Europe: Publication of the regulation on plants containing hydroxyanthracene derivatives (HAD)
On 19 March 2021, Regulation (EU) 2021/468 of 18 March 2021 amending Annex III to Regulation (EC) No 1925/2006 as regards botanical species containing hydroxyanthracene derivatives has been published on the Official Journal of the European Union and will apply on 7 April 2021 (with no transition period).
This regulation adds:
- in Part A of Annex III to Regulation (EC) 1925/2006, corresponding to a ban in Europe:
- 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.
- and in Part C of Annex III to Regulation (EC) 1925/2006, i.e. under Union scrutiny (under scrutiny because of scientific uncertainty: still usable according to national legislations, the industry has 18 months to submit additional scientific data demonstrating the safety of the substances for a possible new assessment by EFSA; and the Commission should take a decision within four years).
- 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.
In terms of implementation, according to the SCPAFF summary report (meeting 5 October 2020):
- The level of 1 ppm for aloe-emodin/emodin and the level of 1 ppm for the sum of aloin A and aloin B are for the time being the lowest levels that can be reliably quantified in laboratories across the EU and can therefore be put forward as limits of quantification (LOQ) in an EU harmonised risk management approach.
- 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.
Concretely from 7 April 2021, only the products containing less than 1 ppm aloe-emodin, 1 ppm emodin and 1 ppm aloin A + aloin B may continue to be marketed in the European Union.