In March, the European Commission will publish a regulation prohibiting the use in food of extracts of the leaf of Aloe, and extracts containing aloe-emodin, emodin and danthron. Even more, the regulation will also put under scrutiny extracts from other plants containing hydroxyanthracene derivatives (‘HADs’), i.e. Rhubarb, Cassia and Buckthorn. This regulation will apply 20 days after its publication. So, it is advisable to review and reformulate all products with these plants immediately.
The gel and juice of the leaf of Aloe are widely used in fortified foods and in food supplements for their laxative effect. In an opinion on a health claim related to HADS the EFSA advised against long-term use and consumption at high doses due to potential safety concerns. In view of that opinion, and of the concerns raised by Member States, the EC requested the EFSA to deliver a scientific opinion on the safety of HADs in food in accordance with Article 8 of Regulation (EC) No 1925/2006.
In 2017 the EFSA adopted a scientific opinion on the evaluation of the safety of HADs for use in food. The EFSA concluded that HADs should be regarded as genotoxic and carcinogenic and that there is a safety concern for extracts containing HADs although uncertainty persists. The EFSA was unable to provide advice on a daily intake of HADs that does not give rise to concerns for human health.
Consequently, the EC decided to prohibit aloe-emodin, emodin, danthron and HAD-containing aloe extracts and place Rheum, Cassia and Rhamnus extracts under Union scrutiny by amending Annex III to Regulation (EC) No 1925/2006 as follows:
- in Part A, the following entries are added:
– aloe-emodin and all extracts in which this substance is present;
– emodin and all extracts in which this substance is present;
– extracts from the leaf of Aloe species containing hydroxyanthracene derivatives;
– danthron and all extracts in which this substance is present.
- in Part C, the following entries are added:
– extracts from the root, rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives;
– extracts from the leaf, fruit of Cassia senna L. containing hydroxyanthracene derivatives;
– extracts from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives.
Food business operators, or any other interested parties, may at any time submit for evaluation to the EFSA scientific data demonstrating the safety of a substance listed in Part C. Within four years the EC will decide to prohibit these substances or authorize them under conditions.
To distinguish products containing HAD from products from which they have been removed but technical impurities remain, the EC proposes 1 ppm of aloe-emodin, emodin or the sum of aloin A and B as the limit of quantification. However, this limit will not be included in the new regulation, it will be published in the report of the meeting of the Standing Committee on Plants, Animals, Food and Feed.
Most Member States currently still authorize the use of these ingredients. The Belgian authorities even determined maximum levels for the use in food supplement. A leaf extract of Aloe macroclada is authorized as a novel food ingredient as well.
The measure will start to apply 20 days after publication in the Official Journal, expected in March and there will be no transition period.
 Commission Regulation (EU) …/… amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives. Available at: https://op.europa.eu/en/publication-detail/-/publication/fc00cb2c-5e26-11ea-b735-01aa75ed71a1
 Scientific Opinion on the substantiation of a health claim related to hydroxyanthracene derivatives and improvement of bowel function pursuant to Article 13(5) of Regulation (EC) No 1924/2006. Available at: https://www.efsa.europa.eu/en/efsajournal/pub/3412
 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1925-20190515
 Safety of hydroxyanthracene derivatives for use in food. Available at: https://www.efsa.europa.eu/en/efsajournal/pub/5090