The European Commission proposes ‘one substance one assessment’ reform

On 7 December 2023, the European Commission proposed a package of three legislative proposals to reform chemical assessments to make the process faster, simpler and more transparent. The ‘one substance one assessment’ package aims to streamline the assessments of chemicals across EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks.

The package involves reallocating tasks between four EU agencies to ensure coherent and transparent assessments of chemicals used in a wide range of products, including medical devices, toys, food, pesticides, and biocides.

Key points of the legislative proposals

The three legislative proposals are part of the Commission’s Chemicals Strategy for Sustainability (CSS) and aim to achieve better prevention through improved chemicals data management. The key points are:

Establishment of a Common Data Platform: The platform will provide access to all data compiled under EU legislation and held by the EU agencies and the Commission. The Common Data Platform will integrate existing platforms such as the Information Platform on Chemical Monitoring (IPCHEM), the Public Activities Coordination Tool (PACT), and the EU Chemicals Legislation Finder (EUCLEF). It will include data on hazards, physico-chemical properties, environmental occurrence, emissions, uses, environmental sustainability of chemicals, and ongoing regulatory processes.

Redistributing tasks and improving of cooperation between EU agencies: To avoid the inefficient use of resources and unnecessary costs of having multiple committees carrying out similar assessments, the aim is to strengthen cooperation and consolidate scientific and technical work on chemicals in the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA), and the European Medicines Agency (EMA). The agencies will be better equipped to coordinate priorities, timelines, processes, and methodologies used for the assessment of chemicals. Moreover, knowledge gained from assessments under one piece of legislation (e.g. biocides) can be re-used for another one (e.g. toys).

Human biomonitoring data collection: A systematic collection of human biomonitoring data (e.g. from blood or breast milk) generated in the EU will be used to estimate the level of exposure of EU citizens to chemicals.

Establishment of a monitoring and outlook framework: Such a framework will allow early detection of chemical risks, such as PFAS, to prevent contamination from becoming widespread. It will facilitate a rapid regulatory response and track the impact of regulatory measures implemented on chemicals. The framework will include an early warning and action system, and a set of indicators,

Enable the European Chemicals Agency (ECHA) to generate data as needed.

Ensure transparency of scientific studies on chemicals, including those commissioned by companies.

The full text of the three proposed regulations can be accessed here, here, and here.

Next steps

The three proposals will now be discussed by the European Parliament and the Council under the ordinary legislative procedure.