Regulations Amending the Food and Drug Regulations (Mica): SOR/2018-248

Canada Gazette, Part II, Volume 152, Number 25

Registration

SOR/2018-248 November 23, 2018

FOOD AND DRUGS ACT

P.C. 2018-1430 November 22, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) footnote a of the Food and Drugs Act footnote b, makes the annexed Regulations Amending the Food and Drug Regulations (Mica).

Regulations Amending the Food and Drug Regulations (Mica)

Amendments

1 (1) The portion of subsection C.01.040.2(2.1) of the Food and Drug Regulations footnote 1 before the definition C.I. (indication of the number) is replaced by the following:

(2.1) The following definitions apply in subsections (3) to (4.1):

(2) The Regulations are amended by adding the following after subsection C.01.040.2(4):

(4.1) Despite subsection (1), no manufacturer shall use a preparation made by extending any of the following substances on a substratum of mica in a drug unless the requirements in subsection (4.3) are met:

(4.2) Despite subsection (2), no person shall import for sale a drug that contains a preparation made by extending any of the substances referred to in paragraphs (4.1)(a) to (c) on a substratum of mica unless the requirements in subsection (4.3) are met.

(4.3) The requirements referred to in subsections (4.1) and (4.2) are the following:

(3) The portion of subsection C.01.040.2(5) of the Regulations before paragraph (a) is replaced by the following:

(5) Subsections (1), (2), (4.1) and (4.2) do not apply in respect of a drug that is represented as being solely for use in the disinfection, for disease prevention, of

Coming into Force

2 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Targeted amendments to the Food and Drug Regulations (FDR) are being made to permit the use of mica coated with titanium dioxide and/or iron oxide as colouring agents in drugs that are in solid or liquid dosage forms for oral administration and for drugs that are for external use. The colourant is currently allowed in foods and natural health products in Canada.

Background

Mica is a silicate mineral that is used as an inactive ingredient in drug products. It occurs physically as layered sheets that provide a shimmering effect when interacting with light. Under the FDR, mica is currently permitted for use as a colouring agent in drugs for external use only; however, mica coated with titanium dioxide and/or iron oxide is not permitted.

When mica is coated with metal oxides such as titanium dioxide or iron oxides, the resulting compound has a pearlescent appearance. Mica coated with these metal oxides has been approved for use in other jurisdictions, which include the United States (U.S.) and the European Union (EU), as colouring agents in various food and drug product formulations. In Canada, mica-based pearlescent pigments are permitted as colour additives with prescribed limits on their concentrations in food and natural health products; however, coated mica is not currently permitted under the FDR to be used in drug products.

In March 2009, a petition from industry was received by the Therapeutic Products Directorate at Health Canada. The petition sought amendments to the FDR to allow the use of mica coated with titanium dioxide and/or iron oxides in drugs for both internal and external routes of administration.

Health Canada completed its scientific review of the petition and supporting data in April 2012 and was supportive of the request, with the provision that the following limits on these colour additives be applied:

These limits are consistent with those required by the U.S. Food and Drug Administration (U.S. FDA) for mica coated with titanium dioxide and/or iron oxide, as defined in Title 21, Section 73.1350 of the United States Code of Federal Regulations (CFR). The CFR uses the term “ingestible drugs.” However, the regulatory amendment in the FDR refers to “solid dosage form intended for oral administration or in a liquid dosage form intended for oral administration,” which is synonymous but better reflects Canadian regulatory drafting conventions.

In late 2017, Health Canada received a submission for a prescription drug which contains two of these colourants and which, without these regulatory amendments, cannot be authorized for the Canadian market.

Objectives

The objective of this amendment is to allow mica coated with titanium dioxide and/or iron oxide to be used as a colourant in drugs in solid or liquid dosage forms for oral administration and/or external use. This would allow manufacturers of drugs with these colourants to be able to market these products in Canada, thereby increasing the range of treatment options for Canadians. The U.S. FDA has approved drugs which contain mica; these drugs could not be marketed in Canada without this amendment because under the current regulation, only products with the permitted list of colourants can be approved for use.

Description

Section C.01.040.2 of the Food and Drug Regulations lists colouring agents permitted for use in drugs. This section would be amended to allow mica coated with titanium dioxide and/or iron oxide to be permitted for use as a colouring agent in drugs for oral administration (in solid or liquid dosage forms) and for external use, with the requirement that the following limits on these colour additives are also applied:

There is no upper limit in the Regulations for liquid dosage forms. The amendments enable patient access to drugs that contain these inactive ingredients and allow Canadians to benefit from increased treatment options. As a specific example, Health Canada is currently reviewing a submission for market authorization for a drug that contains two of these inactive ingredients.

“One-for-One” Rule

The “One-for-One” Rule does not apply to these amendments, as they are not expected to increase administrative burden imposed on businesses.

Small business lens

Health Canada does not anticipate that any small businesses would be affected by these amendments.

Consultation

On December 21, 2017, Health Canada posted a notice on the Health Canada website indicating its intention to amend the FDR to allow for mica coated with titanium dioxide and/or iron oxide to be permitted for use as a colouring agent, subject to the above-mentioned limits. The notice allowed for a 60-day comment period for interested parties.

The Therapeutic Products Directorate received one comment from an industry stakeholder which inquired whether the regulation was going to have retroactive application. No other comments were received.

Health Canada’s response: The amendments will not apply retroactively.

This information was conveyed to the stakeholder directly.

Rationale

These amendments to the FDR permit the use of mica coated with titanium dioxide and/or iron oxide as colouring agents in drugs for both oral administration and for external use. This change has been made in response to a request to allow the use of these colouring agents in ingestible drugs, which included data that supported the safe use of this inactive ingredient at the level prescribed in the proposed amendment.

The scientific data provided in the petition to add the colourant do not suggest that use of this inactive ingredient would present any indirect risks to humans or any negative impact on the environment. While it would not be possible to predict the number of industry stakeholders who would benefit from this proposal, given that the amendment removes a barrier to the use of these colouring agents in both prescription and non-prescription drugs, it is likely to benefit a number of industry stakeholders, beyond the manufacturer who presently has a submission under review. The manufacturing of drugs takes place at an international level: given Canada’s relatively small market size, the drug in question would likely not be reformulated without coated mica solely for the Canadian market. Without these regulatory amendments, this drug cannot be authorized for the Canadian market.

The use of mica coated with titanium dioxide and/or iron oxides will also provide an additional means for patients to differentiate pharmaceutical products since these colourants provide a pearlescent or “shimmer” effect which can be distinguishable from other colours. Being able to clearly differentiate different pharmaceutical products by colour may help reduce medication errors. It may also be useful to thwart counterfeiting of products insofar as the effect produced by coated mica may be difficult to reproduce.

As previously indicated, this amendment will bring Canada into regulatory alignment with the United States with respect to the regulation of coated mica as a colourant in drugs. In the case of the European Union, Health Canada has conducted a scan, but is unable to identify any regulatory controls on this inactive ingredient in drugs in the European Union.

The amendments are relieving in nature, and are not expected to create any costs for industry, consumers or Canadians.

Implementation, enforcement and service standards

The amendments are subject to existing compliance mechanisms under the provisions of the Food and Drugs Act and regulations enforced by the Regulatory Operations and Regions Branch. Direct enforcement is provided in response to complaints from medical professionals and competitors.

Contact

Bruno Rodrigue
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
11 Holland Avenue
Holland Cross, Suite 14
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca