Technical Consultation on Health Canada's Proposal to Amend the Food and Drug Regulations to Permit the Use of the Enzyme Asparaginase in Certain Food Products [December 2009]


Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Health Canada’s Bureau of Chemical Safety has recently completed a detailed safety assessment of the enzyme asparaginase after receiving petitions requesting that the Food and Drug Regulations be amended to include this enzyme produced by 2 separate microbial sources: Aspergillus oryzae (pCaHj621/BECh2#10), and Aspergillus niger ASP72.

Asparaginase is an enzyme that hydrolyses an amino acid, asparagine, to aspartic acid by hydrolyzing the amide in free asparagine to the corresponding acid, aspartic acid.

As a result of this assessment, Health Canada scientists have concluded that there are no health or safety concerns with the use of asparaginase in certain food products, as described in the submission. The Department has therefore initiated the regulatory process to amend Division 16 of the Regulations. The purpose of this communication is to seek public comments on this proposed action.

How to get Involved

These consultations are open for comment starting December 09, 2009 until February 21, 2010 (75 calendar days). Comments on these proposals may be submitted in writing, by regular mail or electronically. If you are submitting your comments electronically, please use the word "asparaginase" in the subject box of your e-mail.

Bureau of Chemical Safety
251 Sir Frederick Banting Drive
Health Canada, Tunney's Pasture
Address Locator: 2203B
Ottawa, Ontario K1A 0L2

Phone: 613-957-0973
Fax: 613-954-4674

Consultation Documents

Submissions must be received by 12:00 a.m. EDT, February 21, 2010.

Supporting Information

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site. If you have any questions, contact us at

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