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REPORT (COM(2022)0461 – C90314/2022 – 2022/0279(COD))

On the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011 as regards emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency

A-9-2023-0244

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 five product regulations to add emergency procedures for conformity assessment, common specifications and market surveillance during an internal market emergency. The emergency articles apply only after the Commission activates the internal market emergency mode under the IMERA Regulation, and only to goods designated as crisis-relevant. Notified bodies must prioritise conformity assessment applications for crisis-relevant goods, increase testing capacity and not charge extraordinary additional costs for prioritisation. National authorities may exceptionally authorise products that have not undergone the usual conformity assessment, subject to conditions, labelling and a six-month validity after the emergency ends. The Commission may adopt common specifications by implementing acts, and products complying with them are deemed compliant after the emergency ends. Market surveillance authorities must cooperate and assist each other, and keep records of products authorised under a derogation for 10 years.

Committee position. The committee adopts Parliament's position at first reading with amendments to the Commission proposal, adding emergency procedures to the sectoral regulations and extending them to Regulations (EU) 2023/988 and (EU) 2023/1230.

Key points

  1. The amended regulations are (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009, (EU) 2023/988, (EU) 2023/1230 and (EU) No 305/2011.
  2. Emergency procedures apply only after the Commission adopts an implementing act activating the internal market emergency mode under the IMERA Regulation.
  3. The procedures apply only to products designated as crisis-relevant goods in that implementing act.
  4. Notified bodies must process applications for crisis-relevant goods as a matter of priority and increase their testing capacities.
  5. Prioritisation must not give rise to extraordinary additional costs for manufacturers who lodged the applications.
  6. National competent authorities may, after a risk assessment and on a justified request, authorise products that have not undergone the required conformity assessment but comply with essential requirements.
  7. Authorisations must set conditions including an end date not beyond the emergency period and labelling requirements indicating authorisation under the emergency mode.
  8. Products authorised under a derogation remain valid for six months after the emergency ends, after which normal authorisation is required.
  9. The Commission may adopt common specifications by implementing acts, applicable until the emergency ends, and products complying with them are deemed compliant afterwards.
  10. Member States may presume compliance for products meeting national or international standards ensuring an equivalent level of protection.
  11. Market surveillance authorities must assist each other during an emergency and keep records of products authorised under a derogation for 10 years.
  12. The regulation applies from the same date as the IMERA Regulation.

Who is affected

  • Manufacturers of cableway installations, PPE, appliances, fertilising products, machinery, consumer products and construction products designated as crisis-relevant goods.
  • Notified bodies, which must prioritise applications and increase testing capacity without extraordinary additional costs.
  • National competent authorities, which may grant derogations and must keep records for 10 years.
  • Market surveillance authorities, which must cooperate and assist each other during an emergency.
  • The Commission, which may adopt common specifications by implementing acts.

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.

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