Articles of ATEX 94/9/CE directive

CHAPTER I : Scope, placing on the market and free movement

Article 1 : Scope and Definitions (1)

Article 2marketing products and provisions for Member States market surveillance

Article 3satisfaction the essential requirements of safety and health in Annex II

Article 4requirement not prohibition, restriction or hindrance by the Member States for placing on the market and putting into service of products

Article 5requirement for Member States to consider as presumed to conform to the requirements of Directive devices protection systems and components constructed in accordance with a harmonized standard

Article 6seized by the Member States or the Commission of the Committee established by Directive 83/189/EEC in case the satisfaont harmonized standards do not entirely meet the essential requirements referred to in Article 3 ,

Article 7 : Procedure for a Member State to withdraw the equipment , protective systems or devices referred to in Article 1 paragraph 2 of the market , to prohibit the placing on the market, putting into service or restrict their freedom of movement when they may compromise the safety of persons and , where appropriate , domestic animals or property.

CHAPTER II - Procedures for conformity assessment

Article 8definition of conformity assessment of equipment in accordance with the requirements of Annex III procedures , in combination with in categories of devices:

- The procedure relating to production quality assurance or product listed in annex IV or VII, or the procedures of the EC unit verification referred to in Annex IX

or

- The procedure relating to product verification referred to in Annex V , or the procedure relating to conformity to type referred to in Annex VI

And the requirement to communicate the dossier provided for in Annex VIII, paragraph 3, to a notified body, which shall acknowledge receipt of the file as soon as possible and keep it ;

Article 9: requirement for Member States to notify the Commission and other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 8

CHAPTER III: CE conformity marking

Article 10 : Definition of EC conformity marking - consist of the initials CE and model defined in Annex X

Article 11 : Monitoring and control of the market by Member States

CHAPTER IV : Final Provisions

Article 12 : appeals procedure if a manufacturer of prohibition, restriction or hindrance by the Member States for placing on the market and putting into service of products

Article 13confidentiality clause for the parties involved in the application of the Directive to all information obtained in the performance of their duties

Article 14Repeal of the old guidelines and validity of old certificates

Article 15requirement for Member States to transpose Directive 94/9/EC into national legislation

Article 16Recipients of the ATEX 94/9/EC Directive : Member States


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.

Original Comment :

Les appareils et systèmes de protection destinés à être utilisés en atmosphères explosibles sont soumis aux exigences de la directive 94/9/CE.

Dans le cas ou les appareils génèrent leur propre atmosphère explosible, ils sont soumis aux exigences de la directive machines 2006/42/CE et doivent dans ce cas satisfaire aux exigences de la directive machines. Toutefois, cette classification doit être nuancée lorsque la machine est équipée de dispositifs de sécurité et autres appareils qui au sein de la machine fonctionnent en ATEX et doivent satisfaire les exigences de la directive ATEX.

Dans certains cas spécifiques, lorsque la machine est nouvelle et n’a jamais fait l’objet d’une certification ou analyse de risque, la question doit être posée aux organismes notifiés en charge de la certification de ce type de produits.

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.

Original Comment :

Les sources potentielles d’inflammation qui leur sont propres. La directive 94/9/CE définit donc des exigences pour les matériels qui par leurs dysfonctionnement peuvent conduire à enflammer une ATEX (par un point chaud ou une étincelle) et conduire à une explosion.

(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.

Original Comment :

La directive 94/9/CE définit les termes « appareils », « systèmes de protection », « composants » et « dispositifs de sécurité ». Les exigences de la directive ATEX s’appliquent à ces 4 types de produits. Ces définitions ne sont pas identiques pour toutes les directives.

Toutefois ces définitions ne se suffisent pas toujours à elles seules. Les questions qui se posent souvent sont :

Est-ce que le produit entre ou n’entre pas dans le champ d'application de la Directive 94/9/CE.

Cela se complique encore lorsque se posent les questions relatives au le lieu d’installation du produit et l’existence d’interfaces avec des atmosphères explosibles différentes (problème qui se pose très souvent sur les sites industriels)

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.

Original Comment :

La présence des 4 conditions est nécessaire, pour que les exigences de la directive 94/9/CE s’appliquent.

Avant 1994, les atmosphères explosibles étaient limitées aux gaz et aux équipements électriques.

La directive a intégré notamment les poussières et les matériels non-électriques (Cf. ci-après annexe II).

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.

Original Comment :

Par exemple, la directive 94/9/CE ne définit pas les valeurs de conditions atmosphériques. Cependant les normes qui s’appliquent aux matériels ATEX précisent que la gamme de température est comprise entre -20°C et +40°C pour les appareils électriques, et la gamme de pression comprise entre 0,8 bar et 1,1 bar.

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.

1. Les États membres adoptent et publient les dispositions législatives, réglementaires et administratives néces(1) JO no L 43 du 20. 2. 1979, p. 20. Directive modifiée en dernier lieu par la directive 90/487/CEE.saires pour se conformer à la présente directive au plus tard le 1er septembre 1995. Ils en informent immédiatement la Commission.


Article 16

This Directive is addressed to the Member States.


 

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