Scientific Opinion on (6S)-5-methyltetrahydrofolic acid, glucosamine salt as a source of folate added for nutritional purposes to food supplements


Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2013;11(10):3358 [20 pp.].
Panel Members
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Pasquale Mosesso, Alicja Mortensen, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Ruud Woutersen and Matthew Wright

The Panel wishes to thank the members of the Working Group A on Food Additives and Nutrient Sources: Pierre Galtier, Rainer Guertler, Ursula Gundert-Remi, Claude Lambré, John Christian Larsen, Jean-Charles Leblanc, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Christina Tlustos and Matthew Wright for the preparatory work on this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
11 settembre 2013
Published in the EFSA Journal
2 ottobre 2013
European Food Safety Authority (EFSA), Parma, Italy

Following a request from the European Commission, the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver an opinion on the safety of (6S)-5-methyltetrahydrofolic acid, glucosamine salt (5MTHF-glucosamine), when added for nutritional purposes to food supplements as a source of folate, and on the bioavailability of folate from this source. 5-Methyltetrahydrofolic acid, calcium salt (5MTHF-Ca), has previously been authorised as a source of folate. 5MTHF-glucosamine is proposed as an alternative source of folate to be used in the manufacture of food supplements and it is proposed to be used at up to 1.8 mg/day, which equates to 1 mg 5MTHF and 0.8 mg glucosamine. A crossover comparative bioavailability study was performed in human volunteers and the Panel concluded that folate from 5MTHF-glucosamine exhibited a similar bioavailability to folate from 5MTHF-Ca. The Panel considered that 5MTHF-glucosamine will readily dissociate to 5MTHF and glucosamine in the aqueous environment of the digestive tract. The 5MTHF component will therefore be expected to be absorbed across the small intestine in a similar manner as 5MTHF originating from dietary sources and 5MTHF-Ca. In vitro genotoxicity studies with 5MTHF-glucosamine have been performed and the Panel concluded that the 5MTHF-glucosamine source did not raise concerns with respect to genotoxicity. The Panel therefore concluded that the proposed use and use levels of 5MTHF-glucosamine as an alternative source of folate to be used for the manufacture of food supplements is not of safety concern. The Panel does not conclude on the safety of 5MTHF-glucosamine in terms of the amount of folate that may be consumed, since this is outside the remit of the ANS Panel; however, the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) will advise on population reference intakes for folate by 2015 (EFSA-Q-2011-01212).

folic acid, 5-methyltetrahydrofolic acid, folate, glucosamine
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