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Technical Alert: Updates – Nitrosamines; Labels Allergens and Other Substances of Concern

31 Mar 2023 3:41 PM | Anonymous member (Administrator)

This technical alert provides members with an update on nitrosamines, including updated information and resources on nitrosamine impurities in medicines from the TGA, and a recent EFSA opinion of nitrosamines in food. Please read the full alert for more details and information for sponsor, manufacturer and raw material supplier consideration. 

Please see below for the update on Labels Allergens and Other Substances of Concern.

Labels - Allergens and Other Substances of concern

The TGA's GMP Forum held on 21 March 2023 has generated discussion in industry regarding the declaration of allergenic substances or other substances of concern (‘allergens’) that do not have any cut-off specified in Column 2 of Schedule 1 of the Standard for labels of non-prescription medicines (currently the TGO 92.)

CMA previously sought clarification for these substances with the TGA after the publication of TGO 92, which resulted in additional information being published in Section 1.5.9 of the Guidance on TGO 92, in particular the part titled 'Determining when a substance is present'.

The complementary medicines industry is a complex one manufacturing many different types of substances. Recent discussions have highlighted that it is very likely that we need improved information, especially in regards to risk assessments and compliance expectations, to ensure that there are fair and transparent labelling expectations which do not inadvertently become inconsistent across the sector, or with the general expectations of allergen peak bodies, or with the labelling approaches taken for foods that are either mandatory (Food Standards) or voluntary (Precautionary Allergen Labelling and the VITAL program).

CMA will continue to work with TGA, our relevant internal committees, and allergen groups where available, about these matters. There are two main opportunities for further clarification or policy improvement:- in the short term through guidance, and at the next remake of the TGA's labelling Standard which is due in 2026.

All member comments, insights and suggestions to CMA are welcome to

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