title: Comparison of different maximum safe levels in fortified foods and supplements using a probabilistic risk assessment approach.
abstract: Different European institutions have developed mathematical models to propose maximum safe levels either for fortified foods or for dietary supplements. The objective of the present study was to compare and check the safety of these different maximum safe levels (MSL) by using a probabilistic risk assessment approach. The potential maximum nutritional intakes were estimated by taking into account all sources of intakes (base diet, fortified foods and dietary supplements) and compared with the tolerable upper intake levels for vitamins and minerals. This approach simulated the consequences of both food fortification and supplementation in terms of food safety. Different scenarios were tested. They are the result of the combination of several MSL obtained using the previous models. The study was based on the second French Individual and National Study on Food Consumption performed in 2006-7, matched with the French food nutritional composition database. The analyses were based on a sample of 1918 adults aged 18-79 years. Some MSL in fortified foods and dietary supplements obtained independently were protective enough, although some others could lead to nutritional intakes above the tolerable upper intake levels. The simulation showed that it is crucial to consider the inter-individual variability of fortified food intakes when setting MSL for foods and supplements. The risk assessment approach developed here by integrating the MSL for fortified foods and dietary supplements is useful for ensuring consumer protection. It may be subsequently used to test any other MSL for vitamins and minerals proposed in the future.
authors.affiliation: Dietary Survey Unit - Nutritional Epidemiology, French Agency for Food, Environmental and Occupational Health Safety, Maisons-Alfort, France. ariane.dufour@anses.fr
authors.forename: Ariane
authors.initials: A
authors.lastname: Dufour
authors.forename: Sandrine
authors.initials: S
authors.lastname: Wetzler
authors.forename: Mathilde
authors.initials: M
authors.lastname: Touvier
authors.forename: Sandrine
authors.initials: S
authors.lastname: Lioret
authors.forename: Jennifer
authors.initials: J
authors.lastname: Gioda
authors.forename: Lionel
authors.initials: L
authors.lastname: Lafay
authors.forename: Carine
authors.initials: C
authors.lastname: Dubuisson
authors.forename: Gloria
authors.initials: G
authors.lastname: Calamassi-Tran
authors.forename: Esther
authors.initials: E
authors.lastname: Kalonji
authors.forename: Irène
authors.initials: I
authors.lastname: Margaritis
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Volatier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D003257:Consumer Product Safety; D019587:Dietary Supplements / Q000009:adverse effects / Q000592:standards*; D005527:Food, Fortified / Q000009:adverse effects / Q000592:standards*; D006801:Humans; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D008903:Minerals; D014815:Vitamins