Phthalate Substance Grouping
Certain phthalates are among those identified as priorities for action for the second phase of the Chemicals Management Plan (CMP). The selection of the phthalates for action was based on the categorization process completed in 2006, and on information received as part of the first phase of the CMP. Fourteen phthalates were included in this substance grouping.
Due to the possibility that some phthalates may have common health effects of concern, the potential for cumulative risk from combined exposure to these substances was addressed by expanding the scope of the Phthalates Substance Grouping from the original 14 phthalates to include an additional 14 phthalates, including 4 previously assessed under the Canadian Environmental Protection Act, 1999 (CEPA 1999): 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).
- Final screening assessment and proposed risk management approach
- Performance measurement
- Follow-up activities
- Summary of publications
- Multi-stakeholder technical workshop
- Information gathering
Final screening assessment and proposed risk management approach
In December 2020, the final screening assessment was released and the related notice was published in the Canada Gazette, Part I: Vol. 154, No. 49 – December 5, 2020. The final screening assessment addressed the 14 substances in the Phthalate Substance Grouping and, in order to consider combined exposure to phthalates, 14 additional phthalates listed on the DSL were included within the scope of the screening assessment. With the exception of 1 substance, DEHP, these additional phthalates were not assessed individually.
The final screening assessment concluded that the 14 substances in the original Phthalate Substance Grouping are not harmful to the environment or to human health as set out in section 64 of CEPA 1999. It also concluded that 1 additional phthalate, DEHP, is harmful to the environment as set out in section 64 (a) of CEPA 1999.
DEHP was previously assessed in 1994 under the Priority Substances List (PSL). This previous assessment concluded that DEHP is harmful to human health in Canada as set out in section 64 (c) of CEPA 1999, and this conclusion remains unchanged. However, a conclusion for potential harm to the environment could not be determined at that time due to insufficient information. In the current screening assessment, new information on DEHP was used to conclude on its potential for harm to the environment.
A proposed Risk Management Approach for DEHP was released in conjunction with this publication for a 60-day public comment period.
In October 2017, the draft screening assessment was released and the related notice was published in the Canada Gazette, Part I: Vol. 151, No. 40 – October 7, 2017. Risk management scopes for B79P and DEHP were also released in conjunction with this publication. There was a 60-day public comment period associated with these publications.
In August 2015, 4 state of the science reports, which collectively considered 14 substances, and a Proposed Approach for Cumulative Risk Assessment of Phthalates were released for a 60-day public comment period ending September 30, 2015.
Conducting performance measurement evaluations allows the Government to assess whether the risk management actions taken on substances found to be toxic under CEPA 1999 were effective in meeting risk management objectives, or whether adjustments would help to protect Canadians and their environment. A performance measurement evaluation report that measures and evaluates the performance of risk management tools taken to help protect Canadians from DEHP exposures that were found to pose a risk to human health has been published. The report measures the effectiveness of the Government of Canada's actions taken prior to the publication of the final screening assessment and proposed risk management approach in December 2020.
Although the combined exposure of phthalates is not considered to be harmful to the environment or human health at levels of exposure considered in the assessment, some of these substances are associated with health and/or ecological effects of concern. Therefore, there may be concern if exposure to certain phthalates were to increase in Canada. For this reason, the Government plans on gathering information to track changes in exposure and commercial use patterns for these substances. Follow-up activities will include human biomonitoring via the Canadian Health Measures Survey, as well as continued food monitoring and surveillance via the Canadian Total Diet Study and the Canadian Food Inspection Agency's targeted surveys. Other follow-up activities may include monitoring house dust via the Canadian House Dust Study, environmental monitoring of Canadian surface waters, wastewater effluents or air, or the use of information gathering mechanisms, such as those outlined in CEPA 1999.
Stakeholders will be given advanced notice of any planned information gathering. If new information becomes available it will be considered through the identification of risk assessment priorities (IRAP) process. Compliance and enforcement of existing requirements for phthalates will continue as part of the Government of Canada's regular enforcement activities.
Summary of publications
|Subgrouping||CAS RN||Chemical substance||Public comments on the draft screening assessment||Final screening assessment||Follow-up activities||State of the science report||Proposed Approach for Cumulative Risk Assessment of Phthalates||Public comments on the state of the science reports and proposed approach for cumulative risk assessment|
|Short-chain phthalate||131-11-3Table 1 Footnote 1||DMP||Short-chain phthalate HTML||Short-chain phthalate 1 HTML||Information gathering (including monitoring)||Short-chain phthalate 2 HTML||Short-chain phthalate 3 HTML||Short-chain phthalate 4 HTML|
|Medium-chain phthalates||84-61-7||DCHP||Medium-chain phthalates HTML|
|84-69-5Table 1 Footnote 1||DIBP|
|71888-89-6Table 1 Footnote 1||DIHepP|
|DINPTable 1 Footnote 2||28553-12-0||DINP||DINP HTML|
|68515-48-0Table 1 Footnote 1|
|Long-chain phthalates||26761-40-0||DIDP||Long-chain phthalates HTML|
|68515-49-1Table 1 Footnote 1|
Table 1 Footnotes
|Subgrouping||CAS RN||Chemical substance||Performance measurement evaluation report||Public comments on the draft screening assessment||Final screening assessment||Proposed risk management approach||Follow-up activities|
|Short-chain Phthalate||84-66-2||DEP||None||HTML||None||None||Information gathering (including monitoring)|
|117-81-7||DEHP||HTML||HTML||HTML||Refer to proposed risk management approach|
|Long-chain Phthalates||68648-93-1||610P||None||None||None||None planned at this time|
|117-84-0||DnOP||Information gathering (including monitoring)|
|68515-43-5||D911P||None planned at this time|
|June 18, 2021||Publication of the Performance Measurement Evaluation for Risk Management of Bis(2-ethylhexyl) phthalate (DEHP), Health Component.|
|December 5, 2020||Publication in Canada Gazette of final screening assessment, including an assessment of cumulative risk for certain substances, and publication and start of 60-day public comment period on the Risk Management Approach for DEHP.|
|October 7, 2017||Publication in Canada Gazette and start of 60-day public comment period on (a) the draft screening assessment, including an assessment of cumulative risk for certain additional phthalates and (b) proposed risk management scopes for B79P and DEHP.|
|April 1, 2017||Publication in Canada Gazette of notice under section 71 of CEPA 1999. The notice applies to 50 substances that are toxic as defined under section 64 of CEPA 1999. One substance in this grouping (DEHP) is included in this notice.|
|August 1, 2015||Release of the state of the science report and the proposed cumulative risk assessment approach and start of 60-day public comment period.|
|January 13, 2014||Deadline for submission of any voluntary information by interested stakeholders.|
|November 13, 2013||Deadline for submission of information for the section 71 notice (without an extension).|
|July 13, 2013||Release of the section 71 notice with respect to certain phthalate substances and the accompanying technical documents.|
|If needed, other information gathering tools could be used to inform potential risk management actions.|
Multi-stakeholder technical workshop
In March 2014, Environment Canada and Health Canada hosted a multi-stakeholder technical workshop in Ottawa. The primary objective of this workshop was to obtain input on:
- a proposed category and read-across approach for the human health effects portion of the planned assessment; and,
- early thinking on approaches for a potential cumulative risk assessment for the human health assessment.
The workshop format encouraged input from stakeholders, and 2 key observations from participants were:
- Overall support for the category and read-across approach, with constructive technical input on specific elements; and,
- Strong interest in staying engaged on scientific considerations as the Government progresses in its assessment of the Phthalate Substance Grouping, in particular on its approach for a cumulative risk assessment.
Following discussions at the stakeholder technical workshop, a technical category approach document was developed and refined by Health Canada that outlined its approach, using chemical categories and read-across data to address data gaps for effects on the developing male reproductive system. The purpose of this exercise was to develop appropriate subgroups for identification of common health effects of concern (for example, reproductive and developmental effects).
Approach for Using Chemical Categories and Read-Across to Address Data Gaps for Effects on the Developing Male Reproductive System
Further to feedback received during the workshop and based on consideration of the complex scientific issues, strong stakeholder interest in providing scientific input, and recent international developments on phthalates, the original risk assessment timelines for the Phthalates Grouping were adjusted by one year. In August 2015, Environment Canada and Health Canada published 4 state of the science reports and the Proposed Cumulative Risk Assessment Approach for a 60-day public comment period. This additional activity was undertaken to solicit input on the science prior to publication of a draft screening assessment, including an assessment of cumulative risk, as appropriate, in summer 2016.
- Approach for Using Chemical Categories and Read-Across to Address Data Gaps for Effects on the Developing Male Reproductive System
2017 Mandatory survey - section 71 notice
In April 2017, a notice was issued in the Canada Gazette, Part I: Vol. 151, No. 13 - April 1, 2017 under section 71 of CEPA 1999. The notice applied to DEHP (CAS RN 117-81-7) as well as 49 other substances that are toxic as defined under section 64 of CEPA 1999. More information is available on the certain substances requiring information for risk management web page.
2013 Mandatory survey - section 71 notice
In July 2013, a notice was issued in the Canada Gazette, Part I: Vol.147, No. 28 - July 13, 2013 under section 71 of the CEPA 1999.
A compilation of the non-confidential data received on certain phthalate substances in response to the section 71 notice, including information submitted on a voluntary basis, is available via the Government of Canada Open Data Portal. Along with the compilation, a non-confidential information summary provides general information on the volume of information received and the substances, activities, substance functions, commercial uses and sectors most often reported.
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