Regulations Amending the Hazardous Products Regulations (GHS, Seventh Revised Edition): SOR/2022-272

Canada Gazette, Part II, Volume 157, Number 1

Registration
SOR/2022-272 December 15, 2022

HAZARDOUS PRODUCTS ACT

P.C. 2022-1315 December 15, 2022

Whereas, under section 19footnote a of the Hazardous Products Act footnote 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, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health makes the annexed Regulations Amending the Hazardous Products Regulations (GHS, Seventh Revised Edition) under subsection 15(1)footnote c of the Hazardous Products Act footnote b.

Regulations Amending the Hazardous Products Regulations (GHS, Seventh Revised Edition)

Amendments

1 The definitions GHS and Manual of Tests and Criteria in subsection 1(1) of the Hazardous Products Regulations footnote 1 are replaced by the following:

GHS
means the United Nations document entitled Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Seventh Revised Edition. (SGH)
Manual of Tests and Criteria
means the United Nations document entitled Manual of Tests and Criteria, as amended from time to time. (Manuel d’épreuves et de critères)

2 (1) Subsection 2(2) of the Regulations is replaced by the following:

Evaluation — order in classification table

(2) When a product, mixture, material or substance is evaluated in accordance with the criteria and requirements of a category or subcategory of a hazard class, the evaluation must proceed in accordance with the order of the hazard’s decreasing severity as presented in each classification table. The product, mixture, material or substance must be classified in the category or subcategory for which it meets the criteria. The product, mixture, material or substance that meets the criteria of more than one category or subcategory of the same classification table must be classified, among those categories or subcategories, in the one that represents the most severe hazard.

Evaluation not necessary for less severe hazard

(2.1) If the product, mixture, material or substance is classified in a category or subcategory of a hazard class that represents a more severe hazard in comparison with another category or subcategory of that hazard class in the same classification table, the product, mixture, material or substance need not be evaluated in respect of the category or subcategory that represents a less severe hazard.

(2) Subsection 2(9) of the Regulations is replaced by the following:

Animal data — not relevant to humans

(9) Animal data from a particular species of animal must not be used for the purpose of classifying a mixture or substance in any of the health hazard classes referred to in Subparts 1 to 10 and 12 of Part 8 when it has been demonstrated conclusively, based on established scientific principles, that the mechanism or mode of action of the mixture or substance in that particular species of animal is not relevant to humans.

3 (1) Paragraph 3(1)(c) of the Regulations is replaced by the following:

(2) Subsection 3(1) of the Regulations is amended by striking out “and” at the end of paragraph (e) and by replacing paragraph (f) with the following:

(3) Subsection 3(2) of the Regulations is replaced by the following:

Codes or instructions

(2) The information elements required by paragraphs (1)(c) to (c.2) need not include alphanumeric codes and the information elements required by paragraphs (1)(c) to (d) must not include instructions that are for the exclusive use of the competent authority, as defined in the GHS, or the supplier.

(4) Section 3 of the Regulations is amended by adding the following after subsection (3):

Chemicals under pressure

(3.1) In the case of a hazardous product that is classified in a category of the “Chemicals Under Pressure” hazard class, the pictogram associated with a symbol in Schedule 3 must be substituted for the symbol that is specified for that category in section 3 of Annex 3 of the United Nations document entitled Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Eighth Revised Edition.

(5) Section 3 of the Regulations is amended by adding the following after subsection (4):

Precautionary statement — Pyrophoric Liquids and Pyrophoric Solids

(4.1) In the case of a hazardous product that is classified in the category “Pyrophoric Liquids – Category 1” or in the category “Pyrophoric Solids – Category 1”, in addition to the information elements that are specified for those categories in section 3 of Annex 3 of the GHS, the following precautionary statement must be used:

Hazard statement — Acute Toxicity (Inhalation)

(4.2) In the case of a hazardous product that is classified in the category “Acute Toxicity (Inhalation) — Category 1”, “Acute Toxicity (Inhalation) — Category 2”, “Acute Toxicity (Inhalation) — Category 3” or “Acute Toxicity (Inhalation) — Category 4 ” further to subsection 8.1.1(2), the hazard statement specified for that category in section 3 of Annex 3 of the GHS need not be used on the label.

(6) Paragraphs 3(5)(a) to (d) of the Regulations are repealed.

4 Subsection 3.2(2) of the Regulations is replaced by the following:

Non-applicable precautionary statements

(2) If a precautionary statement that is required to be provided on a label 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.

5 Section 3.6 of the Regulations is replaced by the following:

Specific rule — signal word

3.6 (1) If there is a requirement to provide the signal word “Danger” on a label, any requirement to provide the signal word “Warning” does not apply.

Specific rule — hazard statement

(2) If there is a requirement to provide the hazard statement “Causes severe skin burns and eye damage” on a label, any requirement to provide the hazard statement “Causes serious eye damage” does not apply.

Specific rule — symbol

(3) In the case of the symbols specified below, the following apply:

6 (1) The portion of subsection 4(1) of the Regulations before paragraph (a) is replaced by the following:

Information elements

4 (1) Subject to section 4.7 and 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:

(2) The portion of paragraph 4(1)(b) of the Regulations before subparagraph (i) is replaced by the following:

7 Section 4.2 of the Regulations is replaced by the following:

Identical identifiers

4.2 The product identifier, the initial supplier identifier and, if applicable, any replacement information required under subsection 5.7(9) or (10) that are provided on the safety data sheet of a hazardous product must be identical to those provided on the label.

8 (1) Subsection 4.4.1(1) of the Regulations is amended by striking out “or” at the end of paragraph (a), by adding “or” at the end of paragraph (b) and by adding the following after paragraph (b):

(2) Subsection 4.4.1(2) of the Regulations is replaced by the following:

Actual concentration within more than one concentration range

(2) For the purposes of paragraphs (1)(b) and (c), 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), then any one of those ranges or a range that falls entirely within any one of those ranges may be provided on the safety data sheet.

(3) The portion of subsection 4.4.1(3) of the Regulations before paragraph (a) is replaced by the following:

Concentration ranges

(3) For the purposes of paragraphs (1)(b) and (c) and subsection (2), the concentration ranges are the following:

(4) Subsection 4.4.1(4) of the Regulations is replaced by the following:

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 the concentration range, a statement to the effect that the actual concentration is withheld as a trade secret.

9 (1) Subsection 4.5(1) of the Regulations is amended by striking out “or” at the end of paragraph (b) and by adding the following after paragraph (b):

(2) Subsection 4.5(2) of the Regulations is replaced by the following:

Actual concentration range within more than one concentration range

(2) For the purposes of paragraphs (1)(b) and (b.1), 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), then any one of those ranges or a range that falls entirely within any one of those ranges may be provided on the safety data sheet.

(3) The portion of subsection 4.5(3) of the Regulations before paragraph (a) is replaced by the following:

Concentration ranges

(3) For the purposes of paragraphs (1)(b) to (c) and subsection (2), the concentration ranges are the following:

(4) Subsection 4.5(4) of the Regulations is replaced by the following:

Statement — trade secret

(4) If the safety data sheet provides a concentration range further to paragraph (1)(b), (b.1) 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.

10 The Regulations are amended by adding the following after section 4.5:

Combined precautionary statements

4.6 (1) The precautionary statements that are required to be provided on a safety data sheet may be combined if the combination contains the same information as would have been conveyed by each of the individual precautionary statements.

Non-applicable precautionary statements

(2) If a precautionary statement that is required to be provided on a safety data sheet 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.

Combined hazard statements

(3) The hazard statements that are required to be provided on a safety data sheet may be combined if the combination contains the same information as would have been conveyed by each of the individual hazard statements.

Specific rule — signal word

4.7 (1) If there is a requirement to provide the signal word “Danger” on a safety data sheet, any requirement to provide the signal word “Warning” does not apply.

Specific rule — hazard statement

(2) If there is a requirement to provide the hazard statement “Causes severe skin burns and eye damage” on a safety data sheet, any requirement to provide the hazard statement “Causes serious eye damage” does not apply.

Hazard statement — Acute Toxicity (Inhalation)

(3) In the case of a hazardous product that is classified in the category “Acute Toxicity (Inhalation) — Category 1”, “Acute Toxicity (Inhalation) — Category 2”, “Acute Toxicity (Inhalation) — Category 3” or “Acute Toxicity (Inhalation) — Category 4” further to subsection 8.1.1(2), the hazard statement specified for that category in section 3 of Annex 3 of the GHS need not be used on the safety data sheet.

Specific rule — symbol

(4) In the case of the symbols specified below, the following apply:

11 Subsection 5(6) of the Regulations is replaced by the following:

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) to (d) if

12 Paragraph 5.1(3)(b) of the Regulations is replaced by the following:

13 Subsection 5.4(1) of the Regulations is replaced by the following:

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 paragraphs 3(1)(c) to (c.2) 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.

14 (1) Subparagraph 5.7(8)(c)(ii) of the Regulations is replaced by the following:

(2) Subsection 5.7(9) of the Regulations is replaced by the following:

Safety data sheet and 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 that information is replaced on the label and safety data sheet by:

(3) The portion of subsection 5.7(10) of the Regulations before paragraph (a) is replaced by the following:

Safety data sheet and 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 on the label and the safety data sheet by

(4) The portion of subsection 5.7(11) of the Regulations before paragraph (a) is replaced by the following:

Safety data sheet — sale to employer

(11) The sale of a hazardous product to an employer is exempt from the requirement to disclose information – other than the product identifier and initial supplier identifier – 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

15 Section 5.10 of the Regulations is replaced by the following:

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) to (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.

16 (1) Paragraph 5.12(2)(b) of the Regulations is replaced by the following:

(2) Paragraph 5.12(3)(b) of the Regulations is replaced by the following:

(3) Paragraph 5.12(4)(b) of the Regulations is replaced by the following:

(4) Paragraph 5.12(5)(b) of the Regulations is replaced by the following:

17 Section 6.1 of the Regulations is replaced by the following:

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 the hazardous product.

18 The heading “Definition” before section 7.2 of the Regulations is replaced by the following:

Definitions

19 Section 7.2 of the Regulations is replaced by the following:

Definitions

7.2 The following definitions apply in this Subpart.

chemically unstable gas
means a flammable gas that is liable to react explosively even in the absence of air or oxygen. (gaz chimiquement instable)
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. (gaz inflammable)
pyrophoric gas
means a flammable gas that is liable to ignite spontaneously in air at a temperature of 54°C or less. (gaz pyrophorique)

20 Section 7.2.1 of the Regulations is replaced by the following:

Exclusions — aerosols

7.2.1 (1) Any product that is classified in a category of the hazard class “Aerosols” need not be classified in any category or subcategory of this hazard class.

Exclusions — chemicals under pressure

(1.1) Any product that is classified in a category of the hazard class “Chemicals Under Pressure” must not be classified in any category or subcategory of this hazard class.

Categories — flammable gas

(2) A flammable gas is classified in a category or subcategory of this hazard class in accordance with the following table:

TABLE
Item

Column 1

Category

Column 2

Subcategory

Column 3

Criteria
1   Flammable Gases — Category 1A, Flammable Gas A flammable 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 flammability limit, unless data demonstrate it meets the criteria for the subcategory "Flammable Gases — Category 1B, Flammable Gas"
2   Flammable Gases — Category 1B, Flammable Gas A flammable gas that meets the criteria for the subcategory "Flammable Gases — Category 1A, Flammable Gas", but does not meet the criteria for the subcategory "Flammable Gases — Category 1A, Pyrophoric Gas", "Flammable Gases — Category 1A, Chemically Unstable Gas A" or "Flammable Gases — Category 1A, Chemically Unstable Gas B", and that has
  • (a) a lower flammability limit of > 6.0% by volume in air; or
  • (b) a fundamental burning velocity < 10 cm/s
3 Flammable Gases — Category 2, Flammable Gas   A flammable gas that does not meet the criteria for the subcategory "Flammable Gases — Category 1A, Flammable Gas" or "Flammable Gases — Category 1B, Flammable Gas"

Subcategories — chemically unstable gas

(2.1) A chemically unstable gas is classified in a subcategory of this hazard class in accordance with the following table:

TABLE
Item

Column 1

Subcategory

Column 2

Criteria
1 Flammable Gases — Category 1A, Chemically Unstable Gas A A flammable gas that, at 20°C and at the standard pressure of 101.3 kPa, is a chemically unstable gas
2 Flammable Gases — Category 1A, Chemically Unstable Gas B A flammable gas that, at > 20°C or at a pressure > 101.3 kPa, is a chemically unstable gas

Subcategory — pyrophoric gas

(2.2) A pyrophoric gas is classified in the subcategory of this hazard class in accordance with the following table:

TABLE
Item

Column 1

Subcategory

Column 2

Criteria
1 Flammable Gases — Category 1A, Pyrophoric Gas A flammable gas that is a pyrophoric gas

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 this hazard class, the calculation method set out in the International Organization for Standardization standard ISO 10156:2017 entitled Gas cylinders — 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.

Data permits classification in category or subcategory

(4) If the data obtained using a calculation method referred to in subsection (3) support the conclusion that the gas must be classified in a category or subcategory of this hazard class in accordance with the tables following subsection 7.2.1(2), (2.1) or (2.2), the gas must be classified in the appropriate category or subcategory.

Data does not permit classification in category or subcategory

(5) If the data obtained using a calculation method referred to in subsection (3) support the conclusion that the gas is a flammable gas, but do not permit for the determination of classification in the appropriate category or subcategory of this hazard class, the gas must be classified in the subcategory “Flammable Gases – Category 1A, Flammable Gas”.

21 The heading “Flammable Aerosols” before section 7.3 of the Regulations is replaced by the following:

Aerosols

22 The definition flammable aerosol in section 7.3 of the Regulations is repealed.

23 Section 7.3.1 of the Regulations is replaced by the following:

Exclusions

7.3.1 (1) Any product that is classified in a category of the hazard class “Chemicals Under Pressure” must not be classified in any category of this hazard class.

Categories

(2) An aerosol is classified in a category of this hazard class in accordance with the following table:

TABLE
Item

Column 1

Category

Column 2

Criteria
1 Aerosols — Category 1 An aerosol dispenser that
  • (a) contains ≥ 85.0% flammable components, by mass, and 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 Aerosols — Category 2 An aerosol dispenser that generates
  • (a) a spray aerosol that does not meet the criteria for the category "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 "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
3 Aerosols — Category 3 An aerosol dispenser that
  • (a) contains ≤ 1.0% flammable components, by mass, and generates an aerosol that has a heat of combustion <20 kJ/g;
  • (b) generates a spray aerosol that does not meet the criteria for the category "Aerosols — Category 1" or "Aerosols – Category 2" and that has
    • (i) 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
    • (ii) 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
  • (c) generates a foam aerosol that does not meet the criteria for the category "Aerosols – Category 1" or "Aerosols – Category 2" and 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, a flame height < 4 cm or a flame duration < 2 s

Default category

(3) 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 (2) must be classified in the category “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.

24 The portion of item 1 of the table to section 7.4.1 of the Regulations in column 2 is replaced by the following:
Item

Column 2

Criteria
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 10156:2017 entitled Gas cylinders — Gases and gas mixtures — Determination of fire potential and oxidizing ability for the selection of cylinder valve outlets, as amended from time to time

25 Section 7.5.1 of the Regulations is replaced by the following:

Exclusions — aerosols

7.5.1 (1) Any product that is classified in a category of the hazard class “Aerosols” need not be classified in any category of this hazard class.

Exclusions — chemicals under pressure

(2) Any product that is classified in a category of the hazard class “Chemicals Under Pressure” must not be classified in any category of this hazard class.

Categories

(3) A gas under pressure is classified in a category of this hazard class in accordance with the following table:

TABLE
Item

Column 1

Category

Column 2

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

26 Subsection 7.6.1(1) of the Regulations is replaced by the following:

Exclusions — aerosols

7.6.1 (1) Any product that is classified in a category of the hazard class “Aerosols” need not be classified in any category of this hazard class.

Exclusions — chemicals under pressure

(1.1) Any product that is classified in a category of the hazard class “Chemicals Under Pressure” must not be classified in any category of this hazard class.

27 (1) Subsection 7.7.1(1) of the Regulations is replaced by the following:

Exclusions — aerosols

7.7.1 (1) Any product that is classified in a category of the hazard class “Aerosols” need not be classified in any category of this hazard class.

Exclusions — chemicals under pressure

(1.1) Any product that is classified in a category of the hazard class “Chemicals Under Pressure” must not be classified in any category of this hazard class.

(2) The portion of subsection 7.7.1(2) of the Regulations before the table is replaced by the following:

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 of Part III of the Manual of Tests and Criteria, in accordance with the following table:

28 The portion of section 7.9.1 of the Regulations before the table is replaced by the following:

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 33.4.5 of Part III of the Manual of Tests and Criteria, in accordance with the following table:

29 The portion of section 7.10.1 of the Regulations before the table is replaced by the following:

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 33.4.4 of Part III of the Manual of Tests and Criteria, in accordance with the following table:

30 Subsection 7.11.1(2) of the Regulations is replaced by the following:

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 33.4.6 of Part III of the Manual of Tests and Criteria, in accordance with the following table:

TABLE
Item

Column 1

Category

Column 2

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
2 Self-heating Substances and Mixtures — Category 2 A solid or liquid in respect of which 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
  • (a) the solid or liquid is packed in packages with a volume > 3 m³;
  • (b) 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
  • (c) a positive result is obtained in a test using a 100 mm sample cube at 100°C

31 Section 7.12 of the Regulations is replaced by the following:

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 greater than one litre of gas per kilogram of the mixture or substance per hour.

32 (1) The portion of subsection 7.12.1(2) of the Regulations before the table is replaced by the following:

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 33.5.4 of Part III of the Manual of Tests and Criteria, in accordance with the following table:

(2) The portion of item 3 of the table to subsection 7.12.1(2) of the Regulations in column 2 is replaced by the following:
Item

Column 2

Criteria
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

33 The table to subsection 7.14.1(2) of the Regulations is replaced by the following:

TABLE
Item

Column 1

Category

Column 2

Criteria Using Test O.1

Column 3

Criteria Using Test O.3
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 A solid that, when tested in a 4:1 or 1:1 mixture, by mass, with cellulose, exhibits a mean burning rate > the mean burning rate of a 3:1 mixture, by mass, of calcium peroxide 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 A solid that, when tested in a 4:1 or 1:1 mixture, by mass, with cellulose, exhibits a mean burning rate ≥ the mean burning rate of a 1:1 mixture, by mass, of calcium peroxide 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 A solid that, when tested in a 4:1 or 1:1 mixture, by mass, with cellulose, exhibits a mean burning rate ≥ the mean burning rate of a 1:2 mixture, by mass, of calcium peroxide and cellulose
34 (1) The portion of paragraph 7(a) of the table to subsection 7.15.1(3) of the Regulations in column 2 is replaced by the following:
Item

Column 2

Criteria
7
  • (a) has a SADT ≥ 60°C when evaluated in a 50 kg package, or

(2) Subsection 7.15.1(4) of the Regulations is replaced by the following:

Mixtures — organic peroxides

(4) Subject to subsection (5), a mixture of organic peroxides must be classified in the same category as the most hazardous organic peroxide in the mixture, unless data of the types referred to in subparagraph 2.1(a)(i) or (ii) or (b)(i) or (ii) are available for the mixture as a whole and the data support the conclusion that the mixture must be classified in a category that represents a less severe hazard.

Mixtures — Type G organic peroxides

(5) A mixture of two or more Type G organic peroxides must be classified in the category “Organic Peroxides — Type G”, unless the self-accelerating decomposition temperature of the mixture results in the mixture being classified in a category that represents a more severe hazard.

35 The portion of paragraph 1(a) of the table to section 7.17.1 of the Regulations in column 2 is replaced by the following:
Item

Column 2

Criteria
1
  • (a) has been shown to, upon ignition, catch fire or explode when dispersed in air; or

36 Subpart 19 of Part 7 of the Regulations is repealed.

37 The Regulations are amended by adding the following after section 7.20.1:

SUBPART 21

Chemicals Under Pressure

Definition

Definition of Chemicals Under Pressure

7.21 In this Subpart, chemicals under pressure means liquids or solids that are packaged in a receptacle — other than an aerosol dispenser — and that are pressurized with a gas at a gauge pressure of 200 kPa or more at 20°C but excludes any gas under pressure as defined in section 7.5.

Classification in a Category of the Class

Exclusions

7.21.1 (1) Any product that is classified in a category of the hazard class “Aerosols” must not be classified in any category of this hazard class.

Categories

(2) A chemical under pressure is classified in a category of this hazard class in accordance with the following table:

TABLE
Item

Column 1

Category

Column 2

Criteria
1 Chemicals Under Pressure — Category 1 A chemical under pressure that contains ≥ 85.0% flammable components, by mass, and has a heat of combustion ≥ 20 kJ/g
2 Chemicals Under Pressure — Category 2 A chemical under pressure that
  • (a) contains > 1.0% flammable components, by mass, and has a heat of combustion < 20 kJ/g; or
  • (b) contains < 85.0% flammable components, by mass, and has a heat of combustion ≥ 20 kJ/g
3 Chemicals Under Pressure — Category 3 A chemical under pressure that contains ≤ 1.0% flammable components, by mass, and has a heat of combustion < 20 kJ/g

38 The portion of the definition acute toxicity in section 8.1 of the Regulations before paragraph (a) is replaced by the following:

acute toxicity
refers to serious adverse health effects, including death, occurring following

39 Subsection 8.1.1(2) of the Regulations is replaced by the following:

Contact with water — gaseous substance

(2) If an acute toxicant that is a substance is not classified in accordance with subsection (1) with respect to the inhalation route of exposure in a category of this hazard class in accordance with Table 3 to subsection (3) and, upon contact with water, the acute toxicant releases a gaseous substance that has an LC50 that falls into one of the ranges indicated in that table, it is classified in accordance with that table with regard to that range.

40 Section 8.1.7 of the Regulations is replaced by the following:

Conversion from range to point estimate

8.1.7 (1) 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 table to subsection (2), for each ingredient for which only that ingredient’s classification category or experimentally obtained acute toxicity range is available.

More than one range

(2) If the experimentally obtained acute toxicity range for an ingredient does not fall entirely within any of the ranges set out in column 2 of the following table, the converted acute toxicity point estimate for that ingredient for the purposes of column 3 is the lowest value of the experimentally obtained acute toxicity range.

TABLE
Item

Column 1

Exposure Routes

Column 2

Classification Category and Associated Experimentally Obtained Acute Toxicity Range Minimum and Maximum Values

Column 3

Converted Acute Toxicity Point Estimate
1 Oral (mg/kg body weight)
  • 0 < Category 1 ≤ 5
  • 5 < Category 2 ≤ 50
  • 50 < Category 3 ≤ 300
  • 300 < Category 4 ≤ 2000
  • 0.5
  • 5
  • 100
  • 500
2 Dermal (mg/kg body weight)
  • 0 < Category 1 ≤ 50
  • 50 < Category 2 ≤ 200
  • 200 < Category 3 ≤ 1000
  • 1000 < Category 4 ≤ 2000
  • 5
  • 50
  • 300
  • 1100
3 Inhalation (gases) (ppmV)
  • 0 < Category 1 ≤ 100
  • 100 < Category 2 ≤ 500
  • 500 < Category 3 ≤ 2500
  • 2500 < Category 4 ≤ 20 000
  • 10
  • 100
  • 700
  • 4500
4 Inhalation (vapours) (mg/l)
  • 0 < Category 1 ≤ 0.5
  • 0.5 < Category 2 ≤ 2.0
  • 2.0 < Category 3 ≤ 10.0
  • 10.0 < Category 4 ≤ 20.0
  • 0.05
  • 0.5
  • 3
  • 11
5 Inhalation (dust/mist) (mg/l)
  • 0 < Category 1 ≤ 0.05
  • 0.05 < Category 2 ≤ 0.5
  • 0.5 < Category 3 ≤ 1.0
  • 1.0 < Category 4 ≤ 5.0
  • 0.005
  • 0.05
  • 0.5
  • 1.5

41 The definitions skin corrosion and skin irritation in section 8.2 of the Regulations are replaced by the following:

skin corrosion
means the production of irreversible damage to the skin, namely, visible necrosis through the epidermis and into the dermis, occurring after exposure to a mixture or substance, 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 irritation
means the production of reversible damage to the skin occurring after exposure to a mixture or substance. (irritation cutanée)
42 The portions of items 1 to 3 of the table to subsection 8.2.2(2) of the Regulations in column 2 is replaced by the following:
Item

Column 2

Criteria
1 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 animal
2 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 animal
3 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 animal

43 (1) Subsection 8.2.11(1) of the Regulations is replaced by the following:

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”, the subcategory “Skin Corrosion — Category 1A”, the subcategory “Skin Corrosion — Category 1B”, the subcategory “Skin Corrosion — Category 1C” 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:

(2) Paragraph 8.2.11(2)(b) of the Regulations is replaced by the following:

(3) Subparagraph 8.2.11(2)(d)(i) of the Regulations is replaced by the following:

44 The definitions eye irritation and serious eye damage in section 8.3 of the Regulations are replaced by the following:

eye irritation
means the production of changes in the eye after exposure of the eye to a mixture or substance that are fully reversible within an observation period of 21 days after that exposure. (irritation oculaire)
serious eye damage
means the production of tissue damage in the eye or serious physical decay of vision, occurring after exposure of the eye to a mixture or substance,
  • (a) for which data demonstrate that it is irreversible; or
  • (b) that is not fully reversible within an observation period of 21 days after that exposure. (lésion oculaire grave)

45 (1) Subsection 8.3.11(1) of the Regulations is replaced by the following:

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”, the category “Eye Irritation — Category 2”, the subcategory “Eye Irritation — Category 2A” or the subcategory “Eye Irritation — Category 2B” is classified in a category or subcategory of this hazard class in accordance with subsection (2), subject to the following:

(2) Paragraphs 8.3.11(2)(a) and (b) of the Regulations are replaced by the following:

(3) Subsection 8.3.11(2) of the Regulations is amended by striking out “or” at the end of paragraph (c) and by adding the following after paragraph (c):

(4) Subparagraphs 8.3.11(2)(d)(i) and (ii) of the Regulations are replaced by the following:

46 The definitions respiratory sensitization and skin sensitization in section 8.4 of the Regulations are replaced by the following:

respiratory sensitization
means the production of hypersensitivity of the airways occurring after inhalation of a mixture or substance. (sensibilisation respiratoire)
skin sensitization
means the production of an allergic response occurring after skin contact with a mixture or substance. (sensibilisation cutanée)

47 Section 8.5 of the Regulations is amended by adding the following in alphabetical order:

germ cell mutagenicity
means an increased occurrence of heritable gene mutations, including heritable structural and numerical chromosome aberrations in germ cells, occurring after exposure to a mixture or substance. (mutagénicité sur les cellules germinales)

48 Section 8.5.3 of the Regulations is replaced by the following:

Ingredient classified in Category 1 or 1A

8.5.3 (1) A mixture is classified in the category “Germ Cell Mutagenicity — Category 1” or the subcategory “Germ Cell Mutagenicity — Category 1A” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Germ Cell Mutagenicity — Category 1A”, unless

Ingredient classified in Category 1 or 1B

(2) A mixture is classified in the category “Germ Cell Mutagenicity — Category 1” or the subcategory “Germ Cell Mutagenicity — Category 1B” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Germ Cell Mutagenicity — Category 1B”, and does not contain any ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Germ Cell Mutagenicity — Category 1A”, unless

49 The heading “Definition” before section 8.6 of the Regulations is replaced by the following:

Definitions

50 Section 8.6 of the Regulations is replaced by the following:

Definitions

8.6 The following definitions apply in this Subpart.

carcinogenic
means, in relation to a mixture or substance, liable to lead to cancer or to increase the incidence of cancer. (cancérogène)
carcinogenicity
means the production of cancer or an increase in the incidence of cancer occurring after exposure to a mixture or substance. (cancérogénicité)

51 Section 8.6.3 of the Regulations is replaced by the following:

Ingredient classified in Category 1 or 1A

8.6.3 (1) A mixture is classified in the category “Carcinogenicity — Category 1” or the subcategory “Carcinogenicity — Category 1A” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Carcinogenicity — Category 1A”, unless

Ingredient classified in Category 1 or 1B

(2) A mixture is classified in the category “Carcinogenicity — Category 1” or the subcategory “Carcinogenicity — Category 1B” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Carcinogenicity — Category 1B”, and does not contain any ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Carcinogenicity — Category 1A”, unless

52 The definition reproductive toxicity in section 8.7 of the Regulations is replaced by the following:

reproductive toxicity
refers to any of the following effects occurring after exposure to a mixture or substance:
  • (a) adverse effects on sexual function and fertility;
  • (b) adverse effects on the development of the embryo, fetus or offspring; or
  • (c) effects on or via lactation. (toxicité pour la reproduction)
53 The portion of item 3 of the table to subsection 8.7.1(1) of the Regulations in column 3 is replaced by the following:
Item

Column 3

Criteria
3 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, provided that such effects are not considered to be a secondary non-specific consequence of other toxic effects

54 Section 8.7.3 of the Regulations is replaced by the following:

Ingredient classified in Category 1 or 1A

8.7.3 (1) A mixture is classified in the category “Reproductive Toxicity — Category 1” or the subcategory “Reproductive Toxicity — Category 1A” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Reproductive Toxicity — Category 1A”, unless

Ingredient classified in Category 1 or 1B

(2) A mixture is classified in the category “Reproductive Toxicity — Category 1” or the subcategory “Reproductive Toxicity — Category 1B” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Reproductive Toxicity — Category 1B”, and does not contain any ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Reproductive Toxicity — Category 1A”, unless

55 (1) Paragraph 8.8.5(1)(c) of the Regulations is amended by striking out “or” at the end of subparagraph (ii), by adding “or” at the end of subparagraph (i) and by repealing subparagraph (iii).

(2) Subsection 8.8.5(1) of the Regulations is amended by striking out “or” at the end of paragraph (b), by adding “or” at the end of paragraph (c) and by adding the following after paragraph (c):

56 The portion of paragraphs 2(a) and (b) of Schedule 1 to the Regulations in column 2 is replaced by the following:

Item

Column 2

Specific Information Elements

2
  • (a) classification of the hazardous product, namely, the appropriate category or subcategory of the hazard class identified in Subparts 2 to 18 and 21 of Part 7 or Subparts 1 to 11 of Part 8, or a name that is its substantive equivalent, or for Subpart 20 of Part 7 and Subpart 12 of Part 8, the category of the hazard class or a description of the identified hazard;
  • (b) subject to subsections 3(2) and (4) to (5) of these Regulations, for each category or subcategory in which the hazardous product is classified, with the exception of the categories referred to in paragraphs (b.1) to (b.3), 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. If the required information element is a symbol, either the name of the symbol or the symbol itself may be used;
  • (b.1) subject to subsection 3(2) of these Regulations, in the case of a hazardous product that is classified in the category "Chemicals Under Pressure – Category 1" or "Chemicals Under Pressure – Category 2", the symbol, signal word, hazard statement and precautionary statement that are specified for that category in section 3 of Annex 3 of the United Nations document entitled Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Eighth Revised Edition. Either the name of the symbol or the symbol itself may be used;
 
  • (b.2) subject to subsection 3(2) of these Regulations, in the case of a hazardous product that is classified in the category "Chemicals Under Pressure – Category 3", the symbol, signal word and precautionary statement that are specified for that category in section 3 of Annex 3 of the United Nations document entitled Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Eighth Revised Edition, as well as the hazard statement "Chemical under pressure: May explode if heated/Produit chimique sous pression : peut exploser sous l’effet de la chaleur". Either the name of the symbol or the symbol itself may be used;
 
  • (b.3) subject to subsection 3(2) of these Regulations, for each category set out in Subparts 17, 18 and 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 (if the required information element is a symbol, either the name of the symbol or the symbol itself may be used), 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;
  • (b.4) the information elements referred to in paragraphs 3(1)(e) to (g) of these Regulations; and
57 The portion of subsection 3(2) of Schedule 1 to the Regulations before paragraph (a) in column 2 is replaced by the following:

Item

Column 2

Specific Information Elements

3

(2) In the case of a hazardous product that is a mixture, for each material or substance in the mixture that, individually, is classified in any category or subcategory of a health hazard class and is present above the concentration limit that is designated for the category or subcategory in which it is classified — regardless of whether the material or substance contributes to the classification of the mixture as a hazardous product — or is present in the mixture at a concentration that results in the mixture being classified in a category or subcategory of any health hazard class,
58 The portion of item 9 of Schedule 1 to the Regulations in column 2 is replaced by the following:

Item

Column 2

Specific Information Elements

9
  • (a) physical state;
  • (b) colour;
  • (c) odour;
  • (d) melting point and freezing point;
  • (e) boiling point or initial boiling point and boiling range;
  • (f) flammability;
  • (g) lower and upper explosion limit or lower and upper flammability limit;
  • (h) flash point;
  • (i) auto-ignition temperature;
  • (j) decomposition temperature;
  • (k) pH;
  • (l) kinematic viscosity;
  • (m) solubility;
  • (n) partition coefficient — n-octanol/water (logarithmic value);
  • (o) vapour pressure;
  • (p) density and relative density;
  • (q) relative vapour density; and
  • (r) particle characteristics

59 Item 14 of Schedule 1 to the Regulations is amended by adding “and” at the end of paragraph (e) and by repealing paragraph (f).

60 Schedule 3 to the Regulations is amended by replacing the references after the heading “Schedule 3” with the following:

(Subsections 3(3) and (3.1), section 3.1, paragraph 5.3(c) and Schedule 5)

61 Schedule 5 to the Regulations is amended by replacing the references after the heading “Schedule 5” with the following:

(Subsection 1(1), subparagraph 3(1)(d)(i), subsection 3(3) and Schedule 1)

62 The portion of item 1 of Part 1 of Schedule 5 to the Regulations in column 5 is replaced by the following:

Item

Column 5

Hazard Statement

1
  • (a) May form combustible dust concentrations in air; or
  • (b) May form explosible dust-air mixture.

63 Part 3 of Schedule 5 to the Regulations is repealed.

Transitional Provision

64 (1) In this section, former Regulations means the Hazardous Products Regulations as they read immediately before the day on which these Regulations come into force.

(2) A supplier may

(3) This section ceases to have effect on the day that is the third anniversary of the day on which these Regulations come into force.

Coming into Force

65 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations or the Order.)

Executive summary

Issues: Under the Canada-United States (U.S.) Regulatory Cooperation Council Joint Forward Plan, Canada has an international commitment to align the Hazardous Products Regulations with the seventh revised edition of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Adopting the seventh revised edition and select provisions from the eighth revised edition of the GHS will provide increased worker health and safety benefits and protections. There are also several issues that have been identified by Health Canada and stakeholders since the Hazardous Products Regulations came into force in February 2015. Health Canada is therefore amending the Hazardous Products Regulations to align with the seventh revised edition and certain provisions from the eighth revised edition of the GHS, provide greater clarity or additional precision regarding certain specific provisions, amend specific provisions to better reflect their original intent, and address administrative updates.

Description: The amendments required to align the Regulations with the seventh revised edition of the GHS include modifications to several definitions, the adoption of a new hazard category for non-flammable aerosols and new subcategories for Flammable Gases, the addition of a new test procedure for Oxidizing Solids, and modifications to Schedule 1 of the Hazardous Products Regulations to update the information elements required to be provided on safety data sheets. In addition, Health Canada is amending Part 1 of Schedule 5 of the Hazardous Product Regulations and adopting a new physical hazard class, Chemicals Under Pressure, from the eighth revised edition of the GHS in a new Subpart 21 of Part 7 of the Hazardous Product Regulations.

The other regulatory amendments are very diverse in nature and address issues identified by the Department and stakeholders. These amendments include clarifications and modifications to existing provisions relating to the classification of hazardous products in the physical and health hazard classes. There are also clarifications and adjustments with regard to hazard communication elements required on labels and safety data sheets, as well as administrative updates to the Hazardous Products Regulations.

Rationale: The amendments will enable Canada to meet its international commitment under the Canada-U.S. Regulatory Cooperation Council Joint Forward Plan. Moreover, the amendments will permit the continued use of one label and one safety data sheet per workplace hazardous product to meet the hazard communication requirements of both countries, subject to Canada’s legal and health and safety frameworks, including official languages requirements. It is expected that there will be a one-time implementation cost for industry during the first three years after the amendments come into force. The cost-benefit analysis identified that the monetized costs of the amendments have a present value of $53.8 million over ten years ($7.7 million annualized average).

Amending the Hazardous Products Regulations to align with the seventh revised edition and select provisions of the eighth revised edition of the GHS will also result in qualitative health and safety benefits to Canadian workers as a result of the more comprehensive and more detailed health and safety information to be provided to workers.

Stakeholders (i.e. representatives of suppliers, employers, worker organizations, and federal, provincial and territorial occupational health and safety government agencies) have been consulted on the proposed amendments. After the publication of the regulatory proposal in the Canada Gazette, Part I, stakeholders were also consulted on specific new proposals including potential new amendments (as suggested by industry representatives) to section 5.12 of the Hazardous Product Regulations, potential amendments to Part 1 of Schedule 5 of the Regulations, and the potential adoption of a new physical hazard class, Chemicals Under Pressure, from the eighth revised edition of the GHS. Based on stakeholder feedback, the final regulatory amendments include the regulatory proposal published in the Canada Gazette, Part I, in addition to the amendments to Part 1 of Schedule 5 of the Hazardous Products Regulations and the adoption of the new physical hazard class, Chemicals Under Pressure.

Some stakeholders expressed concerns regarding the two-year transition period for the regulatory amendments proposed in the Canada Gazette, Part I, publication. In consideration thereof, Health Canada has modified the regulatory proposal to provide a three-year transition period. Stakeholder groups expressed support for the regulatory proposal, indicating that they are in favour of continuing to maintain alignment with the U.S., provided that worker health and safety benefits and protections are maintained or increased and that the timing of the coming into force of the amended regulations is aligned with the U.S., to the extent possible.

Issues

On February 11, 2015, the Hazardous Products Regulations and the amendments to the Hazardous Products Act incorporating the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), fifth revised edition, for workplace hazardous products, came into force. This fulfilled the Canada-United States (U.S.) Regulatory Cooperation Council commitment to align and synchronize implementation of common classification and labelling requirements for workplace hazardous products.

The GHS is continually revised by the United Nations every two years. Since the publication of the Hazardous Products Regulations, updates and improvements have been made to the GHS. The seventh revised edition was published in 2017 and it includes the updates made to the GHS in its sixth and seventh revised editions. The updates made to the GHS between the fifth and seventh revised editions include revised criteria for the classification of Flammable Gases, amended definitions of terms used in some health hazard classes, new information elements required on safety data sheets, and additional or revised precautionary statements for certain hazard classes and categories or subcategories. The seventh revised edition provides increased worker health and safety benefits and protections compared to the fifth revised edition, as it allows for more precise classifications of some products (for example, flammable gas products), and for workplace hazardous products in general. It also provides more comprehensive and more detailed information on labels and safety data sheets. Incorporating the seventh revised edition in Canada will allow workers to better protect themselves against the hazards posed by products that they use and handle in their workplaces.

Under the Canada-U.S. Regulatory Cooperation Council Joint Forward Plan, one of the objectives of the Work Plan for workplace hazardous products is to coordinate the adoption of updates to the GHS. To achieve this international commitment, Canada and the U.S. have publicly committed to coordinate, to the extent possible, amendments to their respective regulations and align with the seventh revised edition of the GHS. Coordinated amendments would avoid the economic costs of misalignment.

On February 16, 2021, the U.S. Occupational Safety and Health Administration published in the U.S. Federal Register their notice of proposed rulemaking to modify the Hazard Communication Standard to conform generally to the GHS seventh revised edition. As such, not amending the Hazardous Products Regulations would result in inconsistencies between the Canadian and U.S. regulations once the amended U.S. Hazard Communication Standard comes into force. These inconsistencies would require Canadian suppliers to evaluate and classify their products against two sets of standards and, for some products, maintain two sets of labels and safety data sheets to be able to market their products in both countries. This would result in increased costs for the chemical industry and other businesses who sell or import hazardous products intended for workplace use. In addition, if the Canadian regulations were not amended, Canadian customers purchasing hazardous products from U.S. suppliers might be charged higher prices since, for products classified in specific hazard classes where the information requirements would end up being different, U.S. suppliers would need to prepare specialized labels and safety data sheets for the Canadian market. Alternatively, some U.S. suppliers could decide to leave the Canadian market due to the misaligned requirements. Adopting the requirements of the seventh revised edition of the GHS in Canada will have significant, positive trade benefits as a result of the common labelling and safety data sheet requirements for workplace hazardous products. These trade benefits will be optimized if the timing of the coming into force of the amended Canadian regulations is aligned with that of the U.S., so as to minimize disruption to industry.

In their notice of proposed rulemaking, the U.S. Occupational Safety and Health Administration also proposed the adoption of select provisions from the eighth revised edition of the GHS. In order to address a potential area of variance, and in response to feedback received from stakeholders, Health Canada is adopting a new physical hazard class that was introduced in the eighth revised edition of the GHS, namely, the Chemicals Under Pressure hazard class. This is in addition to all the regulatory amendments required to align with the seventh revised edition of the GHS.

To address another potential area of variance between the Canadian and U.S. regulatory proposals, and in response to feedback received from stakeholders, Health Canada is amending Part 1 of Schedule 5 of the Hazardous Products Regulations to allow for greater flexibility by providing a second option for the hazard statement for products classified as Combustible Dusts.

Finally, there are several issues that have been identified by Health Canada and stakeholders since the Hazardous Products Regulations came into force. A number of other amendments to the Hazardous Products Regulations are included in this regulatory submission, to provide greater clarity or additional precision to specific provisions or to better reflect the original intent of specific provisions, as well as to address administrative updates.

Background

The Workplace Hazardous Materials Information System (WHMIS) is Canada’s national hazard communication standard with regard to workplace hazardous products. The key elements of the system are hazard classification, cautionary labelling of containers, the provision of safety data sheets, and worker education and training programs. This national system, which has been in place since 1988, is implemented through interlocking federal, provincial and territorial legislation. At the federal level, the Hazardous Products Act and the Hazardous Products Regulations require suppliers of hazardous products intended for use, handling or storage in Canadian workplaces to classify and provide hazard information through labels and safety data sheets. At the workplace level, federal, provincial and territorial occupational health and safety acts and regulations set out requirements for employers. These employer WHMIS requirements help ensure that hazardous products in the workplace are properly labelled, safety data sheets are made available to workers, and workers receive education and training on the safe storage, handling, disposal and use of hazardous products in the workplace.

As indicated in the Regulatory Impact Analysis Statement for the Hazardous Products Regulations (published in the Canada Gazette, Part II, on February 11, 2015), numerous new or reformulated workplace hazardous products enter the Canadian market every year. This is in addition to the hundreds of thousands of hazardous products already offered for sale to, and in use in, Canadian workplaces. According to Industry Canada’s Trade Data Online, the Canadian chemical manufacturing sector imported more than $42 billion worth of chemicals from the U.S. in 2021 and exported more than $35 billion to the U.S. These trade volumes represent only a small fraction of the total value of products used in Canada to which the WHMIS legislation applies. For instance, these figures do not include all imports and exports from the petroleum, natural gas, mining and metal sectors.

In response to the challenges faced by suppliers, employers and workers due to the lack of international alignment in the classification, labelling and provision of safety information for workplace hazardous products, Canada, the U.S. and other countries worked together under the auspices of the United Nations to develop the GHS. The GHS is a common, internationally consistent approach for the classification of chemicals according to their hazards and the communication of hazard information through labels and safety data sheets. The first edition of the GHS “Purple Book” was published by the United Nations in 2005. The United Nations Sub-Committee of Experts on the GHS is responsible for maintaining and updating the GHS, promoting its implementation and providing additional guidance as needs arise. Since the publication of the first edition, the United Nations Secretariat has been regularly updating and preparing consolidated revised editions of the GHS every two years.

In February 2011, Canada and the U.S. jointly announced the creation of the Regulatory Cooperation Council. Its key objective is the facilitation of trade between the two countries. In December 2011, one of 29 initiatives announced as part of the Regulatory Cooperation Council Joint Action Plan was the coordinated implementation of the GHS for workplace hazardous products. Specifically, Canada and the U.S. agreed to align and synchronize the implementation of common classification and labelling requirements for workplace hazardous products within the mandate of the U.S. Occupational Safety and Health Administration and Health Canada, without reducing the level of safety or protection for workers.

On February 11, 2015, the Government of Canada fulfilled this commitment through the publication of the Hazardous Products Regulations in the Canada Gazette, Part II, which, in addition to the amendments made to the Hazardous Products Act under the Economic Action Plan 2014 Act, No. 1, modified WHMIS to incorporate the GHS for workplace hazardous products. The former Controlled Products Regulations were repealed and replaced by the Hazardous Products Regulations on the date of their publication in the Canada Gazette, Part II.

Building on the achievements accomplished under the initial Regulatory Cooperation Council Joint Action Plan, a second phase of regulatory cooperation was initiated in August 2014 with the launch of the Regulatory Cooperation Council Joint Forward Plan. To increase the benefits to Canadian workers with respect to health and safety and meet Canada’s continued international commitments, Health Canada is amending the Hazardous Products Regulations to adopt the updates made to the GHS in its sixth and seventh revised editions by aligning with the seventh revised edition of the GHS. The U.S. Occupational Safety and Health Administration is also moving forward with similar proposed amendments to their Hazard Communication Standard. In addition, Health Canada is adopting the Chemicals Under Pressure physical hazard class from the GHS eighth revised edition, in response to feedback received from stakeholders.

Objective

The main objective of these amendments is to meet an international commitment under the Regulatory Cooperation Council to align with the U.S. in the adoption of the seventh revised edition of the GHS. A new physical hazard class, Chemicals Under Pressure, from the GHS eighth revised edition, is also being adopted. These amendments would help to ensure continued alignment with the U.S., thereby facilitating trade through common hazard communication requirements for workplace hazardous products, while increasing the benefits to Canadian workers with respect to health and safety. A secondary objective is to address issues identified by Health Canada and stakeholders since the coming into force of the Hazardous Products Regulations in February 2015. Specifically, this objective includes clarifying or adding precision to certain provisions (with no changes to the scope or application of these provisions). In addition, the secondary objective includes making substantive changes that include corrections and amendments to other provisions as well as to revise the criteria or requirements to better reflect the original intent of these provisions. These amendments will also provide increased benefits to Canadian workers with respect to health and safety in the form of greater clarity or more appropriate criteria and requirements.

Description

Under the authority of the Hazardous Products Act, and taking into consideration better alignment, to the extent possible and where appropriate, with the U.S. Occupational Safety and Health Administration, Health Canada is amending the Hazardous Products Regulations to

  1. align the Hazardous Products Regulations with the seventh revised edition of the GHS;
  2. adopt a new physical hazard class, Chemicals Under Pressure, from the eighth revised edition of the GHS;
  3. clarify, add precision to, or make changes to certain provisions;
  4. make corrections and amend certain provisions to better reflect their original intent; and
  5. make administrative updates to the Hazardous Products Regulations.

1. Align the Hazardous Products Regulations with the seventh revised edition of the GHS

Amendments include the following (for provisions that the Department is proposing to repeal, a brief rationale is provided):

2. Adopt a new physical hazard class, Chemicals Under Pressure, from the eighth revised edition of the GHS

Amendments include the following:

3. Clarify, add precision to, or make changes to certain provisions

Amendments, which would not change the scope or application of the affected provisions, include the following:

4. Make corrections and amend certain provisions to better reflect their original intent

These amendments would change the scope of the affected provisions, thereby resulting in a change in hazard classification criteria or hazard communication requirements:

5. Make administrative updates to the Hazardous Products Regulations

There are several minor amendments that are being made to update the references in the Hazardous Products Regulations to the United Nations document entitled the “Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria.” In addition, the International Organization for Standardization (ISO) standard number 10156 was updated in 2017. ISO 10156:2010 is referenced in two provisions in the Hazardous Products Regulations and this needs to be updated to “ISO 10156:2017.” Furthermore, as a result of the Regulations Amending the Hazardous Products Regulations that were published in the Canada Gazette, Part II, on April 18, 2018, two provisions need to be updated to refer to the new section 4.4.1 of the Hazardous Products Regulations that was introduced by the 2018 amendment.

In addition, Schedule 2 to the Hazardous Products Act, which lists the hazard classes of the Hazardous Products Regulations, is also amended as follows:

Regulatory development

Consultation

Stakeholder consultations conducted prior to the publication of the proposed amendments to the Hazardous Products Regulations in the Canada Gazette, Part I

Over the years, Health Canada has consulted on a regular basis with WHMIS partners and stakeholders on the GHS and its implementation for workplace hazardous products. Consultations have been conducted by engaging the Intergovernmental WHMIS Coordinating Committee, which is made up of representatives of federal, provincial and territorial occupational health and safety government agencies, as well as the WHMIS multi-stakeholder Current Issues Committee, which is made up of federal, provincial and territorial representatives and representatives from suppliers, employers, and worker organizations.

The regulatory proposal was discussed at four Current Issues Committee meetings held during 2018-2019. In May 2018, Health Canada presented an overview of the regulatory proposal to the Current Issues Committee and subsequently distributed a complete list of the proposed amendments.

Over the course of 2018, Health Canada also distributed two questionnaires to the supplier representatives on the Current Issues Committee to collect data on the anticipated costs associated with the proposed amendments. Their responses provided data to assist Health Canada in quantifying the expected costs, including costs related to product re-evaluation and reclassification, making revisions to labels and safety data sheets and, for suppliers who are also employers, making changes to WHMIS training programs.

In general, there was a large variability in the cost estimates provided by industry. Some representatives replied that the estimated costs would be in the range of approximately $100,000 to $650,000. However, other representatives of industry associations cited estimated costs, per company, in the millions of dollars. The estimated costs associated with the amendments are summarized below in the “Benefits and Costs” section.

To collect additional quantitative data on the estimated costs associated with the proposed regulatory amendments, a third, more detailed questionnaire was distributed to the Current Issues Committee supplier representatives in April 2019, as part of the cost-benefit analysis. The Current Issues Committee supplier representatives distributed the questionnaire to their member companies. It included questions on the estimated costs of re-evaluating products, reclassifying products, revising labels, revising safety data sheets, training workers and managers, and other miscellaneous costs. A more targeted questionnaire was distributed to representatives of the animal feed industry in January 2020. This survey focused on questions concerning the estimated costs of revising labels and safety data sheets for animal feed products. Both surveys provided an opportunity for respondents to convey their comments to Health Canada with regard to the proposed regulatory amendments.

The data received in the completed questionnaires from April 2019 and January 2020 were extrapolated to the national level and a total national cost of $61.5 million to Canadian businesses was estimated. Further details are provided below in the “Benefits and Costs” section.

All respondents to the April 2019 questionnaire indicated that they were in favour of Health Canada’s regulatory proposal to continue to align the Hazardous Products Regulations with the U.S. Hazard Communication Standard. For the January 2020 questionnaire, four animal feed companies responded, but they did not provide any comments to Health Canada with regard to whether they supported the regulatory proposal. Both small and large companies who responded to the April 2019 questionnaire recognized that the one-time costs associated with making revisions to labels and safety data sheets to meet the requirements of the proposed amendments would be outweighed, over the longer term, by the ongoing savings resulting from having the same classification and hazard communication system as in the U.S.

Businesses who responded to the April 2019 questionnaire commented that their support of the regulatory proposal is contingent upon: (1) aligning the timing of the Hazardous Products Regulations amendments with that of the U.S. Hazard Communication Standard 2012 amendments, to the extent possible; and (2) businesses having sufficient time (i.e., at least two years) to make the necessary changes to product classifications, labels and safety data sheets.

Employers and worker organizations also support the regulatory proposal. They noted that the proposed amendments would increase the benefits to Canadian workers with respect to health and safety. Employers and worker organizations want to ensure that worker health and safety protections are maintained or expanded (not reduced) through continued alignment with the U.S.

The provinces and territories are also supportive of the proposal to amend the Hazardous Products Regulations to align with the GHS (seventh revised edition), as well as the other proposed amendments. Their primary concern is ensuring that current worker protections are not reduced through regulatory alignment. Some provincial representatives indicated that amendments to federal, provincial and territorial occupational health and safety legislation and regulations might be required as a result of the proposed amendments. The provinces and territories indicated that they would require time to transition to the proposed amendments to help ensure consistency across the country.

Stakeholder comments from the regulatory proposal’s from the Canada Gazette, Part I, 70-day public comment period and additional stakeholder consultation

The proposed Regulations Amending the Hazardous Products Regulations (GHS, Seventh Revised Edition) and the proposed Order Amending Schedule 2 to the Hazardous Products Act were published in the Canada Gazette, Part I, on December 19, 2020. The 70-day public comment period closed on February 27, 2021. However, through a stakeholder consultation, stakeholders were informed that Health Canada would continue to accept comments until May 19, 2021. This extension was granted to align with the timing of the U.S. public comment period for their Proposed Rulemaking to Amend the Hazard Communication Standard.

Between January 28, 2021, and May 19, 2021, Health Canada received twenty submissions from stakeholders that included comments on the proposed amendments to the Hazardous Products Regulations.

In addition to the general public, stakeholders that were consulted on the regulatory proposal included

Industry representatives expressed their support for Health Canada’s regulatory proposal to amend the Hazardous Products Regulations to align with the seventh revised edition of the GHS. Industry representatives were pleased that work conducted under the Canada – U.S. Regulatory Cooperation Council workplace chemicals initiative had, and continues to have, a positive impact in aligning the hazard communication requirements in Canada and the U.S. One industry association commented that, with regard to proposed regulatory amendments based on updates to the GHS, their members would only support those proposed amendments that have a direct and substantial beneficial impact on the health and safety of Canadian workers. Otherwise, suppliers are faced with the high costs of revising safety data sheets and labels approximately every two years, without any substantial benefit to workers’ health and safety.

Health Canada is committed to the protection of worker health and safety, while taking into consideration the impact of the regulatory amendments on businesses. Many of the regulatory amendments will increase the health and safety benefits and protections for Canadian workers. Some of the amendments are intended to clarify or add precision to specific provisions, amend specific provisions to better reflect their original intent, or make administrative updates to the Regulations. Overall, the amendments are expected to improve worker protections by providing more comprehensive and more detailed health and safety information on hazardous product labels and safety data sheets.

Stakeholder responses emphasized the critical importance of aligning the Canadian and U.S. regulatory proposals as much as possible and ensuring that the number of variances is kept to a minimum. All variances present a potential trade barrier, as they may require suppliers to prepare two sets of labels or safety data sheets or both, to market the same product in Canada and the U.S. This runs counter to the Canada-United States Regulatory Cooperation Council objective of being able to use one label and one safety data sheet per hazardous product. Therefore, stakeholders requested that Health Canada engage in open dialogue with the U.S. Occupational Safety and Health Administration to discuss the key variances and work together to align the Canadian and U.S. requirements to the greatest extent possible.

Health Canada recognizes the importance of aligning the Canadian and U.S. regulatory amendments as much as possible and ensuring that the number of variances is kept to a minimum. As part of the Canada-United States Regulatory Cooperation Council, Health Canada has had continued discussions with the U.S. Occupational Safety and Health Administration during monthly bilateral meetings to discuss possible areas of variance, and has modified the regulatory proposal published in the Canada Gazette, Part I, in order to address such potential variances (as described further below).

The Canada Gazette, Part I, publication proposed a two-year transition period for the regulatory amendments. During the consultation process, stakeholders commented that two years would not be sufficient, in light of the numerous and, in some cases, complex amendments proposed to the Hazardous Products Regulations. In addition, stakeholders commented that many businesses were heavily impacted by the COVID-19 pandemic and it may be a long time before companies are able to fully return to the level of operations that they had prior to the pandemic. As such, industry representatives requested a longer transition period to allow sufficient time for suppliers to become fully compliant with the amended Regulations. Stakeholders requested a two-step approach to transition (i.e. substances first and then mixtures). They also requested that Health Canada implement a phased-in transition period, where the first phase would apply to manufacturers and importers, the second phase would apply to distributors, and the third phase would apply to employers, similar to the transition approach that was adopted in 2015 when the Hazardous Products Regulations were published in the Canada Gazette, Part II, and came into force.

Health Canada has taken into account considerations related to balancing industry’s needs with the protection of workers’ health and safety when considering options for the coming into force of the regulatory amendments and the transition period. As such, since the Canada Gazette, Part I, publication, Health Canada has modified the regulatory proposal to adopt a three-year transition period. Due to practical considerations and feedback from Health Canada’s federal, provincial and territorial partners, Health Canada is unable to undertake a two-step or phased-in transition period. Health Canada has continued to collaborate with the U.S. Occupational Safety and Health Administration to align the timing of coming into force of the Canadian and U.S. regulatory amendments and the transition periods, to the extent possible, with a view to minimizing burden on businesses.

Some stakeholders expressed concerns that the cost estimates associated with revising labels and safety data sheets, as determined in the cost-benefit analysis and summarized in the Regulatory Impact Analysis Statement for the Canada Gazette, Part I, publication, underestimated the actual costs of revising labels and safety data sheets. They also commented that the cost estimates did not take into account the impacts of the COVID-19 pandemic on business operations.

Health Canada recognizes that the regulatory amendments will have impacts on businesses that sell or import workplace hazardous products in Canada, including costs associated with updating safety data sheets and labels. Stakeholder comments related to the costs of the regulatory proposal are addressed below in the “Benefits and Costs” section of this Regulatory Impact Analysis Statement.

Stakeholders also noted that many of the regulatory amendments will require additional guidance and, therefore, it is very important that Health Canada publish its updated Technical Guidance on the Requirements of the Hazardous Products Act and the Hazardous Products Regulations (Technical Guidance document) at the same time as the coming into force of the amended Regulations. In addition, stakeholders would like to have the opportunity to review and provide comments on the draft updates to the Technical Guidance document.

Health Canada is committed to providing stakeholders with additional guidance for the regulatory amendments. In addition to being updated to reflect the amendments to the Hazardous Products Regulations to align with the seventh revised edition of the GHS and certain provisions from the eighth revised edition of the GHS, the Technical Guidance document is also being updated to reflect the amendments to the Hazardous Materials Information Review Act (HMIRA) and the Hazardous Materials Information Review Regulations (HMIRR) that came into force in March 2020. Health Canada is aiming to have an updated Technical Guidance document available for stakeholders soon after the publication of the regulatory amendments in the Canada Gazette, Part II, to the extent possible.

Health Canada also received numerous and diverse comments concerning specific provisions of the Hazardous Products Regulations, including the following:

Health Canada is aiming to provide additional guidance on these issues along with guidance on the amendments to the Hazardous Products Regulations in its updated Technical Guidance document.

Given that the Regulations are being amended to align with the seventh revised edition of the GHS and certain provisions from the eighth revised edition of the GHS, some stakeholders expressed concerns about the frequency of updates to the GHS Purple Book, which has a two-year revision cycle. Stakeholders noted that the regulations of competent authorities, such as the Canadian Hazardous Products Regulations, always lag behind the latest version of the GHS Purple Book by a few years. They requested that Health Canada implement a more predictable and reasonable cycle for regulatory amendments.

As part of Health Canada’s continued participation on the United Nations Sub-Committee of Experts on the GHS, Health Canada will continue to engage the Sub-Committee on this topic.

Finally, Health Canada received various comments from stakeholders that will not be addressed at this time, for one or more of the following reasons:

Additional stakeholder consultation concerning section 5.12 of the Hazardous Products Regulations

From August 9, 2021, until August 30, 2021, Health Canada consulted with stakeholders concerning section 5.12 of the Hazardous Products Regulations, a provision that addresses the updating of labels and safety data sheets of hazardous products when significant new data become available. This consultation was conducted through email with representatives of suppliers, employers, and organized labour, as well as representatives of federal, provincial and territorial occupational health and safety government agencies.

The proposed Regulations Amending the Hazardous Products Regulations (GHS, Seventh Revised Edition) that were published in the Canada Gazette, Part I, on December 19, 2020, included proposed amendments to section 5.12 to specify that, when a supplier is required to provide, obtain or prepare a written document, it must provide the changes to the safety data sheet and/or label that result from the significant new data, rather than the new studies or data themselves.

During the public comment period that followed the publication of Health Canada’s regulatory proposal in the Canada Gazette, Part I, the Department received comments from industry representatives expressing concern with the proposed amendments to section 5.12. Industry representatives commented that, once new data become available with regard to a hazardous product, it takes time for businesses to review the new data and determine the changes that need to be made to the safety data sheet and label. Depending on the complexity of the new data and the level of expertise required to interpret the results of new scientific studies or reports, this work may take several days or weeks to complete.

Industry representatives suggested that, instead of the proposed modifications outlined in the Canada Gazette, Part I, publication, consideration be given to amending section 5.12 of the Hazardous Products Regulations so as to allow more time for suppliers to review new data when it becomes available, and to determine the changes required to their product labels and safety data sheets.

As a result, Health Canada prepared a stakeholder consultation document that outlined the proposal put forward by industry representatives, and requested comments from stakeholders through email correspondence. The stakeholder consultation document stated that Health Canada was considering the following two options: (1) amend section 5.12 of the Hazardous Products Regulations according to the new proposal suggested by industry; or (2) amend section 5.12 of the Hazardous Products Regulations as outlined in Health Canada’s Canada Gazette, Part I, regulatory proposal.

The Department received four responses from stakeholders, including two representatives of industry associations and two representatives of provincial occupational health and safety government agencies. One stakeholder was in favour of the proposal put forward by industry representatives and three were not in favour.

The stakeholder who supported the proposal put forward by industry representatives commented that these proposed amendments to section 5.12 were reasonable, as long as the amended Hazardous Products Regulations would require suppliers to send a letter that lists the changes to the safety data sheet to customers who purchased the product within the first 15 days after significant new data became available, as well as to customers who purchased the product within 16 to 90 days after significant new data became available.

One stakeholder who did not support the proposal put forward by industry representatives noted that it would not maintain the level of health and safety protections to workers currently provided by the Hazardous Products Regulations, would add administrative burden on the employer, and would increase the risk that the relevant information may not be communicated to or made available to the workers. This stakeholder indicated that Health Canada’s proposed modifications to section 5.12 of the Hazardous Products Regulations, as outlined in the Department’s Canada Gazette, Part I, regulatory proposal, would maintain the level of health and safety protections to workers provided by the Regulations.

Two more stakeholders provided comments indicating that they did not support the proposal put forward by industry representatives. They suggested a different approach, namely, that section 5.12 of the Hazardous Products Regulations be amended so as to remove the requirement for suppliers to provide to their customers a written document that outlines the significant new data and the date upon which it became available (i.e. repeal the requirements set out in paragraphs 5.12(2)(b) and 5.12(4)(b) of the Hazardous Products Regulations).They noted that the “written document” requirements impose administrative burden on industry and other countries do not have this requirement. In addition, they noted that, in their opinion, letters that outline significant new data do not contribute significantly to increase workers’ health and safety protections. They also commented that it is difficult to immediately evaluate whether a change, such as, for example, a change in the formulation of a hazardous product, meets the definition of “significant new data.” This could cause confusion because it is possible that customers would receive an initial letter, followed by a second letter that outlines the expected changes to the safety data sheet, but in the end (after further evaluation), the safety data sheet may not get updated after all because it turns out that the new data did not affect the safety data sheet for that particular product.

Based on the feedback received, Health Canada concluded there was a lack of general support for the proposal put forward by industry representatives. Health Canada took note of the comments provided by two stakeholders, requesting that the Department remove the requirement for suppliers to provide to their customers a written document that outlines the significant new data and the date upon which it became available. However, the Department determined that removing this requirement would not maintain the level of safety or protection to workers provided by the Hazardous Products Regulations and, therefore, did not consider the proposal further.

Therefore, as communicated in the Department’s stakeholder consultation document, the proposed amendments to section 5.12 of the Hazardous Products Regulations, as outlined in the Canada Gazette, Part I, regulatory proposal, were retained without additional modifications and are included in the final amendments to the Hazardous Products Regulations.

Health Canada is aiming to update its Technical Guidance document to provide additional guidance on the amended requirements set out in section 5.12 of the Hazardous Products Regulations.

Stakeholder consultation concerning the hazard statement for Combustible Dusts (Part 1 of Schedule 5 of the Hazardous Products Regulations)

From November 29, 2021, until December 20, 2021, Health Canada consulted with stakeholders concerning the hazard statement for products classified as Combustible Dusts. This consultation was conducted through email correspondence with representatives of suppliers, employers, and organized labour, as well as representatives of federal, provincial and territorial occupational health and safety government agencies.

According to Part 1 of Schedule 5 of the Hazardous Products Regulations (SOR/2015-17), the hazard statement required for products classified as Combustible Dusts is “May form combustible dust concentrations in air.” This is aligned with section C.4.30 of Appendix C of the U.S. Hazard Communication Standard 2012.

In the fall of 2021, during regular bilateral meetings held under the Canada-United States Regulatory Cooperation Council workplace chemicals initiative, Health Canada noted that the U.S. Occupational Safety and Health Administration was proposing to amend Appendix C of their Hazard Communication Standard to allow either of the following two hazard statements for products classified as Combustible Dusts:

“May form combustible dust concentrations in air [if small particles are generated during further processing, handling or by other means]”; OR

“May form explosible dust-air mixture [if small particles are generated during further processing, handling or by other means]”.

This is specified in section C.4.31 of Appendix C of the U.S. Occupational Safety and Health Administration’s Proposed Rulemaking to Amend the Hazard Communication Standard.

In order to better align with the U.S.’s proposed amendments, Health Canada presented to stakeholders a proposal to amend Part 1 of Schedule 5 of the Hazardous Products Regulations to allow either of the following two hazard statements for products classified as Combustible Dusts (the proposed modification is in bold):

May form combustible dust concentrations in air; or May form explosible dust-air mixture.

The new proposed amendment to Part 1 of Schedule 5 of the Hazardous Products Regulations would offer flexibility to suppliers, reduce variances and achieve better alignment between the Canadian and U.S. regulatory proposals. In addition, it would help to facilitate the use of one label and one safety data sheet, which is an objective under the Canada-United States Regulatory Cooperation Council workplace chemicals initiative. Furthermore, for products that are already being sold in or imported into Canada that are classified under the Hazardous Products Regulations as Combustible Dusts, the supplier would not need to make changes to the label or safety data sheet with regard to this new proposed amendment, because the hazard statement “May form combustible dust concentrations in air,” which is currently specified in Part 1 of Schedule 5 of the Regulations, would continue to be accepted for Combustible Dust products.

Moreover, it is anticipated that worker health and safety protections would be maintained. The proposed alternate hazard statement, “May form explosible dust-air mixture,” provides similar information to the current hazard statement. The proposed alternate hazard statement would warn employers and workers that there is a potential risk of a dust explosion. In addition, the safety data sheet would provide more detailed information, including information on first-aid measures, firefighting measures, precautions for safe handling and storage, exposure controls/personal protection, stability and reactivity, and much more. This is currently required under the Hazardous Products Regulations and it will continue to be required after the regulatory amendments.

Stakeholders were asked whether they supported the proposal and were invited to provide their comments to Health Canada. In total, Health Canada received seven responses from stakeholders, including representatives of industry associations and representatives of provincial occupational health and safety government agencies. Five stakeholders expressed support for Health Canada’s proposed amendment to Part 1 of Schedule 5 of the Hazardous Products Regulations, noting that it would achieve closer alignment between the Canadian and U.S. regulatory proposals, while at the same time maintaining worker health and safety protections.

Some of these stakeholders expressed concerns with regard to the extent of alignment of the Hazardous Products Regulations with the proposed amendments of the U.S. Occupational Safety and Health Administration. They noted that, according to the U.S. Occupational Safety and Health Administration’s Proposed Rulemaking to Amend the Hazard Communication Standard, it would be permitted in the U.S. to include the additional phrase “if small particles are generated during further processing, handling or by other means,” in either of the hazard statements for Combustible Dust products. However, they noted that this additional phrase is not included in either the existing or the proposed alternate hazard statement for Combustible Dusts, as set out in Part 1 of Schedule 5 of the Hazardous Products Regulations. These stakeholders noted that the longer hazard statements would be allowed on labels and safety data sheets of Combustible Dust products in the U.S., but that such labels and safety data sheets might be non-compliant with the Hazardous Products Regulations in Canada. Health Canada aims to address these comments in its updated Technical Guidance document, or in stakeholder outreach materials.

Two other stakeholders did not oppose the proposed amendment to Part 1 of Schedule 5 of the Hazardous Products Regulations but they provided several questions and comments, which the Department addressed.

Based on the feedback received, Health Canada concluded that there was general support for the Department’s proposal to amend Part 1 of Schedule 5 of the Hazardous Products Regulations to provide a second option for the hazard statement for Combustible Dusts. This amendment is therefore included in the final amendments to the Hazardous Products Regulations.

Stakeholder consultation concerning the potential adoption of the Chemicals Under Pressure physical hazard class from the eighth revised edition of the GHS

From March 21, 2022, to April 13, 2022, Health Canada consulted with stakeholders regarding the potential adoption of the Chemicals Under Pressure physical hazard class from the eighth revised edition of the GHS. Health Canada engaged representatives of federal, provincial, and territorial occupational health and safety government agencies as well as industry representatives, representatives of organized labour, and employer associations.

Health Canada became aware of a potential area of variance between the Canadian and U.S. regulatory proposals early in 2022, after the publication of the U.S. the Proposed Rulemaking to Amend the Hazard Communication Standard. During U.S. OSHA’s consultation on the Proposed Rulemaking to Amend the Hazard Communication Standard, stakeholders were asked for comments related to Chemicals Under Pressure. Stakeholders had previously expressed to Health Canada the importance of aligning the regulatory proposals between the two countries as much as possible. This led Health Canada to consider the adoption of the Chemicals Under Pressure physical hazard class from the GHS eighth revised edition. In the GHS eighth revised edition, Chemicals Under Pressure is included in the same chapter as the Aerosols physical hazard class. The chapter name is listed as “Aerosols And Chemicals Under Pressure” in chapter 2.3 of the GHS eighth revised edition. This chapter includes the definition, classification criteria, hazard communication requirements, classification decision logic, and guidance on specific heat of combustion for Chemicals Under Pressure.

As a result, Health Canada prepared a stakeholder consultation document that presented a new proposed amendment to include the addition of new classification criteria for Chemicals Under Pressure – Categories 1, 2, and 3, and the addition of a reference to the corresponding hazard communication elements that would be required on the labels and safety data sheets for products classified as Chemicals Under Pressure. This would also involve several consequential amendments to the Hazardous Products Regulations.

The proposed amendments would be expected to impact Canadian suppliers who sell or import workplace hazardous products already subject to the Hazardous Products Act and the Hazardous Products Regulations, which also meet the criteria to be classified as Chemicals Under Pressure. These suppliers would need to make changes to their labels and safety data sheets to bring them into compliance with the amended regulations. The proposed adoption of the Chemicals Under Pressure physical hazard class may also bring some new products into the scope of the Hazardous Products Act and the Hazardous Products Regulations, so suppliers of these products would incur some initial costs to prepare new labels and safety data sheets.

During the consultation process, stakeholders were asked whether they supported Health Canada’s proposed amendments to adopt Chemicals Under Pressure. They also had the opportunity to describe any concerns or other comments regarding these proposed amendments. Industry representatives were also asked several optional questions relating to the costs that stakeholders could incur if the Chemicals Under Pressure physical hazard class were adopted. They were asked whether they sell products that may be classified as Chemicals Under Pressure and asked to provide estimates of the number of products that would need to be re-evaluated, reclassified, or would need changes to their labels and safety data sheets because of these proposed amendments. They also had the opportunity to provide an estimate of the average costs for re-evaluating a product, reclassifying a product, revising a label, and revising a safety data sheet, as well as the total cost that their company or organization would incur if Chemicals Under Pressure were adopted.

Health Canada received ten responses to this stakeholder consultation. All responses were supportive or supportive with some considerations, with the exception of one response that was neutral with no comments. Many stakeholders were supportive of the adoption of Chemicals Under Pressure as it would increase workers’ health and safety protections, and reduce potential regulatory variances.

Some stakeholders asked Health Canada to consider adopting Chemicals Under Pressure as its own hazard class, independent from Aerosols. They noted that there are significant differences between Aerosols and Chemicals Under Pressure, such as their size limitations. Health Canada consulted with an internal technical expert on the GHS, who also supported the adoption of Chemicals Under Pressure as a separate hazard class. Stakeholders also requested that Health Canada’s regulations make it clear that Chemicals Under Pressure would not apply to materials classified as Aerosols and vice versa. Some stakeholders also brought up concerns about cost, specifically because the proposed amendments would result in new worker training components. Lastly, one stakeholder suggested that additional clarification be added to the proposed definition of Chemicals Under Pressure.

Two industry stakeholders provided specific estimates for the number of products that their company or organization would need to re-evaluate, reclassify, or would need changes to their labels and safety data sheets as a result of the proposed amendments. They also provided estimates of the costs their company or organization would incur because of these proposed changes. Further details related to the estimated costs of adopting this new hazard class are outlined in the Benefits and Costs section, below.

Health Canada is in agreement with stakeholders that the amendments would be beneficial, since the adoption of the Chemicals Under Pressure hazard class would reduce potential regulatory variances and increase workers’ health and safety protections, and has decided upon the adoption of Chemicals Under Pressure as a separate physical hazard class, rather than the original proposal of adopting Chemicals Under Pressure under the same hazard class as Aerosols. This modification addresses the feedback received from stakeholders, while still reducing potential regulatory variances, and increasing workers’ health and safety protections.

To address stakeholders’ concerns relating to the classification of products as Aerosols versus Chemicals Under Pressure, the regulatory amendment includes provisions indicating that products classified as Aerosols – Category 1, 2, or 3 must not be classified as Chemicals Under Pressure, and products classified as Chemicals Under Pressure – Category 1, 2, or 3 must not be classified as Aerosols. Health Canada also recognizes that there may be additional training costs as a result of the amendments to adopt Chemicals Under Pressure. Since training will already be required for other amendments to the Hazardous Products Regulations, Health Canada believes the adoption of the Chemicals Under Pressure physical hazard class will not significantly impact overall training costs. Finally, Health Canada aims to provide further clarification on the definition of Chemicals Under Pressure in its updated Technical Guidance document.

Modern treaty obligations and Indigenous engagement and consultation

As the Hazardous Products Regulations apply nationally, the amendments will take effect in all areas of modern treaties. However, the amendments would have no foreseeable impacts specifically on Indigenous peoples or laws as this proposal pertains to the requirements related to the classification of hazards found in hazardous products and the communication of health and safety information on labels and safety data sheets.

Instrument choice

In consideration that Health Canada has already incorporated and implemented the GHS (fifth revised edition) in the Hazardous Products Regulations, only regulatory options were considered. Non-regulatory options such as voluntary industry compliance through guidance would create confusion as this would not be consistent with current regulatory requirements. The following two regulatory options were considered:

Option 1. Status quo – Retain the fifth revised edition of the GHS in the Hazardous Products Regulations (no adoption of the seventh revised edition or certain provisions of the eighth revised edition)

Having the Hazardous Products Regulations continue to be based on the fifth revised edition of the GHS would fail to benefit Canadian employers and workers from the health and safety advantages afforded by the improved global standard for classifying workplace hazardous products.

Furthermore, the U.S., which is Canada’s largest trading partner, is in the process of moving forward with the adoption of the seventh revised edition. If Canada were not to proceed with the amendments, in addition to not meeting Canada’s international commitment under the Regulatory Cooperation Council, it would create costs for industry due to eventual misalignment.

Option 2. Adopt the seventh revised edition of the GHS in alignment with the U.S. to the degree possible within Canada’s legal and health and safety frameworks in addition to the adoption of certain provisions from the eighth revised edition of the GHS

In consideration of the importance of implementing the seventh revised edition of the GHS as well as certain provisions from the eighth revised edition of the GHS, while at the same time ensuring no loss of current worker protections in Canada, this option is recommended. This option will allow Health Canada to include additional necessary provisions but will also help to ensure that Canada remains in alignment with the U.S., to the extent possible, in terms of the manner in which workplace hazardous products (or hazardous chemicals, as known in the U.S.) are classified and hazards are communicated. This will also provide additional assurances that more comprehensive and more detailed health and safety information will be provided to Canadian employers and workers.

Regulatory analysis

Benefits and costs

Taking into consideration the cost estimates provided by industry associations in response to two questionnaires distributed by Health Canada in 2018 and in 2019, prior to the publication of Health Canada’s regulatory proposal in the Canada Gazette, Part I, and cost estimates provided by stakeholders in 2022 for adopting the physical hazard class Chemicals Under Pressure from the eighth revised edition of the GHS, this regulatory proposal was determined to have a significant cost. Therefore, a full cost-benefit analysis was conducted. This cost-benefit analysis characterizes the quantitative costs, qualitative costs and qualitative benefits of the implementation of the seventh revised edition of the GHS and of adopting the amendments to Part 1 of Schedule 5 of the Hazardous Products Regulations and the physical hazard class Chemicals Under Pressure from the eighth revised edition of the GHS. In addition, the cost-benefit analysis has been updated to reflect the adoption of a three-year transition period, to adjust the discounting presented in the Regulatory Impact Analysis Statement published in the Canada Gazette, Part I, to better capture the costs of the regulatory amendments, and to account for qualitative impacts associated with the adoption of new amendments.

Cost of the regulatory proposal

The regulatory amendments will impose costs on suppliers who sell or import hazardous products intended for use, handling or storage in Canadian workplaces. For Canadian suppliers who sell products in both Canada and the U.S., these costs will be incurred anyway, regardless of the amendments to the Canadian regulations, given the U.S. adoption of the seventh revised edition. As such, the described costs should be considered as an estimate of the upper boundary of costs, rather than as the actual incremental costs that could be associated with the Regulations. The incremental costs may be considerably less than the described costs (“incremental” refers to costs that suppliers would face due to the regulatory amendments that are over and above the costs they would face in the absence of regulatory amendments). This is because the cost estimates presented in the cost-benefit analysis were calculated independently from the U.S. adoption of similar provisions from the seventh revised edition of the GHS in their regulatory proposal.

To gather data on the anticipated costs, a questionnaire was distributed to industry stakeholders in April 2019 with correspondence with seven supplier associations that were members of the WHMIS Current Issues Committee. This questionnaire did not reflect the amendments made to the regulatory proposal after its publication in the Canada Gazette, Part I. These supplier associations have well over 200 core members and additional affiliate members focused in the sectors responsible for supplying and using workplace hazardous products in Canada. A modified version of the questionnaire was distributed to representatives of the animal feed industry.

In addition, Health Canada consulted with stakeholders in March to April 2022 regarding the potential adoption of the physical hazard class Chemicals Under Pressure from the eighth revised edition of the GHS in the Hazardous Products Regulations. Stakeholders who sell or import Chemicals Under Pressure products intended for use, handling or storage in Canadian work places were asked to provide Health Canada with an estimate of the number of products that would be affected by this proposed amendment and an estimate of the costs their company or organization would incur if this new physical hazard class were to be adopted. Health Canada did not receive sufficient data from the consultation responses to monetize the costs associated with the adoption of Chemicals Under Pressure. As such, a qualitative cost analysis had been conducted.

Assumptions made for the cost-benefit analysis include the following:

Twenty completed questionnaires were received in 2019 from individual companies that are expected to be generally representative of companies that manufacture, sell or import a range of hazardous products. These completed questionnaires provided data on the expected costs of the amendments, including monetized estimates of the costs associated with re-evaluating products, reclassifying products as necessary, revising labels, revising safety data sheets, and training workers and managers. Various other costs were also captured, including costs of updating computer systems, making updates to existing confidential business information claims, filing new confidential business information claims, relabelling existing stocks of products, and disposing of unused labels that would no longer be compliant.

The following business sectors are expected to be among the most impacted initially by this regulatory amendment:

In addition, it is anticipated that initial costs will be faced by all workplaces where hazardous products are used, handled or stored, because workers and managers would need to be trained on the changes to the WHMIS system resulting from the amendments. At the same time, employers will be likely to see accrued benefits as a result of workers receiving more comprehensive and more detailed hazard communication information and consequently, fewer workplace injuries and illnesses.

To develop the total national cost estimate for Canadian businesses, the questionnaire responses were used to estimate the cost associated with each type of incremental expense that would be incurred as a result of the regulatory amendments. With regard to the cost of revising safety data sheets, based on the responses from companies who provided data, three cost estimates were applied, including a low-end estimate, a central (most likely) estimate, and a high-end estimate. These estimates were the following:

It was noted that some safety data sheets would not cost much to revise while others would cost more, depending on the extent of revisions required and on whether computer systems, in-house resources or outsourced approaches are used to make the required changes. The central (most likely) cost estimate was used (i.e. the average cost of revising a safety data sheet was calculated to be $85), and it was estimated that approximately 205 000 safety data sheets would need to be revised in Canada.footnote 2 Using this information, a national one-time cost estimate associated with revising safety data sheets of $17.4 million was calculated.

A similar approach was used to develop the national cost estimate associated with revising labels. There were no data available to estimate the total number of labels in Canada that would need to be revised. Therefore, for this calculation, the cost-benefit analysis identified the questionnaires where respondents provided estimates of: (1) the cost of revising a safety data sheet and label; and (2) the total number of safety data sheets and labels that their business would need to revise. Based on the responses to the April 2019 survey provided by individual companies, the total cost of safety data sheet revisions for these businesses was estimated to be $5.1 million and the total cost of label revisions was estimated to be $3.6 million. This suggests that label revision costs are approximately 28% less than safety data sheet revision costs. Therefore, it was assumed that label revision costs are approximately 28% less than safety data sheet revision costs. Using the central (most likely) cost estimate of $85 per safety data sheet and extrapolating to the national level, the national one-time cost estimate associated with revising labels was calculated to be $12.6 million (72% of $17.4 million, with rounding to three significant digits).

Similarly, there were no data available to estimate the total number of products in Canada that would need to be re-evaluated. Therefore, for this calculation, the cost-benefit analysis identified the questionnaires where respondents provided estimates of the cost of re-evaluating products and the total number of products that their business would need to re-evaluate and reclassify, as necessary. Based on the responses to the April 2019 survey provided by individual companies, the total cost of safety data sheet revisions for these businesses was estimated to be $5.1 million and the total cost of product re-evaluations and reclassifications was estimated to be $3.7 million. This suggests that product re-evaluation and reclassification costs are approximately 26% less than safety data sheet revision costs. Therefore, it was assumed that product re-evaluation and reclassification costs are approximately 26% less than safety data sheet revision costs. Using the central (most likely) cost estimate of $85 per safety data sheet and extrapolating to the national level, the national one-time cost estimate associated with product re-evaluations and reclassifications was calculated to be $12.9 million (74% of $17.4 million).

With regard to training employees, based on the questionnaire responses and on correspondence received from representatives of federal, provincial and territorial occupational health and safety government agencies, it was assumed that on the average, 20 minutes of additional training would be provided to production workers. The number of production workers was estimated at 1.1 million and this resulted in a national one-time cost estimate of $10.1 million for training production workers. Based on the questionnaire responses, it was assumed that health and safety managers would require about two hours of training. The number of health and safety managers was estimated at 85 000 and this resulted in a national one-time cost estimate of $8.5 million for training managers. The other miscellaneous costs identified by businesses (including costs of updating computer systems, making updates to existing confidential business information claims, filing new confidential business information claims, and disposing of unused inventories of labels) were not extrapolated to the national level because the available data did not permit this extrapolation.

By adding up all of the above-mentioned itemized national cost estimates, the total national cost to Canadian businesses was $61.5 million. However, there is a large degree of uncertainty in this estimate owing to the small sample size and the variability in identified impacts by individual businesses. A discounted annual rate of 7% was applied. Based on this, the estimated total present value costs of the regulatory proposal would be $53.8 million over a ten-year period. This translates to an annualized average cost of $7.7 million.

This cost-benefit analysis was finalized in September 2022 and is available upon request to the Departmental contact, found below the “Implementation, compliance and enforcement, and service standards” section.

Stakeholder comments on the costs of the regulatory proposal published in the Canada Gazette, Part I

After the publication of the proposed amendments to the Hazardous Products Regulations in the Canada Gazette, Part I, Health Canada received stakeholder comments during the public comment period and through an additional stakeholder consultation. Health Canada received comments from four industry associations related to the estimates published in the cost-benefit analysis presented in the Regulatory Impact Analysis Statement portion of the Department’s Canada Gazette, Part I, publication. Three industry associations indicated that the cost estimates were too low, and one indicated that the cost estimates were aligned with the estimates provided by their membership.

In the consultation, two stakeholders expressed that the estimates to update safety data sheets due to the proposed regulatory amendments prepublished in the Canada Gazette, Part I, seemed low and may not reflect their industry’s responses to the questionnaires that were used to inform the Regulatory Impact Analysis Statement. One stakeholder noted specifically that their members had responded that the cost estimate to revise a safety data sheet was closer to $1,000 per safety data sheet. During the development of the cost-benefit analysis for the amendments to the Hazardous Products Regulations for publication in the Canada Gazette, Part I, the cost estimate of revising safety data sheets of $1,000 per safety data sheet was treated as an outlier in Health Canada’s analysis. This value was significantly higher than estimates provided by other survey responders.

Stakeholders also expressed that it was unclear why the estimated cost prepublished in the Canada Gazette, Part I, to update a label was calculated at 28% less than the estimated cost to update a safety data sheet due to the proposed regulatory amendments. In the cost-benefit analysis developed for the proposed amendments to the Hazardous Products Regulations published in the Canada Gazette, Part I, Health Canada was not able to determine the number of labels that would need to be revised due to the proposed regulatory amendments. Responses from the April 2019 survey were used to extrapolate the cost estimate for label revisions.

In response to the consultation, stakeholders also raised concerns regarding the accuracy of the cost-benefit analysis prepublished in the Canada Gazette, Part I, due to the limited number of survey responses (twenty responses). Health Canada recognizes that the low number of survey respondents can potentially lead to inaccuracy. However, in order to develop an accurate estimate of the costs, the cost-benefit analysis extrapolated data from estimates developed in the U.S. as well as data used to develop the cost-benefit analysis for the Hazardous Products Regulations that came into force in February 2015. In addition, Health Canada developed low-end, central, and high-end estimates for certain costs in order to account for the uncertainty associated with cost estimate responses to the April 2019 survey.

Stakeholders had also expressed that the cost-benefit analysis prepublished in the Canada Gazette, Part I, did not accurately account for other miscellaneous costs identified by businesses, which could potentially increase the costs of the regulatory proposal. Health Canada agrees that there are other miscellaneous costs that may contribute to the overall costs of the regulatory proposal. However, these costs have been accounted for qualitatively. They include updating computer systems, making updates to existing confidential business information claims, filing new confidential business information claims for exemption, and disposing of unused inventories of labels. It was not possible for Health Canada to systematically extrapolate these miscellaneous costs to the national level in order to develop a quantitative cost estimate.

Stakeholders commented in the consultation that the COVID-19 pandemic has inflated the cost of raw materials, wages, equipment, training and technology investments, and that this had not been accounted for in the cost estimates prepublished in the Canada Gazette, Part I. Health Canada recognizes that the pandemic has contributed to inflation in Canada. However, this cost-benefit analysis uses 2019-constant dollar values.

Finally, stakeholders stated that the cost estimates prepublished in the Canada Gazette, Part I, are based on the U.S. estimates for large businesses, rather than the U.S. estimates for small businesses, and that the cost-benefit analysis should account for most businesses in Canada being small businesses. Health Canada recognizes that the costs for the proposed regulatory amendments prepublished in the Canada Gazette, Part I, are based on U.S. estimates for large business and acknowledges that the regulatory amendments will have an impact on small businesses. However, there is limited data available that would allow Health Canada to address this discrepancy. Health Canada notes that the feedback from four of the stakeholders, who were classified as small businesses in the April 2019 survey, were used to develop the estimates for the cost-benefit analysis. As such, an attempt has been made to represent small businesses in the estimation of costs using this limited data.

Cost estimates for the amendments to Part 1 of Schedule 5 of the Hazardous Products Regulations

In the fall of 2021, during regular bilateral meetings held under the Canada-United States Regulatory Cooperation Council workplace chemicals initiative, Health Canada noted that the U.S. Occupational Safety and Health Administration was proposing to amend Appendix C of their Hazard Communication Standard to allow either of one of two hazard statements for products classified as Combustible Dusts.

In order to better align with the U.S.’s proposed amendments, Health Canada presented to stakeholders a proposal to amend Part 1 of Schedule 5 of the Hazardous Products Regulations to allow either one of two hazard statements for products classified as Combustible Dusts. Based on the feedback received from stakeholders, Health Canada concluded that there was general support for the Department’s proposal to amend Schedule 5 of the Hazardous Products Regulations to provide a second option for the hazard statement for Combustible Dusts.

Significant additional costs associated with this regulatory amendment are not expected. The amendment to Part 1 of Schedule 5 of the Hazardous Products Regulations will not bring new hazardous products within the scope of the Hazardous Products Act or the Regulations as this amendment does not impact the classification criteria for Combustible Dusts. The cost-benefit analysis does not consider the amendments to Part 1 of Schedule 5 as an incremental cost because the use of an alternative hazard statement for products classified as Combustible Dust is not a requirement of the regulatory amendments.

Cost estimates for the adoption of the physical hazard class, Chemicals Under Pressure

In March and April 2022, Health Canada also consulted stakeholders on the potential adoption of the physical hazard class Chemicals Under Pressure from the eighth revised edition of the GHS in the Hazardous Products Regulations. Health Canada became aware of a potential area of variance between the Canadian and U.S. regulatory proposals. Stakeholders had previously expressed to Health Canada the importance of aligning the regulatory proposals between the two countries as much as possible. This led Health Canada to consider the adoption of the Chemicals Under Pressure physical hazard class from the GHS eighth revised edition. Stakeholders from industry associations were asked to provide an estimate of the number of products that would be affected by this proposed amendment and an estimate of the costs their business or company would incur if this new physical hazard class were adopted. These responses would assist Health Canada in estimating the cost of this regulatory amendment. Health Canada received ten responses, only two of which provided an estimate of the expected costs associated with the proposed amendment and the number of products impacted by the proposed adoption of the Chemicals Under Pressure physical hazard class.

For products that meet the criteria to be classified as Chemicals Under Pressure and that are already classified as hazardous products under the Hazardous Products Regulations prior to the amendments to the Regulations to align with the seventh revised edition of the GHS and select provisions from the eighth revised edition of the GHS, the costs associated with this amendment would be to revise the safety data sheet and label, similarly to other products already subject to the Act and the Regulations, rather than to produce a new label and safety data sheet. These costs are not expected to be significant. Health Canada recognizes that there may be some products that would be newly brought under the scope of the Act and the Regulations due to the adoption of this new physical hazard class. For these products, there would be costs to produce a new label and safety data sheet, over and above the reported costs in the monetized analysis above.

Health Canada was not able to accurately estimate the number of products that would be newly brought under the scope of the Act and the Regulations due to the adoption of this new physical hazard class. However, based on the stakeholder consultation responses and an additional analysis undertaken by Health Canada, the Department estimates that it would be a low number of products. Due to limited data, the costs associated with the adoption of Chemicals Under Pressure have been addressed qualitatively.

There would be costs associated with the re-evaluation and reclassification of products already under the scope of the Hazardous Products Act and the Hazardous Products Regulations due to the adoption of Chemicals Under Pressure, but these costs are not expected to be significant. For products that would be newly brought under the scope of the Act and the Regulations due to the adoption of this new physical hazard class, there would be evaluation and classification costs over and above the reported costs in the monetized analysis above. Due to insufficient data, Health Canada was not able to monetize the re-evaluation and reclassification costs; however, the Department estimates that the number of products would be low.

The adoption of the physical hazard class Chemicals Under Pressure is not expected to significantly affect the cost estimate of training employees since workers and managers would already need to undertake training associated with the regulatory amendments to the Hazardous Products Regulations. There could be minor costs incurred in addition to the reported costs in the monetized analysis above.

Cost-benefit statement
Monetized costs
Table 1: Cost statement (2019$)
Impacted stakeholder Description of costs Year 1 Year 2 Year 3 Year 10 Total (present value) Annualized value
Industry Safety data sheet revisions $5,800,000 $5,800,000 $5,800,000 $0 $15,200,000 $2,200,000
Industry Label revisions $4,200,000 $4,200,000 $4,200,000 $0 $11,000,000 $1,600,000
Industry Product re-evaluation $4,300,000 $4,300,000 $4,300,000 $0 $11,300,000 $1,600,000
Industry Worker training $3,400,000 $3,400,000 $3,400,000 $0 $8,800,000 $1,300,000
Industry Manager training $2,800,000 $2,800,000 $2,800,000 $0 $7,400,000 $1,100,000
Industry Total costs $20,500,000 $20,500,000 $20,500,000 $0 $53,800,000 $7,700,000

Notes:

The cost-benefit analysis did not include any risk assessment and all impacts that were quantified were also monetized.

The costs to industry summarized in this table include costs associated with re-evaluating products, reclassifying products as necessary, revising labels and SDSs, and training workers and managers. The values for each of these itemized costs were rounded to two significant figures.

It is expected that the Government of Canada will not experience incremental costs as a result of the regulatory proposal (i.e. costs associated with implementing the proposal, developing training materials, etc., would be factored into the Department’s regular operating budget).

The health and safety benefits of the regulatory proposal to Canadian workers could not be quantified or monetized (see description below).

The figures shown in columns three to six are non-discounted values. The last two columns present discounted values.

The cost-benefit analysis also provided data on the cost breakdown by business size, as well as how impacts may be distributed across the regions in Canada (Table 2). The regional analysis was undertaken by examining the distribution of North American Industry Classification System (NAICS) code 324 (Petroleum and Coal Product Manufacturing) and NAICS code 325 (Chemical Manufacturing) across Canada. Based on data reported in a previous economic analysis of proposed changes to the U.S. Hazard Communication Standard, prepared in September 2009,footnote 3 it is expected that these two sectors would face a large portion of product re-evaluation costs and costs of revising labels and safety data sheets. Based on data from Canadian Industry Statistics, with regard to NAICS codes 324 and 325, the distribution of establishments in these two sectors is relatively similar to the distribution of the population across Canada. Therefore, no disproportionate regional impacts are anticipated.

Table 2: Quantified impacts (costs) breakdown by business size and across the regions in Canada (2019$).
Impacts (costs) on businesses Year 1 Year 2 Year 3 Year 10 Total
(present value)		 Annualized average
Small firms $18,900,000 $18,900,000 $18,900,000 $0.0 $49,500,000 $7,100,000
Medium-sized firms $1,400,000 $1,400,000 $1,400,000 $0.0 $3,800,000 $500,000
Large firms $200,000 $200,000 $200,000 $0.0 $500,000 $100,000
Total $20,500,000 $20,500,000 $20,500,000 $0.0 $53,800,000 $7,700,000
Impacts by region            
Atlantic $600,000 $600,000 $600,000 $0.0 $1,600,000 $200,000
Quebec $5,500,000 $5,500,000 $5,500,000 $0.0 $14,300,000 $2,100,000
Ontario $8,200,000 $8,200,000 $8,200,000 $0.0 $21,500,000 $3,100,000
Prairies $3,600,000 $3,600,000 $3,600,000 $0.0 $9,500,000 $1,400,000
British Columbia $2,600,000 $2,600,000 $2,600,000 $0.0 $6,800,000 $1,000,000
Territories $0.0 $0.0 $0.0 $0.0 $100,000 $0.0
Total $20,500,000 $20,500,000 $20,500,000 $0.0 $53,800,000 $7,700,000

Note: The figures shown in columns two to five are non-discounted values. The two columns present discounted values.

The regulatory amendment has received support from industry. All respondents to the April 2019 questionnaire that was distributed to supplier representatives of the Current Issues Committee expressed their support for the proposed amendments. They noted that failing to update the Canadian regulations to maintain alignment with the U.S. would ultimately impose more significant costs on suppliers of hazardous products because they would be required to prepare two sets of labels and safety data sheets for certain products in order to be able to market them in both countries. Furthermore, Health Canada received similar comments from stakeholders in response to its consultation on the proposed amendment to Part 1 of Schedule 5 of the Regulations and regarding the proposed adoption of the Chemicals Under Pressure physical hazard class from the eighth revised edition of the GHS.

Benefits of the regulatory proposal

This regulatory amendment is expected to result in health and safety benefits to Canadian workers as well as economic benefits to Canadian businesses. There is not enough evidence to support quantification and subsequent monetization of the health and safety benefits of the regulatory amendment to Canadian workers. No data are available to quantify or monetize the expected reduction in injuries, acute and chronic illnesses, or fatalities in the workplace. Available data do not allow quantification of the extent to which injuries, illnesses, and fatalities that are associated with exposure to hazardous products occur in Canadian workplaces. Nor is reliable information available on the extent to which each of these would be reduced by adopting the amendments. Therefore, a qualitative analysis of the health and safety benefits of the regulatory amendment was included in the cost-benefit analysis.

It is expected that, by providing increased health and safety benefits to Canadian workers, these regulatory amendments would translate into

Health and safety benefits

The following elements of the regulatory proposal are expected to provide increased health and safety benefits and protections to Canadian workers:

Economic benefits

Canadian businesses that import, export, and sell hazardous products intended for use in the workplace are expected to experience economic benefits as a result of the regulatory amendments.footnote 4 Although businesses will initially incur costs to bring product labels and safety data sheets into compliance with the amended Hazardous Products Regulations, Canadian companies who sell hazardous products in both Canada and the U.S. will need to incur these costs anyway, regardless of the regulations, when the U.S. adopts the GHS (seventh revised edition). The amendments to the Hazardous Products Regulations will continue to maintain alignment with the U.S. Hazard Communication Standard, thereby preventing inconsistencies that would require Canadian suppliers to prepare two sets of labels and safety data sheets for some products to be able to market their products in both countries. The regulatory amendments will therefore allow Canadian suppliers to avoid additional costs that they would face if there were different requirements for workplace hazardous products in Canada and the U.S.

Over time, it is anticipated that the costs to businesses will be reduced as compared to what they would be if Canada did not update its Hazardous Products Regulations to align with the seventh revised edition of the GHS. Once the amended Hazardous Products Regulations and the amended U.S. Hazard Communication Standard are published and come into effect, suppliers will be able to continue to use one label and one safety data sheet per product to meet the hazard communication requirements of both countries, subject to Canada’s legal and health and safety frameworks, including official languages requirements. It should be noted that the costs associated with amending the Hazardous Products Regulations were calculated independently from the U.S. adoption of similar provisions from the seventh revised edition of the GHS. However, should the U.S. adopt the same provisions in their regulatory proposal for the Hazard Communication Standard, it is anticipated that there will be additional benefits associated with amending the Hazardous Products Regulations. Thus, additional cost savings are anticipated over time. This will generate cost savings and economic benefits for Canadian businesses. Moreover, subject to Canada’s legal and health and safety frameworks, including official languages requirements, Canadian suppliers who import hazardous products from the U.S. will not need to make changes to product labels or safety data sheets, so importers will thereby experience cost savings as well.

It is important to consider the significance of continuing to harmonize Canadian requirements for hazardous products with those of our major trading partners. Based on data from Trade Data Online, approximately one half of all Canadian imports (i.e. imports of all goods, not just workplace hazardous products) arrive from the U.S.

Small business lens

The regulatory amendments will have impacts on small businesses; however, limited data are available to identify the anticipated costs. In response to the cost-benefit analysis questionnaire, four submissions were received from small businesses, all in favour of the regulatory proposal to continue aligning the Hazardous Products Regulations with the U.S. Hazard Communication Standard.

Based on the limited data available, the cost-benefit analysis estimated that the total compliance costs for small businesses would be approximately $49,500,000 (expressed in terms of present value). This translates to an annualized average cost of $7,100,000, as shown in Table 3. These values were calculated based on the total present value costs of the regulatory amendments ($53.8 million, which translates to an annualized average of $7.7 million), and by taking into consideration that small businesses (1 to 99 employees) comprise approximately 92% of all the businesses in NAICS codes 324 (Petroleum and Coal Product Manufacturing) and 325 (Chemical Manufacturing)footnote 5, two sectors which are expected to be among the most affected in terms of the number of safety data sheets that will require revision. There were insufficient data to estimate the total number of small businesses that will be impacted.

Small business lens summary

Table 3: Small business lens summary

Compliance costs
Activity Annualized value Present value
Costs associated with product re-evaluation, reclassification, revising labels and SDSs, and worker training $7,100,000 $49,500,000
Total compliance cost $7,100,000 $49,500,000
Administrative costs
Activity Annualized value Present value
Not applicable because the regulatory proposal does not impose any new administrative burden or new administrative burden costs N/A N/A
Total administrative cost N/A N/A
Total compliance and administrative costs
Totals Annualized value Present value
Total cost (all impacted small businesses) $7,100,000 $49,500,000
Cost per impacted small business insufficient data to calculate insufficient data to calculate

The average costs expected to be faced by small businesses as a result of having to re-evaluate products, reclassify products as necessary, revise labels, revise safety data sheets, and train employees are summarized in Table 4. These costs would fall under “compliance costs” rather than “administrative costs.” The regulatory proposal does not impose any new administrative burden or new administrative burden costs on suppliers. Based on the limited data available, small businesses are not expected to face significantly different costs than larger businesses.

Table 4: Average costs expected for small businesses as a result of the amendments to the Hazardous Products Regulations
  Small businesses All businesses
Average cost per product re-evaluation and reclassification $248table 1 note 1 $210
Average cost per label revision $152 $146
Average cost per SDS revision $63 $164
Average cost per employee trained $54table 1 note 2 $29
Other costs none identified several identifiedtable 1 note 3

Table 1 Notes

Notes:

Table 1 Note 1

The cost per re-evaluation and reclassification among small businesses is skewed by one high-end outlier. If this outlier is removed, the cost per re-evaluation among small businesses falls well below the full sample average of $210.

Return to table 1 note 1 referrer

Table 1 Note 2

The cost per employee trained among small businesses is skewed by one high-end outlier. If this outlier is removed, the cost per employee trained among small businesses falls to half the average for all businesses.

Return to table 1 note 2 referrer

Table 1 Note 3

Other costs included costs of updating computer systems, making updates to existing confidential business information claims, filing new confidential business information claims, relabelling existing stocks of products, and disposing of unused labels that would no longer be compliant.

Return to table 1 note 3 referrer

As is the case for larger businesses, the regulatory amendments will benefit small businesses by continuing to align the Canadian requirements for workplace hazardous products with those of the U.S. The amendments will thereby support the growth of small businesses, given the relatively large market the U.S. provides. If Canada and the U.S. were to adopt different versions of the GHS, the requirements for workplace hazardous products would become misaligned. This would create an obstacle to the growth of small businesses, due to the costs involved in preparing two sets of labels and safety data sheets for some products. Large businesses are more likely to be part of an integrated North American market, and thus are likely to comply with the regulatory requirements in both Canada and the U.S. markets. However, small businesses will likely face a greater compliance challenge due to the amendments to the Hazardous Products Regulations. As such, a three-year transition period to comply with the regulatory amendments is more likely to benefit small businesses.

No flexible mechanism was used to mitigate costs for small businesses, as delaying the timing of required compliance with the amendments for small businesses (as a flexible option) would result in two sets of hazard identification and communication requirements in Canada. This would reduce the extent of economic benefits and worker protection, and possibly increase the costs to small and large businesses alike. A three-year transition period for all suppliers (small, medium, and large businesses) is expected to allow sufficient time for them to transition to the new requirements.

One-for-one rule

The one-for-one rule does not apply since there is no incremental change in administrative burden on business.

Regulatory cooperation and alignment

Under the Regulatory Cooperation Council Joint Forward Plan, Canada and the U.S. jointly developed a Work Plan for the workplace hazardous products initiative in which they publicly committed to coordinate amendments to their respective regulations to align with updates to the GHS. The Hazardous Products Regulations are based on the fifth revised edition of the GHS, which was published in 2013. The seventh revised edition was released in 2017. In order for Canada to meet its international commitment under the Regulatory Cooperation Council Joint Forward Plan, Health Canada is amending the Hazardous Products Regulations to adopt updates made to the GHS to align with the seventh revised edition. The U.S. is currently making similar amendments to their Hazard Communication Standard. In addition, Health Canada is adopting the Chemicals Under Pressure physical hazard class from the GHS eighth revised edition, in response to feedback received from stakeholders.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

The amendments to the Hazardous Products Regulations would have no foreseeable impacts on sex, gender or diversity-related issues. No gender-based analysis plus (GBA+) impacts have been identified for these amendments. The amendments are expected to increase the level of protection to Canadian workers above that which is afforded by the current Hazardous Products Regulations.

Implementation, compliance and enforcement, and service standards

Implementation

The intention is to move forward with these regulatory changes in a timely manner. Attention will also be given to help ensure consistency across Canada through coordination and alignment between federal, provincial and territorial jurisdictions. In addition, Canada and the U.S. are working together to coordinate and synchronize, to the extent possible, the coming into force of the amended Hazardous Products Regulations with the coming into force of the updates to the U.S. Hazard Communication Standard.

A transition period of three years will begin on the date when the amendments to the Hazardous Products Regulations come into force. It is possible that the transition approach and timing may not end up completely aligned between Canada and the U.S. It may turn out that chemical manufacturers, importers and distributors in the U.S. would need to be in compliance with the amended Hazard Communication Standard starting from an earlier date than the date upon which Canadian suppliers would need to be in compliance with the amended Hazardous Products Regulations. If so, then Canadian suppliers who export hazardous products to the U.S. would need to be aware of the earlier transition end date in the U.S. to avoid having product safety data sheets and labels that would be non-compliant in the context of the amended Hazard Communication Standard. An earlier transition end date in the U.S. would not be a concern for Canadian suppliers who import hazardous products from the U.S. into Canada. It is expected that such imported hazardous products would already be in compliance with the amended Hazardous Products Regulations, except where changes may need to be made to safety data sheets and labels to reflect Canada’s official language requirements and any other requirements that are specific to Canada’s legal and health and safety frameworks.

Compliance and enforcement

Health Canada will continue to undertake inspection activities as provided for under the Hazardous Products Act. Working with the Intergovernmental WHMIS Coordinating Committee and the Canadian Association of Administrators of Labour Legislation — Occupational Safety and Health Committee, Health Canada will develop training materials and undertake training sessions for inspectors designated under the Hazardous Products Act to promote a common understanding and interpretation of the new regulations. Costs associated with developing training materials, training inspectors, and other related activities will be factored into the Department’s regular operating budget.

Contact

Lynn Berndt-Weis
Workplace Hazardous Materials Bureau
Department of Health
269 Laurier Avenue West, 8th Floor
Ottawa, Ontario
K1A 0K9
Telephone: 1‑855‑407‑2665
Fax: 613‑952‑2551
Email: hc.whmis-simdut.sc@canada.ca