Monacolin K is produced by Monascus purpureus of which some strains produce also citrinin. Data available on the presence of citrinin in certain red yeast rice preparations revealed high levels of citrinin in those preparations. The consumption of such red yeast rice preparations at the quantity necessary to obtain the claimed effect would result in an exposure significantly above the level of no concern for nephrotoxicity of citrinin. Therefore it is appropriate to establish a maximum level for citrinin in red yeast rice preparations. To obtain the necessary intake of monacolin K, 4-6 capsules of 600 mg of red yeast rice need to be consumed. A maximum level of 2 mg/kg for citrinin in red yeast rice preparation has been established in order to ensure that the possible exposure to citrinin from these red yeast rice preparations remains significantly below the level of nephrotoxicity of 0,2 μg/kg bw foe an adult. Given the gaps in knowledge as regards the presence of citrinin in other foodstuffs and the remaining uncertainties as regards the carcinogenicity and genotoxicity of citrinin, it is appropriate to review the maximum level within two years’ time once more information has been gathered as regards the toxicity of citrinin and the exposure from other foodstuffs.

The addition of substances to or the use of substances in foodstuffs is governed by specific Union and national legislation, as is the classification of products as foodstuffs or medicinal products. The setting of a maximum level in such a substance or product does not constitute an authorisation to the marketing of the substance for which a maximum level is established, a decision on whether the substance can be used in foodstuffs, or a classification of a certain product as a foodstuff.

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,