The Government of Canada conducted a science-based evaluation, called a screening assessment, of the Salicylates Group, to address the potential for harm to Canadians and to the environment.
Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the risk posed by a substance is determined by considering both its hazardous properties (its potential to cause adverse human health or ecological effects) and the amount of exposure there is to people and the environment. A substance may have hazardous properties; however, the risk to human health or to the environment may be low depending upon the level of exposure.
As a result of the screening assessment, the Government is proposing to conclude that wintergreen oil, salicylic acid, and homosalate are harmful to human health, but not to the environment, at current levels of exposure. Phenethyl salicylate may be associated with health effects of concern; however, it is proposed that this substance is not harmful to human health or to the environment at current levels of exposure. It is also proposed that Betula alba extract is not harmful to human health or the environment.
About these substances
This screening assessment focuses on 5 substances referred to collectively under the Chemicals Management Plan (CMP) as the Salicylates Group. The substances addressed in this CMP screening assessment are wintergreen oil, salicylic acid, homosalate, phenethyl salicylate, and Betula alba extract.
According to information gathered by the Government, wintergreen oil, salicylic acid and Betula alba extractare naturally present in the environment, whereas homosalate and phenethyl salicylate are not known to occur naturally.
The substances in the Salicylates Group are generally used as ingredients in cosmetics, natural health products, drugs, food packaging materials, cleaning products, food flavourings.
Wintergreen oil, salicylic acid, and phenethyl salicylate are also reported as ingredients in pesticides in Canada.
Human and ecological exposures
Canadians may be exposed to these substances through the use of cosmetic products, such as massage oils, moisturizers, sunscreens, toothpastes, and hair care products, among others.
Canadians may also be exposed to substances in the Salicylates Group from the use of natural health products and non-prescription drugs such as analgesic creams, acne creams, after-shave creams, and antacid tablets.
Some of these substances may also be used as food flavourings or present in environmental media (such as water and dust).
According to information considered under the Ecological Risk Classification of Organic Substances Approach, substances in the Salicylates Group were identified as having low ecological exposure potential.
Key health and ecological effects (hazard)
Available information indicated that wintergreen oil may have liver and developmental effects. These were considered to be the important or “critical” effects used for characterizing the risk to human health in the assessment.
The critical effects identified for salicylic acid were liver, kidney and developmental effects.
The critical effects identified for homosalate were reproductive effects, along with effects on the kidneys, thymus and thyroid.
There were limited health effects (hazard) data for phenethyl salicylate; therefore, a comparative approach using similar chemicals, called read-across, was used for assessing potential health effects.
Using data available for a similar chemical for phenethyl salicylate, liver and developmental effects were identified as the important or "critical" effects for characterizing the risk to human health.
Available health effects information on Betula alba extract indicates that the substance is of low hazard potential to Canadians.
According to information considered under the Ecological Risk Classification of organic substances approach, salicylic acid, wintergreen oil, and Betula alba extract were identified as having a low ecological hazard potential.
Furthermore, according to information considered under the Ecological Risk Classification of Organic Substances Approach, homosalate and phenethyl salicylate were identified as having high hazard potentials based on possible endocrine disrupting effects. Homosalate has also been identified as having bioaccumulation potential, leading to potential adverse effects in aquatic food webs.
Risk assessment outcomes
Based upon a comparison of levels to which Canadians may be exposed to wintergreen oil, salicylic acid, and homosalate from products available to consumers and levels associated with critical health effects, it was determined that these substances may pose a risk to human health.
Based upon a comparison of levels to which Canadians may be exposed to phenethyl salicylate and levels associated with critical health effects, it was determined that the risk to human health from this substance is low.
Based upon the information presented in the draft screening assessment, the risk to human health from Betula alba extract is low.
Based upon the outcome of the Ecological Risk Classification of Organic Substances Approach, these 5 substances are considered unlikely to cause ecological harm.
As a result of this screening assessment, the Government is proposing that wintergreen oil, salicylic acid, and homosalate are harmful to human health at current levels of exposure. It is also proposed that phenethyl salicylate and Betula alba extract are not harmful to human health at current levels of exposure.
The Government is also proposing that the 5 substances in this group are not entering the environment at levels that are harmful to the environment.
If the proposed conclusions set out in the draft screening assessment are confirmed, the Government will consider adding “oils, wintergreen”, “benzoic acid, 2-hydroxy-“, and “benzoic acid, 2-hydroxy-,3,3,5-trimethylcyclohexyl ester” to Schedule 1 of CEPA, 1999, also called the List of Toxic Substances.
The Government is also considering the following actions:
Communicating measures to reduce exposure to wintergreen oil and homosalate from certain cosmetics by describing wintergreen oil and homosalate as prohibited or restricted on Health Canada’s Cosmetic Ingredient Hotlist. The Hotlist is used to communicate that certain substances may not be compliant with requirements of the Food and Drugs Act or the provisions of the Cosmetic Regulations. Under Canadian legislation, cosmetics that contain substances that are harmful to the user cannot be sold.
Communicating measures to reduce exposures to salicylic acid from certain cosmetics by modifying the current description for salicylic acid on Health Canada’s Cosmetic Ingredient Hotlist.
Prohibiting or restricting wintergreen oil in certain natural health products and salicylic acid in certain natural health products and non-prescription drugs, including changes to the recommended conditions of use.
Further risk mitigation for homosalate in certain non-prescription drugs under the Food and Drugs Act.
Although phenethyl salicylate is not considered to be harmful to human health at the current levels of exposure, this substance is considered to have a health effect of concern (potential developmental effects)therefore; there may be a potential risk for human health if exposure to this substance were to increase.
For this reason, follow-up activities to track changes in exposure or commercial use patterns for phenethyl salicylate are being considered.
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 May 13, 2020.
Risk management actions may evolve, based on the conclusions of the final screening assessment report, or as a result of risk management actions published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.
These substances may be found in products available to consumers. Canadians should follow any safety warnings and directions on product labels and dispose of products responsibly.
Canadians who may be exposed to these substances in the workplace should consult with their employer and an occupational health and safety (OHS) representative about safe handling practices, applicable laws, and requirements under OHS legislation and the Workplace Hazardous Materials Information System (WHMIS).
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