Food and Drug Regulations

C.01.040.2 (1) No manufacturer shall use a colouring agent in a drug other than a colouring agent listed in subsections (3) and (4).

(2) No person shall import for sale a drug that contains a colouring agent other than a colouring agent listed in subsections (3) and (4).

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

C.I. (indication of the number)

C.I. (indication of the number) means the designation used to identify a colouring agent in the Colour Index published by The Society of Dyers and Colourists, as amended from time to time; (C.I. (indication du numéro))

D & C (indication of the colour and the number)

D & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in drugs and cosmetics; (D&C (indication de la couleur et du numéro))

FD & C (indication of the colour and the number)

FD & C (indication of the colour and the number) means the designation used to identify, in accordance with the Code of Federal Regulations of the United States, a colouring agent that can be used in the United States in food, drugs and cosmetics. (FD&C (indication de la couleur et du numéro))

(3) The following colouring agents are permitted in drugs for internal and external use, namely,

• (a) ACID FUCHSIN D (D & C Red No. 33; C.I. No. 17200),

  • ALIZARIN CYANINE GREEN F (D & C Green No. 5; C.I. No. 61570),
  • ALLURA RED AC (FD & C Red No. 40; C.I. No. 16035),
  • AMARANTH (Delisted FD & C Red No. 2; C.I. No. 16185),
  • ANTHOCYANIN DERIVED FROM JUICE EXPRESSED FROM FRESH EDIBLE FRUITS OR VEGETABLES,
  • ß-APO-8¹-CAROTENAL (C.I. No. 40820),
  • BRILLIANT BLUE FCF SODIUM SALT (FD & C Blue No. 1; C.I. No. 42090),
  • BRILLIANT BLUE FCF AMMONIUM SALT (D & C Blue No. 4; C.I. No. 42090),
  • CANTHAXANTHIN (C.I. No. 40850),
  • CARAMEL,
  • CARBON BLACK (C.I. No. 77266),
  • CARMINE (C.I. No. 75470),
  • CARMOISINE (Delisted Ext. D & C Red No. 10; C.I. No. 14720),
  • ß-CAROTENE (C.I. No. 40800),
  • CHLOROPHYLL (C.I. No. 75810),
  • EOSIN YS ACID FORM (D & C Red No. 21; C.I. No. 45380:2),
  • EOSIN YS SODIUM SALT (D & C Red No. 22; C.I. No. 45380),
  • ERYTHROSINE (FD & C Red No. 3; C.I. No. 45430),
  • FAST GREEN FCF (FD & C Green No. 3; C.I. No. 42053),
  • FLAMING RED (D & C Red No. 36; C.I. No. 12085),
  • HELINDONE PINK CN (D & C Red No. 30; C.I. No. 73360),
  • INDIGO (D & C Blue No. 6; C.I. No. 73000),
  • INDIGOTINE (FD & C Blue No. 2; C.I. No. 73015),
  • IRON OXIDES (C.I. Nos. 77489, 77491, 77492, 77499),
  • LITHOL RUBIN B SODIUM SALT (D & C Red No. 6; C.I. No. 15850),
  • LITHOL RUBIN B CALCIUM SALT (D & C Red No. 7; C.I. No. 15850:1),
  • PHLOXINE B ACID FORM (D & C Red No. 27; C.I. No. 45410:1),
  • PHLOXINE B SODIUM SALT (D & C Red No. 28; C.I. No. 45410),
  • PONCEAU 4R (C.I. No. 16255),
  • PONCEAU SX (FD & C Red No. 4; C.I. No. 14700),
  • QUINOLINE YELLOW WS (D & C Yellow No. 10; C.I. No. 47005),
  • RIBOFLAVIN,
  • SUNSET YELLOW FCF (FD & C Yellow No. 6; C.I. No. 15985),
  • TARTRAZINE (FD & C Yellow No. 5; C.I. No. 19140),
  • TITANIUM DIOXIDE (C.I. No. 77891);

• (b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of

  • (i) alumina,

  • (ii) blanc fixe,

  • (iii) gloss white,

  • (iv) clay,

  • (v) zinc oxide,

  • (vi) talc,

  • (vii) rosin,

  • (viii) aluminum benzoate,

  • (ix) calcium carbonate, or

  • (x) any combination of the substances listed in subparagraphs (i) to (ix); and

• (c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of

  • (i) alumina,

  • (ii) blanc fixe,

  • (iii) gloss white,

  • (iv) clay,

  • (v) zinc oxide,

  • (vi) talc,

  • (vii) rosin,

  • (viii) aluminum benzoate,

  • (ix) calcium carbonate, or

  • (x) any combination of the substances listed in subparagraphs (i) to (ix).

(4) The following colouring agents are permitted in drugs for external use, namely,

• (a) ACID VIOLET 43 (Ext. D & C Violet No. 2; C.I. No. 60730),

  • ALIZUROL PURPLE SS (D&C Violet No. 2; C.I. No. 60725),
  • ANNATTO (C.I. No. 75120),
  • BISMUTH OXYCHLORIDE (C.I. No. 77163),
  • CHROMIUM HYDROXIDE GREEN (PIGMENT GREEN 18 (C.I. No. 77289)),
  • DEEP MAROON (D&C Red No. 34; C.I. No. 15880:1),
  • DIBROMOFLUORESCEIN (SOLVENT RED 72 (C.I. No. 45370:1); ORANGE No. 5 (D & C Orange No. 5)),
  • FERRIC FERROCYANIDE (C.I. No. 77510),
  • GUANINE (C.I. No. 75170),
  • MANGANESE VIOLET (C.I. No. 77742),
  • MICA (C.I. No. 77019),
  • ORANGE II (D&C Orange No. 4; C.I. No. 15510),
  • PYRANINE CONCENTRATED (D&C Green No. 8; C.I. No. 59040),
  • QUINIZARIN GREEN SS (D&C Green No. 6; C.I. No. 61565),
  • TONEY RED (D&C Red No. 17; C.I. No. 26100),
  • URANINE ACID FORM (D&C Yellow No. 7; C.I. No. 45350:1),
  • URANINE SODIUM SALT (D&C Yellow No. 8; C.I. No. 45350);
  • ZINC OXIDE (C.I. No. 77947);

• (b) preparations made by extending any of the colouring agents listed in paragraph (a) on a substratum of

  • (i) alumina,

  • (ii) blanc fixe,

  • (iii) gloss white,

  • (iv) clay,

  • (v) zinc oxide,

  • (vi) talc,

  • (vii) rosin,

  • (viii) aluminum benzoate,

  • (ix) calcium carbonate, or

  • (x) any combination of the substances listed in subparagraphs (i) to (ix); and

• (c) preparations made by extending any sodium, potassium, aluminum, barium, calcium, strontium or zirconium salt of any of the colouring agents listed in paragraph (a) on a substratum of

  • (i) alumina,

  • (ii) blanc fixe,

  • (iii) gloss white,

  • (iv) clay,

  • (v) zinc oxide,

  • (vi) talc,

  • (vii) rosin,

  • (viii) aluminum benzoate,

  • (ix) calcium carbonate, or

  • (x) any combination of the substances listed in subparagraphs (i) to (ix).

(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:

• (a) titanium dioxide (C.I. No. 77891);

• (b) iron oxides (C.I. Nos. 77489, 77491, 77492, 77499); or

• (c) a mixed oxide made from substances referred to in both paragraphs (a) and (b).

(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:

• (a) the drug shall be in a solid dosage form intended for oral administration or in a liquid dosage form intended for oral administration or it shall be a drug intended for external use;

• (b) in the case where the drug is in a solid dosage form intended for oral administration, the drug shall not contain more than 3% of the preparation;

• (c) in the case where the preparation was made using iron oxides, the preparation shall not contain more than 55% iron oxides.

(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

• (a) medical devices;

• (b) health care facilities; or

• (c) premises in which food is manufactured, prepared or kept.