Consumer Products Containing Lead Regulations: SOR/2018-83
Canada Gazette, Part II, Volume 152, Number 9
April 23, 2018
CANADA CONSUMER PRODUCT SAFETY ACT
P.C. 2018-437 April 20, 2018
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 37 footnotea of the Canada Consumer Product Safety Act footnoteb, makes the annexed Consumer Products Containing Lead Regulations.
Consumer Products Containing Lead Regulations
1 The following definitions apply in these Regulations.
- accessible part means any part of a product that may be touched, licked, mouthed or swallowed during the reasonably foreseeable use of the product. (partie accessible)
- consumer product containing lead means any of the following products that contains lead:
- (a) a product that is brought into contact with the user’s mouth during normal use, except for
- (i) a kitchen utensil, or
- (ii) a product that is subject to the Glazed Ceramics and Glassware Regulations;
- (b) any clothing or clothing accessory that is intended for use by a child under 14 years of age;
- (c) a product that is intended for use in learning or play by a child under 14 years of age;
- (d) a book or similar printed product that is intended for a child under 14 years of age, except if it is
- (i) printed on paper or cardboard, and
- (ii) printed and bound in a conventional manner using conventional materials;
- (e) a product whose primary purpose is to facilitate the relaxation, sleep, hygiene, carrying or transportation of a child under four years of age. (produit de consommation contenant du plomb)
- good laboratory practices means practices that are in accordance with the principles set out in the Organisation for Economic Co-operation and Development 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. (bonnes pratiques de laboratoire)
Lead content — accessible part
2 (1) Subject to subsection (2), each accessible part of a consumer product containing lead must not contain more than 90 mg/kg of lead when tested in accordance with good laboratory practices.
(2) Each accessible part may contain more than 90 mg/kg of lead if
- (a) lead is necessary to produce an essential characteristic of the part;
- (b) no alternative part containing less lead is available; and
- (c) the part, when tested in accordance with good laboratory practices, does not release more than 90 mg/kg of lead.
3 The Consumer Products Containing Lead (Contact with Mouth) Regulations footnote1 are repealed.
Coming into Force
Six months after publication
4 These Regulations come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published or, if that sixth month has no day with that number, the last day of that sixth month.
REGULATORY IMPACT ANALYSIS STATEMENT
Issues: Exposure to lead poses a health risk to humans, especially young children. Current science indicates that even very low levels of lead exposure may be harmful to children. Health Canada continues to reduce risks of exposure to lead by implementing its Lead Risk Reduction Strategy for Consumer Products (LRRS), which aims to address the risk of childhood lead exposure by reducing the lead content of consumer products, especially children’s products, to the lowest feasible level.
Prior to enactment of the Consumer Products Containing Lead Regulations (the Regulations), there were no specific regulatory lead content limits for
- products intended for use in learning or play (toys) intended for children between the ages of 3 years and under 14 years;
- children’s clothing and accessories; and
- products whose primary purpose is to facilitate the relaxation, sleep, hygiene, carrying or transportation of a child under 4 years of age.
For the remainder of this document, these three product groups will be referred to as Group 2 products.
Various regulations under the Canada Consumer Product Safety Act (CCPSA) set out a 90 milligrams of lead per kilogram of product (90 mg/kg) total lead limit for applied surface coatings on toys, children’s articles, carriages and strollers, and cribs, cradles and bassinets, as well as Group 1 products under the LRRS, which include all toys for children under 3 years of age. Products in Group 2 that contain more than 90 mg/kg total lead have been found on the North American market.
Description: As part of Health Canada’s LRRS, the Regulations will help improve the safety of children by expanding on the product categories subject to a total lead limit of 90 mg/kg.
Cost-benefit statement: Given that the anticipated economic costs are low and that, over time, health benefits may reasonably be expected to result from limiting the lead content of Group 2 products, the economic benefits of the Regulations outweigh the economic costs.
“One-for-One” Rule and small business lens: The
“One-for-One” Rule does not apply as there is no change in administrative costs to business. The small business lens does not apply because estimated nationwide costs of the proposal are less than $1 million per year.
Domestic and international coordination and cooperation: The total lead content limit of these Regulations is in alignment with the international health and safety objective of reducing intentional use of lead as much as possible, although the actual lead limits may differ slightly from one jurisdiction to another. It also ensures consistency for lead limits across the Canadian regulatory regime.
Some industry associations have urged that Health Canada align with the United States (U.S.) limit of 100 mg/kg for toys and children’s clothing and accessories. Despite repeated requests from Health Canada, industry has not identified any products that would be impacted by the slight difference in lead limits, or any associated costs. No adverse trade impacts are anticipated.
Health effects of lead
Children absorb a higher percentage of lead than adults do, and their developing organs and systems are more susceptible to the toxic effects of lead. Lead builds up in the body, so that on-going exposure to even low levels of lead may result in harmful effects on the growth and intellectual development of children.
The Health Canada
“State of the Science Report on Lead” found that developmental neurotoxicity in children has been associated with even very low blood lead levels (i.e. below 5 micrograms/decilitre). At this time, there is no established threshold blood lead level below which harmful health effects do not occur. The report confirms the need to reduce childhood lead exposure to the lowest feasible level, and reinforces the goal of the LRRS for stringent lead limits in affected consumer products to effectively prohibit the intentional use of lead.
Young children also have a higher probability of lead exposure because of their natural exploratory behaviour, which leads them to chew or suck on any objects within their reach. Lead has a sweet taste that encourages children to lick, chew or suck on items containing lead. This mouthing behaviour could result in ingestion of lead by the child.
Regulation of lead in consumer products in Canada
Health Canada sets stringent lead content limits for regulated products under the CCPSA and its regulations, including products intended for use in learning or play (toys) for children under three years of age, children’s jewellery, consumer paints and other surface coatings, products whose normal use involves mouth contact, kettles, corded window coverings, and glazed ceramic and glass foodware, as well as for applied surface coatings on toys, children’s furniture and other articles, cribs, cradles, bassinets, carriages, strollers, pencils, and artists’ brushes.
The LRRS was developed to identify proposed lead content limits for specific consumer products to which children are most likely to be exposed. The LRRS aims to address the risk of childhood lead exposure by reducing the lead content of consumer products, especially children’s products, to the lowest feasible level.
Health Canada introduced the Consumer Products Containing Lead (Contact with Mouth) Regulations (CPCLCMR) in 2010 to restrict lead in the following products, described as Group 1 products under the LRRS:
- (i) products, other than kitchen utensils, that are brought into contact with the user’s mouth in the course of normal use, such as beverage straws, drinking spouts, sports mouthpieces, mouthpieces of musical instruments; and,
- (ii) products intended for use in learning or play (toys) by children under three years of age.
The CPCLCMR impose a total lead limit of 90 mg/kg for Group 1 products.
Health Canada has conducted an assessment of the current science on lead and determined that even low levels of lead exposure are associated with effects on the developing brain in children (Health Canada, 2013). These effects are most commonly observed as a reduction of intelligence quotient (IQ) and deficits in attention-related behaviours. Toxicity to the developing brain has been associated with the lowest levels of lead exposure examined to date, both in observational studies of humans and in animal experiments.
As the current science has not identified a threshold level for lead toxicity on the developing brain of children, additional measures to further reduce exposures of Canadian children to lead are warranted. No
“safe” level of lead in the blood has been identified by scientists; therefore an appropriate risk management objective for lead in consumer products is to reduce the potential exposure of vulnerable populations such as children to the maximum extent practicable. The 90 mg/kg total lead limit for affected products helps to achieve this risk management objective, and is consistent with the lead limit under the CCPSA for other products posing a similar lead exposure risk.
A total lead limit was chosen rather than a migratable limit because total lead is a fixed value, while the amount of lead that will move out of an item is dependent on factors such as the presence or absence of coatings, temperature, duration of exposure to a solvent, and strength of the solvent, and is therefore variable.
Regulation of lead content in the United States and the European Union
In the U.S., the lead content of children’s products is regulated under the 2008 Consumer Product Safety Improvement Act (CPSIA). Under the CPSIA, the total lead limit for products intended primarily for children aged 12 and under has changed from 600 mg/kg in 2008, to 300 mg/kg in 2010, and to 100 mg/kg in 2011. The CPSIA has a provision that requires review of the lead limit for children’s products every five years and further reductions in the lead limit to the lowest amount of lead that is technologically feasible at that time.
Under the CPSIA, the total lead limit for all applied paints and other surface coatings on all children’s products is 90 mg/kg. In addition, there is a limit of 90 mg/kg migratablefootnote4 lead for children’s modelling clays and for toys and toy parts that are likely to be mouthed, including all toys for children less than six years of age.
In April 2015, the European Union (EU) adopted a total lead limit of 0.05% by weight (equivalent to 500 mg/kg) for a broad range of
“articles or accessible parts thereof that may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children.” The requirement applies to children’s clothing and accessories, and to accessible parts of childcare articles. Toys are excluded from the application of this legislation because they are covered under the 2009 EU Toy Safety Directive. This Directive includes migratable lead limits of 160 mg/kg for scraped-off toy materials, including polymers, glass, ceramics, metals, and surface coatings, 13.5 mg/kg for dry, brittle, powder-like or pliable toy materials, such as chalks and modelling clays, and 3.4 mg/kg for liquid or sticky toy materials such as inks, paints, and glues. Effective October 28, 2018, in accordance with the amended Directive, these limits will be replaced by more stringent migratable lead limits of 23 mg/kg for scraped-off materials, 2.0 mg/kg for dry, brittle, powder-like or pliable materials, and 0.5 mg/kg for liquid or sticky materials. (https://members.wto.org/crnattachments/2014/tbt/EEC/14_4268_00_e.pdf)
More detailed information on lead limits for affected products in the U.S. and the EU can be found in Appendix I.
Under normal and reasonably foreseeable conditions of use, children are in frequent and extended contact with Group 2 products. These products have the potential to expose children to unsafe levels of lead.
Health Canada has identified Group 2 products with lead in excess of 90 mg/kg on the North American marketplace. In the past 10 years, there have been recalls due to high lead levels in some of these products, particularly children’s clothing and accessories.
In 2001, children’s wallets were recalled in the U.S. because of lead in the zipper pulls. footnote4 In July 2008, footnote5 children’s pyjamas sets were recalled in the U.S. because of excess lead in screen prints on the tops, while in April 2011, dresses and tops were recalled in the U.S. because beads and trim on the garments were found to contain high levels of lead. footnote6 Similarly, in April 2012, a clothing company voluntarily recalled various garments offered for sale in Canada and the U.S. due to the presence of lead in ornamentation and trim. footnote7
Because the lead content of an item cannot be determined through visual inspection, it is difficult for consumers and caregivers to avoid lead exposure risks from products.
The introduction of a total lead limit for Group 2 products will help to achieve the risk management objective, will result in greater predictability for industry and a clear line for the purposes of inspection and enforcement, and will support greater consumer confidence in the safety of Group 2 products marketed in Canada.
The objective of these Regulations is to help protect children against potential exposure to lead by expanding the requirements of the Consumer Products Containing Lead (Contact with Mouth) Regulations (CPCLCMR) to include Group 2 products.
The CPCLCMR came into force on November 26, 2010, and set a total lead limit of 90 mg/kg for Group 1 products under the LRRS. These Regulations extend the requirements of the CPCLCMR to Group 2 products, which include
- products intended for use in learning or play (toys) by children between the ages of 3 and under 14 years;
- children’s clothing and accessories; footnote8 and
- products whose primary purpose is to facilitate the relaxation, sleep, hygiene, carrying or transportation of a child under 4 years of age.
To reflect the increased scope, the CPCLCMR are repealed and replaced with the Consumer Products Containing Lead Regulations (CPCLR).
The CPCLR include an exemption from the 90 mg/kg total lead limit for parts of affected products if lead is necessary to produce an essential characteristic of the part. Parts exempted from the total lead limit are still subject to a 90 mg/kg migratable lead limit. The CPCLCMR specified that the EN71-3:1994 Safety of Toys — Migration of Certain Elements test method must be used for determining migratable lead content. The CPCLR replace this provision with a more general requirement that good laboratory practices, as defined in the CPCLR, must be used when testing to determine migratable lead content. This change provides industry with more flexibility since it permits both the continued use of the EN71-3 test method and the use of alternative test methods for migratable lead that meet good laboratory practices.
Regulatory and non-regulatory options considered
Option 1: Status quo
The regulatory regime under the CPCLCMR, which imposed a 90 mg/kg total lead limit for toys intended primarily for children under the age of three and products whose normal use involves mouth contact, would have been retained. There would have been no specific lead limits in place for Group 2 products (except for a limit of 90 mg/kg total lead under the Toys Regulations for applied surface coatings).
This option was rejected because it would have resulted in the continuation of an unnecessary lead exposure risk from affected products for children of all ages. Although less common than in children under 3 years of age, mouthing behaviours do occur in the 3 to under 14 year age group. Also, children under the age of 3 very often have access to toys, clothing and accessories purchased and used by older children.
Under this option, Health Canada could take action against lead in Group 2 products by invoking the General Prohibitions (GP) in the CCPSA on the manufacture, importation, sale or advertisement of consumer products that are a danger to the health or safety of Canadians. Although this approach has been taken with other consumer products/hazards, and has successfully demonstrated a key aspect of the modern tools and authorities afforded by the CCPSA, invoking the GP requires extra time to conduct of a risk assessment to support compliance actions. Establishing a total lead limit for Group 2 products in regulations will allow Health Canada to take swifter action on non-compliant products and provides greater clarity for industry regarding the acceptable limit.
Option 2: Voluntary standards
The majority of Canadian manufacturers voluntarily adhere to international standards for juvenile products, which stipulate no intentional addition of lead. This option would allow industry to continue this voluntary approach with respect to Group 2 products.
Although voluntary measures impose no regulatory burden on industry, there are a large number of manufacturers, distributors, and retailers of Group 2 products, most of which are based outside Canada. It would be difficult to obtain the commitment of the entire industry to a voluntary approach.
Under this option, Health Canada would have taken action against lead in Group 2 products by invoking the GP in the CCPSA on the manufacture, importation, sale or advertisement of consumer products that pose a danger to the health or safety of Canadians. Although this approach has been taken with other issues, and has successfully demonstrated a key aspect of the modern tools and authorities afforded by the CCPSA, invoking the GP requires extra time to conduct a risk assessment to support compliance actions. Establishing a total lead limit for Group 2 products in regulations would allow Health Canada to take swifter action on non-compliant products and would provide greater clarity for industry regarding the acceptable limit.
This option was rejected because it would result in the continuation of an unnecessary lead exposure risk to children.
Option 3: Introduction of a mandatory 100 mg/kg lead limit for affected products under the CCPSA
This option was considered as a way to address comments from some industry sectors that the 10 mg/kg difference between the proposed 90 mg/kg total lead limit and the 100 mg/kg total lead limit currently in effect in the U.S. under the CPSIA could result in additional costs for Canadian importers and manufacturers. Industry did not provide evidence that the Regulations would adversely affect international trade or increase industry costs and/or retail prices.
This option was rejected because
- a total lead limit of 100 mg/kg would create regulatory inconsistency within Canada by introducing a lead content limit that is different from the current 90 mg/kg total lead limit for products posing similar lead exposure risks to Canadians, particularly children.
- a 90 mg/kg total lead limit is consistent with Health Canada’s objective of reducing potential exposure to lead, especially for children, as much as possible.
Option 4: Introduction of a mandatory 90 mg/kg total lead limit for Group 2 products under the CCPSA
This is the preferred option and is represented by the CPCLR. This option was chosen because it is consistent with the way other products posing similar lead exposure risks are regulated under the CCPSA, including toys for children under three years of age, products whose normal pattern of use involves mouth contact, consumer paints and other surface coating materials, and applied paints and other surface coating materials on children’s products.
The total lead limit of 90 mg/kg is intended to prevent unnecessary lead exposure to children who are in regular and prolonged contact with one or more affected products. It is a stringent limit that is intended to be protective of children under the worst case exposure scenario, in which a Group 2 product containing lead, for example a toy component, is swallowed and becomes lodged in the digestive system for an extended period.
The choice of a 90 mg/kg limit is also consistent with the objective of Health Canada’s LRRS and its 2013
“Risk Management Strategy for Lead” footnote9 to reduce exposure to lead to the greatest extent practicable. The LRRS is based on the findings of Health Canada’s 2013
“State of the Science Report on Lead,” which recommended additional measures to protect Canadians against lead exposure. Introducing the lowest feasible limits for lead in Group 2 products will support this objective by protecting children against lead exposure risks from chewing, sucking or swallowing Group 2 products containing lead.
The Regulations specify a total lead limit rather than a migratable lead limit because a total lead limit is considered a more reliable measure of maximum exposure risks. Unlike total lead content, migratable lead content is not a fixed value. Factors such as duration of exposure, temperature, composition and condition of the item may greatly influence migration rates. If an item containing lead is swallowed and remains in the digestive tract for an extended period, virtually all the lead in the item may migrate into the body. However, migratable lead can never be greater than the total lead content of an item.
As well, since total lead tests are less costly than migratable lead tests, industry costs to test affected products will be lower.
Benefits and costs
An economic analysis was carried out in 2007 to determine the economic benefits of introducing a 600 mg/kg total lead limit and a 90 mg/kg migratable lead limit for Group 2 products.
An economic cost analysis to determine the impact of a 90 mg/kg total lead limit for Group 2 products was carried out in 2009. A questionnaire was distributed to 319 Canadian manufacturers, importers and distributors, and retailers of affected products, as well as six industry associations. A total of 11 responses were received from two industry associations, five retailers, and four manufacturers. The response rate was too low to permit quantitative estimation of the economic impact of the proposal. However, given the more stringent lead level, the economic benefits of the current proposal would be equal to or greater than those identified in the 2007 benefits study.
An electronic copy of the 2009 study in English and an executive summary in French are available upon request.
Costs to industry
Compliance costs for most companies are expected to be minimal because intentional use of lead in Group 2 products is contrary to current industry standards and is not common practice. Third-party lead testing and certification for children’s products have been mandatory in the U.S. since the CPSIA came into effect in 2008. The vast majority of suppliers to the North American market test for lead to ensure compliance with U.S. requirements as part of their normal practices; therefore, a mandatory limit of 90 mg/kg is not expected to result in significant additional testing costs.
Several respondents to the 2009 questionnaire indicated that incremental costs would be mainly for testing and would depend on the regulatory testing and certification requirements. The U.S. CPSIA has mandatory third-party testing and certification requirements that created a considerable economic burden for U.S. industry, and some industry respondents expressed concern that similar requirements could be put in place in Canada. The CPCLR do not include any specific testing or certification requirements.
Concerns were expressed over the potential impact of increased compliance costs on small businesses, mainly related to product testing. A six-month transition period following registration is included in the regulation in order to give small businesses sufficient time to comply with the new requirements.
Costs to consumers
Costs to industry to comply with these Regulations are likely to be passed on to the consumer. Since industry costs are expected to be minimal, no significant economic costs to the consumer are anticipated.
Costs to Government
Health Canada is responsible for the implementation of the Regulations and for related compliance and enforcement activities. These activities will be a part of Health Canada’s regular compliance and enforcement program for consumer products and the Department will not incur any incremental capital or operating costs due to the Regulations.
Benefits to Canadians
The benefits of the Regulations arise from the reduced risk of lead exposure when children chew, suck or swallow an affected product containing lead. Lead can affect all body systems, but is particularly harmful to the nervous system. Ongoing exposure to even small amounts of lead can have adverse effects on the cognitive development and behaviour of children.
A 2007 economic benefits analysis estimated the benefits of introducing a 600 mg/kg total lead limit and a 90 mg/kg migratable lead limit for Group 2 products at $1.732 million over 10 years when discounted at a rate of 5% (approximately $2.002 million adjusted for 2016 dollars).footnote10 Nearly 90% of the benefits were attributed to avoided losses of lifetime earnings. Other benefits identified included: avoided direct medical costs; avoided juvenile justice expenditures; avoided special education costs; and avoided mortalities.
The 2009 economic cost study for the 90 mg/kg total lead limit determined that if changing the total lead limit from 600 mg/kg to 90 mg/kg resulted in an additional 25% reduction in the contribution of Group 2 products to blood lead burden, the discounted benefits would increase by an additional $779,000 over the 10-year period (approximately $880,000 adjusted for 2016 dollars) beyond the total benefits identified in the 2007 benefits study. This would increase the value of discounted benefits from $1.7 million (approximately $1.92 million adjusted for 2016 dollars) to at least $2.5 million over 10 years (approximately $2.82 million adjusted for 2016 dollars).
Table 1: Summary of economic impacts of the Regulations
Quantified impacts in Can$, August 2016 price level/constant dollars
Avoided direct medical expenses, costs of mortalities, special education costs, juvenile justice costs, and loss of lifetime earnings
Affected individuals, society
“One-for-One” Rule does not apply to these Regulations, as there is no change in administrative burden to business.
Small business lens
The small business lens does not apply because estimated nation-wide costs of the Regulations are less than $1 million per year.
A pre-Canada Gazette consultation on the proposal for these Regulations was completed in February 2012. Responses were received from 13 stakeholders, including 7 industry associations, 2 companies, and 4 public health NGOs. There was no opposition in principle to regulating the lead content of the three affected product categories. Industry respondents expressed a variety of specific concerns related to scope, timing of coming into force, testing and certification, and harmonization with international standards. Public health NGOs strongly supported a total lead limit of 90 mg/kg and favoured the most stringent requirements.
Canada Gazette, Part I, consultation
The proposed Consumer Products Containing Lead Regulations were published in the Canada Gazette, Part I, on December 3, 2016, for a stakeholder comment period that ended on February 17, 2017. A total of 12 submissions were received from 13 respondents, with 2 commenters making a joint submission. Respondents included 7 industry associations, 2 public health non-governmental organizations (NGOs), one consultant, one provincial government, one retailer, and one other (sector unspecified).
An industry association and a public health NGO expressed general support for the proposed Regulations. One industry association expressed support for the exemption for parts of affected products that cannot meet the total lead limit for technical reasons, and a consultant expressed support for the exemption for children’s books.
Four respondents asked for clarification on the scope of the Regulations and two submitted comments or questions relating to test requirements. Health Canada clarified that the proposed Regulations do not include any testing requirements, other than a provision that migratable lead tests must be carried out using good laboratory practices. One provincial government asked for clarification on how the proposed lead limit was established.
Issues identified by stakeholders included the following:
1. Alignment with U.S. requirements
One U.S. and two Canadian industry associations identified alignment with U.S. requirements in general as a central issue. A joint submission from one Canadian and one U.S. association stated that the comments provided by the associations in 2012 in support of alignment with the U.S. limit of 100 mg/kg total lead for children’s products remained
“valid and pertinent.” Another Canadian industry association stated that alignment with U.S. requirements in general is a priority for industry, as well as a commitment by the Government of Canada. The association stated that non-alignment is a serious challenge for industry.
Health Canada response
Health Canada supports the principle of regulatory alignment between the U.S. and Canada. The 90 mg/kg total lead limit is in general alignment with the current U.S. 100 mg/kg total lead limit for children’s products. Industry has not provided any specific information to indicate how serious challenges to industry might arise from the slight misalignment between the requirements of these Regulations and current U.S. requirements, given that a 10 mg/kg misalignment makes a negligible difference from health impact, manufacturing and compliance perspective; therefore, Health Canada is not in a position to determine how a change to the Canadian limit would address such challenges. For reasons that are discussed under Regulatory and non-regulatory options considered, above, and Regulatory cooperation, below, Health Canada has retained the 90 mg/kg total lead limit.
2. Administrative burden
One Canadian industry association stated that the proposed requirements will impose an additional administrative burden on industry, and that the
“One-for-One” Rule section of the Regulatory Impact Analysis Statement (RIAS) should be revised accordingly.
Health Canada response
The purpose of the federal government’s
“One-for-One” Rule is to control new administrative burden on industry resulting from regulations. Administrative burden includes planning, collecting, processing and reporting of information, and completing forms and retaining data required by the federal government to comply with a regulation.
The Consumer Products Containing Lead Regulations do not include any specific industry requirements for recordkeeping or any third party testing or certification requirements. The only testing requirement is that migratable lead tests to determine compliance with the conditions of the essential use exemption in subsection 2(2) must be carried out using good laboratory practices, as determined by the Organisation for Economic Co-operation and Development.
Lead content tests carried out by industry to determine compliance with regulatory lead limits are considered to be compliance costs. Under the
“One-for-One” Rule, compliance costs are not included in the definition of administrative burden. Guidance on the
“One-for-One” Rule can be viewed at https://www.canada.ca/en/treasury-board-secretariat/services/federal-regulatory-management/guidelines-tools/controlling-administrative-burden-guide-one-for-one-rule.html#cha1.
3. Management of lead exposure risks
One public health NGO criticized the limited scope and
“extremely slow” process of introducing lead content limits for consumer products. The stakeholder also expressed concern that Health Canada remains overly focussed on establishing lead content regulations in terms of how products are promoted or marketed.
Health Canada response
In establishing lead content limits for products that may potentially contain lead, Health Canada gives priority to consumer products that children are most likely to interact with regularly and, therefore, pose the greatest lead exposure risk. Lead limits have been introduced or made more stringent for many consumer products.
Health Canada addresses exposure risks through lead content limits, which are inherent to the product itself, rather than through requirements related to product marketing or presentation, such as warnings on labels or packaging.
4. Upper age limit
One U.S. industry association recommended the adoption of an upper age limit of 12 years, rather than the proposed upper age limit of under 14 years, to align with the upper age limit of 12 years for children’s products under the U.S. Consumer Product Safety Improvement Act (CPSIA). The stakeholder provided a statement released by the International Chamber of Commerce (ICC), which recommends 12 as the
“benchmark” age for identifying
Health Canada response
Health Canada has retained the upper age limit of under 14 years.
The ICC Statement is intended to address industry marketing and advertising practices targeted toward children. Health Canada considers that age limits in international health and safety standards are more applicable to health and safety issues and requirements relating to children’s products.
Health Canada’s policy is to interpret the term
“children’s product” as a product intended for use by children under 14 years of age, unless a different age is prescribed within a requirement. This interpretation is consistent with several international safety standards for children’s products. Although the CPSIA defines
“children’s product” as a consumer product designed or intended primarily for children 12 years of age or younger, the Act also mandates the application of ASTM F963-11 Standard Consumer Safety Specification for Toy Safety, which applies to
“toys intended for use by children under 14 years of age.”
5. Implementation timelines
Noting the period of time associated with the implementation of the proposed requirements, one public health NGO urged that the Regulations be implemented without further delay. An industry association stated that for operational and contractual reasons, industry needs a minimum one-year transitional period to achieve compliance with the proposed requirements.
Health Canada response
Health Canada has retained the six-month transition period. Industry has been made aware of the proposal to introduce these regulatory requirements for a number of years, and no evidence has been provided to support the comment that a longer transition period is needed to achieve compliance. Most companies already comply with international standards for products intended for children, which specify that there must be no intentional use of lead. Industry has not provided any data to indicate that compliance with these Regulations would result in additional costs.
The Regulations introduce Canadian requirements for affected products that generally align with requirements in the U.S. While the Regulations result in slight differences between Canadian and U.S. requirements, these differences are being maintained because they (i) ensure consistency for lead limits across the Canadian regulatory regime; (ii) are more protective of health; and/or (iii) ensure consistency with the common objective held by Health Canada and consumer product safety regimes in other jurisdictions to reduce intentional use of lead to the greatest extent feasible.
The U.S. limit applies to products intended for children aged 12 years or under. The CPCLR, which apply to toys and children’s clothing and accessories intended for children under 14 years of age, are consistent with the application of the Toys Regulations under the CCPSA, which define a child as someone under the age of 14 years, and with the U.S. ASTM F963-11 Toy Safety Standard, international toy safety standards, and the EU Toy Safety Directive.
“products whose primary purpose is to facilitate the relaxation, sleep, hygiene, carrying or transportation of a child under four years of age,” a category of affected products in these Regulations, differs from the U.S. definition of
“child care article” as
“a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children aged three and younger, or to help such children with sucking or teething.” The scope of the CPCLR includes products that are
“brought into contact with the user’s mouth during normal use.” Articles to facilitate feeding are considered to fall within this product category and are subject to the 90 mg/kg total lead limit under the Regulations. Conversely the U.S. definition does not cover products such as baby baths, backpacks, slings, and carriers. These products are included in the Regulations as their normal use involves reasonably foreseeable contact with the mouth of a child, and may therefore pose a lead exposure risk.
The total lead limit of 90 mg/kg is only slightly different from the current U.S. limit of 100 mg/kg total lead for children’s products. A 10 mg/kg difference in lead limits will have no demonstrable impact on health. Either value (U.S. or Canadian limit) precludes the intentional use of lead. In the past, industry has expressed concern that the different total lead limits for children’s products in Canada and the U.S. have the potential to add unnecessary complexity and confusion for its members and to increase product testing costs. Industry has not provided any economic or other data as evidence of adverse impacts from the 10 mg/kg difference. Furthermore, there is no practical difference to industry for compliance testing purposes. A single total lead test is sufficient to determine compliance with either limit.
Products that are compliant with the U.S. 100 mg/kg total lead limit (but not the proposed 90 mg/kg limit) would not always result in recall action by Health Canada. Decisions are made on a case-by-case basis, taking into consideration various factors such as past compliance history, type of product, availability on the market/previous amounts sold to consumers, and level of risk posed by the product.
This difference in lead content limits between these Regulations and limits in other jurisdictions reflects the need to achieve internal regulatory consistency by aligning the lead limit for affected products with the existing measures in place under the CCPSA to help protect children against lead in all product categories that present a similar lead exposure risk.
Health Canada supports the Government of Canada’s efforts to work toward greater alignment with U.S. regulatory requirements in order to provide greater consistency for industry and will continue to work with the U.S. Consumer Product Safety Commission and other international and industry partners to ensure children’s products do not contain lead at levels that could harm children’s health. However, Health Canada has decided not to align requirements with a U.S. limit that is higher than Canada’s existing limit for similar products.
The health and safety of young children is of great importance because they are a very vulnerable subgroup of the population and need the highest degree of protection against environmental hazards such as lead. Children’s health is a high priority for the Government of Canada.
In 2013, Health Canada released
“The State of the Science Report on Lead” and the
“Risk Management Strategy for Lead” as part of the Government of Canada’s Chemicals Management Plan, which indicated that developmental neurotoxicity in children has been associated with even very low blood lead levels. The report confirms the need to reduce childhood lead exposure to the lowest feasible level, and reinforces the goal of the LRRS for stringent lead limits in affected consumer products to ensure that there is no intentional use of lead.
A specific regulatory limit provides a clear compliance goal for industry and gives Health Canada the authority to take immediate enforcement action against any Group 2 product that contains more than 90 mg/kg total lead.
The results of stakeholder consultation and the cost-benefit analysis indicate that costs to industry will be minimal and will be outweighed by the societal benefits of reduced lead exposure risk, especially to children.
Implementation, enforcement and service standards
The CPCLR will come into effect six months after the date of publication in the Canada Gazette, Part II. In the interim, Health Canada can take corrective measures using the GP if Group 2 products containing high lead levels are found on the Canadian marketplace.
Compliance and enforcement of the Regulations will follow established departmental policy and procedures. Health Canada’s Cyclical Enforcement (CE) approach for consumer products requires planned monitoring and enforcement surveys of all regulated products at regular intervals. The CE program proactively monitors industry compliance with the CCPSA and its regulations through planned marketplace surveillance surveys within a recurring timeframe. The frequency of CE surveys is based on, among other things, the degree of risk and hazard associated with the regulated products.
Enforcement activities under the Regulations will be primarily targeted toward Group 2 products that pose the highest potential risk. Immediate and appropriate enforcement actions, such as removal from sale and recall of products already sold will be taken against any non-compliant products.
The first CE survey for the products affected by the Regulations may be carried out within six months of their coming into force. The timing and scope of follow-up surveys will be determined by the results of the first survey.
Risk Management Bureau
Consumer Product Safety Directorate
Healthy Environments and Consumer Safety Branch
269 Laurier Avenue West, 4908B