Hazardous Products Regulations (SOR/2015-17)

Regulations are current to 2017-12-11 and last amended on 2015-02-11. Previous Versions

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 1A or 1B

 A mixture is classified in the category “Carcinogenicity — Category 1” 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” or in the subcategory “Carcinogenicity — Category 1B”, 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

effets néfastes sur la fonction sexuelle et la fertilité

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

effets néfastes sur le développement de l’embryon, du foetus ou de la progéniture

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

effets sur ou via l’allaitement

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

toxicité pour la reproduction

reproductive toxicity refers to

  • (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

toxique pour la 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

    ItemColumn 1Column 2Column 3
    CategorySubcategoryCriteria
    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
  • 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

    ItemColumn 1Column 2
    CategoryCriteria
    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.

 
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