The European Union has specified the measures for implementing its Chemicals Strategy for Sustainability, framed within the European Green Deal and the Zero Pollution ambition, through the publication of two key legal acts underpinning the “one substance, one assessment” policy:
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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).
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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:
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Regulatory data: dossiers submitted under REACH, CLP, Biocidal Products, Plant Protection Products, Food Contact Materials, Food Additives and Novel Foods legislation.
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Environmental monitoring and human biomonitoring data: originating from the IPCHEM platform, which will be integrated into the new system.
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Voluntary data: provided by Member States, research institutes and international projects.
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Sustainability-related information: including emissions, climate impact and substance life-cycle data.
In addition, the platform will include dedicated services such as:
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A repository of reference values to harmonise toxicological criteria.
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A database on regulatory processes, providing visibility on ongoing assessments.
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Information on substances in products and articles, supporting the circular economy.
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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:
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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.
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Interoperable data exchange: reinforced obligations to share information between agencies, avoiding duplication and improving consistency.
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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.
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Medical devices: ECHA will be responsible for developing and updating guidance on phthalates and other CMR substances or endocrine disruptors present in medical devices.
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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:
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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.
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Regulatory interoperability: harmonised formats will enable data reuse across different regulatory procedures, reducing costs and timelines.
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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.
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Promotion of safe innovation: the alternatives repository will encourage the development of sustainable solutions and the substitution of substances of concern.
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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:
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Technological adaptation: companies will need to familiarise themselves with new digital formats and systems.
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Confidentiality management: safeguarding sensitive data will be essential to maintain trust.
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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:
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Greater regulatory predictability: visibility of ongoing processes will support anticipation of regulatory changes.
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Resource optimisation: data reuse will reduce duplication and associated costs.
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Enhanced competitiveness: transparency and safe innovation will become key differentiators in global markets.
