Regulatory news and experts insights.

Per- and polyfluoroalkyl substances (PFAS) are a large family of anthropogenic chemicals characterised by highly stable carbon–fluorine bonds. Structurally, PFAS typically contain at least one fully fluorinated methyl (CF₃-) or methylene (-CF₂-) carbon atom.

During our COSMETICK webinar on cosmetic safety assessment, toxicologists raised key questions on endocrine disruption, Margin of Safety (MOS), and toxicological data gaps.

Rôle du PIF dans la mise sur le marché Dans l’Union Européenne, la mise sur le marché d’un produit cosmétique ne peut se faire sans un dossier complet que l’on appelle Product Information File (PIF) ou Dossier d’Information Produit (DIP) en français. Il s’agit d’une obligation légale définie par le Règlement (CE) n°1223/2009.

The identification of endocrine disruptors (EDs) has become a key challenge for many industries. With increasing regulatory requirements and the growing number of substance lists evaluated by authorities, obtaining a clear and rapid overview of a substance’s status has become increasingly complex.

Since the sartans crisis in 2018, the detection of nitrosamines has highlighted systemic gaps in identifying contamination pathways across pharmaceutical supply chains. As impurities belonging to the “cohort of concern” following ICH M7 (R2), nitrosamines present exceptionally high carcinogenic potency.