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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2019-06-20 and last amended on 2019-06-17. Previous Versions

PART CDrugs (continued)

DIVISION 1 (continued)

Miscellaneous (continued)

 No manufacturer shall use methyl salicylate as a medicinal ingredient in a drug for internal use in humans.

  • SOR/78-422, s. 2
  • SOR/78-801, s. 1
  • SOR/81-334, s. 2(F)
  • SOR/89-176, s. 1
  • SOR/92-662, s. 1

Colouring Agents

  •  (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.

  • SOR/84-949, s. 1
  • SOR/86-590, s. 1(E)
  • SOR/94-460, s. 1
  • SOR/95-431, s. 1
  • SOR/2002-369, s. 1
  • SOR/2005-95, s. 1
  • SOR/2018-248, s. 1
 
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