SCIENTIFIC OPINION
ADOPTED: 22 November 2017
doi: 10.2903/j.efsa.2018.5090
Safety of hydroxyanthracene derivatives for use in food
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS),
Maged Younes, Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Metka Filipi c,
Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle,
Claude Lambr e, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus,
Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen,
Rudolf Antonius Woutersen, Raul J Andrade, Cristina Fortes, Pasquale Mosesso,
Patrizia Restani, Fabiola Pizzo, Camilla Smeraldi, Adamantia Papaioannou and Matthew Wright
Abstract
The Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a
scientific opinion on the safety of hydroxyanthracene derivatives and to provide advice on a daily
intake that does not give rise to concerns about harmful effects to health. Hydroxyanthracene
derivatives are a class of chemical substances naturally occurring in different botanical species and
used in food to improve bowel function. The ANS Panel reviewed the available scientific data on a
possible relationship between hydroxyanthracene derivatives exposure and genotoxic and carcinogenic
effects. On the basis of the data currently available, the Panel noted that emodin, aloe-emodin and the
structurally related substance danthron have shown evidence of in vitro genotoxicity. Aloe extracts
have also been shown to be genotoxic in vitro possibly due to the presence of hydroxyanthracene
derivatives in the extract. Furthermore, aloe-emodin was shown to be genotoxic in vivo and the wholeleaf
aloe extract and the structural analogue danthron were shown to be carcinogenic. Epidemiological
data suggested an increased risk for colorectal cancer associated with the general use of laxatives, several
of which contain hydroxyanthracene derivatives. Considering the possible presence of aloe-emodin and
emodin in extracts, the Panel concluded that hydroxyanthracene derivatives should be considered as
genotoxic and carcinogenic unless there are specific data to the contrary, such as for rhein, and that
there is a safety concern for extracts containing hydroxyanthracene derivatives although uncertainty
persists. The Panel was unable to provide advice on a daily intake of hydroxyanthracene derivatives
that does not give rise to concerns about harmful effects to health.
© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf
of European Food Safety Authority.
Keywords: hydroxyanthracene derivatives, food supplements, genotoxicity, carcinogenicity, bowel
function, colorectal cancer, laxatives
Requestor: European Commission
Question number: EFSA-Q-2016-00562
Correspondence: FIP@efsa.europa.eu
SCIENTIFIC OPINION
ADOPTED: 22 November 2017
doi: 10.2903/j.efsa.2018.5090
Safety of hydroxyanthracene derivatives for use in food
EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS),
Maged Younes, Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Metka Filipi c,
Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle,
Claude Lambr e, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus,
Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen,
Rudolf Antonius Woutersen, Raul J Andrade, Cristina Fortes, Pasquale Mosesso,
Patrizia Restani, Fabiola Pizzo, Camilla Smeraldi, Adamantia Papaioannou and Matthew Wright
Abstract
The Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a
scientific opinion on the safety of hydroxyanthracene derivatives and to provide advice on a daily
intake that does not give rise to concerns about harmful effects to health. Hydroxyanthracene
derivatives are a class of chemical substances naturally occurring in different botanical species and
used in food to improve bowel function. The ANS Panel reviewed the available scientific data on a
possible relationship between hydroxyanthracene derivatives exposure and genotoxic and carcinogenic
effects. On the basis of the data currently available, the Panel noted that emodin, aloe-emodin and the
structurally related substance danthron have shown evidence of in vitro genotoxicity. Aloe extracts
have also been shown to be genotoxic in vitro possibly due to the presence of hydroxyanthracene
derivatives in the extract. Furthermore, aloe-emodin was shown to be genotoxic in vivo and the wholeleaf
aloe extract and the structural analogue danthron were shown to be carcinogenic. Epidemiological
data suggested an increased risk for colorectal cancer associated with the general use of laxatives, several
of which contain hydroxyanthracene derivatives. Considering the possible presence of aloe-emodin and
emodin in extracts, the Panel concluded that hydroxyanthracene derivatives should be considered as
genotoxic and carcinogenic unless there are specific data to the contrary, such as for rhein, and that
there is a safety concern for extracts containing hydroxyanthracene derivatives although uncertainty
persists. The Panel was unable to provide advice on a daily intake of hydroxyanthracene derivatives
that does not give rise to concerns about harmful effects to health.
© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf
of European Food Safety Authority.
Keywords: hydroxyanthracene derivatives, food supplements, genotoxicity, carcinogenicity, bowel
function, colorectal cancer, laxatives
Requestor: European Commission
Question number: EFSA-Q-2016-00562
Correspondence: FIP@efsa.europa.eu
indobserver Πηγή Ο ΧΥΜΟΣ ΚΑΙ ΤΟ ΕΚΧΥΛΙΣΜΑ ΦΥΛΛΩΝ ΑΛΟΗΣ ΠΕΡΙΕΧΟΥΝ ΕΝΩΣΕΙΣ ΜΕΤΑΛΛΑΞΟΓΟΝΕΣ ΚΑΙ ΚΑΡΚΙΝΟΓΟΝΕΣ! ΔΕΙΤΕ ΚΑΙ…ΨΑΧΘΕΙΤΕ! ΤΙ ΣΥΜΒΑΙΝΕΙ; Ο ΚΟΣΜΟΣ ΚΑΤΑΝΑΛΩΝΕΙ ΣΥΝΕΧΕΙΑ ΑΛΟΗ!
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