Hazardous Products Regulations (SOR/2015-17)
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Regulations are current to 2024-11-26 and last amended on 2022-12-15. Previous Versions
PART 8Health Hazard Classes (continued)
SUBPART 5Germ Cell Mutagenicity (continued)
Classification in a Category or Subcategory of the Class (continued)
Classification of Mixtures
Marginal note:Order of provisions
8.5.2 The classification of a mixture as a germ cell mutagen in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.5.3 to 8.5.5.
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.
Marginal note:Ingredient classified in Category 2
8.5.4 A mixture is classified in the category “Germ Cell Mutagenicity — Category 2” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 1.0% that is classified in the category “Germ Cell Mutagenicity — Category 2”, 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:Data available for use of bridging principles
8.5.5 If data are available to enable the characterization of the mixture as a germ cell mutagen, in accordance with the bridging principles referred to in subsections 2.3(3), (4) and (7), the mixture must be classified in accordance with those subsections.
SUBPART 6Carcinogenicity
Definitions
- SOR/2022-272, s. 49
Marginal note:Definitions
8.6 The following definitions apply in this Subpart.
- carcinogenic
carcinogenic means, in relation to a mixture or substance, liable to lead to cancer or to increase the incidence of cancer. (cancérogène)
- carcinogenicity
carcinogenicity means the production of cancer or an increase in the incidence of cancer occurring after exposure to a mixture or substance. (cancérogénicité)
Classification in a Category or Subcategory of the Class
Classification of Substances
Marginal note:Categories
8.6.1 A carcinogenic substance is classified in a category or subcategory of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | Column 3 | |
|---|---|---|---|
| Item | Category | Subcategory | Criteria |
| 1 | Carcinogenicity — Category 1 | Carcinogenicity — Category 1A | A substance in respect of which human data establish a causal relationship between exposure to the substance and the development of cancer |
| 2 | Carcinogenicity — Category 1 | Carcinogenicity — Category 1B | A substance in respect of which
|
| 3 | Carcinogenicity — Category 2 | A substance in respect of which
|
Classification of Mixtures
Marginal note:Order of provisions
8.6.2 The classification of a mixture as a carcinogenic mixture in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.6.3 to 8.6.5.
Marginal note:Ingredient classified in Category 1 or 1A
8.6.3 (1) A mixture is classified in the category “Carcinogenicity — Category 1” or the subcategory “Carcinogenicity — 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 “Carcinogenicity — 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 carcinogenic, in which case the mixture is classified as a carcinogenic mixture in accordance with section 8.6.1; or
(b) the mixture as a whole has been subjected to a carcinogenicity study that determines that the mixture is not carcinogenic, and a scientifically validated method was used and the study 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 “Carcinogenicity — Category 1” or the subcategory “Carcinogenicity — 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 “Carcinogenicity — 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 “Carcinogenicity — 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 carcinogenic, in which case the mixture is classified as a carcinogenic mixture in accordance with section 8.6.1; or
(b) the mixture as a whole has been subjected to a carcinogenicity study that determines that the mixture is not carcinogenic, and a scientifically validated method was used and the study 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 2
8.6.4 A mixture is classified in the category “Carcinogenicity — Category 2” 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 category “Carcinogenicity — Category 2”, unless
(a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture is carcinogenic, in which case the mixture is classified as a carcinogenic mixture in accordance with section 8.6.1; or
(b) the mixture as a whole has been subjected to a carcinogenicity study that determines that the mixture is not carcinogenic, and a scientifically validated method was used and the study was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.
Marginal note:Data available for use of bridging principles
8.6.5 If data are available to enable the characterization of the mixture as carcinogenic, in accordance with the bridging principles referred to in subsections 2.3(3), (4) and (7), the mixture must be classified in accordance with those subsections.
SUBPART 7Reproductive Toxicity
Definitions
Marginal note:Definitions
8.7 The following definitions apply in this Subpart.
- adverse effects on sexual function and fertility
adverse effects on sexual function and fertility means any effect of a mixture or substance that is liable to interfere with sexual function or fertility, including
(a) alterations to the female or male reproductive system;
(b) adverse effects on onset of puberty, gamete production or transport, the reproductive cycle, sexual behaviour, parturition or pregnancy outcomes;
(c) premature reproductive senescence; or
(d) any modifications to other functions that are dependent on the integrity of the reproductive system. (effets néfastes sur la fonction sexuelle et la fertilité)
- adverse effects on the development of the embryo, fetus or offspring
adverse effects on the development of the embryo, fetus or offspring means any adverse effects of a mixture or substance on the embryo, fetus or offspring, resulting from exposure of either parent to the mixture or substance prior to conception or exposure of the developing embryo or fetus to the mixture or substance during prenatal development, or of the offspring during postnatal development to the time of sexual maturation, that is manifested at any point in the development of the embryo or fetus, or that is manifested at any point in the lifespan of the offspring, and that includes the loss of the embryo or fetus, death of the developing offspring, structural abnormality, altered growth and functional deficiency. This definition excludes the induction of genetically based inheritable effects in the offspring. (effets néfastes sur le développement de l’embryon, du foetus ou de la progéniture)
- effects on or via lactation
effects on or via lactation means
(a) any effect of a mixture or substance that interferes with lactation; or
(b) the presence of the mixture or substance, or its metabolites, in the maternal milk in amounts for which there is evidence that supports the conclusion, based on established scientific principles, that the health of the breast-fed child or suckling animal is liable to be threatened. (effets sur ou via l’allaitement)
- reproductive toxicity
reproductive toxicity refers to any of the following effects occurring after exposure to a mixture or substance:
(a) adverse effects on sexual function and fertility;
(b) adverse effects on the development of the embryo, fetus or offspring; or
(c) effects on or via lactation. (toxicité pour la reproduction)
- toxic to reproduction
toxic to reproduction means, in relation to a mixture or substance, liable to lead to reproductive toxicity. (toxique pour la reproduction)
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