This is a translation of the Executive Order on electrical equipment and electrical protective systems for use in a potentially explosive atmosphere.
In any case of misinterpretation between the translated version and the Danish version, the Danish version has legal force.
Executive Order no. 289 of 17/03/2016 (In force)
In pursuance of Section 5, paragraph 3, and Section 34, paragraph 2, of Act no. 525 of 29 April 2015 on the Safety of Electrical Plant, Electrical Installations and Electrical Equipment (the Electrical Safety Act), the following is established:
In any case of misinterpretation between the translated version and the Danish version, the Danish version has legal force.
Executive Order no. 289 of 17/03/2016 (In force)
In pursuance of Section 5, paragraph 3, and Section 34, paragraph 2, of Act no. 525 of 29 April 2015 on the Safety of Electrical Plant, Electrical Installations and Electrical Equipment (the Electrical Safety Act), the following is established:
Executive order: ATEX
Part 1: Scope
1. This Executive Order applies to the following, which are subsequently called electrical products:
1) Electrical equipment and electrical protective systems intended for use in a potentially explosive atmosphere.
2) Electrical safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of electrical equipment and electrical protective systems with respect to the risks of explosion.
3) Components intended to be incorporated into electrical equipment and electrical protective systems referred to in no. 1).
2. This Executive Order does not apply to the following:
1) Medical devices intended for use in a medical environment.
2) Electrical equipment and electrical protective systems where the explosion hazard results exclusively from the presence of unstable explosive or chemical substances.
3) Electrical 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 gas.
4) Personal protective equipment covered by Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment.
5) Seagoing vessels and mobile offshore units together with equipment on board such vessels or units.
6) 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 are not excluded from the scope of this Executive Order.
7) Electrical equipment covered by point (b) of Article 346 (1) of the Treaty on the Functioning of the European Union.
Part 2: Definitions
3. The following definitions apply in this Executive Order:
1) Electrical equipment: electrical machines, electrical apparatus, fixed or mobile electrical devices, electrical control components and instrumentation and electrical detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy or the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
2) Electrical protective systems: electrical devices other than components of equipment intended to halt incipient explosions immediately or to limit the effective range of an explosion which are separately made available on the market for use as autonomous systems.
3) Components: any item essential to the safe functioning of electrical equipment and electrical protective systems but with no autonomous function.
4) Explosive atmosphere: a 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.
5) Potentially explosive atmosphere: an atmosphere which could become explosive due to local and operational conditions.
6) Equipment group I: equipment intended for use in underground parts of mines, and in those parts of surface installations of such mines, liable to be endangered by firedamp and/or combustible dust, comprising equipment categories M1 and M2 as set out in Annex 1.
7) Equipment group II: equipment intended for use in other places where danger can arise due to an explosive atmosphere, comprising equipment categories 1, 2 and 3 as set out in Annex 1.
8) Equipment category: the classification of equipment within each equipment group specified in Annex I, determining the requisite level of protection to be ensured.
9) Intended use: the use of a product as prescribed by the manufacturer through assigning the equipment to a particular equipment group and category or by providing all the information which is required for the safe functioning of a protective system, device or component.
10) Making available on the market: any supply of a product for distribution, consumption or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge.
11) Placing on the market: the first making available of a product on the EU market.
12) Manufacturer: any natural or legal person that manufactures a product or has a product designed or manufactured, and markets that product under their name or trade mark or uses it for their own purposes.
13) Authorised representative: any natural or legal person established within the EU that has received a written mandate from a manufacturer to act on their behalf in relation to specified tasks.
14) Importer: any natural or legal person established within the EU that places a product from a third country on the EU market.
15) Distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a product available on the market.
16) Economic operators: the manufacturer, the authorised representative, the importer and the distributor.
17) Technical specification: a document that prescribes technical requirements to be fulfilled by a product.
18) Harmonised standard: harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation 1025/2012/EU.
19) Conformity assessment: a process demonstrating whether the essential health and safety requirements of this Executive Order relating to a product have been fulfilled.
20) Conformity assessment body: a body that performs conformity assessment activities including calibration, testing, certification and inspection.
21) Recall: any measure aimed at achieving the return of a product that has already been made available to the end user.
22) Withdrawal: any measure aimed at preventing a product in the supply chain from being made available on the market.
23) EU harmonisation legislation: all EU legislation harmonising the conditions for the marketing of products.
24) CE marking: marking by which the manufacturer indicates that the product is in conformity with all applicable requirements set out in EU harmonisation legislation providing for its affixing.
Part 3: Obligations of economic operators
Obligations of manufacturers
4. When placing electrical products on the market or using them for their own purposes, manufacturers must ensure that they have been designed and manufactured in accordance with the essential health and safety requirements set out in Annex 2.
5. Manufacturers must draw up the technical documentation referred to in Annexes 3-9 and carry out the conformity assessment procedure referred to in Section 28 or have it carried out.
2. Where compliance of an electrical product, other than a component, with the applicable requirements has been documented by such a procedure, manufacturers must draw up an EU declaration of conformity and affix the CE marking.
3. Where compliance of a component with the applicable requirements has been documented by the relevant conformity assessment procedure, manufacturers must draw up a written attestation of conformity as referred to in Section 29.
6. Manufacturers must ensure that each electrical product is accompanied by a copy of the EU declaration of conformity or of the attestation of conformity, as appropriate. However, where a large number of electrical products are delivered to a single user, the batch or consignment may be accompanied by a single copy.
2. Manufacturers must keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the electrical product has been placed on the market.
7. Manufacturers must ensure that procedures are in place for series production to remain in conformity with this Executive Order. Changes in a product design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of the electrical product is declared must be adequately taken into account.
2. When deemed appropriate with regard to the risks presented by an electrical product, manufacturers must, to protect the health and safety of end users, carry out sample testing of electrical products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and must keep distributors informed of any such monitoring.
8. Manufacturers must ensure that electrical products which they have placed on the market bear a type, batch or serial number or other element allowing their identification. Cf. however subsection 3.
2. Manufacturers must indicate, on the electrical product, their name, registered trade name or registered trade mark and their postal address. The address must indicate a single point at which the manufacturer can be contacted. Cf. however subsection 3. The contact details must be in a language easily understood by end users, the Danish Safety Technology Authority and the other market surveillance authorities.
3. Where the size or nature of the product does not allow compliance with subsection 1-2, the required information must be provided on the packaging or in a document accompanying the product.
9. The manufacturer must ensure that electrical products, other than components, which they have placed on the market bear the specific marking of explosion protection and, where applicable, the other markings and information referred to in point 1.0.5 of Annex 2.
2. Manufacturers must also ensure that the electrical product is accompanied by instructions and safety information in Danish. Such instructions and safety information, as well as any labelling, must be clear and understandable.
10. A manufacturer who knows or have reason to believe that an electrical product which they have placed on the market is not in conformity with the requirements in this Executive Order must immediately take the corrective measures necessary to bring that electrical product into conformity with legislation, to withdraw it or recall it, if appropriate.
2. Where the electrical product presents a risk, manufacturers must immediately inform the Danish Safety Technology Authority and the competent national authorities of the other Member States in which they made the product available on the market to that effect. The manufacturer must also give details, in particular, of the non-compliance with legislation and of any corrective measures taken.
Authorised representatives
11. A manufacturer may, by a written mandate, appoint an authorised representative.
2. The obligations laid down in Section 4 and the obligation to draw up technical documentation referred to in Section 5 (1) must not form part of the authorised representative’s mandate.
12. An authorised representative must perform the tasks specified in the mandate received from the manufacturer. The mandate must allow the authorised representative to do at least the following:
1) Keep the technical documentation, the EU declaration of conformity and, where applicable, the attestation of conformity at the disposal of the Danish Safety Technology Authority and the other national market surveillance authorities for 10 years after the product has been placed on the market.
2) Further to a reasoned request from the Danish Safety Technology Authority or another competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the electrical product with legislation.
3) Cooperate with the Danish Safety Technology Authority or another competent national authority, at their request, on any action taken to eliminate the risks posed by electrical products covered by the authorised representative’s mandate.
Obligations of importers
13. Importers must only place electrical products on the market that comply with the requirements in this Executive Order.
14. Before placing a product on the market, importers must ensure that the appropriate conformity assessment procedure referred to in Section 28 has been carried out by the manufacturer.
2. Importers must also ensure that
1) the manufacturer has drawn up the technical documentation,
2) that the electrical product bears the CE marking and is accompanied by the EU declaration of conformity or the attestation of conformity and the required documentation, and
3) that the manufacturer has complied with the requirements in Section 8 and Section 9 (1).
15. Where an importer knows or has reason to believe that an electrical product is not in conformity with the essential health and safety requirements set out in Annex 2, they must not place the electrical product on the market until it has been brought into conformity with the requirements.
2. Furthermore, where the electrical product presents a risk, the importer must inform the manufacturer, the Danish Safety Technology Authority and the other market surveillance authorities to that effect.
16. Importers must indicate, on the electrical product, their name, registered trade name or registered trade mark and the postal address at which they can be contacted. The contact details must be in a language easily understood by end users, the Danish Safety Technology Authority and the other market surveillance authorities.
2. Where it is not possible to provide the information referred to in paragraph 1 on the electrical product, it must be provided on the packaging or in a document accompanying the electrical product.
17. Importers must ensure that the electrical product is accompanied by instructions and safety information in Danish.
2. Importers must ensure that, while electrical products are under their responsibility, their storage or transport conditions do not jeopardise their compliance with the essential health and safety requirements set out in Annex 2.
3. When deemed appropriate with regard to the risks presented by an electrical product, importers must, to protect the health and safety of end users, carry out sample testing of electrical products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and must keep distributors informed of any such monitoring.
18. An importer who knows or have reason to believe that an electrical product which they have placed on the market is not in conformity with the requirements in this Executive Order must immediately take the corrective measures necessary to bring that electrical product into conformity with legislation, to withdraw it or recall it, if appropriate.
2. Furthermore, where the electrical product presents a risk, importers must immediately inform the Danish Safety Technology Authority and the competent national authorities of the other Member States in which they made the product available on the market to that effect. Importers must also give details, in particular, of the non-compliance with legislation and of any corrective measures taken.
19. Importers must, for 10 years after the electrical product has been placed on the market, keep a copy of the EU declaration of conformity or, where applicable, of the attestation of conformity so that it is at the disposal of the Danish Safety Technology Authority and the other market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.
Obligations of distributors
20. When making an electrical product available on the market, distributors must act with due care in relation to the requirements of this Executive Order.
21. Before making an electrical product available on the market, distributors must check that
1) it bears the CE marking,
2) where applicable, it is accompanied by the EU declaration of conformity or the attestation of conformity and the required documentation,
3) it is accompanied by instructions and safety information in Danish,
4) the manufacturer has complied with the requirements in Section 8 and Section 9(1), and
5) any importer has complied with the requirements in Section 16.
2. Where a distributor knows or has reason to believe that an electrical product is not in conformity with the essential requirements set out in Annex 2, they must not make the electrical product available on the market until it has been brought into conformity with the requirements.
3. Furthermore, where the electrical product presents a risk, the distributor must inform the manufacturer or importer, the Danish Safety Technology Authority and the other market surveillance authorities to that effect.
22. The distributor must ensure that, while electrical products are under their responsibility, their storage or transport conditions do not jeopardise their compliance with the essential health and safety requirements set out in Annex 2.
23. A distributor who knows or have reason to believe that an electrical product which they have made available on the market is not in conformity with this Executive Order must make sure that the corrective measures necessary to bring that electrical product into conformity with legislation, to withdraw it or recall it, if appropriate, are taken.
2. Furthermore, where the electrical product presents a risk, distributors must immediately inform the Danish Safety Technology Authority and the competent national authorities of the other Member States in which they made the product available on the market to that effect. Distributors must also give details, in particular, of the non-compliance with legislation and of any corrective measures taken.
Assumption of the obligations of manufacturers by importers and distributors
24. An importer or distributor is considered to be a manufacturer and is subject to the obligations of the manufacturer, where it places a product on the market under its name or trade mark. Cf. 4-10, Section 37 and Section 41 (1).
2. Subsection 1 also applies if an importer or distributor modifies an electrical product already placed on the market in such a way that compliance with this Executive Order may be affected.
Economic operators' identification of other economic operators
25. Economic operators must, on request, identify the following to the Danish Safety Technology Authority or other market surveillance authorities:
1) any economic operator who has supplied them with an electrical product, and
2) any economic operator to whom they have supplied an electrical product.
2. Economic operators must be able to present the information referred to in subsection 1 for 10 years after they have been supplied with the electrical product and for 10 years after they have supplied the electrical product.
Part 4: Conformity of electrical products
Making available on the market and putting into service
26. Electrical products may only be made available on the market and put into service if they comply with this Executive Order when they are installed and are maintained appropriately and used in accordance with their intended use.
2. Electrical products must comply with the essential health and safety requirements set out in Annex 2, which apply to them in consideration of their intended use.
Presumption of conformity of electrical products
27. Electrical products which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, are presumed to be in conformity with the essential health and safety requirements set out in Annex 2 covered by those standards or parts thereof.
Conformity assessment procedures
28. The procedures to be followed for assessing the conformity of electrical equipment and, where necessary, the devices referred to in Section 1, no. 2, are as follows:
1) For equipment groups I and II, equipment categories M1 and 1, module B in Annex 3 is used, in conjunction with either module D in Annex 4 or module F in Annex 5.
2) For equipment groups I and II and equipment categories M2 and 2, the following are used:
a) For internal combustion engines and electrical equipment, module B in Annex 3 is used, in conjunction with either module C1 in Annex 6 or module E in Annex 7.
b) For other equipment not covered by a), module A in Annex 8 is used. The technical documentation in point 2 in Annex 8 is sent to a notified body, which must acknowledge receipt of it as soon as possible and must retain it.
3) For equipment group II and equipment category 3, module A in Annex 8 is used.
4) For equipment groups I and II, in addition to the procedures referred to in nos. 1-3, conformity based on module G in Annex 9 may also be used.
2. The procedure referred to in subsection 1, no. 1, or subsection 1, no. 4, must be used for conformity assessment of electrical protective systems.
3. With regard to the safety aspects referred to in point 1.2.7 of Annex 2, in addition to the conformity assessment procedures referred to in subsections 1 - 2, the procedure referred to in Annex 8 may also be followed.
4. By derogation from subsections 1-3, the Danish Safety Technology Authority may, on a duly justified request, authorise the placing on the market and putting into service in Denmark of products other than components in respect of which the procedures referred to in subsections 1-3 have not been applied and the use of which is in the interests of protection.
29. The procedures referred to in Section 28, subsection 1, also apply in respect of components with the exception of the affixing of the CE marking and the drawing up of the EU declaration of conformity. A written attestation of conformity must be issued by the manufacturer, declaring the conformity of the components with the applicable provisions of this Executive Order and stating their characteristics and how they must be incorporated into equipment or protective systems to ensure compliance with the essential health and safety requirements set out in Annex 2 applicable to finished equipment or protective systems.
30. Documents and correspondence relating to the conformity assessment procedures referred to in Section 28, subsections 1-3, and Section 29 must be drawn up in Danish or English.
EU declaration of conformity
31. The EU declaration of conformity must state that the fulfilment of the essential health and safety requirements set out in Annex 2 has been documented.
2. The EU declaration of conformity must
1) follow the model in Annex 10,
2) contain the elements specified in the relevant conformity assessment procedures set out in Annexes 3-9,
3) be continuously updated, and
4)be translated into Danish or English if the product is placed or made available on the market in Denmark.
3. Where an electrical product is subject to more than one EU act requiring an EU declaration of conformity, a single EU declaration of conformity must be drawn up in respect of all such EU acts. That declaration must contain the identification of the EU acts concerned, including their publication references.
4. By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the electrical product with the requirements laid down in this Executive Order.
CE marking
32. The CE marking must be affixed before the electrical product is placed on the market.
2. The CE marking is subject to the general principles set out in Article 30 of Regulation 2008/765/EC of the European Parliament and of the Council.
33. The CE marking must be affixed visibly, legibly and indelibly to the electrical product or to its data plate. Where that is not possible or not warranted on account of the nature of the electrical product, it must be affixed to the packaging and to the accompanying documents.
2. The CE marking must be followed by the identification number of the notified body, where that body is involved in the production control phase. The identification number of the notified body must be affixed by the body itself or, under its instructions, by the manufacturer or its authorised representative.
3. The CE marking and, where applicable, the identification number of the notified body must be followed by
2) the symbols of the equipment group and category and,
3) where applicable, the other markings and information referred to in point 1.0.5 of Annex 2.
4. The CE marking and the markings, symbols and information referred to in paragraph 3, and, where applicable, the identification number of the notified body, may be followed by any other mark indicating a special risk or use.
34. Electrical products that are designed for a particular explosive atmosphere must be marked accordingly.
Part 5: Electrical products for use at trade fairs, etc.
35. Electrical products may be presented at trade fairs, exhibitions and demonstrations even if the products are not in conformity with this Executive Order, provided that a visible sign clearly indicates that such products do not comply with this Executive Order and that they are not for sale until they have been brought into conformity by the manufacturer.
2. During demonstrations, cf. subsection 1, adequate safety measures must be taken to ensure the protection of persons.
Part 6: Notified bodies
36. The Director of the Danish Working Environment Authority appoints notified bodies to carry out the procedures for conformity assessment in relation to electrical products subject to this Executive Order.
Part 7: Market surveillance
37. An economic operator is under an obligation, following a reasoned request from the Danish Safety Technology Authority, to provide all information and documentation required to verify compliance with this Executive Order. The information and documentation must be provided in hard copy or in an electronic format.
2. The manufacturer and the importer must provide the information and documentation specified in paragraph 1 in a language easily understood by the Danish Safety Technology Authority.
38. The Danish Safety Technology Authority may notify the public of the danger of electrical products.
39. The economic operators concerned must, in all necessary ways, cooperate with the Danish Safety Technology Authority or another market surveillance authority on their evaluation of an electrical product, where there is sufficient reason to assume that it presents a risk to the health or safety of persons or to domestic animals or property.
40. The Danish Safety Technology Authority may issue an enforcement notice to remove CE marking that has wrongfully been affixed to an electrical product.
Corrective actions by economic operators
41. The manufacturer and the importer must, if the Danish Safety Technology Authority or another competent national authority so requests, cooperate with the authority on corrective actions to eliminate the risks posed by an electrical product that they have placed on the market.
2. Subsection 1 applies accordingly to the authorised representative for electrical products that are subject to their mandate.
3. Subsection 1 applies accordingly to the distributor who made the electrical products available.
42. If the Danish Safety Technology Authority discovers that an electrical product presents a risk to the health or safety of persons or to domestic animals or property, and it does not comply with the requirements in this Executive Order, the Danish Safety Technology Authority immediately requests the economic operator in question to take all necessary corrective actions in relation to the nature of the risk within a reasonable time by
1) bringing the electrical product into conformity with the requirements in this Executive Order,
2) withdrawing the electrical product from the market, or
3) recalling the electrical product.
2. The economic operator in question must ensure that all necessary corrective action is taken in respect of all electrical products concerned that the economic operator has made available on the EU market.
3. The Danish Safety Technology Authority notifies the relevant notified body of any orders under subsection 1.
43. If the economic operator in question does not take the necessary corrective action within the deadline referred to in Section 42 (1), the Danish Safety Technology Authority takes the necessary provisional measures to
1) prohibit or restrict the electrical product being made available on the Danish market,
2) withdraw the electrical product from the market, or
3) recall the electrical product.
2. If the Commission decides that a decision made by the Danish Safety Technology Authority, as referred to in subsection 1, must be amended or revoked, the Authority adapts its decision accordingly or revokes it.
Compliant electrical products which present a risk
44. Where, although an electrical product is in compliance with this Executive Order, it presents a risk to the health or safety of persons or to domestic animals or property, the Danish Safety Technology Authority may order the economic operator to take all necessary corrective action, within a reasonable period determined by the Danish Safety Technology Authority commensurate with the nature of the risk, to
1) ensure that the electrical product concerned, when placed on the market, no longer presents a risk,
2) withdraw the electrical product from the market, or
3) recall the electrical product.
2. The economic operator in question must ensure that all necessary corrective action is taken in respect of all electrical products concerned that the economic operator has made available on the EU market.
3. If the Commission decides that a decision made by the Danish Safety Technology Authority, as referred to in subsection 1, must be amended or revoked, the Authority adapts its decision accordingly or revokes it.
Formal non-compliance
45. The Danish Safety Technology Authority may order an economic operator to remedy the following circumstances within a specific deadline:
1) The CE marking has been affixed in violation of Article 30 of Regulation 765/2008/EC of the European Parliament and of the Council or Section 32 (1) or Section 33.
2) The CE marking, where required, has not been affixed.
3) The specific marking of explosion protection, the symbols of the equipment group and category and, where applicable, the other markings and information have been affixed in violation of point 1.0.5 of Annex 2 or have not been affixed.
4) The identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of Section 33 (2) or has not been affixed.
5) The EU declaration of conformity or the attestation of conformity does not accompany the product or has not been drawn up correctly.
6) Technical documentation is either not available or not complete.
7) The information referred to in Section 8 (2) or Section 16 (1) is absent, false or incomplete.
8) One or more of the other administrative requirements made of the manufacturer and importer in Sections 4-10, Sections 13-19, Section 37 and Section 41 (1) is not fulfilled.
2. Where the circumstance is not remedied within the deadline specified in subsection 1, the Danish Safety Technology Authority may
1) prohibit the electrical product being made available on the market, or
2) order the economic operator to withdraw the electrical product or recall it.
Part 8: Penalties
46. Unless a more severe penalty is incurred under any other legislation, a fine is imposed on anyone who
1) places electrical products on the market in violation of Section 4, Section 5 (1) and (2) or Section 13,
2) makes electrical products available on the market in violation of Section 20, cf. Section 26,
3) puts an electrical product into service in violation of Section 26,
4) neglects to keep documentation under Section 6 (2), Section 19 or Section 25 (2),
5) neglects to provide the electrical product with relevant information, cf. Sections 8-9 or Section 16,
6) neglects to comply with the requirements concerning instructions and safety information, cf. Section 9 (2), Section 17 (1) and Section 21 (1), no. 3,
7) neglects to check that the electrical product is provided with the required information, cf. Section 14 (2), nos. 2 and 3, or Section 21 (1), nos. 1, 2, 4 and 5,
8) neglects to give the Danish Safety Technology Authority the necessary notification under Section 10 (2), Section 15 (2), Section 18 (2), Section 21 (3) or Section 23 (2),
9) neglects to provide the Danish Safety Technology Authority with the information required in accordance with Section 25 (1) or Section 37, or
10) neglects to comply with a prohibition or order under Section 40 or Sections 43-45.
2. Companies, etc. (legal persons) may be subject to criminal liability under the rules of Part 5 of the Danish Penal Code.
3. The period of limitation for criminal liability is 10 years.
Part 9: Entry into force and transitional provisions
47. This Executive Order enters into force on 20 April 2016, cf. however subsection 3.
2. Executive Order no. 697 of 18 August 1995 on electrical equipment and electrical protective systems for use in a potentially explosive atmosphere is repealed.
3. Section 36 enters into force on 19 March 2016.
48. Electrical products that comply with the requirements in Executive Order no. 697 of 18 August 1995 on electrical equipment and electrical protective systems for use in a potentially explosive atmosphere and were placed on the market before 20 April 2016 may continue to be made available in the market and put into service.
Ministry of Business and Growth, 17 March 2016
TROELS LUND POULSEN
Executive order: ATEX; Annex
Annex 01: Criteria determining the classification of equipment groups into categories
1. Equipment group I
a) Equipment category M 1 comprises equipment designed and, where necessary, equipped with additional special means of protection to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.
Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines endangered by firedamp and/or combustible dust.
Equipment in this category is required to remain functional, even in the event of rare incidents relating to equipment, with an explosive atmosphere present, and is characterised by means of protection such that:
– either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,
– or the requisite level of protection is assured in the event of two faults occurring independently of each other.
Equipment in this category must comply with the supplementary requirements referred to in point 2.0.1 of Annex 2.
b) Equipment category M 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a high level of protection.
Equipment in this category is intended for use in underground parts of mines as well as those parts of surface installations of such mines endangered by firedamp and/or combustible dust.
This equipment is intended to be de-energised in the event of an explosive atmosphere.
The means of protection relating to equipment in this category assure the requisite level of protection during normal operation and also in the case of more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.
Equipment in this category must comply with the supplementary requirements referred to in point 2.0.2 of Annex 2.
2. Equipment group II
a) Equipment category 1 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and ensuring a very high level of protection.
Equipment in this category is intended for use in areas in which explosive atmospheres caused by mixtures of air and gases, vapours or mists or by air/dust mixtures are present continuously, for long periods or frequently.
Equipment in this category must ensure the requisite level of protection, even in the event of rare incidents relating to equipment, and is characterised by means of protection such that:
– either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,
– or the requisite level of protection is assured in the event of two faults occurring independently of each other.
Equipment in this category must comply with the supplementary requirements referred to in point 2.1 of Annex 2.
b) Equipment category 2 comprises equipment designed to be capable of functioning in conformity with the operational parameters established by the manufacturer and of ensuring a high level of protection.
Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists or air/dust mixtures are likely to occur occasionally.
The means of protection relating to equipment in this category ensure the requisite level of protection, even in the event of frequently occurring disturbances or equipment faults which normally have to be taken into account.
Equipment in this category must comply with the supplementary requirements referred to in point 2.2 of Annex 2.
c) Equipment category 3 comprises equipment designed to be capable of functioning in conformity with the operating parameters established by the manufacturer and ensuring a normal level of protection.
Equipment in this category is intended for use in areas in which explosive atmospheres caused by gases, vapours, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are likely to do so only infrequently and for a short period only.
Equipment in this category ensures the requisite level of protection during normal operation.
Equipment in this category must comply with the supplementary requirements referred to in point 2.3 of Annex 2.
Annex 02: Essential health and safety requirements relating to the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres
Preliminary observations
A. Technological knowledge, which can change rapidly, must be taken into account as far as possible and be utilised immediately.
B For the devices referred to in Section 1, no. 2, the essential health and safety requirements apply only in so far as they are necessary for the safe and reliable functioning and operation of those devices with respect to the risks of explosion.
1. Common requirements for equipment and protective systems
1.0. General requirements
1.0.1 Principles of integrated explosion safety
Equipment and protective systems intended for use in potentially explosive atmospheres must be designed from the point of view of integrated explosion safety.
In this connection, the manufacturer must take measures:
– above all, if possible, to prevent the formation of explosive atmospheres which may be produced or released by equipment and by protective systems themselves,
– to prevent the ignition of explosive atmospheres, taking into account the nature of every electrical and non-electrical source of ignition,
– should an explosion nevertheless occur which could directly or indirectly endanger persons and, as the case may be, domestic animals or property, to halt it immediately and/or to limit the range of explosion flames and explosion pressures to a sufficient level of safety.
1.0.2. Equipment and protective systems must be designed and manufactured after due analysis of possible operating faults in order as far as possible to preclude dangerous situations.
Any misuse which can reasonably be anticipated must be taken into account.
1.0.3 Special checking and maintenance conditions
Equipment and protective systems subject to special checking and maintenance conditions must be designed and constructed with such conditions in mind.
1.0.4 Surrounding area conditions
Equipment and protective systems must be so designed and constructed as to be capable of coping with actual or foreseeable surrounding area conditions.
1.0.5 Marking
All equipment and protective systems must be marked legibly and indelibly with the following minimum particulars:
– name, registered trade name or registered trade mark, and address of the manufacturer
– CE marking (see Annex II to Regulation (EC) No 765/2008)
– designation of series or type
– batch or serial number, if any
– year of construction
– for equipment group II, the letter ‘G’ (concerning explosive atmospheres caused by gases, vapours or mists), and/or
– the letter ‘D’ (concerning explosive atmospheres caused by dust).
Furthermore, where necessary, equipment and protective systems must also be marked with all information essential to their safe use.
1.0.6 Instructions
a) All equipment and protective systems must be accompanied by instructions, including at least the following particulars:
– a recapitulation of the information with which the equipment or protective system is marked, except for the batch or serial number (see point 1.0.5), together with any appropriate additional information to facilitate maintenance (e.g. address of the repairer, etc.)
– instructions for safe:
– putting into service
– use
– assembling and dismantling
– maintenance (servicing and emergency repair)
– installation
– adjustment
– where necessary, an indication of the danger areas in front of pressure-relief devices
– where necessary, training instructions
– details which allow a decision to be taken beyond any doubt as to whether an item of equipment in a specific category or a protective system can be used safely in the intended area under the expected operating conditions
– electrical and pressure parameters, maximum surface temperatures and other limit values
– where necessary, special conditions of use, including particulars of possible misuse which experience has shown might occur
– where necessary, the essential characteristics of tools which may be fitted to the equipment or protective system
b) The instructions must contain the drawings and diagrams necessary for the putting into service, maintenance, inspection, checking of correct operation and, where appropriate, repair of the equipment or protective system, together with all useful instructions, in particular with regard to safety
c) Literature describing the equipment or protective system must not contradict the instructions with regard to safety aspects.
1.1. Selection of materials
1.1.1. The materials used for the construction of equipment and protective systems must not trigger off an explosion, taking into account foreseeable operational stresses.
1.1.2. Within the limits of the operating conditions laid down by the manufacturer, it must not be possible for a reaction to take place between the materials used and the constituents of the potentially explosive atmosphere which could impair explosion protection.
1.1.3. Materials must be so selected that predictable changes in their characteristics and their compatibility in combination with other materials will not lead to a reduction in the protection afforded; in particular, due account must be taken of the material’s corrosion and wear resistance, electrical conductivity, mechanical strength, ageing resistance and the effects of temperature variations.
1.2. Design and construction
1.2.1. Equipment and protective systems must be designed and constructed with due regard to technological knowledge of explosion protection so that they can be safely operated throughout their foreseeable lifetime.
1.2.2. Components to be incorporated into or used as replacements in equipment and protective systems must be so designed and constructed that they function safely for their intended purpose when they are installed in accordance with the manufacturer’s instructions.
1.2.3. Enclosed structures and prevention of leaks
Equipment which may release flammable gases or dusts must wherever possible employ enclosed structures only.
If equipment contains openings or non-tight joints, these must as far as possible be designed in such a way that releases of gases or dusts cannot give rise to explosive atmospheres outside the equipment.
Points where materials are introduced or drawn off must, as far as possible, be designed and equipped so as to limit releases of flammable materials during filling or draining.
1.2.4. Dust deposits
Equipment and protective systems which are intended to be used in areas exposed to dust must be so designed that deposit dust on their surfaces is not ignited.
In general, dust deposits must be limited where possible. Equipment and protective systems must be easily cleanable.
The surface temperatures of equipment parts must be kept well below the glow temperature of the deposit dust.
The thickness of deposit dust must be taken into consideration and, if appropriate, means must be taken to limit the temperature in order to prevent a heat build up.
1.2.5 Additional means of protection
Equipment and protective systems which may be exposed to certain types of external stresses must be equipped, where necessary, with additional means of protection.
Equipment must withstand relevant stresses, without adverse effect on explosion protection.
1.2.6 Safe opening
If equipment and protective systems are in a housing or a locked container forming part of the explosion protection itself, it must be possible to open such housing or container only with a special tool or by means of appropriate protection measures.
1.2.7 Protection against other hazards
Equipment and protective systems must be so designed and manufactured as to:
a. avoid physical injury or other harm which might be caused by direct or indirect contact
b. ensure that surface temperatures of accessible parts or radiation which may cause danger are not produced
c. eliminate non-electrical dangers which are revealed by experience
d. ensure that foreseeable conditions of overload do not give rise to dangerous situations.
Where, for equipment and protective systems, the risks referred to in this point are wholly or partly covered by other EU legislation, Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres1)does not apply or ceases to apply in the case of such equipment and protective systems and of such risks upon application of that specific EU legislation.
1.2.8 Overloading of equipment
Dangerous overloading of equipment must be prevented at the design stage by means of integrated measurement, regulation and control devices, such as over-current cut-off switches, temperature limiters, differential pressure switches, flowmeters, time-lag relays, overspeed monitors and/or similar types of monitoring devices.
1.2.9 Flameproof enclosure systems
If parts which can ignite an explosive atmosphere are placed in an enclosure, measures must be taken to ensure that the enclosure withstands the pressure developed during an internal explosion of an explosive mixture and prevents the transmission of the explosion to the explosive atmosphere surrounding the enclosure.
1.3. Potential ignition sources
1.3.1 Hazards arising from different ignition sources
Potential ignition sources such as sparks, flames, electric arcs, high surface temperatures, acoustic energy, optical radiation, electromagnetic waves and other ignition sources must not occur.
1.3.2 Hazards arising from static electricity
Electrostatic charges capable of resulting in dangerous discharges must be prevented by means of appropriate measures.
1.3.3 Hazards arising from stray electric and leakage currents
Stray electric and leakage currents in conductive equipment parts which could result in, for example, the occurrence of dangerous corrosion, overheating of surfaces or sparks capable of provoking ignition must be prevented.
1.3.4 Hazards arising from overheating
Overheating caused by friction or impacts occurring, for example, between materials and parts in contact with each other while rotating or through the intrusion of foreign bodies must, as far as possible, be prevented at the design stage.
1.3.5 Hazards arising from pressure compensation operations
Equipment and protective systems must be so designed or fitted with integrated measuring, control and regulation devices that pressure compensations arising from them do not generate shock waves or compressions which may cause ignition.
1.4. Hazards arising from external effects
1.4.1. Equipment and protective systems must be so designed and constructed as to be capable of performing their intended function in full safety, even in changing environmental conditions and in the presence of extraneous voltages, humidity, vibrations, contamination and other external effects, taking into account the limits of the operating conditions established by the manufacturer.
1.4.2. Equipment parts used must be appropriate to the intended mechanical and thermal stresses and capable of withstanding attack by existing or foreseeable aggressive substances.
1.5. Requirements in respect of safety-related devices
1.5.1. Safety devices must function independently of any measurement and/or control devices required for operation.
As far as possible, failure of a safety device must be detected sufficiently rapidly by appropriate technical means to ensure that there is only very little likelihood that dangerous situations will occur.
The fail-safe principle is to be applied in general.
Safety-related switching must in general directly actuate the relevant control devices without intermediate software command.
1.5.2. In the event of a safety device failure, equipment and/or protective systems must, wherever possible, be secured.
1.5.3. Emergency stop controls of safety devices must, as far as possible, be fitted with restart lockouts. A new start command may take effect on normal operation only after the restart lockouts have been intentionally reset.
1.5.4. Control and display units
Where control and display units are used, they must be designed in accordance with ergonomic principles in order to achieve the highest possible level of operating safety with regard to the risk of explosion.
1.5.5. Requirements in respect of devices with a measuring function for explosion protection.
In so far as they relate to equipment used in explosive atmospheres, devices with a measuring function must be designed and constructed so that they can cope with foreseeable operating requirements and special conditions of use.
1.5.6. Where necessary, it must be possible to check the reading accuracy and serviceability of devices with a measuring function.
1.5.7. The design of devices with a measuring function must incorporate a safety factor which ensures that the alarm threshold lies far enough outside the explosion and/or ignition limits of the atmospheres to be registered, taking into account, in particular, the operating conditions of the installation and possible aberrations in the measuring system.
1.5.8 Risks arising from software
In the design of software-controlled equipment, protective systems and safety devices, special account must be taken of the risks arising from faults in the program.
1.6. Integration of safety requirements relating to the system
1.6.1. Manual override must be possible in order to shut down the equipment and protective systems incorporated within automatic processes which deviate from the intended operating conditions, provided that this does not compromise safety.
1.6.2. When the emergency shutdown system is actuated, accumulated energy must be dispersed as quickly and as safely as possible or isolated so that it no longer constitutes a hazard.
This does not apply to electrochemically-stored energy.
1.6.3. Hazards arising from power failure
Where equipment and protective systems can give rise to a spread of additional risks in the event of a power failure, it must be possible to maintain them in a safe state of operation independently of the rest of the installation.
1.6.4 Hazards arising from connections
Equipment and protective systems must be fitted with suitable cable and conduit entries.
When equipment and protective systems are intended for use in combination with other equipment and protective systems, the interface must be safe.
1.6.5 Placing of warning devices as parts of equipment
Where equipment or protective systems are fitted with detection or alarm devices for monitoring the occurrence of explosive atmospheres, the necessary instructions must be provided to enable them to be provided at the appropriate places.
2.Supplementary requirements in respect of equipment
2.0. Requirements applicable to equipment in equipment group 1
2.0.1 Requirements applicable to equipment category M1 of equipment group 1
2.0.1.1. Equipment must be so designed and constructed that sources of ignition do not become active, even in the event of rare incidents relating to equipment.
It must be equipped with means of protection such that:
– either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,
– or the requisite level of protection is assured in the event of two faults occurring independently of each other.
Where necessary, equipment must be equipped with additional special means of protection.
It must remain functional with an explosive atmosphere present.
2.0.1.2. Where necessary, equipment must be so constructed that no dust can penetrate it.
2.0.1.3. The surface temperatures of equipment parts must be kept clearly below the ignition temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended dust.
2.0.1.4. Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active or intrinsically safe conditions. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.
If necessary, equipment must be fitted with appropriate additional interlocking systems.
2.0.2. Requirements applicable to equipment category M2 of equipment group 1
2.0.2.1. Equipment must be equipped with means of protection ensuring that sources of ignition do not become active during normal operation, even under more severe operating conditions, in particular those arising from rough handling and changing environmental conditions.
This equipment is intended to be de-energised in the event of an explosive atmosphere.
2.0.2.2. Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active conditions or via appropriate interlocking systems. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.
2.0.2.3. The requirements regarding explosion hazards arising from dust applicable to equipment category M1 must be applied.
2.1. Requirements applicable to equipment category 1 of equipment group 2
2.1.1. Explosive atmospheres caused by gases, vapours or mists
2.1.1.1. Equipment must be so designed and constructed that sources of ignition do not become active, even in the event of rare incidents relating to equipment.
It must be equipped with means of protection such that:
– either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,
– or the requisite level of protection is assured in the event of two faults occurring independently of each other.
2.1.1.2. For equipment with surfaces which may heat up, measures must be taken to ensure that the stated maximum surface temperatures are not exceeded even in the most unfavourable circumstances.
Temperature rises caused by heat build-ups and chemical reactions must also be taken into account.
2.1.1.3. Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active or intrinsically safe conditions. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.
If necessary, equipment must be fitted with appropriate additional interlocking systems.
2.1.2. Explosive atmospheres caused by air/dust mixtures
2.1.2.1. Equipment must be so designed and constructed that ignition of air/dust mixtures does not occur even in the event of rare incidents relating to equipment.
It must be equipped with means of protection such that:
– either, in the event of failure of one means of protection, at least an independent second means provides the requisite level of protection,
– or the requisite level of protection is assured in the event of two faults occurring independently of each other.
2.1.2.2. Where necessary, equipment must be so designed that dust can enter or escape from the equipment only at specifically designated points.
This requirement must also be met by cable entries and connecting pieces.
2.1.2.3. The surface temperatures of equipment parts must be kept well below the ignition temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended dust.
2.1.2.4. With regard to the safe opening of equipment parts, requirement 2.1.1.3 applies.
2.2. Requirements applicable to equipment category 2 of equipment group 2
2.2.1. Explosive atmospheres caused by gases, vapours or mists
2.2.1.1. Equipment must be so designed and constructed as to prevent ignition sources arising, even in the event of frequently occurring disturbances or equipment operating faults, which normally have to be taken into account.
2.2.1.2. Equipment parts must be so designed and constructed that their stated surface temperatures are not exceeded, even in the case of risks arising from abnormal situations anticipated by the manufacturer.
2.2.1.3. Equipment must be so designed that the opening of equipment parts which may be sources of ignition is possible only under non-active conditions or via appropriate interlocking systems. Where it is not possible to render equipment non-active, the manufacturer must affix a warning label to the opening part of the equipment.
2.2.2. Explosive atmospheres caused by air/dust mixtures
2.2.2.1. Equipment must be designed and constructed so that ignition of air/dust mixtures is prevented, even in the event of frequently occurring disturbances or equipment operating faults which normally have to be taken into account.
2.2.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies.
2.2.2.3. With regard to protection against dust, requirement 2.1.2.2 applies.
2.2.2.4. With regard to the safe opening of equipment parts, requirement 2.2.1.3 applies.
2.3. Requirements applicable to equipment category 3 of equipment group 2
2.3.1 Explosive atmospheres caused by gases, vapours or mists
2.3.1.1. Equipment must be so designed and constructed as to prevent foreseeable ignition sources which can occur during normal operation.
2.3.1.2. Surface temperatures must not exceed the stated maximum surface temperatures under intended operating conditions. Higher temperatures in exceptional circumstances may be allowed only if the manufacturer adopts special additional protective measures.
2.3.2 Explosive atmospheres caused by air/dust mixtures
2.3.2.1. Equipment must be so designed and constructed that air/dust mixtures cannot be ignited by foreseeable ignition sources likely to exist during normal operation.
2.3.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies.
2.3.2.3. Equipment, including cable entries and connecting pieces, must be so constructed that, taking into account the size of its particles, dust can neither develop explosive mixtures with air nor form dangerous accumulations inside the equipment.
3. Supplementary requirements in respect of protective systems
3.0. General requirements
3.0.1. Protective systems must be dimensioned in such a way as to reduce the effects of an explosion to a sufficient level of safety.
3.0.2. Protective systems must be designed and capable of being positioned in such a way that explosions are prevented from spreading through dangerous chain reactions or flashover and incipient explosions do not become detonations.
3.0.3. In the event of a power failure, protective systems must retain their capacity to function for a period sufficient to avoid a dangerous situation.
3.0.4. Protective systems must not fail due to outside interference.
3.1. Planning and design
3.1.1 Characteristics of materials
With regard to the characteristics of materials, the maximum pressure and temperature to be taken into consideration at the planning stage are the expected pressure during an explosion occurring under extreme operating conditions and the anticipated heating effect of the flame.
3.1.2. Protective systems designed to resist or contain explosions must be capable of withstanding the shock wave produced without losing system integrity.
3.1.3. Accessories connected to protective systems must be capable of withstanding the expected maximum explosion pressure without losing their capacity to function.
3.1.4. The reactions caused by pressure in peripheral equipment and connected pipe-work must be taken into consideration in the planning and design of protective systems.
3.1.5 Pressure-relief systems
If it is likely that stresses on protective systems will exceed their structural strength, provision must be made in the design for suitable pressure-relief devices which do not endanger persons in the vicinity.
3.1.6 Explosion suppression systems
Explosion suppression systems must be so planned and designed that they react to an incipient explosion at the earliest possible stage in the event of an incident and counteract it to best effect, with due regard to the maximum rate of pressure increase and the maximum explosion pressure.
3.1.7 Explosion decoupling systems
Decoupling systems intended to disconnect specific equipment as swiftly as possible in the event of incipient explosions by means of appropriate devices must be planned and designed so as to remain proof against the transmission of internal ignition and to retain their mechanical strength under operating conditions.
3.1.8. Protective systems must be capable of being integrated into a circuit with a suitable alarm threshold so that, if necessary, there is cessation of product feed and output and shutdown of equipment parts which can no longer function safely.
Annex 03: Module B: EU-type examination
1. EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a product and verifies and attests that the technical design of the product meets the relevant requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
2. The EU-type examination may be carried out by examination of a specimen, representative of the production envisaged, of the complete product (production type).
3. The manufacturer must lodge an application for EU-type examination with a single notified body of its choice.
The application must include:
a) The name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well.
b) A written declaration that the same application has not been lodged with any other notified body.
c) The technical documentation. The technical documentation must make it possible to assess the product’s conformity with the relevant requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, and must include an adequate analysis and assessment of the risk(s). The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation must contain at least the following elements:
i. A general description of the product.
ii. Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
iii. Descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product.
iv. A list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation must specify the parts which have been applied.
v. Results of design calculations made, examinations carried out, etc.
vi. Test reports.
d) The specimens representative of the production envisaged. The notified body may request further specimens if needed to carry out the test programme.
4. The notified body must:
4.1. Examine the technical documentation, verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications.
4.2. Carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly.
4.3. Carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the essential health and safety requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
4.4. Agree with the manufacturer on a location where the examinations and tests will be carried out.
5. The notified body draws up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body releases the content of that report, in full or in part, only with the agreement of the manufacturer.
6. Where the type meets the requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres that apply to the product concerned, the notified body issues an EU-type examination certificate to the manufacturer. That certificate must contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached.
The EU-type examination certificate and its annexes must contain all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control.
Where the type does not meet the requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, the notified body refuses to issue an EU-type examination certificate and informs the applicant accordingly, giving detailed reasons for its refusal.
7. The notified body must keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, and determines whether such changes require further investigation. If so, the notified body informs the manufacturer accordingly.
The manufacturer must inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the product with the essential health and safety requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres or the conditions of validity of that certificate. Such modifications require additional approval in the form of an addition to the original EU-type examination certificate.
8. Each notified body informs its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and, periodically or upon request, makes available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body informs the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body keeps a copy of the EU-type examination certificate, its annexes and additions, as well as the technical documentation, including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
9. The manufacturer keeps a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market.
10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.
Annex 04: Module D: Conformity to type based on quality assurance of the production process
1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on its sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the relevant requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
2. Manufacturing
The manufacturer must operate an approved quality system for production, final product inspection and testing of the products concerned as specified in point 3, and must be subject to surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer lodges an application for assessment of its quality system with the notified body of its choice for the products concerned.
The application must include:
a) The name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well.
b) A written declaration that the same application has not been lodged with any other notified body.
c) All relevant information for the product category envisaged.
d) Documentation concerning the quality system.
e) The technical documentation of the approved type and a copy of the EU-type examination certificate.
3.2. The quality system must ensure that the products are in conformity with the type described in the EU-type examination certificate and comply with the relevant requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.
The documentation must, in particular, contain an adequate description of:
a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality
b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used
c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out
d) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc., and
e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
3.3. The notified body assesses the quality system to determine whether it satisfies the requirements referred to in point 3.2.
It must presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
In addition to experience in quality management systems, the auditing team must have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres. The audit must include an assessment visit to the manufacturer’s premises. The auditing team must review the technical documentation referred to in point 3.1(e) to verify the manufacturer’s ability to identify the relevant requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
The manufacturer must be notified of the decision. The notification must contain the conclusions of the audit and the reasoned assessment decision.
3.4. The manufacturer undertakes to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
3.5. The manufacturer informs the notified body that has approved the quality system of any intended change to the quality system.
The notified body evaluates any proposed changes and decides whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It notifies the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer must, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and provide it with all necessary information, in particular:
a) documentation concerning the quality system
b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
4.3. The notified body carries out periodic audits to make sure that the manufacturer maintains and applies the quality system and provides the manufacturer with an audit report.
4.4. In addition, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body provides the manufacturer with a visit report and, if tests have been carried out, with a test report.
5. CE marking, EU declaration of conformity and attestation of conformity
5.1. The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
5.2. The manufacturer draws up a written EU declaration of conformity for each product model other than a component and keeps it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity must identify the product model for which it has been drawn up.
A copy of the EU declaration of conformity must accompany every product, other than a component.
5.3. The manufacturer draws up a written attestation of conformity for each component model and keeps it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity must identify the component model for which it has been drawn up. A copy of the attestation of conformity must accompany every component.
6.The manufacturer must, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:
a) the documentation referred to in point 3.1
b) the information relating to the changes referred to in point 3.5, as approved
c) the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
7. Each notified body must inform its notifying authority of quality system approvals issued or withdrawn, and must, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.
Each notified body must inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Annex 05: Module F: Conformity to type based on product verification
1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
2. Manufacturing
The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the EU-type examination certificate and with the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
3. Verification
A notified body chosen by the manufacturer carries out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EU-type examination certificate and with the appropriate requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
The examinations and tests to check the conformity of the products with the appropriate requirements will be carried out by examination and testing of every product as specified in point 4.
4. Verification of conformity by examination and testing of every product
4.1. All products are individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications are carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
In the absence of such a harmonised standard, the notified body concerned decides on the appropriate tests to be carried out.
4.2. The notified body issues a certificate of conformity in respect of the examinations and tests carried out, and affixes its identification number to each approved product or has it affixed under its responsibility.
The manufacturer must keep the certificates of conformity available for inspection by the national authorities for 10 years after the product has been placed on the market.
5. CE marking, EU declaration of conformity and attestation of conformity
5.1. The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual product other than a component that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
5.2. The manufacturer draws up a written EU declaration of conformity for each product model other than a component and keeps it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity must identify the product model for which it has been drawn up.
A copy of the EU declaration of conformity must accompany every product, other than a component.
If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the products other than components.
5.3. The manufacturer draws up a written attestation of conformity for each component model and keeps it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity must identify the component model for which it has been drawn up. A copy of the attestation of conformity must accompany every component.
6. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s identification number to the products during the manufacturing process.
7. Authorised representative
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in point 2.
Annex 06: Module C1: Conformity to type based on internal production control plus supervised product testing
1. Conformity to type based on internal production control plus supervised product testing is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on its sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
2. Manufacturing
The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the EU-type examination certificate and with the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
3. Product checks
For each individual product manufactured, one or more tests on one or more specific aspects of the product must be carried out by the manufacturer or on its behalf in order to verify conformity with the type described in the EU-type examination certificate and with the corresponding requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres. The tests must be carried out under the responsibility of a notified body, chosen by the manufacturer.
The manufacturer must, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
4. CE marking, EU declaration of conformity and attestation of conformity
4.1. The manufacturer must affix the CE marking to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
4.2. The manufacturer draws up a written EU declaration of conformity for a product model other than a component and keeps it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity must identify the product for which it has been drawn up.
A copy of the EU declaration of conformity must accompany every product, other than a component.
4.3. The manufacturer draws up a written attestation of conformity for each component model and keeps it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity must identify the component model for which it has been drawn up. A copy of the attestation of conformity must accompany every component.
5. Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Annex 07: Module E: Conformity to type based on product quality assurance
1. Conformity to type based on product quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on its sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the relevant requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
2. Manufacturing
The manufacturer must operate an approved quality system for final product inspection and testing of the products concerned as specified in point 3 and must be subject to surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer lodges an application for assessment of its quality system with the notified body of its choice for the products concerned.
The application must include:
a) The name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well.
b) A written declaration that the same application has not been lodged with any other notified body.
c) All relevant information for the product category envisaged.
d) Documentation concerning the quality system, and
e) The technical documentation of the approved type and a copy of the EU-type examination certificate.
3.2. The quality system must ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.
The documentation must, in particular, contain an adequate description of:
a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality
b) the examinations and tests that will be carried out after manufacture
c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
d) the means of monitoring the effective operation of the quality system.
3.3. The notified body assesses the quality system to determine whether it satisfies the requirements referred to in point 3.2.
It must presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
In addition to experience in quality management systems, the auditing team must have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres. The audit must include an assessment visit to the manufacturer’s premises. The auditing team must review the technical documentation referred to in point 3.1(e) to verify the manufacturer’s ability to identify the relevant requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
The manufacturer must be notified of the decision. The notification must contain the conclusions of the audit and the reasoned assessment decision.
3.4. The manufacturer undertakes to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
3.5. The manufacturer informs the notified body that has approved the quality system of any intended change to the quality system.
The notified body evaluates any proposed changes and decides whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It notifies the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer must, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and provide it with all necessary information, in particular:
a) documentation concerning the quality system
b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
4.3. The notified body carries out periodic audits to make sure that the manufacturer maintains and applies the quality system and provides the manufacturer with an audit report.
4.4. In addition, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body provides the manufacturer with a visit report and, if tests have been carried out, with a test report.
5. CE marking, EU declaration of conformity and attestation of conformity
5.1. The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter’s identification number to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
5.2. The manufacturer draws up a written EU declaration of conformity for each product model other than a component and keeps it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity must identify the product model for which it has been drawn up.
A copy of the EU declaration of conformity must accompany every product, other than a component.
5.3. The manufacturer draws up a written attestation of conformity for each component model and keeps it at the disposal of the national authorities for 10 years after the product has been placed on the market. The attestation of conformity must identify the component model for which it has been drawn up. A copy of the attestation of conformity must accompany every component.
6. The manufacturer must, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:
a) The documentation referred to in point 3.1.
b) The information relating to the changes referred to in point 3.5, as approved.
c) The decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
7. Each notified body must inform its notifying authority of quality system approvals issued or withdrawn, and must, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.
Each notified body must inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Annex 08: Module A: Internal production control
1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on its sole responsibility that the products concerned satisfy the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
2. Technical documentation
The manufacturer draws up the technical documentation. The documentation must make it possible to assess the product’s conformity to the relevant requirements, and must include an adequate analysis and assessment of the risk(s).
The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation must contain at least the following elements:
a) a general description of the product
b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product
d) a list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation must specify the parts which have been applied
e) results of design calculations made, examinations carried out, etc. and
f) test reports.
3. Manufacturing
The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
4. CE marking, EU declaration of conformity and attestation of conformity
4.1. The manufacturer must affix the CE marking to each individual product other than a component that satisfies the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
4.2. The manufacturer must draw up a written EU declaration of conformity for a product model other than a component and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product, other than a component, has been placed on the market. The EU declaration of conformity must identify the product for which it has been drawn up.
A copy of the EU declaration of conformity must accompany every product, other than a component.
4.3. The manufacturer draws up a written attestation of conformity for each component model and keeps it together with the technical documentation at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity must identify the component for which it has been drawn up. A copy of the attestation of conformity must accompany every component.
5. Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Annex 09: Module G: Conformity based on unit verification
1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares on its sole responsibility that the product concerned, which has been subject to the provisions of point 4, is in conformity with the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
2. Technical documentation
2.1. The manufacturer draws up the technical documentation and makes it available to the notified body referred to in point 4. The documentation must make it possible to assess the product’s conformity to the relevant requirements, and must include an adequate analysis and assessment of the risk(s). The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation must contain at least the following elements:
a) a general description of the product
b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product
d) a list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation must specify the parts which have been applied
e) results of design calculations made, examinations carried out, etc. and
f) test reports.
2.2. The manufacturer must keep the technical documentation at the disposal of the relevant national authorities for 10 years after the product has been placed on the market.
3. Manufacturing
The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
4. Verification
A notified body chosen by the manufacturer must carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the product with the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres. In the absence of such a harmonised standard, the notified body concerned decides on the appropriate tests to be carried out.
The notified body issues a certificate of conformity in respect of the examinations and tests carried out, and affixes its identification number to each approved product or has it affixed under its responsibility.
The manufacturer must keep the certificates of conformity at the disposal of the national authorities for 10 years after the product has been placed on the market.
5. CE marking, EU declaration of conformity and attestation of conformity
5.1. The manufacturer affixes the CE marking and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each product other than a component that satisfies the applicable requirements of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres.
5.2. The manufacturer draws up a written EU declaration of conformity and keeps it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity must identify the product for which it has been drawn up.
A copy of the EU declaration of conformity must accompany every product, other than a component.
5.3. The manufacturer draws up a written attestation of conformity and keeps it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity must identify the component for which it has been drawn up. A copy of the attestation of conformity must accompany every component.
6. Authorised representative
The manufacturer’s obligations set out in points 2.2 and 5 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Annex 10: EU Declaration of Conformity (no. xxxx)
1. Product model/product (product, type, batch or serial number):
2. Name and address of the manufacturer and, where applicable, its authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (identification of product allowing traceability; it may, where necessary for the identification of the product, include an image):
5. The object of the declaration described above is in conformity with the relevant EU harmonisation legislation:
6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:
7. Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate:
8. Additional information:
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature):
Executive order: ATEX: Notes
Official notes
The Executive Order contains provisions that implement parts of Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres, Official Journal 2014, no. L 96, page 309.
Directive 2014/34/EU is implemented in Danish law by this Executive Order.