Food and Drug Regulations — C.01.040.2
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