In 2016, the European Commission requested EFSA to deliver a scientific opinion on the safety of hydroxyanthracene derivatives in food in accordance with Article 8 of Regulation (EC) 1925/2006. In the scientific opinion adopted by EFSA on 22 November 2017, the safety assessment noted proof of genotoxicity associated with the use of aloe-emodin, emodin, danthron and aloe extracts containing hydroxyanthracene derivatives. No safe daily intake level could be established for these substances. The Commission concludes that these substances should be prohibited and included in Annex III, Part A of Regulation (EC) 1925/2006.
In addition, considering that there is scientific uncertainty about whether Rheum, Cassia and Rhamnus extracts contain the substances listed in Annex III, Part A of the above Regulation, the Commission proposes to place these botanical extracts under scrutiny in Part C of Annex III of Regulation (EC) 1925/2006 for use in food.
The Commission draft Regulation to restrict the use of the named substances has been made available for feedback until 22 april here.
Orchidali can help you in the preparation and writing of regulatory files.
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Food safety and hydroxyanthracene derivatives: The EU Commission would like to hear the stakeholder views until 22 April 2020
In 2016, the European Commission requested EFSA to deliver a scientific opinion on the safety of hydroxyanthracene derivatives in food in accordance with Article 8 of Regulation (EC) 1925/2006. In the scientific opinion adopted by EFSA on 22 November 2017, the safety assessment noted proof of genotoxicity associated with the use of aloe-emodin, emodin, danthron and aloe extracts containing hydroxyanthracene derivatives. No safe daily intake level could be established for these substances. The Commission concludes that these substances should be prohibited and included in Annex III, Part A of Regulation (EC) 1925/2006.
In addition, considering that there is scientific uncertainty about whether Rheum, Cassia and Rhamnus extracts contain the substances listed in Annex III, Part A of the above Regulation, the Commission proposes to place these botanical extracts under scrutiny in Part C of Annex III of Regulation (EC) 1925/2006 for use in food.
The Commission draft Regulation to restrict the use of the named substances has been made available for feedback until 22 april here.
Orchidali can help you in the preparation and writing of regulatory files.
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