The European Chemicals Agency (ECHA) has launched IUCLID 6 Version 9, introducing significant format changes that broaden the software's regulatory applications and improve its usability for a diverse set of stakeholders. Released on 27 May 2025, the update supports new legislative requirements under the EU’s Drinking Water Directive, REACH restrictions on microplastics, and Biocidal Products Regulation (BPR), while integrating recent international harmonisation efforts.
New Functionalities Across EU Regulations
The latest version of IUCLID enables:
- Submissions for notifications of intention under the Drinking Water Directive.
- Reporting of estimated emissions for synthetic polymer microparticles under REACH.
- Enhanced data structuring for biocides with a simplified table of contents and refined validation rules.
Additional improvements support the new hazard classifications under the Classification, Labelling and Packaging (CLP) Regulation, including the integration of PBT/vPvB and PMT/vPvM hazard classes into Poison Centre Notification (PCN) formats.
Harmonised Format and OECD-Driven Changes
IUCLID 6 v9 includes updates aligned with OECD test guidelines and harmonised templates. Notable revisions include:
- New sections for in vitro immunotoxicity, nanomaterial size distribution, and extended reproductive toxicity.
- Refined reporting structures for toxicokinetics and ecotoxicological studies.
- Integration of OECD test guideline 125 for nanomaterial particle characterisation.
The fourth edition of the OECD report Customisation Opportunities of IUCLID for the Management of Chemical Data, published on 28 May 2025, complements this release. The report highlights IUCLID’s adaptability across jurisdictions, presenting user stories and practical examples from regulatory bodies. It showcases how the software supports varying regulatory frameworks through configuration and interface translation, reinforcing its utility as a global chemical data platform.
Drinking Water Directive: Final Preparations Underway
With the first notification period set for 2026, the finalised IUCLID working context for the Drinking Water Directive includes a detailed manual and validation tools. A dissemination preview feature has also been introduced, ensuring submitters can verify publicly shared information. Further work on the application process context is ongoing for release in 2026.
Stakeholder engagement continues through the DWD IT Tools User Group, with ongoing testing and feedback loops intended to fine-tune the tools ahead of mandatory compliance deadlines.
Biocides: Refined Structures and New Templates
For the BPR, IUCLID v9 features:
- Consolidated and renamed sections to reflect Annex II and III requirements.
- New documents for microbial products.
- Harmonised terminology and improved reporting for components, manufacturers, and risk mitigation measures.
User Experience and Software Support Enhancements
User interface upgrades now allow inline editing in tables and clearer delineation of ‘Other’ entries. Report generation has been improved with new templates for Classification and Labelling dossiers. ECHA has ended local installation support for Mac OS and Derby databases, advising migration to PostgreSQL for server deployments.
