A Review of Health Canada Efficacy Requirements for Professional-use handrubs/handwashes in Healthcare and Food Handling

Introduction

In 2024, Health Canada revised the monograph for Antiseptic Skin Cleansers intended for Personal, Domestic, and Commercial Use. Importantly, the revised monograph explicitly excludes antiseptics intended for professional use in healthcare settings (hospitals, nursing homes, clinics, dental offices) and food-handling premises (restaurants, food processing plants). These professional-use antiseptic products must comply separately with the broader regulatory frameworks outlined by the Food and Drug Regulations or the Natural Health Products Regulations administered by the Natural and Non-prescription Health Products Directorate (NNHPD). Compliance includes specific requirements for product labelling, manufacturing standards, and product specifications (1).

Given the evolving regulatory landscape and clarification needs of manufacturers, this article summarizes key efficacy testing requirements for handrubs and handwashes intended for professional healthcare and food handler use as outlined by Health Canada.

Relevant Testing Methods

Health Canada currently references the “Guidance Document – Human-Use Antiseptic Drugs” published in 2009, supplemented by a notice issued in 2019. This guideline specifies acceptable testing methodologies and labelling criteria:

Handwash vs. Handrub Testing

Health Canada’s guidance document references ASTM E1174 for efficacy testing; however, ASTM E1174 is primarily suitable for handwash products. For handrub antiseptics, ASTM E2755 is now widely recognized and accepted by Health Canada as more appropriate. ASTM E2755 closely aligns with EN 1500 methodologies and has become the preferred standard for assessing the efficacy of handrub products used by healthcare professionals and food handlers (2).

Representative Microorganisms for Testing

Health Canada’s tables for “Professional Food Handler Use Products” (Table 8) and “General Healthcare Personnel Use” (Table 10) originally list two Gram-negative bacteria (Escherichia coli and Serratia marcescens) as required test organisms. Notably, no Gram-positive bacteria, such as Staphylococcus aureus, were initially included. Health Canada now explicitly permits substituting Escherichia coli with Staphylococcus aureus, if ASTM E2755 is used, thereby aligning test practices with broader microbiological relevance (2).

Labelling and Microbial Claims

Per the 2019 notice, antiseptic products demonstrating efficacy only against bacteria must clearly label their limitations. Products must indicate explicitly: “Not shown to be effective against fungi and viruses.” Claims regarding efficacy against fungi and viruses require additional specific testing (in vitro and in vivo).

Minimum Acceptance Criteria

• Bacteria:
  • In vitro: ≥5-log reduction
  • In vivo: ≥3-log reduction
• Fungi and Viruses:
  • In vitro: ≥4-log reduction
  • In vivo: ≥2-log reduction

For fungi, in vitro and in vivo efficacy testing must be performed against:

• Candida albicans (ATCC 10231)
• Aspergillus brasiliensis (ATCC 16404)

For fungi and virus testing, accepted methods include ASTM E2613 (finger pad method) and ASTM E2011 (hand method); respectively.

Required Bacterial Panel for Healthcare Professional-Use handrubs/handwashes (In vitro)

Health Canada mandates testing against a comprehensive panel of microorganisms, including but not limited to the microorganisms listed in Table 1.

Table 1: List of bacteria for in vitro testing on professional-use handrubs/handwashes products

Conclusion

Understanding Health Canada’s efficacy testing requirements is crucial for manufacturers producing antiseptics for professional use in healthcare and food handling settings. Compliance with current guidelines, appropriate testing methodologies, and clear labelling standards ensures public health protection and facilitates regulatory approval.

CREM Co Labs is fully prepared to assist manufacturers in generating the necessary in vivo and in vitro efficacy data required for the registration of their professional-use human antiseptic drugs.

References

1. Health Canada. Antiseptic Skin Cleansers (Personal Domestic / Commercial Use) Monograph. 2024. Available from: https://webprod.hc-sc.gc.ca/nhpid-bdipsn/
2. Health Canada. Guidance Document – Human-Use Antiseptic Drugs. 2009; updated 2019 and notice added 2022. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/human-use-antiseptic-drugs.html