Summary of Comments from Health Canada's Proposal to Amend the Food and Drug Regulations to Permit the Use of Asparaginase in Certain Food Products

Background

Health Canada's Bureau of Chemical Safety, Food Directorate, received two submissions from different companies for the food additive use of the enzyme asparaginase from two genetically modified source organisms, Aspergillus oryzae pCaHj621/BECh2#10 and Aspergillus niger ASP72. Public consultation on the proposal to amend the Food and Drug Regulations to permit the use of asparaginase in certain food products was conducted through postings on Health Canada's website. The final consultation closed on February 21, 2010 at 12 am EDT; although, comments received after this date were accepted. The proposed amendments would allow for asparaginase from two specific source organisms to be used as a food additive in bread, flour and whole wheat flour, and unstandardized foods, where such use is technologically justified, including baked goods, French fries, potato chips, and ready-to-eat breakfast cereals.

Summary of Comments

Health Canada received more than six-hundred comments from consumers, health professionals, health organizations, and food and agricultural organizations. Over 97% of the comments received were from individual consumers.

The majority of comments were not in favour of Health Canada's proposal, however most of the unfavourable comments were based on misconceptions and inaccuracies about how asparaginase would be used as a food additive. In response to the large volume of questions that were received, the Bureau of Chemical Safety, in Health Canada's Food Directorate, has prepared a document entitled, Questions and Answers Regarding Health Canada's Proposal to Amend the Food and Drug Regulations to Permit the Use of the Enzyme Asparaginase in Certain Food Products. This document provides responses to the most common questions that were posed during the consultation period and also attempts to address the misconceptions and correct the inaccuracies that may have been reported about Health Canada's proposal.  

A summary of the most common questions and concerns raised by stakeholders during the consultation period is presented below. The question/answer in the above-noted document that addresses each concern is also indicated.

Common Questions/Concerns Raised during the Consultation Period

• Is Health Canada approving the use of an enzyme in food that is also used as a chemotherapeutic drug? (Question 2)
• Could the side effects associated with L-asparaginase (the prescription drug) also be experienced by people who are exposed to asparaginase in foods? (Questions 2 and 8)
• Is Health Canada proposing to add a genetically modified enzyme to foods? (Question 4)
• Has Health Canada conducted toxicity tests for the asparaginase enzyme? (Question 6)
• What are the long-term health effects of asparaginase in humans? (Question 7)
• What are the effects of the breakdown products of asparaginase on human health? (Question 10)
• Are there real benefits to human health to using asparaginase to reduce acrylamide levels in foods? (Questions 17, 18, and 19)
• How does the addition of asparaginase to numerous "junk foods" fit into the overall mandate of Health Canada to promote healthy food and lifestyle choices? (Questions 19, 20, and 21)
• Will asparaginase be labelled on the list of ingredients of pre-packaged foods so that consumers can avoid it if they so choose? (Question 37)
• Who brought the proposal to permit the use of asparaginase as a food additive to Health Canada? (Questions 27 and 31)