Guide to application of ATEX 2014/34/EU directive second edition

The European Commission has published the ATEX 2014/34/UE guide lines 2nd edition December 2017.

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-second edition in PDF


The guide that was published before is presented here after

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

  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.
  2. 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.
  3. 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.
  4. 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 all the EU official languages on http://ec.europa.eu/DocsRoom/documents/18027.
  2. 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. 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[6].


Table of Content

Preamble to the ATEX Directive - The Citations and the Recitals

 

§ 1

The citations

 

§ 2

The legal basis of the ATEX Directive

 

§ 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

Recitals 26, 27, 28, 29,

§ 20

The CE marking

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 noncompliant products

Recital 48

§ 27

Enforcement: penalties

Recital 49

§ 28

Transitional arrangements

Recital 50

§ 29

Subsidiarity and proportionality

Recitals 51, 52

§ 30

Transposition

The articles of 2014/34/EU directive

Article 1

§ 31

General provisions

 

 

§ 32

Products covered by the ATEX Directive

 

 

§ 33

Used, repaired or modified products and spare parts

 

 

§ 34

Place of intended use

 

 

§ 35

Interface to different potentially explosive atmospheres

 

 

§ 36

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

 

 

§ 37

Products excluded from the scope of the ATEX Directive

 

 

§ 38

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

 

Article 2

§ 39

Definitions

 

 

§ 40

Equipment

 

 

§ 41

"Own" ignition source

 

 

§ 42

Non-electrical equipment

 

 

§ 43

Electrical equipment

 

 

§ 44

Combined equipment (assemblies)

 

 

§ 45

Protective systems

 

 

§ 46

Components

 

 

§ 47

Difference between equipment and components. Specific requirements given in the manual of products

 

 

§ 48

Examples and problems on equipment and components

 

 

§ 49

Explosive atmosphere and potentially explosive atmosphere

 

 

§ 50

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

 

 

§ 51

Equipment group and category

 

 

§ 52

Intended use

 

 

§ 53

Making available on the market

 

 

§ 54

Placing on the market

 

 

§ 55

Manufacturer

 

 

§ 56

Authorised representative

 

 

§ 57

Importer

 

 

§ 58

Distributor

 

 

§ 59

Economic operators

 

 

§ 60

Technical specification

 

 

§ 61

Harmonised standard

 

 

§ 62

Accreditation and national accreditation body

 

 

§ 63

Conformity assessment

 

 

§ 64

Recall and withdrawal

 

 

§ 65

Union harmonisation legislation

 

 

§ 66

CE marking

 

Article 3

§ 67

Making available on the market and putting into service

 

 

§ 68

Making available ATEX products on the market

 

 

§ 69

Placing ATEX products on the market

 

 

§ 70

Putting ATEX products into service

 

Article 4

§ 71

Essential health and safety requirements

 

Article 5

§ 72

Free movement

 

 

§ 73

Obligations of economic operators

 

Article 6

§ 74

Obligations of manufacturers

 

§ 75

Use of subcontractor services by a manufacturer

 

§ 76

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

 

§ 77

Certificates and CE marking without the name of the original manufacturer

 

§ 78

Manufacturing of ATEX products for own use

 

§ 79

The official languages of the European Union

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 EUtype 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 to the ATEX Directive

 

The Annexes to the ATEX Directive

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

  1. Supplementary requirements in respect of equipment

§  176 Supplementary requirements in respect of equipment

  1. 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

§ 185 Obligations for the notified body 186 Validity of EU-type examination certificates

8.                                                           § 187 Obligations for the manufacturer

9.                                                           § 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 Directives 2008/68/EC and 98/91/EC (ADR)

                                               § 235

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

                                               § 236

Pressure Equipment Directive 2014/68/EU (PED) and Simple Pressure Vessels Directive

2014/29/EU (SPVD)

                                               § 237

Radio Equipment Directive 2014/53/EU (RED)

                                               § 238

Gas Appliances Directive 2009/142/EC (GAD)

                                               § 239

Construction Products Regulation (EU) No 305/2011 (CPR)

                                               § 240

Marine Equipment Directive 2014/90/EU (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

                                               § 254

Motor protection for category 3 motors

                                               § 255

Wi-Fi access points

                                               § 256

Refrigerators and storage cabinets for volatile substances

 

Borderline list – ATEX products

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

Useful ATEX 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).

[6] 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).