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
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.
not required to name a foreign manufacturer
It can be transmitted with Customs docs
PROFECO Pro-Consumer Week: Requirements for children's products and certification & testing for non children's products - English
U.S. Consumer Product Safety Commission CPSC requirements for children’s products andcertification & testing for non-children’s productsThis presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of, the Commission.
MissionProtecting 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 • Engaging in product safety system processes by supporting improvements to voluntary standards/codes CPSC staff promotes • Creating and enforcingconsumer product safety } technical regulations and bansthrough 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
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 inadequaciesCPSC staff does not vote.
Voluntary Standard Development Organizations for Consumer ProductsANSI (American National Standards Institute) – Motorized Equipment – Lawn & Garden Equipment – Household Products – Safety LabelingASTM International – Children’s Products • Recreational ProductsUnderwriters Laboratories (UL) – Electrical and other products
Voluntary Standards and RecallsIn some cases, failure to comply with a consensusvoluntary standard indicates to the CPSC that aproduct contains a defect that presents a substantialproduct 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 RegulationsRegulatory process can be started by vote of theCommission 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
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
Age Grading of Toys• “Children’s products” are defined as consumer products designed or intended primarily for children 12 years old or younger.• A "childrens 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.
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 • 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
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
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)
Lead Content ExceptionsMetal 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 onlyOrdinary Books and Paper-Based Materials 20
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
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)
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 childs 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 childs mouth is defined as any part of a toy that can be brought to the childs 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 childrens 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
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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 Childrens Product Certificate (CPC) at www.cpsc.gov/3PT.
Example: Testing & Certification Requirements for Children’s Raincoat1. Determine whether this product is regulated by the CPSC. – www.cpsc.gov/businfo/regsbyproduct.html2. 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 Raincoat3. 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 ConformityIf the U.S. manufacturer or importer makes amaterial change to the product after initialcertification:1. Re-test the affected component part or the entire product; and2. 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
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
New Safety Rules for Durable Infant ProductsThe Commission has issued safety rules for sevenproducts. By law, the Commission must continue todevelop 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
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’sproducts:• 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 Bicycle1. Determine whether this product is regulated by the CPSC. – www.cpsc.gov/businfo/regsbyproduct.html2. List all applicable rules. – 16 CFR part 1512 (requirements for bicycles)
Example: Testing & Certification Requirements for an Adult Bicycle3. 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.
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.
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.
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.
How to Find More InformationGo to CPSC’s website: www.cpsc.gov/cpsia and find astep-by-step guide to navigate the CPSIA and links toother 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).
For New Certification, Testing and OtherRequirements:www.cpsc.gov/businfo/intl/newusreq.html
Responsibility to Comply with Voluntary Standards and Technical Regulations All equally responsible Manufacturers Distributors Retailers ImportersImporters, although reliant on foreign producers,are directly responsible for the safety of productsthey bring into the United States.
Importance of Using U.S. Technical Regulations and Voluntary StandardsTo 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.
How the CPSC Works with ManufacturersDevelop guidance and help firms complywith the law through:• International program outreach• Domestic manufacturer seminars• Participation at ICPHSO symposiums• Advice and guidance to trade associations and consultants
Best Manufacturing PracticesManufacturers and importers should use bestpractices to ensure safe products enter into thechain 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.
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