Tolerable upper limits for vitamin D:

11.             In 2012, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) established tolerable upper levels (TULs) for vitamin D (EFSA, 2012), based on a risk assessment conducted in 2003 by the Scientific Committee on Food (SCF, 2003). The SCF risk assessment used hypercalcaemia as the adverse effect induced by excessive vitamin D exposure. The TULs established by EFSA in 2012 were as follows:

• For infants (birth to 1 year of age), the TUL was 25 µg per person, per day.
• For children aged 1 to 4 years, the TUL was 50 µg per person, per day.

12.             In 2014, the COT published a statement on the adverse effects of high levels of vitamin D, in which the COT agreed with the TULs set by EFSA in 2012 (COT, 2014).

13.             However, in 2018, based on the overall evidence, the EFSA NDA Panel kept the TUL of 25 µg/day for infants up to 6 months old, but set a new UL of 35 µg /day for infants aged 6-12 months (EFSA, 2018). A summary of EFSA’s rationale for this is provided in Annex A. The TUL for toddlers above 1 year of age (50 μg per person, per day) was not changed in EFSA’s 2018 assessment following its original establishment in 2003 and confirmation in 2012.

14.             The COT reviewed the rationale for the revised TUL for 6 - <12 month-olds of 35 μg/person/day established by the EFSA NDA Panel and agreed with the revised TUL for this age group.