Aiming to streamline regulatory compliance and reduce duplication, the OECD’s new guidance sets a global standard for chemical data sharing across the industry.
The Organisation for Economic Co-operation and Development (OECD) has published a landmark Best Practice Guide on Chemical Data Sharing Between Companies in October 2025. Designed to support manufacturers, importers, and stakeholders throughout the chemicals value chain, the guide addresses growing challenges in accessing and exchanging non-clinical health, safety, and environmental data.
By promoting transparent and fair data sharing mechanisms, this guidance aligns with international chemical management frameworks and helps reduce regulatory delays, particularly in jurisdictions implementing new or REACH-like regulations.
Harmonising Regulatory Compliance Across Borders
The OECD’s guide comes at a critical moment, as countries expand their chemical safety regulations. From the EU REACH to Korea’s AREC and Türkiye’s KKDIK, firms increasingly face obligations to submit comprehensive data dossiers to gain or maintain market access.
In many jurisdictions, companies must demonstrate either ownership of, or legal rights to refer to, existing toxicological or ecotoxicological data. Without proper access, firms risk inconsistent hazard classifications or delayed registrations. The OECD underscores the importance of avoiding redundant studies—especially those involving animal testing—by encouraging industry-wide data-sharing models.
Transparency, Fair Compensation and Global Reach
A major pillar of the guidance focuses on transparency—calling on data owners to make existing studies more discoverable and accessible. It recommends maintaining up-to-date inventories of available data, using service providers to manage access, and publishing robust study summaries in interoperable formats such as IUCLID.
Crucially, the guide tackles the thorny issue of fair compensation. Data owners are urged to avoid profiteering and instead apply clear, reasonable valuation methodologies. For instance, a table on page 31 outlines suggested cost ranges (10%–90% of study value) depending on whether sublicensing rights are granted and the scope of geographic use.
Additionally, the guidance supports flexible licensing—allowing for global, multi-country, or individual jurisdiction access—tailored to the buyer’s regulatory needs.
Avoiding Market Disparities and Regulatory Delays
Disparities in access to data can lead to divergent risk assessments across regions. An example cited in the guide shows how a registrant in Türkiye may submit a weaker dossier than its EU counterpart, purely due to lack of data ownership—potentially leading to different regulatory decisions for the same substance.
To mitigate such risks, the OECD calls for stronger collaboration mechanisms, especially in jurisdictions without mandatory joint submissions. It further recommends the development of a centralised global data index to track available studies and rights-holders—reducing administrative burdens and improving access across borders.
