interim marketing authorization regarding the use of lipase enzyme in the production of bread flour whole wheat flour and unstandardized bakery products 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. 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 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