The EU strengthens chemical substances management with a new legal framework based on data and scientific cooperation

• Regulation (EU) 2025/2455, which establishes a common data platform on chemical substances, to be managed by the European Chemicals Agency (ECHA), ensuring that chemical data are findable, accessible, interoperable and reusable (FAIR principles).

• Regulation (EU) 2025/2457, which amends core legislation (Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021) to strengthen scientific cooperation between agencies and prevent inconsistent scientific opinions.

Both regulations pursue a shared objective: more coherent, efficient and transparent risk assessments, reducing duplication and increasing public trust.

Common data platform: towards an integrated digital ecosystem

Regulation (EU) 2025/2455 establishes a digital infrastructure to centralise chemical substance information generated across the EU. The common data platform and its dedicated services must be operational by 2 January 2029 at the latest, and will incorporate:

• Regulatory data: dossiers submitted under REACH, CLP, Biocidal Products, Plant Protection Products, Food Contact Materials, Food Additives and Novel Foods legislation.

• Environmental monitoring and human biomonitoring data: originating from the IPCHEM platform, which will be integrated into the new system.

• Voluntary data: provided by Member States, research institutes and international projects.

• Sustainability-related information: including emissions, climate impact and substance life-cycle data.

In addition, the platform will include dedicated services such as:

• A repository of reference values to harmonise toxicological criteria.

• A database on regulatory processes, providing visibility on ongoing assessments.

• Information on substances in products and articles, supporting the circular economy.

• A repository of alternatives to substances of concern, fostering safe and sustainable innovation.

Enhanced scientific cooperation: a more robust framework

Regulation (EU) 2025/2457 introduces significant changes across food law (Regulation (EC) No 178/2002), environmental monitoring (Regulation (EC) No 401/2009), medical devices (Regulation (EU) 2017/745) and persistent organic pollutants (Regulation (EU) 2019/1021). Key developments include:

• Mandatory cooperation: EFSA, ECHA, EMA and the EEA are required to collaborate on the development of common methodologies, standardised formats and controlled vocabularies for chemical substance assessment.

• Interoperable data exchange: reinforced obligations to share information between agencies, avoiding duplication and improving consistency.

• Management of scientific divergences: where conflicting opinions arise, agencies must seek resolution before referring the matter to the Commission. In critical cases, ECHA may prepare harmonised classification and labelling (CLP) proposals.

• Medical devices: ECHA will be responsible for developing and updating guidance on phthalates and other CMR substances or endocrine disruptors present in medical devices.

• Persistent organic pollutants (POPs): ECHA’s role is strengthened in reviewing limit values and conducting socio-economic analyses for new restrictions.

How does this impact the agri-food sector?

These regulatory changes have a direct impact on the agri-food sector and the entire supply chain:

• Greater transparency and traceability: the common data platform will provide access to information on contaminants, additives, food contact materials and residues, supporting informed decision-making.

• Regulatory interoperability: harmonised formats will enable data reuse across different regulatory procedures, reducing costs and timelines.

• Early warning capability: the emerging risk surveillance system, managed by the EEA, will support the early identification of new chemical threats affecting ingredients, packaging or processes.

• Promotion of safe innovation: the alternatives repository will encourage the development of sustainable solutions and the substitution of substances of concern.

• Reduction of animal testing: the integration of existing data and the increased use of alternative methods will help minimise animal experimentation.

Conclusion

The new EU legal framework on chemical substances represents a clear commitment to a digital, collaborative ecosystem that will transform chemical risk management. Data integration, methodological harmonisation and transparency are central pillars in progressing towards a toxic-free environment, while strengthening public confidence and business competitiveness.

However, this transition also presents key challenges:

• Technological adaptation: companies will need to familiarise themselves with new digital formats and systems.

• Confidentiality management: safeguarding sensitive data will be essential to maintain trust.

• Capacity building: training will be required to ensure effective use of the platform and proper interpretation of data.

At the same time, significant opportunities arise:

• Greater regulatory predictability: visibility of ongoing processes will support anticipation of regulatory changes.

• Resource optimisation: data reuse will reduce duplication and associated costs.

• Enhanced competitiveness: transparency and safe innovation will become key differentiators in global markets.