May. 12 – Canada: Food and Drug Regulations — Amendments
An annoucement recently posted in the Canada Gazette:
Interim Marketing Authorization
Provision currently exists in the Food and Drug Regulations for the use of L-leucine as a lubricant at a maximum level of use of 3% of tablet weight in the manufacture of table-top sweetener tablets containing aspartame.
Health Canada has received a submission to permit the use of L-leucine as a lubricant and/or binder in table-top sweetener tablets containing sucralose. Evaluation of available data supports the safety and effectiveness of L-leucine as a lubricant and/or binder in table-top sweetener tablets.
The use of L-leucine will benefit consumers through increased availability of quality table-top sweetener 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 Food and Drug Regulations be amended to permit the use of L-leucine as a lubricant and/or binder in table-top sweetener tablets at levels consistent with good manufacturing practice.
As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to permit the immediate use of L-leucine in the manufacture of table-top sweetener tablets containing sucralose, at levels consistent with good manufacturing practice, while the regulatory process is undertaken to formally amend the Regulations. Click on the above link to read the full annoucement.