ARCHIVED — Phthalates Regulations

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Vol. 143, No. 25 — June 20, 2009

Statutory authority

Hazardous Products Act

Sponsoring department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Order or the regulations.)

Executive summary

Issue: A product composed in whole or in part of soft vinyl containing certain phthalate plasticizers has the potential to cause harmful health effects in young children that suck or chew on the soft vinyl for prolonged periods of time. The voluntary action already taken by domestic industry to remove the two predominantly used phthalates [di(2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate (DINP)] from soft vinyl teethers, pacifiers and other products designed for and intended to be mouthed by young children safeguards only a small portion of soft vinyl children’s products marketed in Canada. The vast majority of these products are manufactured offshore, where voluntary Canadian restrictions are not always applied. The United States and European Union recently set legislation restricting the level of six phthalates in soft vinyl children’s toys and child care articles on precautionary grounds either based on adverse reproductive effects in animals [DEHP, dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP)] or despite the absence of scientific certainty regarding health risks [DINP, diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DNOP)].

Description: A restriction under Part II of Schedule I to the Hazardous Products Act is the most effective measure for ensuring that soft vinyl children’s toys and child care articles imported, sold or advertised in Canada do not contain phthalates that are restricted in the United States and European Union. To this end, it is proposed that the concentration of each of DEHP, DBP and BBP be restricted to no more than 1 000 mg/kg in soft vinyl of all children’s toys and child care articles, and the concentration of each of DINP, DIDP and DNOP be restricted to no more than 1 000 mg/kg in soft vinyl of children’s toys and child care articles where the soft vinyl can, in a reasonably foreseeable manner, be placed in the mouth of a child under four years of age.

Cost-benefit statement: The total annual cost of a restriction of only DEHP on an individual business in Canada is estimated to be less than 1% to a maximum of about 5% of revenues, and no additional costs are anticipated with a restriction of additional phthalates. The resultant cost to consumers in terms of higher retail prices is likely to be limited. Consequently, this proposal is considered to be a reasonable preventative measure for reducing children’s exposure to phthalates and avoiding health problems and associated health care costs later in life.

Business and consumer impacts: It is expected that the proposed restriction will have a minor overall impact on industry, while consumers will have the benefit of providing their children with safer products at little or no additional cost.

Domestic and international coordination and cooperation: This proposal is consistent with the actions taken on phthalates in the United States and European Union. It ensures that Canadian children will have the same level of protection from phthalate exposure as children in these other jurisdictions, and will prevent Canada from potentially becoming a dumping ground for soft vinyl children’s toys and child care articles that are noncompliant in these jurisdictions.

Performance measurement and evaluation plan: The effectiveness of the restriction will be determined in accordance with standard Health Canada policies and procedures, including regular sampling and testing of products in the marketplace and follow-up of consumer and trade complaints. Actions on noncompliant products will range from recall to criminal prosecution.

Issue

Phthalates are a class of chemicals commonly used as plasticizers (softening agents) in the manufacture of soft vinyl (also known as polyvinyl chloride [PVC]), which in turn is used in the manufacture of many consumer products, including soft vinyl children’s toys and child care articles. Phthalates do not bind to the soft vinyl, but are present as mobile components of the vinyl. However, the mere presence of phthalates in soft vinyl does not in itself equate to a health risk. It is the amount of phthalates that leach out of soft vinyl and are absorbed into the body that can be harmful. Although exposure to phthalates in soft vinyl through dermal contact or inhalation is negligible, phthalates may leach out of soft vinyl during periods of sustained mouthing action (sucking and chewing, but not licking) and enter the body through the saliva. Once in the body, some phthalates have the potential to cause adverse effects on reproduction and development, as outlined in the following paragraphs.

The United States and European Union have identified the following six phthalates as a potential concern for human health:

Di(2-ethylhexyl) Phthalate (DEHP) — CAS Number 117-81-7

Dibutyl Phthalate (DBP) — CAS Number 84-74-2

Benzyl Butyl Phthalate (BBP) — CAS Number 85-68-7

Diisononyl Phthalate (DINP) — CAS Numbers 28553-12-0 and 68515-48-0

Diisodecyl Phthalate (DIDP) — CAS Numbers 26761-40-0 and 68515-49-1

Di-n-octyl Phthalate (DNOP) — CAS Number 117-84-0

According to the 1994 Priority Substances List Assessment Report for DEHP under the Canadian Environmental Protection Act (CEPA), exposure to DEHP causes harmful effects on reproduction (e.g. reduced fertility) and development (e.g. testicular damage) in rodents. Studies using primates do not show similar results, and data in humans is limited and inconclusive. Liver and kidney effects in rodents have also been noted, although the relevance of these effects to humans is unclear. The estimated average daily intake of DEHP for children up to four years of age was determined to approach or slightly exceed the tolerable daily intake developed on the basis of studies in laboratory animals. It was concluded that DEHP was toxic under CEPA because it may enter the environment in a quantity or concentration or under conditions that may constitute a danger in Canada to human life or health. CEPA assessments of DBP (1994) and BBP (2000) showed that while exposure to these chemicals is hazardous to the reproduction and development of rodents, the estimated average daily intake is well below the tolerable daily intake for people of all ages. It was concluded that DBP and BBP do not constitute a danger to human life or health. CEPA assessments of DNOP (1993, 2003) concluded that data was inadequate to determine a tolerable daily intake and whether it is hazardous to reproduction or development. However, the estimated daily intake by infants was substantially below the exposure levels that caused histopathological changes in subchronic studies in rodents. It was concluded that DNOP does not constitute a danger to human life or health. DINP and DIDP have not been assessed under CEPA. The CEPA Priority Substances List Assessment Reports for DEHP, DBP and DNOP are available at www.ec.gc.ca/substances/ese/eng/psap/psl1-1.cfm, and the report for BBP is available at www.ec.gc.ca/substances/ese/eng/psap/psl2-1.cfm.

A risk assessment of soft vinyl children’s products containing DINP was conducted in 1998 by Health Canada. On the basis of liver toxicity in rodents, it was concluded that a potential health risk is present for children under three years of age that suck or chew on soft vinyl children’s products containing DINP for prolonged periods of time. It is now recognized that the liver toxicity seen in rodents may not be relevant to humans. However, a re-calculation of the risk assessment using developmental toxicity in rodents as a health endpoint shows that DINP may still pose a risk for children under three years of age.

A 2001 report by the Chronic Hazard Advisory Panel on Diisononyl Phthalate (DINP) to the United States Consumer Product Safety Commission (CPSC) concluded that, while exposure to DINP from DINP-containing soft vinyl toys is expected to pose a minimal risk of injury for the majority of children, there may be a concern for children 0 to 18 months old who routinely mouth DINP-containing soft vinyl children’s toys for 75 minutes per day or more; see www.cpsc.gov/LIBRARY/FOIA/Foia01/os/dinp.pdf.

The United States National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) concluded that, on the basis of studies in rodents, DEHP, DBP and BBP are hazardous to reproduction and development, DINP and DIDP are hazardous to development, and DNOP has no measurable effects on reproduction or development. The NTP-CERHR considers animal data to be relevant to human reproduction and development. The NTP-CERHR Phthalate Expert Panel Reports are available at http://cerhr.niehs.nih.gov/reports/index.html.

Under the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in the European Union, DEHP is classified as a reproductive toxin category 2 with a risk description of “R60” (May impair fertility) and “R61” (May cause harm to an unborn child). DBP and BBP are each classified as a reproductive toxin category 2 with a risk description of “R61” (May cause harm to an unborn child) and a reproductive toxin category 3 with a risk description of “R62” (Possible risk of impaired fertility). DINP and DIDP were determined to pose no apparent risk to human health. All classifications are based on studies in rodents. An assessment of DNOP is not available. The European Union Risk Assessment Reports for DEHP, DBP, BBP, DINP and DIDP are available at www.phthalates.com/RAs.

More recently, the International Chemical Secretariat (ChemSec), in collaboration with leading NGOs in the European Union, developed the REACH SIN (Substitute It Now) List 1.0 of substances of very high concern for replacement by safer alternatives. This list is available at www.sinlist.org. DEHP, DBP and BBP are included on the SIN list based on their reproductive toxin classifications. DINP is also included on the SIN list; although DINP is not classified as a reproductive toxin under REACH, detrimental effects on reproduction and development have been reported and it is a suspected endocrine disruptor. DIDP and DNOP are not included on the SIN list. Nevertheless, the European Union has noted that there may be cause for concern if these phthalates were used at levels comparable to DINP and DEHP.

In 2008, the Australian Government reported that DEHP, DBP, BBP and DINP are hazardous to reproduction and development, and that DIDP is hazardous to development, whereas DNOP does not appear to be hazardous to either reproduction or development. Phthalates assessments by the Australian Government, Department of Health and Ageing, National Industrial Chemicals Notification and Assessment Scheme (NICNAS) are available at www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp.

The potential for certain phthalates to be harmful to human reproduction and development on the basis of studies in laboratory animals, combined with their potential for exposure from ingestion, has raised concerns in Canada and abroad regarding phthalate use in soft vinyl consumer products.

The most significant exposures to phthalates in soft vinyl consumer products are likely to result from the use of soft vinyl children’s toys and child care articles mouthed by children under four years of age. Older children are not considered to be at risk because they are less sensitive to the effects of phthalates, and they do not suck or chew on toys and other articles frequently for prolonged periods like younger children. On a similar basis, there is no expected risk of adverse fetal development in pregnant women using soft vinyl consumer products containing phthalates.

In 1998, Health Canada asked domestic manufacturers, importers, distributors and retailers to stop marketing soft vinyl buccal products (i.e. teethers, pacifiers, rattles and other products designed for and intended to be mouthed by young children) if the products contain DINP. Anticipating that DEHP would be the next target for buccal products, industry stopped using this phthalate the same year as DINP; until then, DEHP and DINP had been the predominant phthalates in these products. Subsequent Health Canada surveys have shown that the majority of soft vinyl buccal products sold in Canada have remained in compliance with industry’s voluntary withdrawal of DEHP and DINP. However, the use of DEHP and DINP appears to be increasing in other soft vinyl children’s products marketed in Canada that are not intended to be mouthed by young children, but that could easily be mouthed nonetheless, such as baby bibs and bath toys. This is likely the result of increased globalization and outsourcing of product manufacturing to offshore sites, predominantly in Asia, where Canadian authorities have little, if any, influence on manufacturing practices.

In May 2006, Private Member’s Bill C-307 (Phthalate Control Act) was introduced in the House of Commons to prohibit the use of DEHP, BBP and DBP in a number of products. Bill C-307 was amended, and the version passed by the House of Commons in November 2007 proposed two actions: (i) DEHP was to be prohibited under the Hazardous Products Act in products that are brought into contact with the mouth of a child of less than three years of age within 12 months after the proposed Act came into force, and (ii) DBP and BBP were to be reassessed under CEPA 1999 within 24 months. Actions were also proposed for DEHP in cosmetics and medical devices. In May 2008, Bill C-307 went through the second reading at the Senate and was referred to the Standing Committee on Energy, the Environment and Natural Resources, where it remained until its withdrawal with the dissolution of the 39th Parliament in September 2008. Details of Bill C-307 are available at www.parl.gc.ca/LEGISINFO/index.asp?Language=E&Session=15&query=5105&List=toc.

Regulatory actions on phthalates have already been taken in the United States under section 108 of the Consumer Product Safety Improvement Actof 2008 (CPSIA) [www.cpsc.gov/cpsia.pdf] and in the European Union in accordance with Directive 2005/84/EC of the European Parliament and of the Council of December 14, 2005 (eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L: 2005:344:0040:0043:EN:PDF). As of January 16, 2007, or earlier, in the European Union, and in effect on February 10, 2009, in the United States, DEHP, BBP and DBP are prohibited from being used in all soft vinyl toys and child care articles at concentrations of more than 0.1% on the basis of potential reproductive toxic effects. The United States and European Union have also used the precautionary approach, despite uncertainty regarding the associated health risks, to prohibit DINP, DIDP and DNOP at concentrations of more than 0.1% in soft vinyl toys and child care articles that can be placed in a child’s mouth. A phthalate concentration of 0.1% or less in soft vinyl is considered to be tolerable to children’s health and indicative of no intentional addition of the phthalate.

In mid-2007, 100 assorted children’s products labelled or perceived to contain soft vinyl that could reasonably be mouthed by young children were sampled at retail across Canada and assessed for the content of phthalate and non-phthalate plasticizers by Health Canada’s Product Safety Laboratory; this targeted survey was not representative of all children’s products available on the retail market. Of the 100 products that were sampled, 72 tested positive for PVC and were further tested for phthalates and non-phthalate plasticizers. Of the 72 products that contained PVC, 54 (75%) contained added phthalates (i.e. phthalates at concentrations of more than 0.1%). Of these 54 products, 33 (61%) contained DEHP, 35 (65%) contained DINP and 4 (7%) contained DBP; average concentrations were 12.5% (DEHP), 21.9% (DINP) and 0.08% (DBP). None of the products contained BBP, DIDP or DNOP. This study also showed that, compared to past surveys, the use of non-phthalate plasticizers (i.e. phthalate substitutes) in soft vinyl children’s products is increasing. Phthalate substitutes included acetyl tributyl citrate (ATBC), butyl palmitate (BP), diethyl hexyl adipate (DEHA), di-isononyl cyclohexane (DINCH) and ethylene glycol dibenzoate (EGDB). Of the 72 products that contained PVC, 17 (24%) contained non-phthalate plasticizers exclusively.

Objectives

The objective of this regulatory proposal is to restrict the sale, importation and advertising in Canada of products that present a likely or potential risk for children to develop adverse health effects from exposure to phthalates by harmonizing Canadian requirements for phthalates in soft vinyl children’s toys and child care articles with those of the United States and the European Union.

Description

The following three actions are proposed:

(i) The Phthalates Regulations are to be added under the authority of the Hazardous Products Act to restrict the concentration of each of DEHP, DBP and BBP to no more than 1 000 mg/kg (see footnote a) in the vinyl of all children’s toys and child care articles, and to restrict the concentration of each of DINP, DIDP and DNOP to no more than 1 000 mg/kg (see footnote b) in the vinyl of children’s toys and child care articles where the vinyl can, in a reasonably foreseeable manner, be placed in the mouth of a child under four years of age.

Within the context of the Regulations, “toys” will mean “products that are intended for use by a child of any age in learning or play” and “child care articles” will mean “products that are intended to facilitate the relaxation, sleep, hygiene, feeding, sucking or teething of a child under four years of age.” A product or part of a product containing vinyl will be considered capable of being “placed in the mouth of a child” if it can be brought to the child’s mouth and kept there so that it can be sucked or chewed, and if one of its dimensions is less than 5 cm; the dimensions of an inflatable vinyl product or part of a product containing vinyl will be determined in its deflated state. Products or parts of a product containing vinyl that exceed a size of 5 cm in all dimensions or that can just be licked as well as parts of a product that are inaccessible are not regarded as capable of being placed in the mouth of a child.

The restriction in child care articles that are intended to facilitate the feeding, sucking or teething of a child under four years of age mirrors industry’s voluntary action restricting phthalates in buccal products sold in Canada since 1998, and is proposed to be effective immediately upon registration of the Regulations. A transition period of six months is proposed for all other products subject to these Regulations.

(ii) Part II of Schedule I to the Hazardous Products Act is to be amended by adding an item respecting toys and child care articles composed of vinyl containing phthalates within the meaning of the Phthalates Regulations.

(iii) Subsection 12(2) of the Hazardous Products (Toys) Regulations is to be consequentially amended by adding “a phthalate referred to in the Phthalates Regulations” to the list of substances that are excluded from the allowance to be present in a plastic material at a concentration of one per cent or less in toys, equipment and other products for use by a child under three years of age in learning or play.

Regulatory and non-regulatory options considered

1. Voluntary restriction on the use of DEHP and DINP in soft vinyl buccal products (status quo)

Under this option, there would continue to be no legal restrictions on the sale, importation or advertisement of soft vinyl children’s toys and child care articles containing more than 1 000 mg/kg DEHP, DBP, BBP, DINP, DIDP or DNOP. Domestic industry would voluntarily continue to market soft vinyl buccal products without DEHP or DINP, the two predominant phthalates used in the manufacture of other types of soft vinyl children’s products. However, Canadian children would continue to be exposed to these chemicals since the majority of soft vinyl children’s toys and child care articles marketed in Canada are manufactured offshore, where voluntary Canadian guidelines may or may not be followed. It is also possible that other phthalates which are not currently found in soft vinyl children’s toys and child care articles marketed in Canada (BBP, DIDP and DNOP) or which are found in low amounts in a small number of these products (DBP) may be introduced in these products in the future. Since phthalates are less costly than phthalate substitutes, those in the industry who are striving to provide safe products by using phthalate substitutes would continue to face higher production costs and lost sales compared to those using phthalates. Canadian consumers wishing to buy safe Canadian-made products would continue to face higher purchasing costs. The absence of legal restrictions may also render Canada a dumping ground for phthalate-containing soft vinyl children’s toys and child care articles that are illegal in Europe and the United States. For these reasons, this option was rejected.

2. Mandatory labelling for phthalate content in soft vinyl children’s toys and child care articles

The main purpose of precautionary labelling on a consumer product is to help people use the product safely. Mandatory labelling to identify an inherent health risk from the reasonably foreseeable use of a product would nevertheless allow the product to be sold without reducing the health risk. In addition, it is unreasonable to mandate the industry to disclose information on a product label that would deter people from buying the product.

With respect to a soft vinyl children’s toy or child care article containing more than 1 000 mg/kg DEHP, DBP, BBP, DINP, DIDP or DNOP, a child’s health is at risk when the child sucks or chews on the product for a prolonged period of time every day, behaviour that is typical of young children. The only effective risk control message on a soft vinyl children’s toy or child care article containing one or more of these phthalates would be a warning that a child should not suck or chew on the product for a prolonged period of time per day. In other words, the warning would require that a young child change his or her normal behaviour of sucking or chewing, or that parents and caregivers be more aware of how long a child interacts with the product. For products such as teethers, rattles, pacifiers and baby bottle nipples that are intended to be mouthed by young children for prolonged periods of time, the warning would also prevent the product from being used for its intended purpose. Therefore, labelling for phthalates is not a viable option.

3. Prohibition of DEHP in soft vinyl children’s toys and child care articles for children under three years of age (aligns with Private Member’s Bill C-307)

DEHP is classified as toxic under CEPA on the basis of health concerns for children. Therefore, this option is expected to have a positive impact on the health and safety of young children, the demographic most vulnerable to the toxic effects of DEHP and also most likely to be exposed to DEHP in soft vinyl toys and child care articles intended for this age group, where the vinyl can be placed in the mouth and sucked or chewed for prolonged periods of time.

In July 2007, Health Canada’s Consumer Product Safety Bureau began preparing to satisfy the requirements set out in Bill C-307 for children’s products. Approximately 850 stakeholders received a consultation letter on a proposal to prohibit DEHP in soft vinyl products for children under three years of age that are likely to be mouthed, and a copy of the letter was also posted at www.hc-sc.gc.ca/cps-spc/legislation/consultation/ ethylhexyle_consult-eng.php. The results of the consultation are provided in the “Consultation” section of this document. Early in 2008, a cost-benefit analysis was done to assess the potential economic impact of the proposed prohibition of DEHP on manufacturers, importers, distributors and retailers of soft vinyl products for children under three years of age and on manufacturers of raw plastics and chemical additives used in the manufacture of such products. In anticipation of a possible future obligation to take action on additional phthalates and/or additional soft vinyl children’s products, the cost-benefit analysis also assessed the potential economic impact of prohibiting the two predominant phthalates, DEHP and DINP, in soft vinyl products for all children. The results of the cost-benefit analysis are provided in the “Benefits and costs” section of this document.

Late in 2008, Health Canada was well underway to introducing proposed regulations under the Hazardous Products Act reflecting the content of Bill C-307, and despite the Bill’s withdrawal in September 2008, was aiming for pre-publication in Part I of the Canada Gazette before the end of the 2008–2009 fiscal year. However, recent regulatory actions taken on phthalates in soft vinyl children’s toys and child care articles in the United States, which mirrored the actions taken by the European Union, prompted Health Canada to consider further measures for phthalates.

4. Harmonization with regulatory actions on phthalates in the United States and European Union (regulatory proposal)

The regulatory actions taken on phthalates in soft vinyl children’s toys and child care articles by the United States and European Union are described in the “Issue” section of this document.

Of the six phthalates that are proposed for restriction in soft vinyl children’s toys and child care articles, only DEHP has been classified as toxic under CEPA because of its inherent potential to cause adverse effects on reproduction and development (hazard) and because exposure estimates for infants and toddlers who mouth on soft vinyl children’s products containing DEHP approach levels at which adverse effects on reproduction and development are likely to occur (risk).

CEPA assessments for DBP and BBP showed that while exposure to DBP and BBP has the potential to be hazardous to reproduction and development, the exposure estimates are well below levels at which health effects are likely to occur. BBP is not found in soft vinyl children’s toys and child care articles that are currently marketed in Canada, and DBP is found only in low amounts in a small number of these products. However, these phthalates have been reported to occur in these products marketed in the European Union. If BBP and DBP are used as substitutes in these products marketed in Canada in the future at levels comparable to DEHP and DINP, it is likely that exposure to these chemicals by children less than four years of age may cause adverse effects on development and/or fertility problems later on in life.

DINP and DIDP have not been assessed under CEPA. However, a report on DINP by the Chronic Hazard Advisory Panel to the United States CPSC concluded that DINP may pose a risk to children 0 to 18 months old who routinely mouth DINP-containing soft vinyl children’s toys for 75 minutes per day or more. DINP is also included on the European Union’s REACH SIN list; although DINP is not classified as a reproductive toxin under REACH, detrimental effects by DINP on reproduction and development have been reported in laboratory animals and it is a suspected endocrine disruptor. Considering also that DINP is present in soft vinyl children’s toys in Canada at levels comparable to DEHP, it is reasonable to conclude that exposure to DINP by young children who mouth on soft vinyl children’s toys containing DINP is likely to cause adverse effects on reproduction and development. A similar conclusion could also be drawn for DIDP if it were used in soft vinyl children’s toys marketed in Canada at levels comparable to DEHP and DINP, because DIDP shows many structural similarities to DINP and developmental effects from DIDP exposure in laboratory animals have recently been reported by the Australian Government. Although DIDP is not currently found in soft vinyl children’s toys marketed in Canada, it has been found in children’s toys marketed in the European Union.

Data for DNOP were inadequate to determine either a hazard or a risk under CEPA. It is uncertain whether DNOP is hazardous to either reproduction or development based on available scientific information, and it is not found in soft vinyl children’s toys and child care articles currently marketed in Canada. However, DNOP has been reported to occur in products marketed in the European Union, and based on existing uncertainties and lack of data, the European Union concluded that DNOP should be subject to the same restrictions as DINP and DIDP.

Developmental and reproductive endpoints are considered to be serious and irreversible in nature. Therefore, it is considered prudent for Health Canada to mirror regulatory actions on phthalates in other jurisdictions to reduce phthalate exposures by Canadian children, despite some uncertainties in the current scientific knowledge.

Rationale

Health Canada is proposing to proceed with option 4. Compared to option 3, harmonization with phthalate requirements already in effect in the United States and European Union is expected to have a greater positive impact on the health and safety of young children because it restricts more harmful or potentially harmful phthalates in more soft vinyl products with which these children interact on a regular basis. With harmonization, Canadian children are ensured the same level of protection from phthalate exposure as children in the United States and European Union. Harmonization also prevents certain harmful or potentially harmful phthalates that are not found in soft vinyl children’s toys and child care articles currently marketed in Canada (BBP, DIDP and DNOP) or that are found in low amounts in a small number of these products (DBP) from being widely used in the manufacture of these products in the future. In addition, harmonization prevents Canada from becoming a potential dumping ground for noncompliant soft vinyl children’s toys and child care articles from the United States and European Union. For industry, harmonization provides broader access to international markets by making it easier and more economically viable to market and compete in a global marketplace. Internationally aligned legislation is also more readily accepted by industry, which leads to higher compliance rates; media articles indicate that some Canadian retailers have already phased out soft vinyl children’s products containing phthalates. Opportunities are also provided to peripheral industries that supply materials, equipment and services to manufacturers of the regulated products.

Benefits and costs

A Cost-Benefit Analysis to Support the Proposed Prohibition of DEHP under the Hazardous Products Act (March 31, 2008) was prepared for Health Canada by HDR/HLB Decision Economics Inc. The purpose of the study was to assess the potential economic impact of the then-proposed prohibition of DEHP (option 3) on manufacturers, importers, distributors and retailers of soft vinyl products for children less than three years of age as well as on manufacturers of raw plastics and chemical additives used in the manufacture of such products. Data was collected by means of an online survey, and approximately 50 industry members were invited to participate.

In anticipation of possible future actions to better align with international requirements by taking action on other phthalates and more products, the potential economic impact of prohibiting both DEHP and DINP in soft vinyl products intended for use by children of all ages was also assessed. As reported in the “Issue” section of this document, a recent Health Canada survey had shown DEHP and DINP to be the main phthalates used in soft vinyl children’s products sold in Canada.

Costs were assessed in quantitative terms, while benefits were qualitative and based on findings from animal studies because data on human health effects from DEHP or DINP exposure were not available.

Costs

The response rate for this survey was low. Only one respondent fully completed the survey. Based on this response, the total annual cost of the proposed DEHP prohibition on an individual company was estimated to be in the range of $250,000 to $1,450,000 to cover the higher cost of using phthalate substitutes as well as costs associated with increased product testing to ensure compliance. These values amounted to less than 1% to a maximum of about 5% of revenues for the company, defined by HDR/HLB Decision Economics Inc. as a small to moderate cost impact. Eight other respondents partially completed the survey. None of these respondents expressed a concern about the proposed DEHP prohibition and its impact on their revenues, employment, or profit margins.

With respect to consumer costs, only one respondent indicated that they would experience a moderate (5–15%) increase in product prices in the event of a DEHP prohibition. No other respondent indicated an impact on product prices. In a British consultation document titled Phthalates in Toys and Childcare Articles, Toluene, Carcinogens, Mutagens and Substances Toxic to Reproduction (CMRS), Consultation on the Implementation in the United Kingdom Of European Directives 2005/84/EC, 2005/59/EC and 2005/90/EC Concerning the Prohibition of Phthalates, Toluene, and Certain CMRS from Being Placed on the Market for Sale to the General Public (April 2006), available at www.berr.gov.uk/consultations/page27545.html, the British Toy and Hobby Association estimated that the phthalate prohibition in the European Union (which is harmonised with the regulatory action currently being proposed for Canada [option 4]) would result in a 4% increase in wholesale prices of soft vinyl children’s toys. Although some of this increase could be passed on to consumers through higher retail prices, it was estimated that the scope for raising prices would be limited due to intense competition in the market.

Only one respondent completed the portion of the survey related to a prohibition of both DEHP and DINP in soft vinyl children’s products. Compared to the estimated costs of a prohibition of DEHP only, no additional costs were anticipated with a prohibition of both DEHP and DINP. Since the other four phthalates under the current proposal are either not found in soft vinyl children’s products sold in Canada (BBP, DIDP and DNOP) or are found in low amounts in a small number of these products (DBP), any additional cost impact of prohibiting all six phthalates compared to prohibiting DEHP alone is also likely to be negligible on industry.

Monitoring, sampling, testing and enforcement costs for Health Canada’s Product Safety Directorate are estimated to be $140,000 in the year after the regulatory action is introduced. These costs are expected to decline over time as noncompliant products are removed from the marketplace. Costs for subsequent years are estimated to average $20,000 per year.

Benefits

As described in the economic report, most children, if not all, are exposed early in life to soft vinyl children’s toys and child care articles covered by this proposal. Since a substantial proportion of these products currently marketed in Canada contain added DEHP (33/72 or 46% according to a 2007 Health Canada survey, at an average concentration of 12.5%), a DEHP concentration limit of 0.1% in these products would significantly reduce DEHP exposure in young children. Given that DEHP is a known toxin to reproduction and development in animals, and animal data is considered to be relevant to human reproduction and development, limiting the DEHP concentration to unintentional levels (i.e. 0.1% or less) is expected to generate substantial benefits in the form of avoidance of future health problems, especially those related to fertility. This in turn is likely to generate benefits in the form of avoided direct costs to the healthcare system stemming from infertility treatment as well as psychological trauma or anxiety to individuals and couples having fertility problems. Infertility treatment can be very expensive, depending on the treatment required. For example, a successful pregnancy through in vitro fertilization (IVF) can cost $40,000 or more (based on 2002 dollars); see www.asklenore.com/infertility/costs.html.

According to the economic report, the benefits of prohibiting DINP are less obvious since the evidence of the damaging effects of DINP is weak. However, the report may have downplayed the DINP risk to young children who mouth DINP-containing soft vinyl children’s toys for 75 minutes per day or more, as reported by the Chronic Hazard Advisory Panel on DINP. It took into consideration only children’s mouthing studies that showed average daily mouthing times below 75 minutes; however, average daily mouthing times as high as 5 hours have also been reported (see www.berr.gov.uk/files/file21800.pdf). The economic report also did not take into account more recent DINP assessments by the European Union and Australia, which showed detrimental effects of DINP on reproduction and development as well as an endocrine disruption potential, which led to its placement on the REACH SIN list, a new European tool for phasing out chemicals of high concern. Given the likelihood for DINP to cause adverse effects on reproduction and development from exposure to DINP-containing products, and that DINP is used at the same levels in products marketed in Canada as is DEHP, the benefits of prohibiting DINP are likely as high as the benefits of prohibiting DEHP.

DBP, BBP and DIDP are not found in soft vinyl children’s toys and child care articles marketed in Canada (BBP and DIDP) or they are found only in low amounts in a small number of these products (DBP). Consequently, there are no immediate health benefits of prohibiting DBP, BBP and DIDP. However, it is possible that in the absence of a prohibition, DBP, BBP and DIDP may be used as substitutes in products marketed in Canada at levels comparable to DEHP and DINP, and that products from the United States or European Union that contain illegal levels of DBP, BBP or DIDP may be dumped onto the Canadian market. Therefore, there are obvious preventive benefits to prohibiting DBP, BBP and DIDP in Canada given that exposure to these phthalates has the potential to be harmful to reproduction (DBP, BBP) and development (DBP, BBP, DIDP). A listing of children’s toys and child care articles recalled in the European Union on the basis of levels of DBP, BBP or DIDP exceeding the 0.1% limit is available through the European Commission’s Consumer Affairs Web site for the Rapid Alert System for non-food consumer products (RAPEX) at ec.europa.eu/consumers/safety/rapex/index_en.htm.

DNOP is not found in soft vinyl children’s toys and child care articles marketed in Canada, but recalled children’s products containing DNOP in excess of 0.1% are listed in RAPEX. Since the potential of DNOP to be harmful to health is not clear, however, the benefits of a DNOP prohibition to children’s health or as a preventive measure are not apparent at this time.

Creating and selling products with a better health profile also benefits industry. As an example, it improves corporate image and sales in the domestic market. It also allows access to international markets with similar legislation. Common requirements through legislation also create a level playing field between industry members striving to produce and sell high quality and safe products, and those who would not otherwise adopt such high standards.

Net benefit

Given that the expected costs of a restriction on phthalates in soft vinyl children’s toys and child care articles are small to moderate, and that phthalate exposure has the potential to cause serious and irreversible effects on children’s health, this regulatory proposal is considered to be a reasonable preventative measure for reducing children’s exposure to phthalates and avoiding health problems and associated health care costs later in life.

Consultation

In mid-July 2007, a consultation document on the DEHP prohibition that was being proposed at the time was mailed to approximately 850 stakeholders. A copy of the document was also posted on Health Canada’s Web site at www.hc-sc.gc.ca/cps-spc/ legislation/consultation/ethylhexyle_consult-eng.php. The closing date of the consultation was September 30, 2007.

Comments were received from eight stakeholders. A trade association representing the phthalate chemical industry declared the DEHP prohibition to be unnecessary because the reproductive effects of DEHP seen in rodents are absent in primates. In addition, the voluntary restriction by domestic industry in the 1990’s on the use of DEHP (and DINP) in soft vinyl children’s products intended to be mouthed was considered by this association to be fully protective of children’s health. Health Canada does not concur. On the first point, both the CEPA Priority Substances List Assessment Report for DEHP at www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-lsp1/bis_2_ethylhexyl/index-eng.php and the European Union Risk Assessment Report for DEHP at www. dehp-facts.com/RA conclude that while DEHP does not pose a significant health risk to the general population, there is a possible health risk to children from mouthing soft vinyl toys and other children’s articles. This risk is highest in young children for whom mouthing is a very common and necessary behaviour that satisfies nutritive (e.g. breast- or bottle-feeding) as well as non-nutritive (e.g. pacifier, thumb, toy, blanket) needs. On the second point, the 2007 Health Canada survey shows that the vast majority of soft vinyl children’s products sold in Canada are predominantly manufactured in Asia, where voluntary Canadian restrictions on DEHP are not always applied.

A trade association representing the plastics industry, in its commitment to ensuring the safety of vinyl products, supported the DEHP prohibition, but asked that the DEHP limit be increased from 0.1% to 3% to allow for background levels of DEHP, and that the prohibition be applied only to children’s products “intended to be mouthed” since young children will mouth anything. Health Canada does not support these changes.

On the first point, it is noted that the 3% background level corresponds to the allowance for DEHP in section 4.3.8 of ASTM F963-07, Standard Consumer Safety Specification For Toy Safety, which states that “Pacifiers, rattles, and teethers shall not intentionally contain DI (2-ethylhexyl) phthalate [also known as dioctyl phthalate]. To prevent trace amounts of DEHP (DOP) from affecting analysis, up to 3% of total solid content will be accepted in the result, when tested in accordance with Practice D 3421.” Practice D 3421 refers to the ASTM standard Practice for Extraction and Determination of Plasticizer Mixtures from Vinyl Chloride Plastics that was withdrawn in 1987, with no replacement. It required the use of large volumes of carbon tetrachloride solvent in Soxlet extractors for 16 hours. Carbon tetrachloride is a recognized carcinogen and the use of Soxlet extractors is strongly discouraged today. The method itself was effective in extracting plasticizers from soft vinyl, but was not very precise nor accurate. Modern laboratory practices and sophisticated instrumentation offer much better precision and accuracy for this type of analysis and the 3% DEHP background level, while applicable until 1987, is not applicable today. The current internationally accepted background limit for DEHP in soft vinyl children’s products is 0.1%, which is considered tolerable to children’s health. Canadian industry exporting soft vinyl children’s products to the United States and European Union are already meeting a 0.1% DEHP limit. The likely reason for finding the 3% DEHP allowance in ASTM F963-07 is that section 4.3.8 was not deliberated during the 2007 revision.

On the second point, limiting the prohibition to products intended to be mouthed by young children is not considered by Health Canada to be sufficiently protective of children’s health. It is recognized that young children, particularly once they become mobile, mouth a variety of items in the home, including items not intended to be mouthed, since this is how these children explore their world. It is also recognized that parents cannot always be watching their children and controlling what they put in their mouth. It is impossible and impractical to control through legislation what people have in their homes or what children put in their mouths. However, it is a priority for Health Canada to set legislation which ensures that children’s products are as safe as possible. A prohibition limited in scope to products intended to be mouthed by young children is too narrow to be protective of health given that an estimated 75% of items mouthed by young children are those not designed for or intended to be mouthed according to a study on Research into the mouthing behaviour of children up to 5 years old (July 2002) by the Consumer and Competition Policy Directorate, Department of Trade and Industry, United Kingdom, available at www.berr.gov.uk/files/file21800.pdf. This study also found that nearly half of all the toys and other objects mouthed by young children were made of plastic, likely because plastic is so common in the home. A broader product scope is required for the prohibition. The current proposal applies to all children’s toys and child care articles with a potential to pose a risk of phthalate exposure to children under four years of age.

No other industry members commented on the proposal to prohibit DEHP. Other comments were received from a testing laboratory, a public interest organization and the general public. All were in favour of the DEHP prohibition. Requests to expand the prohibition to include more phthalates (notably DBP, BBP and DINP) and/or more products were made.

Late in 2008, Health Canada began consultations on the current proposal with the associations representing the phthalate chemical industry and the plastics industry, the only stakeholders to have expressed concerns regarding the DEHP prohibition proposed initially. A number of concerns have been raised by industry on the current proposal: (i) section 6 of the Hazardous Products Act requires regulatory actions to be science-based, however current science does not support a restriction on all six phthalates; (ii) plasticizers are already regulated under section 12 of the Hazardous Products (Toys) Regulations; (iii) regulatory action on all six phthalates is not warranted because some of the phthalates cannot be used as plasticizers in soft vinyl children’s products; and (iv) the direct economic impact of the proposal is small because the toy market accounts only for approximately 5% of phthalate sales. However, the indirect economic impact across vinyl market segments is expected to be large, particularly in the construction products market, which accounts for approximately 70% of phthalate sales. This indirect economic impact across market segments is already being felt in the European Union, and is likely the result of a false perception by consumers and manufacturers of vinyl products that no phthalates are safe in any vinyl product.

On the first point, Health Canada has determined that scientific support is available for most of the six phthalates included in this regulatory proposal, as discussed in preceding sections of this document. Section 6 of the Hazardous Products Act allows regulatory action to be taken on “any product, material or substance that . . . is or is likely to be a danger to the health and safety of the public”; scientific certainty is not necessary. In addition, the Cabinet Directive on Streamlining Regulation (available at www. regulation.gc.ca) requires the Government to “make (regulatory) decisions based on evidence and the best available knowledge and science in Canada and worldwide, while recognizing that the application of precaution may be necessary when there is an absence of full scientific certainty and a risk of serious or irreversible harm.”

On the second point, subsection 12(1) of the Hazardous Products (Toys) Regulations allows plasticizers that are acceptable for use in food packaging and food containers to be present at concentrations of up to 1% in plastic products for use by a child of less than three years of age in learning or play. For added certainty, heavy metals, compounds of heavy metals, and toxic substances set out in items 8 or 9 of Part I of Schedule I to the Hazardous Products Act are excluded from this allowance in subsection 12(2). It is proposed that subsection 12(2) be amended as shown in the “Description” section of this document to reflect the content of the proposed Phthalates Regulations.

On the third point, Health Canada has determined from its surveys of soft vinyl children’s products on the Canadian market and from a review of soft vinyl children’s products recalled in Europe (these are listed on the European Commission’s RAPEX Web site) that while DEHP and DINP are the prevalent phthalates in these products, DBP, BBP, DIDP and DNOP are also used; maximum concentration levels for these four phthalates ranging from 7.81% (BBP) to 48.1% (DNOP) have been reported.

On the last point, CEPA assessments of DEHP, DBP and BBP showed that the major exposures are from mouthing of soft vinyl children’s products by young children (DEHP) and ingestion of food by the general population (DEHP and BBP). Exposures to all three phthalates from ambient air, indoor air, drinking water and soil are considerably lower and not of concern to health. Since the presence of phthalates in the environment could be attributed in part to leaching of phthalates from vinyl consumer products during use or after disposal, and given that these levels are very low, it is reasonable to conclude that vinyl consumer products that contain phthalates, other than the products subject to this regulatory proposal, are not harmful to the health of Canadians. A joint effort on risk communication between Health Canada and industry could be considered.

Implementation, enforcement and service standards

Compliance and enforcement of the Phthalates Regulations and the consequential amendment to subsection 12(2) of the Hazardous Products (Toys) Regulations will follow standard departmental policies and procedures, including sampling and testing of affected soft vinyl children’s toys and child care articles, and follow-up of consumer and trade complaints. Actions taken on non-compliant products will be based on the powers given to Health Canada inspectors under the Hazardous Products Act. These actions may range from negotiation with traders for the voluntary recall of noncompliant products to prosecution under the Hazardous Products Act. Health Canada will also maximize compliance with the phthalate restriction through industry and retailer education. Co-operation from the Canada Border Services Agency in the case of imported soft vinyl children’s toys and child care articles will be negotiated as required.

Contact

Mary Korpan
Project Officer
Chemistry and Flammability Division
Consumer Product Safety Bureau
Department of Health
Address Locator: 3504D
123 Slater Street
Ottawa, Ontario
K1A 0K9
Fax: 613-952-9138
Email: mary_korpan@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to section 5 (see footnote c) of the Hazardous Products Act (see footnote d), proposes to make the annexed Phthalates Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Mary Korpan, Project Officer, Chemistry and Flammability Division, Consumer Product Safety Bureau, Department of Health, Address Locator: 3504D, 123 Slater Street, Ottawa, Ontario K1A 0K9 (fax: 613-952-9138; e-mail: mary_korpan@hc-sc.gc.ca).

Ottawa, June 11, 2009

JURICA ČAPKUN
Acting Assistant Clerk of the Privy Council

PHTHALATES REGULATIONS

INTERPRETATION

Definitions 1. The following definitions apply in these Regulations.
“child care article”
«article de puériculture»

“child care article” means a product that is intended to facilitate the relaxation, sleep, hygiene, feeding, sucking or teething of a child under four years of age.

“good laboratory practices”
«bonnes pratiques de laboratoire»

“good laboratory practices” means practices that are in accordance with the principles set out in the Organisation for Economic Co-operation and Development’s document entitled OECD Principles of Good Laboratory Practice, Number 1 of the OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, ENV/ MC/CHEM(98)17, the English version of which is dated January 21, 1998 and the French version of which is dated March 6, 1998.

“phthalate” «phtalate»

“phthalate” means di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) or di-n-octyl phthalate (DNOP).

“toy”
«jouet»

“toy” means a product that is intended for use by a child of any age in learning or play.

 

AUTHORIZATION

Advertising, sale and importation

2. The advertising, sale and importation of toys and child care articles composed of vinyl containing phthalates are authorized if the toys and child care articles meet the requirements of these Regulations.

 

REQUIREMENTS

DEHP, DBP and BBP

3. The vinyl in a toy or child care article shall contain not more than 1 000 mg/kg of di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) or benzyl butyl phthalate (BBP) when tested in accordance with a method that conforms to good laboratory practices.

DINP, DIDP and DNOP

4. (1) The vinyl in any part of a toy or child care article that can, in a reasonably foreseeable manner, be placed in the mouth of a child under four years of age shall contain not more than 1 000 mg/kg of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) or di-n-octyl phthalate (DNOP) when tested in accordance with a method that conforms to good laboratory practices.

Interpretation

(2) For the purpose of subsection (1), a part of a toy or child care article can be placed in the mouth of a child under four years of age if

(a) it can be brought to the child’s mouth and kept there so that it can be sucked or chewed; and

(b) one of its dimensions is less than 5 cm.

Dimension — deflated state

(3) For the purpose of paragraph (2)(b), if a part of a toy or child care article is inflatable, its dimensions shall be determined in its deflated state.

 

COMING INTO FORCE

Registration

5. These Regulations come into force

(a) in respect of child care articles that are intended to facilitate the feeding, sucking or teething of a child under four years of age, on the day on which they are registered; and

(b) in respect of toys and in respect of child care articles that are intended to facilitate the relaxation, sleep or hygiene of a child under four years of age, six months after the day on which they are registered.

 

[25-1-o]

Footnote a
It is proposed that the phthalate concentration limit be expressed in the inter- nationally recognized SI units of milligrams per kilogram (mg/kg); 1 000 mg/kg is equivalent to the 0.1% weight/weight limit for each of DEHP, DBP, BBP, DINP, DIDP and DNOP in the United States and the European Union.

Footnote b
It is proposed that the phthalate concentration limit be expressed in the inter- nationally recognized SI units of milligrams per kilogram (mg/kg); 1 000 mg/kg is equivalent to the 0.1% weight/weight limit for each of DEHP, DBP, BBP, DINP, DIDP and DNOP in the United States and the European Union.

Footnote c
S.C. 2004, c. 9, s. 2

Footnote d
R.S., c. H-3