Conclusions and Questions on which the views of the Committee are sought

Conclusions

101.     Exposure in, pregnant and lactating women, and women attempting conception who do not take calcidiol supplements, and whose only exposure to calcidiol is from food sources, does not exceed the ACNFP TUL of 40 µg/day and EFSA’s safe intake level of 10 µg/day.

102.    When considering exposure estimates from all sources (food and supplements combined), for women of childbearing age, all intakes were below the ACNFP TUL of 40 µg/day. Only the minimum and maximum 97.5^th percentile intakes exceed the EFSA safe intake level of 10 µg/day up to 1.1 and 2.1-fold respectively. However, it should be noted supplements are likely the greatest contributor to calcidiol exposure in these population groups. Furthermore, not all women of child-bearing age take supplements, it has been estimated that 20% of females aged 19-64 years take vitamin D supplements.

103.    Ultimately, whilst exposure in healthy pregnant and lactating women from calcidiol supplements is unlikely to exceed the established Health Based Guidance Values, sensitive individuals with loss or function mutations would be more susceptible to the effects of calcidiol.

Questions on which the views of the Committee are sought

1.         Does the Committee have any comments on the potential risks of calcidiol supplements on maternal or fetal health?

2.         Is the Committee content with using a HBGV of 10 or 40 µg/day for risk characterisation?

3.         Does the Committee have any other comments on the contents of this review?

Secretariat

December 2024