The document discusses the requirements for certifying children's products and non-children's products according to the Consumer Product Safety Improvement Act (CPSIA). It outlines that children's products must be certified through third-party testing and periodic testing to ensure compliance with all applicable rules. Importers and manufacturers must exercise due care in certifying products, which requires gaining knowledge and assurance about testing and compliance. The document also notes that while certification requirements were established for children's products, requirements for non-children's products through a Reasonable Testing Program have yet to be defined by the Consumer Product Safety Commission.
The document summarizes new rules for third party testing of children's products that took effect in 2013. It outlines requirements for initial certification testing, component part testing, material change testing, and periodic testing for continued production. Manufacturers must have products tested by accredited laboratories, issue certificates of compliance, and maintain testing records. The rules aim to provide assurance that children's products meet safety standards for substances like lead and phthalates.
An international panel comprised of members of AQSIQ (China), INMETRO (Brazil), Health Canada and CPSC (U.S.) used this presentation to discuss the regulatory structure and suggestions for businesses.
This document outlines the terms and conditions for Ecocert Greenlife to verify that raw materials meet the COSMOS and Ecocert standards for natural and organic cosmetics. It defines key terms like approval, client, contract, raw material, standard, and verification. It describes the verification process, how clients can reference approved raw materials, how Ecocert will list them on their website, and pricing terms. The purpose is for Ecocert to verify raw materials and issue approvals that allow their use in certified finished cosmetic products.
Staff introduction for CPSC workshop on third party testing cost reduction through possible material determinations. Provides workshop agenda, background, and workshop goals
2014 updates for durable infant and toddler products. How to locate CPSC data on regulatory non-compliance notices, which are also called "letters of advice" (LOAs). The referenced Excel table will be updated frequently with the names of the firm, the foreign manufacturer, and other information. Businesses may integrate this information into their compliance workflows to assist them in sourcing safe & compliant consumer products.
CPSC experts and representatives of a law firm used this presentation to discuss testing and certification issues, component parts testing, and certificates of conformity.
This document provides certificates of conformity for various commercial products to be used in organic farming. It lists 14 products from the company CERTIS EUROPE B.V. Sucursal en Espana, including insecticides, fungicides, molluscicides, and others. For each product, it specifies the regulations and standards the product meets to be used in organic farming, including Demeter International and Regulation (EC) 834/2007, as well as any restrictions. The certificates are valid until January 31, 2021.
The document summarizes new rules for third party testing of children's products that took effect in 2013. It outlines requirements for initial certification testing, component part testing, material change testing, and periodic testing for continued production. Manufacturers must have products tested by accredited laboratories, issue certificates of compliance, and maintain testing records. The rules aim to provide assurance that children's products meet safety standards for substances like lead and phthalates.
An international panel comprised of members of AQSIQ (China), INMETRO (Brazil), Health Canada and CPSC (U.S.) used this presentation to discuss the regulatory structure and suggestions for businesses.
This document outlines the terms and conditions for Ecocert Greenlife to verify that raw materials meet the COSMOS and Ecocert standards for natural and organic cosmetics. It defines key terms like approval, client, contract, raw material, standard, and verification. It describes the verification process, how clients can reference approved raw materials, how Ecocert will list them on their website, and pricing terms. The purpose is for Ecocert to verify raw materials and issue approvals that allow their use in certified finished cosmetic products.
Staff introduction for CPSC workshop on third party testing cost reduction through possible material determinations. Provides workshop agenda, background, and workshop goals
2014 updates for durable infant and toddler products. How to locate CPSC data on regulatory non-compliance notices, which are also called "letters of advice" (LOAs). The referenced Excel table will be updated frequently with the names of the firm, the foreign manufacturer, and other information. Businesses may integrate this information into their compliance workflows to assist them in sourcing safe & compliant consumer products.
CPSC experts and representatives of a law firm used this presentation to discuss testing and certification issues, component parts testing, and certificates of conformity.
This document provides certificates of conformity for various commercial products to be used in organic farming. It lists 14 products from the company CERTIS EUROPE B.V. Sucursal en Espana, including insecticides, fungicides, molluscicides, and others. For each product, it specifies the regulations and standards the product meets to be used in organic farming, including Demeter International and Regulation (EC) 834/2007, as well as any restrictions. The certificates are valid until January 31, 2021.
The National Association of Manufacturers (NAM) advocates on behalf of US manufacturers. It represents over 11,000 member companies of all sizes, accounting for 85% of US manufacturing output. The NAM works to shape legislation and regulations in a way that promotes US economic growth and manufacturing competitiveness. Regulatory compliance costs American manufacturers $162 billion annually, disproportionately impacting small manufacturers. The Consumer Product Safety Improvement Act (CPSIA) strengthened safety standards for children's products and imposed new testing, certification, and labeling requirements that increased costs for manufacturers.
Slides for morning discussion session of electronic certificate workshop on a *proposed* amendment to the current certification rule, 16 CFR Part 1110. Slides consist of CPSC staff presentation followed by non-CPSC panelist presentations.
The document provides an overview of the U.S. Consumer Product Safety Commission (CPSC). It discusses that the CPSC is an independent federal agency established in 1973 that is responsible for protecting the public from unreasonable risks of injury from consumer products. The CPSC works to reduce an estimated 34,500 deaths and 36 million injuries annually associated with consumer products through regulation and enforcement, recalls, education, and monitoring of voluntary standards. It summarizes the CPSC's laws, regulations, testing and certification requirements, market surveillance, data collection and analysis, and international cooperation to promote product safety.
VACCINES Reg Path in India & WHO Pq_ 01.10.20.pptxY Srinivasa Rao
This document discusses regulatory approval pathways for vaccines in India and WHO prequalification. It provides an overview of the Indian regulatory pathway, which involves approvals from regulatory bodies like the Central Drugs Standard Control Organization and State Licensing Authority. The process includes import/manufacturing licenses, clinical trials approval, post-trial manufacturing license, and other approvals. It also summarizes the WHO prequalification process, which provides an independent assessment of vaccine quality, safety and efficacy. The process involves dossier submission and evaluation, sample testing, site inspections, annual reporting by manufacturers, and reassessments.
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
FDA’s Draft Guidance on Biosimilar Product Development and Intellectual Prope...Patton Boggs LLP
The FDA released draft guidelines for biosimilar product development to help sponsors gain approval for biosimilar drugs under an abbreviated pathway. The guidelines recommend extensive data collection to demonstrate biosimilarity to the reference product using a totality of evidence approach. Sponsors should consider analytical factors like expression systems, properties, activities, and stability testing. Following these guidelines closely during development is important for positioning products for approval and reducing litigation risks with the reference product patent owner.
Biosimilars: Regulatory and Clinical ConsiderationsCovance
Other considerations for clinical studies are that the regulations are written with some flexibility, and although clinical studies have been required thus far, they are not mandated by the regulations. Perception from sponsors is that innovators make process changes all the time that impact structure and no clinical study is done because of good analytical characterization so why are biosimilars different? With solid analytical and functional data, we should continue to challenge regulators on the need for clinical studies.
This presentation provides an overview of toy safety regulations in Canada and the United States. It discusses the key legislation governing consumer product safety in both countries, including the Canada Consumer Product Safety Act and regulations in Canada, as well as the Consumer Product Safety Act and other laws in the US. The presentation also provides highlights of recent changes and initiatives at Health Canada and the CPSC, and outlines requirements for toys in areas such as heavy metals, phthalates, small parts, and sound. Finally, it discusses regulatory cooperation between the two countries through initiatives like joint recalls and information sharing.
This presentation provides an overview of toy safety regulations in Canada and the United States. It outlines the key legislation governing consumer product safety in each country, including the Canada Consumer Product Safety Act and regulations in Canada, as well as the Consumer Product Safety Act and other laws in the US. The presentation highlights recent updates to requirements and enforcement efforts at Health Canada and the US CPSC. It reviews safety testing and certification expectations for toys and children's products being sold in Canada and the US to ensure compliance with regulations addressing hazards like heavy metals, phthalates, small parts, and more.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
The document provides guidelines for the evaluation of similar biotherapeutic products (SBPs). It outlines key principles for licensing SBPs, which include:
1) Development of a SBP involves stepwise comparability exercises starting with quality comparisons to a reference biotherapeutic product (RBP), with demonstration of similarity a prerequisite for reduced non-clinical and clinical data requirements.
2) Licensing of a SBP is based on its demonstrated similarity to a suitable RBP in quality, non-clinical, and clinical parameters.
3) Comparability exercises include integrated quality, non-clinical and clinical studies to provide comparative data between the SBP and RBP. Differences require investigation and may necessitate additional data.
BRCGS for Food Safety - issue 9 (Draft).pdfhodahassan26
Senior management at the site must demonstrate commitment to food safety and continual improvement through a documented policy signed by the person responsible for the site. They must define and maintain a clear plan for developing a positive food safety culture involving all relevant staff and including activities to improve communication, training, feedback and behaviors. Objectives to maintain and improve product safety must be documented, communicated, monitored and reported to staff quarterly.
The final rules for the FDA's Food Safety Modernization Act (FSMA) are expected later this year and next year. This document discusses several key sections of FSMA that will impact food packaging manufacturers, including inspection of records, sanitary transport, mandatory recall authority, and administrative detention. It advises food packaging manufacturers to prepare now for these new FSMA requirements by updating policies and training employees on regulatory inspections, implementing transportation sanitation programs, revising recall policies, and establishing supplier approval programs.
The document provides an overview of the CBER lot release system. It discusses how the CBER Office of Compliance and Biologics Quality is responsible for receiving, processing, and releasing product lots using the lot release system. It explains the lot release process, what products are covered, how it works at different stages such as for routine lot release of approved products and for products submitted in applications or supplements. It discusses regulations around lot release, alternatives to lot release such as placing products on surveillance, and future directions for the lot release system.
The document discusses the new public health system in England and its implications for sport and physical activity organizations. It covers the establishment of Public Health England and health and wellbeing boards, and how these changes will require demonstrating impact and forming local partnerships. The Youth Sport Trust is provided as an example of aligning programs with health outcomes, partnering with local authorities, and independently evaluating initiatives like Change4Life sports clubs in schools. Attendees are encouraged to consider how to advocate, create new partnerships, and demonstrate impact in their own organizations.
The Youth Sport Trust is a charity established in 1995 that uses sport to change lives. It has two main locations, with 90 staff in Loughborough and 20 in London. Its mission is that sport changes lives. It faces new challenges with leadership and funding changes since 2010. Its strategic plan focuses on being efficient, agile, self-supporting, and providing an evidence base on impact. It has a broad range of partners in both the public and private sectors to help address challenges in society through sport.
The National Association of Manufacturers (NAM) advocates on behalf of US manufacturers. It represents over 11,000 member companies of all sizes, accounting for 85% of US manufacturing output. The NAM works to shape legislation and regulations in a way that promotes US economic growth and manufacturing competitiveness. Regulatory compliance costs American manufacturers $162 billion annually, disproportionately impacting small manufacturers. The Consumer Product Safety Improvement Act (CPSIA) strengthened safety standards for children's products and imposed new testing, certification, and labeling requirements that increased costs for manufacturers.
Slides for morning discussion session of electronic certificate workshop on a *proposed* amendment to the current certification rule, 16 CFR Part 1110. Slides consist of CPSC staff presentation followed by non-CPSC panelist presentations.
The document provides an overview of the U.S. Consumer Product Safety Commission (CPSC). It discusses that the CPSC is an independent federal agency established in 1973 that is responsible for protecting the public from unreasonable risks of injury from consumer products. The CPSC works to reduce an estimated 34,500 deaths and 36 million injuries annually associated with consumer products through regulation and enforcement, recalls, education, and monitoring of voluntary standards. It summarizes the CPSC's laws, regulations, testing and certification requirements, market surveillance, data collection and analysis, and international cooperation to promote product safety.
VACCINES Reg Path in India & WHO Pq_ 01.10.20.pptxY Srinivasa Rao
This document discusses regulatory approval pathways for vaccines in India and WHO prequalification. It provides an overview of the Indian regulatory pathway, which involves approvals from regulatory bodies like the Central Drugs Standard Control Organization and State Licensing Authority. The process includes import/manufacturing licenses, clinical trials approval, post-trial manufacturing license, and other approvals. It also summarizes the WHO prequalification process, which provides an independent assessment of vaccine quality, safety and efficacy. The process involves dossier submission and evaluation, sample testing, site inspections, annual reporting by manufacturers, and reassessments.
Crossroads: U.S. Medical Device Regulation vs. Innovation
The U.S. medical device industry is at a regulatory and potentially economic crossroad as the FDA continues to refine its 510(k) regulatory submission requirements and guidelines. Medical device manufacturers have been urging the FDA and Congress to expedite new product review processes to spur innovation and bring new medical technologies to market faster. However, supporters of stricter FDA regulations claim that a faster regulatory review process causes unsafe devices to enter the market.
As a result of numerous exchanges between both sides of the issue, CDRH (FDA) recently issued multiple updates to its initiatives for the 510(k) approval process. To shed light on key changes, we obtained the support of the office of Dr. Jeffrey Shuren MD JD, Director of CDRH and Dr. John Smith MD JD, of Hogan Lovells, a prominent international law firm with a medical regulatory specialty, on their interpretations of the 510(k) regulatory guidelines and the impact these guidelines will have on medical device manufacturers.
Listen to the Dr. John Smith podcast interview here:
http://youtu.be/iHVpwwXi7dY
The MarkeTech Group
502 Mace Blvd.
Davis, CA 95618
http://www.themarketechgroup.com
FDA’s Draft Guidance on Biosimilar Product Development and Intellectual Prope...Patton Boggs LLP
The FDA released draft guidelines for biosimilar product development to help sponsors gain approval for biosimilar drugs under an abbreviated pathway. The guidelines recommend extensive data collection to demonstrate biosimilarity to the reference product using a totality of evidence approach. Sponsors should consider analytical factors like expression systems, properties, activities, and stability testing. Following these guidelines closely during development is important for positioning products for approval and reducing litigation risks with the reference product patent owner.
Biosimilars: Regulatory and Clinical ConsiderationsCovance
Other considerations for clinical studies are that the regulations are written with some flexibility, and although clinical studies have been required thus far, they are not mandated by the regulations. Perception from sponsors is that innovators make process changes all the time that impact structure and no clinical study is done because of good analytical characterization so why are biosimilars different? With solid analytical and functional data, we should continue to challenge regulators on the need for clinical studies.
This presentation provides an overview of toy safety regulations in Canada and the United States. It discusses the key legislation governing consumer product safety in both countries, including the Canada Consumer Product Safety Act and regulations in Canada, as well as the Consumer Product Safety Act and other laws in the US. The presentation also provides highlights of recent changes and initiatives at Health Canada and the CPSC, and outlines requirements for toys in areas such as heavy metals, phthalates, small parts, and sound. Finally, it discusses regulatory cooperation between the two countries through initiatives like joint recalls and information sharing.
This presentation provides an overview of toy safety regulations in Canada and the United States. It outlines the key legislation governing consumer product safety in each country, including the Canada Consumer Product Safety Act and regulations in Canada, as well as the Consumer Product Safety Act and other laws in the US. The presentation highlights recent updates to requirements and enforcement efforts at Health Canada and the US CPSC. It reviews safety testing and certification expectations for toys and children's products being sold in Canada and the US to ensure compliance with regulations addressing hazards like heavy metals, phthalates, small parts, and more.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
The document provides guidelines for the evaluation of similar biotherapeutic products (SBPs). It outlines key principles for licensing SBPs, which include:
1) Development of a SBP involves stepwise comparability exercises starting with quality comparisons to a reference biotherapeutic product (RBP), with demonstration of similarity a prerequisite for reduced non-clinical and clinical data requirements.
2) Licensing of a SBP is based on its demonstrated similarity to a suitable RBP in quality, non-clinical, and clinical parameters.
3) Comparability exercises include integrated quality, non-clinical and clinical studies to provide comparative data between the SBP and RBP. Differences require investigation and may necessitate additional data.
BRCGS for Food Safety - issue 9 (Draft).pdfhodahassan26
Senior management at the site must demonstrate commitment to food safety and continual improvement through a documented policy signed by the person responsible for the site. They must define and maintain a clear plan for developing a positive food safety culture involving all relevant staff and including activities to improve communication, training, feedback and behaviors. Objectives to maintain and improve product safety must be documented, communicated, monitored and reported to staff quarterly.
The final rules for the FDA's Food Safety Modernization Act (FSMA) are expected later this year and next year. This document discusses several key sections of FSMA that will impact food packaging manufacturers, including inspection of records, sanitary transport, mandatory recall authority, and administrative detention. It advises food packaging manufacturers to prepare now for these new FSMA requirements by updating policies and training employees on regulatory inspections, implementing transportation sanitation programs, revising recall policies, and establishing supplier approval programs.
The document provides an overview of the CBER lot release system. It discusses how the CBER Office of Compliance and Biologics Quality is responsible for receiving, processing, and releasing product lots using the lot release system. It explains the lot release process, what products are covered, how it works at different stages such as for routine lot release of approved products and for products submitted in applications or supplements. It discusses regulations around lot release, alternatives to lot release such as placing products on surveillance, and future directions for the lot release system.
The document discusses the new public health system in England and its implications for sport and physical activity organizations. It covers the establishment of Public Health England and health and wellbeing boards, and how these changes will require demonstrating impact and forming local partnerships. The Youth Sport Trust is provided as an example of aligning programs with health outcomes, partnering with local authorities, and independently evaluating initiatives like Change4Life sports clubs in schools. Attendees are encouraged to consider how to advocate, create new partnerships, and demonstrate impact in their own organizations.
The Youth Sport Trust is a charity established in 1995 that uses sport to change lives. It has two main locations, with 90 staff in Loughborough and 20 in London. Its mission is that sport changes lives. It faces new challenges with leadership and funding changes since 2010. Its strategic plan focuses on being efficient, agile, self-supporting, and providing an evidence base on impact. It has a broad range of partners in both the public and private sectors to help address challenges in society through sport.
This document is a directive from the European Parliament and Council on waste electrical and electronic equipment (WEEE), also known as the WEEE Directive. It aims to improve the collection and treatment of WEEE to reduce waste and contribute to efficient use of resources. Key points include establishing producer responsibility for financing WEEE management, setting collection targets for Member States, and requiring proper treatment including preparation for reuse, recycling and recovery of valuable materials from WEEE. The directive seeks to harmonize rules on WEEE across the EU to prevent illegal exports and ensure a high level of environmental and human health protection.
This executive summary provides an overview of a new report on grassroots sports participation in America. The report examines motivations for starting and continuing in youth sports, as well as reasons for stopping participation. It also looks at brand usage, spending patterns, and influences on participation for both youth and adults across various sports. Key findings include that 92% of youth and 88% of teens start sports for fun, and that children are more active when their parents are also more active. The report aims to help various organizations understand participation drivers and barriers to help grow sports participation.
The document analyzes the size and growth of the European sports market in 2010, estimating it to be 66 billion Euros and growing 2% from 2009, with the largest markets being Germany, France, the UK, Italy, and Spain. Equipment and apparel make up the largest segments of the market. The sports market is fragmented across Europe with large variations in per capita spending between countries.
The Federation of Sports and Play Associations (FSPA) is the national trade body representing 18 associations in the UK's sports, play, golf, and angling industries. As the largest trade body, the FSPA acts as the voice of the UK sports and play industry. It aims to represent its member associations, promote UK businesses, and liaise with government on legislative issues affecting the industry.
- Unicorn Products Limited is a privately owned British family business that manufactures quaint, eccentric English sports goods since 1937.
- It has headquarters in Kent, operations center in Nottingham, and employs 75 people in the UK. It sells products in over 100 countries worldwide.
- India represents an interesting market opportunity due to its large population and economy, as well as widespread interest in cricket. However, the market is varied and unorganized with competition from local producers.
- To succeed in India, Unicorn appointed a distributor to handle sales and distribution. The distributor has licensed the Unicorn brand and grown sales every year since 2004 due to increased spending on imports and rising incomes.
The Indian sports market is large and growing rapidly. It is projected that India will have 583 million middle-class consumers by 2025, fueling growth in discretionary spending on sports. While regular sports participation is currently low at less than 1.5%, it is growing among urban youth in sports like cricket, football, and badminton. The total Indian sports market was estimated to be €2.58 billion in 2010 across international brands, semi-branded/unorganized suppliers, and sports equipment. Key challenges to the market include weak infrastructure, high costs due to imports, and low profitability.
The document discusses Knowledge Transfer Partnerships (KTP), a program that pairs graduate students from Loughborough University with industrial partners. The program is partially government funded and benefits all parties by allowing industrial partners to access university expertise, graduates to gain work experience, and the university to disseminate research and build relationships with industry. Common motivations for companies to participate include the need to innovate, boost performance, and develop specialist skills.
This document discusses sources of external funding for research and development from Derbyshire Associates Ltd. It outlines various types of grants available from regional and national sources to support R&D projects, including those focusing on innovation, commercial prospects, jobs creation, and low carbon initiatives. International funding is also available through the European Union's Framework 7 programme which invests over €53 billion in collaborative R&D projects across Europe. Contact details are provided for Derbyshire Associates Ltd to discuss options for securing external funding.
This document discusses sources of external funding for research and development from Derbyshire Associates Ltd. It outlines various types of grants available from regional and national sources to support R&D projects, including those focusing on innovation, commercial prospects, jobs creation, and low carbon initiatives. European funding is also described, particularly the large Framework 7 budget which supports multi-country collaborative projects. Contact details are provided for Derbyshire Associates Ltd to discuss options further.
This document provides an overview of UK R&D tax relief schemes, including the Small or Medium Enterprise (SME) regime and Large Company Scheme. It defines qualifying expenditures and R&D activities, outlines the tax credits and savings available, and addresses common misconceptions about the programs. The document encourages businesses to consider R&D tax relief and seek guidance to maximize potential benefits.
FSPA Social Media Day, with Promote PR@s Sue Anstiss providing a detailed overview of all the key social media streams and tools which can be used to maximise a sports businesses presence.
More from Federation of Sports and Play Associations (FSPA) (13)
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
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