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Understanding US CPSIA
                        Product Certification
      Complying with New and Existing Requirements
for Apparel, Children’s Products, Toys and Hard Goods
     A White Paper from Bureau Veritas Consumer Products Services
              Prepared by Doug Boehm, Global Technical Engineer – February 2, 2012
© 2012 Bureau Veritas Consumer Products Services, Inc.

All rights reserved. No part of this publication or the information contained herein may be reproduced, copied, translated, sold, or
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contained herein, other than portions in the public domain or owned by third parties, are the property of BVCPS Inc. and are protected
by law, including, but not limited to, U.S. copyright laws and international treaty provisions. BVCPS Inc. has exclusive proprietary
rights in the information provided herein. Any unauthorized use of this publication or any part thereof could result in civil and/or
criminal claims for damages and penalties.

BVCPS Inc. provides the information in this publication as a resource of general information. The information contained herein is
subject to change without notice from BVCPS Inc., governments, regulatory bodies, or other industry associations. It does not
constitute nor should be deemed to constitute a legal opinion on the subject matter presented, nor does the information contained
herein replace any applicable legal or regulatory requirements and is provided “as is.”

BVCPS Inc. does not warrant the accuracy, completeness, timeliness, or availability of any information contained herein. BVCPS
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                                    Bureau Veritas Consumer Products Services, Inc. (BVCPS)
                                                    100 Northpointe Parkway
                                                  Buffalo, New York 14228-1884

                                                   Cover image ©iStockphoto.com/yuriarcurs
Contents
Introduction .............................................................................................................. 4

Product Certification Per the Consumer Product Safety
Improvement Act (CPSIA) ........................................................................................5

Certification of Children’s Products ........................................................................6

Reasonable Testing Programs for Nonchildren’s Products ............................... 10

Summary ..................................................................................................................14

About this White Paper ..........................................................................................14

About the Author ....................................................................................................15

Sources .....................................................................................................................15

Appendix:

Summary Chart of Requirements for Children’s
and NonChildren’s Products ..................................................................................17

Comparison Chart US and European Toy Certification
Requirements ..........................................................................................................19




                                                                                                                            www.bureauveritas.com/knowledge   3
Introduction
                                    The Consumer Product Safety Improvement Act of 2008 (CPSIA) drastically changed the
                                    regulatory landscape for toys and other consumer products through the establishment
                                    of a number of new requirements, including new restrictions on phthalates in childcare
                                    articles and toys; lead in substrates of children’s products; increased restrictions on
                                    lead in surface coatings on children’s products, furniture, and in paint; and required
                                    mandatory third-party testing and documentation from an accredited laboratory for
                                    children’s products.

                                    While each of these represented a significant change, the law also required new
                                    regulation to be created for the testing and certification of regulated products. Upon
                                    CPSIA’s passage, the Consumer Product Safety Commission (CPSC) was given 15
                                    months to establish a rule defining this certification program for children’s products.This
                                    regulation, commonly referred to as the “15-Month Rule,” took 38 months to develop
                                    and be passed by the Commission due to the complexity of the rule and the challenges
                                    faced by manufacturers trying to comply with the many new requirements of CPSIA. A
                                    summary of this process is provided below beginning with the publication of the original
                                    CPSC proposal.

                                    On May 20, 2010, the CPSC published a proposed rule about testing and labeling
                                    for product certifications in the Federal Register. The proposed rule was the first
                                    draft of the certification program requirements for products subject to a consumer
                                    product rule, ban, or standard. The proposed rule was broken into subparts that
                                    describe requirements for reasonable testing programs for nonchildren’s products and
                                    certification of children’s products.

                                    Upon publication of the proposed rule, the CPSC opened a comment period for all
                                    stakeholders until August 3, 2010. The Commission received extensive comments
                                    and considered the comments when drafting the final rule. On September 21, 2011
                                    the Commission released the final rule in a briefing package. This document included a
                                    preamble that discussed the changes made from the proposed rule to the final rule and
                                    CPSC staff responses to the comments received. Where the proposed rule addressed
                                    certification of both non-children’s and children’s products, the final rule only defined
                                    certification requirements for children’s products and reserved the section defining
                                    requirements for non-children’s product.

                                    The final rule, effective 15 months after the date of publication in the Federal Register,
                                    was passed in late October and published in the Federal Register as 16 CFR 1107 on
                                    November 8, 2011. That means products manufactured after February 8, 2013 will need
                                    to comply with the rules of 16 CFR 1107.

                                    This white paper provides an overview of the requirements for product certification in
                                    accordance with CPSIA and 16 CFR 1107, including children’s products requirements
                                    and a discussion of current guidance on a Reasonable Testing Program (RTP) for non-
                                    children’s products.


4   Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
Product Certification Per the Consumer
Product Safety Improvement Act (CPSIA)
CPSIA requires a domestic manufacturer or importer of a consumer product subject to
a rule, ban, or standard to issue a certificate certifying conformity. That certificate must
be available at importation and can accompany the shipment physically or be available
electronically.

These requirements apply to all consumer products with an applicable CPSC rule,
ban, or standard, whether children’s products or general use (non-children’s) products.
Certificates for general use products are known as General Conformity Certificates
(GCCs). The certificates for children’s products do not have a defined name in the
law but are sometimes referred to as Children’s Product GCCs or Children’s Product
Certificates (CPCs); the CPSC has been using the latter name recently. Both GCCs
and CPCs must be based on a compliant testing program, either a Reasonable
Testing Program, or Children’s Product Testing Program based on third-party testing,
respectively.

The requirement to implement a certification program and issue a conformity certificate,
falls upon the importer (for products of foreign manufacture) or domestic manufacturer
(for products made in the US). This is the primary party of responsibility in the scope
of the new rule, and they must assure compliance, even if they do not directly take all
steps required by the rule. The CPSC may request evidence, through documentation
of these steps, that a compliant program was in place for product certification and
the CPSC could take action under this regulation against any responsible importer or
domestic manufacturer found to not comply. This review will likely be retroactively
triggered by incident or complaint, but could become proactive where the CPSC may
make requests on a product of high-risk or in a product category that has had recent
incidents or history of incidents. Though most products, free of incident or complaint,
will only have their conformity certificate checked, a required document at the time of
importation.

The manufacturers and importers of certain products have been required to issue these
certificates since November 2008, though requirements for the certification programs
as mandated by the 15-Month Rule were not established until November 2011 and do
not take effect until February 8, 2013. As a result, certificates issued from November
2008 through February 2013 can be issued without following any specific program.
However, upon the final rule for testing and labeling pertaining to product certification
becoming effective, a valid children’s product certificate can only be issued following
the published requirements.




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Certification of Children’s Products
                                    16 CFR 1107.20-.26, Subpart C – Certification of Children’s Products.

                                    One of the major requirements instituted by CPSIA was the requirement for third-party
                                    testing of children’s products. With third-party testing requirements already established
                                    for children’s products since 2008, the final rule does not significantly readdress
                                    these requirements. Rather, the certification requirements in this section focus on
                                    new additional requirements and outline a whole program that establishes good
                                    manufacturing practices that must be followed to certify product. These elements,
                                    which take effect February 8, 2013, are found in Subpart C of the final rule and
                                    summaries of each section are provided below:

                                     General Requirements: The general requirements section of Subpart C reiterates the
                                    n	
                                     third-party testing and certification requirements established for children’s products
                                     per CPSIA (i.e., all children’s products must be tested to all applicable rules, bans,
                                     and standards at a CPSC-approved third-party lab). This certification testing must be
                                     conducted on a sufficient number of samples to give a high degree of assurance
                                     (HDoA) that all products comply with the requirements.

                                     Periodic Testing: Children’s products require continued periodic testing throughout
                                    n	
                                     production. Periodic testing is required to be conducted a minimum of once per year,
                                     and periodic testing must be conducted at a CPSC-approved third-party test lab. (Note:
                                     There are some exemptions for manufacturers who implement additional production
                                     testing, not required at a third-party lab, which could extend the maximum time
                                     interval to two or three years.) The determination for testing volume and frequency is
                                     based on factors such as production lot size, severity of potential injury, intended age
                                     group of the user, variability in production and history of product recalls or consumer
                                     complaints. In general, children’s products have a higher risk of injury and the lower
                                     age of use plays a significant factor in evaluation of risk.

                                     Representative Samples: Samples tested for periodic testing must be representative
                                    n	
                                     of the production lot such that the manufacturer can infer the rest of the lot produced
                                     in that period is in compliance. A sufficient number of representative samples must
                                     also be selected to support that inference. Documentation of how the samples were
                                     chosen and evidence of those samples (i.e., the date they were selected and testing
                                     results) must be maintained for the records.




6   Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
Material Change: A manufacturer is required to track and maintain records for all
n	
 material changes that occur during a product’s production. When a material change
 occurs that could affect compliance with a rule, ban, or standard, the manufacturer
 must recertify to the affected rule(s). When the material change only affects the ability
 of a component or multiple components to comply with a rule, the manufacturer
 may recertify based on the original certification testing and new component part
 certification. All component level certification must be conducted in accordance with
 16 CFR 1109, passed at the same time as this rule.

 Undue Influence: CPSIA mandated that manufacturers of children’s products
n	
 and those employees who interact with third-party assessment bodies be trained
 to prevent undue influence. This training must include required procedures for
 confidential reporting to the CPSC if there is evidence or knowledge of any undue
 influence occurring. Originally, the proposed rule required training to be renewed
 yearly, but the final rule only requires retraining when a significant change has been
 made to the policy.

 Corrective Actions: The final rule removed the formal section requiring remedial
n	
 action plans, which were established plans that would be enacted if any non-
 conformity was found. Despite that section’s removal, the general requirements
 still state a “manufacturer must investigate the reasons for the failure and take the
 necessary steps to address the reasons for failure,” and cannot certify “until the
 manufacturer establishes, with a high degree of assurance, that the finished product
 does comply.” As a result, in addition to a passing retest, the manufacturer must have
 taken an appropriate corrective action to address the reason for failure. Without that
 action and understanding, the manufacturer will not have reasonable assurance the
 production is compliant.

 Recordkeeping: The proposed rule required the documents to be maintained in
n	
 English, in the US and for five years after importation or production has ended. Those
 requirements were loosened with the final rule and documents can be maintained
 outside the US and in a language other than English as long as a translated document
 is readily available within 48 hours upon request. The documents only need to be
 maintained for five years, regardless of the end date of importation or production. For
 a children’s products testing program, the manufacturer must maintain documentation
 of certification testing and children’s product certificates of conformity; periodic
 testing plans with sample selection and test results; documentation of all material
 changes; records of the undue influence training and associated employee training
 records; and any corrective actions.




                                                                                       www.bureauveritas.com/knowledge   7
Considerations for Certification of Children’s Products

                                    When considering the actions to be taken and the complexity of the supply chain
                                    involved in certification, the certifying party should understand the expectations that
                                    are upon them. The certification rule addresses this by indicating the responsible
                                    importer or manufacturer needs to exercise due care when certifying their product, in
                                    particular when relying on the actions taken by other parties, like supplier component
                                    part certifications or periodic testing conducted at a foreign manufacturer. The rule
                                    defines due care:

                                         “Due care means the degree of care that a prudent and competent person
                                         engaged in the same line of business or endeavor would exercise under
                                         similar circumstances. Due care does not permit willful ignorance.”

                                    The CPSC has given the direction that due care requires knowledge and assurance,
                                    though the actions necessary for an importer to go beyond willful ignorance and gain
                                    knowledge and assurance are not specifically defined. The CPSC will likely rely on
                                    their determination to identify what actions a prudent and competent manufacturer/
                                    importer would take.

                                    Commissioner Anne Northrup sent questions to the CPSC staff regarding due care
                                    comments in the preamble of the new rule where staff stated an importer, acting
                                    with due care, must ensure periodic testing is conducted by the foreign manufacturer.
                                    In clarifying what actions an importer could take the staff stated:

                                         “The requirement should be specified in the importer’s purchase order
                                         to the foreign manufacturer, clearly communicating the requirement to
                                         conduct the required periodic testing and requiring submission of the
                                         foreign manufacturer’s periodic testing plan. Simply reviewing the foreign
                                         manufacturer’s periodic testing plan does not satisfy the requirement, as this
                                         approach lacks evidence that the periodic testing plan has been implemented.
                                         An importer may need to conduct occasional site visits to his supplier’s
                                         manufacturing facility to examine evidence that the required periodic testing
                                         has been properly performed or may need to verify the authenticity of the
                                         supplier’s test reports by contacting the testing laboratory for verification. An
                                         importer may also wish to occasionally submit samples from product received
                                         from the supplier for testing, to compare the test results to those conducted
                                         by the foreign manufacturer.”




8   Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
The clear expectation of CPSC staff is that an importer would do more than rely on
a contract with the vendor or attestation from the vendor, as those methods lack
evidence. Considering the full scope of certification – including all elements discussed
in the section above – is the responsibility of the importer, the CSPC staff view is that
due care by a prudent and competent importer requires evidence.



    The following children’s products or applicable rules, bans, and
    standards require a certification program:
    Baby walkers                                  Infant walkers
    Children’s ATVs                               Infant rattles
    Children’s bikes                              Pacifiers
    Children’s bike helmets                       Toys
    Children’s bunk beds                          Caps and toy guns
    Children’s carpets and rugs                   Children’s sleepwear
    Children’s clothing                           Durable infant products
    Children’s mattresses/pads                    Lead in surface coatings
    Children’s metal jewelry                      Lead in substrates
    Children’s vinyl plastic films                Small parts
    Cribs                                         ASTM F963
    Dive sticks                                   Phthalates




                                                                                       www.bureauveritas.com/knowledge   9
Reasonable Testing Programs for
                                     Nonchildren’s Products
                                     16 CFR 1107.10, Subpart B – Reasonable Testing Program for
                                     Nonchildren’s Products (Reserved)

                                     The CPSC reserved Subpart B in the final rule, meaning no defined requirements were
                                     passed for a Reasonable Testing Program (RTP). In the October 19, 2011 decisional
                                     meeting Commissioner Robert Adler and Chairman Inez Tenenbaum stressed that the
                                     reservation of the section defining a Reasonable Testing Program was in no way an
                                     exemption for manufacturers from establishing one for certification and it is still very
                                     much required. They are quoted as saying:

                                       	 “If you’re not going to test every single product then you must have a
                                         Reasonable Testing Program.” – Adler

                                       	 “[Anyone] subject to our regulations for non-children’s products must still either
                                         test each product or have a Reasonable Testing Program” – Tenenbaum

                                     The CPSC may choose to define these requirements at a later date, or they may stay
                                     silent with no formal rules being developed. Since no requirements were defined in
                                     the final rule, a manufacturer has more leeway in how to establish their Reasonable
                                     Testing Program. The proposed rule can be used to provide guidance for a manufacturer
                                     in defining their program, with the goal of providing a high degree of assurance their
                                     products comply, and we will base our discussion on that document.

                                     Per the proposed rule, manufacturers certifying nonchildren’s products “pursuant to a
                                     reasonable testing program” must ensure that such a program provides “a high degree
                                     of assurance [HDoA] that the consumer products covered by the program will comply
                                     with all applicable rules, bans, standards or regulations.” The proposed rule defines a
                                     high degree of assurance to mean “… an evidence-based demonstration of consistent
                                     performance of a product regarding compliance based on knowledge of a product and
                                     its manufacture.” Note: These requirements are currently in effect and have been
                                     applicable since 2008.




10   Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
The following general use products require certification per a
    Reasonable Testing Program:
    Adult apparel                                 Fireworks
    Adult bikes                                   Garage door openers
    Adult bunk beds                               Lawn mowers
    Adult carpets                                 Matchbooks
    Adult vinyl plastic film                      Multi-purpose lighters
    Architectural glazing                         Adult ATV’s
    Candles (metal wicks)                         General use furniture (coatings)
    CB antennas                                   Adult mattresses
    Cellulose insulation                          Paint
    Child-resistance on portable gas              Refrigeration door latches
      containers                                  Special packaging under PPPA
    Cigarette lighters                            Swimming pool slides
    Contact adhesives                             Unstable refuse bins




In the proposed rule, the CPSC outlined a series of elements that can be used to
establish a Reasonable Testing Program for nonchildren’s products. Brief summaries
for each component of a Reasonable Testing Program for a nonchildren’s products are
as follows:

 Product Specification: The goal of a product specification is to differentiate a product
n	
 from other products which may be similar, or from other products made by the
 manufacturer. CPSC lists examples of suitable content for product specifications as:
 “color photograph or illustration, model names or numbers, a detailed bill of materials,
 a parts listing, raw material selection and sourcing requirements.” A manufacturer
 also should list all requirements that apply to the product, to which the product must
 be certified.




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Certification Tests: A product must have certification testing or other support to
                                     n	
                                      show compliance with all applicable rules, bans, and standards. A manufacturer must
                                      submit to a lab or do first-party testing on a sufficient amount of samples, materially
                                      representative of all samples produced, for certification testing to ensure with a
                                      high degree of assurance (HDoA) that all products produced are compliant with all
                                      applicable rules, bans, or standards. If there is a material change in a product that
                                      could affect compliance, the product must be recertified though testing or other
                                      means of verification. If testing at a component level would be sufficient to indicate
                                      compliance, component-level testing is acceptable. CPSC defined material change to
                                      mean:

                                       	 ”any change in the product’s design, manufacturing process, or sourcing of
                                         component parts that a manufacturer exercising due care knows, or should
                                         know, could affect the product’s ability to comply with the applicable rules,
                                         bans, standards, or regulations.”

                                      Production Testing Plan: After initial compliance testing, a manufacturer should
                                     n	
                                      implement a production testing plan to identify intervals of testing, number of tests to
                                      be conducted, and which samples will be pulled for testing. The plan must be unique
                                      for each location of manufacture.

                                       The intervals and number of tests should provide a high degree of assurance (HDoA)
                                       of continued compliance for products produced after compliance testing. This may
                                       be supported by non-testing methods, such as control programs, statistical process
                                       control programs, or failure mode and effects analyses (FMEAs). Regardless of
                                       whether these alternative methods or interval testing are used, the production
                                       testing plan needs to describe why the established plan provides a high degree of
                                       assurance (HDoA). The draft rule gave no minimum frequency or minimum number
                                       of samples for production testing. In CPSC’s discussion of the proposed rule, they
                                       did provide guidelines to consider: production lot size, severity of potential injury,
                                       intended age group of the user, variability in production, and history of product
                                       recalls or consumer complaints.

                                      Remedial Action Plan: This plan addresses and tracks noncompliances found in
                                     n	
                                      certification or product testing, as well as the actions taken to address them. It can
                                      exist prior to any noncompliances, and outline processes to be taken to address
                                      any findings. The main goals of this plan are to be able to determine the cause of
                                      a nonconformity, to differentiate the compliant and noncompliant products within
                                      the lot, and to resolve the nonconformity so further production will comply with all
                                      applicable requirements.




12   Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
Recordkeeping: Since certification must be based on a Reasonable Testing Program
n	
 (RTP), and the CPSC can request evidence of the program from the manufacturer,
 documentation of that program is necessary, despite no final RTP rules. The proposed
 rule had stricter requirements than the final rule defined for a children’s product testing
 program so it is recommended that the recordkeeping requirements for children’s
 products be adopted into the Reasonable Testing Program and used for non-children’s
 products. This means documents should have the same five-year maintenance from
 creation, and be readily available upon request, in English.

Considerations for a Reasonable Testing Program
Since the Reasonable Testing Program elements are based upon CPSC guidance and
are not part of the final rule there is a large degree of flexibility in how each may be
executed. However, regardless of the approach, the underlying questions every certifier
must ask are:

  	“Does my program provide a high degree of assurance my product is
   compliant?”

  	 “Did I perform my due diligence to ensure my program followed what would
    reasonably be expected of a certifier?”

If the manufacturer is able to answer “Yes” to both questions, their program should be
compliant. Establishing a “high degree of assurance” and “due diligence” are crucial
to answering these questions. Additionally, an importer should act with due care when
certifying their products, particularly when relying on actions taken within their supply
chain, where visibility to those actions may be limited. It also should be understood that
just because the CPSC choose not to define specific criteria for a Reasonable Testing
Program such a program is still required by law, and should provide a high degree of
assurance in the same way a children’s product testing program does.




                                                                                         www.bureauveritas.com/knowledge   13
Summary
                                     This white paper has provided a general overview of the requirements for CPSIA
                                     Certification Programs for children’s products and adult products. The goal of each of
                                     these programs is to prevent noncompliant products from reaching consumers, as well
                                     as to ensure the ability of manufacturers and importers to locate the source of any
                                     issues that might arise, along with the scope of products affected.

                                     With the enactment deadline approaching, engaging a partner with regulatory
                                     knowledge and experience are first steps toward compliance. Bureau Veritas Consumer
                                     Products Services can assist you in all aspects of establishing a successful approach
                                     toward understanding, applying, and complying with any and all requirements of CPSIA,
                                     including the certification requirements described within this white paper. For more
                                     information on these services or to subscribe for complimentary regulatory updates,
                                     please visit us at www.bureauveritas.com/cpsia-rtp.



                                     About this White Paper
                                     This white paper is published by the Information Resources Center of Bureau Veritas
                                     Consumer Products Services. For over 15 years, our Information Resources Center
                                     has worked successfully with top companies around the world to help them better
                                     understand the consumer market and regulatory environment. With access to a print
                                     collection of over 27,000 documents, subscriptions to 34,000 databases, and contacts
                                     in over 140 countries, the Information Resources Center is staffed by a trained team of
                                     information professionals and is an industry leading resource dedicated to monitoring
                                     and understanding regulatory information that affects consumer products around
                                     the world. White papers published by the Information Resources Center represent a
                                     collaborative team effort with Bureau Veritas Subject Matter Consultants (SMCs) from
                                     throughout our network. As part of their responsibilities, these individuals participate
                                     in a variety of technical committees including ASTM, CEN, IABFLO, and the US Toy
                                     Industry Association (TIA), placing our technical services teams at the forefront of new
                                     and emerging compliance globally. To learn more about how our Information Resources
                                     Center can help you, please visit us at: www.bureaveritas.com/knowledge or call us for
                                     a complimentary consultation at 1-716-505-3591.




14   Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
About the Author
As a Global Technical Engineer with Bureau Veritas Consumer Products Services, Doug
Boehm is the lead technical consultant for testing and labeling pertaining to product
certification in North America. Doug began his career with Bureau Veritas in 2006 as
a product test engineer in the Toys and Juvenile Products department, working with
various manufacturers and major retail programs. In 2009, Doug joined the Toys and
Juvenile Products Technical Services team as a product engineer and assumed his
current responsibilities. Doug is a member of committees within ASTM F08 (sports
equipment and facilities) and F15 (consumer products). He holds a bachelors and
masters in mechanical engineering from the University at Buffalo.



       Sources
       Consumer Product Safety Improvement Act of 2008 (CPSIA), Public Law
       110–314, August 14, 2008
       http://www.cpsc.gov/cpsia.pdf

       “Reasonable Testing Program & Third-Party Testing,” Consumer Product
       Safety Commission (CPSC), CPSC Public Workshop on CPSIA Product
       Testing, December 10, 2009
       http://www.cpsc.gov/about/cpsia/cpsiatestingreason.pdf

       Consumer Product Safety Commission, Proposed Rule, 16 CFR Part 1107,
       Testing and Labeling Pertaining to Product Certification; Federal Register,
       Vol. 75, No. 97, 28336, May 20, 2010
       http://www.cpsc.gov/businfo/frnotices/fr10/testing.pdf

       U.S. Consumer Product Safety Commission’s (CPSC’s) staff memo
       “Response to Commissioner Anne M. Northup’s Questions Related to
       Pending Proposals for Testing and Certification and Component Parts,”
       October 18, 2011
       http://www.cpsc.gov/LIBRARY/FOIA/FOIA12/brief/testcertCOAN.pdf

       Consumer Product Safety Commission, Final Rule, 16 CFR Part 1107,
       Testing and Labeling Pertaining to Product Certification; Federal Register,
       Vol. 76, No. 216, 69482, November 8, 2011
       http://www.cpsc.gov/businfo/frnotices/fr12/certfinal.pdf




                                                                                     www.bureauveritas.com/knowledge   15
16   Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
Appendix A
Summary Chart of Requirements for Children’s and NonChildren’s Products
                       Children’s      Reasonable
                     Product Testing     Testing
                        Program         Program      Bureau Veritas Solutions
Requirement                                          Simplifying Compliance for You
                       Children’s      General Use   Let Us Help You...
                        Products        Consumer
                     including Toys      Products

Certification                                        Test your products for compliance and
                                                     receive drafts of the necessary Confor-
Testing                                              mity Certificates

                                                     Create a production testing plan with
Testing Plans                                        our guidance in determining appropriate
                                                     sample size and testing frequency

Material                                             Implement our material change template
Change                                               to track all pertinent information
Tracking

Representative                                       Use our sample collection services to
Sampling                                             select proper, representative samples for
                                                     testing

Records of                                           Adopt a simple program developed by us
Undue                                                to train your employees to prevent undue
                                                     influence
Influence

                                                     Use our CAP solution to automatically
Corrective                                           trigger documented actions to resolve
Actions                                              any non-conformity found in testing

                                                     Develop product specifications with our
Product                                              services that will help confirm products
Specifications                                       are produced consistently with those
                                                     tested for compliance

                                                     Implement our Product Technical Folder
Documentation                                        solution for full-service storage of all your
                                                     required documents as well as benefit
Storage                                              from its supply chain management
                                                     features

        = Required    = Suggested



                                                                        www.bureauveritas.com/knowledge   17
Appendix B
                                     Comparing US and European Toy Requirements

                                     The New Toy Safety Directive (NTSD) in the European Union (EU) and the Consumer
                                     Product Safety Improvement Act (CPSIA) in the US share a similar goal, to make
                                     children’s products safer. While the EU NTSD was more focused specifically on toy
                                     safety than the US CPSIA, both used similar methods to achieve an increased level
                                     of safety for their covered products. In particular, they both set requirements for good
                                     manufacturing practices to avoid non-conformities resulting from design and production
                                     flaws, as well as requiring robust documentation of the processes used to ensure
                                     conformity.

                                     In the EU NTSD as well as the US CPSIA, the importer takes on the primary responsibility
                                     for products they bring into the regional jurisdiction and must declare conformity with
                                     appropriate rules at importation. They must also take steps to ensure products in
                                     continuous production continue to meet any safety requirements and are not affected
                                     by changes in materials or production processes.

                                     The chart on the following page gives a comparison of the two new rules, showing
                                     where similarities lie and where differences would require additional action. As
                                     companion to this white paper on the EU NTSD, this chart helps further illustrate the
                                     requirements in a new context to provide additional understanding for companies doing
                                     business in both markets.




18   Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
Comparison Chart US and European Toy Certification Requirements


                           Consumer Product Safety               New Toy Safety
                           Improvement Act (CPSIA)               Directive (NTSD)                                     Comments
                           US Children’s Products & Toys                EU Toys



                                                                                             CPSIA & NTSD: Require certification and declaration that a
                                                                                             product complies with all applicable safety rules.
                                                                                             CPSIA: Requires third-party testing of children’s products as
                                                                                             the basis to issue a children’s product certificate. The certificate
                           Children’s Product Certification                                  must accompany the product at importation, electronic
Conformity Certification           (of Conformity)
                                                              EC Declaration of Conformity   documentation is acceptable.
                                                                                             NTSD: Requires EC declaration of conformity; does not
                                                                                             specifically require third-party testing for certificate and
                                                                                             certificate only needs to be maintained and available upon
                                                                                             request.

                                                                                             Industry Best Pratice: Continued testing, on representative
                                                                                             samples, is required to show products stay in compliance.
                                  Periodic Testing
                                                                                             CPSIA: Third-party testing at 1 year minimum interval, 2 years
                                                                                             with additional testing/manufacturing controls.
  Continued Testing
                                                                                             NTSD: No defined testing requirements but must test
                             Representative Sampling                                         sufficiently to ensure continued compliance.



                                                                                             Industry Best Pratice: A manufacturer must have knowledge
                                      Product                                                of their product, what goes into their product and how it is
                                                                                             produced. Knowledge of applicable regulations, as well as
                              Specification (Optional)                                       potential hazards of the product are vital information for a
                                                                                             manufacturer to ensure conformity.
                                                                                             CPSIA: A manufacturer must have third-party testing to certify
                                                                                             all material changes in production (can be component level
                                  Material Change                                            testing). To track material changes, best industry practices
        Product                                                  Bill of Materials (BOM)     have the manufacturer using a well documented BOM of
                                 Tracking & Testing                                          Product Specification for traceability of those materials from
      Information                                                                            receipt to product.
                                                                                             NTSD: A manufacturer must have a BOM that identifies all
                                                                                             substances used in a product including materials, additives
                                                                                             or colorants. The manufacturer must do a safety assessment
                                                                  Safety Assessment          listing all their requirements and potential hazards in regard to
                                                                                             Mechanical, Physical, Flammability, Chemical, Electrical,
                                                                                             Hygiene and Radioactive hazards.


                                                                                             CPSIA Only: Certifiers must act ethically but only the US
                                                                                             requires manufacturers/importers to train staff to prevent
                                  Undue Influence                                            undue influence on third-party testing labs and maintain
    Ethical Conduct                  Training                                                records for all trained staff.



                                                                                             CPSIA & NTSD: No formal process is defined but both require
                                                                                             non-conformities to be investigated and products must be
                                                                                             modified to be brought into compliance or recalled in
  Corrective Actions            Failure Investigation             Corrective Measures        accordance with each region’s established reporting/recall
                                                                                             requirements.



                                                                                             CPSIA & NTSD: Documents supporting certifications must be
                                                                                             complete, and available at request of the regulatory body.
                                                                                             CPSIA: Documents require 5 year storage, in English or
                                                                                             translated within 48 hours of request.
                                                                                             NTSD: Requires 10 years maintenance after end of
                                   Documentation
    Recordkeeping                     Storage
                                                                 Product Technical File      distribution and must be in English, French or German.
                                                                                             Documents may need to be translated into other member state
                                                                                             languages following a reasoned request. Documents must be
                                                                                             available in 30 days or less upon request and failure to provide
                                                                                             complete documentation may trigger mandatory testing to
                                                                                             demonstrate compliance.




                                                                                                          www.bureauveritas.com/knowledge                    19
About Bureau Veritas and
                        Bureau Veritas Consumer Products Services

Since its founding in 1828, the Bureau Veritas Group has consistently built internationally recognized services

to help companies better manage their risk and comply with industry standards and government regulations

in a variety of industries including consumer goods, marine, industry and facilities, and government

services/international trade. With over 40,000 employees in 900 locations and laboratories in 140+ countries,

Bureau Veritas serves large and small organizations around the globe.



The Consumer Products Services Division of Bureau Veritas specializes in serving the global consumer

product and retail markets, assisting clients around the world to effectively monitor the performance and

quality of their products. As a proactive partner, we help companies manage risk, comply with regulations

and protect their brand. From apparel and toys to consumer electronics and hard goods, we assist clients

around the world with locations in 40 countries supported by more than 9,000 employees and over 35 years

of experience.



For over 15 years, Bureau Veritas’ Information Resources Center (IRC) has been dedicated to monitoring

changes in the consumer products industry and providing comprehensive knowledge services.

.


                               www.bureauveritas.com/cps
                             www.bureauveritas.com/knowledge

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Bv wp cpsia product cert

  • 1. Understanding US CPSIA Product Certification Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods A White Paper from Bureau Veritas Consumer Products Services Prepared by Doug Boehm, Global Technical Engineer – February 2, 2012
  • 2. © 2012 Bureau Veritas Consumer Products Services, Inc. All rights reserved. No part of this publication or the information contained herein may be reproduced, copied, translated, sold, or distributed in any form or by any means without the express prior written consent of BVCPS Inc. This publication and the information contained herein, other than portions in the public domain or owned by third parties, are the property of BVCPS Inc. and are protected by law, including, but not limited to, U.S. copyright laws and international treaty provisions. BVCPS Inc. has exclusive proprietary rights in the information provided herein. Any unauthorized use of this publication or any part thereof could result in civil and/or criminal claims for damages and penalties. BVCPS Inc. provides the information in this publication as a resource of general information. The information contained herein is subject to change without notice from BVCPS Inc., governments, regulatory bodies, or other industry associations. It does not constitute nor should be deemed to constitute a legal opinion on the subject matter presented, nor does the information contained herein replace any applicable legal or regulatory requirements and is provided “as is.” BVCPS Inc. does not warrant the accuracy, completeness, timeliness, or availability of any information contained herein. BVCPS Inc. is not liable for any direct, indirect, incidental, special, punitive, consequential or other damages, costs, expenses, legal fees, or losses (including without limitation lost profits, lost income, or lost opportunity costs) of any kind in connection with this publication and/or any use of this publication or information contained herein, or information made available through or referenced by this publication. In connection with this publication and all content herein, BVCPS INC. DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. This publication includes references to websites and hyperlinks for the convenience of the reader. These websites and hyperlinks are owned and operated by third parties. BVCPS Inc. does not own or control these third-party websites, and does not guarantee the accuracy, completeness, timeliness, reliability, or availability of any information included within these third-party websites. Access and use of these third-party websites is at the reader’s own risk. Third-party trademarks or other intellectual property, used or referenced but not owned by BVCPS Inc., are protected by law. Such third parties have proprietary rights in those trademarks or other intellectual property. Bureau Veritas Consumer Products Services, Inc. (BVCPS) 100 Northpointe Parkway Buffalo, New York 14228-1884 Cover image ©iStockphoto.com/yuriarcurs
  • 3. Contents Introduction .............................................................................................................. 4 Product Certification Per the Consumer Product Safety Improvement Act (CPSIA) ........................................................................................5 Certification of Children’s Products ........................................................................6 Reasonable Testing Programs for Nonchildren’s Products ............................... 10 Summary ..................................................................................................................14 About this White Paper ..........................................................................................14 About the Author ....................................................................................................15 Sources .....................................................................................................................15 Appendix: Summary Chart of Requirements for Children’s and NonChildren’s Products ..................................................................................17 Comparison Chart US and European Toy Certification Requirements ..........................................................................................................19 www.bureauveritas.com/knowledge 3
  • 4. Introduction The Consumer Product Safety Improvement Act of 2008 (CPSIA) drastically changed the regulatory landscape for toys and other consumer products through the establishment of a number of new requirements, including new restrictions on phthalates in childcare articles and toys; lead in substrates of children’s products; increased restrictions on lead in surface coatings on children’s products, furniture, and in paint; and required mandatory third-party testing and documentation from an accredited laboratory for children’s products. While each of these represented a significant change, the law also required new regulation to be created for the testing and certification of regulated products. Upon CPSIA’s passage, the Consumer Product Safety Commission (CPSC) was given 15 months to establish a rule defining this certification program for children’s products.This regulation, commonly referred to as the “15-Month Rule,” took 38 months to develop and be passed by the Commission due to the complexity of the rule and the challenges faced by manufacturers trying to comply with the many new requirements of CPSIA. A summary of this process is provided below beginning with the publication of the original CPSC proposal. On May 20, 2010, the CPSC published a proposed rule about testing and labeling for product certifications in the Federal Register. The proposed rule was the first draft of the certification program requirements for products subject to a consumer product rule, ban, or standard. The proposed rule was broken into subparts that describe requirements for reasonable testing programs for nonchildren’s products and certification of children’s products. Upon publication of the proposed rule, the CPSC opened a comment period for all stakeholders until August 3, 2010. The Commission received extensive comments and considered the comments when drafting the final rule. On September 21, 2011 the Commission released the final rule in a briefing package. This document included a preamble that discussed the changes made from the proposed rule to the final rule and CPSC staff responses to the comments received. Where the proposed rule addressed certification of both non-children’s and children’s products, the final rule only defined certification requirements for children’s products and reserved the section defining requirements for non-children’s product. The final rule, effective 15 months after the date of publication in the Federal Register, was passed in late October and published in the Federal Register as 16 CFR 1107 on November 8, 2011. That means products manufactured after February 8, 2013 will need to comply with the rules of 16 CFR 1107. This white paper provides an overview of the requirements for product certification in accordance with CPSIA and 16 CFR 1107, including children’s products requirements and a discussion of current guidance on a Reasonable Testing Program (RTP) for non- children’s products. 4 Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
  • 5. Product Certification Per the Consumer Product Safety Improvement Act (CPSIA) CPSIA requires a domestic manufacturer or importer of a consumer product subject to a rule, ban, or standard to issue a certificate certifying conformity. That certificate must be available at importation and can accompany the shipment physically or be available electronically. These requirements apply to all consumer products with an applicable CPSC rule, ban, or standard, whether children’s products or general use (non-children’s) products. Certificates for general use products are known as General Conformity Certificates (GCCs). The certificates for children’s products do not have a defined name in the law but are sometimes referred to as Children’s Product GCCs or Children’s Product Certificates (CPCs); the CPSC has been using the latter name recently. Both GCCs and CPCs must be based on a compliant testing program, either a Reasonable Testing Program, or Children’s Product Testing Program based on third-party testing, respectively. The requirement to implement a certification program and issue a conformity certificate, falls upon the importer (for products of foreign manufacture) or domestic manufacturer (for products made in the US). This is the primary party of responsibility in the scope of the new rule, and they must assure compliance, even if they do not directly take all steps required by the rule. The CPSC may request evidence, through documentation of these steps, that a compliant program was in place for product certification and the CPSC could take action under this regulation against any responsible importer or domestic manufacturer found to not comply. This review will likely be retroactively triggered by incident or complaint, but could become proactive where the CPSC may make requests on a product of high-risk or in a product category that has had recent incidents or history of incidents. Though most products, free of incident or complaint, will only have their conformity certificate checked, a required document at the time of importation. The manufacturers and importers of certain products have been required to issue these certificates since November 2008, though requirements for the certification programs as mandated by the 15-Month Rule were not established until November 2011 and do not take effect until February 8, 2013. As a result, certificates issued from November 2008 through February 2013 can be issued without following any specific program. However, upon the final rule for testing and labeling pertaining to product certification becoming effective, a valid children’s product certificate can only be issued following the published requirements. www.bureauveritas.com/knowledge 5
  • 6. Certification of Children’s Products 16 CFR 1107.20-.26, Subpart C – Certification of Children’s Products. One of the major requirements instituted by CPSIA was the requirement for third-party testing of children’s products. With third-party testing requirements already established for children’s products since 2008, the final rule does not significantly readdress these requirements. Rather, the certification requirements in this section focus on new additional requirements and outline a whole program that establishes good manufacturing practices that must be followed to certify product. These elements, which take effect February 8, 2013, are found in Subpart C of the final rule and summaries of each section are provided below: General Requirements: The general requirements section of Subpart C reiterates the n third-party testing and certification requirements established for children’s products per CPSIA (i.e., all children’s products must be tested to all applicable rules, bans, and standards at a CPSC-approved third-party lab). This certification testing must be conducted on a sufficient number of samples to give a high degree of assurance (HDoA) that all products comply with the requirements. Periodic Testing: Children’s products require continued periodic testing throughout n production. Periodic testing is required to be conducted a minimum of once per year, and periodic testing must be conducted at a CPSC-approved third-party test lab. (Note: There are some exemptions for manufacturers who implement additional production testing, not required at a third-party lab, which could extend the maximum time interval to two or three years.) The determination for testing volume and frequency is based on factors such as production lot size, severity of potential injury, intended age group of the user, variability in production and history of product recalls or consumer complaints. In general, children’s products have a higher risk of injury and the lower age of use plays a significant factor in evaluation of risk. Representative Samples: Samples tested for periodic testing must be representative n of the production lot such that the manufacturer can infer the rest of the lot produced in that period is in compliance. A sufficient number of representative samples must also be selected to support that inference. Documentation of how the samples were chosen and evidence of those samples (i.e., the date they were selected and testing results) must be maintained for the records. 6 Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
  • 7. Material Change: A manufacturer is required to track and maintain records for all n material changes that occur during a product’s production. When a material change occurs that could affect compliance with a rule, ban, or standard, the manufacturer must recertify to the affected rule(s). When the material change only affects the ability of a component or multiple components to comply with a rule, the manufacturer may recertify based on the original certification testing and new component part certification. All component level certification must be conducted in accordance with 16 CFR 1109, passed at the same time as this rule. Undue Influence: CPSIA mandated that manufacturers of children’s products n and those employees who interact with third-party assessment bodies be trained to prevent undue influence. This training must include required procedures for confidential reporting to the CPSC if there is evidence or knowledge of any undue influence occurring. Originally, the proposed rule required training to be renewed yearly, but the final rule only requires retraining when a significant change has been made to the policy. Corrective Actions: The final rule removed the formal section requiring remedial n action plans, which were established plans that would be enacted if any non- conformity was found. Despite that section’s removal, the general requirements still state a “manufacturer must investigate the reasons for the failure and take the necessary steps to address the reasons for failure,” and cannot certify “until the manufacturer establishes, with a high degree of assurance, that the finished product does comply.” As a result, in addition to a passing retest, the manufacturer must have taken an appropriate corrective action to address the reason for failure. Without that action and understanding, the manufacturer will not have reasonable assurance the production is compliant. Recordkeeping: The proposed rule required the documents to be maintained in n English, in the US and for five years after importation or production has ended. Those requirements were loosened with the final rule and documents can be maintained outside the US and in a language other than English as long as a translated document is readily available within 48 hours upon request. The documents only need to be maintained for five years, regardless of the end date of importation or production. For a children’s products testing program, the manufacturer must maintain documentation of certification testing and children’s product certificates of conformity; periodic testing plans with sample selection and test results; documentation of all material changes; records of the undue influence training and associated employee training records; and any corrective actions. www.bureauveritas.com/knowledge 7
  • 8. Considerations for Certification of Children’s Products When considering the actions to be taken and the complexity of the supply chain involved in certification, the certifying party should understand the expectations that are upon them. The certification rule addresses this by indicating the responsible importer or manufacturer needs to exercise due care when certifying their product, in particular when relying on the actions taken by other parties, like supplier component part certifications or periodic testing conducted at a foreign manufacturer. The rule defines due care: “Due care means the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances. Due care does not permit willful ignorance.” The CPSC has given the direction that due care requires knowledge and assurance, though the actions necessary for an importer to go beyond willful ignorance and gain knowledge and assurance are not specifically defined. The CPSC will likely rely on their determination to identify what actions a prudent and competent manufacturer/ importer would take. Commissioner Anne Northrup sent questions to the CPSC staff regarding due care comments in the preamble of the new rule where staff stated an importer, acting with due care, must ensure periodic testing is conducted by the foreign manufacturer. In clarifying what actions an importer could take the staff stated: “The requirement should be specified in the importer’s purchase order to the foreign manufacturer, clearly communicating the requirement to conduct the required periodic testing and requiring submission of the foreign manufacturer’s periodic testing plan. Simply reviewing the foreign manufacturer’s periodic testing plan does not satisfy the requirement, as this approach lacks evidence that the periodic testing plan has been implemented. An importer may need to conduct occasional site visits to his supplier’s manufacturing facility to examine evidence that the required periodic testing has been properly performed or may need to verify the authenticity of the supplier’s test reports by contacting the testing laboratory for verification. An importer may also wish to occasionally submit samples from product received from the supplier for testing, to compare the test results to those conducted by the foreign manufacturer.” 8 Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
  • 9. The clear expectation of CPSC staff is that an importer would do more than rely on a contract with the vendor or attestation from the vendor, as those methods lack evidence. Considering the full scope of certification – including all elements discussed in the section above – is the responsibility of the importer, the CSPC staff view is that due care by a prudent and competent importer requires evidence. The following children’s products or applicable rules, bans, and standards require a certification program: Baby walkers Infant walkers Children’s ATVs Infant rattles Children’s bikes Pacifiers Children’s bike helmets Toys Children’s bunk beds Caps and toy guns Children’s carpets and rugs Children’s sleepwear Children’s clothing Durable infant products Children’s mattresses/pads Lead in surface coatings Children’s metal jewelry Lead in substrates Children’s vinyl plastic films Small parts Cribs ASTM F963 Dive sticks Phthalates www.bureauveritas.com/knowledge 9
  • 10. Reasonable Testing Programs for Nonchildren’s Products 16 CFR 1107.10, Subpart B – Reasonable Testing Program for Nonchildren’s Products (Reserved) The CPSC reserved Subpart B in the final rule, meaning no defined requirements were passed for a Reasonable Testing Program (RTP). In the October 19, 2011 decisional meeting Commissioner Robert Adler and Chairman Inez Tenenbaum stressed that the reservation of the section defining a Reasonable Testing Program was in no way an exemption for manufacturers from establishing one for certification and it is still very much required. They are quoted as saying: “If you’re not going to test every single product then you must have a Reasonable Testing Program.” – Adler “[Anyone] subject to our regulations for non-children’s products must still either test each product or have a Reasonable Testing Program” – Tenenbaum The CPSC may choose to define these requirements at a later date, or they may stay silent with no formal rules being developed. Since no requirements were defined in the final rule, a manufacturer has more leeway in how to establish their Reasonable Testing Program. The proposed rule can be used to provide guidance for a manufacturer in defining their program, with the goal of providing a high degree of assurance their products comply, and we will base our discussion on that document. Per the proposed rule, manufacturers certifying nonchildren’s products “pursuant to a reasonable testing program” must ensure that such a program provides “a high degree of assurance [HDoA] that the consumer products covered by the program will comply with all applicable rules, bans, standards or regulations.” The proposed rule defines a high degree of assurance to mean “… an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.” Note: These requirements are currently in effect and have been applicable since 2008. 10 Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
  • 11. The following general use products require certification per a Reasonable Testing Program: Adult apparel Fireworks Adult bikes Garage door openers Adult bunk beds Lawn mowers Adult carpets Matchbooks Adult vinyl plastic film Multi-purpose lighters Architectural glazing Adult ATV’s Candles (metal wicks) General use furniture (coatings) CB antennas Adult mattresses Cellulose insulation Paint Child-resistance on portable gas Refrigeration door latches containers Special packaging under PPPA Cigarette lighters Swimming pool slides Contact adhesives Unstable refuse bins In the proposed rule, the CPSC outlined a series of elements that can be used to establish a Reasonable Testing Program for nonchildren’s products. Brief summaries for each component of a Reasonable Testing Program for a nonchildren’s products are as follows: Product Specification: The goal of a product specification is to differentiate a product n from other products which may be similar, or from other products made by the manufacturer. CPSC lists examples of suitable content for product specifications as: “color photograph or illustration, model names or numbers, a detailed bill of materials, a parts listing, raw material selection and sourcing requirements.” A manufacturer also should list all requirements that apply to the product, to which the product must be certified. www.bureauveritas.com/knowledge 11
  • 12. Certification Tests: A product must have certification testing or other support to n show compliance with all applicable rules, bans, and standards. A manufacturer must submit to a lab or do first-party testing on a sufficient amount of samples, materially representative of all samples produced, for certification testing to ensure with a high degree of assurance (HDoA) that all products produced are compliant with all applicable rules, bans, or standards. If there is a material change in a product that could affect compliance, the product must be recertified though testing or other means of verification. If testing at a component level would be sufficient to indicate compliance, component-level testing is acceptable. CPSC defined material change to mean: ”any change in the product’s design, manufacturing process, or sourcing of component parts that a manufacturer exercising due care knows, or should know, could affect the product’s ability to comply with the applicable rules, bans, standards, or regulations.” Production Testing Plan: After initial compliance testing, a manufacturer should n implement a production testing plan to identify intervals of testing, number of tests to be conducted, and which samples will be pulled for testing. The plan must be unique for each location of manufacture. The intervals and number of tests should provide a high degree of assurance (HDoA) of continued compliance for products produced after compliance testing. This may be supported by non-testing methods, such as control programs, statistical process control programs, or failure mode and effects analyses (FMEAs). Regardless of whether these alternative methods or interval testing are used, the production testing plan needs to describe why the established plan provides a high degree of assurance (HDoA). The draft rule gave no minimum frequency or minimum number of samples for production testing. In CPSC’s discussion of the proposed rule, they did provide guidelines to consider: production lot size, severity of potential injury, intended age group of the user, variability in production, and history of product recalls or consumer complaints. Remedial Action Plan: This plan addresses and tracks noncompliances found in n certification or product testing, as well as the actions taken to address them. It can exist prior to any noncompliances, and outline processes to be taken to address any findings. The main goals of this plan are to be able to determine the cause of a nonconformity, to differentiate the compliant and noncompliant products within the lot, and to resolve the nonconformity so further production will comply with all applicable requirements. 12 Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
  • 13. Recordkeeping: Since certification must be based on a Reasonable Testing Program n (RTP), and the CPSC can request evidence of the program from the manufacturer, documentation of that program is necessary, despite no final RTP rules. The proposed rule had stricter requirements than the final rule defined for a children’s product testing program so it is recommended that the recordkeeping requirements for children’s products be adopted into the Reasonable Testing Program and used for non-children’s products. This means documents should have the same five-year maintenance from creation, and be readily available upon request, in English. Considerations for a Reasonable Testing Program Since the Reasonable Testing Program elements are based upon CPSC guidance and are not part of the final rule there is a large degree of flexibility in how each may be executed. However, regardless of the approach, the underlying questions every certifier must ask are: “Does my program provide a high degree of assurance my product is compliant?” “Did I perform my due diligence to ensure my program followed what would reasonably be expected of a certifier?” If the manufacturer is able to answer “Yes” to both questions, their program should be compliant. Establishing a “high degree of assurance” and “due diligence” are crucial to answering these questions. Additionally, an importer should act with due care when certifying their products, particularly when relying on actions taken within their supply chain, where visibility to those actions may be limited. It also should be understood that just because the CPSC choose not to define specific criteria for a Reasonable Testing Program such a program is still required by law, and should provide a high degree of assurance in the same way a children’s product testing program does. www.bureauveritas.com/knowledge 13
  • 14. Summary This white paper has provided a general overview of the requirements for CPSIA Certification Programs for children’s products and adult products. The goal of each of these programs is to prevent noncompliant products from reaching consumers, as well as to ensure the ability of manufacturers and importers to locate the source of any issues that might arise, along with the scope of products affected. With the enactment deadline approaching, engaging a partner with regulatory knowledge and experience are first steps toward compliance. Bureau Veritas Consumer Products Services can assist you in all aspects of establishing a successful approach toward understanding, applying, and complying with any and all requirements of CPSIA, including the certification requirements described within this white paper. For more information on these services or to subscribe for complimentary regulatory updates, please visit us at www.bureauveritas.com/cpsia-rtp. About this White Paper This white paper is published by the Information Resources Center of Bureau Veritas Consumer Products Services. For over 15 years, our Information Resources Center has worked successfully with top companies around the world to help them better understand the consumer market and regulatory environment. With access to a print collection of over 27,000 documents, subscriptions to 34,000 databases, and contacts in over 140 countries, the Information Resources Center is staffed by a trained team of information professionals and is an industry leading resource dedicated to monitoring and understanding regulatory information that affects consumer products around the world. White papers published by the Information Resources Center represent a collaborative team effort with Bureau Veritas Subject Matter Consultants (SMCs) from throughout our network. As part of their responsibilities, these individuals participate in a variety of technical committees including ASTM, CEN, IABFLO, and the US Toy Industry Association (TIA), placing our technical services teams at the forefront of new and emerging compliance globally. To learn more about how our Information Resources Center can help you, please visit us at: www.bureaveritas.com/knowledge or call us for a complimentary consultation at 1-716-505-3591. 14 Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
  • 15. About the Author As a Global Technical Engineer with Bureau Veritas Consumer Products Services, Doug Boehm is the lead technical consultant for testing and labeling pertaining to product certification in North America. Doug began his career with Bureau Veritas in 2006 as a product test engineer in the Toys and Juvenile Products department, working with various manufacturers and major retail programs. In 2009, Doug joined the Toys and Juvenile Products Technical Services team as a product engineer and assumed his current responsibilities. Doug is a member of committees within ASTM F08 (sports equipment and facilities) and F15 (consumer products). He holds a bachelors and masters in mechanical engineering from the University at Buffalo. Sources Consumer Product Safety Improvement Act of 2008 (CPSIA), Public Law 110–314, August 14, 2008 http://www.cpsc.gov/cpsia.pdf “Reasonable Testing Program & Third-Party Testing,” Consumer Product Safety Commission (CPSC), CPSC Public Workshop on CPSIA Product Testing, December 10, 2009 http://www.cpsc.gov/about/cpsia/cpsiatestingreason.pdf Consumer Product Safety Commission, Proposed Rule, 16 CFR Part 1107, Testing and Labeling Pertaining to Product Certification; Federal Register, Vol. 75, No. 97, 28336, May 20, 2010 http://www.cpsc.gov/businfo/frnotices/fr10/testing.pdf U.S. Consumer Product Safety Commission’s (CPSC’s) staff memo “Response to Commissioner Anne M. Northup’s Questions Related to Pending Proposals for Testing and Certification and Component Parts,” October 18, 2011 http://www.cpsc.gov/LIBRARY/FOIA/FOIA12/brief/testcertCOAN.pdf Consumer Product Safety Commission, Final Rule, 16 CFR Part 1107, Testing and Labeling Pertaining to Product Certification; Federal Register, Vol. 76, No. 216, 69482, November 8, 2011 http://www.cpsc.gov/businfo/frnotices/fr12/certfinal.pdf www.bureauveritas.com/knowledge 15
  • 16. 16 Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
  • 17. Appendix A Summary Chart of Requirements for Children’s and NonChildren’s Products Children’s Reasonable Product Testing Testing Program Program Bureau Veritas Solutions Requirement Simplifying Compliance for You Children’s General Use Let Us Help You... Products Consumer including Toys Products Certification Test your products for compliance and receive drafts of the necessary Confor- Testing mity Certificates Create a production testing plan with Testing Plans our guidance in determining appropriate sample size and testing frequency Material Implement our material change template Change to track all pertinent information Tracking Representative Use our sample collection services to Sampling select proper, representative samples for testing Records of Adopt a simple program developed by us Undue to train your employees to prevent undue influence Influence Use our CAP solution to automatically Corrective trigger documented actions to resolve Actions any non-conformity found in testing Develop product specifications with our Product services that will help confirm products Specifications are produced consistently with those tested for compliance Implement our Product Technical Folder Documentation solution for full-service storage of all your required documents as well as benefit Storage from its supply chain management features = Required = Suggested www.bureauveritas.com/knowledge 17
  • 18. Appendix B Comparing US and European Toy Requirements The New Toy Safety Directive (NTSD) in the European Union (EU) and the Consumer Product Safety Improvement Act (CPSIA) in the US share a similar goal, to make children’s products safer. While the EU NTSD was more focused specifically on toy safety than the US CPSIA, both used similar methods to achieve an increased level of safety for their covered products. In particular, they both set requirements for good manufacturing practices to avoid non-conformities resulting from design and production flaws, as well as requiring robust documentation of the processes used to ensure conformity. In the EU NTSD as well as the US CPSIA, the importer takes on the primary responsibility for products they bring into the regional jurisdiction and must declare conformity with appropriate rules at importation. They must also take steps to ensure products in continuous production continue to meet any safety requirements and are not affected by changes in materials or production processes. The chart on the following page gives a comparison of the two new rules, showing where similarities lie and where differences would require additional action. As companion to this white paper on the EU NTSD, this chart helps further illustrate the requirements in a new context to provide additional understanding for companies doing business in both markets. 18 Understanding US CPSIA Product Certification: Complying with New and Existing Requirements for Apparel, Children’s Products, Toys and Hard Goods
  • 19. Comparison Chart US and European Toy Certification Requirements Consumer Product Safety New Toy Safety Improvement Act (CPSIA) Directive (NTSD) Comments US Children’s Products & Toys EU Toys CPSIA & NTSD: Require certification and declaration that a product complies with all applicable safety rules. CPSIA: Requires third-party testing of children’s products as the basis to issue a children’s product certificate. The certificate Children’s Product Certification must accompany the product at importation, electronic Conformity Certification (of Conformity) EC Declaration of Conformity documentation is acceptable. NTSD: Requires EC declaration of conformity; does not specifically require third-party testing for certificate and certificate only needs to be maintained and available upon request. Industry Best Pratice: Continued testing, on representative samples, is required to show products stay in compliance. Periodic Testing CPSIA: Third-party testing at 1 year minimum interval, 2 years with additional testing/manufacturing controls. Continued Testing NTSD: No defined testing requirements but must test Representative Sampling sufficiently to ensure continued compliance. Industry Best Pratice: A manufacturer must have knowledge Product of their product, what goes into their product and how it is produced. Knowledge of applicable regulations, as well as Specification (Optional) potential hazards of the product are vital information for a manufacturer to ensure conformity. CPSIA: A manufacturer must have third-party testing to certify all material changes in production (can be component level Material Change testing). To track material changes, best industry practices Product Bill of Materials (BOM) have the manufacturer using a well documented BOM of Tracking & Testing Product Specification for traceability of those materials from Information receipt to product. NTSD: A manufacturer must have a BOM that identifies all substances used in a product including materials, additives or colorants. The manufacturer must do a safety assessment Safety Assessment listing all their requirements and potential hazards in regard to Mechanical, Physical, Flammability, Chemical, Electrical, Hygiene and Radioactive hazards. CPSIA Only: Certifiers must act ethically but only the US requires manufacturers/importers to train staff to prevent Undue Influence undue influence on third-party testing labs and maintain Ethical Conduct Training records for all trained staff. CPSIA & NTSD: No formal process is defined but both require non-conformities to be investigated and products must be modified to be brought into compliance or recalled in Corrective Actions Failure Investigation Corrective Measures accordance with each region’s established reporting/recall requirements. CPSIA & NTSD: Documents supporting certifications must be complete, and available at request of the regulatory body. CPSIA: Documents require 5 year storage, in English or translated within 48 hours of request. NTSD: Requires 10 years maintenance after end of Documentation Recordkeeping Storage Product Technical File distribution and must be in English, French or German. Documents may need to be translated into other member state languages following a reasoned request. Documents must be available in 30 days or less upon request and failure to provide complete documentation may trigger mandatory testing to demonstrate compliance. www.bureauveritas.com/knowledge 19
  • 20. About Bureau Veritas and Bureau Veritas Consumer Products Services Since its founding in 1828, the Bureau Veritas Group has consistently built internationally recognized services to help companies better manage their risk and comply with industry standards and government regulations in a variety of industries including consumer goods, marine, industry and facilities, and government services/international trade. With over 40,000 employees in 900 locations and laboratories in 140+ countries, Bureau Veritas serves large and small organizations around the globe. The Consumer Products Services Division of Bureau Veritas specializes in serving the global consumer product and retail markets, assisting clients around the world to effectively monitor the performance and quality of their products. As a proactive partner, we help companies manage risk, comply with regulations and protect their brand. From apparel and toys to consumer electronics and hard goods, we assist clients around the world with locations in 40 countries supported by more than 9,000 employees and over 35 years of experience. For over 15 years, Bureau Veritas’ Information Resources Center (IRC) has been dedicated to monitoring changes in the consumer products industry and providing comprehensive knowledge services. . www.bureauveritas.com/cps www.bureauveritas.com/knowledge