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MOTION FOR A RESOLUTION (D099926/03 – 2026/2839(RPS))

On the draft Commission regulation amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards certain botanical species containing hydroxyanthracene derivatives

B-10-2026-0465

Committee on the Environment, Climate and Food Safety · Rapporteur: Pascal Arimont

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Parliament opposes the draft Commission regulation that would ban foods containing preparations from certain Rheum, Cassia senna and Rhamnus species with hydroxyanthracene derivatives (HADs). It says the draft exceeds the Commission's implementing powers under Regulation (EC) No 1925/2006 and does not show a harmful effect for each preparation and use covered. It asks the Commission to withdraw or defer the draft until the Court of Justice rules on pending appeals against the annulment of Regulation (EU) 2021/468. Before any new measure, it wants a complete scientific assessment of individual HADs, exposure, dose and vulnerable groups, and clarification of divergences between EFSA and EMA. It calls on the Commission to justify why a complete prohibition is necessary and proportionate, and to examine less restrictive measures under Part B of Annex III.

Key points

  1. The draft Commission regulation would prohibit foods containing preparations from specified Rheum, Cassia senna and Rhamnus species where they contain hydroxyanthracene derivatives (HADs).
  2. Those preparations were placed under Union scrutiny in Part C of Annex III by Regulation (EU) 2021/468; the draft would move them to Part A, a complete prohibition.
  3. The General Court annulled the provisions of Regulation (EU) 2021/468 placing those preparations under scrutiny, and appeals are pending before the Court of Justice.
  4. The provisions were annulled because the conditions in Article 8 of Regulation (EC) No 1925/2006 for delegated powers to amend Annex III were not met.
  5. EFSA has concerns about genotoxicity of HAD-containing preparations although uncertainty persists, while EMA recognises certain medicinal uses under defined conditions, restrictions and warnings.
  6. Parliament opposes adoption of the draft Commission regulation.
  7. It considers the draft exceeds the implementing powers in Regulation (EC) No 1925/2006, treats inability to establish safety as enough for a complete prohibition, extends a concern about one component to every HAD preparation, and does not demonstrate a harmful effect for each category covered.
  8. It calls on the Commission to withdraw the draft or defer adoption until the Court of Justice gives final judgment in the pending appeals and, if cases are referred back, until the remaining pleas are assessed.
  9. It says adopting the prohibition before the appeals are decided risks parallel proceedings, inconsistent outcomes, irreversible adaptation costs and reduced effectiveness of judicial review.
  10. It calls for a complete, transparent and up-to-date scientific assessment covering individual HADs, hazard characterisation, exposure and dose, manufacturing, conditions of use and vulnerable groups, and for examination of divergences between EFSA, EMA and other bodies.
  11. It asks the Commission to clarify whether Article 30 of Regulation (EC) No 178/2002 applies and how its mechanism has been used.
  12. It calls on the Commission to justify a complete prohibition as necessary and proportionate, examine less restrictive measures under Part B of Annex III, and define regulated categories by precise botanical, compositional, analytical and concentration criteria.

Who is affected

  • Farmers, herb growers and food business operators, who would face economic consequences from a complete prohibition.
  • Member States whose national law permits use of some of the botanical species or preparations under compositional requirements, conditions and warnings.
  • The Commission, which is asked to withdraw or defer the draft and to obtain further scientific assessment.
  • EFSA and EMA, whose assessments are to be examined for divergences and possible use of the Article 30 mechanism.

Figures and deadlines

  • 22 November 2017: date EFSA adopted its scientific opinion on the safety of hydroxyanthracene derivatives for use in food.
  • 23 January 2018: date that EFSA opinion was published.
  • 1 July 2026: date the Standing Committee on Plants, Animals, Food and Feed delivered its opinion.

Legal basis: Article 8(5), first subparagraph, of Regulation (EC) No 1925/2006.