THE ARTICLES OF THE ATEX DIRECTIVE
CHAPTER 1
GENERAL PROVISIONS
§ 31 General provisions
General provisions of the ATEX Directive 2014/34/EU include articles on scope and definitions.
Article 1
Scope
1. This Directive shall apply to the following, hereinafter referred to as “products”:
(a) equipment and protective systems intended for use in potentially explosive atmospheres;
(b) safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion;
(c) components intended to be incorporated into equipment and protective systems referred to in point (a).
…
§ 32 Products covered by the ATEX Directive: in which cases does Directive 2014/34/EU apply?
The term “product” covers equipment, protective systems, safety devices, controlling devices, regulation devices, components, and their combinations.
It has to be stressed that the ATEX Directive 2014/34/EU carries obligations and responsibilities for the person who places products on the market and/or puts products into service, be it the manufacturer, his authorised representative or any other responsible person. This “product” Directive does not regulate the use of equipment in a potentially explosive atmosphere which is covered by the ATEX “workplace” Directive 1999/92/EC and other similar European and national legislation (see footnote 7).
The manufacturer, his authorised representative or the person who first places a product on the EU market or puts a product into service in the EU market has to decide whether it is covered by the ATEX Directive 2014/34/EU and, if so, apply its provisions. The manufacturer (in the broadest sense of the Directive) must therefore make an ATEX analysis on the basis of the Directive.
§ 33 Used, repaired or modified products and spare parts
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As a general rule, manufacturers need to consider whether the product is being placed onto the EU market or taken into service for the first time, or if the modifications are such that the intention or the result is to place a product onto the market, which has to be considered as a new product. If the answer to either of these questions is "yes", then Directive 2014/34/EU fully applies. In all other cases the Directive 2014/34/EU does not apply and the responsible person will have to ensure that any other relevant national or EU legislation are considered as appropriate.
Within this context two points should be made:
·
In the following paragraphs, these Guidelines refer only to products for which Directive 2014/34/EU is potentially applicable. Products not subject to Directive 2014/34/EU are therefore excluded from these discussions.
·
The application of Directive 2014/34/EU to an "as new" product is without any prejudice to intellectual property legislation
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.
With regard to the information to be provided for repair of equipment, see section § 151 on instructions.
Used products and second hand products
This is a product which has been placed on the EU market prior to the coming into force of Directive 2014/34/EU and put into service on the EU territory. This product was in compliance with the then applicable legislation: national or EU (as Directive 94/9/EC, applicable from 1 July 2003 to 19 April 2016), depending on the date. In this case Directive 2014/34/EU does not apply.
Used products that were on the market and used in the EU before the date of entry into force of Directive 2014/34/EU are not covered by it. These products have been marketed and used in accordance with the regulations in force at that time. They circulate in the European Union based, among others, on Articles 28 and 30 of the Treaty on the Functioning of the European Union (TFEU: free movement of goods), unless they are modified so that health and safety characteristics have been affected.
For used products imported from a non-EU country and made available for the first time in the EU after 20 April 2016 for the purpose of distribution and/or use in the EU, Directive 2014/34/EU shall apply.
Reconditioned (or refurbished
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) products
These are used products which were on the market and used in the EU but whose performance has changed over time (due to ageing, obsolescence, etc.), and which have been modified so as to be restored. The case of products whose external appearance has been modified and improved by a cosmetic or aesthetic operation after they have been placed on the market and put into service is a particular form of refurbishment aimed at restoring the external appearance of the product
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. If this occurs with no substantial modification Directive 2014/34/EU does not apply.
Reconfigured products
These are used products which were on the market and used in the EU but whose configuration has been modified, by the addition (upgrading) or the removal (downgrading) of one or more parts (components, sub-assemblies such as plug-in cards or modules, etc.). If this occurs with no substantial modification Directive 2014/34/EU does not apply.
Substantially modified products
In the sense of Directive 2014/34/EU, a substantial modification is any modification to a product affecting one or more of the health and safety characteristics covered by essential health and safety requirements (e.g. temperature) or the integrity of a type protection. In this case Directive 2014/34/EU has to be applied. Of course this does not preclude the application of other relevant EU legislation, if it is the case.
According to the above, the general principle is that Directive 2014/34/EU re-applies to a modified product where the modification is considered to be substantial and if it is intended to be placed again on the EU market for distribution and/or use.
Repaired products
These are products whose functionality has been restored following a defect without adding new features or any other modification. As this occurs after the product has been placed on the market and the product is not to be sold as a new product, in this case Directive 2014/34/EU does not apply.
This does not preclude that national regulations of the Member States on the working environment may require some kind of assessment of the repaired product as well.
Spare parts
These are items intended to replace a defective or worn out part of a product previously placed and put into service on the EU market. A typical repair operation would be replacement by a spare part.
The manufacturer of the spare part is normally not required to comply with Directive 2014/34/EU unless the spare part represents an item of equipment or a component as defined by the Directive. If so, all obligations laid down in the Directive have to be fulfilled.
If the manufacturer of the original spare part offers a new, different one in its place (due to technical progress, discontinued production of the old part, etc.), and it is used for the repair, the repaired product (as long as no substantial modification of the repaired product takes place) does not need to be brought into conformity at this time with Directive 2014/34/EU as the repaired product is not then placed on the market and put into service.
§ 34 Which kinds of products are covered by Directive 2014/34/EU?
To be within the scope of the ATEX Directive 2014/34/EU, a product has to be:
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equipment or a protective system, as defined in Article 1(1)(a);
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a safety device, a controlling device or a regulating device as defined in Article 1(1)(b); or
·
a component, as defined in Article 1(1)(c),
according to their intended use.
In some specific circumstances clarification is needed, in order to decide whether a certain product falls within the scope of Directive 2014/34/EU or not. This will be clarified using different examples:
- Inerting systems (see section § 241)
- Paint spray booths (see section § 242)
- Filter units and vented silo bins (see section § 243)
- Gas turbines (see section § 244)
- Steam turbines (see section § 245)
- Petrol pumps (see section § 246)
- Cables (see section § 247)
- Rotating mechanical seals (see section § 248)
- Bucket elevators (see section § 249)
- Fork lift trucks (see section § 250)
- Transportable, pressurised cabins ("modules") (see section § 251)
- Automatically lubricating systems (see section § 252)
- Electrical trace heating systems (see section § 253)
Also, the "Borderline list - ATEX products" (see pages 225-228) is useful to clarify the situation of a number of products (equipment, protective systems, components, safety controlling or regulating devices, and others) with respect to the ATEX Directive 2006/42/EU.
§ 35 Place of intended use
This point seeks to provide guidance on the place of installation of equipment and protective systems. In fact, manufacturers of explosion protected equipment (e.g. in cases where potentially explosive atmospheres are conveyed) sometimes feel unsure whether and to what extent their products are covered by Directive 2014/34/EU. This applies especially to cases where only parts of the equipment are in contact with the explosive atmosphere.
Directive 2014/34/EU deals with the special risk of explosion and has one major aim to prevent "own potential sources of ignition" (Article 2(1)) of equipment and protective systems (as far as it has its own potential source of ignition) from becoming active. Beside Article 1(2) no restrictions are made with regard to local and technical conditions.
The probability of occurrence of the potential source of ignition determines the category. The technical requirements are summarised in Annex II 1.0.1; especially the 2nd indent describes the importance of the potential of the source of ignition. For this effect the place of installation is not decisive (see Article 1(1)(b) safety-, controlling-, regulation devices), but the possible effect of the potential source of ignition on a potentially explosive atmosphere.
In the light of these ideas the place of installation "in, at or beside" a potentially explosive atmosphere is not decisive for the application of Directive 2014/34/EU. The decisive fact is whether the potential sources of ignition of equipment are in contact – or have an interface – to a potentially explosive atmosphere, with the effect that the combustion may spread to the entire unburned mixture (see definition "explosive atmosphere", Article 2(4)). In this case the potential source of ignition is in the potentially explosive atmosphere.
Equipment may have an internal explosive mixture (without limitation to dangerous quantities), which has an interface in the sense of a spreading of the combustion to a potentially explosive atmosphere even in the case it is not installed completely inside a potentially explosive atmosphere. An example could be an extraction system installed outside the potentially explosive atmosphere with a ventilator – own potential source of ignition – which exhausts explosive atmosphere out of a storage tank, or another potentially explosive atmosphere, via a pipe acting as connecting interface to the potentially explosive atmosphere.
It is important to underline in this context how machinery having a potentially explosive atmosphere inside under operating conditions, but having no interface to external potentially explosive atmospheres has to be considered. Such machines, as an integral whole, do not fall under scope of the ATEX Directive 2014/34/EU.
However, the essential health and safety requirement 1.5.7 "Explosion" in Annex I to the Machinery Directive 2006/42/EC, requires that "Machinery must be designed and constructed in such a way as to avoid any risk of explosion posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery. Machinery must comply, as far as the risk of explosion due to its use in a potentially explosive atmosphere is concerned, with the provisions of the specific Community [read 'Union'] Directives" (see also the "Guide to application of the Machinery Directive 2006/42/EC", §§ 91 and 228).
It is therefore evident that equipment, protective systems and components intended for use in this potentially explosive atmosphere – and safety and controlling devices outside, but contributing to their safe functioning – are within the scope of the ATEX Directive 2014/34/EU. It is understood that the latter applies provided that "atmospheric conditions" in the sense of Directive 2014/34/EU are present in the machine.
In this context the following questions have arisen:
a) Has the manufacturer the obligation to perform a zone classification inside this machinery?
It has been considered that:
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the manufacturer of the machine has to carry out a risk analysis, including the risk of explosion;
·
Annex I to the ATEX Directive 2014/34/EU contains clear and unambiguous definitions concerning the place where they are intended to be used for every single equipment-group and category;
·
as opposed to the fully harmonising scope of the Machinery Directive, the zone concept applied in the framework of the ATEX "workplace" Directive 1999/92/EC allows Member States to apply more stringent requirements than those defined in this Directive.
In order to avoid a non-harmonised approach in the framework of a fully harmonised field like the Machinery Directive, it is not necessary to apply the zone concept as it is defined in Directive 1999/92/EC. Instead, the manufacturer should:
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carry out the risk assessment (the manufacturer could apply the harmonised standard EN 1127-1
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which describes the general concepts and methodology for explosion protection);
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define the requirements of the equipment to be used inside the potentially explosive atmosphere – and of safety and controlling devices outside, but contributing to their safe functioning – in order to ensure full compliance of the machinery with the requirements of the Machinery Directive;
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define the requirements for additional explosion protection measures (e.g. explosion-resistant design, autonomous protective system…) as a result of the risk assessment (e.g. for powder mills);
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purchase or produce the equipment having those requirements, i.e. intended to be used under the conditions defined during the risk analysis, and in conformity to Directive 2014/34/EU.
b) Must the "non-electrical" equipment used inside this machinery be also in conformity to 2014/34/EU?
The equipment used inside must be in conformity to the applicable legislation. When the original Machinery Directive 89/392/EEC was drafted, European Directives regulated only electrical equipment for use in potentially explosive atmospheres; therefore non-electrical equipment was not mentioned.
It is nevertheless a common understanding of the ATEX Committee that after the date of application of the previous ATEX Directive 94/9/EC (1 July 2003), both electrical and non-electrical equipment used in machinery having a potentially explosive atmosphere inside must comply with the ATEX Directive, now 2014/34/EU (from 20 April 2016). This position is also reflected in the Machinery Directive 2006/42/EC.
§ 36 Interface to different potentially explosive atmospheres
This point seeks to provide guidance on the application of the ATEX Directive 2014/34/EU to equipment
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intended to operate with interfaces to different potentially explosive atmospheres.
At this point it is necessary to note that equipment that contains a potentially explosive atmosphere but is neither connected to, nor intended for use in, an external or process related potentially explosive atmosphere does not fall under the scope of Directive 2014/34/EU. However, any equipment inside this "container" will, so long as it fulfils the criteria for inclusion in scope, need to comply with the relevant provisions.
The categorisation of equipment is to be determined on the basis of the ignition risk assessment
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by the manufacturer or his authorised representative and the equipment's relationship with respect to its interface with its process atmosphere and any external atmosphere.
The following diagram illustrates this point:
For example, the inside or process side of a pump for flammable liquid which normally runs full but occasionally contains an explosive atmosphere may, depending on the actual situation, be considered zone 1
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if no other measures have been taken to prevent the pump running dry. If it has been decided that the surroundings or external explosive atmosphere is zone 2 then a pump conforming to category 2 inside and category 3 outside must be used to meet the essential health and safety requirements of the Directive.
Note: the process atmosphere zone (and the respective category) needs not necessarily to be the same for the two connections to the process atmosphere.
The following guidelines may help in the selection of an appropriate category:
The category (or categories) assigned to equipment shall be determined for each part of the equipment which comes into contact with, or is connected to, a zone with a potentially explosive atmosphere (see Directive 1999/92/EC).
The category assigned to a piece of equipment intended to contain a potentially explosive atmosphere not connected to the outside of that equipment is determined by the ignition risk associated with the outside parts of the equipment, not by its internal atmosphere i.e. only the part of the equipment which is intended to come into contact with a zone is relevant for the assignment of the appropriate category.
The category (or categories) assigned to the process connecting points of equipment containing an explosive atmosphere cannot be higher than that appropriate to the ignition risk.
For example, consider the case of a fan conveying an explosive gas atmosphere over its rotating blades, or a powder mill producing an explosive dust atmosphere inside the mill. Each having an outlet connected to an external potentially explosive atmosphere. The ignition risk assessment for both these items of equipment has shown for these specific examples that an effective ignition source (for the explosive atmosphere connected to them) is not present in normal operation but may be present in the case of an expected malfunction. If such equipment/assembly is placed on the market without additional ignition protection or a protective system it can only be classified as category 3
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.
Such equipment can only be used when it is connected to an explosive atmosphere which is present continuously (i.e. zone 0/20) if additional ignition protection or a protective system is fitted (see Directive 1999/92/EC).
Where a piece of equipment is fitted with an autonomous protective system such as flame arresters, or a suppression system which is already compliant to Directive 2014/34/EU, additional testing and conformity assessment of the resulting assembly, i.e. equipment together with the protective system, is not required provided the protective system is used within its intended design capabilities covering the specific case, is installed in accordance with the manufacturer's instructions and no new ignition hazards are introduced. However, an ignition risk assessment will be required and relevant action taken (see section § 45 on assemblies) if additional hazards are identified.
Similarly, Directive 2014/34/EU does not require that the pressure resistance of a vessel or container protected against the effects of an explosion by an autonomous protective system be tested, if it has been demonstrated that the autonomous protective system successfully detects and suppresses an explosion and if the vessel can withstand the residual pressure peak of the suppressed explosion.
Example
Note: The following is one of many examples that can be used to illustrate the above points. The assumptions made in this example should not be taken as the only possible situation. The categorisation of a particular piece of equipment will depend on the specific ignition hazard assessment that is made of the equipment and its intended use together with any ignition protection measures applied. The example only considers the inside and connecting explosive atmospheres, i.e. the process side. A separate ignition hazard assessment and categorisation must be made of the outside if the equipment is to be used in potentially explosive atmosphere.
Consider a powder mill as shown in the following figure:
The ignition hazard assessment carried out by the manufacturer has identified that in this case:
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there is no ignition source inside the mill which can become effective in normal operation
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;
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there is an ignition source inside the mill which can become effective during expected malfunctions.
The highest category that can be assigned to the mill is therefore category 3 when it is placed on the market as shown. The outlet from the mill in this case produces fine dust in the form of a potentially explosive dust cloud which is continuously present in normal operation, i.e. category 1 is required. In cases when category 1 cannot be provided, the manufacturer has to take additional measures that the mill can used safely, e.g. to provide an explosion-resistant design of the mill. If the explosion safety can be reached through additional explosion prevention or protection measures of the end-user, the manufacturer's instructions must therefore make clear that the mill can only be used with these additional measures.
Analysis
Directive 2014/34/EU defines equipment as follows:
- intended for use in potentially explosive atmospheres;
- and/or for the processing of material;
- capable of causing an explosion through their own potential sources of ignition.
This definition applies to the grinding assembly of a mill for combustible materials of the food and fodder industry. Therefore, these are within the scope of Directive 2014/34/EU.
The intended purpose of a grinding assembly in a mill is the grinding of combustible materials whereby the content of fine particles is increased considerably.
According to the risk assessment the grinding installation should fulfil the requirements for category 1, but in the best case it will meet category 3. Despite all construction measures to prevent ignition sources, the occurrence of dust explosions cannot be excluded definitely. Therefore, the mill when fully installed must be provided with additional protection measures, which reduce the effect of a dust explosion for people and goods to below a dangerous level.
These measures are essential for the grinding system to fulfil the requirements of Directive 2014/34/EU.
Consequently:
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all requirements on the construction of the grinding assembly (e.g. suitable selection of material and bearings, minimum distances between rotating and fixed parts), on certain equipment of the mill (e.g. foreign particles separator, overload protection, temperature detector at the bearings)
and
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all construction measures of the mill (explosion pressure resistant design for the maximum explosion pressure, or explosion pressure resistant design for the reduced explosion pressure in combination with explosion pressure relief or explosion suppression, and in most cases additional explosion decoupling for connected installations)
are necessary to make the grinding operation safe.
§ 37 Safety devices, controlling devices and regulating devices as defined in Article 1(1)(b)
Devices in the scope of Article 1(1)(b) of the ATEX Directive 2014/34/EU
1. Safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres, but which are required for, or influence the safe functioning of equipment and protective systems, with respect to the risks of explosion, are also covered by the scope of the Directive.
Devices which influence the safe functioning of equipment and protective systems with respect to the risk of explosion can also be inside potentially explosive atmospheres. However if they are located within the explosive atmosphere, an additional risk assessment is required to take account of the risks of explosion for the safety devices, controlling devices and regulating device (e.g. a safety device inside an enclosure type of protection “d” or safety device may also comply with type of protection “i”).
Although the Directive does not explicitly say so, these devices can be designated as pieces of equipment in their own right.
2. These safety, controlling or regulating devices need be classified into categories, as required for the equipment within an explosive atmosphere, but identified by classification of the categories in brackets, e.g. "II (2) G" where the figure in brackets refers to the category of the equipment which is being influenced by the safety, controlling or regulating device.
3. If a safety instrumentation system (e.g. a sensor, PLC and an actuator, operating in one circuit) is considered, the entire system should be viewed as a safety device. Parts of this safety device may be located inside (e.g. a sensor) or outside (e.g. PLC) the potentially explosive atmosphere. The part located inside the potentially explosive atmosphere may have its own ignition risk and therefore must have its own verification in accordance to ignition risks and classification.
For such devices, the essential requirements shall only apply, so far as necessary, for their safe and reliable use with respect to the hazards of ignition (Annex II, Preliminary observation B).
Examples:
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Most electrical machines are protected against overload to prevent overheating. Usually the over-current device and/or the embedded temperature sensors plus control unit, switch off the electrical machine before the machine reaches a critical temperature. These safety devices shall fulfil, depending on the category of the machine, the requirements of “Safety devices required for the safe functioning of equipment with respect to explosion risks”. A machine fed by a converter follows the same principles. In some cases the converter, or parts of the converter, could be seen as the safety device.
·
Turbine pumps submerged in petrol tanks: a submersible turbine pump which is located inside the underground petrol storage tank is generally submersed in petroleum but may, from time to time, be partially or completely exposed to the explosive atmosphere that is present when the level of petrol drops below the level of the pump. Therefore the category of the pump is at least Category 2. A protection device shall ensure that the pump is submerged. Various means of achieving this are possible; for example a flow rate meter, a level gauge indicator or a load control device. The submerged pump could also be controlled by a Variable Frequency Speed Controller, typically located outside the hazardous area.
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Rotating Mechanical Seal: a rotating mechanical seal may create a hot surface due to friction. For category 2 equipment, a temperature monitoring device is necessary. If the manufacturer is putting the rotating mechanical seal on the market as equipment under the directive 94/9/EC together with the monitoring system the latter has to be considered a safety device.
Devices outside the scope of Article 1(1)(b)
1. Devices other than safety, controlling and regulating devices.
2. All devices, including safety, controlling and regulating devices, neither contributing to nor required for the safe functioning with respect to the hazards of ignition or with respect to the hazard of uncontrolled explosion.
3. Even safety, controlling and regulating devices contributing to or required for the safe functioning but with respect to hazards other than the hazards of ignition or – respectively – with respect to the hazard of uncontrolled explosion.
4. Monitoring devices providing only an alarm signal to protect persons but without control of the equipment inside the hazardous area.
5. Monitoring system designed by an end-user and installed under his responsibility in order to implement some additional(*) control of ignition hazards on an equipment/installation according to the requirements of directive 1999/92/EC. In this case the end-user doesn’t buy a complete safety instrumentation system but the various constituent parts of this system.
(*) Additional control means that this control is not mandatory according to the manufacturer’s instructions or the relevant standards as EN 60079 series for this equipment.
Examples:
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Switchgear, numeric controllers, etc. not related to any safety functions (with respect to the ignition hazard); see 2. above.
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Water spray systems designed to protect plant from fire.
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Blast doors designed to withstand a stated overpressure (these are designed primarily as doors, and they do no more than the walls they are placed in to protect against an explosion.
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Gas detector systems that raise an alarm but have no controlling function on the equipment.
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Emergency ventilation systems which act when gas is detected.
Article 1
Scope (continued)
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2. This Directive shall not apply to:
(a) medical devices intended for use in a medical environment;
(b) equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances;
(c) equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas;
(d) 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 (1);
(e) seagoing vessels and mobile offshore units together with equipment on board such vessels or units;
(f) means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or by road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Vehicles intended for use in a potentially explosive atmosphere shall not be excluded from the scope of this Directive;
(g) the equipment covered by point (b) of Article 346(1) of the Treaty on the Functioning of the European Union.
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(1) OJ L 399, 30.12.1989, p. 18.
§ 38 Products excluded from the scope of the ATEX Directive
Exclusions based on Article 1(2) (a) to (g) of Directive 2014/34/EU are:
a)
medical devices intended for use in a medical environment;
b)
equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances (see also footnote 26);
c)
equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas. The question has also been discussed as to whether this implicitly conveys the meaning that equipment intended for use in domestic and non-commercial environments, where the leakage is not fuel gas, are included within scope. As a general rule such types of equipment are excluded from Directive 2014/34/EU as they are not intended for use in a potentially explosive atmosphere;
d)
personal protective equipment covered by Directive 89/686/EEC
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. There are occasions where personal protective equipment with its own potential sources of ignition is intended for use in potentially explosive atmospheres. This type of personal protective equipment should follow the procedures laid down in Directive 2014/34/EU to provide the necessary level of explosion safety (see also section § 235);
e)
seagoing vessels and mobile offshore units together with equipment on board such vessels or units, as they are already covered by the International Maritime Organisation (IMO) Conventions
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;
f)
means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air, road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Vehicles intended for use in a potentially explosive atmosphere are not excluded;
g)
the equipment covered by point (b) of Article 346(1) of the Treaty on the Functioning of the European Union (TFEU) concerning production of or trade in arms, munitions and war material for specifically military purposes, i.e. designed and manufactured specifically for use by the armed forces or in the maintenance of law and order. Dual-purpose equipment is not excluded.
The list in Article 1(2) is intended to be exhaustive concerning products explicitly excluded from the scope of Directive 2014/34/EU.
§ 39 Examples of equipment not covered by Directive 2014/34/EU
“Simple” products
For “simple” electrical products, European harmonised standards provide a good basis to assess the effectiveness of electrical ignition source and, consequently, to determine whether or not these can be considered effective or not.
In general, many simple mechanical products do not fall under the scope of Directive 2014/34/EU as they do not have their own source of ignition. Examples without their own source of ignition are hand tools such as hammers, spanners, saws and ladders (see also the "Borderline list - ATEX products", pages 225-228).
Other examples that in most cases have no potential ignition source are given below. However, the manufacturer will need to consider each item in turn with respect to potential ignition hazard to consider whether Directive 2014/34/EU applies:
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clockwork time pieces; mechanical camera shutters (metallic);
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pressure relief valves, self-closing doors;
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equipment moved only by human power, a hand operated pump, hand powered lifting equipment, hand-operated valves.
The issue of hand-operated valves has also been discussed. Given that these will move slowly, with no possibility of forming hot surfaces (as discussed in section § 43 on non-electrical equipment) they are not in scope of the Directive. Some designs incorporate polymeric parts, which could become charged, but this is no different from plastic pipes. Given that it is clear that the latter is outside of the scope of Directive 2014/34/EU it has been accepted that such valves do not fall within scope.
Some manufacturers have argued that their valves are specially adapted for ATEX, in that they have either selected more conductive polymers, or taken steps to ensure that no metal parts could become charged because they are unearthed. Other manufacturers state that all their valves meet this requirement simply by the way they are constructed, and they see no distinction from valves used to process non-flammable materials. To avoid confusion between those who claim correctly that their valves have no source of ignition, and are out of scope, and those who claim that they have done some very simple design change and wish to claim that their valves are now category 2 or even 1, it has been agreed that valves having characteristics as described above are out of scope. Nevertheless (as discussed in section § 43), where potentially flammable atmospheres exist, users must always consider the electrostatic ignition risks.
Installations
The ATEX Directive 2014/34/EU does not regulate the process of installation. Installing such (already ATEX-compliant) equipment at the end-user premises or under his responsibility will generally be subject to legal requirements either from the workplace directives (see footnote 7) or the domestic legislation of the Member States.
However, the question is frequently asked to distinguish between the responsibilities of manufacturers, building a piece of equipment or an assembly under the ATEX Directive 2014/34/EU and those responsibilities of an end user, buying in equipment parts to build an installation. (One might use the analogy of the difference between the manufacturing a discreet piece of equipment which can be placed on the market, such as a television – LVD 2014/35/EU –, and equipping a house with all its utilities built into which a range of products will be installed and connected, this would clearly be an installation and come under Workplace Directive 89/391/EEC – see footnote 7 – or other directives concerning workplace safety.)
A common situation is that pieces of already ATEX-compliant equipment are placed on the market independently by one or more manufacturer(s), and are not placed on the market by a single legal person as a single functional unit (as described in section § 45 on assemblies which are fully specified configuration of parts). Combining such equipment and installing at the user's premises is not considered as manufacturing and thus does not result in equipment; the result of such an operation is an installation and is outside the scope of Directive 2014/34/EU. The installer has to ensure that the initially compliant pieces of equipment still comply when they are taken into service. For that reason he has to carefully follow all installation instructions of the manufacturers. The Directive does not regulate the process of installation. Installing of ATEX-compliant equipment will generally be subject to legal requirements of the Member States. An example could be instrumentation consisting of a sensor, a transmitter, a Zener barrier and a power supply if provided by several different manufacturers installed under the responsibility of the user.
It is understood that there is not always a clear line between an installation and an assembly.
For assemblies and installations the responsibilities will either fall on the person who places the assembly on the market, or the end-user. Each must draw up a technical file setting out how they have complied with the relevant legislation. Much of the technical content will be the same.
The result, this is to say, the installation of equipment in a plant, will usually not to be a "product" under the ATEX Directive 2014/34/EU if:
- the end-user, or an installer purchases parts (including ATEX equipment and installation materials) from different manufacturers and they are installed under his responsibility after a full risk assessment has been undertaken;
- the user carries out a whole series of different processes requiring the integration of ATEX-compliant equipment and parts on site, and they are installed according to a unique layout;
- the end-user commissions the building of parts of his installation off-site, which may be unique, but certainly not a production run, and which is done under his direct responsibility, or indirectly through a contractor, working under contract to him;
- commissioning tests or adjustments are needed once the plant is built and are carried out under the final responsibility of the end user.
Article 2
Definitions
For the purposes of this Directive, the following definitions shall apply:
…
§ 40 Definitions
The definitions in Article 2 of the ATEX Directive 2014/34/EU include those specific to the scope of the Directive as well as the general ones of the New Legislative Framework, from Decision No 768/2008/EC.
Article 2
Definitions (continued)
…
(1) 'equipment' means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing of material and which are capable of causing an explosion through their own potential sources of ignition;
…
§ 41 Equipment
Equipment; as defined in the ATEX Directive 2014/34/EU, means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
It should be noted that intrinsically safe electrical equipment is included in the scope of the Directive.
§ 42 “Own” ignition source
A defining element of equipment in the sense of the Directive is that it has to have its own potential source of ignition.
Potential sources of ignition could be: electric sparks, arcs and flashes, electrostatic discharges, electromagnetic waves, ionising radiation, hot surfaces, flames and hot gases, mechanically generated sparks, optical radiation, chemical flame initiation
[13]
, compression.
In some cases a product may only contain a potentially explosive atmosphere which is deliberately ignited. It is clearly not the intention that these fall under the scope of Directive 2014/34/EU unless other relevant hazards exist. Most equipment made to the Gas Appliances Directive 2009/142/EC will fall into this category (see section § 238).
Equipment can be said to have its own potential source of ignition, if, when operated as intended (including malfunctions, etc. to an extent depending on its category – see Annex I to the Directive) in a potentially explosive atmosphere, it is capable of igniting the latter unless specific safety measures are taken. Therefore, equipment must ensure the required level of protection.
To ensure this required level of protection various techniques can be applied, e.g.: intrinsic safety, pressurisation, increased safety, etc.
Many common items are made from plastics (polymers) with very low electrical conductivity. These can become charged, e.g. if they are rubbed, or if dust or a liquid flows over the surface. However, in most cases this may be controlled by the user, and if they are used in hazardous areas it shall be assessed and controlled according to the requirements of relevant national or EU legislation (e.g. Directive 1999/92/EC). In any case the user of such equipment has to consider these ignition sources when undertaking a risk assessment in the workplace. Examples are plastic containers used for transporting chemicals, polyethylene pipes, buckets and chairs.
If the only source of electrostatic charging comes from the process, such items are not considered to have their own source of ignition, and they are not in scope of Directive 2014/34/EU. In these cases they should not be Ex or CE marked according to Directive 2014/34/EU.
If the polymeric item is intended to be incorporated into ATEX equipment, and could become charged by the movement of the equipment (for example a fan blade) or by the intended use of the equipment, they may be classed as ordinary parts of the equipment with specific properties (e.g. to be electrostatically dissipative) or as ATEX components if they are placed on the market specifically for this intended use.
§ 43 Non-electrical equipment
If non-electrical equipment has a potential ignition source, in most cases this is due to moving parts able to create a potential ignition risk either from hot surfaces, or friction sparks. Examples are: gears, fans, pumps, compressors, mixers, brakes. Mechanical equipment of this type usually has to be connected to a power source, such as an electric motor. Together placed on the market in this form, it might be an assembly (see section § 45).
Mechanical equipment may be fitted with a thermocouple or similar measuring device that generates only very low voltages and currents. If these measuring devices can be considered as 'simple apparatus’ (as described in section § 39) and there are no other electrical parts, the equipment should follow the conformity assessment procedures for non-electrical equipment. If the equipment contains electrical apparatus that can be clearly separated, the conformity assessment procedure for non-electrical parts can be made separately if the conditions described for electrical equipment (e.g. pump) apply (see section § 44). If the electrical equipment fitted to the non-electrical equipment is not "simple apparatus", the product is usually considered as an assembly (see section § 45 on assemblies).
All potential ignition sources should be considered for equipment that is within the scope. For a list of potential ignition sources, see the relevant harmonised standards for equipment. In many cases the equipment will also be machinery within scope of Directive 2006/42/EC (see section § 233).
Many mechanical items move very slowly, or have very low power input. Such equipment may be incapable of forming hot surfaces or other ignition sources, even in cases of rare malfunction. The manufacturer should assess if such equipment is potentially capable of igniting an explosive atmosphere, and if it is not, it shall not be classed as ATEX equipment nor be marked according to Directive 2014/34/EU (see also section § 39).
§ 44 Electrical equipment
Directive 2014/34/EU does not specifically define “electrical equipment”. However, because such equipment is subject to its own conformity assessment procedure it may be useful to provide a definition, which has been generally accepted by the majority of Member States.
In this sense, electrical equipment can be considered as equipment containing electrical elements, used for the generation, storage, measurement, distribution and conversion of electrical energy, for controlling the function of other equipment by electrical means or for processing materials by the direct application of electrical energy. It should be noted, that a final product assembled using both electrical and mechanical elements may not require assessment as electrical equipment provided the combination does not lead to additional ignition hazards for this assembly.
For further details, see section § 45.
§ 45 Assemblies
From the term 'jointly' in the definition of equipment in the Directive (Article 2(1)) it follows that an assembly, formed by combining two or more pieces of equipment, together with components if necessary, has to be considered as a product falling under the scope of Directive 2014/34/EU, provided that this assembly is placed on the market and/or put into service by a responsible person (who will then be the manufacturer of that assembly) as a single functional unit.
Such assemblies may not be ready for use but require proper installation. The instructions (Annex II, 1.0.6.) shall take this into account in such a way that compliance with Directive 2014/34/EU is ensured without any further conformity assessment provided the installer has correctly followed the instructions.
In the case of an assembly consisting of different compliant pieces of equipment as defined by Directive 2014/34/EU which were previously placed on the market by different manufacturers these items of equipment have to conform with the Directive, including being subject to proper conformity assessment, CE-marking, etc. The manufacturer of the assembly may presume conformity of these pieces of equipment and may restrict his own risk assessment of the assembly to those additional ignition and other relevant hazards (as defined in Annex II) which become relevant because of the final combination. If there are additional ignition hazards, a further conformity assessment of the assembly regarding these additional risks is necessary. Likewise, the assembler may presume the conformity of components which are accompanied by a written attestation of conformity issued by their manufacturer (Article 6(2)) (see also section § 75).
However, if the manufacturer of the assembly integrates parts without CE marking into the assembly (because they are parts manufactured by himself or parts he has received from his supplier in view of further processing by himself) or components not accompanied by the written attestation of conformity, he shall not presume conformity of those parts and his conformity assessment of the assembly shall cover those parts as required.
Note that the manufacturer's own risk assessment does not necessarily preclude the use of notified bodies in the applicable conformity assessment procedure(s).
In order to clarify the concept of “assembly” in the sense of Directive, a pump/electric motor combination intended for use in potentially explosive atmospheres can be used as an example.
1. For the purposes of Directive 2014/34/EU, a split tube motor pump constitutes a single item of equipment with respect to the ignition hazard, i.e. the pump and electric motor cannot be considered separately for the purposes of assessing explosion risk(s). In this case, the unit as a whole has to undergo the conformity assessment procedure of electrical equipment. The same applies e.g. for an electrical ventilating fan where the fan is an integral part of the motor.
2. a) In some cases the pump and electric motor can be considered separately although they form a functional unit. If in this case there is no additional ignition hazard as a result of assembling the pump and motor, this functional unit as a whole does not constitute a single item of equipment which falls within the scope of Directive 2014/34/EU. It is then to be considered a combination of "individual items of equipment" in terms of explosion protection. In this case, therefore, the manufacturer of pump and electrical motor must supply an EU declaration of conformity for each of both items.
2. b) A manufacturer may nevertheless choose to supply pump and motor as described in 2. a) with one EU declaration of conformity for the assembly as a whole. In this case further clarification is required as to the obligation of the assembler where only ATEX compliant products (such as equipment and autonomous protective systems) are used. Here it is clear that the assembler needs to undertake an ignition risk assessment to ensure that the nature of the incorporation and assembly has not altered the explosion characteristics of the products with respect to the essential health and safety requirements of the Directive. If the assembler is in any way uncertain as to how to undertake such an assessment, technical advice should be sought and taken into account. This might be the case, for example, if a manufacturer of mechanical equipment needs to connect different pieces of ATEX electrical equipment together as part of the assembly. Once the assembler has successfully undertaken such an assessment and no additional ignition risk has been identified, the general agreement is that he then draws up a technical file, affixes the CE and ex marking according to Annex II 1.0.5 of the Directive to the assembly, indicating intended use, signs the EU declaration of conformity covering the whole of the assembly indicating the technical specifications/ standards applied (for example, for electrical inter-connection) and provide instructions for safe use. The assembler therefore takes complete responsibility for the assembly. This procedure does not require the involvement of a notified body.
2. c) If there is an additional ignition hazard as a result of assembling pump and motor, or if one item is not already in full conformity with the Directive, the assembly has to undergo the complete conformity assessment procedure appropriate for the category.
Assemblies may be placed on the market in different ways: with specified configurations of parts or with various configurations.
Assemblies which are fully specified configurations of parts
In this case the manufacturer has already defined one or more invariable combination(s) of parts and places them on the market as a single functional unit / single functional units.
An example could be instrumentation consisting of a sensor, a transmitter, a Zener barrier and a power supply if provided by one manufacturer.
The above mentioned parts are put together by the same person (the manufacturer of the assembly), and placed on the market as a single functional unit. This person assumes responsibility for the compliance of the integral assembly with the Directive.
The EU declaration of conformity, as well as the instructions for use must refer to the assembly as a whole. It must be clear (e.g. by enclosing a list of all parts and/or a list of the safety related data) which is/are the combination(s) that form(s) the assemblies. The manufacturer assumes responsibility for compliance with the Directive, and must therefore, in accordance with Annex II 1.0.6, provide clear instructions for assembly/installation/operation/maintenance etc. in the instructions for use.
Assemblies with various configurations
Here the manufacturer has defined a whole range of different parts, forming a "modular system". Either he or the user/installer selects and combines parts out of this range to form an assembly, which serves the specific task.
An example could be a modular system for flameproof switch- and control gear, consisting of a range of flameproof enclosures of different size, a range of switches, terminals, circuit breakers etc.
Although in this case the parts are not necessarily put together by the manufacturer of the assembly, and placed on the market as a single functional unit, the manufacturer is responsible for the compliance of the assembly as long as the parts are chosen from the defined range and selected and combined according to his instructions.
The EU declaration of conformity, as well as the instructions for use must refer to the "modular system" as a whole. It must be clear which the parts that form the modular system are, and how they are to be selected to form a compliant assembly. Therefore the manufacturer must, in accordance with Annex II 1.0.6, provide clear instructions for selection of parts and their assembly/installation /operation/maintenance etc. in the instructions for use. The conformity assessment of such modular systems may be done (as a minimum) by means of the assessment of those intended configurations which are the most unfavourable regarding the relevant risks (worst cases). If those configurations are considered compliant to the essential health and safety requirements of Directive 2014/34/EU the manufacturer may conclude conformity of all other intended configurations as well. If later on other parts are to be added to the "modular system" it may of course become necessary to identify and assess the worst case scenario again.
The Table 1: Summary of requirements for assemblies (on the following page) gives a condensed overview of the various situations regarding assemblies and their requirements under the ATEX Directive 2014/34/EU.
Table 1: Summary of requirements for assemblies under the ATEX Directive 2014/34/EU
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Situation:
1. Parts:
Assembly is composed of…
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Equipment, protective systems, devices (Article 1(1)) all CE-marked (accompanied by an EU declaration of conformity) and components accompanied by a written attestation of conformity (Article 13(3))
(parts with proven conformity) (*)
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Equipment, protective systems, devices (Article 1(1)), including non CE-marked, and components not accompanied by a written attestation of conformity (Article 13(3))
(parts without proven conformity)
|
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2. Configuration:
Assembly is placed on the market as…
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Exactly defined configuration(s)
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A "modular system" of parts, to be specifically selected and configured to serve a specific purpose, maybe by the user/installer.
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Exactly defined configuration(s)
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A "modular system" of parts, to be specifically selected and configured to serve a specific purpose, maybe by the user/installer.
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3. RESULT:
Manufacturer may presume conformity for…
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All parts
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All parts
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Only parts with proven conformity
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Only parts with proven conformity
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4. Conformity assessment
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Conformity assessment has to cover the whole configuration regarding all risks, which might arise by the interaction of the combined parts, with respect to the intended use.
See also Note (*)
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Conformity assessment has to cover at least those of the possible and useful configurations, which are assessed to be the most unfavourable regarding all risks, which might arise, by the interaction of the combined parts, with respect to the intended use.
See also Note (*)
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Conformity assessment has to cover:
- all parts without proven conformity regarding all risks, and
- all configuration(s) regarding all risks which might arise by the interaction of the combined parts, both with respect to the intended use.
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Conformity assessment has to cover:
- all parts without proven conformity which are part of the "modular system", regarding all risks, and
- at least those of the possible and useful configurations, which are assessed to be the most unfavourable regarding all risks which might arise by the interaction of the combined parts, both with respect to the intended use.
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5. Information to be provided:
a) by EU declaration of conformity
b) by instructions for installation and use
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a) identification of the items in the assembly that are ATEX equipment in their own right, and which have been separately assessed;
b) instructions for installation and use, sufficient to ensure that resulting assembly complies with all relevant EHSRs of Directive 2014/34/EU.
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a) identification of the items in the "modular system" that are ATEX equipment in their own right, and which have been separately assessed;
b) instructions for the selection of parts, to be combined to fulfil the required purpose, and instructions for installation and use, sufficient to ensure that resulting assembly complies with all relevant EHSRs of Directive 2014/34/EU.
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a) identification of the items in the assembly that are ATEX equipment in their own right, and which have been separately assessed;
b) instructions for installation and use, sufficient to ensure that resulting assembly complies with all relevant EHSRs of Directive 2014/34/EU.
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a) identification of the items in the "modular system" that are ATEX equipment in their own right, and which have been separately assessed;
b) instructions for the selection of parts, to be combined to fulfil the required purpose, and instructions for installation and use, sufficient to ensure that resulting assembly complies with all relevant EHSRs of Directive 2014/34/EU.
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(*) Note: A written attestation of conformity for a component cannot guarantee, in general, the safety of the equipment into which the component is to be incorporated, as for a component, all possible use cannot be foreseen. In this case, further investigation and evaluation by a notified body shall be carried out in the assembly, when required.
Article 2
Definitions (continued)
…
(2) 'protective systems' means devices other than components of equipment which are intended to halt incipient explosions immediately and/or to limit the effective range of an explosion and which are separately made available on the market for use as autonomous systems;
…
§ 46 Protective systems
According to the definition in the ATEX Directive 2014/34/EU, examples of autonomous protective systems are:
-
flame arresters;
-
explosion relief systems (using e.g. bursting discs, vent panels, explosion doors, etc.);
-
extinguishing barriers;
-
explosion suppression systems.
It is clear that certain simple products used in coal mines act as protective systems but cannot be subject to the provisions of the Directive (e.g. inert stone dust on planks).
From its intended function it is obvious that a protective system will, at least partially, be installed and used in a potentially explosive atmosphere.
Because a protective system has the function to eliminate or reduce the dangerous effects of an explosion (a safety function) it is subject to the Directive regardless as to whether it has its own potential source of ignition or not. In this first case it would have to comply with the specific essential health and safety requirements for equipment as well.
According to Article 2(2) protective systems are placed on the market separately for use as autonomous systems. Consequently their conformity with the relevant essential health and safety requirements of Annex II has to be assessed according to Article 13(2) and they have to be marked according to Article 16.
Of course "protective systems" may also be placed on the market as an integral part of equipment. Technically speaking these remain "protective systems" because of their function, but are not considered as autonomous protective systems in the sense of the Directive regarding conformity assessment and marking. In such cases their conformity is assessed in the course of the conformity assessment of the equipment they are integrated into, using the procedures foreseen in Article 13 according to the group and category of that equipment. They are not separately marked.
It is, however, important to note that the specific essential health and safety requirements of section 3 of Annex II also apply for integrated "protective systems".
Article 2
Definitions (continued)
(3) 'components' means any item essential to the safe functioning of equipment and protective systems but with no autonomous function;
…
§ 47 Components
The two defining elements for components are that:
·
they are essential to the safe functioning of equipment and protective systems with respect to explosion protection (otherwise they would not need to be subject to the Directive);
·
they have no autonomous function (otherwise they would have to be regarded either as equipment, protective system or as device according to Article 1(1)(b)).
A product is considered to have an autonomous function if it can be safely used to deliver, or contribute towards the delivery of, one or more of the intended functions of Article 1, without the need to add any further parts. This does not preclude that specific instructions for installation and use are to be followed.
Some kinds of products may, depending on the extent of the conformity assessment already undertaken before being placed on the market and/or put into service, be considered either as with or without autonomous function.
If the function of the product can be delivered without further parts then, where relevant, it cannot be considered a component.
Components intended for incorporation into equipment or protective systems which are accompanied by a written attestation of conformity including a statement of their characteristics and how they must be incorporated into products (see Article 13(3)), are considered to conform to the applicable provisions of Directive 2014/34/EU. Ex-components as defined in the European standards harmonised under Directive 2014/34/EU are components in the sense of the ATEX as well.
Components must not have the CE marking affixed unless otherwise required by other directives (e.g. the Electromagnetic Compatibility Directive 2014/30/EU) (see section § 231).
Examples for items which could be placed on the market as components, if they are explicitly intended to be incorporated into ATEX products, are the following:
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terminals;
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push button assemblies;
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relays;
-
empty flameproof enclosures;
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ballasts for fluorescent lamps;
-
encapsulated relays and contactors, with terminals and/or flying leads;
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machinery brakes designed to be part of ATEX equipment;
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a pressurised container including suppressant powder forming part of an explosion suppression system;
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conveyor belting for a conveyor transporting combustible dusts;
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non-autonomous protective systems;
-
suction hoses used on vacuum cleaners;
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forks for forklift trucks.
According to Article 13(3) the conformity of components has to be assessed by means of the same procedures as the equipment, protective systems or devices according to Article 1 into which they are to be integrated. Some components may be assigned a category, in which case they will always be used in equipment of that category. Other components may be more widely used, and no category can be defined. In addition, components for e.g. autonomous protective systems do not need to bear a category as the protective systems themselves are not categorised. It depends on the detail that is given in any documentation provided (e.g. where relevant by means of a written attestation of conformity).
For example, drive-belts, bearings, mechanical seals, Zener diodes, etc. are not usually placed on the market with the explicit intention to be incorporated into equipment, protective systems or devices according to Article 1(1)(b) but for general engineering purposes. Their conformity (i.e. their suitability for the intended purpose as regards safety of the product they are integrated into) has to be assessed in the course of the conformity assessment of the integral product.
If components are to be placed on the market with the explicit intention of incorporation into equipment, protective systems or devices according to Article 1(1)(b) (as e.g. increased safety terminal blocks, flameproof enclosures, etc.), they shall be assessed separately according to Article 13(3) and either accompanied by a written attestation of conformity as referred to in Article 13(3), or the attestation of conformity shall be made accessible to all customers by cross-media documentation e.g. QR-codes with reference to internet, electronic catalogues, web-link on the package unit or delivery papers, etc.
The obligations for manufacturers established in Article 6(2) and (8) concerning accompanying documents for products (EU declaration of conformity or attestation of conformity, instructions and safety information) could be not proportionate and even problematic for components. In fact, components often are very small items supplied in a wide range of batch sizes and package quantities, with the possibility of small delivery quantities associated with enormous quantities produced and large possible variances installed in the final end user application (device). In this sense, an alternative means of satisfying the information obligation is a reference to be provided in the delivery documentation or on the smallest additional packaging to a website or other source from which the information can be obtained. Such sources of information may include:
a)
a link to the manufacturer's website in plain text on each packaging unit or on the delivery documentation;
b)
cross-media information (such as a QR code or a radio-frequency identification chip) on each packaging unit or in the delivery documentation that links to a database or provides the required data directly.
Otherwise, Member States can prohibit, restrict or impede their placing on the market (Article 5) and cannot presume their conformity (Article 12(1)).
If a component is subject to a conformity assessment procedure under which a notified body issues an EU-type examination certificate, the certificate must detail those requirements of Annex II that have been assessed.
§ 48 Specific requirements given in the manual of products
It is the obligation of manufacturers, importers or authorized representatives to follow the requirements for products within the scope of the Directive, when they are placing these products on the market. For some products the involvement of a notified body is required: both, manufacturer and notified body, have to consider whether a product is equipment or component. Any equipment and its instructions must meet the essential health and safety requirements of the Directive. It is the obligation of the manufacturer to issue instructions, which can include so-called "specific conditions of use". These specific conditions of use cannot specify additional safety measures which have to be part of the manufacturing process or are part of the type testing by a notified body.
If it is not possible for the end-user to fulfil the requirements given as "specific conditions of use" because they are too general, a product does not meet the requirements of the Directive. The manufacturer and the notified body, if involved, have to bear in mind, that the users normally do not have the detailed knowledge or the needed test equipment. Therefore it should not happen that specific conditions of use will not result in a product complying with the requirements of the Directive. The complete safety evaluation of equipment has to be done by the manufacturer based on his responsibility for the equipment. With his EU declaration of conformity the manufacturer attests the full compliance with the ATEX Directive. The use of such equipment must not create dangerous situations. The manufacturer is responsible for the foreseeable misuse if the user is not able to fulfil the specific conditions for use correctly.
It is the clear aim of the ATEX Directive that only safe products are being placed on the EU market. Products, which have to undergo additional verification acts, are components. These components can not be transferred into equipment by creating non-dischargeable "specific conditions for use". With the manual the manufacturer has to prescribe the details, how it will be possible for the user to fulfil the specific conditions of use. If the user has to add items such as an enclosure, the user will act as a manufacturer.
§ 49 Differences between equipment and components
The main differences between equipment and components can be shown in the following Table 2: Equipment and components according to Directive 2014/34/EU.
Table 2: Equipment and components according to Directive 2014/34/EU
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Equipment
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Components
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Definition in the ATEX Directive 2014/34/EU, Article 2(1):
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Definition in the ATEX Directive 2014/34/EU, Article 2(3):
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All aspects and requirements of explosion protection according to Annex II to Directive 2014/34/EU have to be fulfilled.
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Components must be so designed and constructed that they function safely for their intended purpose of explosion protection when they are installed in accordance with the manufacturer's instructions (Annex II, 1.2.2).
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The equipment is marked according to the ATEX Directive, marked with the CE marking and accompanied by
a) the EU declaration of conformity, and
b) instructions for use.
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The component is marked according to the ATEX Directive but not marked with the CE marking, and is accompanied by
a) a written attestation of conformity, and
b) instructions for assembling.
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The equipment is ready for use based on the instructions for use of the manufacturer and installation requirements.
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The component is not ready for use. The final conformity assessment of the component is done together with the assessment of the complete equipment, in/with which the component will be fixed or installed.
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Definition of the standard EN60079-0:2012:
3.25
Equipment (for explosive atmospheres)
General term including apparatus, fittings, devices, components, and the like used as a part of, or in connection with, an electrical installation in an explosive atmosphere.
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Definition of the standard EN 60079-0:2012:
3.28
Ex Component
Part of electrical equipment or a module, marked with the symbol “U”, which is not intended to be used alone and requires additional consideration when incorporated into electrical equipment or systems for use in explosive atmospheres.
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3.8.2
Equipment Certificate
A certificate prepared for equipment other than an Ex Component. Such equipment may include Ex Components, but additional evaluation is always required as part of their incorporation into equipment.
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3.8.1
Ex Component Certificate
A certificate prepared for an Ex Component.
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3.53
Symbol "X"
Symbol used to denote specific conditions of use.
NOTE:
The symbol "X" is used to provide a means of identifying that essential information for the installation, use, and maintenance of the equipment is contained within the certificate.
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3.52
Symbol "U"
Symbol used to denote an Ex Component
NOTE:
The symbol "U" is used to identify that the equipment is incomplete and is not suitable for installation without further evaluation.
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Examples and problems
a) Panel
A product with open terminals is placed on the market as category 3 equipment. In the instructions the following “special condition of use” requires: “The use of this equipment needs an enclosure of at least IP65. The equipment has to be mounted in an area with a lower risk of mechanical impact”.
This product is a component because it is incomplete (missing enclosure) and further actions (e.g. test), considerations and information are necessary for safe use.
The manufacturer has to consider the following topics:
1.
IP 65 alone is not sufficient to make clear the requirements of Annex II of the Directive 2014/34/EU. The enclosure has to fulfil also the requirements of Annex II and the EN 60079-0 ff.
2.
The meaning of "low risk of mechanical impact" is unclear. The manufacturer has to specify the details to fulfil this special condition.
3.
It is not sufficient to use any enclosure to protect the equipment against impact.
The same questions arise for similar category 2 equipment certified by a Notified Body.
b) Switch
In an EU-type examination certificate for a category 2 switch, the following "special condition of use" was found: “The mechanical test according EN 60079-0:2006, clause 26.4.1.2 and the impact test according clause 26.4.2 were not done with this switch. A similar protection technique has to be used for an installation in hazardous areas."
This special condition of use is not allowable, because further tests are required, which have to be done by a notified body. Therefore this product is to be regarded a component.
c) Empty Ex-"d" enclosure
An Ex-"d" empty enclosure was certified as category 2 equipment with a "special condition of use", describing how to drill the holes for cable entry devices by a notified body. During the EU-type examination, the manufacturer showed the notified body an assembled enclosure. But the manufacturer sold the enclosures without assembling them
This product is a component because part of the production process of assembling has to be covered by the quality assessment of the manufacturer and must not be part of the installation.
If the manufacturer allows machining works (e.g. drilling holes) done by the user, he is nevertheless responsible for the final product. Normally this machining work is part of the quality assessment done by a notified body. In case of drilling holes into an Ex-"d" enclosure this assessment for the machining work would be necessary but is not done by the user.
After drilling the holes and mounting the cable entries or other devices additional tests of the applicable standards, such as flame transmission and pressure tests according EN 60079-1?
Another problem is the maximum surface temperature. Also this assessment of maximum surface temperature and of the temperature behaviour inside of the enclosure is up to the manufacturer and the notified body involved.
Article 2
Definitions (continued)
…
(4) 'explosive atmosphere' means 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' means an atmosphere which could become explosive due to local and operational conditions;
…
§ 50 Explosive atmosphere and potentially explosive atmosphere
Equipment is only considered to be within the scope of the ATEX Directive 2014/34/EU if it is intended (either in whole or in part) to be used in a potentially explosive atmosphere.
If a product containing an intended potentially explosive atmosphere, for example a vessel, itself contains equipment as defined in the Directive, then the latter equipment is in effect in a potentially explosive atmosphere, albeit one which is contained by the vessel, and is therefore subject to the Directive.
If equipment containing a potentially explosive atmosphere can, due to its construction, operation etc. create a potentially explosive atmosphere itself, which wholly or partially surrounds it, then such equipment is in effect in a potentially explosive atmosphere, and is therefore subject to the Directive.
A third scenario is that there may not only be a surrounding potentially explosive atmosphere but also a process that requires such a mixture to enter and/or be released from the product. The interface between the equipment and the process input/ output will also require consideration. This may lead, in some cases, to equipment having more than one category, one (or more) for the external atmosphere and another for the process atmosphere.
§ 51 Potentially explosive atmosphere in the sense of Directive 2014/34/EU
Directive 2014/34/EU is a directive following the “New Approach” and the “New Legislative Framework” and therefore is intended to enable the free movement of goods within the EU. This is achieved by harmonisation of legal safety requirements, following a risk-related approach. Its objective is also to eliminate or at least minimise the risks resulting from the use of certain products in or in relation to a potentially explosive atmosphere. The manufacturer has to make assumptions about the intended use of his product including the contact with potentially explosive atmospheres.
An explosive atmosphere for the purposes of Directive 2014/34/EU is defined as a mixture
i)
of flammable substances in the form of gases, vapours, mists or dusts;
ii)
with air;
iii)
under atmospheric conditions
[1]
;
iv)
in which, after ignition, the combustion spreads to the entire unburned mixture (It has to be noted that sometimes (mainly with dusts) not always the whole quantity of the combustible material is consumed by the combustion).
An atmosphere which could become explosive due to local and/or operational conditions, is called a potentially explosive atmosphere. It is only this kind of potentially explosive atmosphere which products falling under the ATEX Directive 2014/34/EU are designed for.
It is important to note that products are not covered by Directive 2014/34/EU where they are intended for use in or in relation to mixtures which might potentially be explosive, but one or more of the defining elements i) to iv) above are not present. For example:
·
A product within a potentially explosive mixture without the presence of air is not in the scope of the Directive
[2]
. Special processes of this type require equipment that has been specially designed for the risks, as equipment intended for use in potentially explosive atmospheres may pose an ignition hazard for mixtures under non-atmospheric conditions.
·
Conveying equipment where some parts but not all are under atmospheric pressure with internal pressures different from atmospheric pressure can fall under the scope of Directive 2014/34/EU. When performing a risk assessment it will become evident that although parts of the described equipment are outside the scope of Directive 2014/34/EU during normal operation (pressure oscillates between too low and too high values in relation to "atmospheric conditions") some parts or spaces still are under the scope and that the whole equipment during start-up and shut-down is under the scope, at least.
So, both the following examples fall under the scope of Directive 2014/34/EU:
a) A vapour recovery pump for petrol stations is connected at its inlet and outlet to a potentially explosive atmosphere in the sense of Directive 2014/34/EU.
b) A vacuum pump sucking from a vacuum container and conveying the mixture into a pressure vessel or pressure line. In this case the inner parts of the pump are not connected to a potentially explosive atmosphere in the sense of Directive 2014/34/EU.
Note: The manufacturer may wish to sell this equipment for use under atmospheric conditions of the inlet and outlet side additionally, and then case a) applies. In any case, the complete working cycle needs to be considered, including start-up and shut-down, which may cause an atmospheric pressure to exist. If the equipment is not intended for atmospheric use, the Directive does not apply. Risk assessment must be carried out according to Directive 1999/92/EC.
As long as the user is not able to ensure the absence of a potentially explosive atmosphere, start-up and shut-down are relevant to determine the application of the Directive.
Article 2
Definitions (continued)
…
(6) 'equipment-group I' means 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 M 1 and M 2 as set out in Annex I;
(7) 'equipment-group II' means equipment intended for use in other places liable to be endangered by explosive atmospheres, comprising equipment categories 1, 2 and 3 as set out in Annex I;
(8) 'equipment category' means the classification of equipment, within each equipment group, specified in Annex I, determining the requisite level of protection to be ensured;
…
§ 52 Equipment group and category
The ATEX Directive 2014/34/EU divides equipment into groups and categories. Annex I defines the criteria determining the classification of equipment-groups and categories (see sections §§ 133-138).
Article 2
Definitions (continued)
…
(9) 'intended use' means the use of a product prescribed by the manufacturer by 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;
…
§ 53 Intended use
Intended use means either the use for which the equipment is intended in accordance with the information provided by the person placing it on the market, or the ordinary use as determined by the design and construction of the product.
Manufacturers have to match a level of protection for the users of the equipment which corresponds to the use that the manufacturer prescribes for the equipment in the product information, under the conditions of use which can be reasonably foreseen. This is particularly relevant in the cases where misuse of the equipment is possible/likely – even if ATEX equipment is normally used by trained operators.
The consequence for manufacturers is that they have to consider the conditions of use which can be reasonably foreseen prior to placing equipment on the market.
Manufacturers have to look beyond what they consider the intended use of the equipment and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product.
See also § 2.7. “Intended use / Misuse” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(10) 'making available on the market' means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
…
§ 54 Making available on the market
A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. The concept of making available refers to each individual product.
This means the first making available in the European Union, against payment or free of charge, of products, for the purpose of distribution and/or use in the EU territory.
"Making available" means the transfer of the product, that is, either the transfer of ownership, or the physical hand-over of the product by the manufacturer, his authorised representative in the EU or the importer to the person responsible for distributing these onto the EU market or the passing of the product to the final consumer, intermediate supplier or user in a commercial transaction, for payment or free of charge, regardless of the legal instrument upon which the transfer is based (sale, loan, hire, leasing, gift, or any other type of commercial legal instrument). The ATEX product must comply with the Directive at the moment of transfer.
See also § 2.2. “Making available” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(11) 'placing on the market' means the first making available of a product on the Union market;
…
§ 55 Placing on the market
A product is placed on the market when it is made available for the first time on the Union market.
Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market.
See also § 2.3. “Placing on the market” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(12) 'manufacturer' means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trade mark or uses it for his own purposes;
…
§ 56 Manufacturer
For the obligations of manufacturers, see section § 75.
According to the definition, the manufacturer may design and manufacture the product itself, or alternatively may use bought-in items, third-party subcontractor services or components, CE marked or not, to assist in the manufacture of the product.
Whoever substantially modifies a product resulting in an "as-new" product, such that its health and safety characteristics (and/or performance) are in any way affected, with a view to placing it on the EU market, also becomes the manufacturer.
As long as the end-user only uses a product and does not manufacture it, he is not a manufacturer according to the definition of the Directive. Using products also includes the integration of already ATEX-compliant products by the end-user in his plant after having performed a full risk assessment including occupational safety items, interfaces and interactions to the existing plant.
From the above, it follows that such an integration, which is unique and considers the well-known purposes and specific conditions of operation of the plant, will not fall into the scope of the Directive.
Example:
The integration of a pump, a clutch, an engine, the mounting plate, and a level indicator as a dry run protection by the end-user in a plant considering the parameters of the conveyed media and the conditions of operation is an installation.
See also § 3.1. “Manufacturer” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(13) 'authorised representative' means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
§ 57 Authorised representative
For the obligations of authorised representatives, see section § 80.
An authorised representative is the person or persons expressly appointed by the manufacturer by a written mandate to act on his behalf in respect of certain manufacturer's obligations within the EU. The extent to which the authorised representative may enter into commitments binding on the manufacturer is restricted by the relevant Articles of the Directive and determined by the mandate conferred on him by the latter.
As an example, he could be appointed to undertake the testing in the EU territory, sign the EU declaration of conformity, affix the CE marking and hold the EU declaration of conformity and the technical documentation within the EU at the disposal of the competent authorities.
The quality assessment system of the authorised representative/responsible person shall not be subject to assessment by a notified body, but the quality assessment system of the actual manufacturer. It would not be reasonable to assess a quality assessment system of a facility that is not producing the product. However, if the authorised representative is carrying out tests and/or verifications required by the Directive to determine conformity with the essential health and safety requirements, he shall be subject to quality assurance assessment.
See also § 3.2. “Authorised representative” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(14) 'importer' means any natural or legal person established within the Union who places a product from a third country on the Union market;
…
§ 58 Importer
For the obligations of importers, see section § 81.
The importer is the economic operator established in the EU who places a product from a third country on the Union market.
See also § 3.3. “Importer” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(15) 'distributor' means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;
…
§ 59 Distributor
For the obligations of distributors, see section § 82.
The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.
See also § 3.4. “Distributor” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(16) 'economic operators' means the manufacturer, the authorised representative, the importer and the distributor;
…
§ 60 Economic operators
The New Legislative Framework as in Decision No 768/2008/EC defines the manufacturer, the authorised representative, the importer and the distributor as “economic operators”.
Article 2
Definitions (continued)
…
(17) 'technical specification' means a document that prescribes technical requirements to be fulfilled by a product;
…
§ 61 Technical specification
This is a very general concept that includes different kinds of technical requirements for products or categories of products, according to applicable legislation and/or to sectoral provisions. Technical specifications can be provided by standards or any other technical document drafted by authorised experts as well as by public or private organisations. They can establish a "minimum" as "essential requirements" or can be more detailed in terms of specific technical solutions for design and manufacturing of a product.
Since the New Approach calls for common essential requirements to be made mandatory by legislation, this approach is appropriate only where it is possible to distinguish between essential requirements (see section § 72) and technical specifications.
Article 2
Definitions (continued)
…
(18) 'harmonised standard' means harmonised standard as defined in point (c) of point (1) of Article 2 of Regulation (EU) No 1025/2012;
…
§ 62 Harmonised standard
The ATEX Directive 2014/34/EU provides manufacturers with the option of complying with its requirements by designing and manufacturing directly in accordance with the essential health and safety requirements of the Directive, or to harmonised standards which are developed specifically to allow a presumption of conformity with those requirements.
See also section § 86 on presumption of conformity of products.
Article 2
Definitions (continued)
…
(19) 'accreditation' means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
(20) 'national accreditation body' means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
…
§ 63 Accreditation and national accreditation body
Accreditation is the attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity.
It is based on the international standards for conformity assessment bodies that have been harmonised in the New Legislative Framework and the references of which have been published in the Official Journal of the European Union (OJEU). With Regulation No 765/2008, only national accreditation bodies are allowed to provide accreditation of conformity assessment bodies.
Accreditation is to be operated as a public authority activity and is to be provided on a not-for-profit basis.
Each EU Member State may appoint one single national accreditation body. The responsibilities and tasks of the national accreditation body have to be clearly distinguished from those of other national authorities.
Within the EU, accreditation bodies are not allowed to compete with other accreditation bodies. They are only to be active on the territory of their own Member State.
See also § 6. “Accreditation” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(21) 'conformity assessment' means the process demonstrating whether the essential health and safety requirements of this Directive relating to a product have been fulfilled;
(22) 'conformity assessment body' means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
…
§ 64 Conformity assessment
As for the other EU legislative acts under the New Approach and the New Legislative Framework covering products, two important elements of the ATEX Directive 2014/34/EU are:
- the legislative requirements governing the characteristics of the products covered, and
- the conformity assessment procedures the manufacturer carries out in order to demonstrate that a product, before it is placed on the market, conforms to these legislative requirements.
Conformity assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled.
A product is subjected to conformity assessment both during the design and production phase. Conformity assessment is the responsibility of the manufacturer. Should a manufacturer subcontract design or production, he still remains responsible for the execution of conformity assessment.
The essential objective of a conformity assessment procedure is to demonstrate that products placed on the market conform to the requirements expressed in the provisions of the relevant legislation.
Conformity assessment bodies (notified bodies under the ATEX Directive 2014/34/EU) provide the professional and independent judgements, which consequently enable manufacturers or their authorised representatives to fulfil the procedures in order to presume conformity to the Directive. Their intervention is required:
•
for issuing of EU-type examination certificates, and for inspection, verification and testing of equipment, protective systems, devices and components before they can be placed on the market and/or put into service;
•
for the assessment of manufacturer’s quality assurance system in the production phase.
See also § 5. “Conformity assessment” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(23) 'recall' means any measure aimed at achieving the return of a product that has already been made available to the end-user;
(24) 'withdrawal' means any measure aimed at preventing a product in the supply chain from being made available on the market;
…
§ 65 Recall and withdrawal
Competent national authorities must take action to enforce conformity, when they discover that a product is not in compliance with the provisions of the Directive.
Enforcement of conformity can be achieved by obliging the manufacturer, the authorised representative, or other responsible persons, to take required measures.
In case of formal non-compliance the market surveillance authority should first oblige the manufacturer, or the authorised representative, to make the product intended to be placed on the market and if necessary, the product already on the market, comply with the provisions and to remedy the infringement.
See also § 7.3.6. “Corrective measures – Bans – Withdrawals-recalls” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 2
Definitions (continued)
…
(25) 'Union harmonisation legislation' means any Union legislation harmonising the conditions for the marketing of products;
…
§ 66 Union harmonisation legislation
Harmonisation legislation issued by the European Union, for products in the single internal market, is mainly made by Regulations and Directives.
Article 2
Definitions (continued)
…
(26) 'CE marking' means a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.
§ 67 CE marking
See also sections §§ 144-145 on marking and CE marking.
As a general rule, New Approach and New Legislative Framework directives, including the ATEX Directive 2014/34/EU, provide for the affixing of the CE marking as part of the conformity assessment procedures in the perspective of total harmonisation.
Where a product is subject to several directives, which all provide for the affixing of CE marking, the marking indicates that the product is presumed to conform to the provisions of all these directives.
The CE marking is mandatory and must be affixed before any equipment or protective system is placed on the market or put into service. As stated in Article 13(3) components are excluded from this provision. Instead of being CE marked, components have to be delivered with a written attestation stating the conformity with the provisions of the Directive, stating their characteristics and indicating how they must be incorporated into equipment or protective systems. This separate statement goes along with the definition of components, which have as structural parts no autonomous function.
Article 3
Making available on the market and putting into service
1. Member States shall take all appropriate measures to ensure that products may be made available on the market and put into service only if, when properly installed and maintained and used in accordance with their intended use, they comply with this Directive.
2. This Directive shall not affect Member States’ entitlement to lay down such requirements as they may deem necessary to ensure that persons and, in particular, workers are protected when using relevant products provided that this does not mean that such products are modified in a way not specified in this Directive.
3. At trade fairs, exhibitions and demonstrations, Member States shall not prevent the showing of products which do not comply with this Directive, provided that a visible sign clearly indicates that such products do not comply with this Directive and that they are not for sale until they have been brought into conformity by the manufacturer. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons.
§ 68 Making available on the market and putting into service
A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. This concept of “making available” refers to each individual product.
The concept of “placing on the market” is directly related to “making available” in the sense that a product is placed on the market when it is made available for the first time on the Union market. Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market.
“Putting into service “takes place at the moment of first use of a product within the Union by the end-user.
§ 69 Making available ATEX products on the market
“Making available” means the transfer of the product, that is, either the transfer of ownership, or the physical hand-over of the product by the manufacturer, his authorised representative in the EU or the importer to the person responsible for distributing these onto the EU market or the passing of the product to the final consumer, intermediate supplier or user in a commercial transaction, for payment or free of charge, regardless of the legal instrument upon which the transfer is based (sale, loan, hire, leasing, gift, or any other type of commercial legal instrument). The ATEX product must comply with the Directive at the moment of transfer.
§ 70 Placing ATEX products on the market
The concept of “placing on the market” determines the moment when products pass for the first time from the manufacturing stage to the market of the EU or the importing stage from a non-EU country to that of distribution and/or use in the EU. Since the concept of placing on the market refers only to the first time products are made available in the EU for the purpose of distribution and/or use in the EU, the ATEX Directive 2014/34/EU covers only:
a) new products manufactured within the EU,
b) "as-new" products (according to section § 56),
c) new or used products imported from a non-EU country,
d) new or "as-new" products labelled by a person who is not the original manufacturer.
The Directive's provisions and obligations concerning placing on the market apply as by 20 April 2016 to each product individually and are irrespective of the date and place of manufacturing. It is the manufacturer's responsibility to ensure that each and all of his products comply where they fall under the scope of the Directive.
If a manufacturer, his authorised representative in the EU or the importer offers products covered by the Directive in a catalogue, they are deemed not to have been placed on the market until they are actually been made available for the first time. Therefore products offered in a catalogue do not have to be in full conformity with the provisions of the Directive 2014/34/EU, but this fact should be clearly advertised in the catalogue.
The placing of products on the market does not concern:
- the disposal of products from the manufacturer to his authorised representative established in the EU who is responsible on behalf of the manufacturer for ensuring compliance with the Directive;
- imports into the EU for the purpose of re-export, i.e., under the processing arrangements;
- the manufacture of products in the EU for export to a non-EU country;
- the display of products at trade fairs and exhibitions. These may not be in full conformity with the provisions of the Directive 2014/34/EU, but this fact must be clearly advertised next to the products being exhibited.
The person placing the product on the EU market, be it the manufacturer, his authorised representative or, if neither of them is established in the EU, the importer or any other responsible person, must retain at the disposal of the competent authority the EU declaration of conformity. The technical documentation has to be made available on request of the enforcement authorities within a reasonable time (see Annexes III, VI, VIII to the Directive). These documents shall be maintained by such a person at the disposal of the competent authorities for ten years after the last item has been manufactured. This applies to products manufactured in the EU as well as those imported from a non-EU country.
§ 71 Putting ATEX products into service
It is the first use of products referred to in Directive 2014/34/EU in the EU territory, by its end user. Products covered by Directive 2014/34/EU are put into service at the moment of first use.
However, a product which is ready for use as soon as it is placed on the market and which does not have to be assembled or installed, and where the distribution conditions (storage, transport, etc.) makes no difference to the performance or safety characteristics of the product with reference to the essential health and safety requirements of Directive 2014/34/EU, is considered to have been put into service as soon as it is placed on the market, if it is impossible to determine when it is first used.
See also §§ 2.2. “Making available”, 2.3. “Placing on the market” and 2.5 “Putting into service or use (and installation)” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 4
Essential health and safety requirements
Products shall meet the essential health and safety requirements set out in Annex II which apply to them, account being taken of their intended use.
§ 72 Essential health and safety requirements
A fundamental feature of the ATEX Directive 2014/34/EU, as for other Union harmonisation legislation, is to limit legislative harmonisation to the essential health and safety requirements (EHSRs) that are of public interest. These requirements deal with the protection of health and safety of users (e.g. consumers and workers) but may also cover other fundamental requirements (for example protection of property, scarce resources or the environment).
The ATEX essential health and safety requirements are set out in Annex II of the Directive, although no detailed manufacturing specifications are included. Such technical specifications can be provided for by standards, in particular European harmonised standards (voluntary) use of which confers presumption of conformity with the relevant requirements.
See also § 4.1 “Essential product requirements” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 5
Free movement
Member States shall not prohibit, restrict or impede the making available on the market and putting into service in their territory of products which comply with this Directive.
§ 73 Free movement
The objective of eliminating trade barriers among the EU Member States and of strengthening the free movement of products is stated by a free movement clause, inserted in the ATEX Directive 2014/34/EU, which guarantees the free movement of products complying with the legislation. Therefore, Member States cannot impede the making available on the market of a product which complies with all the provisions of the Directive.
See also § 8 “Free movement of products within the EU” “The ‘Blue Guide’ on the implementation of EU product rules”.
CHAPTER 2
OBLIGATIONS OF ECONOMIC OPERATORS
§ 74 Obligations of economic operators
Chapter 2 of the ATEX Directive 2014/34/EU deals with obligations and identification of manufacturers, authorised representatives, importers and distributors, collectively defined as "economic operators". Those are the "active parts" in the supply chain when a product is placed on the EU market and in this sense, specific obligations and responsibilities are defined. It should be noted that users (consumers, workers…) are not considered as "economic operators" with respect to the Directive.
See also § 3. “The actors in the product supply chain and their obligations” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 6
Obligations of manufacturers
1. When placing their products on the market or using them for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential health and safety requirements set out in Annex II.
2. Manufacturers shall draw up the technical documentation referred to in Annexes III to IX and carry out the relevant conformity assessment procedure referred to in Article 13 or have it carried out.
Where compliance of a product, other than a component, with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
Where compliance of a component with the applicable requirements has been demonstrated by the relevant conformity assessment procedure, manufacturers shall draw up a written attestation of conformity as referred to in Article 13(3).
Manufacturers shall ensure that each 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 products is delivered to a single user, the batch or consignment concerned may be accompanied by a single copy.
3. Manufacturers shall keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the product has been placed on the market.
4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in a product design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of a product is declared shall be adequately taken into account.
When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of end-users, carry out sample testing of products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring.
5. Manufacturers shall ensure that products which they have placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
6. Manufacturers shall ensure that 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 II.
7. Manufacturers shall indicate, on the product, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the product. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
8. Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by end-users, as determined by the Member State concerned. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible.
9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the product with this Directive, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
§ 75 Obligations of manufacturers
For the definition of manufacturer, see section § 56.
On the basis of obligations stated in the ATEX Directive 2014/34/EU, the manufacturer bears responsibility for:
·
undertaking an analysis to conclude if his product is subject to the Directive and which requirements apply (as explained in section § 32);
·
design and construction of the product in accordance with the essential health and safety requirements laid down in the Directive;
·
following the procedures for the assessment of the conformity of the product with the essential health and safety requirements laid down in the Directive (see Article 13);
·
signing the EU declaration of conformity or the written attestation of conformity;
·
providing marking and instructions for safe use, maintenance etc. as described in Annex II to the Directive.
The manufacturer has sole and ultimate responsibility for the conformity of his product to the applicable Union legislation. He must understand both the design and construction of the product to be able to declare such conformity in respect of all applicable provisions and requirements of the relevant Union legislation.
For the purposes of market surveillance the EU declaration of conformity and, when applicable, the written attestation of conformity must accompany the information given with each single product, or each batch of identical products delivered for the same end user.
Articles 12 to 16 and their associated annexes of the Directive 2014/34/EU define the obligations incumbent on the manufacturer with regard to conformity assessment, CE marking, the EU declaration of conformity, the written attestation of conformity (if relevant) and the arrangements for holding the EU declaration of conformity, together with the technical documentation, at the disposal of the competent authorities for a period of 10 years after the last product has been manufactured.
See also § 3.1. “Manufacturer” in “The ‘Blue Guide’ on the implementation of EU product rules”.
§ 76 Use of subcontractor services by a manufacturer
The manufacturer may have the product designed, manufactured, assembled, packaged, processed or labelled by subcontractors, with a view to placing the product on the market under its own name, and thus presenting itself as the manufacturer, disregarding its involvement in the physical/actual manufacturing processes.
Where subcontracting of this type takes place, the manufacturer must retain the overall control for the product and ensure that it receives all the information that is necessary to fulfil the responsibilities of a manufacturer according to the Directive.
In such cases, it cannot discharge itself from its responsibilities as a manufacturer, as it is responsible for the application of relevant conformity assessment procedures, including engaging a notified body where required to do so by the Directive, for example to approve and carry out periodic surveillance of the manufacturer's quality management system.
§ 77 Manufacturers and conformity assessment based on quality assurance (Annex IV, Annex VII)
Due to the use of subcontractors, the manufacturer may not be able to demonstrate (to a notified body) that its own quality assurance system ensures the product complies with the requirements of the Directive. The quality assurance of the production process (Annex IV) or the product quality assurance (Annex VII) systems at the actual manufacturing plant premises, of the manufacturer itself and/or of subcontractors, need to be the subject of an assessment by a notified body, including periodic audit visits.
The manufacturer may not rely on the notified body audits of the third-parties to discharge its responsibilities under the Directive. The notified body shall not issue the subcontractor with a quality assurance notification for this purpose, unless the subcontractor holds its own EU-type examination certificate for the same product.
In case a manufacturer A uses a subcontractor B for the production or labelling of a product, which places the same product on the market under its own name, it is sufficient for the manufacturer to apply for a second certificate based on the certificate of the subcontractor. The manufacturer will be expected to submit
- the original certificate,
- a declaration by the original manufacturer that the equipment to be produced under the name of the trade agent will be identical with the originally certified equipment,
- a declaration by the trade agent that the equipment brought to the market will be identical to that originally certified, and
- a copy of the contractual agreement between the manufacturer A and the subcontractor B.
§ 78 Certificates and CE marking without the name of the original manufacturer
Different possible cases are dealt with in this section.
Case 1: Authorised representative
The manufacturer applies for assessment and the certificate, if granted, is in the name of the manufacturer.
The EU declaration of conformity and the application of the CE marking may be effected either by the manufacturer or his authorised representative, but not by both. Required marking shall show the manufacturer’s name and the number of the notified body involved in the manufacturer’s production phase shall appear be placed after the CE marking.
Any person who is not an authorised representative is not allowed to issue an EU declaration of conformity or to apply the CE marking.
An authorised representative is assimilated with and regarded as an extension of the manufacturer’s operation. The name of the manufacturer shall be on the rating plate.
Case 2: "De facto" manufacturer
Any person who is not the manufacturer may apply for assessment and, if successful, have the certificate granted in his name and puts his name on the rating plate provided he can satisfy the chosen notified body that he is fully responsible and has control over the design of the saleable product.
Irrespective of where the product is manufactured, he can issue the EU declaration of conformity, affix the CE marking and add the number of the notified body concerned with the approval of the production phase provided he is fully responsible for and in control of the production.
In this case, he is the "de facto" manufacturer of the product. He can show full responsibility by, for example, placing a sub-contract for production with the actual manufacturer. The "de facto" manufacturer, in this case, is also responsible for engaging a notified body to approve and carry out periodic surveillance of the quality management system used in production, whether in the EU or elsewhere in the world.
The number to be applied after the CE marking is that of the notified body appointed by the “de facto” manufacturer to assess the quality management system.
Case 3: Second EU-type examination certificate in a second manufacturer or trade agent’s name
A manufacturer A, whose quality management system is approved according to Directive 2014/34/EU by a notified body NB1, produces and sells equipment for which he holds an EU-type examination certificate issued in his own name. A second manufacturer acting as a trade agent B, whose quality management system is approved according to Directive 2014/34/EU by another notified body NB2, applies for an EU-type examination certificate in his name, B, based on the certificate previously granted to original manufacturer A by a notified body NB. On receipt of the certificate he then manufactures the product, issues his own EU declaration of conformity, affixes the CE-mark with the identification number of the notified body NB2 and sells the equipment in his own name on the EU market.
Alternatively, manufacturer B may choose to have the equipment manufactured under subcontract. In this case he must ensure that the quality system used by the sub-contractor is in compliance with the relevant requirements of Directive 2014/34/EU. If the quality system is again approved by notified body NB2, the manufacturer B can issue his own EU declaration of conformity, affix the CE-mark together with the identification number of the notified body NB2 and sell the product in his own name on the EU market.
Although the procedure for issuing a second EU-type examination certificate in a second manufacturer’s name is not explicitly covered by Directive 2014/34/EU, it would appear justifiable in order to support established commercial practices, e.g. manufacturing or selling under licence.
In applying for the second certificate, in order to get the required product certification for the EU market place, manufacturer or trade agent B has to submit to the appropriate notified body:
- the original or a copy of the EU-type examination certificate issue by notified body NB in A’s name,
- a declaration by the original manufacturer A that the equipment to be produced under the name of the second manufacturer or trade agent B will be identical with the originally certified equipment,
- a declaration by the second manufacturer or trade agent B that the equipment brought to the EU market will be identical to that originally certified, and
- the original or a copy of the contractual agreement between A and B.
NB, as the notified body assessing manufacturer A’s product, will issue a new EU-type examination certificate and report based upon the EU-type examination certificate and report issued in manufacturer A’s name.
This is necessary to follow the line of quality management back to the original EU-type examination assessment, to ensure the traceability of Quality Assurance. In fact, manufacturer or trade agent B needs to get the required Quality Assurance Notification (QAN) for the EU market place: notified body NB2 assessing B’s quality assurance system will issue a Quality Assurance Notification to B once they have assured that the requirements of the appropriate Directive Annex has been satisfied. Since B does not physically produce the ATEX product himself, a full assessment against Annex IV or VII cannot be achieved unless the compliance of manufacturer A’s quality assurance system, as the actual producer of B’s product, has been established to ensure the following:
- the line of quality assurance can be followed back to the original EU-type examination assessment issued by notified body NB1 and held by manufacturer A;
- compliance with the requirements of Annex IV or VII have been demonstrated through the combined quality assurance systems of trade agent B (covered by the QAN issued by notified body NB2) and the actual producer, manufacturer A (covered by the QAN issued by notified body NB1);
- an appropriate quality assurance system exists for the products identified in EU-type examination certificate, so that notified body NB2 can issue its own QAN to trade agent B and permit the use of its NB2 number adjacent to the CE-mark on the label of the B's product.
See the diagram:
So, trade agent B has been granted an EU-type examination certificate, issued by notified body NB, based upon the EU-type examination certificate issued in manufacturer A’s name, and holds a Quality Assurance Notification in his own name, issued by notified body NB2, that allows that the ATEX product placed onto the market in B’s name to bear NB2 number. NB2 must inform NB1 accordingly.
The EU market is presented with a new ATEX product that appears to be made by B and satisfies the requirements of the ATEX Directive; but the market place, in principle, has no knowledge of the relationship between companies B and A, and, under the ATEX Directive, B is considered the "manufacturer" and has fulfilled all the necessary requirements for a manufacturer.
In order to ensure that the requirements of the directive are effectively fulfilled, it is necessary to keep visible traceability of the QAN held by trade agent B to the QAN issued to manufacturer A, in particular to guarantee:
- that the original EU-type examination certificate held by A and used as the basis for the EU-type examination certificate issued to B is included in an existing QAN;
- that the version labelled for B will be examined by the original product manufacturer's notified body NB1, during the course of their surveillance assessment as they may be unaware of the existence of B’s activities which have been conducted through a different notified body NB2.
Otherwise, there is a significant danger that the product described on the EU-type examination certificate issued to trade agent B by notified body NB is never subjected to a quality assurance system assessment at the actual place of production by NB1 as the notified body of the original manufacturer, A, fundamentally undermining the principles of the ATEX Directive.
As a solution, when trade agent B is provided with an EU-type examination certificate, B’s QAN and A’s QAN as the actual manufacturer with whom B has a contractual agreement, are to be updated to identify the products covered by B's EU-type examination certificate within the schedules. This ensure that the quality assurance system at trade agent B’s location and manufacturer A’s, the actual product producer, are examined by their relevant notified bodies NB1 and NB2.
In addition, in the event of trade agent B identifying, or being advised of, an issue related to the safety of its ATEX product, there is a mean by which the quality assurance of the product can be easily traced back to the original producer, manufacturer A, irrespective of how many notified bodies are involved, and all other trade agents of the same type of product can then be easily advised of the issues.
§ 79 Manufacturing of ATEX products for own use
Whoever puts into service products covered by the Directive, which he has manufactured for his own use, is considered to be a manufacturer. He is obliged to conform to the Directive in relation to putting into service.
Article 7
Authorised representatives
1. A manufacturer may, by a written mandate, appoint an authorised representative.
The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative's mandate.
2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
(a) keep the EU declaration of conformity or, where applicable, the attestation of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the product has been placed on the market;
(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;
(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by the authorised representative's mandate.
§ 80 Authorised representatives
For the definition of authorised representative, see section § 57.
Article 7 of the ATEX Directive 2014/34/EU, as well as the specific provisions in Annexes III to IX, defines the obligations incumbent on the authorised representative established within the EU with regard to conformity assessment, CE markings, EU declaration of conformity and the arrangements for holding this EU declaration of conformity, together with the technical documentation, at the disposal of the competent authorities for a period of 10 (ten) years after the last product has been manufactured.
See also § 3.2. “Authorised representative” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 8
Obligations of importers
1. Importers shall place only compliant products on the market.
2. Before placing a product on the market importers shall ensure that the appropriate conformity assessment procedure referred to in Article 13 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the product bears the CE marking, where applicable, is accompanied by the EU declaration of conformity or the attestation of conformity and the required documents, and that the manufacturer has complied with the requirements set out in Article 6(5), (6) and (7).
Where an importer considers or has reason to believe that a product is not in conformity with the essential health and safety requirements set out in Annex II, he shall not place the product on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
3. Importers shall indicate on the product their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the product. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
4. Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by end-users, as determined by the Member State concerned.
5. Importers shall ensure that, while a product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential health and safety requirements set out in Annex II.
6. When deemed appropriate with regard to the risks presented by a product, importers shall, to protect the health and safety of end-users, carry out sample testing of products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring.
7. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
8. Importers shall, for 10 years after the product has been placed on the market, keep a copy of the EU declaration of conformity or, where applicable, of the attestation of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.
9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a product in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
§ 81 Obligations of importers
For the definition of importer, see section § 58.
The importer has important and clearly defined responsibilities under the Directive; to a large extent they build on the type of responsibilities which a manufacturer based in the EU is subjected to.
The importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple re-seller of products, but has a key role to play in guaranteeing the compliance of imported products.
See also § 3.3. “Importer” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 9
Obligations of distributors
1. When making a product available on the market distributors shall act with due care in relation to the requirements of this Directive.
2. Before making a product available on the market distributors shall verify that the product bears the CE marking, where applicable, that it is accompanied by the EU declaration of conformity or the attestation of conformity and the required documents and by instructions and safety information, in a language which can be easily understood by end-users in the Member State in which the product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5), (6) and (7) and Article 8(3) respectively.
Where a distributor considers or has reason to believe that a product is not in conformity with the essential health and safety requirements set out in Annex II, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.
3. Distributors shall ensure that, while a product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential health and safety requirements set out in Annex II.
4. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with this Directive shall make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the product presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
5. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a product. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have made available on the market.
§ 82 Obligations of distributors
For the definition of distributor, see section § 59.
Along with manufacturers and importers, distributors are the third category of economic operators who are subject to specific obligations. Retailers, wholesalers and other distributors in the supply chain are not required to have a preferential relationship with the manufacturer like the authorised representative. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor.
Distributor must act with due care in relation to the applicable requirements. They have to know, for instance, which products must bear the CE marking, what information is to accompany the product (for example the EU declaration of conformity), what are the language requirements for labelling, user instructions or other accompanying documents, and what is a clear indication of the product being non-compliant. Distributors have an obligation to demonstrate to the national market surveillance authority that they have acted with due care and ensure that the manufacturer, or his authorised representative, or the person who provided him with the product has taken the measures required by the Directive as listed in the obligations for distributors.
Conformity assessment, drawing up and keeping the EU declaration of conformity and the technical documentation remain the responsibility of the manufacturer and/or importer in the case of products from third countries. It is not part of the distributor’s obligations to check whether a product already placed on the market is still in conformity with the legal obligations that are currently applicable in case these have changed. The obligations of the distributor refer to the legislation applicable when the product was placed on the market by the manufacturer or the importer unless specific legislation provides otherwise.
The distributor must be able to identify the manufacturer, his authorised representative, the importer or the person who has provided him with the product in order to assist the market surveillance authority in its efforts to obtain the EU declaration of conformity and the necessary parts of the technical documentation. Market surveillance authorities have the possibility to address their request for the technical documentation directly to the distributor. The latter is however not expected to be in possession of the relevant documentation.
See also § 3.4. “Distributor” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 10
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to the obligations of the manufacturer under Article 6, where he places a product on the market under his name or trade mark or modifies a product already placed on the market in such a way that compliance with this Directive may be affected.
§ 83 Obligations of manufacturers for importers and distributors
If the product is marketed under another person’s name or trademark, this person will be considered as the manufacturer.
The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes or labels ready-made products and places them on the market under his own name or trademark. Further, the responsibility of the manufacturer is placed on any person who changes the intended use of a product in such a way that different essential or other legal requirements will become applicable, or substantially modifies or re-builds a product (thus creating a new product), with a view to placing it on the market.
See also § 3.1. “Manufacturer” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 11
Identification of economic operators
Economic operators shall, on request, identify the following to the market surveillance authorities:
(a) any economic operator who has supplied them with a product;
(b) any economic operator to whom they have supplied a product.
Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the product and for 10 years after they have supplied the product.
§ 84 Identification of economic operators
Economic operators are obliged to keep track of the economic operators they supplied their product to or from whom they bought products for a period of 10 (ten) years. End-users are not covered by this requirement as they are not considered to be economic operators.
The way to comply with this requirement by economic operators is not prescribed by the Directive, but it must be noted that market surveillance authorities can ask for relevant documents, including invoices, allowing the origin of the product to be traced. Hence, it could be useful to keep invoices for a longer period than envisaged in accounting legislation to comply with the requirements on traceability.
See also § 4.2.2.4. “Identification of economic operators” in “The ‘Blue Guide’ on the implementation of EU product rules”.
CHAPTER 3
CONFORMITY OF THE PRODUCT
§ 85 Conformity of the product
Chapter 3 of the ATEX Directive 2014/34/EU deals with presumption of conformity of products, conformity assessment procedures and the EU declaration of conformity.
Article 12
Presumption of conformity of products
1. 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 shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those standards or parts thereof.
2. In the absence of harmonised standards, Member States shall take any steps which they deem necessary to bring to the attention of the parties concerned the existing national standards and technical specifications regarded as important or relevant to the proper implementation of the essential health and safety requirements set out in Annex II.
§ 86 Presumption of conformity of products
The presumption of conformity of products is conferred by the use of European harmonised standards the reference of which is published in the Official Journal of the European Union (OJEU).
The European Standardisation Organisations (CEN, CENELEC and ETSI) and their specific Technical Committees, as well as other sectoral interested parties (national experts, notified bodies, industry, etc.) are involved in the development of European standards. These standards are likely the preferred option for demonstrating compliance once they become available as harmonised standards.
Voluntary harmonised standards are the only documents the application of which provides for presumption of conformity in the sense of the Directive. Manufacturers may also decide to use other existing technical European, international or national standards and specifications regarded as important, relevant or useful to cover the applicable essential health and safety requirements of the Directive, together with additional controls addressing those other requirements not already covered.
European standards are amended and updated in a regular basis and in response to new technical knowledge, to reflect the available “state of the art”. During the process of updating, a manufacturer may continue to use a current harmonised standard to claim full compliance with the Directive, until a new harmonised standard replaces (supersedes) the previous one, at the end of the established transition period, as usually set.
§ 87 European harmonised standards in the Official Journal
The consolidated lists of references of European harmonised standards under the ATEX Directive 2014/34/EU, published on the Official Journal of the European Union, can be found on Eur-Lex http://eur-lex.europa.eu/oj/direct-access.html and on the European Commission's website http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/equipment-explosive-atmosphere/index_en.htm.
European standards for ATEX are available from two European Standardisation Organisations:
- European Committee for Standardization (CEN): avenue Marnix 17, 1000 Brussels, Belgium; tel. (32-2) 550 08 11; fax (32-2) 550 08 19; website http://www.cen.eu;
- European Committee for Electrotechnical Standardization (CENELEC): avenue Marnix 17, 1000 Brussels, Belgium; tel. (32-2) 519 68 71; fax (32-2) 519 69 19; website http://www.cenelec.eu.
National transpositions of Harmonised Standards are available from the national standardisation bodies, members of CEN and CENELEC.
§ 88 Standardisation programme
There are two standardisation programmes addressed to the European Standardisation Organisations active in the ATEX sector: CEN and CENELEC. Each one is the subject of a standardisation mandate drawn up by the European Commission.
The European Commission has granted a mandate to CEN and CENELEC to produce European standards to be harmonised. The mandate covers the standardisation work necessary for the optimum functioning of the Directive in both the electrical and non-electrical field.
The mandate requires intensive co-operation between CEN and CENELEC to carry out the following work:
- to review and, where appropriate, modify existing standards with a view to aligning them with the essential health and safety requirements of the Directive;
- to establish the new standards required, giving priority to horizontal standards, which apply to broad ranges of products, rather than to specific products, with the need for them to be demonstrated on a case-by-case basis.
To carry out their mandate in the ATEX field, CEN and CENELEC has established two specific Technical Committees (TCs):
- CEN/TC 305 "Potentially explosive atmospheres - Explosion prevention and protection"
and
- CLC/TC 31 "Electrical apparatus for potentially explosive atmospheres".
Several working groups and sub-committees carry out the detailed work within each of these Technical Committees. These Committees have been working in the potentially explosive atmosphere field for a considerable number of years.
CEN and CENELEC are responsible for the preparation of standards of the electrical and non-electrical sectors of industry respectively. They have the responsibility to ensure that:
- there is uniform interpretation of the ATEX Directive 2014/34/EU, and other relevant directives when applicable;
- safety requirements for the electrical and non-electrical sectors are compatible where they overlap, and the levels of safety sought are equivalent;
- the preparation of standards in the future by one of the organisations satisfactorily reflects the needs of the other, and vice versa.
Article 13
Conformity assessment procedures
1. The procedures to be followed for assessing the conformity of equipment and, where necessary, the devices referred to in point (b) of Article 1(1) shall be as follows:
(a) for equipment-group I and II, equipment-category M 1 and 1, the EU-type examination set out in Annex III, in conjunction with either of the following:
– conformity to type based on quality assurance of the production process set out in Annex IV;
– conformity to type based on product verification set out in Annex V;
(b) for equipment-group I and II, equipment-category M 2 and 2:
(i) in the case of internal combustion engines and electrical equipment in these groups and categories, the EU-type examination set out in Annex III, in conjunction with either of the following:
– conformity to type based on internal production control plus supervised product testing set out in Annex VI;
– conformity to type based on product quality assurance set out in Annex VII;
(ii) in the case of other equipment in these groups and categories, internal production control set out in Annex VIII and the communication of the technical documentation provided for in Annex VIII, point 2, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it;
(c) for equipment-group II, equipment-category 3, internal production control set out in Annex VIII;
(d) for equipment-groups I and II, in addition to the procedures referred to in points (a), (b) and (c) of this paragraph, conformity based on unit verification set out in Annex IX may also be followed.
2. The procedure referred to in points (a) or (d) of paragraph 1 shall be used for conformity assessment of protective systems.
3. The procedures referred to in paragraph 1 shall be applied 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 shall be issued by the manufacturer, declaring the conformity of the components with the applicable provisions of this Directive and stating their characteristics and how they must be incorporated into equipment or protective systems to assist compliance with the essential health and safety requirements set out in Annex II applicable to finished equipment or protective systems.
4. With regard to the safety aspects referred to in point 1.2.7 of Annex II, in addition to the conformity assessment procedures referred to in paragraphs 1 and 2, the procedure referred to in Annex VIII may also be followed.
5. By derogation from paragraphs 1, 2 and 4, the competent authorities may, on a duly justified request, authorise the placing on the market and putting into service on the territory of the Member State concerned of the products other than components in respect of which the procedures referred to in paragraphs 1, 2 and 4 have not been applied and the use of which is in the interests of protection.
6. Documents and correspondence relating to the conformity assessment procedures referred to in paragraphs 1 to 4 shall be drawn up in a language, determined by the Member State concerned.
§ 89 Conformity assessment procedures
Article 13 of the Directive describes the conformity assessment procedures whereby the manufacturer or his authorised representative established within the EU ensures and declares that the product complied with the ATEX Directive 2014/34/EU and its relevant essential health and safety requirements. References are made to the procedures as described in Annexes III to IX, from the Modules A to G included in Annex II to the Decision No 768/2008/EC of the New Legislative Framework (see section § 5).
Article 13(1)(a) describes the procedures in the case of equipment; autonomous protective systems; for safety devices for such equipment or systems; and for components for such equipment, systems or devices, under equipment-groups I and II, equipment categories M 1 and 1. The options are either:
i) EU-type examination
[3]
(Module B) followed by:
- Conformity to type based on quality assurance of the production process
[4]
(Module D), or,
- Conformity to type based on product verification
[5]
(Module F);
ii) Conformity based on unit verification
[6]
(Module G).
Article 13(1)(b) describes the procedure in the case of equipment; for safety devices for such equipment; and for components of such equipment or devices, under equipment-groups I and II, equipment categories M 2 and 2. The options are either:
For internal combustion engines and electrical equipment:
i) EU-type examination8 (Module B) followed by:
- Conformity to type based on internal production control plus supervised product testing
[7]
(Module C1), or,
- Conformity to type based on product quality assurance
[8]
(Module E).
ii) Conformity based on unit verification11 (Module G).
For other equipment:
i) Internal production control
[9]
(Module A) and the communication/deposit of the technical documentation
[10]
to a notified body
[11]
, or,
ii) Conformity based on unit verification11 (Module G).
Article 13(1)(c) describes the procedure in the case of equipment; for safety devices for such equipment; and for components for such equipment and devices under equipment-group II, equipment category 3. The options are either:
i) Internal production control14 (Module A), or,
ii) Conformity based on unit verification11 (Module G).
On the other hand, safety, controlling and regulating devices have to comply with the requirements of Annex II, clause 1, especially clause 1.5.
The formal conformity assessment procedures of Article 8 apply and the safety devices are assessed according to the equipment group and category of the system consisting of the safety device and the equipment under control. In some cases it is necessary to perform the assessment for the combination (e.g. inverter fed motors), but generally the assessment for a group of equipment and the appropriate safety devices can be done separately (e.g. type "e" motor).
Example: a type "e" motor of category 2 is controlled by an overload protection device located outside the explosive atmosphere. The conformity assessment procedure of equipment group II and category 2 is applied for the safety device.
In brief, the different conformity assessment procedures, as appropriate for each kind of ATEX products, are listed in the following Table 3: Conformity assessment procedures for the ATEX Directive 2014/34/EU and showed in the chart provided overleaf.
Table 3: Conformity assessment procedures for the ATEX Directive 2014/34/EU
|
Conformity assessment procedure
|
Directive 2014/34/EU
|
Short description
|
|
EU-type examination (Module B)
|
Annex III
|
Provides a specimen of the envisaged production to a notified body which undertakes the necessary evaluation to determine that the "type" meets the essential requirements of Directive 2014/34/EU and issues an EU-type examination certificate.
|
|
Conformity to type based on quality assurance of the production process (Module D)
|
Annex IV
|
Operates a quality system approved by a notified body for production, final equipment inspection and testing, subject to on-going surveillance.
|
|
Conformity to type based on product verification (Module F)
|
Annex V
|
Examination and tests by a notified body of every product to check the conformity of the equipment, protective system or device with the requirements of Directive 2014/34/EU and draw up a certificate of conformity.
|
|
Conformity to type based on internal production control plus supervised product testing (Module C1)
|
Annex VI
|
Tests carried out by a manufacturer on each piece of equipment manufactured to check the explosion protection aspects of the design. Carried out under the responsibility of a notified body.
|
|
Conformity to type based on product quality assurance (Module E)
|
Annex VII
|
A quality system approved by a notified body for the final inspection and testing of equipment, subject to on-going surveillance.
|
|
Internal production control (Module A)
|
Annex VIII
|
Product and quality system assessment procedure carried out by the manufacturer and retention of documentation.
|
|
Conformity based on unit verification (Module G)
|
Annex IX
|
A notified body examines individual equipment or protective system and carries out tests as defined in European harmonised standards, if they exist, or otherwise in European, international or national standards or conduct equivalent tests to ensure conformity with the relevant requirements of Directive 2014/34/EU and draw up a certificate of conformity.
|
|
Internal production control plus communication and retention of technical documentation by a notified body
|
Article 13(1)(b)(ii)
|
Product and quality system assessment procedure carried out by the manufacturer and retention of documentation by a notified body.
|
(*) and their components and devices according to Article 1(1), if separately assessed
Note: According to Article 13(4) for all equipment and protective systems of all groups and categories conformity to 1.2.7 of Annex II to the Directive 2014/34/EU (protection against other hazards) can be fulfilled by following the procedure of Internal Production Control (Annex VIII).
§ 90 Conformity assessment procedures in the case of different categories within one product
A question arises on which conformity assessment procedures have to be performed in the case of different categories within one product, or mixes of equipment and protective systems according to Article 1(1)(a).
If a product is made of parts which are assigned to different conformity assessment procedures it will be up to the manufacturer to decide how these parts and the whole product shall be placed on the market. The manufacturer can decide to realise the appropriate conformity assessment procedures for each part or for the whole product, even if he decides to place the product as an entirety on the market. In the case of separate conformity assessment procedures for each part of the assembled equipment (“assembly”) the manufacturer may presume conformity of these pieces of equipment and may restrict his own risk assessment of the assembly to those additional ignition and other hazards, which become relevant because of the final combination. If additional hazards are identified a further conformity assessment of the assembly regarding these additional risks is necessary.
If the manufacturer explicitly asks a notified body to assess the entire product, then that conformity assessment procedure, which covers the highest requirements, has to be applied. The notified body shall include into the EU-type examination (if relevant) all aspects of the product. Existing conformity declarations of the manufacturer for parts of the product should be given due consideration.
The notified body should inform the manufacturer about the possibilities of separate conformity assessment procedures for each part of the assembly.
Any certificate issued by the notified body should make clear which aspects of the product have been assessed by the notified body, and which have been assessed by the manufacturer alone.
Example: Vapour recovery pump for petrol stations
(a) The pump is sucking the petrol vapour-air mixture from the atmosphere and conveying it in pipe-work attributed to zone 0. Accordingly it is connected at its inlet and outlet to a potentially explosive atmosphere classified as zone 0. The pump itself is placed in a zone 1 environment.
With regard to the inlet and outlet connection the pump then has to comply with the requirements for category 1 equipment. The corresponding EU-type examination (equipment) has to be carried out by a notified body. With regard to the remaining (outer) body and integrated parts of the pump the notified body includes the necessary category 2 assessment into the certification, even if there are only non-electrical ignition sources to be considered.
Both categories shall be indicated in the EU-type examination certificate, making clear which aspects of the product have been assessed by the notified body, and which have been assessed by the manufacturer alone, and in the marking. For those category 2 parts of the pump, which show only non-electrical ignition sources and which are placed separately on the market, and for which the technical documentation has been communicated to a notified body, an EU declaration of conformity (for equipment) or a written attestation of conformity (for components) of the manufacturer are sufficient.
(b) Often the pump is expected to prevent the passage of a deflagration flame from the inlet to the outlet connection, as typical vapour recovery pumps contain flame arresters in the inlet and outlet pipe. In this case the pump simultaneously may qualify as a protective system (in-line deflagration arrester).
A notified body – after having carried out a corresponding assessment of the flame arresting capability – may then issue a separate EU-type examination certificate for the pump as a protective system. In case that both aspects (equipment and protective system) have been assessed by the same notified body, only one EU-type examination certificate may be issued.
§ 91 Clarification for equipment with categories 2 or 3
See Table 4: Clarification for equipment with categories 2 or 3 on the following page.
Table 4: Clarification for equipment with categories 2 or 3
|
Item
|
Marking
|
Product explanation
|
Comment
|
Equipment
|
EU-type examination certificate
|
|
Electric
|
Non-electric
|
|
1
|
II 1/2 G
|
Equipment installed with one part in zone 0 and one part in zone 1
|
|
X
|
X
|
Yes
|
|
2
|
II 2/3 G
|
Equipment installed with one part in zone 1 and one part in zone 2
|
|
X
|
|
Yes
|
|
3
|
II 2/3 G
|
|
|
X
|
No (*)
|
|
4
|
II 3 (2) G
|
Equipment installed in zone 2 and connected to an equipment placed in zone 1
|
An intrinsically safe barrier installed in zone 2
|
X
|
|
Yes
|
|
7
|
II 2 G
II 3 G
|
Equipment installed in zone 1 or in zone 2
|
Equipment with two versions based on the same housing
|
X
|
|
II 2 G ð Yes
II 3 G ð No (*)
|
|
8
|
II 2 G
II 3 D
|
Equipment installed in zone 1 or 22
|
|
X
|
|
II 2 G ð Yes
II 3 D ð No (*)
|
|
9
|
II 2 G D
II 3 G D
|
Equipment to be installed in zones 1 or 21 or 2 or 22
|
The same equipment with two different markings
|
X
|
|
II 2 G D ð Yes
II 3 G D ð No (*)
|
(*) For those cases, only a type examination certificate can be issued by the certification body (but not as notified body)
§ 92 Exceptional derogations of the conformity assessment procedures
All products referred to in Article 1(1)(a) and (b) of the ATEX Directive 2014/34/EU are covered by the provisions of Article 13(5). This article gives the competent authority of the relevant Member State the possibility, in exceptional circumstances, to authorise the placing on the market and putting into service products (other than components) where the conformity assessment procedures have not been applied. This exception is possible:
- following a duly justified and successful request to the competent authority of the relevant Member State; and,
- if the use of the product is in the interests of protection of health and safety, and where, for example, such interests would be hindered by the delay associated with conformity assessment procedures; and,
- it is restricted to the territory of the Member State concerned.
This provision may be applied in safety relevant cases, in which the products in question are needed urgently and there is insufficient time to undergo the complete conformity assessment procedures (or to complete these procedures). The intention is to give Member States (in the interest of health and safety) the possibility to allow the placing on the market and putting into service innovative products without delay. But even in such cases the essential requirements of the Directive must be fulfilled.
With regard to the restrictive application conditions it has to be emphasised that the use of this clause has to remain exceptional and must not become a normal procedure. In the interests of transparency and to assist administrative co-operation (see also section § 116) Member States are encouraged to provide the competent Commission services with details of any use of Article 13(5).
Article 14
EU declaration of conformity
1. The EU declaration of conformity shall state that the fulfilment of the essential health and safety requirements set out in Annex II has been demonstrated.
2. The EU declaration of conformity shall have the model structure set out in Annex X, shall contain the elements specified in the relevant conformity assessment procedures set out in Annexes III to IX and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the product is placed or made available on the market.
3. Where a product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements laid down in this Directive.
§ 93 EU declaration of conformity
The EU declaration of conformity is a legal statement by the manufacturer or his authorised representative established in the EU attesting that the concerned equipment or the protective system for potentially explosive atmospheres complies with all of the relevant provisions of the ATEX Directive 2014/34/EU.
Once the manufacturer has undertaken the appropriate procedures to assure conformity with the essential health and safety requirements of the Directive, it is the responsibility of the manufacturer or his authorised representative established in the EU to affix the CE marking and to draw up a written EU declaration of conformity.
The manufacturer or his authorised representative established in the EU keeps a copy of this EU declaration of conformity for a period of 10 (ten) years after the last equipment has been manufactured (see Articles 6 and 7). Where neither the manufacturer nor his authorised representative is established within the EU, the obligation to keep the copy of the EU declaration of conformity available, during the same period of 10 years, is the responsibility of the person who places the product on the EU market.
In respect of the notified bodies possibly involved in the conformity assessment procedure, the EU declaration of conformity must contain, where appropriate, the name, the identification number and the address of the notified body, as well as the number of the EU-type examination certificate. The name and address of a notified body involved in the production phase, where relevant, is not a mandatory requirement.
As far as assemblies of ATEX equipment are concerned, if an assembly is to be treated as a new item of ATEX equipment, the EU declaration of conformity needs only to identify the unit and the related information. Details of the items of equipment making up the assembly will be included on the technical file. However, there is a duty on all those in the supply chain to pass on the relevant information relating to the items of equipment where these have been previously placed on the market accompanied by their own EU declaration of conformity and instructions.
Annex X to the ATEX Directive 2014/34/EU states what the EU declaration of conformity must contain, as a minimum (see section § 227).
See also § 4.4 “Declaration of conformity” in “The ‘Blue Guide’ on the implementation of EU product rules”.
§ 94 Written attestation of conformity for components
The EU declaration of conformity must not be confused with the written attestation of conformity for components mentioned in Article 13(3) of the ATEX Directive 2014/34/EU. In addition to declaring the conformity of the components with the provisions of the Directive, the written attestation of conformity has to state the characteristics of the components and how the components are to be incorporated into equipment or protective systems to ensure that the finished equipment or protective system meets the applicable essential health and safety requirements of the Directive.
Article 15
General principles of the CE marking
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 16
Rules and conditions for affixing the CE marking and other markings
1. The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate. Where that is not possible or not warranted on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents.
2. The CE marking shall be affixed before the product is placed on the market.
3. The CE marking shall 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 shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.
4. The CE marking and, where applicable, the identification number of the notified body shall be followed by the specific marking of explosion protection 
, the symbols of the equipment group and category and, where applicable, the other markings and information referred to in point 1.0.5 of Annex II.
5. The CE marking and the markings, symbols and information referred to in paragraph 4, and, where applicable, the identification number of the notified body, may be followed by any other mark indicating a special risk or use.
Products that are designed for a particular explosive atmosphere shall be marked accordingly.
6. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
§ 95 The CE marking. Rules and conditions for affixing the CE marking and other markings
Regulation (EC) No 765/2008 lays down the general principles governing the CE marking, while Decision No 768/2008/EC provides for the rules governing its affixing. The ATEX Directive 2014/34/EU, as the other sectoral Union harmonisation legislation providing for CE marking, is based on the abovementioned Regulation and Directive.
See also § 4.5 “Marking requirements” in “The ‘Blue Guide’ on the implementation of EU product rules”.
See also sections §§ 144-150 on marking.
CHAPTER 4
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
§ 96 Notification of conformity assessment bodies: notified bodies
Chapter 4 of the ATEX Directive 2014/34/EU deals with the requirements and notification procedures for notifying authorities in the EU Member States and for notified conformity assessment bodies – in short, “notified bodies”. The Directive includes the related contents of the Decision No 768/2008/EC.
Notified bodies must provide the professional and independent judgements, which consequently enable manufacturers or their authorised representatives to fulfil the procedures in order to presume conformity to the Directive. Their intervention is required:
- for issuing EU-type examination certificates, and for inspection, verification and testing of equipment, protective systems, devices and components before they can be placed on the market and/or put into service;
- for the assessment of manufacturer's quality assurance system in the production phase.
See also §§ 5.2. “Conformity assessment bodies” and 5.3 “Notification” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 17
Notification
Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Directive.
§ 97 Notification
The bodies responsible for undertaking the work referred to in Article 13 of the Directive 2014/34/EU must be notified by the Member State under whose jurisdiction they fall, on their own responsibility, to the Commission and the other Member States of the EU. This notification also includes the relevant scope of competence for which that body has been assessed as technically competent to certify against the essential health and safety requirements as shown in the Directive. For the EU Member States, this responsibility of notification involves the obligation to ensure that the notified bodies permanently maintain the technical competence required by Directive 2014/34/EU and that they keep their notifying authorities informed on the performance of their tasks.
Therefore, an EU Member State, which does not have a technically competent body under its jurisdiction to notify, is not required to make such a notification. This means that an EU Member State which does not have such a body is not required to create one if it does not feel the need to do so. A manufacturer always has the choice of contacting any body with the appropriate scope of technical competence, which has been notified by a Member State.
On their own responsibility, Member States reserve the right not to notify a body and to remove an appointment. In the latter circumstance the relevant Member State shall inform the Commission and all other Member States.
Article 18
Notifying authorities
1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with the provisions of Article 23.
2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 19. In addition it shall have arrangements to cover liabilities arising out of its activities.
4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
§ 98 Notifying authorities
A notifying authority is the governmental or public body that is tasked with designating and notifying conformity assessment bodies under the ATEX Directive 2014/34/EU. Most often it is the national administration responsible for the implementation and management of the Directive under which the body is notified. Each Member State must designate a notifying authority to be responsible for the assessment, notification and monitoring of conformity assessment bodies. The notifying authority assumes full responsibility for the competence of the bodies it notifies.
Article 19
Requirements relating to notifying authorities
1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.
2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.
4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis.
5. A notifying authority shall safeguard the confidentiality of the information it obtains.
6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
§ 99 Requirements relating to notifying authorities
Each Member State must establish its notifying authorities in such a way that there is no conflict of interest with conformity assessment bodies. They must be organised and operated so as to safeguard the objectivity and impartiality of their activities. Each decision relating to notification of a conformity assessment body must be taken by competent persons different from those who carried out the assessment.
Further requirements on a notifying authority are that it must not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis. It must safeguard the confidentiality of the information it obtains, and it must have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
Article 20
Information obligation on notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.
The Commission shall make that information publicly available.
§ 100 Information obligation on notifying authorities
Member States must inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies. The Commission makes that information publicly available on its website.
Article 21
Requirements relating to notified bodies
1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.
2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.
3. A conformity assessment body shall be a third-party body independent of the organisation or the product it assesses.
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.
4. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
5. Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.
6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes III to VII and Annex IX and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;
(c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.
7. The personnel responsible for carrying out conformity assessment tasks shall have the following:
(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
(c) appropriate knowledge and understanding of the essential health and safety requirements set out in Annex II, of the applicable harmonised standards, of the relevant provisions of Union harmonisation legislation and of national legislation;
(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
8. The impartiality of the conformity assessment bodies, their top level management, and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.
The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.
10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III to VII and Annex IX or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.
11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under the relevant Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
§ 101 Requirements relating to notified bodies
Article 21 of the ATEX Directive 2014/34/EU defines the criteria that notified bodies must fulfil. Bodies which are able to provide proof of their conformity with such criteria by presenting to their notifying authorities a certificate of accreditation and evidence that all additional requirements have been met, or other means of documentary proof, are considered notifiable and in this respect they conform to Article 21 of the Directive.
Notified bodies are designated to assess conformity with the essential health and safety requirements of the Directive, and to ensure consistent technical application of these requirements according to the relevant procedures in the Directive. The notified bodies must have appropriate facilities and technical staff that enable them to carry out technical and administrative tasks related to conformity assessment. They must also apply appropriate procedures of quality control in relation to such services provided. Manufacturers are free to choose any notified body that has been designated to carry out the conformity assessment procedure in question according to the Directive.
A notified body wishing to offer services according to several conformity assessment procedures must fulfil the relevant requirements for the respective tasks, and this has to be assessed according to the requirements for each different procedure in question. However, a notified body does not need to be qualified to cover all products falling within the scope of the Directive, but may be notified for a defined range of products only.
Notified bodies must have appropriate structures and procedures to ensure that the conduct of conformity assessment and the issuing of certificates are subject to a review process. Relevant procedures must, in particular, cover obligations and responsibilities in relation to suspension and withdrawal of certificates, requests addressed to the manufacturer to take corrective measures, and reporting to the competent authority.
Article 22
Presumption of conformity of notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 21 in so far as the applicable harmonised standards cover those requirements.
§ 102 Presumption of conformity of notified bodies
Relevant European harmonised standards provide useful and appropriate mechanisms towards presumption of conformity of notified bodies to the criteria set out in Article 21 of the Directive. However, this does not rule out the possibility that bodies not conforming to the harmonised standards may be notified, on the grounds that compliance is obligatory only with respect to the criteria set out in Article 21 to the Directive.
Article 23
Subsidiaries of and subcontracting by notified bodies
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 21 and shall inform the notifying authority accordingly.
2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.
4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III to VII and Annex IX.
§ 103 Subsidiaries of and subcontracting by notified bodies
In order to comply with the provisions of Article 23 of the ATEX Directive 2014/34/EU, notified bodies are to keep a register of any subcontracting or subsidiarity to allow effective monitoring by the responsible Member State in order to ensure activities are being conducted properly. The register is to be updated systematically. The register contains information about the name and location of the subcontractor or the subsidiary, the nature and scope of work undertaken, the results of regular evaluations of the subcontractor, or the subsidiary including evidence that details of tasks are monitored as well as evidence that the subcontractor or the subsidiary is competent and maintains competence for the tasks specified and evidence that a direct private law contract exists.
A notified body may engage experts in support of its assessment activities but the experts’ activities are to be controlled as if the expert were directly employed by the notified body under the same contractual obligations and operate within the notified body's own quality system.
The European ATEX Notified Bodies Group (ExNBG) (see section § 117) has concurred that further (serial) sub-contracting by any sub-contractor is strictly prohibited.
Although assessment can be sub-contracted including assessment against the relevant essential health and safety requirements, the notified body remains entirely responsible for the whole operation and shall safeguard impartiality and operational integrity.
Procedures for reviewing and accepting the work of any subcontractor or subsidiary will ensure that the subcontractor or the subsidiary has not offered or provided consultancy or advice to the manufacturer, supplier, authorised representative or their commercial competitor with respect to the design, construction, marketing or maintenance of the products which are the subject of the subcontracted task.
Article 24
Application for notification
1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.
2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 21.
3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 21.
Article 25
Notification procedure
1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 21.
2. They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.
3. The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and the product or products concerned and the relevant attestation of competence.
4. Where a notification is not based on an accreditation certificate as referred to in Article 24(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 21.
5. The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification where an accreditation certificate is used or within two months of a notification where accreditation is not used.
Only such a body shall be considered a notified body for the purposes of this Directive.
6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.
§ 104 Application for notification and notification procedure
The New Legislative Framework from Decision No 768/2008/EC established detailed requirements for notified bodies and national authorities concerning, on one hand, the application for notification and the notification procedure.
See also § 5.3. “Notification” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 26
Identification numbers and lists of notified bodies
1. The Commission shall assign an identification number to a notified body.
It shall assign a single such number even where the body is notified under several Union acts.
2. The Commission shall make publicly available the list of the bodies notified under this Directive, including the identification numbers that have been assigned to them and the activities for which they have been notified.
The Commission shall ensure that the list is kept up to date.
§ 105 Identification numbers and lists of notified bodies. The NANDO database
When a body is notified for the first time under Union harmonisation legislation, the Commission assign to it an identification number, in the format "NB xxxx" (4-digits correlative number).
For information purposes, the lists of notified bodies are made publicly available by the Commission on a specific database on its EUROPA server, called NANDO (“New Approach Notified and Designated Organisations” information system), available on http://ec.europa.eu/enterprise/newapproach/nando/.
The lists are updated as and when the notifications are published, and the website is refreshed daily to keep it up-to-date.
See also § 5.3.3. “Publication by the Commission - the NANDO web site” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 27
Changes to notifications
1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 21, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.
2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
§ 106 Changes to notification
In case of changes to notifications, the relevant national authority must substantially follow the same procedure for notification with regard to information to the Commission and the other EU Member States, in order to keep duly updated the list of notified bodies.
See also § 5.3.4. “Suspension - withdrawal - appeal” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 28
Challenge of the competence of notified bodies
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.
2. The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.
3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary.
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 39(2).
§ 107 Challenge of the competence of notified bodies
The New Legislative Framework as in Decision No 768/2008/EC establishes the possibility to raise objections concerning a notified body, its competence and its activities. In such cases, the Commission has to carry out an investigation and, when the results demonstrate that a notified body does not meet or no longer meets the requirements for its notification, the Commission will adopt an implementing act (as an "Implementing Commission Decision") requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary.
Article 29
Operational obligations of notified bodies
1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII and Annex IX.
2. Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the product with the requirements of this Directive.
3. Where a notified body finds that the essential health and safety requirements set out in Annex II or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity.
4. Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.
5. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate.
§ 108 Operational obligations of notified bodies
The operational obligations of notified bodies when performing their activities are listed in detail in the New Legislative Framework as from Decision No 768/2008/EC.
§ 109 Documents issued by the notified body
A body notified under Directive 2014/34/EU issues the following documents according to the provisions of the relevant conformity assessment procedures:
- EU-type examination certificate.
- Product and production quality assurance notification.
- Conformity to type notification.
- Product verification, certificate of conformity.
- Unit verification, certificate of conformity.
These documents need not accompany the product.
It is not possible to issue an EU-type examination certificate for products of category 2 non-electrical equipment and of category 3, as mentioned in Article 13(1)(b)(ii) and 13(1)(c). Further, it is also not permissible to list such goods on an EU-type examination certificate issued for goods of categories other than these. This is because an EU-type examination certificate is an attestation that the goods listed on it have undergone the necessary conformity assessment procedures that result in the issuing of an EU-type examination certificate; it is not necessary for such goods to undergo such conformity assessment procedures.
Where a single item is covered by more than one category, it may be permissible to issue an EU-type examination certificate. Under such circumstances, these items need to comply with the highest applicable conformity assessment requirements. If this requirement results in an EU-type examination certificate being issued, these goods are permitted to be listed on an EU-type examination certificate.
A typical example of this is found in the semiconductor fabrication industry where a high vacuum pump is used to extract hydrogen but cannot meet the physical clearances necessary to justify category 2. Category 3 is adequate for the process as the pump is normally filled with pure hydrogen at low pressure, so there is no ignition risk except during the very brief transitions between operation and non-operation.
In this case, it is only the electrical part that is truly subject to EU-type examination but it is already established that a mechanical part can be considered along with the electrical part if they are integral with each other, rather than a mere assembly.
In such cases, it is not unreasonable to mention such items in the same set of documentation i.e. the goods have an EU-type examination certificate issued for them.
However, where the goods are discrete items e.g. two different type categories of a hand-held radio, one of which is category 2 and the other category 3, a single EU-type examination certificate should never be issued; the category 3 goods should be listed on a separate document that in no way implied it was an EU-type examination certificate. The same should be true for components of items.
However, the voluntary issue of a certificate for goods that are not permitted to be listed on an EU-type examination certificate is possible. The certification body may not give an indication on the certificate that it is a notified body because it would not be acting in that capacity. Therefore, the number of the notified body must not be affixed. Further, it is not permissible to affix the CE marking to such certificates.
§ 110 Provision of evaluation and test results with EU-type examination certificates
Although being a separate document, the report describing how the equipment fulfils the essential health and safety requirements of the Directive is considered to be integral to the provision of a certificate. Evaluation and test results supporting the decision to issue an EU-type examination certificate should accompany the certificate from the notified body to the manufacturer.
§ 111 Acceptance of test results of manufacturers by a notified body
Test reports can be a part of the technical documentation the manufacturer has to present to the notified body and the latter may take them into consideration appropriately.
Concerning safety relevant aspects in connection with Annex III (EU-type examination) and Annexes V (Product verification) and IX (Unit verification) to Directive 2014/34/EU, a notified body's independent and transparent intervention vis-à-vis the client and all interested parties (e.g. Member States, European Commission, manufacturers, other notified bodies) is required legally. Therefore a notified body only may accept test reports of manufacturers under certain conditions. The requirements included in the standard EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025) shall be used as basis for acceptance of test results.
The notified body has to state the acceptance of test results in his test report. In any case the notified body remains fully responsible for accepted test results and for the EU-type examination certificate (Annex III) or the certificate of conformity (Annexes V and IX) based on them.
§ 112 Minimum content of a European standardised ATEX test and assessment report
The term "test report" is used in a twofold way. In fact certification in scope of the Directive 2014/34/EU is based on three levels of reports:
- test in a laboratory, for example the measurement of a temperature, called "test report";
- assessment to the requirements of harmonised standards, called "assessment report";
- assessment to the essential health and safety requirements of the Directive, called "assessment report", too.
Having the possibility for very different types of test reports to be issued, varying from very poor reports, hardly including any information, to test reports with detailed test and evaluation results, a standardised ATEX assessment report format enables and ensures the following goals:
- Recognizable as an ATEX assessment report.
- Specified minimum content.
- Meeting the requirements for test reports as laid down in EN ISO/IEC 17025 and other applicable standards.
- Easy to use/integrate with existing formats currently used by all ATEX notified bodies.
- An ATEX assessment report is only issued if all applicable requirements are met and if all tests have been conducted with positive results (but still allowing waiving tests provided that the reasoning is given in the test report).
a) Recognizable as ATEX assessment report
The ATEX assessment report should be easy to identify as such by manufacturers, Ex notified/certification bodies and any other party as a genuine ATEX assessment report. To realise this, an identical approach could be followed as for the content and format of ATEX Annex III EU-type examination certificates; laid down in ExNB Clarification Sheet No. ExNB/09/340. Another possibility is to just require the use of the wording "ATEX assessment report" (exact wording to be agreed upon) on the cover page of the report; without the need for a standardized template for the ATEX assessment report as has been done for Annex III certificates.
b) Specified minimum content
The report shall contain a minimum amount of information that enables manufacturers to easily obtain other local/regional approvals/certificates based on the information in the report and any associated test documentation. An assessment report issued by an ATEX notified body that supports the issue of an EU-type examination shall contain:
- General information about the product, type designation, applicant, manufacturer, types of protection, technical data.
- Technical evaluation of the construction of the equipment. For most types of protection this can be a checklist (Yes / No / Not applicable + remarks) combined with the test documentation that specifies the construction; for intrinsic safety however a descriptive format is usually the best (if not the only) useable format. A detailed assessment narrative that confirms compliance with the standards used to support compliance with the ATEX Directive. If no standards are used, then the assessment narrative shall confirm compliance with the Directive. Since explosion safety standards are concept standards occasionally some interpretation is involved: the report should make clear how the assessment has been carried out.
- Results of tests:
- details of tests carried out, relevant information about the test conditions, method and results shall be provided as part of the test report;
- details of tests that have been waived and the justification for waiving those tests (the standard EN 60079-0 calls for a justification for waiving tests) shall be part of the assessment report;
- details of tests that have been accepted from other organisations, test laboratories, etc. and a justification for accepting those tests shall be part of the assessment report. If tests are being accepted from other sources, then this should be clear, because the body that produces that data should be scrutinised. It could easily be disguised that test data from unsuitable sources had been used.
- Routine tests, if any: applicable to the product and agreed upon between the manufacturer and the notified body (applicable standards are EN 80079-34 Explosive atmospheres - Part 34: Application of quality systems for equipment manufacture (ISO/IEC 80079-34), too).
c) Requirements for reporting
An ATEX test report shall meet all requirements for the content of test reports as specified in EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025). In practice, this should not be any problem for a notified body since all of them conduct and report testing according to EN ISO/IEC 17025.
An ATEX assessment report shall meet all requirements as specified in EN ISO/IEC 17065 Conformity assessment - Requirements for bodies certifying products, processes and services (ISO/IEC 17065).
d) Easy to use and integrate by notified bodies
It should be easy to integrate the European standardized ATEX assessment report in the operational procedures and documents used by a notified body. This requires that the format itself should not be 100% specified in detail, but only to the extent that all parties involved – issuing and receiving notified bodies and manufacturers – know what to find in the test report. So the focus is on the content of the report, not its layout, numbering, etc. This should make it easy to implement the ATEX assessment report in the existing way of working of all individual notified bodies. It should not cause a significant increase (if any) in the costs for the manufacturer to obtain an ATEX certificate.
e) Full report
To avoid any confusion about the expected content of an ATEX assessment report, such a report should only be issued when the product involved meets all applicable requirements and has passed all applicable tests with positive results. An ATEX Assessment Report shall not be issued in case of any negative results or in case that only a part of the applicable requirements (for example IP54 requirements) have been evaluated or tested. This does not preclude the issuance of an ATEX assessment report for an Ex component, certified under a "U" certificate.
If a report with negative results or not fully assessed applicable requirements is given to the manufacturer is must be unambiguous that this is not an ATEX assessment report.
§ 113 Retention of technical documentation
Under Article 13(1)(b)(ii) of the ATEX Directive 2014/34/EU the manufacturer is required to undertake the conformity procedure at Annex VIII and then to carry out the communication of the technical documentation provided for in Annex VIII, point 2, to a notified body, which shall acknowledge receipt of it as soon as possible and shall retain it.
Bodies notified for this procedure should be so according to Article 13(1)(b)(ii) and not to Annex VIII as this latter procedure does not involve a notified body.
The referred technical documentation is not returned to the manufacturer on request (but may be added to), and in general it is retained for a period of 10 (ten) years following the last placing of the product onto the market. The intention is that market surveillance authorities in the different Member States should be given access to this dossier, in cases where there is a need to investigate the design or manufacturing details of a particular product.
With respect to the media used, it is accepted that this technical documentation may be in electronic format so long as it is legible and "readable" over the period concerned.
Article 30
Appeal against decisions of notified bodies
Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.
§ 114 Appeal against decisions of notified bodies
Decisions taken by notified bodies – in particular concerning issuing or refusing of certificates – must be appealable by manufacturers or any other interested party, through appropriate legal procedures set out by the Member States. This should take into consideration the specific private/civil legal framework in which contractual agreements are stipulated between notified bodies and their customers (manufacturers or their authorised representatives).
Article 31
Information obligation on notified bodies
1. Notified bodies shall inform the notifying authority of the following:
(a) any refusal, restriction, suspension or withdrawal of a certificate;
(b) any circumstances affecting the scope of or conditions for notification;
(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
2. Notified bodies shall provide the other bodies notified under this Directive carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.
§ 115 Information obligation on notified bodies
Notified bodies have specific information obligations with regard to their activities, to be provided to the notifying authorities by default or on their request.
Also a notified body which gets knowledge of faulty products, but is neither engaged in the module for EU-type examination nor in a module for surveillance of the manufacturer, should take some action.
If there is no immediate danger, if after contact with the responsible notified body for EU-type examination and with the notified body responsible for surveillance of the production of the faulty product no satisfactory solution after appropriate time is reached, the notified body should inform its own authorities in charge of market surveillance to initiate the adequate measures.
In the case of immediate danger, the notified body should inform its own authority in charge of market surveillance, the notified body for EU-type examination and the notified body for surveillance of the production without delay.
Article 32
Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
§ 116 Exchange of experience
This kind of activity is usually carried out in the framework of the activities of horizontal/inter-sectoral working parties organized by the Commission with Member States representatives, such as the Internal Market for Products - Market Surveillance Group (IMP-MSG) and the Senior Officials Group on Standardisation and Conformity Assessment Policy - Market Surveillance (SOGS-MSG), as well as within the sectoral Administrative Co-operation Group (ATEX AdCo).
In particular, the ATEX AdCo Group is integrated by representatives of the national authorities of the EU Member States in charge of market surveillance activities. They usually meet twice a year to inform about, discuss and interchange experiences and practices, and to make proposals to be submitted to the working parties under the ATEX Directive 2014/34/EU. Communications take place also through a specific Interest Group on the CIRCABC system.
All these activities receive specific support by the Commission.
Article 33
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Directive are put in place and properly operated in the form of a sectoral group of notified bodies.
Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.
§ 117 Coordination of notified bodies. The European ATEX Notified Bodies Group (ExNBG)
All notified bodies are required to participate in appropriate co-ordination activities. Under the ATEX Directive 2014/34/EU (and already established and active under the previous Directive 94/9/EC) there is the European ATEX Notified Bodies Group (ExNBG).
The ExNBG is run by notified bodies in accordance with Article 33 of the ATEX Directive 2014/34/EU and section § 5.2.4 of “The ‘Blue Guide’ on the implementation of EU product rules” in order to assist in achieving a uniform application of the Directive. While it is independent of the ATEX Committee and Working Group, it nonetheless needs to work closely with those bodies and with the European Commission services, all of which have a responsibility for the effective and uniform application of the Directive.
The ExNBG plays an important role as coordinator of notified bodies, as well as technical reference and feedback to the standardisers. The group normally meets annually and is made up of representatives of notified bodies with observers from the Commission, manufacturers and users' trade associations, standards-making bodies and other invitees. Attendance at each meeting is by invitation and any party wishing to be considered should contact the Chairperson of the group either through the Commission or via a notified body of your country.
The group is responsible for discussing issues of a technical nature to ensure that the technical provisions of the Directive and harmonised standards are applied in a uniform way. The group issues specific guidance documents called "Clarification Sheets" where ambiguities exist in technical procedures and also issues technical guidance documents where less detailed specifications require amplification.
Communication between ATEX notified bodies is also ensured by a specific Interest Group on the CIRCABC information system: the “ATEX Group of Notified Bodies” on https://circabc.europa.eu/w/browse/33b0bed8-1c65-4d9e-b857-1f34d2d91c04. It is required that all the notified bodies listed on NANDO must have at least one representative member of the Interest Group on CIRCABC.
§ 118 Status and use of ExNBG Clarification Sheets issued by the European ATEX Notified Bodies Group
ExNBG Clarification Sheets are not legally binding but are references agreed by the European ATEX Notified Bodies Group (ExNBG) in order to minimise divergent interpretation by notified bodies of the technical requirements of the ATEX Directive.
ExNBG Clarification Sheets are intended to be applied by each notified body, as they are required to keep "the highest degree of technical competence", by following the technical progress or the "state of the art" and participating in coordination. For other interested parties, ExNBG Clarification Sheets should be considered as voluntary guidance to the practical application of the Directive, as an "expert opinion" related to the technical progress or the "state of the art", coming from qualified representatives of notified bodies. In other words, ExNBG Clarification Sheets could be regarded as useful practical recommendations, at the same level of "Recommendation for Use Sheets" issued by European co-ordinations of notified bodies under other harmonisation legislation such as such as Machinery, Lifts, Personal Protective Equipment, etc.
In any case, the use of ExNBG Clarification Sheets cannot be considered a proof concerning health and safety requirements of the ATEX Directive 2014/34/EU. European harmonised standards give presumption of conformity with the essential requirements of the directive, but not ExNBG Clarification Sheets.
ExNBG Clarification Sheets can be endorsed or "noted" by the ATEX Committee or Working Group as guidance documents, by recognising their importance and utility in order to provide expert interpretation guidance, not only to notified bodies, but also to manufacturers and other interested parties. The "noting" process is carried out by the ATEX Working Group though a "Written Procedure" via the relevant Interest Group on CIRCABC or, at request of Committee Members (by introducing comments, remarks etc.), by using an "Oral Procedure" at the Working Group meetings.
"Noted" ExNBG Clarification Sheets, as such, are made publicly available on the Commission website on
http://ec.europa.eu/DocsRoom/documents/9568/attachments/1/translations/en/renditions/native.
Those Clarification Sheets which are not noted by the ATEX Committee but needed for the work of ExNBG are also available in the internet but in an external private website, for information purpose only:
http://www.vdtuev.de/themen/industrie_und_anlagensicherheit/brand_und_exschutz/clarification-sheets-of-exnb.
The content of specific ExNBG Clarification Sheets could be proposed to draft a "Consideration Paper" by the ATEX Committee and/or to be included into the ATEX Guidelines. In this case, the ExNBG withdraws the relevant Clarification Sheets.
It is important to remark that, in any case, "noting" by the ATEX Committee or Working Group is not necessary for an ExNBG Clarification Sheet to be used by the notified bodies, according to its purpose and scope, and taking into due account the above considerations.
CHAPTER 5
UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
§ 119 EU market surveillance, control of products entering the EU market and EU safeguard procedure
Chapter 5 of the ATEX Directive 2014/34/EU deals with EU market surveillance, control of products entering the EU market and the EU safeguard procedure.
See also § 7. “Market surveillance” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 34
Union market surveillance and control of products entering the Union market
Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to products covered by Article 1 of this Directive.
§ 120 EU market surveillance and control of products entering the Union market
The referred articles of the Regulation, setting out requirements for accreditation and market surveillance relating to the marketing of products, are included into Chapter III: "Community [read 'Union'] market surveillance framework and controls of products entering the Community market”. Regarding the ATEX Directive 2014/34/EU, they apply to the products falling into its scope: equipment and protective systems; safety devices, controlling devices and regulating devices; and components.
See also § 7.3.3. “Control of products from third countries by custom: national organisation and coordination” in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 35
Procedure for dealing with products presenting a risk at national level
1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a product presents a risk to the health or safety of persons or to domestic animals or property, they shall carry out an evaluation in relation to the product concerned covering all relevant requirements laid down in this Directive. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the product does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements, to withdraw the product from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union.
4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the products being made available on their national market, to withdraw the product from that market or to recall it.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
5. The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following:
(a) failure of the product to meet requirements relating to the health or safety of persons or to the protection of domestic animals or property; or
(b) shortcomings in the harmonised standards referred to in Article 12 conferring a presumption of conformity.
6. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the adopted national measure, of their objections.
7. Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the product from the market, are taken in respect of the product concerned without delay.
§ 121 Procedure for dealing with products presenting a risk at national level
When a product presents a risk a national level, a detailed procedure is set up for the relevant Member State authorities in charge of market surveillance on their territory, with specific obligations for the concerned economic operators.
See also §§ 7.3.5. “Market surveillance procedures (including safeguard mechanisms), 7.3.6. "Corrective measures - Bans - Withdrawals-recalls" and 7.3.7. "Sanctions" in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 36
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 35(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not.
The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator or operators.
2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant product is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.
3. Where the national measure is considered justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 35(5) of this Directive, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
§ 122 EU safeguard procedure
The safeguard clause referred to in Article 36 of the Directive 2014/34/EU is the EU procedure whereby any measure taken by a Member State, on the grounds of non-compliance with the essential health and safety requirements and where it is deemed that equipment is liable to endanger persons, animals or property for the purpose of withdrawing from the market, prohibiting the placing on the market or restricting the free movement of equipment accompanied by one of the means of attestation provided for in the Directive and therefore bearing the CE marking, must be immediately notified to the Commission by the Member State which has taken it.
In considering whether the safeguard clause should be triggered, Member States and the respective enforcement authorities will need to consider whether the non-compliance is substantial or can be considered a non-substantial non-compliance to be resolved without recourse to the procedures enabled via the safeguard mechanism.
For example, a non-substantial non-compliance could consist of illegibility of the CE marking. In such cases, the Member State could issue a compliance notice to the manufacturer or authorised representative or take other actions allowed by national legislation to encourage the responsible person(s) to take appropriate corrective action.
Member States will need to consider in each case whether the non-compliance is liable to endanger persons, animals or property and if the safeguard clause is the most effective means of ensuring the safety of persons, animals or property, which remains paramount under this section of the Directive.
Where objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission must carry out a process of consultation with the parties concerned, it is to say, the Member States, the manufacturer or his authorised representative established within the EU or, failing them, the person who placed the product on the EU market.
The consultation procedure enables the Commission to assess whether the restrictive measure is justified or not, on the basis of the information provided by the notifying authorities, as well as the positions of all the parties concerned, in particular regarding the reasons why the essential health and safety requirements laid down in the Directive have not been complied with by the product concerned.
Where the Commission finds, following such consultation, that the measures are justified, it informs all the parties concerned. All the Member States must take appropriate measures to ensure that the non-compliant product is withdrawn from their market. On the contrary, if the national measure is considered unjustified, the Member State concerned must withdraw that measure and immediately take the appropriate action to re-establish the free movement of the products in question on its territory.
See also § 7.4. “Safeguard mechanisms for Member States" in “The ‘Blue Guide’ on the implementation of EU product rules”.
Article 37
Compliant products which present a risk
1. Where, having carried out an evaluation under Article 35(1), a Member State finds that although a product is in compliance with this Directive, it presents a risk to the health or safety of persons or to domestic animals or property, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw the product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.
2. The economic operator shall ensure that corrective action is taken in respect of all the products concerned that he has made available on the market throughout the Union.
3. The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide by means of implementing acts whether the national measure is justified or not, and where necessary, propose appropriate measures.
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 39(3).
On duly justified imperative grounds of urgency relating to the protection of health and safety of persons or to the protection of domestic animals or property, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 39(4).
5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
§ 123 Compliant products which present a risk
A specific procedure is provided for products compliant with the requirements of the Directive but nevertheless they present a health and safety risk. The relevant national authority has to take appropriate action, involving the concerned economic operators, and must inform the Commission and the other Member States. The Commission has to duly analyse the case and issue an implementing decision on whether the national measure adopted is justified or not.
Article 38
Formal non-compliance
1. Without prejudice to Article 35, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 16 of this Directive;
(b) the CE marking, where required, has not been affixed;
(c) 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 II or have not been affixed;
(d) the identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of Article 16 or has not been affixed;
(e) the EU declaration of conformity or the attestation of conformity, as appropriate, does not accompany the product;
(f) the EU declaration of conformity or, where required, the attestation of conformity has not been drawn up correctly;
(g) technical documentation is either not available or not complete;
(h) the information referred to in Article 6(7) or Article 8(3) is absent, false or incomplete;
(i) any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.
2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market.
§ 124 Formal non-compliance
Non-compliance of a product is considered as formal when it is not directly related to a health and safety risk, but it could be an indicator of possible risks.
The cases listed in Article 38(1) include defects in markings, documents and other information to be provided with the product.
CHAPTER 6
COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS
§ 125 Committee, transitional and final provisions
Chapter 6 of the ATEX Directive 2014/34/EU includes the provisions on the ATEX Committee, the enforcement measures by Member States (penalties) and the transitional and final provisions.
Article 39
Committee procedure
1. The Commission shall be assisted by the Committee on equipment and protective systems intended for use in potentially explosive atmospheres. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
5. The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by any other Union legislation.
The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
§ 126 The ATEX Committee
As indicated in Recitals 45, 46 and 47, the ATEX Committee has a specific role in examining different questions related to the implementation, application and management of the Directive.
Regulation (EU) No 182/2011 (the "Comitology Regulation") establishes the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers. In its Article 3 "Common provisions" it defines the role and composition of committees; when Article 4 deals with the "Advisory procedure" and Article 5 with the "Examination procedure", also in conjunction with Article 8 on "Immediately applicable implementing acts".
Reference to Regulation (EU) No 1025/2012 on European standardisation recalls consultation of sectoral experts on matters regarding requests for European standards or objections to harmonised standards.
The ATEX Committee sets up its own rules of procedure and it is chaired by the Commission and integrated by the representatives of EU Member States. The ATEX Committee creates the ATEX Working Group enlarged to other EU-wide interested parties, such as standards makers, notified bodies, industry, trade unions, consumers etc.
Article 40
Penalties
Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. Such rules may include criminal penalties for serious infringements.
The penalties provided for shall be effective, proportionate and dissuasive.
§ 127 Enforcement: penalties
As indicated in Recital 48, national authorities of EU Member States in charge of enforcement of the provisions of the ATEX Directive 2014/34/EU (the market surveillance authorities) must be able to impose appropriate penalties if those provisions are not correctly applied. Such penalties must be foreseen by the national legislative acts transposing the provisions of the Directive into national law.
Article 41
Transitional provisions
1. Member States shall not impede the making available on the market or the putting into service of products covered by Directive 94/9/EC which are in conformity with that Directive and which were placed on the market before 20 April 2016.
2. Certificates issued under Directive 94/9/EC shall be valid under this Directive.
§ 128 Transitional provisions
Products placed on the market before the date of applicability of Directive 2014/34/EU, in conformity with the applicable Directive 94/9/EC, can continue circulating on the EU market.
Regarding certificates issued under Directive 94/9/EC before 20 April 2016, they remain valid under the ATEX Directive 2014/34/EU. Therefore the manufacturer must inform the notified body that holds the technical documentation relating to the EC-type examination certificates validly issued under Directive 94/9/EC of all modifications to the approved type that may affect the conformity of the product with the essential health and safety requirements of this Directive or the conditions for validity of that certificate. Such modifications could require an additional approval in the form of a new EU-type examination certificate to be issued under Directive 2014/34/EU.
More detailed information on horizontal and vertical transitional issues can be found in the "Commission's guidance document on the ATEX transition", available on the ATEX website http:// .
Article 42
Transposition
1. Member States shall adopt and publish by 19 April 2016 the laws, regulations and administrative provisions necessary to comply with Article 1, points 2 and 8 to 26 of Article 2, Article 3, Articles 5 to 41 and Annexes III to X. They shall forthwith communicate the text of those measures to the Commission.
They shall apply those measures from 20 April 2016.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
§ 129 Transposition
The legal acts to be adopted and published by 19 April 2016 (the day before the applicability of the ATEX Directive 2014/34/EU) transposing the Directive into the national legislation of each EU Member State must comply with the following provisions:
- definitions of “protective systems”, “equipment category”, “intended use”, “making available on the market”, “placing on the market”, “manufacturer”, “authorised representative”, “importer”, “distributor”, “economic operators”, “technical specification”, “harmonised standard”, “accreditation”, “national accreditation body”, “conformity assessment”, “conformity assessment body”, “recall”, “withdrawal”, “Union harmonisation legislation”, “CE marking” (Article 2, points (2) and (8) to (26)),
- “making available on the market and putting into service” (Article 3),
- “free movement”, “obligations of economic operators”, “conformity of the product”, “notification of conformity assessment bodies”, “union market surveillance, control of products entering the Union market and Union safeguard procedure”, “committee procedure”, “penalties”, “transitional provisions” (Articles 5 to 41),
- conformity assessment procedures (Annexes III to IX), and
- model for EU declaration of conformity (Annex X),
The texts of those legal measures (as laws, regulations, administrative provisions etc.) must be communicated to the Commission.
Article 43
Repeal
Directive 94/9/EC, as amended by the Regulations listed in Annex XI, Part A, is repealed with effect from 20 April 2016, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and the dates of application of the Directive set out in Annex XI, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex XII.
§ 130 Repeal
The new ATEX Directive 2014/34/EU repeals the previous Directive 94/9/EC on 20 April 2016. Taking into consideration that the new act is the result of the alignment and recast of the previous one, references to Directive 94/9/EC remaining after the repeal date have to be considered as references to the new Directive 2014/34/EU, according to the correlation table in Annex XII.
Article 44
Entry into force and application
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Points 1 and 3 to 7 of Article 2, Article 4 and Annexes I, II, XI and XII shall apply from 20 April 2016.
§ 131 Entry into force and application
As the ATEX Directive 2014/34/EU was published in the Official Journal of the European Union (OJEU) on 29 March 2014, it entered into force on 18 April 2014. This concern in particular the provisions indicated in Article 42(1) as the object of transposition of the Directive by the EU Member States to their national legislation (see section § 129).
On the contrary, the provisions related to:
- definitions of “equipment”, “components”, “explosive atmosphere”, “potentially explosive atmosphere”, “equipment-group I” and “equipment-group II” (Article 2, points (1) and (3) to (7)),
- “essential health and safety requirements” (Article 4),
- “criteria determining the classification of equipment-groups into categories” (Annex I),
- “essential health and safety requirements relating to the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres” (Annex II), and
- “repealed Directive” and “correlation table” (Annexes XI and XII),
even if they are in force since 18 April 2014, too, they are applicable from 20 April 2016 (2 years after the entry into force of the Directive).
This means that the ATEX Directive 2014/34/EU can be used to place products on the EU market with the relevant conformity assessment procedures etc. only from 20 April 2016. Before that date, the previous Directive 94/9/EC still applies.
Article 45
Addressees
This Directive is addressed to the Member States.
Done at Strasbourg, 26 February 2014.
For the European Parliament For the Council
The President The President
M. SCHULZ D. KOURKOULAS
§ 132 Addresses and signatories of the Directive
The Directive is addressed to the Member States, since the transposition of the provisions of the Directive into national law is necessary in order to create binding legal obligations for the economic operators.
The Directive is signed by the Presidents of the European Parliament and of the Council at the date, since it was adopted by these EU Institution according to the ordinary legislative procedure (formerly known as “co-decision”) set out in Article 294 of the TFEU (see also section § 2 on the legal basis of the ATEX Directive).
[1]
Directive 2014/34/EU does not define atmospheric conditions. However, a surrounding temperature range of –20 °C to 60 °C and a range of pressure between 0.8 bar and 1.1 bar may be appropriate as a basis for design and intended use of products. This does not preclude that products may be specifically designed and assessed for operation occasionally outside these conditions. It should be noted that electrical products are normally designed and tested for use in the ambient temperature range –20 °C to 40 °C in conformity with the harmonised standards. Products designed for use outside of this range will require additional marking to be added and further testing as appropriate. This will normally require agreement between the manufacturer and the intended user.
[2]
Examples for such atmospheres could be: mixtures which are explosive without air (e.g. H2 mixed with Cl2), mixtures of flammable substances with other oxidants than air, pressure and/or temperature conditions outside the atmospheric range, etc.
[3]
See Annex III to the Directive.
[4]
See Annex IV to the Directive.
[5]
See Annex V to the Directive.
[6]
See Annex IX to the Directive.
[7]
See Annex VI to the Directive.
[8]
See Annex VII to the Directive.
[9]
See Annex VIII to the Directive.
[10]
See paragraph 2 of Annex VIII.
[11]
Conditions of communication and of retention/storage of documents shall be agreed between the notified body and its client.
[1]
The application of the ATEX Directive to "as-new equipment" is without any prejudice to intellectual property legislation. See Directive 89/104/EEC relating to the marks and the decision of the European Court of Justice of 11 July 1996, C427/93, 429/93, 436/93 Bristol Meyer Squibb.
[2]
See Directive 89/104/EEC relating to the marks and the decision of the European Court of Justice of 11 July 1996 in joined cases C-427/93 and C-436/93 Bristol Meyer Squibb.
[3]
Both terms, reconditioned/refurbished, as well as reconditioning/refurbishment are used interchangeably in this section.
[4]
This can involve a modification of the electrostatic characteristics. The use of different materials or different external dimensions of the product might adversely change its ATEX performances. For example, a plastic enclosure may provide much lower electrostatic protection than a metallic enclosure.
[5]
EN 1127-1:2011 Explosive atmospheres - Explosion prevention and protection - Part 1: Basic concepts and methodology
[6]
Equipment here is taken to mean all products within scope of Directive 2014/34/EU.
[7]
The category classification is performed by the person responsible for making the EU declaration of conformity according to Directive 2014/34/EU.
[8]
"Zoning" is not a concept to be found in Directive 2014/34/EU but in Directive 1999/92/EC dealing with employer's obligations with respect to employees operating in hazardous atmospheres. It is not the responsibility of the manufacturer to "zone" but evidently this it is helpful to give an example of the area of intended use.
[9]
Additional measures to cover expected malfunctions may provide category 2; if two faults or one rare fault are dealt with, category 1 can be reached.
[10]
It is clear that for some milling technologies an ignition source may be unavoidable.
[11]
Council Directive of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC) (OJ L 399, 30.12.1989, p. 18).
[13]
Account needs to be taken of the specific exclusion at Article 1(2)(b) of the Directive 2014/34/EU of equipment where explosion hazards result exclusively from the presence of explosive substances or unstable chemical substances.
