Calcium L-methionate, magnesium L-methionate and zinc mono-Lmethionine sulphate added for nutritional purposes to food supplements

The Panel considered the safety of methionine resulting from the use of the different supplements under consideration. A dose of methionine of 100 mg/kg bw (i.e. 6 g for a 60 kg person) resulted in an acute increase in plasma homocysteine. A dose of 1 g/kg bw (i.e. 60 g for a 60 kg person) given in error resulted in death while methionine intakes 5 times higher than normal (i.e. intakes approximately 12.5 g methionine/day; normal intakes being estimated at about 2.5 g methionine/day) resulted in elevated homocysteine levels. However, longer-term studies in adults indicated no adverse effects of moderate fluctuations in dietary methionine intake. In line wit the Scientific Committee for Food (SCF), the Panel considers that the use of L-amino acids in food supplements should not give rise to a nutritional imbalance of the amino acids. Thus the Panel concludes that the use of methionine sources at these levels, together giving rise to a methionine intake of 12 g per day for a 60kg person, could be of safety concern. Calcium L-methionate, magnesium L-methionate and zinc mono-Lmethionine sulphate added for nutritional purposes to food supplements As already indicated, if calcium was to be supplied at the highest level (1200 mg) as calcium L-methionate, the Panel calculated that th potential exposure to methionine would be about 9 g methionine/day for an adult. The Panel notes that this would be an additional exposure above the normal intake of methionine from the diet (i.e. about 2.5 g/day) resulting in a total intake of approximately 11.5 g methionine/day. The Panel has no data that demonstrate that such a level of methionine intake would be safe. Similarly, for magnesium L-methionate, if magnesium was supplied at the UL (250 mg magnesium/day) the Panel calculated an exposure to methionine of about 3 g methionine/day resulting in a total methionine intake (supplemental + dietary) of approximately 5.5 g/day. The Panel has no data to prove that this would be a safe intake level for methionine. The Panel further calculated that in the case of zinc mono-L-methionine sulphate, if all the zinc in food supplements were to be provided by zinc mono-L-methionine sulphate (CAS No 56329-42-1) at the upper level of 25 mg zinc per day the potential exposure to methionine would be 57.2 mg methionine/day. The Panel considers this level of methionine to be of no safety concern. Finally, the Panel notes that the SCF evaluated the general safety of L-amino-acids and considered their use acceptable provided that their addition to food does not give rise to a nutritional imbalance of the amino acids. In the absence of data that demonstrate the safety of the potential total exposure to about 11.5 g methionine/day resulting from intakes from both calcium L-methionate supplements and from the diet, or to about 5.5 g methionine/day from both magnesium L-methionate supplements and from the diet, the Panel concludes that the proposed use levels of calcium Lmethionate and magnesium L-methionate as sources for calcium and magnesium at the proposed levels of use could be of safety concern. Although the safety of zinc itself, in terms of the amounts that may be safely consumed, is outside its remit, the Panel wishes to indicate that, at the 97.5th percentile the dietary zinc intake from total food only is already close to the UL established by the SCF. The intake of zinc from food supplements and/or fortified food in addition to the normal dietary zinc intake could cause the UL to be exceeded, especially for consumers at high percentiles. The Panel further concludes that in the case of zinc mono-L-methionine sulphate the potential exposure to methionine and sulphate is negligible compared to the normal dietary intake of these compounds and that the use of zinc mono-L-methionine sulphate at the proposed level of use as a source of zinc is not of safety concern