One Substance, One Assessment: Building the Regulatory Backbone for NAMs

New Approach Methodologies (NAMs) are advancing quickly across toxicology. Yet their uptake in regulation remains uneven. 

❗The barrier is often not science. It is structure.

𝗨𝗻𝗱𝗲𝗿 𝘁𝗵𝗲 𝗰𝘂𝗿𝗿𝗲𝗻𝘁 𝗘𝗨 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸: 

 • The same substance may be assessed separately under different legislation

 • Acceptance of NAMs can vary across sectors

 • Data requirements are not always aligned

 • Companies may rely on traditional study packages to reduce uncertainty

𝗢𝗻𝗲 𝗦𝘂𝗯𝘀𝘁𝗮𝗻𝗰𝗲, 𝗢𝗻𝗲 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 (𝗢𝗦𝗢𝗔) 𝗼𝗳𝗳𝗲𝗿𝘀 𝗮𝗻 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝘆 𝘁𝗼 𝘀𝗵𝗶𝗳𝘁 𝘁𝗵𝗶𝘀 𝗱𝘆𝗻𝗮𝗺𝗶𝗰. 🚀🚀🚀

One Substance, One Assessment (OSOA) is a European Union initiative designed to ensure that each chemical substance is assessed only once for hazard and risk, with that assessment shared across all EU regulatory frameworks. 

OSOA strengthens the governance foundations that NAMs require in order to scale by promoting:

 ✅ One coordinated hazard assessment per substance

 ✅ Shared scientific conclusions across regulatory frameworks

 ✅ Better integration of expertise across regulatory domains

 ✅ Greater transparency and data sharing

𝗜𝘁𝘀 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗶𝗺𝗽𝗮𝗰𝘁 𝗶𝗻𝗰𝗹𝘂𝗱𝗲𝘀: 

 ✅ Enabling a NAM accepted once to support multiple regulatory decisions

 ✅ Reducing duplication of studies and limiting repeat animal testing

 ✅ Supporting harmonised evaluation standards

 ✅ Increasing confidence in integrated, non animal testing strategies

💡 If implemented ambitiously, OSOA could become a structural catalyst for modern, animal free regulatory science in Europe.

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Contributed by Faizan Sahigara, in silico (QSAR) expert and Business Developer at CEHTRA