The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people and the environment.
When needed, the Government implements risk management measures under CEPA and other federal acts to help prevent or reduce potential harm.
The Government is proposing that aluminum hydroxychloride and aluminum chlorohydrate may be harmful to human health due to inhalation exposure from the use of certain aerosol antiperspirants and aerosol foot deodorant spray. These substances are associated with adverse health effects, including non-cancer lung effects.
The Government is proposing to modify the current entry for “aluminum chlorohydrate and its associated complexes” on Health Canada’s Cosmetic Ingredient Hotlist to reduce inhalation exposure to aluminum chlorohydrate substances.
The other 53 substances in this group are not proposed to be harmful to human health and none of the 55 substances in this group are proposed to be harmful to the environment, at levels of exposure considered in the assessment.
About these substances
The assessment focuses on 55 substances, referred to collectively as the Aluminium-containing Substances Group under the third phase of the Chemicals Management Plan (CMP).
Included are 8 aluminium-containing substances that were identified following prioritization of the Revised In Commerce List.
Aluminium chloride, aluminum nitrate and aluminum sulphate were previously assessed as part of the second Priority Substances List (PSL2). These substances were found to be not harmful to the environment or human health.
Substances in the Aluminium-containing Substances Group are human-made, but aluminium also occurs naturally in the environment through a cycle of weathering, erosion, and deposition processes.
According to information gathered by the Government, these 55 aluminium-containing substances are used in a variety of products and applications including arts, crafts and hobby materials; automotive care products; building and construction materials; cleaning products; food packaging; ink, toner and colourants; self-care products (cosmetics; natural health products and non-prescription drugs); paints and coatings; pest control products; plastics; textiles; and other industrial and commercial uses.
Human and ecological exposures
People in Canada may be exposed to substances in the Aluminium-containing Substances Group from their use in products and manufactured items available to consumers, as described above.
Exposure may also occur due to the presence of these substances in drinking water and in the environment (soil, house dust, and air).
Aluminium may be present in foods from the use of aluminium-containing food additives, its potential use as a component in incidental additives used in food processing establishments and in the manufacture of food packaging materials, and through leaching from aluminium cookware.
A science approach document based on biomonitoring data was used to characterize the human health risks resulting from oral exposure to these substances. Human biomonitoring is the measurement of substances in blood, urine or other human tissues and fluids (such as human milk, nails or hair) through health studies or surveys, such as the Canadian Health Measures Survey. The information on measured levels in humans is important to estimating exposure to Canadians.
The human health risks associated with inhalation exposure from the use of aerosol antiperspirants and aerosol foot deodorant spray were characterized using traditional risk assessment approaches to account for lung-specific health effects.
Detailed ecological exposure scenarios were developed for primary aluminium manufacturing, cement manufacturing, metal mining, electric power generation, and pulp and paper manufacturing.
Canadian long-term surface water quality data and available data on concentrations of aluminium in soil were also used to characterize exposure.
The critical effects identified for characterizing the risk to human health from substances in the Aluminium-containing Substances Group were:
neurotoxicity through oral exposure
non-cancer lung effects (for example, inflammation) through inhalation exposure
In freshwater organisms, aluminium may cause toxicity by disrupting blood ion concentrations and, particularly for fish, respiratory effects (precipitating aluminium may clog fish gills).
Consideration of subpopulations who may be more susceptible or highly exposed
There are groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects from exposure to substances.
Certain subpopulations are routinely considered throughout the assessment process, such as infants, children, and people of reproductive age. For instance, age-specific exposures are routinely estimated and developmental and reproductive toxicity studies are evaluated for potential adverse health effects. Human biomonitoring data were available for infants, children and pregnant females. These subpopulations were taken into account in the risk assessment outcomes of aluminium-containing substances.
In addition, exposure from consuming traditional, subsistence or country foods for certain Indigenous communities and exposure from outdoor air for people living near sources of release were examined.
Risk assessment outcomes
Assessments focus on information critical to determining whether substances are harmful to human health or the environment under CEPA. This is done by considering scientific information, including information, if available, on subpopulations who may have greater susceptibility or greater exposure, vulnerable environments and cumulative effects and by incorporating a weight of evidence approach and precaution. The potential for cumulative effects was considered in the assessment by examining cumulative exposures from the broader aluminium moiety.
Based upon a comparison of levels to which Canadians may be exposed to aluminum hydroxychloride and aluminum chlorohydrate from aerosol antiperspirant and aerosol foot deodorant spray, and levels associated with non-cancer lung effects, it was determined that these substances may pose a risk to human health.
For the remaining 53 aluminium-containing substances in this group, it was determined that the risk to human health is low when comparing exposure of people in Canada and levels associated with critical health effects.
Considering all information presented, it was determined that there is low risk of harm to the environment from the 55 substances in the Aluminium-containing Substances Group.
Proposed assessment conclusions
The Government is proposing that aluminum hydroxychloride (CAS RN 1327-41-9) and aluminum chlorohydrate (CAS RN 12042-91-0) may be harmful to human health at levels of exposure considered in the assessment. The Government is also proposing that the other 53 substances in the Aluminium-containing Substances Group are not harmful to human health at levels of exposure considered in the assessment.
The Government is proposing that these 55 substances are not entering the environment at levels that are harmful.
Aluminum hydroxychloride and aluminum chlorohydrate are proposed to meet the persistence but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.
Preventive actions and risk reduction
If the proposed conclusions are confirmed in the final assessment, the Government will consider proposing to add aluminum hydroxychloride and aluminum chlorohydrate to Part 2 of Schedule 1 to CEPA. Adding a substance to Schedule 1 enables the Government to take enforceable risk management actions under CEPA using a 2-track approach to manage risks.
Toxic substances that pose the highest risk (that is, meet certain criteria) are added to Part 1 of Schedule 1. These are prioritized for total, partial or conditional prohibition.
Other toxic substances are added to Part 2 of Schedule 1 and are prioritized for pollution prevention.
Regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic or toxic to reproduction may be developed. When criteria are available, some substances considered for addition to Part 2 of Schedule1 may instead be considered for addition to Part 1 of Schedule 1.
Publication of the risk management scope aims to initiate discussion with stakeholders on the development of proposed risk management option(s).
The Government is considering modifying the current entry on Health Canada’s Cosmetic Ingredient Hotlist for aluminium chlorohydrate substances. The Hotlist is used to communicate that certain substances may not be compliant with requirements of the Food and Drugs Act or the Cosmetic Regulations. Under Canadian legislation, cosmetics that contain substances that are harmful to the user cannot be sold.
The risk management option may also evolve through consideration of assessments and risk management options or actions published for other CMP substances, as well as other activities that may address the exposures of concern identified in the draft assessment.
Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites.
Related resources
Substances in the Aluminium-containing Substances Group are found in many products and manufactured items available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.
Aluminium has been assessed by the Federal-Provincial-Territorial Committee on Drinking Water, and a guideline technical document has been published by Health Canada. The guideline technical document reviews and assesses all identified health risks associated with aluminium in drinking water.
Assessments conducted under CEPA focus on risks of exposure of the general population. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). If a substance is harmful to the general population, it could also be of concern for individuals in situations where a higher volume of the substance is used or where the substance is used for a longer duration (for example, the workplace). The Government of Canada recognizes that it is the responsibility of the federal, provincial and territorial occupational health and safety organizations to coordinate legislation for the safe use of chemicals in the workplace. We are working to support this role by integrating the information, tools, and/or technical expertise of the CMP and Health Canada’s Workplace Hazardous Products Program.
