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Enlargement and Technical Standards

Enlargement and Technical Standards. 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)

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Enlargement and Technical Standards

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  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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