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.