Fatty Acids and Derivatives Group – information sheet
On this page
- About these substances
- Exposure of Canadians and the environment
- Key health and ecological effects (hazard)
- Risk assessment outcomes
- Important to know
- The Government of Canada conducted a science-based evaluation, called a screening assessment, of 10 substances in the Fatty Acids and Derivatives Group, to address the potential for harm to Canadians and to the environment.
- Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the risk posed by a substance is determined by considering both its hazardous properties (its potential to cause adverse human health or ecological effects) and the amount of exposure there is to people and the environment. A substance may have hazardous properties; however, the risk to human health or to the environment may be low depending upon the level of exposure.
- The ecological hazard and exposure potentials of these substances were classified using the Ecological Risk Classification of Organic Substances Approach.
- Substances in the Fatty Acids and Derivatives Group may be associated with certain human health and/or ecological effects; however, the risk to Canadians and the environment is low at current levels of exposure. Therefore, it is proposed that these substances are not harmful to human health or to the environment.
About these substances
- This screening assessment focuses on 10 of 16 substances referred to collectively under the Chemicals Management Plan (CMP) as the Fatty Acids and Derivatives Group. The substances addressed in this screening assessment are undecylenic acid, α-linolenic acid (ALA), tung oil, fats and glyceridic oils, margosa, tall oil fatty acid (tall oil acid), potassium tallate, evening primrose oil, dimer acid, trimer acid, and ethylhexyl cocoate.
- There were 4 other substances in the Fatty Acids and Derivatives Group [Chemical Abstract Services Registry Number (CAS RN) 68139-89-9, 53980-88-4, 68647-55-2, and Domestic Substances List (DSL) Confidential Accession Number 11556-0] that were determined to be of low concern to both human health and the environment, through other approaches.
- Conclusions for CAS RN 68139-89-9 are provided in the Screening Assessment for Substances Identified as Being of Low Concern based on the Ecological Risk Classification of Organic Substances and the Threshold of Toxicological Concern (TTC)-based Approach for Certain Substances.
- Conclusions for CAS RNs 53980-88-4, 68647-55-2, and DSL Confidential Accession Number 11556-0 are provided in the Screening Assessment for the Rapid Screening of Substances with Limited General Population Exposure.
- Additionally, 2 substances originally included in the Fatty Acids and Derivatives Group (CAS RNs 68476-03-9 and 73138-45-1) were placed into another substance group to which they are more appropriately suited on the basis of scientific considerations. Conclusions for these substances are provided in the Screening Assessment for Seven Hydrocarbon-based Substances.
- The Government gathers information on substances, including details on their commercial status in Canada, to support risk assessment and risk management of substances under the CMP.
- Substances in the Fatty Acids and Derivatives Group occur naturally in the environment and/or are derived from natural sources, such as plants and animal fats and oils.
- ALA, an omega-3 fatty acid, is essential for humans and is naturally present in certain foods.
- In Canada, these substances are used in cosmetics, natural and non- prescription health products, lubricants and greases, adhesives and sealants, paints and coatings, fuels and related products, and food packaging materials.
Exposure of Canadians and the environment
- Canadians may be exposed to these substances through the use of products available to consumers, such as cosmetics and natural and non-prescription health products.
- Exposure to undecylenic acid may also occur through food, from its potential use as a food flavouring agent.
- Canadians may also be exposed to ALA through food, from its natural presence in food.
- Tung oil was identified as having a high ecological exposure potential due to high emission rates to the environment, whereas the remaining 9 substances were identified as having a low ecological exposure.
Key health and ecological effects (hazard)
- To identify health effects, international reports of data on these substances were reviewed.
- ALA and the major components of fats and glyceridic oils, margosa, tall oil acid, evening primrose oil, dimer acid, trimer acid and the free fatty acid of ethylhexyl cocoate have been assessed by the OECD Cooperative Chemicals Assessment Programme and a Screening Information Data Set (SIDS) Initial Assessment Report (SIAR) is available.
- Fats and glyceridic oils, margosa were reviewed by the United States Environmental Protection Agency (U.S. EPA) for biopesticides registration.
- A form of a major component of tung oil was reviewed by the European Food Safety Authority (EFSA).
- Dimer acid was reviewed by the Australian Government Department of Health (AGDH).
- Using these existing assessments, ALA, tung oil, fats and glyceridic oils, margosa, tall oil acid, potassium tallate, evening primrose oil, dimer acid, and trimer acid are not considered to have hazardous properties for human health.
- Available information indicates that undecylenic acid and ethylhexyl cocoate may have effects on organ and body weights.
- Undecylenic acid, tung oil, dimer acid, trimer acid, and ethylhexyl cocoate, were identified as having a low ecological hazard potential.
- ALA, fats and glyceridic oils, margosa, tall oil acid, potassium tallate, and evening primrose oil were identified as having high ecological hazard potential, based on the substance's moderate level of ecotoxicity and their potential to accumulate in aquatic and terrestrial food webs.
Risk assessment outcomes
- Based upon a comparison of levels to which Canadians may be exposed to and the levels associated with health effects, along with the consideration of international assessments, the risk to human health from these substances is considered to be low.
- The Ecological Risk Classification of Organic Substances Approach characterized undecylenic acid, trimer acid, dimer acid, and ethylhexyl cocoate as posing a low risk of harm to organisms and the environment. On the basis of low exposure potential ALA, tung oil, fats and glyceridic oils, margosa, tall oil acid, potassium tallate and evening primrose oil were also characterized as posing a low risk of harm to the environment.
- The Government of Canada published the Draft Screening Assessment for Fatty Acids and Derivatives on August 18, 2018. This publication has a 60-day public comment period ending on October 17, 2018.
Proposed screening assessment conclusions
- As a result of this assessment, the Government is proposing that undecylenic acid, ALA, tung oil, fats and glyceridic oils, margosa, tall oil acid, potassium tallate, evening primrose oil, trimer acid, dimer acid, and ethylhexyl cocoate are not harmful to human health at current levels of exposure.
- The Government is also proposing that these substances are not entering the environment at levels that are harmful to the environment.
Important to know
- Substances in the Fatty Acids and Derivatives Group may be found in certain products available to consumers. Canadians should follow any safety warnings and directions on product labels and dispose of products responsibly.
- Canadians who may be exposed to these substances in the workplace can consult with their employer and an occupational health and safety (OHS) representative about safe handling practices, applicable laws, and requirements under OHS legislation and the Workplace Hazardous Materials Information System (WHMIS).
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