Notice - Amendments to the Food and Drug Regulations for Mica

December 21, 2017

Our file number: 17-114005-350

Health Canada intends to amend the Food and Drug Regulations to permit the use of mica coated with titanium dioxide and/or iron oxide as colouring agents in drugs for both internal and external use. This action is in response to a request to allow the use of these colouring agents in ingestible drugs. These inactive ingredients are currently permitted, with limits on their concentrations, in Canadian foods and ingestible natural health products.

Health Canada has reviewed the supporting scientific evidence and is in agreement with the request, with the provision that the following limits on these colour additives are applied:

• Not more than 3% by weight in solid oral dosage forms;
• Not more than 0.3% in liquid oral dosage forms; and
• Not more than 55% iron oxide, by weight, in the finished pigment.

These limits are consistent with those required by the United States Food & Drug Administration for mica coated with titanium dioxide and/or iron oxide in ingested drugs, as defined in Title 21, Section 73.1350 of the United States’ Code of Federal Regulations (CFR.) The CFR however do not impose a limit for these colouring agents when used in liquid oral dosage forms.

It is anticipated that the proposed amendments to the Food and Drug Regulations will receive final publication in the Canada Gazette, Part II, in spring 2018.

Questions or concerns regarding this notice should be directed to Policy_Bureau_Enquiries@hc-sc.gc.ca for a 60 day period starting December 22, 2017 until February 20, 2018.