Scientific Opinion on the substantiation of health claims related to monacolin K from red yeast rice and maintenance of normal blood LDL cholesterol concentrations (ID 1648, 1700) pursuant to Article 13(1) of Regulation (EC) No 1924/2006
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Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924No /2006.This opinion addresses the scientific substantiation of health claims in relation to monacolin K from red yeast rice and maintenance of normal blood LDL-cholesterol concentrations.The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food that is the subject of the health claim is red yeast rice (i.e.rice fermented with the red yeast Monascus purpureus).The Panel considers that, whereas red yeast rice is not sufficiently characterised in relation to the claimed effect, the food constituent, monacolin K from red yeast rice, is sufficiently characterised.
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Based on published reports, the European Food Safety Authority has approved red yeast rice as a food for maintenance of normal cholesterol levels.
“Based on these published reports, the European Food Safety Authority has approved RYR as a food for maintenance of normal cholesterol levels [32].”
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Marked Variability of Monacolin Levels in Commercial Red Yeast Rice Products: Buyer Beware!
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- Authors
- EFSA Panel on Dietetic Products, N. A. A. (.
- Corresponding author
- EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
- Venue
- EFSA Journal
- Publisher
- Wiley
- Published
- 2011-07
- Volume
- 9
- Issue
- 7
- ISSN
- 1831-4732 (ISSN-L)
- OpenAlex
- W2913766220
- Cited by
- 84
- References
- 6
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 6 · 2023: 2 · 2022: 4 · 2021: 3 · 2020: 7 · 2019: 7 · 2018: 9 · 2017: 11 · 2016: 12 · 2015: 8 · 2014: 2 · 2013: 5 · 2012: 2
- FWCI
- 2.83
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- EFSA Journal (publishedVersion, cc-by-nd)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Technical University of Denmark, DTU Orbit (Technical University of Denmark, DTU) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Consumer Attitudes and Food Labeling
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biotechnology › Microbial Metabolism and Applications
- Life Sciences › Agricultural and Biological Sciences › Plant Science › Mycotoxins in Agriculture and Food
- Keywords
- lovastatin, red yeast rice, Monascus purpureus, health claims, LDL cholesterol, serum cholesterol, cholesterol-lowering effect, Regulation (EC) No 1924/2006
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