Summary of Comments on the Proposed Hazardous Products Regulations published in Canada Gazette, Part I on August 9, 2014

Health Canada received 47 submissions from industry associations, chemical companies, provincial and territorial governments and other federal government departments, worker organizations and other professional organizations. Comments were received from both Canadian and United States stakeholders.

The below table contains a summary of the comments received. The table is organized based on the structure of the Hazardous Products Regulations and the topic of the comment. Each entry contains a condensed version of the comments and a response.

Section of HPR Topic Comment Response

1(1)

Definition of “aerosol dispenser”

Health Canada should exclude refillable aerosol containers from the definition of “aerosol dispenser” to be consistent with the former requirements of the Controlled Products Regulations.

The proposed regulations were revised to specify that the definition “aerosol dispenser” includes only “non-refillable aerosols”. This is consistent with the former requirements of the Controlled Products Regulations and is aligned with the U.S. Hazard Communication Standard 2012 with regard to the definition of “aerosol dispenser”.

Definition of “acute toxicity estimates”

Health Canada should clarify whether acute toxicity estimates are required for mixtures and their ingredients, and provide information on how to calculate the acute toxicity estimate.

This topic will be clarified in guidance.

Definition of “GHS”

Health Canada should address the potential for confusion due to small differences in hazard class names between the GHS and the proposed regulations.

The proposed regulations were revised to clarify how the names of the hazard classes in the Hazardous Products Regulations correspond to those in the GHS.

Health Canada should reference the 4th revised edition of the GHS instead of the 5th revised edition to align with the U.S. and avoid minor variations in precautionary statement requirements.

The 5th revised edition corrected errors in the hazard statements in the French version of the GHS.  Adopting the 5th revised edition was necessary to maintain the level of protection for workers. The variations in precautionary statements in the English text are minor and do not affect their intended meaning.

Health Canada should confirm that Canada and the U.S. adopted the same 'building blocks' of the GHS.

Canada has adopted the same ‘building blocks’ as the U.S.

Definition of “liquid”

Health Canada should provide clarification regarding “pastes” in respect of the definition of liquid.

This topic will be clarified in guidance.

Definitions of “substance” and “mixture”

Health Canada should add definitions for "substance" and "mixture" in the proposed Hazardous Products Regulations.

Definitions for “substance” and “mixture” are provided in the Hazardous Products Act.

Definition of “UN number”

Health Canada should address the lack of consistency between the French version of the regulations and French version of the UN Model Regulations.

The French version of the regulations is consistent with the English version of the GHS.  Clarification will be provided in guidance.

2(6) former

Two or more discrete materials, mixtures or substances in common packaging

Health Canada should include a provision that specifically allows the use of consolidated labels on common packaging.  

The Hazardous Products Regulations allows the use of consolidated labels on common packaging (e.g., one sticker containing two labels). This topic will be clarified in guidance.

2.1

Classification

Health Canada should specify in the regulations that information such as the route of exposure, mechanistic information, and metabolism studies should be taken into consideration when considering the relevance of animal study findings to humans.

The proposed regulations were revised to clarify the relevant requirements.

Health Canada should address situations where hazardous ingredients are contained in a bound matrix (e.g., body fillers, adhesives and coatings).

This topic will be clarified in guidance.

Health Canada should not adopt a “single study rule” that encourages the use of ‘junk science’.

The regulations require that a scientifically validated method be used and that studies be performed in accordance with generally accepted standards of good scientific practices.

Health Canada should require the disclosure of carcinogens that are on a carcinogen list.

The regulations require the disclosure of substances and ingredients in mixtures that have been determined to be carcinogenic as a result of testing or studies carried out in accordance with generally accepted standards of good scientific practice and conclusions based on established scientific principles.  A list of carcinogens produced by an organization such as the International Agency for Research on Cancer (IARC) would meet these criteria.  This topic will be clarified in guidance.

2.8

Biological availability

Health Canada should exempt manufactured articles under the concept of “biological availability”.

Manufactured articles are excluded from the application of the Hazardous Products Act and regulations.

3(1)(b)

Initial supplier identifier

Health Canada should clarify the definitions and use of the terms “initial supplier identifier”, “first supplier”, and “subsequent supplier”.

This topic will be clarified in guidance.

3(1)(c)

Label elements required by the GHS

Health Canada should clearly identify, in the regulations, the label elements that are required by the GHS.

The proposed regulations were revised to clarify what is meant by information elements (i.e., symbol, signal word, hazard statement and precautionary statements) to avoid potential confusion.

Health Canada should clarify what information is required on the label including first aid treatment and a reference to the safety data sheet.

This topic will be clarified in guidance.

3(1)(e)

Unknown acute toxicity

Health Canada should not require a statement on the label for unknown acute toxicity if the product is not classified as acutely toxic.

The regulations indicate that if a product is not classified as acutely toxic, the statement is not required.

Health Canada should clarify if the route of exposure should or must be included in the unknown acute toxicity statement.

This topic will be clarified in guidance.

3(1)(f)

Water activated toxicants

Health Canada should align the approach to water activated toxicant hazard statements with the U.S., by requiring their inclusion on the safety data sheet only.

The requirement for the hazard statement on the label for water activated toxicants was maintained to be consistent with the level of protection provided by the former requirements in the Controlled Products Regulations

3(4)

All applicable organs

With respect to disclosure of affected organs on labels, Health Canada should revise the regulations so that the label and safety data sheet convey any information that is known to the supplier regardless of whether the effects on all organs are known.

The proposed regulations were revised accordingly.

3(6)(b)

Information elements for certain categories (eye irritation)

Health Canada should clarify the classification requirements for eye irritants.

This topic will be clarified in guidance.

3.1

Pictograms

Health Canada should confirm if it is possible to use a different pictogram background colour (besides white).

Both Canada and the U.S. require the background colour to be white. This topic will be clarified in guidance.

3.2

Not applicable hazard statements

Health Canada should allow a hazard statement to be omitted if the statement is inappropriate. 

In order to maintain the level of worker protection, hazard statements cannot be omitted.

3.3

Information elements on label grouped together

Health Canada should clarify the requirements for the grouping of pictograms, warning and hazard statements.

This topic will be clarified in guidance.

Health Canada should include a requirement for the WHMIS hatched border.

The hatched border would not be aligned with the U.S. or the GHS, and is not required to maintain the level of protection for workers.

3.4

Legibility of label

Health Canada should clarify requirements regarding the placement and legibility of labels.

This topic will be clarified in guidance.

Health Canada should require a minimum size for text and pictograms.

The regulations include legibility requirements; these requirements will be clarified in guidance.

4(1)(c)

Additional information

Health Canada should clarify the use of the term “applicable” in this section.

This topic will be clarified in guidance.

Health Canada should remove the requirement to disclose all additional hazard information in respect of the hazardous product.

This requirement was maintained to be consistent with the level of protection provided by the former requirements in the Controlled Products Regulations.

4(2)

“Not applicable” in SDS section 11

Health Canada should allow the use of the phrase “not applicable” in section 11 of safety data sheets.

The proposed regulations were revised to allow the use of “not applicable” in section 11 of safety data sheets.

4(3)

SDS sections 12 to 15 optional

Health Canada should clarify environmental hazards and whether they are covered under the regulations.  

Environmental hazards are outside the scope of the regulations. This topic will be clarified in guidance.

Health Canada should make transportation information mandatory on safety data sheets.

Transportation information is outside the scope of the regulations. This topic will be clarified in guidance.

4.1

Reaction products

Health Canada should clarify the scope of section 4.1.

This topic will be clarified in guidance.

Health Canada should align more closely with the U.S. regarding information on new hazards that arise as a result of mixing products together.

The proposed regulations were revised to more closely align with the U.S. in this area.

4.2

Identical identifiers

Health Canada should remove the requirement for identical supplier identifiers on the label and SDS.

Identical supplier identifiers on the label and SDS are important for matching a label to a safety data sheet.

Health Canada should clarify the application of section 4.2 in guidance.

This topic will be clarified in guidance.

4.3

Concentration units

Health Canada should clarify the application of section 4.3.

This topic will be clarified in guidance.

4.5

Concentration ranges

Health Canada should revise this section to allow concentration ranges to be used to protect confidential business information without filing a claim for exemption.

The protection of confidential business information is provided for under the Hazardous Materials Information Review Act, and will be addressed in guidance.

Health Canada should clarify the use of concentration ranges.

This topic will be clarified in guidance.

5(1) to (6)

Lab sample exemptions

Health Canada should allow exemptions for product samples that are not laboratory samples.

This requirement was maintained to be consistent with the level of protection provided by the former requirements in the Controlled Products Regulations

5.2

Outer container

Health Canada should clarify this exemption in relation to the requirements for the transportation of dangerous goods.

This topic will be clarified in guidance.

5.3

Outer container label exemption

Health Canada should exempt outer containers from all label requirements.

This requirement was maintained to be consistent with the level of protection provided by the former requirements in the Controlled Products Regulations

5.5

Bulk shipment

Health Canada should exclude intermediate bulk containers from the bulk shipment exemption.

The bulk shipment exemptions provisions are consistent with the U.S. requirements and the former requirements under the Controlled Products Regulations.

Health Canada should use terminology from the regulations related to the transportation of dangerous goods in this section.

The terminology used is consistent with the U.S. requirements and the former requirements of the Controlled Products Regulations.

5.6

Complex mixtures

Health Canada should replace the term “complex mixture” with “complex substance”.

The term “complex mixture” must be used in the regulations in order to classify these products accurately based on their component parts if data on the product as a whole is not available.

Health Canada should allow the use of data on similar mixtures to support the classification of complex mixtures.

Guidance on the use of bridging principles will be provided, including the use of data on similar mixtures to support classification.

Health Canada should provide guidance on the requirements for complex mixtures.

This topic will be clarified in guidance.

5.7

Confidential business information

Health Canada should replace the current confidential business information protection mechanism with one like that in the U.S.

Harmonizing the protection mechanism for confidential business information was not within the scope of the Regulatory Cooperation Council commitment on workplace chemicals. 

5.9

Importation for own use in workplace

Health Canada should provide an exemption for products imported for use in the importer’s workplace.

This exemption exists and will be clarified in guidance.

5.10

Repetition of symbols on label

Health Canada should clarify whether the pictogram exemption is mandatory for labels that already have transportation symbols.

This exemption is not mandatory. This topic will be clarified in guidance.

5.12

Updating labels and SDSs based on “significant new data”

Health Canada should clarify the new requirements with respect to updating SDS and label information.

This topic will be clarified in guidance.

Health Canada should remove the requirement to provide a written notification to customers during the time that significant new data is available but the SDS has not yet been updated.

This requirement was maintained to be consistent with the level of protection provided by the former requirements in the Controlled Products Regulations The provisions are aligned with the timelines allowed for updating SDSs and labels in the U.S. and they address the need to provide accurate health and safety information in a timely manner.

5.14

Goods in transit

Health Canada should revise section 5.14 to require WHMIS labels and SDSs for goods in transit.

Goods in transit are regulated under the Transportation of Dangerous Goods Act, not the Hazardous Products Act.

5.15

Label exemption for imported products

Health Canada should include a label exemption for imported products until the products can be re-labelled to comply with Canadian requirements.

The proposed regulations were revised to include a label exemption for imported products on the condition that they be re-labelled to comply with Canadian requirements prior to their re-sale or use in Canada.

6(2)

Confidentiality

Health Canada should clarify the requirement to inform health professionals that information provided to them is confidential when a supplier wants to maintain the confidentiality of that information.

This topic will be clarified in guidance.

6.2

Bilingual requirements

Health Canada should clarify bilingual requirements for labels.

This topic will be clarified in guidance.

Health Canada should remove the requirement to provide safety data sheets in both official languages.

The bilingual requirements for labels and safety data sheets are required pursuant to the Official Languages Act.

7.1

Explosives

Health Canada should include explosives, and require that they only be labelled for explosive effects.

A full regulatory process would need to be undertaken before the exclusion for explosives in the Hazardous Products Act could be revised or removed.

7.3

Definition of “foam aerosol” and “spray aerosol”

Health Canada should amend the definitions of “foam aerosol” and “spray aerosol” to exclude aerosols fitted with a metering device to align with U.S. requirements.

The regulations are aligned with U.S. requirements.

7.6

Flammable liquids

Health Canada should remove the provision that allows the use of the flashpoint of the lowest flashpoint in the mixture.

This requirement was revised because of the risk of over-classification. Suppliers have two options for classification (testing or calculation).

7.17

Combustible dust

Health Canada should align with the U.S. and the work of the UN sub-committee regarding the definition of “combustible dust”.

Health Canada revised the definition to align as closely as possible with the U.S. and the work of the UN sub-committee. Products considered as combustible dusts under Health Canada’s definition would also be considered as combustible dusts in the U.S.

7.20 and 8.12

Physical and health hazards not otherwise classified

Health Canada should align the definition and requirements for “hazards not otherwise classified” by removing the requirements for labels and ingredient disclosure.

As defined, these hazards may cause serious injury or death.  These requirements were maintained to be consistent with the level of protection provided by the former requirements in the Controlled Products Regulations and to ensure the appropriate disclosure of ingredients that present health hazards.

8.1

Acute toxicity: preferred species and non-toxic ingredients

Health Canada should clarify the preferred species for test data used to classify in the acute toxicity hazard class.

This topic will be clarified in guidance.

Health Canada should clarify the exclusion of ingredients that are presumed not acutely toxic (e.g., water, sugar) to ensure consistency with the U.S.

This topic will be clarified in guidance.

8.4.5

Respiratory or skin sensitizers: data available

Health Canada should clarify the use of data on ingredients when classifying respiratory or skin sensitizers.

This topic will be clarified in guidance.

8.6

Carcinogenicity

Health Canada should make labels optional for products that contain Category 2 carcinogens at between 0.1% and 1.0%.

This requirement was maintained to be consistent with the level of protection provided by the former requirements in the Controlled Products Regulations.

Health Canada should not allow data on the product as a whole to be used for carcinogenicity classification and should only allow data on ingredients to be used.

This requirement was maintained, as it is consistent with accepted standards of good scientific practice and is aligned with U.S. requirements and the former requirements in the Controlled Products Regulations.

8.8.1

Specific Target Organ Toxicity – Single Exposure

Health Canada should provide guidance regarding classification of Specific Target Organ Toxicity.

This topic will be clarified in guidance.

8.11.1

Biohazardous infectious materials concentration cut-off

Health Canada should establish a concentration cut-off for biohazardous infectious materials.

Concentration cut-offs are not appropriate for biohazardous infectious materials as they present a hazard even in miniscule amounts.

8.12

Corrosive to the respiratory tract

Health Canada should provide guidance on how substances and mixtures that are corrosive to the respiratory tract will be covered.

The corrosive to the respiratory tract hazard falls under Health Hazards Not Otherwise Classified. This topic will be clarified in guidance.

Schedule 1

Equivalent names of hazard classes

Health Canada should allow for equivalent names of hazard classes to be used, and descriptions of the hazards for non-GHS hazard classes.

The regulations allow for the use of equivalent names for hazard classes, and descriptions of the hazards are allowed for Physical Hazards Not Otherwise Classified and Health Hazards Not Otherwise Classified. This will be discussed further in guidance.

Schedule 2

Information sheets

Health Canada should indicate the availability of safety data sheets for biohazardous infectious materials.

This topic will be clarified in guidance.

Schedule 3

Pictogram borders

Health Canada should allow the use of black borders around pictograms instead of red borders.

The use of red borders is a critical component of the hazard communication system in the GHS. The use of black borders would be out of alignment with the U.S. and the GHS.

Schedule 4

Classification of products, mixtures, materials or substances

Health Canada should clarify how substances and mixtures are put on the schedule of prescribed classifications.

This topic will be clarified in guidance.

Part 3

Inner container label exemption

Health Canada should allow the use of foreign labels on inner containers.

Foreign labels can be used as long as they comply with the Canadian requirements.  This topic will be clarified in guidance.

Part 4

Generic safety data sheets

Health Canada should allow the use of generic safety data sheets with multiple products that have the same ingredients but in slightly different concentrations.

The regulations allow the use of generic safety data sheets. This topic will be clarified in guidance.

Other

Food and drugs

Health Canada should remove the exclusion for food and drugs.

A full regulatory process would need to be undertaken before this exclusion could be revised or removed.

Other

Pesticides

Health Canada should implement the GHS for pesticides.

The Pest Management Regulatory Agency has indicated its intention to implement the GHS for pesticides under the Pest Control Products Act.

Other

Consumer products

Health Canada should clarify the application of the Hazardous Products Act to consumer products.

Consumer products are excluded from the application of the Hazardous Products Act. This topic will be clarified in guidance.

Other

Coming into force

The Government of Canada should have the regulations come into force as soon as possible.

The regulations came into force on February 11, 2015, more than three months before the date to which the Prime Minister and President had committed (June 1, 2015).

Other

Transition

Health Canada should extend the proposed transition period.

The proposed transition period was extended: manufacturers and importers have over two years to transition to the new requirements, and distributors have over three years to transition to the new requirements.  This topic will be clarified in guidance.

Health Canada should consider establishing different transition periods based on the type of hazardous product.

The transitional provisions were laid out in the Hazardous Products Act, which received Royal Assent in June 2014. It was therefore not possible to change the provisions to reflect types of hazardous products.

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