Transcript European Commission DG Enterprise and Industry

European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Anna Solé Mena
Policy Officer - European Commission
DG Enterprise and Industry
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Approval Schemes for Electrical
Equipment in the EU
EU-Taiwan high voltage equipment management forum
25/26 March 2014
Anna Solé Mena
DG Enterprise and Industry
European Commission
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Electrical Equipment:
High and Low Voltage
EU Low Voltage Directive
(2006/95/EC)
Taiwanese Directive 401
• Over 600 V
Overlap
Products between 600-1000(1500) V
For this reason we will provide information on EU Low Voltage
Directive
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Electrical Equipment
High Voltage
• For equipment of higher voltage than 1000 V (AC) and
1500 V (DC) :
 No EU-wide Directive
 Ensuring safety is the responsibility of the
manufacters themselves.
 EU Member States can take corrective actions and
punishments if necessary, such as prohibiting
placing the products on the market
 We will hear the examples of the Netherlands and
Germany, but all MS proceed similarly.
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
EU Low voltage Directive
• MANDATORY: Products placed on the market must
fulfil safety objectives (defined by Directive)
• VOLUNTARY: Harmonised standards: Presumption of
conformity
• Conformity Assessment Procedures must be followed. The
manufacturer must :
 establish Technical Documentation proving the product's safety
and keep it at the disposal of the authorities
 issue a Declaration of Conformity
 affix the CE marking on the product
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
CONFORMITY ASSESSMENT FOR ELECTRICAL
EQUIPMENT
• Internal control of production:
 At all times manufacturers must ensure that only
compliant products reach the market
• The Government role is to police the market
(market surveillance): we achieved a very high
safety record
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Safety objectives of the LVD
• Article 2
 1. The Member States shall take all appropriate
measures to ensure that electrical equipment may be
placed on the market only if, having been constructed
in accordance with good engineering practice in safety
matters in force in the Community, it does not endanger
the safety of persons, domestic animals or property
when properly installed and maintained and used in
applications for which it was made.
 2. The principal elements of the safety objectives
referred to in paragraph 1 are listed in Annex I.
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Safety objectives of the LVD
1. General conditions
a) The essential characteristics… shall be marked on the equipment
b) The manufacturers or brand name or trade mark should be clearly printed on the electrical
equipment
c) ensure that it can be safely and properly assembled and connected.
d) … protection against the hazards is assured providing that the equipment is used in applications for
which it was made and is adequately maintained.
2. Protection against hazards arising from the electrical equipment
a) protection against danger of physical injury or other harm which might be caused by electrical
contact direct or indirect;
b) that temperatures, arcs or radiation which would cause a danger, are not produced;
c) protection non-electrical dangers caused by the electrical equipment which are revealed by
experience;
d) insulation must be suitable for foreseeable conditions.
3. Protection against hazards which may be caused by external influences
a) electrical equipment meets the expected mechanical requirements
b) electrical equipment shall be resistant to non-mechanical influences in expected environmental
conditions
c) protection in foreseeable conditions of overload.
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Presumption of Conformity-Harmonised
Standards
• Harmonised European standards elaborated by
CEN / CENELEC / ETSI
• Publication of reference in the Official Journal !
• Voluntary application by manufacturers: presumption of
conformity
• 75% of European Harmonised Standards IDENTICAL to
international standards (ISO/IEC).
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Technical file and DoC
• Technical file must contain trustworthy evidence of
compliance (design, tests done, etc.)
• DoC:
 Drawn up and signed by the manufacturer (or his
authorised representative) on own responsibility
 The information must include the product, the
manufacturer, applicable directives, applied harmonized
standards, assurance of conformity and, - if used - the
Conformity Assessment Body Notified to COM and MS
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
CE Marking
•
Affixed visibly, legibly and indelibly
on the own responsibility by
manufacturer or his authorised
representative
•
Means that the manufacturer
DECLARES to meet the legal
requirements and to be marketable
•
It is not a quality mark or a mark of
origin
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Enforcement-Post Market Control
• EU Market Surveillance Framework (Regulation 765/2008)
• National Responsibility (principle of subsidiarity) to organise and
carry out surveillance and organise cooperation
• Carried out by Government Officials:
Market Surveillance Authorities – can perform controls, withdraw
dangerous products…
• EU level: coordination, uniform enforcement, risk assessment
methodologies, international cooperation…
 Rapid exchange of information on products posing a risk to health
and safety
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
THIRD COUNTRIES
• Extension of EU Internal Market:
 EEA States (Iceland, Norway, Liechtenstein)
 Customs Union with Turkey (equivalent legislation)
• Mutual Recognition Agreements:
 Switzerland – equivalent legislation
 US – 2000 – Electrical Safety Annex
 Japan – 2002 – Electrical Products
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Conclusion
• We oblige manufacturers to ensure that products are totally safe
• They must at all times be able to proof that the products are safe and
keep technical documentation at the disposal of the authorities
• While the EU encourages the use of international standards, ISO/IEC
17025 only sets general requirements for the competence of testing
and calibration laboratories, while ISO/IEC 9001 refers to quality
management. They do not aim directly at the safety of products.
• In the EU we do not require testing/third party certification in
government recognised laboratories
• The Government's role is to police the market: we achieve a very high
safety record.
European Commission
ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL
Thank you
for your attention