Brussels, 14 June 2024 11:30
Today, the EU Council adopted its mandate for the forthcoming negotiations with the European Parliament on the so-called ‘one substance one assessment’ (OSOA) package. The aim is to improve the assessment and strengthen knowledge of chemicals across the EU.
This will help to better protect human health and the environment through the development and use of safe and sustainable chemicals.
The ‘one substance one assessment’ package comprises the following proposals:
- directive concerning the re-attribution of scientific and technical tasks
- regulation aimed at enhancing cooperation among Union agencies in the area of chemicals
- regulation establishing a common data platform on chemicals
According to the ‘one substance, one assessment’ approach, technical and scientific work should be performed by the appropriate EU agency, building on its demonstrated experience and established tools in its field.
Re-attribution of tasks to European Chemicals Agency (ECHA)
The use of hazardous substances can be limited or banned in the European Union by including them on the EU list of restricted substances. The new rules aim to increase the transparency of the procedures already in place.
According to the new rules, applications for exemption from the list will now be submitted to the European Chemicals Agency (ECHA) and not to the Commission, as ECHA has the necessary scientific and technical expertise and has developed capacities for this task. Following input from its committees with regard to risk assessment and socio-economic analysis, ECHA will then issue an opinion.
In their negotiating mandate, member states concurred that the Commission should periodically review and amend the list of restricted substances (at least every five years) in order to ensure a high level of protection of human health, the environment and consumer safety.
Member states also acknowledged that the committees would need stable resources and sufficient capacity to tackle this increasing number of additional tasks. This should be taken into account in future legislation on ECHA’s funding.
Better cooperation among EU bodies
The new rules require active cooperation between ECHA, other EU agencies and the Commission in order to ensure coherent assessment methods are used, including through data interoperability and easy exchange of data. A dedicated procedure is to be set up to resolve any divergence of scientific opinion amongst them.
One-stop-shop for chemicals data
The new rules aim to bring together data and information on chemicals through the creation of a common data platform, including human biomonitoring data. This platform, managed by ECHA, will also provide a complete overview of studies performed on chemicals. It will therefore be the widest possible scientific base for evidence-based policymaking on chemicals. The platform also sets an early warning and action system for emerging chemical risks.
In order to improve chemical assessments in the EU and to strengthen public trust in scientific decision-making, EU agencies and the general public will have free and easy access to the common platform, with due respect to the principle of confidentiality.
Member states clarified that all data relating to chemical products should appear on this platform, including data generated or submitted before the regulation came into force.
The platform will also contain medical data on active substances and on environmental risk assessments. Member states introduced the obligation for the Commission to consider adding more medical data to the platform within six years of the entry into force of the legislation
Next steps
The Council is now ready to negotiate with the European Parliament on the final shape of the legislation following the negotiating mandate reached today. The European Parliament is expected to start examining the OSOA package after the European elections.
Background
On 7 December 2023, the Commission transmitted to the European Parliament and the Council these three proposals, aiming to streamline assessments of chemicals across relevant EU legislation, strengthen the knowledge base for chemicals, and ensure early detection of and action on emerging chemical risks.
The ‘one substance, one assessment’ approach is part of the European Green Deal. It aims to simplify the existing legal framework on chemicals and improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation.
An ad hoc working party on OSOA was set up under the Belgian presidency to effectively address the cross-sectoral matters covered by the proposed package.
Source – EU Council