Updated EMA-Acceptable intakes (AIs) established for N-nitrosamines

[Yosukemino]

Thank you for asking, @chrischar. As explained in the following @ccdw 's post, the AIs of nitrosamines in Appendix 1 are submitted to NS OEG for checking before publishment. The selection of the compounds is MAH’s responsibility and nitrosamines in Appendix 1 are not necessarily contaminated in the products.

EMA Q&A Rev. 19 (EMA/409815/2020 Rev.19)

EMA Q&A 10 now says: If the nitrosamine is not included in Appendix 1, MAH/MA applicants can also refer to a CPCA category from another source e.g. CPCA categories published by other regulatory authorities, but this will need confirmation to allow control of the substance at the level corresponding to that category. It does not specify if that confirmation can also happen at the national competent authority level or requires confirmation of the CPCA exercise by the NcWP. At the same time Q&A …