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European Court of Justice annuls prohibition for hydroxyanthracene derivatives (HADs) in Aloe spp.
- By: admin
- On: 11/14/2024 13:50:16
- In: IASC Updates
Regulation had prohibited the presence of HADs in preparations of Aloe spp.
On Nov. 13, 2024, the European Court of Justice (ECJ) annulled portions of European Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006, as regards to botanical species containing hydroxyanthracene derivatives (HADs). The EJC decision was issued as part of the consideration of four different legal actions that had been brought against the European Commission (EC) following the issuance of the regulation in March 2021.
The ECJ agreed with applicant arguments that the EC had incorrectly applied the requirements of Article 8 of the Regulation to prohibit use of preparations of Aloe spp., as no threshold had been identified for daily intake of Aloe spp. that would give rise to human health concerns. Among other findings, the ECJ also concluded that the EC had exceeded what is permitted to be prohibited under Article 8 of the Regulation. The regulation as written prohibited all “preparations from the leaf of Aloe species containing [HADs],” and the ECJ concluded that Article 8 provisions cannot be used to prohibit use of specific foodstuffs or botanicals.
These decisions may impact EC action that was expected to also prohibit the use of preparations containing HADs from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids; from the leaf or fruit of Cassia senna L.; and from the bark of Rhamnus frangula L. or Rhamnus purshiana DC. These botanicals had been added to Part C (under scrutiny) of Annex III to Regulation No 1925/2006 in March 2021, and recent indications were that these botanicals would also be prohibited by moving them to Part A of the regulation. The decisions could also impact future handling of the prohibition of botanicals or botanical constituents of concern by the EC.
IASC member company Aloe Vera of Europe (Netherlands) was one of the four organizations that brought forth legal applications in this matter. Other applicants included Ortis (Belgium); Synadiet (France); and the group of Aboca SpA Soc. agr., Coswell SpA (Italy), and Associação Portuguesa de Suplementos Alimentares (Portugal).