Canada Gazette, Part I, Volume 159, Number 4: GOVERNMENT NOTICES
January 25, 2025
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 21912
Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment and the Minister of Health have assessed information in their possession in respect of the substance trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl-, Chemical Abstracts Service Registry Number 17861-60-8, under section 83 of the Canadian Environmental Protection Act, 1999;
Whereas the substance is not specified on the Domestic Substances List;
And whereas the ministers suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Act,
Therefore, the Minister of the Environment indicates, pursuant to section 85 of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of that act applies with respect to the substance in accordance with the Annex.
The Honourable Steven Guilbeault
Minister of the Environment
ANNEX
Information requirements
(Section 85 of the Canadian Environmental Protection Act, 1999)
1. The following definitions apply in this notice:
- “cosmetic” means a cosmetic as defined in section 2 of the Food and Drugs Act;
- “rinse-off cosmetic” means any cosmetic that is intended to be removed after application to the skin, hair or mucous membranes, and includes products such as body soap, shampoo, conditioner, facial wash, facial cleanser, exfoliant, shaving cream and hair removal cream; and
- “substance” means trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl-, Chemical Abstracts Service Registry Number 17861-60-8.
2. In relation to the substance, a significant new activity is
- (a) the use of the substance in the manufacture of a cosmetic other than
- (i) hair dye in which the substance is present at a concentration of 5% by weight or less,
- (ii) a rinse-off cosmetic in which the substance is present at a concentration of 10% by weight or less, or
- (iii) foundation makeup, facial makeup remover, hair gel, or lipstick in which the substance is present at a concentration of 1% by weight or less; and
- (b) the distribution for sale of the substance if it is contained in a cosmetic other than those referred to in subparagraphs (a)(i) to (iii).
3. Despite section 2, a use of the substance is not a significant new activity if the substance is used
- (a) as a research and development substance or as a site-limited intermediate substance, as these terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers) [the Regulations]; or
- (b) in the manufacture of a cosmetic that is for export only.
4. For each proposed significant new activity, the following information must be provided to the Minister of the Environment at least 90 days before the day on which the activity begins:
- (a) a description of the significant new activity in relation to the substance;
- (b) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
- (c) the information specified in paragraphs 7(c) and (d) of Schedule 4 to the Regulations;
- (d) the information specified in paragraphs 8(f) and (g) of Schedule 5 to the Regulations;
- (e) the function of the substance in the cosmetic;
- (f) the test data and the test report from one in vitro dermal absorption study in respect of the substance, conducted in accordance with the methodology described in the Organisation for Economic Co-operation and Development (OECD) guideline for the testing of chemicals, Test No. 428, entitled Skin Absorption: In Vitro Method, that is current at the time the test is conducted;
- (g) the test data and the test report from one repeated dose mammalian toxicity study in respect of the substance, conducted in accordance with the methodology described in the OECD guideline for the testing of chemicals, Test No. 407, entitled Repeated Dose 28-Day Oral Toxicity Study in Rodents, that is current at the time the test is conducted;
- (h) the test data and the test report from one mammalian reproductive and developmental toxicity study in respect of the substance, conducted in accordance with the methodology described in the OECD guideline for the testing of chemicals, Test No. 421, entitled Reproduction/Developmental Toxicity Screening Test, that is current at the time the test is conducted;
- (i) a summary of all other information and test data in respect of the substance that are in the possession of the person who is proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the adverse effects that the substance may have on the environment and human health and the degree of environmental and public exposure to the substance;
- (j) the name of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency;
- (k) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person who is proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; and
- (l) a certification that the information is accurate and complete, dated and signed by the person who is proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf.
5. Any studies provided under paragraphs 4(f), 4(g) and 4(h) must be conducted in accordance with the OECD Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, that are current at the time the test is conducted.
6. The information provided under section 4 is to be assessed within 90 days after the day on which it is received by the Minister.
Transitional provisions
7. Despite section 2, in the period between the date of publication of the present notice and January 24, 2026, a significant new activity is
- (a) the use of the substance in quantities greater than 100 kg in the manufacture of a cosmetic other than
- (i) hair dye in which the substance is present at a concentration of 5% by weight or less,
- (ii) a rinse-off cosmetic in which the substance is present at a concentration of 10% by weight or less, or
- (iii) foundation makeup, facial makeup remover, hair gel, or lipstick in which the substance is present at a concentration of 1% by weight or less; and
- (b) the distribution for sale of the substance, in quantities greater than 100 kg, if it is contained in a cosmetic other than those referred to in subparagraphs (a)(i) to (iii).
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This Significant New Activity (SNAc) Notice is a legal instrument adopted by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (the Act) to apply the SNAc provisions of that Act to the substance trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl-, Chemical Abstracts Service (CAS) Registry Number 17861-60-8. The Notice is now in force, and it has force of law. It is therefore mandatory for a person who intends to use the substance for a significant new activity as defined in the Notice to meet all the applicable requirements set out in the Notice.
A SNAc Notice does not constitute an endorsement from the Minister of the Environment, the Department of the Environment or the Government of Canada of the substance to which it relates, nor does it constitute an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.
Applicability of the Significant New Activity Notice
The Notice requires that any person (individual or corporation) engaging in a significant new activity in relation to the substance trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl-, CAS Registry Number 17861-60-8, submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 90 days prior to using the substance for the significant new activity.
In order to address the human toxicity concerns, the Notice requires notification in relation to the use of the substance in the manufacture of cosmetics in Canada in any quantity, other than hair dyes at concentrations up to 5% by weight, rinse-off cosmetics at concentrations up to 10% by weight, and foundation makeup, facial makeup remover, hair gel, or lipstick at concentrations up to 1% by weight. Notification is also required in relation to the distribution for sale in Canada of the substance when contained in cosmetics other than hair dyes at concentrations of up to 5% by weight, rinse-off cosmetics at concentrations of up to 10% by weight, and foundation makeup, facial makeup remover, hair gel, or lipstick at concentrations up to 1% by weight.
A SNAN is required 90 days before the use of the substance in a significant new activity.
Activities not subject to the Notice
Uses of the substance that are regulated under the Acts of Parliament listed in Schedule 2 of the Act, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are excluded from the Notice. The Notice also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the provisions of the Act. See subsection 81(6) and section 3 of the Act, and section 3.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers) for additional information.
Activities involving the use of the substance as a research and development substance or a site-limited intermediate or an export-only product are excluded from the Notice. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers).
Information to be submitted
The Notice sets out the information that must be provided to the Minister 90 days before the day on which the substance trisiloxane, 3-ethyl-1,1,1,3,5,5,5-heptamethyl-, CAS Registry Number 17861-60-8 is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct a risk assessment within 90 days after the complete information is received.
The assessment of the substance identified potential concerns related to reproductive, developmental and oral toxicity associated with the use of the substance in cosmetics other than those specified, at identified threshold concentrations. The SNAc Notice is issued to gather toxicity information to ensure that the substance will undergo further assessment before significant new activities are undertaken.
The information requirements in the Notice relate to general information in respect of the substance, details surrounding its use, exposure information, and toxicity to human health and the environment. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).
Additional guidance on preparing a SNAN can be found in section 9.6.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers).
Transitional provision
A transitional provision is included in the Notice to facilitate compliance by persons who may already have imported or manufactured the substance up to 100 kg and started activities with it in concentrations that exceed threshold limits as defined in the Notice. The Notice comes into force immediately. However, for the period between the publication of the Notice and January 24, 2026, the substance may be used in a quantity not exceeding 100 kg in the manufacture of cosmetics or the distribution for sale of the substance in Canada if it is present in cosmetics described in the “Applicability of the Significant New Activity Notice” section. On January 25, 2026, the threshold will be lowered.
Compliance
When assessing whether or not a substance is subject to SNAc provisions, a person is expected to make use of information in their possession or to which they may reasonably have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheets (SDSs).
Although an SDS is an important source of information on the composition of a product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to a SNAc notice due to human health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.
Where a person involved in activities with the substance obtains information that reasonably supports the conclusion that the substance is toxic or is capable of becoming toxic, the person is obligated, under section 70 of the Act, to provide that information to the Minister without delay.
A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the person from whom they obtained the substance.
Under section 86 of the Act, any person who transfers the physical possession or control of a substance subject to a SNAc notice must notify all persons to whom the physical possession or control is transferred of the obligation to comply with the notice, including the obligation to notify the Minister of any SNAc and to provide all the required information outlined above.
A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.
For further information, please contact the Substances Management Information Line (substances@ec.gc.ca [email], 1‑800‑567‑1999 [toll-free in Canada], and 819‑938‑3232 [outside of Canada]).
The Act is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999 (CEPA, 1999). In instances of non-compliance, consideration is given to the following factors, when deciding which enforcement measure to take: nature of the alleged violation, effectiveness in achieving compliance with the Act and its regulations and consistency in enforcement.
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after assessment of the substances in the 14 Terpene and Terpenoid Substances Group specified on the Domestic Substances List (section 77 of the Canadian Environmental Protection Act, 1999)
Whereas a summary of the draft assessment conducted on the 14 substances identified in the annex below pursuant to paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999 is annexed hereby;
And whereas it is proposed to conclude that 12 of these substances meet one or more of the criteria set out in section 64 of the Act,
Notice therefore is hereby given, for the purposes of paragraph 77(1)(a), that the Minister of the Environment and the Minister of Health (the ministers) propose to recommend to Her Excellency the Governor in Council that these substances be added to Part 2 of Schedule 1 to the Act.
Notice is given that, for the purposes of paragraph 77(1)(b) of the Act, the risks identified in relation to human health associated with isobornyl cyclohexanol (IBCH), sandal cyclohexanol, bornyl cyclohexanol (BCH), and sandela are regulated by section 16 of the Food and Drugs Act.
Notice is furthermore given that the ministers have released a risk management scope document for these substances to initiate discussions with stakeholders on the development of risk management options.
And whereas it is proposed to conclude that norlimbanol and amberlyn do not meet any of the criteria set out in section 64 of the Act,
Notice therefore is hereby given, for the purposes of paragraph 77(1)(a), that the ministers propose to take no further action on these two substances at this time.
Public comment period — January 25, 2025, to March 26, 2025
Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical substances) website. The draft assessment and the risk management scope documents may also be consulted.
How to participate: All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Substance Prioritization, Assessment and Coordination Division, Department of the Environment, Gatineau, Quebec K1A 0H3,
- by email to substances@ec.gc.ca; or
- by using the online reporting system available through Environment and Climate Change Canada’s Single Window.
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.
The request must provide reasons as provided for under subsection 313(2) of the Act
Jacqueline Gonçalves
Director General
Science Reporting and Assessment Directorate
On behalf of the Minister of the Environment
Jacinthe David
Director General
Industrial Sectors and Chemicals Directorate
On behalf of the Minister of the Environment
Greg Carreau
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX
Summary of the draft assessment of the substances in the 14 Terpene and Terpenoid Substances Group
Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted an assessment of 14 substances hereinafter referred to as the “14 Terpene and Terpenoid Substances Group.” The Chemical Abstracts Service Registry Numbers (CAS RNsfootnote 1), the subgroups, the Domestic Substances List (DSL) names, and the common names and/or abbreviations of these substances are listed in the table below.
CAS RN | Subgroup | DSL name | Common name (abbreviation) |
---|---|---|---|
8013-10-3 table 1 note a | Individual | Oils, cade | Cade oil |
8023-75-4 table 1 note a | Individual | Oils, jonquil | Jonquil oil |
70788-30-6 | Individual | Cyclohexanepropanol, 2,2,6-trimethyl-α-propyl- | Norlimbanol |
84961-67-1 table 1 note a | Individual | Verbena officinalis, ext. | Verbena officinalis extract |
90045-36-6 table 1 note a | Individual | Ginkgo biloba, ext. | Ginkgo biloba extract |
3738-00-9 | Individual | Naphtho[2,1-b]furan, dodecahydro-3a,6,6,9a-tetramethyl- | Amberlyn |
8016-37-3 table 1 note a | Individual | Oils, myrrh | Myrrh oil |
164288-52-2 table 1 note a | Individual | Cork tree, Phellodendron amurense, ext. | Cork tree extract |
8022-56-8 table 1 note a | 1 | Oils, sage | Sage oil |
8008-93-3 table 1 note a | 1 | Oils, wormwood | Wormwood oil |
3407-42-9 | 2 | Cyclohexanol, 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)- | Isobornyl cyclohexanol (IBCH) |
66068-84-6 | 2 | Cyclohexanol, 4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)- | Sandal cyclohexanol |
68877-29-2 | 2 | Cyclohexanol, (1,7,7-trimethylbicyclo[2.2.1]hept-2-yl)- | Bornyl cyclohexanol (BCH) |
70955-71-4 table 1 note a | 2 | Phenol, 2-methoxy-, reaction products with 2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane, hydrogenated | Sandela |
Table 1 note(s)
|
Terpenes are chemicals with repeating isoprene units, and are classified according to the number of isoprene units they contain. Monoterpenes are the smallest unit containing two isoprene units and these may be acyclic or cyclic in structure. These substances are components of essential oils and are found in a wide variety of plants.
All of the substances in the 14 Terpene and Terpenoid Substances Group have been included in surveys issued pursuant to section 71 of CEPA. Except for amberlyn, none of the substances in this group were reported to be manufactured or imported into Canada in quantities greater than 100 kg during the 2011 reporting year. Amberlyn was reported to be imported in quantities ranging from 100 kg to 1 000 kg. The substances in the 14 Terpene and Terpenoid Substances Group are generally used as ingredients in cosmetics; drugs, including natural health products (NHPs); cleaning products; and air fresheners. These substances are also used as essential oils used in do-it-yourself (DIY) applications to create these products, or are added to diffusers, facial steamers, or baths, among others. Some of these substances are also present in pest control products (PCPs) as formulants. In addition, some occur naturally in food and may be used as food flavouring agents.
The ecological risks of the substances in the 14 Terpene and Terpenoid Substances Group were characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate, or high level of potential concern for substances on the basis of their hazard and exposure profiles. Based on the outcome of the ERC analysis, the substances in the 14 Terpene and Terpenoid Substances Group are considered unlikely to be causing ecological harm.
Considering all available lines of evidence presented in this draft assessment, there is a low risk of harm to the environment from the substances in the 14 Terpene and Terpenoid Substances Group. It is proposed to conclude that the substances in the 14 Terpene and Terpenoid Substances Group do not meet the criteria under paragraph 64(a) or (b) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.
For the human health risk assessment, 6 of the 14 substances in this group have been addressed under two subgroups due to similarities in chemical structure, properties, and/or toxicity, while the remaining substances were addressed individually.
An impact on human health from exposure to the 14 substances through environmental media is not expected due to the low quantities reported in response to a CEPA section 71 survey. Where applicable, exposures were characterized from use of cosmetics, non-prescription drugs (NPDs), and NHPs, and from possible use as food flavouring agents, cleaning products, air fresheners, and DIY applications. Where the health effects datasets were considered to be limited, the toxicological data from its major components were taken into consideration.
Cade oil is the volatile oil extracted from the wood and branches of Juniperus oxycedrus following destructive distillation using high heat. Among the major components of cade oil, cresols were associated with the lowest effect levels. Carcinogenicity observed in laboratory animal studies as well as non-cancer central nervous system effects were identified as the critical effects associated with cresols and were used as the basis for characterization of the risk to human health from exposure to cade oil. Comparison of the critical health effect levels to estimates of exposure to cade oil from uses in perfumes (roll-on) and face moisturizers, as well as from DIY essential oil uses in aromatic diffusers, facial steamers, bath oils, body moisturizer preparations, massage oil preparations, and topical preparations applied on abraded/damaged skin, resulted in margins of exposure (MOEs) that are considered potentially inadequate to address uncertainties in the health effects and exposure data used to characterize risk.
Jonquil oil is a substance of unknown or variable composition, complex reaction products, or biological material (UVCB) defined as the “extractives and their physically modified derivatives obtained from Narcissus jonquilla L., Amaryllidaceae.” Benzyl benzoate and trans-methylisoeugenol were the major components associated with the lowest effect levels in the health effects database. Non-cancer effects (that is, developmental effects, and general toxicity) and carcinogenicity observed in laboratory animal studies were identified as the critical effects for risk characterization. Comparison of the critical health effect levels to estimates of exposure to jonquil oil from DIY uses in aromatic diffusers, facial steamers, bath oils, as well as massage oil preparations and body moisturizer preparations resulted in MOEs that are considered potentially inadequate to address uncertainties in the health effects and exposure data used to characterize risk.
Norlimbanol is not present naturally in the environment but is manufactured from the condensation of citral with 2-pentanone. The critical health effects associated with norlimbanol include reproductive and developmental toxicity observed in laboratory animal studies. Comparison of the critical health effects to the estimates of exposure to norlimbanol from the use of spray colognes resulted in MOEs that are considered adequate to address uncertainties in the health effects and exposure data used to characterize risk.
Verbena officinalis extract is an extract of the aerial parts and roots of the Verbena officinalis plant also known as the common vervain. On the basis of the health effects data available on citral (one of its major components), the critical effects identified for Verbena officinalis extract were developmental effects, reduced body weight, and severe respiratory tract irritation observed in laboratory studies. Comparison of the critical health effect levels with estimates of exposure to 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 resulted in MOEs that are potentially inadequate to address uncertainties in the health effects and exposure data used to characterize risk.
The critical effects associated with Ginkgo biloba extract include developmental effects (reduced fetal body weight and reduced intrauterine growth), as well as increased incidence of liver tumours observed in laboratory studies. Comparison of the critical health effect levels with estimates of exposure to Ginkgo biloba extract from the use of Ginkgo biloba extract 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) resulted in MOEs that are considered inadequate to address uncertainties in the health effects and exposure data used to characterize risk.
Amberlyn is a naturally occurring terpenoid found in ambergris. The substance can also be obtained from the oxidation of components present in clary sage oil. The critical effects identified for amberlyn include changes in biochemical or blood parameters (for example platelets, cholesterol levels) and histopathological changes in certain organs (for example kidneys). Comparison of the critical health effect levels to the estimates of exposure to amberlyn from the use of an air freshener, a body lotion, and a food flavouring agent resulted in MOEs that are considered adequate to address uncertainties in the health effects and exposure data used to characterize risk.
Myrrh oil is a UVCB substance defined as the “extractives and their physically modified derivatives from Commiphora, Burseraceae.” The critical effects identified for myrrh oil in laboratory studies included effects on biochemistry (that is, bile acids) and reproductive parameters (that is, sperm levels). Comparison of the critical health effect levels with estimates of exposure to myrrh oil from 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, and use of essential oils in DIY applications such as for stomach remedies, aromatic diffusers, and face steamers, resulted in MOEs that are potentially inadequate to address uncertainties in the health effects and exposure data used to characterize risk.
Cork tree extract is a UVCB substance derived from the bark of the Phellodendron amurense tree. On the basis of the health effects data available on the extract, the critical effects identified for cork tree extract were effects on the heart and liver. Comparison of the critical health effects and estimates of exposure to cork tree extract from use in cosmetics and NHPs, including face moisturizers, body moisturizers, and analgesic sprays, resulted in MOEs that are considered potentially inadequate to address uncertainties in the health effects and exposure databases. In addition, DIY applications of cork tree extract, including oral ingestion of cork tree extract and use of the substance in aromatic diffusers and massage oil preparations, resulted in MOEs that are also potentially inadequate to address uncertainties in the health effects and exposure data used to characterize risk.
Sage oil is a UVCB substance that is defined as the extracts derived from the botanical species Salvia officinalis. Wormwood oil is also a UVCB substance and is defined as the “extractives and their physically modified derivatives from Artemisia absinthium, Compositae.” Thujone, a major component in both substances, was associated with the lowest effect levels in the health effects data sets for sage and wormwood oils. On the basis of the health effects data available on thujone, the critical effects identified for risk characterization were neurological effects (that is, convulsions). As the health effects data sets for both sage oil and wormwood oil were informed by thujone, these substances were assessed together as a subgroup of substances (that is, subgroup 1).
A comparison of the critical health effect levels to estimates of exposure to 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), analgesic creams (NHPs), and DIY applications of sage oil in aromatic diffusers and face steamers resulted in MOEs that are potentially inadequate to address uncertainties in the health effects and exposure data used to characterize risk. Oral exposure to sage oil from breath fresheners, mouth washes, toothpastes, oral supplements (NHPs), motion sickness medications (NHPs), and throat sprays (NHPs) also resulted in MOEs that are considered potentially inadequate.
A comparison of the critical health effect levels to estimates of exposure to wormwood oil from use of NHPs and NPDs, including hand sanitizers and analgesic creams, and when used in DIY applications, including aromatic diffusers, facial steamers, bath oils, massage oil preparations, and body moisturizer preparations, resulted in MOEs that are potentially inadequate to address uncertainties in the health effects and exposure data used to characterize risk. Oral ingestion of wormwood oil also resulted in MOEs considered potentially inadequate to address uncertainties.
Due to their structural similarities and the use of their common names as synonyms in the literature, isobornyl cyclohexanol (IBCH), sandal cyclohexanol, bornyl cyclohexanol (BCH), and sandela were assessed together as a subgroup of substances (that is, subgroup 2). The toxicological data for sandal cyclohexanol, BCH, and sandela were limited, and the health effects data on IBCH was used to inform the human health risk assessment for all substances in subgroup 2. The critical effects identified included reproductive and developmental effects. Comparison of the critical health effect levels with estimates of exposure to substances in subgroup 2 from use in spray perfumes and body moisturizers resulted in MOEs that are considered potentially inadequate to address uncertainties in the health effects and exposure data used to characterize risk.
The human health assessment for each substance took into consideration those groups of individuals within the Canadian population who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects. Certain subpopulations, such as infants, children, and people of reproductive age, are routinely considered throughout the assessment process. For instance, age-specific exposures are routinely estimated, and developmental and reproductive studies are evaluated for potential adverse health effects. These subpopulations with potential for higher exposure and those who may be more susceptible were taken into account in the risk assessment outcomes.
Considering all the information presented in this draft assessment, it is proposed to conclude 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 meet the criteria under paragraph 64(c) of CEPA as they are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Considering all the information presented in this draft assessment, it is proposed to conclude that norlimbanol and amberlyn do not meet the criteria under paragraph 64(c) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.
Proposed overall conclusion
It is therefore proposed to conclude 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 meet one or more of the criteria set out in section 64 of CEPA, and that norlimbanol and amberlyn do not meet any of the criteria set out in section 64 of CEPA.
The draft assessment and the risk management scope document for these substances are available on the Canada.ca (Chemical substances) website.
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication of supplemental material after updated draft screening assessment of melamine, CAS RNfootnote 1 108-78-1, specified on the Domestic Substances List (section 77 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment and the Minister of Health (the ministers) published a summary of the updated draft screening assessment of melamine in the Canada Gazette on October 17, 2020, for a 60-day public comment period ending on December 16, 2020;
Whereas the ministers at that time proposed to conclude that the substance meets one or more of the criteria set out in section 64 of the Act;
Whereas new critical human health effects concerning the substance have been identified since then;
Whereas the Minister of Health has developed an additional risk characterization document on melamine pursuant to paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the additional risk characterization conducted on melamine is annexed hereby;
And whereas the proposed conclusion that the substance meets one or more of the criteria set out in section 64 of the Act has not changed,
Notice therefore is hereby given that the ministers may use the supplemental material in the additional risk characterization document to inform the final assessment of melamine.
Notice is furthermore given that the ministers have released an updated risk management scope document for this substance to initiate discussions with stakeholders on the development of risk management options, and to inform the subsequent risk management of melamine.
Public comment period — January 25, 2025, to March 26, 2025
Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical substances) website. The additional risk characterization document for melamine and the Revised Risk Management Scope Document may also be consulted.
How to participate: All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Substance Prioritization, Assessment and Coordination Division, Department of the Environment, Gatineau, Quebec K1A 0H3,
- by email to substances@ec.gc.ca; or
- by using the online reporting system available through Environment and Climate Change Canada’s Single Window.
In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential. The request must provide reasons as provided for under subsection 313(2) of the Act.
Jacinthe David
Director General
Industrial Sectors and Chemicals Directorate
On behalf of the Minister of the Environment
Greg Carreau
Director General
Safe Environments Directorate
On behalf of the Minister of Health
ANNEX I
Summary of the additional risk characterization document
An updated draft of the assessment of 1,3,5-triazine-2,4,6-triamine (Chemical Abstracts Service Registry Number [CAS RN] 108-78-1), commonly known as melamine, was published on October 17, 2020. It proposed that melamine was harmful to human health but not to the environment. Melamine is a substance included in the Certain Organic Flame Retardants (OFR) Substance Grouping under Canada’s Chemicals Management Plan, which includes 10 organic substances having a similar function: application to materials to slow the ignition and spread of fire.
Since the publication of the updated draft assessment of melamine, new critical health effects were identified and exposure to melamine was re-examined. This current document contains an updated characterization of the human health risk associated with exposure to melamine to inform the melamine assessment. The public has the opportunity to comment on data and analysis included herein prior to the data and analysis being considered in the finalization of the assessment of melamine, and, if appropriate, the corresponding risk management approach document. Data related to human health with respect to melamine, identified or generated since the publication of the updated draft assessment, are included herein.
Melamine does not occur naturally in the environment. It is not manufactured in Canada; however, imports of melamine, as a pure substance or blended into products, in the range of 10 million kilograms to 100 million kilograms were reported for the year 2011. In Canada, melamine has numerous industrial applications; its predominant use is in the manufacture of melamine-based resins for application in laminates and plastics, and as a flame retardant in polyurethane foams, paints, and coatings. Globally, melamine is used primarily in the synthesis of melamine–formaldehyde resins for similar applications, and in adhesives and moulding compounds (for example for melaware). Due to its high nitrogen content, melamine has also been used globally as a fertilizer.
The main sources of exposure to melamine for people living in Canada are expected to be from the use of products available to consumers, including melamine-containing tableware and kitchen utensils (“melaware,” including bambooware), foam-containing products (for example mattresses, upholstered furniture, infant and child restraint systems as well as booster seats), textiles, paints, sealants, and cooktop cleaners, as well as from food and environmental media (water, dust). Biomonitoring data were also available from the Unites States (U.S.) population.
Based principally on the weight of evidence from assessments from international agencies and other available information, critical effects associated with exposure to melamine are carcinogenicity, effects on the urinary system and reproductive toxicity. Available information indicates that melamine is not genotoxic. Comparisons between levels associated with critical effects in animal studies and estimates of exposure from environmental media, food and textiles are considered to be adequate to address uncertainties in the health effects and exposure data used to characterize risk. However, comparisons between levels associated with critical effects in animal studies and estimates of exposure from melaware, including bambooware (through migration into food/beverages), foam-containing products (including mattresses, upholstered furniture, infant and child restraint systems as well as booster seats), paints (brush/roller paint and in spray format), sealants, and cooktop cleaners are considered potentially inadequate to address uncertainties in the health effects and exposure datasets.
The human health assessment took into consideration those groups of individuals living in Canada who, due to greater susceptibility or greater exposure, may be more vulnerable to experiencing adverse health effects from exposure to substances. The potential for increased susceptibility during development and reproduction was assessed and age-specific exposure estimates were derived. Generally, infants and children were found to have higher exposure to melamine than adults. All of these populations were taken into consideration while assessing the potential harm to human health.
On the basis of information presented in this risk characterization document, exposure to melamine from melaware (including bambooware), foam-containing products (including mattresses, upholstered furniture, infant and child restraint systems as well as booster seats), paints, sealants, and cooktop cleaners may be harmful to human health.
The supplemental materials for this substance are available on the Canada.ca (Chemical substances) website.
ANNEX II
Summary of the updated risk management scope
This Revised Risk Management Scope Document outlines risk management options under consideration for melamine to address risks outlined in the Human Health Risk Characterization Document for the Assessment of Melamine. Melamine is a substance that is part of the Certain Organic Flame Retardants Substance Grouping, which has been proposed to be harmful to human health.
For the purposes of paragraph 77(1)(a) of the Canadian Environmental Protection Act, 1999 (CEPA), the Government of Canada proposes to recommend that melamine be added to Part 2 of Schedule 1 to CEPA.footnote 2 As a result, the Government of Canada is considering the new risk management actions that follow.
Flame retardant uses: Regulatory and non-regulatory actions to help reduce prolonged dermal exposure of the general population and oral exposure of infants 0 to 3 years old to melamine in products made with polymeric foams, such as polyurethane foam (PUF) [including upholstered furniture, mattresses, mattress toppers, and other foam-based products to which prolonged skin contact may be expected], and to reduce prolonged dermal exposure of infants and children to melamine in polymeric foam in infant and child restraint seats, including booster seats.
Melaware and bambooware tableware and kitchen utensils: Regulatory and non-regulatory actions to help reduce dietary exposure of the general population to melamine from melamine-containing tableware and kitchen utensils (“melaware,” including bambooware) through migration of melamine from melaware into food or beverages.
Do-it-yourself products: Regulatory and non-regulatory actions to help reduce dermal and/or inhalation exposure to melamine in paints, and dermal exposure to melamine in sealants.
Cleaning products: Regulatory and non-regulatory actions to help reduce dermal exposure to melamine in cooktop cleaners.
To inform risk management decision-making, information on the following topics should be provided (ideally on or before March 26, 2025) to the contact details identified in section 8 of the revised scope document:
- (1) Ongoing and anticipated changes in the use of melamine in upholstered furniture, mattresses, mattress toppers, child restraint seats, and other foam-based products available to consumers, whether in response to
- changes in performance-based flammability requirements and/or standards;
- market forces; and/or
- other reasons (please provide information on these reasons).
- (2) The use of melamine in textiles, including textile backings in furniture.
- (3) The use of melamine in polymeric foams other than PUFs, which may be used in products such as upholstered furniture, mattresses, mattress toppers, and other foam-based products to which prolonged skin contact may be expected.
- (4) The amount of melamine present in melamine-containing tableware and kitchen utensils (melaware and bambooware).
- (5) The amount of melamine necessary in melamine-containing tableware and kitchen utensils (melaware and bambooware) to ensure a functional product.
- (6) The market share of bambooware made from melamine resin in the bambooware market.
- (7) The use of melamine in paints, sealants, and cooktop cleaners.
The risk management options outlined in this Revised Risk Management Scope Document may evolve through consideration of assessments and risk management options published for other Chemicals Management Plan (CMP) substances as required to ensure effective, coordinated, and consistent risk management decision-making.
Note: The above summary is an abridged list of options under consideration to manage this substance and to seek information on identified gaps. Refer to section 3 of the updated risk management scope document for more details in this regard. It should be noted that the proposed risk management options may evolve through consideration of additional information obtained from the public comment period, literature and other sources.
The supplemental materials for this substance are available on the Canada.ca (Chemical substances) website.
PRIVY COUNCIL OFFICE
Appointment opportunities
We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.
We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.
The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.
Current opportunities
The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.
Position | Organization | Closing date |
---|---|---|
Director | Bank of Canada | |
Chairperson | Canada Deposit Insurance Corporation | |
Chairperson | Canada Industrial Relations Board | |
Vice-Chairperson | Canada Industrial Relations Board | |
Chairperson | Canada Infrastructure Bank | |
Director | Canada Lands Company Limited | |
President | Canada Water Agency | |
Chief Executive Officer | Canadian Accessibility Standards Development Organization | |
Assistant Chief Commissioner | Canadian Grain Commission | |
President | Canadian High Arctic Research Station | |
Chief Commissioner | Canadian Human Rights Commission | |
Permanent Member | Canadian Nuclear Safety Commission | |
Director | Canadian Tourism Commission | |
President | Canadian Tourism Commission | |
Chairperson | Civilian Review and Complaints Commission for the Royal Canadian Mounted Police | |
Vice-Chairperson | Civilian Review and Complaints Commission for the Royal Canadian Mounted Police | |
Director | Defence Construction (1951) Limited | |
Reviewer | Department of Citizenship and Immigration | |
Member | Employment Insurance Board of Appeal | February 3, 2025 |
Vice-Chairperson | Federal Public Sector Labour Relations and Employment Board | |
Chairperson | First Nations Infrastructure Institute | |
Director | First Nations Infrastructure Institute | |
Director (Federal) | Halifax Port Authority | |
Member | Historic Sites and Monuments Board of Canada | |
Member | National Seniors Council | |
Member | Natural Sciences and Engineering Research Council | |
Commissioner of Official Languages | Office of the Commissioner of Official Languages | |
Deputy Director of Public Prosecutions | Office of the Director of Public Prosecutions | |
Ombudsperson for the Department of National Defence and the Canadian Forces | Office of the Ombudsperson for the Department of National Defence and the Canadian Forces | |
Member | Payments in Lieu of Taxes Dispute Advisory Panel | |
Chief Public Health Officer | Public Health Agency of Canada | |
Principal | Royal Military College of Canada | |
Director | Sept-ÃŽles Port Authority | |
Administrator | Ship-source Oil Pollution Fund and Fund for Railway Accidents Involving Designated Goods | |
Co-chair | Sustainable Jobs Partnership Council | |
Member | Sustainable Jobs Partnership Council | |
Chairperson | The Jacques-Cartier and Champlain Bridges Inc. | |
Secretary | The National Battlefields Commission | |
Member | Transportation Appeal Tribunal of Canada | |
Chairperson | VIA Rail Canada Inc. | |
Chairperson | Windsor-Detroit Bridge Authority |