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, and were selected for a number of different reasons: some have been identified as potentially being associated with reproductive and developmental effects; some have a wide range of consumer applications; some are associated with potential ecological effects of concern; and some have been identified as priorities internationally.

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). Other phthalates on the Domestic Substances List (DSL), or that have been notified for use in Canada under the New Substances Notification Regulations (Chemicals and Polymers) may also be considered in the cumulative risk assessment.

Draft screening assessment and risk management scopes

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 for a 60-day public comment period. This draft screening assessment addresses 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 draft screening assessment proposes to conclude that 13 of the 14 substances in the Phthalate Substance Grouping are not harmful to the environment or to human health as set out in section 64 of CEPA 1999. It also proposes to conclude that the remaining substance in the Grouping, B79P, and that the one additional phthalate assessed individually, DEHP, are 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. 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 propose a conclusion on its potential for harm to the environment.

Although the combined exposure of phthalates is not considered to be harmful to the environment or human health at current levels of exposure based on available toxicity data, some of these substances are associated with ecological and health effects of concern. Therefore, there may be 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.

Risk management scope documents for B79P and DEHP were released in conjunction with this publication. There is a 60-day public comment period associated with these publications.

State of the science reports and Proposed Approach for Cumulative Risk Assessment of Phthalates

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.

Summary of publications

Fourteen phthalates in the Phthalates Substance Grouping
Subgrouping CAS RN Chemical substance Draft screening assessment Risk management scope document 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 131-11-3 DMP HTML None Under consideration HTML HTML HTML
Medium-chain phthalates 84-61-7 DCHP HTML
84-64-0 BCHP
84-69-5 DIBP
523-31-9 DBzP
5334-09-8 CHIBP
16883-83-3 B84P
27215-22-1 BIOP
27987-25-3 DMCHP
68515-40-2 B79P HTML See proposed risk management scope
71888-89-6 DIHepP None Under consideration
DINPTable 1 footnote 1 28553-12-0 DINP Under consideration HTML
68515-48-0
Long-chain phthalates 26761-40-0 DIDP None planned at this time HTML
68515-49-1
3648-20-2 DUP
Table 1 footnote 1

Based on differences in the scientific considerations related to physical-chemical properties and potential health effects of concern, DINP is considered as a medium-chain phthalate for the purposes of the health review, and as a long-chain phthalate for the purposes of the ecological review

Return to Table 1 footnote 1 referrer

Fourteen phthalates in the Phthalates Substance Grouping
Subgrouping CAS RN Chemical substance Draft screening assessment Risk management scope document 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 131-11-3 DMP HTML None Under consideration HTML HTML HTML
Medium-chain phthalates 84-61-7 DCHP HTML
84-64-0 BCHP
84-69-5 DIBP
523-31-9 DBzP
5334-09-8 CHIBP
16883-83-3 B84P
27215-22-1 BIOP
27987-25-3 DMCHP
68515-40-2 B79P HTML See proposed risk management scope
71888-89-6 DIHepP None Under consideration
DINPTable 1 footnote 1 28553-12-0 DINP Under consideration HTML
68515-48-0
Long-chain phthalates 26761-40-0 DIDP HTML
68515-49-1
3648-20-2 DUP None planned at this time
Table 1 footnote 1

Based on differences in the scientific considerations related to physical-chemical properties and potential health effects of concern, DINP is considered as a medium-chain phthalate for the purposes of the health review, and as a long-chain phthalate for the purposes of the ecological review

Return to Table 1 footnote 1 referrer

Fourteen additional phthalate substances considered in the evaluation of cumulative risk
Subgrouping CAS RN Chemical substance Draft screening assessment Risk management scope document Follow-up activities
Short-chain Phthalate 84-66-2 DEP Not applicable Not applicable Under consideration
Medium-chain Phthalates 131-16-8 DPrP
84-74-2 DBP
85-68-7 BBP
84-75-3 DnHP
111381-89-6 79P
27554-26-3 DIOP
117-81-7 DEHP HTML HTML See Proposed Risk Management Scope
Long-chain Phthalates 68648-93-1 610P Not applicable Not applicable None planned at this time
117-84-0 DnOP Under consideration
68515-43-5 D911P None planned at this time
111381-91-0 D911P-2
85507-79-5 DIUP
68515-47-9 DTDP
Timelines
Date Activity
July 2018 Anticipated publication in Canada Gazette of final screening assessment decisions under subsection 77(6) of CEPA 1999, including an assessment of cumulative risk for certain substances, and proposed risk management approach documents.
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 scope documents 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:

  1. a proposed category and read-across approach for the human health effects portion of the planned assessment; and,
  2. early thinking on approaches for a potential cumulative risk assessment for the human health assessment.

The workshop format encouraged input from stakeholders, and two 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.

Summary report

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 document 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.

Information gathering

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 applies to 50 substances that are toxic as defined under section 64 of CEPA 1999. One phthalate substance, DEHP (CAS RN 117-81-7), is included in this notice. More information, including how to submit a response, is available on the certain substances requiring information for risk management webpage.

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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