CPSC permits a manufacturer or importer of children's products to rely upon the test results or a certification from a component part supplier if the requirements in the regulation at 16 CFR part 1109 are met.
The 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, and must be based on the results of testing from a laboratory whose accreditation has been accepted by 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 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.
What 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.
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:
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.
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.
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:
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.
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.
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.
This communication has been prepared for general informational purposes only and is based upon the facts and information presented. This communication does not, and is not intended to, constitute legal advice and has not been reviewed or approved by the Commission, and does not necessarily represent their views. Any views expressed in this communication may be changed or superseded by the Commission.