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.
As a result of the draft screening assessment, the Government is proposing that these substances are not harmful to human health or to the environment, at levels of exposure considered in the assessment.
Although 4 of the substances (DEA, LDE, CDE and TEA) have effects of concern for human health, it was determined that the risk posed by these substances to Canadians is low at levels of exposure considered in the assessment.
About these substances
The screening assessment summarized here focuses on 11 substances, referred to collectively under the Chemicals Management Plan (CMP) as the Alkanolamines and Fatty Alkanolamides Group. These substances are MEA, DEEA, LME, DEA, LDE, CDE, CADEA, TADEA, TEA, TIPA, and BATEA.
Three of the 11 substances (LME, LDE and CDE) were moved from the Fatty Amides Group to this group, as they potentially contain residual alkanolamines.
With the exception of MEA, none of the substances occur naturally.
According to information gathered by the Government, these substances may be used in a range of industrial and consumer processes. Uses of BATEA were not identified for the general population in Canada. Some of the other substances in this group may be used in food packaging materials, cosmetics, drugs, natural and non-prescription health products, household cleaners, and other products available to consumers. MEA is naturally present in certain foods.
Human and ecological exposures
Exposure of Canadians to BATEA is expected to be minimal, based on its expected limited use in Canada and since it was not identified in products available to consumers.
Canadians may be exposed to the other substances in the Alkanolamines and Alkanolamides Group from environmental sources (for example, air and drinking water), food, food packaging materials, or from the use of products available to consumers, such as floor polish/wax, all-purpose cleaning sprays, wall paint, dishwashing liquid, liquid body soap, and shampoo.
According to information considered under the ERC Approach, these substances were identified as having low ecological exposure potential.
IARC has classified DEA and CDE as "possibly carcinogenic to humans".
There were limited health effects (hazard) data for LME; therefore, a comparative approach using similar chemicals, called read-across, was used for assessing potential health effects.
The critical health effects identified in the screening assessment included:
reproductive effects and effects on the larynx (for MEA)
effects on the liver and on body weight (for DEEA)
carcinogenicity (ability to cause cancer) and effects on the kidneys, liver, and blood (for DEA)
carcinogenicity and effects on the kidney and liver (for LDE and CDE)
reproductive effects (for CADEA and TADEA)
carcinogenicity, reproductive effects and effects on the liver (for TEA).
Based upon available information, no critical health effects have been identified for LME, TIPA, and BATEA.
According to information considered under the ERC Approach, these substances were identified as having low ecological hazard potential.
Risk assessment outcomes
The risk to human health from MEA, DEEA, LME, DEA, LDE, CDE, CADEA, TADEA, TEA, and TIPA is considered to be low based upon a comparison of levels to which Canadians may be exposed to these substances and the levels associated with health effects.
The risk to human health from BATEA is considered to be low given the information presented in this screening assessment.
Based upon the outcome of the ERCApproach, these 11 substances are considered unlikely to be causing ecological harm.
The Government is proposing that MEA, DEEA, LME, DEA, LDE, CDE, CADEA, TADEA, TEA, TIPA, and BATEA are not harmful to human heath at levels of exposure considered in the assessment, and that these 11 substances are not entering the environment at levels that are harmful to the environment.
Preventive actions and reducing risk
DEA is described on Heath Canada's Cosmetic Ingredient Hotlist as a prohibited ingredient under the entry, secondary dialkanolamines. The Hotlist is used to communicate that certain substances may not be compliant with requirements of the Food and Drugs Act or the Cosmetic Regulations. Under Canadian legislation, cosmetics that contain substances that are harmful to the user cannot be sold.
DEA, LDE, CDE and TEA are not considered to be harmful to human health at levels of exposure considered in the assessment; however, these substances are considered to have a health effect of concern based on their potential carcinogenicity. Therefore, there may be a potential risk for human health if exposure to these substances were to increase.
For these reasons, follow-up activities to track changes in exposure and/or commercial use patterns for DEA, LDE, CDE, and TEA are being considered.
Stakeholders are encouraged to provide any information pertaining to these substances that may help inform the choice of follow-up activity during the 60-day public comment period on the assessment. This could include information on new or planned import, manufacture or use of the substance.
Substances in the Alkanolamines and Fatty Alkanolamides Group may be found in products available to consumers. Canadians should follow any safety warnings and directions related to this product and dispose of products responsibly.