Vol. 150, No. 49 — December 3, 2016

Consumer Products Containing Lead Regulations

Statutory authority

Canada Consumer Product Safety Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

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.

Currently there are 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 total lead limit of 90 milligrams of lead per kilogram of product (90 mg/kg) 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 three 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 Consumer Products Containing Lead Regulations (the proposed Regulations) would help improve the safety of children by expanding the scope of the current Consumer Products Containing Lead (Contact with Mouth) Regulations to include a total lead limit of 90 mg/kg for Group 2 products under the LRRS.

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 proposed 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 proposed 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. The proposed Regulations also ensure consistency for lead limits across the Canadian regulatory regime.

Some industry associations indicated that they would like Health Canada to align the limit with the United States’ 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 affected by the slight difference in lead limits, or any associated costs. No adverse trade impacts are anticipated.

Background

Health effects of lead

Lead is a very toxic metal, especially to children, and its adverse effects on this population have been documented in numerous studies. (see footnote 1), (see footnote 2)

Children absorb a higher percentage of the lead they ingest than adults do, and their developing body organs and systems are more susceptible to the toxic effects of lead. Lead builds up in the body, so that ongoing exposure to even low levels of lead may result in harmful effects on the growth and intellectual development of children.

The Health Canada Final Human Health 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 it. This mouthing behaviour could result in ingestion of lead by children.

Regulation of lead in consumer products in Canada

Health Canada sets stringent lead content limits for regulated products under the Canada Consumer Product Safety Act (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:

The CPCLCMR impose a total lead limit of 90 mg/kg for Group 1 products.

Calculations by Health Canada scientists, based on the World Health Organization provisional tolerable daily intake of 3.75 micrograms of lead per kilogram of body weight, showed that a 600 mg/kg total lead limit could potentially expose children to harmful amounts of lead and that a 90 mg/kg total lead limit would provide adequate protection to children against lead exposure from Group 1 products. 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, the duration of exposure to a solvent, and the strength of the solvent, and is therefore variable.

Regulation of lead content in the United States and the European Union

In the United States, 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 was reduced from 600 mg/kg in 2008 to 300 mg/kg in 2010, and then to 100 mg/kg in 2011. The CPSIA has a provision that requires a 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 to achieve.

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 migratable 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 EU’s 2009 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.

More detailed information on lead limits for affected products in the United States and the EU can be found in Appendix 1.

Issues

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, if they contain lead, and the absence of lead content limits for affected products creates a preventable risk of lead exposure for children.

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 July 2008, (see footnote 3) children’s pyjama sets were recalled in the United States because of excess lead in screen prints on the tops, while in April 2011, dresses and tops were recalled in the United States because beads and trim on the garments were found to contain high levels of lead, (see footnote 4) and in April 2012, a clothing company voluntarily recalled various garments offered for sale in Canada and the United States due to the presence of lead in ornamentation and trim. (see footnote 5) In 2001, children’s wallets were recalled in the United States because of lead in the zipper pulls. (see footnote 6)

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.

Currently, there are no specific limits in Canada for lead in Group 2 products. Health Canada can take regulatory action against lead in Group 2 products by using the general prohibitions (GP) in the CCPSA that prohibit the manufacture, import, advertisement or sale of consumer products that are a danger to human health or safety.

The introduction of a total lead limit for Group 2 products would result in greater predictability for industry and a clear line for the purposes of inspection and enforcement, and would support greater consumer confidence.

Objectives

The objective of these proposed Regulations is to help protect children against potential exposure to lead by expanding the requirements of the CPCLCMR to include Group 2 products.

Description

The current CPCLCMR came into effect on November 26, 2010, and set a total lead limit of 90 mg/kg for Group 1 products under the LRRS. The current regulatory proposal would extend the requirements of the CPCLCMR to Group 2 products, which include the following:

  1. Products intended for use in learning or play (toys) by children from the ages of 3 to under 14;
  2. Children’s clothing and accessories; (see footnote 7) and
  3. Products whose primary purpose is to facilitate the relaxation, sleep, hygiene, carrying or transportation of a child under 4 years of age.

Under the proposal, the existing CPCLCMR would be repealed and replaced with the Consumer Products Containing Lead Regulations (CPCLR) to reflect the increased scope of consumer products covered.

Both the current CPCLCMR and the proposed 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 exempt from the total lead limit are subject to a 90 mg/kg migratable lead limit. The CPCLCMR specify that the EN 71-3:1994 Safety of toys — Migration of certain elements test method must be used for determining migratable lead content. The proposed CPCLR would replace this provision with a more general requirement that good laboratory practices, as defined in the proposed Regulations, must be used when testing to determine migratable lead content. This change would provide industry with more flexibility since it would permit 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 current regulatory regime, which imposes a 90 mg/kg total lead limit under the CPCLCMR for toys intended primarily for children under the age of three, and products whose normal use involves mouth contact, would be retained. There would be 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 considered and rejected because it would result 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 years age group. Also, children under the age of 3 very often have access to toys, clothing and accessories purchased for older children.

Under this option, Health Canada could take 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 are a danger to the health or safety of Canadians. Although this approach has been taken with other consumer products and hazards, and has successfully demonstrated a key aspect of the modern tools and authorities afforded by the CCPSA, invoking the GP presents the extra burden of 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 to industry regarding the acceptable limit.

Option 2: Voluntary standards

The majority of Canadian manufacturers voluntarily comply with international standards for products intended for children, which stipulate that there must be no intentional addition of lead. This option would allow industry to continue this voluntary compliance with respect to Group 2 products.

Although voluntary measures impose no regulatory burden on industry, there is a large number of manufacturers, distributors, and retailers of Group 2 products, most of which are based outside Canada, and it would be difficult to obtain the commitment of the entire industry to a voluntary approach.

Under this option, Health Canada could take 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 presents the extra burden of 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 to 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 Consumer Products Containing Lead Regulations

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 United States under the CPSIA could result in additional costs for Canadian importers and manufacturers. To date, industry has not provided evidence that the proposed Regulations would adversely affect international trade or increase industry costs and/or retail prices.

This option was rejected for the following reasons:

  1. 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.
  2. 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 Consumer Products Containing Lead Regulations

This is the preferred option and is represented by the current regulatory proposal to introduce a 90 mg/kg total lead limit for Group 2 products.

This option is recommended 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 provides a margin of safety to children in regular and prolonged contact with one or more affected products. It is a stringent limit that is adequately 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 (see footnote 8) to reduce exposure to lead to the greatest extent practicable. The LRRS is based on the findings of Health Canada’s 2013 Final Human Health 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.

This preferred option specifies 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, 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.

Furthermore, since total lead tests are less costly than migratable lead tests, industry costs to test affected products will be reduced.

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 6 industry associations. Eleven 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 United States 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 proposed amendments do not include any specific testing and 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 regulatory proposal and would give small businesses additional time to comply with the new requirements.

Costs to consumers

Costs to industry to comply with this regulatory proposal 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 would be responsible for the implementation of the proposed Regulations and for related compliance and enforcement activities. These activities would be a part of Health Canada’s regular compliance and enforcement program for consumer products and the Department would not incur any incremental capital or operating costs due to the proposed Regulations.

Benefits to Canadians

The benefits of the proposal 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).9 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 proposed 90 mg/kg total lead limit determined that if changing the proposed 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 the 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 proposed Regulations

Quantified impacts in Can$, August 2016 price level / constant dollars

 

B8ase Year

Total (PV) (see footnote 9)

Annualized Average

Positive impacts

By stakeholder

2016

   

Avoided direct medical expenses, costs of mortalities, special education costs, juvenile justice costs, and loss of lifetime earnings

Affected individuals, society

 

2,820,000

365,202

Total benefits

2,820,000

365,202

Qualitative impacts

Consumer (negative)

  • Any additional industry costs are likely to be passed to the consumer; however, these costs are expected to be insignificant.

Industry (negative)

  • Some companies may face additional costs related to sourcing of compliant materials and testing affected products to ensure compliance with the lead limit; however, these costs are expected to be insignificant.

Government (positive)

  • Reduction in medical, education, and juvenile justice costs.

“One-for-One” Rule

The “One-for-One” Rule does not apply to this proposal, as there is no change in administrative burden to business.

Small business lens

The small business lens does not apply because estimated nationwide costs of the proposal are less than $1 million per year.

Consultation

A pre-Canada Gazette consultation on the current regulatory proposal 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 the proposed total lead limit of 90 mg/kg and favoured the most stringent requirements.

Specific issues raised by industry included the following:

  1. The scope of the Group 2 category — “products whose primary purpose is to facilitate the relaxation, sleep, hygiene, carrying or transportation of a child under four years of age” — under the proposal should be the same as the definition of “child care article” in the Phthalates Regulations or in the U.S. CPSIA.

    Health Canada has reviewed the proposed scope for this product category and determined that it is appropriate. There are some Group 2 products, such as baby backpacks, slings, and similar items, that are not covered by the definition of child care article in the Phthalates Regulations or the definition in the CPSIA, but could involve reasonably foreseeable, sustained contact with the mouth of a child during use.

  2. The upper age limit of 13 years for children’s clothing and accessories and for products intended for use by children in learning or play should be reduced to 12 years, so the limit is aligned with that of the U.S. definition of children’s product.

    Health Canada believes that the upper age limit of under 14 years is appropriate and is aligned with international standards. It is consistent with the limit specified in well-recognized international toy safety standards such as ISO 8124-1, EN71-1 and ASTM F963, and with the 2009 EU Toy Directive.

  3. Members of the printing industry requested an exemption from the proposed amendments for children’s books and other similar printed materials.

    Health Canada did not intend for books and similar products to be covered by this regulatory proposal and has added a clause specifically excluding them from its application.

  4. A number of industry respondents recommended adoption of the U.S. limit of 100 mg/kg total lead under the CPSIA.

    Health Canada has retained the proposed 90 mg/kg total lead limit. The rationale for this decision is outlined under Option 3 in the “Regulatory and non- regulatory options considered” section and in the “Regulatory cooperation” section.

  5. Some industry respondents recommended that the proposal apply only to products manufactured or imported after the date of coming into force.

    Regulations under the CCPSA are not applied retroactively. Group 2 products would be subject to the proposed Regulations only if they were manufactured, imported or sold after the coming-into-force date.

    Furthermore, the proposed six-month interval between publication of the proposed Regulations and their coming into force would give industry additional time to adapt their product lines to meet the new requirements.

  6. Some industry respondents asked for clarification of the testing and certification requirements for affected products.

    The proposal does not include any specific requirements for product testing and certification, other than testing in accordance with good laboratory practices. Companies may choose any commonly accepted, appropriate test method to verify compliance with the total lead limit under the proposed Regulations.

Regulatory cooperation

The proposed Regulations introduce Canadian requirements for affected products that generally align with requirements in the United States. While the proposed amendments would result in slight differences between Canadian and U.S. requirements, these differences are being maintained because they would either (i) ensure consistency for lead limits across the Canadian regulatory regime, (ii) be 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 current proposal, which applies to toys and children’s clothing and accessories intended for children under 14 years of age, is 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.

The “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 products affected by this proposal, differs from “child care article,” defined by the United States 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.” Articles to facilitate feeding are already subject to a 90 mg/kg total lead limit under the current CPCLCMR. Conversely the U.S. definition does not cover products such as baby baths, backpacks, slings, and carriers. These products are included in the proposed Regulations, as their normal use involves reasonably foreseeable contact with the mouth of a child, and may therefore pose a lead exposure risk.

The proposed 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 would have no demonstrable impact on health. Either value (U.S. or Canadian limit) would preclude 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 United States 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 would be 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.

The difference in lead content limits between this regulatory proposal 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 protect children against lead in other product categories that present a similar lead exposure risk.

Health Canada supports the Government of Canada’s efforts to work toward greater alignment with American 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.

Rationale

The health and safety of young children is of great importance, because children 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 Final Human Health 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 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 would provide a clear compliance goal for industry and would give Health Canada the authority to take immediate enforcement action against any Group 2 products that contain more than 90 mg/kg total lead.

The results of stakeholder consultation and the cost- benefit analysis indicate that costs to industry would be minimal and would be outweighed by the societal benefits of reduced lead exposure risk, especially to children.

Implementation, enforcement and service standards

The proposed amendments would come into effect six months after the date of publication in the Canada Gazette, Part II. In the interim, Health Canada could take corrective measures using the GP and orders regime if Group 2 products containing high lead levels were found on the Canadian marketplace.

Compliance and enforcement of the proposed Regulations would 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 time frame. The frequency of CE surveys is based on the degree of risk and hazard associated with the regulated products.

Enforcement activities under the proposed Regulations would be 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, would be taken against any non-compliant products.

The first CE survey for the products affected by the proposed Regulations may be carried out within six months of their coming into force. The timing and scope of follow-up surveys would be determined by the results of the first survey.

Contact

Sarah Sheffield
Project Officer
Risk Management Bureau
Consumer Product Safety Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
269 Laurier Avenue West, 4908B
Ottawa, Ontario K1A 0K9
Fax: 613-952-2551
Email: Sarah.Sheffield@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to section 37 of the Canada Consumer Product Safety Act (see footnote a), proposes to make the annexed Consumer Products Containing Lead 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 Sarah Sheffield, Project Officer, Risk Management Bureau, Consumer Product Safety Directorate, Healthy Environments and Consumer Safety Branch, Department of Health, Address Locator 4908B, 269 Laurier Avenue West, Ottawa, Ontario K1A 0K9 (fax: 613-952-2551; email: sarah.sheffield@hc-sc.gc.ca).

Ottawa, November 24, 2016

Jurica Čapkun
Assistant Clerk of the Privy Council

Consumer Products Containing Lead Regulations

Interpretation

Definitions

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:

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)

Requirements

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.

Exception

(2) Each accessible part may contain more than 90 mg/kg of lead if

Repeal

3 The Consumer Products Containing Lead (Contact with Mouth) Regulations (see footnote 10) 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.

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