Nutraveris

Europe: ongoing discussions on a draft regulation on botanicals containing hydroxyanthracene derivatives (HAD)

The European Commission received 70 feedbacks on its consultation (open until 23 April 2020) on a draft regulation concerning plants containing hydroxyanthracene derivatives (HAD), according to article 8 of Regulation (EC) 1925/2006 and following the opinion of EFSA in 2018 on hydroxyanthracene derivatives.

This draft regulation would add:

  • in Part A of Annex III to Regulation (EC) 1925/2006, corresponding to a ban in Europe when the text will come into force:
    • 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.
  • 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 will have 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).
    • 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.

Following these feedbacks, additional discussions would take place between European authorities and interesting parties on this draft text. The final text could be published in the European Official Journal by the end of 2020.

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