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Summary of Public Comments received on the Challenge substance Pigment Red 3 (CAS RN 2425-85-6) Proposed Risk Management Approach document for Batch 3


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Comments on the Proposed Risk Management Approach document for Pigment Red 3 to be addressed as part of the Chemicals Management Plan Challenge were provided by Clariant Produkte, Canadian Vehicle Manufacturing Association, Colour Pigment Manufacturers Association, Chemical Sensitivities Manitoba, and the Canadian Environmental Law Association. The table contains a condensed version of each comment and a response in non-technical terms.

A summary of comments and responses is included below, organized by topic:

A summary of comments and responses is included below, organized by topic: Alternatives, Risk management, Vulnerable populations and Occupational health and safety
TopicCommentResponse
AlternativesIt will be difficult for users to seek and use alternatives to Pigment Red 3. Suppliers of alternatives should be sought out and engaged to minimize effects of risk management such as the need to find and use alternatives for Pigment Red 3.The participation of stakeholders is helpful in assisting the Government to develop strong and effective risk management actions. Where available and relevant, information on the availability and cost of alternatives for a substance used in Canada , including the economic, social and environmental implications, will be considered in the development of risk management tools. Information on these impacts may be generated from a number of sources, including direct engagement with stakeholders.
Government- approved alternatives to Pigment Red 3 for anti-fouling industrial paints should be used.Pigments are stabilized in dry paint, minimizing exposure risks in the general population. Under the Pest Control Products Act, anti-fouling paints containing Pigment Red 3 are subject to health and environmental assessments, and are registered as pest control products. The Risk Management Approach document identifies two anti-fouling paints that are currently registered. They both contain low amounts of Pigment Red 3 (<1.0%).
Risk managementTo protect human health, Pigment Red 3 should be prohibited.The proposed human health objective for Pigment Red 3 is to protect human health by reducing exposure. The Assessment Report has identified that there is negligible exposure and risk once Pigment Red 3 is bound within plastic, dry paint, dry ink or coating resins. As a result, the Government of Canada plans to implement Significant New Activity provisions under CEPA 1999 to Pigment Red 3. This would require that any proposed new manufacture, import or use be subject to further assessment, and would determine if the new activity requires further risk management consideration.
Pigment Red 3 is not used in cosmetics in Canada. It is mostly used in commercial formulations. Since Pigment Red 3 is almost completely insoluble and is stabilized in plastic or dry paint, ink, or coating resins, exposure is negligible. Given the low risk of exposure and the requirement to report new uses under Canadian regulation the risk management of Pigment Red 3 is fair, reasonable and effective.The Screening Assessment Report has identified that there is negligible exposure and risk once Pigment Red 3 is bound within plastic, dry paint, dry ink or coating resins. The Government of Canada plans to implement Significant New Activity provisions under CEPA 1999 to Pigment Red 3. This would require that any proposed new manufacture, import or use be subject to further assessment, and would determine if the new activity requires further risk management consideration.
Vulnerable populationsThe presence of this chemical in children’s cosmetic products requires action to ensure that similar imported products are prohibited for use or sale in Canada. This requires a regulation to ensure that Pigment Red 3 is not present in products imported into Canada.The Government of Canada recently proposed the addition of Pigment Red 3 to the Cosmetic Ingredient Hotlist, which is an administrative tool that provides guidance as to which substances are subject to the cosmetic safety provisions of Section 16 of the Food and Drugs Act.
Occupational health and safetyWorkplace exposures to Pigment Red 3 and other harmful chemicals create health risks that require full consideration.The scope of assessment reports under CEPA 1999 are focused on the potential risks to the general Canadian public, occupational exposures are considered with respect to the potential health effects associated with a substance. Detailed scientific information within the assessment report is made available to occupational health and safety representatives to inform precautionary actions in the workplace.

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