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Understanding EU's Technical Standards Approach

Explore EU's 'New Approach' to technical standardization, compliance directives, mutual recognition agreements, and WTO TBT Agreement. Learn about product conformity, penalties for non-compliance, and contact details for legal assistance.

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Understanding EU's Technical Standards Approach

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Presentation Transcript

  1. Enlargement and Technical Standards

  2. Overview of EU’s approach • ‘New Approach’ to technical standardization • General Directives (wide scope) • Compliance with essential safety requirements • Conformity assessment depends on product type (e.g. self-certification, type approval) • Technical file (where required) • EC Declaration of Conformity and CE Marking • Compliance with technical standards offers rebuttable presumption of conformity (but: compliance with standards is only voluntary)

  3. Overview of EU’s approach, cont’d • Examples of ‘New Approach’ Directives • Machinery • Electrical (low voltage) equipment • EMC • Medical Devices • Radio and telecoms terminal equipment • PPE • Toys

  4. Overview of EU’s approach, cont’d • All products marketed in the EU (whether domestic or imported) must comply with the relevant Directive(s) • Penalties (imposed at national level) for non-compliance may include • withdrawal or recall of products • fines • imprisonment • negative publicity • In addition, new GPSD and Producer Liability Directive apply

  5. Mutual Recognition Agreements • Aim at facilitating trade but are often neglected • Products can be checked in country of export for compliance with requirements of country of import (= saves money and time) • Checks performed by previously approved conformity assessment bodies • EU has concluded MRAs with US, Canada, Japan, Australia, New Zealand, Israel and Switzerland covering various sectors

  6. WTO TBT Agreement • Covers technical regulations (mandatory) and standards (not mandatory) • MFN clause / National treatment • General requirements for adoption of technical regulations and standards • Notification / Publication requirements • Dispute settlement • Very important in case national a technical regulation or standard restricts/prohibits access to a market

  7. Contact Kostas Katsoulis European Law Centre Baker & McKenzie 149 Avenue Louise Eighth Floor Brussels tel. +32 2 639 36 11 konstantinos.katsoulis@bakernet.com

  8. Enlargement and Technical standards

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