Hazardous Products Regulations

Marginal note:Ingredient classified in Category 1 or 1A

• 8.5.3 (1) A mixture is classified in the category “Germ Cell Mutagenicity — Category 1” or the subcategory “Germ Cell Mutagenicity — Category 1A” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Germ Cell Mutagenicity — Category 1A”, unless

  • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture is a germ cell mutagen, in which case the mixture is classified as a germ cell mutagen in accordance with section 8.5.1; or

  • (b) the mixture as a whole has been subjected to an in vivo heritable germ cell mutagenicity test that determines that the mixture is not a germ cell mutagen, and a scientifically validated method was used and the test was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.

• Marginal note:Ingredient classified in Category 1 or 1B

  (2) A mixture is classified in the category “Germ Cell Mutagenicity — Category 1” or the subcategory “Germ Cell Mutagenicity — Category 1B” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Germ Cell Mutagenicity — Category 1B”, and does not contain any ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Germ Cell Mutagenicity — Category 1A”, unless

  • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture is a germ cell mutagen, in which case the mixture is classified as a germ cell mutagen in accordance with section 8.5.1; or

  • (b) the mixture as a whole has been subjected to an in vivo heritable germ cell mutagenicity test that determines that the mixture is not a germ cell mutagen, and a scientifically validated method was used and the test was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.