Foods in the EU containing certain preparations from plants such as Aloe, Chinese rhubarb (Rheum palmatum) and Japanese knotweed (Reynoutria japonica) will require reformulation very soon.
In the coming days, a new Regulation prohibiting the presence in food of aloe-emodin, emodin, danthron, as well as preparations from the leaf of Aloe species containing hydroxyanthracene derivatives (HADs) (such as aloin) is expected to enter into force, as confirmed by the European Commissioner for Health and Food Safety.
Preparations containing the substances concerned are often used in food supplements to maintain normal bowel function and for their laxative effect. However, the European Food Safety Authority (EFSA) in its scientific opinion (adopted in 2017) expressed some safety concerns and this was followed by a proposed amendment to Regulation 1925/2006 banning the substances.
The prohibition means that certain preparations must contain no detectable levels of the substances concerned. It is noted in the summary report of the Standing Committee on Plants, Animals, Food and Feed (Section General Food Law) on 5 October 2020 that levels below 1 ppm aloe-emodin and/or 1 ppm emodin and/or 1 ppm aloin A + aloin B in products ready for use after preparation in accordance with the manufacturer's instructions would be tolerated.
In addition, the proposed amendment places under Union scrutiny HAD containing preparations 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., Rhamnus purshiana DC because of scientific uncertainty. Any interested party can submit to EFSA for its evaluation additional scientific data demonstrating the safety of the listed substances. The European Commission is obliged to decide on the final status (allowed, prohibited, or restricted) of the substances within four years from the substance listing date. In the meantime, the use of the substances under scrutiny is subject to national legislation in Member States.
It should be noted that no transitional periods regarding products already placed on the market have been suggested in the proposed amendment. Therefore, food business operators will have only 19 days starting on the day of the official publication of the Regulation to prepare for its entry into force.
ASTA ŠAMULEVIČIŪTĖ | Senior Regulatory Affairs Associate, FCI