U.S. Consumer Product Safety Commission

CPSC requirements for children’s products and certification & testing for non-children’s products

This presentation was prepared by CPSC staff, has not been reviewed or

approved by, and may not reflect the views of, the Commission.

Mission

Protecting the public against unreasonable Protecting the public against unreasonable risks of injury from consumer products

through education, safety standards through education, safety standards activities, regulation and enforcement.

Consumer Product

“. . . any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or

around a permanent or temporary household or residence, a school, in recreation, or otherwise, or

(ii) for the personal use, consumption or enjoyment (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or

temporary household or residence, a school, in recreation, or otherwise…”1

1 Section 3(a)(5) of the Consumer Product Safety Act, 15 U.S.C. § 2052 (a)(5)

3

U.S. Estimated Annual Losses Associated with Consumer Products

34,500Deaths 34,500Deaths

36 Million Injuries

36 Million InjuriesDeaths Deaths InjuriesInjuries

$1 Trillion

in Societal

Costs

$1 Trillion

in Societal

Costs

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Consumer Products EXCLUDED from CPSC Jurisdiction

“… any article which is not customarily produced or distributed for sale to, or use or consumption by, or enjoyment of, a consumer…”2

Alcoholic beverages, tobacco, firearms and explosives (BATFE)Motor vehicles and equipment (NHTSA)Pesticides (EPA)Aircraft (FAA)

2 Section 3(a)(5)(A) of the Consumer Product Safety Act, 15 U.S.C. § 2052 (a)(5)(A)

Aircraft (FAA)Boats (Coast Guard)Food and drugs (USDA and FDA)Occupational products (OSHA)Fixed-site amusement park rides (State jurisdiction)

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Four Types of Safety Concerns

• Product fails to comply with a mandatory safety standard or ban under the Acts

• Product fails to comply with voluntary standards relied upon by the Commissionstandards relied upon by the Commission

• Product contains a defect which could create a “substantial product hazard”

• Product creates an “unreasonable risk” of serious injury or death

Product Hazard Prevention Strategies

CPSC staff promotes consumer product safety

• Engaging in product safety system processes by supporting improvements to voluntary standards/codes

• Creating and enforcing technical regulations and bans}consumer product safety

through a multi-pronged approach

technical regulations and bans

• Identifying and removing products with defects and hazards through surveillance activities and recalls

• Developing education programs for consumers, importers, U.S. and foreign manufacturers, and retailers

}

CPSC Voluntary Standards Monitoring

Participate in committees

Participate in committees

Analyze injury/death

Analyze injury/death

Propose standards Propose

standards injury/death data for hazard

patterns

injury/death data for hazard

patterns

Review standards for inadequacies

Review standards for inadequacies

Conduct tests and evaluations

to support findings

Conduct tests and evaluations

to support findings

standards development or revisions

standards development or revisions

CPSC staff does not vote.

Some Voluntary Standards Development Organizations for Consumer Products

ANSI (American National Standards Institute)

– Motorized Equipment

– Lawn & Garden Equipment

– Household Products

Safety Labeling– Safety Labeling

ASTM International

– Children’s Products

– Recreational Products

Voluntary Standards and Recalls

In some cases, failure to comply with a consensus voluntary standard indicates to the CPSC that a product contains a defect that presents a substantial product hazard.

Example: These lights do Example: These lights do not meet the major voluntary standards due to insufficient wire size. They can overheat and pose a fire and shock risk.

CPSC can seek a recall.

Technical Regulations

Regulatory process can be started by vote of the Commission or by a petition from an interested party

CPSC statutes specify that voluntary standards

should be relied upon. However, a regulation may However, a regulation may

be issued if:

the current voluntary

standard does not adequately reduce the risk

there is not substantial compliance.

or

Overview of U.S. Toy Regulations

• Age grading of toys

• Requirements for Toys under the Federal Hazardous Substances Act (FHSA)

• Mandatory Toy Standards ASTM F963-11 and • Mandatory Toy Standards ASTM F963-11 and ASTM F963-07

• Additional requirements under the Consumer Product Safety Improvement Act (CPSIA)

Age Grading of Toys

• Age grading:

–matches the attributes of the toy to the capabilities of the child; and

–is used to determine the appropriate –is used to determine the appropriate tests with which a product must comply.

Age Grading of Toys

• The Commission considers:

– If the manufacturer’s labeling is reasonable.

–Whether the product is represented in its advertisement, promotion, or marketing as appropriate for use by that age child.appropriate for use by that age child.

–Whether the product is commonly recognized by consumers as being intended for that age child.

–Age Determination Guidelines – September 2002. www.cpsc.gov/BUSINFO/adg.pdf

• “Children’s products” are defined as consumer products designed or intended primarily for children 12 years old or younger.

• A "children's toy" is defined as a consumer product designed or intended by the manufacturer for a child who is 12 years old or younger for use by the

Age Grading of Toys

designed or intended by the manufacturer for a child who is 12 years old or younger for use by the child when the child plays.

• "Child care article" means a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.

Key Federal Hazardous Substance Act (FHSA) Requirements for Toys

• Small Parts Requirements * 16 C.F.R. Part 1501.

• Sharp Points/ 16 C.F.R. § § 1500.48/49.

Edge Requirements

• CSPA Labeling Requirements 16 C.F.R. § 1500.19 and

16 C.F.R. § 1500.121. 16 C.F.R. § 1500.121.

• Art Material Requirements 16 C.F.R. § 1500.14(b)(8).

• Lead-in-Paint* 16 C.F.R. Part 1303.

• Electrically Operated Toys/ 16 C.F.R. Part 1505.

Children’s Products**

* Third party testing required

** Third party testing required except for small batch manuf. (“Group B”)

ASTM F963

• Not All Sections of F963 Apply to Every Toy.

• Some Sections of F963 Require Third Party Testing, Some Sections Do NOT require Third Party Testing.Party Testing.

• Some Sections of F963 Are Covered by Existing CPSC Regulations in the CFR (Code of Federal Regulations 16 CFR Part 1000 to End).

Partial List of Products in ASTM F963

• Sound-Producing Toys

• Battery-Operated Toys

• Small Objects

• Stuffed and Beanbag-type Toys

• Projections

• Wheels, Tires, and Axles

• Magnets

• Pacifiers

• Balloons

• Projectile Toys

• Certain Toys with • Projections

• Marbles and Balls

• Folding Mechanisms and Hinges

• Hemispheric-Shaped Objects

• Cords and Elastics in Toys

• Certain Toys with Spherical Ends

• Rattles

• Teethers and Teething Toys

• Squeeze Toys

• Yo-Yo Elastic Tether Toys

Updated Standard: ASTM F963-11

Commission voted on February 15, 2012 to approve the revised standard (F963-11) and it became effective on June 12, 2012.

ASTM F963-11 Key Revisions

• Heavy Metals-Limits for toy substrates

• Compositing Procedure for Total Heavy Metal Analysis

• Bath Toy Projections• Bath Toy Projections

• Other revisions to include: jaw entrapment; toys with spherical ends; stability of ride on toys; requirements for squeeze toys attached to rings; use of cords, straps and elastics; packaging film; and yo-yo tether balls.

Children’s Products and the CPSIA

• Key requirements for children’s products , children’s toys and clothes included:

– Lead in accessible components (100 ppm)

– Lead in paint and surface coatings (90 ppm)– Lead in paint and surface coatings (90 ppm)

– Phthalates (0.1% per banned phthalate) – Toys and child care articles (sleeping & feeding only)

– Third party testing by CPSC-accepted labs

–Conformity certificates issued by importers & manufacturers (Children’s Product Certificate)

– Tracking labels

• 100 parts per million (100ppm) limit applies to all accessible components of children’s products.

Lead Content Limits

• CPSC issued guidance on determining whether a part is accessible or inaccessible.

CPSIA section 101(a)(2)

• The determinations identify materials whose lead content will not exceed 100 ppm

• Apply primarily to natural materials, such as dyed and undyed textiles (cotton, wool),

Lead “Determinations”

as dyed and undyed textiles (cotton, wool), wood (and paper), precious and semiprecious stones

• Do not include metal or plastic fastenerssuch as buttons, screws, grommets or zippers used in apparel or elsewhere

• 90 ppm limit

• Applies to:

– Paint sold to consumers

– Toys and other articles intended for children bearing paint or other surface coating

Limit for Lead in Paint

bearing paint or other surface coating

– Some household furniture bearing paint or other surface coating

CPSIA section 101(f)

Ban on Phthalates

• Congress has permanently banned three types of phthalates (DEHP, DBP, BBP) for children’s toys and child care articles.

• Congress has also banned on an interim basis • Congress has also banned on an interim basis three additional types (DINP, DIDP, DnOP) for toys that can be placed in a child's mouth or child-care article that contains concentration of more than 0.1%.

CPSIA section 108

Ban on Phthalates

• The ban is for any amount greater than 0.1 percent (computed for each phthalate individually)

• Applies to toys that can be placed in a child's mouth, which is defined as any part of a toy that mouth, which is defined as any part of a toy that can be brought to the child's mouth and can be sucked or chewed on. If a toy or a part of the toy is smaller than 5 centimeters, it can be placed in the mouth.

• Applies for sleepwear for children under three.

Ban on Phthalates

• The ban does not apply to component parts that are inaccessible to a child.

• Applies only to plasticized component parts of children's toys and child care articles and only those parts of the product should be third party children's toys and child care articles and only those parts of the product should be third party tested for phthalates.

• It is not necessary to test and certify materials that are known not to contain phthalates or to certify that phthalates are absent from materials that are known not to contain phthalates.

Third Party Testing

• Third party testing is testing performed by an accredited laboratory that is owned by a third party (i.e., not you) and is accepted by the CPSC to conduct testing on consumer products using approved test methods in accordance with established federal safety standards.established federal safety standards.

• There are four types of third party testing: – Initial third party testing (also called certification

testing);

– Component part testing;

– Material change testing; and

– Periodic testing for continued production.

Identify a CPSC-Accepted Laboratory

• All non-exempt materials must be third party tested by a CPSC-accepted laboratory.

• Laboratories are accepted by the CPSC • Laboratories are accepted by the CPSC on a test-by-test basis. To lower costs, you should try to find a single laboratory that can address all of your testing needs.

• www.cpsc.gov/labsearch

Initial Testing & Certificate of Conformity

• The U.S. manufacturer or importer must submit samples to be tested.

• CPSC-accepted laboratory performs applicable testing and provides testing results.

• Testing needs to be completed before entry at the port or distributing in commerce.

• The U.S. manufacturer or importer is responsible for issuing a certificate of conformity based on passing results. Find a model for Children's Product Certificate (CPC) at www.cpsc.gov/cpc.

Component Part Testing

• Voluntary; 16 CFR Part 1109

• If a finished product manufacturer purchases a component from a supplier who a component from a supplier who voluntarily test its product (e.g., a paint supplier), that manufacturer must exercise due care to rely upon the component part certificate or results in drafting its own Children’s Product Certificate.

Material Change Testing & Certificate of Conformity

If the U.S. manufacturer or importer makes a material change to the product after initial certification:

1. Re-test the affected component part or the

entire product; and

2. Issue a new Children’s Product Certificate

• If you – the manufacturer or importer – have continued production of your children’s product, you must periodically retest your product using a CPSC-accepted laboratory.

Periodic Testing Rule

• Periodic testing only applies if you have continued production.

• Mandatory; 16 CFR Part 1107

Periodic Testing Rule

• The Periodic Testing Rule took effect on February 8, 2013.

• After initial testing and certification, periodic testing is required at a minimum of:testing is required at a minimum of:

– Once per year

– Every two years with a production testing plan

– Every three years using a testing laboratory accredited to ISO/IEC 17025:2005(E).

Tracking Labels

• A permanent mark affixed to the product andits packaging, if practicable

• Requirements:– Name of the manufacturer or private labeler– Name of the manufacturer or private labeler

– Location and date of production of the product

– Detailed information on the manufacturing process, such as a batch or run number, or other identifying characteristics

– Other information to facilitate identifying the source

• No mandated format

Example: Testing & Certification Requirements for Children’s Raincoat

1. Determine whether this product is regulated by the CPSC.

www.cpsc.gov/Regulations-Laws--Standards/Regulations-Mandatory-Standards--Bans/Regulated-Products/

2. List all applicable rules:2. List all applicable rules:

– 16 CFR part 1611

(vinyl plastic film)

– Section 101 of the CPSIA

(lead content)

– Tracking labels

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Example: Testing & Certification Requirements for Children’s Raincoat

3. Arrange for testing by a CPSC-accepted testing laboratory.

− Component part testing can be used for certification testing.

4. Collect test reports and other information in a CPC.

5. “Enter into Commerce.”

What Must be Certified?

• Any product that is subject to a consumer product safety rule or similar rule, ban, standard, or regulation and which is “imported for consumption or warehousing” or “distributed in commerce.”

Certification is the responsibility of the importer • Certification is the responsibility of the importer or domestic manufacturer. Importers and manufacturers should have a clear understanding of which standards need to be met.

• Foreign manufacturers/suppliers should insist on a list of which regulations and standards apply.

• All certificates of conformity must:

– Identify the manufacturer or importer issuing the certificate and any third party on whose testing the certificate depends, by name, address and phone number.

Content of Certificates

and phone number.

– Specify each applicable regulation, standard, ban, etc.

– Spell out the date and place where the product was manufactured and date and place of testing.

– Show contact information for person maintaining test records.

• Certificates must “accompany” each product or shipment of products covered by the same certificate.

• A copy of the certificate must be “furnishedto each distributor or retailer of the

Availability of Certificates

A copy of the certificate must be “furnishedto each distributor or retailer of the product” (no requirement to provide to ultimate consumer).

• A copy of the certificate must be made available to the Commission and Customs upon request.

• The Commission by rule has confirmed that certificates in electronic form are acceptable.

• Key requirements:

–Certificate must be created no later than

Electronic Certificates

–Certificate must be created no later than the time of shipment to United States.

–The certificate must be reasonably accessible from information on the product or accompanying the shipment.

Go to CPSC’s website: www.cpsc.gov/cpsia and find a step-by-step guide to navigate the CPSIA and links to other subject matter websites, such as:

• www.cpsc.gov/lead• www.cpsc.gov/leadinpaint

How to Find More Information

• www.cpsc.gov/leadinpaint• www.cpsc.gov/phthalates• www.cpsc.gov/durableinfantproducts• www.cpsc.gov/toysafety• www.cpsc.gov/gettingstarted• www.cpsc.gov/businfo/generaluse.html

(for non-children’s products).

For New Certification, Testing and Other Requirements:

www.cpsc.gov/businfo/intl/newusreq.htmlwww.cpsc.gov/businfo/intl/newusreq.html

www.cpsc.gov/es/Business--Manufacturing/International/Spanish/

Responsibility to Comply with Voluntary Standards and Technical Regulations

All equally responsible

Manufacturers

ImportersDistributors Retailers

Importers, although reliant on foreign producers, are directly responsible for the safety of products they bring into the United States.

Importers

Importance of Using U.S. Technical Regulations

and Voluntary Standards

To avoid entry problems with the U.S.government (Customs and CPSC), foreignmanufacturers SHOULD comply with BOTH:

–CPSC Regulations (mandatory)–CPSC Regulations (mandatory)

–Private Sector Standards (consensus voluntary standards)

Both play essential safety roles.

Develop guidance and help firms comply with the law through:

• International program outreach

How the CPSC Works with Manufacturers

• Domestic manufacturer seminars

• Participation at ICPHSO symposiums

• Advice and guidance to trade associations and consultants

Best Manufacturing Practices

Manufacturers and importers should use best practices to ensure safe products enter into the chain of commerce.

– Importers/suppliers must work as a team.–Know where and how your product will be –Know where and how your product will be

used. –Know and understand all requirements and

standards.–Comply with consensus standards and

technical regulations.

Best Manufacturing Practices

–Design safety into product. It is your responsibility to work with the designer.

–Control your supply chain (supply chain integrity).integrity).

–Preventive action is better than corrective action.

–Avoid long-term repercussions: Damage to Brand Name and “Made in My Country”.

Best Manufacturing Practices

–To avoid problems, samples should be tested randomly, early and often.

–The cost of testing is a tiny fraction of the costs associated with recalls and violations.costs associated with recalls and violations.

–Seek products with third party certification.

–Unauthorized component substitutions can easily lead to a recall.

–Conduct spot inspections.

Best Manufacturing Practices

John Golden

Section Chief, Safety Attaché

Contact Information

Section Chief, Safety Attaché

E-mail: Goldenjx@state.gov