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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Directive 2014/34/EU came into force on the 18th April 2014, however, the current directive (94/9/EC) will not be repealed until 20th April 2016 and until this 2016 date, manufacturers can continue to place products on the market that comply with the current Directive.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which, if issued under the ATEX Directive, will cease to be valid when the current ATEX Directive (94/9/EC) is repealed on 20th April 2016.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.

The Text of the New ATEX Directive

The PDF text of the new ATEX Directive 2014/34/EU can be accessed through the link below:

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0034&from=EN

Update on the new ‘Consumer Product Safety’ Regulation

During 2009 to 2011 the European Commission held public consultations regarding the suitability and effectiveness of the General Product Safety Directive (2001/95/EC). Whilst it was generally felt that the Directive contains the correct core elements, it was decided that a revision was required due to overlaps in; current market surveillance rules set out in various pieces of EU legislation; and, the requirements of the New Legislative Framework for the Marketing of Products and its corresponding Regulation (EC) No 765/2008 (Requirements for accreditation and market surveillance relating to the marketing of products). Subsequently, in 2013 a ‘Product Safety and Market Surveillance’ package was introduced which includes four main elements;

1)   A proposal for a NEW Regulation on Consumer Product Safety.
2)   A proposal for a single Regulation regarding Market Surveillance for Products.
3)   A communication setting out a multi-annual plan to improve current market surveillance and product safety.
4)   A report on the implementation of Regulation (EC) No 765/2008

Significantly, the proposed new ‘Consumer Product Safety Regulation’, that is set to repeal Directives 2001/95/EC (General Product Safety) and 87/357/EEC (Dangerous Imitations), is intended to; simplify legislation, create uniform rules and remove legislative overlaps in regards to the safety of consumer products; improve product identification and traceability combined with the enhanced use of the Rapid Alert Information System (RAPEX); align itself with Regulation (EC) No 768/2008 (A common framework for the marketing of products); and, promote the increased use of European standards by developing existing standards and creating new ones in alignment with the European Standardisation Regulation 1025/2012.

As a result, it is hoped that; it will become easier to identify and remove dangerous products from the EU market; the responsibilities of manufacturers, importers and distributors will be more clearly defined; product recalls and other marketing restrictions (such as bans) will be easier to implement through improved traceability; there will be increased synergy between RAPEX and ICSMS (the Information and Communication System for Market Surveillance) resulting in improved awareness of dangerous products; there will be significant alignment between all consumer product safety rules and market surveillance activities.

The actions proposed in the Product Safety and Market Surveillance package were intended to be implemented from 2013 to 2015 and it is understood that this has been the case, however, it is still unclear precisely when the proposed Consumer Product Safety Regulation will come into force and repeal the GPSD. Indeed, the requirements of this proposed regulation are yet to be confirmed as being set in stone.

The ‘proposed’ Consumer Product Safety Regulation is available from the Europa website;http://ec.europa.eu/consumers/archive/safety/psmsp/docs/psmsp-act_en.pdf

CE Marking Presentation from the Northern Manu Show

Our presentation is now available to download – Please click here (PDF – 1MB)

northern-show-2014The Northern Manufacturing and Electronic Shows is coming to Manchester on the 1st & 2nd October 2014 and the CE Marking Association are offering FREE seminars about CE marking and the forthcoming changes. Parking and admittance to the show is also FREE!

At the Northern Show, Peter Evans, Principal Compliance Engineer at the CE Marking Association, will be giving the a FREE seminar on both days (14:10 on Wednesday 1st October and then 10:50 on Thursday 2nd). During seminar Peter will discuss the conformity requirements for placing your products on the market in Europe, including equipment built for own use. We will also discuss the forthcoming changes in product legislation in 2014 and beyond. After the discussion, Peter and his colleague, Neil Sulem, will be available to discuss and answer any questions on product conformity.

The exhibition also features other free manufacturing related seminars and features hundreds of exhibitors with products and services that cover all aspects of manufacturing and electronics. The Northern Show will be held at Event City which is near the Trafford shopping centre in Manchester (Postcode M17 8AS) and like our CE Marking seminars, the show is FREE to attend, so long as you are an industry professional. Free parking is also available.

If you would like to attend, then why not pre-register today for free at http://www.industrynorth.co.uk/

We look forward to meeting you at the show!

New Low Voltage Directive – What are the changes?

electric-shock-symbolThe Low Voltage Directive, now 2006/95/EC, has seen little change, other than its recodification from the previous number 73/23/EEC, since it became mandatory for most manufacturers of electrical equipment in 1996. However, as part of the measures initiated by the New Legislative Framework (NLF) in 2008, the Low Voltage Directive is one of a number of CE Marking Directives that have been revised with a view to aligning them with the common framework as defined in EU Decision No. 768/2008/EU. Subsequently, a NEW recast Low Voltage Directive 2014/35/EU was published in the Official Journal of the European Union on 29th March 2014. This new Directive came into force on the 18th April 2014, however, the current directive (2006/95/EC) will not be repealed until April 20th 2016 and until this 2016 date, manufacturers can continue to distribute products that comply with the current Directive.

OVERVIEW:

The new Directive certainly appears very different at first glance, the pdf. version expanding from 10 pages to 18, but upon closer examination much of these changes appear to be reformatting, rewording and reordering with some elaboration on certain requirements and terms. The actual changes, and how they are likely to affect manufacturers are relatively slight, and as such, changing to the new Directive should be fairly simple.

SCOPE:

The scope remains the same, however, the list of equipment and phenomena outside the scope of the Directive has had a new addition:

Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

OBLIGATIONS:

As with most of the other recast Directives that have been aligned with the NLF, for manufacturers there are no real changes and the process is pretty much the same as the current Directive, providing that they follow the general principles as set out in Article 30 of Regulation (EC) No 765/2008. Additional, or expanded, requirements for manufacturers include;

  • The need to carry out sample testing on products, and, if necessary, keeping a register of complaints, of non-conforming electrical equipment and product recalls.  Distributors should be informed of any such monitoring.
  • Equipment should bear a type, batch or serial number, or other element, allowing its identification, unless this is not possible due to its size.
  • Equipment must be accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users.
  • Manufacturers who have reason to believe that their equipment is not in conformity with 2014/35/EU shall immediately take corrective measures, withdraw it or recall it, as appropriate. Furthermore, where there is a risk to consumers, the National Authorities must be made aware of the non-conformity and the measures being employed to resolve it.

 

Additionally, the Directive now specifically details the obligations of Authorised Representatives, Importers and Distributors. In particular, the obligations for importers have been spelt out, which goes a long way to clarifying their role in the CE Marking process. These obligations include;

  • Importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer, including compilation of the Technical File and the marking of the equipment with the CE mark.
  • Importers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted on the electrical equipment (unless that is not possible, in which case it should be included on the packaging or in an accompanying document).
  • Importers shall ensure that the electrical equipment is accompanied by instructions and safety information in an appropriate language.
  • Importers shall ensure that, while equipment is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the safety objectives.
  • Importers shall, where appropriate, carry out sample testing of equipment and, if necessary, keep a register of complaints, of non-conforming equipment and product recalls. Distributors are to be informed of any such monitoring.
  • Importers shall keep a copy of the EU declaration of conformity (for 10 years) and must ensure that this and the technical documentation are made available to the market surveillance authorities.

 

Lastly, a completely new addition in Articles 13 and 14 of 2014/35/EU include provision for acquiring a ‘Presumption of Conformity’ on the basis of complying with International and/or National standards where an appropriate European harmonised standard is not published in the Official Journal of the EU.

TECHNICAL FILE requirements:

Whilst the itemised minimum contents required for the technical file have not changed, and it is still a requirement that documentation shall cover, as far as relevant for the assessment, the design, manufacture and operation of the electrical equipment, sufficient to assess the electrical equipment’s conformity to the relevant requirements, it is now stated that the technical documentation shall include ‘an adequate analysis and assessment of the risk(s)’.

SAFETY OBJECTIVES:

The requirement to include the brand name or the trade mark on the electrical equipment or, where not possible, on the packaging, has been removed from the safety Objectives as still listed in Annex I, however, Article 6(6) of the Directive requires that manufacturers indicate their name, trade name, or trade mark, and the postal address at which they can be contacted on the electrical equipment, or, where that is not possible, on its packaging or in an accompanying document.

DECLARATION:

The requirements for the Declaration of Conformity, now to be found in Annex IV, have been slightly modified. As opposed to list of contents, Annex IV is a suggested template for the Declaration, and the changes include;

  • The title is now ‘EU Declaration of Conformity’
  • A number can be assigned to the Declaration (this is optional).
  • It should state: This declaration has been issued under the sole responsibility of the manufacturer.
  • It should state: The object of the declaration is in conformity with the relevant Union harmonisation Legislation.
  • Suitable identification of the product should be included, sufficient to allow product traceability (there is a suggestion that a colour image of the product could be employed).
  • It is no longer required that the last two digits of the year in which the CE mark was affixed are included.
  • And, of course, the new Directive number should be employed: 2014/35/EU.

 

The new Low Voltage Directive 2014/35/EU can be found:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0035&from=EN

 

Standards Updates – Jul-Aug 14

The following lists of harmonised standards referenced on the European Commission’s Official Journal have been updated  in July and August 2014:

General Product Safety Directive

Machinery Directive

Construction Products Regulation

Energy Labelling & Eco-Design Requirements of Vacuum Cleaners

 

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