Nutrition, Dietetic Products, Novel Food and Allergy

Vitamin E and B6 - assessment of suggested maximum limits in food supplements

Commissioned:

Report no: 2017: 3 (vitamin B6) og 2017: 4 (vitamin E)

Published: 07.03.2017

Main message:

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority (NFSA), evaluated the intake of vitamin E and B6 in the Norwegian population.

VKM has also conducted scenario estimations to illustrate the consequences of amending maximum limits for vitamin E (alpha tocopherol) and vitamin B6 (pyridoxine) in food supplements. The NFSA will evaluate the national maximum limits for vitamin E and B6 in the food supplement regulation.

VKM has made calculations for all age groups aged one year and over.

Vitamin E

The existing maximum limit for vitamin E in food supplements is 30 mg/day. VKM evaluated the consequences of amending the maximum limit for vitamin E to 15, 50, 100, 150, 200 and 300 mg/day.

VKM propose to adopt the tolerable upper intake level of 300 mg/day for adults set by the former EU Scientific Committee for Food Safety (SCF).

No negative effects have been reported after intake of vitamin E from the diet alone, and the tolerable upper intake levels therefore only applies to the intake of vitamin E from supplements.

High doses of vitamin E can cause bleeding

High doses of vitamin E in food supplements can cause haemorrhage and interrupt blood coagulation.

The tolerable upper intake level for supplemental vitamin E for adults is 300 mg/day. Therefore, none of the suggested amendments of the maximum limit in food supplements (to 15, 50, 100, 150, 200 and 300 mg/day) will lead to exceedance of this upper level in adults.

Lower upper intake level for children and adolescents

The upper intake level for children and adolescents was extrapolated from adults based on body weight. That means it is taken into account that children tolerate less because of their body weight. 

In 13-year-olds supplements with 300 mg/day vitamin E will lead to exceedance of the upper level. In 9-year-olds supplements with 200 mg/day vitamin E will lead to exceedance of the upper level. In 4- and 2-year-olds supplements with 150 mg/day vitamin E will lead to exceedance of the upper level.

Vitamin B6

The existing maximum limit for vitamin B6 in food supplements is 4.2 mg/day. VKM has also conducted scenario calculations to illustrate the consequences of amending the maximum limit to 2, 6, 8, 10, 20 or 25 mg/day.

VKM propose to adopt the tolerable upper intake level of 25mg / day for adults set by the SCF.

There are no reports of adverse health effects from intake of vitamin B6 from food and drink alone.
Sensory neuropathy has been reported to be the most sensitive adverse health effect of vitamin B6 supplementation.

To illustrate the consequences of amending the maximum limit for vitamin B6 in food supplements to 2, 6, 8, 10, 20 or 25 mg/day in the different age groups, VKM has used the scenarios with P95 from food and added the alternative amounts of supplements.

VKM has compared these scenarios with the tolerable upper intake levels set by the SCF for adults, adolescents and children.

2- and 4-year-old children will exceed the tolerable upper intake level with use of 6 mg/day or higher vitamin B6 in supplements. 9-year-old children will exceed the tolerable upper intake level with supplemental use of 10 mg/day. 13-year-old adolescents will exceed the tolerable upper intake level with 20 mg/day of vitamin B6 in supplements. Adults will exceed the tolerable upper intake level with use of 25 mg/day of vitamin B6/pyridoxine in supplements.

The VKM Panel on Nutrition, Dietetic Products, Novel Food and Allergy has been responsible for these assessments.

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