A new decree recently published by the Belgian authorities sets new maximum limits for caffeine, lutein, lycopene and red yeast rice in food supplements.
The decree updates an existing Royal decree on substances other than nutrients and plants or plant preparations which already included maximum limits for choline and ubiquinone and specified the chemical form of carnitine. The new limits are:
caffeine: maximum 80 mg/day (total content, including other sources e.g. plants);
lutein: between 2 and 10 mg/day;
lycopene: between 2.5 and 15 mg/day; and
red yeast rice (or any other source of monacolin K): maximum 10 mg/day of monacolin K.
For food supplements with red yeast rice several requirements apply:
The following warnings are mandatory: "This product is not suitable for pregnant or lactating women, children and adolescents, people over 70 years of age, people with liver, kidney or muscular problems, people taking medicinal products liable to interact (e.g. cholesterol-lowering drugs) or people intolerant to statins. In case of doubt, please seek advice from your doctor or pharmacist." ;
The maximum content of citrinin must be below 2000 µg/kg, in accordance with Regulation 212/2014/EC;
Only products complying with Regulation 2015/2283/EC on novel food ingredients are allowed;
The dose of monacolin K must be standardized (maximum 10% deviation); and
The content of monacolin K must be stated in the notification file.
The maximum levels are based on the advice of the Superior Health Council and the Mixed Commission.
As a transitional measure, food supplements which were placed on the market or labeled before November 29, 2018, and which do not comply with the provisions of the new decree, may continue the to be marketed until exhaustion of stocks and until October 26, 2019 at the latest. However, the transitional measure does not apply to supplements with red yeast rice (or others source of monacolin K). For those products the new restrictions apply immediately.
Many other EU Member States apply a maximum limit of 200 mg of caffeine per day in food supplements following the EFSA advice on caffeine (e.g. France, Italy and Romania).
Consolidated version of the decree: Arrêté Ministeriel du 19 Février 2009 relatif à la fabrication et au commerce de compléments alimentaires contenant d’autres substances que des nutriments et des plantes ou des préparations de plantes