ATEX Directive

CE Marking Directives

ATEX Directive

A potentially explosive atmosphere exists when a mixture of air gases, vapours, mists, or dusts combine in a way that can ignite under certain operating conditions.

Equipment and protective systems intended for use in potentially explosive atmospheres (ATEX) cover a range of products, including those used on fixed offshore platforms, petrochemical plants, mines, and flour mills, amongst others.

The ATEX Directive 2014/34/EU covers equipment and protective systems intended for use in potentially explosive atmospheres. The directive defines the essential health and safety requirements and conformity assessment procedures, to be applied before products are placed on the EU market. It is aligned with the new legislative framework policy and became law from 20 April 2016, replacing the previous Directive 94/9/EC.

Need for a notified body?

Before proceeding with the conformity assessment procedure, it is important to determine whether you, the manufacturer under an internal control of production or EC Type Examination which involves a notified body. If unsure please feel free to contact the team.

The ATEX Directive applies to the following “products”:

(a) mechanical or electrical 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).

However, 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, compression.

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

Assemblies are an combination of parts previously considered separately, interconnected to create a combined product or assembly, to be placed on the market and/or put into service 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 is assured without any further conformity assessment provided the installer has correctly followed the instructions.

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.

Important Note;

With regard to explosion protection in a potentially explosive atmosphere, Directive 2014/34/EU takes precedence and has to be applied. So equipment that complies with ATEX, and which is also a machine can be assumed to comply with the specific essential safety requirements concerning ignition risk with respect to explosive atmospheres in the Machinery Directive. For other relevant risks concerning machines, the requirements of the Machinery Directive also have to be applied.

Products which are Used, Modified or Repaired, and Spare Parts

As a general rule, manufacturers need to consider whether the product is being placed onto the 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.

Used products that were on the market and used 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 and can still be used unless they are modified so that health and safety characteristics have been affected.

Check conformity

As a general rule, "New Approach" and New Legislative Framework legislation, 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 or regulations, which all provide for the affixing of CE marking, by affixing the CE marking the manufacturer indicates that the product conforms to the provisions of all these directives and regulations.

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.

A fundamental feature of the ATEX Directive, 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 harmonised standards although voluntary, if use confers presumption of conformity with the relevant essential health and safety requirements.

The manufacturer has sole and ultimate responsibility for the conformity of the product to the applicable Union legislation. The manufacturer 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. These documents, as well as the translations according to the language requirements in national legislation's transposing the Directive, need to be provided on paper, in a similar way as for safety information that also must accompany the product according to the ATEX Directive. While safety information needs to be provided in paper copy, the other non-safety instructions can be provided on electronic or other data storage format. However, a paper version should always be available upon request and free of charge for the market surveillance authorities and the end-users.

The determination by the Member State concerned of the "language which can be easily understood by end-users", as indicated in Article 6(8) for instructions and safety information, is related to the official languages used in the 28 EU Member States.

Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).

The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain at least the following elements: See Risk Assessments

Internal Production Control

Annex VIII to the ATEX Directive 2014/34/EU includes module A "Internal production control" (indicated as "Internal control of production" in the previous Directive 94/9/EC). In this conformity assessment procedure, the product and quality system assessment procedure is carried out by the manufacturer.

The technical file should comprise at least the following

• a general type-description
• conceptual design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.
• descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product
• The following assessments should be documented if applicable
o a design risk assessment, (ISO 12100:2010)
o ignition risk assessment (BS EN 1127:2019)
o Clause by Clause assessment of standards used (ISO 80079-36 & ISO 80079-37)
o If only parts of the harmonised standards or other international standards are used you must detail which EHSR's have been applied and how the other EHSR's have been addressed
• results of design calculations made, examinations carried out, etc.
• test reports

The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed on the market.

HOW WE CAN HELP:

Our customers contact us because they need help and advice on how to apply the UKCA or CE Mark to their products.

The CE Marking Authority have a positive attitude and approach regulatory compliance by looking at the opportunities rather than seeing them as an inconvenience and meddling with your practices. We specialise in staying ahead of the game by using our technical knowledge (skills) conducting the necessary assessments to help our clients demonstrate their technical files meet the requirements of the regulations

Our expert team is here to help you meet the UKCA and CE Marking the requirements

• Free initial consultation to assess your requirements and plan the CE marking of your product.
• Identify the statutory instruments, the essential safety requirements, and harmonised standards, which apply to the product.
• Perform design risk assessments and clause by clause assessments against the designated standards
• Conduct a product compliance report to the applicable requirements outlining areas of non-compliance and advice on how to close out any gaps found.
• Assist in the compilation of the technical construction file, which contains the information required by the EU safety regulations.
• Provide a draft EU Declaration of Conformity and help you complete it.
• Offer follow up advice on changes in requirements for the life cycle of the product
• Act as your Authorised Representative in the UK or EU via or European office if required.

The many benefits of compliance range from brand and reputation, revenue enhancement, asset protection, higher profitability and lower costs, improved workforce performance, the provision of better data for better-made business decisions, and allows for a total harmonisation of your systems