The document outlines the Consumer Product Safety Commission's (CPSC) requirements for children's products, including mandatory toy standards, lead and phthalate limits, third-party testing, and certification. It also discusses the CPSC's approach to ensuring safety of non-children's products through voluntary standards, regulations if needed, and general certification requirements. Testing and certification requirements vary depending on if a product is for children or not and what specific safety rules apply.
PROFECO Pro-Consumer Week: Requirements for children's products and certification & testing for non children's products - English
1. 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.
2. Mission
Protecting the public against unreasonable
risks of injury from consumer products
through education, safety standards
activities, regulation and enforcement.
3. 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 Commission
• Product contains a defect which could create a
“substantial product hazard”
• Product creates an “unreasonable risk” of
serious injury or death
4. Product Hazard Prevention Strategies
• Engaging in product safety
system processes by
supporting improvements
to voluntary
standards/codes
CPSC staff promotes • Creating and enforcing
consumer product safety
} technical regulations and
bans
through a multi-pronged • Identifying and removing
products with defects and
approach
hazards through
surveillance activities and
recalls
• Developing education
programs for consumers,
importers, U.S. and foreign
manufacturers, and retailers
5. CPSC Voluntary Standards
Monitoring
Participate in
committees
Propose Analyze
standards injury/death
development data for hazard
or revisions patterns
Conduct tests Review
and evaluations
standards for
to support
findings inadequacies
CPSC staff does not vote.
6. Voluntary Standard Development
Organizations for Consumer Products
ANSI (American National Standards Institute)
– Motorized Equipment
– Lawn & Garden Equipment
– Household Products
– Safety Labeling
ASTM International
– Children’s Products
• Recreational Products
Underwriters Laboratories (UL)
– Electrical and other products
7. 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 not
meet the voluntary
Underwriters Laboratory
(UL) standard due to
insufficient wire size. They
can overheat and pose a fire
and shock risk.
CPSC can seek a recall.
8. 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
be issued if:
the current
voluntary there is not
standard does or substantial
not adequately compliance.
reduce the risk
9. 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 with toy chest provision
(previously voluntary)
• Additional requirements under the
Consumer Product Safety Improvement Act
(CPSIA)
10. 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
tests with which a product must
comply.
11. 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.
– 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
12. Age Grading of Toys
• “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
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.
13. 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.
• 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”)
14. 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.
• Some Sections of F963 Are Covered by
Existing CPSC Regulations in the CFR (Code
of Federal Regulations 16 CFR Part 1000 to
End).
15. Partial List of Products in ASTM F963
• Sound-Producing Toys • Wheels, Tires, and Axles
• Battery-Operated Toys • Magnets
• Small Objects • Pacifiers
• Stuffed and Beanbag-type • Balloons
Toys • Projectile Toys
• Projections • Certain Toys with
• Marbles and Balls Spherical Ends
• Folding Mechanisms and • Rattles
Hinges • Teethers and Teething
• Hemispheric-Shaped Toys
Objects • Squeeze Toys
• Cords and Elastics in Toys • Yo-Yo Elastic Tether Toys
16. ASTM F963-11 Key Revisions
• Heavy Metals-Limits for toy substrates
• Compositing Procedure for Total Heavy
Metal Analysis
• 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.
17. When will I be required to comply
with the new standard?
• Commission voted on February 15, 2012 to
approve the revised standard (F963-11) and it
became effective on June 12, 2012.
• Compliance with the revised standard is
currently required. Third party testing at CPSC-
accepted laboratory will be required soon for the
new requirements. Otherwise, you must continue
third party testing for compliance with the
unchanged sections of F963-08.
18. Children’s Products and the CPSIA
• Key requirements for children’s products :
– Lead in accessible components (100 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
19. Lead Content Limits
• 100 parts per million (100ppm) limit
applies to all accessible components of
children’s products, effective Aug 2011.
• CPSC issued guidance on determining
whether a part is accessible or
inaccessible.
CPSIA section 101(a)(2)
20. Lead Content Exceptions
Metal Bicycle Components
– Exempt from third party lead content testing, but must be compliant
to 300 ppm by weight.
– Not exempt from third party testing to the bicycle standard or any
other applicable rule.
– Must Certify Compliance.
ATVs
– Only excluded from testing & certifying to the 100 ppm lead
requirement.
Electronic components of children’s electronic devices
– No required limit for electric components only
Ordinary Books and Paper-Based Materials 20
21. Lead “Determinations”
• 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),
wood (and paper), precious and
semiprecious stones
• Do not include metal or plastic fasteners
such as buttons, screws, grommets or
zippers used in apparel or elsewhere
22. Limit for Lead in Paint
• 90 ppm limit became effective 8/14/09
• Applies to:
– Paint sold to consumers
– Toys and other articles intended for children
bearing paint or other surface coating
– Some household furniture bearing paint or other
surface coating
CPSIA section 101(f)
23. 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
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
24. Ban on Phthalates
• The ban is for any amount greater than 0.1
percent (computed for each phthalate
individually)
• A toy that can be placed in a child's mouth 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.
25. 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
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.
26. 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.
• There are three types of third party testing:
– Initial third party testing (also called certification
testing);
– Material change testing; and
– Periodic testing.
27. Identify a CPSC-Accepted Laboratory
• All non-exempt materials must be third
party tested by a CPSC-accepted laboratory.
– Alternative requirements for registered small
batch manufacturers. www.cpsc.gov/smallbatch
• 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
28. Austria México
Bangladesh Pakistán
Bélgica Perú
Brasil Filipinas
Canadá Portugal
Dinamarca Singapur
Francia Corea del Sur
Grecia
España
Guatemala
Sri Lanka
Indonesia
Suiza
Italia
Tailandia
Japón
Turquía
Malasia
Vietnam
Mauricio
29. 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/3PT.
30. Example: Testing & Certification
Requirements for Children’s Raincoat
1. Determine whether this product is regulated by the
CPSC.
– www.cpsc.gov/businfo/regsbyproduct.html
2. List all applicable rules:
– 16 CFR part 1611
(vinyl plastic film)
– Section 101 of the CPSIA
(lead content)
– Tracking labels
30
31. 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.”
32. 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
33. Periodic Testing Rule
• The Periodic Testing Rule will take effect on
February 8, 2013.
• After initial testing and certification, periodic
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).
34. Tracking Labels
• A permanent mark affixed to the product and
its packaging, if practicable
• Requirements:
– 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
35. New Safety Rules for Durable Infant
Products
• Third party testing and certification required
for durable infant and toddler products with
safety rules
• Consumer registration requirement
• www.cpsc.gov/durableinfantproducts
36. New Safety Rules for Durable Infant
Products
The Commission has issued safety rules for seven
products. By law, the Commission must continue to
develop mandatory rules for the remaining products.
• Bed rails • High Chairs, • Stationary activity
(portable) booster seats, hook centers
• Bath seats on chairs • Infant carriers
• Full-size cribs • Gates and other • Children’s folding
enclosures for chairs
• Non-full-size confining a child
cribs • Changing tables
• Strollers
• Infant walkers • Bouncers
• Swings
• Toddler beds • Bathtubs
• Bassinets and
• Play yards cradles • Slings
36
37. Non- Children’s products and the
CPSIA
• New regulations for some non-Children’s
products require:
– Testing: Any laboratory can perform the
testing for non-children’s products. Third
party testing is not required.
– Certification: A General Certification of
Conformity (GCC) is required for all
products subject to a rule, ban, standard
or regulation enforced by the CPSC.
38. What Testing Requirements Exist for
Non-Children’s Products?
Reasonable Testing Program (RTP)
• Some standards contain an RTP for their
products.
• General RTP for all regulated non-
children’s products has not been defined
by the Commission.
39. What Testing Requirements Exist for
Non-Children’s Products?
Model of an RTP for non-children’s
products:
• Notice of proposed rulemaking for
testing and labeling pertaining to
certification at 75 FR 28336, 28362 (May
20, 2010): www.gpo.gov/fdsys/pkg/FR-
2010-05-20/pdf/2010-11365.pdf.
40. Example: Testing & Certification
Requirements for an Adult Bicycle
1. Determine whether this product is
regulated by the CPSC.
– www.cpsc.gov/businfo/regsbyproduct.html
2. List all applicable rules.
– 16 CFR part 1512
(requirements for bicycles)
41. Example: Testing & Certification
Requirements for an Adult Bicycle
3. Arrange for testing (test each unit or test
using a reasonable testing program).
– First party test (you);
– Third party test (testing laboratory); or
– Third party test (CPSC-accepted testing laboratory).
4. Collect test reports and other information in a
certificate.
5. “Enter into Commerce.”
42. 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
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.
43. Content of Certificates
• 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.
– 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.
44. Availability of Certificates
• Certificates must “accompany” each
product or shipment of products covered by
the same certificate.
• A copy of the certificate must be “furnished
to 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.
45. Electronic Certificates
• The Commission by rule has confirmed that
certificates in electronic form are acceptable.
• Key requirements:
– Certificate must be created no later than
the time of shipment to United States or
first distribution within the United States.
– The certificate must be reasonably
accessible from information on the product
or accompanying the shipment.
46. How to Find More Information
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
• 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).
47. For New Certification, Testing and Other
Requirements:
www.cpsc.gov/businfo/intl/newusreq.html
48. Responsibility to Comply with Voluntary
Standards and Technical Regulations
All equally responsible
Manufacturers
Distributors Retailers
Importers
Importers, although reliant on foreign producers,
are directly responsible for the safety of products
they bring into the United States.
49. Importance of Using U.S. Technical Regulations
and Voluntary Standards
To avoid entry problems with the U.S.
government (Customs and CPSC), foreign
manufacturers SHOULD comply with BOTH:
– CPSC Regulations (mandatory)
– Private Sector Standards (consensus
voluntary standards)
Both play essential safety roles.
50. How the CPSC Works with
Manufacturers
Develop guidance and help firms comply
with the law through:
• International program outreach
• Domestic manufacturer seminars
• Participation at ICPHSO symposiums
• Advice and guidance to trade associations
and consultants
51. 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
used.
– Know and understand all requirements and
standards.
– Comply with consensus standards and
technical regulations.
52. Best Manufacturing Practices
– Design safety into product. It is your
responsibility to work with the designer.
– Control your supply chain (supply chain
integrity).
– Preventive action is better than corrective
action.
– Avoid long-term repercussions: Damage to
Brand Name and “Made in My Country”.
53. 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.
– Seek products with third party certification.
– Unauthorized component substitutions can
easily lead to a recall.
– Conduct spot inspections.
55. Contact Information
Dean W. Woodard, M.S.
Director, Office of Education, Global Outreach, and
Small Business Ombudsman
E-mail: Dwoodard@cpsc.gov
Phone: 301-504-7651
Tilven M. Bernal
Program Manager for the Western Hemisphere
International Programs
E-mail: Tbernal@cpsc.gov
Phone: 301-504-7309
Notas del editor
CPSC supports continuous improvement to voluntary safety standards
Small Parts Regulations U. S. regulations require children’s products to be constructed to withstand the reasonably foreseeable uses and abuses of childrento whom a product will appeal and for whom it will be purchased. Determining the appropriate age of potential users of a product requires a toy manufacturer to match the characteristics of a toy to aparticular age user based on children’s developmental abilities and interests.Toys and games that are intended for children ages three to six must have a choking hazard warning on their packaging if they contain small partsSimilar cautionary labeling is required for balloons, small balls and marbles, as well as toys that contain these, if they are intended for children ages 3 to 8
GPOaccess.govBookstore.gpo.gov
Revisions now approved for F963 include the following: • Heavy Metals—Limits for heavy metals in toy substrates have been added to the existing surface coating requirements. A soluble approach for determination of heavy elements in toys and toy components has been maintained as this has been demonstrated to be more closely correlated than total content with the amount of element which is bioavailable, and therefore with risk of toxicity.Heavy metals: Cadmium, Barium, Antimony• Compositing Procedure for Total Heavy Metal Analysis—Revisions outline detailed procedures for accomplishing this end by specifying the conditions under which compositing is allowable, when a composite result may be relied upon without further testing, and when testing of individual samples must subsequently be performed.• Bath Toy Projections—Revisions are intended to address the potential hazards that may be presented by vertical, or nearly vertical, rigid projections on bath toys. This requirement is intended to minimize possible puncture or other hazards to the skin that might be caused if a child were to fall on a rigid projection.• Among other revised areas of the standard are sections on 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.
Same as 1000 parts per million
Same as 1000 parts per million
A part is "inaccessible" if it is has a sealed covering or casing and will not become physically exposed through reasonably foreseeable use and abuse of the product. Reasonable foreseeable use and abuse includes swallowing, mouthing, breaking or other children's activities, and the aging of the product.
3rd party labs: As of February 22, 2011, CPSC had approved 329 labs in 34 countries to test products to be sold in the United States. Almost one third of those approved labs are located in China and Hong Kong.
A manufacturer of a children's product that must comply with one or more of these rules must support its certification of compliance with test results from one of these laboratories.
A material change in a product is a change: - in the product design or manufacturing process, including the sourcing of component parts, - which a manufacturer exercising due care knows, or should know, could affect the product’s ability to comply with the applicable children’s product safety rules.
What does a periodic testing plan look like? What does a production testing plan look like?A periodic testing plan must be in writing, and it must include the tests to be conducted, the intervals at which the tests will be conducted, and the number of samples to be tested. The testing interval may vary, depending upon which children's product safety rule is applicable to the product and the factors outlined in the regulation.A production testing plan must be in writing and must describe the process-management techniques used; the tests to be conducted or the measurements to be taken; the intervals at which those tests or measurements will be taken; the number of samples tested; and an explanation describing how these techniques and tests provide a high degree of assurance of compliance with the applicable regulations.
does not require all information on one labeldoes not require creation of batch or lot system, but you need some method of tracking parts
In order to improve recall effectiveness, Congress has required that manufacturers of covered products:Provide consumers with a postage-paid consumer registration form with each product; Maintain a record of the names, addresses, e-mail addresses, and other contact information of consumers who register their products; and Permanently place the manufacturer name and contact information, model name and number, and the date of manufacture on each durable infant or toddler product.