DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Food and Drug Regulations — Amendments
Interim Marketing Authorization
Provisions currently exist in the Food and Drug Regulations (the Regulations) for the use of the enzyme lipase derived from animal pancreatic tissue, Aspergillus niger var., Aspergillus oryzae var., edible forestomach tissue of calves, kids or lambs and Rhizopus oryzae var., in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice.
Health Canada has received a submission to permit the use of the lipase enzyme derived from a genetically modified Aspergillus niger strain, Aspergillus niger (LFS-54), that carries the gene from Fusariumculmorum coding for this enzyme. This lipase enzyme will be used in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice. Evaluation of available data supports the safety and effectiveness of this lipase derived from Aspergillus niger (LFS-54) in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice.
The use of this lipase will benefit consumers by increasing the availability of quality food products. It will also benefit industry through more efficient and improved manufacturing conditions.
Therefore, it is the intention of Health Canada to recommend that the Regulations be amended to permit the use of lipase derived from Aspergillus niger (LFS-54) in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice.
As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization is being issued to permit the immediate use of lipase derived from Aspergillus niger (LFS-54) in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice while the regulatory process is undertaken to amend the Regulations. The standardized foods described above are exempted from the application of sections 6 and 6.1 of the Food and Drugs Act, paragraph B.01.042(c) and section B.16.007 of the Regulations. The unstandardized foods listed above are exempted from paragraph B.01.043(a) and section B.16.007 of the Regulations.
The proposed regulatory amendments would be enabling measures to allow the sale of the foods mentioned above that have been manufactured through the use of the lipase from Aspergillus niger (LFS-54). The amendments are supported by the safety assessment and would have low impact on the economy and on the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.
Interested persons may make representations, with respect to Health Canada’s intention to amend the Regulations, within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the contact person identified below.
Contact
Rick O’Leary, Acting Associate Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, 251 Sir Frederick Banting Driveway, Address Locator 2203B, Ottawa, Ontario K1A 0K9, 613-957-1750 (telephone), 613-941-6625 (fax), sche-ann@hc-sc.gc.ca (email).
August 25, 2010
MEENA BALLANTYNE
Assistant Deputy Minister
Health Products and Food Branch
[37-1-o]
FOOD AND DRUGS ACT
Food and Drug Regulations — Amendments
Interim Marketing Authorization
Provisions currently exist in the Food and Drug Regulations (the Regulations) for the use of the enzyme lipase derived from animal pancreatic tissue, Aspergillus niger var., Aspergillus oryzae var., edible forestomach tissue of calves, kids or lambs and Rhizopus oryzae var., in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice.
Health Canada has received a submission to permit the use of the lipase enzyme derived from a genetically modified Aspergillus niger strain, Aspergillus niger (LFS-54), that carries the gene from Fusariumculmorum coding for this enzyme. This lipase enzyme will be used in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice. Evaluation of available data supports the safety and effectiveness of this lipase derived from Aspergillus niger (LFS-54) in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice.
The use of this lipase will benefit consumers by increasing the availability of quality food products. It will also benefit industry through more efficient and improved manufacturing conditions.
Therefore, it is the intention of Health Canada to recommend that the Regulations be amended to permit the use of lipase derived from Aspergillus niger (LFS-54) in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice.
As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization is being issued to permit the immediate use of lipase derived from Aspergillus niger (LFS-54) in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practice while the regulatory process is undertaken to amend the Regulations. The standardized foods described above are exempted from the application of sections 6 and 6.1 of the Food and Drugs Act, paragraph B.01.042(c) and section B.16.007 of the Regulations. The unstandardized foods listed above are exempted from paragraph B.01.043(a) and section B.16.007 of the Regulations.
The proposed regulatory amendments would be enabling measures to allow the sale of the foods mentioned above that have been manufactured through the use of the lipase from Aspergillus niger (LFS-54). The amendments are supported by the safety assessment and would have low impact on the economy and on the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.
Interested persons may make representations, with respect to Health Canada’s intention to amend the Regulations, within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the contact person identified below.
Contact
Rick O’Leary, Acting Associate Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, 251 Sir Frederick Banting Driveway, Address Locator 2203B, Ottawa, Ontario K1A 0K9, 613-957-1750 (telephone), 613-941-6625 (fax), sche-ann@hc-sc.gc.ca (email).
August 25, 2010
MEENA BALLANTYNE
Assistant Deputy Minister
Health Products and Food Branch
[37-1-o]
Comment