EMA revised its Q&A on Nitrosamine on 7th July 2023. The question No. 10, related to the AI limit of Nitrosamine, is updated with the inclusion of a “Carcinogenic Potency Categorization Approach” (CPCA) to establish AI limit of Nitrosamine without Carcinogenicity data.

The updates have provided a process to predict the potency category of Nitrosamine.

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