Vol. 150, No. 25 — December 14, 2016
SOR/2016-308 December 2, 2016
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
P.C. 2016-1083 December 2, 2016
Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part I, on October 15, 2011, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;
And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substances set out in the annexed Order are toxic substances;
Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 1) is amended by adding the following in numerical order:
- 135. Hexanedioic acid, bis(2-ethylhexyl) ester, which has the molecular formula C22H42O4
- 136. Reaction products of 2-propanone with diphenylamine
- 137. 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, which has the molecular formula C22H16N4O
Coming into Force
2 This Order comes into force on the day on which it is registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
The Government of Canada (the Government) has carried out screening assessments for three chemical substances to determine whether they may constitute a danger to human health or the environment. The substances are
- Hexanedioic acid, bis(2-ethylhexyl) ester (Chemical Abstracts Service [CAS] Registry No. 103-23-1), hereafter referred to as “DEHA;”
- Reaction products of 2-propanone with diphenylamine (CAS Registry No. 68412-48-6), hereafter referred to as “PREPOD;” and
- 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]- (CAS Registry No. 85-86-9), hereafter referred to as “Solvent Red 23.”
The screening assessments determined that these substances may have harmful effects on the environment or human health as defined in paragraphs 64(a) and (c) of the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, the Government is adding the three substances to the List of Toxic Substances in Schedule 1 of CEPA.
On December 8, 2006, the Government launched the Chemicals Management Plan (CMP) to assess and manage chemical substances that may have detrimental effects on human health or the environment. A key element of the CMP was the Challenge initiative, which included approximately 200 high priority chemical substances. These substances were divided into 12 batches of 10 to 20 chemicals each. DEHA and PREPOD belong to batch 11 while Solvent Red 23 belongs to batch 6 of the Challenge initiative.
Under the Challenge initiative, via mandatory surveys issued under section 71 of CEPA, affected industry stakeholders were required to submit information on the approximately 200 substances such as quantities imported, manufactured or used in Canada.
Based on the information received through the Challenge initiative and other available information, screening assessments for DEHA, PREPOD and Solvent Red 23 were conducted to assess whether the substances meet the criteria of section 64 of CEPA. Under section 64 of CEPA, a substance is considered toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that
- (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- (b) constitute or may constitute a danger to the environment on which life depends; or
- (c) constitute or may constitute a danger in Canada to human life or health.
The draft screening assessments were peer-reviewed and additional advice was sought through the Challenge Advisory Panel. (see footnote 2) It was concluded that the three substances meet the criterion set out for a toxic substance under section 64 of CEPA. The draft screening assessments were published on the Chemical Substances website along with a notice published in the Canada Gazette, Part I, on October 2, 2010.
After considering public comments and available information, the final screening assessments were published on the Chemical Substances website along with a notice that was published in the Canada Gazette, Part I, on September 10, 2011. Risk management approach documents, which include information on existing risk management actions associated with the substances in Canada, including an indication of where the Government will focus its risk management activities, were also released in conjunction with these publications. (see footnote 3) A proposed Order adding the three substances to Schedule 1 of CEPA was published in the Canada Gazette, Part I, on October 15, 2011. (see footnote 4)
In addition, documents providing an update on the risk management activities for PREPOD, DEHA and Solvent Red 23 were published by the Department of the Environment in September 2013. (see footnote 5)
All the publications mentioned above may be obtained from the Chemical Substances website or from the Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, 819-938-5212 (fax), or by email at email@example.com.
Substance descriptions, screening assessment summaries and conclusions
The substance DEHA is not produced naturally in the environment. It is primarily used as a plasticizer in the flexible vinyl industry and is widely used in flexible polyvinylchloride (PVC) such as cling wraps for food packaging. Also, it is used in rubber, urethane, adhesives, sealants, hydraulic fluids, lubricants, auto protectants and heavy-duty hand cleansers, as well as in certain personal care products. (see footnote 6)
According to submissions in response to a survey made under section 71 of CEPA, between 1 000 000 and 10 000 000 kg of DEHA were manufactured in Canada and approximately 250 000 kg were imported into Canada in 2006. The substance may be released to the environment during its manufacture, distribution, industrial use and the use and disposal of finished products by consumers.
According to the available information at the time, the screening assessment concluded that DEHA can be released into the Canadian environment in quantities that have the potential to cause harm to aquatic organisms. Based on its detrimental ecological properties and its estimated releases into the environment, it was concluded that DEHA met the criterion set out in paragraph 64(a) of CEPA. However, after the finalization of the screening assessment, the Government acquired new environmental monitoring and industrial practices information from industrial facilities manufacturing or using DEHA in Canada, and measured concentrations associated with industrial and municipal wastewater treatment plants. This information called into question the validity of the published monitoring data that were an important line of evidence in the screening assessment. The new data were documented and analysed in the Ecological State of the Science Report. (see footnote 7) The new ecological exposure data indicate that concentrations of DEHA in the aquatic environment are likely below the level causing environmental harm, and the substance is not expected to cause harm to aquatic organisms. Therefore, according to the Ecological State of the Science Report, DEHA does not meet the criterion set out in paragraph 64(a) of CEPA.
Canadians are currently exposed to DEHA, particularly through the use of certain personal care products. Based on identified health effects related to DEHA (developmental effects), and current exposure levels of the general population, it is estimated that Canadians are exposed to DEHA at levels that may constitute a danger to human health. As a result, it was concluded that DEHA meets the criterion set out in paragraph 64(c) of CEPA.
Since the new data had no bearing on human health risks, the Ecological State of the Science Report did not reassess human health risks. Therefore, the original conclusion that DEHA meets the criterion set out in paragraph 64(c) of CEPA has not changed.
In April 2014, DEHA was added to Health Canada’s list of prohibited and restricted cosmetic ingredients (the Cosmetic Ingredient Hotlist) as a restricted substance, to address the potential harm from DEHA to human health. The wording outlined in the Natural Health Products Ingredients Database with regards to the permitted use of DEHA in natural health products was also revised for consistency with the Cosmetic Ingredient Hotlist. Targeted surveys of DEHA in foods and food packaging materials were performed and DEHA was added to the Canadian Total Diet Study (TDS) to better define Canadian exposure to DEHA through dietary intake. Results of the targeted survey and TDS samples have been published. (see footnote 8), (see footnote 9)
Internationally, the Organisation for Economic Co-operation and Development (OECD) developed a Screening Information Data Set Initial Assessment Report (SIAR) for DEHA that identified its potential chronic aquatic hazards. In May 2012, the United States Environmental Protection Agency (US EPA) announced that it will reassess DEHA under the Integrated Risk Information System. In the European Union (EU), DEHA is listed for future assessment under the European Chemical Agency’s Community Rolling Action Plan, as it is on the list of carcinogenic, mutagenic and toxic to reproduction (CMR) substances.
The substance PREPOD is not naturally produced in the environment. It is an organic substance used mainly as an antioxidant in rubber products to prevent the loss of strength and flexibility of the rubber. It is used in tires, as well as in other automotive parts. PREPOD consists of numerous chemical components, not all of which may have been identified, and the concentrations of the individual components in the mixture can vary. (see footnote 10) As a result, PREPOD is classified as being of “Unknown or Variable Composition, a Complex Reaction Product or Biological Material,” or UVCB for short.
According to information submitted in response to a survey under section 71 of CEPA, between 100 000 and 1 000 000 kg of PREPOD were manufactured in Canada in 2006. During the same year, between 100 and 1000 kg of PREPOD were imported into Canada as a component of vehicle parts. The quantity of PREPOD manufactured and used in Canada indicates significant potential for release of this substance into the Canadian environment.
Based on their physical and chemical properties, many components of PREPOD are expected to persist in water, soil and sediment, but not in air. Moreover, one component, diisopropyldimethylacridan (DIPDMA), has been identified as having the potential to accumulate in organisms and may increase in concentration within food chains. Both DIPDMA and one other component, 4-(1-methyl-1-phenylethyl)-N-(4-(1-methyl-1-phenylethyl)phenyl)aniline (DCDPA) are potentially harmful to aquatic organisms. The screening assessment concluded that PREPOD meets the criterion as set out in paragraph 64(a) of CEPA.
With respect to human health, the screening assessment determined that, at current exposure levels, PREPOD does not pose a danger to human health in Canada.
Based on the available evidence, PREPOD meets the criteria set out in the Persistence and Bioaccumulation Regulations, made under CEPA. Because of this, and because it is not a naturally occurring substance, PREPOD meets the criteria for virtual elimination set out under subsection 77(4) of CEPA.
In the United States, this substance (CAS RN 68412-48-6) is listed as a high priority for future ambient monitoring in sediment under the U.S. National Water-Quality Assessment Program.
Solvent Red 23
Solvent Red 23 is not naturally produced in the environment. It is an organic substance that is used as a colourant in oils, fats and waxes, in alcohol-based ester and hydrocarbon solvents and in polystyrene. In Canada, it is used in cosmetics, and is also identified as being used in natural health products where it is permitted for external use only. Although it is permitted in Canada to be used as a colourant in externally applied non-prescription drugs, no pharmaceutical or veterinary products have been identified. The substance is also used as a colourant in some pesticides (for commercial pesticides only).
According to information submitted in response to section 71 surveys, Solvent Red 23 was not manufactured in Canada in 2005 and 2006. However, between 100 and 1 000 kg of the substance were imported in 2005. Importation of the substance was reported to be in some retail personal care products.
Solvent Red 23 is a member of a class of substances characterized by the presence of one or more azo groups containing bonds which, when broken, may result in the release of 4-aminoazobenzene. 4-Aminoazobenzene has been classified as a carcinogen by the International Agency for Research on Cancer (IARC) and the European Commission on the basis of its genotoxicity and carcinogenicity. Also, Solvent Red 23 is structurally similar to Sudan I, which has been classified as a mutagen and carcinogen by the European Commission. Therefore, it is determined that genotoxicity and carcinogenicity are the effects considered critical to assessing the risks to human health.
Based on potential exposure of the general population to Solvent Red 23 from use of certain personal care products (i.e. oral exposure from use of lip gloss/lip balm), and the evidence of genotoxicity and carcinogenicity, the screening assessment concluded that Solvent Red 23 has the potential to be harmful to human health. As a result, this substance was concluded to meet the criterion as set out in paragraph 64(c) of CEPA.
The quantity of Solvent Red 23 that may be released to the environment is below the level expected to cause harm to organisms. Therefore, it was concluded that Solvent Red 23 is not likely to be harmful to the environment and does not meet the criterion as set out in paragraph 64(a) of CEPA.
In April 2014, Solvent Red 23 was added to the Health Canada’s Cosmetic Ingredient Hotlist as a restricted substance to address the potential harm from Solvent Red 23 to human health. As a result, Solvent Red 23 is not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, nose or mouth and hair dye products containing Solvent Red 23 must contain warnings. The wording outlined in the Natural Health Products Ingredients Database with regards to the permitted use of Solvent Red 23 in natural health products was also revised for consistency with the Cosmetic Ingredient Hotlist.
Internationally, the health effects of Solvent Red 23 have been previously evaluated by IARC, the European Commission Scientific Committee on Consumer Products (SCCP), and the European Food Safety Authority (EFSA). The IARC and SCCP indicated there was insufficient information for a clear conclusion on the carcinogenicity of Solvent Red 23; however, in the absence of sufficient data, EFSA considered it prudent to assume Solvent Red 23 to be “potentially genotoxic and possibly carcinogenic.” (see footnote 11)
The objective of the Order Adding Toxic Substances to Schedule 1 of the Canadian Environmental Protection Act, 1999 is to enable the Government to implement regulatory instruments under the statutory authority of CEPA if such actions are deemed necessary.
The Order adds DEHA, PREPOD and Solvent Red 23 to Schedule 1 of CEPA (the List of Toxic Substances).
The proposed Order, which was published on October 15, 2011, proposed the addition of “Reaction products of 2-propanone with diphenylamine, containing diisopropyldimethylacridan that has the molecular formula C21H27N” (i.e. PREPOD containing DIPDMA) to Schedule 1 of CEPA. Given that DIPDMA cannot be intentionally removed from PREPOD, the Order now only lists “PREPOD,” without specifying the component DIPDMA.
The “One-for-One” Rule does not apply, as the Order will not impose any administrative burden on business.
Small business lens
The small business lens does not apply, as the Order will not impose any compliance or administrative costs on small business.
On October 2, 2010, the Minister of the Environment and the Minister of Health (the Ministers) published summaries of the draft screening assessments in the Canada Gazette, Part I, and made available the full screening assessments on the Chemical Substances website for a 60-day public comment period. Risk management scope documents were also released on the same date, outlining the preliminary options being examined for the management of the substances meeting the criteria under section 64 of CEPA.
Prior to this publication, the Department of the Environment and the Department of Health (the Departments) informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the screening assessments on the substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC.
During the 60-day public comment period, no comments were received on the draft screening assessment for Solvent Red 23. A total of seven submissions on the screening assessments for DEHA and PREPOD were received from three industry stakeholders, one researcher, two industry associations, and two non-governmental organizations (NGOs). (see footnote 12) All comments were considered in developing the final screening assessments for the three substances.
Below is a summary of some key comments and responses:
- A non-governmental organization commented that the quantities of substances in commerce are reported without any explanation for changes over time or differences in use patterns. For persistent and bioaccumulative substances, past uses represent a problem of historic, long-term contamination.
Response: Where information is available to explain why the quantity of a substance in commerce, or its use patterns, have changed over time, this is included in the screening assessment. However, for many substances this type of information is not available. The discussion of use patterns and quantities in commerce is often dependent on the information provided by stakeholders, which is typically for individual reporting years and does not include data showing time trends or data on marketplace changes that may have led to differences in use patterns. Stakeholders are encouraged to voluntarily provide information that is helpful to the preparation of screening assessments, including use patterns and quantities in commerce for previous years.
- A non-governmental organization commented that in the mass balance estimates for releases, no quantities are provided, only percentages, which do not give a true account of the actual releases to the environment. This information is important (particularly for persistent substances) and unfortunately, not available, even if it were known (due to confidentiality).
Response: Typically, a mass balance estimate is produced in order to determine at which step of the life cycle, and to which media potential releases may occur. This information is presented in the “Release” section of the screening assessment. Releases are most suitably expressed as a percentage (%) as they are a function of the handling of the substance, more so than its actual quantity. Also, in some cases, actual quantities cannot be provided due to confidential business information requirements. When developing actual exposure scenarios to estimate environmental concentrations, the release percentages can then be applied to the quantity of substance in commerce in order to estimate the quantity released for a specific scenario. Every attempt is made to acquire accurate information on quantities of the substances imported or manufactured, even if these quantities are not reported in the screening assessment.
Summary of comments and responses related to DEHA:
- An industry organization commented that DEHA is not listed in the Canadian Cosmetic Toiletry and Fragrance Association (CCTFA) cosmetic ingredient list. It also mentioned that there is quite a disparity in the concentrations reported by the Cosmetic Ingredient Review (CIR)  and the notifications submitted under the Cosmetic Regulations to the Department of Health, suggesting that exposure was overestimated in some instances and underestimated in other instances. (see footnote 13) Also, the highest percentages of use notified under the Cosmetic Regulations are inaccurate and do not reflect actual use.
Response: Notification of all cosmetic products imported or manufactured for sale in Canada is a requirement of the Cosmetic Regulations issued under the Food and Drugs Act. Notifications submitted under the Cosmetic Regulations to the Department of Health are a relevant source of Canadian specific information on ingredients in cosmetic products available in Canada. The CCTFA database does not provide information on the concentrations of ingredients found in cosmetics. The CIR provides information on U.S. products reported to the U.S. Food and Drug Administration and is not considered as representative of the Canadian market as the notifications submitted to the Department of Health. DEHA concentrations used in Canadian cosmetic products notified to the Department of Health are reported as ranges, and refinement of the upper range of these concentrations was incorporated as appropriate.
- One non-governmental organization commented that exposure of the general public to DEHA is most likely underestimated due to the limitation of data availability (e.g. prepackaged foods were not included in the food intake estimates).
Response: The screening assessment derived upper-bounding estimates of exposure to characterize the risk posed by DEHA to the general population. In the case of exposure from food, empirical data on concentrations of DEHA in food relevant to the Canadian context were used when available, but lack of data identifying levels of DEHA in prepared food stored in contact with plastic film is recognized as an uncertainty. However, the margins of exposure, which are based on upper bounding estimates of exposure from food, are considered adequate to account for the uncertainties in information on health effects and exposure.
- An industry stakeholder commented that the aquatic toxicity tests were conducted above a substance’s water solubility limit, which is not consistent with the procedures outlined by the Canadian Council of Ministers of the Environment (CCME) in their Protocol for the Derivation of Water Quality Guidelines for the Protection of Aquatic Life.
Response: Two studies used the slow-stir method to estimate the water solubility of DEHA (0.0032–0.0055 mg/L). Toxicity values within approximately a tenfold range of the estimated water solubility are deemed acceptable for risk assessment, recognizing variability and uncertainties in test procedures. The critical toxicity value chosen (0.035 mg/L) lies within the range considered acceptable for ecological risk assessment, and the observed effects may be attributed to uptake of the chemical. In addition, laboratory tests are conducted under relatively pristine conditions, and do not take into account the various co-solvents that exist in the environment that may ultimately affect the solubility and bioavailability of a substance. This aspect is considered in ecological risk assessments.
Summary of comments and responses related to PREPOD:
- A researcher commented that it is unlikely that PREPOD ends up in landfills because this substance is used in rubber and in the automobile industry. Automobiles are sent to metallurgical furnaces for recycling of steel, and rubber is generally sent to cement kilns or sent to places specially designed for recycling.
Response: The exposure scenario has been revised in the final screening assessment; however, there is still uncertainty regarding the relative quantities of PREPOD that are recycled and sent to landfills. Additional information to be collected during the risk management phase will help quantify these amounts.
Comments received following publication of the proposed Order in the Canada Gazette, Part I
On October 15, 2011, the Ministers published a proposed Order to add substances including DEHA, PREPOD containing DIPDMA, and Solvent Red 23 to Schedule 1 of CEPA in the Canada Gazette, Part I, for a 60-day public comment period. (see footnote 14)
During the 60-day public comment period, a Notice of Objection was filed by one industry association, under subsection 332(2) of CEPA, regarding the proposed addition of DEHA to Schedule 1 of CEPA, requesting the establishment of a Board of Review pursuant to section 333 of CEPA.
The information provided in the Notice of Objection was reviewed by the Departments. It was determined that none of the information provided supports a change in the conclusions of the screening assessment that DEHA is harmful to the environment and human health. After considering whether an inquiry into the nature and extent of the danger posed by that substance was necessary, the Ministers decided not to establish a Board of Review. (see footnote 15)
In addition to the Notice of Objection regarding DEHA, two submissions related to the overall proposed Order were received from four citizens. These submissions supported the addition of the substances to Schedule 1 of CEPA. One of these two submissions also provided comments on Solvent Red 23.
Summary of comments and responses from the Notice of Objection on DEHA
- The industry association commented that skin absorption of DEHA through potential exposure from the use of personal care and consumer products was significantly overestimated, and not specific to DEHA.
Response: The value of 10% dermal absorption used in the screening assessment was based on consideration of multiple lines of evidence including the physical and chemical properties of DEHA; results of a Department of Health dermal absorption study conducted in 2010; and other available information including outputs of predictive models.
The results from the Department of Health in vitro dermal absorption study indicated that dermal absorption is generally low based on its physical and chemical properties. However, based on the quantity of skin bound residues, it could not be concluded that dermal absorption was lower than 10%. A dermal absorption of 10% is consistent with a value estimated using the predictive approach and is considered to be the most appropriate value for use in the screening assessment, taking into consideration the uncertainties in the available information.
- The industry association commented that the DEHA exposure estimates from use of personal care products generated by the Department of Health exceed those derived from a biomonitoring study conducted by the European Plasticised PVC Film Manufacturers’ Association (EPFMA).
Response: The EPFMA study was reviewed by the Department of Health and was noted in the final screening assessment for DEHA as not being representative of current general population use in Canada.
The use pattern of DEHA in 1997–1998 in Europe was not considered to be representative of the use pattern of DEHA in Canada at the time of the publication of the final screening assessment. Additionally, only male participants were included in the EPFMA study. The absence of females in the EPFMA was considered to be a significant limitation of the study in terms of its utility in characterizing general Canadian population exposure as females are expected to have a different exposure profile with regard to personal care products in comparison to males.
Information from the cosmetic notifications submitted to the Department of Health was considered to be the most appropriate data from which to derive estimates of exposure to DEHA from use of cosmetics by the general population in Canada.
- The industry association commented that, given the substance’s water solubility, the toxicity data used by the screening assessment is inappropriate. The screening assessment uses the chronic aquatic toxicity results from a study in 1986 to calculate a predicted no-effect concentration (PNEC).
Response: The critical toxicity value used to derive a PNEC lies within the acceptable range of laboratory measurements of water solubility. In ecological screening assessments, it is recognized that there is method and measurement variability in all tests, and that laboratory tests are conducted under conditions that do not take into account the various co-solvents that exist in the environment that may influence the solubility and bioavailability of a substance. The critical toxicity value, which is based on the acceptable chronic study by Felder et al. (1986), is also used by the OECD in their assessment report for DEHA.
- The industry association commented that data on environmental levels used in the screening assessment report were unpublished, poorly documented, and inconsistent with extensive data collected in the United States and in Europe. In assessing potential environmental effects, the Department of the Environment’s reliance on Canadian monitoring data discounts the volumes of U.S. data available. These data show environmental levels that are much lower than those assumed in the draft screening assessment, despite the fact that DEHA use is greater in the United States than in Canada.
Response: Monitoring data used in the screening assessment consisted of data published in well-known, peer-reviewed journals and unpublished data for which contact information was provided in the screening assessments. An important consideration in the relevance of such data is the distance of sampling from possible sources of the release of the substance. Canadian information in particular is important for identifying potential areas of concern, and can help focus risk management efforts, if needed. Although environmental monitoring data from outside of Canada is considered, Canadian data is considered to be of greater relevance. (see footnote 16)
Summary of comment and response related to Solvent Red 23
- One of the submissions from citizens recommended the virtual elimination of Solvent Red 23.
Response: Solvent Red 23 was concluded in the screening assessment to meet the criteria for persistence but not for bioaccumulation as defined under the Persistence and Bioaccumulation Regulations; therefore, under CEPA, this substance does not meet the criteria for virtual elimination under paragraph 77(4) of CEPA.
Summary of stakeholder engagement following publication of the proposed Order in the Canada Gazette, Part I
The Government has had regular discussions with stakeholders since the proposed Order to add DEHA, PREPOD and Solvent Red 23 to Schedule 1 of CEPA was published in 2011. In the Risk Management Update (see footnote 17) published in September 2013, stakeholders were advised that the Government had added PREPOD to the CMP Monitoring and Surveillance Program and that an analytical method was being developed. In early 2014, multiple stakeholders using the substance were contacted to confirm if they were still using PREPOD and also to invite them to participate in a sampling campaign to measure releases of the substance into the environment.
In addition, the Department of Health has had opportunities to engage with stakeholders who use DEHA and Solvent Red 23. In April and October 2013, the Department was invited to speak at industry meetings where various stakeholders were informed of potential additions to the Cosmetic Ingredient Hotlist, including DEHA and Solvent Red 23. In April 2014, DEHA and Solvent Red 23 were added to the Cosmetic Ingredient Hotlist. Prior to being formally added, proposed changes to the Cosmetic Ingredient Hotlist were posted for consultation on Health Canada’s website for a 60-day comment period. Three comments were provided with respect to the addition of DEHA and four comments were received with respect to the addition of Solvent Red 23 to the Cosmetic Ingredient Hotlist. None of the comments received impacted the course of action.
Developmental toxicity is the critical health effect from exposure to DEHA. As the margin between estimated exposures to DEHA and the level at which DEHA is harmful to human health is inadequate, it is concluded that DEHA is harmful to human health and meets the criterion set out in paragraph 64(c) of CEPA.
Based on their physical and chemical properties, all components of PREPOD evaluated are expected to persist in water, soil and sediment, but not in air. Moreover, one component, DIPDMA has been identified as having the potential to accumulate in organisms and may increase in concentration within food chains. In addition, it is found that at least two components of PREPOD are potentially harmful and present a risk to aquatic organisms. Given these concerns, it is concluded that PREPOD meets the criterion set out in paragraph 64(a) of CEPA.
Exposure of the general population to Solvent Red 23 can occur through the use of certain personal care products. The potential breakdown product of Solvent Red 23 has been classified as a carcinogen by the IARC and the analogue, Sudan I, has also been classified as a mutagen and carcinogen by the European Commission. Given these concerns, it is concluded that Solvent Red 23 is harmful to human health and meets the criterion set out in paragraph 64(c) of CEPA.
One of the following three measures can be taken after a screening assessment is conducted under CEPA:
- taking no further action (under the legislative authority of CEPA) with respect to the substance;
- adding the substance to the Priority Substances List for further assessment, unless the substance is already on the list; or
- recommending that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA, and where applicable, recommending the implementation of virtual elimination.
Given the concerns identified above and the screening assessment conclusions, the addition of DEHA, PREPOD, and Solvent Red 23 to Schedule 1 of CEPA is therefore the preferred option among the three alternatives.
The addition of the three substances to Schedule 1 of CEPA does not impose any incremental impacts (benefits or costs) on the public or on industry, since there are no compliance requirements. Accordingly, there is no compliance or administrative burden on small businesses or businesses in general.
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed. See http://www.chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php.
Implementation, enforcement and service standards
The Order adds DEHA, PREPOD, and Solvent Red 23 to Schedule 1 of CEPA, thereby allowing for developing and publishing regulations or instruments under CEPA if such actions are deemed necessary. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary for this Order.
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-938-3232 (outside of Canada)
Risk Management Bureau
Department of Health
- Footnote a
S.C. 2004, c. 15, s. 31
- Footnote b
S.C. 1999, c. 33
- Footnote c
S.C. 1999, c. 33
- Footnote 1
S.C. 1999, c. 33
- Footnote 2
The Challenge Advisory Panel, made up of experts from fields such as chemical policy and production, economics and environmental health, was formed to provide advice to the Government on the application of precaution and weight of evidence to the screening assessment of these substances.
- Footnote 3
More information on risk management approaches for DEHA, PREPOD, or Solvent Red 23 can be found at http://www.ec.gc.ca/ese-ees/2AC65068-8621-4EAD-A161-06FE3C68645D/batch11_103-23-1_rm_en.pdf; http://www.ec.gc.ca/ese-ees/987ED817-89D0-43E8-B048-4FD074210138/batch11_68412-48-6_rm_en.pdf; and http://www.ec.gc.ca/ese-ees/ADAC50A6-9B1A-4DBF-A0D4-1907890324FC/batch6_85-86-9_rm_en.pdf, respectively.
- Footnote 4
The proposed Order can be found at http://canadagazette.gc.ca/rp-pr/p1/2011/2011-10-15/pdf/g1-14542.pdf.
- Footnote 5
The documents can be found at http://www.ec.gc.ca/toxiques-toxics/default.asp?lang=En&n=A613CFD7-1, http://www.ec.gc.ca/toxiques-toxics/default.asp?lang=En&n=FAD3E8F0-1, http://www.ec.gc.ca/toxiques-toxics/default.asp?lang=En&n=C763B7F1-1.
- Footnote 6
For the purpose of this document, a personal care product is defined as a substance or mixture of substances which is generally recognized by the public for use in daily cleansing or grooming. Depending on how the product is represented for sale and its composition, personal care products may fall into one of three regulatory categories in Canada: cosmetics, non-prescription drugs or natural health products.
- Footnote 7
The Ecological State of the Science Report can be found at http://www.ec.gc.ca/ese-ees/FFEBC5CE-94F1-4BBC87A4-F0D81E546C9D/SoS_Batch%2011%20-%20103-23-1_EN. pdf.
- Footnote 8
More information on the Canadian Total Diet Study (TDS) can be found at http://www.hc-sc.gc.ca/fn-an/surveill/total-diet/index-eng.php.
- Footnote 9
Results from the targeted surveys were published in the Journal of Food Protection found at http://www.ncbi.nlm.nih.gov/pubmed/24215707 and http://www.ncbi.nlm.nih.gov/pubmed/24680073.
- Footnote 10
Five components of PREPOD were identified as representative for the purposes of the screening assessment.
- Footnote 11
The EFSA considered a potential concern for Solvent Red 23 due to its structural similarity to the carcinogenic analogue Sudan I and its potential to form similar metabolites.
- Footnote 12
The two NGOs submitted a joint submission.
- Footnote 13
The industry organization referred to the “notifications under the Cosmetic Regulations” as the Cosmetic Notification System (CNS).
- Footnote 14
Another substance, BENPAT, was also included in the same proposed Order.
- Footnote 15
The Ministers’ response to the Notice of Objection can be found at http://ec.gc.ca/lcpe-cepa/6E52AE02-5E01-48B0-86DE-0C366ACC863F/DEHA_NoO_Min_Response.pdf.
- Footnote 16
However, new monitoring results were obtained as part of additional sampling performed for or by the Department of the Environment after the publication of the final screening assessment. An analysis of this new data has been documented in an Ecological State of the Science Report. The sampling results indicate that there are no longer ecological concerns for DEHA.
- Footnote 17
The Risk Management Update can be found at http://www.ec.gc.ca/toxiques-toxics/default.asp?lang=En&n=A613CFD7-1.