The risks posed by a substance are determined both by its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people or 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 4 of the 15 substances in this group (CAS RNs 118-82-1, 128-37-0, 36443-68-2, and 61788-44-1) may be entering the environment at levels that are harmful. These 4 substances may cause adverse effects to organisms due to environmental releases.
The Government is considering regulatory and/or non-regulatory options for industrial formulation activities involving these 4 substances to limit their releases into the environment.
The other 11 substances are not proposed to be harmful to the environment.
Some of the substances in this group may be associated with health effects; however, at levels of exposure considered in the assessment, none of these 15 substances are proposed to be harmful to human health.
Two of the 15 substances (CAS RNs 4221-80-1 and 36443-68-2) were considered as priorities for assessment based on the results of the identification of risk assessment priorities approach.
Of the 15 substances, CAS RN 98-54-4 and the monostyrenated phenol component in CAS RN 61788-44-1 are non-hindered phenol substances; the remaining 13 substances and di- and tri-styrenated phenol components in CAS RN 61788-44-1 are partially or fully hindered phenols.
According to information gathered by the Government, these substances are used in Canada in a variety of industrial, commercial and consumer applications, including in lubricant and fuel additives, plastic and rubber additives, paints and coatings, personal care products, food packaging, adhesives and sealants, and fabric and textiles.
Human and ecological exposures
The assessment indicates that people in Canada may be exposed to the 15 substances in the Substituted Phenols Group from drinking water, food and food packaging, as well as products available to consumers such as cosmetics, paints, plastics or lubricants.
According to the information considered under the ERC Approach, CAS RNs 85-60-9 and 6386-38-5 were identified as having low ecological exposure potential. CAS RN 2082-79-3, however, was classified as having a high ecological exposure potential based on a long overall persistence and a large reported use quantity. CAS RN 41484-35-9 was classified as having a moderate ecological exposure potential based on a long overall persistence and moderate reported quantities used.
An environmental exposure assessment was conducted for the 11 other substances in the group. In general, point source releases of substances are expected to occur during their use in various industrial applications. Surface water is expected to be the main receiving environment following release through wastewater treatment systems. The environmental exposure was estimated in 8 different scenarios pertaining to formulation of lubricant and fuel additives, plastic and rubber additives, lubricants, plastic products, rubber products, paints and coatings, personal care products, and fuel.
There were limited health effects (hazard) data for CAS RNs 35958-30-6 and 96-76-4; therefore, a comparative approach using a similar chemical, called read-across, was used for assessing potential health effects.
The critical effects identified for characterizing the risk to human health from substances in the Substituted Phenols Group, based on laboratory studies, included:
liver and thyroid effects (endocrine effects) (for CAS RNs 128-37-0 and 36443-68-2)
testis effects in males and liver and thyroid effects in females (for CAS RN 35958-30-6)
liver, spleen, and adrenal effects (for CAS RN 1843-03-4)
liver effects (for CAS RNs 85-60-9, 96-76-4, 118-82-1, 128-39-2, and 2082-79-3)
developmental effects (for CAS RNs 96-69-5 and 98-54-4)
Based upon available information, no critical effects were identified for CAS RNs 4221-80-1, 6386-38-5, 41484-35-9 and 61788-44-1.
Further details on potential health effects that were considered for each substance of this group are available in the assessment.
According to information considered under the ERC Approach, CAS RNs 2082-79-3, 6386-38-5 and 41484-35-9 were identified as having a low ecological hazard potential, while CAS RN 85-60-9 was identified as having a high ecological hazard potential. This was based on CAS RN 85-60-9 as potentially having endocrine effects, and potentially affecting aquatic organisms given its bioaccumulation potential.
For the ecological assessment of the other 11 substances, the ecological effects assessment was based on available data and the application of read-across to fill data gaps.
Nine of 11 substances were identified as being capable of causing adverse effects to aquatic organisms at or below their water saturation limits, while the other 2 did not demonstrate adverse effects in studies at or below their water saturation limits.
CAS RN 98-54-4 and a component of CAS RN 61788-44-1 have the capacity to cause effects at low concentrations possibly through an endocrine-mediated mode of action.
Consideration of subpopulations who may have greater susceptibility or greater exposure
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. These subpopulations were taken into account in the risk assessment outcomes of certain substances in the Substituted Phenols Group.
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.
Based upon a comparison of levels to which people in Canada may be exposed to substances in this group, and levels associated with health effects, as well as the information presented in the draft assessment, it was determined that the risk to human health from the 15 substances in the Substituted Phenols Group is low.
Based upon the outcome of the ERC Approach, CAS RNs 85-60-9, 2082-79-3, 6386-38-5 and 41484-35-9 are considered unlikely to be causing ecological harm.
In the ecological risk assessment for the remaining 11 substances, it was found that environmental releases associated with the use of CAS RNs 118-82-1, 128-37-0, 36443-68-2, and 61788-44-1 may pose a risk to organisms. The other 7 substances in the group are considered unlikely to be causing ecological harm.
Proposed assessment conclusions
The Government is proposing that the 15 substances in the Substituted Phenols Group are not harmful to human health at levels of exposure considered in the assessment.
The Government is also proposing that 4 substances in the group (CAS RNs 118-82-1, 128-37-0, 36443-68-2, and 61788-44-1) are entering the environment at levels that may be harmful. It is proposed that the other 11 substances in the Substituted Phenols Group are not entering the environment at concentrations that are harmful.
It is also proposed that CAS RNs 118-82-1 and 61788-44-1 meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA and that CAS RNs 128-37-0 and 36443-68-2 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 conclusion is confirmed in the final assessment, the Government will consider proposing to add CAS RNs 118-82-1 and 61788-44-1 to Part 1 of Schedule 1 to CEPA and CAS RNs 128-37-0 and 36443-68-2 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.
Until regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic or toxic to reproduction are available, CAS RNs 128-37-0 and 36443-68-2 are proposed to be recommended for addition to Part 2 of Schedule 1. Following the availability of the criteria, the substances may be moved to Part 1 of Schedule 1, if applicable.
Publication of the risk management scope aims to inform stakeholders of proposed risk management options and initiate discussion about their development. The Government will consider the following actions to address ecological concerns:
For CAS RNs 128-37-0 and 36443-68-2, regulatory or non-regulatory initiatives are being considered that could set release limits, best practices or other requirements to limit releases of these substances from industrial formulation facilities to the aquatic environment.
For the 2 substituted phenols that are proposed toxic and are both persistent and bioaccumulative (CAS RNs 118-82-1 and 61788-44-1), regulatory or mandatory initiatives are being considered, such as regulations to prohibit or restrict the substances (to phase out generation and use, or to control releases to the lowest level that can be reliably measured).
Information is being sought by the Government to inform risk management decision-making. Details can be found in the risk management scope, including where to send information during the public comment period, ending March 13, 2024.
Risk management actions may evolve through consideration of assessments and risk management actions published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.
Additional considerations
Although CAS RNs 96-69-5 and 98-54-4 are not considered to be harmful to human health or to the environment at current levels of exposure, these substances are associated with effects of concern. Therefore, there may be a concern if exposures were to increase. For this reason, CAS RNs 96-69-5 and 98-54-4 may be considered in future initiatives to track their commercial status or identify new uses or exposures.
Stakeholders are encouraged to provide any information pertaining to these substances that may help inform the choice of follow-up activities, during the 60-day public comment period on the assessment. This could include information on new or planned import, manufacture or use of the substances.
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
Substituted phenols are found in products available to consumers. People in Canada should follow any safety warnings and directions related to the product and dispose of products responsibly.
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 recognises 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.
