March 19, 2021
The European Commission has published the final Commission Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives. This regulation prohibits the use of “preparations from the leaf of Aloe species containing hydroxyanthracene derivatives” and places other botanical species under scrutiny. The full text of the final regulation can be accessed here.
While the text of the regulation does not define what is meant by “preparations from the leaf of Aloe species containing hydroxyanthracene derivatives,” the meeting summary from the October 5, 2020 meeting of the Standing Committee on Plants, Animals, Food, and Feed (SCOPAFF) contains a discussion of the work performed by the European Reference Laboratory (EURL) to examine analytical methods for these compounds and identify limits of quantification (LOQs) for botanical preparations. The Committee agreed to the following statement, as provided in the meeting summary:
“The Committee concluded that products ready for use after preparation in accordance with the manufacturer's instructions containing an analysed level higher than or equal to 1 ppm aloe-emodin and/or 1 ppm emodin and/or 1 ppm aloin A + aloin B provide clear evidence of presence of these substances in the products and are therefore of concern for public health. The sum of the analysed contents of aloin A and aloin B can be used to quantify the total HAD content in preparations from the leaf of Aloe species, since aloin A and B are the most commonly occurring HADs in Aloe species. Measures as regards such products should be taken to ensure a high level of human health protection.”
At present, aloe vera preparations (finished products) having levels of aloin (total aloin A+B) of less than 1 ppm as “ready for use” would be considered to not have clear evidence of containing HADs, and would be acceptable under the new regulation. While this is the present expectation for enforcement purposes, it does not provide legal certainty for the aloe vera industry since a definitive threshold is not part of the regulation and it may be subject to change in the future.
This regulation is applicable to ingestible products only, and not to topical or cosmetic uses of aloe vera.
If you have any questions about this new regulation, please contact Jane Wilson, Executive Director, at 734-476-9690 or by email at email@example.com.