Bioequivalence and Bioavailability Forum

❝ Regarding an upcoming product dossier submission, we have included beeswax in an ointment formulation.

❝ Could anyone confirm if it is required to declare this ingredient on the product label for Malaysian registration?

Clause 17 of Appendix 19, NPRA's General Labelling Requirements, does not apply to low-risk or commonly used materials intended for human consumption, such as lactose, milk derivatives, beeswax in ointment products, and printing/coloring inks derived from insect sources. Hence, it may not be required to declare beeswax on the product label.