application guide of 2014/34/EU directive - preambule, citations and recitals

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DIRECTIVE 2014/34/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February 2014

on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)

(Text with EEA relevance)

PREAMBLE TO THE ATEX DIRECTIVE - THE CITATIONS AND THE RECITALS

§ 1    The citations

The citations included in the preamble to the ATEX Directive 2014/34/EU indicate the legal basis of the Directive, the opinions expressed by the relevant consultative Committee and the procedure according to which the Directive was adopted.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal 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 (1),

Acting in accordance with the ordinary legislative procedure (2),

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(1) OJ C 181, 21.6.2012, p. 105.

(2) Position of the European Parliament of 5 February 2014.

§ 2    The legal basis of the ATEX Directive

The legal basis of the ATEX Directive 2014/34/EU is provided by Article 114 of the Treaty on the Functioning of the European Union (TFEU)[1] (ex-Article 95 of the EC Treaty)[2] that enables the European Union to adopt measures to harmonise the legislation of the Member States in order to ensure the establishment and functioning of the single internal market. Such measures must take as a basis the highest possible level of protection of the health and safety of people and of the environment. The Directive thus has a dual objective: to permit the free movement of products with the internal market whilst ensuring a high level of protection of health and safety.

Following the proposal by the European Commission, the Directive was adopted by the European Parliament and the Council of the European Union after consulting the European Economic and Social Committee, according to the ordinary legislative procedure (formerly known as “co-decision”) set out in Article 294 of the TFEU.

The footnotes to the citation give the references and dates of the successive steps of the procedure. The text of the ATEX Directive 2014/34/EU was published on the Official Journal of the European Union (OJEU) L 96, 29.3.2014, p. 309.

§ 3    The recitals

The recitals, also known as consideranda, introduce the main provisions of the Directive and present the reasons for their adoption. Some of the recitals explain the changes that have been made in the new ATEX Directive 2014/34/EU compared with the previous Directive 94/9/EC (basically, the alignment to the New Legislative Framework through the provisions of Decision No 768/2008/EC: see section § 5).

The recitals do not have legal force as such and do not usually figure in the national legislation transposing and implementing the Directive. However, they help to understand the Directive, in particular, by clarifying the meaning of certain provisions. When interpreting the text of the Directive, the Courts may take the recitals into consideration in order to ascertain the intention of the legislators.

In the following comments, reference is made to the Articles and Annexes of the Directive introduced by each of the recitals. For further explanations, please refer to the comments on the Articles and Annexes concerned.

(1)          Directive 94/9/EC of the European Parliament and of the Council 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) has been substantially amended (4). Since further amendments are to be made, that Directive should be recast in the interests of clarity.

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(3) OJ L 100, 19.4.1994, p. 1.

(4) See Annex XI, Part A.

§ 4    The previous ATEX Directive

The first recital recalls that the new ATEX Directive 2014/34/EU is based on the previous Directive 94/9/EC. This Directive was a total harmonisation directive, i.e. its provisions replaced existing divergent national and European legislation which covered the same subjects. In particular, the previous ATEX Directive replaced and repealed, as from 1 July 2003, a framework Directive on electrical equipment for use in potentially explosive atmospheres (76/11/EEC)[3] and a Directive concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to fire damp (82/130/EEC)[4].

Directive 94/9/EC was subject to two corrigenda[5] and two amendments[6]. It was applicable from 1 July 2003 and remained in force until 19 April 2016.

Directive 2014/34/EU is termed as a recast of the ATEX Directive since the modifications are presented in the form of a new Directive.

(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 (5) 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 (6) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Directive 94/9/EC should be adapted to that Decision.

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(5) OJ L 218, 13.8.2008, p. 30.

(6) OJ L 218, 13.8.2008, p. 82.

§ 5    The New Legislative Framework

The new ATEX Directive 2014/34/EU is the result of the alignment of the previous Directive 94/9/EC to the “New Legislative Framework” (NLF), configured as the improvement and update of the regulatory method known as the “New Approach to technical harmonisation and standards”. The set of legislative acts of the NLF includes the Regulation (EC) No 765/2008 and the Decision No 768/2008/EC.

See also § 1.2. “The 'New Legislative Framework'” in “The 'Blue Guide' on the implementation of EU product rules”.

In particular, the new contents in Directive 2014/34/EU related – among others – to definitions and obligations of economic operators, to notified bodies, to conformity assessment procedures and declaration of conformity, come directly from the NLF Decision, as additions and/or terminology adaptation.

(4)          This Directive covers products which are new to the Union market when they are placed on the market; that is to say they are either new products made by a manufacturer established in the Union or products, whether new or second-hand, imported from a third country.

(5)          This Directive should apply to all forms of supply, including distance selling.

§ 6    The scope and the objective of the ATEX Directive

The scope and the objective of the ATEX Directive remain unchanged from the previous Directive 94/9/EC to the new Directive 2014/34/EU, to ensure free movement for the products to which it applies in the EU territory. Therefore, the ATEX Directive provides for harmonised requirements and procedures to establish compliance for products placed on the EU market for the first time.

The ATEX Directive carries specific obligations for the person (natural or legal) who places products on the market and/or puts products into service, be it the manufacturer, its authorised representative, the importer, the distributor or any other responsible person. The Directive does not regulate the use of equipment in a potentially explosive atmosphere which is covered by different EU or national legislation: for instance, the ATEX “workplace” Directive 1999/92/EC (see footnote 7).

The Directive is applicable to all forms of making products available on the EU market, regardless of the selling technique. Therefore, it includes distance selling and selling through electronic means (Internet, e-commerce…), as the whole EU harmonisation legislation.

(6)          It is the duty of Member States to protect, on their territory, the health and safety of persons, especially workers, and, where appropriate, domestic animals and property, especially against the hazards resulting from the use of equipment and systems providing protection against potentially explosive atmospheres.

§ 7    Health and safety

The obligations for Member States related to health and safety are based on the provisions of the Treaty on the Functioning of the European Union (TFEU), in particular Articles 4, 36, 114, 153 and 169.

The protection of health and safety is both a fundamental duty and a prerogative of the Member States. Since the ATEX Directive 2014/34/EU harmonises the health and safety requirements for the design and construction of equipment and protective systems for use in potentially explosive atmospheres at EU level, the responsibility of Member States to protect health and safety of persons etc. with regards to the associated risks implies that the requirements of the ATEX Directive are correctly applied.

It should be recalled that the use of equipment in a potentially explosive atmosphere is covered by the ATEX “workplace” Directive 1992/92/EC (see footnote 7). This Directive specifies minimum requirements and can be added to by national requirements of the Member States.

(7)          Directive 94/9/EC has made positive steps towards effective protection against explosion hazards for both mining and surface equipment. Those two groups of equipment are used in a large number of commercial and industrial sectors and possess considerable economic significance.

§ 8    Protection against explosion hazards

The new ATEX Directive 2014/34/EU ensures continuity with the substantial provisions of the previous Directive 94/9/EC, recognising its positive contribution to health and safety by providing for protection against explosion hazards for both mining and surface equipment during almost 13 years of operation in the European Union.

(8)          Compliance with the health and safety requirements is essential in order to ensure the safety of equipment and protective systems. Those requirements should be subdivided into general and additional requirements which need to be met by equipment and protective systems. In particular, the additional requirements should take account of existing or potential hazards. Equipment and protective systems should, therefore, meet at least one of those requirements where this is necessary for their proper functioning or is to apply to their intended use. The notion of intended use is of prime importance for the explosion-proofing of equipment and protective systems. It is essential that manufacturers supply full information. Specific, clear marking of equipment and protective systems, stating their use in a potentially explosive atmosphere, should also be necessary.

(9)          Compliance with the essential health and safety requirements laid down in this Directive should be imperative in order to ensure the safety of equipment and protective systems. For the implementation of those requirements, both the technology obtained at the time of manufacture and overriding technical and economic requirements should be taken into account.

§ 9    Safety of ATEX equipment and protective systems: essential health and safety requirements

According to the principles and objectives of the New Approach and the New Legislative Framework, essential requirements regarding health and safety need to be defined through which a high level of protection will be ensured. These essential health and safety requirements (EHSRs) are listed in Annex II to the ATEX Directive 2014/34/EU and are specific with respect to:

  • potential ignition sources of equipment intended for use in potentially explosive atmospheres;
  • autonomous protective systems intended to come into operation following an explosion with the prime objective to halt the explosion immediately and/or limit the effects of explosion flames and pressures;
  • safety devices intended to contribute to the safe functioning of such equipment with respect to ignition source and to the safe functioning of autonomous protective systems;
  • components with no autonomous function essential to the safe functioning of such equipment or autonomous protective system(s).

Since 1 July 2003 relevant products could only be placed on the market in the EU territory[7], freely moved and operated as designed and intended in the expected environment if they comply with the ATEX Directive (and other relevant legislation), that is to say, Directive 94/9/EC – until 19 April 2016 – or Directive 2014/34/EU – from 20 April 2016.

Directive 2014/34/EU provides for harmonised requirements for electrical and non-electrical equipment, intended for use in environments which are potentially explosive due to dust or gas hazards, and protective systems. Safety devices intended for use outside explosive atmospheres which are required for or contribute to the safe functioning of equipment or protective systems with respect to risks of explosion are also included.

(10)        Economic operators should be responsible for the compliance of products with this Directive, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of health and safety of persons, especially workers, and, where appropriate, protection of domestic animals and property, and to guarantee fair competition on the Union market.

(11)        All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market products which are 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.

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

§ 10  Responsibilities of economic operators

Union harmonisation legislation defines the manufacturer, the authorised representative, the importer and the distributor as “economic operators”. Within the New Legislative Framework, the responsibilities and obligations of the economic operators are defined more in detail: all of them have to play key roles in the supply chain, in particular in terms of compliance of products, appropriate measures, communication and co-operation.

See also § 3 “The actors in the product supply chain and their obligations" in “The 'Blue Guide' on the implementation of EU product rules”.

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

§ 11  Responsibilities of manufacturers: conformity assessment

Conformity assessment according to the conformity assessment procedures applicable to the product, is the responsibility of the manufacturer only, whether the Directive provides for the involvement of a notified conformity assessment body, or not.

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

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

§ 12  Responsibilities of importers

The importer is the economic operator established in the Union who places a product from a third country on the Union market for the first time. He has important and clearly defined responsibilities under the Directive. To a large extent they build on the type of responsibilities which a manufacturer based in the EU is subjected to.

The importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple re-seller of products, but has a key role to play in guaranteeing the compliance of imported products.

(16)        The distributor makes a product 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 product does not adversely affect the compliance of the product.

§ 13  Responsibilities of distributors

Along with manufacturers and importers, distributors are the third category of economic operators who are subject to specific obligations. The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.

Retailers, wholesalers and other distributors in the supply chain are not required to have a preferential relationship with the manufacturer like the authorised representative. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor.

Distributors must act with due care in relation to the applicable requirements of the Directive. Due care refers to the effort made by an ordinarily prudent or reasonable party to avoid harm to another, taking the circumstances into account. It refers to the level of judgment, precaution, prudence, determination and activity that a person would reasonably be expected to do under particular circumstances.

They have to know, for instance, which products must bear the CE marking, what information is to accompany the product (for example the EU declaration of conformity), what are the language requirements for labelling, user instructions or other accompanying documents, and what is a clear indication of the product being non-compliant. Distributors have an obligation to demonstrate to the national market surveillance authority that they have acted with due care and ensure that the manufacturer, or his authorised representative, or the person who provided him with the product has taken the measures required by the Directive as listed in the responsibilities and obligations for distributors, as far as can be reasonably expected.

(17)        Any economic operator that either places a product on the market under his own name or trade mark or modifies a product in such a way that compliance with this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

§ 14  Obligations of the manufacturer for economic operators

If the product is marketed under another person’s name or trademark, this person will be considered as the manufacturer.

The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes or labels ready-made products and places them on the market under his own name or trademark. Further, the responsibility of the manufacturer is placed on any person who changes the intended use of a product in such a way that different essential or other legal requirements will become applicable, or substantially modifies or re-builds a product (thus creating a new product), with a view to placing it on the market.

(18)        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 product concerned.

(19)        Ensuring traceability of a product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant products available on the market. When keeping the information required under this Directive for the identification of other 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 product or to whom they have supplied a product.

§ 15  Information and traceability of products for market surveillance

Economic operators (manufacturers, distributors and importers) must co-operate with national authorities to carry out effective market surveillance activities, including provision of information and ensuring the traceability of products throughout the whole supply chain.

(20)        This Directive should be limited to the expression of the essential health and safety requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for a presumption of conformity for products which are 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 (1) for the purpose of expressing detailed technical specifications of those requirements.

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(1) OJ L 316, 14.11.2012, p. 12.

§ 16  Essential health and safety requirements: presumption of conformity from harmonised standards

The ATEX Directive 2014/34/EU relies on the regulatory method known as the "New Approach to technical harmonisation and standards”, as aligned to the “New Legislative Framework”. The legislation itself sets out the mandatory essential health and safety requirements (EHSRs) that products placed on the EU market must fulfil, and the procedures for assessing their conformity.

Detailed technical solutions for complying with these EHSRs are given in European harmonised standards, defined and adopted according to the Regulation (EU) No 1025/2012 (the "Standardisation Regulation"), in particular Articles 2 and 10. Application of harmonised standards remains voluntary, but confers a presumption of conformity with the EHSRs they cover.

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

§ 17  Formal objections to harmonised standards

Article 11 of the Standardisation Regulation (EU) No 1025/2012 sets out the procedure for disputing a harmonised standard – the "formal objection" procedure – where the standard is considered by a Member State or by the European Parliament to not entirely satisfy the requirements which it aims to cover and which are set out in the relevant EU product legislation.

(22)        In order to enable economic operators to demonstrate and the competent authorities to ensure that products made available on the market conform to the essential health and safety requirements it is necessary to provide for conformity assessment procedures. 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.

§ 18  Conformity assessment procedures

Among the modules established by the "New Legislative Framework" Decision No 768/2008/EC, the ATEX Directive 2014/34/EU includes seven modules for conformity assessment procedures (Annexes III to IX) for assessing the conformity of equipment and protective systems intended for use in potentially explosive atmospheres with the applicable essential health and safety requirements.

See also § 5.1. "Modules for conformity assessment" in “The 'Blue Guide' on the implementation of EU product rules”.

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

(24)        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. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.

§ 19  EU declaration of conformity

Recitals 23 and 24 introduce the provisions related to the EU declaration of conformity, to be drafted up by the manufacturer for products to be placed on the EU market. The ATEX Directive 2014/34/EU includes such provisions in Article 14 and in Annex X.

See also § 4.4 "EU Declaration of conformity" in “The 'Blue Guide' on the implementation of EU product rules”.

(25)        The CE marking, indicating the conformity of a product, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking should be laid down in this Directive.

§ 20  The CE marking

Recital 25 introduces the provisions related to the CE marking, making reference to the general principles set out in Article 30 of the "New Legislative Framework" Regulation (CE) No 765/2008. The ATEX Directive 2014/34/EU includes the reference to those provisions as well as the rules and conditions for affixing the CE marking, and other markings, in Articles 15 and 16.

See also § 4.5.1 "CE marking" in “The 'Blue Guide' on the implementation of EU product rules”.

(26)        Certain 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.

(27)        Experience has shown that the criteria set out in Directive 94/9/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 notified bodies throughout the Union. It is, however, essential that all notified 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.

(28)        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.

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

(30)        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.

(31)        Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, 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.

(32)        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 products 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.

(33)        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.

(34)        Since notified 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.

(35)        In the interests of competitiveness, it is crucial that notified 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 notified bodies.

§ 21  Conformity assessment bodies: notified bodies

Conformity assessment bodies, known as notified bodies for being notified by the competent national authorities of the EU Member States to the Commission and to the other Member States, are required to intervene in a number of conformity assessment procedures of Directive 2014/34/EU, as indicated in:

  • Annex III: EU-type examination
  • Annex IV: Quality assurance of the production process
  • Annex V: Product verification
  • Annex VI: Internal production control plus supervised product testing
  • Annex VII: Product quality assurance
  • Annex IX: Unit verification

The ATEX Directive devotes the whole Chapter 4 – Articles 17 to 33 – to notified bodies, basically reproducing the relevant contents of the Decision No 768/2008/EC. Rules on accreditation for notified bodies are provided in the Regulation (EC) No 765/2008.

See also §§ 5.2 "Conformity assessment bodies" and 5.3 “Notification", as well as § 6 "Accreditation", in “The 'Blue Guide' on the implementation of EU product rules”,

(36)        Member States should take all appropriate measures to ensure that products covered by this Directive 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. Products covered by this Directive should be considered as non-compliant with the essential health and 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.

(37)        In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to products covered by this Directive. This Directive should not prevent Member States from choosing the competent authorities to carry out those tasks.

§ 22  Compliance of products on the market and market surveillance

The term "market surveillance" designates the activity of the competent national authorities of the Member States, checking the conformity of products subject to the EU harmonisation legislation, after they have been placed on the market or put into service on the EU market, and taking the necessary action to deal with non-compliant products.

See also § 7 "Market surveillance" in “The 'Blue Guide' on the implementation of EU product rules”.

(38)        Directive 94/9/EC already provides for a safeguard procedure which is necessary to allow the possibility for contesting the conformity of a product. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States.

(39)        The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to products presenting a risk to the health or safety of persons, especially workers, or to domestic animals or property. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such products.

(40)        Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.

§ 23  The safeguard clause procedure

The new "safeguard clause procedure" for dealing with non-compliant and dangerous products under the ATEX Directive 2014/34/EU comes from the Decision No 768/2008/EC, with the aim to make it more efficient and effective in terms of information, communication, resources and results.

See also § 7.4 "Safeguard mechanisms for Member States" in “The 'Blue Guide' on the implementation of EU product rules”.

When non-compliance is related to shortcomings of a harmonised standard, the "formal objection" procedure applies (see section § 17).

(41)        In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on 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 Member States of the Commission's exercise of implementing powers (1).

(42)        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.

(43)        The examination procedure should be used for the adoption of implementing acts with respect to compliant products which present a risk to the health or safety of persons or to other aspects of public interest protection.

(44)        The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant products which present a risk to the health or safety of persons or to domestic animals or property, imperative grounds of urgency so require.

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(1) OJ L 55, 28.2.2011, p. 13.

§ 24  Implementing powers and procedures

Implementing powers are conferred and monitored by the EU legislators (European Parliament and the Council) to the European Commission to ensure that certain measures are uniformly implemented across the EU, in accordance with Article 291 of the Treaty on the Functioning of the European Union (TFEU). Regulation (EU) No 182/2011 (the "Comitology Regulation") establishes the rules and general principles on the exercise of such implementing powers by the Commission.

Within the ATEX Directive 2014/34/EU, adoption of an implementing act is required in case of objections raised concerning a notified body (see section § 107), and in case of compliant products on the market presenting a risk. According to Article 2(2) and (3) of Regulation (EU) No 182/2011, the examination procedure applies for implementing acts with respect to products, being related to "protection of the health or safety of humans and animals" (b)(iii), when the advisory procedure applies for implementing acts on corrective measures in respect of notified bodies (see also section § 26).

(45)        In line with established practice, the committee set up by this Directive can play a useful role in examining matters concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.

(46)        When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and, where appropriate, an invitation to attend such meetings.

§ 25  The ATEX Committee

The ATEX Directive 2014/34/EU confirms the role of the ATEX Committee in examining different questions related to the implementation, application and management of the Directive. Specific provisions related to the committee procedure are set out in Article 39 of the Directive.

Under the Regulation (EU) No 182/2011 (the "Comitology Regulation"), the ATEX Committee has an obligation of information and documentation to the European Parliament, about the issues under discussion, other than those specifically related to the implementation or infringements of the Directive.

 (47)       The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant products are justified or not.

§ 26  Implementing acts concerning measures on non-compliant products

Adoption of an implementing act by the Commission is required not only in cases related to notified bodies or to compliant products presenting a risk (see section § 24), but also when Member States take actions in respect of non-compliant products (the safeguard clause procedure – see section § 23).

(48)        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 those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.

§ 27  Enforcement: penalties

Recital (48) corresponds to Article 40 of the Directive.

(49)        It is necessary to provide for reasonable transitional arrangements that allow the making available on the market and putting into service, without the need to comply with further product requirements, of products that have already been placed on the market in accordance with Directive 94/9/EC before the date for application of national measures transposing this Directive. Distributors should therefore be able to supply products that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of national measures transposing this Directive.

§ 28  Transitional arrangements

Specific transitional provisions for products and certificates, from the previous ATEX Directive 94/9/EC to the new 2014/34/EU, are provided for in Article 41. These are in line with the other Directives aligned to the New Legislative Framework.

 (50)       Since the objective of this Directive, namely to ensure that products on the market fulfil the requirements providing for a high level of protection of health and safety of persons, especially workers, and, where appropriate, protection of domestic animals and property, while guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather, 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.

§ 29  Subsidiarity and proportionality

Recital 50 is a justification of the ATEX Directive 2014/34/EU with respect to the principles of subsidiarity and proportionality set out in Article 5 of the Treaty on European Union (TEU). According to these principles, the European Union shall take action only if the same objectives cannot be better achieved by the action of the Member States.

In fact, it is clear that without the Directive, manufacturers of equipment and equipment for potentially explosive atmospheres would have to apply different rules, requirements and procedures for safety of products in each EU Member State, which would both constitute a serious obstacle to the single internal market (free circulation of goods) and be a less effective means of ensuring and improving safety of ATEX products.

(51)        The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to the earlier Directive. The obligation to transpose the provisions which are unchanged arises under the earlier Directive.

(52)        This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and the dates of application of the Directive set out in Annex XI, Part B,

§ 30  Transposition

Transposition provisions are provided for in Article 42 of the Directive.

 

[1] OJ C 326, 26.10.2012, p. 47.

[2] Sometimes the ATEX “product” Directive (94/9/EC until 19 April 2016; 2014/34/EU as by 20 April 2016) is still referred to as “the ATEX 95 Directive”, when the ATEX “workplace” Directive 1999/92/EC is mentioned as “the ATEX 137 Directive”, being based on the Article 153 of the TFEU (ex-Article 137 of the EC Treaty).

[3] OJ L 24, 31.1.1976, p. 45; as last amended by Directive 90/487/EEC (OJ L 270, 2.10.1990, p. 23).

[4] OJ L 59, 2.3.1982, p. 10.

[5] Corrigendum OJ L 21, 26.1.2000, p. 42, and Corrigendum OJ L 304, 5.12.2000, p. 19.

[6] Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, OJ L 284, 31.10.2003, p. 1, and Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012, OJ L 316, 14.11.2012, p. 12.

[7] Directive 2014/34/EU is also applicable in the EEA territories (see footnote 2) as well in other territories where a suitable international agreement is in operation. See the DG Growth website for more details: http://ec.europa.eu/growth/industry/international-aspects/index_en.htm.

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