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Hazardous Products Regulations (SOR/2015-17)

Regulations are current to 2024-05-01 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)

Marginal note:Ingredient classified in Category 2

 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

 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

 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

 A carcinogenic substance is classified in a category or subcategory of this hazard class in accordance with the following table:

TABLE

Column 1Column 2Column 3
ItemCategorySubcategoryCriteria
1Carcinogenicity — Category 1Carcinogenicity — Category 1AA substance in respect of which human data establish a causal relationship between exposure to the substance and the development of cancer
2Carcinogenicity — Category 1Carcinogenicity — Category 1B

A substance in respect of which

  • (a) human data establish a causal relationship between exposure to the substance and the development of cancer, but there are additional data that do not support, based on established scientific principles, the conclusion that the substance is the causative agent;

  • (b) animal data establish a causal relationship between exposure to the substance and an increased incidence of malignant neoplasms or a combination of benign and malignant neoplasms in

    • (i) two or more species of animals, as demonstrated by one or more studies,

    • (ii) one species of animal, as demonstrated by two or more independent studies carried out at different times, in different laboratories or under different protocols, or

    • (iii) one species of animal, as demonstrated by a single study, if the neoplasms observed in the study are, based on established scientific principles, atypical in relation to the incidence, site, type or age at onset for the species of animal under study; or

  • (c) human data support a positive association between exposure to the substance and the development of cancer, and animal data support a positive association between exposure to the substance and an increased incidence of malignant or benign neoplasms, but the data supporting either positive association do not support a conclusion of a causal relationship, based on established scientific principles

3Carcinogenicity — Category 2

A substance in respect of which

  • (a) human data support a positive association between exposure to the substance and the development of cancer, but do not support a conclusion of a causal relationship, based on established scientific principles; or

  • (b) animal data support a positive association between exposure to the substance and an increased incidence of malignant or benign neoplasms, but do not support a conclusion of a causal relationship, based on established scientific principles

Classification of Mixtures

Marginal note:Order of provisions

 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

  •  (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

 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

 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

 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)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Categories or subcategories — Categories 1A, 1B and 2

  •  (1) A substance that is toxic to reproduction is classified in a category or subcategory of this hazard class in accordance with the following table:

    TABLE

    Column 1Column 2Column 3
    ItemCategorySubcategoryCriteria
    1Reproductive Toxicity — Category 1Reproductive Toxicity — Category 1AA substance in respect of which human data demonstrate that exposure to the substance leads to adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring
    2Reproductive Toxicity — Category 1Reproductive Toxicity — Category 1B

    A substance in respect of which animal data demonstrate that exposure of the animal to the substance leads to the following:

    • (a) adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in the absence of other toxic effects; or

    • (b) adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in the presence of other toxic effects, provided that such adverse effects are not considered to be a secondary non-specific consequence of the other toxic effects

    3Reproductive Toxicity — Category 2A substance in respect of which human or animal data support a positive association between exposure to the substance and adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, but do not support a conclusion, based on established scientific principles, that exposure to the substance leads to such effects, provided that such effects are not considered to be a secondary non-specific consequence of other toxic effects
  • Marginal note:Category — effects on or via lactation

    (2) A substance that is toxic to reproduction is classified in the category of this hazard class in accordance with the following table:

    TABLE

    Column 1Column 2
    ItemCategoryCriteria
    1Reproductive Toxicity — Effects on or via LactationA substance that, according to human or animal data, has effects on or via lactation
Classification of Mixtures

Marginal note:Order of provisions

 Subject to subsection 8.7.5(2), the classification of a mixture as a mixture that is toxic to reproduction in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.7.3 to 8.7.6.

Marginal note:Ingredient classified in Category 1 or 1A

  •  (1) A mixture is classified in the category “Reproductive Toxicity — Category 1” or the subcategory “Reproductive Toxicity — 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 “Reproductive Toxicity — Category 1A”, unless

    • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture has adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in which case the mixture is classified as a mixture that is toxic to reproduction in accordance with subsection 8.7.1(1); or

    • (b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, 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 “Reproductive Toxicity — Category 1” or the subcategory “Reproductive Toxicity — 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 “Reproductive Toxicity — 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 “Reproductive Toxicity — Category 1A”, unless

    • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture has adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in which case the mixture is classified as a mixture that is toxic to reproduction in accordance with subsection 8.7.1(1); or

    • (b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, 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.

 

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