Regulatory news and experts insights.

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.

Since 12 January 2026, the European Union has reached a major milestone in the protection of public health and water resources. The transition period provided for under Directive (EU) 2020/2184 (recast Drinking Water Directive) has now ended.

The recent amendment to the European Cosmetic Regulation significantly expands the list of fragrance allergens that must be declared on the INCI label (Regulation (EU) No 2023/1545 updating certain entries of Annex III of the EU Cosmetic Regulation). In the original version of Regulation (EC) No 1223/2009, 26 allergens were subject to mandatory labelling.

In December 2025, the European Commission published a targeted legislative proposal under its Food and Feed Safety Simplification Omnibus. One of its most relevant elements for the biocides sector is a proposed amendment to Regulation (EU) No 528/2012 (the Biocidal Products Regulation, or BPR), extending certain data protection periods for active substances still undergoing review.