Opinion on Pyridoxal 5'-phosphate as a source for vitamin B-6 added for nutritional purposes in food supplements Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food

摘要

Following a request from the Commission, the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC Panel) has been asked to evaluate the safety and bioavailability of pyridoxal 5'-phosphate as a source for vitamin B-6 when added for nutritional purposes in food supplements. Vitamin B-6 has been evaluated by the Scientific Committee on Food in 2000 which defined tolerable upper intake levels of vitamin B-6. The tolerable upper intake level amounted to 25 mg per day for adults, with tolerable upper intake levels for children defined based on body weight differences compared to adults. Vitamin B-6 is the collective term for a family of chemical substances that are structurally related and includes pyridoxine, pyridoxine 5'-phosphate, pyridoxal, pyridoxal 5'-phosphate, pyridoxamine, and pyridoxamine 5'-phosphate which can be converted into one another. The present opinion deals only with the safety and bioavailability of pyridoxal 5'-phosphate as a particular source of vitamin B-6, intended for the general population, to be added for nutritional purposes to food supplements. The safety of vitamin B-6, in terms of amounts that may be consumed, is outside the remit of this Panel. The toxicity of vitamin B-6 has been evaluated in several opinions. The principal toxicity of concern associated with excess intakes of vitamin B-6 (as pyridoxine hydrochloride) is neuronal damage and sensory and motor effects. None of these effects have been specifically linked to the pyridoxal 5'-phosphate form of the vitamin. Pyridoxal 5'-phosphate did not cause clinical signs or lesions similar to those produced by pyridoxine even when injected in maximum tolerated doses. The Panel considers that bioavailability and safety of pyridoxal 5'-phosphate will not be significantly different from those of other forms of vitamin B-6. Therefore and because of the fact that pyridoxal 5'-phosphate is one of the vitamin B-6 vitamers the safe upper use levels defined for vitamin B-6 can be used for judging the safety of pyridoxal 5'-phosphate. The Panel concluded that the use of pyridoxal 5'-phosphate as a source for vitamin B-6 in food supplements intended for the general population would be of no safety concern if use levels were in compliance with defined upper safe use levels. However, the Panel is concerned that the use levels of pyridoxal 5'-phosphate proposed by the petitioners are 50 and 90 mg/day and are substantially higher than the tolerable upper intake levels defined by the SCF in 2000 of 25 mg/day for adults and 5-20 mg for children depending on their body weight. The Panel noted that the specifications of pyridoxal 5'-phosphate as commercialised should comply with the specifications for vitamin B-6 and its derivatives used as food additives.