Regulatory news and experts insights.

Directive (EU) 2026/805 of 30 March 2026 constitutes a major revision of the European Union’s water legislation. By simultaneously amending the Water Framework Directive (2000/60/EC), the Groundwater Directive (2006/118/EC), and the Environmental Quality Standards Directive (2008/105/EC), the text aims to align the protection of water resources with the European Green Deal’s “zero pollution” ambition.

The safety of cosmetic products is generally assessed from the perspective of human health, considering endpoints such as skin irritation, skin sensitisation, systemic toxicity, and endocrine disruption. However, the environmental properties of cosmetic ingredients are becoming increasingly important in substance assessment processes and product development strategies, particularly when selecting formulation ingredients.

China is revising its rules on new chemical substance registration, with a draft revision of the Measures for the Environmental Management Registration of New Chemical Substances, commonly referred to as China REACH. The draft was released by China’s Ministry of Ecology and Environment on 11 June 2026 and was open for public comment until 12 July 2026. Once finalised, the revised measures are expected to replace MEE Order No. 12 of 2020.

In pharmaceutical development, the preparation of CTD Tabulated Summaries is a critical component of regulatory submissions. These documents require scientific rigor, consistency, and accuracy, while also involving extensive data compilation, formatting, and verification activities.

On 15 June 2026, Regulation (EU) 2026/1165 entered into force, amending the Biocidal Products Regulation (BPR) and extending data protection for certain active substance dossiers until 31 December 2030. The amendment addresses a long-standing concern arising from delays in the Review Programme for existing active substances and restores protection that had expired at the end of 2025.

On 27 November 2024, the European Union reached a landmark milestone with the adoption of Directive (EU) 2024/3019 on urban wastewater treatment. This text, which lays down minimum requirements for the collection, treatment and monitoring of urban wastewater, is the result of a comprehensive recast of the 1991 directive.

Fragrance diffusers, often perceived as wellness or decorative products, are becoming increasingly common in homes: reed diffusers, electric diffusers (plug-in, nebulisers, ultrasonic devices, etc.), sprays, stone diffusers, candles, and more. Their promise is simple: to create a pleasant and relaxing olfactory atmosphere.

Un produit peut contenir une substance dangereuse sans nécessairement présenter un risque inacceptable, à condition que l’exposition de l’utilisateur reste maîtrisée. À l’inverse, une faible concentration apparente ne suffit pas toujours à garantir la sécurité. Tout dépend de la toxicité de la substance, de la manière dont elle est libérée, et des conditions réelles d’utilisation.

In response to the public health and environmental challenges posed by endocrine disruptors (EDs), and following two previous national strategies on endocrine disruptors, the French government has unveiled its new roadmap for the next five years with a clear ambition: moving towards “zero exposure to endocrine disruptors”.

Calculating Margins of Safety (MoS) is at the core of cosmetic ingredient safety assessment. On paper, the principle appears simple: comparing a no-effect dose to an estimated exposure in order to verify that a sufficient safety margin exists. In practice, however, things are often far more complex.

The adoption of Directive (EU) 2024/3019 on urban wastewater treatment (UWWTD), published on 12 December 2024, introduces unprecedented requirements for the pharmaceutical industry. Integrated into the EU “Zero Pollution” Action Plan, this legislation imposes stringent management obligations for pharmaceutical residues

La Directive (UE) 2020/2184 introduit une réforme majeure de la sécurité sanitaire des eaux destinées à la consommation humaine. Son Article 11 est le pilier central des exigences minimales d’hygiène applicables aux matériaux en contact avec l’eau, visant à garantir que ces derniers ne compromettent pas la santé humaine, n'altèrent pas les propriétés organoleptiques de l'eau (notamment le goût, l’odeur ou la couleur) et ne favorisent pas la croissance microbienne.

In today’s organisations, ensuring effective regulatory and toxicological monitoring of chemical substances has become a major challenge for regulatory teams, toxicologists, and R&D departments.

PFAS remain a complex topic for industry stakeholders. Between rapidly evolving regulations, traceability challenges, and analytical limitations, compliance can no longer be reduced to a simple check.

In August 2023, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) jointly published a landmark guidance document on the impact of water treatment processes on residues of active substances in water abstracted for drinking water production (EFSA Journal, doi: 10.2903/j.efsa.2023.8194).

The draft 24th Adaptation to Technical Progress (ATP) to the CLP Regulation (EC) No 1272/2008 proposes a significant number of new harmonised classifications that could affect chemical substance portfolios across several industrial sectors.

The sanitary safety of drinking water in the EU is primarily based on an increasing synergy between two legislative pillars: Directive (EU) 2020/2184 (Drinking Water Directive), which constitutes a revision of the pre-existing Directive 98/83/EC, and Regulation (EU) No 528/2012 (BPR).

In January 2026, the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods, and Food Allergens (NDA) endorsed a draft opinion on the safety of plant preparations containing berberine.

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.