Phthalate substance grouping

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Certain phthalate substances are among those identified as priorities for action for the second phase of the Chemicals Management Plan (CMP). The selection of the phthalate substances 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 phthalate substances were included in this substance grouping, and were selected for a number of different reasons: some have been identified as potentially 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 phthalate substances 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 Grouping from the original 14 phthalates to include an additional 14 phthalates, including three previously assessed under the Canadian Environmental Protection Act, 1999 (CEPA 1999) (dibutyl phthalate [DBP], butyl benzyl phthalate [BBP], and diethyl hexyl phthalates [DEHP]). Other phthalates on the Domestic Substances List, 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.

State of the Science Reports and Proposed Approach for Cumulative Risk Assessment of Phthalates

In August 2015, four state of the science reports, which collectively consider 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.

The Government of Canada is soliciting comments on these documents. Interested parties are encouraged to provide comments and suggestions by September 30, 2015 to the Substances Management Information Line, indicating on the envelope or subject line "Phthalates state of the science reports and proposed approach for cumulative risk assessment of phthalates".

Summary of Publications

Phthalate Substances
Subgrouping CAS RN Chemical Substance State of the Science Report Proposed Approach for Cumulative Risk Assessment of Phthalates

Table 1 footnotes

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

Short-chain Phthalate 131-11-3 DMP  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
71888-89-6 DIHepP
DINPTable 1 footnote 1 28553-12-0
Long-chain Phthalates 26761-40-0
3648-20-2 DUP
Date Activity
Summer 2017 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.
Summer 2016 Anticipated release of the draft screening assessment, in Canada Gazette including an assessment of cumulative risk for certain substances, and start of 60-day public comment period.
August 1, 2015 Release of the state of the science report and the proposed cumulative risk assessment approach, in Canada Gazette, 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.

Submissions Received

Submissions Received for the Phthalate Substance Grouping
Type of Response Approximate Number
Responses to mandatory section 71 Notice (responses were received relating to 27 substances in the grouping) 132
Requests for extension of the deadline for section 71 Notice responses granted 37
Expressions of "Stakeholder Interest" (responses were received relating to 32 substances in the grouping) 70
Other submissions (for example, studies, additional information) (submissions were received relating to 5 substances in the grouping) 12


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 on 2014 Phthalates Stakeholder Technical Workshop

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 four 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.

Section 71 Notice (Mandatory Survey)

On July 13, 2013, a Notice was issued in the Canada Gazette, Part I: Vol.147, No. 28 - July 13, 2013 (PDF Version - 2,257 K) under section 71 of the CEPA 1999.

Every person to whom this Notice applied was required to comply with the Notice no later than 5:00 p.m. EST, November 13, 2013.

If you have questions or comments, please contact us. Indicate on the envelope or subject line "Phthalate Substance Grouping."

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