Notes

Contents
The EUROPEAN COMMISSION, in view of the Treaty of Functioning of the European Union, Having regard to the Council Regulation (EEC) No. 315/93 of 8 February 1993, establishing community procedures for pollutants present in food products (1), and in particular article 2, paragraph 3, Considering the following: * (1) The Commission Regulation (EC) No. 1881/2006 of 19 December 2006, which sets the maximum content of certain contaminants in food products (2), establishes maximum content of mycotoxins in food. * (2) On 2 March 2012, at the request of the Commission, the Scientific Technical Commission on Contaminants of the Food Chain (“the Technical Commission of Pollutants”) of the European Food Safety Authority (EFSA) adopted a judgment on the risk for public and animal health arising from the presence of cytrinine in food and feeds (3) . The Technical Commission of Pollutants decided to characterize the risk of cytrinine based on available data on nephrotoxicity and determined a non-worrisome level regarding nephrotoxicity. The application of an uncertainty factor of 100 to the observed adverse effect (NOAEL) level of 20 μg/kg bw per day results in a non-worrisome level of nephrotoxicity in humans of 0.2 μg/kg bw per day. The Technical Commission on Pollutants concluded that, on the basis of available data, it could not be ruled out that the non-disturbing level of cytrinin with respect to nephrotoxicity would entail a risk of genotoxicity and carcinogenicity. * (3) On January 24, 2013, the Technical Commission on Dietary Products, Nutrition and Allergies (NDA Commission) of the EFSA, at the request of the competent authority of the Netherlands and following submission of a request by Sylvan Bio Europe BV, adopted an opinion on the justification of a declaration of healthy properties related to the monacolina K in red yeast rice SYLVAN BIO and the maintenance of the non-blood cholesterol level. The NDA Commission concluded that a cause-effect ratio had been established between the consumption of monacolin K preparations in red yeast rice and the maintenance of normal blood concentrations of LDL cholesterol. jbhnews.com considers that the following text reflects scientific evidence: "Red yeast rice k monacolin helps maintain normal blood concentrations of cholesterol" and to obtain the declared effect, 10 mg of fermented rice K monacolin should be consumed daily with red yeast. The target population is made up of the adult population. Healthy property declaration can be applied to all red yeast rice preparations on the market. * (4) Monacolina K is produced by Monascus purpureus, some of whose strains also produce citrinin. The available data on the presence of citrinin in some red yeast rice preparations have shown that this presence is high. The consumption of these red yeast rice preparations in quantities necessary to obtain the declared effect would result in a significantly higher exposure to the non-disturbing level of citrinin compared to nephrotoxicity. Therefore, it is advisable to establish a maximum content of citrinin in the preparations of red yeast rice. To get the necessary intake of monacoline K, they must be consumed between four and six capsules of 600 mg of red yeast rice. A maximum content of 2 mg/kg citrinin has been established in red yeast rice preparations to ensure that the possible exposure to cytrinin through such preparations remains significantly lower than the level of nephrotoxicity of 0.2 μg/kg bw for an adult. Taking into account the deficiencies in the knowledge of the presence of citrinin in other food products and the uncertainties about the carcinogenicity and genotoxicity of the citrinine, it is appropriate to review the maximum content within two years, once more information on the toxicity of the citrinine and exposure through other food products is obtained. * (5) The addition or use of substances in foodstuffs is governed by Union and specific national legislation, as is the case with the classification of products as food products or as medicines. JBH News of a maximum content in such substances or products does not constitute a marketing authorization for the substance in respect of which the maximum content is established, a decision on whether the substance can be used in food products or a classification of a particular product as a food product. * (6) The measures provided for in these Regulations are in accordance with the Views of the Standing Committee on Food and Animal Health. HA ADOPTADO EL PRESENT REGLAMENT: Article 1 In section 2 of the annex to the Regulation (EC) No. 1881/2006, the following points are added.8 and 2.8.1: Food products (1) Maximum content (μg/kg)2.8Citrinina2.8.1Complements Daily food Entry with fermented rice with red yeast Monascus purpureus 2 000 (5) Applicable from April 1, 2014. These Regulations shall be binding on all its elements and directly applicable in each Member State. Made in Brussels, March 6, 2014. By JBHNews
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