What is CE Marking?
A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
ATEX products are equipment and systems which are intended to be used in potentially explosive atmospheres.
You will find these products anywhere from factories to various petrochemical operations.
Until the publication of the ATEX Directive 2014/34/EU on February 26, 2014 and the subsequent 2 year transition period, the ATEX Directive 94/9/EC was the reigning legal framework for ATEX products. From April 20, 2016, the ATEX Directive 2014/34/EU became fully applicable in the EU as the main legal framework for ATEX products.
Any product placed and made available on the EU Market must comply with the ATEX Directive 2014/34/EU.
Non-EU manufacturers wishing to make their products available to EU citizens should appoint a European Authorized Representative. (A manufacturer is defined as 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.)
Products which fail to comply may be subject to public notification (RAPEX), withdrawal requirements, warehousing fees, fines or total destruction of the products.
The Equipment and Protective systems intended for use in Potentially Explosive Atmospheres (ATEX) Directive 94/9/EC of 23 March 1994, provides the essential health and safety requirements – leaving to standards developed by European standardization organizations their technical expression – and the relevant conformity assessment procedures before placing such equipment on the European market.
Directive 94/9/EC is also a total harmonization directive, since its provisions replace existing divergent national and European legislation which cover the same subjects as stipulated by Directive 94/9/EC. In this context, with effect from 1 July 2003 this Directive repealed: Council Directive 76/177/EEC (electrical equipment for use in potentially explosive atmospheres); Council Directive 79/196/EEC (electrical equipment for use in potentially explosive atmospheres employing certain types of protection); Council Directive 82/130/EEC (electrical equipment for use in potentially explosive atmospheres in mines susceptible to firedamp).
The general objective of the Directive is to eliminate or at least minimize the risks resulting from the use of certain products in or in relation to a potentially explosive atmosphere, i.e. an atmosphere, which could become explosive due to local and/or operational conditions. In particular, an explosive atmosphere for the purposes of ATEX Directive 94/9/EC is defined as a: Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapors, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.
To be within the scope of the ATEX Directive 94/9/EC, a product has to be:
In addition, a product within the scope of ATEX directive may fall as well within the scope of other directives, which have to be applied in parallel. This may be the case of the following Directives: EMC (2004/108/EC), LVD (2006/95/EC), MSD (98/37/EC), PPE (89/686/EC), PED (97/23/EC) and CPD (89/106/EC).
As per article 1.4 of the Directive the following equipment are not within the scope of the Directive:
Only equipment and protective systems complying with Directive 94/9/EC and bearing the CE marking, which must be visibly affixed, may move freely throughout the European Union market. Once the manufacturer has undertaken the appropriate procedures to assure conformity with the essential requirements of the Directive it is the responsibility of the manufacturer or his authorized representative established in the EU not only to affix the CE marking, but also to draw up a written EC Declaration of Conformity, and keep a copy within the EU for a period of ten years after the last equipment has been manufactured.
According to the Directive, in order to determine the appropriate conformity assessment procedure, the manufacturer must base the decision on the intended use of the product to identify as to which Group and Category it belongs.
Group I includes equipment intended for use in the underground parts of mines, and to those parts of surface installations of such mines, likely to become endangered by firedamp and/or combustible dust;
Group II includes equipment intended for use in other places likely to become endangered by explosive atmospheres;
After identifying to which Group and Category the product belongs, the appropriate conformity assessment procedure must be adopted:
Evidently, non-compliant products enter the EU Market everyday – whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors.
As there is no “approval” in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.
Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.
The main consequences include, but are not limited to:
Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.
It is the responsibility of the manufacturer to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to be compliant as the legislation applicable to their products evolves. Post-Marketing surveillance activities include, but are not limited to:
Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.
Explore our Authorised Representative services for ATEX products. Contact us for inquiries.