Following a request from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for folic acid/folate. Systematic reviews of the literature were conducted to assess evidence on priority adverse health effects of excess intake of folate (including folic acid and the other authorised forms, (6S)-5-methyltetrahydrofolic acid glucosamine and l-5-methyltetrahydrofolic acid calcium salts), namely risk of cobalamin-dependent neuropathy, cognitive decline among people with low cobalamin status, and colorectal cancer and prostate cancer. The evidence is insufficient to conclude on a positive and causal relationship between the dietary intake of folate and impaired cognitive function, risk of colorectal and prostate cancer. The risk of progression of neurological symptoms in cobalamin-deficient patients is considered as the critical effect to establish an UL for folic acid. No new evidence has been published that could improve the characterisation of the dose–response between folic acid intake and resolution of megaloblastic anaemia in cobalamin-deficient individuals. The ULs for folic acid previously established by the Scientific Committee on Food are retained for all population groups, i.e. 1000 μg/day for adults, including pregnant and lactating women, 200 μg/day for children aged 1–3 years, 300 μg/day for 4–6 years, 400 μg/day for 7–10 years, 600 μg/day for 11–14 years and 800 μg/day for 15–17 years. A UL of 200 μg/day is established for infants aged 4–11 months. The ULs apply to the combined intake of folic acid, (6S)-5-methyltetrahydrofolic acid glucosamine and l-5-methyltetrahydrofolic acid calcium salts, under their authorised conditions of use. It is unlikely that the ULs for supplemental folate are exceeded in European populations, except for regular users of food supplements containing high doses of folic acid/5-methyl-tetrahydrofolic acid salts.
The Panel wishes to thank for their contribution to this output the WG on Upper Levels: Peter Aggett, Brandy Beverly, Torsten Bohn, Julia Bornhorst, Marta Crous-Bou, Francesco Cubadda, Aymeric Dopter, Susan Fairweather-Tait, Reginald Fitzgerald, Susan Lanham New, Georg Lietz, Harry J. McArdle, Anne Molloy, Androniki Naska, Giovanni Passeri, Kristina Pentieva, Marco Vinceti and Misha Vrolijk; and EFSA staff members: Irene Muñoz Guajardo, Franco Neri, Roanne Marie Saad and Angeliki Sofroniou. The Panel also wishes to thank Carmen Peláez for her contribution as member of the NDA Panel until June 2023. The Panel acknowledges Agneta Åkesson, Linnea Bärebring, Jacob Juel Christensen, Thomas Olsen, Fredrik Söderlund and Cornelia Witthöft for the preparatory work as part of a procurement procedure. The Panel also wishes to acknowledge the contribution of all national institutions in European countries that provided consumption data for this scientific output and the authors of published papers on folate who provided additional information upon request.
© 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
- folic acid
- 5-methyltetrahydrofolic acid salt
- tolerable upper intake level