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Adopted text

Re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

TA-10-2025-0047 · P10_TA(2025)0047 · PE763.253

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Parliament's amended version of the proposed regulation re-attributing scientific and technical tasks and improving cooperation among EU agencies on chemicals. It reinforces procedures for resolving divergent scientific opinions, prioritising the most protective opinion for vulnerable groups, and expands ECHA's role in hazard assessment. It also adjusts rules on medical devices, waste containing persistent organic pollutants, and delegated acts, and requires the Commission to monitor ECHA's resources and tasks.

Key points

  1. Differences in assessment methodologies leading to divergent opinions must be justified, especially regarding protection of vulnerable groups; priority goes to the most protective opinion.
  2. When the Authority and another body cannot resolve a divergence, they must draw up a public joint report outlining contentious issues, uncertainties, and possible causes including methodological differences.
  3. If divergence involves a Member State body, the Authority and that body must cooperate to resolve it or prepare a public joint document.
  4. The Authority may extend the period for adopting outputs if it requests additional information from another authority, after consulting that body and informing the Commission.
  5. The Commission may request ECHA to develop a proposal for harmonised classification and labelling to resolve scientific divergence on hazard identification of chemicals.
  6. Medical devices must not contain substances classified as endocrine disruptors Category 1 under Regulation (EC) No 1272/2008, replacing the previous 'identified' wording.
  7. ECHA must publish a notice on its website when it receives a request for a report on amending Annex IV or V of the POPs Regulation, inviting comments within 8 weeks.
  8. The Committee for Socio-economic Analysis must adopt an opinion on the report and proposed concentration limits within 9 months of submission.
  9. The Commission may amend Annexes IV and V to adapt to changes in the list of substances in Annexes I, II or III of the POPs Regulation, or to the Convention or Protocol, or to scientific progress.
  10. The Commission must monitor ECHA's resources and the tasks of its scientific committees and, if necessary, propose legislation to address needs from this Regulation.
  11. The period for objecting to delegated acts may be extended by two months at the initiative of Parliament or the Council.

Who is affected

  • European Food Safety Authority and other Union agencies: must cooperate to resolve scientific divergences and prioritise protective opinions.
  • European Chemicals Agency: gains tasks in harmonised classification and labelling, and must publish notices and receive opinions from its committee.
  • Member State bodies: must cooperate with the Authority on scientific divergences.
  • Manufacturers of medical devices: must avoid using certain endocrine disruptors.
  • Waste operators and users of recycled materials: can comment on reports on amending POPs annexes.

Figures and deadlines

  • 8 weeks for submitting comments on ECHA's notice about a report on amending Annex IV or V.
  • 9 months for the Committee for Socio-economic Analysis to adopt an opinion on the report.
  • Two months for objecting to a delegated act, extendable by two months.