Safe addition of vitamins and minerals to foods: setting maximum levels for fortification in the Netherlands

BACKGROUND: In 2004, the European Court of Justice decided that the prohibition of fortification with vitamin A, vitamin D, folic acid, selenium, copper, and zinc in the Netherlands conflicts with the principle of free movement of goods in the European Union. This decision led to a change in the Dutch policy, resulting in a more flexible handling of requests for exemption from this prohibition to fortify. Therefore, an investigation was proposed in which it would be determined whether a general exemption could be granted for food fortification with a certain maximum safe amount per micronutrient. AIM OF THE STUDY: To develop a risk assessment model to estimate maximum safe fortification levels (MSFLs) of vitamins and minerals to foods on the Dutch market, and to evaluate these levels to derive allowed fortification levels (AFLs), which can be used for a general exemption. METHODS: We developed a risk assessment model to estimate MSFLs of vitamins and minerals to foods on the basis of existing models. We used European tolerable upper intake levels in combination with national food consumption data to estimate MSFLs for fortification of foods for several age groups. Upon extensive stakeholder dialogue, the risk manager considered these estimated MSFLs and the final AFLs for a general exemption were set. RESULTS: For folic acid, vitamin A, and vitamin D, the MSFLs were calculated in the risk-assessment model. Children up to 6-years old were the group most sensitive to folic acid fortification, and they had an MSFL of 0 µg/100 kcal, but following a risk management evaluation, this was upgraded to an AFL of 100 µg/100 kcal. The MSFL for vitamin D was 3.0 µg/100 kcal (children 4–10 years old), and the risk manager increased this to an AFL of 4.5 µg/100 kcal. Children up to 10 years old, men, and postmenopausal women were the groups most sensitive to vitamin A fortification (MSFL = 0 µg/100 kcal). Because these groups represent a large part of the population and because of the seriously harmful effects of excessive vitamin A, the risk manager did not allow a general exemption. CONCLUSIONS: The combination of a risk assessment model and risk manager evaluation led to the setting of AFLs for general exemption of fortification with folic acid and vitamin D. This model is also applicable for other micronutrients, for which an UL is derived, and in other countries.