Machinery directive 2006/42/CE - Functional safety & ATEX directive 2014/34/EU

ANNEX I: SPECIFIC MARKING OF EXPLOSION PROTECTION (εx) DRAWN FROM DIRECTIVE 84/47/EEC⁵⁷

All values related to ‘a’

⁵⁷ Commission Directive 84/47/EEC of 16 January 1984 adapting to technical progress Council Directive 79/196/EEC on the approximation of the laws of the Member States concerning electrical equipment for use in potentially explosive atmospheres employing certain types of protection (OJ L 31, 2.2.1984, p. 19).

14 USEFUL WEBSITES

European Commission's website on EUROPA on Equipment and protective systems for Potentially Explosive Atmospheres - ATEX:

http://ec.europa.eu/enterprise/sectors/mechanical/atex

Directive 94/9/EC:

http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/atex/index_en.htm

ATEX - Management of the Directive:

http://ec.europa.eu/enterprise/sectors/mechanical/atex/directive-management/index_en.htm

Guidance documents:

http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/atex/index_en.htm

Considerations papers by the ATEX Standing Committee:

http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/atex/standing-committee

Transposition into national law:

http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/atex/transposition/index_en. htm

ATEX competent authorities for Market Surveillance:

http://ec.europa.eu/enterprise/sectors/mechanical/files/atex/atex-ca_en.pdf

ATEX contact points in Member States, candidate and EEA countries:

http://ec.europa.eu/enterprise/sectors/mechanical/files/atex/atex-cp_en.pdf

Notified Bodies:

http://ec.europa.eu/enterprise/sectors/mechanical/documents/legislation/atex/notified­bodies/index_en.htm

CE Marking for professionals - Equipment and protective systems intended for use in potentially explosive atmospheres:

http://ec.europa.eu/enterprise/policies/single-market­goods/cemarking/professionals/manufacturers/directives/index_en.htm?filter=6

European standards - Equipment for explosive atmospheres (ATEX):

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/equipment­explosive-atmosphere/index_en.htm

CEN Technical Committee 305 Potentially explosive atmospheres - Explosion prevention and protection:

http://www.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/Pages/d efault.aspx?param=6286&title=CEN/TC+305

CENELEC Technical Committee 31 Electrical apparatus for potentially explosive atmospheres:

http://www.cenelec.eu/dyn/www/f?p=104:7:2623002190173595::::FSP_ORG_ID:66

Industry associations and international organisations:

http://ec.europa.eu/enterprise/sectors/mechanical/links

ATEX Directive interest group on CIRCABC:

https://circabc.europa.eu/w/browse/0cb52e92-2074-480c-8235-a4cac539d591

ATEX Administrative Co-operation (AdCo) interest group on CIRCABC:

https://circabc.europa.eu/w/browse/95700477-ba5c-4b52-9552-2375dc1a808d

ATEX group of Notified Bodies (ExNBG) interest group on CIRCABC:

https://circabc.europa.eu/w/browse/33b0bed8-1c65-4d9e-b857-1f34d2d91c04

​13 EUROPEAN HARMONISED STANDARDS⁵⁵

Directive 94/9/EC provides manufacturers with the option of complying with its requirements by designing and manufacturing directly in accordance with the Essential Health and Safety Requirements, or to harmonised standards which are developed specifically to allow a presumption of conformity with those requirements. In other words, in the case of a challenge, the responsible national authorities will have to prove that the equipment is not in conformity with the Essential Health and Safety Requirements of the Directive.

The presumption of conformity is conferred, in regulatory terms, only by the use of the national standards transposing a harmonised standard the reference of which is published in the OJEU. Where the relevant national standardisation body has not transposed the standard, use of the original harmonised standard or of a transposed standard in another Member of the EU confers the same presumption of conformity. However, such transposition must have taken place into the national standards collection of at least one of the Member States of the European Union.

Industry and many Notified Bodies are involved in the development of these standards and it is likely that these standards will be the preferred option for demonstrating compliance once they become available.

Voluntary harmonised standards are the only documents the application of which provides for presumption of conformity. Manufacturers may also decide to use existing European, national and other technical standards and specifications regarded as important or relevant to cover the relevant essential health and safety requirements, together with additional controls addressing those other requirements not already covered.

Standards are amended and updated in response to new technical knowledge. During the process of updating, a manufacturer may continue to use a current harmonised standard to claim full compliance with the Directive, even though it is clear that the standard will change in time.

13.1 European Harmonised Standards published in the Official Journal

By way of information, a reference list of European Harmonised Standards can be found on the European Commission's website⁵⁶.

European standards for ATEX are available from the European Standardisation Organisations:

• European Committee for Standardization (CEN): avenue Marnix 17, 1000 Brussels, Belgium; tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cen.eu)
• European Committee for Electrotechnical Standardization (CENELEC): avenue Marnix 17, 1000 Brussels, Belgium; tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.eu).

National transpositions of Harmonised Standards are available from the national standardisation bodies.

13.2 Standardisation Programme

Two standardisation programmes addressed to the European standardisation bodies. Each one is the subject of a standardisation mandate drawn up by the European Commission.

The European Commission has granted a mandate to CEN/CENELEC to produce European standards. The mandate covers the standardisation work necessary for the optimum functioning of the Directive in both the electrical and mechanical field.

The mandate requires intensive co-operation between CEN and CENELEC to carry out the following work:

1. to review and, where appropriate, modify existing standards with a view to aligning them with the Essential Health and Safety Requirements of the Directive;
2. to establish the new standards required, giving priority to horizontal standards, which apply to broad ranges of products, rather than to specific products, with the need for them to be demonstrated on a case-by-case basis.

To carry out their mandate CEN established a technical committee CEN/TC 305 "Potentially explosive atmospheres - Explosion prevention and protection". Several working groups carry out the detailed work.

To carry out their mandate CENELEC allocated the work to TC 31 "Electrical apparatus for potentially explosive atmospheres", and its sub-committees. These Committees have been working in the potentially explosive atmosphere field for a considerable number of years and have produced a series of Standards under the Old Approach directive.

CEN and CENELEC are responsible for the preparation of standards of the electrical and non­electrical sectors of industry respectively. They have the responsibility to ensure that:

• there is uniform interpretation of the New Approach directive for potentially explosive atmospheres, and other relevant directives;
• safety requirements for the electrical and non-electrical sectors are compatible where they overlap, and the levels of safety sought are equivalent;
• The preparation of standards in the future by one of the organisations satisfactorily reflects the needs of the other, and vice versa.

⁵⁵ See also http://ec.europa.eu/enterprise/policies/single-market-goods/documents/blue-guide ("Blue Guide").

⁵⁶ http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm.

12 SAFEGUARD CLAUSE⁵² AND PROCEDURE

The safeguard clause referred to in Article 7 of the Directive is the EU procedure whereby any measure taken by a Member State, on the grounds of non-compliance with the Essential Health and Safety Requirements and where it is deemed that equipment is liable to endanger persons, animals or property for the purpose of withdrawing from the market, prohibiting the placing on the market or restricting the free movement of equipment accompanied by one of the means of attestation provided for in the Directive and therefore bearing the CE marking, must be immediately notified to the Commission by the Member State which has taken it.

In considering whether the safeguard clause should be triggered, Member States and the respective enforcement authorities will need to consider whether the non-compliance is substantial or can be considered a non-substantial non-compliance to be resolved without recourse to the procedures enabled via the safeguard mechanism.

For example, a non-substantial non-compliance could consist of illegibility of the CE marking. In such cases, the Member State could issue a compliance notice to the manufacturer or authorised representative or take other actions allowed by national legislation to encourage the responsible person(s) to take appropriate corrective action.

Member States will need to consider in each case whether the non-compliance is liable to endanger persons, animals or property and if the safeguard clause is the most effective means of ensuring the safety of persons, animals or property, which remains paramount under this section of the Directive.

Any notification, which fulfils the criteria of invoking the safeguard clause, is followed by a process of consultation between the Commission and the "parties concerned". The "parties concerned" primarily means all Member States of the EU, the manufacturer or his authorised representative established within the EU or, failing them, the person who placed the product on the EU market.

The consultation procedure enables the Commission, on the basis of the above reasons, to assess whether the restrictive measure is justified. This means that the measures notified to the Commission must be accompanied by detailed information specifying in particular the reasons why the Essential Health and Safety Requirements laid down in the Directive have not been complied with by the product concerned.

Where the Commission finds, following such consultation, that the measures are justified, it immediately informs the Member State which took the initiative and the other Member States. In the Commission's view, the objective of informing the other Member States is to prompt these Member States to take appropriate measures in accordance with Article 3 of the Directive.

Where the Commission finds that the measures, adopted by the Member State are not justified, it will ask that Member State to withdraw its measures and immediately to take the appropriate action to re-establish the free movement of the products in question on its territory. If a Member State refuses to follow the Commission's position the Commission reserves the right to proceed under Article 226 of the EC Treaty.⁵³

In order to ensure transparency and the proper uniform application of the safeguard clause, Article 7.4 states that "the Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure".

In addition to this provision the Directive foresees in Article 6 (1) a specific Standards Safeguard Clause. Where a Member State or the Commission considers that a harmonised standard does not fully meet the Essential Health and Safety Requirements of the Directive they shall bring the matter before a special Committee set up under Directive 98/34/EC​⁵⁴. The Committee shall examine the case and deliver an opinion to the Commission. In the light of this opinion the Commission shall inform Member States whether or not it is necessary to withdraw the references to those standards from the published information.

⁵² For a detailed analysis of the "Safeguard clause", see the "Guide to implementation of the Community harmonisation Directives based on the New Approach and the Global Approach", sheet I/E, Chapters 2, 3, 4. 

⁵³ Article 226 of the EC Treaty: if the Commission considers that a Member State has failed to fulfil an obligation under this Treaty, it shall deliver a reasoned opinion on the matter after giving the State concerned the opportunity to submit its observations. If the State concerned does not comply with the opinion within the period laid down by the Commission, the latter may bring the matter before the Court of Justice.

⁵⁴ Directive 98/34/EC of the European Parliament and the Council laying down a procedure for the provision of information in the field of technical standards and regulations; OJ L 204, 21.7.1998, p. 37, as amended by Directive 98/48/EC.

9 NOTIFIED BODIES

9.1 Designation

Annex XI to Directive 94/9/EC defines the criteria that these bodies must fulfil. Bodies which are able to provide proof of their conformity with Annex XI by presenting to their Competent Authorities a certificate of accreditation and evidence that all additional requirements have been met or other means of documentary proof as defined below, are considered notifiable and in this respect they conform to Annex XI of the Directive. The appropriate (voluntary) harmonised standards provide useful and appropriate mechanisms towards presumption of conformity to Annex XI. However, this does not rule out the possibility that bodies not conforming to the harmonised standards may be notified, on the grounds that compliance is obligatory only with respect to the criteria set out in Annex XI to the Directive.

Notified Bodies provide the professional and independent judgements, which consequently enable manufacturers or their authorised representatives to fulfil the procedures in order to presume conformity to Directive 94/9/EC. Their intervention is required:

• for issuing of EC-Type Examination Certificates, and for inspection, verification and testing of equipment, protective systems, devices and components before they can be placed on the market and/or put into service;
• for the assessment of manufacturer's quality assurance system in the production phase. 

The bodies responsible for undertaking the work referred to in Article 8 of the Directive must be notified by the Member State under whose jurisdiction they fall, on their own responsibility to the Commission and the other Member States of the EU. This notification also includes the relevant scope of competence for which that body has been assessed as technically competent to certify against the Essential Health and Safety Requirements as shown in the Directive. For the Member States of the EU, this responsibility of notification involves the obligation to ensure that the Notified Bodies permanently maintain the technical competence required by Directive 94/9/EC and that they keep their notifying authorities informed on the performance of their tasks.

Therefore, a Member State of the EU, which does not have a technically competent body under its jurisdiction to notify, is not required to make such a notification. This means that a Member State of the EU which does not have such a body is not required to create one if it does not feel the need to do so. A manufacturer always has the choice of contacting any body with the appropriate scope of technical competence, which has been notified by a Member State.

On their own responsibility Member States reserve the right not to notify a body and to remove an appointment. In the latter circumstance the relevant Member States shall inform the Commission and all other Member States.

For further information concerning Notified Bodies, e.g. responsibilities, conformity assessment, testing, inspection facilities and sub-contracting, please see the "Guide to the implementation of Directives based on New Approach and Global Approach" (see footnote 6).

9.2 Co-ordination and Co-operation

All Notified Bodies are asked to participate in Notified Body co-ordination activities. The Group of Notified Bodies established under Directive 94/9/EC, the so-called ExNBG, normally meets annually and is made up of representatives of Notified Bodies with observers from the Commission, manufacturers and users trade associations, standards making bodies and other invitees. Attendance at each meeting is by invitation and any party wishing to be considered should contact the Chairman of the Group either through the Commission or via a Notified Body of your country. The group is responsible for discussing issues of a technical nature to ensure that the technical provisions of the Directive and harmonised standards are applied in a uniform way. The group issues "Clarification Sheets" where ambiguities exist in technical procedures and also issues technical guidance documents where less detailed specifications require amplification.

Clarification Sheets and guidance documents are noted by the Standing Committee and published on the internet (http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/atex/clarification).

9.3 Subcontracting

It has been agreed that Notified Bodies are to keep a register of any subcontracting to allow effective monitoring by the responsible member state in order to ensure activities are being conducted properly. The register is to be updated systematically. The register contains information about the name and location of the subcontractor, the nature and scope of work undertaken, the results of regular evaluations of the subcontractor, including evidence that details of tasks are monitored as well as evidence that the subcontractor is competent and maintains competence for the tasks specified and evidence that a direct private law contract exists.

A Notified Body may engage experts in support of its assessment activities but the experts’ activities are to be controlled as if the expert were directly employed by the Notified Body under the same contractual obligations and operate within the Notified Body's own quality system.

The ExNBG has concurred that further (serial) sub-contracting by any sub-contractor is strictly prohibited.

Although assessment can be sub-contracted including assessment against the requirements of EHSRs, the Notified Body remains entirely responsible for the whole operation and shall safeguard impartiality and operational integrity.

Procedures for reviewing and accepting the work of any sub-contractor will ensure that the sub­contractor has not offered or provided consultancy or advice to the manufacturer, supplier, authorised representative or their commercial competitor with respect to the design, construction, marketing or maintenance of the products which are the subject of the sub-contracted task.

9.4 Retention of documentation

Under Article 8.1 (b)(ii) of the ATEX Directive 94/9/EC the manufacturer is required to undertake the conformity procedure at Annex VIII and then:

"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".

Bodies notified for this procedure should be so according to Article 8.1 (b)(ii) and not to Annex VIII as this latter procedure does not involve a Notified Body.

This dossier is not returned to the manufacturer on request (but may be added to), and in general it is retained for a period of ten years following the last placing of the product onto the market. The intention is that market surveillance authorities in the different member states should be given access to this dossier, in cases where there is a need to investigate the design or manufacturing details of a particular product.

With respect to the media used, it is accepted that this dossier may be in electronic format so long as it is legible and "readable" over the period concerned.

9.5 Notified Bodies having knowledge of faulty products* on the market

Also a Notified Body which gets knowledge of faulty products, but is neither engaged in the module for EC-Type examination nor in a module for surveillance of the manufacture, should take some action.

If there is no immediate danger, if after contact with the responsible Notified Body for EC-Type examination and with the Notified Body responsible for surveillance of the production of the faulty product no satisfactory solution after appropriate time is reached, the Notified Body should inform his own authorities in charge of market surveillance to initiate the adequate measures.

In the case of immediate danger, the Notified Body should inform his own authority in charge of market surveillance, the Notified Body for EC-Type examination and the Notified Body for surveillance of the production without delay.

* see Note 1 of the Guidelines

7 USED, REPAIRED OR MODIFIED PRODUCTS AND SPARE PARTS ³⁷

7.1 General

As a general rule, manufacturers need to consider whether the product is being placed onto the EU market or taken into service for the first time, or if the modifications are such that the intention or the result is to place a product onto the market, which has to be considered as a new product. If the answer to either of these questions is "yes", then Directive 94/9/EC fully applies. In all other cases the Directive 94/9/EC does not apply and the responsible person will have to ensure that any other relevant national or EU legislation are considered as appropriate.

Within this context two points should be made:

• In the following paragraphs, these Guidelines refer only to products for which Directive 94/9/EC is potentially applicable. Products not subject to Directive 94/9/EC are therefore excluded from these discussions.
• The application of Directive 94/9/EC to an "as new" product is without any prejudice to intellectual property legislation.³⁸

With regard to the information to be provided for repair of equipment, see § 10.1.3 "Documents accompanying the product".

7.2 Definitions

Used product and second hand product: a product which has been placed on the EU market prior to the coming into force of Directive 94/9/EC and put into service on the EU territory. This product was in compliance with the then applicable legislation: national or EU, depending on the date. The ATEX Directive 94/9/EC does not apply.

Used products that were on the market and used in the EU before the date of entry into force of Directive 94/9/EC are not covered by it. These products have been marketed and used in accordance with the regulations in force at that time. They circulate in the EU based on Articles 28/30 of the EC Treaty unless they are modified so that health and safety characteristics have been affected.

For used products imported from a non EU country and made available for the first time in the EU after 30 June 2003 for the purpose of distribution and/or use in the EU Directive 94/9/EC shall apply.

7.3 Reconditioned (or refurbished³⁹) products

These are used products which were on the market and used in the EU but whose performance has changed over time (due to ageing, obsolescence, etc.), and which have been modified so as to be restored. The case of products whose external appearance has been modified and improved by a cosmetic or aesthetic operation after they have been placed on the market and put into service is a

³⁷ The application of the ATEX Directive to "as-new equipment" is without any prejudice to intellectual

property legislation. See Directive 89/104/EEC relating to the marks and the decision of the European

Court of 11th July 1996, C427/93, 429/93, 436/93 Bristol Meyer Squibb.

³⁸ See Directive 89/104EEC relating to the marks and the decision of the European Court of Justice of 11

July 1996 in Joined Gases C-427/93 and C-436/93 Bristol Meyer Squibb. ³⁹ Both terms, reconditioned/refurbished, as well as reconditioning/refurbishment are used interchangeably

in this chapter.

particular form of refurbishment aimed at restoring the external appearance of the product⁴⁰. If this occurs with no substantial modification Directive 94/9/EC does not apply.

7.4 Reconfigured products

Reconfigured products are used products which were on the market and used in the EU but whose configuration has been modified, by the addition (upgrading) or the removal (downgrading) of one or more parts (components, sub-assemblies such as plug-in cards or modules, etc.). If this occurs

with no substantial modification Directive 94/9/EC does not apply.

7.5 Substantially modified products

In general, the relevant text of the "Guide to the Implementation of Directives Based on New Approach and Global Approach" (Blue Guide)⁴¹, chapter 2.1. "Products submitted to directives" applies. In the sense of Directive 94/9/EC it is any modification affecting one or more of the health and safety characteristics covered by EHSRs (e.g. temperature) or the integrity of a type protection. In this case Directive 94/9/EC has to be applied. This does not preclude the application of other relevant directives.

The general principle is that Directive 94/9/EC re-applies to a modified product where the modification is considered to be substantial and if it is intended to be placed again on the EU market for distribution and/or use.

7.6 Repaired products

These are products whose functionality has been restored following a defect without adding new features or any other modification. As this occurs after the product has been placed on the market and the product is not to be sold as a new product:

The ATEX Directive 94/9/EC does not apply.

This does not preclude that national regulations of the Member States on the working environment may require some kind of assessment of the repaired product as well.

7.7 Spare parts

These are items intended to replace a defective or worn out part of a product previously placed and put into service on the EU market. A typical repair operation would be replacement by a spare part.

The manufacturer of the spare part is normally not required to comply with Directive 94/9/EC unless the spare part represents an equipment or component as defined by the Directive. If so, all obligations laid down in the Directive have to be fulfilled.

If the manufacturer of the original spare part offers a new, different one in its place (due to technical progress, discontinued production of the old part, etc.), and it is used for the repair, the repaired product (as long as no substantial modification of the repaired product takes place) does not need to be brought into conformity at this time with Directive 94/9/EC as the repaired product is not then placed on the market and put into service.

⁴⁰ This can involve a modification of the electrostatic characteristics. The use of different materials or different external dimensions of the product might adversely change its ATEX performances. For example, a plastic enclosure may provide much lower electrostatic protection than a metallic enclosure.

⁴¹ http://ec.europa.eu/enterprise/policies/single-market-goods/documents/blue-guide.

6 APPLICATION OF DIRECTIVE 94/9/EC ALONGSIDE OTHERS THAT MAY APPLY

In principle if a product is within the scope of other directives at the same time, all directives have to be applied in parallel to fulfil the provisions of each directive.

6.1 Electromagnetic Compatibility 2004/108/EC (EMC)

In the case of Directive 94/9/EC and the Directive relating to Electromagnetic Compatibility 2004/108/EC (EMC), the Directive 94/9/EC has to be applied to fulfil the requirements concerning "explosive atmospheres" safety requirements. The EMC Directive must also be applied so as to ensure that the product does not cause electromagnetic disturbance and that its normal operation is not affected by such disturbances. There will be some applications, where the "normal" level for electromagnetic immunity provided by Directive 2004/108/EC might not be sufficient for granting the necessary immunity level for safe performance under the scope of Directive 94/9/EC. In this case the manufacturer is required to specify the electromagnetic immunity achieved by his products according to Annex II 1.2.7 to Directive 94/9/EC. For example, protective systems where the performance of data acquisition and data transmission may have direct influence on explosion safety.

6.2 Low Voltage 2006/95/EC (LVD)

Products for use in potentially explosive atmospheres are explicitly excluded from the scope of the Low Voltage Directive 2006/95/EC (LVD). All "Low Voltage essential objectives" have to be covered by the Directive 94/9/EC (see Annex II 1.2.7). The standards published in the Official Journal of the European Union with reference to Directive 2006/95/EC may be listed in the EC declaration of conformity to fulfil the requirements 1.2.7 of Annex II to Directive 94/9/EC. Not excluded from the scope of the LVD are the safety, controlling and regulating devices mentioned in Article 1(2) of the Directive 94/9/EC which are intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems. In such cases both Directives shall be applied.

6.3 Machinery 2006/42/EC (MD)

The relation between Directive 94/9/EC and the Machinery Directive 2006/42/EC is different. The Directive 94/9/EC, which is a "specific Directive" within the meaning of Article 3 of the Machinery Directive, contains very specific and detailed requirements to avoid hazards due to potentially explosive atmospheres, while the Machinery Directive itself contains only very general requirements against explosion hazards (Annex I, 1.5.7 MD). With regard to explosion protection in a potentially explosive atmosphere Directive 94/9/EC takes precedence and has to be applied. So equipment that complies with ATEX, and which is also a machine can be assumed to comply with the specific essential safety requirements concerning ignition risk with respect to explosive atmospheres in the Machinery Directive. For other relevant risks concerning machines, the requirements of the Machinery Directive also have to be applied.

See also § 4.1.2.3.

6.4 Transport of dangerous goods by road 94/55/EC and 98/91/EC (ADR)

In order to avoid possible overlapping with Directives 94/55/EC and 98/91/EC on transport of dangerous goods by road most means of transport have been excluded from the scope of Directive 94/9/EC (Art. 1 (4)). Generally, those vehicles still included in 94/9/EC do not leave the user's premises. Typical examples are means of transport on rails used in "gassy" mines, forklift trucks and other mobile machinery where the internal combustion engine, braking systems and electrical circuits may be potential sources of ignition.

It is possible for both Directives to be applied in parallel. For example, where the manufacturer designs and constructs a means of transportation intended for transporting dangerous (in this case flammable) goods on public roads as well as for use in areas where explosive atmospheres may exist.

The criteria for application of Directive 94/9/EC are that the vehicle would need to:

• be defined as an equipment, a protective system or safety device according to Article 1(2) of the Directive;
• have its own potential source of ignition;
• be intended for use in a potentially explosive atmosphere36.

In order to determine under which intended conditions both Directives will apply the exclusion at Article 1(4) of Directive 94/9/EC needs to be considered.

This exclusion explicitly determines that "means of transport" except those "intended for use in a potentially explosive atmosphere shall not be excluded".

The definition of "means of transport" is given further detail at Article 2 of Directive 98/91/EC and, in broad terms, is interpreted to be an activity on a public highway or space including unloading and loading operations.

The ATEX Standing Committee therefore considered that, as described in the Commission guidance, a vehicle under the scope of Directive 98/91/EC might also be covered by the ATEX Directive 94/9/EC.

Where such a vehicle is intended for use in a potentially explosive atmosphere both Directives will apply. However, this does not include where such environments are likely to occur solely as a result of loading and unloading operations as described in 98/91/EC. An example of this is a road tanker transporting petrol when the loading/unloading site is such that it is not initially considered to have a potentially explosive atmosphere because of its location with respect to the storage facility. As noted above, if this environment becomes potentially explosive because of the loading/unloading operation, only the requirements of Directive 98/91/EC need be applied.

In addition, it was agreed that the conformity assessment and technical requirements of 94/55/EC as further defined by 98/91/EC may not fully align with those required for compliance to Directive 94/9/EC.

In this context the question arose whether manufacturers of internal monitoring or other devices attached to or inside a vehicle such as a petrol tanker have to apply the ATEX Directive 94/9/EC and to affix CE marking? The following has been concluded:

1.  Based on Article 75 of the EC Treaty and transposing the ADR, Directive 94/55/EC fully harmonises rules for the safe transport of dangerous goods by road.
2. Additionally, based on Article 95 of the EC Treaty, Directive 98/91/EC provides for full harmonisation regarding technical requirements for the following categories of vehicles intended for the transport of dangerous goods by road as follows:

• Category N: Motor vehicles having at least four wheels when the maximum weight exceeds 3.75 metric tons, or having three wheels when the maximum weight exceeds 1 metric ton, and used for the carriage of goods.
• Category O: Trailers (including semi-trailers).

According to Article 4, if the requirements of the Annexes of this Directive are fulfilled for the completed vehicle, Member States may not refuse to grant EC type approval or to grant national type approval, or prohibit the registration, sale or entry into service of those vehicles on grounds relating to the transport of dangerous goods.

3. Directive 98/91/EC contains, by reference to Directive 94/55/EC, requirements covering both electrical (e.g. wiring, batteries) and non electrical equipment (e.g. heat protection of engine,

Unless it is a safety device as defined under Article 1(2) of Directive 94/9/EC.

combustion heaters) of vehicles designed for the carriage of dangerous goods, which may contribute towards the formation of explosive atmospheres.

4. Provided that:

-Such vehicles are not intended for use in a potentially explosive atmosphere other than that caused temporarily by loading or unloading.

• The goods, which shall be transported, are substances and articles as defined in Article 2 of Directive 94/55/EC.
• The exemptions of Annex A, paragraph 1.1.3, of Directive 94/55/EC and the ADR agreement are not pertinent.

Under these circumstances the exclusion at Article 1(4) of Directive 94/9/EC applies to the WHOLE of the vehicle including ALL associated equipment necessary for the carriage of dangerous goods

(e.g. "breather valves" of manhole covers, vehicle tracking systems).

In all other cases Directive 94/9/EC may apply.

Note 1: At some sites tankers may have to access a zone (e.g. Zone 1). In this case users responsible for that site may demand the supplier to use tankers with ATEX compliant products.

Note 2: Even if the vehicle or parts of it are intended to be permanently used in a potentially explosive atmosphere, devices like "breather valves" of manhole covers normally would not fall within the scope of Directive 94/9/EC. Normally these devices have no own ignition source, are no safety devices in the sense of ATEX and are normally not provided with a protective system, such as a flame arrester.

6.5 Personal Protective Equipment 89/686/EEC (PPE)

The equipment covered by the Personal Protective Equipment (PPE) Directive 89/686/EEC is specifically excluded from Directive 94/9/EC. However, the manufacture of PPE for use in explosive atmospheres is covered by Basic Health and Safety Requirement 2.6 in Annex II to the PPE Directive. PPE intended for use in explosive atmospheres must be so designed and manufactured that it cannot be the source of an electric, electrostatic or impact-induced arc or spark likely to cause an explosive mixture to ignite. Following the EHSRs in Directive 94/9/EC is one way to demonstrate compliance.

6.6 Pressure Equipment 97/23/EC (PED)

Pressure Equipment Directive (PED) 97/23/EC is a single market directive similar to Directive 94/9/EC. Relatively few items of pressure equipment have their own source of ignition. There are a small number of examples of safety accessories which may be autonomous protective systems or, possibly, equipment. Flame arrestors have been judged to be pressure accessories in the sense of the PED. There are no additional requirements for the flame arrester element under the PED. PED specifically excludes from its own scope equipment classified no higher than Category I under Article 9 of PED but inside the scope of ATEX.

The Pressure Equipment Directive deals only with the pressure hazard and does not consider the prevention of and protection against explosions/inflammations, which are not triggered by pressure. In most cases it is presumed that PED equipment does not have an own ignition source when it is properly installed according to the instructions of the manufacturer (including information about maintenance and repair of the connecting devices, e.g. valves, flanges). If such PED equipment shows hot surfaces occurring during operation caused by the temperature of its content solely, it is not applicable to consider this equipment under the ATEX Directive 94/9/EC.

6.7 Simple Pressure Vessels 87/404/EEC

Simple Pressure Vessel Directive 87/404/EEC applies to a limited range of equipment for holding air or nitrogen under pressure. ATEX equipment may incorporate a simple pressure vessel in an assembly, but it is considered that there are relatively few occasions when both Directives will apply to the same product.

6.8 Gas Appliances 90/396/EEC (GAD)

Gas Appliances Directive (GAD) 90/396/EEC applies to equipment for domestic and non commercial use but does not apply to equipment designed for industrial processes. Most equipment within scope of GAD is capable of igniting a surrounding explosive atmosphere and cannot comply with ATEX.

It should also be noted that the Directive 94/9/EC contains the following exclusion:

"- 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;"

The question has been raised as to whether this implicitly conveys the meaning that such equipment, where the leakage is not fuel gas, are included in the scope of ATEX Directive 94/9/EC.

It was agreed that, as a general rule, such types of equipment are excluded from the Directive as they are not intended for use in a potentially explosive atmosphere.

6.9 Construction Products 89/106/EEC (CPD)

Besides the above Directives it is necessary to mention the relationship between Directive 94/9/EC and the Construction Products Directive (CPD) 89/106/EEC. During the standardisation work for both Directives it was identified that (in a few areas) the scopes of both Directives could overlap. The areas already identified where:

• explosion protection systems and fire suppression systems using the same media;
• both areas are using common hardware for distribution systems such as pipes, pipe hangers, nozzles, etc.

In general, it can be stated that in cases of doubt the Construction Products Directive is applicable if the subject under discussion is fixed to a building and becomes then a part of the building or if it can be seen as a building itself (e.g. a silo). In such instances the CPD and the ATEX Directive 94/9/EC apply in parallel. Compliance with the EHSRs of Directive 94/9/EC will in general show compliance with the EHSRs of the CPD regarding ignition hazards.

In this context it is important to note, that a Notified Body is only allowed to cover aspects related to two or more directives if the Body is notified under all directives with an appropriate scope.

6.10 Marine Equipment Directive 96/98/EC (MED)

The Marine Equipment Directive (MED) 96/98/EC is not a "New Approach" Directive, as it is based on the principles of the "Global Approach" and does not provide for CE marking. Directive 94/9/EC specifically excludes from its scope "seagoing vessels and mobile offshore units together with equipment on board such vessels or units", and equipment for use on board a ship is subject only to the MED directive, excluding all others. Nevertheless, the constructional requirements for explosion-protected equipment at sea are generally the same as onshore: this is illustrated by the reference of the MED to the same or very similar standards, as harmonised under the ATEX Directive. In fact, certain products (as gas detection equipment) are used offshore and onshore, thus requiring certification per the ATEX Directive and/or by the MED, according to their intended use.

5 EQUIPMENT NOT IN THE SCOPE OF DIRECTIVE 94/9/EC

5.1 Exclusions based on Article 1.4 of Directive 94/9/EC

• 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. The question has also been discussed as to whether this implicitly conveys the meaning that equipment intended for use in domestic and non-commercial environments, where the leakage is not fuel gas, are included within scope. It was agreed by the ATEX Standing Committee as a general rule such types of equipment are excluded from Directive 94/9/EC as they are not intended for use in a potentially explosive atmosphere;
• personal protective equipment covered by Directive 89/686/EEC³⁵. There are occasions where personal protective equipment with its own potential sources of ignition is intended for use in potentially explosive atmospheres. This type of personal protective equipment should follow the procedures laid down in Directive 94/9/EC to provide the necessary level of explosion safety (see as well chapter 6);
• seagoing vessels and mobile offshore units together with equipment on board such vessels or units, as they are already covered by the IMO Convention.
• means of transport i.e. vehicles and their trailers intended solely for transporting passengers by air, 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. Means of transport intended for use in a potentially explosive atmosphere are not excluded;
• equipment covered by Article 296 (1)(b) of the EC Treaty, i.e. designed and manufactured specifically for use by the armed forces or in the maintenance of law and order. Dual-purpose equipment is not excluded.

5.2 Examples for equipment not covered by Directive 94/9/EC

5.2.1 "Simple" products

For "simple" electrical products, European harmonised standards provide a good basis to assess the effectiveness of electrical ignition source and, consequently, to determine whether or not these can be considered effective or not.

In general, many simple mechanical products do not fall under the scope of Directive 94/9/EC as they do not have their own source of ignition (see chapter 3.7.2). Examples without own source of ignition are hand tools such as hammers, spanners, saws and ladders.

Other examples that in most cases have no potential ignition source are given below. However, the manufacturer will need to consider each item in turn with respect to potential ignition hazard to consider whether Directive 94/9/EC applies (see also chapter 3.7.3):

• Clockwork time pieces; mechanical camera shutters (metallic);
• Pressure relief valves, self-closing doors;
• Equipment moved only by human power, a hand operated pump, hand powered lifting equipment, hand operated valves.

³⁵ OJ L 399, 30.12.1989, amended by Directive 93/95/EEC, OJ L 276, 9.11.1993 and Directive 93/68/EEC, OJ L 220, 30.8.1993.

The issue of hand operated valves has also been discussed. Given that these will move slowly, with no possibility of forming hot surfaces, as discussed in section 3.7.3 they are not in scope of the Directive. Some designs incorporate polymeric parts, which could become charged, but this is no different from plastic pipes. Given that it is clear that the latter is outside of the scope of Directive 94/9/EC it has been accepted that such valves do not fall within scope.

Some manufacturers have argued that their valves are specially adapted for ATEX, in that they have either selected more conductive polymers, or taken steps to ensure that no metal parts could become charged because they are unearthed. Other manufacturers state that all their valves meet this requirement simply by the way they are constructed, and they see no distinction from valves used to process non-flammable materials. To avoid confusion between those who claim correctly that their valves have no source of ignition, and are out of scope, and those who claim that they have done some very simple design change and wish to claim that their valves are now Category 2 or even 1, it has been agreed that valves having characteristics as described above are out of scope. Nevertheless, as discussed in section 3.7.3, where potentially flammable atmospheres exist, users must always consider the electrostatic ignition risks.

5.2.2 Installations

The Directive does not regulate the process of installation. Installing such equipment will generally be subject to legal requirements either workplace directives (see footnote 7) or the domestic legislation of the Member States.

However, the question is frequently asked to distinguish between the responsibilities of manufacturers, building a piece of equipment or an assembly under the ATEX Directive 94/9/EC and those responsibilities of an end user, buying in equipment parts to build an installation. (One might use the analogy of the difference between the manufacturing a discreet piece of equipment which can be placed on the market, such as a television (LVD 2006/95/EC), and equipping a house with all its utilities built into which a range of products will be installed and connected, this would clearly be an installation and come under Workplace Directive 89/391/EEC or other directives concerning workplace safety.)

A common situation is that pieces of already compliant equipment are placed on the market independently by one or more manufacturer(s), and are not placed on the market by a single legal person as a single functional unit (as described in 3.7.5.1). Combining such equipment and installing at the user's premises is not considered as manufacturing and thus does not result in equipment; the result of such an operation is an installation and is outside the scope of Directive 94/9/EC. The installer has to ensure that the initially compliant pieces of equipment still comply when they are taken into service. For that reason he has to carefully follow all installation instructions of the manufacturers. The Directive does not regulate the process of installation. Installing such equipment will generally be subject to legal requirements of the Member States. An example could be instrumentation consisting of a sensor, a transmitter, a Zener barrier and a power supply if provided by several different manufacturers installed under the responsibility of the user.

It is understood that there is not always a clear line between an installation and an assembly.

For assemblies and installations the responsibilities will either fall on the person who places the assembly on the market, or the end-user. Each must draw up a technical file setting out how they have complied with the relevant legislation. Much of the technical content will be the same.

The plant will usually be an installation if:

• The end user, or an installer purchases parts (including ATEX components or equipment) from different manufacturers and they are installed under his responsibility after a full risk assessment has been undertaken;
• The user carries out a whole series of different processes requiring the integration of mainly ATEX compliant equipment and parts on site, and they are installed according to a unique layout;
• The end-user commissions the building of parts of his installation off-site, which may be unique, but certainly not a production run, and which is done under his direct responsibility, or indirectly through a contractor, working under contract to him;
• Commissioning tests or adjustments are needed once the plant is built and are carried out under the final responsibility of the end user.

2 OBJECTIVE OF THE ATEX DIRECTIVE 94/9/EC

The objective of Directive 94/9/EC is to ensure free movement for the products to which it applies in the EU territory. Therefore the Directive, based on Article 95 of the EC Treaty, provides for harmonised requirements and procedures to establish compliance.

The Directive notes that to remove barriers to trade via the New Approach, provided for in the Council Resolution of 7 May 1985⁸, essential requirements regarding safety and other relevant attributes need to be defined by which a high level of protection will be ensured. These Essential Health and Safety Requirements (EHSRs) are listed in Annex II to Directive 94/9/EC.

These Essential Health and Safety Requirements 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 territory⁹, freely moved and operated as designed and intended in the expected environment if they comply with Directive 94/9/EC (and other relevant legislation).

Directive 94/9/EC provides for the first time harmonised requirements for non-electrical equipment, equipment intended for use in environments which are potentially explosive due to dust 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. This is an increase in scope compared to former national regulations for equipment and systems intended for use in potentially explosive atmospheres.

The requirements for compliance with the provisions of Directive 94/9/EC will be further developed in the following chapters.

⁸ OJ C 136, 4.6.1985, p. 1.

⁹ Directive 94/9/EC is also applicable in other territories where a suitable international agreement is in operation. See the DG Enterprise and Industry website for more details: http://ec.europa.eu/enterprise/sectors/mechanical/international-competitiveness.

The objective of these Guidelines is to clarify certain matters and procedures referred to in Directive 94/9/EC⁵ concerning equipment and protective systems intended for use in potentially explosive atmospheres. The Guidelines should be used in conjunction with the Directive and with the European Commission's "Guide to the implementation of directives based on New Approach and Global Approach (Blue Guide)"⁶.

These Guidelines are not only for the use of Member States’ competent authorities, but also by the main economic operators concerned, such as manufacturers, their trade associations, bodies in charge of the preparation of standards as well as those entrusted with the conformity assessment procedures.

First and foremost, this document must ensure that, when correctly applied, the Directive leads to the removal of obstacles and difficulties related to the free circulation (free movement) of goods within the European Union (see footnote 2). It should be noted that the statements in these Guidelines refer only to the application of Directive 94/9/EC unless otherwise indicated. All parties concerned should be aware of other requirements, which may also apply (see chapter 6).

Directive 94/9/EC is a "New Approach" directive laying down Essential Health and Safety Requirements and leaving it to standards, primarily European harmonised standards, to give technical expression of the relevant requirements contained in the Directive.

Directive 94/9/EC is a total harmonisation directive, i.e. its provisions replace existing divergent national and European legislation which cover the same subjects as stipulated by Directive 94/9/EC.

As of 1 July 2003, all other relevant national regulations have been abolished and Directive 94/9/EC, as transposed into the national legislation of the Member States, is the sole legal instrument applicable.

"Use" Directives

The reader will want to be aware that where ATEX products are intended for use in a place of work, national and community legislation, intended to ensure the safety of employees will usually apply. In this respect different legislation applies to land based industries, the underground extraction of coal and other minerals, and offshore oil production⁷.

⁵ 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 (OJ L 100, 19.4.1994, p. 1). Amended by 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). Corrected by Corrigendum OJ L 21, 26.1.2000, p. 42; and by Corrigendum OJ L 304, 5.12.2000, p. 19.

⁶ http://ec.europa.eu/enterprise/policies/single-market-goods/documents/blue-guide. 

⁷ Directive 1999/92/EC of the European Parliament and of the Council of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 023 , 28.1.2000, p. 57). Council Directive 92/91/EEC of 3 November 1992 concerning the minimum requirements for improving the safety and health protection of workers in the mineral-extracting industries through drilling (eleventh individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (OJ L 348, 28.11.1992, p. 9).

Council Directive 92/104/EEC of 3 December 1992 on the minimum requirements for improving the safety and health protection of workers in surface and underground mineral-extracting industries (twelfth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (OJ L 404, 31.12.1992, p. 10).