title: A proposed framework for an appropriate evaluation scheme for microorganisms as novel foods with a health claim in Europe.
abstract: This paper concerns the procedure and the scientific approach to obtain market authorization for a microorganism to be recognized as a novel food with a health claim. Microorganisms that have not been traditionally used during food production in Europe prior to 1997 are considered as novel foods, which should undergo an in-depth characterization and safety assessment before being authorized on the European market. If a novel food bacterium is claimed to provide a beneficial effect on health, these claims must also be investigated before they can be authorized. Some requirements to obtain novel food certification are shared with those required to obtain a health claim. Although regulation exists that deals with these issues for foods in general, bacteria in food raise a specific set of questions that are only minimally addressed in official documentation. We propose a framework and suggest a list of criteria that should be assessed to obtain marketing authorization and health claim for a bacterium in accordance with European health policy.
authors.affiliation: Commensal and Probiotics-Host Interactions Laboratory, UMR1319 Micalis, INRA, AgroParisTech, Domaine de Vilvert, 78350, Jouy en Josas, France. sylmiquel@gmail.com.|AgroParisTech, UMR 1319 MICALIS, F-78350, Jouy-en-Josas, France. sylmiquel@gmail.com.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Miquel
authors.affiliation: Commensal and Probiotics-Host Interactions Laboratory, UMR1319 Micalis, INRA, AgroParisTech, Domaine de Vilvert, 78350, Jouy en Josas, France. martin.beaumont@hotmail.fr.|AgroParisTech, UMR 1319 MICALIS, F-78350, Jouy-en-Josas, France. martin.beaumont@hotmail.fr.
authors.forename: Martin
authors.initials: M
authors.lastname: Beaumont
authors.affiliation: Commensal and Probiotics-Host Interactions Laboratory, UMR1319 Micalis, INRA, AgroParisTech, Domaine de Vilvert, 78350, Jouy en Josas, France. rebeca.martinrosique@jouy.inra.fr.|AgroParisTech, UMR 1319 MICALIS, F-78350, Jouy-en-Josas, France. rebeca.martinrosique@jouy.inra.fr.
authors.forename: Rebeca
authors.initials: R
authors.lastname: Martín
authors.affiliation: Commensal and Probiotics-Host Interactions Laboratory, UMR1319 Micalis, INRA, AgroParisTech, Domaine de Vilvert, 78350, Jouy en Josas, France. philippe.langella@jouy.inra.fr.|AgroParisTech, UMR 1319 MICALIS, F-78350, Jouy-en-Josas, France. philippe.langella@jouy.inra.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Langella
authors.affiliation: VAB-nutrition, Clermont-Ferrand, France. veronique.braesco@vab-nutrition.com.
authors.forename: Véronique
authors.initials: V
authors.lastname: Braesco
authors.affiliation: Commensal and Probiotics-Host Interactions Laboratory, UMR1319 Micalis, INRA, AgroParisTech, Domaine de Vilvert, 78350, Jouy en Josas, France. muriel.thomas@jouy.inra.fr.|AgroParisTech, UMR 1319 MICALIS, F-78350, Jouy-en-Josas, France. muriel.thomas@jouy.inra.fr.
authors.forename: Muriel
authors.initials: M
authors.lastname: Thomas
mesh_terms: D003257:Consumer Product Safety / Q000592:standards*; D005060:Europe; D005513:Food Inspection / Q000379:methods / Q000592:standards*; D005516:Food Microbiology / Q000379:methods / Q000592:standards*; D017408:Guidelines as Topic; D007422:Intestines / Q000382:microbiology; D007881:Legislation, Food / Q000592:standards*; D064307:Microbiota; D011634:Public Health / Q000379:methods / Q000592:standards; D013997:Time Factors