title: Regulation of probiotic substances as ingredients in foods: premarket approval or "generally recognized as safe" notification.
abstract: This article discusses options and examples of regulations or "generally recognized as safe" determinations that are related to microorganisms in food. A balanced picture of information about the microorganism and its characteristics is needed to make conclusions about its safety.
authors.affiliation: Division of Biotechnology and GRAS Notice Review, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland 20740, USA. antonia.mattia@fda.hhs.gov
authors.forename: Antonia
authors.initials: A
authors.lastname: Mattia
authors.forename: Robert
authors.initials: R
authors.lastname: Merker
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence* / Q000592:standards; D019649:Food Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D005516:Food Microbiology / Q000331:legislation & jurisprudence* / Q000592:standards; D058870:Food, Organic / Q000592:standards*; D006801:Humans; D007880:Legislation, Drug; D007881:Legislation, Food; D019936:Probiotics / Q000592:standards* / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence