title: Novel probiotics and prebiotics: road to the market.
abstract: Novel probiotics and prebiotics designed to manipulate the gut microbiota for improving health outcomes are in demand as the importance of the gut microbiota in human health is revealed. The regulations governing introduction of novel probiotics and prebiotics vary by geographical region. Novel foods and foods with health claims fall under specific regulations in several countries. The paper reviews the main requirements of the regulations in the EU, USA, Canada and Japan. We propose a number of areas that need to be addressed in any safety assessment of novel probiotics and prebiotics. These include publication of the genomic sequence, antibiotic resistance profiling, selection of appropriate in vivo model, toxicological studies (including toxin production) and definition of target population.
authors.affiliation: Functional Foods Forum, University of Turku, Itäinen Pitkakatu 4a 5ks, Turku 20520, Finland.
authors.forename: Himanshu
authors.initials: H
authors.lastname: Kumar
authors.affiliation: Functional Foods Forum, University of Turku, Itäinen Pitkakatu 4a 5ks, Turku 20520, Finland. Electronic address: sepsal@utu.fi.
authors.forename: Seppo
authors.initials: S
authors.lastname: Salminen
authors.affiliation: National Institute for Public Health and the Environment (RIVM), PO Box 1, 3720 BA Bilthoven, The Netherlands; University of Ulster, Cromore Road, Coleraine, BT52 1SA Northern Ireland, United Kingdom.
authors.forename: Hans
authors.initials: H
authors.lastname: Verhagen
authors.affiliation: University of Reading, Reading RG6 6AP, United Kingdom.
authors.forename: Ian
authors.initials: I
authors.lastname: Rowland
authors.affiliation: JHeimbach LLC, 923 Water Street, P.O. Box 66, Port Royal, VA 22535, USA; Dairy & Food Culture Technologies, Centennial, CO 80122, USA.
authors.forename: Jim
authors.initials: J
authors.lastname: Heimbach
authors.affiliation: Abad Oliba - CEU University, Bellesguard, 30-08022 Barcelona, Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: Bañares
authors.affiliation: Kleinfeld, Kaplan, and Becker LLP, USA.
authors.forename: Tony
authors.initials: T
authors.lastname: Young
authors.affiliation: Yakult Central Institute, Kunitachi, Tokyo 186-8650, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Nomoto
authors.affiliation: Bio-K Plus International Inc., 495 boul. Armand-Frappier, Laval, QC, H7V 4B3 Canada.
authors.forename: Mélanie
authors.initials: M
authors.lastname: Lalonde
mesh_terms: D000818:Animals; D005106:Exploratory Behavior; D006801:Humans; D040541:Marketing; D064307:Microbiota; D056692:Prebiotics / Q000009:adverse effects; D019936:Probiotics / Q000009:adverse effects
chemical_list: D056692:Prebiotics