Transcript 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.

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
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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
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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
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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,
dT/dt < 0,5 K/min, RH = 5% to 85 % , O2 = 20.9 ± 0.2 Vol %
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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)
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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
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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 (1b) of the
Treaty
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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
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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
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European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Equipment - Group I
• Category M1: for use in mines endangered by
firedamp and/or combustible dust
• Category M2: 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
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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 III
Annex VI
Annex IV
Annex VII
Annex V
Annex IX
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European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Involvement of
Notified Bodies
Notified Body involved in
the PRODUCT DESIGN
phase
Notified Body involved in
the PRODUCTION phase
COMMUNICATION of
TECHNICAL FILE to
Notified Body
SELF DECLARATION
of the manufacturer
Equipment of
category
M1 & 1 ;
autonom.
protective
systems
Electrical
equipment and
internal
combustion
engines of cat.
M2 & 2
X
X
X
X
Other
equipment of
category
M2 & 2
Equipment of
category 3
X
X
X
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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
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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
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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)





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)
 Liability insurance
 Professional secrecy
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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
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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)
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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
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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)
 Minimum harmonisation, Member States free to set more stringent
requirements
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European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
How to apply the Directive
 Guidelines on the application of Directive 94/9/EC
 Consideration Papers by the ATEX Standing
Committee
 ExNBG Clarification Sheets noted by the ATEX
Standing Committee
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European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Thank you
for the attention
http://ec.europa.eu/enterprise/atex
[email protected]
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