Hazardous Products Regulations
SOR/2015-17
Registration 2015-01-30
Hazardous Products Regulations
P.C. 2015-40 2015-01-29
Whereas, pursuant to section 19Footnote a of the Hazardous Products ActFootnote b, the Minister of Health has consulted with the government of each province and with the organizations representative of workers, organizations representative of employers and organizations representative of suppliers that the Minister considers appropriate;
Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 15(1)Footnote c of the Hazardous Products ActFootnote b, makes the annexed Hazardous Products Regulations.
Return to footnote aS.C. 2014, c. 20, s. 120
Return to footnote bR.S., c. H-3
Return to footnote cS.C. 2014, c. 20, ss. 115(1) to (3)
PART 1Interpretation
Marginal note:Definitions
1 (1) The following definitions apply in these Regulations.
- Act
Act means the Hazardous Products Act. (Loi)
- aerosol dispenser
aerosol dispenser means a non-refillable receptacle made of metal, glass or plastic and containing a gas that is compressed, liquefied or dissolved under pressure, with or without a liquid, foam, mousse, paste, gel or powder, and fitted with a release device allowing the contents to be ejected in the form of solid or liquid particles in suspension in a gas, as a foam, mousse, paste, gel or powder or in a liquid or gaseous state. (générateur d’aérosol)
- ATE
ATE means an acute toxicity estimate, and includes the LD50 and the LC50, and the acute toxicity point estimate determined in accordance with the table to section 8.1.7. (ETA)
- CAS registry number
CAS registry number means the identification number assigned to a chemical by the Chemical Abstracts Service, a division of the American Chemical Society. (numéro d’enregistrement CAS)
- chemical name
chemical name means a scientific designation of a material or substance that is made in accordance with the rules of nomenclature of either the Chemical Abstracts Service, a division of the American Chemical Society, or the International Union of Pure and Applied Chemistry, or a scientific designation of a material or substance that is internationally recognized and that clearly identifies the material or substance. (dénomination chimique)
- flash point
flash point means the lowest temperature, corrected to the standard pressure of 101.3 kPa, at which the application of an ignition source causes the vapours of a liquid to ignite. (point d’éclair)
- gas
gas means a mixture or substance that
(a) at 50°C has an absolute vapour pressure of greater than 300 kPa; or
(b) is completely gaseous at 20°C and at the standard pressure of 101.3 kPa. (gaz)
- GHS
GHS means the United Nations document entitled Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Fifth Revised Edition. (SGH)
- hazardous ingredient
hazardous ingredient means an ingredient in a mixture that, when evaluated as an individual substance, is classified in a category or subcategory of a health hazard class. (ingrédient dangereux)
- hazard statement
hazard statement means a phrase assigned to a category or subcategory of a hazard class or, in the case of column 5 of Parts 4 to 6 of Schedule 5, the required statement that describes the nature of the hazard presented by a hazardous product. (mention de danger)
- initial boiling point
initial boiling point means the temperature of a liquid at which its vapour pressure is equal to the standard pressure of 101.3 kPa, i.e., the temperature at which the first gas bubble appears. (point d’ébullition initial)
- initial supplier identifier
initial supplier identifier means the name, address and telephone number of
(a) the manufacturer; or
(b) the importer of the hazardous product who operates in Canada. (identificateur du fournisseur initial)
- LC50
LC50 means the concentration of a mixture or substance in air that causes the death of 50.0% of a group of test animals. (CL50)
- LD50
LD50 means the single dose of a mixture or substance that, when administered by a particular exposure route in an animal study, is expected to cause the death of 50.0% of a given animal population. (DL50)
- liquid
liquid means a mixture or substance that
(a) at 50°C has a vapour pressure of 300 kPa or less;
(b) is not completely gaseous at 20°C and at the standard pressure of 101.3 kPa; and
(c) has a melting point or initial melting point of 20°C or less at the standard pressure of 101.3 kPa or, in the case of a mixture or substance for which neither can be determined, is shown
(i) to be a liquid as a result of the ASTM International method ASTM D4359-90, entitled Standard Test Method for Determining Whether a Material Is a Liquid or a Solid, as amended from time to time, or
(ii) to not be pasty as a result of the test for determining fluidity (penetrometer test), referred to in section 4 of chapter 3 of Part 2, numbered 2.3.4, of Annex A of the European Agreement Concerning the International Carriage of Dangerous Goods by Road, as amended from time to time. (liquide)
- Manual of Tests and Criteria
Manual of Tests and Criteria means the United Nations document entitled Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria, as amended from time to time. (Manuel d’épreuves et de critères)
- manufacturer
manufacturer means a supplier who, in the course of business in Canada, manufactures, produces, processes, packages or labels a hazardous product and sells it. (fabricant)
- OECD
OECD means the Organisation for Economic Co-operation and Development. (OCDE)
- outer container
outer container means the most outward container of a hazardous product that is visible under normal conditions of handling, but does not include the most outward container if it is the only container of the hazardous product. (contenant externe)
- pictogram
pictogram means a graphical composition that includes a symbol along with other graphical elements, such as a border or background colour. (pictogramme)
- precautionary statement
precautionary statement means a phrase that describes the recommended measures to take in order to minimize or prevent adverse effects resulting from exposure to a hazardous product or resulting from improper storage or handling of a hazardous product. (conseil de prudence)
- product identifier
product identifier means, in respect of a hazardous product, the brand name, chemical name, common name, generic name or trade name. (identificateur de produit)
- risk group classification
risk group classification means, in relation to the “Biohazardous Infectious Materials” health hazard class, classification in Risk Group 2, Risk Group 3 or Risk Group 4 as defined in subsection 3(1) of the Human Pathogens and Toxins Act. (classification par groupe de risque)
- SADT
SADT or self-accelerating decomposition temperature means the lowest temperature at which self-accelerating decomposition occurs. (TDAA ou température de décomposition autoaccélérée)
- scientifically validated method
scientifically validated method means, in relation to a hazard, a method that specifies standards for the evaluation of that hazard and whose results are accurate and reproducible, in accordance with established scientific principles. (méthode validée sur le plan scientifique)
- signal word
signal word means, in respect of a hazardous product, the word “Danger” or “Warning” that is used to alert the reader to a potential hazard and to indicate its severity. (mention d’avertissement)
- solid
solid means a mixture or substance that is not a liquid or gas. (solide)
- United Nations Model Regulations
United Nations Model Regulations means the United Nations document entitled Recommendations on the Transport of Dangerous Goods: Model Regulations, as amended from time to time. (Règlement type des Nations Unies)
- UN number
UN number means the four-digit identification number issued in accordance with the United Nations Model Regulations. (numéro ONU)
- vapour
vapour means the gaseous form of a mixture or substance released from its liquid or solid state. (vapeur)
- work place
work place means a place where a person works for remuneration. (lieu de travail)
Marginal note:Reference to hazard class
(2) In these Regulations, a reference to a hazard class is to be read as a reference to a hazard class that is listed in Schedule 2 to the Act.
Marginal note:Health professionals
(3) For the purposes of Parts 5 and 6, health professionals are
(a) physicians who are registered, and entitled under the laws of a province to practise medicine and who are practising medicine under those laws in that province; and
(b) nurses who are registered or licensed, and entitled under the laws of a province to practise nursing and who are practising nursing under those laws in that province.
Marginal note:Interpretation of “should”
(4) When the word “should” is used in a text that is referenced or incorporated by reference in these Regulations, it is to be read as imperative, unless the context requires otherwise.
PART 2Classification of a Product, Mixture, Material or Substance
General
Marginal note:Order of decreasing severity
2 (1) In each Subpart of Parts 7 and 8, the categories and subcategories in each of the classification tables to those Subparts are set out in the order of the hazard’s decreasing severity, except for the categories of the classification table to Subpart 5 of Part 7.
Marginal note:Evaluation — more severe hazard
(2) If a product, mixture, material or substance has been evaluated in accordance with the criteria and requirements of a category or subcategory of a hazard class that represents the more severe hazard in a classification table compared to another category or subcategory of that hazard class in the same classification table and is classified in that category or subcategory, the product, mixture, material or substance need not be evaluated in respect of a category or subcategory of the same classification table of the same hazard class that represents a less severe hazard.
Marginal note:Prescribed classification
(3) Subject to subsections (4) and (5), any product, mixture, material or substance for which classification in a category or subcategory of a hazard class is prescribed in Schedule 4 is classified in that category or subcategory. The product, mixture, material or substance must also be evaluated in accordance with section 2.1, 2.2 or 2.7 in respect of each of the categories or subcategories of the other hazard classes.
Marginal note:Ingredient — more severe hazard
(4) If a product, mixture, material or substance is one for which classification in a category or subcategory of a hazard class is prescribed in Schedule 4, and if it has been mixed with one or more ingredients that are classified in a category or subcategory of the same classification table of the same hazard class that represents a more severe hazard, the mixture as a whole must be classified in the category or subcategory that represents the more severe hazard.
Marginal note:Prescribed classification — Subpart 1, 4, 7 or 8 of Part 8
(5) A mixture, material or substance — for which classification in a category or subcategory of a classification table of a hazard class set out in Subpart 1, 4, 7 or 8 of Part 8 is prescribed in Schedule 4 — must also be evaluated in accordance with section 2.1 or 2.2, in the case of Subpart 1, 4 or 7 of Part 8, in respect of each of the categories or subcategories of the other classification tables of the same hazard class, and in the case of Subpart 8 of Part 8, in respect of each of the categories of the same classification table.
Marginal note:Impurities, stabilizing solvents and stabilizing additives — substance
(6) Any impurities, stabilizing solvents or stabilizing additives that are known to the supplier to be present in a substance and that are classified must be considered for the purpose of classification of the substance if they are present at a concentration above the concentration limit for an ingredient in a mixture set out in a particular category or subcategory of any hazard class.
Marginal note:Impurities, stabilizing solvents and stabilizing additives — mixture
(7) Any impurities, stabilizing solvents or stabilizing additives that are known to the supplier to be present in a mixture and that are classified must be considered for the purpose of classification of the mixture if they are present at a concentration above the concentration limit for an ingredient in a mixture set out in a particular category or subcategory of any hazard class.
Marginal note:Individually packaged in outer container
(8) If two or more different and individually packaged products, mixtures, materials or substances, designed to be accessed individually, are packaged together in an outer container for sale or importation, the assemblage of the products, mixtures, materials and substances in the outer container must not be considered as a single product for the purpose of classification, as each product, mixture, material or substance is subject to the classification provisions of this Part.
Marginal note:Animal data — not relevant to humans
(9) Animal data that demonstrate conclusively, based on established scientific principles, that the mechanism or mode of action of the substance or mixture in animals is not relevant to humans must not be used for the purpose of classifying a substance or mixture in any of the health hazard classes referred to in Subparts 1 to 10 and 12 of Part 8.
Material or Substance
Marginal note:Classification — material or substance
2.1 Subject to sections 2.8 and 2.9, for the purpose of establishing whether a material or substance is classified in a category or subcategory of a hazard class, the material or substance must be evaluated in accordance with established scientific principles, with respect to the criteria and requirements of each category or subcategory of the hazard class as set out in Parts 7 and 8, using available data of the following types, as applicable:
(a) in relation to the material or substance itself,
(i) results of testing or studies carried out in accordance with the test methods referred to in Part 7 or 8,
(ii) results of testing or studies carried out in accordance with generally accepted standards of good scientific practice at the time the test or study was carried out,
(iii) conclusions based on established scientific principles, and
(iv) case reports or documented observations; and
(b) except for Subparts 2 and 3 of Part 8, if the data of the types referred to in paragraph (a) are insufficient to evaluate the material or substance in accordance with the criteria and requirements set out in Parts 7 and 8, in relation to a material or substance that has similar properties,
(i) results of testing or studies carried out in accordance with the test methods referred to in Part 7 or 8,
(ii) results of testing or studies carried out in accordance with generally accepted standards of good scientific practice at the time the test or study was carried out,
(iii) conclusions based on established scientific principles, and
(iv) case reports or documented observations.
Mixture
Classification
Marginal note:Part 7
2.2 (1) Subject to section 2.8, for the purpose of establishing whether a mixture is classified in a category or subcategory of a physical hazard class, the mixture must be evaluated, in respect of each category or subcategory of each physical hazard class, using data of the types referred to in subparagraphs 2.1(a)(i) to (iv) in relation to the mixture or, if the data of those types are insufficient to evaluate the mixture in accordance with the criteria and requirements set out in Part 7, using data of the types referred to in subparagraphs 2.1(b)(i) to (iv) in relation to a mixture with similar properties.
Marginal note:Part 8
(2) Subject to section 2.9, for the purpose of establishing whether a mixture is classified in a category or subcategory of a health hazard class, the mixture must be evaluated, in respect of each category or subcategory of each health hazard class, using data of the types referred to in subparagraphs 2.1(a)(i) to (iv), in relation to the ingredients, the mixture as a whole or a mixture with similar properties, following the order of the provisions, in relation to mixtures, as presented in each Subpart of Part 8.
Marginal note:Part 8 — order of provisions
(3) When following the order of the provisions in accordance with subsection (2), the mixture must be classified in accordance with the first provision that permits its classification. Once the mixture is classified, the provisions that follow within the same Subpart in relation to mixtures do not apply, except in the case of Subparts 1, 4, 7 and 8 of Part 8.
Bridging Principles
Marginal note:Definitions
2.3 (1) The following definitions apply in this section.
- production batch
production batch means a batch that results from a consistent production process using fixed physico-chemical parameters when there is no intention to alter the characteristics of the final product. (lot de fabrication)
- tested
tested refers to a mixture for which there are data of a type referred to in subparagraph 2.1(a)(i), (ii) or (iv). (testé)
Marginal note:Application of bridging principles
(2) In the case of the health hazard classes set out in Subparts 1 to 10 of Part 8, the bridging principles set out in subsections (3) to (8) must be applied if there is an indication to that effect.
Marginal note:Dilution
(3) If a tested mixture that is classified in a category or subcategory of a health hazard class set out in Subparts 1 to 10 of Part 8 is diluted with a diluent, the following applies provided that the diluent is a mixture or substance that, with respect to that health hazard class, has an equivalent or less severe hazard classification than the least hazardous ingredient of the tested mixture and, based on established scientific principles, does not affect the classification of the tested mixture:
(a) in the case of a tested mixture that is classified in a category or subcategory of a health hazard class set out in Subparts 1 to 3 of Part 8, either the method referred to in section 8.1.5, 8.2.11 or 8.3.11, as the case may be, must be used to establish whether the diluted mixture must be classified in a category or subcategory of a hazard class, or the diluted mixture must be classified in the same category or subcategory of the health hazard class as the tested mixture; or
(b) in all other cases, the diluted mixture must be classified in the same category or subcategory of the health hazard class as the tested mixture.
Marginal note:Production batches
(4) The classification is the same for a mixture in all production batches of that mixture that are manufactured, produced or processed by the same supplier, unless there is a significant variation between the batches that affects the classification of the mixture.
Marginal note:Increase in concentration of hazardous ingredient
(5) If the concentration of a hazardous ingredient of a tested mixture is increased, the following applies:
(a) in the case of the health hazard classes set out in Subparts 1, 4 and 8 to 10 of Part 8, if the tested mixture is classified in the Category 1 category of the health hazard class, the new mixture resulting from the increased concentration must be classified in the same category of the same health hazard class, without additional evaluation with regard to that hazard class;
(b) in the case of the health hazard class set out in Subpart 2 of Part 8,
(i) if the tested mixture is classified in the Category 1A subcategory of the health hazard class, the new mixture resulting from the increased concentration must be classified in the same subcategory of the same health hazard class, without additional evaluation with regard to that hazard class, or
(ii) if the tested mixture does not contain any hazardous ingredient classified in the Category 1 category and is classified in the Category 2 category of the health hazard class, the new mixture resulting from the increased concentration must be classified in the same category of the same health hazard class, without additional evaluation with regard to that hazard class; and
(c) in the case of the health hazard class set out in Subpart 3 of Part 8,
(i) if the tested mixture is classified in the Category 1 category of the health hazard class, the new mixture resulting from the increased concentration must be classified in the same category of the same health hazard class, without additional evaluation with regard to that hazard class, or
(ii) if the tested mixture does not contain any hazardous ingredient classified in the Category 1 category and is classified in the Category 2A subcategory of the health hazard class, the new mixture resulting from the increased concentration must be classified in the same subcategory of the same health hazard class, without additional evaluation with regard to that hazard class.
Marginal note:Interpolation
(6) In the case of the health hazard classes set out in Subparts 1 to 4 and 8 to 10 of Part 8, when three mixtures (A, B and C) contain identical ingredients — some or all of which are hazardous — if mixtures A and B have been tested and are classified in the same category or subcategory of the same health hazard class and if mixture C has not been tested and has the same hazardous ingredients as mixtures A and B with concentrations intermediate to the concentrations of those hazardous ingredients in mixtures A and B, then mixture C must be classified in the same category or subcategory of the same health hazard class as mixtures A and B.
Marginal note:Substantially similar mixtures
(7) If one of the mixtures (ingredient A + ingredient B) or (ingredient C + ingredient B) is a tested mixture that is classified in a category or subcategory of a health hazard class, the other mixture must be classified in the same category or subcategory of the same health hazard class if the following conditions are met:
(a) the concentration of ingredient B is the same in both mixtures;
(b) the concentration of ingredient A is the same as that of ingredient C; and
(c) ingredients A and C are classified in the same category or subcategory of the same health hazard class and, based on established scientific principles, do not affect the classification of ingredient B.
Marginal note:Aerosols — health hazard classes
(8) In the case of the health hazard classes set out in Subparts 1 to 4, 8 and 9 of Part 8, a mixture to which a propellant has been added and that is contained in an aerosol dispenser must be classified in the same category or subcategory of the same health hazard class as the mixture to which no propellant was added if, based on established scientific principles, the added propellant does not affect the classification of the mixture on spraying.
Other Principles
Marginal note:Synergistic effects
2.4 (1) In order to establish whether a mixture is classified in a category or subcategory of a health hazard class, if the evaluation of the mixture is carried out in accordance with a provision that requires the use of data available on the ingredients in the mixture, then all data available on the potential occurrence of synergistic effects among the ingredients of the mixture must be used in the evaluation carried out in accordance with section 2.2.
Marginal note:Antagonistic effects
(2) If antagonistic effects among the ingredients of the mixture are considered in order to establish the classification of the mixture in a category or subcategory of a health hazard class in the course of the evaluation carried out in accordance with section 2.2, the data in respect of the antagonistic effects must be conclusive, based on established scientific principles.
Marginal note:Concentration limits — lower concentration
2.5 (1) In the case of Subparts 1 to 10 and 12 of Part 8, if an ingredient is present in a mixture at a lower concentration than the concentration limit for a particular category or subcategory of a health hazard class, but still presents the hazard identified by the category or subcategory of that hazard class at that concentration, the mixture must be classified in that category or subcategory.
Marginal note:Concentration limits — equivalent or higher concentration
(2) In the case of Subparts 1 to 10 and 12 of Part 8, subject to subsection 2.4(1), if an ingredient is present in a mixture at an equivalent or higher concentration than the concentration limit for a particular category or subcategory of a health hazard class, but further to evidence based on established scientific principles it does not present the hazard identified by the category or subcategory of that hazard class at that concentration, the mixture need not be classified in that category or subcategory in relation to that specific ingredient.
Marginal note:Maximum concentration
2.6 If a mixture with a specific product identifier contains a hazardous ingredient that is not always present at the same concentration, the maximum concentration must be used for the purposes of establishing whether the mixture is classified in a category or subcategory of a health hazard class.
Product
Marginal note:Classification — product
2.7 Subject to section 2.8, to establish whether a product is classified in a category or subcategory of a physical hazard class, it must be evaluated in accordance with section 2.1 or 2.2.
Specific Rules
Marginal note:Solids
2.8 In the case of the physical hazard classes set out in Subparts 7, 10 to 12 and 14 of Part 7, the data used for the purposes of evaluation of a solid must relate to the solid in the physical form in which it is sold or imported. If the solid is in a physical form that is different from that used to generate the data and the solid in that physical form is liable to display different behaviour, the solid must also be evaluated in that other physical form.
Marginal note:Biological availability
2.9 If it can be shown by conclusive experimental data from scientifically validated methods that the mixture, material or substance is not biologically available, it need not be classified in any health hazard class.
PART 3Labelling
Marginal note:Information elements
3 (1) Subject to section 3.6 and for the purposes of paragraphs 13(1)(b) and 14(b) of the Act, the label of a hazardous product or the container in which the hazardous product is packaged must provide, in respect of the hazardous product, the following information elements:
(a) the product identifier;
(b) the initial supplier identifier;
(c) subject to subsections (2) to (5), for each category or subcategory in which the hazardous product is classified, with the exception of the categories referred to in paragraph (d), the information elements, namely, the symbol, signal word, hazard statement and precautionary statement, that are specified for that category or subcategory in section 3 of Annex 3 of the GHS;
(d) subject to subsections (2) to (4), for each category set out in Subparts 17 to 20 of Part 7 and in Subparts 11 and 12 of Part 8 in which the hazardous product is classified,
(i) the information elements that are specified for that category in Schedule 5, and
(ii) any precautionary statements that are applicable to the hazardous product in terms of
(A) general precautionary statements,
(B) prevention precautionary statements,
(C) response precautionary statements,
(D) storage precautionary statements, and
(E) disposal precautionary statements;
(e) in the case of a hazardous product classified in a category of Subpart 1 of Part 8 and to which paragraph 8.1.6(b) applies, the supplemental label element “[Insert the total concentration in percentage of ingredients with unknown acute toxicity] % of the mixture consists of an ingredient or ingredients of unknown acute toxicity/[Insérez la concentration totale en pourcentage d’ingrédients ayant une toxicité aiguë inconnue] % du mélange consiste en ingrédients de toxicité aiguë inconnue”; and
(f) in the case of a hazardous product that is classified as an acute toxicant and that, upon contact with water, releases a gaseous substance that has an LC50 that falls into one of the ranges indicated in Table 3 to subsection 8.1.1(3), the supplemental label elements that consist of the following hazard statements:
(i) in the case of Categories 1 and 2, “In contact with water, releases gases which are fatal if inhaled/Au contact de l’eau, libère des gaz mortels en cas d’inhalation”,
(ii) in the case of Category 3, “In contact with water, releases gases which are toxic if inhaled/Au contact de l’eau, libère des gaz toxiques en cas d’inhalation”, or
(iii) in the case of Category 4, “In contact with water, releases gases which are harmful if inhaled/Au contact de l’eau, libère des gaz nocifs en cas d’inhalation”.
Marginal note:Codes or instructions
(2) The information elements required by paragraph (1)(c) need not include alphanumeric codes and the information elements required by paragraphs (1)(c) and (d) must not include instructions that are for the exclusive use of the competent authority, as defined in the GHS, or the supplier.
Marginal note:Substitution by pictogram
(3) The pictogram associated with a symbol in Schedule 3 must be substituted for the symbol that is specified for a category or subcategory in section 3 of Annex 3 of the GHS or for a category in Schedule 5.
Marginal note:Hazard statement — Specific Target Organ Toxicity — Single Exposure
(4) In the case of a hazardous product that is classified in the category “Specific Target Organ Toxicity — Single Exposure — Category 3” of the hazard class “Specific Target Organ Toxicity — Single Exposure”, the hazard statement specified for that category in section 3 of Annex 3 of the GHS that relates to the effects for which the product was classified must be used. If the hazardous product causes narcotic effects and respiratory tract irritation, as those terms are defined in Subpart 8 of Part 8, then both hazard statements must be used.
Marginal note:Information elements for certain categories or subcategories
(5) The information elements, namely, the symbol, signal word, hazard statement and precautionary statement, specified in section 3 of Annex 3 of the GHS that are to be used for hazardous products classified in the categories or subcategories below are as follows:
(a) if the hazardous product is classified in the category “Flammable Gases — Category 1”, the information elements specified for the category “Flammable Gases (Including Chemically Unstable Gases)” Hazard category 1;
(b) if the hazardous product is classified in the category “Flammable Gases — Category 2”, the information elements specified for the category “Flammable Gases (Including Chemically Unstable Gases)” Hazard category 2;
(c) if the hazardous product is classified in the category “Flammable Aerosols — Category 1”, the information elements specified for the category “Aerosols” Hazard category 1, with the exception of the hazard statement “Pressurized container: may burst if heated”;
(d) if the hazardous product is classified in the category “Flammable Aerosols — Category 2”, the information elements specified for the category “Aerosols” Hazard category 2, with the exception of the hazard statement “Pressurized container: may burst if heated”;
(e) if the hazardous product is classified in the category “Skin Corrosion — Category 1”, the information elements specified for the subcategory “Skin Corrosion/Irritation” Hazard category 1A;
(f) if the hazardous product is classified in the subcategory “Skin Corrosion — Category 1A”, in the subcategory “Skin Corrosion — Category 1B” or in the subcategory “Skin Corrosion — Category 1C”, the information elements specified for the subcategory “Skin Corrosion/Irritation” Hazard category 1A to 1C;
(g) if the hazardous product is classified in the category “Skin Irritation — Category 2”, the information elements specified for the category “Skin Corrosion/Irritation” Hazard category 2;
(h) if the hazardous product is classified in the category “Serious Eye Damage — Category 1”, the information elements specified for the category “Eye Damage/Irritation” Hazard category 1;
(i) if the hazardous product is classified in the category “Eye Irritation — Category 2”, the information elements specified for the subcategory “Eye Damage/Irritation” Hazard category 2A;
(j) if the hazardous product is classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”, the information elements specified, respectively, for the subcategory “Eye Damage/Irritation” Hazard category 2A or the subcategory “Eye Damage/Irritation” Hazard category 2B;
(k) if the hazardous product is classified in the category “Respiratory Sensitizer — Category 1”, in the subcategory “Respiratory Sensitizer — Category 1A” or in the subcategory “Respiratory Sensitizer — Category 1B”, the information elements specified for the category or subcategory “Sensitization — Respiratory” Hazard category 1, 1A or 1B;
(l) if the hazardous product is classified in the category “Skin Sensitizer — Category 1”, in the subcategory “Skin Sensitizer — Category 1A” or in the subcategory “Skin Sensitizer — Category 1B”, the information elements specified for the category or subcategory “Sensitization — Skin” Hazard category 1, 1A or 1B;
(m) if the hazardous product is classified in the subcategory “Germ Cell Mutagenicity — Category 1A” or in the subcategory “Germ Cell Mutagenicity — Category 1B”, the information elements specified for the category “Germ Cell Mutagenicity” Hazard category 1;
(n) if the hazardous product is classified in the subcategory “Carcinogenicity — Category 1A” or in the subcategory “Carcinogenicity — Category 1B”, the information elements specified for the category “Carcinogenicity” Hazard category 1; and
(o) if the hazardous product is classified in the subcategory “Reproductive Toxicity — Category 1A” or in the subcategory “Reproductive Toxicity — Category 1B”, the information elements specified for the category “Reproductive Toxicity” Hazard category 1.
Marginal note:Pictograms
3.1 Any pictogram required to be provided on a label must, except with respect to size, be an exact reproduction of that pictogram as set out in column 3 of Schedule 3 and must,
(a) except for the pictogram for “Biohazardous Infectious Materials”, have a black symbol on a white background with a red border in the shape of a square set on one of its points; and
(b) in the case of the pictogram for “Biohazardous Infectious Materials”, have a black symbol on a white background with a black border in the shape of a circle.
Marginal note:Combined precautionary statements
3.2 (1) The precautionary statements that are required to be provided on a label may be combined if the combination contains the same information as would have been conveyed by each of the individual precautionary statements.
Marginal note:Non-applicable precautionary statements
(2) If a precautionary statement does not apply in a particular case with regard to the normal conditions of use, handling and storage of the hazardous product, it may be omitted.
Marginal note:Combined hazard statements
(3) The hazard statements that are required to be provided on a label may be combined if the combination contains the same information as would have been conveyed by each of the individual hazard statements.
Marginal note:Information elements of label
3.3 The pictogram, signal word and hazard statement must be grouped together on the label.
Marginal note:Legibility
3.4 The information elements of the label of the hazardous product or container in which it is packaged must be clearly and prominently displayed on a surface that is visible under normal conditions of use, easily legible without the aid of any device other than corrective lenses and contrasted with any other information on the hazardous product or the container.
Marginal note:Durability
3.5 The information elements of the label of the hazardous product or container in which it is packaged must, under normal conditions of transport and use, remain affixed to, printed or written on or attached to the hazardous product or the container and remain legible.
Marginal note:Specific rule — signal word
3.6 (1) If there is a requirement to provide the signal word “Danger”, any requirement to provide the signal word “Warning” does not apply.
Marginal note:Specific rule — hazard statement
(2) If there is a requirement to provide the hazard statement “Causes severe skin burns and eye damage”, any requirement to provide the hazard statement “Causes serious eye damage” does not apply.
Marginal note:Specific rule — symbol
(3) In the case of the symbols specified below, the following apply:
(a) if there is a requirement to provide the “skull and crossbones” symbol, any requirement to provide the “exclamation mark” symbol to indicate acute toxicity does not apply;
(b) if there is a requirement to provide the “corrosion” symbol, any requirement to provide the “exclamation mark” symbol to indicate skin or eye irritation does not apply; and
(c) if there is a requirement to provide the “health hazard” symbol to indicate respiratory sensitization, any requirement to provide the “exclamation mark” symbol to indicate skin sensitization or skin or eye irritation does not apply.
PART 4Safety Data Sheet
Marginal note:Information elements
4 (1) For the purposes of paragraphs 13(1)(a) and 14(a) of the Act, the safety data sheet of a hazardous product must provide, in respect of the hazardous product, the following information elements:
(a) the headings set out in column 1 of Schedule 1, in the order they are presented, including the corresponding item number, which is to be placed immediately before the heading;
(b) subject to section 4.5, the content of the specific information elements set out in paragraphs 3(1)(a) and (2)(a) and (d) of Schedule 1 for the heading for item 3 and, for each heading of that Schedule, if the information is available and applicable, the content of the other specific information elements of that Schedule, including the unit of measure, if applicable, taking into account the following:
(i) if any of the information — except that required by paragraphs 3(1)(a) and (2)(a) and (d) of that Schedule — is not available or not applicable, an indication to that effect must be clearly stated in lieu of the required specific information element, and
(ii) in the case of a mixture, the information provided under the heading for item 11 of Schedule 1 must be information that is available on the mixture as a whole, and if information is not available on the mixture as a whole, it must be information that is available on the hazardous ingredients in the mixture, together with a clear indication of the chemical name of the hazardous ingredient to which the information pertains; and
(c) under any applicable heading, all additional hazard information that is available with respect to
(i) the hazardous product, and
(ii) a product, mixture, material or substance that has similar properties, including any evidence based on established scientific principles, if that information is applicable to the normal conditions of use of the hazardous product and is not redundant, indicated alongside an identification of the product, mixture, material or substance that has similar properties.
Marginal note:Items 12 to 15 of Schedule 1
(2) Despite subsection (1), under each heading set out for items 12 to 15 of Schedule 1, the content of the specific information elements in that Schedule may be omitted.
Marginal note:Biohazardous Infectious Materials — additional information elements
(3) The following information elements must be provided, immediately following the information elements required by subsection (1), on the safety data sheet of a hazardous product that is classified in a category of the hazard class “Biohazardous Infectious Materials”:
(a) the headings set out in Schedule 2, in the order they are presented;
(b) under each heading, the name of each specific information element set out in column 2 in respect of that heading in the order they are presented; and
(c) under the name of each specific information element, the content of the information element, if the information is available and applicable, including the unit of measure, if applicable, taking into account the following:
(i) if any of the information is not available or not applicable, an indication to that effect must be clearly stated in lieu of the required information, and
(ii) any information provided under one heading of the safety data sheet need not be repeated under any other heading.
Marginal note:More than one biohazardous infectious material
(4) In the case where a mixture contains more than one ingredient that is classified as a biohazardous infectious material, the information required by subsection (3) must be provided in distinct parts on the safety data sheet, sequentially, for each biohazardous infectious material.
Marginal note:Instructions for use — new material or substance
4.1 (1) In the case of a hazardous product for which instructions for use, provided at the time of the sale or importation, require its combination with one or more products, mixtures, materials or substances resulting in the creation of one or more new materials or substances that present one or more new or more severe hazards not already identified on the safety data sheet of the hazardous product, the safety data sheet must also provide the following information elements, in respect of each new material or substance and clearly indicate that they pertain to that new material or substance:
(a) the nature of the new or more severe hazard; and
(b) the content of the applicable specific information elements set out in items 4 to 11, column 2, of Schedule 1, for each corresponding heading, that is available.
Marginal note:Placement of information elements
(2) Despite subsection 4(1), the information elements required by subsection (1) may appear anywhere on the safety data sheet.
Marginal note:Identical identifiers
4.2 The product identifier and the initial supplier identifier that are provided on the safety data sheet of a hazardous product must be identical to those provided on the label.
Marginal note:Concentration units
4.3 If the concentration of a material or substance in a hazardous product is expressed as a percentage on the safety data sheet, the units used to calculate the percentage must be provided.
Marginal note:Most hazardous concentration
4.4 If ingredients in a mixture that is a hazardous product are present in a range of concentrations, the information provided on the safety data sheet must be based on data available that correspond to the most hazardous concentration of each ingredient in the mixture, whether those data pertain to an ingredient or the mixture as a whole.
Marginal note:Concentration range — material or substance always present at the same concentration
4.4.1 (1) If the concentration of a material or substance in a hazardous product is required to be provided on a safety data sheet and the material or substance is always present at the same concentration, the safety data sheet must provide
(a) the actual concentration of the material or substance in the hazardous product; or
(b) one of the concentration ranges set out in subsection (3) within which the actual concentration of the material or substance in the hazardous product falls.
Marginal note:Actual concentration within more than one concentration range
(2) For the purpose of paragraph (1)(b), if the actual concentration of a material or substance in a hazardous product falls within more than one of the concentration ranges set out in subsection (3), any one of those ranges may be provided on the safety data sheet.
Marginal note:Concentration ranges
(3) For the purposes of paragraph (1)(b) and subsection (2), the concentration ranges are the following:
(a) from 0.1 to 1%;
(b) from 0.5 to 1.5%;
(c) from 1 to 5%;
(d) from 3 to 7%;
(e) from 5 to 10%;
(f) from 7 to 13%;
(g) from 10 to 30%;
(h) from 15 to 40%;
(i) from 30 to 60%;
(j) from 45 to 70%;
(k) from 60 to 80%;
(l) from 65 to 85%; and
(m) from 80 to 100%.
Marginal note:Statement — trade secret
(4) If the safety data sheet provides a concentration range further to paragraph (1)(b), it must also provide, immediately following the concentration range, a statement to the effect that the actual concentration is withheld as a trade secret.
- SOR/2018-68, s. 1
Marginal note:Concentration range — material or substance not always present at the same concentration
4.5 (1) If the concentration of a material or substance in a hazardous product is required to be provided on a safety data sheet and the material or substance is not always present at the same concentration, the safety data sheet must provide
(a) the actual concentration range of the material or substance in the hazardous product;
(b) one of the concentration ranges set out in subsection (3) within which the actual concentration range of the material or substance in the hazardous product falls entirely; or
(c) if the actual concentration range of the material or substance in the hazardous product is equal to or greater than 0.1% but less than or equal to 30%, and the actual concentration range does not fall entirely within any of the concentration ranges set out in subsection (3), a concentration range that is created by combining two consecutive ranges from those set out in paragraphs (3)(a) to (g), provided that the combined concentration range does not include any range that falls entirely outside the actual concentration range in which the material or substance is present in the hazardous product.
Marginal note:Actual concentration range within more than one concentration range
(2) For the purposes of paragraph (1)(b), if the actual concentration range of a material or substance in a hazardous product falls entirely within more than one of the concentration ranges set out in subsection (3), any one of those ranges may be provided on the safety data sheet.
Marginal note:Concentration ranges
(3) For the purposes of paragraphs (1)(b) and (c) and subsection (2), the concentration ranges are the following:
(a) from 0.1 to 1%;
(b) from 0.5 to 1.5%;
(c) from 1 to 5%;
(d) from 3 to 7%;
(e) from 5 to 10%;
(f) from 7 to 13%;
(g) from 10 to 30%;
(h) from 15 to 40%;
(i) from 30 to 60%;
(j) from 45 to 70%;
(k) from 60 to 80%;
(l) from 65 to 85%; and
(m) from 80 to 100%.
Marginal note:Statement — trade secret
(4) If the safety data sheet provides a concentration range further to paragraph (1)(b) or (c), it must also provide, immediately following that concentration range, a statement to the effect that the actual concentration range is withheld as a trade secret.
- SOR/2018-68, s. 1
PART 5Exceptions
Definition of laboratory sample
5 (1) In this section, laboratory sample means a sample of a hazardous product that is packaged in a container that contains less than 10 kg of the hazardous product and that is intended solely to be tested in a laboratory, but does not include a sample that is to be used
(a) by the laboratory for testing other products, mixtures, materials or substances; or
(b) for educational or demonstration purposes.
Marginal note:Sale or importation — biohazardous infectious materials — safety data sheet
(2) Subject to subsection (3), the sale or importation of a laboratory sample that is classified only in the category “Biohazardous Infectious Materials — Category 1” is exempt from the application of paragraphs 13(1)(a) and (a.1) and 14(a) of the Act.
Marginal note:Transfer of possession — biohazardous infectious materials — safety data sheet and label
(3) The transfer of possession of a laboratory sample for a specific purpose, without transferring ownership, if that laboratory sample is classified only in the category “Biohazardous Infectious Materials — Category 1”, is exempt from the application of section 13 of the Act.
Marginal note:Transfer of possession — safety data sheet
(4) The transfer of possession of a laboratory sample for a specific purpose, without transferring ownership, if that laboratory sample is one of the following types, is exempt from the application of paragraphs 13(1)(a) and (a.1) of the Act:
(a) a laboratory sample for which the chemical name and concentration of the hazardous product or its ingredients are not known; or
(b) a laboratory sample for which the supplier has not offered or exposed the hazardous product for transfer of ownership.
Marginal note:Sale or importation — biohazardous infectious materials — label
(5) Subject to subsection (3), the sale or importation of a laboratory sample that is classified only in the category “Biohazardous Infectious Materials — Category 1” is exempt from the application of paragraph 3(1)(d) if the label provides the chemical name or generic chemical name of any material that is in the hazardous product and that is classified as a biohazardous infectious material, if known by the supplier, and the statement “Hazardous Laboratory Sample. For hazard information or in an emergency, call/Échantillon pour laboratoire de produit dangereux. Pour obtenir des renseignements sur les dangers ou en cas d’urgence, composez”, followed by an emergency telephone number for the purpose of obtaining the information that must be provided on the safety data sheet of the hazardous product.
Marginal note:Transfer of possession — label
(6) The transfer of possession of a laboratory sample for a specific purpose, without transferring ownership, is exempt from the application of paragraphs 3(1)(c) and (d) if the label provides the chemical name or generic chemical name of any material or substance that is in the hazardous product and that is referred to in subsection 3(2) of Schedule 1, if known by the supplier, and the statement “Hazardous Laboratory Sample. For hazard information or in an emergency, call/Échantillon pour laboratoire de produit dangereux. Pour obtenir des renseignements sur les dangers ou en cas d’urgence, composez”, followed by an emergency telephone number for the purpose of obtaining the information that must be provided on the safety data sheet of the hazardous product, and if that laboratory sample is one of the following types:
(a) a laboratory sample for which the chemical name and concentration of the hazardous product or its ingredients are not known; or
(b) a laboratory sample in respect of which the supplier has not offered or exposed the hazardous product for transfer of ownership.
Marginal note:Mixture of radioactive nuclides and non-radioactive carriers — section 13 or 14 of Act
5.1 (1) The sale or importation of a hazardous product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carriers is exempt from the application of section 13 or 14 of the Act if the carrier
(a) is present in an amount that is
(i) in the case of a liquid or gaseous carrier, less than or equal to 1.0 ml, or
(ii) in the case of a solid carrier, less than or equal to 1.0 g; and
(b) is not
(i) classified in any category or subcategory of the “Carcinogenicity”, “Germ Cell Mutagenicity”, “Reproductive Toxicity” or “Biohazardous Infectious Materials” hazard class,
(ii) classified in the category “Acute Toxicity (Oral) — Category 1” or “Acute Toxicity (Dermal) — Category 1” of the “Acute Toxicity” hazard class, or
(iii) classified in the category “Acute Toxicity (Inhalation) — Category 1” or “Acute Toxicity (Inhalation) — Category 2” of the “Acute Toxicity” hazard class.
Marginal note:Mixture of radioactive nuclides and non-radioactive carriers — paragraph 13(1)(b) or 14(b) of Act
(2) The sale or importation of a hazardous product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carriers is exempt from the application of paragraph 13(1)(b) or 14(b) of the Act in respect of the requirement to have a label on the inner container of the hazardous product if the hazardous product is packaged in more than one container and the outer container has a label that provides the information elements required by Part 3.
Marginal note:Mixture of radioactive nuclides and non-radioactive carriers
(3) The sale or importation of a hazardous product that is a mixture of one or more radioactive nuclides and one or more non-radioactive carriers is exempt from the application of
(a) paragraph 3(1)(b); and
(b) paragraph 3(1)(c) and subparagraph 3(1)(d)(ii), in respect of the requirement to provide any precautionary statement on the label of the hazardous product or the container in which it is packaged.
Marginal note:Outer container
5.2 The sale or importation of a hazardous product is exempt from the application of paragraph 13(1)(b) or 14(b) of the Act in respect of the requirement to have a label on the outer container of the hazardous product if
(a) the label on the inner container is visible and legible through the outer container under normal conditions of storage and handling; or
(b) the outer container has a label that meets the requirements set out in the Transportation of Dangerous Goods Regulations.
Marginal note:Label — outer container — at least two hazardous products
5.3 In the case of an outer container in which at least two different hazardous products are packaged, subsection 3(1) does not apply if the label provides the following information elements:
(a) the product identifier for each hazardous product contained in the outer container;
(b) the initial supplier identifier;
(c) subject to subsection 3.6(3), the pictogram set out in column 3 of Schedule 3 designated for each category or subcategory in which each hazardous product contained in the outer container is classified;
(d) the precautionary statement applicable to the storage of each of the hazardous products contained in the outer container; and
(e) the statement “See individual product labels for signal words, hazard statements and precautionary statements/Voir les étiquettes sur chacun des produits pour les mentions d’avertissement, les mentions de danger et les conseils de prudence”.
Marginal note:Small-capacity containers — 100 ml or less
5.4 (1) The sale or importation of a hazardous product in a container that has a capacity of less than or equal to 100 ml, including any subsequent container of the same capacity in which that first container is packaged, is exempt from the application of paragraph 3(1)(c) and subparagraph 3(1)(d)(i) or (ii) in respect of the requirement to provide any precautionary statement or hazard statement on the label of the hazardous product or the container.
Marginal note:Small-capacity containers — 3 ml or less
(2) The sale or importation of a hazardous product in a container that has a capacity of less than or equal to 3 ml is exempt from the application of section 3.5 in respect of normal conditions of use if the label interferes with the normal use of the hazardous product.
Definition of bulk shipment
5.5 (1) In this section, bulk shipment means a shipment of a hazardous product that is contained in any of the following, without intermediate containment or intermediate packaging:
(a) a vessel that has a water capacity equal to or greater than 450 l;
(b) a freight container, road vehicle, railway vehicle or portable tank;
(c) the hold of a ship; or
(d) a pipeline.
Marginal note:Bulk shipments and unpackaged hazardous products
(2) The sale or importation of a bulk shipment or a hazardous product without packaging of any sort is exempt from the application of paragraph 13(1)(b) or 14(b) of the Act.
Definition of complex mixture
5.6 (1) In this section, complex mixture means a mixture that has a commonly known generic name and that is
(a) naturally occurring;
(b) a fraction of a naturally occurring mixture that results from a separation process; or
(c) a modification of a naturally occurring mixture or a modification of a fraction of a naturally occurring mixture that results from a chemical modification process.
Marginal note:Complex mixture
(2) The sale or importation of a hazardous product that is a complex mixture is exempt from the application of paragraph 4(1)(b) in respect of the requirements set out in paragraphs 3(2)(a) and (d) of Schedule 1, and in paragraphs 3(2)(b) and (c) of that Schedule, if that information is available and applicable, in relation to the ingredients of the complex mixture, if the commonly known generic name of the complex mixture is provided for item 3 of the safety data sheet.
Marginal note:Complex mixture — ingredient
(3) Subject to subsection (4), the sale or importation of a hazardous product that contains an ingredient that is a complex mixture is exempt from the application of paragraph 4(1)(b) in respect of the requirements set out in paragraphs 3(2)(a) and (d) of Schedule 1, and in paragraphs 3(2)(b) and (c) of that Schedule, if that information is available and applicable, in relation to the ingredients of the complex mixture if the complex mixture, individually, is classified in a category or subcategory of a health hazard class and the commonly known generic name of the complex mixture and its concentration in the hazardous product are provided for item 3 of the safety data sheet.
Marginal note:Concentration results in classification
(4) If the complex mixture is present at a concentration that results in the product being classified in a category or subcategory of any health hazard class further to subsection 2.5(1), the commonly known generic name and concentration of the complex mixture must be provided on the safety data sheet of the hazardous product.
Marginal note:Definitions
5.7 (1) The following definitions apply in this section.
- first supplier
first supplier means a supplier who is exempted from the requirement to disclose the information specified in subsection 11(1) of the Hazardous Materials Information Review Act, by virtue of that Act. (premier fournisseur)
- subsequent supplier
subsequent supplier means a supplier who sells or imports a hazardous product that is the subject of an exemption granted to the first supplier from the requirement to disclose the information specified in subsection 11(1) of the Hazardous Materials Information Review Act. (fournisseur subséquent)
Marginal note:Confidential information
(2) If any information is the subject of an exemption under the Hazardous Materials Information Review Act, the information must be replaced by the information required under subsection (3) or (4).
Marginal note:Subsection 11(1) of Hazardous Materials Information Review Act
(3) A supplier who, under subsection 11(1) of the Hazardous Materials Information Review Act, files a claim for exemption from a requirement to disclose information in respect of a hazardous product on a safety data sheet or on a label must, in respect of the sale or importation of the hazardous product, provide on the safety data sheet and, if applicable, on the label of the hazardous product or container in which the hazardous product is packaged a statement that a claim was filed, the date that the claim was filed and the registry number assigned to the claim under the Hazardous Materials Information Review Act until
(a) in the case that an order was issued by a screening officer under subsection 16(1) or 17(1) of the Hazardous Materials Information Review Act, the end of the period that begins on the final disposition of the proceedings in relation to the claim for exemption and does not exceed the period specified in the order, as the word “proceedings” is defined in subsection 19(3) of the Hazardous Materials Information Review Act; or
(b) in any other case, the end of the period not exceeding 30 days after the final disposition of the proceedings in relation to the claim for exemption, as the word “proceedings” is defined in subsection 19(3) of the Hazardous Materials Information Review Act.
Marginal note:Information to be disclosed
(4) A supplier who receives notice of a decision made under the Hazardous Materials Information Review Act that their claim or a portion of their claim for exemption from a requirement to disclose information in respect of a hazardous product on a safety data sheet or a label is valid must, during the period beginning no later than the end of the applicable period specified in subsection (3) and on compliance with any order issued under subsection 16(1) or 17(1) of the Hazardous Materials Information Review Act, if applicable, and ending on the last day of the exemption period, in respect of the sale or importation of the hazardous product, provide on the safety data sheet and, if applicable, on the label of the hazardous product or container in which the hazardous product is packaged the following information:
(a) a statement that an exemption has been granted;
(b) the date of the decision granting the exemption; and
(c) the registry number assigned to the claim under the Hazardous Materials Information Review Act.
Marginal note:Non-application — paragraphs 3(1)(a) to (d) or (2)(a) to (c) of Schedule 1
(5) The sale or importation of a hazardous product is exempt from the application of paragraph 4(1)(b) in respect of the requirements set out in paragraph 3(1)(a) or (2)(a) of Schedule 1 and, if the information is available and applicable, in paragraphs 3(1)(b) to (d) or 2(b) and (c) of that Schedule, if it is the subject of a claim for exemption under paragraph 11(1)(a) of the Hazardous Materials Information Review Act and if the generic chemical name of the material, substance or ingredient is provided for item 3 of the safety data sheet.
Marginal note:Non-application — paragraph 3(2)(d) of Schedule 1
(6) Paragraph 3(2)(d) of Schedule 1 does not apply in respect of a hazardous product that is the subject of a claim for exemption under subparagraph 11(1)(b)(iii) of the Hazardous Materials Information Review Act.
Marginal note:Sale or importation — paragraphs 3(1)(a) to (d) or (2)(a) to (c) of Schedule 1
(7) The sale or importation of a hazardous product by a subsequent supplier is exempt from the application of paragraph 4(1)(b) in respect of the requirements set out in paragraph 3(1)(a) or (2)(a) of Schedule 1, and, if the information is available and applicable, in paragraphs 3(1)(b) to (d) or 2(b) and (c) of that Schedule, if
(a) the first supplier is exempt from those requirements;
(b) the information is unknown to the subsequent supplier, or the information is known to the subsequent supplier but the subsequent supplier has obtained the information in confidence, express or implied, and is obligated, expressly or implicitly, by contract or a relationship based on trust and confidence, or otherwise by law or equity, to maintain the confidentiality of the information; and
(c) the safety data sheet for the hazardous product that the subsequent supplier provides on the sale, or obtains or prepares on the importation, provides in lieu of the information referred to in paragraph 3(1)(a) or (2)(a) of Schedule 1, and, if the information is available and applicable, in paragraphs 3(1)(b) to (d) or 2(b) and (c) of that Schedule,
(i) the information referred to in subsection (3) or (4) in respect of,
(A) if the subsequent supplier is exempted from the requirement to provide information that could be used to identify the first supplier, that exemption, or
(B) in any other case, the exemption of the first supplier, with the words “other supplier/autre fournisseur” in parentheses after that information, and
(ii) the generic chemical name of the material, substance or ingredient as provided by the first supplier.
Marginal note:Sale or importation — paragraph 3(2)(d) of Schedule 1
(8) The sale or importation of a hazardous product by a subsequent supplier is exempt from the application of paragraph 4(1)(b) in respect of the requirement set out in paragraph 3(2)(d) of Schedule 1, if
(a) the first supplier is exempt from that requirement;
(b) the information is unknown to the subsequent supplier, or the information is known to the subsequent supplier but the subsequent supplier has obtained the information in confidence, express or implied, and is obligated, expressly or implicitly, by contract or a relationship based on trust and confidence, or otherwise by law or equity, to maintain the confidentiality of the information; and
(c) the safety data sheet for the hazardous product that the subsequent supplier provides on the sale, or obtains or prepares on the importation, provides in lieu of the information referred to in paragraph 3(2)(d) of Schedule 1
(i) the information referred to in subsection (3) or (4) in respect of,
(A) if the subsequent supplier is exempted from the requirement to provide information that could be used to identify the first supplier, that exemption, or
(B) in any other case, the exemption of the first supplier, with the words “other supplier/autre fournisseur” in parentheses after that information, and
(ii) subject to section 4.5, the concentration of the first supplier’s hazardous product that is in the subsequent supplier’s hazardous product.
Marginal note:Label — confidential product identifier — paragraphs 3(1)(a) and 4(1)(b)
(9) Paragraph 3(1)(a) and the requirement in paragraph 4(1)(b) in relation to paragraph 1(a) of Schedule 1, if the information is available and applicable, do not apply in respect of the sale of a hazardous product to an employer who is exempt under the Hazardous Materials Information Review Act or under the laws of a province from the requirement to disclose the product identifier of a hazardous product if the label provides a code name or code number specified by the supplier and
(a) if available, the information referred to in subsection (3) or (4) in respect of the employer’s claim for exemption under the Hazardous Materials Information Review Act; or
(b) if the information referred to in paragraph (a) is not available, the information required to be provided under the laws of the province.
Marginal note:Label — confidential supplier identifier — paragraphs 3(1)(b) and 4(1)(b)
(10) Paragraph 3(1)(b) and the requirement in paragraph 4(1)(b) in relation to paragraph 1(d) of Schedule 1, if the information is available and applicable, do not apply in respect of the sale of a hazardous product to an employer who is exempt under the Hazardous Materials Information Review Act or under the laws of a province from the requirement to disclose any information that could be used to identify the supplier of the hazardous product if that information is replaced by
(a) if available, the information referred to in subsection (3) or (4) in respect of the employer’s claim for exemption under the Hazardous Materials Information Review Act; or
(b) if the information referred to in paragraph (a) is not available, the information required to be provided under the laws of the province.
Marginal note:Safety data sheet — sale to employer
(11) The sale of a hazardous product to an employer is exempt from the requirement to disclose information on the safety data sheet that could be the subject of a claim for exemption under subsection 11(2) of the Hazardous Materials Information Review Act if
(a) the employer is exempt, under that Act or the laws of a province, from the requirement to disclose that information in respect of the hazardous product; and
(b) the safety data sheet of the hazardous product provided in respect of that sale provides in lieu of that information
(i) if available, the information referred to in subsection (3) or (4) in respect of the employer’s claim for exemption under that Act, or
(ii) if the information referred to in subparagraph (i) is not available, an emergency telephone number of the employer that will enable a health professional to obtain any information referred to in subsection 4(1) that is in the possession of the employer for the purpose of making a medical diagnosis of, or rendering medical treatment to, a person in an emergency.
Marginal note:Subsequent sale by supplier — safety data sheet
5.8 (1) The sale of a hazardous product by a supplier to whom the hazardous product was sold is exempt from the application of paragraph 4(1)(b) in respect of the requirement set out in paragraph 1(d) of Schedule 1 to provide the initial supplier identifier on the safety data sheet if their name, address and telephone number are provided on the safety data sheet.
Marginal note:Subsequent sale by supplier — label
(2) The sale of a hazardous product by a supplier to whom the hazardous product was sold is exempt from the application of paragraph 3(1)(b) in respect of the requirement to provide the initial supplier identifier on the label if their name, address and telephone number are provided on the label.
Marginal note:Following supplier
(3) If the initial supplier identifier referred to in subsection (1) or (2) has been replaced by the name, address and telephone number of a supplier to whom the hazardous product has been sold, any following supplier of the hazardous product may replace that information with their own name, address and telephone number.
Marginal note:Importation for use in own work place — safety data sheet
5.9 (1) If an importer imports a hazardous product from a foreign supplier for use in their own work place in Canada and obtains a safety data sheet from the foreign supplier, the importer is exempt from the requirement to provide, on the safety data sheet, the specific information element set out in paragraph 1(d) of Schedule 1 if the name, address and telephone number of the foreign supplier is retained on the safety data sheet.
Marginal note:Importation for use in own work place — label
(2) If an importer imports a hazardous product from a foreign supplier for use in their own work place in Canada, the importer is exempt from the application of paragraph 3(1)(b) in respect of the requirement to provide the initial supplier identifier on the label if the name, address and telephone number of the foreign supplier is retained on the label.
Marginal note:Repetition of symbols on label
5.10 The sale or importation of a hazardous product is exempt from the application of paragraphs 3(1)(c) and (d), in respect of the requirement to provide a pictogram on the label of the hazardous product or its container, if the symbol of the pictogram appears on another label in accordance with the Transportation of Dangerous Goods Regulations on that same hazardous product or that same container and if the other label also meets the requirements of section 3.5.
Marginal note:Safety data sheet for hazardous products — same product identifier
5.11 The sale or importation of a hazardous product is exempt from the application of paragraph 13(1)(a.1) or 14(a) of the Act in respect of the requirement to provide, or cause to be provided, a safety data sheet on the sale or to obtain or prepare a safety data sheet on or before the importation, if
(a) the hazardous product is part of a shipment of hazardous products that have the same product identifier and a safety data sheet is obtained, prepared or provided for one of them; or
(b) the supplier has provided to the person or government that acquires possession or ownership, or the supplier who imports the hazardous product has in their possession, a safety data sheet for a hazardous product that has the same product identifier and the safety data sheet provides, subject to section 5.12, information that is current at the time of the sale or importation.
Definition of significant new data
5.12 (1) In this section, significant new data means new data regarding the hazard presented by a hazardous product that change its classification in a category or subcategory of a hazard class, or result in its classification in another hazard class, or change the ways to protect against the hazard presented by the hazardous product.
Marginal note:Significant new data available within 90 days — sale
(2) The sale of a hazardous product for which significant new data became available within 90 days prior to the sale is exempt from the application of subsection 4(1) in respect of the requirement to provide, on the safety data sheet, information that is available at the time of the sale if, at the time of the sale, the supplier ensures that the person or government that acquires possession or ownership is provided with
(a) a safety data sheet that includes all information available at the time of the sale, with the exception of the significant new data; and
(b) the significant new data and the date on which they became available, in writing.
Marginal note:Significant new data available within 90 days — importation
(3) The importation of a hazardous product for which significant new data became available within 90 days prior to the importation is exempt from the application of subsection 4(1) in respect of the requirement to provide, on the safety data sheet, information that is available at the time of the importation if, at the time of the importation, the supplier
(a) obtains a safety data sheet that includes all of the information available at the time of the importation, with the exception of the significant new data; and
(b) obtains or prepares a document that provides the significant new data and the date on which they became available and appends that document to the safety data sheet referred to in paragraph (a).
Marginal note:Significant new data available within 180 days — sale
(4) The sale of a hazardous product for which significant new data became available within 180 days prior to the sale is exempt from the application of subsection 3(1) in respect of the requirement to provide, on the label, information elements for each category or subcategory of the hazard class in which the hazardous product is classified at the time of the sale if, at the time of the sale,
(a) the hazardous product or container in which the hazardous product is packaged has a label that provides all the information elements for each category or subcategory of the hazard class in which the hazardous product is classified at the time of the sale, with the exception of the significant new data; and
(b) the person or government that acquires possession or ownership is provided with the significant new data and the date on which they became available, in writing.
Marginal note:Significant new data available within 180 days — importation
(5) The importation of a hazardous product for which significant new data became available within 180 days prior to the importation is exempt from the application of subsection 3(1) in respect of the requirement to provide, on the label, information elements for each category or subcategory of the hazard class in which the hazardous product is classified at the time of the importation if, at the time of the importation,
(a) the hazardous product or container in which the hazardous product is packaged has a label that includes all of the information elements for each category or subcategory of the hazard class in which the hazardous product is classified at the time of the importation, with the exception of the significant new data; and
(b) the supplier obtains or prepares a document that provides the significant new data and the date on which they became available.
Marginal note:Transfer of possession for purpose of transportation
5.13 The transfer of possession of a hazardous product that creates a bailment for the purpose of transportation or, in Quebec, the transfer of possession of a hazardous product for the purpose of transportation, without transferring ownership, and with the obligation to deliver it to the person or government that acquired possession or ownership, is exempt from the application of paragraph 13(1)(a.1) of the Act in respect of the requirement to provide, or cause to be provided, a safety data sheet to the person to whom the possession of the product is transferred for the purpose of transportation.
Definition of transit
5.14 (1) In this section, transit means, in relation to a hazardous product, its transport through Canada after being imported and before being exported, when the place of initial loading and the final destination are outside of Canada, and, while in transport, its loading, unloading, packing, unpacking or storage.
Marginal note:Importation — transit
(2) The importation of a hazardous product is exempt from the application of section 14 of the Act if
(a) the hazardous product is or is intended to be in transit; and
(b) the hazardous product is not intended for use in a work place in Canada.
Marginal note:Sale — exportation
(3) The sale of a hazardous product, for the purpose of its exportation, is exempt from the application of section 13 of the Act if
(a) the hazardous product is or is intended to be transported or, while in transport, is or is intended to be loaded, unloaded, packed, unpacked or stored, for the purpose of that sale; and
(b) the hazardous product is not intended for use in a work place in Canada.
Marginal note:Importation to bring into compliance
5.15 (1) The importation of a hazardous product is exempt from the application of paragraph 14(b) of the Act if the hazardous product is imported for the purpose of being brought into compliance with the labelling requirements of these Regulations before it is used or sold.
Marginal note:Credible evidence
(2) A supplier who imports a hazardous product for the purpose described in subsection (1) must, on the request of an inspector, provide credible evidence to the inspector that it is being brought into compliance with the labelling requirements of these Regulations.
PART 6Additional Requirements
Marginal note:Communication of information elements — health professionals
6 (1) A supplier who sells or imports a hazardous product intended for use, handling or storage in a work place in Canada must provide, as soon as feasible, any information element in respect of the hazardous product that is referred to in subsection 4(1) and is in the possession of the supplier to any health professional who requests that information for the purpose of making a medical diagnosis of, or rendering medical treatment to, an individual in an emergency.
Marginal note:Confidentiality
(2) Any information that, by virtue of an exemption under the Hazardous Materials Information Review Act or these Regulations, is not required to be provided on the safety data sheet but has nevertheless been provided by a supplier to any health professional who requests that information for the purpose of making a medical diagnosis of, or rendering medical treatment to, an individual in a medical emergency must be kept confidential, except for the purpose for which it was provided, if the health professional has been informed by the supplier that the information is to be kept confidential.
Marginal note:Communication of source for toxicological data
6.1 Subject to the Hazardous Materials Information Review Act, a supplier who sells or imports a hazardous product intended for use, handling or storage in a work place in Canada must disclose, as soon as feasible, the source of information for any toxicological data used in the preparation of a safety data sheet on the request of an inspector, any person or government to which the hazardous product is sold or any user of a hazardous product.
Marginal note:Bilingual safety data sheet and label
6.2 (1) The information elements provided on a safety data sheet and on a label must be in both official languages of Canada.
Marginal note:Bilingual presentation
(2) The information elements referred to in subsection (1) may
(a) in the case of a safety data sheet, appear either on a single bilingual safety data sheet or in a document in two unilingual parts that constitute one bilingual safety data sheet; and
(b) in the case of a label, appear either on a single bilingual label or in a group of information elements in two unilingual parts that constitute one bilingual label.
PART 7Physical Hazard Classes
SUBPART 1Explosives
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SUBPART 2Flammable Gases
Definition
Definition of flammable gas
7.2 In this Subpart, flammable gas means a gas that has a flammable range when mixed with air at 20°C and at the standard pressure of 101.3 kPa.
Classification in a Category of the Class
Marginal note:Exclusions
7.2.1 (1) Any product that is classified in a category of the hazard class “Flammable Aerosols” need not be classified in any category of this hazard class.
Marginal note:Categories
(2) A flammable gas is classified in a category of this hazard class in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Flammable Gases — Category 1 A gas that
(a) is ignitable when mixed with air at a concentration ≤ 13.0% by volume; or
(b) has a flammable range when mixed with air ≥ 12 percentage points, regardless of the lower flammable limit
2 Flammable Gases — Category 2 A gas that is not classified in the category “Flammable Gases — Category 1” and has a flammable range when mixed with air Marginal note:Calculation method
(3) Test data have priority over data obtained using a calculation method. If a calculation method is used to establish whether a gas is classified in a category of this hazard class, the calculation method set out in the International Organization for Standardization standard ISO 10156:2010 entitled Gases and gas mixtures — Determination of fire potential and oxidizing ability for the selection of cylinder valve outlets, as amended from time to time, or any other calculation method that is a scientifically validated method, must be used.
SUBPART 3Flammable Aerosols
Definitions
Marginal note:Definitions
7.3 The following definitions apply in this Subpart.
- flammable aerosol
flammable aerosol means a product that contains one or more flammable components in an aerosol dispenser and that, when dispensed, is liable to ignite, but excludes a product that contains flammable components in an aerosol dispenser at a concentration less than or equal to 1.0% and that has a heat of combustion less than 20 kJ/g. (aérosol inflammable)
- flammable component
flammable component means a mixture or substance that is classified in a category or subcategory of a hazard class in Subpart 2, 6 or 7 of this Part. (composant inflammable)
- foam aerosol
foam aerosol means the content that is dispensed from an aerosol dispenser having a spray distance of less than 15 cm and that is in the form of a foam, mousse, gel or paste. (mousse d’aérosol)
- spray aerosol
spray aerosol means the content that is dispensed from an aerosol dispenser and that is not a foam aerosol. (aérosol vaporisé)
Classification in a Category of the Class
Marginal note:Categories
7.3.1 (1) A flammable aerosol is classified in a category of this hazard class in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Flammable Aerosols — Category 1 An aerosol dispenser that
(a) contains ≥ 85.0% flammable components and that generates an aerosol that has a heat of combustion ≥ 30 kJ/g;
(b) generates a spray aerosol that has an ignition distance ≥ 75 cm, based on test results from the ignition distance test for spray aerosols performed in accordance with sub-section 31.4 of Part III of the Manual of Tests and Criteria; or
(c) generates a foam aerosol that has, based on test results from the aerosol foam flammability test performed in accordance with sub-section 31.6 of Part III of the Manual of Tests and Criteria, either
(i) a flame height ≥ 20 cm and a flame duration ≥ 2 s, or
(ii) a flame height ≥ 4 cm and a flame duration ≥ 7 s
2 Flammable Aerosols — Category 2 An aerosol dispenser that generates
(a) a spray aerosol that does not meet the criteria for the category “Flammable Aerosols — Category 1” and that has
(i) a heat of combustion ≥ 20 kJ/g,
(ii) an ignition distance ≥ 15 cm, based on test results from the ignition distance test for spray aerosols performed in accordance with sub-section 31.4 of Part III of the Manual of Tests and Criteria,
(iii) a time equivalent ≤ 300 s/m3, based on test results from the enclosed space ignition test performed in accordance with sub-section 31.5 of Part III of the Manual of Tests and Criteria, or
(iv) a deflagration density ≤ 300 g/m3, based on test results from the enclosed space ignition test performed in accordance with sub-section 31.5 of Part III of the Manual of Tests and Criteria; or
(b) a foam aerosol that does not meet the criteria for the category “Flammable Aerosols — Category 1” and that has a flame height ≥ 4 cm and a flame duration ≥ 2 s, based on test results from the aerosol foam flammability test performed in accordance with sub-section 31.6 of Part III of the Manual of Tests and Criteria
Marginal note:Default category
(2) A product that contains flammable components in an aerosol dispenser for which there are no test results in accordance with subparagraph 2.1(a)(i) and referred to in subsection (1) must be classified in the category “Flammable Aerosols – Category 1”, unless the product contains flammable components at a concentration less than or equal to 1.0% and has a heat of combustion less than 20 kJ/g.
SUBPART 4Oxidizing Gases
Definition
Definition of oxidizing gas
7.4 In this Subpart, oxidizing gas means a gas that is liable to cause or contribute to the combustion of other material more than air does.
Classification in the Category of the Class
Marginal note:Category
7.4.1 An oxidizing gas is classified in the category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Oxidizing Gases — Category 1 | A gas that has an oxidizing power > 23.5% based on one of the methods set out in the International Organization for Standardization standard ISO 10156:2010 entitled Gases and gas mixtures — Determination of fire potential and oxidizing ability for the selection of cylinder valve outlets, as amended from time to time |
SUBPART 5Gases Under Pressure
Definitions
Marginal note:Definitions
7.5 The following definitions apply in this Subpart.
- critical temperature
critical temperature means the temperature above which a pure gas cannot be liquefied, regardless of the degree of compression. (température critique)
- gas under pressure
gas under pressure means a product that consists of a gas contained in a receptacle at a gauge pressure of 200 kPa or more at 20°C, or that is liquefied, or liquefied and refrigerated, but excludes any gas that has an absolute vapour pressure of not more than 300 kPa at 50°C or that is not completely gaseous at 20°C and the standard pressure of 101.3 kPa. (gaz sous pression)
Classification in a Category of the Class
Marginal note:Categories
7.5.1 A gas under pressure is classified in a category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Gases Under Pressure — Compressed Gas | A gas that when packaged under pressure is entirely gaseous at -50°C, including all gases with a critical temperature ≤ -50°C |
| 2 | Gases Under Pressure — Liquefied Gas | A gas that when packaged under pressure is partially liquid at temperatures > -50°C |
| 3 | Gases Under Pressure — Refrigerated Liquefied Gas | A gas that when packaged is partially liquid because of its low temperature |
| 4 | Gases Under Pressure — Dissolved Gas | A gas that when packaged under pressure is dissolved in a liquid phase solvent |
SUBPART 6Flammable Liquids
Definitions
Marginal note:Definitions
7.6 The following definitions apply in this Subpart.
- appropriate closed-cup method
appropriate closed-cup method means the methods listed in paragraph 2.6.4.2.5 of the GHS, as amended from time to time. (méthode de creuset fermé appropriée)
- flammable liquid
flammable liquid means a liquid that has a flash point of not more than 93°C. (liquide inflammable)
Classification in a Category of the Class
Marginal note:Exclusions
7.6.1 (1) Any product that is classified in a category of the hazard class “Flammable Aerosols” need not be classified in any category of this hazard class.
Marginal note:Categories
(2) A flammable liquid is classified in a category of this hazard class in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Flammable Liquids — Category 1 A liquid that has a flash point < 23°C and initial boiling point ≤ 35°C 2 Flammable Liquids — Category 2 A liquid that has a flash point < 23°C and initial boiling point > 35°C 3 Flammable Liquids — Category 3 A liquid that has a flash point ≥ 23°C and ≤ 60°C 4 Flammable Liquids — Category 4 A liquid that has a flash point > 60°C and ≤ 93°C Marginal note:Determination of flash point — substance
(3) In the case of a liquid that is a substance, the flash point must be determined by
(a) tests using an appropriate closed-cup method; or
(b) use of scientific literature that reports a value obtained from an appropriate closed-cup method.
Marginal note:Determination of flash point — mixture
(4) In the case of a liquid that is a mixture, the flash point must be determined by
(a) tests using an appropriate closed-cup method; or
(b) use of an applicable calculation method under conditions for which it has been validated according to generally accepted standards of good scientific practice at the time the validation was carried out.
SUBPART 7Flammable Solids
Definitions
Marginal note:Definitions
7.7 The following definitions apply in this Subpart.
- flammable solid
flammable solid means a readily combustible solid or a solid that is liable to cause or contribute to fire through friction. (solide inflammable)
- readily combustible solid
readily combustible solid means a powdered, granular or pasty mixture or substance that can be easily ignited by brief contact with an ignition source and, when ignited, has a flame that spreads rapidly. (solide facilement inflammable)
Classification in a Category of the Class
Marginal note:Exclusions
7.7.1 (1) Any product that is classified in a category of the hazard class “Flammable Aerosols” need not be classified in any category of this hazard class.
Marginal note:Categories
(2) A flammable solid that is a readily combustible solid is classified in a category of this hazard class, based on results from testing performed in accordance with the burning rate test in sub-section 33.2.1 of Part III of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Flammable Solids — Category 1 A solid that is
(a) other than a metal powder, in respect of which
(i) the burning time is < 45 s or the burning rate is > 2.2 mm/s, and
(ii) the wetted zone does not stop the fire or stops the fire for less than 4 min; or
(b) a metal powder, in respect of which the burning time is ≤ 5 min
2 Flammable Solids — Category 2 A solid that is
(a) other than a metal powder, in respect of which
(i) the burning time is < 45 s or the burning rate is > 2.2 mm/s, and
(ii) the wetted zone stops the fire for at least 4 min; or
(b) a metal powder, in respect of which the burning time is > 5 min and ≤ 10 min
Marginal note:Fire through friction
(3) A flammable solid that is a solid that is liable to cause or contribute to fire through friction is classified in the category “Flammable Solids — Category 2”.
SUBPART 8Self-reactive Substances and Mixtures
Definitions
Marginal note:Definitions
7.8 The following definitions apply in this Subpart.
- as packaged
as packaged means packaged in the form and condition described in test series B, D, G and H of Part II of the Manual of Tests and Criteria. (tel qu’il est emballé)
- explosive properties
explosive properties means the properties of a self-reactive substance or mixture that, in laboratory testing according to test series A, C or E of Part II of the Manual of Tests and Criteria, make the substance or mixture liable to detonate, deflagrate rapidly or show a violent effect when heated under confinement. (propriétés explosives)
- self-reactive
self-reactive means, in relation to a thermally unstable liquid or solid product, mixture or substance, liable to undergo a strongly exothermic decomposition, having a heat of decomposition equal to or greater than 300 J/g, even without participation of oxygen. (autoréactif)
Classification in a Category of the Class
Marginal note:Exclusions
7.8.1 (1) The following need not be classified in any category of this hazard class:
(a) mixtures or substances, or mixtures or substances as packaged, that are classified in a category of the hazard class “Organic Peroxides”;
(b) liquid or solid mixtures that are classified in a category of the hazard class “Oxidizing Liquids” or “Oxidizing Solids”, and contain less than 5.0% of combustible organic substances; and
(c) liquid or solid substances that are classified in a category of the hazard class “Oxidizing Liquids” or “Oxidizing Solids”.
Marginal note:Categories
(2) Subject to subsection (3), a self-reactive substance or mixture is classified in a category of this hazard class, based on results from testing performed in accordance with test series A to H of Part II of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Self-reactive Substances and Mixtures — Type A A liquid or solid that, as packaged, is liable to detonate, or deflagrate rapidly 2 Self-reactive Substances and Mixtures — Type B A liquid or solid that possesses explosive properties and, as packaged, neither detonates, nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package 3 Self-reactive Substances and Mixtures — Type C A liquid or solid that possesses explosive properties and, as packaged, neither detonates, nor deflagrates rapidly nor undergoes a thermal explosion in that package 4 Self-reactive Substances and Mixtures — Type D In laboratory testing, a liquid or solid that
(a) detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement;
(b) does not detonate, deflagrates slowly and shows no violent effect when heated under confinement; or
(c) neither detonates nor deflagrates, and shows a medium effect when heated under confinement
5 Self-reactive Substances and Mixtures — Type E In laboratory testing, a liquid or solid that neither detonates nor deflagrates and shows low or no effect when heated under confinement 6 Self-reactive Substances and Mixtures — Type F In laboratory testing, a liquid or solid that neither detonates in the cavitated state nor deflagrates and
(a) shows low or no effect when heated under confinement, as well as low or no explosive power; or
(b) shows no effect when heated under confinement nor any explosive power, and either
(i) has a SADT < 60°C when evaluated in a 50 kg package, or
(ii) in the case of a liquid mixture, has a diluent that is used for desensitization with a boiling point < 150°C
7 Self-reactive Substances and Mixtures — Type G In laboratory testing, a liquid or solid that neither detonates in the cavitated state nor deflagrates, shows no effect when heated under confinement nor any explosive power, and either
(a) has a SADT of 60°C to 75°C when evaluated in a 50 kg package, or
(b) in the case of a liquid mixture, has a diluent that is used for desensitization with a boiling point ≥ 150°C
Marginal note:Exclusion after evaluation
(3) A mixture or substance with a self-accelerating decomposition temperature greater than 75°C when evaluated in a 50 kg package need not be classified in any category of this hazard class.
SUBPART 9Pyrophoric Liquids
Definition
Definition of pyrophoric liquid
7.9 In this Subpart, pyrophoric liquid means a liquid that is liable to ignite within five minutes after coming into contact with air.
Classification in the Category of the Class
Marginal note:Category
7.9.1 A pyrophoric liquid is classified in the category of this hazard class, based on results from testing performed in accordance with test N.3 of sub-section 33.3.1.5 of Part III of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Pyrophoric Liquids — Category 1 | A liquid that, within 5 min, either
|
SUBPART 10Pyrophoric Solids
Definition
Definition of pyrophoric solid
7.10 In this Subpart, pyrophoric solid means a solid that is liable to ignite within five minutes after coming into contact with air.
Classification in the Category of the Class
Marginal note:Category
7.10.1 A pyrophoric solid is classified in the category of this hazard class, based on results from testing performed in accordance with test N.2 of sub-section 33.3.1.4 of Part III of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Pyrophoric Solids — Category 1 | A solid that ignites within 5 min after coming into contact with air |
SUBPART 11Self-heating Substances and Mixtures
Definition
Definition of self-heating
7.11 In this Subpart, self-heating means, in relation to a solid or liquid, liable to self-heat by reaction with air and without energy supply.
Classification in a Category of the Class
Marginal note:Exclusions
7.11.1 (1) The following need not be classified in any category of this hazard class:
(a) a liquid classified in the category of the hazard class “Pyrophoric Liquids”; and
(b) a solid classified in the category of the hazard class “Pyrophoric Solids”.
Marginal note:Categories
(2) Subject to subsection (3), a self-heating substance or mixture is classified in a category of this hazard class, based on results from testing performed in accordance with test N.4 of sub-section 33.3.1.6 of Part III of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Self-heating Substances and Mixtures — Category 1 A solid or liquid in respect of which a positive result is obtained in a test using a 25 mm sample cube at 140°C and the spontaneous ignition temperature of a 450 l volume of the solid or liquid is ≤ 50°C 2 Self-heating Substances and Mixtures — Category 2 A solid or liquid in respect of which
(a) a positive result is obtained in a test using a 100 mm sample cube at 140°C, a negative result is obtained in a test using a 25 mm sample cube at 140°C and
(i) the solid or liquid is packed in packages with a volume > 3 m3,
(ii) a positive result is obtained in a test using a 100 mm sample cube at 120°C and the solid or liquid is packed in packages with a volume > 450 l, or
(iii) a positive result is obtained in a test using a 100 mm sample cube at 100°C; or
(b) a positive result is obtained in a test using a 25 mm sample cube at 140°C and the spontaneous ignition temperature of a 450 l volume of the solid or liquid is > 50°C
Marginal note:Exclusion after evaluation
(3) A mixture or substance with a temperature of spontaneous combustion higher than 50°C for a volume of 27 m3 need not be classified in any category of this hazard class.
SUBPART 12Substances and Mixtures Which, in Contact with Water, Emit Flammable Gases
General Provision
Marginal note:Interpretation
7.12 In this Subpart, substances and mixtures which, in contact with water, emit flammable gases are liquids and solids that, by interaction with water, are liable to become spontaneously flammable or give off flammable gases in dangerous quantities, that is, in quantities that are equal to or greater than one litre of gas per kilogram of the mixture or substance per hour.
Classification in a Category of the Class
Marginal note:Exclusions
7.12.1 (1) The following liquids or solids need not be classified in any category of this hazard class:
(a) those that have a chemical structure that does not contain metals or metalloids;
(b) those that have been shown, through accumulated experience in production or handling, not to react with water; and
(c) those that are soluble in water to form a stable mixture.
Marginal note:Categories
(2) A liquid or solid which, in contact with water, emits flammable gases is classified in a category of this hazard class, based on results from testing performed in accordance with test N.5 of sub-section 33.4.1.4 of Part III of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Substances and Mixtures Which, in Contact with Water, Emit Flammable Gases — Category 1 A liquid or solid that
(a) reacts with water at ambient temperature and produces a gas that is liable to ignite spontaneously;
(b) reacts with water at ambient temperature such that the rate of evolution of flammable gas is ≥ 10 l/kg of liquid or solid over any one minute; or
(c) reacts with water at ambient temperature to ignite spontaneously in any step of the test procedure
2 Substances and Mixtures Which, in Contact with Water, Emit Flammable Gases — Category 2 A liquid or solid that reacts with water at ambient temperature such that the maximum rate of evolution of flammable gas is ≥ 20 l/kg of liquid or solid per hour 3 Substances and Mixtures Which, in Contact with Water, Emit Flammable Gases — Category 3 A liquid or solid that reacts with water at ambient temperature such that the maximum rate of evolution of flammable gas is ≥ 1 l/kg of liquid or solid per hour
SUBPART 13Oxidizing Liquids
Definition
Definition of oxidizing liquid
7.13 In this Subpart, oxidizing liquid means a liquid, whether or not combustible, that is liable to cause or contribute to the combustion of other material.
Classification in a Category of the Class
Marginal note:Exclusions
7.13.1 (1) The following liquids need not be classified in any category of this hazard class:
(a) any organic liquid that does not contain oxygen, fluorine or chlorine;
(b) any organic liquid that contains oxygen, fluorine or chlorine if those elements are chemically bonded only to carbon or hydrogen; and
(c) any inorganic liquid that does not contain oxygen or halogens.
Marginal note:Categories
(2) An oxidizing liquid is classified in a category of this hazard class, based on results from testing performed in accordance with test O.2 of sub-section 34.4.2 of Part III of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Oxidizing Liquids — Category 1 A liquid that, when tested in a 1:1 mixture, by mass, with cellulose, spontaneously ignites, or exhibits a mean pressure rise time < the mean pressure rise time of a 1:1 mixture, by mass, of 50.0% perchloric acid and cellulose 2 Oxidizing Liquids — Category 2 A liquid that, when tested in a 1:1 mixture, by mass, with cellulose, exhibits a mean pressure rise time ≤ the mean pressure rise time of a 1:1 mixture, by mass, of 40.0% aqueous sodium chlorate solution and cellulose 3 Oxidizing Liquids — Category 3 A liquid that, when tested in a 1:1 mixture, by mass, with cellulose, exhibits a mean pressure rise time ≤ the mean pressure rise time of a 1:1 mixture, by mass, of 65.0% aqueous nitric acid and cellulose
SUBPART 14Oxidizing Solids
Definition
Definition of oxidizing solid
7.14 In this Subpart, oxidizing solid means a solid, whether or not combustible, that is liable to cause or contribute to the combustion of other material.
Classification in a Category of the Class
Marginal note:Exclusions
7.14.1 (1) The following solids need not be classified in any category of this hazard class:
(a) any organic solid that does not contain oxygen, fluorine or chlorine;
(b) any organic solid that contains oxygen, fluorine or chlorine if those elements are chemically bonded only to carbon or hydrogen; and
(c) any inorganic solid that does not contain oxygen or halogens.
Marginal note:Categories
(2) An oxidizing solid is classified in a category of this hazard class, based on results from testing performed in accordance with test O.1 of sub-section 34.4.1 of Part III of the Manual of Tests and Criteria or test O.3 of sub-section 34.4.3 of that Part, in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Oxidizing Solids — Category 1 A solid that, when tested in a 4:1 or 1:1 mixture, by mass, with cellulose, exhibits a mean burning time < the mean burning time of a 3:2 mixture, by mass, of potassium bromate and cellulose 2 Oxidizing Solids — Category 2 A solid that, when tested in a 4:1 or 1:1 mixture, by mass, with cellulose, exhibits a mean burning time ≤ the mean burning time of a 2:3 mixture, by mass, of potassium bromate and cellulose 3 Oxidizing Solids — Category 3 A solid that, when tested in a 4:1 or 1:1 mixture, by mass, with cellulose, exhibits a mean burning time ≤ the mean burning time of a 3:7 mixture, by mass, of potassium bromate and cellulose
SUBPART 15Organic Peroxides
Definitions
Marginal note:Definitions
7.15 The following definitions apply in this Subpart.
- as packaged
as packaged means packaged in the form and condition described in test series B, D, G and H of Part II of the Manual of Tests and Criteria. (tel qu’il est emballé)
- explosive properties
explosive properties means the properties of an organic peroxide that, in laboratory testing according to test series A, C or E of Part II of the Manual of Tests and Criteria, make the liquid or solid liable to detonate, deflagrate rapidly or show a violent effect when heated under confinement. (propriétés explosives)
- organic peroxide
organic peroxide means an organic liquid or solid that contains the bivalent -O-O- structure. (peroxyde organique)
Classification in a Category of the Class
Marginal note:Exclusions
7.15.1 (1) An organic peroxide that contains any of the following need not be classified in any category of this hazard class:
(a) not more than 1.0% available oxygen from the organic peroxides when containing not more than 1.0% hydrogen peroxide; or
(b) not more than 0.5% available oxygen from the organic peroxides when containing more than 1.0% but not more than 7.0% hydrogen peroxide.
Marginal note:Available oxygen content
(2) The available oxygen content, in percent, of an organic peroxide mixture referred to in paragraph (1)(a) or (b) is determined by the following formula:
where
- ni
- is the number of peroxygen groups per molecule of organic peroxide i;
- ci
- is the concentration (mass %) of organic peroxide i; and
- mi
- is the molecular mass of organic peroxide i.
Marginal note:Categories
(3) An organic peroxide is classified in a category of this hazard class, based on results from testing performed in accordance with test series A to H of Part II of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Organic Peroxides — Type A A liquid or solid that, as packaged, is liable to detonate, or deflagrate rapidly 2 Organic Peroxides — Type B A liquid or solid that possesses explosive properties and, as packaged, neither detonates, nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package 3 Organic Peroxides — Type C A liquid or solid that possesses explosive properties and, as packaged, neither detonates, nor deflagrates rapidly, nor undergoes a thermal explosion in that package 4 Organic Peroxides — Type D In laboratory testing, a liquid or solid that
(a) detonates partially, but does not deflagrate rapidly and shows no violent effect when heated under confinement;
(b) does not detonate, but deflagrates slowly and shows no violent effect when heated under confinement; or
(c) neither detonates nor deflagrates, but shows a medium effect when heated under confinement
5 Organic Peroxides — Type E In laboratory testing, a liquid or solid that neither detonates nor deflagrates, and shows low or no effect when heated under confinement 6 Organic Peroxides — Type F In laboratory testing, a liquid or solid that neither detonates in the cavitated state nor deflagrates and
(a) shows low or no effect when heated under confinement, as well as low or no explosive power; or
(b) shows no effect when heated under confinement nor any explosive power, and either
(i) has a SADT < 60°C when evaluated in a 50 kg package, or
(ii) in the case of a liquid mixture, has a diluent that is used for desensitization with a boiling point < 150°C
7 Organic Peroxides — Type G In laboratory testing, a liquid or solid that neither detonates in the cavitated state nor deflagrates, shows no effect when heated under confinement nor any explosive power, and either
(a) has a SADT of 60°C to 75°C when evaluated in a 50 kg package, or
(b) in the case of a liquid mixture, has a diluent that is used for desensitization with a boiling point ≥ 150°C
Marginal note:Mixtures
(4) A mixture of organic peroxides must be classified in the same category as the most hazardous organic peroxide in the mixture, unless the self-accelerating decomposition temperature of the mixture results in the mixture being classified in a category that represents a more severe hazard.
SUBPART 16Corrosive to Metals
Definition
Definition of corrosive to metals
7.16 In this Subpart, corrosive to metals means, in relation to a mixture or substance, liable to damage or destroy metal by chemical action.
Classification in the Category of the Class
Marginal note:Category
7.16.1 A mixture or substance that is corrosive to metals is classified in the category of this hazard class, based on results from testing performed in accordance with sub-section 37.4 of Part III of the Manual of Tests and Criteria, in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Corrosive to Metals — Category 1 | A mixture or substance that has a corrosion rate on either steel or aluminium surfaces that is > 6.25 mm per year at a test temperature of 55°C |
SUBPART 17Combustible Dusts
Definition
Definition of combustible dust
7.17 In this Subpart, combustible dust means a mixture or substance that is in the form of finely divided solid particles that, upon ignition, is liable to catch fire or explode when dispersed in air.
Classification in the Category of the Class
Marginal note:Category
7.17.1 A combustible dust is classified in the category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Combustible Dusts — Category 1 | A mixture or substance that
|
SUBPART 18Simple Asphyxiants
Definition
Definition of simple asphyxiant
7.18 In this Subpart, simple asphyxiant means any gas that is liable to cause asphyxiation by the displacement of air.
Classification in the Category of the Class
Marginal note:Category
7.18.1 A simple asphyxiant is classified in the category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Simple Asphyxiants — Category 1 | A gas that is a simple asphyxiant |
SUBPART 19Pyrophoric Gases
Definition
Definition of pyrophoric gas
7.19 In this Subpart, pyrophoric gas means any mixture or substance in a gaseous state that is liable to ignite spontaneously in air at a temperature of 54°C or less.
Classification in the Category of the Class
Marginal note:Category
7.19.1 A pyrophoric gas is classified in the category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Pyrophoric Gases — Category 1 | A gas that is a pyrophoric gas |
SUBPART 20Physical Hazards Not Otherwise Classified
Definition
Definition of physical hazard not otherwise classified
7.20 In this Subpart, physical hazard not otherwise classified means a physical hazard presented by a product, mixture, material or substance that is different from any other physical hazard addressed by any other Subpart in this Part and that has the characteristic of occurring by chemical reaction and resulting in the serious injury or death of a person at the time the reaction occurs.
Classification in the Category of the Class
Marginal note:Category
7.20.1 A product, mixture, material or substance is classified in the category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Physical Hazards Not Otherwise Classified — Category 1 | A product, mixture, material or substance that presents a physical hazard not otherwise classified |
PART 8Health Hazard Classes
SUBPART 1Acute Toxicity
Definitions
Marginal note:Definitions
8.1 The following definitions apply in this Subpart.
- acute toxicant
acute toxicant means a mixture or substance that is liable to cause acute toxicity, or a mixture or substance that, upon contact with water, releases a gaseous substance that is liable to cause acute toxicity. (toxique aigu)
- acute toxicity
acute toxicity refers to adverse effects occurring following
(a) oral or dermal administration of a single dose of a mixture or substance, or multiple doses given within 24 hours; or
(b) an inhalation exposure to a mixture or substance of four hours or of a duration that is converted to four hours in accordance with subsection 8.1.1(4). (toxicité aiguë)
- dust
dust means solid particles that are suspended in a gas, usually air. (poussières)
- mist
mist means liquid droplets that are suspended in the air. (brouillard)
Classification in a Category of the Class
Classification of Substances
Marginal note:LD50 or LC50 — associated range
8.1.1 (1) An acute toxicant that is a substance is classified, with respect to each applicable route of exposure, in a category of this hazard class in accordance with the tables to subsection (3) if it has an LD50 by the oral or dermal exposure route, or an LC50 by the inhalation exposure route, that falls into one of the ranges indicated in the applicable table to that subsection.
Marginal note:Contact with water — gaseous substance
(2) In addition to subsection (1), an acute toxicant that is a substance is classified with respect to the inhalation route of exposure in a category of this hazard class in accordance with Table 3 to subsection (3) if upon contact with water, it releases a gaseous substance that has an LC50 that falls into one of the ranges indicated in that table, unless that substance is already classified in a category of this hazard class for the inhalation route of exposure that represents a more severe hazard.
Marginal note:LD50 or LC50 not available
(3) If an LD50 by the oral or dermal exposure route or an LC50 by the inhalation exposure route is not available, an acute toxicity point estimate must be established in accordance with the table to section 8.1.7, and the acute toxicant must be classified based on that acute toxicity point estimate, with respect to each applicable route of exposure, in a category of this hazard class in accordance with the following tables:
TABLE 1
Oral Exposure Route
Column 1 Column 2 Item Category Ranges for LD50 or for Acute Toxicity Point Estimates (mg/kg body weight) 1 Acute Toxicity (Oral) — Category 1 ≤ 5 2 Acute Toxicity (Oral) — Category 2 > 5 and ≤ 50 3 Acute Toxicity (Oral) — Category 3 > 50 and ≤ 300 4 Acute Toxicity (Oral) — Category 4 > 300 and ≤ 2000 TABLE 2
Dermal Exposure Route
Column 1 Column 2 Item Category Ranges for LD50 or for Acute Toxicity Point Estimates (mg/kg body weight ) 1 Acute Toxicity (Dermal) — Category 1 ≤ 50 2 Acute Toxicity (Dermal) — Category 2 > 50 and ≤ 200 3 Acute Toxicity (Dermal) — Category 3 > 200 and ≤ 1000 4 Acute Toxicity (Dermal) — Category 4 > 1000 and ≤ 2000 TABLE 3
Inhalation Exposure Route
Column 1 Column 2 Column 3 Column 4 Ranges for LC50 or for Acute Toxicity Point Estimates Item Category Gases (ppmV) Vapours (mg/l) Dusts and Mists (mg/l) 1 Acute Toxicity (Inhalation) — Category 1 ≤ 100 ≤ 0.5 ≤ 0.05 2 Acute Toxicity (Inhalation) — Category 2 > 100 and ≤ 500 > 0.5 and ≤ 2 > 0.05 and ≤ 0.5 3 Acute Toxicity (Inhalation) — Category 3 > 500 and ≤ 2500 > 2 and ≤ 10 > 0.5 and ≤ 1 4 Acute Toxicity (Inhalation) — Category 4 > 2500 and ≤ 20 000 > 10 and ≤ 20 > 1 and ≤ 5 Marginal note:One-hour exposure period
(4) For the purposes of Table 3 to subsection (3), the LC50 is based on a four-hour exposure period. If existing acute inhalation toxicity data have been generated according to a one-hour exposure period, the LC50 for gases and vapours must be divided by two, and the LC50 for dusts and mists must be divided by four.
Classification of Mixtures
Marginal note:Order of provisions
8.1.2 (1) The classification of a mixture as an acute toxicant in a category of this hazard class must proceed in accordance with the order of sections 8.1.3 to 8.1.6.
Marginal note:Concentrations for the purpose of classification
(2) Only ingredients present at concentrations equal to or greater than the concentration limit of 1.0% — w/w for solids, liquids, dusts, mists and vapours and v/v for gases — must be considered for the purpose of classification.
Marginal note:Data available for mixture as a whole
8.1.3 If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified as an acute toxicant in accordance with section 8.1.1.
Marginal note:Data available for use of bridging principles
8.1.4 If data are available to enable the characterization of the mixture as an acute toxicant, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in a category of this hazard class in accordance with those subsections.
Marginal note:Data available for all ingredients
8.1.5 If data are available for all ingredients in the mixture, the mixture must be classified as an acute toxicant in accordance with section 8.1.1 using the ATE of the mixture that is determined in respect of each applicable route of exposure by the following formula:
where
- ATEmix
- is the ATE of the mixture determined using this formula;
- Ci
- is the concentration of ingredient i;
- n
- is the number of ingredients and i is running from 1 to n;
- ATEi
- is the ATE of ingredient i, which is either
(a) the LD50 or the LC50 based on or converted to a four-hour exposure period, for i, or
(b) if the LD50 or the LC50 is unavailable, the acute toxicity point estimate established for i in accordance with the table to section 8.1.7; and
- i
- is each ingredient in the mixture with
(a) an ATE within the ranges set out in the applicable table to subsection 8.1.1(3),
(b) an oral or dermal LD50 greater than 2000 mg/kg body weight but less than or equal to 5000 mg/kg body weight, or
(c) an LC50 based on or converted to a four-hour exposure period within a range having an amplitude comparable to the one in paragraph (b).
Marginal note:Data not available for all ingredients
8.1.6 If the ATE is not available for one or more ingredients of the mixture, the mixture must be classified as an acute toxicant in accordance with section 8.1.1 using the ATE of the mixture that is determined in respect of each applicable route of exposure according to the following:
(a) if data permit the ATE to be estimated for each of those ingredients in accordance with established scientific principles, the formula in section 8.1.5 must be used;
(b) if data do not permit the ATE to be estimated for an ingredient in accordance with established scientific principles, and the concentration of the ingredient in the mixture is equal to or greater than the concentration limit of 1.0%, the mixture is classified based only on the ingredients having an ATE, such that
(i) if the total concentration of all ingredients with unknown acute toxicity is less than or equal to 10.0% of the mixture, the formula in section 8.1.5 must be used, or
(ii) if the total concentration of all ingredients with unknown acute toxicity is greater than 10.0% of the mixture, the following formula must be used:
where
- ATEmix
- is the ATE of the mixture determined using this formula,
- Ci
- is the concentration of ingredient i,
- Cunknown
- is the concentration of ingredients i with unknown ATE values,
- n
- is the number of ingredients and i is running from 1 to n,
- ATEi
- is the ATE of ingredient i, which is either
(a) the LD50 or the LC50 based on or converted to a four-hour exposure period, for i, or
(b) if the LD50 or the LC50 is unavailable, the acute toxicity point estimate established for i in accordance with the table to section 8.1.7, and
- i
- is each ingredient in the mixture with
(a) an ATE within the ranges set out in the applicable table to subsection 8.1.1(3),
(b) an oral or dermal LD50 greater than 2000 mg/kg body weight but less than or equal to 5000 mg/kg body weight, or
(c) an LC50 based on or converted to a four-hour exposure period within a range having an amplitude comparable to the one in paragraph (b).
Marginal note:Conversion from range to point estimate
8.1.7 If a formula in section 8.1.5 or 8.1.6 is used, an acute toxicity point estimate must be determined, in accordance with the following table, for each ingredient for which only that ingredient’s classification category or experimentally obtained acute toxicity range is available:
TABLE
| Column 1 | Column 2 | Column 3 | |
|---|---|---|---|
| Item | Exposure Routes | Classification Category and Associated Experimentally Obtained Acute Toxicity Range Minimum and Maximum Values | Converted Acute Toxicity Point Estimate |
| 1 | Oral (mg/kg body weight) |
|
|
| 2 | Dermal (mg/kg body weight) |
|
|
| 3 | Inhalation (gases) (ppmV) |
|
|
| 4 | Inhalation (vapours) (mg/l) |
|
|
| 5 | Inhalation (dust/mist) (mg/l) |
|
|
SUBPART 2Skin Corrosion/Irritation
Definitions
Marginal note:Definitions
8.2 The following definitions apply in this Subpart.
- skin corrosion
skin corrosion means the production of irreversible damage to the skin, namely, visible necrosis through the epidermis and into the dermis, and includes ulcers, bleeding, bloody scabs and, within a 14-day observation period, discoloration due to blanching of the skin, complete areas of alopecia, and scars. (corrosion cutanée)
- skin-corrosive
skin-corrosive means, in relation to a mixture or substance, liable to cause skin corrosion. (corrosif pour la peau)
- skin-irritant
skin-irritant means, in relation to a mixture or substance, liable to cause skin irritation. (irritant pour la peau)
- skin irritation
skin irritation means the production of reversible damage to the skin. (irritation cutanée)
Classification in a Category or Subcategory of the Class
Classification of Substances
Marginal note:Order of provisions
8.2.1 The classification of a skin-corrosive substance or a skin-irritant substance in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.2 to 8.2.7, unless, after applying subsections 8.2.2(1) to (3), the substance is not classified further to subsection 8.2.2(4).
Marginal note:Human data — skin corrosion
8.2.2 (1) A substance for which human data demonstrate that it is a skin-corrosive substance is classified in the category “Skin Corrosion — Category 1”.
Marginal note:Animal data — skin corrosion
(2) A substance for which purposely generated animal data demonstrate that it is a skin-corrosive substance is classified in the category “Skin Corrosion — Category 1” and is, if the applicable data are available, further classified in accordance with the following table:
TABLE
Column 1 Column 2 Item Subcategory Criteria 1 Skin Corrosion — Category 1A A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of three minutes or less, and within one hour of observation, in at least one of three animals 2 Skin Corrosion — Category 1B A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of more than three minutes and up to and including one hour, and within 14 days of observation, in at least one of three animals 3 Skin Corrosion — Category 1C A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of more than one hour and up to and including four hours, and within 14 days of observation, in at least one of three animals Marginal note:Human or animal data — skin irritation
(3) A substance for which there are human data or purposely generated animal data with respect to skin irritation is classified in the category “Skin Irritation — Category 2” in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Skin Irritation — Category 2 A substance
(a) that, according to human data, is skin-irritant; or
(b) in respect of which animal data reveal
(i) in the case of data acquired from a test performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 404, entitled Acute Dermal Irritation/Corrosion, as amended from time to time, a mean score of ≥ 2.3 and ≤ 4.0 for erythema and eschar or for edema in at least two of three animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from gradings on three consecutive days after the onset of skin reactions,
(ii) in the case of data acquired from a scientifically validated method, inflammation, namely, local alopecia, hyperkeratosis, hyperplasia and scaling, that persists to the end of the observation period specified by the method in at least two animals, or
(iii) in the case of data acquired from a scientifically validated method, evidence of severe skin irritation in only one animal
Marginal note:No classification
(4) A substance that meets the following conditions need not be classified in any category or subcategory of this hazard class:
(a) there are human data or purposely generated animal data on the substance, acquired from a scientifically validated method, with respect to skin corrosion or skin irritation;
(b) the substance is not classified further to subsection (1), (2) or (3); and
(c) the data referred to in paragraph (a) demonstrate that it is neither a skin-corrosive substance nor a skin-irritant substance.
Marginal note:Other skin data from animals
8.2.3 A substance for which there are animal data on dermal exposure, acquired from a scientifically validated method, that have not been purposely generated and that demonstrate that the substance is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.
Marginal note:In vitro or ex vivo data
8.2.4 A substance for which the data, in vitro or ex vivo, acquired from a scientifically validated method for the evaluation of skin corrosion or skin irritation demonstrate that the substance is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.
Marginal note:pH
8.2.5 A substance for which the pH is less than or equal to two or equal to or greater than 11.5 is classified in the category “Skin Corrosion — Category 1”, unless an assessment of alkali or acid reserve performed in accordance with established scientific principles supports the conclusion that it need not be classified as a skin-corrosive substance on the basis of its pH.
Marginal note:Structure-activity relationship — skin corrosion
8.2.6 (1) A substance for which a structure-activity relationship, established in accordance with established scientific principles, supports the conclusion that the substance must be classified in the category “Skin Corrosion — Category 1” is classified in that category.
Marginal note:Structure-activity relationship — skin irritation
(2) A substance for which a structure-activity relationship, established in accordance with established scientific principles, supports the conclusion that the substance must be classified in the category “Skin Irritation — Category 2” is classified in that category.
Marginal note:Totality of available data
8.2.7 A substance for which an evaluation of the totality of available data, performed in accordance with established scientific principles, supports the conclusion that the substance is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.
Classification of Mixtures
Marginal note:Order of provisions
8.2.8 The classification of a mixture as skin-corrosive or as skin-irritant in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.9 to 8.2.11.
Marginal note:Data available for mixture as a whole
8.2.9 (1) If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified in accordance with the order of sections 8.2.2 to 8.2.7, unless under subsection 8.2.2(4) the mixture need not be classified.
Marginal note:Data available for mixture as a whole — sections 8.2.10 and 8.2.11
(2) If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, but the mixture cannot be classified further to subsections 8.2.2(1) to (3) or sections 8.2.3 to 8.2.7, its classification in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.10 and 8.2.11.
Marginal note:Data available for use of bridging principles
8.2.10 If data are available to enable the characterization of the mixture as a skin-corrosive mixture or a skin-irritant mixture, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in a category or subcategory of this hazard class in accordance with those subsections.
Marginal note:Data available for ingredients
8.2.11 (1) Subject to subsection (3), a mixture that contains one or more ingredients that are classified in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2” is classified in a category or subcategory of this hazard class in accordance with subsection (2), subject to the following:
(a) ingredients that are classified in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2” and are present in the mixture at a concentration equal to or greater than the concentration limit of 1.0% must be included in the calculation of the sum of concentrations of ingredients; and
(b) ingredients that are classified in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2” and are present in the mixture at a concentration of less than the concentration limit of 1.0% must be included in the calculation of the sum of concentrations of ingredients only if there is evidence that, at the concentration at which they are present, the ingredients are skin-corrosive substances or skin-irritant substances.
Marginal note:Classification — mixture
(2) A mixture is classified in a category of this hazard class in accordance with the following:
(a) if the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1” is equal to or greater than 5.0%, the mixture is classified in the category “Skin Corrosion — Category 1”;
(b) if the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1” is equal to or greater than 1.0% but less than 5.0%, the mixture is classified in the category “Skin Irritation — Category 2”;
(c) if the sum of concentrations of ingredients classified in the category “Skin Irritation — Category 2” is equal to or greater than 10.0%, the mixture is classified in the category “Skin Irritation — Category 2”; or
(d) if the sum of the results of the following subparagraphs is equal to or greater than 10.0%, the mixture is classified in the category “Skin Irritation — Category 2”:
(i) 10 times the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1”, and
(ii) the sum of concentrations of ingredients classified in the category “Skin Irritation — Category 2”.
Marginal note:Mixtures containing particular ingredients
(3) A mixture is classified in a category of this hazard class in accordance with the following table if it contains one or more substances, such as acids, bases, inorganic salts, aldehydes, phenols or surfactants, which could be corrosive or irritant at concentrations below the concentration limits set out in subsection (2) and at least one ingredient with a concentration that is above the concentration limits set out below:
TABLE
Column 1 Column 2 Column 3 Item Category Ingredient Concentration Limits 1 Skin Corrosion — Category 1 Acid with pH ≤ 2 ≥ 1.0% 2 Skin Corrosion — Category 1 Base with pH ≥ 11.5 ≥ 1.0% 3 Skin Corrosion — Category 1 Other ingredients classified in the category “Skin Corrosion — Category 1” ≥ 1.0% 4 Skin Irritation — Category 2 Other ingredients classified in the category “Skin Irritation — Category 2”, including acids and bases ≥ 3.0%
SUBPART 3Serious Eye Damage/Eye Irritation
Definitions
Marginal note:Definitions
8.3 The following definitions apply in this Subpart.
- eye irritation
eye irritation means the production of changes in the eye that are fully reversible within an observation period of 21 days. (irritation oculaire)
- serious eye damage
serious eye damage means the production of tissue damage in the eye or serious physical decay of vision
(a) for which data demonstrate that it is irreversible; or
(b) that is not fully reversible within an observation period of 21 days. (lésion oculaire grave)
Classification in a Category or Subcategory of the Class
Classification of Substances
Marginal note:Order of provisions
8.3.1 The classification of a substance that causes serious eye damage or eye irritation in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.3.2 to 8.3.7, unless, after applying subsections 8.3.2(1) to (4), the substance is not classified further to subsection 8.3.2(5).
Marginal note:Human or animal data — serious eye damage
8.3.2 (1) A substance for which there are human data or purposely generated animal data with respect to serious eye damage is classified in the category of this hazard class in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Serious Eye Damage — Category 1 A substance
(a) that, according to human data, causes serious eye damage;
(b) that, according to animal data acquired from a scientifically validated method from at least one animal, produces effects on the cornea, iris or conjunctiva
(i) that are irreversible as demonstrated by data, or
(ii) that are not fully reversible within an observation period of 21 days; or
(c) in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate a positive response in at least two of three animals, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is
(i) in the case of corneal opacity, ≥ 3, or
(ii) in the case of iritis, > 1.5
Marginal note:Human data — eye irritation
(2) A substance for which human data demonstrate that it causes eye irritation is classified in the category “Eye Irritation — Category 2”.
Marginal note:Animal data — eye irritation
(3) A substance for which purposely generated animal data demonstrate that it causes eye irritation is classified in the category “Eye Irritation — Category 2” and is, if the applicable data are available, further classified in the appropriate subcategory in accordance with the following table:
TABLE
Column 1 Column 2 Column 3 Item Category Subcategory Criteria 1 Eye Irritation — Category 2 Eye Irritation — Category 2A A substance that is not classified in the category “Serious Eye Damage — Category 1” and in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate in at least two of three animals a positive response that fully reverses within an observation period of more than seven days but not more than 21 days, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is
(a) in the case of corneal opacity, ≥ 1;
(b) in the case of iritis, ≥ 1;
(c) in the case of conjunctival redness, ≥ 2; or
(d) in the case of conjunctival edema (chemosis), ≥ 2
2 Eye Irritation — Category 2 Eye Irritation — Category 2B A substance that is not classified in the category “Serious Eye Damage — Category 1” and in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate in at least two of three animals a positive response that fully reverses within an observation period of seven days, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is
(a) in the case of corneal opacity, ≥ 1;
(b) in the case of iritis, ≥ 1;
(c) in the case of conjunctival redness, ≥ 2; or
(d) in the case of conjunctival edema (chemosis), ≥ 2
Marginal note:Skin corrosion data
(4) A substance that is classified in the category “Skin Corrosion — Category 1” in accordance with subsections 8.2.2(1) and (2) is also classified in the category “Serious Eye Damage — Category 1” of this hazard class.
Marginal note:No classification
(5) A substance that meets the following conditions need not be classified in any category of this hazard class:
(a) the substance is not classified further to subsections (1) to (4); and
(b) human data or purposely generated animal data on the substance, acquired from a scientifically validated method, with respect to serious eye damage or eye irritation, demonstrate that the substance does not cause serious eye damage or eye irritation.
Marginal note:Other animal data — eye or skin exposure
8.3.3 A substance for which there are animal data on eye exposure that demonstrate, or animal data on skin exposure that support the conclusion, that the substance causes serious eye damage or eye irritation is classified in the category “Serious Eye Damage — Category 1” or the category “Eye Irritation — Category 2”, and, in the latter case, if the applicable data are available, the substance is further classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”.
Marginal note:In vitro or ex vivo data — serious eye damage
8.3.4 (1) A substance for which the data, in vitro or ex vivo, acquired from a scientifically validated method for the evaluation of serious eye damage demonstrate that the substance causes serious eye damage is classified in the category “Serious Eye Damage — Category 1”.
Marginal note:In vitro or ex vivo data — eye irritation
(2) A substance for which the data, in vitro or ex vivo, acquired from a scientifically validated method for the evaluation of eye irritation demonstrate that the substance causes eye irritation is classified in the category “Eye Irritation — Category 2” and, if the applicable data are available, the substance is further classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”.
Marginal note:pH
8.3.5 A substance for which the pH is less than or equal to two or equal to or greater than 11.5 is classified in the category “Serious Eye Damage — Category 1”, unless an assessment of alkali or acid reserve performed in accordance with established scientific principles supports the conclusion that it need not be classified as a substance that causes serious eye damage on the basis of its pH.
Marginal note:Structure-activity relationship — serious eye damage
8.3.6 (1) A substance for which a structure-activity relationship, established in accordance with established scientific principles, supports the conclusion that the substance must be classified in the category “Serious Eye Damage — Category 1” is classified in that category.
Marginal note:Structure-activity relationship — eye irritation
(2) A substance for which a structure-activity relationship, established in accordance with established scientific principles, supports the conclusion that the substance must be classified in the category “Eye Irritation — Category 2” is classified in that category and, if the applicable data are available, the substance is further classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”.
Marginal note:Totality of available data
8.3.7 A substance for which an evaluation of the totality of available data, performed in accordance with established scientific principles, supports the conclusion that the substance causes serious eye damage or eye irritation is classified in the category “Serious Eye Damage — Category 1” or the category “Eye Irritation — Category 2” and, in the latter case, if the applicable data are available, the substance is further classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”.
Classification of Mixtures
Marginal note:Order of provisions
8.3.8 The classification of a mixture as a mixture that causes serious eye damage or eye irritation in a category of this hazard class must proceed in accordance with the order of sections 8.3.9 to 8.3.11.
Marginal note:Data available for mixture as a whole
8.3.9 (1) If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified in accordance with the order of sections 8.3.2 to 8.3.7 unless, under subsection 8.3.2(5), the mixture need not be classified.
Marginal note:Data available for mixture as a whole — sections 8.3.10 and 8.3.11
(2) If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, but the mixture cannot be classified further to subsections 8.3.2(1) to (4) or sections 8.3.3 to 8.3.7, its classification in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.3.10 and 8.3.11.
Marginal note:Data available for use of bridging principles
8.3.10 If data are available to enable the characterization of the mixture as a mixture that causes serious eye damage or eye irritation, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in a category or subcategory of this hazard class in accordance with those subsections.
Marginal note:Data available for ingredients
8.3.11 (1) Subject to subsection (3), a mixture that contains one or more ingredients that are classified in the category “Serious Eye Damage — Category 1” or the category “Eye Irritation — Category 2” is classified in a category of this hazard class in accordance with subsection (2), subject to the following:
(a) ingredients that are classified in the category “Serious Eye Damage — Category 1” or the category “Eye Irritation — Category 2” and are present in the mixture at a concentration equal to or greater than the concentration limit of 1.0% must be included in the calculation of the sum of concentrations of ingredients; and
(b) ingredients that are classified in the category “Serious Eye Damage — Category 1” or the category “Eye Irritation — Category 2” and are present in the mixture at a concentration of less than the concentration limit of 1.0% must be included in the calculation of the sum of concentrations of ingredients only if there is evidence that, at the concentration at which they are present, the ingredients are substances that cause serious eye damage or eye irritation.
Marginal note:Classification — mixture
(2) A mixture is classified in a category of this hazard class in accordance with the following:
(a) if the sum of concentrations of ingredients classified in the categories “Serious Eye Damage — Category 1” and “Skin Corrosion — Category 1” is equal to or greater than 3.0%, the mixture is classified in the category “Serious Eye Damage — Category 1”;
(b) if the sum of concentrations of ingredients classified in the categories “Serious Eye Damage — Category 1” and “Skin Corrosion — Category 1” is equal to or greater than 1.0% but less than 3.0%, the mixture is classified in the category “Eye Irritation — Category 2”;
(c) if the sum of concentrations of ingredients classified in the category “Eye Irritation — Category 2” is equal to or greater than 10.0%, the mixture is classified in the category “Eye Irritation — Category 2”; or
(d) if the sum of the results of the following subparagraphs is equal to or greater than 10.0%, the mixture is classified in the category “Eye Irritation — Category 2”:
(i) 10 times the total of the sum of concentrations of ingredients classified in the category “Serious Eye Damage — Category 1” and the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1”, and
(ii) the sum of concentrations of ingredients classified in the category “Eye Irritation — Category 2”.
Marginal note:Mixtures containing particular ingredients
(3) A mixture is classified in a category of this hazard class in accordance with the following table if the mixture contains one or more substances, such as acids, bases, inorganic salts, aldehydes, phenols or surfactants, which could cause serious eye damage or eye irritation at concentrations below the concentration limits set out in subsection (2) and at least one ingredient with a concentration that is above the concentration limits set out below:
TABLE
Column 1 Column 2 Column 3 Item Category Ingredient Concentration Limits 1 Serious Eye Damage — Category 1 Acid with pH ≤ 2 ≥ 1.0% 2 Serious Eye Damage — Category 1 Base with pH ≥ 11.5 ≥ 1.0% 3 Serious Eye Damage — Category 1 Other ingredients classified in the category “Serious Eye Damage — Category 1” ≥ 1.0% 4 Eye Irritation — Category 2 Other ingredients classified in the category “Eye Irritation — Category 2”, including acids and bases ≥ 3.0%
SUBPART 4Respiratory or Skin Sensitization
Definitions
Marginal note:Definitions
8.4 The following definitions apply in this Subpart.
- respiratory sensitization
respiratory sensitization means the production of hypersensitivity of the airways following inhalation. (sensibilisation respiratoire)
- respiratory sensitizer
respiratory sensitizer means a mixture or substance that is liable to lead to hypersensitivity of the airways following inhalation. (sensibilisant respiratoire)
- skin sensitization
skin sensitization means the production of an allergic response following skin contact. (sensibilisation cutanée)
- skin sensitizer
skin sensitizer means a mixture or substance that is liable to lead to an allergic response following skin contact. (sensibilisant cutané)
Classification in a Category or Subcategory of the Class
Classification of Substances
Marginal note:Respiratory sensitizer — category
8.4.1 (1) A substance that is a respiratory sensitizer is classified in the category of this hazard class in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Respiratory Sensitizer — Category 1 A substance
(a) that, according to human data, leads to specific respiratory hypersensitivity; or
(b) in respect of which animal data acquired from scientifically validated methods for the evaluation of respiratory sensitization demonstrate positive results
Marginal note:Respiratory sensitizer — subcategories
(2) A substance classified in the category “Respiratory Sensitizer — Category 1” under subsection (1) is, if the applicable data are available, further classified in the subcategory “Respiratory Sensitizer — Category 1A” or in the subcategory “Respiratory Sensitizer — Category 1B” in accordance with the following table:
TABLE
Column 1 Column 2 Column 3 Item Category Subcategory Criteria 1 Respiratory Sensitizer — Category 1 Respiratory Sensitizer — Category 1A A substance
(a) that, according to human data, leads to a high frequency of occurrence of respiratory sensitization; or
(b) in respect of which animal data support the probability of a high respiratory sensitization rate in humans
2 Respiratory Sensitizer — Category 1 Respiratory Sensitizer — Category 1B A substance
(a) that, according to human data, leads to a low to moderate frequency of occurrence of respiratory sensitization; or
(b) in respect of which animal data support the probability of a low to moderate respiratory sensitization rate in humans
Marginal note:Skin sensitizer — category
(3) A substance that is a skin sensitizer is classified in the category of this hazard class in accordance with the following table:
TABLE
Column 1 Column 2 Item Category Criteria 1 Skin Sensitizer — Category 1 A substance
(a) that, according to human data, leads to skin sensitization; or
(b) in respect of which animal data acquired from scientifically validated methods for the evaluation of skin sensitization demonstrate positive results
Marginal note:Skin sensitizer — subcategories
(4) A substance classified in the category “Skin Sensitizer — Category 1” under subsection (3) is, if the applicable data are available, further classified in the subcategory “Skin Sensitizer — Category 1A” or in the subcategory “Skin Sensitizer — Category 1B” in accordance with the following table:
TABLE
Column 1 Column 2 Column 3 Item Category Subcategory Criteria 1 Skin Sensitizer — Category 1 Skin Sensitizer — Category 1A A substance
(a) that, according to human data, leads to a high frequency of occurrence of skin sensitization; or
(b) in respect of which animal data acquired from scientifically validated methods for the evaluation of skin sensitization support the probability of a high skin sensitization rate in humans
2 Skin Sensitizer — Category 1 Skin Sensitizer — Category 1B A substance
(a) that, according to human data, leads to a low to moderate frequency of occurrence of skin sensitization; or
(b) in respect of which animal data acquired from scientifically validated methods for the evaluation of skin sensitization support the probability of a low to moderate skin sensitization rate in humans
Classification of Mixtures
Marginal note:Order of provisions
8.4.2 The classification of a mixture as a respiratory sensitizer or a skin sensitizer, or both, in one or more categories of this hazard class must proceed in accordance with the order of sections 8.4.3 to 8.4.5.
Marginal note:Data available for mixture as a whole
8.4.3 If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified as a respiratory sensitizer or a skin sensitizer, or both, in accordance with section 8.4.1.
Marginal note:Data available for use of bridging principles
8.4.4 If data are available to enable the characterization of the mixture as a respiratory sensitizer or a skin sensitizer, or both, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in a category of this hazard class in accordance with those subsections.
Marginal note:Data available for ingredients
8.4.5 A mixture is classified as a respiratory sensitizer or as a skin sensitizer, or both, as the case may be, in accordance with the following:
(a) as a respiratory sensitizer,
(i) in the category “Respiratory Sensitizer — 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 category “Respiratory Sensitizer — Category 1”,
(ii) in the subcategory “Respiratory Sensitizer — 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 “Respiratory Sensitizer — Category 1A”, or
(iii) in the subcategory “Respiratory Sensitizer — Category 1B”, if it does not contain ingredients classified in the subcategory “Respiratory Sensitizer — Category 1A” at a concentration equal to or greater than the concentration limit of 0.1% and
(A) it contains at least one ingredient that is a solid or a liquid at a concentration equal to or greater than the concentration limit of 1.0% that is classified in the subcategory “Respiratory Sensitizer — Category 1B”, or
(B) it contains at least one ingredient that is a gas at a concentration equal to or greater than the concentration limit of 0.2% that is classified in the subcategory “Respiratory Sensitizer — Category 1B”; or
(b) as a skin sensitizer,
(i) in the category “Skin Sensitizer — 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 category “Skin Sensitizer — Category 1”,
(ii) in the subcategory “Skin Sensitizer — 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 “Skin Sensitizer — Category 1A”, or
(iii) in the subcategory “Skin Sensitizer — Category 1B”, if it does not contain ingredients classified in the subcategory “Skin Sensitizer — Category 1A” at a concentration equal to or greater than the concentration limit of 0.1% and 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 subcategory “Skin Sensitizer — Category 1B”.
SUBPART 5Germ Cell Mutagenicity
Definitions
Marginal note:Definitions
8.5 The following definitions apply in this Subpart.
- genotoxicity
genotoxicity means the alteration of the structure, information content or segregation of DNA by an agent or process, including those agents or processes that cause DNA damage by interfering with normal replication processes or that in a non-physiological manner temporarily alter its replication. (génotoxicité)
- germ cell mutagen
germ cell mutagen means a mixture or substance that is liable to lead to an increased occurrence of mutations in the germ cells of a population. (mutagène des cellules germinales)
- mutagenic
mutagenic means, in relation to a mixture or substance, liable to lead to an increased occurrence of mutations in populations of cells or organisms. (mutagène)
- mutagenicity
mutagenicity means an increased occurrence of mutations in populations of cells or organisms. (mutagénicité)
- mutation
mutation means a permanent change in the amount or structure of the genetic material in a cell and includes
(a) the heritable genetic changes that may be manifested at the phenotypic level; and
(b) the underlying DNA modifications when known, including specific base pair changes and chromosomal translocations. (mutation)
Classification in a Category or Subcategory of the Class
Classification of Substances
Marginal note:Categories
8.5.1 A substance that is a germ cell mutagen 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 | Germ Cell Mutagenicity — Category 1 | Germ Cell Mutagenicity — Category 1A | A substance that, according to data from human epidemiological studies, induces heritable mutations in germ cells |
| 2 | Germ Cell Mutagenicity — Category 1 | Germ Cell Mutagenicity — Category 1B | A substance in respect of which
|
| 3 | Germ Cell Mutagenicity — Category 2 | A substance in respect of which
|
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 1A or 1B
8.5.3 A mixture is classified in the category “Germ Cell Mutagenicity — 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 “Germ Cell Mutagenicity — Category 1A” or in the subcategory “Germ Cell Mutagenicity — 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 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
Definition
Definition of carcinogenic
8.6 In this Subpart, carcinogenic means, in relation to a mixture or substance, liable to lead to cancer or increase the incidence of cancer.
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 1A or 1B
8.6.3 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
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
(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
8.7.1 (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 1 Column 2 Column 3 Item Category Subcategory Criteria 1 Reproductive Toxicity — Category 1 Reproductive Toxicity — Category 1A A 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 2 Reproductive Toxicity — Category 1 Reproductive 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
3 Reproductive Toxicity — Category 2 A 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 1 Column 2 Item Category Criteria 1 Reproductive Toxicity — Effects on or via Lactation A substance that, according to human or animal data, has effects on or via lactation
Classification of Mixtures
Marginal note:Order of provisions
8.7.2 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
8.7.3 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
8.7.4 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
8.7.5 (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
8.7.6 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
8.8 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
8.8.1 (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 1 Column 2 Item Category Criteria 1 Specific 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
2 Specific Target Organ Toxicity — Single Exposure — Category 2 A 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 3 Specific Target Organ Toxicity — Single Exposure — Category 3 A 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 1 Column 2 Column 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 Item Toxic Effects on the Central Nervous System and Respiratory Tract Toxic Effects on Other Specific Target Organs Category of the “Specific Target Organ Toxicity — Single Exposure” Hazard Class 1 None Item 1 Category 1 2 Item 1 None Category 1 3 Item 1 Item 1 Category 1 4 None Item 2 Category 2 5 Item 2 None Category 2 6 Item 1 Item 2 Category 1 7 Item 2 Item 1 Category 1 8 Item 2 Item 2 Category 2 9 Item 3 None Category 3 10 Item 3 Item 1 Category 1 and Category 3 11 Item 3 Item 2 Category 2 and Category 3
Classification of Mixtures
Marginal note:Order of provisions
8.8.2 The classification of a mixture as a mixture that causes specific target organ toxicity arising from a single exposure in a category of this hazard class must proceed in accordance with the order of sections 8.8.3 to 8.8.5.
Marginal note:Data available for mixture as a whole
8.8.3 If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified as a mixture that causes specific target organ toxicity arising from a single exposure in accordance with section 8.8.1.
Marginal note:Data available for use of bridging principles
8.8.4 If data are available to enable the characterization of the mixture as a mixture that causes specific target organ toxicity arising from a single exposure, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in one or more categories of this hazard class, based on the table to subsection 8.8.1(2), in accordance with those subsections.
Marginal note:Data available for ingredients — Category 1, 2 or 3
8.8.5 (1) A mixture that contains one or more ingredients that are classified as a substance that causes specific target organ toxicity arising from a single exposure is classified as follows:
(a) in the category “Specific Target Organ Toxicity — Single Exposure — Category 1”, 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 “Specific Target Organ Toxicity — Single Exposure — Category 1”;
(b) in the category “Specific Target Organ Toxicity — Single Exposure — 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 “Specific Target Organ Toxicity — Single Exposure — Category 2”; or
(c) in the category “Specific Target Organ Toxicity — Single Exposure — Category 3”, if it contains at least one ingredient that is classified in the category “Specific Target Organ Toxicity — Single Exposure — Category 3” that is
(i) at a concentration equal to or greater than the concentration at which the effect is elicited, if known,
(ii) at a concentration equal to or greater than the concentration limit of 20.0%, or
(iii) at a concentration of 1.0% or more that which, when added to the concentration of all other ingredients present individually at a concentration of 1.0% or more and classified in the category “Specific Target Organ Toxicity — Single Exposure — Category 3”, is equal to or greater than the concentration limit of 20.0%.
Marginal note:Data available for ingredients — Categories 1 and 3 or 2 and 3
(2) Despite subsection 2.2(3), a mixture that has been classified in accordance with paragraph (1)(a) or (b) and meets the criteria of paragraph (1)(c) is also classified in the category “Specific Target Organ Toxicity — Single Exposure — Category 3”.
SUBPART 9Specific Target Organ Toxicity — Repeated Exposure
Definitions
Marginal note:Definitions
8.9 The following definitions apply in this Subpart.
- organ
organ includes any biological system. (organe)
- specific target organ toxicity arising from repeated exposure
specific target organ toxicity arising from repeated exposure means specific toxic effects on target organs that arise from repeated 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’expositions répétées)
Classification in a Category of the Class
Classification of Substances
Marginal note:Categories
8.9.1 A substance that causes specific target organ toxicity arising from repeated exposure is classified in a category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Specific Target Organ Toxicity — Repeated Exposure — Category 1 | A substance that
|
| 2 | Specific Target Organ Toxicity — Repeated Exposure — Category 2 | A substance that, according to animal data, causes specific target organ toxicity arising from repeated exposure at moderate exposure concentrations, within the concentration value ranges set out in Table 3.9.2 of the GHS |
Classification of Mixtures
Marginal note:Order of provisions
8.9.2 The classification of a mixture as a mixture that causes specific target organ toxicity arising from repeated exposure in a category of this hazard class must proceed in accordance with the order of sections 8.9.3 to 8.9.5.
Marginal note:Data available for mixture as a whole
8.9.3 If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified as a mixture that causes specific target organ toxicity arising from repeated exposure in accordance with section 8.9.1.
Marginal note:Data available for use of bridging principles
8.9.4 If data are available to enable the characterization of the mixture as a mixture that causes specific target organ toxicity arising from repeated exposure, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in a category of this hazard class in accordance with those subsections.
Marginal note:Data available for ingredients
8.9.5 A mixture that contains one or more ingredients that are classified as a substance that causes specific target organ toxicity arising from repeated exposure is classified as follows:
(a) in the category “Specific Target Organ Toxicity — Repeated Exposure — Category 1”, 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 “Specific Target Organ Toxicity — Repeated Exposure — Category 1”; or
(b) in the category “Specific Target Organ Toxicity — Repeated Exposure — 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 “Specific Target Organ Toxicity — Repeated Exposure — Category 2”.
SUBPART 10Aspiration Hazard
Definitions
Marginal note:Definitions
8.10 The following definitions apply in this Subpart.
- aspiration toxicant
aspiration toxicant means a mixture or substance that is liable to cause aspiration toxicity. (toxique par aspiration)
- aspiration toxicity
aspiration toxicity includes severe acute effects, such as chemical pneumonia, varying degrees of pulmonary injury or death, following the entry of a liquid or solid directly through the oral or nasal cavity, or indirectly from vomiting, into the trachea and lower respiratory system. (toxicité par aspiration)
Classification in the Category of the Class
Classification of Substances
Marginal note:Category
8.10.1 A substance that is an aspiration toxicant is classified in the category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Aspiration Hazard — Category 1 | A substance that
|
Classification of Mixtures
Marginal note:Order of provisions
8.10.2 The classification of a mixture as an aspiration toxicant in the category of this hazard class must proceed in accordance with the order of sections 8.10.3 to 8.10.5.
Marginal note:Data available for mixture as a whole
8.10.3 If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified as an aspiration toxicant in accordance with section 8.10.1.
Marginal note:Data available for use of bridging principles
8.10.4 If data are available to enable the characterization of the mixture as an aspiration toxicant, in accordance with the bridging principles referred to in subsections 2.3(3) to (7), the mixture must be classified in accordance with those subsections. However, subsection 2.3(3) does not apply if the concentration of aspiration toxicant in the mixture is less than the concentration limit of 10.0%.
Marginal note:Data available for ingredients
8.10.5 A mixture that contains one or more ingredients that are classified as an aspiration toxicant is classified in the category “Aspiration Hazard — Category 1” if
(a) the sum of the concentrations of the ingredients that are present individually at a concentration of 1.0% or more and that are classified in the category “Aspiration Hazard — Category 1” is equal to or greater than the concentration limit of 10.0% and the mixture has a kinematic viscosity less than or equal to 20.5 mm2/s, measured at 40°C; or
(b) it separates into two or more distinct layers, in one of which the sum of the concentrations of the ingredients that are present individually at a concentration of 1.0% or more and that are classified in the category “Aspiration Hazard — Category 1” is equal to or greater than the concentration limit of 10.0% and the kinematic viscosity of this layer, measured at 40°C, is less than or equal to 20.5 mm2/s.
SUBPART 11Biohazardous Infectious Materials
Definition
Definition of biohazardous infectious material
8.11 In this Subpart, biohazardous infectious material means any microorganism, nucleic acid or protein that causes or is a probable cause of infection, with or without toxicity, in humans or animals.
Classification in the Category of the Class
Classification of Substances
Marginal note:Category
8.11.1 A substance that is a biohazardous infectious material is classified in the category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Biohazardous Infectious Materials — Category 1 | A biohazardous infectious material that
|
Classification of Mixtures
Marginal note:Mixture containing more than one biohazardous infectious material
8.11.2 A mixture that contains one or more ingredients that are classified as a biohazardous infectious material must be classified in accordance with section 8.11.1.
SUBPART 12Health Hazards Not Otherwise Classified
Definition
Definition of health hazard not otherwise classified
8.12 In this Subpart, health hazard not otherwise classified means a health hazard presented by a mixture or substance that is different from any other health hazard addressed by any other Subpart in this Part and that has the characteristic of occurring via acute or repeated exposure and having an adverse effect on the health of a person exposed to it, including an injury, or resulting in the death of that person.
Classification in the Category of the Class
Classification of Substances
Marginal note:Category
8.12.1 A substance that presents a health hazard not otherwise classified is classified in the category of this hazard class in accordance with the following table:
TABLE
| Column 1 | Column 2 | |
|---|---|---|
| Item | Category | Criteria |
| 1 | Health Hazards Not Otherwise Classified — Category 1 | A substance that presents a health hazard not otherwise classified |
Classification of Mixtures
Marginal note:Order of provisions
8.12.2 The classification of a mixture as a health hazard not otherwise classified in the category of this hazard class must proceed in accordance with the order of sections 8.12.3 and 8.12.4.
Marginal note:Data available for mixture as a whole
8.12.3 If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified as a health hazard not otherwise classified in accordance with section 8.12.1.
Marginal note:Data available for ingredients
8.12.4 A mixture that contains one or more ingredients that are classified as a health hazard not otherwise classified at a concentration equal to or greater than the concentration limit of 1.0% is classified in the category “Health Hazards Not Otherwise Classified — Category 1”.
PART 9Consequential Amendments, Transitional Provisions, Repeals and Coming into Force
Consequential Amendments
Food and Drug Regulations
9 [Amendment]
Hazardous Materials Information Review Regulations
10 [Amendments]
11 [Amendment]
12 [Amendment]
13 [Amendment]
Hazardous Materials Information Review Act Appeal Board Procedures Regulations
14 [Amendments]
15 [Amendments]
16 [Amendment]
Consumer Chemicals and Containers Regulations, 2001
17 [Amendment]
Safety of Human Cells, Tissues and Organs for Transplantation Regulations
18 [Amendment]
Transitional Provisions
Marginal note:Definitions
19 (1) The following definitions apply in this section.
- controlled product
controlled product has the same meaning as in section 2 of the Hazardous Products Act as it read immediately before the day on which subsection 111(1) of the Economic Action Plan 2014 Act, No. 1 comes into force. (produit contrôlé)
- former Regulations
former Regulations means the Controlled Products Regulations and the Ingredient Disclosure List as they each read immediately before the day on which these Regulations come into force. (règlements antérieurs)
Marginal note:Compliance — supplier
(2) These Regulations do not apply to a supplier in respect of the sale or importation of a controlled product that is a hazardous product, as defined in section 2 of the Hazardous Products Act as enacted by subsection 111(3) of the Economic Action Plan 2014 Act, No. 1, if the supplier sells or imports the controlled product on or after the first day on which both sections 114 and 115 of the Economic Action Plan 2014 Act, No. 1 are in force, but before a day to be fixed by order of the Governor in Council for the purposes of sections 130, 133 and 135 of the Economic Action Plan 2014 Act, No. 1, and if the supplier would not, were the former Regulations in force at the time, be in contravention of the former Regulations.
Marginal note:Hazardous product that is not controlled product
(3) These Regulations do not apply to a supplier in respect of the sale or importation of a hazardous product, as defined in section 2 of the Hazardous Products Act as enacted by subsection 111(3) of the Economic Action Plan 2014 Act, No. 1, that is not a controlled product, if the supplier sells or imports the hazardous product on or after the first day on which both sections 114 and 115 of the Economic Action Plan 2014 Act, No. 1 are in force, but before a day to be fixed by order of the Governor in Council for the purposes of section 130 of the Economic Action Plan 2014 Act, No. 1.
Marginal note:Compliance — supplier
(4) These Regulations do not apply to a supplier to whom a controlled product that is a hazardous product, as defined in section 2 of the Hazardous Products Act as enacted by subsection 111(3) of the Economic Action Plan 2014 Act, No. 1, was sold if the supplier sells the controlled product on or after the first day on which both sections 114 and 115 of the Economic Action Plan 2014 Act, No. 1 are in force, but before a day to be fixed by order of the Governor in Council for the purposes of sections 131, 134 and 136 of the Economic Action Plan 2014 Act, No. 1, and if the supplier would not, were the former Regulations in force at the time, be in contravention of the former Regulations.
Marginal note:Hazardous product that is not controlled product
(5) These Regulations do not apply to a supplier to whom a hazardous product, as defined in section 2 of the Hazardous Products Act as enacted by subsection 111(3) of the Economic Action Plan 2014 Act, No. 1, that is not a controlled product, was sold if the supplier sells the hazardous product on or after the first day on which both sections 114 and 115 of the Economic Action Plan 2014 Act, No. 1 are in force, but before a day to be fixed by order of the Governor in Council for the purposes of section 131 of the Economic Action Plan 2014 Act, No. 1.
Marginal note:Compliance — importation — own use in work place
(6) These Regulations do not apply to a supplier in respect of the importation of a controlled product that is a hazardous product, as defined in section 2 of the Hazardous Products Act as enacted by subsection 111(3) of the Economic Action Plan 2014 Act, No. 1, if the supplier imports the controlled product only for use in their work place on or after the first day on which both sections 114 and 115 of the Economic Action Plan 2014 Act, No. 1 are in force, but before a day to be fixed by order of the Governor in Council for the purposes of sections 132, 134 and 137 of the Economic Action Plan 2014 Act, No. 1, and if the supplier would not, were the former Regulations in force at the time, be in contravention of the former Regulations.
Marginal note:Hazardous product that is not controlled product
(7) These Regulations do not apply to a supplier in respect of the importation of a hazardous product, as defined in section 2 of the Hazardous Products Act as enacted by subsection 111(3) of the Economic Action Plan 2014 Act, No. 1, that is not a controlled product, if the supplier imports the hazardous product only for use in their work place on or after the first day on which both sections 114 and 115 of the Economic Action Plan 2014 Act, No. 1 are in force, but before a day to be fixed by order of the Governor in Council for the purposes of section 132 of the Economic Action Plan 2014 Act, No. 1.
Repeals
20 [Repeal]
21 [Repeal]
Coming into Force
Marginal note:S.C. 2014, c. 20
Footnote *22 These Regulations come into force on the first day on which sections 114, 115 and 120 of the Economic Action Plan 2014 Act, No. 1 are all in force, but if they are registered after that day, they come into force on the day on which they are registered.
Return to footnote *[Note: Regulations in force February 11, 2015, see SI/2015-5.]
SCHEDULE 1(Paragraphs 4(1)(a) and (b), subsection 4(2), paragraph 4.1(1)(b) and subsections 5(6), 5.6(2) and (3), 5.7(5) to (10), 5.8(1) and 5.9(1))
Information Elements on Safety Data Sheet
| Column 1 | Column 2 | |
|---|---|---|
| Item | Heading | Specific Information Elements |
| 1 | Identification |
|
| 2 | Hazard identification |
|
| 3 | Composition/Information on ingredients |
|
| 4 | First-aid measures |
|
| 5 | Fire-fighting measures |
|
| 6 | Accidental release measures |
|
| 7 | Handling and storage |
|
| 8 | Exposure controls/Personal protection |
|
| 9 | Physical and chemical properties |
|
| 10 | Stability and reactivity |
|
| 11 | Toxicological information | Concise but complete description of the various toxic health effects and the data used to identify those effects, including
|
| 12 | Ecological information |
|
| 13 | Disposal considerations | Information on safe handling for disposal and methods of disposal, including any contaminated packaging |
| 14 | Transport information |
|
| 15 | Regulatory information | Safety, health and environmental regulations, made within or outside Canada, specific to the product in question |
| 16 | Other information | Date of the latest revision of the safety data sheet |
SCHEDULE 2(Subsection 4(3))
Information Elements on Safety Data Sheet — Biohazardous Infectious Materials
| Column 1 | Column 2 | |
|---|---|---|
| Item | Heading | Specific Information Elements |
| 1 | Section I — Infectious Agent |
|
| 2 | Section II — Hazard Identification |
|
| 3 | Section III — Dissemination |
|
| 4 | Section IV — Stability and Viability |
|
| 5 | Section V — First Aid/Medical |
|
| 6 | Section VI — Laboratory Hazard |
|
| 7 | Section VII — Exposure Controls/Personal Protection |
|
| 8 | Section VIII — Handling and Storage |
|
| 9 | Section IX — Regulatory and Other Information |
|
SCHEDULE 3(Subsection 3(3), section 3.1, paragraph 5.3(c) and Schedule 5)
Symbols and Pictograms
| Column 1 | Column 2 | Column 3 | |
|---|---|---|---|
| Item | Name of Symbol | Symbol | Pictogram |
| 1 | Flame |  |  |
| 2 | Flame over circle |  |  |
| 3 | Exploding bomb |  |  |
| 4 | Corrosion |  |  |
| 5 | Gas cylinder |  |  |
| 6 | Skull and crossbones |  |  |
| 7 | Exclamation mark |  |  |
| 8 | Health hazard |  |  |
| 9 | Biohazardous infectious materials |  |  |
SCHEDULE 4(Subsections 2(3) to (5))
Prescribed Classification
| Column 1 | Column 2 | Column 3 | |
|---|---|---|---|
| Item | Chemical Name/Description | UN Number or CAS Registry Number | Classification |
| 1 | Ammonium picrate, wetted with not less than 10.0% water, by mass | 1310 | Physical Hazards Not Otherwise Classified — Category 1 |
| 2 | Dinitrophenol, wetted with not less than 15.0% water, by mass | 1320 | Physical Hazards Not Otherwise Classified — Category 1 |
| 3 | Dinitrophenolates, wetted with not less than 15.0% water, by mass | 1321 | Physical Hazards Not Otherwise Classified — Category 1 |
| 4 | Dinitroresorcinol, wetted with not less than 15.0% water, by mass | 1322 | Physical Hazards Not Otherwise Classified — Category 1 |
| 5 | Nitroguanidine or picrite, wetted with not less than 20.0% water, by mass | 1336 | Physical Hazards Not Otherwise Classified — Category 1 |
| 6 | Nitrostarch, wetted with not less than 20.0% water, by mass | 1337 | Physical Hazards Not Otherwise Classified — Category 1 |
| 7 | Trinitrophenol, wetted with not less than 30.0% water, by mass | 1344 | Physical Hazards Not Otherwise Classified — Category 1 |
| 8 | Silver picrate, wetted with not less than 30.0% water, by mass | 1347 | Physical Hazards Not Otherwise Classified — Category 1 |
| 9 | Sodium dinitro-o-cresolate, wetted with not less than 15.0% water, by mass | 1348 | Physical Hazards Not Otherwise Classified — Category 1 |
| 10 | Sodium picramate, wetted with not less than 20.0% water, by mass | 1349 | Physical Hazards Not Otherwise Classified — Category 1 |
| 11 | Trinitrobenzene, wetted with not less than 30.0% water, by mass | 1354 | Physical Hazards Not Otherwise Classified — Category 1 |
| 12 | Trinitrobenzoic acid, wetted with not less than 30.0% water, by mass | 1355 | Physical Hazards Not Otherwise Classified — Category 1 |
| 13 | Trinitrotoluene, wetted with not less than 30.0% water, by mass | 1356 | Physical Hazards Not Otherwise Classified — Category 1 |
| 14 | Urea nitrate, wetted with not less than 20.0% water, by mass | 1357 | Physical Hazards Not Otherwise Classified — Category 1 |
| 15 | Zirconium picramate, wetted with not less than 20.0% water, by mass | 1517 | Physical Hazards Not Otherwise Classified — Category 1 |
| 16 | Barium azide, wetted with not less than 50.0% water, by mass | 1571 | Physical Hazards Not Otherwise Classified — Category 1 |
| 17 | Nitrocellulose with water (not less than 25.0% water, by mass) | 2555 | Physical Hazards Not Otherwise Classified — Category 1 |
| 18 | Nitrocellulose with alcohol (not less than 25.0% alcohol, by mass, and not more than 12.6% nitrogen, by dry mass) | 2556 | Physical Hazards Not Otherwise Classified — Category 1 |
| 19 | Nitrocellulose mixture, with not more than 12.6% nitrogen, by dry mass, with or without plasticizer, with or without pigment | 2557 | Physical Hazards Not Otherwise Classified — Category 1 |
| 20 | Dipicryl sulfide, wetted with not less than 10.0% water, by mass | 2852 | Physical Hazards Not Otherwise Classified — Category 1 |
| 21 | Isosorbide dinitrate mixture with not less than 60.0% lactose, mannose, starch or calcium hydrogen phosphate | 2907 | Physical Hazards Not Otherwise Classified — Category 1 |
| 22 | Nitrocellulose membrane filters, with not more than 12.6% nitrogen, by dry mass | 3270 | Physical Hazards Not Otherwise Classified — Category 1 |
| 23 | 5-Tert-butyl-2,4,6-trinitro-m-xylene or Musk xylene | 2956 | Physical Hazards Not Otherwise Classified — Category 1 |
| 24 | 2-Bromo-2-nitropropane-1,3-diol | 3241 | Physical Hazards Not Otherwise Classified — Category 1 |
| 25 | Isosorbide-5-mononitrate with less than 30.0% non-volatile, non-flammable phlegmatizer | 3251 | Physical Hazards Not Otherwise Classified — Category 1 |
| 26 | Azodicarbonamide, technically pure or preparations having a SADT higher than 75°C | 3242 | Physical Hazards Not Otherwise Classified — Category 1 |
| 27 | Nitroglycerin mixture, desensitized, solid, n.o.s., with more than 2.0% but not more than 10.0% nitroglycerin, by mass | 3319 | Physical Hazards Not Otherwise Classified — Category 1 |
| 28 | Pentaerythritol tetranitrate mixture, desensitized, solid, n.o.s., with more than 10.0% but not more than 20.0% pentaerythrite tetranitrate (PETN) by mass | 3344 | Physical Hazards Not Otherwise Classified — Category 1 |
| 29 | Chlorine dioxide | CAS 10049-04-4 | Physical Hazards Not Otherwise Classified — Category 1 |
| 30 | Chloropicrin | 1580 | Physical Hazards Not Otherwise Classified — Category 1 |
| 31 | Nitromethane | 1261 | Physical Hazards Not Otherwise Classified — Category 1 |
| 32 | Ozone | CAS 10028-15-6 | Physical Hazards Not Otherwise Classified — Category 1 |
| 33 | Perchloric acid solutions > 72.0% | CAS 7601-90-3 | Physical Hazards Not Otherwise Classified — Category 1 |
| 34 | Self-heating liquid, organic, n.o.s. | 3183 | Self-heating Substances and Mixtures — Category 1 |
| 35 | Self-heating liquid, toxic, organic, n.o.s. | 3184 | Self-heating Substances and Mixtures — Category 1 |
| 36 | Self-heating liquid, corrosive, organic, n.o.s. | 3185 | Self-heating Substances and Mixtures — Category 1 |
| 37 | Self-heating liquid, inorganic, n.o.s. | 3186 | Self-heating Substances and Mixtures — Category 1 |
| 38 | Self-heating liquid, toxic, inorganic, n.o.s. | 3187 | Self-heating Substances and Mixtures — Category 1 |
| 39 | Self-heating liquid, corrosive, inorganic, n.o.s. | 3188 | Self-heating Substances and Mixtures — Category 1 |
SCHEDULE 5(Subsection 1(1), subparagraph 3(1)(d)(i) and subsection 3(3))Information Elements for Specified Categories
PART 1
Combustible Dusts
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |
|---|---|---|---|---|---|
| Item | Category | Name of Symbol | Symbol | Signal Word | Hazard Statement |
| 1 | Combustible Dusts — Category 1 | No symbol | No symbol | Warning | May form combustible dust concentrations in air |
PART 2
Simple Asphyxiants
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |
|---|---|---|---|---|---|
| Item | Category | Name of Symbol | Symbol | Signal Word | Hazard Statement |
| 1 | Simple Asphyxiants — Category 1 | No symbol | No symbol | Warning | May displace oxygen and cause rapid suffocation |
PART 3
Pyrophoric Gases
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |
|---|---|---|---|---|---|
| Item | Category | Name of Symbol | Symbol | Signal Word | Hazard Statement |
| 1 | Pyrophoric Gases — Category 1 | Flame | | Danger | Catches fire spontaneously if exposed to air |
PART 4
Physical Hazards Not Otherwise Classified
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |
|---|---|---|---|---|---|
| Item | Category | Name of Symbol | Symbol | Signal Word | Hazard Statement |
| 1 | Physical Hazards Not Otherwise Classified — Category 1 | (Name of any symbol in Schedule 3 that is applicable to the hazard) | (Any symbol in Schedule 3 that is applicable to the hazard) | Danger | (Wording that describes the nature of the hazard) |
PART 5
Biohazardous Infectious Materials
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |
|---|---|---|---|---|---|
| Item | Category | Name of Symbol | Symbol | Signal Word | Hazard Statement |
| 1 | Biohazardous Infectious Materials — Category 1 | Biohazardous infectious materials | | Danger | (Wording that describes the nature of the hazard) |
PART 6
Health Hazards Not Otherwise Classified
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |
|---|---|---|---|---|---|
| Item | Category | Name of Symbol | Symbol | Signal Word | Hazard Statement |
| 1 | Health Hazards Not Otherwise Classified — Category 1 | (Name of any symbol in Schedule 3 that is applicable to the hazard) | (Any symbol in Schedule 3 that is applicable to the hazard) | Danger | (Wording that describes the nature of the hazard) |
- Date modified: