Netherlands Food and Consumer Product Safety AuthorityMinistry of Economic Affairs

Evert Van Wilgenburg Senior Inspector Market Surveillance DevelopmentAdvisor and Product Safety Expert, Division Consumer and SafetyNetherlands Food and Consumer Product Safety Authority

Netherlands Food and Consumer Product Safety AuthorityMinistry of Economic Affairs

Approval Schemes for High Voltage Electrical Equipment in the EU

EU-Taiwan high voltage equipment management forum25/26 March 2014

Netherlands Food and Consumer Product Safety AuthorityMinistry of Economic Affairs

Evert van WilgenburgSenior Inspector Market Surveillance Development

Advisor and Product Safety Expert

Division Consumer and Safety

T 0031 (0)88 2233333 M 0031 (0)88 2232981e.vanwilgenburg@nvwa.nl

http://www.nvwa.nl

Netherlands Food and Consumer Product Safety AuthorityMinistry of Economic Affairs

Inhoud

• The NVWA• Low Voltage Directive• High Voltage Equipment• Economic operators• ISO/IEC 17025• Recommendation

Netherlands Food and Consumer Product Safety Authority NVWA

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The NVWA safeguards the health of animals and plants, animal welfare and the safety of food and products and enforces legislation in the field of nature.

– NVWA is part of the central government (Ministry of Economic Affairs) and has 2000 employees.– Main assignments from two ministries:

Ministry of Economic Affairs and Ministry of Health

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KNOWLEDGE & EXPERTISE

RISK ASSESMENT

RISK

COMMUNICATION

ENFORCEMENT

Core business

Risk assesmentRisk communicationEnforcement

Netherlands Food and Consumer Product Safety Authority NVWA

Low Voltage Directive

• Low Voltage Directive 2006/95/EC

• Method to show complianceCompile Technical FileDeclaration of ConformityCE-marking

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Low Voltage Directive

• Technical file:Technical documentation must enable the conformity of the electrical equipment to the requirements of this Directive to be assessed. (LVD Annex IV).

Declaration of conformity:

The manufacturer (or representative) declares conformity with the Directive and the references that are used (LVD Annex III B format and also part of the technical file).

CE-marking

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Low Voltage Directive

For the purposes of this Directive, ‘electrical equipment’ means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current

and

between 75 and 1500 V for direct current,

other than the equipment and phenomena listed in LVD Annex II.

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Electrical Equipment

LVD 50 and 1000 VAC / 75 and 1500 VDC

Within the scope of the LVD

Outside the scope of the LVD

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High Voltage Equipment

LVD 50 and 1000 VAC / 75 and 1500 VDC

Outside the scope of the LVD

A technical file can be used in the same way as for the LVD in order to show evidence of compliance.

•No DOC obligation•CE marking not allowed

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High Voltage Equipment

LVD 50 and 1000 VAC / 75 and 1500 VDC

Outside the scope of the LVD

Every state will have law that enable government to take corrective measures and/or to punish in case of non-compliance

Criminal, administrative or civil law (Commodity act in NL)

Economic operators

There are considerable differences between economic operators that produce: -household appliances or -products operating on high voltages:

• Manufacturer knowledge of the products• Customers knowledge and awareness• Impact at non-compliance

Economic operators

Accreditation based on ISO/IEC 9001 ensure to a certain level that manufacturers are obligated to:

• Comply with law• Be able to show evidence of compliance• Investigate complaints• Take appropriate actions when necessary

ISO/IEC 17025

Introduction:It contains all of the requirements that testing and calibration laboratories have to meet.

Scope:This International Standard specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

ISO/IEC 17025

• The obligation for accreditation based on ISO/IEC 17025 is only useful for test laboratories that perform testing for third parties.

• Using ISO/IEC 17025 does not prevent that manufacturers can produce non-compliant products.

ISO/IEC 17025

Experiences and evaluation of accidents and incidents show that there is no relation between application of ISO/IEC 17025 and preventing those events.

Explanation based on accident and incidents examples

RECOMMENDATION

Because is does not contribute in preventing incidents and accidents, we would like to support the withdrawal of the use of ISO/IEC 17025 in Directive 401 as part of the obligation to manufacturers.

Thank youfor your attention