Accepted claims for unauthorized ingredients or conditions of use: retrospective on the 6 batch.

In the 2nd batch, Melatonin could be used to claim on the alleviation of subjective feelings of jet lag with a 0.5 to 5 mg uptake. In the 3rd batch, Hydroxypropyl methylcellulose (HPMC) could be used to claim both on the reduction of post-prandial glycaemic responses and the maintenance of normal blood cholesterol concentrations with at least 5 g per day. In the 5th batch, Melatonin again, could be used to claim on the reduction of sleep onset latency with a 1 mg of melatonin uptake. However melatonin stays for a long time non authorized in food supplement and HPMC is only an additive authorized in vegetable capsules.
Since the last and 6th batch, monacolin K from red yeast rice can be used to claim on the maintenance of normal blood LDL- cholesterol concentrations. While 10 mg of monacolin K from fermented red yeast rice preparations should be consumed daily in order to obtain the claimed effect, this dosage is not possible in food supplement and 10 mg of monacolin correspond to a drug.

Then, while many allowed ingredients, interesting for industrials and the health nutrition market received negative opinion deeply damaging huge market in terms of employment and sales, one can be surprised by these anecdotal cases of accepted claims for unauthorized ingredients, therefore accepted but unusable claims !

Data Solution

The most efficient DATA Solution to create your products in the 28 European Member States


The artificial intelligence solution for regulatory review & labelling. Enter your formula and start the analysis!