EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10860/2018 
(POOL/E1/2018/10860/10860 -EN.doc)  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and 
of the Council as regards botanical species containing hydroxyanthracene derivatives  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and 
of the Council as regards botanical species containing hydroxyanthracene derivatives  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the 
Council of 20 December 2006 on the addition of vitamins and minerals and of certain other 
substances to foods1, and in particular Article 8(2) (a)(i) and (b)  thereof,  
Whereas:  
(1) Pursuant to Article 8(2) of Regulation (EC) No 1925/2006, o n 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.  
(2) Plants containing hydroxyanthra cene 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.  
(3) In its Scientific Opinion of 9 October 2013 on the scientific substantiat ion of a health 
claim  related to hydroxyanthracene derivatives and improvement of bowel function2, 
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 .  
(4) In view of t hat 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 prepara tions 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.  
                                                 
1 OJ L 404, 30.12.2006, p. 26.  
2 EFSA Journal 2013;11(10)  :3412   
EN 2  EN (5) The information provide d 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  307/20123.  
(6) On 22 November 2017, the Authority adopted a scientific opinion on the eval uation of 
the safety of hydroxyanthracene derivatives for use in food4. 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 thei r 
hybrids; leaves or fruits of Cassia senna L .; bark of Rhamnus frangula L ., bark of 
Rhamnus purshiana D C. and in leaves of Aloe barbadensis Miller  and/or various Aloe 
species, mainly Aloe ferox Miller  and its hybrids.  
(7) The Authority found that the hydroxy anthracene derivative aloe -emodin and emodin 
and structural ly 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 . 
(8) 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 Author ity was unable to provide advice on a daily intake of 
hydroxyanthracene derivatives that does not give rise to concerns for human health.   
(9) Considering th e severe harmful effects on health associated with the use of aloe -
emodin, emodin , danthron  and aloe ex tracts 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 a loe extracts  should be included in Annex III, Part A of Regulation (EC) 
No 1925/2006.  
(10) 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 A nnex III to Regulation (EC) No 1925/2006.  
(11) Regulation (EC) No 1925/2006 should therefore be amended accordingly.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
                                                 
3 Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing 
rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parl iament and 
of the Council on the addition of vitamins and minerals and of certain other substances to foods  
(OJ L 102, 12.4.2012, p. 2).  
4 The Panel on Food Additives and Nutrient Sources added to Food (ANS ); Scientific O pinion on the 
safety of hydroxyanth racene derivatives . EFSA Journal  2018;16(1):5090 .  
EN 3  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III to Regulation (EC) No 1925/2006 is amended as follows:  
(1) in Part A, the following entr ies are added  in alphabetical order :  
‘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 ’. 
(2) in Part C, the following entr ies are added  in alphabetical order :  
‘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 ., Rhamnu s purshiana D C. containing 
hydroxyanthracene derivatives ’. 
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publica tion in 
the Official Journal of the European Union. This Regulation shall be binding in its entirety 
and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER