New ATEX Directive - What are the changes?

The ATEX Directive 94/9/EC is one of a number of CE Marking Directives that are getting a make-over to bring them into line with EU Decision No. 768/2008/EU, in accordance with the New Legislative Framework (NLF) that was introduced in 2008. Subsequently, a new recast, Equipment for Explosive Atmospheres (ATEX) Directive 2014/34/EU came into force on the 18th April 2014, however, the current directive (94/9/EC) will not be repealed until 20th April 2016 and until this 2016 date, manufacturers can continue to place products on the market that comply with the current Directive.

Overview

The new Directive appears quite different to the Directive it will replace, and the pdf version is 65% larger, but other than rewording, reformatting, reordering and clarifications, the actual changes and the impact on manufacturers is relatively slight. Changing to the new Directive should not be too difficult for manufacturers and furthermore EC-type-examination certificates which have been issued under the current ATEX Directive (94/9/EC) will be valid under the new Directive (2014/34/EU).

Please note: EC-type-examination certificates are NOT the same as EU Declarations of Conformity which, if issued under the ATEX Directive, will cease to be valid when the current ATEX Directive (94/9/EC) is repealed on 20^th April 2016.

Terminology Changes, Clarifications and Additions

As with the other Directives which have been aligned with the NLF, a number of terms have been changed and even some new terms have been introduced, as can be seen in the tables below:

Table 1- Terminology correlation table

Term used in 94/9/EC	Term used in 2014/34/EU
Category	Equipment Category
Community Directives	Union Legislation
EC-Type Examination	EU-Type Examination
EC-Type Examination Certificate	EU-Type Examination Certificate
EC Declaration of Conformity	EU Declaration of Conformity
Certificate (in relation to the indication of conformity of a component)	Attestation of Conformity

Table 2 – New definitions in 2014/34/EU

Term	Definition
Making available on the market	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
Placing on the market	the first making available of a product on the Union market
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
Authorised representative	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
Importer	any natural or legal person established within the Union who places a product from a third country (i.e. not a EU member state or a country which is part of European Economic Area – European Free Trade Association), on the Union market
Distributor	any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market
Economic operators	the manufacturer, the authorised representative, the importer and the distributor
Technical specification	a document that prescribes technical requirements to be fulfilled by a product
Conformity assessment	the process demonstrating whether the essential health and safety requirements of this Directive relating to a product have been fulfilled
Conformity assessment body	a body that performs conformity assessment activities including calibration, testing, certification and inspection

Scope

The types of products which are covered by the directive remains the same, however the scope has been modified to make it clear that components intended to be incorporated into equipment and protective systems, do fall within the scope of the ATEX Directive.

Obligations of Economic Operators

The Directive now specifically details the obligations of Manufacturers (M), Authorised Representatives (AR), Importers (I) and Distributors (D). These obligations are summarised in the table below:

Table 3 – Summary of obligations to be undertaken by economic operators

Obligation	M	AR	I	D
Ensure the product has been produced in accordance with EHSR’s of the Directive	X	N/A
Only place compliant products on the market			X
Act with due care in relation to the requirements of the Directive				X
Draw up the technical documentation	X	N/A
Ensure the technical documentation has been drawn up			X
Carry out (or have carried out) the relevant conformity assessment	X
Ensure the conformity assessment has been carried out			X
Draw-up DofC and affix the CE marking or produce a written attestation of conformity for a component and ensure it is accompanied with the product	X
Ensure the DofC or attestation of conformity has been produced & accompanies the product along with other required documents, and the CE marking is placed on the product (where possible)			X	X
Keep technical documentation & DofC/attestation of conformity for 10 years after the product has been placed on the market	X	X	X
Ensure procedures are in place for series production to remain in conformity with the Directive	X
When risk appropriate, carry out sample testing of products and where necessary keep a register of: complaints; non-conforming products; and product recalls, and keep distributors informed	X		X
Ensure products bear, (or where not possible, on other documents accompanying the product) a type, batch or serial number or other element allowing identification	X		X	X
Ensure products other than components bear Ex markings and other relevant ATEX markings required by the Directive or applied harmonised standards	X		X	X
Ensure it is indicated on the product (or where not possible, on other documents accompanying the product) the manufacturers name, registered trade name/mark, postal address	X		X	X
Ensure it is indicated on the product (or where not possible, on other documents accompanying the product) the importers name, registered trade name/mark, postal address			X	X
Ensure the product is accompanied by instructions and safety information in a language easily understood by the end-users	X		X	X
Take corrective actions/inform national authorities when a product they have placed on the market is not in conformity with the Directive	X		X	X
Inform the importer, manufacturer & market surveillance authorities where the product presents a risk			X	X
If requested, provide the national authority with the technical documentation in a language easily understood by the authority, and cooperate with the authority to eliminate the risk posed by the products which they have placed on the market	X	X	X	X
Ensure a products compliance is not jeopardised due to storage or transport conditions			X	X
On request by a market surveillance authority: identify any economic operator (i.e. manufacturer, authorised representative, importer or distributor), who has supplied them with a product; or any economic operator to whom they have supplied a product, for up to 10 years after the product has been supplied.	X	X	X	X
Note 1: An authorised representative may have further tasks to undertake as per the mandate agreed between themselves and the manufacturer. Note 3: Specific obligations which the authorised representative can/cannot fulfil are also specified is each conformity module. Note 2: An importer or distributor shall be considered a manufacturer where they place a product on the market under their name or trade mark or modify a product already placed on the market in such a way that compliance with the Directive may be affected

Essential Health and Safety Requirements

The requirements of manufacturers contained within the Annex II of the Directive, concerning the Essential health and safety requirements remain largely the same as the previous Directive. The only potentially significant difference is contained within clause 1.5 which contains requirements with respect to safety-related-devices. The clause now states that the ‘fail-safe principle’ should be applied in general, as opposed to just the electrical circuits, as was the previous requirement. In reality the majority of manufactures have already been applying the fail-safe principle to all systems in their products where necessary as determined through the use of Ignition Hazard Assessment and Harmonised Standards.

Assessment Modules

The assessment modules have been aligned with the NLF and Decision 768/2008/EC. As such many of the titles have been modified as indicated below:

Table 4 – Correlation table for module headings

Annex	94/9/EC	2014/34/EU
III	Module: EC-Type Examination	Module B: EU-Type Examination
IV	Module: Production quality assurance	Module D: Conformity to type based on quality assurance of the production process
V	Module: Product Verification	Module F: Conformity to type based on product verification
VI	Module: Conformity to Type	Module C1: Conformity to type based on internal production control plus supervised product testing
VII	Module: Product Quality Assurance	Module E: Conformity to type based on product quality assurance
VIII	Module: Internal Control of Production	Module A: Internal production control
IX	Module: Unit Verification	Module G: Conformity based on unit verification

Each conformity module has been split into the following distinct topic sections with the following headings (where applicable to the conformity module):

Technical documentation
Manufacturing
Quality system
Product checks
Verification
Verification of conformity by examination and testing of every product
Quality system
Surveillance under the responsibility of the notified body
CE marking, EU declaration of conformity and attestation of conformity
Authorised representative

However the only sections which add or modify any requirements for an economic operator are highlighted below along with a summary of the changes.

Application to a notified body – When applicable, the application lodged by the manufacturer to the notified body for an assessment of the quality system now needs to include: the name and address of the manufacturer and authorised representative (if the application is lodged by the authorised representative): and a written declaration that the same application has not been lodged with any other notified body.
Technical Documentation – The technical documentation requirements now specify that an adequate analysis and assessment of the risk(s) should be provided. Following the official European guidelines from the current ATEX Directive (94/9/EC), this requirement could be interpreted to mean that an Ignition Hazard Assessment should be undertaken.
Authorised Representative – It is clarified that a written mandate is required in order to appoint an authorised representative and their specific responsibilities in relation to the ATEX Directive must be stated. The authorised representatives responsibilities must be aligned to those stated in the specific conformity module being followed and the general requirements stated in article 7 of the Directive
CE marking, EU declaration of conformity and attestation of conformity – It is clarified that declarations/attestations of conformity should accompany every product / component

EU Declaration of Conformity

The EC Declaration of Conformity is now referred to as an EU Declaration of Conformity and should now include the following information:

If a Declaration is given a number, it is required that this number is placed ‘EU Declaration of Conformity’ title.
It is now a specific requirements that the product, type, batch or serial number of the product is stated on the Declaration
It is clarified that the description of the product should be sufficient to allow its tractability and may require an image to be provided on the Declaration
A sentence stating that ‘This declaration of conformity is issued under the sole responsibility of the manufacturer.’ is now required to be included
A statement that the object of the declaration is in conformity with the relevant Union harmonisation legislation is now required to be included
Where applicable it is now required that the description of the intervention performed by the notified body is stated on the Declaration

Other Changes

There are a number of other differences between the current and new ATEX Directives, but theses generally will only affect the operation of notified bodies and member states and will not require manufacturers and other economic operators to make changes in order for them to be accommodated.