Fourteen Terpene and Terpenoid Substances Group - information sheet
Part of the Terpenes and Terpenoids Group
Publications summarized:
- Draft Assessment for the Fourteen Terpene and Terpenoid Substances Group (published on January 25, 2025, for a 60-day public comment period ending on March 26, 2025).
- Risk Management Scope for Certain Substances in the Fourteen Terpene and Terpenoid Substances Group (published on January 25, 2025, for a 60-day public comment period ending on March 26, 2025).
- Associated notice: Canada Gazette, Part I: Vol. 159, No. 4 – January 25, 2025
On this page
- Overview
- About these substances
- Human and ecological exposures
- Key health and ecological effects (hazard)
- Consideration of subpopulations who may have greater susceptibility or greater exposure
- Risk assessment outcomes
- Preventive actions and risk reduction
- Related resources
Overview
- The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA) 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 to which people or the environment are exposed.
- When needed, the Government implements risk management measures under CEPA and other federal acts to help prevent or reduce potential harm.
- As a result of the assessment, the Government is proposing that 12 of the 14 substances in this group [cade oil, jonquil oil, Verbena officinalis extract, Ginkgo biloba extract, myrrh oil, cork tree extract, sage oil, wormwood oil, isobornyl cyclohexanol (IBCH), sandal cyclohexanol, bornyl cyclohexanol (BCH), and sandela] may be harmful to human health at levels of exposure considered in the assessment.
- The exposures of concern are from certain cosmetics, natural health products (NHPs), non-prescription drugs (NPDs), oral supplements, and other products available to consumers including certain teas. Do-it-yourself (DIY) uses of essential oils, such as in aromatic diffusers, facial steamers, bath oils, massage oils, moisturizers, or oral ingestion of the oils are also of concern for some of these substances. These 12 substances are associated with effects on human health.
- Risk management actions are proposed to help reduce exposures of people in Canada to the 12 substances from the various products and uses of concern, as described further below.
- The Government is also proposing that norlimbanol and amberlyn are not harmful to human health at levels of exposure considered in the assessment.
- The ecological hazard and exposure potentials of the 14 substances in this group were classified using the Ecological Risk Classification of Organic Substances (ERC) Approach. None of the 14 substances in this group are proposed to be causing harm to the environment.
About these substances
- There are 76 substances in the larger Terpenes and Terpenoids Group for which assessment started under the third phase of the Chemicals Management Plan (CMP). Information on these substances is provided in their corresponding assessments, which are outlined in the background section of the 14 Terpene and Terpenoid Substances Group web page.
- Most of these terpene and terpenoid substances are essential oils, extracts or components of these, from a wide variety of plants. Essential oils are mixtures of volatile organic compounds that contribute to the flavour and fragrance of the plant. The plant-derived essential oils have many components and can be extracted from different parts of the plant (for example, leaves, seeds, stems, flowers, roots, fruits, woods, barks, grasses, gums, tree blossoms, bulbs, or flower buds).
- The assessment summarized here focuses on the substances in the 14 Terpene and Terpenoid Substances Group. The substances are cade oil, jonquil oil, norlimbanol, Verbena officinalis extract, Ginkgo biloba extract, amberlyn, myrrh oil, cork tree extract, sage oil, wormwood oil, IBCH, sandal cyclohexanol, BCH, and sandela. Further details on the substance names and CAS RNs for the group of 14 are found in the summary of publications section of the group web page.
- According to information gathered by the Government, these 14 substances are generally used as ingredients in cosmetics, drugs including NHPs, cleaning products, air fresheners, and other products available to consumers. Certain substances within the group that have aromatic properties are available to consumers as essential oil products at a concentration of up to 100%. Therefore, these substances may be used to create DIY products, such as massage oils, bath products, and body moisturizers, or may be added to facial steamers and aromatic diffusers.
- Some of these substances are also present in pest control products as formulants. In addition, some of them occur naturally in food or may be used as food flavouring agents.
Human and ecological exposures
- The assessment indicates that environmental exposure of people in Canada to the 14 substances in this group would not have an impact on human health.
- People in Canada may be exposed to these substances from cosmetics, NPDs, NHPs, possible use as food flavouring agents, cleaning products, air freshener products, and other products available to consumers, depending on the substances. Exposures may also occur from the use of these substances in DIY applications with essential oils and extracts. Where applicable, these human exposures were characterized.
- According to the information considered under the ERC Approach, all 14 substances in the group were identified as having low ecological exposure potential.
Key health and ecological effects (hazard)
- To help inform the health effects characterization in the assessment, international and national data on these substances or similar substances were considered, among other sources of information. This included assessments by the United States Environmental Protection Agency, and the European Chemicals Agency (ECHA), among others.
- There were limited health effects (hazard) data for some of the substances in this group. Therefore, data on main components of the substances or a comparative approach using a similar chemical (called read-across) was used for assessing potential health effects. Critical health effects are based on laboratory studies.
- Critical health effects used to characterize risk to human health for substances in this group were as follows:
- For cade oil: carcinogenicity (potential to cause cancer) and effects on the central nervous system, based on major components of cade oil called cresols
- For jonquil oil: developmental effects, general toxicity, and carcinogenicity, which are associated with the major components of jonquil oil, benzyl benzoate and trans-methylisoeugenol
- For norlimbanol: reproductive and developmental effects
- For Verbena officinalis extract: developmental effects, general effects on the body and severe respiratory tract irritation, based on one of its major components, citral
- For Ginkgo biloba extract: developmental effects and liver tumours
- For amberlyn: changes in biochemical or blood parameters (for example, platelets, cholesterol levels) and changes in certain organs (for example, kidneys)
- For myrrh oil: effects on certain biochemistry (bile acids) and reproduction parameters (effects on sperm levels)
- For cork tree extract: effects on the heart and liver
- For sage oil and wormwood oil: neurological effects (convulsions), based on their major component called thujone
- For IBCH, sandal cyclohexanol, BCH, and sandela: reproductive and developmental effects, based on data for IBCH
- According to information considered under the ERC Approach, 11 of the 14 substances were classified as having a low ecological hazard potential. Cade oil was classified as having high hazard potential, based on its high potential to cause adverse effects in aquatic food webs, given its potential to bioaccumulate. Verbena officinalis extract and Ginkgo biloba extract were also classified as having a high hazard potential; however, for all 3 substances, their potential effects on the environment were not further investigated due to the low exposure of these substances.
Consideration of subpopulations who may have greater susceptibility or greater exposure
- There are groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects from exposure to substances.
- Certain subpopulations are routinely considered throughout the assessment process, such as infants, children, and people of reproductive age. For instance, age-specific exposures are routinely estimated and developmental and reproductive toxicity studies are evaluated for potential adverse health effects. For substances in this group, these subpopulations were taken into account in the risk assessment outcomes.
Risk assessment outcomes
- Assessments focus on information critical to determining whether substances are harmful to human health or the environment under CEPA. This is done by considering scientific information, including information, if available, on subpopulations who may have greater susceptibility or greater exposure, vulnerable environments and cumulative effects; and by incorporating a weight of evidence approach and precaution .
- The risk characterizations for some of the substances in this group are based on that of their main chemical components.
- Based upon a comparison of levels to which people in Canada may be exposed to cade oil, jonquil oil, Verbena officinalis extract, Gingko biloba extract, myrrh oil, cork tree extract, sage oil, wormwood oil, IBCH, sandal cyclohexanol, BCH and sandela, and levels associated with critical health effects, it is proposed that these substances may pose a risk to human health. Specifically, it is proposed that exposures to these substances may pose a risk to human health, as follows:
- For cade oil: from uses in perfumes (roll-on) and face moisturizers, as well as cade essential oil DIY uses in aromatic diffusers, facial steamers, bath oils, body moisturizer preparations, massage oil preparations, and topical preparations applied on abraded/damaged skin.
- For jonquil oil: from DIY uses in aromatic diffusers, facial steamers, bath oils, as well as massage oil preparations and body moisturizer preparations.
- For Verbena officinalis extract: from its use in massage oils, body exfoliants, shampoos, hand creams, face moisturizers, oral supplements (NHPs), liquid extracts, and DIY applications of Verbena officinalis essential oil in aromatic diffusers and face steamers.
- For Ginkgo biloba extract: from its use in face exfoliants, hair perm/straighteners, hand creams, permanent hair dyes, makeup remover, aftershaves, face masks, body oils, sunless tanning products, massage products, liquid face foundations, genital lubricants, face and body moisturizers, hair mists, spray antiperspirants, face toners, liquid body soaps, face cleansers, shampoos, face sunscreens (NHPs and NPDs), sunscreen lotions (NHPs), oral supplements (including NHPs), and teas (including NHP herbal tea blends).
- For myrrh oil: from its use in permanent hair dye, hair styling products, massage oils, bath oils, face exfoliants, hair removal aftercare products, sunless tanning products, aftershaves, body moisturizers, face moisturizers, antiperspirants, liquid body soaps, spray perfumes, tooth powders, mouthwashes, teeth whiteners, body lotions (NHPs), pain gels (NHPs), sunscreen lotions (NHPs), hand sanitizers (NHPs), oral capsules (NHPs), and resin incense. Myrrh oil may also pose a risk to human health from the use of essential oil containing myrrh oil in DIY applications, such as stomach remedies, aromatic diffusers, and face steamers.
- For cork tree extract: from its use in cosmetics and NHPs, including face moisturizers, body moisturizers, and analgesic sprays (NHPs). DIY products available to consumers used for oral ingestion of cork tree extract and as an essential oil in DIY aromatic diffusers and massage oil preparations may also pose a risk to human health.
- For sage oil: from use of massage oils (cosmetics and NHPs), sunless tanning products, douches, face masks, antiperspirants, rinse-off conditioners, spray perfumes, face moisturizers, body moisturizers (cosmetics and NHPs), hair styling products, makeup removers, liquid body soaps, shampoos, hand sanitizers (NHPs), and analgesic creams (NHPs), and from DIY applications of sage oil in aromatic diffusers and face steamers. Oral exposure to sage oil from breath fresheners, mouthwashes, toothpastes, oral supplements (NHPs), motion sickness medications (NHPs), and throat sprays (NHPs) may also pose a risk to human health.
- For wormwood oil: from use of hand sanitizers (NHPs) and analgesic creams (NPDs), and from DIY applications of wormwood oil including in aromatic diffusers, facial steamers, bath oils, massage oil preparations, and body moisturizer preparations. Oral ingestion of wormwood oil may also pose a risk to human health.
- For IBCH, sandal cyclohexanol, BCH, and sandela: from use of spray perfumes and body moisturizers.
- A comparison of levels to which people in Canada may be exposed to norlimbanol and amberlyn and levels associated with health effects indicated that the risk to human health from exposure to either of these substances is low.
- Based upon the outcome of the ERC Approach, the 14 substances in this group are considered unlikely to be causing ecological harm.
Proposed assessment conclusions
- The Government is proposing that cade oil, jonquil oil, Verbena officinalis extract, Ginkgo biloba extract, myrrh oil, cork tree extract, sage oil, wormwood oil, IBCH, sandal cyclohexanol, BCH, and sandela may be harmful to human health at levels of exposure considered in the assessment. The Government is also proposing that norlimbanol and amberlyn are not harmful to human health at levels of exposure considered in the assessment.
- The Government is also proposing that none of the 14 substances in this group are entering the environment at levels that are harmful.
Preventive actions and risk reduction
- If the proposed conclusion is confirmed in the final assessment, the Government will consider proposing to add cade oil, jonquil oil, Verbena officinalis extract, Ginkgo biloba extract, myrrh oil, cork tree extract, sage oil, wormwood oil, IBCH, sandal cyclohexanol, BCH, and sandela to Part 2 of Schedule 1 to CEPA. Adding a substance to this list does not, in itself, restrict its use, manufacture or import. Rather, it enables the Government to take enforceable risk management actions under CEPA.
- Toxic substances that pose the highest risk (that is, meet certain criteria) are added to Part 1 of Schedule 1. These are prioritized for total, partial or conditional prohibition.
- Other toxic substances are added to Part 2 of Schedule 1 and are prioritized for pollution prevention actions, which may include prohibition.
- Regulations specifying criteria for the classification of substances that pose the highest risk or that are carcinogenic, mutagenic or toxic for reproduction may be developed. When criteria are available, some substances considered for addition to Part 2 of Schedule 1 will instead be considered for addition to Part 1 of Schedule 1.
- Publication of the risk management scope aims to inform stakeholders of proposed risk management options and initiate discussions about their development. The Government will consider the following actions to address human health concerns:
- For consumer products, including essential oils or products sold directly to consumers in vials for use in DIY applications and resin incense:
- Regulatory or non-regulatory actions to help reduce dermal, inhalation and/or oral exposures to cade oil, jonquil oil, Verbena officinalis extract, Ginkgo biloba extract, myrrh oil, cork tree extract, sage oil, and wormwood oil from essential oils used in DIY applications, and to reduce inhalation exposure to myrrh oil in resin incense products to levels that are protective of human health.
- A public communications approach for DIY consumer product essential oils of concern for human health.
- For food:
- Regulatory or non-regulatory actions to help reduce oral exposure of the general population to Ginkgo biloba extract from teas.
- For cosmetics:
- Listing cade oil, Verbena officinalis extract, Ginkgo biloba extract, myrrh oil, cork tree extract, sage oil, IBCH, sandal cyclohexanol, BCH, and sandela as prohibited or restricted ingredients on Health Canada’s Cosmetic Ingredient Hotlist to help reduce dermal, inhalation and/or oral exposure to these substances from certain cosmetics. 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.
- For NHPs and NPDs:
- Listing Verbena officinalis extract, Ginkgo biloba extract, myrrh oil, cork tree extract, sage oil, and wormwood oil as restricted ingredients in Health Canada’s Natural Health Products Ingredients Database (NHPID) to help reduce dermal, inhalation and /or oral exposures to these substances from certain topical NHPs or NPDs. Actions may aim to lower the concentration of these substances when used as non-medicinal ingredients in certain NHPs and/or NPDs to levels that are protective of human health.
- For consumer products, including essential oils or products sold directly to consumers in vials for use in DIY applications and resin incense:
- Information is being sought by the Government to inform risk management decision-making. Details can be found in the risk management scope, including where to send information during the public comment period, ending March 26, 2025.
- Risk management options may evolve through consideration of assessments and risk management options published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.
Where to find updates on risk management actions
- Additional information on the risk management of substances as well as a table of risk management actions for substances addressed under the CMP is 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
- The substances in this group are found in products available to consumers. People in Canada should follow any safety warnings and directions related to the product and dispose of products responsibly.
- Visit Healthy home for information on chemical safety in and around the home, including on Ginkgo biloba extract, essential oils and botanical extracts, and synthetic sandalwood fragrances.
- Cosmetics must include a list of all ingredients on the product label using the International Nomenclature of Cosmetic Ingredients (INCI) system. Juniperus Oxycedrus Wood Oil (Cade oil), Verbena officinalis extract, Ginkgo biloba (leaf, nut or root) extract, Commiphora Myrrha Oil (myrrh oil), Phellodendron Amurense Bark Extract (cork tree extract), Salvia Officinalis (Sage) Oil, and Camphylcyclohexanol (BCH) are all INCI names.
- Assessments conducted under CEPA focus on risks of exposure of the general population. Hazards related to chemicals used in the workplace are defined within the Workplace Hazardous Materials Information System (WHMIS). If a substance is harmful to the general population, it could also be of concern for individuals in situations where a higher volume of the substance is used or where the substance is used for a longer duration (for example, the workplace). The Government of Canada recognizes that it is the responsibility of the federal, provincial and territorial occupational health and safety organizations to coordinate legislation for the safe use of chemicals in the workplace. We are working to support this role by integrating the information, tools, and technical expertise of the CMP and Health Canada’s Workplace Hazardous Products Program.
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