Food products

Draft Commission Regulation (EU) 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 (Text with EEA relevance). Language(s): English. Number of pages: 5

This draft Commission Regulation concerns the prohibition of use in food of certain plant preparations containing hydroxyanthracene derivatives based on the scientific opinion of EFSA and following a period of Union scrutiny during which food business operators, or any other interested parties, may submit scientific data to demonstrate the safety of plant preparations in question.

On 22 November 2017, the European Food Safety Authority (EFSA) adopted a scientific opinion on the evaluation of the safety of hydroxyanthracene derivatives for use in food. In that opinion it concluded that there is a possibility of harmful effects on health associated with the use of Rheum, Cassia and Rhamnus and their preparations in food, but scientific uncertainty persists. Consequently, pursuant to the procedure laid down in Article 8(2) of Regulation (EC) No 1925/2006, the plant preparations concerned were put under Union scrutiny by means of Regulation (EU) 2021/468 of 18 March 2021 for a period of four years from the entry into force of that Regulation, which allowed interested parties to provide EFSA with evidence of safety within 24 months.

On 20 March 2024, EFSA adopted a scientific opinion on additional scientific data related to the safety of preparations of Rheum palmatum L., Rheum officinale Baill. and their hybrids, Rhamnus purshiana DC., Rhamnus frangula L., and Cassia senna L. submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006. In its opinion, EFSA concluded that the safety of plant preparations under evaluation cannot be established based on the submitted studies. Therefore, pursuant to the procedure of Article 8(5) of Regulation (EC) No 1925/2006, the plant preparations concerned should be included in Part A of Annex III to Regulation (EC) No 1925/2006, which means that their use in food will be prohibited.