EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10056/2019    
(POOL/E2/2019/10056/10056 -EN.docx)       
D060605/03  
[…](2019) XXX  draft 
 
COMMISSION REGULATION (EU) No …/..  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of citrinin in food 
supplements based on rice fermented with red yeast Monascus purpureus   
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) No …/..  
of XXX  
amending Regulation (EC) No 1881/2006 as regards maximum levels of citrinin in food 
supplements based on rice fermented with red yeast Monascus purpureus   
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of  the European Union,  
Having regard to Council Regulation (EEC) No  315/93 of 8  February 1993 laying down 
Community procedures for contaminants in food1, and in particular Article 2(3) thereof,  
Whereas:  
(1) Commission Regulation (EC) No  1881/20062 sets maximum l evels for citrinin in food 
supplements based on rice fermented with red yeast Monascus purpureus . 
(2) Following a request from the Commission  to deliver a scientific opinion on the health 
risks from citrinin in food and feed , on 2 March 2012, the Scientific Panel on 
Contaminants in the Food Chain  of the European Food Safety Authority ( 'the 
Authority' )  adopted  an opinion on the risk s for public and animal health r elated to the 
presence of citrinin in food and feed3. The Scientific Panel on Contaminants 
conclu ded that b ased on the available data, a concern for genotoxicity and 
carcinogenicity could not be excluded as regards citrinin at the level of no concern for 
nephrotoxicity.  
(3) Data available on the presence of citrinin in certain  red yeast rice preparations revealed 
high levels of citrinin  in those preparations . Therefore , a maximum level for citrinin in 
red yeast rice preparations  was established in Regulation (EC) No  1881/2006 . Given 
the gaps in knowledge as regards the presence of citrinin in  red yeast rice preparations 
and in other foodstuffs and the remaining uncertainties as regards its carcinogenicity 
and genotox icity, a review of the maximum level was considered to be appropriate .   
(4) In 2015,  the Authority published a call for proposals  to investigate the concentrations 
of citrinin in food samples with special focus on grains and grain -based products  from 
different  geographic regions in Europe . The report  describing the outcome of these 
investigations “Occurrence of citrinin in food”4 was published in 2017.  Representative 
                                                 
1 OJ L 37, 13.2.1993, p. 1.  
2 Commission Regulation (EC) No  1881/2006 of 19 December 2006 setting maximum levels for  certain 
contaminants in foodstuffs  (OJ L 364, 20.12.2006, p. 5 ).  
3 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on the risks for public 
and animal health related to the presence of citrinin in food and feed. EFSA Journal 2012;10(3):2605. 
[82 pp.] Available online:  www.efsa.europa.eu/efsajournal  
4 López P, de Nijs M, Spanjer M, Pietri A, Bertuzzi T, Starski A, Postupolski J, Castellari M and Hortós 
M, 2017. Generation of  occurrence data on citrinin in food. EFSA supporting publication 2017:EN -
1177. 47 pp.  
 EN 2  EN data on the occurrence of citrinin in food in Europe were obtained, mainly in cereals 
and cereal products and food supplements based on rice fermented with red yeast.  
(5) The new occurrence data  on citrinin indicate that th ere is no need to establish  the 
maximum levels of  citrinin in food other than red yeast rice supplements . However, 
for citrinin in food supplements containing red yeast Monascus purpureus  the obtained 
representative occurrence data provide evidence that the maximum level should be 
lowered. No new toxicity data on citrinin, requiring an update of the Authority’s 
assessment of the risks of citrinin for public health, have become available. Therefore, 
the uncertainties as regards the genotoxicity and carcino genicity of citrinin remain. It 
is therefore necessary for the protection of public health that the levels of citrinin in 
food are as low as reasonable achievable. This is particularly relevant for food 
supplements based on rice fermented with red yeast as  data provide evidence that very 
high levels of citrinin can be found in certain samples of these products, resulting in a 
high exposure to citrinin for consumers of these products.  At the same time,  according 
to the available data , it follows that  by appl ying good manufacturing processes low  
level s of citrinin in food supplements based on rice fermented with red yeast 
Monascus purpureus  can be achieved .  Given the remaining uncertainties as regards 
the toxicity of citrinin and the feasibility to achieve lo w levels of citrinin by applying 
good manufacturing practices, i t is appropriate to lower the maximum level for citrinin 
in  food supplements  based on rice fermented with red yeast Monascus purpureus  to 
ensure a high lev el of human  health protection.  
(6) A reasonable period should be provided to allow the Member States and food business 
operators to adapt to the new requirements set out in this Regulation. Regulation (EC) 
No 1881/2006 should therefore be amended accordingly.  
(7) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
The Annex to  Regulation (EC) No  1881/2006 is amended in accordance with the An nex to 
this Regulation .  
Article 2 
Food supplements based on rice fermented with red yeast Monascus purpureus  that were  
lawfully placed on the market before the entry into force of this Regulation may remain on the 
market until their date of minimum durabi lity or use -by-date.  
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
It shall apply from 1 April 2020.  EN 3  EN This Regulation shall be binding in its entirety  and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President