There is a new step towards the restrictions of red yeast rice Monacolins in food supplements… with a negative outlook.
The European permanent committee SCOPAFF (Standing Committee on Plants, Animals, Food and Feed) has fully adopted the regulation suggested by the European Food Safety Authority, which means that Monacolins:
- are forbidden in a quantity more or equal than 3 mg per day
- are accepted in a quantity less than 3 mg per day with many additional labelling requirements
- will be evaluated within the next four years by the Commission, to confirm restrictions or prohibit this ingredient
What happens next? The European Parliament has to examine this regulation. The estimated period is two or three months. If no objections are issued, the text will be published and come into effect twenty days later.
This decision comes after a strong debate between the Authority and the trade organizations, which in turn have provided statements to support the safe use of monacolins from red yeast rice in combination with adequate consumer information on the safe use of the substance. On the contrary, the Authority highlighted different results supporting the comparison between monacolin K in lactone form and lovastatin for which adverse effects are well documented.
As a conclusion of this infamous debate, the Authority could not identify a dietary intake of Monacolins from red yeast rice that does not give rise to concerns about harmful effects to health, neither to the general population, nor to the more vulnerable subgroups of the population. Given the possible presence of harmful effects on health associated with the use of monacolins from red yeast rice and the ongoing conflicting scientific uncertainty, the use of monacolins from red yeast rice in food supplements will be placed under Union scrutiny.