Toy Safety in Canada and the United States

Regulatory Overview, Updates, and Cooperation

Note: Presentation Available for Download: www.slideshare.net/USCPSC

VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION OR HEALTH CANADA.

TODAY’S PRESENTATION

• Provide an overview of consumer product safety legislation and authorities in both jurisdictions

• Provide brief highlights of what’s new at CPSC and Health Canada

• Review key requirements for industry

• Highlight regulatory cooperation initiatives in North America

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CONSUMER PRODUCT SAFETY LEGISLATION IN CANADA AND THE

UNITED STATES

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KEY LEGISLATION

Canada Consumer Product Safety Act (CCPSA)• Addresses dangers to human health or safety that are posed by

consumer products in Canada, including those that circulate within Canada and those that are imported. • “General Prohibition” against the supply of consumer products that pose a

danger to human health or safety• 35 regulations, including several relevant to toys• No premarket certification requirements under CCPSA

• Onus is on suppliers to ensure products they bring to market comply with the Act and its regulations.

• Establishes responsibilities for manufacturers, importers, advertisers, and retailers of consumer products, including:

• Mandatory Incident Reporting• Record-keeping to allow traceability of products within the distribution

chain 4

KEY POWERS AVAILABLE TO HEALTH CANADA

• Issue public communications• Order suppliers to conduct tests or studies on a product to

verify compliance• Order suppliers to stop manufacturing, importation, sale, etc.

of a product• Order suppliers to carry out recalls and to take other

corrective actions• Prosecute criminal offences or apply Administrative Monetary

Penalties• Seize product, documents or materials• Disclose personal or business information necessary to

identify or address a serious danger to human health or safety

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KEY LEGISLATION

Consumer Product Safety Act (CPSA)• Manufacturers and importers must third party test and certify

children’s products to ensure products they bring to market comply with the Act and regulations.

• Industry self-reporting through Section 15.

Federal Hazardous Substances Act (FHSA)• Requires precautionary labeling on the immediate container of

hazardous household products to help consumers safely store and use those products and to give them information about immediate first aid steps to take if an accident happens.

• Bans certain products that are so dangerous or the nature of the hazard is such that the labeling the act requires is not adequate to protect consumers. 6

KEY POWERS AVAILABLE TO CPSC

• Order a manufacturer to cease distribution, repair, replace, or refund the purchase price of a product

• Seize and destroy product at the port of entry• Issue public communications and warnings re: a

product and a recall/corrective action plan• Investigate for civil and criminal penalties for failure to

report in a timely and adequate manner; other violations

• Injunctive relief• Above can be via court or administrative proceedings or

voluntary, in cooperation with the manufacturer.7

WHAT’S NEW?

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WHAT’S NEW AT HEALTH CANADA• In April 2014, Health Canada’s Minister announced its Regulatory Transparency

and Openness Framework.

• An Action Plan for 2014-2015 is featured on the Health Canada website and includes 15 activities that focus on providing timely, credible and understandable health and safety information. Consumer Product Safety Program related activities under the action plan of interest to business include:

– Posting the Consumer Product Safety Risk Assessment Framework– Posting Quarterly Consumer Product Safety Incident Report Summaries– Posting Consumer Product Enforcement Summary Reports

• The website features a feedback button for Canadians and stakeholders to submit their comments pertaining to transparency and openness.

• Health Canada has committed to reporting annually on what is achieved in each fiscal year.

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WHAT’S NEW AT HEALTH CANADA

• On April 3, 2014, Health Canada published regulations amending Schedule 2 to the Canada Consumer Product Safety Act (CCPSA) to prohibit tris (2-chloroethyl) phosphate (TCEP) in certain products.

• As per item 16, Schedule 2 to the CCPSA, products that are made, in whole or in part, of polyurethane foam that contains TCEP and that are intended for a child under three years of age are prohibited.

• This prohibition came into force on October 23, 2014.

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WHAT’S NEW AT CPSC • Prohibition of Children's Toys and Child Care

Articles Containing Specified Phthalates (Proposed)– Proposes banning 5 phthalates in addition to phthalates

already banned in CPSIA in concentrations greater than 0.1%

• Potential Ways to Reduce Third Party Testing Costs Consistent with Assuring Compliance– $1M being spent in 2015

• Study on HDXRF testing for heavy metals in toys to lower testing costs

• Proposed Rule on Certificates of Compliance• Prior Violations List: www.cpsc.gov/violations 11

REQUIREMENTS IN CANADA AND THE UNITED STATES

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CANADIAN SAFETY REQUIREMENTS FOR CHILDREN’S TOYS

• The main regulation in Canada is the Toys Regulations (SOR/2011-17)

- The Toys Regulations is the new title for the previous Hazardous Products (Toys) Regulations that were in place from 1970 to 2011 under the Hazardous Products Act.

• The Toys Regulations set out mandatory safety requirements that address a wide range of mechanical, flammability, toxicological, electrical, thermal and other hazards associated with children’s toys (http://laws-lois.justice.gc.ca/eng/regulations/SOR-2011-17/index.html).

• Several other regulations under the CCPSA may also apply to a specific toy, depending on the toy’s design, construction, contents and, in some cases, how it is marketed.

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TESTING TOYS FOR SAFETY - CANADA• In Canada, provincial and territorial legislation requires that electric toys must bear

a compliance certification mark from a certification body accredited by the Standards Council of Canada.

- The certification mark indicates that the toy has been tested and meets all relevant requirements under the Canadian Electrical Code.

• No other test or certification requirements are mandatory under the CCPSA for toys.

• However, testing a toy against the requirements under the CCPSA is the only way to verify compliance.

• Health Canada urges industry members to complete compliance testing before a toy is placed on the market in Canada.

• Instructions for obtaining Health Canada’s test methods:www.hc-sc.gc.ca/cps-spc/prod-test-essai/index-eng.php

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TOY SAFETY – HEALTH CANADA ENFORCEMENT

• Health Canada carries out regular compliance and enforcement projects where toys on the Canadian market are sampled and reviewed.• Suppliers can be asked to provide product tests or studies to verify

compliance.• Health Canada may conduct compliance testing.

• Health Canada investigates complaints and incident reports related to toy safety.• If a toy is found unsafe, or if a toy is found to violate a requirement, then

Health Canada will take action to protect the public.• This action can include product recall, seizure and prosecution.

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U.S. REQUIREMENTS

• Requirements in the CFR have been in effect since the 1970s

• CPSIA included the requirements of the CFR in ASTM F963, mandatory since 2008

• New changes to ASTM F963 are incorporated into regulation via Commission vote

• www.cpsc.gov/BusinessEducation

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• CPSC has ongoing enforcement programs and partnerships with Customs and Border Protection for imports

• Individual claims are investigated by the Agency

• Injury Data from hospitals are monitored

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US TOY ENFORCEMENT

U.S. REGULATED PRODUCT TESTING

• Three different divisions conduct regulated product testing– Mechanical– Electrical and Flammability– Chemistry

• Timing; Import samples• Priorities

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A FEW HIGHLIGHTS ON US/CANADA REQUIREMENTS…

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Head*:• Heavy Elements, including lead, in Surface Coating Materials– ASTM F963 section 4.3 outlines the

toxicology requirements for Antimony, Arsenic, Barium, Cadmium Chromium, Lead, Mercury, Selenium- US limits to not more than 100ppm

• Phthalates –Plasticized components of toys must be tested to demonstrate compliance with the phthalates limitations currently in effect.

• Hard Eye & Nose Attachments – depending on age determination, these features could be subject to a Torque and Tension test up to 15 lbs of force…small parts?

• Flashing- Most plastic flashing cannot be classified as a sharp edge, however the toy may be classified as a defect.

Torso*:• Stuffing – US requires that stuffing be clean, no

vermin, no sharpness, non-toxic• If the batteries are found to be accessible, they will

be subject to ASTM F963 section 4.25• Seam strength test (16 CFR 1500.51)• Flammability (F963 4.2) is NOT a requirement for

CPSC testing per Congress

Hand, Pacifier*:Pacifiers – US specifies requirements for pacifiers in 16 CFR 1511, nitrosamines

Mouth:Sound – US specifies 85 dB LAeq and 115 dB LCpeak limits measured at 50 cm for this particular toy (ASTM F963 4.5)

Hand, Projectile Device*:Projectiles – ASTM F963 section 4.21

Feet*:• Hazardous magnets would be determined by ASTM F963 section 4.38• Any material intended for children less than 6 years of age, that is, all

accessible parts and components where there is a probability that those parts and components may come into contact with the mouth are subject to the Heavy Elements requirements of ASTM F963 section 4.3

Neck Bolts*:• Small Parts – (16 CFR 1512) The same small parts

cylinder is used on both sides of the border• A flexure test could be applied (16 CFR 1500.51) if

the wire holding the head still could produce a sharp point

• Hazardous magnets would be determined by ASTM F963 section 4.38

*Product may be subject to additional requirements in the CPSIA and other CPSC requirements. www.cpsc.gov/BusinessEducatio

Head*:• Surface Coating Materials - Canada specifies limits for certain heavy elements & prescribes

specific test parameters. Seven regulated heavy elements: lead, mercury, antimony, arsenic, cadmium, selenium and barium (Toys Regulations, section 23).

• Lead (substrate) – Canada limits total lead content to not more than 90 ppm in toys for children under 3 years of age (Consumer Products Containing Lead (Contact with Mouth) Regulations, section 2).

• Phthalates - If material is vinyl Canada specifies limits for certain phthalates (Phthalates Regulations, sections 3 and 4).

• Flammability – In Canada the hair must not flame with a 1-second flame impingement or must self-extinguish in 2 seconds with flame removal (Toys Regulations, section 34).

• Hard Eye & Nose Attachments – Canada requires that each hard eye or nose component must not be grippable or must not detach when a 9 kg weight is freely suspended from it for 5 minutes (Toys Regulations, section 31).

• Flashing – a sharp edge must not be present after RFU testing (Toys Regulations, section 10(a)).

Torso*:• Flammability – In Canada the outer covering,

including clothing, must have a flame spread time greater than 7 s (1 s flame impingement, 45°) (Toys Regulations, section 32).

• Stuffing – Canada requires that stuffing be clean, no vermin, no sharpness, non-toxic and non-irritant (Toys Regulations, section 29).

• Stuffing – Canada does not allow plant seeds (regardless of toy’s age grade) (Toys Regulations, section 35).

Hand, Pacifier*:• Pacifiers – Canada specifies

requirements and tests for pacifiers in the Hazardous Products (Pacifiers) Regulations).

• In Canada, the Phthalates Regulations, Consumer Products Containing Lead (Contact with Mouth) Regulations also apply.

Head*:Sound – Canada specifies a 100 decibel limit (LAFmax) measured at an ordinary use distance from the user's ear (Toys Regulations, section 19) an ordinary use distance of 15 cm is applied for hand held toys such as this.

*Complete details are provided in the Canada Consumer Product Safety Act and its associated Regulations.

Hand, Projectile Device*:Projectiles – Canada specifies that projectiles capable of causing a puncture wound must have a protective tip (Toys Regulations, section 16).

Feet*:• Flammability – In Canada the outer covering, including clothing, must have

a flame spread time greater than 7 s (1 s flame impingement, 45°) (Toys Regulations, section 32).

• Small, Powerful Magnets – In Canada there is no specific regulatory requirement. The general prohibition for products that pose a danger to human health or safety is applied where a magnet or a magnetic component is loose or separable, small and powerful (Canada Consumer Product Safety Act, sections 7 & 8).

Neck Bolts*:• Small Parts – Canada specifies that small separable parts

are not allowed in toys likely to be used by children under 3 years of age (Toys Regulations, section 7).  The same small parts cylinder is used on both sides of the border.  Canada can apply a 4.45 N force to test if a small part can be totally enclosed in the cylinder.

• Small, Powerful Magnets – In Canada there is no specific regulatory requirement. The general prohibition for products that pose a danger to human health or safety is applied where a magnet or a magnetic component is loose or separable, small and powerful (Canada Consumer Product Safety Act, sections 7 & 8).

WORKING TOGETHER

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BILATERAL COOPERATION CANADA - US

• Although requirements between Canada and the United States vary, we share the goal of safe products, including safer toys, in the North American market.

• We schedule periodic calls to exchange technical information and best practices.

• We work together to share information on new hazards and to develop proposals for risk mitigation (e.g. public education, regulation or standards development).

• We regularly align efforts to announce Joint Canada-US Recalls (302 bilateral recalls between 2009 and 2014).

• Technical staff from both agencies participate on ASTM Subcommittee F15.22 on Toy Safety (ASTM F963).

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NORTH AMERICAN COOPERATION ON CONSUMER PRODUCT SAFETY

• North America Free Trade Agreement has fostered the need for greater cooperation between Canada, United States, and Mexico.

• In 2011 Health Canada, CPSC and Mexico’s Profeco established a mechanism for enhanced collaboration on consumer product safety at the first Consumer Product Safety Summit in Bethesda, Maryland.

• The Cooperative Engagement Framework was updated and renewed at the second Consumer Product Safety Summit in Ottawa, Canada in 2013.

• The Third North America Summit will be held in Mexico City, hosted by Profeco in 2015.

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ACTIVITIES UNDER THE FRAMEWORK1) Consumer Outreach

• Coordinated joint consumer outreach activities and campaigns:– Campaign on Sports Safety timed with FIFA World Cup (2014); Poison Prevention (2013);

Toy Safety (2014)

2) Industry Outreach • Joint presentations to highlight product safety requirements at key industry events

– ICPHSO (2014); Las Vegas ABC Kids Fair (2014)

3) Utilization of the XRF (X-Ray Fluorescence) Analyzer• Sharing technical information on current practices, product analysis and reference levels for

the XRF analyzer to screen for heavy metals in toys and children’s products

4) Customs Communications Work for Enforcement Purposes• Composed of product safety staff and customs officials • Identification of opportunities for enhanced communication, information sharing and actions

related to potentially dangerous consumer products at points of entry for the three jurisdictions

5) Early Consultation Initiative 26

JOINT RECALLS: CRITERIA

• Product sold in at least 2 or all 3 countries• Product must also be under the jurisdiction of all

agencies• Corrective measures and customer support

extended to customers in affected countries• Timing works for regulator and company• Have agreement from company to share all

information with both jurisdictions early in the process

• Recall is conducted voluntarily

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Joint RecallsJOINT RECALLS

Conclusion

• Though consumer product safety requirements may vary, we share the goal of safe products in the North American market

• We are working together to align where possible and collaborate on a range of activities, including recalls.

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KEY RESOURCESHealth Canada

www.healthcanada.gc.ca/cpswww.healthcanada.gc.ca/reportaproduct

www.hc-sc.gc.ca/cps-spc/pubs/indust/index-eng.php

www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/index-eng.php

Consumer Product SafetyCommission

www.cpsc.gov/BusinessEducationwww.cpsc.gov/DesktopGuidewww.cpsc.gov/Testing www.cpsc.gov/DurableInfantProducts 30

THANK YOU / MERCI

Joanne Brathwaite Consumer Product Safety ProgramHealth Canada

cps-spc@hc-sc.gc.ca

Neal S. CohenSmall Business OmbudsmanU.S Consumer Product Safety Commissionwww.cpsc.gov/SmallBiz/Contact

Health Canada

United States Consumer Product Safety Commission

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