Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission consultation, 4 March 2020
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Commission consultation: List of substances in food prohibited or permitted under scrutiny (hydroxyanthracene derivatives) A copy of this document is available on this site (click on image) |
The Commission is consultating on this proposed legislation. The consultation period ends on 22 April 2020. For details, see: Commission consultation. The following are the recitals taken from the draft.
Pursuant to Article 8(2) of Regulation (EC) No 1925/2006, on its own initiative or on the basis of information provided by Member States, the Commission may initiate a procedure to include a substance or an ingredient containing a substance other than a vitamin or a mineral in Annex III to Regulation (EC) No 1925/2006 listing the substances whose use in foods is prohibited, restricted or under Union scrutiny, if that substance is associated with a potential risk to consumers as defined by Article 8(1) of Regulation (EC) No 1925/2006.
Plants containing hydroxyanthracene derivatives are numerous and belong to different botanical families and genera. They are widely used in food supplements and herbal medicinal products for their laxative effect.
In its Scientific Opinion of 9 October 2013 on the scientific substantiation of a health claim related to hydroxyanthracene derivatives and improvement of bowel function, the European Food Safety Authority (‘the Authority`) concluded that hydroxyanthracene derivatives in food can improve bowel function, but advised against long-term use and consumption at high doses due to potential safety concerns such as the danger of electrolyte imbalance, impaired function of the intestine and dependence on laxatives.
In view of that opinion, and of the concerns raised by Member States, during the discussion on the health claim under consideration in 2013 about the possible harmful effects associated with the consumption of foods containing hydroxyanthracene derivatives and preparations thereof, the Commission in 2016 requested the Authority to deliver a scientific opinion on the evaluation of safety in use of hydroxyanthracene derivatives in food in accordance with Article 8 of Regulation (EC) No 1925/2006.
The information provided by the Member States to the Commission fulfilled the necessary conditions and requirements laid down in Articles 3 and 4 of Commission Implementing Regulation (EU) No 307/2012 [see Note 1 below].
On 22 November 2017, the Authority adopted a scientific opinion on the evaluation of the safety of hydroxyanthracene derivatives for use in food [see Note 2 below]. The hydroxyanthracene derivatives considered relevant for this risk assessment were those found in the root and rhizome of Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids; leaves or fruits of Cassia senna L.; bark of Rhamnus frangula L., bark of Rhamnus purshiana DC. and in leaves of Aloe barbadensis Miller and/or various Aloe species, mainly Aloe ferox Miller and its hybrids.
The Authority found that the hydroxyanthracene derivative aloe-emodin and emodin and structurally related substance danthron have been shown to be genotoxic in vitro. Aloe extracts have also been shown to be genotoxic in vitro most likely due to hydroxyanthracene derivatives present in the extract. Furthermore, aloe-emodin was shown to be genotoxic in vivo. The whole leaf aloe extract and structural analogue danthron were shown to be carcinogenic.
Given that aloe-emodin and emodin may be present in the extracts, the Authority concluded that hydroxyanthracene derivatives should be regarded as genotoxic and carcinogenic unless there are specific data to the contrary and that there is a safety concern for extracts containing hydroxyanthracene derivatives although uncertainty persists. The Authority was unable to provide advice on a daily intake of hydroxyanthracene derivatives that does not give rise to concerns for human health.
Considering the severe harmful effects on health associated with the use of aloe-emodin, emodin, danthron and aloe extracts containing hydroxyanthracene derivatives in food, and that no daily intake of hydroxyanthracene derivatives that does not give rise to concerns for human health could be set, such substances should be prohibited. Therefore, aloe-emodin, emodin, danthron and hydroxyanthracene derivative-containing aloe extracts should be included in Annex III, Part A of Regulation (EC) No 1925/2006.
As there is a possibility of harmful effects on health associated with the use of Rheum, Cassia and Rhamnus extracts in food, but scientific uncertainty persists about whether such extracts contain the substances listed in Annex III, Part A of Regulation (EC) No 1925/2006, such substances should be placed under Union scrutiny and therefore, should be included in Part C of Annex III to Regulation (EC) No 1925/2006.
Regulation (EC) No 1925/2006 should therefore be amended accordingly.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.
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