One Substance, One Assessment: New EU Regulations Now in Force – ECHA Developing a Platform for Chemical Data

The OSOA (One Substance, One Assessment) statutory package consists of three pieces of legislation. They were published in the Official Journal of the European Union on December 12, 2025, and have been in force since January 1, 2026. The EU aims at making the assessment of chemicals more consistent, transparent, and efficient.

The new legislation consists of

EU Regulation 2025/2455 establishing a common data platform on chemicals
EU Regulation 2025/2457 reattributing technical tasks and improving cooperation among EU agencies, and
EU Directive 2025/2456 reattributing technical tasks to the European Chemicals Agency (ECHA).

Goal

The EU wants to use the legal regulations to identify chemicals and their risks more quickly so that it can take swift countermeasures through regulatory action. That’s why the EU plans to:

Consolidate and harmonize substance assessments in various regulatory areas, including industrial chemicals, biocides, pesticides, food, medical devices, and toys.
Establish a unified data platform for chemicals to consolidate data from more than 70 individual laws.
Improve cooperation and task sharing between the various EU agencies: The ECHA, the European Food Safety Authority (EFSA), the European Environment Agency (EEA), the European Medicines Agency (EMA), and the European Agency for Safety and Health at Work (EU-OSHA).

The roadmap

The data platform will be built gradually. According to Chemical Watch, the platform’s core services should be available within three years, and the entire platform should be fully functional in ten years.

Advantages for companies

Companies have often had to register or have chemicals evaluated by different authorities. The new platform eliminates this duplication of work because companies can submit all relevant information and applications through a single access point, which then applies to all EU regulations. The uniform risk assessments, in turn, provide greater planning security for product development and approvals. Companies can more reliably assess whether a substance will be approved or if restrictions are likely.

More responsibility

However, the benefits rise and fall with the timeliness of the data. Companies must therefore update data immediately if they have new information about the risks or safety aspects of substances. They face severe penalties if they fail to do so. After all, greater transparency also means that violations can be detected and sanctioned more quickly.

Do you have any questions about OSOA? Please contact us at sales@kft.de.