title: Allergen reference doses for precautionary labeling (VITAL 2.0): clinical implications.
abstract: BACKGROUND
  There has been a dramatic proliferation of precautionary labeling by manufacturers to mitigate the perceived risk from low-level contamination from allergens in food. This has resulted in a significant reduction in choice of potentially safe foods for allergic consumers.
  
  
  OBJECTIVE
  We aimed to establish reference doses for 11 commonly allergenic foods to guide a rational approach by manufacturers based on all publically available valid oral food challenge data.
  
  
  METHODS
  Reference doses were developed from statistical dose-distribution modeling of individual thresholds of patients in a dataset of more than 55 studies of clinical oral food challenges. Sufficient valid data were available for peanut, milk, egg, and hazelnut to allow assessment of the representativeness of the data used.
  
  
  RESULTS
  The data were not significantly affected by the heterogeneity of the study methodology, including little effect of age on results for those foods for which sufficient numbers of adult challenge data were available (peanut and hazelnut). Thus by combining data from all studies, the eliciting dose for an allergic reaction in 1% of the population estimated for the following were 0.2 mg of protein for peanut, 0.1 mg for cow's milk, 0.03 mg for egg, and 0.1 mg for hazelnut.
  
  
  CONCLUSIONS
  These reference doses will form the basis of the revised Voluntary Incidental Trace Allergen Labeling (VITAL) 2.0 thresholds now recommended in Australia. These new levels will enable manufacturers to apply credible precautionary labeling and provide increased consumer confidence in their validity and reliability, as well as improving consumer safety.
authors.affiliation: Murdoch Childrens Research Institute, Parkville, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Australia; Department of Allergy and Immunology, Royal Children's Hospital, Parkville, Australia. Electronic address: katie.allen@rch.org.au.
authors.forename: Katrina J
authors.initials: KJ
authors.lastname: Allen
authors.affiliation: Food Allergy Research & Resource Program (FARRP), University of Nebraska, Lincoln, Neb.
authors.forename: Benjamin C
authors.initials: BC
authors.lastname: Remington
authors.affiliation: Food Allergy Research & Resource Program (FARRP), University of Nebraska, Lincoln, Neb.
authors.forename: Joseph L
authors.initials: JL
authors.lastname: Baumert
authors.affiliation: Safety & Environmental Assurance Centre, Unilever, Colworth Science Park, Sharnbrook, Bedford, United Kingdom.
authors.forename: Rene W R
authors.initials: RW
authors.lastname: Crevel
authors.affiliation: TNO, Zeist, The Netherlands.
authors.forename: Geert F
authors.initials: GF
authors.lastname: Houben
authors.affiliation: Allergen Bureau of Australia, Hobart, Australia.
authors.forename: Simon
authors.initials: S
authors.lastname: Brooke-Taylor
authors.affiliation: TNO, Zeist, The Netherlands.
authors.forename: Astrid G
authors.initials: AG
authors.lastname: Kruizinga
authors.affiliation: Food Allergy Research & Resource Program (FARRP), University of Nebraska, Lincoln, Neb.
authors.forename: Steve L
authors.initials: SL
authors.lastname: Taylor
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000276:immunology; D001315:Australia; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic / Q000379:methods*; D054796:Drug Dosage Calculations; D005260:Female; D005512:Food Hypersensitivity / Q000276:immunology / Q000628:therapy*; D005515:Food Labeling / Q000379:methods*; D006801:Humans; D007073:Immunoglobulin E / Q000276:immunology; D007223:Infant; D008297:Male; D012015:Reference Standards; D055815:Young Adult
chemical_list: D000485:Allergens; D007073:Immunoglobulin E
keywords: ED; Eliciting dose; FARRP; Food Allergy Research & Resource Program; Food allergy; GLRT; Generalized log-rank test; LOAEL; Lowest-observed-adverse-effect level; NOAEL; No-observed-adverse-effect level; VITAL; Voluntary Incidental Trace Allergen Labeling; allergen thresholds; cow's milk; egg; hazelnut; peanut; precautionary labeling; soy