ARCHIVED - Summary of Input Received on Health Canada's Consultation to Permit the use of the Enzyme Asparaginase as a Food Additive in Canada [August 2009]

August 2009


On February 20th 2009, Health Canada sent a letter to stakeholders to inform them of the department's proposal to permit the use of asparaginase as a food additive for use in the reduction of formation of acrylamide in certain foods sold in Canada after the completion of a safety evaluation by Health Canada's scientists. Information on this proposal was also made available on Health Canada's website on March 02, 2009, providing the larger stakeholder community and the public with information supporting Health Canada's evaluation of this food additive and its recommendation to permit its use in foods available for sale in Canada. Comments were accepted until 12:00am EDT on Thursday May 21, 2009. [note: certain stakeholders were permitted to submit their comments after this date upon request].

Summary Of Stakeholder Input

Health Canada received input from several stakeholders representing the food industry and professional organizations including:

  • The Baking Association of Canada (BAC)
  • McCain Foods (Canada)
  • The Enzyme Technical Association (ETA)
  • Frito Lay Canada
  • Food and Consumer Products of Canada

All stakeholders expressed their support to Health Canada's recommendation to permit the use of asparaginase as a food additive for use in certain food applications in Canada.

Certain stakeholders had specific requests that would require that Health Canada broaden/verify the scope of intended use within the FDR amendments to ensure that asparaginase could be used in other pertinent food applications such as its addition to various flour(s), and French fries.

Other stakeholder comments included that Health Canada should continue to treat the approval of all tools with the potential of reducing acrylamide formation in food as a high priority and strive to harmonize its regulations to reflect what has been approved by other major food regulatory agencies internationally.

Conclusion And Next Steps

In view of the results of Health Canada's evaluation concluding to the safe use of asparaginase as a food additive in certain food commodities, and of the input received from stakeholders, Health Canada's Food Directorate will proceed with the drafting of regulatory amendments to add asparaginase to Table IX, Division 6 of Part B of the Food and Drug Regulations as follows:

Table 1: Proposed Addition to Table Table V, Division 16 of the Food and Drug Regulations to allow asparaginase to be used as a food additive in fabricated potato chips, cut potato products such as French fries, sliced potato products, and wheat dough based products such as cookies, crackers and bread, at a maximum level of use of Good Manufacturing Practice. The proposed listing could appear in Table V as follows:

Item No. Column I
Column II
Permitted Source
Column III
Permitted in or Upon
Column IV
Maximum Level of Use
TBD Asparaginase Aspergillus niger (ASP72);
Aspergillus oryzae

  1. Bread; Flour; Whole wheat flour
  2. Unstandardized foods
  1. Good Manufacturing Practice
  2. Good Manufacturing Practice

Bread, flour and whole wheat flour are subject to compositional standards in the Regulations. In order to permit the addition of asparaginase to these foods, amendments would be required to paragraph B.13.021(h) and subparagraphs B.13.001(e)(iii) and B.13.005(d)(iii).

In doing so, Health Canada's Food Directorate would fulfill the department's obligation under section B.16.003 of the Food and Drug Regulations to enable the use of this food additive given that the requirements set out in Section B.16.002 of the Food and Drug Regulations are met.

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