Children’s Jewellery Regulations: SOR/2018-82

Canada Gazette, Part II, Volume 152, Number 9

Registration

April 23, 2018

CANADA CONSUMER PRODUCT SAFETY ACT

P.C. 2018-436 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 Children’s Jewellery Regulations.

Children’s Jewellery Regulations

Interpretation

Definitions

1 The following definitions apply in these Regulations.

• children’s jewellery means jewellery that is manufactured, sized, decorated, packaged, advertised or sold in a manner that appeals primarily to children under 15 years of age but does not include merit badges, medals for achievement or other similar objects normally worn only occasionally. (bijoux pour enfants)
• 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

2 Children’s jewellery, when tested using good laboratory practices, must not contain more than 90 mg/kg of lead.

Cadmium content

3 Children’s jewellery, when tested using good laboratory practices, must not contain more than 130 mg/kg of cadmium if the jewellery item is small enough to be totally enclosed in the small parts cylinder illustrated in the schedule when a force of not more than 4.45 N is applied.

Repeal

4 The Children’s Jewellery Regulations ^footnote1 are repealed.

Coming into Force

Six months after publication

5 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.

SCHEDULE

(Section 3)

Small Parts Cylinder

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Background

Lead is a heavy metal which is very toxic,^{footnote2,footnote3} especially to children. Young children are also more likely to be exposed to lead because of their natural habit of mouthing objects. Lead has historically been used in children’s jewellery because it is inexpensive and easily moulded. A number of lead poisoning cases in children, including one fatality in the U.S., have been associated with chewing, sucking or swallowing jewellery with high lead content.

The current CJR restrict the use of lead in jewellery items intended for children under the age of 15 years to 600 mg/kg total lead and 90 mg/kg migratable^footnote4 lead, and do not include any limits on cadmium.

Cadmium is also a highly toxic heavy metal. Unlike lead, which has a sweet taste, cadmium tastes very bitter and it is unlikely that children would regularly chew or suck cadmium-containing jewellery. However, Health Canada scientists have concluded that there is potential for serious health effects in children who swallow jewellery items made with cadmium. Ingested cadmium has been associated with adverse effects on the kidneys, liver, heart, blood system, nervous system, reproductive system and immune system.

Health Canada has reason to believe that unintentional ingestion of jewellery by children occurs frequently. The United States Consumer Product Safety Commission (U.S. CPSC) reported in 2006 that from 2000–2005, there were more than 300 000 emergency room visits in the U.S. by children 18 years of age or below because of foreign object ingestion. It was estimated that 80% of these children were below 7 years of age and that approximately 20 000 of the swallowed objects were jewellery items. There is no risk to human health from simply wearing children’s jewellery containing high levels of lead and/or cadmium.

In 2009–2010, Health Canada carried out a survey of children’s jewellery products to determine the level of marketplace compliance with the lead content limits of the CJR. Because of concerns that manufacturers may have been increasingly substituting scrap cadmium for lead in children’s jewellery, all 103 survey samples were also tested for cadmium. Very high cadmium levels, up to 93% (930 000 mg/kg), were found in some of the samples. Health Canada issued a consumer advisory on lead and cadmium in children’s jewellery on January 10, 2010.^footnote5

Children’s jewellery items with high cadmium content were also found at the same time on the American market. In 2010, the U.S. CPSC announced a number of recalls of children’s jewellery items because of high levels of cadmium.

Issues

Children who chew, suck or swallow children’s jewellery containing lead and/or cadmium are at serious risk of harmful, even fatal, adverse health effects. It is difficult for parents and caregivers to protect children against lead or cadmium in children’s jewellery because it is not possible to accurately determine whether an item contains lead or cadmium without tests which cannot feasibly be carried out by the general public.

Lead

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.

Since 2005, Health Canada has reduced existing total lead content limits for products like consumer paints and other surface coating materials, toys for children under 3 years of age and applied surface coatings on children’s articles to the more stringent level of 90 mg/kg. However, for children’s jewellery, the total lead content limit remained at 600 mg/kg. 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 were 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 children’s jewellery under the CCPSA is consistent with other products posing a similar risk. Market surveys conducted by Health Canada indicate this is an achievable level and the majority of children’s jewellery items are already in compliance.

Cadmium

Historically, use of cadmium in consumer products has been limited to a few special applications. However, following the introduction of stringent lead limits, Health Canada discovered that children’s jewellery items containing high levels of cadmium were available on the Canadian marketplace.

As a result of the discovery of children’s jewellery items with very high cadmium content on the Canadian marketplace during Health Canada’s 2009–2010 survey in October 2010, the former Minister of Health called on industry to voluntarily stop the production, import, and sale of children’s jewellery items containing cadmium. It was also indicated that if there was no improvement, regulatory measures might be put in place. The results of follow-up marketplace surveys by Health Canada in 2011, 2012 and 2013 showed that children’s jewellery items containing high cadmium levels were still available on the Canadian marketplace.

Health Canada toxicologists carried out a risk assessment^footnote6 in 2011 to identify a cadmium limit for children’s jewellery which would sufficiently protect children against cadmium exposure if they swallowed a children’s jewellery item. A limit of 130 mg/kg total cadmium was identified as being sufficiently protective of children under the worst-case exposure scenario in which a child swallowed a children’s jewellery item which became lodged in the stomach over an extended period.

Prior to introducing these amendments, Health Canada could take action against children’s jewellery containing cadmium only by use of the general prohibition (GP) in the CCPSA which prohibits the manufacture, import, advertisement or sale of consumer products that pose a danger to human health or safety. Health Canada wanted to formalize cadmium requirements for children’s jewellery in CJR while updating the lead limits to collate applicable restrictions on metals used in children’s jewellery.

Objectives

The objective of the amendments to the CJR is to help protect children against serious risks to health from chewing, sucking or swallowing children’s jewellery containing lead or cadmium by introducing a limit on total cadmium content and further restricting total lead levels in children’s jewellery products to more protective levels.

Description

The amendments to the CJR

• (1) replace the current 600 mg/kg total lead limit and 90 mg/kg migratable lead limit with a 90 mg/kg total lead limit for all children’s jewellery items; and
• (2) add a limit of 130 mg/kg total cadmium for children’s jewellery items which are small enough to be totally enclosed in a small parts cylinder. (The small parts cylinder is an internationally recognized gauge used to determine whether an item can be swallowed by a child.)

The new CJR will come into force six months after the date of publication in CGII.

Regulatory and non-regulatory options considered

Option 1: Status quo

Cadmium — Health Canada could have continued to take action against cadmium in children’s jewellery 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 fixed total cadmium limit in regulations will allow Health Canada to take swifter action on non-compliant products and provide greater clarity for industry regarding the acceptable limit.

Lead — The current limits of 600 mg/kg total lead and 90 mg/kg migratable lead did not reflect the fact that harmful health effects may occur at very low levels of lead exposure, especially to children. They were also inconsistent with current lead limits under the CCPSA for other products posing a similar exposure risk to children.

The existence of a migratable limit in addition to a total lead limit also created potential for additional industry costs, since migratable lead testing was required if the total lead content was between 90 mg/kg and 600 mg/kg.

This option was rejected because it would result in the continuation of an unnecessary risk of exposure to cadmium and lead from children’s jewellery, provide insufficient clarity on acceptable cadmium limits, and is not consistent with lead limits currently in effect or proposed for other products that pose a similar lead exposure risk.

Option 2: Voluntary industry standards for cadmium

Despite the former Minister of Health’s October 2010 challenge to industry to voluntarily discontinue the use of cadmium in children’s jewellery, follow-up marketplace surveys carried out by Health Canada in 2011, 2012, and 2013 determined that children’s jewellery with high cadmium levels were still being sold in Canada. These results showed that the request for voluntary action had been ineffective in removing children’s jewellery with dangerous levels of cadmium from the marketplace.

Similarly, in 1999 and again in 2000, Health Canada requested that industry voluntarily refrain from selling children’s jewellery made with lead. Follow-up marketplace surveys in 1999 and 2001 showed that the voluntary request had been ineffective and items with high lead content were still being sold in Canada.

Voluntary standards are generally effective only when endorsed and enforced by industry. The children’s jewellery industry in Canada is fragmented and constantly changing, with many distribution channels and retail outlets. Almost all manufacturers and suppliers marketing children’s jewellery in Canada are based offshore, mainly in Asia. Because of these factors, it would be difficult to obtain commitment or effective enforcement from industry for a voluntary Canadian standard.

This option was rejected because it would have created misalignment among CCPSA regulatory requirements for products with similar lead exposure risks. It would also have created incompatibility between the way lead exposure risks and cadmium exposure risks from children’s jewellery were managed since the risk of exposure to lead in children’s jewellery is already managed through specific regulatory limits on lead content.

Option 3: Addition of the cadmium requirements of ASTM F2923-11 Standard Specification for Children’s Jewelry and retention of the current lead limits in the CJR

The U.S. does not have a federal regulatory limit for cadmium in children’s jewellery. In 2011, the U.S. ASTM standards organization published a voluntary standard, F2923-11 Standard Specification for Children’s Jewelry, which includes cadmium limits. This standard does not place any limit on the total amount of cadmium that a children’s jewellery item may contain. It establishes a screening level of 300 ppm (300 mg/kg) total cadmium; above that level, migration testing must be completed using specified test methodologies. The migratable cadmium limits in the standard vary depending on the type and size of jewellery material.

Since cadmium tastes very bitter, Health Canada scientists consider that exposure to cadmium in children’s jewellery is most likely to occur if a jewellery item containing cadmium is swallowed. The worst case exposure scenario would occur if a swallowed jewellery item made with cadmium became lodged in the acid environment of the stomach over a period of days or weeks, continually releasing cadmium into the child’s body. Analogous exposure scenarios involving lead in children’s jewellery resulted in a fatal case of childhood lead poisoning in 2006 and a non-fatal case in 2003. ASTM F2923-14 cadmium provisions do not take this exposure scenario into account.

Scientific data on the toxicity of ingested cadmium to humans is very limited. Health Canada has conducted studies on the migration of cadmium from children’s jewellery over extended periods, and the results indicate that limits based on migratable content alone do not offer sufficient protection to children. Migration tests for periods of 24 hours or less (as defined by the ASTM standard) do not reflect the worst case exposure scenario in which a child swallows a piece of jewellery that subsequently becomes lodged in the child’s stomach, continually releasing cadmium.

Migration testing by Health Canada also found that there was no consistent relationship between the total cadmium content of a jewellery sample and the amount of cadmium that might be released from it in the simulated environment of the stomach over an extended period of time. Since standardized migration testing does not accurately predict the amount of cadmium that might be leached out of a swallowed children’s jewellery item, use of a total cadmium limit is considered the most health-protective approach. It is Health Canada’s conclusion that migratable cadmium limits alone are not sufficiently protective if a children’s jewellery item is swallowed and remains lodged in the digestive system.

Under this option, the current lead limits under the CJR would have been retained. This option was rejected because these limits are inconsistent with current or proposed lead limits for other products posing similar lead exposure risks and with the fact that no threshold of safety for lead exposure has been identified. This option would also have created an inconsistency between the way lead and cadmium exposure risks from children’s jewellery are managed, since the risk of exposure to lead in children’s jewellery is already managed through specific regulatory limits on lead content.

Option 4: Adoption of the 130 mg/kg total cadmium limit for items small enough to be swallowed by a child and replacement of the current 600 mg/kg total and 90 mg/kg migratable lead limits for children’s jewellery with a single limit of 90 mg/kg total lead

This is the option represented by these Regulations and was chosen for the following reasons:

1. The limit of 130 mg/kg total cadmium includes a margin of safety and provides the greatest level of protection for children.
2. Specific regulatory requirements for cadmium in children’s jewellery will provide certainty and predictability to industry and facilitate compliance and enforcement action when required. They will allow Health Canada to take immediate compliance and enforcement action without having to demonstrate on a case-by-case basis that a specific product poses a “danger to human health or safety.”
3. The cadmium requirements focus on items small enough to be swallowed because the main cadmium exposure risk is from swallowed items. Because cadmium tastes very bitter, children are not likely to suck or chew on items made with cadmium.
4. Introduction of a specific cadmium limit for children’s jewellery in regulations is consistent with the way risks from lead in children’s jewellery are managed.
5. Replacement of the 600 mg/kg total lead limit and 90 mg/kg migratable lead limit with a 90 mg/kg total lead limit aligns lead limits for children’s jewellery with limits currently in effect or proposed under the CCPSA for other products posing a similar lead exposure risk.
6. Since total cadmium and lead tests are less costly than migratable tests, and there will be no requirement for migratable tests, introduction of total lead and cadmium limits will minimize industry costs to test children’s jewellery.

Benefits and costs

A cost-benefit analysis of this proposal was carried out between November 2013 and March 2014. A survey questionnaire was distributed to 27 industry stakeholders, including one Canadian manufacturer, 12 wholesalers/retailers, 10 retailers, 2 industry associations, including an association representing small business, regulators in the U.S., and a supplier of metal testing equipment. Responses were received from eight companies, including retailers, wholesalers and one manufacturer, in addition to one response from a U.S.-based industry association.

Seven companies indicated that they did not expect any significant costs from the amendments. One company indicated that it would incur significant compliance costs. Industry respondents in general expressed the view that regulatory requirements for children’s jewellery should be harmonized with those of the U.S.

The study estimated that the market for children’s jewellery in Canada was in the range of $35 million per year at retail.

Costs to industry

The 2013–2014 cost-benefit analysis identified estimated industry costs in undiscounted 2016 Canadian dollars over 20 years. Discounted at 7%, total costs would be $4.6 million over 20 years. Industry costs included an average of $0.25 per non-compliant piece to procure compliant metals and metal mixes, and an average of $0,25 per piece for additional testing and certification costs, assumed to apply to all pieces of children’s jewellery sold in Canada. The costs were assumed to be similar for all companies.

These costs would initially be borne by (predominantly foreign) children’s jewellery manufacturers, and are expected to be passed through the supply chain to consumers.

Costs to consumers

The cost-benefit analysis assumed that nearly all costs to industry would ultimately be borne by Canadian buyers of children’s jewellery and that the average price increase per piece of jewellery would be approximately $0.10.

The amendments may also potentially result in reduced consumer choice. Some companies chose to stop marketing children’s jewellery after lead content limits were introduced in 2005, and it is likely that other companies may choose to stop marketing children’s jewellery rather than incur additional costs to meet the new limits.

Costs to Government

Health Canada is responsible for the implementation of the amended requirements for children’s jewellery, 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 amendments.

Benefits to Canadians

The 2014 cost-benefit study for the proposal to introduce these amendments identified a number of major gaps in the data necessary to estimate the benefits of the amendments. Data gaps included

• the share of children’s jewellery on store shelves that has a total lead concentration between 90 and 600 mg/kg and a cadmium concentration above 130 mg/kg;
• the probability that a fatality would occur arising from a piece of children’s jewellery with a total lead concentration between 90 and 600 mg/kg and a cadmium concentration above 130 mg/kg;
• the probability that non-fatal health effects would occur from exposure to children’s jewellery with a total lead concentration between 90 and 600 mg/kg and a cadmium concentration above 130 mg/kg; and
• the extent that those non-fatal health effects would lead to other economic impacts.

Because information in these core areas was lacking and could not feasibly be obtained, it was not possible to make a quantitative estimate of benefits from the proposal.

Qualitative benefits included avoidance of fatalities, illnesses and consequent medical costs, loss of lifetime earnings, and special education and justice/corrections costs related to lead or cadmium poisoning. A break-even analysis suggested that benefits would outweigh costs if one fatality was avoided within approximately six years of adopting the proposed limits.

Benefits to industry

Removal of the migratable limit will simplify compliance testing for industry by eliminating any need to test for migratable lead. Under the current CJR, migratable testing was required if total lead content was between 90 and 600 mg/kg. Total lead content tests are less expensive than migratable lead tests. Thus business (including small business) compliance costs may be reduced as a result of the amendments. However, the size of this is not directly measurable because under the current lead limits, migratable lead tests were required only if the total lead content was between 90 and 600 mg/kg, and the percentage of children’s jewellery currently marketed in Canada that contains lead within this range is unknown.

Benefits to Government

Replacement of the current lead limits with a single total lead limit will also simplify testing for Health Canada and eliminate costs associated with migratable lead testing. Introduction of a specific cadmium limit simplifies compliance and enforcement activities relating to cadmium in children’s jewellery and eliminates the need to assess samples on a product-by-product basis to determine if the cadmium content poses a danger to human health or safety.

Table 1: Economic impact of proposed regulatory amendments

Quantified impacts in CAN$, in millions, August 2016 price level / constant dollars
		Base Year	Total (PV)footnote7	Annualized Average
Negative impacts	By stakeholder	2016
Compliance costs	Industry		4.6	0.44
Qualitative impacts
Consumer (negative) Additional industry costs are likely to be passed to consumers; the average retail price increase to meet increased industry costs was estimated at $0.10 per item. Consumer (positive) Decreased risk to the health of children from exposure to lead and cadmium in children’s jewellery, with a corresponding decrease in costs and other negative effects arising from harm to health, including illness, fatalities, and other societal impacts. Industry (positive) A specific cadmium limit for children’s jewellery will provide increased clarity on Health Canada’s requirements for children’s jewellery and will simplify compliance efforts. Removal of a migratable lead limit will eliminate any need for industry to conduct migratable lead tests. Government (positive) No need for additional health care, or other social costs arising from exposure to lead and cadmium in children’s jewellery.

“One-for-One” Rule

The “One-for-One” Rule does not apply, since the Regulations do not impose any administrative burden on industry.

Small business lens

The small business lens does not apply because the estimated nation-wide cost impact is less than $1M per year.

Consultation

A consultation document, the “Draft Proposal for Cadmium Guidelines in Children’s Jewellery,” was posted on the Health Canada website from July–November 2011 for stakeholder comment.^footnote8 The document proposed 130 mg/kg total cadmium as a guideline limit for children’s jewellery and requested industry feedback on the guideline limit. Only one response was received, from an American industry association that called on Canada to adopt the cadmium requirements of the voluntary ASTM F2923-11 Standard Specification for Children’s Jewelry.

An economic cost-benefit analysis on the proposed amendments was completed in March 2014. A survey questionnaire was distributed to 27 industry stakeholders, including one Canadian manufacturer, 12 wholesalers/retailers, 10 retailers, and 2 industry associations, including an association representing small business. Responses were received from eight companies, including four retailers and four wholesalers, one manufacturer, and one U.S.-based industry association.

Seven of the companies indicated that they did not expect any significant costs from the amendments. The remaining company indicated that it would incur significant compliance costs. Industry respondents in general expressed the view that regulatory requirements for children’s jewellery should be harmonized with those of the U.S.

Canada Gazette, Part I (CGI) consultation

The proposed amendments to the CJR were published in the CGI on December 3, 2016, for public comment. A link to the CGI publication was posted on the Health Canada website. Emails were sent directly to stakeholders through the Consumer Product Safety listserv. Health Canada also mailed a letter with a link to the consultation document to a targeted group of approximately 800 stakeholders, which included public health non-government organizations (NGOs), provincial/territorial public health authorities, retailers, manufacturers, importers and product-testing laboratories. Interested parties were invited to provide comments on the proposal within 75 days.

Submissions were received from 12 stakeholders (with one providing comments twice), including 2 manufacturers, one manufacturer/distributor, one importer/ distributor, one retailer, 3 industry associations, one consultant, 2 public health NGOs, and one provincial government.

Consultation results

One industry association, one manufacturer, one manufacturer/distributor, and one importer/distributor expressed general support for the proposed amendments on the basis that they would better protect children’s health. One manufacturer/ distributor and one retailer specifically stated that the proposal would not impact their business. Clarification was provided to a respondent who asked how the small parts cylinder test would be applied and to another who asked if the proposed cadmium limit would be applied to an item as a whole or to each component part.

Lead limits

No specific opposition to replacement of the former 600 mg/kg total lead limit with the 90 mg/kg total lead limit and the elimination of the migratable lead limit was expressed. One provincial government asked for clarification on how the lead limit was determined. One consultant expressed support for the 90 mg/kg limit on the basis that removal of the migratable lead limit would simplify requirements and reduce industry test costs, and a public health NGO expressed support on the basis that the 90 mg/kg limit better protects children’s health.

Cadmium limits

No stakeholder expressed opposition to the introduction of a cadmium limit for children’s jewellery. One industry association, one consultant, and two public health NGOs expressed support in principle for the introduction of a cadmium limit for children’s jewellery, and one consultant and one provincial government expressed support specifically for the 130 mg/kg total cadmium limit.

One Canadian industry association stated that they do not support the proposed approach and proposed alignment with the voluntary U.S. standard. Health Canada does not feel that a migratable cadmium limit is adequately protective.

Issues identified by respondents included the following:

• 1. Non-alignment with U.S. requirements

One Canadian industry association stated that alignment with U.S. requirements in general is a priority for industry, as well as a commitment from the Government of Canada. The association stated that non-alignment is a serious challenge for industry and urged that regulatory requirements for children’s jewellery be aligned with U.S. requirements.

One U.S. industry association urged Health Canada to align with U.S. requirements by adopting the migratable cadmium limits in voluntary U.S. standard ASTM F2923-14 Standard Specification for Children’s Jewelry, preferably for children of all ages, or at a minimum, for children above a “very young” age. The stakeholder provided extensive information in support of the cadmium limits in the standard.

The U.S. industry association also urged that Health Canada adopt the requirements of ASTM F2923-14 in their entirety, on the basis that this would provide more comprehensive protection to children and align with U.S. requirements. (Note: In addition to specifications on cadmium, the standard addresses a number of potential hazards from children’s jewellery that are not specifically regulated in Canada under the CCPSA.)

Health Canada response

Health Canada supports the principle of regulatory alignment between Canada and the U.S.; however, harmonization must be rooted in health and safety considerations. Health Canada’s primary role is to protect the health and safety of the Canadian public.

Regarding comments on the cadmium limit, for reasons that are discussed under Regulatory and non-regulatory options considered, above, and Regulatory cooperation, below, it is Health Canada’s conclusion that migratable cadmium limits alone are not sufficiently protective if a children’s jewellery item is swallowed and remains lodged in the digestive system. Therefore, Health Canada has retained the 130 mg/kg total cadmium limit, which is based on a departmental risk assessment that also went through public consultation.

Regarding comments on the lead limit, the 90 mg/kg total lead limit is in general aligned with the current U.S. 100 mg/kg total lead limit for children’s jewellery, as a 10 mg/kg difference is negligible from a health effect, manufacturing, and compliance and enforcement perspective. For reasons that are also discussed under Regulatory and non-regulatory options considered, above, and Regulatory cooperation, below, Health Canada has retained the 90 mg/kg total lead limit.

Health Canada recognizes that hazards other than lead or cadmium may potentially be associated with children’s jewellery; however, Health Canada is not aware of any incidents associated with these potential hazards.

The CCPSA GP prohibit the manufacture, importation, sale or advertisement in Canada of consumer products that are a “danger to human health or safety,” which is defined in section 2 of the CCPSA. Since the Act came into force, the GP has been used by Health Canada to take action on a product-by-product basis against children’s jewellery containing levels of cadmium that had been determined to be a danger to human health or safety. In the future, the GP could be used by Health Canada to help protect the public from a danger to health or safety associated with a particular piece of children’s jewellery that is not specifically addressed in the CJR.

Adherence with F2923-14 requirements is voluntary in the U.S.; however, some sections in the standard refer to requirements that are also mandated under U.S. federal legislation. In the Canadian context, industry may sometimes use voluntary standards, such as F2923-14, to assist them to meet their obligations under the CCPSA, including demonstration of due diligence with respect to the GP. Similarly, Canadian industry may voluntarily choose to use certain F2923-14 requirements as guidance to address other potential hazards in children’s jewellery, which would help demonstrate their products’ compliance with the CCPSA.

Because migratable tests are substantially more costly than total content tests, the introduction of only a total cadmium limit will help to minimize industry compliance costs. Since ASTM F2923-14 requires a screening test for total cadmium, compliance with the 130 mg/kg total cadmium limit will not result in test costs beyond what is currently required by ASTM F2923-14 cadmium specifications.

The 130 mg/kg total cadmium limit is comparable to the EU limit of 100 mg/kg (0.01% by weight) for all “fashion jewellery” for all ages. Several U.S. states have also introduced total cadmium limits for children’s jewellery.

• 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 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 current CJR do not include any specific industry requirements for record keeping (or any specific testing and certification requirements) that would be considered administrative burden and this would not change under these amendments. As a result, the “One-for-One” Rule is not applicable.

• 3. Exemption for parts that do not fit in the small parts cylinder

A public health NGO did not support this exemption on the basis that it reduces the level of protection of children. A consultant did not support it on the basis that a limit that applies to all parts of children’s jewellery would be simpler for industry.

Health Canada response

Health Canada has retained the exemption. Children are unlikely to repeatedly mouth items made with cadmium because of its extremely bitter taste. Jewellery parts that do not fit in the small parts cylinder are too large to be swallowed by a child and were determined by Health Canada to pose a low cadmium exposure risk.

Health Canada tests each part of a children’s jewellery item separately to determine its compliance with the small parts cylinder specification. Parts are tested separately because of the possibility that an item may break into its component parts during normal and reasonably foreseeable use and misuse.

If any accessible part fits within the small parts cylinder, all accessible parts must meet the 130 mg/kg total cadmium limit. The vast majority of parts fit within the small parts cylinder, and would be subject to the regulatory cadmium limit.

• 4. Upper age limit

Two public health NGOs stated that lead and cadmium content restrictions should be introduced for all costume jewellery, rather than only for items intended primarily for children under 15 years of age, on the basis that young children may have access to adult jewellery, and “economic considerations should not take precedence over the health and safety of children.” One U.S. industry association recommended that the upper age limit in the Regulations should be 12 years as in ASTM F2923-14.

Health Canada response

Health Canada has retained the current upper age limit of under 15 years, considering that it achieves an appropriate balance for the level of risk without being overly restrictive. While childhood mouthing behaviours decrease sharply after the age of three, they do occur in older children. Also, young children often have access to jewellery items that are marketed towards older children. For these reasons, Health Canada considers it important to capture the 10–14 year-olds (“tweens-young teens”) marketing category in the Regulations.

It is recognized that children may also have access to adult costume jewellery, but Health Canada considers that the risk of exposure to cadmium or lead in adult jewellery is not comparable to the risk of exposure from jewellery specifically marketed for children. Health Canada messaging advises parents and caregivers to discourage children from mouthing items that are not food or toys, and in particular to keep adult jewellery out of the reach of children.

• 5. Implementation timelines

One industry association stated that for operational and contractual reasons, industry needs a minimum one-year transition period to achieve compliance with the amended requirements.

Health Canada response

Health Canada has retained the provision that the new CJR will come into force six months after the date of publication in CGII. Health Canada believes that most companies should be in a position to comply with the requirements within six months.

Health Canada marketplace surveys indicate that most companies already comply with international standards for products intended for children, which specify that there must be no intentional use of lead. Considering that Health Canada indicated its intent to introduce a cadmium limit for children’s jewellery in 2011 and has used the 130 mg/kg total cadmium limit as a guidance limit since the fall of 2011, the six-month transition period in the Regulations gives industry enough time to prepare for the regulated cadmium limit. Health Canada marketplace surveys since 2011 also indicate that industry has adapted to this limit for cadmium and there has been a shift in the Canadian marketplace to compliance.

Regulatory cooperation

Lead

Under the U.S. Consumer Product Safety Improvement Act (CPSIA), the lead limit for children’s jewellery and other children’s products is currently 100 mg/kg total lead, except for applied surface coatings on children’s products, which have a 90 mg/kg total lead limit. The lead limits apply to all jewellery items intended for children aged 12 or under.

The proposed CJR introduce requirements for affected products that are generally aligned with requirements in the U.S. While the amendments result in slight differences between Canadian and U.S. requirements for lead, these differences are being maintained because they will (i) ensure consistency for lead limits across the Canadian regulatory regime, (ii) are more protective of health, 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.

Unlike the U.S. requirement, the CJR apply to all jewellery items intended primarily for children under 15 years of age. Health Canada chose the broader age limit because it is more reflective of industry marketing practices, which target the 10–14 year “tweens-young teens” age range as a single group.

While the amendments preserve a slight difference between Canadian and U.S. lead limits for certain products, they ensure consistency for lead limits across the Canadian regulatory regime. There is currently a 90 mg/kg total lead limit under the CCPSA for all other regulated products that pose a similar lead exposure risk to children.

The total lead limit of 90 mg/kg is only slightly different from the current U.S. limit of 100 mg/kg. A 10 mg/kg difference in lead limits would likely 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 would be sufficient to determine compliance with either limit.

Jewellery items that are compliant with the U.S. 100 mg/kg total lead limit (but not the 90 mg/kg limit) will 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.

The differences in lead content limits between these regulatory amendments and limits in other jurisdictions reflect the need to achieve internal regulatory consistency by aligning the lead limit for children’s jewellery with the existing measures in place under the CCPSA to help protect children against lead in other product categories which present a similar lead exposure risk.

Health Canada supports the Government of Canada’s efforts to work towards greater alignment with U.S. regulatory requirements in order to provide greater consistency for industry and will continue to work with the U.S. CPSC and other international and industry partners so that children’s products do not contain lead at levels that could harm children’s health. However, Health Canada has decided to align lead requirements for children’s jewellery with domestic limits for related products.

Cadmium

The addition of a 130 mg/kg total cadmium level to the CJR is not aligned with the U.S., as there is no U.S. federal limit for cadmium in children’s jewellery. Instead, a voluntary national standard, ASTM F2923-11 Standard Specification for Children’s Jewelry, developed in 2011, is in place. The standard is applicable to jewellery items intended for children aged 12 and under. It does not include any total cadmium limit but requires migratable cadmium testing if total cadmium is greater than 300 mg/kg. The migratable cadmium limits vary depending on the material being tested and the size.

Health Canada does not consider the migratable cadmium limits in the ASTM standard to be sufficiently protective in the case of an exposure situation in which an item becomes lodged in the digestive system over an extended period of time.

As well, the 130 mg/kg limit is within the acceptable range currently in place in the EU. The EU currently imposes a total cadmium limit of 0.01% by weight (100 mg/kg ±50) for both adult and children’s fashion jewellery.

Rationale

The lead or cadmium content of a product cannot be determined through visual inspection and consumers and caregivers cannot effectively prevent their children from mouthing objects to which they have access. Regulatory intervention is needed to help manage the risk of lead and cadmium exposure and the results of stakeholder consultation indicate that costs to industry would be outweighed by the societal benefits of reduced lead and cadmium exposure risk to children.

The amendments will help protect children under the age of 15 years against adverse health risks posed by lead and cadmium in children’s jewellery. However, the risks are most pronounced for children 4 years old or younger because of their normal mouthing behaviour. Children in this age group routinely place objects in their mouths and may repeatedly chew, suck or even accidentally swallow small items they find. Thus, children who are 4 years old and younger face a disproportionate level of risk and would be the age group likely to benefit the most from the amendments.

The amendments would also help to protect the broader Canadian population against exposure to toxic metals, and reduce the amount of lead and cadmium in the human environment by discouraging its non-essential use.

Specific total cadmium and lead limits provide a clear compliance goal for industry and give Health Canada the authority to take immediate enforcement action against any children’s jewellery items that are not in compliance with the Regulations.

Since 2011, Health Canada has requested recalls of children’s jewellery that exceeded the 130 mg/kg guideline limit on cadmium under the authority of the CCPSA’s GP. Although this has successfully demonstrated a key aspect of the modern tools and authorities afforded by the CCPSA, invoking the provisions requires the extra time to conduct a risk assessment to support compliance actions. Establishing cadmium limits in regulations allows Health Canada to take swifter action on non-compliant products and provides greater clarity for industry regarding acceptable limits.

Adoption of a 90 mg/kg total lead limit under the CJR requires a lower lead content in children’s jewellery and promotes internal alignment of lead content limits for other products regulated under the CCPSA. The 90 mg/kg total lead limit is considered health protective and is consistent with the need to reduce the potential for lead exposure as much as possible since no “safe” level of lead exposure has been scientifically identified.

Implementation, enforcement and service standards

The amended Regulations will come into effect six months after the date of publication in CGII. In the interim, Health Canada will continue to take corrective measures using the GP if children’s jewellery containing high cadmium levels are found on the Canadian marketplace.

Compliance and enforcement of the amended Regulations will follow established departmental policy and procedures. Health Canada’s Cyclical Enforcement (CE) policy 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 proposed amendments will be primarily targeted towards affected 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.

A CE survey for children’s jewellery may be carried out within six months of their coming-into-force of the CJR. The timing and scope of follow-up surveys would be determined by the results of this initial survey.

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