L'apparition inattendue d'impuretés de N-nitrosamines dans les médicaments a marqué un tournant réglementaire majeur. Ces composés, connus dans l'environnement et l'alimentation, ont forcé l'industrie pharmaceutique mondiale à revoir ses processus. Face à cette situation, une coordination internationale sans précédent a vu le jour entre les agences réglementaires mondiales, telles que la FDA (États-Unis),

When a company develops a new ingredient, whether it is a concentrated plant extract, a biotech-derived ferment, a processed algae or a “functional” mushroom, one recurring question always arises: is a Novel Food procedure required before marketing the ingredient within the EU?  This question often emerges when the project is already well advanced: the formulation is nearly finalized, the marketing identity is ready, the first commercial discussions have started…

The identification of endocrine disruptors (EDs) has become a major public health and environmental concern worldwide. EDs are chemical substances capable of interfering with the hormonal system, leading to adverse effects on both humans and wildlife. Monitoring and assessing these substances is essential to protect human health, particularly among vulnerable populations such as pregnant women, children, and wild species. To this end, the U.S. Environmental Protection Agency (EPA) has develop