Scientific Opinion on the substantiation of health claims related to melatonin and alleviation of subjective feelings of jet lag (ID 1953), and reduction of sleep onset latency, and improvement of sleep quality (ID 1953) pursuant to Article 13(1) of Regulation (EC) No 1924/2006
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren, and Hans Verhagen.
Acknowledgment
The Panel wishes to thank for the preparation of this opinion: The members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group on Mental/Nervous System: Jacques Rigo, Astrid Schloerscheidt, Barbara Stewart-Knox, Sean (J.J.) Strain, Joachim Westenhoefer and Peter Willatts.
Contact
nda@efsa.europa.eu
No abstract available
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to melatonin and alleviation of subjective feelings of jet lag, reduction of sleep onset latency, and contribution to sleep quality. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.
The food constituent that is the subject of the health claims is melatonin. The Panel considers that melatonin is sufficiently characterised.
Alleviation of subjective feelings of jet lag
The claimed effect is "sleep-wake cycle regulation”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that “sleep-wake cycle regulation” encompasses subjective feelings of jet lag. The Panel considers that alleviation of subjective feelings of jet lag might be a beneficial physiological effect.
In weighing the evidence, the Panel took into consideration the conclusions of the Cochrane review, which indicated that melatonin was effective in alleviating the subjective symptoms of jet lag.
On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of melatonin and alleviation of subjective feelings of jet lag. In order to bear the claim, the melatonin dose should be between 0.5 and 5 mg and should be taken close to bedtime on the first day (and any subsequent day) of travel and on the following few days after arrival at the destination. The target population is the general population.
Reduction of sleep onset latency and improvement of sleep quality
The claimed effect is "sleep-wake cycle regulation”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that “sleep-wake cycle regulation” encompasses helping to reduce sleep onset latency and helping to improve sleep quality. The Panel considers that reduction of sleep onset latency and improvement of sleep quality might be beneficial physiological effects.
In weighing the evidence, the Panel accepted the conclusions of the meta-analysis with respect to the outcomes of sleep onset latency and sleep quality.
On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of melatonin and reduction of sleep onset latency or improvement of sleep quality.
Melatonin, jet lag, sleep onset latency, sleep quality, health claims
