EFSA: Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006
The Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of monacolins from red yeast rice (RYR), which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925/2006.
In 2018, EFSA published its first opinion on the safety of monacolin from red rice, based on an inquiry under Article 8 of Regulation (EC) No 1925/2006. The assessment raised concerns about possible adverse effects on the liver and musculoskeletal system from the ingestion of monacolin K.
The NDA panel now evaluated data submitted by interested parties during the Union scrutiny period, and maintains its previous conclusions, i.e., that the data submitted do not allow establishing the safety of monacolins in RYR supplements below 3 mg/day or to identify a daily intake of monacolins from RYR in food supplements that does not raise safety concerns for the general population or vulnerable subgroups thereof.
EFSA - European Food Safety Authority
Anmerkungen:
- Monascus purpureus ist in der Schweiz bereits in Anhang 4 Verordnung des EDI
über den Zusatz von Vitaminen, Mineralstoffen und sonstigen Stoffen in Lebensmitteln (VZVM) bei den Stoffen, die Lebensmitteln nicht zugesetzt werden dürfen, aufgeführt.
- Die EU hat 2024 die vorher zugelassene gesundheitsbezogene Angabe für Monacolin K aus Rotschimmelreis wieder gestrichen. Hintergrund ist der fehlende Nachweis der Sicherheit der Monacoline von Monascus purpureus (Rotschimmelreis) bei der erforderlichen Dosierung von 10mg, vgl. http://data.europa.eu/eli/reg/2024/2041/oj