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 and the environment.
When needed, the Government implements risk management measures under CEPA 1999 and other federal acts to help prevent or reduce potential harm.
The Government concluded that:
The 14 substances in the original Phthalate Substance Grouping are not harmful to human health or to the environment at levels of exposure considered in the assessment. Some of these substances may be associated with health or ecological effects.
One of the 14 additional phthalate substances, 1,2-benzenedicarboxylic acid, bis(2-ethylhexyl) ester (also called DEHP), is harmful to the environment. Also, a previous assessment of DEHP in 1994 concluded that DEHP is harmful to human health and this conclusion remains unchanged. A performance measurement evaluation of the risk management of DEHP for human health concerns was published on June 4, 2021.
To address ecological concerns with DEHP, the Government is proposing amending the Prohibition of Certain Toxic Substances Regulations, 2012 to prohibit the manufacture, import, use, sale and offer for sale of DEHP and products containing DEHP.
The screening assessment focused on 14 substances referred to collectively as the Phthalate Substance Grouping under the third phase of the Chemicals Management Plan (CMP). These substances are DMP, DIBP, CHIBP, BCHP, DCHP, DBzP, B79P, DMCHP, DIHepP, BIOP, B84P, DINP, DIDP, and DUP.
To address the potential for cumulative risk from combined exposure to phthalates, the scope of the assessment was expanded to also consider an additional 14 substances. These substances are DEP, DPrP, DBP, BBP, DnHP, 79P, DIOP, DEHP, 610P, DnOP, D911P, D911P-2, DIUP, and DTDP.
With the exception of DEHP, these additional substances were not assessed individually in the screening assessment.
Four of the additional substances (DBP, BBP, DEHP, and DnOP) were previously assessed on an individual basis as part of the Priority Substances List (PSL) or in follow-up reports.
In those reports, DBP, BBP, and DnOP were found not harmful to the environment or to human health.
DEHP was determined to be harmful to human health in the 1994 PSL assessment; however, there was not enough information available at that time to conclude on the potential for harm to the environment. In the current screening assessment, new information on DEHP was used to conclude on its potential for harm to the environment.
Four state of the science reports and a Proposed Approach for Cumulative Risk Assessment of Phthalates were previously released for a 60-day public comment period that ended September 30, 2015.
These substances are not expected to occur naturally in the environment.
According to information gathered by the Government, in Canada, these substances may be used in a variety of consumer, commercial and industrial products, including plastics, paints and coatings, adhesives and sealants, automotive parts, electronics, personal care products (such as, cosmetics and natural health products) and in certain food packaging materials.
Human and ecological exposures
The screening assessment indicated that Canadians may be exposed to these substances from food, including breast milk, environmental sources (for example, dust and for certain phthalates, indoor air), and contact with plastic items.
Canadians may also be exposed to some of these substances as a result of using certain cosmetics and natural health care products (for example, diaper creams, body lotions, and hairsprays).
Exposure to DIBP and DINP may also occur from the use of certain plastic toys and children's articles (for example, from mouthing these objects).
The assessment took into consideration the results of human biomonitoring studies. Measuring substances in blood, urine or breast milk is called biomonitoring. The information on measured levels in humans is important for estimating exposure of Canadians.
In Canada, these substances have the potential to be released to the environment, primarily to air and water.
Releases may occur during their manufacturing and processing, including transportation and storage, and during the production, use and disposal of products containing them (for example, "down the drain" releases into wastewater systems from use in cosmetics).
Key health and ecological effects (hazard)
For the human health assessment, available information indicates that these substances may have developmental and reproductive effects, as well as effects on the liver and kidneys. These were considered to be the critical effects identified for characterizing the risk to human health.
In the environment, these substances have the potential to cause adverse effects in aquatic organisms. Some phthalates may also affect the normal function of the endocrine system of organisms.
Risk assessment outcomes
Phthalate Substance Grouping
Based upon a comparison of levels to which Canadians may be exposed to these substances, and the levels associated with health effects, it was determined that the risk to human health from these 14 substances is considered to be low.
Considering all information presented, it was determined that there is low risk of harm to the environment from these 14 substances.
The draft screening assessment proposed that there was a risk of harm to the environment from 1 of the 14 phthalate substances, B79P; however, based upon new information, it was determined that there is low risk of harm to the environment from B79P, at levels of exposure considered in the assessment.
DEHP has not been re-assessed for its potential risk to human health in Canada at current levels of exposure; the previous PSL assessment conclusion that DEHP may be harmful to human health remains unchanged.
Considering all information presented, it was determined that there is risk of harm to the environment from DEHP.
Cumulative Risk Assessment
In addition to the 14 phthalates in the Phthalate Substance Grouping, the Government considered an additional 14 phthalate substances in a cumulative assessment as there is a likelihood of co-exposure.
When the combined exposure to phthalates that have a common health effect is considered, the quantities are not harmful to human health at levels of exposure current at the time of the assessment.
When the combined exposure of phthalates to organisms in the environment is considered, the quantity entering the environment is below the levels that are expected to cause death to organisms. There was not enough information to assess the potential for other, long-term effects resulting from combined exposures.
Screening assessment conclusions
The Government concluded that the 14 substances in the Phthalate Substance Grouping are not harmful to human health at levels of exposure considered in the assessment, and that these substances are not entering the environment at levels that are harmful to the environment.
The Government concluded that DEHP is entering or may enter the environment at levels that are harmful to the environment.
DEHP is on Schedule 1 of CEPA 1999, also called the List of Toxic Substances. Adding a substance to the list does not restrict its use, manufacture or import. Rather, it enables the Government to take risk management actions under CEPA 1999.
Existing risk management measures are already in place to address human health concerns with DEHP:
The existing reporting requirements for medical devices containing DEHP will continue as part of the regular enforcement of the Medical Devices Regulations under the Food and Drugs Act.
DEHP (and other phthalates) in food continues to be measured as part of Health Canada's Total Diet Study and the Canadian Food Inspection Agency (CFIA)'s targeted surveys. Compliance and enforcement under the Food and Drugs Act will continue to ensure food safety.
The Government is proposing the following actions to address the ecological concerns with DEHP:
The proposed risk management actions are subject to public consultation. Following the publication, additional information obtained from the public comment period and from other sources will be considered in the selection of risk management instruments.
Risk management actions may also 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.
The Government measures the performance of its risk management actions for substances that are concluded to be toxic (harmful to human health or the environment) under CEPA 1999. This is done to determine whether actions taken to help protect human health or the environment are effective over time.
Although the other substances in the screening assessment are not considered to be harmful to the environment or human health at levels of exposure current at the time of the assessment, 20 of the 28 phthalate substances within the scope of the screening assessment are considered to have health and/or ecological effects of concern, and there may be a potential risk if exposure to any of these substances were to increase
Substances with human health-only effects of concern: CHIBP, DIHepP, B84P, 79P, DIOP
Substances with ecological-only effects of concern: DMP, DEP, DnOP
Substances with human health and ecological effects of concern: DIBP, BCHP, DCHP, DBzP, B79P, DMCHP, BIOP, DINP, DPrP, DBP, BBP, DnHP
For this reason, the Government plans on gathering information to track changes in exposure and commercial use patterns for these substances, through activities such as:
Monitoring the outcome of existing and planned Government of Canada research for human biomonitoring (CHMS), food (Canadian Total Diet Study, Canadian Food Inspection Agency targeted survey), and dust (Canadian House Dust Study)