Czech Republic notifies new draft decree on food supplements / by Joris Geelen

The Czech Republic has notified a draft decree on food supplements and the composition of foodstuffs to the European Commission which contains a lists with maximal levels for 16 plants (e.g. 2 g hydroxycitric acid of the peel of Garcinia gummi-gutta) and for 7 substances (e.g. 10 mg Monacolin K from fermented red yeast rice). More importantly, the decree also contains a list with 108 forbidden plants and 8 other substances.

 In the list of forbidden plants there are several anthranoid containing plants (like rhubarb) which are authorized under conditions in other Member States.

Melatonin, N-acetylcysteine banned

 The list of forbidden substances includes melatonin and N-acetylcysteine. In Italy 1 mg melatonin is allowed in food supplements. In Belgium the maximum level for N-acetylcysteine is 150 mg/day. With the additional restriction that it can only be used by adults and children above 12 years and with two mandatory warnings.

No BELFRIT or positive list of plants

 Most surprisingly the decree did not include a list of authorized plants. Last year, the Czech authorities hosted an event to promote harmonization. Many Member States spoke out in favor of the so-called 'BELFRIT list', the harmonized list drafted by Belgium, France and Italy. 

Next steps

The notification procedure established by Directive (EU) 2015/1535 is a tool for information, prevention and dialogue in the field of technical regulations on products and Information Society services (TRIS). It helps to anticipate and prevent the creation of barriers to trade. The provisional end of standstill period is till September 5th. However, this period will most probably be extended by three or six months because it can be expected that several member states will issue a comment or a detailed opinion, considering the fact that this decree would have a negative effect on the intercommunal trade.