Conclusions and Questions

This is a paper for discussion. This does not represent the views of the Committee and should not be cited.

Conclusions

104.                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 the level EFSA established as safe (i.e., up to 10 μg/day).

105.               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 level EFSA established as safe (i.e., up to 10 μg/day) up to 1.1 and 2.1-fold respectively. However, the COT noted that 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.

106.               Exposure from calcidiol supplements and calcidiol from food sources in healthy pregnant and lactating women are unlikely to result in significant exceedances of the ACNFP TUL and the level EFSA established as safe . However, 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

May 2025