Potential benefits and safety of dietary supplements are required to be assessed by scientifically validated means, in the context of REGULATION (EU) 2015/2283 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25/11/2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 and the Guidance for submission for food additive evaluations. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). European Food Safety Authority (EFSA). 16/08/2012. EFSA Journal 10(7):2760.

Toxicological data, including genotoxicity, information on absorption, distribution, metabolism and excretion (ADME) have to be collected to support the approval from the competent Authorities.

Demonstration of efficacy typically depends on a number of research approaches ranging from basic in vitro research on the mechanisms of action to animal and human studies. Depending on the claim, Galileo Research can help to design and validate in vitro and in vivo experimental methodologies suitable to identify the effects of the product.

To develop food supplements, it is fundamental to assess not only the benefits but also the potential risks associated with consumption/over-consumption of certain food, dietary supplements or individual substances added to supplements or fortified food. Our scientists have strong experience in the field of nutritional risk assessment and can help in the selection of substances with nutritional or physiological effect to be added to food and food supplements.

OECD 471, OECD 490, OECD 487, OECD 476, OECD 473, OECD 474, OECD 475.

OECD 415, OECD 414, OECD 443, OECD 416.

OECD 452, OECD 408, OECD 402, OECD 425, OECD 407, OECD 423, OECD 420, OECD 411, OECD 410.

Subscribe to our newsletter

Copyright 2021 © Galileo Research Srl - All rights reserved - C.F./P.I. 01855640502

Powered by

Change your consentRevoke your consent