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Risk Management Scope for Azo Disperse Dyes Risk Management ApproachChemical Abstracts Service Registry Number 2832 40 8Environment and Climate Change CanadaTable of contentsSummary of Proposed Risk Management1.

Context2. Issue2.1 Final Screening Assessment Report Conclusion2.2 Recommendation under CEPA2.3 Public Comment Period on the Risk Management Scope3. Proposed Risk Management3.1 Proposed Environmental Objective3.2 Proposed Risk Management Objective and Proposed Action3.3 Risk Management Information Gaps4. Background4.1 Azo Disperse Dyes4.2 Current Use and Identified Sector of Disperse Yellow 35. Exposure Sources and Identified Risks5.1 Formulation of Disperse Yellow 35.2 Using Disperse Yellow 3 in Textile Dyeing5.3 Exposure of Concern in Canada5.4 Identified Risks6. Risk Management Considerations6.1 Alternatives and Alternate Technologies6.2 Socio economic and Technical Considerations7. Overview of Existing Risk Management7.1 Related Canadian Risk Management Context Textile Mill Effluents7.2 Related International Risk Management Context8. Next Steps8.1 Public Comment Period8.2 Timing of Actions9. ReferencesAppendiciesAppendix A: Preliminary Non Exhaustive List of Azo Disperse Dyes on the Domestic Substances List with Molar Weights below 360 g/molAppendix B: List of International Risk Management for Azo Disperse Dyes related to Disperse Yellow 3 and includes Azo Disperse Dyes with Ecological Effects of ConcernSummary of proposed risk managementThis document outlines the proposed risk management action for Disperse Yellow 3 (CAS RN 2832 40 8, and referred throughout this document as Yellow 3 an azo dye. In particular, the Government of Canada is consideringdeveloping a Notice requiring the preparation and implementation of a pollution prevention plan under section 56 of the Canadian Environmental Protection Act, 1999 (CEPA) in order to control activities (such as manufacture, import or use) of Disperse Yellow 3 in textile dye formulation and the textile dyeing sector in Canada. Refer to section 3 of this document for more complete details in this regard. 1. As part of the second phase of the Chemicals Management Plan, the Ministers plan to assess and manage, where appropriate, the potential health and ecological risks associated with approximately 500 substances, in 9 substance groupings (Canada 2011a). Its use as a solvent dye has not been identified as a risk to the environment nor human health (Canada 2016c). During the draft assessment stage, all azo disperse dyes including Disperse Yellow 3 were proposed to meet the criteria under section 64(a) of CEPA indicating they are toxic to the environment (Canada 2013). The risk management scope for Azo Disperse Dyes was published on November 2, 2013 and outlined risk management options for all azo disperse dyes as a class, including Disperse Yellow 3. Based on additional information, only Disperse Yellow 3 meets the criteria of section 64. Therefore the scope of this document focuses solely on Disperse Yellow 3. 2. Issue2.1 Final Screening Assessment Report conclusion and Environment and Climate Change Canada conducted joint screening assessments relevant to the evaluation of the subgroups of certain Azo Disperse Dyes and certain Azo Solvent Dyes in Canada (since Disperse Yellow 3, has both azo solvent dye and azo disperse dye applications). A notice summarizing the scientific considerations and conclusion of Disperse Yellow 3 as part of the final Screening Assessment Report of Certain Azo Disperse Dyes was published in the Canada Gazette,Part I, on March 11th 2017 (Canada 2017a)Footnote3. Based on the information available regarding the reported uses and exposure concerns of Disperse Yellow 3 in Canada, the final Screening Assessment Report for Certain Azo Disperse Dyes concludes that Disperse Yellow 3 is toxic under section 64 (a) of CEPA because it is or may be entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long term harmful effect on the environment or its biological diversity (Canada 2017b). Disperse Yellow 3 may persist in water, soil and sediment, but not air and is not likely to bioaccumulate in organisms. It has been determined that Disperse Yellow 3 meets the persistence agenda louis vuitton usata criteria but does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA (Canada 2000). The exposure sources of concern, identified in the final Screening Assessment Report for Certain Azo Disperse Dyes, are based on the release of Disperse Yellow 3 to surface water from textile dye formulation and potential for release from synthetic textile dyeing (disperse dye application) (refer to section 5.2). 2.1.1 Azo Disperse Dye substances with ecological and/or human health effects of concernThe Screening Assessment Report for Certain Azo Disperse Dyes also noted that azo disperse dyes with molar weights below 360 g/mol have demonstrated a higher level of toxicity to aquatic organisms, likely due to their increased bioavailability and therefore are substances with ecological effects of concern. Nine substances that were assessed in this subgroup have a molar weight less than 360 g/mol. Disperse Yellow 3 is the only one of these nine substances that has been identified as being in commerce according to a survey conducted under section 71 of CEPA (Canada 2011b) and is the only dye of this assessment that meets the section 64 criteria under CEPA. other eight substances which had a molar weight below 360 g/mol were not identified as being in commerce in Canada according to recent surveys under section 71 of CEPA and as such, do not meet section 64 criteria under CEPA. Similarly, there are an additional sixteen azo dye substances on louis vuitton alma epi the Domestic Substances List (DSL) which could be used in azo disperse dye applications (Annex A) with molar weights below 360 g/mol, that have effects of concern. It is not certain if these additional sixteen substances are in commerce and are being used in disperse dye applications. In addition, although a risk louis vuitton bucket bag gm to human health has not been identified at current levels of exposure; three Azo Disperse Dyes (including Disperse Yellow 3) are recognized as substances with human health effects of concern due to potential carcinogenicity. A consultation document outlines potential options on how to best monitor changes to and prevent increases in exposures and/or releases of these and other aromatic azo and benzidine based substances with ecological and/or human health effects of concern and requests input from stakeholders on these options (Canada 2017a). Refer to the for further information on Certain Azo Disperse Dyes which includes the assessment conclusion for Disperse Yellow 3, and the Screening Assessment Report for Certain Azo Solvent Dyes which includes additional assessment louis vuitton purses brown thomas information on Disperse Yellow 3. 2.2 Recommendation under CEPABased on the findings of the ecological assessment in the final screening assessment conducted as per CEPA, the Ministers recommend that Disperse Yellow 3 be added to the List of Toxic Substances in Schedule 1 of the ActFootnote 4. The Ministers have taken into consideration comments made by stakeholders during the 60 day public comment period on the draft Screening Assessment Report for Certain Azo Disperse Dyes and Risk Management Scope document, by analysing additional data and studies provided by stakeholders. The proposed ecological conclusion at the draft assessment stage that all azo disperse dyes may be harmful to the environment has changed because new data suggests that only smaller azo disperse dyes have ecological effects of concern. The result is a significantly narrower scope of the final Screening Assessment conclusion, where only a single Azo Disperse Dye, Disperse Yellow 3, is concluded to meet section 64 (a) criteria. As the Ministers finalize the recommendation to add Disperse Yellow 3 to Schedule 1, risk management instruments must be proposed and finalized within a set period of time, as outlined in sections 91 and 92 of CEPA (refer to section 8 for targeted publication dates applicable to Disperse Yellow 3). 2.3 Public Comment Period on the Risk Management ScopeThe Risk Management Scope document for Azo Disperse Dyes (including CAS 2832 40 8), which summarized the proposed risk management actions under consideration at that time for all azo disperse dyes, was published on November 2, 2013.

Industry and other interested stakeholders were invited to submit comments on the Risk Management Scope document during a 60 day comment period. Comments received on the Risk Management Scope document were taken into consideration in the development of this document. A summary of responses to received is available.


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