DIRECTIVE 94/9/EC OF THE EUROPEAN PARLIAMENT AND 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
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social Committee (2),
Acting in accordance with the procedure referred to in Article 189b of the Treaty establishing the European Community,
Whereas it is the duty of Member States to protect, on their territory, the safety and health of persons and, where appropriate, domestic animals and property and, in particular, that of workers, especially against the hazards resulting from the use of equipment and systems providing protection against potentially explosive atmospheres;
Whereas mandatory provisions within the Member States determine the level of safety to be achieved by protective equipment and systems intended for use in potentially explosive atmospheres; whereas these are generally electrical and non-electrical specifications having an effect on the design and structure of equipment which can be used in potentially explosive atmospheres;
Whereas the requirements to be met by such equipment differ from one Member State to another in respect of their extent and differing inspection procedures; whereas these differences are, therefore, likely to raise barriers to trade within the Community;
Whereas harmonization of national legislation is the only way in which to remove these barriers to free trade; whereas this objective cannot be satisfactorily achieved by the individual Member States; whereas this Directive merely lays down the requirements vital to freedom of movement for the equipment to which it applies;
Whereas the regulations intended to remove technical barriers to trade are required to follow the new approach provided for in the Council resolution of 7 May 1985 (3), 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;
Whereas the existing Directives on the approximation of the laws of the Member States to electrical equipment for use in potentially explosive atmospheres have made positive steps towards protection against explosions via measures linked with the structure of the equipment at issue and which have helped to remove barriers to trade in this area; whereas, in parallel, a revision and expansion of the existing Directives is necessary since, more particularly, in an overall context, action must be taken to guard against the potential hazards arising from such equipment. This implies in particular that measures intended to guarantee effective protection of users and third parties must already be contemplated at the design and manufacturing states;
Whereas the form taken by the hazard, the protective measures and the test methods are often very similar, if not identical, for both mining and surface equipment; whereas it is, therefore, absolutely necessary to cover by a single Directive protective equipment and systems falling within both groups;
Whereas the two groups of equipment referred to above are used in a large number of commercial and industrial sectors and possess considerable economic significance;
Whereas compliance with the basic safety and health requirements is essential in order to ensure the safety of protective equipment and systems; whereas those requirements have been subdivided into general and additional requirements which must be met by protective equipment and systems; whereas, in particular, the additional requirements are intended to take account of existing or potential hazards; whereas protective equipment and systems will, therefore, embody at least one of those requirements where this is necessary for their proper functioning or is to apply to their intended use; whereas the notion of intended use is of prime importance for the explosion-proofing of protective equipment and systems; whereas it is essential that manufacturers supply full information; whereas specific, clear marking of said equipment, stating its use in a potentially explosive atmosphere, is also necessary;
Whereas the intention is to prepare a Directive on operations in potentially explosive atmospheres which is based on Article 118a; whereas that additional Directive will, in particular, aim at explosion hazards which derive from a given use and/or types and methods of installation;
Whereas compliance with essential health and safety requirements is imperative if the safety of equipment is to be ensured; whereas judgment will have to be exercised in the implementation of those requirements in order to take account of both the technology obtaining at the time of manufacture and overriding technical and economic requirements;
Whereas, therefore, this Directive sets out essential requirements only; whereas, in order to facilitate the task of proving compliance with the essential requirements, harmonized European standards are necessary, more especially with regard to the non-electrical aspects of protection against explosions - standards relating to the design, manufacture and testing of equipment, compliance with which enables a product to be presumed to meet such essential requirements; whereas harmonized European standards 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 Electrotechnical Standardization (Cenelec) are recognized as the bodies competent to adopt harmonized standards which follow the general guidelines for cooperation between the Commission and those two bodies, signed on 13 November 1984; 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 prompting of the Commission pursuant to Council Directive 83/189/EEC of the 28 March 1983 providing for a procedure governing the provision of information on technical standards and regulations (1) and pursuant to the general guidelines referred to above;
Whereas the legislative framework should be improved in order to ensure that employers and workers make an effective and appropriate contribution towards the standardization process; whereas this should be completed by the time this Directive is implemented;
Whereas, in view of the nature of the risks involved in the use of equipment in potentially explosive atmospheres it is necessary to establish procedures applying to the assessment of compliance with the basic requirements of the Directives; whereas these procedures must be devised in the light of the level of risk which may be inherent in equipment and/or against which systems must protect the immediate environment; whereas, therefore, each category of equipment conformity must be supplemented by an adequate procedure or a choice between several equivalent procedures; whereas the procedures adopted comply fully with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization Directives (2);
Whereas the Council has provided for the affixing of the CE marking by either the manufacturer or his authorized representative within the Community; whereas that marking means that the product complies with all the basic requirements and assessment procedures provided for by the Community law applying to that product;
Whereas it is appropriate that the Member States, as provided for by Article 100a of the Treaty, may take temporary measures to limit or prohibit the placing on the market and the use of equipment and protective systems in cases where they present 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;
Whereas the recipients of any decision taken as part of this Directive must be aware of the reasons behind that decision and the means of appeal open to them;
Whereas, on 18 December 1985, the Council adopted a framework Directive on electrical equipment for use in potentially explosive atmospheres (76/117/EEC) (3) and, on 15 February 1982, a Directive concerning electrical equipment for use in potentially explosive atmospheres in mines susceptible to fire damp (82/130/EEC) (4); whereas, from the outset of harmonization work, the conversion into total harmonization of the optional and partial harmonization on which these Directives are based had been contemplated; whereas this Directive fully covers the scope of the abovementioned Directives and whereas, therefore, these Directives must be repealed;
Whereas the internal market incorporates an area without internal frontiers within which the free movement of goods, persons, services and capital is assured;
Whereas it is necessary to provide for a transitional arrangement enabling equipment manufactured in compliance with the national regulations in force at the date of adoption of this Directive to be marketed and placed in service,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I Scope, placing on the market and freedom of movement
Article 1
1. This Directive applies to equipment and protective systems intended for use in potentially explosive atmospheres.
2. Safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion are also covered by the scope of this Directive.
3. For the purposes of this Directive, the following definitions shall apply:
Equipment and protective systems intended for use in potentially explosive atmospheres (a) 'Equipment' means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
(b) 'Protective systems' means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems.
(c) 'Components' means any item essential to the safe functioning of equipment and protective systems but with no autonomous function.
Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.
Potentially explosive atmosphere An atmosphere which could become explosive due to local and operational conditions.
Equipment groups and categories Equipment group I applies to equipment intended for use in underground parts of mines, and to those parts of surface installations of such mines, liable to be endangered by firedamp and/or combustible dust.
Equipment group II applies to equipment intended for use in other places liable to be endangered by explosive atmospheres.
The categories of equipment defining the required levels of protection are described in Annex I.
Equipment and protective systems may be designed for a particular explosive atmosphere. In this case, they must be marked accordingly.
Intended use The use of equipment, protective systems, and devices referred to in Article 1 (2) in accordance with the equipment group and category and with all the information supplied by the manufacturer which is required for the safe functioning of equipment, protective systems and devices.
4. The following are excluded from the scope of this Directive:
- medical devices intended for use in a medical environment,
- equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances,
- equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas,
- personal protective equipment covered by Directive 89/686/EEC (1),
- seagoing vessels and mobile offshore units together with equipment on board such vessels or units,
- means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Vehicles intended for use in a potentially explosive atmosphere shall not be excluded,
- the equipment covered by Article 223 (1) (b) of the Treaty.
Article 2
1. Member States shall take all appropriate measures to ensure that the equipment, protective systems and devices referred to in Article 1 (2) to which this Directive applies may be placed 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.
2. The provisions of this Directive shall not affect Member States' entitlement to lay down, in due observance of the provisions of the Treaty, such requirements as they may deem necessary to ensure that persons and, in particular, workers are protected when using the equipment, protective systems, and devices referred to in Article 1 (2) in question provided that this does not mean that such equipment, protective systems, or devices are modified in a way not specified in the Directive.
3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of equipment, protective systems, or the devices referred to in Article 1 (2) which do not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such equipment, protective systems, and devices referred to in Article 1 (2) do not conform and that they are not for sale until they have been brought into conformity by the manufacturer or his authorized representative established in the Community. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons.
Article 3
Equipment, protective systems, and the devices referred to in Article 1 (2) to which this Directive applies must meet the essential health and safety requirements set out in Annex II which apply to them, account being taken of their intended use.
Article 4
1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of equipment, protective systems, or devices referred to in Article 1 (2) which comply with this Directive.
2. Member States shall not prohibit, restrict or impede the placing on the market of components which, accompanied by a certificate of conformity as referred to in Article 8 (3), are intended to be incorporated into equipment or protective systems within the meaning of this Directive.
Article 5
1. Member States shall regard as conforming to all the provisions of this Directive, including the relevant conformity assessment procedures laid down in chapter II:
- equipment, protective systems, and devices referred to in Article 1 (2) accompanied by the EC declaration of conformity referred to in Annex X and bearing the CE marking provided for in Article 10,
- the components referred to in Article 4 (2), accompanied by the certificate of conformity referred to in Article 8 (3).
In the absence of harmonized standards, Member States shall take any steps which they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications regarded as important or relevant to the proper implementation of the essential health and safety requirements in Annex II.
2. Where a national standard transposing a harmonized standard, the reference for which has been published in the Official Journal of the European Communities, covers one or more of the essential health and safety requirements, the equipment, protective system, device referred to in Article 1 (2), or the component referred to in Article 4 (2), constructed in accordance with that standard shall be presumed to comply with the relevant essential health and safety requirements.
Member States shall publish the references of national standards transposing harmonized standards.
3. Member States shall ensure that appropriate measures are taken to enable the social partners to influence the process of preparing and monitoring the harmonized standards at national level.
Article 6
1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 5 (2) do not entirely satisfy the relevant essential health and safety requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the Committee set up under Directive 83/189/EEC, hereinafter referred to as 'the Committee', giving reasons therefor. The Committee shall deliver an opinion without delay.
Upon receipt of the Committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the published information referred to in Article 5 (2).
2. The Commission may adopt any appropriate measure with a view to ensuring the practical application in a uniform manner of this Directive in accordance with the procedure laid down in paragraph 3.
3. The Commission shall be assisted by a Standing Committee, consisting of representatives appointed by the Member States and chaired by a representative of the Commission.
The Standing Committee shall draw up its own rules of procedure.
The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.
4. The Standing Committee may furthermore examine any question relating to the application of this Directive and raised by its chairman either on the latter's initiative, or at the request of a Member State.
Article 7
1. Whee a Member State ascertains that equipment, protective systems or devices referred to in Article 1 (2) bearing the CE conformity marking and used in accordance with their intended use are liable to endanger the safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate meaures to withdraw such equipment or protective systems from the market, to prohibit the placing on the market, putting into service or use thereof, or to restrict free movement thereof.
The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-conformity is due to:
(a) failure to satisfy the essential requirements referred to in Article 3;
(b) incorrect application of the standards referred to in Article 5 (2);
(c) shortcomings in the standards referred to in Article 5 (2).
2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States. Where the Commission considers, after this consultation, that the action is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community. Where the decision referred to in paragraph 1 is based on a shortcoming in the standards and where the Member State at the origin of the decision maintains its position, the Commission shall immediately inform the Committee in order to initiate the procedures referred to in Article 6 (1).
3. Where equipment or a protective system which does not comply bears the CE conformity marking, the competent Member State shall take appropriate action against the person(s) having affixed the marking and shall so inform the Commission and the other Member States.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
CHAPTER II Conformity assessment procedures
Article 8
1. The procedures for assessing the conformity of equipment, including where necessary the devices referred to in Article 1 (2), shall be as follows:
(a) equipment-group I and II, equipment-category M 1 and 1 The manufacturer or his authorized representative established in the Community must, in order to affix the CE marking, follow the CE type-examination procedure (referred to in Annex III), in conjunction with:
- the procedure relating to production quality assurance (referred to in Annex IV),
or - the procedure relating to product verification (referred to in Annex V);
(b) Equipment-group I and II, equipment-category M 2 and 2 (i) In the case of internal combustion engines and electrical equipment in these groups and categories, the manufacturer or his authorized representative established in the Community shall, in order to affix the CE mark, follow the EC-type examination procedure (referred to in Annex III), in conjunction with:
- the procedure relating to conformity to type referred to in Annex VI, or - the procedure relating to product quality assurance referred to in Annex VII;
(ii) in the case of other equipment in these groups and categories, the manufacturer or his authorized representative established in the Community must, in order to affix the CE mark, follow the procedure relating to internal control of production (referred to in Annex VIII) and communicate the dossier provided for in Annex VIII, paragraph 3, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it.
(c) equipment-group II, equipment-category 3 The manufacturer or his authorized representative established in the Community must, in order to affix the CE marking, follow the procedure relating to internal control of production referred to n Annex VIII;
(d) equipment-groups I and II In addition to the procedures referred to in paragraph 1(a), (b) and (c), the manufacturer or his authorized representative established in the Community may also, in order to affix the CE marking, follow the procedure relating to CE unit verification (referred to in Annex IX).
2. The provisions of 1(a) or 1(d) above shall be used for conformity assessment of autonomous protective systems.
3. The procedures referred to in paragraph 1 shall be applied in respect of components as referred to in Article 4 (2), with the exception of the affixing of the CE marking. A certificate shall be issued by the manufacturer or his authorized representative established in the Community, declaring the conformity of the components with the provisions of this Directive which apply to them and stating their characteristics and how they must be incorporated into equipment or protective systems to assist compliance with the essential requirements applicable to finished equipment or protective systems.
4. In addition, the manufacturer or his authorized representative established in the Community may, in order to affix the CE marking, follow the procedure relating to internal control of production (referred to in Annex VIII) with regard to the safety aspects referred to in point 1.2.7 of Annex II.
5. Notwithstanding the previous paragraphs, the competent authorities may, on a duly justified request, authorize the placing on the market and putting into service on the territory of the Member State concerned of the equipment, protective systems and individual devices referred to in Article 1 (2) in respect of which the procedures referred to in the previous paragraphs have not been applied and the use of which is in the interests of protection.
6. Documents and correspondence relating to the procedures referred to in the abovementioned paragraphs shall be drawn up in one of the official languages of the Member States in which those procedures are being applied or in a language accepted by the notified body.
7. (a) Where the equipment and protective systems are subject to other Community Directives covering other aspects which also provide for the affixing of the CE marking referred to in Article 10, that marking shall indicate that the equipment and protective systems are also presumed to conform with the provisions of those other Directives.
(b) However, where one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity only with the Directives applied by the manufacturer. In this case, particulars of the said Directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying the equipment and protective systems.
Article 9
1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 8, together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies, with their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the criteria laid down in Annex XI in assessing the bodies to be indicated in such notification. Bodies meeting the assessment criteria laid down in the relative harmonized standards shall be presumed to fulfil those criteria.
3. A Member State which has approved a body must withdraw its notification if it finds that the body no longer meets the criteria referred to in Annex XI. It shall immediately inform the Commission and the other Member States accordingly.
CHAPTER III CE conformity marking
Article 10
1. The CE conformity marking shall consist of the initials 'CE'. The form of the marking to be used is shown in Annex X. The CE marking shall be followed by the identification number of the notified body where such body is involved in the production control stage.
2. The CE marking shall be affixed distinctly, visibly, legibly and indelibly to equipment and protective systems, supplementary to the provisions of point 1.0.5. of Annex II.
3. The affixing of markings on the equipment or protective systems which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the equipment or protective systems, provided that the visibility and legibility of the CE marking is not thereby reduced.
Article 11
Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been incorrectly affixed, the manufacturer or his authorized representative established within the Community shall be obliged to make the product conform as regards the provisions concerning the CE marking and to end the infringement under the conditions imposed by the Member State;
(b) in the event of continuing non-conformity, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.
CHAPTER IV Final provisions
Article 12
Any decision taken pursuant to this Directive which restricts or prohibits the placing on the market and/or the putting into service or requires the withdrawal from the market of equipment, a protective system, or a device referred to in Article 1 (2) shall state the exact grounds on which it is based. Such a decision shall be notified forthwith to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.
Article 13
Member States shall ensure that all the parties involved in the application of the Directive are bound to observe confidentiality in respect of all information obtained in the performance of carrying out their tasks. This does not affect the obligations of the Member States and of the notified bodies regarding reciprocal information and the dissemination of warnings.
Article 14
1. Directive 76/117/EEC, Directive 79/196/EEC (1) and Directive 82/130/EEC shall be repealed as from 1 July 2003.
2. EC certificates of conformity to the harmonized standards obtained in accordance with the procedures laid down in the Directives referred to in paragraph 1 shall continue to be valid until 30 June 2003 unless they expire before that date. Their validity shall continue to be limited to the harmonized standards indicated in the aforementioned Directives.
3. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 8 (1) to (4) for the assessment of the conformity of electrical equipment placed on the market before 1 July 2003 take account of the results of tests and verifications already carried out under the Directives referred to in paragraph 1.
Article 15
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 September 1995. They shall forthwith inform the Commission thereof.
The Member States shall apply these measures with effect from 1 March 1996.
When Member States adopt the measures referred to in the first subparagraph, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States.
2. However, Member States shall allow the placing on the market and the putting into service of equipment and protective systems conforming with the national regulations in force in their territory at the date of adoption of this Directive for the period until 30 June 2003.
Article 16
This Directive is addressed to the Member States.
Done at Brussels, 23 March 1994.