Table of Contents
Certificates of Conformity
What is certification of children's products?
Certification means the issuance of a written Children's Product Certificate in which the manufacturer, importer, or private labeler certifies that its children's product complies with all applicable children's product safety rules.
Certification of children's products must be based upon the results of third party testing, as described below. The third party testing laboratory provides the testing services and results but does not issue the children's product certificate. The manufacturer, importer, or private labeler is responsible for drafting and issuing the Children's Product Certificate.
Does the CPSC have a sample Children's Product Certificate?
Yes. There is a model of how to draft a Children's Product Certificate (pdf). (The model is actually of a General Certificate of Conformity (GCC) that is used for non-children's or general use products. However, the same principles apply, and the model includes a location to list the third party testing laboratory.)
You are not required to, but you may, copy the layout and title the document: "Children's Product Certificate" and include the details pertinent to your product; or, if you prefer, you may create your own form, as long as it captures all of the requirements listed in section 14(g) of the Consumer Product Safety Act (pdf). (The model Children's Product Certificate captures all of the 14(g) requirements.)
Can one Children's Product Certificate certify that the product complies with multiple children's product safety rules?
Yes. For example, if - for a product manufactured after December 31, 2011 - you are certifying that your product complies with the ban on phthalates, the toy safety standard, limits on total lead content and lead in paint, the small parts requirements, and other applicable regulations, then Part 2 of your Children's Product Certificate would read as follows:
Sec. 108 of the Consumer Product Safety Improvement Act of 2008, Pub. L. No. 110-314 (August 14, 2008) (CPSIA), Ban on Certain Phthalates in Toys and Children's Products.
ASTM F963-08, Standard Consumer Safety Specification for Toy Safety. (You must list the specific numeric sections of the toy safety standard to which you are certifying.)
Sec. 101 of the Consumer Product Safety Improvement Act of 2008, Pub. L. No. 110-314 (August 14, 2008) (CPSIA), Ban on Total Lead Content in Children's Products in Excess of 100 ppm in Children's Products.
16 CFR part 1303, Ban of Lead-Containing Paint and Certain Consumer Products Bearing Lead-Containing Paint for Toys and Other Articles Intended for Children.
16 CFR part 1501, Small Parts Ban for Toys and Other Articles Intended for Children under 3 Years of Age which Present Choking, Aspiration, or Ingestion Hazards.
If your product is subject to an additional mandatory regulation, rule, ban, or standard for which third party testing and certification currently is required, then you would include the citation to that regulation, rule, ban, or standard as well.
The full title of each requirement is provided above for your information only and does not need to be included in your children's product certificate. Part 2 of the Children's Product Certificate is adequate if you reference the specific section(s) of the children's product safety rule to which you are certifying the product without including the full title of each requirement.
Who must issue the Children's Product Certificate?
Under the Commission's rule (pdf) on certificates of conformity, the Children's Product Certificate must be issued by the importer for products manufactured overseas. The Children's Product Certificate must be issued by the U.S. manufacturer for products manufactured domestically.
To whom must I provide my Children's Product Certificate?
If you are a manufacturer or importer, you must "furnish" the Children's Product Certificate to your distributors and retailers. The requirement to "furnish" the Children's Product Certificate is satisfied if the manufacturer or importer provides its distributors and retailers a reasonable means to access the certificate. You can provide an actual hard copy of the certificate to your distributors and retailers, or you can provide a dedicated website with that specific certificate on your invoice. (See the answer addressing electronic certificates below.)
Additionally, federal law requires you to provide a copy of the Children's Product Certificate to the CPSC and to the Commissioner of Customs, upon request.
Where must I file the Children's Product Certificate?
A Children's Product Certificate does not have to be filed with the government. As noted above, the certificate must "accompany" the product shipment and be "furnished" to distributors and retailers, and, upon request, to the CPSC and to the Commissioner of Customs.
What must I base my Children's Product Certificate on?
The certificate must be based on tests of sufficient samples of each product, conducted by an accredited third party laboratory that the CPSC has accepted to perform the specific tests for each applicable children's product safety rule.
What if I sell directly to consumers and do not use retailers or distributors?
The law requires manufacturers or importers to issue a Children's Product Certificate; that the certificate accompany each product or shipment of products; that the certificate be furnished to retailers and distributors; and that the certificate be provided to the CPSC, upon request. Accordingly, you do not have to provide the certificate to consumers in direct-to-consumer sales.
Is a Children's Product Certificate required for each shipment of my product?
Yes. The law requires each import (and domestic manufacturer) shipment to be "accompanied" by the required certificate. The requirement applies to imports and products manufactured domestically. Under CPSC regulations, an electronic certificate is "accompanying" a shipment if the certificate is identified by a unique identifier and can be accessed via a World Wide Web URL or other electronic means, provided the URL or other electronic means and the unique identifier are created in advance and are available with the shipment.
If I import children's products and the foreign manufacturer has already tested and certified the product, do I need to retest or recertify the product? Can I just pass along the foreign manufacturer's children's product certificate?
CPSC requires that certificates of conformity be issued by the domestic manufacturer or the importer of products made outside the United States. This means that an importer cannot simply pass along a foreign manufacturer's certificate of conformity. However, the component part testing regulation, at 16 CFR part 1109, allows importers to use a foreign manufacturer's test results or their component part or finished product certifications of a children's product to issue their own Children's Product Certificate, as long as the importer exercises due care to ensure the validity of the test results or the certificate and receives the documentation required by the rule.
Can electronic certificates, instead of paper certificates, be used to meet the requirements of section 102 of the CPSIA?
The Commission has issued a rule specifically allowing the use of an electronic certificate, as long as: the Commission has reasonable access to it; it contains all of the information required by section 14 of the CPSA; and it complies with the other requirements of the rule.
If I post the certificate of conformity - either a Children’s Product Certificate or a General Certificate of Conformity - on the Internet, do I need to change it for each shipment, batch, or lot of the product?
If each shipment is materially unchanged from the prior shipment, a single certificate of conformity may be acceptable, but the certificate would need to describe the date range of products covered, using either batch/lot information or other identifying information.
One Children's Product Certificate may apply to (or "cover") multiple batches or lots of productions if you have exercised an appropriate level of due care to ensure the continued compliance of each additional batch or lot of production with all applicable children's product safety rules.
Remember that although a single Children's Product Certificate may "cover" more than one shipment or unit of production if a manufacturer chooses to do so, the certificate would need to describe the date range of products covered, using either batch/lot information or other identifying information. For each new shipment or unit of production entered into the stream of commerce, the Children's Product Certificate would need to be updated to reflect the new group of products. The manufacturer of the finished children's product will need this information to ensure the accuracy of the tracking label affixed to each children's product and its packaging.
Do I have to sign the Children's Product Certificate?
No. You do not have to sign the certificate. The act of issuing the certificate satisfies the new law. Any statement that you issue must be accurate whether it is signed or not.
Are there penalties for failing to comply with the certificate requirement?
Yes. It is a violation of the CPSA to fail to furnish a Children's Product Certificate, to issue a false certificate of conformity under certain conditions, and to otherwise fail to comply with section 14 of the CPSA. A violation of the CPSA could lead to a civil penalty and possibly criminal penalties and asset forfeiture.
How will I know when third party testing will be implemented for the remaining requirements?
You may view the complete list of children's product safety rules for which testing and certification currently are required here.
On January 1, 2012, certification and third party testing will be required for nearly all of the children's product safety rules.
Every six months, approximately, new requirements will be put in place for certain durable infant or toddler products. So far, the Commission has issued requirements for the following durable infant or toddler products:
- Infant Walkers
- Toddler Beds and
- Bath Seats
Once the Commission issues a "Notice of Requirements" to the testing laboratories for a requirement, third party testing is generally required 90 days thereafter.
The best way to stay current on the durable infant or toddler product rulemaking schedule is to sign up for the following CPSC e-mail services:
CPSIA Mailing List: Distributes official Commission documents published in the Federal Register and other documents, as needed.
Small Business Ombudsman Mailing List: Distributes plain language explanations of certain Commission actions and provides occasional updates on Commission rulemaking and other activities.
What is third party testing?
Third party testing means testing performed by a third party accredited laboratory that the CPSC has accepted to perform the specific tests for each children's product safety rule. The law requires a third party test in order to have an objective, unbiased laboratory ensure that the product is properly tested and compliant with the law.
Nearly all children's products are required to undergo third party testing.
Third party testing serves as the basis for a company to certify in a Children's Product Certificate (pdf) that its children's products are compliant with each applicable children's product safety rule.
A single children's product may be required to undergo multiple third party tests to ensure compliance with many different regulatory requirements. Accordingly, to save costs, you should try to identify a single laboratory that the CPSC recognizes as qualified to perform all of the tests that you need to certify that your children's product is compliant. Depending upon the specific requirements of your children's product, however, you may need to use more than one laboratory to perform all of the tests required for your children's product.
What are the different types of third party testing required for my children's product?
There are three types of third party testing:
- initial third party testing (also called certification testing);
- material change testing; and
- periodic testing.
Initially, every children's product that is required to be third party tested must be third party tested by a CPSC-accepted laboratory for compliance with all applicable children's product safety rules. Based on the results of the third party testing, the manufacturer must then issue a Children's Product Certificate. If a material change is made later to that children's product or to a component part of that children's product, then either the component part or the entire product needs to be retested by a third party, CPSC-accepted laboratory and a new Children's Product Certificate needs to be issued.
Periodic testing applies to continuing production of a children's product. If a children's product initially is certified, and then additional production continues, effective February 8, 2013, periodic testing is required for all the applicable children's product safety rules, even if there are no material changes. Periodic testing is in addition to material change testing. Periodic testing must be conducted often enough to assure ongoing compliance with the applicable safety rules and no less than 1-, 2-, or 3-year intervals, depending on whether the manufacturer has a periodic testing plan, a production testing plan, or conducts continued testing using an accredited ISO/IEC 17025:2005 laboratory, as discussed further below.
The manufacturer that issues the Children's Product Certificate for the finished product is responsible for knowing whether periodic testing is required and for ensuring that periodic testing is conducted at least at the minimum required frequency
How can I determine which children's product safety rules are applicable to my children's product?
You may view the list of requirements for which third party testing and certification are required here. Effective January 1, 2012, nearly every children's product safety rule will require third party testing.
Where can I find accredited laboratories that are accepted by the CPSC?
The CPSC has accepted hundreds of laboratories worldwide. The CPSC accepts a laboratory as qualified to test a particular children's product safety rule. (Each laboratory that the CPSC has accepted will likely be qualified to test for different children's product safety rules based on the type of equipment and expertise that particular laboratory possesses.) That means that you will need to ensure that your chosen laboratory is accepted by the CPSC to perform each and every test for your product in the scenario where your product(s) is subject to more than one children's product safety rule.
The list of accredited laboratories accepted by the CPSC can be found here.The easiest way to use this page is to scroll to the part of the page titled "Narrow the Laboratory List," choose your region by highlighting your geographic area, select your scope by highlighting the children's product safety rule for which you need to third party test and certify, and click the "Narrow List" button. You also may search by keyword.
The page will reload and all of the CPSC-accepted laboratories in your designated geographic area will appear in the middle box. You will need to scroll down again to view the updated list of CPSC-accepted labs.
You will likely need to run the laboratory search multiple times until you have located an accepted laboratory that can complete the testing for all children's product safety rules that are applicable to your product.
Specific information on third party testing requirements for small batch manufacturers is available
Once I have tested and certified that my children's products are in compliance with the applicable requirements, how often must I retest and certify my children's products?
Generally, you must retest children's products when there is a material change to the product and periodically after the initial certification of the product. This "periodic testing" requirement is explained in more detail below. Any material changes, such as changing the paint used on a children's toy or changing the product's design or manufacturing process, for example, could render the children's product noncompliant. In that situation, you only need to retest for compliance to those rules affected by the material change. You may also need to update your Children's Product Certificate.
The requirement to test your children's product when there is a material change and the requirement for periodic testing become effective on February 8, 2013. However, you must still ensure that your children's product complies with the regulatory requirements at all times.
This summary does not provide all of the details included in the Commission's final rule on testing and certification. Please refer to the regulation published in 16 CFR part 1107 for those details. This summary of the continuing testing requirements does not replace or supersede the requirements in the regulation.
Am I required to test every batch or every product that I produce?
No. At a minimum, you must third party test your first production batch or lot using a CPSC-accepted laboratory to certify your product. After initial certification, you will need to periodically retest your ongoing production, at least once per year for most manufacturers. You need to retest your production batch any time a material change has been made that could impact compliance of the product with any applicable children's product safety rule.
For example, a manufacturer of ink or paint likely does not need to retest each new vat of ink or paint if the manufacturer has taken the steps to ensure that no material changes have occurred in the production process. Periodic testing of the inks or paints is required, and the manufacturer is best positioned to determine the appropriate frequency. In creating a periodic testing plan or a production testing plan, a company may institute controls over incoming materials into its factory, process controls on the manufacturing floor, additional management controls to minimize variance and risk, and other techniques to have a high degree of assurance about the continued compliance of its goods. Each company will need to analyze its own procedures to determine the appropriate frequency of periodic testing.
Do I need to have each shipment of product tested by a CPSC-accepted laboratory?
It depends. If there have been no material changes, then it is likely you do not need to retest each shipment. However, if there have been material changes, or you are uncertain about whether there have been material changes, then it is likely you will need to test each shipment in order to certify your product properly. This is a decision you need to make with care considering what you know about the reliability of your supply chain and the manufacturing process.
Beginning in February 2013, all manufacturers will have to periodically test their continuing production to ensure continuing compliance with all children’s product safety rules.
What is a material change?
A material change is a change that the manufacturer makes to their product's design, to the manufacturing process, or to the source of component parts for the product, which a manufacturer, exercising due care, knows, or should know, could affect the product's ability to comply with the applicable children's product standards.
What am I required to do if I think that I may have made a material change to my children's product?
If you think that you may have made a material change to your children's product, you must submit a sufficient number of samples of the product or component part of the product with the material changes to a CPSC-accepted third party laboratory. The laboratory will then have that product or component part tested for compliance to the affected children's product safety rule(s); after the testing, you must issue a new Children's Product Certificate based upon the results of the testing.
Do I have to retest the whole product if there is a material change to only one component part of the product?
No. Component part testing may be sufficient for a material change to only one component. When there is a material change to a component part of a product that does not affect other component parts, and it does not affect the finished product's ability to comply with other applicable children's product safety rules, then a manufacturer may issue a new Children's Product Certificate based upon the earlier third party certification tests, along with the new test results for the materially changed component part. Please refer to the regulation published in 16 CFR part 1109 for those details..
For example, if you manufacture a painted wooden toy car, and you change paint suppliers, you need to test only the paint (and not the metal axles) for compliance in order to issue a new Children's Product Certificate. In other words, because the metal axles did not change, you do not have to retest them. If, however, a component part is changed that may affect the proper mechanical function or the structural integrity of the finished product, then the whole product may need to be retested.
Do I need to have each batch or lot of my children's product tested by a CPSC-accepted laboratory?
Not necessarily. After a children's product is initially tested and certified, the frequency with which new shipments of the children's product needs to be tested depends upon various factors. A manufacturer must exercise due care in determining whether each new batch or lot of its particular product needs to be retested.
The manufacturer must have a high degree of assurance that the children's products it manufactured after the issuance of a Children's Product Certificate, or since the previous periodic testing was conducted, continue to comply with the applicable children's product safety rules. Manufacturers need to be aware of all material changes that may require retesting after a material change.
In the absence of any knowledge of the manufacturing process, materials, suppliers, and product, the importer likely should consider the units in the discrete lot as the population and determine the sample size based on this population. The calculation of sufficient sample size can be made based on the importer's determination of a high degree of assurance of compliance of the product.
A manufacturer can obtain that assurance through various approaches, depending upon the particulars of the product in question. See Periodic Testing for more information.
Also, effective February 8, 2013, a manufacturer will be required to implement a periodic testing plan and/or a production testing plan for each of the children's products it manufactures in order to provide the high degree of assurance discussed above.
Are there any exceptions to the third party testing requirement?
Yes. You should refer to the regulations or the "frequently asked questions" for each individual children's product safety rule to determine if an exception applies to your children's product.
Do I have to retest the entire product if I change the manufacturer of the product?
Yes. The manufacturer, the manufacturing facility, its equipment, and its processes and process controls may all impact the likelihood of the product's compliance (or lack thereof) with the applicable consumer product safety rule(s) for that product. Therefore, the product would require retesting and recertification.
What is periodic testing?
Periodic testing is third party testing that must be conducted, after the initial certification of a children's product, within specified maximum testing intervals depending on which of the three options - explained in the following questions - that you choose. Periodic testing must be done by a CPSC-accepted third party laboratory.
How often do I have to do periodic testing?
How often periodic testing must be done depends upon which options you choose and upon the facts and circumstances surrounding your particular product. The general principle set forth in the regulation is that you, as the manufacturer, must have a periodic testing plan and conduct periodic testing (using a CPSC-accepted laboratory) at least once per year.
In addition to the general principle of periodic testing described above, a manufacturer may also choose to implement a production testing plan or conduct continued testing using an ISO/IEC 17025-2005-accredited lab. If you establish a production testing plan for your product, you must conduct periodic testing at least once every 2 years. If you conduct continued testing using an ISO/IEC 17025-2005-accredited lab, you must conduct periodic testing at least once every 3 years. Please refer to the regulation for further details about setting up a production testing plan and conducting continued testing using an ISO/IEC 17025:2005-accredited lab. This summary does not provide all of the details included in the periodic testing requirements.
Periodic testing may need to be conducted more than once per year and should be conducted frequently enough to provide the manufacturer or importer a high degree of assurance that continuing production of the children's product continues to comply with all applicable children's product safety rules. You are expected to know whether the facts and circumstances of manufacturing your product may warrant more frequent testing than once per year.
For example, the periodic testing rule states that in determining the frequency (by batch, lot, or other measurement) at which testing of ongoing production should be performed, a manufacturer may wish to consider various factors, such as high variability in test results, measurements that are close to the allowable numerical limit for quantitative tests, known manufacturing process factors that could affect compliance with a rule, introduction of a new set of component parts into the manufacturing process, the potential for serious injury or death resulting from a noncompliant children's product, and other factors, as set forth in 16 CFR § 1107.21(b)(2).
A manufacturer is expected to know the best way that compliance of its product can be achieved and to use their knowledge of the product's design and manufacturing process to create a periodic testing plan that provides the manufacturer with a high degree of assurance that its children's product continues to be compliant with the applicable children's product safety rules. In one example concerning "known manufacturing process factors which could affect compliance with a rule," the Commission describes a situation in which a manufacturer knows that a casting die wears down as the die nears the end of its useful life and states that the manufacturer may wish to test more often as the casting die wears down. Similarly, a manufacturer who uses volatile chemicals or produces products with complex mechanical structures, both of which have a greater potential for production error than a simpler product, may need to test more frequently than a manufacturer who produces, for example, basic unpainted, solid wooden blocks.
In addition, manufacturers should recognize that periodic testing is not the only way to have a high degree of assurance. Rather, everything that a manufacturer does to control for potential variability in its production process (e.g., incoming inspection of raw materials, first party testing, in-factory QA/QC systems), plus periodic testing, should work together to provide the desired high degree of assurance. In order to ensure continued compliance of its children's products, a manufacturer is required to conduct periodic testing at least once per year, but a manufacturer, depending on the qualities associated with their children's product, may wish to add additional controls into its manufacturing process. It is also critical, and required by law, that a manufacturer maintain records of its periodic testing plan and the other actions it has taken to secure a high degree of assurance.
An importer, or a manufacturer who exercises little or no control over the manufacturing process, will need to exercise due care to ensure that it has the knowledge necessary to make appropriate decisions about the frequency of testing necessary for continued production and additional batches and lots of products.
What does a periodic testing plan look like? What does a production testing plan look like?
A periodic testing plan must be in writing, and it must include the tests to be conducted, the intervals at which the tests will be conducted, and the number of samples to be tested. The testing interval may vary, depending upon which children's product safety rule is applicable to the product and the factors outlined in the regulation.
A production testing plan must be in writing and must describe the process-management techniques used; the tests to be conducted or the measurements to be taken; the intervals at which those tests or measurements will be taken; the number of samples tested; and an explanation describing how these techniques and tests provide a high degree of assurance of compliance with the applicable regulations.
This summary does not include all of the details included in the periodic testing requirements. Please refer to the regulation for further details about setting up a periodic or production testing plan.
How long must I keep records of the testing and certification performed for each product?
You must maintain records for 5 years from the date of production of your product. The records must include a copy of the Children's Product Certificate for each product, records of each third party certification test (for each manufacturing site), descriptions of all material changes in product design, manufacturing process, component part sourcing, test values and certification test runs, undue influence procedures, and one of the following:
- a periodic test plan and periodic test results;
- a production test plan, production test results, and periodic test results; or
- results of tests conducted by a testing laboratory accredited to ISO/IEC 17025:2005 and periodic test results.
The records must be made available, in hard copy or electronically (such as through email or via an Internet website), for inspection by the CPSC, upon request. Please refer to the regulation for further details.
Component Part TestingIf my component part supplier has already third party tested part of my product, can I rely upon that third party testing to issue a Children's Product Certificate for my product?
Yes, provided that certain conditions are satisfied. The Commission has issued a rule regarding testing component parts. You can rely upon the test results or a certification from a component part supplier if the requirements in our regulation at 16 CFR part 1109 (pdf) are met. That rule requires that in order to rely upon test results or a certification from a supplier, you must use due care to ensure that the tests results or the certificate is valid, and be given access to the underlying documentation, such as test results and attestations regarding how the testing was conducted and by whom. Generally, certifications of a component part must satisfy the requirement for a children's product certificate (pdf), and must be based on the results of testing from a laboratory whose accreditation has been accepted by the CPSC.
Can I third party test all of the materials coming in to my factory instead of third party testing the finished product?
It depends, but you may be able to use this approach depending on your particular product.
For safety rules that require testing of the finished product in order to determine compliance, such as functional or mechanical testing, or the accessibility of component parts, the finished product must always be tested.
For products that do not have such requirements, third party testing the incoming materials may be acceptable, provided that no subsequent non-third party tested materials enter the production process after the testing, and provided that no further chemical changes occur after the testing. For example, a manufacturer who tests all of the color varieties of plastic pellets coming into its factory that will be used in its plastic injection molding process would not need to test the final products, even if the same pellets were used to produce a wide variety of plastic products (subject to the caveats already described about functional and mechanical testing, if necessary.)
Do I have to retest the whole product if there is a material change to only one component part of the product?
No. Component part testing may be sufficient for a material change to only one component. When there is a material change to a component part of a product that does not affect other component parts, and it does not affect the finished product's ability to comply with other applicable children's product safety rules, then a manufacturer may issue a new Children's Product Certificate based upon the earlier third party certification tests, along with the new test results for the materially changed component part. Please refer to the regulation published in 16 CFR part 1109 (pdf) for those details..
For example, if you manufacture a painted wooden toy car, and you change paint suppliers, you need to test only the paint (and not the metal axles) for compliance in order to issue a new Children's Product Certificate. In other words, because the metal axles did not change, you do not have to retest them. If, however, a component part is changed that may affect the proper mechanical function of the finished product, then the whole product may need to be retested.
Are there any circumstances when I cannot rely on testing done by my component part supplier?
Testing of the component part also must be sufficient to certify compliance of the product to a particular regulation. For example, lead content and phthalate content testing on a component part is sufficient to assess compliance because the chemical content of the component presumably will not change when it is incorporated into the finished product. On the other hand, a component part test may not be sufficient for a children's product that is being tested for its structural integrity because that testing needs to be conducted on the finished product. Testing of toys to the small parts regulation would be an example of where component part testing is not appropriate. It is your responsibility to ensure that all required certification testing has been completed before issuing a Children's Product Certificate.
Is composite testing allowed for testing for lead in paint and other surface coatings?
Composite testing is allowed to test for lead in paint and other surface coatings as long as certain requirements are met. Requirements for composite testing are contained in our regulation on component part testing at 16 CFR § 1109.21. This regulation states that you may test a combination of different paint samples as long as test procedures are followed to ensure that no failure to comply with applicable limits will go undetected, and as long as the other requirements for component part testing are met. Section 1109.21 further provides that when using composite testing, only the total amount or percentage of the target chemical is determined, not how much of the target chemical is in each paint. Therefore, to determine whether each paint is within the applicable limit of 90 parts per million (ppm), the entire amount of the target chemical in the composite is attributed to each paint. If this method yields an amount of the target chemical that exceeds the limit applicable to any individual paint in the composite sample, additional testing would be required to determine which of the paints, if any, fails to meet the applicable limit. In order for composite testing of paints (and other surface coatings) to be tested for compliance to the lead in paint limits, the sample(s) submitted for testing must contain each component paint in known quantities.
For example, if different parts of a doll are painted with small amounts of different paints, the paints could be mixed together and tested for the amount of lead content in the paints. Assume that the doll has three different paints, A, B, and C. The composite of a mixture of 50 percent A, 30 percent B, and 20 percent C is tested for lead content. (To be clear, it is the percentages in the tested composite sample that are used to calculate the potential lead concentration of each constituent, not the percentage used on the product.) The lead content of the composite is 40 ppm. When the total lead content is applied to each paint, the potential concentration of lead in each paint is the measured amount, divided by the percentage of the composite, or:
In this example, because both paints B and C potentially could contain more than 90 ppm lead, more testing is needed to determine if this is actually the case.
- Potential lead content of paint A = 40 ppm/50% or 80 ppm.
- Potential lead content of paint B = 40 ppm/30% or 133 ppm.
- Potential lead content of paint C = 40 ppm/20% or 200 ppm.
Additionally, component part testing is allowed for the base constituents of paints, which can be considered component parts. For example, assume 10 base color constituents, plus a binder, are mixed in varying quantities to create a variety of paint colors. If each base color constituent and the binder are individually tested and found compliant with the lead in paint limit, then any combination of base color constituents and binder would also be compliant, and the mixed paint does not also require additional testing.
Is composite testing of plastics and other materials allowed as a test for total lead content testing in substrates and phthalate content testing in materials?
Yes. Composite testing is also allowed as a test for total lead content in substrates and phthalate content in materials, as long as certain requirements are met. The same principles apply as those set forth above for testing for lead in the paint or other surface coatings. Requirements for composite testing are contained in CPSC's regulation on component part testing at 16 CFR § 1109.21. This regulation states that you may test a combination of component parts for lead content and for phthalate content, as long as test procedures are followed to ensure that no failure to comply with applicable limits will go undetected, and as long as the other requirements for component part testing are met. Section 1109.21 further provides that when using composite testing, only the total amount or percentage of the target chemical is determined, not how much of the target chemical is in each component part. Therefore, to determine that each component part is within the applicable limit, the entire amount of the target chemical in the composite is attributed to each component part. If this method yields an amount of the target chemical that exceeds the limit applicable to any component part in the composite sample, additional testing would be required to determine which of the component parts, if any, fails to meet the applicable limit. In order for composite testing of plastics or other materials to be tested for compliance to the lead and phthalate content limits, the sample(s) submitted for testing must contain each component part in known quantities.
For example, if a toy is made of three plastic component parts that are molded from different colored plastic pellets, the three types of pellets could be mixed together and tested for lead and phthalate content. Assume the toy uses three different plastics, A, B, and C. The composite of a mixture of 50 percent A, 30 percent B, and 20 percent C is tested for lead content. The lead content of the composite is 40 ppm. (To be clear, it is the percentages in the composite tested sample that are used to calculate the potential lead concentration of each constituent, not the percentage used on the product.) When the total lead content is applied to each component part, the potential concentration of lead in each component is the measured amount divided by the percentage of the composite, or:
In this example, because components B and C potentially could contain more than 100 ppm lead, more testing is needed to determine if this is actually the case.
- Potential lead content of component plastic A = 40 ppm/50% or 80 ppm.
- Potential lead content of component plastic B = 40 ppm/30% or 133 ppm.
- Potential lead content of component plastic C = 40 ppm/20% or 200 ppm.
We sell craft materials, some packages of beads can have 12 or more colors of beads. Can we combine three or more colors at a time in a composite sample to test the beads?
Yes. Any combination of bead colors may be included in a composite sample, as long as the composite sample tested has known percentages of each color. For example if 5 grams of bead A were combined in a composite sample together with 3 grams of bead B and 2 grams of bead C, the proportions would be the same as in the example above. Care must be taken to ensure that a sample representing all the component parts in the proportions listed is tested. This might require extra processing of the sample(s), such as mixing, grinding, or other homogenization techniques to ensure that the tests accurately measure the combination of the component parts. As noted above, the total measured lead or phthalate content is applied to each component part. The potential concentration of lead or phthalates is determined by dividing the measured concentration by the percentage of the component part in the composite.
Due CareWhat does it mean to "exercise due care"?
A party "exercising due care" must use 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 concept of due care is flexible, and will vary depending on the circumstances and the industry in question. At a minimum, due care requires taking some affirmative step to ensure the validity of the test report or certification being relied upon.
Actions taken by a certifier to ensure the reliability of test reports from a supplier may differ depending on the nature of the component part supplied, the risk of noncompliance, the industry involved, and the nature of the relationship with the supplier. A long term relationship with a trusted supplier that receives a large portion of its profits from one manufacturer may not require the same level of inquiry or monitoring as that of a new supplier that provides parts to many different manufacturers infrequently. Depending on the industry and the facts, a certifier may take various actions in order to know something about the validity of the test reports or certifications being relied upon.
For example, depending on the industry and the circumstances, the exercise of due care may include:
- receiving and reviewing the required documentation, and making inquiry regarding any discrepancies;
- asking questions about testing and sampling procedures;
- requesting written test procedures;
- ensuring the supplier's third party conformity assessment body is CPSC accepted;
- spot checking a supplier's test results; or
- visiting a supplier's factory or third party laboratory.
How does an importer "exercise due care"?
There are several approaches that may serve as evidence of due care by an importer to ensure that a foreign manufacturer, that has provided a foreign manufacturer's certification, conducts periodic testing as specified in the final rule. 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, production testing plan, or the results of continued testing using an ISO/IEC 17025:2005 -accredited lab. Simply reviewing the foreign manufacturer's periodic testing plan or production testing plan may not satisfy the requirement, without further evidence that the plans were actually 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.
Undue Influence TrainingIf a manufacturer uses software or a website to conduct the undue influence training required by 16 CFR § 1107.24, does a digital signature satisfy the requirement to “sign a statement attesting to participation in such training” under 16 CFR § 1107.24(b)(1)?
Manufacturers are required under 16 CFR § 1107.24(b)(1) to make sure “that every appropriate staff member receive training on avoiding undue influence and sign a statement attesting to participation in such testing.” A digital signature or other electronic attestation (such as a check box) that an employee took the training included as part of software or online training would meet the requirement to “sign a statement attesting.”