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Miquel et al. Microbial Cell Factories
Vol. 14, No. 48, 2015; Pages: 1 - 11

A proposed framework for an appropriate evaluation scheme for microorganisms as novel foods with a health claim in Europe

Sylvie Miquel, Martin Beaumont, Rebeca Martín, Philippe Langella, Véronique Braesco and Muriel Thomas

Commensal and Probiotics-Host Interactions Laboratory, UMR1319 Micalis,INRA, AgroParisTech, Domaine de Vilvert, 78350 Jouy en Josas, France.


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

Keywords: Beneficial microbes, Probiotic, Regulation, Safety, Gastro Intestinal (GI) tract

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