title: Application of the BRAFO tiered approach for benefit-risk assessment to case studies on dietary interventions.
abstract: The respective examples, described in this paper, illustrate how the BRAFO-tiered approach, on benefit-risk assessment, can be tested on a wide range of case studies. Various results were provided, ranging from a quick stop as the result of non-genuine benefit-risk questions to continuation through the tiers into deterministic/probabilistic calculations. The paper illustrates the assessment of benefits and risks associated with dietary interventions. The BRAFO tiered approach is tested with five case studies. In each instance, the benefit-risk approach is tested on the basis of existing evaluations for the individual effects done by others; no new risk or benefit evaluations were made. The following case studies were thoroughly analysed: an example of food fortification, folic acid fortification of flour, macronutrient replacement/food substitution; the isocaloric replacement of saturated fatty acids with carbohydrates; the replacement of saturated fatty acids with monounsaturated fatty acids; the replacement of sugar-sweetened beverages containing mono- and disaccharides with low calorie sweeteners and an example of addition of specific ingredients to food: chlorination of drinking water.
authors.affiliation: National Institute for Public Health and the Environment, RIVM, 3720 Bilthoven, The Netherlands.
authors.forename: Hans
authors.initials: H
authors.lastname: Verhagen
authors.forename: Rikke
authors.initials: R
authors.lastname: Andersen
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Antoine
authors.forename: Paul
authors.initials: P
authors.lastname: Finglas
authors.forename: Jeljer
authors.initials: J
authors.lastname: Hoekstra
authors.forename: Alwine
authors.initials: A
authors.lastname: Kardinaal
authors.forename: Hervé
authors.initials: H
authors.lastname: Nordmann
authors.forename: Gülden
authors.initials: G
authors.lastname: Pekcan
authors.forename: Kristina
authors.initials: K
authors.lastname: Pentieva
authors.forename: Tom A
authors.initials: TA
authors.lastname: Sanders
authors.forename: Henk
authors.initials: H
authors.lastname: van den Berg
authors.forename: Henk
authors.initials: H
authors.lastname: van Kranen
authors.forename: Alessandro
authors.initials: A
authors.lastname: Chiodini
mesh_terms: D001939:Bread; D031204:Caloric Restriction; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D002713:Chlorine / Q000009:adverse effects / Q000032:analysis; D004032:Diet; D004040:Dietary Carbohydrates / Q000008:administration & dosage / Q000009:adverse effects; D004041:Dietary Fats / Q000008:administration & dosage / Q000009:adverse effects; D060766:Drinking Water / Q000009:adverse effects / Q000737:chemistry; D002149:Energy Intake; D005060:Europe; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage / Q000009:adverse effects; D005527:Food, Fortified; D006293:Health Promotion; D006801:Humans; D009369:Neoplasms / Q000209:etiology; D011247:Pregnancy; D018570:Risk Assessment / Q000379:methods*; D013549:Sweetening Agents / Q000008:administration & dosage / Q000009:adverse effects; D015431:Weight Loss
chemical_list: D004040:Dietary Carbohydrates; D004041:Dietary Fats; D060766:Drinking Water; D005229:Fatty Acids, Monounsaturated; D013549:Sweetening Agents; D002713:Chlorine; D005492:Folic Acid