Food supplements

Commission Regulation (EU) amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice (Text with EEA relevance). Language(s): English. Number of pages: 8

This draft Commission Regulation concerns the inclusion of monacolins from red yeast rice (RYR) in Annex III of Regulation (EC) No 1925/2006 ('the Regulation').

EFSA, in its scientific opinion adopted on 28 June 2018, considered that monacolin K in lactone form is identical to lovastatin, the active ingredient of several medicinal products authorised for the treatment of hypercholesterolemia in the European Union. EFSA concluded that monacolins in RYR when used as food supplements were of significant safety concern at the use level of 10 mg/day, and that individual cases of severe adverse reactions had been reported at intake levels as low as 3 mg/day. Furthermore, EFSA noted that the profile of adverse effects to RYR was similar to that of lovastatin. Therefore, pursuant to the procedure of Article 8 of the Regulation, this substance should be included in Annex III (Part B) to the Regulation.

Furthermore, as EFSA could not identify a safe dietary intake of monacolins from RYR, and therefore, there is still the possibility of harmful effects on health but scientific uncertainty persists in this regard, this substance should be placed under Union scrutiny (Part C of the 'Regulation').