The decree, which must now be checked for barriers to EU trade, outlines a number of different requirements for supplements including conditions of use for 16 botanicals like Ginkgo biloba and Rhodiola rosea; conditions of use for seven 'other substances' including monacolin K and taurine; and an outright ban on 108 plants including yohimbe bark and sea buckthorn and eight 'other substances' including melatonin and lactulose.
Dr Luca Bucchini, managing director of Rome-based Hylobates Consulting, told us the decision for melatonin was particularly worrying in that it marked another EU member state deviation on an ingredient that holds two authorised EU health claims.
Melatonin is a naturally occurring hormone produced by the pineal gland in the brain and involved in coordinating the body's sleep-wake cycle.
The European Food Safety Authority (EFSA) authorised health claims for melatonin for the ‘reduction of time taken to fall asleep’ and ‘alleviation of subjective feelings of jet lag’.
“Therefore the harmonisation brought by the NHCR [nutrition and health claim regulation] is emptied since firms need to check country by country if a substance is approved there, and considered medicinal or dangerous.”
The Czech decree follows a similar line as that taken in France and the UK, where melatonin is allowed as a drug but not food ingredient.
In Italy and Spain this status depends on the dose, with Italy allowing the use of up to 1 mg in food supplements.
“Melatonin is possibly a lost cause,” Bucchini said.
See you in court
Disparity on melatonin has already resulted in court cases brought by disgruntled supplement firms.
In 2014 French courts rejected a complaint against its national measures from British distribution firm Natural, German firm Vitamins as well as the French Institute of Biological Research, distributor Noria and Arkopharma Laboratories.
Botanical botch
More generally Bucchini said it was “not a good sign” that member states were passing their own national measures on botanicals at the same time the European Commission investigates pan-EU harmonisation for the sector under the REFIT programme.
“The result of these restrictive measures - with no provision and procedure for mutual recognition - is less intra-EU trade,” he said.
“If the EC does not act, this may become a perverse spiral: less trade, fewer firms with an interest in the single market, and even less trade.”