Technical consultations of the Consumer Chemical Sector Working Group (CCSWG)

Face to face meeting 1800 Walkley road, Ottawa, Ontario February 4 and 5, 2008

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Table of Contents

• Ad hoc Expert Group for Chronic Hazards for Consumer Chemicals (AHEGCHCC)
• 1. Respiratory or skin sensitization
  • Respiratory sensitizer
  • Skin sensitizer
• 2. Germ cell mutagenicity
• 3. Carcinogenicity
• 4. Reproductive toxicity
• 5. Specific Target Organ Toxicity (TOT) - Repeated Exposure:
  
  
• Cut-offs for mixtures
• 1. Respiratory or skin sensitization
  • Respiratory sensitizer
  • Skin sensitizer
• 2. Germ cell mutagenicity
• 3. Carcinogenicity
• 4. Reproductive toxicity
• 5. Specific Target Organ Toxicity (TOT) - Repeated Exposure:

This guide has been prepared to facilitate the technical discussions of the CCSWG regarding the implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in Canada. Where possible, it reflects opinions expressed by consumer chemical stakeholders for the development of the revised Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001).

Note: Downstream consequences of classification such as prohibitions and child resistant container requirements are not under the scope of the GHS. It is not the intention of the GHS to harmonize these requirements. The proposed options in this paper do not affect the current requirements of the CCCR, 2001 which are maintained where possible. However, this does not preclude discussions with other sectors and/or NAFTA (North American Free Trade Agreement) partners regarding these issues.

Ad hoc Expert Group for Chronic Hazards for Consumer Chemicals (AHEGCHCC)

An ad hoc expert group for chronic hazards for consumer chemicals, chaired by Ms. Kim Headrick, was created in February 2005 with the mandate of determining whether or not consumer chemical products should be subject to the chronic hazard classes of the GHS, and if so, which hazard classes and categories should be covered. The final report from the ad hoc expert group was written and sent to the CCSWG on July 19, 2007. Since the GHS document (Purple Book) provides the option that consumer products labelling could be based on the likelihood of injury for each chronic hazard class, both the risk- and hazard-based approaches were discussed. Consensus was reached on the following points:

• Chronic hazards should be considered for consumer chemical products.
• A risk-based approach is not appropriate for 'germ cell mutagenicity' because no exposure cut-offs exist.
• If a risk assessment cannot or is not conducted, then by default, the classification will be hazard-based.

No consensus was reached on whether an exposure threshold exists for carcinogenicity, reproductive toxicity and developmental toxicity. It is important to note that the expert group did not indicate which categories they wished to see adopted for chronic health hazard classifications that result in more than one category.

Element to consider
None of the chronic criteria proposed by the GHS currently exist within the CCCR, 2001, therefore their adoption will increase the level of protection currently offered.

Purpose of this discussion document
The GHS is a labelling scheme where criteria are linked to specific symbols, signal words and hazard statements. However, Health Canada may decide to use some of these GHS criteria to create other restrictions such as prohibitions for chemicals substances that would be deemed too dangerous to be used in consumer chemicals. Health Canada may also decide to create new mandatory labelling requirements based on the GHS criteria which may also be decided based strictly on a hazard-based approach or risk-based when appropriate. Should Health Canada opt to have an approach where risk is taken into account, we would need to develop a risk-based approach that meets the expectation of Health Canada and also serves the best interests of Canadian consumers.

No decisions have been finalized up to now. This document contains a series of options which are suggested for the purpose of gathering reactions, comments and opinions which will allow Health Canada to take an enlightened decision and identify what would be the best course of action.

1. Respiratory or skin sensitization

Definitions
A respiratory sensitizer is a substance that will induce hypersensitivity of the airways following inhalation of the substance.
A skin sensitizer is a substance that will induce an allergic response following skin contact.

Respiratory sensitizer

Hazard category
Substances shall be classified as a category 1 respiratory sensitizer in accordance with the following criteria:

• there is evidence in humans that the substance can induce specific respiratory hypersensitivity; or
• there are positive results from an appropriate animal test.

Classification
Substance classification as category 1 if it meets the above criteria

Based on the AHEGCHCC recommendation, this category should be adopted for consumer chemicals, however, no consensus was reached to determine if the approach should be risk-based or hazard-based.

Proposed option for discussion: Adopt the GHS criteria for category 1 respiratory sensitizer on a hazard-based approach to create a mandatory labelling requirement.

Skin sensitizer

Hazard category
Substances shall be classified as a category 1 contact sensitizer in accordance with the following criteria:

• there is evidence in humans that the substance can induce sensitization by skin contact in a substantial number of persons; or
• there are positive results from an appropriate animal test.

Classification
Substance classification as category 1 if it meets the above criteria

Only one category: Category 1

Based on the AHEGCHCC recommendation, this category should be adopted for consumer chemicals, however, no consensus was reached to determine if the approach should be risk-based or hazard-based.

Proposed option for discussion: Adopt the GHS criteria for category 1 skin sensitizer with a hazard-based approach to create a mandatory labelling requirement.

2. Germ cell mutagenicity

Definitions
Mutagens or mutagenics: Chemicals that may cause mutation to the germ cells of humans that can be transmitted to the progeny or agent giving rise to an increased occurrence of mutation in populations of cells and/or organism.

Mutation: permanent change in the amount or structure of the genetic material in a cell. This term applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modification when known.

Genotoxic and genotoxicity: applies to agents or processes which alter the structure, information content, or segregation of DNA.

Classification
Substance classification as category 1A if it is a chemical known to induce heritable mutations or to be regarded as if they induce heritable mutations in germ cells of humans.

• Criterion: Positive evidence from human epidemiological studies.

Substance classification as category 1B if it is a chemical which should be regarded as if they induce heritable mutations in the germ cells of humans.

• Criteria: Positive results from in vivo heritable germ cell mutagenicity tests in mammals;
• or
• positive results from in vivo somatic cell mutagenicity tests in mammals in combination with some evidence of potential to cause mutation to germ cells;
• or
• positive results from tests showing mutagenic effects in the germ cell of human without demonstration of transmission to progeny

Substance classification as category 2 if it is a chemical which causes concern for human owing to the possibility that they may induce heritable mutation in the germ cells of humans.

• Criteria: Positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
  • somatic cell mutagenicity tests in vivo in mammals; or
  • other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

The AHEGCHCC came to the agreement that a risk assessment is not appropriate for germ cell mutagenicity because no exposure cut-offs exist, it is therefore recommended that the criteria be adopted strictly on a hazard-based approach. This is consistent with section 3.5.2.3 of the GHS 1^st revised edition "purple book".

Proposed options for discussion:

• 1- Adopt the GHS criteria for category 1A and 1B on a hazard-based approach to create a prohibition for consumer chemicals containing substances that meet this criteria.
• 2- Adopt the GHS criteria for category 2 with an hazard-based approach to create a mandatory labelling requirement.

3. Carcinogenicity

Definition
Carcinogens: Chemical substances or a mixture of chemical substances which induce cancer or increase its incidence. Substances which have induced benign and malignant tumours in well performed experimental studies on animal are considered also to be presumed or suspected human carcinogens unless there is a strong evidence that the mechanism of tumour formation is not relevant for humans.

The classification of a chemical carcinogenic hazard is based on the inherent properties of the chemical and does not provide information on the level of human cancer risk which the use of the chemical may represent.

Classification
Substances are classified as category 1A if they are known to have carcinogenic potential for humans (largely based on human evidence).

• Substances are classified as category 1B if they are presumed to have carcinogenic potential for humans (largely based on animal evidences).
  • Based on strength of evidence together with additional considerations, may be derived from human studies that establish a causal relationship between human exposure to a chemical and development of cancer (known human carcinogen). May also be derived from animal experiments for which there is sufficient evidence to demonstrate animal carcinogenicity (presumed human carcinogen). May also use scientific judgement to consider as a presumed carcinogen derived from studies showing limited evidences of carcinogenicity in human together with limited evidence of carcinogenicity in experimental animals.
• Substances are classified as category 2 if they are suspected human carcinogens.
  • Done on basis of evidences obtained from human and/or animal studies not sufficiently convincing to place in category 1.

Based on the AHEGCHCC recommendation, this category should be adopted for consumer chemicals, however, no consensus was reached to determine if the approach should be risk-based or hazard-based.

Proposed options for discussion:

• 1- Adopt the GHS criteria for category 1A and 1B on a hazard-based approach to create a prohibition for consumer chemicals containing substances that meet this criteria.
• 2- Adopt the GHS criteria for category 2 with a hazard-based approach to create a mandatory labelling requirement.
• 3- Adopt the GHS criteria for category 2 with an approach where risk is considered to create a mandatory labelling requirement.

4. Reproductive toxicity

Definitions
Reproductive toxicity: Adverse effects on sexual function and fertility in adult males and females, including developmental toxicity in the offspring. Known induction of genetically based inheritable effects in the offspring is addressed in germ cell mutagenicity. Reproductive toxic effects that cannot be clearly assigned to either impairment of sexual functions and fertility or to developmental toxicity will be classified as reproductive toxicants.

Effect on or via lactation: Effect induced by a substance which are absorbed by women and have been shown to interfere with lactation or which may be present (including metabolites) in breast milk in amounts sufficient to cause concern for the health of a breastfed child.

Classification

Category 1: Known to have produced an adverse effect on sexual function and fertility or on development in humans or for which there is evidences from animal studies possibly with other information to provide a strong presumption of a capacity to interfere with reproduction in human.

• Substances are classified as category 1A if they are known human reproductive toxicants.
  • Largely based on evidence from human.
• Substances are classified as category 1B if they are presumed human reproductive toxicants.
  • Largely based on evidence from experimental animals. Animal studies that could provide clear evidences of an adverse effect on sexual function and fertility or on development in the absence of toxic effect.
• Substances are classified as category 2 if they are suspected human reproductive toxicants.
  • When there is some evidences from human or experimental animals of adverse reaction on sexual function and fertility or on development in the absence of toxic effect.
• Substances are classified as in the additional category if they are substances that will have an effect on or via lactation.
  • Absorption, metabolism, distribution and excretion studies that would indicate likelihood of potentially toxic levels in breast milk.
  • Results of one (1) or two (2) generation studies in animals which provide clear evidence of adverse effect in the offspring due to transfer in milk or adverse effect on the quality of the milk.
  • Human evidence indicating hazard to babies during lactation.

Based on the AHEGCHCC recommendation, this category should be adopted for consumer chemicals, however, no consensus was reached to determine if the approach should be risk-based or hazard-based.

Proposed options for discussion:

• 1- Adopt the GHS criteria for category 1A and 1B on a hazard-based approach to create a prohibition for consumer chemicals containing substances that meet this criteria.
• 2- Adopt the GHS criteria for category 2 with a hazard-based approach to create a mandatory labelling requirement.
• 3- Adopt the GHS criteria for category 2 with an approach where risk is considered to create a mandatory labelling requirement.
• 4- Adopt the GHS criteria for "effect on or via lactation" with a hazard-based approach to create a mandatory labelling requirement.
• 5- Adopt the GHS criteria for "effect on or via lactation" with an approach where risk is considered to create a mandatory labelling requirement.

5. Specific Target Organ Toxicity (TOT) - Repeated Exposure:

Definition
Specific Target Organ Toxicity: All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed are included. It must affect the function or morphology of a tissue/organ or produced serious changes to the biochemistry or haematology of the organism and these changes are relevant for human health. Non-lethal toxic effect after a single-event exposure are classified as specific target organ systemic toxicity - single exposure.

Classification
Substances are classified as category 1 if they produce significant toxicity in humans, or that, on the basis of evidences from studies in experimental animals can be presumed to have the potential to produce significant toxicity in humans following repeated exposure.

• Reliable and good quality evidence from human cases or epidemiological studies; or
• observations from appropriate studies in experimental animals in which significant effect of relevance to human health were produced at generally low concentration.

Substances are classified as category 2 if, on the basis of evidence from studies in experimental animals, they can be presumed to have the potential to be harmful to human health following repeated exposure.

• Done on basis of observation from appropriate studies in experimental animal in which significant toxic effect of relevance to human health were produced at generally moderate exposure concentration.

Based on the AHEGCHCC recommendation, this category should be adopted for consumer chemicals, however, no consensus was reached to determine if the approach should be risk-based or hazard-based.

Proposed options for discussion:

• 1- Adopt the GHS criteria for category 1 on a hazard-based approach to create a prohibition for consumer chemicals containing substances that meet this criteria.
• 2- Adopt the GHS criteria for category 2 with a hazard-based approach to create a mandatory labelling requirement.
• 3- Adopt the GHS criteria for category 2 with an approach where risk is considered to create a mandatory labelling requirement.

Cut-offs for mixtures

The GHS chronic hazards criteria propose different cut-offs for mixtures within the purple book. Since we are aiming at a harmonisation between sectors (consumer chemicals, workplace chemicals and pest control products) we must look at the cut-offs selected by the other sectors and consider these as a baseline.

1. Respiratory or skin sensitization

Respiratory sensitizer

Mixtures will be classified as category 1 respiratory sensitizers if they meet the above criteria as a whole, if bridging principles can be applied, or, if an ingredient that meets the criteria is present in a concentration of at least 0.1% or 1% for solid and liquid and 0.1% or 0.2% for gas.

Only one category: Category 1

*The WHMIS Working Group has agreed to incorporate GHS Category 1 and to retain the full labelling requirements for all mixtures that contain solid, liquid or gaseous respiratory sensitizers at concentrations ≥ 0.1% .

Proposed option for discussion:

Adopt category 1 with WHMIS cut-offs.

Skin sensitizer

Mixtures will be classified as category 1 skin sensitizers if they meet the above criteria as a whole, if bridging principles can be applied, or, if an ingredient that meets the criteria in a concentration of at least 0.1% or 1% (see below options).

Only one category: Category 1

* The WHMIS working Group agreed to incorporate GHS Category 1 for respiratory sensitization and to adopt the 0.1% cut-off value with reduced labelling requirements for mixtures containing sensitizers at concentrations between 0.1% and 1.0% and a stipulation that, where an elicitation response for an ingredient in a mixture may be evident below 0.1%, the mixture should be classified and supplementary labeling be used accordingly. In this situation, supplementary labelling means only including a statement that identifies the sensitizer that is present in the mixture.

Proposed options for discussion:

• -Adopt a cut-off of 0.1% for category 1.
• -Adopt a cut-off of 1.0 % for category 1.
• -Adopt category 1 with WHMIS cut-offs (variation of labelling to be determined).

2. Germ cell mutagenicity

Mixtures will be classified as a mutagens when at least one ingredient has been classified as a category 1 or category 2 mutagen and is present in the mixture at the appropriate cut-off, that is, for a category 1 at least 0.1% and for a category 2 at least 1.0%.

* The WHMIS working Group agreed to incorporate GHS Categories 1 and 2 for germ cell mutagenicity and also agreed to adopt the 0.1% and 1.0% cut-off values for classification of mixtures containing Category 1 and 2 mutagens respectively.

Proposed option for discussion:

Adopt categories 1 and 2 with WHMIS threshold values in a hazard-based approach.

3. Carcinogenicity

Mixtures will be classified as carcinogens when at least one ingredient has been classified as a category 1 or category 2 carcinogen and is present in the mixture at the appropriate cut-off. For a category 1 this cut-off is at least 0.1%, and for a category 2 it is at least 1.0%.

* The WHMIS working Group agreed to incorporate the GHS Categories 1 and 2 for carcinogenicity
And also agreed to adopt the 0.1% cut-off value for classification of mixtures containing Category 1 or 2 carcinogens.

Proposed option for discussion:

Adopt categories 1 and 2 with WHMIS cut-offs.

4. Reproductive toxicity

Mixtures will be classified as reproductive toxicants when at least one ingredient has been classified as a category 1 or category 2 or in the additional category for 'effect on or via lactation' and is present in the mixture at a minimal concentration of 1%.

* The WHMIS working Group agreed to incorporate the GHS Categories 1 and 2, and the category for "effects on or via lactation" for reproductive toxicity and also agreed to adopt the 0.1% cut-off value for classification of mixtures containing Category 1 or 2 reproductive toxicants or substances classified under the category "effects on or via lactation"

Proposed option for discussion:

Adopt categories 1, 2 and "effects on or via lactation" with WHMIS cut-offs.

5. Specific Target Organ Toxicity (TOT) - Repeated Exposure:

Mixtures will be classified as a specific target organ systemic toxicity if it contain at least 1% of an ingredient that has been classified as either a category 1 or category 2 TOT - RE.

* The WHMIS working Group agreed to incorporate the GHS Categories 1 and 2 for TOT - repeated exposure and also agreed to adopt the 1.0% cut-off value for classification of mixtures containing Category 1 or 2 repeated exposure target organ/systemic toxicants.

Proposed option for discussion:

Adopt categories 1 and 2 with WHMIS cut-offs.