Summary of public comments received on the draft screening assessment and risk management scope for the Anthraquinones Group

Comments on the Draft Screening Assessment and Risk Management Scope for the Anthraquinones Group, assessed under the Chemicals Management Plan (CMP), were submitted by Canadian Consumer Specialty Products Association (CCSPA), Canadian Network for Human Health and the Environment (CNHHE), Charles Tennant & Company, Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD) North America, L’Oreal Canada, and Lanxess.

Summarized public comments and responses are provided below, organized by topic:

Overarching

Summarized commentSummarized response
Stakeholders appreciate the opportunity to submit comments on the draft screening assessment for the Anthraquinones Group.Noted.
Additional sources of information that should be reviewed were identified. Based on these examples, it may be useful to examine possible gaps in the collection of information about the amount and variety of uses of chemicals in Canada, especially given future planning activities for CMP.Screening assessments are based on the best available data during a specified time period. Information received at a later point in time which did not allow it to be included in the draft screening assessment were considered in finalizing the assessment. 

The comment on the collection of information in the future is noted.

Additional information

Summarized commentSummarized response
Stakeholders provided additional use information for Solvent Violet 13.The additional information submitted was compared to existing information in the assessment, and it was taken into consideration in the finalization of the assessment.  
New data on colorants in the Anthraquinones Group has become available through Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This data should be considered to refine the screening assessment and minimize the sources of uncertainty. Also, information from Healthy Building Network's open source Data Commons indicates that there may be potential ecological and/or human health effects for Acid Blue 239 and Solvent Violet 13.The additional information, including that from Healthy Building Network's open source Data Commons, was considered in the finalization of the screening assessment. With respect to the ecological assessment, the Ecological Risk Classification of organic substances (ERC) approach characterizes the hazard of a substance using key metrics, including mode of toxic action, chemical reactivity, food web-derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Based on the outcome of the ERC approach, Acid Blue 239 and Solvent Violet 13 were identified as having high ecological hazard potential. 
Given the available information on anthraquinones, the limited information on the substances under assessment, and the potential emphasis on informed substitution in CMP in the future, the Government of Canada should go beyond its proposed actions.   With respect to proposed actions, the Government of Canada selects the most appropriate tools to manage the risk related to a substance. Selection is made using a thorough and consistent approach that takes into consideration information in the screening assessment and other sources, including stakeholder input. 

Health & ecological effects

Summarized commentSummarized response
According to the European Chemicals Agency (ECHA), the Globally Harmonized System (GHS) classifications for Solvent Violet 13 lead to two warnings: H317: May cause an allergic skin reaction; and H413: May cause long lasting harmful effects to aquatic life. The first classification contradicts the reference in the draft screening assessment to a 2003 study finding that the chemical is not a skin sensitizer.The inconsistency regarding skin sensitization has been addressed during finalization of the screening assessment. The warning for Solvent Violet 13 under ECHA: May cause long lasting harmful effects to aquatic life is consistent with the outcome of ERC approach, which identified Solvent Violet 13 as having high ecological hazard potential. 

Uses

Summarized commentSummarized response
The draft screening assessment does not cite an ECHA source for information about Solvent Violet 13. ECHAprovides information about a wide range of products in which the chemical is used, far more than are listed in thescreening assessment, linking them toenvironmental/occupational releases/exposures.Although the screening assessments conducted under the CMP focus on Canadian uses, the screening assessment for the Anthraquinones Group was revised to include updated global uses in products available to consumers that were identified in the REACH dossier. Screening assessments conducted under CEPA are based on the best available data at the time and focus on exposure of Canadians. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS).

The Government of Canada is currently working with provinces and territories to explore ways to enhance the protection of workers from exposure to chemicals by integrating and leveraging the information, tools, and/or technical expertise of the CMP and Health Canada’s Workplace Hazardous Products Program. For more information, please visit: An Integrated Strategy for the Protection of Canadian Workers from Exposure to Chemicals; publication date: 2019-07-11.

Human exposure assessment

Summarized commentSummarized response
Concerns were expressed by a stakeholder with respect to the assumptions used in the screening assessment in the estimation of potential human exposure from use of personal care products. Additional information on cosmetics uses and concentrations was provided.This information was considered in the finalization of the screening assessment. The screening assessment takes into consideration information from all available sources when selecting the concentration used in the estimation of exposure, and this information did not result in any changes to the screening assessment. Of note, screening assessments do not include all possible exposure estimates; rather, exposure estimates are presented for sentinel scenarios only which are considered representative and result in the highest exposure to the general population.

Read-across approach

Summarized commentSummarized response
Stakeholder supports the use of analogues in the read-across approach, but suggests that an extensive search for the most relevant analogue, outside the group, be performed to ensure the most accurate estimation. Acid Violet 43 (CAS RN 4430-18-6) was cited as a potential analogue to Solvent Violet 13.  Potential analogues outside the Anthraquinones Group were considered in the read-across approach. The screening assessment was revised with updated substance-specific health effects data for Solvent Violet 13 and other substances, and information on the updated read-across approach was incorporated.

Risk management

Summarized commentSummarized response
It is important to consider all actual exposure scenarios to develop the most appropriate risk management tool. Screening assessments do not include all possible exposure estimates; rather, exposure estimates are presented for sentinel scenarios only which are considered representative and result in the highest exposure to the general population.

A consistent instrument selection process that includes environmental, health and socio-economic considerations is followed to select the most promising instrument (or mix of instruments) to manage risks associated with a toxic substance.

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