Memorandum 2010-04: Requirement to test veterinary biologics for residual formaldehyde

59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Telephone: 613-773-7408
Facsimile: 613-773-7570

December 21, 2010

Veterinary Biologics Manufacturers and Veterinary Biologics Quality Control Laboratories

The purpose of this memorandum is to clarify the regulatory requirements for residual formaldehyde testing of veterinary biologics.

Veterinary biologics that have been inactivated with formaldehyde must undergo residual formaldehyde testing to ensure that the amount of free formaldehyde contained in the finished product does not exceed acceptable limits. Reliance on pre-blending volume calculations alone is unacceptable, as variability in the biomass and inactivation process may result in levels of residual formaldehyde in the finished product that differ from the expected value.

Please visit the Canadian Food Inspection Agency – Canadian Centre for Veterinary Biologics (CFIA-CCVB) website to obtain a copy of Guidance for Industry: Testing of Residual Formaldehyde, VICH GL 25.

No action is required if the current testing protocol is in compliance with this requirement. Companies not currently complying with this requirement must submit a letter to the CFIA-CCVB, explaining when and how this requirement will be met. The compliance with these requirements will be verified during on-site facility inspections or renewal of permits and supporting documentation.

If you have any questions or require additional information about the above requirement, please contact our office at 613-773-7408.

Glen Gifford, DVM, MSc
National Manager
Canadian Centre for Veterinary Biologics
Terrestrial Animal Health Division
Canadian Food Inspection Agency