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The Advocate General proposes the annulment of the provisions requiring pharmaceutical and cosmetics producers to finance at least 80% of the costs associated with quaternary wastewater treatment. Importantly, the Opinion does not challenge the environmental objectives of the Directive, the need to reduce micropollutants in wastewater, nor the legitimacy of introducing quaternary treatment. Instead, it focuses on the scientific and evidentiary basis underpinning the allocatio

Environmental considerations have become an established part of the regulatory development of human medicinal products in the European Union. Active pharmaceutical substances can enter the environment through the use and disposal of medicines, and their potential impact therefore needs to be assessed as part of the marketing authorisation process.

This report constitutes a document of major strategic importance for the European nutraceutical sector. By identifying, at an early stage, emerging risks associated with the consumption of food supplements (excluding vitamins and minerals), this text acts as an important signal of EFSA’s future priorities.

Assessing the endocrine-disrupting potential of a substance rarely comes down to reviewing a single study or obtaining a simple positive or negative result. The real challenge lies in interpreting all available data: what is already known about the substance? Do the existing data adequately address endocrine activity and potential adverse effects?

Regulatory compliance rarely involves a single question. Depending on the product, substance and target market, companies may need to address regulatory requirements, toxicological or ecotoxicological data, risk assessment, testing strategies, dossier preparation or ongoing regulatory monitoring.