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) In subsections (3) and (4),
- 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).
(5) Subsections (1) and (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
- Date modified: