PROFECO Pro-Consumer Week: Requirements for children's products and certification & testing for non children's products - English

U.S. Consumer Product Safety Commission

This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of, the Commission.

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

products

Mission

Protecting the public against unreasonable risks of injury from

consumer products through education, safety standards activities, regulation and

enforcement.

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

Product Hazard Prevention Strategies

CPSC staff promotes consumer product

safety through a multi-pronged approach

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

• Creating and enforcing 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

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CPSC Voluntary Standards Monitoring

Participate in

committees

Analyze injury/death

data for hazard

patterns

Review standards

for inadequacie

s

Conduct tests and

evaluations to support findings

Propose standards

development or

revisions

CPSC staff does not vote.

Voluntary Standard Development Organizations for Consumer

ProductsANSI (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

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.

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 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 with toy chest provision (previously voluntary)

• 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 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.

–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 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.

Age Grading of Toys

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”)

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).

Partial List of Products in ASTM F963

• Sound-Producing Toys • Battery-Operated Toys• Small Objects • Stuffed and Beanbag-

type Toys• Projections • Marbles and Balls• Folding Mechanisms

and Hinges• Hemispheric-Shaped

Objects• Cords and Elastics in

Toys

• Wheels, Tires, and Axles• Magnets• Pacifiers• Balloons• Projectile Toys• Certain Toys with

Spherical Ends• Rattles• Teethers and Teething

Toys• Squeeze Toys• Yo-Yo Elastic Tether Toys

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.

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.

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

• 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)

Lead Content Limits

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 Materials20

• 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

Lead “Determinations”

• 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

Limit for Lead in Paint

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 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)

• 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.

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.

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.

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

Austria Bangladesh

BélgicaBrasil

Canadá Dinamarca

Francia

GreciaGuatemala Indonesia

ItaliaJapón

Malasia Mauricio

EspañaSri Lanka

SuizaTailandia TurquíaVietnam

México Pakistán

Perú Filipinas Portugal Singapur

Corea del Sur

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.

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

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.”

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

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).

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

• Third party testing and certification required for durable infant and toddler products with safety rules

• Consumer registration requirement

• www.cpsc.gov/durableinfantproducts

New Safety Rules for Durable Infant Products

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

(portable)• Bath seats• Full-size cribs• Non-full-size

cribs• Infant walkers• Toddler beds• Play yards

• High Chairs, booster seats, hook on chairs

• Gates and other enclosures for confining a child

• Strollers• Swings• Bassinets and

cradles

• Stationary activity centers

• Infant carriers• Children’s

folding chairs• Changing

tables• Bouncers• Bathtubs• Slings

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.

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.

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.

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)

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.”

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.

• 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.

Content 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.

Availability of 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.

Electronic Certificates

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).

How to Find More Information

For New Certification, Testing and Other Requirements:

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

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

Responsibility to Comply with Voluntary Standards and Technical Regulations

All equally responsible

ManufacturersImporters

Distributors Retailers

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)

–Private Sector Standards (consensus voluntary standards)

Both play essential safety roles.

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

How the CPSC Works with Manufacturers

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.

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”.

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.

Best Manufacturing Practices

Dean W. Woodard, M.S.Director, Office of Education, Global Outreach, and

Small Business OmbudsmanE-mail: [email protected]

Phone: 301-504-7651

Tilven M. BernalProgram Manager for the Western Hemisphere

International ProgramsE-mail: [email protected]

Phone: 301-504-7309

Contact Information