Towards 'one substance - one assessment': An analysis of EU chemical registration and aquatic risk assessment frameworks

Abstract

With the Green Deal the EU aims to achieve a circular economy, restore biodiversity and reduce environmental pollution. As a part of the Green Deal a 'one-substance one-assessment' (OS-OA) approach for chemicals has been proposed. The registration and risk assessment of chemicals on the European market is currently fragmented across different legal frameworks, dependent on the chemical's use. In this review, we analysed the five main European chemical registration frameworks and their risk assessment procedures for the freshwater environment, covering 1) medicines for human use, 2) veterinary medicines, 3) pesticides, 4) biocides and 5) industrial chemicals. Overall, the function of the current frameworks is similar, but important differences exist between the frameworks' environmental protection goals and risk assessment strategies. These differences result in inconsistent assessment outcomes for similar chemicals. Chemicals are also registered under multiple frameworks due to their multiple uses, and chemicals which are not approved under one framework are in some instances allowed on the market under other frameworks. In contrast, an OS-OA will require a uniform hazard assessment between all different frameworks. In addition, we show that across frameworks the industrial chemicals are the least hazardous for the freshwater environment (median PNEC of 2.60E-2 mg/L), whilst biocides are the most toxic following current regulatory assessment schemes (median PNEC of 1.82E-4 mg/L). Finally, in order to facilitate a successful move towards a OS-OA approach we recommend a) harmonisation of environmental protection goals and risk assessment strategies, b) that emission, use and production data should be made publicly available and that data sharing becomes a priority, and c) an alignment of the criteria used to classify problematic substances.

Keywords: Chemical legislation; Green deal; PNEC; Regulatory risk assessment; Water pollution.