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REPORT (COM(2022)0462 – C90313/2022 – 2022/0280(COD))

On the proposal for a directive of the European Parliament and of the Council amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2013/29/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU and 2014/68/EU as regard emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency

A-9-2023-0245

Committee on the Internal Market and Consumer Protection · Rapporteur: Andreas Schwab

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Written by a language model from the full text only; every figure comes from the text. The paragraph links open the paragraph a statement rests on — check the text itself before relying on it.

Parliament's amended version of the Commission proposal amends 13 sectoral directives on product rules to add emergency procedures for a Single Market emergency. It renames the framework the Internal Market Emergency and Resilience Act (IMERA) and replaces 'Single Market' with 'internal market' throughout. The amended rules let notified bodies prioritise conformity assessment of crisis-relevant goods, and let national authorities temporarily authorise products that have not gone through the usual conformity assessment, after a risk assessment and on a justified request from an operator in their member state. Authorisations must set conditions including an end date, labelling requirements and record-keeping for 10 years, and remain valid for six months after the emergency ends. The Commission may adopt common specifications by implementing acts, and mandatory common specifications are deleted. Market surveillance authorities must make all reasonable efforts to help each other during an emergency, including sending expert teams and reinforcing testing capacity.

Committee position. The committee adopts its position at first reading with amendments to the Commission proposal, renaming the framework IMERA, adding emergency procedures for conformity assessment, common specifications and market surveillance, and deleting provisions on mandatory common specifications.

Key points

  1. The amended text renames the framework the Internal Market Emergency and Resilience Act (IMERA) and replaces 'Single Market' with 'internal market' throughout the directives.
  2. Emergency measures transposing the new articles apply only if the Commission has adopted an implementing act under Article 14(5) of the IMERA Regulation, and only during the internal market emergency mode.
  3. Notified bodies must ensure all reasonable efforts are made to process conformity assessment applications for crisis-relevant goods as a matter of priority, without extraordinary additional costs for manufacturers, and to increase testing capacities.
  4. National competent authorities may, after a risk assessment and on a justified request from an operator established in their member state, authorise placing on the market of specific crisis-relevant goods that have not undergone the required conformity assessment, if compliance with applicable requirements is demonstrated.
  5. Authorisations must set out conditions and requirements including at least an end date not beyond the last day of the emergency mode and labelling requirements, including radio frequency identification, indicating authorisation under the emergency mode.
  6. National authorities may amend the conditions and requirements of an authorisation after the deactivation or expiry of the internal market emergency mode.
  7. Market surveillance authorities may take corrective and restrictive measures at national level, must keep records of products authorised under a derogation for 10 years, and must make them available to other authorities on request.
  8. Products authorised under a derogation remain valid for six months after the end of deactivation or expiration of the internal market emergency mode; after that they need authorisation under the normal procedure.
  9. The Commission may adopt common specifications by implementing acts, applicable until the last day of the emergency mode, giving manufacturers a presumption of conformity; it must take into account views of relevant bodies and duly consult all relevant stakeholders.
  10. The provisions on mandatory common specifications are deleted from the directives.
  11. Member states must ensure market surveillance authorities make all reasonable efforts to assist other authorities during an emergency, including by mobilising expert teams and reinforcing testing capacity for crisis-relevant goods.
  12. The rapporteur's explanatory statement says the title should change to 'Internal Market Emergency and Resilience Act' (IMERA) and that resilience, free movement and cooperation with companies should be strengthened.

Who is affected

  • Manufacturers of products covered by the 13 directives, who may benefit from prioritised assessment or temporary authorisations.
  • Notified bodies, which must prioritise crisis-relevant goods and increase testing capacity.
  • National competent authorities, which may grant temporary authorisations and must keep records for 10 years.
  • Market surveillance authorities, which must assist each other and may take corrective measures.
  • Consumers and end-users, whose health and safety must be fully assured under derogations.

Figures and deadlines

  • Authorisations remain valid for six months after deactivation or expiration of the internal market emergency mode.
  • Market surveillance authorities must keep records of products authorised under a derogation for 10 years.
  • The Commission may adopt common specifications by implementing acts under Article 14(5) of the IMERA Regulation.

Legal basis: Article 294(2) and Articles 91 and 114 of the Treaty on the Functioning of the European Union.