CE Marking Directives
The CE Marking Authority delivers innovative and bespoke compliance solutions to meet your business needs. By helping you bring your equipment to the market and ensuring technical and regulatory documentation demonstrates compliance, our network of experts enables you to keep ahead of your competitors
We offer you flexible solutions for your business needs by supplying you with a test plan which can be conducted by you in-house, saving time and expense. Then we review the data or we can conduct the testing for you. Then finally, we supply you with a complete technical file that demonstrates compliance with the applicable legislation and the appropriate certification.
As part of the Compliance Management System, we monitor all the applicable regulations and standards and inform you when they are updated enabling you to manage your technical file effectively and giving you peace of mind.
Our services cover
ATEX Zone 2 or Zone 22 Electrical
ATEX Zone 1 & 2 or Zone 21 & 22 Mechanical
A potentially explosive atmosphere exists when a mixture of air gases, vapours, mists, or dust 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 on 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, ionizing radiation, hot surfaces, flames, and hot gases, mechanically generated sparks, optical radiation, chemical flame initiation, and 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, and 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 a 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 the 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.
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 that 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 Directive 2014/34/EU does not apply and the responsible person will have to ensure that any other relevant national or EU legislation is 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.
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 with 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 the 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 a 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 every 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 in 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.
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 EHSRs 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.