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Hazardous Products Regulations (SOR/2015-17)

Regulations are current to 2022-09-22 and last amended on 2020-03-18. Previous Versions

PART 8Health Hazard Classes (continued)

SUBPART 6Carcinogenicity (continued)

Classification in a Category or Subcategory of the Class (continued)

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

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

  • (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
  • 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 Reproductive Toxicity — Category 1A or 1B

 A mixture is classified in the category “Reproductive Toxicity — 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 “Reproductive Toxicity — Category 1A” or in the subcategory “Reproductive Toxicity — Category 1B”, 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 Reproductive Toxicity — Category 2

 A mixture is classified in the category “Reproductive Toxicity — 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 “Reproductive Toxicity — Category 2”, 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 Reproductive Toxicity — Effects on or via Lactation

  •  (1) A mixture is classified in the category “Reproductive Toxicity — Effects on or via Lactation” 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 “Reproductive Toxicity — Effects on or via Lactation”, unless

    • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture has effects on or via lactation, in which case the mixture is classified as a mixture that is toxic to reproduction in accordance with subsection 8.7.1(2); or

    • (b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have effects on or via lactation, 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:Classification in Category 1A, 1B or 2 and in Reproductive Toxicity — Effects on or via Lactation

    (2) Despite subsection 2.2(3), a mixture that has been classified in accordance with section 8.7.3 or 8.7.4 and meets the criteria of subsection (1) is also classified in the category “Reproductive Toxicity — Effects on or via Lactation”.

Marginal note:Data available for use of bridging principles

 If data are available to enable the characterization of the mixture as toxic to reproduction 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, in the following categories:

  • (a) “Reproductive Toxicity — Category 1”;

  • (b) “Reproductive Toxicity — Category 2”;

  • (c) “Reproductive Toxicity — Effects on or via Lactation”;

  • (d) both “Reproductive Toxicity — Category 1” and “Reproductive Toxicity — Effects on or via Lactation”; or

  • (e) both “Reproductive Toxicity — Category 2” and “Reproductive Toxicity — Effects on or via Lactation”.

SUBPART 8Specific Target Organ Toxicity — Single Exposure

Definitions

Marginal note:Definitions

 The following definitions apply in this Subpart.

narcotic effects

narcotic effects means central nervous system depression that

  • (a) in humans, may present as drowsiness, narcosis, reduced alertness, loss of reflexes, lack of coordination, vertigo, severe headache or nausea and may lead to reduced judgment, dizziness, irritability, fatigue, impaired memory function, deficits in perception or coordination, prolonged reaction time or sleepiness; and

  • (b) in animals, may be observed as lethargy, lack of coordination righting reflex, narcosis or ataxia. (effets narcotiques)

organ

organ includes any biological system. (organe)

respiratory tract irritation

respiratory tract irritation means localized redness, edema, pruritis or irritant effects in the respiratory tract that impair its function, whether or not accompanied by cough, pain, choking, breathing difficulties or other respiratory symptoms. (irritation des voies respiratoires)

specific target organ toxicity arising from a single exposure

specific target organ toxicity arising from a single exposure means specific, non-lethal toxic effects on target organs that arise from a single exposure to a mixture or substance, including all health effects liable to impair function of the body or any of its parts, whether reversible or irreversible, immediate or delayed, but excludes effects resulting from health hazards addressed by Subparts 1 to 7 and 10 of this Part. (toxicité pour certains organes cibles à la suite d’une exposition unique)

Classification in a Category of the Class

Classification of Substances

Marginal note:Two evaluations

  •  (1) In order to establish the classification of a substance that causes specific target organ toxicity arising from a single exposure in one or more categories of this hazard class, the substance must be evaluated in accordance with all the criteria set out in column 2 of the following table, in relation to toxic effects on

    • (a) the central nervous system and respiratory tract; and

    • (b) other specific target organs.

    TABLE

    Column 1Column 2
    ItemCategoryCriteria
    1Specific Target Organ Toxicity — Single Exposure — Category 1

    A substance that

    • (a) according to human data, causes specific target organ toxicity arising from a single exposure; or

    • (b) according to animal data, causes specific target organ toxicity arising from a single exposure at low exposure concentrations, within the concentration value ranges set out for Category 1 in Table 3.8.1 of the GHS

    2Specific Target Organ Toxicity — Single Exposure — Category 2A substance that, according to animal data, causes specific target organ toxicity arising from a single exposure at moderate exposure concentrations, within the concentration value ranges set out for Category 2 in Table 3.8.1 of the GHS
    3Specific Target Organ Toxicity — Single Exposure — Category 3A substance in respect of which data demonstrate that a single exposure to the substance generates transient narcotic effects or transient respiratory tract irritation
  • Marginal note:Classification

    (2) Following the evaluations referred to in subsection (1), the substance is classified in one or more categories of this hazard class, based on the results of the evaluations of its toxic effects as set out in columns 1 and 2 of the following table, in accordance with the corresponding category set out in column 3:

    TABLE

    Column 1Column 2Column 3
    Item Number of the Table to Subsection (1) that is Associated with the Criteria in Column 2 of that Table that are Determined to Have Been Met as a Result of the Evaluation of the Following:Classification
    ItemToxic Effects on the Central Nervous System and Respiratory TractToxic Effects on Other Specific Target OrgansCategory of the “Specific Target Organ Toxicity — Single Exposure” Hazard Class
    1NoneItem 1Category 1
    2Item 1NoneCategory 1
    3Item 1Item 1Category 1
    4NoneItem 2Category 2
    5Item 2NoneCategory 2
    6Item 1Item 2Category 1
    7Item 2Item 1Category 1
    8Item 2Item 2Category 2
    9Item 3NoneCategory 3
    10Item 3Item 1Category 1 and Category 3
    11Item 3Item 2Category 2 and Category 3
 
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