Analysis of monacolins in food supplements and raw materials

Following the scientific opinion on the safety consumption of monacolins in red yeast rice (RYR) delivered by the Panel on Food Additives and Nutrient Sources added to Food (ANS), the EU Commission has finally published the Regulation (EU) 2022/860 amending Annex III to Regulation (EC) No 1925/2006 as regards monacolins from red yeast rice. The Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union (1 june 2022).

The aim of the Regulation (EU) 2022/860
The aim of the Regulation (EU) 2022/860 is limiting the use in foods and food supplements by including the monacolins from RYR in Part B (substances subject to restrictions) and Part C (substances under Community control) of Annex III of Reg. EC 1925/2006.
Here below, a summary which lists the main points at hand:

• Daily consumption shall provide less than 3 mg of monacolins from RYR
• European Commission refers to generic monacolins, and not only to monacolin K
• No transitional period
• The label shall include a list of warnings concerning its consumption.

How Mérieux NutriSciences can support?

Analytical services
In order to ensure that the product or ingredient meets the draft requirements, Mérieux NutriSciences has developed a new analytical service to detect the monacolins:

1. Quantitative determination of monacolins K – monacolin K hydroxyacid (MKA) and monacolin K in lactone form (MK) – on raw materials and finished products through HPLC-UV/DAD validated method.
2. Quantitative estimation of total monacolins on raw materials through HPLC-UV/DAD method and secondary qualified reference standard, including the following minor monacolins:
   1. monacolin J hydroxyacid (MJA)
   2. monacolin J (MJ)
   3. monacolin M (MM)
   4. monacolin L hydroxyacid (MLA)
   5. monacolin X (MX)
   6. monacolin L (ML)
   7. compactin / mevastatin (P1)
   8. dehydroxymonacolin (DMK)
3. On demand characterization of minor monacolins on finished product

Regulatory services
Food supplements are required by Article 6 of Directive 2002/46/EC to be labeled with mandatory elements including the recommended quantity of product for daily consumption together with a warning not to exceed the stated recommended daily dose.
Mérieux NutriSciences Expert Services Unit offers a range of services to assist companies in labeling of new or existing food supplements to conform to continuously changing legal requirements.