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.
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 levels of exposure considered in the assessment. Therefore, it is concluded that these substances are not harmful to human health or to the environment.
About these substances
The screening assessment focused on 9 of 16 substances referred to collectively under the Chemicals Management Plan (CMP) as the Fatty Acids and Derivatives Group. The substances addressed in the screening assessment are: undecylenic acid; α-linolenic acid (ALA); tung oil; tall oil fatty acid; tall oil fatty acids, potassium salts; evening primrose oil; dimer acid; trimer acid; and ethylhexyl cocoate.
The substance fats and glyceridic oils, margosa was included in the draft screening assessment for the Fatty Acids and Derivatives Group published on August 18, 2018; however, based on additional information received, this UVCB (Unknown or Variable Composition, Complex Reaction Products or Biological Materials) substance requires further assessment. Therefore, further evaluation of this substance will be provided in a separate screening assessment.
There were 4 other substances in the Fatty Acids and Derivatives Group [Chemical Abstract Services Registry Numbers (CAS RNs) 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.
Additionally, 2 substances (CAS RNs 68476-03-9 and 73138-45-1) originally included in the Fatty Acids and Derivatives Group, 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.
According to information gathered by the Government, the 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 have a variety of uses, such as in cosmetics, natural and non-prescription health products, lubricants and greases, adhesives and sealants, paints and coatings, fuels and related products, food packaging materials, and for undecylenic acid, as a food flavouring agent.
Human and ecological exposures
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 its natural presence in food.
According to the information considered under the ERC Approach, tung oil was identified as having a high ecological exposure potential based on the critical emission rate of the substance to the environment, whereas the remaining 8 substances were identified as having a low ecological exposure.
Key health and ecological effects (hazard)
To identify health effects information, international reports of data on these substances were reviewed.
Using information from these existing assessments, ALA; tung oil; tall oil fatty acid; tall oil fatty acids, potassium salts; 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.
According to information considered under the ERC Approach, undecylenic acid; tung oil; trimer acid; dimer acid; and ethylhexyl cocoate were identified as having a low ecological hazard potential.
New information has been considered under the ERC approach, following the public comment period of the original draft screening assessment for this Group. As a result, the hazard profiles of tall oil fatty acid and tall oil fatty acids, potassium salts were reclassified from high to low, on the basis of their low potential ecotoxicity and a low potential to accumulate in aquatic food webs.
ALA and evening primrose oil were identified as having high ecological hazard potential, based on their moderate potency and potential to cause adverse effects in aquatic and terrestrial food webs, given their bioaccumulation potentials.
Risk assessment outcomes
Based upon a comparison of levels to which Canadians may be exposed, 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.
Based upon the outcome of the ERC approach, undecylenic acid; tung oil; tall oil fatty acid; tall oil fatty acids, potassium salts; trimer acid; dimer acid; and ethylhexyl cocoate are considered unlikely to be causing ecological harm.
The Government concluded that undecylenic acid; ALA; tung oil; tall oil fatty acid; tall oil fatty acids, potassium salts; evening primrose oil; ethylhexyl cocoate; trimer acid; and dimer acid are not harmful to human health at levels of exposure considered in the assessment.
The Government also concluded that these 9 substances are not entering the environment at levels that are harmful to the environment.
Substances in the Fatty Acids and Derivatives Group 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.