Journal article · Report
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL - cholesterol concentrations pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Following an application from Sylvan Bio Europe BV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to monacolin K in SYLVAN BIO red yeast rice and maintenance of normal blood LDL-cholesterol concentrations.
The food, monacolin K in SYLVAN BIO red yeast rice, that is the subject of the health claim is sufficiently characterised. The claimed effect, maintenance of normal blood LDL-cholesterol concentrations, is a beneficial physiological effect. A claim on monacolin K from red yeast rice and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome at daily intakes of 10 mg monacolin K from any red yeast rice preparation (which would include SYLVAN BIO red yeast rice).
The evidence provided by the applicant for the present application does not establish that monacolin K in SYLVAN BIO red yeast rice is different from monacolin K in other red yeast rice preparations with respect to its effect on blood LDL-cholesterol concentrations. © European Food Safety Authority, 2013
Language: | English |
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Publisher: | European Food Safety Authority |
Year: | 2013 |
Series: | Efsa Journal |
ISSN: | 23149396 , 18314732 and 18305458 |
Types: | Journal article and Report |
DOI: | 10.2903/j.efsa.2013.3084 |