids in Group 1 with a DN greater than 25 (Annex II, table 6),;

– for fluids in Group 2 with a DN greater than 32 and a product of PS and DN greater than 1000 bar (Annex II, table 7);

(bii) liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal atmospheric pressure (1013 mbar), within the following limits:

– for fluids in Group 1 with a DN greater than 25 and a product of PS and DN greater than 2000 bar (Annex II, table 8),;

– for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and a product of PS and DN greater than 5000 bar (Annex II, table 9).

ê 97/23/EC (adapted)

1.4.(d) Ssafety and pressure accessories intended for equipment covered by 1.1, 1.2 and 1.3 subparagraphs (a), (b), and (c) including where such equipment is incorporated into an assembly.

2. The Ö following Õ assemblies defined in Article 1, section 2.1.5, which include at least one item of pressure equipment covered by section paragraph 1 of this Article and which are listed in 2.1, 2.2 and 2.3 of this Article must satisfy the essential Ö safety Õ requirements set out in Annex I.

ê 97/23/EC

è1 Corrigendum 97/23/EC

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2.1.(a) Aassemblies intended for generating steam or superheated water at a temperature higher than è1 110 °C ç comprising at least one item of fired or otherwise heated pressure equipment presenting a risk of overheating.

2.2.(b) Aassemblies other than those referred to in 2.1 point (a), if the manufacturer intends them to be placed ð made available ï on the market and put into service as assemblies.

ê 97/23/EC (adapted)

ð new

2.3. By way of derogation from the first subparagraph introductory paragraph to this section, assemblies intended for generating warm water at temperatures not greater than 110 °C which are manually fed with solid fuels and have a PS·V greater than 50 bar·L must comply with the essential Ö safety Õ requirements referred to in points 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I.

3. Pressure equipment and/or assemblies below or equal to the limits Ö set out Õ in sections 1.1, 1.2 points (a), (b) and (c) of paragraph 1 and in paragraph 2 and 1.3 and section 2 respectively must Ö shall Õ be designed and manufactured in accordance with the sound engineering practice of a Member State in order to ensure safe use. Pressure equipment and/or assemblies must be accompanied by adequate instructions for use and must bear markings to permit identification of the manufacturer or of his authorized representative established within the Community. Such equipment and/or assemblies must Ö shall Õ not bear the CE marking referred to in Article 1518.

Article 45

Free movement

1. 1.1. Member States shall not, on grounds of the hazards Ö risks Õ due to pressure, prohibit, restrict or impede the placing ð making available ï on the market or Ö the Õ putting into service under the conditions specified by the manufacturer of pressure equipment or assemblies referred to in Article 1 which comply with this Directive and bear the CE marking indicating that they have undergone conformity assessment in accordance with Article 10.

1.2. Member States shall not, on grounds of the hazards Ö risks Õ due to pressure, prohibit, restrict or impede the placing ð making available ï on the market or Ö the Õ putting into service of pressure equipment or assemblies which comply with Article 34(3).

2. Member States may require, to the extent that it is needed for safe and correct use of pressure equipment and assemblies, the information referred to in Annex I sections points 3.3 and 3.4 of Annex I to be provided in the official language(s) of the Community Ö Union Õ which may be determined in accordance with the Treaty by the Member State in which the equipment or assembly reaches the final user.

14.2.3. When a Member State has designated a user inspectorate in accordance with the criteria Ö requirements Õ set out in this Article ð 25 ï , it may not, on grounds of the hazards Ö risks Õ due to pressure, prohibit, restrict or impede the placing on the market or putting into service under the conditions provided for in this Article 16, of pressure equipment or assemblies the conformity of which has been assessed by a user inspectorate designated by another Member State in accordance with the criteria Ö requirements Õ set out in this Article ð 25 ï .

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CHAPTER 2

OBLIGATIONS OF ECONOMIC OPERATORS

Article 6 [Article R2 of Decision No 768/2008/EC]

Obligations of manufacturers

1. When placing their pressure equipment referred to in Article 4(1) and (2) on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements set out in Annex I.

When placing their pressure equipment referred to in Article 4(3) on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the sound engineering practice of a Member State.

2. For pressure equipment referred to in Article 4(1) and (2), manufacturers shall draw up the technical documentation referred to in Annex II and carry out the conformity assessment procedure referred to in Article 14 or have it carried out.

Where compliance of pressure equipment referred to in Article 4(1) and (2), with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the pressure equipment has been placed on the market.

4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in pressure equipment design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of pressure equipment is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by pressure equipment, manufacturers shall, to protect the health and safety of consumers and other users, carry out sample testing of pressure equipment made available on the market, investigate, and, if necessary, keep a register of complaints of non-conforming pressure equipment and recalls of such equipment, and shall keep distributors informed of any such monitoring.

5. Manufacturers shall ensure that their pressure equipment bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the equipment does not allow it, that the required information is provided on the packaging or in a document accompanying the equipment.

6. Manufacturers shall indicate their name, registered trade name or registered trade mark, the postal address, and, if available, the website address at which they can be contacted on the pressure equipment or, where that is not possible, on their packaging or in a document accompanying the equipment. The address must indicate a single point at which the manufacturer can be contacted.

7. Manufacturers shall ensure that the pressure equipment referred to in Article 4(1) and (2), is accompanied by instructions and safety information in accordance with points 3.3 and 3.4 of Annex I, in a language which can be easily understood by consumers and other users, as determined by the Member State concerned. Such instructions and safety information shall be clear, understandable and intelligible.

Manufacturers shall ensure that the pressure equipment referred to in Article 4(3), is accompanied by instructions and safety information in accordance with Article 4(3), in a language which can be easily understood by consumers and other users, as determined by the Member State concerned. Such instructions and safety information shall be clear, understandable and intelligible.

8. Manufacturers who consider or have reason to believe that the pressure equipment which they have placed on the market is not in conformity with this Directive shall immediately take the necessary corrective measures necessary to bring that pressure equipment into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the pressure equipment presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the pressure equipment available on the market to that effect, giving details, in particular, of the noncompliance and of any corrective measures taken.

9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the pressure equipment with this Directive, in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the pressure equipment which they have placed on the market.

Article 7 [Article R3 of Decision No 768/2008/EC]

Authorised representatives

1. A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 6(1) and the drawing up of technical documentation shall not form part of the authorised representative's mandate.

2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a) keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for 10 years after the pressure equipment has been placed on the market;

(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the pressure equipment;

(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by pressure equipment covered by the authorised representative’s mandate.

Article 8 [Article R4 of Decision No 768/2008/EC]

Obligations of importers

1. Importers shall place only compliant pressure equipment on the market.

2. Before placing on the market pressure equipment referred to in Article 4(1) and (2), importers shall ensure that the appropriate conformity assessment procedure in accordance with Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the pressure equipment bears the CE marking and is accompanied by instructions and safety information in accordance with points 3.3 and 3.4 of Annex I, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).

Before placing on the market pressure equipment referred to in Article 4(3), importers shall ensure that the manufacturer has drawn up the technical documentation and that the pressure equipment is accompanied by adequate instructions for use and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).

Where an importer considers or has reason to believe that pressure equipment is not in conformity with the essential safety requirements set out in Annex I, he shall not place the pressure equipment on the market until it has been brought into conformity. Furthermore, where the pressure equipment presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

3. Importers shall indicate their name,