Ministerial decree amending the Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations

The draft provides for an amendment to the Ministerial Decree of 19 February 2009 regarding the manufacture and marketing of food supplements that contain substances other than nutrients and plants or plant preparations

The draft defines the minimum and/or maximum values of four substances to be consumed per day in food supplements, namely:

- caffeine: maximum 80 mg/day

- lutein: between 2 and 10 mg/day

- lycopene: between 2.5 and 15 mg/day

- red yeast rice or any other source of monacolin K: maximum 10 mg/day of monacolin K

In order to ensure safety, a compulsory warning shall be introduced for caffeine and red yeast rice, which must appear on the product labelling:

- caffeine: ‘Unsuitable for children or pregnant or lactating women.’

- red yeast rice: ‘This product is unsuitable for pregnant or lactating women, children and adolescents, those over 70 years of age, those with liver, kidney or muscular problems, those taking medicinal products liable to interact (e.g.: cholesterol-lowering drugs) or those intolerant to statins.

If in doubt, please seek advice from your doctor or pharmacist.’

As a transitional measure, food supplements that do not meet the provisions of the draft decree but do meet the provisions of the existing decree may continue to be traded or labelled until [publication date + 10 days]; those which do not meet the provisions of the latter may continue to be marketed until stocks have been exhausted or until [signature date + 1 year], with the exception of products based on red yeast rice for which the decree shall be effective immediately, due to the increasing evidence of adverse effects.