Phthalate Substance Grouping – information sheet
What are they?
- Fourteen phthalates are included in the screening assessment of the Phthalate Substance Grouping, with an additional 14 included to consider combined exposure to phthalates.
- These 28 phthalates are industrial chemicals. They are not expected to occur naturally in the environment.
How are they used?
- In Canada, phthalates may be used in a variety of consumer, commercial and industrial products, including plastics, paints and coatings, adhesives and sealants, automotive parts, and electronics, as well as in personal care products (such as cosmetics and natural health products).
- Based on the most recent data, some of these substances are manufactured in and/or imported into the country in large quantities. Seven of the 28 phthalates were not manufactured or imported in Canada.
Why is the Government of Canada assessing them?
- Phthalates were considered as part of the Substance Groupings Initiative under the Chemicals Management Plan. These substances were included for screening assessment of potential risks to the environment and to human health.
- Fourteen phthalates included in the Phthalate Substance Grouping screening assessment were identified as priorities for assessment based on the categorization of substances within the Domestic Substances List (DSL) or were considered a priority based on human health concerns.
- Fourteen additional phthalates on the DSL were included within the scope of the screening assessment to consider combined exposure to phthalates. These additional phthalates were not assessed as individual substances in the same way as the 14 that are in the Phthalate Substance Grouping.
- Of these 14 additional phthalates, 4 were previously assessed in the Priority Substances List (PSL) or in follow-up reports [DBP (CAS RN 84-74-2), BBP (CAS RN 85-68-7), DEHP (CAS RN 117-81-7) and DnOP (CAS RN 117-84-0)].
- 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 Canada in the 1994 PSL assessment; however, there was not enough information available to conclude on the potential for harm to the environment at that time. In the current screening assessment, new information on DEHP was used to propose a conclusion on its potential for harm to the environment.
How are Canadians exposed to them?
- Exposure to the general population of Canada to phthalates is expected to be from food, including breast milk, environmental media (dust and for certain phthalates, indoor air), and contact with plastic items.
- The assessment took into consideration the results of biomonitoring studies. Measuring substances in blood, urine or breast milk is called biomonitoring and is done on an ongoing basis through health studies or surveys, such as the Canadian Health Measures Survey. Finding the substance in the body does not necessarily mean that it is causing harm. Harmful effects will depend on the levels and the properties of the substances. The information on measured levels in humans is important to estimating exposure to Canadians.
- Canadians may also be exposed to some of these phthalates as a result of using certain cosmetics and natural health care products (for example, diaper creams, body lotions and hairsprays).
- Exposure to certain phthalates may also occur from plastic toys and children’s articles (for example, from mouthing these objects).
How are they released into the environment?
- In Canada, phthalates have a potential for release 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, release into wastewater systems from use in cosmetics).
What are the results of the assessment?
- The Government of Canada conducted a science-based evaluation of phthalates, called a screening assessment.
- Screening assessments address the potential for harm to the general population of Canada and to the environment. More information on types of approaches used to address substances can be found in the Risk Assessment Toolbox fact sheet.
- Results of the draft screening assessment indicate that phthalates are not expected to remain in the environment for a long time or accumulate in organisms.
- Furthermore, the 14 substances in the Phthalate Substance Grouping are not considered to cause harm to the broader integrity of the environment.
- For 13 of the phthalates in the Phthalate Substance Grouping, the quantity that may be released to the environment is below the level expected to cause harm to organisms.
- However, the quantity of 1 phthalate from the grouping (B79P) and 1 additional phthalate (DEHP) that may be released to the environment is above the level expected to cause harm to organisms.
- DEHP has not been re-assessed for its potential risk to human health in Canada at current levels of exposure; the previous PSL conclusion that DEHP may be harmful to human health remains unchanged.
- The Government of Canada is therefore proposing that B79P and DEHP are entering or may enter the environment at levels that are harmful to the environment or its biological diversity.
- The Government of Canada is also proposing that individually, the 14 phthalates in the Phthalate Substance Grouping are not harmful to human health at current levels of exposure.
- In addition to the individual screening assessments conducted on the 14 phthalates in the Phthalate Substance Grouping and the updated ecological assessment of the additional phthalate, DEHP, the Government of Canada considered an additional 14 phthalates in a cumulative assessment as there is a likelihood of co-exposure.
- 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.
- When the combined exposure to phthalates that have a common health effect is considered, the quantities are not harmful to human health at current levels of exposure.
What is the Government of Canada doing?
- The Government of Canada published the Draft Screening Assessment for the Phthalate Substance Grouping , the Proposed Risk Management Scope Document for B79P and the Proposed Risk Management Scope Document for DEHP on October 7 , 2017. These publications are associated with a 60-day public comment period ending on December 6 , 2017.
- 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.
- If the proposed conclusion is confirmed in the final screening assessment, the Government of Canada will consider the implementation of regulatory and non-regulatory controls to minimize the release of B79P and DEHP to the Canadian environment, in order to address ecological concerns, as appropriate.
- DEHP, which was previously concluded to be harmful to human health, was added to the Cosmetic Ingredient Hotlist in 2009. The listing indicates that the use of DEHP is prohibited and must not be present in cosmetic products.
- For soft vinyl children’s toys and child-care articles, compliance and enforcement of the existing regulation of DEHP (and 5 other phthalates) will continue as part of the regular enforcement of the Phthalates Regulations under the Canada Consumer Product Safety Act.
- Compliance and enforcement of the existing 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.
- Phthalates in food continue to be measured as part of Health Canada's Total Diet Study.
- Although the combined exposure of phthalates is not considered to be harmful to the environment or human health at current levels of exposure, some of these substances are associated with ecological and health effects of concern. Therefore, it may be of concern for human health or the environment if use patterns of certain phthalates were to increase in Canada.
- Follow-up activities to track changes in exposure and/or commercial use patterns for certain phthalates are being considered.
- Stakeholders are encouraged to provide any information relevant to these substances that may help inform the choice of tracking activity, during the 60-day public comment period on the assessment. This could include information on new or planned import, manufacture or use of the substance if not already submitted.
What can Canadians do?
- The health risks associated with a substance depend on its hazard (its potential to cause health effects) and the amount of substance to which a person is exposed.
- As a general precaution, Canadians are reminded when using any product, to carefully follow safety warnings and directions and to dispose of the products appropriately.
- Canadians who may be exposed to the phthalates in the workplace should consult with their employer and occupational health and safety (OHS) representatives about safe handling practices, applicable laws and requirements under the OHS legislation and the Workplace Hazardous Materials Information System (WHMIS).
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