The Council and the European Parliament reached a provisional deal on the OSOA (one substance one assessment) package, which aims to streamline assessments of chemicals across relevant EU legislation, strengthen the knowledge base on chemicals, and ensure early detection and action on emerging chemical risks. The package contains three proposals: a directive concerning the re-attribution of scientific and technical tasks, a regulation aimed at enhancing cooperation among Union agencies in the area of chemicals, and a regulation establishing a common data platform on chemicals.
The co-legislators maintain the objectives of the legislative package but enlarge the information available in the common platform (i.e. to include scientific data submitted voluntarily), clarify how medical data should be treated, and ensure that the content of the platform is publicly available, in line with EU legislation on access to information.
Gathering data just once
The OSOA package creates a common platform that integrates existing databases and offers a ‘one-stop shop’ for chemical data from EU agencies and the Commission. It enables knowledge sharing from one legislative area to another and mandates the systematic collection of human biomonitoring data to inform policymakers about chemical exposure levels.
A monitoring and outlook framework will detect chemical risks early, support fast regulatory responses, and track impacts through an early warning system and indicators. It also empowers the European Chemicals Agency (ECHA) to generate data when needed and ensures transparency of scientific studies
Main elements of the agreement
The deal reached today makes sure that over time the common data platform to be hosted by ECHA should provide access to all chemicals data generated or submitted as part of the implementation of about 70 pieces of EU legislation.
The agreement requires ECHA to create and manage a database, inside the common data platform, that lists alternatives to substances of concern (chemicals that presents a potential risk to human health or the environment). This database should include alternative technologies and materials that do not require such substances of concern.
The agreement specifically supports the voluntary submission of scientific data to be included in the platform.
Data on medicinal products
The deal reached today considers that certain categories of newly generated data relating to chemical substances present in medicinal products from the European Medicines Agency (EMA) must be addressed as well.
The Commission will carry out an assessment to analyse whether in the future it is appropriate to include in the platform further categories of chemicals data related to medicinal products (for instance, other elements than active substances, substances that are now considered non-relevant, or data held by national agencies).
The co-legislators also agreed that legacy data from EMA (i.e. data generated and submitted before the entry into force of the regulation) will be gradually integrated into the platform, starting six years after the regulation enters into force.
Public access
The co-legislators agreed that the platform should give access to data that is already public in line with the rules of the originating legal acts. Horizontal legislation governing public access to information (Regulation (EC) no 1049/2001) will apply to all data that is not confidential.
Human biomonitoring studies
The package will help ECHA, and other agencies, to generate studies for multiple purposes. The agreement proposes already a practical application of this possibility. Four years after the regulation on the common data platform enters into force, ECHA should commission a Union-wide human biomonitoring study to better understand the population’s exposure to chemicals. Human biomonitoring data from the EU and national research programs will also be included in the platform.
Next steps
The provisional agreement reached with the European Parliament now needs to be endorsed and formally adopted by both institutions.
Background
Global chemicals production is projected to double by 2030, according to the UN Environment Programme (Global Chemicals Outlook II, 2019), underscoring the growing importance of the EU’s chemical regulations.
The “one substance one assessment” was part of the Chemicals Strategy for Sustainability, that the Commission made public on 14 October 2020. As a core element of the European Green Deal’s zero pollution ambition, the strategy aims to strengthen protection for people and the environment while driving innovation toward safe and sustainable chemicals.
- Proposal for a Directive concerning the re-attribution of scientific and technical tasks
- Proposal for a regulation enhancing cooperation among Union agencies in the area of chemicals
- Proposal for a Regulation establishing a common data platform on chemicals
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