Health Canada received a food additive submission seeking the approval of the enzyme asparaginase for use in the manufacture of wheat dough-based products such as bread, crackers and cookies, cut potato products such as French fries, sliced potato products and fabricated potato chips. Asparaginase meets the regulatory definition of a food additive, but is not currently listed in Table V, Division 16 of the Regulations.
Health Canada has completed a safety assessment of the food additive submission and determined that there are no public health or safety concerns with the use of asparaginase in certain food products, as described in the submission. In addition, efficacy data demonstrated that the use of asparaginase results in less acrylamide in foods. Therefore, Health Canada is proposing amendments to the Regulations to allow asparaginase to be used in the manufacture of bread and unstandardized foods.
Background:
Asparaginase is an enzyme that hydrolyses an amino acid, asparagine, to aspartic acid by hydrolyzing the amide in free asparagine. Asparaginase has no activity on asparagine residues in peptides or proteins. Aside from free asparagine, asparaginase only acts on free glutamine. It has no activity on other amino acids.
The purpose for using asparaginase in food manufacture is to reduce asparagine in food, and thereby reduce the risk of formation of acrylamide. Acrylamide is formed as a reaction product between asparagine and reducing sugars when certain foods are baked or fried at temperatures exceeding 120°C. Both asparagine and reducing sugars are commonly found in many raw food materials. Dietary exposure to acrylamide has been identified as of potential concern by the Next link will take you to another website Joint FAO/WHO Expert Committee on Food Additives (JECFA).1
In Canada, enzymes used in food applications, such as asparaginase, may be considered food additives, depending on their conditions of use. Permitted food additives are listed in the food additives tables in Division 16 of the Regulations. Table V lists those food additives that may be used as food enzymes in Canada.
Before a new food additive is allowed to be used in Canada, a submission must be filed with Health Canada so the Department can conduct a safety evaluation of the proposed use(s) of the additive. Food manufacturers are not permitted to use the additive until the safety assessment has been completed by Health Canada and the Regulations are amended to formally enable its use.
Rationale:
* Dietary exposure to acrylamide has been identified as a potential concern by Joint FAO/WHO Expert Committee on Food Additives (JECFA); therefore, Health Canada is supportive, in general, of efforts by industry to find ways to reduce acrylamide in foods;
* The purpose for using asparaginase in food manufacture is to reduce the risk of acrylamide formation in baked or fried food products. Enabling the use of asparaginase would provide the industry with the option of using this enzyme in the production of foods sold in Canada;
* The information provided by the petitioner has satisfactorily met the requirements for a food additive submission outlined in section B.16.002 of the Regulations.
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