The Government of Canada conducted a science-based evaluation, called a screening assessment, to address the potential for harm to Canadians and to the environment from substances in the Parabens Group.
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 draft screening assessment, it is proposed that methylparaben, propylparaben, butylparaben and iso-butylparaben may be harmful to human health, but not to the environment, at current levels of exposure.
It is also proposed that ethylparaben, benzylparaben and iso-propylparaben are not harmful to human health or to the environment at current levels of exposure.
About these substances
The screening assessment focuses on 7 substances, methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, iso-propylparaben, and iso-butylparaben, which are referred to collectively as the Parabens Group under the Chemicals Management Plan (CMP).
These substances were considered priorities for risk assessment based on the results of the Identification of Risk Assessment Priorities review process in 2015, on the basis of human health concerns. The 2015 review identified new hazard and/or exposure information for substances that are on the Domestic Substances List which were not recently, currently being, or already scheduled to be assessed under the CMP.
Parabens may be naturally present at very low levels in foods such as berries, fruit, wine, and vanilla.
Methylparaben, ethylparaben, propylparaben, butylparaben, iso-propylparaben, and iso-butylparaben may be used as preservatives, fragrance ingredients and/or flavour enhancers in cosmetics, natural health products, and non-prescription drugs.
Methylparaben, ethylparaben, and propylparaben may be used in prescription drugs.
Methylparaben, ethylparaben, propylparaben and butylparaben are formulants in registered pest control products, regulated under the Pest Control Products Act.
Methylparaben and propylparaben are approved food additives, which may be used as preservatives in certain foods and beverages sold in Canada.
No Canadian uses have been identified for benzylparaben.
Human and ecological exposures
The main source of exposure of Canadians to methylparaben, ethylparaben, propylparaben, butylparaben, iso-propylparaben, and iso-butylparaben is from the use of certain cosmetics (such as moisturizers, make-up, toothpaste, hair, and shaving products), natural health products, and prescription and/or non-prescription drugs (such as oral medicines, supplements, sunscreens, medicated creams and ointments).
Methylparaben and propylparaben may be added to certain foods and beverages, however exposure from this source is expected to be limited.
No sources of exposure for Canadians to benzylparaben have been identified.
The assessment took into consideration the results of human biomonitoring studies. The information on measured levels in humans is important to estimating exposure to Canadians.
According to information considered under the ERC Approach, these substances were identified as having low ecological exposure potential.
Key health and ecological effects (hazard)
The critical effects identified for characterizing the risk to human health in the screening assessment included:
effects on the stomach, spleen and thyroid for methylparaben
developmental and/or reproductive effects for ethylparaben, butylparaben, benzylparaben, and iso-butylparaben
changes in blood chemistry and effects on the kidneys and liver for iso-propylparaben.
There were limited health effects (hazard) data for benzylparaben; therefore, a comparative approach using a similar chemical, called read-across, was used for assessing potential health effects.
Available information indicates that adverse effects on human health due to propylparaben exposure cannot be excluded at high levels of exposure.
According to information considered under the ERC Approach, these substances were identified as having a low ecological hazard potential.
Risk assessment outcomes
Based upon a comparison of levels to which Canadians may be exposed to substances, and levels associated with critical health effects, it was determined in the draft screening assessment that:
Methylparaben, propylparaben, and butylparaben may pose a risk to human health through the use of certain cosmetics, natural health products, and/or non-prescription drugs with intermittent use patterns.
Iso-butylparaben may pose a risk to human health through the use of certain cosmetics, natural health products, and non-prescription drugs with daily and intermittent use patterns.
Ethylparaben and iso-propylparaben have low risk to human health.
Exposure of Canadians to benzylparaben is not expected; therefore, the risk to human health is considered to be low.
Based upon the outcome of the ERC Approach, methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, iso-propylparaben, and iso-butylparaben are considered unlikely to cause ecological harm.
As a result of the draft screening assessment, the Government is proposing that methylparaben, propylparaben, butylparaben and iso-butylparaben may be harmful to human health at current levels of exposure. It is also proposed that ethylparaben, benzylparaben and iso-propylparaben are not harmful to human health at current levels of exposure.
The Government is also proposing that these 7 substances are not entering the environment at levels that are harmful to the environment.
It is also proposed that methylparaben, propylparaben, butylparaben and iso-butylparaben do not meet the persistence and bioaccumulation criteria, as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.
If the proposed conclusion is confirmed in the final screening assessment, the Government will consider adding methylparaben, propylparaben, butylparaben and iso-butylparaben to Schedule 1 of CEPA 1999, also called the List of Toxic Substances, and will consider the following actions to address human health concerns:
Communicating measures to reduce exposures of Canadians to butylparaben and iso-butylparaben from certain cosmetics by describing these substances as prohibited or restricted ingredients on the Health Canada 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 Cosmetic Regulations. Under Canadian legislation, cosmetics that contain substances that are harmful to the user cannot be sold.
Modifying applicable databases, in accordance with the Food and Drugs Act, to reduce exposures of butylparaben and iso-butylparaben in non-prescription drugs.
Modifying applicable databases, in accordance with the Food and Drugs Act, to reduce exposures of methylparaben, propylparaben, butylparaben and iso-butylparaben in natural health products.
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.
Risk management actions may evolve, based on the conclusions of the final screening assessment report, or as a result of risk management options or actions published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.
Substances in the Parabens Group are found in certain products available to consumers. Canadians should follow any safety warnings and directions related to the product 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.
