Resins and Rosins Group – information sheet

Publications summarized:

• Final Screening Assessment for the Resins and Rosins Group (published on July 23, 2022). Public comments received on the draft screening assessment and risk management scope were considered and a summary of the comments with Government responses was published.
• Risk Management Approach for Crude tall oil (CTO) in the Resins and Rosins Group (published on July 23, 2022 for a 60-day public comment period ending on September 21, 2022). Risk management was proposed.
• Associated notice: Canada Gazette, Part I: Vol. 156, No. 30 – July 23, 2022

On this page

• Overview
• About these substances
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Risk assessment outcomes
  • Screening assessment conclusions
• Preventive actions and risk reduction
  • Additional considerations
  • Where to find updates on risk management actions
• Related resources

Overview

• The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to determine whether they present or may present a risk to human health or to the environment.
  • The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people or the environment.
  • When needed, the Government implements risk management measures under CEPA 1999 and other federal acts to help prevent or reduce potential harm.
• The ecological hazard and exposure potentials of 4 of the 12 substances in the Resins and Rosins Group were classified using the Ecological Risk Classification of Organic Substances (ERC) Approach.
• The Government concluded that tall oil (CAS RN 8002-26-4), specifically on the basis of risk presented by crude tall oil (CTO), is harmful to the environment, but not to human health.
  • The Government is proposing to include CTO in amendments to the Pulp and Paper Effluent Regulations under the Fisheries Act to risk manage this substance.
• The Government also concluded that the other 11 substances in the group of 12 (including the 4 evaluated using the ERC Approach) are not harmful to human health or the environment at levels of exposure considered in the assessment.
  • There were limited health effects reported for the substances in this group, such as decreased body weight and cellular changes in some organs. Some substances in this group consist of components that could have potential effects on the environment at low exposure concentrations.

About these substances

• The screening assessment focused on 12 substances referred to as the Resins and Rosins Group. They were assessed under the third phase of the Chemicals Management Plan (CMP) and are listed below:
  1. 1-Phenanthrenecarboxylic acid, 1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-, [1R-(1α,4aβ,10aα)] (DHAA; CAS RN 1740-19-8)
  2. Tall oil [CTO or distilled tall oil (DTO); CAS RN 8002-26-4]
  3. Tall-oil pitch (TOP; CAS RN 8016-81-7)
  4. Storax (balsam) (referred to as storax; CAS RN 8046-19-3)
  5. Rosin (CAS RN 8050-09-7)
  6. Resin acids and rosin acids, hydrogenated, Me esters (RHME; CAS RN 8050-15-5)
  7. Rosin, maleated (RMa; CAS RN 8050-28-0)
  8. Tall-oil rosin (also known as rosin; CAS RN 8052-10-6)
  9. Resin acids and rosin acids, calcium salts (RCa; CAS RN 9007-13-0)
  10. Resin acids and rosin acids, sodium salts (RNa; CAS RN 61790-51-0)
  11. Resin acids and rosin acids, Me esters (RME; CAS RN 68186-14-1)
  12. Resin acids and rosin acids (also known as rosin; CAS RN 73138-82-6)
• Under the Domestic Substances List, "tall oil" covers 2 distinct materials usually referred to in Canada as crude tall oil (CTO) and distilled tall oil (DTO).
• Two additional substances (that is, in addition to the group of 12) were determined to be of low concern to both human health and the environment through other approaches. Conclusions for 1-phenanthrenemethanol, dodecahydro-1,4a-dimethly-7-(1-methylethyl)-, (CAS RN 26266-77-3) are provided in the Final Screening Assessment for Substances Identified as Being of Low Concern using the Ecological Risk Classification of Organic Substances and the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances and conclusions for rosin, reaction products with formaldehyde (CAS RN 91081-53-7) are provided in the Final Screening Assessment for the Rapid Screening of Substances with Limited General Population Exposure.
• Substances in the Resins and Rosins Group are naturally occurring in the environment. CTO may serve as a source material for several downstream products, including other substances in the assessment (TOP, rosin, and DTO).
• According to information gathered by the Government, these substances may be used in Canada as processing aids, electronics solder, concrete production, rubber compounding, steelmaking and in paints or coatings. They may also be used in products available to consumers such as adhesives, binding agents, cosmetics, natural health products and non-prescription drugs.

Human and ecological exposures

• RMa and rosin (CAS RN 8052-10-6) were previously evaluated through the Rapid Screening of Substances with Limited General Population Exposure approach, which determined that further assessment was required. In the Resins and Rosins Group assessment summarized here, it was determined that exposure of the general population to these 2 substances is considered to be negligible.
• The human health risk of TOP was characterized using the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances. The estimate of exposure generated for TOP was lower than the TTC value, indicating low concern to human health on the basis of current levels of exposure.
• The screening assessment indicated that Canadians may be exposed to substances in this group through the dermal route (skin contact) from the use of rosin as a gripping agent (by athletes and violinists), as a non-medicinal ingredient in sunscreens, and in cosmetic products (such as moisturizers and cleansers). There is also the potential for oral exposure from other uses, such as in dental varnishes, dental sealants, and lipsticks.
• Major sources of exposure to the environment are emissions of these substances from manufacturing and industrial uses in Canada. Releases of concern are primarily to water and ecological scenarios were developed for 8 of the 12 substances (CTO and DTO, TOP, rosin CAS RN 8050-09-7, rosin CAS RN 8052-10-6, RCa, RNa, RMe and RHME).
• According to the information considered under the ERC Approach, the remaining 4 of the 12 substances were identified as having low ecological exposure potential (DHAA, storax, RME and rosin CAS RN 731380-82-6).

Key health and ecological effects (hazard)

• Limited health effects were reported in studies for the substances in the Resins and Rosins Group, such as decreased body weight and cellular changes in some organs.
• Eight of the 12 substances were identified as having potential effects on the environment at low concentrations.
• Storax and RME were identified as having a low ecological hazard potential, while DHAA and rosin (CAS RN 731380-82-6) were identified as having moderate and high ecological hazard potential respectively, under the ERC Approach.

Risk assessment outcomes

• Using the approaches mentioned above, 3 of the 12 substances (TOP, RMa and rosin CAS RN 8052-10-6) were considered to be a low concern for human health at levels of exposure considered in the assessment.
• Based upon comparisons of levels to which Canadians may be exposed to resin and rosin substances, and levels associated with health effects, it was determined that the risk to human health from the remaining 9 of the 12 substances is also considered to be low.
• Ecological scenarios were done for 8 of the 12 substances in this group. Based on these, it was determined that only CTO poses a risk to the environment due to its incidental co-production in the kraft pulping process. There was no risk identified for the other 7 substances, including DTO.
• Based upon the outcome of the ERC Approach, the 4 remaining substances of the group of 12 are considered unlikely to be causing ecological harm.

Screening assessment conclusions

• The Government concluded that the 12 substances in the Resins and Rosins Group are not harmful to human health at levels of exposure considered in the assessment.
• However, the Government also concluded that tall oil (CAS RN 8002-26-4) is entering the environment at levels that are harmful to the environment, specifically due to CTO. It was also concluded that the other 11 substances are not entering the environment at levels that are harmful.

Preventive actions and risk reduction

• The proposed order adding CTO to Schedule 1 to CEPA 1999, also called the List of Toxic Substances, was published for a 60-day public comment period ending on April 17, 2023. Adding a substance to the list does not restrict its use, manufacture or import. Rather, it enables the Government to take risk management actions under CEPA 1999.
• Publication of the risk management approach aims to inform stakeholders of proposed risk management actions and continue discussion about their development. The Government will consider the following action to address ecological concerns:
  • including CTO in amendments to the Pulp and Paper Effluent Regulations (PPER) under the Fisheries Act. Although the CAS RN for "tall oil" covers both CTO and DTO, the concern is with CTO and not DTO.
• Risk management actions may evolve through consideration of assessments and risk management actions published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.

Additional considerations

• Although 6 substances in this group (DTO, 3 rosin substances, RCa, and RNa) are not considered to be harmful to human health or the environment at levels of exposure considered in the assessment, these substances are associated with ecological effects of concern. There may be a potential risk if exposure levels were to increase.
• For this reason, the Government is considering follow-up activities for these 6 substances, such as including them in future information gathering initiatives, to track changes in use (or quantity) and releases in Canada.
• Also, the Government intends to apply the Significant New Activity (SNAc) provisions of CEPA 1999 to 5 of these 6 substances (3 rosin substances, RCa, and RNa, but not DTO). The SNAc provisions would require that the Government be notified of certain proposed new activities related to the substances, and that the new activity be assessed before being undertaken.

Where to find updates on risk management actions

• Updates on actions can be found on the timeline for the Resins and Rosins Group and up-to-date information on the PPER is available.
• Information about SNAc provisions applied to substances, including new notices and orders, and those already published, can be found in the SNAc publications dataset.
• Notice of information gathering initiatives and additional information on the risk management of substances addressed under the CMP are available.
• Use the Substances Search tool to find substances that are referenced in certain legislative or regulatory instruments or on Government of Canada websites.

Related resources

• Resin and rosin substances may be found in products available to consumers. Canadians should follow any safety warnings and directions related to the product and dispose of products responsibly.
• The screening assessment focused on potential risks from exposure of the general population of Canada, rather than occupational exposure. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). For information concerning workplace health and safety and what steps to take in the workplace, Canadians should consult their employer or the Occupational Health and Safety Regulator in their jurisdiction.