REGUL ATIONS 
COMMI SSION REGUL ATION (EU) 2019/1901 
of 7 November 2019 
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 EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regard to Council Regulation (EEC) No 315/93 of 8 Febr uary 1993 laying down Community procedures for 
contaminants in food (1), and in particular Article 2(3) thereof, 
Whereas: 
(1) Commission Regulation (EC) No 1881/2006 (2) sets maximum levels for citrinin in food supplements based on rice 
fermented with red yeast Monascus purpureu s. 
(2) Following a request from the Commission to deliver a scientifi c opinion on the health risks from citrinin in food and 
feed, on 2 Marc h 2012, the Scientific Panel on Contaminants in the Food Chain of the European Food Safet y 
Authority (‘the Auth ority’) adop ted an opinion on the risks for public and animal health relat ed to the presence of 
citrinin in food and feed (3). The Scientifi c Panel on Contaminants concluded that based on the available data, a 
concer n for genoto xicity and carcinog enicity could not be excluded as regards citrinin at the level of no concer n for 
nephroto xicity . 
(3) Data available on the presence of citrinin in certain red yeast rice preparations revealed high levels of citrinin in those 
preparations. Theref ore, a maximum level for citrinin in red yeast rice preparations was established in Regulation 
(EC) No 1881/2006. Given the gaps in kno wledge as regar ds the presence of citrinin in red yeast rice preparations 
and in other foodstuffs and the remaining uncer tainties as regar ds its carcinogenicity and genot oxicity , a review of 
the maximum level was considered to be appropr iate. 
(4) In 2015, the Auth ority published a call for proposals to inve stigat e the concentrations of citrinin in food samples 
with special focus on grains and grain-based products from diffe rent geographic regions in Europe. The repor t 
descr ibing the outcome of these investigat ions ‘Occur rence of citrinin in food’ (4) was published in 2017. 
Representative data on the occur rence of citrinin in food in Europe were obtained, mainly in cereals and cereal 
products and food supplements based on rice fermente d with red yeast. 
(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 (CONT AM); Scientific Opinion on the risks for public and animal health relate d to the 
presence of citrinin in food and feed. EFSA Jour nal 2012;10(3):2605. [82 pp.] Available online: www .efsa.europa.eu/efsajournal 
(4)López P, de Nijs M, Spanjer M, Pietr i A, Bertuzzi T, Starski A, Postupolski J, Castellar i M and Hor tós M, 2017. Generation of occur rence 
data on citrinin in food. EFSA suppor ting publication 2017:EN-1177. 47 pp. EN Offi cial Jour nal of the European Union L 293/2                                                                                                                                         14.11.2019   (5) The new occur rence data on citrinin indicate that there 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 occur rence data provide evidence that the maximum level should be lowered. 
No new toxicity data on citrinin, requir ing an update of the Author ity’s assessment of the risks of citrinin for public 
health, have become available. Theref ore, the uncer tainties as regards the genot oxicity and carcinog enicity of citrinin 
remain. It is theref ore necessar y for the protection of public health that the levels of citrinin in food are as low as 
reasonable achievab le. 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 
follo ws that by applying good manufactur ing processes low levels of citrinin in food supplements based on rice 
fermented with red yeast Monascus purpureus can be achieved. Given the remaining uncer tainties as regar ds the 
toxicity of citrinin and the feasibility to achi eve low levels of citrinin by applying good manufactur ing practices, it is 
appropr iate to lowe r the maximum level for citrinin in food supplements based on rice fermented with red yeast 
Monascus purpureus to ensure a high level of human health protect ion. 
(6) A reasonable period should be provid ed to allow the Member States and food business operat ors to adap t to the new 
requirements set out in this Regulation. Regulation (EC) No 1881/2006 should theref ore be amended according ly. 
(7) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The Annex to Regulation (EC) No 1881/2006 is amended in accordance with the Annex to this Regulation. 
Article 2 
Food supplements based on rice fermented with red yeast Monascus purpureu s that were lawfully placed on the mark et 
before the entr y into force of this Regulation may remain on the market until their date of minimum durability or use-by- 
date . 
Article 3 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 1 Apr il 2020. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 7 November 2019.  
For the Commission 
The President 
Jean-Claude JUNCKER     EN Offi cial Jour nal of the European Union 14.11.2019                                                                                                                                         L 293/3   ANNEX 
The Annex to Regulation (EC) No 1881/2006 is amended as follo ws: 
(1) In section 2 of the Annex to Regulation (EC) No 1881/2006, the followi ng entr y 2.8.1 is replaced by: 
‘Foodstuffs (1) Maximum levels (µg/kg) 
2.8 Citr inin  
2.8.1 Food supplements based on rice fer­
mente d with red yeast Monascus pur­
pureu s 100’   
(2) The footnote ‘(*) The maximum level is to be reviewed before 1 Januar y 2016 in the light of information on exposure to 
citrinin from other foodstuffs and updat ed information on the toxicity of citrinin in particular as regar ds 
carcinog enicity and genoto xicity’ is delet ed.   EN Offi cial Jour nal of the European Union L 293/4                                                                                                                                         14.11.2019