title: Safe addition of vitamins and minerals to foods: setting maximum levels for fortification in the Netherlands.
abstract: 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.
  
  
  OBJECTIVE
  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 microg/100 kcal, but following a risk management evaluation, this was upgraded to an AFL of 100 microg/100 kcal. The MSFL for vitamin D was 3.0 microg/100 kcal (children 4-10 years old), and the risk manager increased this to an AFL of 4.5 microg/100 kcal. Children up to 10 years old, men, and postmenopausal women were the groups most sensitive to vitamin A fortification (MSFL = 0 microg/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.
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, 3720 BA Bilthoven, The Netherlands.
authors.forename: Janneke
authors.initials: J
authors.lastname: Kloosterman
authors.forename: Heidi P
authors.initials: HP
authors.lastname: Fransen
authors.forename: Joyce
authors.initials: J
authors.lastname: de Stoppelaar
authors.forename: Hans
authors.initials: H
authors.lastname: Verhagen
authors.forename: Cathy
authors.initials: C
authors.lastname: Rompelberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004032:Diet / Q000009:adverse effects / Q000379:methods; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage / Q000009:adverse effects; D005527:Food, Fortified / Q000009:adverse effects / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards*; D008962:Models, Theoretical; D009426:Netherlands; D018673:Nutrition Policy; D018570:Risk Assessment / Q000379:methods; D014801:Vitamin A / Q000008:administration & dosage / Q000009:adverse effects; D014807:Vitamin D / Q000008:administration & dosage / Q000009:adverse effects; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards*; D055815:Young Adult
chemical_list: D008903:Minerals; D014815:Vitamins; D014801:Vitamin A; D014807:Vitamin D; D005492:Folic Acid