Monascus

Food supplement declared in France, declaration No 2023-5-503, decision dated 11 May 2023

Monascus (Biotikon) is a food supplement declared in France. Status: déclaré en France, commercialisation possible : l'administration ne s'est pas opposée à la déclaration (ce n'est ni une autorisation ni une évaluation de sécurité). 1 rule of use applies to its ingredients (limits and warnings).

Brand: Biotikon
Food business operator placing the product on the market: Biotikon
Status: Déclaré en France, commercialisation possible : l'administration ne s'est pas opposée à la déclaration (ce n'est ni une autorisation ni une évaluation de sécurité)
Form: Capsule
Daily dose: 1
Not recommended for (according to the manufacturer): Adolescents (moins de 18 ans), Enfants (moins de 12 ans), Enfants en bas âge (1 à 3 ans), Femmes enceintes, Nourrissons (moins de 1 an), Enfants (de moins de 6 ans), Enfants (de moins de 10 ans)
Flavourings: neutre

Declaration 194167, procedure Article 15. Compl'Alim, food supplement declarations (France), retrieved 23 October 2026.

Regulatory points

Conditions légales
Contains red yeast rice. Monacolins must remain below 3 mg per daily portion, with mandatory warnings on the label. The monacolin content is not declared in Compl'Alim.
Source: Regulation (EC) No 1925/2006, latest consolidated version, annexe III, partie B (règlement (UE) 2022/860).

Declared composition

Plants

Plant	Part	Preparation	Per day
Monascus purpureus Went	Graine	Autre extrait sec	67.39 mg

List from the declaration, administrative decision dated 11 May 2023 (Compl'Alim, food supplement declarations (France)).

List recorded in 2023. Photograph the packaging to check whether it has changed.

Has the product changed? Photograph the packaging.

This information reproduces the manufacturer's declaration to the administration (DGAL). It does not say whether the product is effective and does not replace advice from a doctor or pharmacist, particularly during pregnancy or when taking medication.

Brand : Biotikon