Nutrition, Dietetic Products, Novel Food and Allergy
Risk assessment of folic acid in dietary supplements
Report no: 2015: 05
The Norwegian Scientific Committee for Food Safety (VKM) has at the request of the Norwegian Food Safety Authority (NFSA) assessed whether the Tolerable Upper Intake Level (UL) of folic acid should be amended. VKM concludes that there is no support to alter the existing UL for folic acid supplementation.
Folic acid is a synthetic form of folate and is commonly used in food supplements and in food fortification because of its stability and bioavailability. Folate has many functions in the body, and women are advised to take supplements of folic acid before and during pregnancy to reduce the incidence of neural tube defects.
VKM does not alter the upper safe intake level
In 2000, the, Scientific Committee on Food (SCF), set an UL of 1000 microgram folic acid per day. The UL for folic acid has been reassessed by other authorities, most recently in 2009 by EFSA who upheld an UL of 1000 microgram per day.
Studies have been published that indicate a possible link between high intake of folic acid and cancer risk.
VKM has evaluated scientific literature for potential connections between folic acid and cancer, published after 2009, but has found no new evidence for increased risk of cancer related to folic acid intake.
Folic acid supplements have been given to patients previously treated for colorectal adenomas. This group is considered particularly vulnerable for developing cancer, but no increased risk of colon cancer or adenomas have been reported. VKM concludes that results of the studies examining cancer, published after 2009, do not provide support to alter the existing UL for folic acid.
Intake from supplements and products added folic acid
About 26% of women and 18% of men aged 18-70 years participating in the nationwide dietary survey Norkost 3, reported to take folic acid supplements. The mean intake of folic acid among users was 149 microgram per day among women and 172 microgram among men. Among pregnant women participating in The Norwegian Mother and Child Cohort Study, 62% reported use of folic acid in 2008. Mean intake was 388 microgram.
Data on consumption of fortified products are not available. However, according to a Norwegian model for food fortification, 53 microgram folic acid per 100 kcal can be added to food and drinks without exceeding the UL for folic acid in any age groups. With the current levels in supplements and current levels in fortified products, the UL for folic acid will not be exceeded.
Consequences if the maximum limit for folic acid in supplements increased
VKM was also asked to assess the possible consequences of amending the current maximum limit of 200 micrograms for folic acid in food supplements. Increasing the maximum limits in food supplements to 400 micrograms will imply exceedance of UL for children younger than 6 years, and an intake close to UL in children 7-10 years. An increase in the maximum limits in food supplements to 600 micrograms will imply exceedance of UL for children younger than 10 years and an intake close to UL in children 11-14 years.
Increasing the maximum limits in food supplements to 400 or 600 micrograms will not imply exceedance of UL among adults.
These calculations are based on the model for the assessment of food fortification.
Background for the assignment
In 2006 the European Commission initiated work to set common limits for vitamins and minerals. The work was temporarily put on standstill in 2009.
Pending establishment of common maximum limits in the EU, the Norwegian Food Safety Authority is evaluating the national maximum limits for vitamins and minerals in food supplements.
The VKM Panel on Nutrition, Dietetic Products, Novel Food and Allergy has been responsible for the risk assessment.