The Ministero della Salute - Italy's Ministry of Health - has cut the maximum approved levels of melatonin in supplements to 1mg per day - citing recent health claim assessments by the European Food Safety Agency (EFSA) as having brought new definition to the 'melatonin levels useful for physiological effects' which differ from those authorised for medical use at higher levels.
The ministry statement (found here) noted that EFSA's scientific assessments have shown melatonin to be physiologically active at levels of 0.5mg per day 'to help alleviate the effects of jet lag' and 1mg per day for 'the reduction of the time required to get to sleep'.
At the same time, the Ministero della Salute noted that the European Union has authorised the use of medicines containing a daily dose of 2mg for therapeutic use.
"It is therefore necessary to reduce levels of intake of melatonin supplements allowed so far in Italy food for a demarcation use of the substance for purposes of a physiological than to those of a therapeutic," said the ministerial statement.
"To this end, in the current situation, it is believed that in food supplements the daily intake of 1 mg of melatonin, useful to support the health claims authorised, should be considered at the same time also the maximum allowable contribution for the purposes of physiological type."
Health claims are 'not about maximum limits'
Luca Bucchini PhD, managing director of Hylobates Consulting told NutraIngredients that the case of melatonin 'is complex and in many ways unique' - noting that Italy's Ministry of Health is keen to implement EU law, but that its interpretation of EFSA's health claims approvals is misguided and may be dangerous.
"The NHCR is about claims, not about maximum limits or safety," he said. "Any off-label use of the Regulation is not in Europe's best interests."
Bucchini added that consumers should be able to enjoy the advantages of food supplements, "and not overpay for products needlessly classified as medicines."
"At the same time, substances best classified as medicines should certainly not be marketed as food supplements - it's necessary to protect consumers," he commented.
Bucchini also suggested that the move to lower maximum levels in Italy may mean other countries within Europe - which have so far not allowed melatonin use in supplements - could consider allowing its use at the new, lower levels.
"On the positive side for the food supplement sector, other Member States which have so far refused to contemplate the use of melatonin at any concentration in food supplements may now accept that one mg of the substance is compatible with food law," he suggested.
The Italian authority said that the new limit of use - at 1mg per day - will come in to effect 'no later than 30 September 2013.'