The Government of Canada conducted a science-based evaluation, called a screening assessment, to address the potential for harm to Canadians and to the environment from substances in the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group.
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 5 of the 15 substances in the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group (rose oil, mandarin oil, tangerine oil, turpentine oil, and turpentine) may be harmful to human health at current levels of exposure. While some of the remaining substances may be associated with health effects, the risk to Canadians is low at current levels of exposure. Therefore, the Government is also proposing that 10 of the 15 substances are not harmful to human health, and that none of the 15 substances are harmful to the environment, at current levels of exposure.
About these substances
There are 76 substances in the larger Terpenes and Terpenoids Group.
Decisions for the remaining 57 substances will be provided in future screening assessments.
The 15 substances addressed in the screening assessment are bois de rose oil, palmarosa oil, geranium oil, coriander oil, rose oil, lemongrass oil, geranyllinalool, mandarin oil, tangerine oil, sweet orange oil, alpha-pinene, turpentine oil, turpentine, fir oil, and pine oil. Most of the substances in this grouping are of unknown or variable composition, complex reaction products, or biological materials (UVCBs).
These 15 substances are naturally occurring and derived from different parts of various plants (for example, leaves, seed, stem, flower, root, fruits, woods, barks, grass, gum, tree blossoms, bulbs, or flower buds).
According to information gathered by the Government, these substances are generally used as fragrances in personal care products (that is, cosmetics, drugs, and natural health products) such as shampoo, body lotion and supplements. They are also used in cleaning products and air fresheners.
Some of these substances may be present in pest control products as active ingredients and/or formulants. They may also be used as food flavoring agents and in food packaging materials.
In addition, turpentine oil is present in furniture, shoe polish and car wax. It is also used as a solvent to clean paint brushes or to remove paint.
Human and ecological exposures
Canadians may be exposed to these substances from the use of products available to consumers, such as personal care products, cleaning products, air fresheners, and from their use as food flavouring agents. Human exposures from their use in incidental additives and food packaging are either not expected or negligible.
Additionally, Canadians may be exposed to turpentine oil from its use in solvents.
Exposure of Canadians to alpha-pinene or the main components of sweet orange oil, turpentine oil/turpentine, fir oil and pine oil is also expected from the environment (for example, indoor and outdoor air).
According to information considered under the Ecological Risk Classification of Organic Substances Approach, all 15 substances were identified as having a low ecological exposure potential.
There were limited health effects (hazard) data for mandarin and tangerine oils, turpentine oil/turpentine, and fir oil. Therefore, data on the main components or comparative approaches using similar chemicals were used for assessing potential health effects.
The critical or important effects used to characterize the risk to human health from these substances in the screening assessment were:
for coriander oil, effects on the kidney and liver;
for rose oil, effects to red blood cells and the spleen;
for lemongrass oil, potential reproductive effects and effects on the liver;
for mandarin and tangerine oils, potential developmental effects;
for alpha-pinene, turpentine oil/turpentine, and fir oil, effects on the bladder and male reproductive system; and
for pine oil, potential reproductive and systemic effects.
Based upon available information, bois de rose oil, palmarosa oil, geranium oil, geranyllinalool, or sweet orange oil are considered to be of low hazard to human health.
According to information considered under the Ecological Risk Classification of Organic Substances Approach, 13 of the 15 substances were identified as having a low ecological hazard potential while the other 2 substances (alpha-pinene and pine oil) were identified as having a moderate ecological hazard potential based on their moderate level of ecotoxicity and bioaccumulation potential.
Risk assessment outcomes
Based upon a comparison of levels to which Canadians may be exposed to these substances, and the levels associated with health effects, along with the consideration of international assessments, it was determined that the risk to human health from bois de rose oil, palmarosa oil, geranium oil, coriander oil, lemongrass oil, geranyllinalool, sweet orange oil, alpha-pinene, fir oil, and pine oil is low.
Based upon a comparison of levels to which Canadians may be exposed to rose, mandarin, and tangerine oils from products available to consumers, such as body moisturizer and/or dietary supplement (natural health product), and levels associated with critical health effects, it was determined that these 3 substances may pose a risk to human health.
A similar comparison between exposure to turpentine oil/turpentine from the use of paint thinner and remover, and from its presence as a non-medicinal ingredient in a topical medicated vapour product and a counterirritant product, and levels associated with critical health effects indicated that these 2 substances may also pose a risk to human health.
Based upon the outcome of the Ecological Risk Classification of Organic Substances Approach, these 15 substances are considered unlikely to cause ecological harm.
As a result of the draft screening assessment, the Government is proposing that rose oil, mandarin oil, tangerine oil, turpentine oil, and turpentine may be harmful to human health, at current levels of exposure. It is also proposed that the other 10 substances are not harmful to human health at current levels of exposure.
The Government is proposing that none of the 15 substances are entering the environment at levels that are harmful to the environment.
It is also proposed that rose oil, turpentine oil, and turpentine do not meet the persistence or bioaccumulation criteria, while mandarin and tangerine oil meet the bioaccumulation criteria but not the persistence criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.
If the proposed conclusion is confirmed in the final screening assessment, the Government will consider adding rose oil, mandarin oil, tangerine oil, turpentine oil, and turpentine to Schedule 1 of CEPA 1999, also called the List of Toxic Substances.
Also, the Government will consider the following actions to address health concerns:
Measures to reduce exposures of infants and toddlers to rose oil from certain cosmetics by describing rose oil as prohibited or restricted ingredients on the Health Canada Cosmetic Ingredient Hotlist. 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.
Measures to reduce exposures to mandarin oil and tangerine oil from certain cosmetics by describing mandarin oil and tangerine oil as prohibited or restricted ingredients on the Health Canada Cosmetic Ingredient Hotlist
Measures to reduce exposure to mandarin oil and tangerine oil in natural health products
Measures to reduce exposure of Canadians to turpentine and turpentine oil in certain products available to consumers and natural health products, and to prevent an increase in exposure to these substances in cosmetics.
Information is being sought by the Government to inform risk management decision-making. Details can be found in the risk management scope document, including where to send information during the public comment period, ending May 13, 2020.
Risk management actions may evolve, based on the conclusions of the final screening assessment, or as a result of risk management actions published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.
These substances may be found in 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 should 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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