European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL ATEX

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL ATEX Directive 94/9/EC UNECE WP. 6 Break-out session on equipment for explosive atmospheres Geneva, 6 November 2007 Fabrizio Sacchetti European Commission Directorate-General for Enterprise and Industry 1

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL ATEX Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres 2

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Scope of Directive 94/9/EC • Equipment • Protective systems when intended for use in a potentially explosive atmosphere and • Devices according to Art. 1(2) • Components Must comply when placed on the market or put into service 3

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Potentially Explosive Atmosphere • • flammable substance (gas, vapour, mist or dust) mixed with air under atmospheric conditions (*) after ignition, combustion spreads to entire mixture (*) atmospheric conditions according to standards: T = -20 °C to +40 °C, p = 0. 8 bar to 1. 1 bar, d. T/dt < 0, 5 K/min, RH = 5% to 85 % , O 2 = 20. 9 ± 0. 2 Vol % 4

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Equipment • Intended for use in a potentially explosive atmosphere • Must have its own potential source of ignition Protective System Intended to halt an incipient explosion and/or to limit the effective range of an explosion • When placed on the market separately as autonomous system: Protective system in the sense of the Directive • When integrated into equipment: To be assessed with the complete equipment (no own CE-mark) 5

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Device according to Art. 1(2) Safety-, controlling- or regulating devices which are: • Situated outside the potentially explosive atmosphere • Essential to the safe functioning of equipment or protective systems with respect to the risk of explosion Component • Items essential to the safe functioning of equipment or protective systems but with no autonomous function • Placed on the market with the explicit intention of integration into ATEX equipment or protective systems 6

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Exclusions • Medical devices intended for use in medical environment • Equipment for use in the presence of explosives or unstable chemical substances • Personal Protective Equipment (PPE) • Seagoing vessels, mobile offshore units • Means of transport except vehicles intended for use in an explosive atmosphere • Equipment for military use covered by Art. 223 (1 b) of the Treaty 7

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Installations and Assemblies • Directive does not regulate “installations” or “plants”, which are subject to workplace directives (as the ATEX “user” Directive 1999/92/EC) or national legislation • Not always a clear line between installation and “assembly” The plant will usually be an installation if the end user or an installer e. g. : – purchases parts from different manufacturers to install them under his responsibility – carries out a whole series of different processes, requiring the integration of ATEX certified equipment installed according to a unique layout on site – commissions the installation off-site, which may certainly not be a production run, under his direct responsibility, or indirectly through a contractor 8

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Classification of Equipment: Groups and Categories • Group I: intended for use in the underground parts of mines, likely to become endangered by firedamp and/or combustible dust • Group II: intended for use in other places, likely to become endangered by explosive atmospheres These groups are subdivided into categories. The way in which this categorisation has been developed highlights one of the main distinctions of groups I and II 9

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Equipment - Group I • Category M 1: for use in mines endangered by firedamp and/or combustible dust • Category M 2: for use in mines likely to be endangered by firedamp and/or combustible dust Equipment - Group II • Category 1: for use in areas in which explosive atmospheres are present continuously, for long periods or frequently • Category 2: for use in areas in which explosive atmospheres are likely to occur • Category 3: for use in areas in which explosive atmospheres are unlikely or occur only infrequently and for a short period 10

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Modules for conformity assessment Council Decision 93/465/EEC Directive 94/9/EC Module A - Internal Production Control Module B - EC Type-Examination Module C - Conformity to Type Module D - Production Quality Assurance Module E - Product Quality Assurance Module F - Product Verification Module G - Unit Verification Annex VIII Annex VI Annex IV Annex VII Annex V Annex IX 11

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL 12

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Essential health and safety requirements relating to design and construction of ATEX equipment (Annex II to the Directive) • Legal requirements • Common requirements applicable to any ATEX product + supplementary requirements for each specific category / equipment groups and protective systems • Based on the principle of integrated explosion safety (risks assessed and prevented in the design phase) • Harmonised standards developed in support of the legal requirements 13

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Harmonised standards • Technical specification adopted by CEN (European Committee for Standardisation) or CENELEC (European Committee for Electrotechnical Standardisation) based on a mandate from the European Commission • Equipment, protective systems and devices constructed in accordance with that harmonised standards, the references of which have been published in the Official Journal of the EU, are presumed to comply with the relevant essential health and safety requirements covered by such standards 14

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Notified Bodies • Established in the territory of an EU Member State • Designated by the EU Member States to carry out the specific tasks foreseen for them under the conformity assessment procedures established by the Directive • Subcontracting possible but Notified Body retains full responsibility for the subcontractor’s work • Minimum assessment criteria (Annex XI to the Directive) Ø Ø Ø Independence Technical competence Necessary staff and facilities to carry out the relevant tasks Staff skills (technical and professional training, knowledge of the standards, test methods, tec. ) Impartiality of inspection staff (remuneration not linked to number of tests carried out or their results) Ø Liability insurance Ø Professional secrecy 15

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL CE marking • Attests conformity of a product with the provisions of the Directive • Where a product is subject to several Directives providing for the CE marking, its affixing indicated conformity to the provisions of all applicable Directives • Affixed by the manufacturer or his authorised representative after the conformity assessment procedure has been completed (generally, during the production control phase 16

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Other relevant EU Directives • Electromagnetic Compatibility (EMC) (2004/108/EC) • Low Voltage (LVD) (2006/95/EC) (only for safety, controlling and regulating devices, other ATEX equipment being excluded from the LVD scope) • Machinery (98/37/EC) • Construction Products (89/106/EEC) 17

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Market Surveillance • In the EU system, market surveillance is a Member States’ responsibility in accordance with the principle of subsidiarity • General market surveillance obligation set out in Article 2(1) of the ATEX Directive: “Member State shall take all appropriate measures to ensure that the equipment, protective systems and devices … to which this Directive applies may be placed on the market and put into service only if, when properly installed and maintained ad used for their intended purpose, they do not endanger the health and safety of persons and, where appropriate, domestic animals or property” • Safeguard clause procedure: restrictive measures taken by the Member States on CE-marked equipment are subject to the European Commission’s scrutiny 18

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL ATEX “use” Directives • ATEX Directive 94/9/EC concerns the first placing on the market and putting into service • Other national and EU legislation intended to ensure the safety of workers, including on periodical inspection, maintenance and repair, will usually apply in relation to the use of ATEX equipment at the workplace (obligations for the employer) • Different EU legislation applies to land-based industries, the underground extraction of coal and other minerals, and offshore oil production (Directives 1999/92/EC, 92/91/EEC and 92/104/EEC) Ø Minimum harmonisation, Member States free to set more stringent requirements 19

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL How to apply the Directive ü Guidelines on the application of Directive 94/9/EC ü Consideration Papers by the ATEX Standing Committee ü Ex. NBG Clarification Sheets noted by the ATEX Standing Committee 20

European Commission ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Thank you for the attention http: //ec. europa. eu/enterprise/atex@ec. europa. eu 21