Guide to application of the ATEX Directive 2014/34/EU

The European Commission has published the ATEX 2014/34/UE guide lines 1st edition April 2016.

You can find the official document on the european commission website and on the following page :

Guide to application of the ATEX Directive 2014/34/EU-first edition in PDF


The draft guide that was published before is presented here after

Guide to application of the ATEX Directive 2014/34/EU

A project of Guide to application of the ATEX Directive 2014/34/EU has been published on  circabc.europa.eu website

This guide is a Draft and thiis is the official publication is planned for the  1st EDITION – April 2016 (DRAFT 4 (September 2015))

The exact designation is : Guide to application of the Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the law of the Member States relating to Equipment and Protective Systems intended for use in Potentially Explosive Atmospheres

This guide change of structure for presentation compared to the former presentations of ATEX 94/9/EC guideline an is similar in its form to the machinery directive guide. The summary and links to its contents are presented hereafter

PRELIMINARY NOTES

  1. These ATEX Guidelines are intended to be a manual for all parties directly or indirectly affected by Directive 2014/34/EU[1], commonly referred to as the ATEX (“Atmosphères explosibles”) “product” directive, applicable from 20 April 2016, replacing the previous Directive 94/9/EC applicable from 1 July 2003 until 19 April 2016.

 

  1. Readers’ attention is drawn to the fact that these Guidelines are intended only to facilitate the application of Directive 2014/34/EU, and it is the relevant national transposition of the text of the Directive which is legally binding. However, this document does represent a reference for ensuring consistent application of the Directive by all interested parties and stakeholders. The ATEX Guidelines are intended to help ensure the free movement of products within the scope of the ATEX Directive in the European Union[2] by consensus amongst Member States’ government experts and other parties concerned.

 

  1. These Guidelines have been prepared by the competent services of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG Growth)[3], in co-operation with representatives and experts from EU Member States, European standardisation, notified bodies, industry and other relevant sectoral stakeholders, with the specific contribution of the "New ATEX Guidelines Editorial Group (NAGEG)". They are based on the last issue (4th Edition - September 2012 - Revision December 2013) of the Guidelines on the application of Directive 94/9/EC, applicable until 19 April 2016, as well as on other horizontal and vertical guidance documents.

 

  1. The European Commission services will undertake to maintain these Guidelines. It is our goal to ensure that the information provided is both timely and accurate. If errors are brought to our attention, we will try to correct them as soon as possible. However, the Commission accepts no responsibility or liability whatsoever with regard to the information in this document.

This information is:

  • of a general nature only and is not intended to address the specific circumstances of any particular individual or entity;
  • not necessarily comprehensive, complete, accurate or up-to-date;
  • sometimes refers to external information over which the Commission services have no control and for which the Commission assumes no responsibility;
  • not professional or legal advice.

 

  1. All references to the CE marking and the EU declaration of conformity in these ATEX Guidelines relate only to the Directive 2014/34/EU. To place products falling under Directive 2014/34/EU in the European Union territory, all other relevant legislation must be applied.

For wider information on the whole system, see the latest version of “The ‘Blue Guide’ on the implementation of EU product rules”, available in 22 EU official languages on http://ec.europa.eu/DocsRoom/documents/11502.

 

  1. Further guidance, especially concerning specific types of products, can be found on the European Commission's website on EUROPA regarding ATEX: http://ec.europa.eu/growth/sectors/mechanical-engineering/atex/.

Any query can be addressed to the GROW ATEX functional mailbox:
GROW-DIR-ATEX@ec.europa.eu.

 

 

INTRODUCTION

The objective of these ATEX Guidelines is to clarify certain matters and procedures referred to in Directive 2014/34/EU1 concerning equipment and protective systems intended for use in potentially explosive atmospheres. The Guidelines should be used in conjunction with the Directive itself and with the European Commission's document “The ‘Blue Guide’ on the implementation of EU product rules[4].

These Guidelines are not only for the use of Member States’ competent authorities, but also by the main economic operators concerned, such as manufacturers, their trade associations, bodies in charge of the preparation of standards as well as those entrusted with the conformity assessment procedures.

First and foremost, this document must ensure that, when correctly applied, the Directive leads to the removal of obstacles and difficulties related to the free circulation (free movement) of goods within the European Union (EU) and the European Economic Area (EEA). It should be noted that the statements in these Guidelines refer only to the application of Directive 2014/34/EU unless otherwise indicated. All parties concerned should be aware of other requirements, which may also apply.

Directive 2014/34/EU is a total harmonisation directive and a "New Approach"[5] directive aligned to the “New Legislative Framework”[6]. It lays down essential health and safety requirements and leaves it to standards, primarily European harmonised standards, to give technical expression of the relevant requirements contained in the Directive.

The ATEX Directive 2014/34/EU replaced the previous ATEX Directive 94/9/EC which was applicable between 1 July 2013 and 19 April 2016. As of 20 April 2016, Directive 2014/34/EU, as transposed into the national legislation of the EU Member States, is the sole legal instrument applicable.

The reader will want to be aware that where ATEX products are intended for use in a place of work, national and EU legislation, intended to ensure the safety of employees, will usually apply. In this respect different legislation applies to land based industries, the underground extraction of coal and other minerals, and offshore oil production[7].

 

 

TABLE OF CONTENTS

The Citations

                                               § 1         The citations

                                               § 2         The legal basis of the ATEX Directive

The Recitals

                                               § 3         The recitals

Recital 1                                § 4         The previous ATEX Directive

Recitals 2, 3                         § 5         The New Legislative Framework

Recitals 4, 5                         § 6         The scope of the ATEX Directive

Recital 6                                § 7         Health and safety

Recital 7                                § 8         Protection against explosion hazards

Recitals 8, 9                         § 9         Safety of ATEX equipment and protective systems: essential health and safety requirements

Recitals 10, 11, 12              § 10       Responsibilities of economic operators

Recital 13                             § 11       Responsibilities of manufacturers: conformity assessment

Recitals 14, 15                     § 12       Responsibilities of importers

Recital 16                             § 13       Responsibilities of distributors

Recital 17                             § 14       Obligations of the manufacturer for economic operators

Recitals 18, 19                     § 15       Information and traceability of products for market surveillance

Recital 20                             § 16       Essential health and safety requirements: presumption of conformity from harmonised standards

Recital 21                             § 17       Formal objections to harmonised standards

Recital 22                             § 18       Conformity assessment procedures

Recitals 23, 24                     § 19       EU declaration of conformity

Recital 25                             § 20       The CE marking

Recitals 26, 27, 28, 29,

30, 31, 32, 33, 34, 35          § 21       Conformity assessment bodies: notified bodies

Recitals 36, 37                     § 22       Compliance of products placed on the market and market surveillance

Recitals 38, 39, 40              § 23       The safeguard clause procedure

Recitals 41, 42, 43, 44        § 24       Implementing powers and procedures

Recitals 45, 46                     § 25       The ATEX Committee

Recital 47                             § 26       Implementing acts concerning measures on non-compliant products

Recital 48                             § 27       Enforcement: penalties

Recital 49                             § 28       Transitional arrangements

Recital 50                             § 29       Subsidiarity and proportionality

Recitals 51, 52                     § 30       Transposition

The Articles

                                               § 31       General provisions

Article 1                                 § 32       Products covered by the ATEX Directive: in which cases does Directive 2014/34/EU apply?

                                               § 33       Used, repaired or modified products and spare parts

                                               § 34       Which kinds of products are covered by Directive 2014/34/EU?

                                               § 35       Place of intended use

                                               § 36       Interface to different potentially explosive atmospheres

                                               § 37       Safety devices, controlling devices and regulating devices as defined in Article 1(b)

                                               § 38       Products excluded from the scope of the ATEX Directive

                                               § 39       Examples of equipment not covered by Directive 2014/34/EU

Article 2                                 § 40       Definitions

                                               § 41       Equipment

                                               § 42       “Own” ignition source

                                               § 43       Non-electrical equipment

                                               § 44       Electrical equipment

                                               § 45       Assemblies

                                               § 46       Protective systems

                                               § 47       Components

                                               § 48       Specific requirements given in the manual of products

                                               § 49       Differences between equipment and components

                                               § 50       Explosive atmosphere and potentially explosive atmosphere

                                               § 51       Potentially explosive atmosphere in the sense of Directive 2014/34/EU

                                               § 52       Equipment group and category

                                               § 53       Intended use

                                               § 54       Making available on the market

                                               § 55       Placing on the market

                                               § 56       Manufacturer

                                               § 57       Authorised representative

                                               § 58       Importer

                                               § 59       Distributor

                                               § 60       Economic operators

                                               § 61       Technical specification

                                               § 62       Harmonised standard

                                               § 63       Accreditation and national accreditation body

                                               § 64       Conformity assessment

                                               § 65       Recall and withdrawal

                                               § 66       Union harmonisation legislation

                                               § 67       CE marking

Article 3                                 § 68       Making available on the market and putting into service

                                               § 69       Making available ATEX products on the market

                                               § 70       Placing ATEX products on the market

                                               § 71       Putting ATEX products into service

Article 4                                 § 72       Essential health and safety requirements

Article 5                                 § 73       Free movement

                                               § 74       Obligations of economic operators

Article 6                                 § 75       Obligations of manufacturers

                                               § 76       Use of subcontractor services by a manufacturer

                                               § 77       Manufacturers and conformity assessment based on quality assurance (Annex IV, Annex VII)

                                               § 78       Certificates and CE marking without the name of the original manufacturer

                                               § 79       Manufacturing of ATEX products for own use

Article 7                                 § 80       Authorised representatives

Article 8                                 § 81       Obligations of importers

Article 9                                 § 82       Obligations of distributors

Article 10                               § 83       Obligations of manufacturers for importers and distributors

Article 11                               § 84       Identification of economic operators

                                               § 85       Conformity of the product

Article 12                               § 86       Presumption of conformity of products

                                               § 87       European harmonised standards in the Official Journal

                                               § 88       Standardisation programme

Article 13                               § 89       Conformity assessment procedures

                                               § 90       Conformity assessment procedures in the case of different categories within one product

                                               § 91       Clarification for equipment with categories 2 or 3

                                               § 92       Exceptional derogations of the conformity assessment procedures

Article 14                               § 93       EU declaration of conformity

                                               § 94       Written attestation of conformity for components

Articles 15, 16                      § 95       The CE marking. Rules and conditions for affixing the CE marking and other markings

                                               § 96       Notification of conformity assessment bodies: notified bodies

Article 17                               § 97       Notification

Article 18                               § 98       Notifying authorities

Article 19                               § 99       Requirements relating to notifying authorities

Article 20                               § 100    Information obligation on notifying authorities

Article 21                               § 101    Requirements relating to notified bodies

Article 22                               § 102    Presumption of conformity of notified bodies

Article 23                               § 103    Subsidiaries of and subcontracting by notified bodies

Articles 24, 25                      § 104    Application for notification and notification procedure

Article 26                               § 105    Identification numbers and lists of notified bodies. The NANDO database

Article 27                               § 106    Changes to notification

Article 28                               § 107    Challenge of the competence of notified bodies

Article 29                               § 108    Operational obligations of notified bodies

                                               § 109    Documents issued by the notified body

                                               § 110    Provision of evaluation and test results with EU-type examination certificates

                                               § 111    Acceptance of test results of manufacturers by a notified body

                                               § 112    Minimum content of a European standardised ATEX test and assessment report

                                               § 113    Retention of technical documentation

Article 30                               § 114    Appeal against decisions of notified bodies

Article 31                               § 115    Information obligation on notified bodies

Article 32                               § 116    Exchange of experience

Article 33                               § 117    Coordination of notified bodies. The European ATEX Notified Bodies Group (ExNBG)

                                               § 118    Status and use of ExNBG Clarification Sheets issued by the European ATEX Notified Bodies Group

                                               § 119    EU market surveillance, control of products entering the EU market and EU safeguard procedure

Article 34                               § 120    EU market surveillance and control of products entering the EU market

Article 35                               § 121    Procedure for dealing with products presenting a risk at national level

Article 36                               § 122    EU safeguard procedure

Article 37                               § 123    Compliant products which present a risk

Article 38                               § 124    Formal non-compliance

                                               § 125    Committee, transitional and final provisions

Article 39                               § 126    The ATEX Committee

Article 40                               § 127    Enforcement: penalties

Article 41                               § 128    Transitional provisions

Article 42                               § 129    Transposition

Article 43                               § 130    Repeal

Article 44                               § 131    Entry into force and application

Article 45                               § 132    Addresses

The Annexes

Annex I - Criteria determining the classification of equipment-groups into categories

                                               § 133    Classification of equipment-groups into categories

1. Equipment-group I

                                               § 134    Equipment-group I, category M1

                                               § 135    Equipment-group I, category M2

2. Equipment-group II

                                               § 136    Equipment-group II, category 1

                                               § 137    Equipment-group II, category 2

                                               § 138    Equipment-group II, category 3

Annex II - Essential health and safety requirements relating to the design and construction of equipment and protective systems intended for use in potentially explosive atmospheres

                                               § 139    Essential health and safety requirements

                                               § 140    Preliminary observations

1. Common requirements for Equipment and protective systems

1.0.                                         § 141    General requirements

1.0.1., 1.0.2.                          § 142    Principles of integrated explosion safety. Risk assessment for ATEX products

1.0.3., 1.0.4.                          § 143    Special conditions: checking, maintenance, surrounding area

1.0.5.                                      § 144    Marking

                                               § 145    CE marking

                                               § 146    Supplementary/specific marking

                                               § 147    Additional marking for standards

                                               § 148    Marking of small products

                                               § 149    Marking of components

                                               § 150    Marking of assemblies

1.0.6.                                      § 151    Instructions

1.1., 1.1.1, 1.1.2., 1.1.3        § 152    Selection of materials

1.2., 1.2.1., 1.2.2.                 § 153    Design and construction

1.2.3.                                      § 154    Enclosed structures and prevention of leaks

1.2.4                                       § 155    Dust deposits

1.2.5                                       § 156    Additional means of protection

1.2.6                                       § 157    Safe opening

1.2.7                                       § 158    Protection against other hazards

1.2.8                                       § 159    Overloading of equipment

1.2.9                                       § 160    Flameproof enclosure systems

1.3.                                         § 161    Potential ignition sources

1.3.1.                                      § 162    Hazards arising from different ignition sources

1.3.2.                                      § 163    Hazards arising from static electricity

1.3.3.                                      § 164    Hazards arising from stray electric and leakage currents

1.3.4.                                      § 165    Hazards arising from overheating

1.3.5.                                      § 166    Hazards arising from pressure compensation operations

1.4., 1.4.1., 1.4.2.                 § 167    Hazards arising from external effects

1.5., 1.5.1., 1.5.2., 1.5.3.      § 168    Requirements in respect of safety-related devices

1.5.4.                                      § 169    Control and display units

1.5.5., 1.5.6, 1.5.7.               § 170    Requirements in respect of devices with a measuring function for explosion protection

1.5.8.                                      § 171    Risks arising from software

1.6., 1.6.1., 1.6.2.                 § 172    Integration of safety requirements relating to the system

1.6.3.                                      § 173    Hazards arising from power failure

1.6.4.                                      § 174    Hazards arising from connections

1.6.5.                                      § 175    Placing of warning devices as part of equipment

2. Supplementary requirements in respect of equipment

                                               § 176    Supplementary requirements in respect of equipment

3. Supplementary requirements in respect of protective systems

                                               § 177    Supplementary requirements in respect of protective systems

Annex III - Module B: EU-type examination

1., 2.                                       § 178    EU-type examination

3.                                            § 179    The application for EU-type examination

4.                                            § 180    Tasks to be performed by the notified body

5.                                            § 181    The evaluation report

6.                                            § 182    The EU-type examination certificate

                                               § 183    The EU-type examination certificate and the responsibilities of stakeholders

7.                                            § 184    Changes and modifications

8.                                            § 185    Obligations for the notified body

                                               § 186    Validity of EU-type examination certificates

9.                                            § 187    Obligations for the manufacturer

10.                                          § 188    Authorised representative

Annex IV - Module D: Conformity to type based on quality assurance of the production process

1.                                            § 189    Conformity to type based on quality assurance of the production process

2.                                            § 190    Manufacturing

3.                                            § 191    Quality system

4.                                            § 192    Surveillance under the responsibility of the notified body

5.                                            § 193    CE-marking, EU declaration of conformity and attestation of conformity

6.                                            § 194    Obligations for the manufacturer: retention of documentation - quality assurance

7.                                            § 195    Obligations for the notified body

8.                                            § 196    Authorised representative

Annex V - Module F: Conformity to type based on product verification

1.                                            § 197    Conformity to type based on product verification

2.                                            § 198    Manufacturing

3., 4.                                       § 199    Verification

5.                                            § 200    CE-marking, EU declaration of conformity and attestation of conformity

6.                                            § 201    The notified body’s identification number

7.                                            § 202    Authorised representative

Annex VI - Module C1: Conformity to type based on internal production control plus supervised product testing

1.                                            § 203    Conformity to type based on internal production control plus supervised product testing

2.                                            § 204    Manufacturing

3.                                            § 205    Product checks

4.                                            § 206    CE-marking, EU declaration of conformity and attestation of conformity

5.                                            § 207    Authorised representative

Annex VII - Module E: Conformity to type based on product quality assurance

1.                                            § 208    Conformity to type based on product quality assurance

2.                                            § 209    Manufacturing

3.                                            § 210    Quality system

4.                                            § 211    Surveillance under the responsibility of the notified body

5.                                            § 212    CE-marking, EU declaration of conformity and attestation of conformity

6.                                            § 213    Obligations for the manufacturer

7.                                            § 214    Obligations for the notified body

8.                                            § 215    Authorised representative

Annex VIII - Module A: Internal product control

1.                                            § 216    Internal product control

2.                                            § 217    Technical documentation

3.                                            § 218    Manufacturing

4.                                            § 219    CE-marking, EU declaration of conformity and attestation of conformity

5.                                            § 220    Authorised representative

Annex IX - Module G: Conformity based on unit verification

1.                                            § 221    Conformity based on unit verification

2.                                            § 222    Technical documentation

3.                                            § 223    Manufacturing

4.                                            § 224    Verification

5.                                            § 225    CE-marking, EU declaration of conformity and attestation of conformity

6.                                            § 226    Authorised representative

Annex X - EU declaration of conformity

                                               § 227    The EU declaration of conformity

Annex XI

                                               § 228    References of the repealed Directive

Annex XII - Correlation table

                                               § 229    Correlation table

Statement of the European Parliament

                                               § 230    Statement of the European Parliament

Application of Directive 2014/34/EU alongside others that may apply

                                               § 231    Electromagnetic Compatibility Directive 2014/30/EU (EMC)

                                               § 232    Low Voltage Directive 2014/35/EU (LVD)

                                               § 233    Machinery Directive 2006/42/EC

                                               § 234    Transport of dangerous goods by road Directives 94/55/EC and 98/91/EC (ADR)

                                               § 235    Personal Protective Equipment Directive 89/686/EEC (PPE)

                                               § 236    Pressure Equipment Directive 2014/68/EU (PED)

                                               § 237    Simple Pressure Vessels Directive 2014/29/EU (SPVD)

                                               § 238    Gas Appliances Directive 2009/142/EC (GAD)

                                               § 239    Construction Products Regulation No 305/2011 (CPR)

                                               § 240    Marine Equipment Directive 96/98/EC (MED)

Application of Directive 2014/34/EU to specific equipment

                                               § 241    Inerting systems

                                               § 242    Paint spray booths

                                               § 243    Filter units and vented silo bins

                                               § 244    Gas turbines

                                               § 245    Steam turbines

                                               § 246    Petrol pumps

                                               § 247    Cables

                                               § 248    Rotating mechanical seals

                                               § 249    Bucket elevators

                                               § 250    Fork lift trucks

                                               § 251    Transportable, pressurised cabins ("modules")

                                               § 252    Automatically lubricating systems

                                               § 253    Electrical trace heating systems

 

Borderline list – ATEX products

Specific marking of explosion protection (ex) drawn from Directive 84/47/EEC

Useful websites

 

[1] Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast) (OJEU L 96, 29.3.2014, p. 309).

[2] According to the agreement related to the European Economic Area (EEA) (Decision of the Council and the Commission 94/1/EC of 13 December 1993, OJ L1, 3.1.1994, p.1), the territories of Iceland, Liechtenstein and Norway have to be considered, for the implementation of Directive 2014/34/EU, in the same right as of the EU territory. When this term, EU territory, is used in this Guide, the same applies to the EEA territory.

[3] The former Directorate-General for Enterprise and Industry, until 31 October 2014.

[5] Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (OJ C 136, 4.6.1985, p. 1).

[7] Among others, the ATEX “workplace” Directive 1999/92/EC of the European Parliament and of the Council of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (OJ L 23, 28.1.2000, p. 57).