Commission Regulation (EU) no. 2021/468 amending Annex III to Regulation (EC) no. 1925/2006 of the European Parliament and of the Council on botanical species containing hydroxyanthracene derivatives (HADs) was published on 18 March 2021 and applied on 7 April 2021 (with no transition period).
The plants containing hydroxyanthracene derivatives are widely used in food supplements and herbal medicinal products for their laxative effect.
New validated method in our Labs to quantify hydroxyanthracene derivatives in food supplements
The R&D department of Mérieux NutriSciences has developed and validated a method for the determination of HADs in dietary, herbal and food supplement products through LC-MS/MS analysis (LoQ = 0,3 mg/kg and LoD = 0,1 mg/kg):
- Aloin A
- Aloin B
- Sum of Aloin-A + Aloin-B
Our experts can also quantify other HAD molecules in plants under observation (Rheum palmatum L., Rheum officinale Baillon and other hybrids, Cassia senna L., Rhamnus frangula L., Rhamnus purshiana DC and others).
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EFSA reported that some hydroxyanthracene derivatives proved to be genotoxic in vitro and in vivo. In consideration of this and the concerns expressed about possible adverse effects associated with the consumption of food containing hydroxyanthracene derivatives and their preparations, in 2016 the European Commission required EFSA to produce a scientific opinion on the safety assessment of the use of these substances.
10 June 2020
During the meeting of the EU Commission and Member States (General Food Law Section,) no agreement was reached on the draft Regulation that –if approved– would define the issue of hydroxyanthracenics whose limit cannot be currently established for their safe use in food supplements.
19 March 2021
Commission Regulation (EU) no. 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) n. 1925/2006 of the European Parliament and of the Council on botanical species containing hydroxyanthracene derivatives was published.
The inclusion of the following substances/preparations in Part A of Annex III of Regulation 1925/2006, resulting in a ban on their use in food supplements, concerns the following substances/preparations:
- preparations from the leaf of Aloe species containing HAD derivatives;
- Aloe-emodin and all preparations in which this substance is present;
- Emodin and all preparations in which this substance is present;
- Danthron and all preparations in which this substance is present.
As regards the analytical determinations of the HAD levels in the finished product, the Commission reported that a level greater than or equal to:
- 1 mg/kg of aloe-emodin and/or
- 1 mg/kg of emodin and/or
- 1 mg/kg of the sum of aloin A and aloin B (the sum of which can be used as a quantification of the total amount of HADs present in the product)
constitutes evidence of the presence of these substances, including total HADs.
The same regulation then places the following food ingredients under Union supervision in Part C of Annex III to Regulation 1925/2006:
- preparations from the root or rhizome of Rheum palmatum L., Rheum officinale Baillon and their hybrids containing hydroxyanthracene derivatives;
- preparations from the leaf or fruit of Cassia senna L. containing hydroxyanthracene derivatives;
- preparations from the bark of Rhamnus frangula L., Rhamnus purshiana DC. containing hydroxyanthracene derivatives.
What to do?
Regulation (EU) no. 2021/468 of the European Parliament and of the Council was published. The rule restricts the commercial sale of certain foods and food supplements containing hydroxyanthracene derivatives, and it has come into force on 7th April 2021.
During manufacturing, hydroxyanthracene derivatives can be removed from botanical preparations through a series of filtering processes, resulting in products that only contain traces of these substances in the form of impurities.