The Natural and Non-prescription Health Products Directorate (NNHPD) has updated the Interim guide on isopropyl alcohol for use in alcohol-based hand sanitizers and disinfectants. The updates include additional information on good manufacturing practices (GMP) requirements under the Natural Health Products Regulation (NHPR), manufacturing responsibilities and clarification on the application of isopropyl alcohol (IPA) in alcohol-based hand sanitizers.
Pharmaceutical IPA is the most acceptable grade to use in your formulation. If alternate quality grades are to be used, you must test the IPA to determine if it is of equal or higher than the quality standards listed in the interim guide.
For technical-grade IPA, companies must carry out additional tests to identify all impurities that are present in the IPA. These tests can include identification, impurities, and acidity tests. Manufacturers planning on using technical-grade IPA must notify Health Canada by email before selling the product.
Formulations and ingredients
Formulations must meet the safety and efficient requirements outlined in Health Canada’s Antiseptic Skin Cleansers (Personal Domestic Use) monograph. Health Canada recommends manufacturers to use the WHO IPA hand sanitizer formulation as it ensures that impurities commonly found in IPA do not exceed USP limits.
Non-medicinal ingredients (NMIs) used in a hand sanitizer must be listed in Health Canada’s natural health products ingredient database. It is recommended that manufactures do not use priority food allergens in their hand sanitizers, to ensure everyone can use the products.
Manufacturers must keep records on how the hand sanitizer is prepared including calculations of the final IPA dilution in the finished product. Documents such as product specifications and certificates of analysis will also need to be kept and be made available to Health Canada if requested.
GMP must be followed for all finished hand sanitizers. More information can be found under Part 3 of the Natural Health Products Regulations.
Labelling requirements for hand sanitizers is outlined in the licensing approach to produce and distribute alcohol-based hand sanitizers. There is no additional labelling requirements for hand sanitizers containing IPA.
If you have any questions, or would like to register your alcohol-based hand sanitizer, contact Nexreg.