On April 8, 2021, the new European Regulation that limits the sale of food and food supplements containing hydroxyanthracene (HAD) derivatives came into force

In 2013, EFSA concluded that derivatives of hydroxyanthracene in food can improve intestinal function, but warned against long-term use and consumption at high doses due to potential safety concerns.
Following further investigation, EFSA today concluded that some hydroxyanthracene derivatives are genotoxic and carcinogenic.
COMMISSION REGULATION (EU) 2021/468 of 18 March 2021 entered into force on 08/04/2021 does not provide for transitional periods.

This Regulation concerning botanical species containing hydroxyanthracene derivatives amends Reg. (EC) No. 1925/2006 in All. Part A III, adding the following to the list of prohibited substances:
– Aloe-emodin and all preparations in which this substance is present
– Emodin and all preparations in which this substance is present
– Preparations from the leaf of Aloe species containing hydroxyanthracene derivatives
– Danthron and all preparations in which this substance is present

The prohibition does not apply to the following plants and parts of plants which are still under surveillance (as amended by Reg. (EC) No 1925/2006 in All. III Part C):
– Preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives
– Preparations from the leaf or fruits of Cassia senna L. containing hydroxyanthracene derivatives
– Preparations from the bark of Rhamnus frangula L. or Rhamnus purshiana DC. containing hydroxyanthracene derivatives

The Regulation specifies that banned substances may be present in ready-to-use products only at the level of impurities. The meaning of impurities has been expressed in the past by the European Commission (Standing Committee on Plants, Animals, Food and Feed Section General Food Law on 05 October 2020) concluding that products ready for use after preparation in accordance with the manufacturer’s instructions containing an analysed level of 1 ppm or more of Aloe-emodin and / or 1 ppm of Emodin and / or 1 ppm of Aloin A + Aloin B provide clear evidence of the presence of these substances in products and are therefore a concern for public health. The sum of the analyzed contents of Aloin A and Aloin B can be used to quantify the total content of HAD in the preparations from the leaf of the species of Aloe, since Aloin A and B are the most common HAD in the species of Aloe.

For support and advice from the new Complife Nutraceutical Regulatory Department please contact directly Silvia Giambuzzi, Nutraceutical Regulatory Manager, sending an email to [email protected]