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Dyes of the Aromatic Azo and Benzidine-based Substance Grouping

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The Aromatic Azo and Benzidine-based Substances are among those identified as priorities. Read more about the Aromatic Azo and Benzidine-based Substance Grouping.

Summary of Publications

Final Screening Assessments for Dyes of the Aromatic Azo and Benzidine-based Substance Grouping
Subgroup Chemical Substances Public Comments on the Draft Screening Assessment Final Screening Assessment Proposed Risk Management Approach
Certain Azo Acid Dyes See List of Certain Azo Acid Dyes HTML HTML None
Certain Azo Basic Dyes See List of Certain Azo Basic Dyes HTML HTML None
Certain Azo Direct Dyes and Certain Azo Reactive Dyes See List of Certain Direct Dyes and List of Certain Reactive Dyes HTML HTML None
Certain Azo Metal Complexes and Other Azo Substances See List of Certain Azo Metal Complexes and Other Azo Substances None HTML None
Certain Azo Solvent Dyes See List of Certain Azo Solvent Dyes None HTML CAS RN: 85-86-9: Refer to the Risk Management Action Milestones for Solvent Red 23
CAS RN 2832-40-8: HTML
All other: None
Certain Benzidine-based Dyes and Related Substances See List of Certain Benzidine-based Dyes and Related Substances HTML HTML None
Draft Screening Assessments for Dyes of the Aromatic Azo and Benzidine-based Substance Grouping
Subgroup Chemical Substances Draft Screening Assessment Proposed Risk Management Scope
Certain Azo Disperse Dyes See List of Certain Azo Disperse Dyes HTML HTML
Timelines
Date Subgroup Affected Activity
If needed, information gathering tools could be used to inform potential risk management actions.
Fall 2016 Certain Azo Disperse Dyes Anticipated publication in Canada Gazette of final assessment decision under subsection 77(6) of CEPA 1999.
June 18, 2016Certain Azo Acid DyesPublication in Canada Gazette of final assessment decision under subsection 77(6) of CEPA 1999.
May 28, 2016 Certain Azo Basic Dyes Publication in Canada Gazette of final assessment decision under subsection 77(6) of CEPA 1999 and proposal to rescind the SNAc provisions for one substance, CAS RN 59709-10-3.
May 28, 2016 Certain Azo Solvent Dyes Publication in Canada Gazette of final assessment decision under subsection 77(6) of CEPA 1999.
April 4, 2015 Certain Azo Direct Dyes, Certain Azo Reactive Dyes Publication in Canada Gazette of final assessment decision under subsection 77(6) of CEPA 1999.
April 4, 2015 Certain Azo Metal Complexes and Other Azo Substances Publication in Canada Gazette of final assessment decision under subsection 77(6) of CEPA 1999.
March 11, 2015 Certain Benzidine-based Dyes and Related Substances Publication in Canada Gazette, Part II of Order amending the Domestic Substances List (DSL) to rescind the Significant New Activity (SNAc) provisions on TDBD (CAS RN 1871-22-3).
December 24, 2014 Certain Azo Acid Dyes Deadline for submission of public comments on draft screening assessment.
November 29, 2014 Certain Benzidine-based Dyes and Related Substances Publication in Canada Gazette of final assessment decision under subsection 77(6) of CEPA 1999 and proposal to rescind the Significant New Activity (SNAc) provisions for one substance, TDBD (CAS RN 1871-22-3).
October 25, 2014 Certain Azo Acid Dyes Publication in Canada Gazette of proposed assessment decision under subsection 77(1) of CEPA 1999, and start of 60-day public comment period on the draft screening assessment.
September 24, 2014 Certain Azo Basic Dyes Deadline for submission of public comments on draft screening assessments.
July 26, 2014 Certain Azo Basic Dyes Publication in Canada Gazette of proposed assessment decision under subsection 77(1) of CEPA 1999, and start of 60-day public comment period on the draft screening assessment.
July 16, 2014 Certain Azo Metal Complexes and Other Azo Substances Deadline for submission of public comments on draft screening assessments.
May 28, 2014 Certain Azo Direct Dyes, Certain Azo Reactive Dyes Deadline for submission of public comments on draft screening assessments.
May 17, 2014 Certain Azo Metal Complexes and Other Azo Substances Publication in Canada Gazette of proposed assessment decision under subsection 77(1) of CEPA 1999, and start of 60-day public comment period on the draft screening assessment.
March 29, 2014 Certain Azo Direct Dyes, Certain Azo Reactive Dyes Publication in Canada Gazette of proposed assessment decision under subsection 77(1) of CEPA 1999, and start of 60-day public comment period on the draft screening assessment.
January 1, 2014 Certain Azo Disperse Dyes, Certain Azo Solvent Dyes Deadline for submission of public comments on a) draft screening assessments and b) the proposed risk management scope document for Azo Disperse Dyes (including CAS RN 2832-40-8).
November 2, 2013 Certain Azo Disperse Dyes, Certain Azo Solvent Dyes Publication in Canada Gazette of proposed assessment decisions under subsection 77(1) of CEPA 1999 and start of 60-day public comment period on a) the draft screening assessments and b) the proposed risk management scope document for Azo Disperse Dyes (including CAS RN 2832-40-8).
August 14, 2013 Certain Benzidine-based Dyes and Related Substances Deadline for submission of public comments on draft screening assessment.
June 15, 2013 Certain Benzidine-based Dyes and Related Substances Publication in Canada Gazette of proposed assessment decision under subsection 77(1) of CEPA 1999, and start of 60-day public comment period on the draft screening assessment.
April 16, 2012 Certain Azo Acid Dyes, Certain Azo Basic Dyes, Certain Azo Direct Dyes,Certain Azo Disperse Dyes, Certain Azo Metal Complexes and Other Azo Substances, Certain Azo Reactive Dyes, Certain Azo Solvent Dyes, and Certain Benzidine-based Dyes and Related Substances Deadline for submission of additional information by interested stakeholders, including on the extent and nature of the management/stewardship.

Final Screening Assessments and Risk Management Approaches

Certain Azo Acid Dyes

In June 2016, the final screening assessment for 52 substances was released and the related Notice was published in the Canada Gazette, Part I: Vol. 150, No. 25 – June 18, 2016 (PDF Version – 2,741 K).

The final screening assessment concluded that these 52 substances do not meet any of the criteria under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). Therefore, the Minister of Environment and Climate Change and the Minister of Health have proposed to take no further action on these substances at this time under the Act.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances assessed under the Aromatic Azo and Benzidine-based Substance Grouping are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase in products available to consumers.

Options on how best to monitor changes in uses of substances that are considered to have human health effects of concern are being investigated, and this was communicated to stakeholders when the draft screening assessment was published. Health Canada and Environment and Climate Change Canada are currently developing, and plan to publish, a consultation document describing potential options for information gathering or preventive actions on these substances, as well as other similar substances that are considered to have potential health effects of concern. Publication of the consultation document, currently planned for publication in summer/fall 2016, will provide an opportunity for stakeholders to contribute feedback. In October 2014, the draft screening assessment was released and the related Notice was published in the Canada Gazette, Part I: Vol. 148, No. 43 - October 25, 2014 (PDF Version - 995 K).

Certain Azo Basic Dyes

In May 2016, the final screening assessment for 33 substances was released and the related Notice was published in the Canada Gazette, Part 1: Vol. 150, No. 22 - May 28, 2016 (PDF Version - 2,437 K).

The final screening assessment concluded that these 33 substances do not meet any of the criteria under section 64 of the CEPA 1999. The Minister of the Environment and Climate Change and the Minister of Health propose to take no further action on these substances at this time under the Act.

Among the 33 substances in the Azo Basic Dyes subgroup, one substance (NDTHPM) was previously assessed under Batch 9 of the Challenge Initiative of the Chemicals Management Plan and was found not to pose a risk to the environment or to human health as set out in section 64 of CEPA 1999. This conclusion remains unchanged.

The current screening assessment concludes that the potential ecological concern identified in the previous assessment of CAS RN 59709-10-3 with respect to new uses as described in the screening assessment of 145 PBiT Substances, published in April 2008, has changed. The current screening assessment concludes that this substance is no longer of concern to the environment, nor considered as having effects of concern. Consequently, amendments to the Domestic Substances List, indicating that the Significant New Activity provisions under subsection 81(3) of the Act no longer apply to this substance, are being considered. A notice to that effect will be published shortly.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances assessed under the Aromatic Azo and Benzidine-based Substance Grouping are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase through products available to consumers.

Options on how best to monitor changes in the use profile of these substances are being investigated, where applicable. Stakeholders will have the opportunity to provide feedback on a consultation document, which describes potential options for information gathering or preventive actions, that will be published once assessments for all of the Aromatic Azo and Benzidine-based Substance Grouping are completed.

In July 2014, the draft screening assessment was released and the related Notice was published in the Canada Gazette, Part I: Vol. 148, No. 30 – July 26, 2014 (PDF version – 1,124 K) for a 60-day public comment period. There was no risk management scope document associated with this release.

Certain Azo Direct Dyes and Certain Azo Reactive Dyes

In April 2015, the final screening assessment for 69 substances was released and the related Notice was published in the Canada Gazette, Part I: Vol. 149, No. 14 - April 4, 2015 (PDF Version - 815 K).

The final screening assessment concluded that these 69 substances do not meet any of the criteria under section 64 of CEPA 1999. Therefore, the Minister of the Environment and the Minister of Health have proposed to take no further action on these substances at this time under the Act.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances assessed under the Aromatic Azo and Benzidine-based Substance Grouping are recognized to have effects of concern based on their potential to cause cancer. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase in products available to consumers.

Options on how best to monitor changes in the use profile of these substances are being investigated, where applicable. Stakeholders will have the opportunity to provide feedback on a consultation document, which describes potential options for information gathering or preventive actions, that will be published once assessments for all of the Aromatic Azo and Benzidine-based Substance Grouping are completed.

In March 2014, the draft screening assessment was released and the related Notice was published in the Canada Gazette, Part I: Vol. 148, No. 13 - March 29, 2014 (PDF Version - 11,279 K).

Certain Azo Metal Complexes and Other Azo Substances

In April 2015, the final screening assessment for 6 substances was released and the related Notice was published in the Canada Gazette, Part I: Vol. 149, No. 14 - April 4, 2015 (PDF Version - 815 K).

The final screening assessment concluded that these 6 substances do not meet any of the criteria under section 64 of CEPA 1999. Therefore, the Minister of the Environment and the Minister of Health have proposed to take no further action on these substances at this time under the Act.

In May 2014, the draft screening assessment was released and the related Notice was published in the Canada Gazette, Part I: Vol. 148, No. 20 - May 17, 2014 (PDF Version - 1,241 K) for a 60-day public comment period.

Certain Azo Solvent Dyes

In May 2016, the final screening assessment for 22 substances was released and the related Notice was published in the Canada Gazette, Part I: Vol. 150, No. 22 - May 28, 2016 (PDF Version - 2,437 K).

The final screening assessment concluded that the azo solvent dyes assessed do not meet any of the criteria set out in section 64 of CEPA 1999. Therefore the Minister of the Environment and Climate Change and the Minister of Health have proposed to take no further action on these substances at this time under the Act. No proposed risk management approach document was prepared. The ecological component of the screening assessment for Solvent Yellow 77, also known as Disperse Yellow 3, which presented a proposed toxic to the environment conclusion in the draft screening assessment, will now be included in the final screening assessment of Certain Azo Disperse Dyes that will be published at a later date. The human health conclusion for this substance is also included in the Azo Disperse Dye assessment.

Two substances included in the solvent dyes subgroup, Solvent Red 3 and Solvent Yellow 18, were previously assessed under the Challenge Initiative of the Chemicals Management Plan and are currently subject to the SNAc provisions of CEPA 1999. Three other substances included in the solvent dyes subgroup, Solvent Red 4 (CAS RN 2653-64-7), CAS RN 73528-78-6 and CAS RN 85392-21-8, were previously assessed in April 2008 as part of an assessment of 145 PBiT substances. As a result of its conclusion, these substances are currently subject to the SNAc provisions of CEPA 1999.The current screening assessment now concludes that these five substances no longer have any human health or ecological concerns. As the original human health or ecological concern identified to support the application of the SNAc provisions has changed based on the current screening assessment, it is proposed to rescind the SNAc provisions for these five substances. A notice to that effect will be published shortly.

Five substances in this subgroup were previously assessed under the Challenge Initiative of the Chemicals Management Plan: Solvent Red 1 (CAS RN 1229-55-6), Solvent Red 3 (CAS RN 6535-42-8), Solvent Orange 7 (CAS RN 3118-97-6) and Solvent Red 23 (CAS RN 85-86-9) were assessed in Batch 6, and Solvent Yellow 18 (CAS RN 6407-78-9) was assessed in Batch 7. It was concluded that Solvent Red 23 poses a risk to human health as set out in paragraph 64(c) of CEPA 1999. The conclusions for these substances previously assessed under the Challenge Initiative remain unchanged.

Significant new information relevant to the assessment of Azo Solvent Dyes, including the previously assessed five substances, informed the ecological assessment of the Azo Solvent Dyes subgroup. Similarly, significant new information relevant to the assessment of Solvent Red 1, Solvent Red 3 and Solvent Yellow 18 informed the human health assessment of the Azo Solvent Dyes subgroup. The screening assessment of Azo Solvent Dyes reflects this updated information.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances assessed under the Aromatic Azo and Benzidine-based Substance Grouping are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase in products available to consumers.

Options on how best to monitor changes in the use profile of these substances are being investigated, where applicable. Stakeholders will have the opportunity to provide feedback on a consultation document, describing potential options for information gathering or preventive actions, to be published once assessments for all of the Aromatic Azo and Benzidine-based Substance Grouping are completed.

In November 2013, the draft screening assessment was released and the related Notice was published in the Canada Gazette, Part I: Vol. 147, No. 44 - November 2, 2013  (PDF Version - 1,732 K). A risk management scope document for Solvent Yellow 77 (and Azo Disperse Dyes) was also released on this date. 60-day public comment periods were associated with these publications.

Certain Benzidine-based Dyes and Related Substances

In November 2014, the final screening assessment for 42 substances was released and the related Notice was published in the Canada Gazette, Part I: Vol. 148, No. 48 - November 29, 2014 (PDF Version – 1,172 K).

The final screening assessment concluded that these 42 substances do not meet any of the criteria under section 64 of CEPA 1999. The Minister of the Environment and the Minister of Health propose to take no further action on these substances at this time under the Act.

Five subgroups are included in this screening assessment; Benzidine-based Acid Dyes (9 substances), Benzidine-based Direct Dyes (24 substances), Benzidine-based Precursors (2 substances), Benzidine-based Cationic Indicators (2 substances), and Benzidine derivatives (5 substances).

One Benzidine-based Acid Dye (Acid Red 111) and one Benzidine-based Direct Dye (Direct Black 38) were previously assessed during the Challenge Initiative of the CMP. It was concluded that Acid Red 111 and Direct Black 38 did not meet the criteria under section 64 of CEPA 1999 (Environment Canada, Health Canada 2009, 2011). No significant new information has been identified for Acid Red 111 or Direct Black 38 since the Challenge assessments, and therefore these substances are not included in the current Screening Assessment.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances assessed under the Aromatic Azo and Benzidine-based Substance Grouping are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase in products available to consumers.

Options on how best to monitor changes in the use profile of these substances are being investigated, where applicable. Stakeholders will have the opportunity to provide feedback on a consultation document, which describes potential options for information gathering or preventive actions, that will be published once assessments for all of the Aromatic Azo and Benzidine-based Substance Grouping are completed.

One of the substances in this subgroup, TDBD (CAS RN 1871-22-3) was previously assessed in April 2008 as part of an assessment of 145 PBiT substances. As a result of its conclusion, it is currently subject to the SNAc provisions of CEPA 1999. However, it is now concluded that it does not meet the criteria for bioaccumulation or inherent toxicity to aquatic organisms. As a result, it is proposed to rescind the SNAc provisions on TDBD. A notice to that effect will be published shortly.

In June 2013, the draft screening assessment was released and the related Notice was published in the Canada Gazette, Part I: Vol. 147, No. 25 - June 15, 2013 (PDF Version - 2,106 K) for a 60-day public comment period. There was no risk management scope document associated with this release.

Draft Screening Assessments and Risk Management Scopes

Certain Azo Disperse Dyes

In November 2013, the draft screening assessment was released and the related Notice was published in the Canada Gazette, Part I: Vol. 147, No. 44 - November 2, 2013 (PDF Version - 1,732 K). A risk management scope document for Azo Disperse Dyes was also released on this date for a 60-day public comment period. The draft assessment proposed that these substances pose a risk to the environment as set out in paragraph 64(a) of CEPA 1999. In addition to the 73 substances in this draft screening assessment, other azo disperse dyes are also proposed to pose a risk to the environment.

Among 73 azo disperse dyes in the Azo Disperse Dyes subgroup, 24 substances were previously assessed under the Challenge Initiative of the Chemicals Management Plan and were found not to pose a risk to the environment or to human health as set out in section 64 of CEPA 1999. These human health conclusions remain unchanged, however, the proposed ecological conclusion has been updated.

Significant new information relevant to the assessment of these 24 substances was identified to inform the ecological assessment of the Azo Disperse Dyes subgroup. Similarly, significant new information relevant to the assessment of 13 of the 24 substances was identified to inform the human health assessment of the Azo Disperse Dyes subgroup. The draft screening assessment of Azo Disperse Dyes reflects this updated information.

Although a risk to human health has not been identified for the general population of Canada at current levels of exposure, some substances assessed under the Aromatic Azo and Benzidine-based Substance Grouping are recognized to have effects of concern based on their potential carcinogenicity. There may be a concern for human health if exposures to the general population of Canada to these substances were to increase in products available to consumers.

Options on how best to monitor changes in the uses of substances that are considered to have human health effects of concern are being investigated, and this was communicated to stakeholders when the draft screening assessment was published. Health Canada and Environment and Climate Change Canada are currently developing, and plan to publish, a consultation document describing potential options for information gathering or preventive actions on these substances, as well as other similar substances that are considered to have potential health effects of concern. Publication of the consultation document, currently planned for publication in summer/fall 2016, will provide an opportunity for stakeholders to contribute feedback.

Submissions Received

Information on dyes included in the Aromatic Azo and Benzidine-based Substances Grouping was gathered from industry and interested stakeholders through a mandatory survey Notice issued under section 71 of CEPA 1999. They were also invited to complete a voluntary questionnaire. This Notice applies to a Subset of the Aromatic Azo and Benzidine-based Substances covered in this initiative.

The numbers in the tables that follow include only survey submissions from a 2010 survey that covered 225 out of 358 substances in it's the Aromatic Azo and Benzidine-based Substance Grouping. Many of the azo and benzidine-based substances were not included within this survey because they had been previously surveyed within other initiatives.

Submissions Received for Certain Azo Acid Dyes
Type of Response Number of Submissions
Mandatory section 71 Notice 20
Declaration of Stakeholder Interest 16
Voluntary Data Submissions (for example, studies, additional information) 4
Submissions Received for Certain Azo Basic Dyes
Type of Response Number of Submissions
Mandatory section 71 Notice 1
Declaration of Stakeholder Interest 0
Voluntary Data Submissions (for example, studies, additional information) 1
Submissions Received for Certain Azo Direct Dyes and Azo Reactive Dyes
Type of Response Number of Submissions
Mandatory section 71 Notice 6
Declaration of Stakeholder Interest 3
Voluntary Data Submissions (for example, studies, additional information) 2
Submissions Received for Certain Azo Disperse Dyes
Type of Response Number of Submissions
Mandatory section 71 Notice 2
Declaration of Stakeholder Interest 0
Voluntary Data Submissions (for example, studies, additional information) 2
Submissions Received for Certain Azo Metal Complexes and Other Substances
Type of Response Number of Submissions
Mandatory section 71 Notice 1
Declaration of Stakeholder Interest 2
Voluntary Data Submissions (for example, studies, additional information) 1
Submissions Received for Certain Azo Solvent Dyes
Type of Response Number of Submissions
Mandatory section 71 Notice 0
Declaration of Stakeholder Interest 12
Voluntary Data Submissions (for example, studies, additional information) 3
Submissions Received for Certain Benzidine-based Dyes and Related Substances
Type of Response Number of Submissions
Mandatory section 71 Notice 0
Declaration of Stakeholder Interest 2
Voluntary Data Submissions (for example, studies, additional information) 2

If you have questions or comments, please contact us. Indicate on the envelope or subject line "Certain Dyes of the Aromatic Azo and Benzidine-based Substance Grouping."