Annex III to Regulation (EC) No 1925/2006 is amended as follows:
1.
The following entry is added in the table in Part B ‘Restricted substances’ in alphabetical order:
Restricted substance
Conditions of use
Additional requirements
‘Monacolins from red yeast rice
Individual portion of the product for daily consumption shall provide less than 3 mg of monacolins from red yeast rice.
The label shall provide the number of individual portions of the product for maximum daily consumption and a warning not to consume a daily amount of 3 mg of monacolins from red yeast rice or more.
The label shall indicate the content of monacolins per portion of the product.
The label shall include the following warnings:
“Should not be consumed by pregnant or lactating women, children below 18 years old and adults above 70 years old”.
“Seek advice from a doctor on consumption of this product if you experience any health problems”;
“Should not be consumed if you are taking cholesterol-lowering medication”;
“Should not be consumed if you are already consuming other products containing red yeast rice”.’
2.
The following entry is added in the table in Part C ‘Substances under Community scrutiny’ in alphabetical order:
‘Monacolins from red yeast rice’