Performance measurement evaluation for risk management of bis(2-ethylhexyl) phthalate (DEHP), health component

Executive summary

This report measures and evaluates the performance of risk management tools taken to help protect Canadians from bis(2-ethylhexyl) phthalate (DEHP) exposures that were found to pose a risk to human health. DEHP was selected for performance measurement evaluation as the substance met several readiness criteria that are outlined in the Performance Measurement Evaluation Strategy. This includes having risk management tools implemented for a sufficient amount of time to measure impact, key performance indicator data, and baseline information against which to gauge the key performance indicators.

DEHP was first assessed by the Government of Canada in 1994, where it was concluded that DEHP may enter the environment in a quantity or concentration or under conditions that may constitute a danger in Canada to human health. Risk management tools (Cosmetic Ingredient Hotlist [2009], the Phthalates Regulations [2011], reporting of DEHP content under the Medical Devices Regulations [2008], and provisions under the Food and Drugs Act [1985]) were established to help reduce DEHP exposures to the general population of Canada in these products.

Overall, risk management tools are meeting their intended goals. Biomonitoring data collected from three cycles (2007 to 2017) of the Canadian Health Measures Survey (CHMS) demonstrates that Canadians’ exposure to DEHP has progressively decreased since risk management tools were implemented.

1. About performance measurement

The Government of Canada is conducting performance measurement evaluation on the risk management of toxic substances to ascertain whether actions taken to help protect Canadians and their environment are meaningful and effective over time. Performance measurement evaluation will help determine how well the risk management actions have reduced or eliminated the risk(s) associated with each toxic substance. Adjustments may be required when risk management actions and tools are not achieving the intended outcome.

The Government of Canada establishes goals in order to help protect Canadians and their environment from risks posed by toxic substances. The Government attempts to achieve these goals by setting human health, environmental and risk management objectives, and then developing a strategy to meet those objectives. Performance measurement assesses how risk management actions contribute to protecting Canadians and their environment from toxic substances and identifies any areas of improvement that should be addressed moving forward.

2. Background

Bis(2-ethylhexyl) phthalate (DEHP), CAS RN 117-81-7, is a medium chain phthalate substance. DEHP was among the first substances to be identified by the Government of Canada as part of the Priority Substances List (PSL) published in 1989, which pre-dates the Chemicals Management Plan (CMP). The 1994 Priority Substances List Assessment Report on DEHP established that DEHP met the criterion in paragraph 11(c) of the Canadian Environmental Protection Act, 1988 (Canada, 1988), where it was concluded that DEHP may enter the environment in a quantity or concentration or under conditions that may constitute a danger in Canada to human health (Canada, 1994).

DEHP is a commonly used plasticizer in polyvinyl chloride (PVC) polymers, giving PVC flexibility and strength (Graham, 1973; Frederiksen et al., 2007). DEHP is lipophilic, meaning the substance dissolves readily in fats. DEHP is not chemically bound to PVC and can be released from PVC when in contact with some foods or bodily fluids (e.g., blood, saliva) (Rodricks & Turnbull, 1984; Page & Lacroix, 1995; Babich et al., 2004; Cao, 2010).

Globally, the general population could be exposed to DEHP through food, dust, indoor air, contact with plastic items available to consumers, such as mouthing of plastic toys and children’s articles (Koch et al., 2004); when bodily fluids come into contact with medical devices (Canada, 2020a); and the use of certain cosmetic products (Koniecki et al., 2011; Guo & Kannan, 2013; Guo et al., 2013). A study conducted in France found that DEHP was detected more frequently in children who used cosmetics (lipsticks, make-up pencils, foundation, nail polish, etc.) and hair products (gel, foams, hairsprays, etc.) (Esteban, 2019). Infants may have additional sources of exposure to DEHP from breast milk and through the use of infant and child care articles such as diaper change pads (US CPSC CHAP, 2014).

DEHP was selected for performance measurement evaluation as it met several readiness criteria that are outlined in the Performance Measurement Evaluation Strategy. The criteria include that risk management tools have been implemented and in place for a sufficient amount of time for impacts to be measureable; key performance indicator data is available and baseline data exists against which the key performance indicators can be evaluated. This performance measurement evaluation considers the effectiveness of the risk management tools implemented subsequent to the PSL assessment to address the human health concerns associated with certain DEHP exposures.

3. Risk Management actions and information gathering

3.1 Human health related risk management tools

3.1.1 The Cosmetic Ingredient Hotlist (the Hotlist)

The Government of Canada took action to help prevent the deliberate use of DEHP in cosmetic products by describing the substance as a prohibited ingredient on Health Canada’s Cosmetic Ingredient Hotlist in 2009. Health Canada uses this administrative tool to inform manufacturers and others that a cosmetic containing DEHP at any concentration may contravene section 16 of the Food and Drugs Act (FDA). Compliance with section 16 of the FDA is monitored, in part, through the mandatory notification provisions of section 30 of the Cosmetic Regulations, which requires that all manufacturers and importers provide a list of the cosmetic’s ingredients to Health Canada (Canada, 2019). Similar regulations exist in the European Union (EU No 1223/2009 on cosmetic products [2009]); and Australia (Competition and Consumer Act [2010]).

3.1.2 Phthalates Regulations

Health Canada implemented the Phthalates Regulations under the Canada Consumer Product Safety Act to limit the concentration of six phthalates, including DEHP, in the soft vinyl used in toys and child care articles to 1,000 mg/kg, or <0.1% by weight (w/w). The regulations apply to child care articles (products intended for children under the age of four years old, including products intended for relaxation, feeding, hygiene, sleep and teething) and toys (products used for learning or play that are intended for use by children under the age of fourteen) (Canada, 2016). These regulations were published in December 2010 and came into force in June 2011. Similar regulations exist in the United States (Consumer Product Safety Improvement Act [2008] 16 CFR Part 1307); the European Union (Phthalates Directive [2005] and Entry 51 in Annex XVII REACH); and Australia (Competition and Consumer Act [2010]).

3.1.3 Food and Drugs Act (FDA)

The safety of chemicals, including DEHP, used in food packaging materials is subject to section 4(1)(a) of the Food and Drugs Act and Division 23 of the Food and Drug Regulations. Food packaging assessments of DEHP, as a component in food packaging materials, have determined that dietary exposures do not represent a risk to human health. In Canada, food additives are regulated by both the Food and Drug Regulations (Division 16) and Marketing Authorizations (MAs), issued by the Minister of Health, that incorporate by reference the Lists of Permitted Food Additives. DEHP is not permitted to be used as a food additive in Canada. Regulations exist related to DEHP in food packaging adhesives and coatings in the United States (US Code of Federal Regulations, 2011); and the European Union (EU, 2011).

DEHP (and other phthalates) in food continue to be measured as part of Health Canada's Total Diet Study (TDS) and the Canadian Food Inspection Agency (CFIA)’s targeted surveys to ensure that exposure from food remains within acceptable levels. If an elevated concentration of a contaminant is found, Health Canada conducts a human health risk assessment on a case-by-case basis. If a potential safety concern is identified, appropriate risk management actions are taken, such as product recalls or corrective actions at the manufacturing level.

The CFIA works closely with Health Canada, as well as international food safety partners, to help ensure the chemical safety of domestic and imported foods that are sold in Canada. If a safety concern is identified, risk management actions would be taken such as removal of the product from the market or corrective action by the food manufacturer.

3.2. Information gathering actions related to DEHP

3.2.1 Reporting on DEHP content in medical devices

Medical devices must be licenced in Canada and are regulated under the FDA through the Medical Devices Regulations. Health Canada does not typically assess the safety of individual components of a medical device, but of the whole device as part of biocompatibility testing. For a medical device identified as potentially containing DEHP, the DEHP may only be found in a small component part. Devices are licensed based on a demonstration of the benefits (compared to risks) from an assessment of the safety and effectiveness of the whole system, not its components when used as indicated. 

The medical device licence application process was modified in 2008, requiring manufacturers to indicate when a medical device imported or sold in Canada may contain DEHP at a concentration of ≥ 0.1% by weight (w/w) (Canada, 2008). Reporting on DEHP is required in the initial application, when a device is amended, and in the annual licence renewal. It should be noted that there is no requirement to lower the DEHP content in a medical device.

3.2.2 Section 71 notices of CEPA

Under CEPA 1999, mandatory surveys, as set out in section 71, are conducted to collect information used to inform decision-making for the risk management of implicated substances from industry and other stakeholders on industrial and commercial processes. This includes informing the performance of existing risk management instruments; identifying new sources of exposure that may require risk management; and informing the development and implementation of new risk management tools. DEHP was identified as a substance that required additional information on product and industrial processes. To address this, two information gathering notices were issued (Canada, 2013a & 2017) requiring manufacturers, importers and users to disclose names, product types and concentration ranges of the products that contain DEHP.

4. Performance measurement indicators

4.1 Biomonitoring

Biomonitoring is the measurement of a chemical substance or the products that are created when a substance is broken down (metabolized) in humans. The levels or concentrations are typically sampled from blood and/or urine, while other tissues and fluids such as hair, nails and breast milk can also be sampled. The measurements indicate how much of a chemical is present in the human body. The Canadian Health Measures Survey is a national direct health measures survey conducted by Statistics Canada. Through the CHMS, Health Canada measured several phthalate metabolites (substances resulting from the breakdown of phthalates in the body) in the urine of CHMS participants aged 6 to 49 years in cycle 1 (2007–2009), and in participants aged 3 to 79 years in cycle 2 (2009–2011) and cycle 5 (2016–2017).

Biomonitoring data is the primary performance indicator of DEHP exposure in the Canadian population and was used to determine whether the risk management tools have met their objectives to reduce exposure from products used by consumers (e.g., toys, child care products, medical devices and food). An advantage of using biomonitoring data is that it indirectly accounts for all possible sources of exposure of Canadians to DEHP, and is the most relevant indicator for measuring trends in human exposures over time.

4.2 Presence of DEHP in cosmetics

Section 30 of the Cosmetic Regulations requires that manufacturers and importers notify Health Canada within 10 days after they first sell a cosmetic in Canada. The notification includes product details and a list of the product ingredients. Under section 31 of the Cosmetic Regulations, manufacturers or importers must amend the cosmetic notification (i.e., if ingredients or concentrations change, this information needs to be updated on the notification) whenever a change affecting the information on a cosmetic notification is made. Data from notifications received by Health Canada and cosmetic product testing for DEHP by Health Canada was used to assess the effectiveness of adding DEHP to the prohibition section of the Hotlist and the performance of the Hotlist as a risk management tool.  

4.3 Presence of DEHP in consumer products

Health Canada administers and enforces the Canada Consumer Product Safety Act and regulations made under the Act. Health Canada conducted market surveillance of DEHP content in PVC based toys and child care articles prior to the Phthalates Regulations coming into force to create a product baseline. Cyclical Enforcement projects are carried out to verify compliance with various regulations once in force, including the Phthalates Regulations for toys and child care articles, depending on the product risk and compliance history. The performance indicator related to consumer product safety is the percentage of toys and child care articles that contain greater than 1,000 mg/kg or 0.1% w/w DEHP before and after the coming into force of the Phthalates Regulations. This data was used to determine the effectiveness of the regulation in helping to reduce potential DEHP exposure in children.

4.4 Presence of DEHP in food

DEHP (and other phthalates) in food continue to be measured as part of Health Canada’s TDS and CFIA targeted surveys. DEHP may be found at low levels in foods (Canada, 2020a). For the general population in Canada, food and beverages are the primary source of exposure to DEHP compared to other sources of exposure considered in the 2020 screening assessment (Canada, 2020a). A compilation of data on DEHP levels in various foods sold in Canada, as well as information on dietary intake of DEHP, was used to inform whether this source of exposure has changed over time.

4.5 Presence of DEHP in medical devices

The tracking of medical devices that have been licensed for use in Canada that may contain ≥0.1% DEHP shows changes since the reporting requirement first took effect. The annual number of licensed medical devices that may contain ≥0.1% DEHP w/w, and the number of devices that have been removed from the market (reformulated without DEHP) was used to observe changes subsequent to the reporting requirement that was implemented in 2008.

4.6. Section 71 survey data

CEPA section 71 mandatory surveys were conducted in 2013 for information on the 2012 reporting year (Canada, 2013a and Canada, 2013b) and in 2017 for the reporting years 2015 or 2016 (Canada, 2017) for several substances, including DEHP. The two surveys had differing reporting scopes, objectives, thresholds and types of reportable manufactured and imported items; therefore, the survey results cannot be compared directly. The section 71 survey results provide a point in time snapshot on the types of products in commerce that used DEHP and the quantity of DEHP that was used in each survey year.

5. Key performance indicator data

It should be noted that the estimated human exposures to DEHP from the 1994 PSL assessment cannot be reliably compared to those presented in the 2020 Screening Assessment Report for the Phthalate Substance Grouping for a number of reasons, including advances in analytical technology; updated exposure factors for human health risk assessments and data from dust or biomonitoring were not available in the PSL assessment.

5.1 Biomonitoring

Monoester phthalate metabolites were measured in the urine of CHMS participants aged 6 to 49 years in cycle 1 (2007–2009) (Health Canada, 2010), 3 to 79 years in cycle 2 (2009–2011) (Health Canada, 2013), and 3 to 79 years in cycle 5 (2016–2017) (Health Canada, 2019a). Three of the metabolites, mono(2-ethylhexyl) phthalate (MEHP), mono(2-ethyl-5-oxohexyl) phthalate (MEOHP), and mono(2-ethyl-5-hydroxyhexyl) phthalate (MEHHP), that were measured are biomarkers of DEHP exposure. Certain phthalate metabolites were detected in over 95% of the population, which demonstrates the widespread nature of phthalate exposure among Canadians. It should be noted that detecting phthalate metabolites in urine is an indicator of exposure to phthalates and does not necessarily mean that an adverse health effect will occur.

Biomonitoring data from the U.S. National Health and Nutrition Examination Survey (NHANES) provides a North American context and a historical perspective of DEHP exposure (Figure 1) (CDC, 2014). The interconnectedness of the U.S. and Canadian economies, the shared border and the similar timing of regulatory uptake support the idea that exposure to DEHP would be similar between countries prior to 2008, when U.S. risk management tools came into force.

Figure 1. Urinary DEHP concentrations in the Canadian and U.S. populations aged 6 to 79. Geometric mean concentrations of the U.S. population for 2001–2016 from the U.S. NHANES and of the Canadian population for 2009–2011 and 2016–2017 from the CHMS. DEHP was calculated as the sum of DEHP metabolites (MEHP, MEHHP, and MEOHP).

The geometric mean concentration of a chemical represents the average concentration of this chemical in a measured population. The geometric mean is less influenced by a small number of high values, which are common when measuring chemicals in blood or urine. The vertical lines in the figure denote the 95% confidence intervals of the geometric mean values. There is a 95% chance that the range of values represented by the vertical lines contain the actual geometric mean of the population. Generally, data are more variable (and confidence intervals are wider) when the sample size is smaller.

Figure 1 shows that concentrations of DEHP were lower in the U.S. and Canadian populations from 2009 to 2017 compared to the U.S. population from 2001 to 2008, prior to risk management tool implementation. Levels of DEHP were similar in the U.S. and Canadian populations in 2009–2011 and 2015–2017 and, more importantly, both populations showed a reduction in DEHP concentrations between those time periods.

Biomonitoring data also allows the comparison of DEHP exposures between different subgroups of the population, such as that of the First Nation on-reserve population (Figure 2).

Figure 2. DEHP metabolite (MEHP, MEOHP and MEHHP) concentrations in the general population and the First Nation on-reserve population in Canada. The vertical lines denote the 95% confidence intervals.

The geometric mean concentrations are shown in Figure 2 for the First Nation on-reserve population aged 20 and older from the First Nations Biomonitoring Initiative (2011) (AFN, 2013) and for the Canadian population aged 20 to 79 from the CHMS cycle 2 (2009–2011). Concentrations of DEHP metabolites were similar for First Nations in 2011 and the general population in 2009–2011.

Figure 3. Urinary DEHP concentrations in the Canadian population aged 6 to 49 from the CHMS cycle 1 (2007–2009), cycle 2 (2009–2011), and cycle 5 (2016–2017). Figure 3A shows the geometric mean and 95th percentile concentrations, and the biomonitoring equivalent for DEHP; Figure 3B shows the geometric mean concentrations only. The vertical lines denote the 95% confidence intervals. 

The geometric mean and 95th percentile concentrations of the Canadian population aged 6 to 49 are presented in Figure 3A, with DEHP calculated as the sum of DEHP metabolites (MEHP, MEHHP, and MEOHP). The biomonitoring equivalent (BE) for DEHP of 610 µg/L (Aylward et al., 2009) is based on Health Canada’s 1994 tolerable daily intake (TDI) of 44 µg/kg bodyweight/day. The BE is an estimate of the concentration of a chemical in a biological medium (e.g., blood or urine) that is consistent with an exposure guidance value. The guidance value is the maximum amount of a chemical that can be absorbed (e.g., ingested or inhaled) on a daily basis over a lifetime without increased risk of adverse health effects.

Biomonitoring data indicate that DEHP concentrations, as measured by the sum of DEHP metabolites, in Canadian’s urine are far below the BE threshold. These results show that, based on our current understanding, these concentrations are not of concern for population health. Exposure to DEHP in the Canadian population has decreased between 2007–2009 and 2016–2017, following implementation of risk management tools (Figure 3). This is especially true among the most exposed Canadians, those at the 95th percentile (Figure 3A: 95% of the population is expected to have concentrations below the 95th percentile, and 5% above the 95th percentile). Figure 3B shows the extent of change in DEHP exposure in the average DEHP concentration for the population, with the most noticeable declines occurring after the risk management tools were implemented.

Figure 4. Urinary DEHP concentrations in the Canadian population from the CHMS cycle 1 (2007–2009), cycle 2 (2009–2011), and cycle 5 (2016–2017) by age group. The geometric mean concentrations are shown for the Canadian population aged 3 to 5, 6 to 11, 12 to 19, 20 to 39, 40 to 59, and 60 to 79 for 2007 to 2009, 2009 to 2011, and 2016 to 2017. DEHP was calculated as the sum of DEHP metabolites (MEHP, MEHHP, and MEOHP). Concentrations of these metabolites were measured in 6 to 49 year olds in 2007 to 2009, and therefore were not available (NA) for individuals aged 3 to 5, 40 to 59, or 60 to 79 for that period of time. The vertical lines denote the 95% confidence intervals. 

Exposure to DEHP in the Canadian population aged 6-11, 12-19, and 20-39 has decreased between 2007–2009 and 2016–2017. DEHP exposure has also decreased between 2009–2011 and 2016–2017 in the Canadian population in all age groups represented in each cycle. Figure 4 shows the younger age groups (ages 3 to 5 and 6 to 11) have higher exposure to DEHP compared to the older age groups (12 years and older). The data also demonstrates that all age groups have concentrations well below the BE of 610 µg/L.

5.2 Cosmetics

No cosmetic notifications were received indicating DEHP as an ingredient in cosmetics prior to it being described as a prohibited substance on the Hotlist in 2009. One cosmetic notification indicating DEHP as an ingredient was received in 2010 for a fragrance. Health Canada informed the notifying company that DEHP is described as a prohibited ingredient on the Hotlist and requested confirmation that the product was either no longer sold or would be reformulated. The notifying company confirmed the product was no longer sold in Canada (Health Canada, 2019b).

A Health Canada study published in 2011 tested phthalate concentrations, including DEHP, in cosmetics that were available in Canada between December 2007 and April 2008 (Koniecki et al., 2011). The data published in this study provides a baseline of the cosmetics market before DEHP was added to the Hotlist. Table 1 demonstrates potential sources of DEHP exposure through cosmetic products found in Canada at that time.

ND= non-detectable

Koniecki et al., (2011) also found that DEHP detection frequency was relatively low compared to other phthalates analysed in cosmetic products obtained from the Canadian marketplace (1% to 5%). Three cosmetic products were found to have elevated DEHP concentrations (521 and 382 μg/g in two fragrance products, and 1045 μg/g in a nail polish). It should be noted that these products were available in Canada before DEHP was added to the Hotlist. The cosmetic notification received in 2010 was unrelated to the fragrances tested in Koniecki et al., (2011).

5.3 Consumer products

Results from Health Canada’s Canadian retail market surveillance and Cyclical Enforcement projects provide information on toys and child care articles that contain greater than 1,000 mg/kg (or ≥0.1% w/w) DEHP. Table 2 shows the type of products each market surveillance and Cyclical Enforcement project considered.

^a The year represents the date of product testing, not the date of publication.

^b A product included 3 pieces, two were tested, contained >0.1% DEHP and included as individual products sampled.

Identified products found to contain vinyl/PVC were tested for DEHP, while identified products that did not contain vinyl/PVC were not tested for DEHP as they are beyond the scope of the Phthalates Regulations.

Figure 5. The percentage of tested toys and child care articles that contained less than 0.1% DEHP w/w (yellow) and greater than 0.1% w/w DEHP (blue), with the percentage value provided above each bar. 

Figure 5 shows a larger proportion (46% in 2007, and 32% in 2008) of toys and child care articles were available for sale in Canada that contained >0.1% w/w DEHP before the implementation of the Phthalates Regulations in 2011. The Cyclical Enforcement projects conducted between 2012 and 2015 showed all of the products tested, which were items intended for feeding or that could be put in a child’s mouth, were in compliance with the Phthalates Regulations. The 2011 child care articles and toys project results showed 89% product compliance, which means that 89% of products tested that contained PVC had less than 0.1% DEHP. The 2017 toys project results showed 85% of the products tested contained less than 0.1% w/w DEHP. The toys that were found to contain greater than 0.1% DEHP in 2011 and 2017 were removed from commerce through product recalls or stop sale and destruction at the point of sale.

Compliance with the Phthalates Regulations appears to have improved over time, with only 3 toys found to contain >0.1% w/w DEHP in 2017, compared with 7 in the 2011 project. Overall, the DEHP content of toys and child care articles has decreased since the Phthalates Regulations came into force.

5.4 Food

Foods analyzed for DEHP in both the TDS and by the CFIA surveys were sampled from retail locations within Canada and included both domestic and imported food products.  Based on the limited dataset and differences in analytical methods employed, clear trends in the DEHP concentrations in all food cannot be observed. However, the DEHP levels in some commonly consumed foods sold in Canada have decreased over time. Examples of foods demonstrating decreasing DEHP concentrations since 1986, the first year that DEHP was measured in the TDS, are presented in Figure 6, using data from food composite samples measured in the 1986, 1996, and 2013 Canadian TDS.

Figure 6^{Footnote 1}. DEHP concentrations in selected Canadian Total Diet Study food composite samples^{Footnote 2} and corresponding food samples from CFIA targeted surveys^{Footnote 3}.

Figure 6 demonstrates decreasing levels of DEHP in selected foods included in the TDS since 1986. Due to its lipophilic nature, DEHP was historically observed at some of the highest concentrations in butter and cheese (Figure 6), and these foods showed the most noticeable decreases in DEHP concentrations which likely occurred within the timeframe that risk management tools for other products were implemented.

5.5 Medical devices

The number of medical devices that may contain ≥0.1% DEHP fluctuates based on the number of licences applied for or renewed, compared to the number of medical devices that no longer contain ≥0.1% DEHP or are no longer in use.

Figure 7. The number of new and amended medical device licences (blue) and the number of devices that were removed (orange) from use in Canada that contained ≥0.1% DEHP from 2008 to 2019.

The number of new and amended medical devices reported to contain ≥0.1% DEHP by weight varies, with a peak number of devices that may contain ≥0.1% DEHP licensed in 2011. The number of devices reported to contain ≥0.1% DEHP withdrawn from the Canadian marketplace has gradually increased since 2009, and the number of new and amended medical devices which may contain ≥0.1% DEHP declined from 2012 to 2018. There is an increase in devices reported to contain ≥0.1% DEHP available in Canada in 2019 as well as a decline in withdrawn medical devices that may contain DEHP ≥0.1%.

5.6 Section 71 survey data

The total quantity of DEHP used in product manufacturing in Canada was 2,009 tonnes reported for 2012 by 22 companies and 944 tonnes reported for 2016 by 11 companies (Table 3). 

Responses from the 2013 survey indicated toys, playground, and sporting equipment contained DEHP. There were no items reported as cosmetic packaging that contained >0.001% DEHP in the 2013 survey. Seven (7) categories of imported products containing DEHP were reported as intended for use by or for children under the age of six years. One of the seven categories was toys, playground and sporting equipment, which was subject to the Phthalates Regulations at that time, and included items with DEHP concentrations above 0.1%.

Both surveys indicated that DEHP was used in pharmaceutical and medical device manufacturing; food packaging; clothing and footwear; building materials; electronics and household appliances, which were all permitted uses of DEHP at the time of reporting.

6. Performance measurement evaluation

6.1 Biomonitoring

Overall, DEHP exposure in Canada has declined following the implementation of risk management tools starting in 2008 (Figures 1 and 3). First Nations and the general population showed similar exposure to DEHP based on the concentration of metabolites measured in 2011 and 2009-2011 respectively. Biomonitoring data for Canadians shows that DEHP levels are far below the biomonitoring equivalent threshold of 610 µg/L, as the concentrations of DEHP metabolites in urine have declined between 2007–2009 and 2016–2017 (Figure 3A). The DEHP concentrations in every age group represented in Figure 4 have decreased between 2007–2009 and 2016–2017, which corresponds to the period of time before and after risk management tools took effect. The levels of exposure observed in the younger segments of the population remain below levels of concern and show a notable decline between 2009–2011 and 2016–2017. This decline in exposure may be attributed to the Phthalates Regulationswhich specifically addressed the risk for DEHP exposure from mouthing and contact of soft vinyl toys and child care articles by children aged 14 and under.

6.2 Cosmetics

One cosmetic notification that identified DEHP as an ingredient was received in 2010 and it was confirmed that the product did not enter the Canadian marketplace. This demonstrates that the addition of DEHP to the Hotlist has limited DEHP exposure by helping to prevent deliberate use of DEHP in cosmetic products available in the Canadian marketplace.

6.3 Consumer products

There has been a decline in the number of toys and child care articles that contain greater than 0.1% w/w DEHP available for sale in Canada since the Phthalates Regulations came into force in 2011 (Figure 5). Less than 15% of toys and child care articles were found to have greater than 0.1% w/w DEHP subsequent to the Phthalates Regulations coming into force in 2011. The compliance and enforcement mechanisms were effective in promptly removing non-compliant toys and child care articles from the marketplace through product recalls and stop sales. The compliance rate for DEHP content in toys that retail in Canada has decreased by 4% between the 2011 and 2017 Cyclical Enforcement projects. The 2017 Cyclical Enforcement project found 3 out of 17 toys that were tested for DEHP exceeded the concentration set out in the Phthalates Regulations, showing that non-compliance still occurs to some degree. 

Overall, there has been good product compliance with the DEHP concentration limit set out in the Phthalates Regulations in toys and child care articles since coming into force. This finding shows that Canadian children are being protected from DEHP exposure from toys and child care articles as a result of the Phthalates Regulations, and measures are in place to remove non-compliant toys found in the Canadian marketplace.  

6.4 Food

Canadians’ total dietary exposure to DEHP has decreased over time based on the decreasing levels of DEHP in certain foods included in the TDS that have been observed since 1986 (Figure 6). Dietary exposure to DEHP was estimated in the Phthalate Substance Grouping screening assessment (Canada, 2020a) based on the 2013 TDS data. While these estimates likely overestimate the exposure of Canadians to DEHP from foods, they demonstrate that exposure to DEHP has decreased by at least 2-fold relative to dietary exposure estimates presented in the 1994 assessment (Canada, 1994).

6.5 Medical devices

The number of new or amended medical devices potentially containing ≥0.1% DEHP by weight that are available in Canada has gradually declined since DEHP information reporting began in 2008 to 2018 (Figure 7). It should be noted that the uptake of either DEHP or non-DEHP is a practice of medicine choice, and beyond the scope of this document.

7. Conclusion

The Government of Canada took action to help prevent Canadians’ exposure to DEHP by adding DEHP to the Cosmetic Ingredient Hotlist, introducing the Phthalates Regulations, continuing the oversight of potentially harmful chemicals in food and food packaging in accordance with the Food and Drugs Act and regulations, and by introducing the DEHP information reporting requirement for medical device licensing under the Medical Devices Regulations. Biomonitoring data shows that DEHP concentrations in Canadians’ urine, as measured by the sum of DEHP metabolites, are far below the biomonitoring equivalent threshold based on Health Canada’s tolerable daily intake. Biomonitoring data illustrates that Canadians’ exposure to DEHP has decreased since risk management tools were implemented.

Continued inclusion of DEHP metabolites in the Canadian Health Measures Survey is recommended to verify that the risk management tools continue to be effective in reducing Canadians’ exposure to DEHP.  Ongoing monitoring of the Phthalates Regulations could help protected Canadian infants and children from DEHP exposure, as the younger segments of the population experienced greater exposure to DEHP than adults and toys continue to be available for sale in Canada that exceed the regulated concentration.  Ongoing collection of information on DEHP concentrations in medical devices could be used to further understand the changing trends in the number of licenced medical devices potentially containing DEHP in Canada.

8. References

Agency for Toxic Substances and Disease Registry (ATSDR). (2002). Toxicological profile for Di(2-ethylhexyl)phthalate (DEHP). Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service.

Assembly of First Nations (AFN). (2013). First Nations Biomonitoring Initiative; National results (2011) [PDF]. 

Australia. (2011). Competition and Consumer Act 2010 -Consumer Protection Notice No. 11 of 2011 - Permanent ban on children's products containing more than 1% diethylhexyl phthalate (DEHP).

Aylward, L. L., Hays, S. M., Gagné, M., & Krishnan, K. (2009). Derivation of Biomonitoring Equivalents for di (2-ethylhexyl) phthalate (CAS No. 117-81-7). Regulatory Toxicology and Pharmacology. 55(3), 249-258.

Babich MA, Chen SB, Greene MA, Kiss CT, Porter WK, Smith TP, Wind ML, Zamula WW. (2004). Risk assessment of oral exposure to diisononyl phthalate from children’s products. Requl Toxicol Pharmacol. 40:151–67.

Canada. (1988). Canadian Environmental Protection Act (c. 16, R.S.C. 1985 (4th Supp.)

Canada. (1994). Priority Substance List (PSL) Assessment: Bis(2-ethylhexyl) phthalate. Cat. No:En40-215/37E. Conducted under the Canadian Environmental Protection Act. 

Canada. (1999). Canadian Environmental Protection Act, 1999. S.C., 1999, c. 33. Part III, vol. 22, no. 3 [PDF].

Canada. (2008). Bis(2-ethyhexyl) phthalate (DEHP) and Bisphenol A (BPA) - Questions and Answers - Medical Devices - Health Canada. August 15, 2008.

Canada. (2013a). Section 71. CEPA 1999 section 71 Notice with respect to certain phthalate substances. Mandatory survey - section 71 notice. Canada Gazette, Part I: Vol.147, No. 28 - July 13, 2013.

Canada. (2013b). Summary of information received in response to the data gathering initiative on certain phthalate substances (2013).

Canada. (2016). Phthalates Regulations. SOR/2016-188.

Canada. (2017). Section 71. CEPA 1999 Section 71 Notice to provide information for the risk management of certain substances. Mandatory survey - section 71 notice. Canada Gazette, Part I: Vol. 151, No. 13 - April 1, 2017.

Canada. (2019). Cosmetic Ingredient Hotlist: Prohibited and Restricted Ingredients. Health Canada.

Canada (2020a). Screening Assessment Phthalate Substance Grouping. December 2020.  

Canada (2020b). Risk management approach for 1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester (DEHP). December 2020.

Cao X. (2010). Phthalate esters in foods: sources, occurrence, and analytical methods. Compr Rev Food Sci Food Saf. 9:21–43.

Cao XL, Zhao W, Dabeka R. (2015). Di-(2-ethylhexyl) adipate and 20 phthalates in composite food samples from the 2013 Canadian Total Diet Study. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 32(11):1893-901. 

CDC. (2014). Centers for Disease Control and Prevention. National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey Data, 2001 - 2010. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

Esteban (2019). Imprégnation de la population française par les phtalates [PDF]. Programme national de biosurveillance, Esteban 2014-2016. Saint-Maurice : Santé publique France, septembre 2019. 51 p. (available in French only)

EU. (2005). Directive 2005/84/EC of 14 December 2005 amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles).

EU. (2009). Commission Regulation (EU) No 1223/2009 of 30 November 2009 on cosmetic products (Text with EEA relevance) OJ L 342, 22.12.2009, p. 59–209.

EU. (2011). Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. OJ L 12, 15.1.2011, p. 1–89.  

Frederiksen H, Skakkebaek NE, Andersson AM. (2007). Metabolism of phthalates in humans. Mol Nutr Food Res. 51:899–911.

Graham PR. (1973). Phthalate ester plasticizers – why and how they are used. Environ Health Perspect. 3:3–12.

Guo Y, and Kannan K. (2013). A survey of phthalates and parabens in personal care products from the United States and its implications for human exposure. Environ Sci Technol. 47:14442-14449.

Guo Y, Wang L, and Kannan K. (2013). Phthalates and parabens in personal care products from China: concentrations and human exposure. Arch Environ Contam Toxicol. 66(1):113-119. 

Health Canada (2007). Market Evaluation: Analysis of phthalate content in children's toys. Consumer Product Safety Bureau. Project #850950.

Health Canada (2009). Survey-determination of phthalate in various children's toys. Consumer Product Safety Bureau. Project #2008-1090.

Health Canada (2010). Report on Human Biomonitoring of Environmental Chemicals in Canada - Results of the Canadian Health Measures Survey Cycle 1 (2007-2009), 2010.

Health Canada (2012). Phthalates in toys: Cyclical Enforcement 2011-2012. Consumer Product Safety Bureau. Project #2011-1387.

Health Canada (2013). Second Report on Human Biomonitoring of Environmental Chemicals in Canada - Results of the Canadian Health Measures Survey Cycle 2 (2009–2011), 2013.

Health Canada (2014). Survey 2014-15: Determination of a Series of 34 Phthalates in Plastic Consumer Products. Consumer Product Safety Bureau. Project #2014-2047.

Health Canada (2018). Cyclical Enforcement of Toys (Phthalates). Consumer Product Safety Directorate. Project Number: C&E-017-014.

Health Canada. (2019a). Fifth Report on Human Biomonitoring of Environmental Chemicals in Canada - Results of the Canadian Health Measures Survey Cycle 5 (2016- 2017).

Health Canada (2019b). Personal communication from Consumer and Hazardous Products Safety Directorate, Health Canada, to Performance Measurement Division, Health Canada, July 2019.

Koch, H. M., Drexler, H. & Angerer, J. (2004). Internal exposure of nursery-school children and their parents and teachers to di(2-ethylhexyl)phthalate (DEHP). Int J Hyg Environ Health. 207: 15–22.

Koniecki D, Wang R, Moody RP, Zhu J. (2011). Phthalates in cosmetic and personal care products: concentrations and possible dermal exposure. Environ Res. 111(3):329-336.

Page B. D. and Lacroix G.M. (1995). The occurrence of phthalate ester and di-2-ethylhexyl adipate plasticizers in Canadian packaging and food sampled in 1985-1989: A survey. Food Additives and Contaminants. 12:129-151.

Rodricks, J.V. and D. Turnbull. (1984). "Assessment of Possible Carcinogenic Risk Resulting from Exposure to Di(2-ethylhexyl)Phthalate (DEHP) in Children's Products", prepared for the Phthalate Esters Panel, Chemical Manufacturers Association, Washington, DC, 122 pp. 

US. (2008). Consumer Product Safety Improvement Act. 2008. United States of America. 122 STAT. 3016 PUBLIC LAW 110–314- AUG. 14, 2008.

US CPSC CHAP. (2014). Consumer Product Safety Commission Chronic Hazard Advisory Panel. 2014. Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives Final Report. 

US Code of Federal Regulations Title 21. (2011). TITLE 21—Food and Drugs. Chapter I —Food and Drug Administration, Department of Health and Human Services. Subchapter B - Food for Human Consumption. Part 175 Indirect Food Additives: Adhesives and Components of Coating.