Vol. 138, No. 14 — April 3, 2004

Regulations Amending the Food and Drug Regulations (1398 — Addition of Ferric Ferrocyanide to Paragraph C.01.040.2(4)(a))

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

Description

The Therapeutic Products Directorate proposes to add Ferric Ferrocyanide (Colour Index 77510) to the Food and Drug Regulations, paragraph C.01.040.2(4)(a), the list of colouring agents permitted in drugs for external use.

Rationale

Colouring agents permitted for use in drugs are restricted to those listed in section C.01.040.2 of the Food and Drug Regulations. Subsection C.01.040.2(4) lists colours which are permitted in drugs only for external use.

Ferric Ferrocyanide refers to ferric hexacyanoferrate pigment characterized by the structural formula Fe₄[Fe(CN)₆]₃, which functions as a colourant predominantly in cosmetics.

Names and description:

Colour Index Number: CI 77510
Chemical Abstract Service (CAS): 14038-43-8
EINECS Number: 237-875-5
Colour/Shade: Blue
Other Common Names: Prussian Blue (United States), Pigment Blue 27, Berlin Blue, Ferrihexacyanoferrate, Ferrotsin, Paris Blue.

The proposal to add Ferric Ferrocyanide to subsection C.01.040.2(4) is based on a review by the Therapeutic Products Directorate of relevant safety data and an assessment of the use of this colour in other products for external and internal use.

Ferric Ferrocyanide has been approved for use in externally applied drugs and cosmetics in the United States and in cosmetics in Europe and Japan.

The Cosmetics Programme of the Product Safety Programme of Health Canada has not objected to the use of Ferric Ferrocyanide in cosmetics. Approximately 800 cosmetic products, including 627 deodorants, contain this substance identified as C.I. 77510.

In the United States, the use of Ferric Ferrocyanide is permitted to colour externally applied drugs, including those for use in the area of the eye. In addition, Ferric Ferrocyanide is recognized to be a safe and effective internal treatment for thallium poisoning. This recommendation provides further indication of the safety of this compound.

Alternatives

The alternative option was not to propose the addition of Ferric Ferrocyanide to the Regulations. This option was not considered to be acceptable, as it would unduly restrict manufacturers' ability to market drug products for external use containing a colouring agent which is widely used in other products for external use.

Benefits and costs

This amendment would permit an additional colourant for external use drug products and would impact on the following sectors.

1. Industry

The industry sector would benefit from being permitted to market in Canada drug products for external use that contain Ferric Ferrocyanide.

2. Government

This amendment is not expected to result in additional costs.

3. Public

Consumers would benefit from access to a wider selection of drug products for external use.

Consultation

This proposal is being prepublished in the Canada Gazette, Part I, with a 75-day comment period. Comments received will be taken into consideration in preparation of the final regulatory amendment.

Compliance and enforcement

This amendment would be subject to existing compliance mechanisms under the provisions of the Food and Drugs Act and Regulations enforced by the Health Products and Food Branch Inspectorate. Direct enforcement is provided through complaints from the medical profession and competitors.

Contact

Ms. Alexandra Bray, Policy Bureau, Therapeutic Products Directorate, Holland Cross, Tower B, 2nd Floor, Address Locator 3102C5, 1600 Scott Street, Ottawa, Ontario K1A 1B6, (613) 957-6447 (telephone), (613) 941-6458 (facsimile), alexandra_ bray@hc-sc.gc.ca (electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1398 — Addition of Ferric Ferrocyanide to Paragraph C.01.040.2(4)(a)).

Interested persons may make representations with respect to the proposed 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 Alexandra Bray, Therapeutic Products Directorate, Department of Health, Address Locator 3102C5, 1600 Scott Street, 2nd Floor, Tower B, Ottawa, Ontario K1A 1B6 (fax: (613) 941-6458; e-mail: alexandra_bray@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, March 30, 2004

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1398 — ADDITION OF FERRIC FERROCYANIDE TO PARAGRAPH C.01.040.2(4)(a))

AMENDMENT

1. Paragraph C.01.040.2(4)(a) of the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

FERRIC FERROCYANIDE (C.I. NO. 77510),

COMING INTO FORCE

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

[14-1-o]

Footnote a

S.C. 1999, c. 33, s. 347

Footnote 1

C.R.C., c. 870

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.

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