FOOD SUPPLEMENTS: D2M SANTE’S CONTRIBUTION FOR HEALTH CLAIMS

D2M Santé and your products’ development
The company has a broad experience in the formulation of products from the overall Health industry sector ensuring the manufacture of both pilot batches and batches for clinical trials. Products, whatever their status i.e. medicinal products, medical devices, food supplements, cosmetic products, are manufactured in pharmaceutical premises.
For more details, please see the D2M Santé R&D technical sheet


Scientific substantiation of health claims as per article 15 and the following from the EC regulation dated 18.1.2007
Each individual claim which is related to the reduction of disease risk, children’s development and health should be evaluated by the EFSA and then, authorized by the European commission on the basis of EFSA’s recommendation. In these cases, the individual health claim could be relative to the finished product and the active ingredient as well.

Scientific substantiation of health claims as per the article 18 from the EC regulation dated 18.1.2007
Any manufacturer with regards to the food supplement category of interest may apply for the inclusion of a health claim in the permitted Community list as published by the European commission. In this case, the applicant has to provide the EFSA with the list of studies establishing the scientific evidence for such a claim.
Data obtained from randomised controlled clinical trials with measurable evaluation criteria i.e. objective benefit or biomarkers and, from epidemiological studies when available, allow the substantiation of the scientific evidence.


The Investigational products as developed and manufactured by D2M Santé fulfil the requirements in terms of Good Manufacturing Practices and Good Distribution Practices.
For more details, please see the D2M Santé Clinical supplies technical sheet