This service is part of our Scientific and Regulatory Expertise in health nutrition to help you design and launch your products in Europe, USA and Asia, through a panel of services : Novel Food consulting evaluation, Regulatory Compliance & notification, Health Claims, …
Thanks to its certification as a professional training organization, scientific and regulatory experts offers you personalized custom made training sessions, in our office or in yours, depending on your needs, in the following areas:
Regulatory
European / national regulatory framework and their evolution:
- Food supplements
- Sports nutrition
- Food for Special Medical Purposes (FSMP)
- Infant nutrition
- Meal replacements
- Fortified foods
- Novel food
Legal status of formulations (authorized ingredients, maximum doses, warnings, mutual recognition), of labeling rules, procedures of notification or registration.
Communication (labels, sales material/leaflets/brochures, instructions, web and advertising on sell location): scientifically and legally acceptable claims in the field of the Regulation 1924/2006 about nutrition and health claims, taking into account the importance of knowing the limits which could lead to a requalification to a drug by presentation or a judgment for misleading advertisement.
Regulation 1924/2006 about nutritional and health claims: interpret the European community’s text, procedure and imposition, deadlines, files constitution, prerequisites, analysis of authorities’ opinions and explanations of the reasons, how to be compliant with the regulation and law penalties.
Scientific
Nutrition and dietetic basis: structures, roles, sources and needs in macronutrients, vitamins, minerals, functional ingredients (CoQ10…).
Being conversant with principal ingredients by application: Indications of the major dietary supplement market segments (energy, weight management, joints, skin, stress/sleep, vision, urinary comfort…) and explanation of the principal health benefits and issues with physiological (not pharmacological) improvement targets by key ingredients.
Studies and efficacy/safety files: requirements and prerequisites, file’s typology, necessary studies in the context of the regulation about claims and nutrivigilance.