Summary of public comments received on the risk management approach for methanone, diphenyl- (benzophenone)
Comments on the Risk Management Approach for Methanone, Diphenyl- (Benzophenone), assessed under the Chemicals Management Plan (CMP), were submitted by: Canadian Consumer Specialty Products Association (CCSPA); Canadian Paint and Coatings Association (CPCA); Dow Chemical Canada ULC; and two individuals.
Summarized public comments and responses are provided below, organized by topic.
General comments
Comment summary 1: It was requested that the Schedule 1 listing and related communications be in the context of the specific uses of concern, and that it be made clear that other uses are not of concern, and not toxic under the Canadian Environmental Protection Act, 1999 (CEPA).
Response 1: The final screening assessment for benzophenone concluded that the substance is posing harm to human health. It is therefore proposed to add benzophenone to Part 2 of Schedule 1 to CEPA.
The proposed order adding benzophenone to Schedule 1 to CEPA is not use-specific; however, proposed risk management actions will focus on addressing the exposure sources of concern identified in the screening assessment (that is, human health concerns from the use of the following products available to consumers: certain cosmetics; exterior and interior paints, as well as stains).
New information and data
Comment summary 2: A stakeholder identified a study with new exposure data related to preservative use in paints and it was suggested to update exposure models for paint application based on this data.
Response 2: This study was previously provided during the 60-day public comment period on the draft screening assessment for benzophenone, published August of 2018, and has been addressed in the public comments and responses publication for the benzophenone draft screening assessment. The new exposure data related to preservative use in paints was not considered to be applicable to benzophenone, and exposure estimates for paint scenarios modeled using ConsExpo were retained in the final screening assessment.
Comment summary 3: Additional information was provided by stakeholders regarding the current quantities and concentrations of benzophenone used in exterior and interior paint, stain and coating products, and the quantity and product types impacted.
Response 3: Information submitted by stakeholders was considered when developing the Code of Practice.
Comment summary 4: Further research on the environmental release and potential exposure sources of benzophenone should be conducted, including further studies on leaching of benzophenone from food packaging. Additional research is required on substitutes of benzophenone, including the use of natural substitutes. Research on transformation of benzophenone in the environment and production of more toxic or bioaccumulative substances is also required. Additionally, data on concentrations of benzophenone in paints and its reaction with other ingredients in paint products are needed.
Response 4: Screening assessments are based on the best available data. New information can be submitted through several mechanisms defined under specific sections of CEPA and other legislation. All substances assessed under the CMP are subject to future evaluation if new, significant information is received that indicates a need for further consideration. On the basis of low hazard and low exposure classifications, benzophenone is classified as having a low potential for ecological risk. It is therefore unlikely that this substance is resulting in concerns for the environment in Canada. Conservative estimates of exposure to benzophenone from environmental media and food (including leaching from food packaging) for the general population of Canada did not result in a concern for human health. In order to make informed decisions on the proposed risk management, implicated stakeholders were invited to provide further information on current quantities and concentrations of benzophenone used in both exterior and/or interior paint, stain and coating products that are available to consumers in Canada, as well as potential alternative substances to benzophenone for use in exterior and interior paint, stain and coating products that are available to consumers.
Sources and releases
Comment summary 5: Information was provided by an individual summarizing the use activities and exposure scenarios for benzophenone.
Response 5: The majority of use and exposure scenarios identified by the commenter have been covered by the screening assessment. While not all products specified were assessed, the exposure scenarios reviewed in the final screening assessment can be considered to be comprehensive and in agreement with the submitted content.
Environmental fate and behaviour
Comment summary 6: An individual expressed concerns about the effects of benzophenone on coral reef conservation.
Response 6: Substance screening assessments under CEPA are not intended to be site-specific evaluations; rather, they are based on available information that represents a range of potential exposure scenarios in Canada. On the basis of low hazard and low exposure classifications, benzophenone is classified as having a low potential for ecological risk. It is therefore unlikely that this substance is resulting in concerns for the environment in Canada.
Risk characterization
Comment summary 7: Several comments from an individual on the ecological and human health effects of benzophenone were received.
Response 7: Potential effects of benzophenone on humans and the environment are evaluated during the risk assessment process. The final screening assessment was published in January 2021. Through its ongoing prioritization process, the Government will continue to monitor and review any new scientific evidence that is brought forward. This information will inform any future prioritization, risk assessment or risk management activities. Additional details on the prioritization process can be found at Proposed Plan of Priorities: substances prioritized for assessment under CEPA - Canada.ca.
Risk management
Comment summary 8: Several stakeholders expressed concerns regarding the challenges associated with replacing benzophenone in paint products, and that additional time would be required to continue the search for alternatives and to conduct appropriate safety assessments to avoid regrettable substitution. Additionally, stakeholders indicated that the development of socio-economic impact estimates depends on the compliance timelines and specific requirements that will be imposed by the risk management instrument.
Response 8: The Government of Canada is committed to consulting extensively with all affected stakeholders as part of the risk management process and has done so for benzophenone.
The Government is exploring ways to advance responsible replacement of chemicals of concern, including ways to apply informed substitution to support chemicals management.
Comment summary 9: An individual noted that benzophenone in cosmetics, washing detergents, and food should be banned. Use of benzophenone in paints could be continued, but only after additional studies and testing to evaluate safety. Use of benzophenone in pesticides should be avoided.
Response 9: The risks posed by a substance are determined both by its hazardous properties and by the nature of the exposure that takes place. Estimates of exposure to benzophenone in food as a result of its use as a flavour enhancer or from use in food packaging were derived in the screening assessment. These estimates were much lower when compared to the levels associated with health effects and therefore not identified as a concern to human health.
Levels of exposure to benzophenone in products such as certain cosmetics and paints were also estimated. These estimates were greater than levels associated with health effects, resulting in a potential concern to human health. Therefore, the exposure sources of concern identified in the screening assessment are from the use of nail polishes, exterior and interior paints, as well as stains, and are the focus of the risk management approach for benzophenone.
Exposure resulting from pesticide uses of benzophenone is outside the scope of the screening assessment and proposed risk management approach and is regulated under the Pest Control Products Act (PCPA).
Comment summary 10: Stakeholders commented on the use of labelling as a risk management tool. One stakeholder indicated that clear labelling on products containing benzophenone should be a requirement, along with communication of risks from industry regarding occupational safety, consumer awareness, and proper product disposal.
Another stakeholder indicated that substantial safety labelling is already present on paint, stain and coating products available to consumers. They are opposed to any additional labelling requirements for these products as they will be costly, difficult to manage for already overcrowded labels, and their efficiency in reducing exposure among general consumers is not proven.
Response 10: Currently, paint, stain and coating products available to consumers may be subject to the labelling and container requirements set out in the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001), made under the Canada Consumer Product Safety Act (CCPSA). Specifically, products that meet an acute human health or physical hazard classification under the CCCR, 2001 must display hazard symbols, hazard statements, instructions for safe use, and a first aid statement including a list of hazardous ingredients.
Additional labelling as a risk management tool was explored in collaboration with stakeholders, but it was concluded that the risk management and human health objectives could be attained through an agreed change to the concentration limit of benzophenone.
With regards to occupational safety, screening assessments conducted under CEPA focus on risks of exposure to the general population, rather than risks of exposures in the workplace. 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 the 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.
Comment summary 11: The proposed addition of benzophenone to Health Canada’s Cosmetic Ingredient Hotlist is an appropriate action. A ‘prohibited’ listing is more suitable given the screening assessment results and risk margin.
Response 11: Noted. Further to the CMP assessment under CEPA, benzophenone was added to the list of substances described as restricted in May 2024, due to potential maternal effects, such as decreased body weight, for certain cosmetic uses.
Comment summary 12: Health Canada’s consideration of aligning the requirements of the Natural Health Products Ingredients Database (NHPID) with those described for benzophenone on Health Canada’s Cosmetic Ingredient Hotlist is encouraged.
Response 12: Noted. The NHPID was updated in June 2024 to align with the Cosmetic Ingredient Hotlist. The presence of this ingredient as restricted on the List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient Hotlist) indicates that there are potential safety issues. This ingredient must be used in accordance with the restrictions set out on the Hotlist when included in natural health products, unless additional evidence for safety is submitted.
Comment summary 13: The terms of the code of practice should include Government engagement in tracking and facilitating progress towards informed substitution of paints containing benzophenone. Given the uncertainty regarding the availability and efficiency of alternatives, the code of practice should allow sufficient time to research and reformulate. Should there be unforeseeable obstacles in the development of alternatives, the code of practice timeline can then be re-evaluated and possibly extended.
Response 13: Noted. The Government is exploring ways to advance responsible replacement of chemicals of concern, including ways to apply informed substitution to support chemicals management. As part of the risk management process, the Government of Canada is committed to consulting extensively with all affected stakeholders throughout the development of the Code of Practice.
Comment summary 14: It is suggested that a waiver or "Risk Based Compliance Alternative" clause be included in the final code of practice to allow for the use of benzophenone above the proposed maximum concentration in situations where a risk assessment determines safety based on a specific product use pattern. Such a clause would support the development of new science, retain specific substance benefits, and also permit use in emergency situations, without compromising environmental or human health.
Response 14: Noted. The Government of Canada is not considering this sort of provision within the proposed Code of Practice at this time.
Comment summary 15: The proposed risk management option is causing unfortunate misalignment with the United States (US), and, although the European Union is considering concentration limits, the limit is still undecided. Despite these differences, replacement of this substance should be undertaken in Canada (and, indirectly, in the US, as an importer) in order to eliminate any potential health risks to the Canadian population. This risk management instrument will be disruptive for manufacturers and importers; therefore, key product usages should be maintained on the market.
Response 15: Noted.
Consultation and/or stakeholder engagement
Comment summary 16: Information was provided by a stakeholder to support a 0.2% w/w benzophenone concentration in paint products as an appropriate health-protective limit, which meets the risk management objective. It was suggested that the final concentration limit in paint products be determined through detailed risk management discussions with stakeholders.
Response 16: The published Risk Management Approach document proposed a target concentration of 0.1% w/w in exterior and interior paint, stain and/or coating products. However, following the publication, additional consideration on the occasional use of these products, and the health effects observed in the critical study identified in the CMP assessment, a higher acceptable limit of 0.2% w/w in paints, stains, and/or coatings was determined.
The Government of Canada committed to consulting with all affected stakeholders to develop effective and appropriate risk management measures, including consulting on the maximum benzophenone concentration in paint products.
Comment summary 17: The code of practice needs to include resin suppliers that are non-Canadian entities in the joint working group, as all should be considered for scientific expertise in the consideration of the proposed 0.1% w/w limit.
Response 17: The Government of Canada consulted with interested stakeholders during the development of the Code of Practice.