This document discusses periodic testing requirements for children's products. It explains that periodic testing must be conducted by a CPSC-accepted third party laboratory, with the required frequency depending on the manufacturer's chosen option - either annually, every 2 years if a production testing plan is established, or every 3 years if using an ISO-accredited lab for continued testing. The frequency may also need to be more than annually based on factors like variability in test results or potential for serious injury. Manufacturers must document their periodic testing plan and maintain testing records for 5 years. Component part testing by suppliers can be relied on if certain conditions are met.
Periodic testing requirements for children's products
1. What is periodic testing?
Periodic testing is third party testing that must be conducted, after the initial certification of
achildren'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 doneby
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
conductperiodic 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
2. 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.
Animporter, 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,
theintervals 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
3. product design, manufacturing process, component part sourcing, test values and certification
test runs, undue influence procedures, and one of the following:
i. a periodic test plan and periodic test results;
ii. a production test plan, production test results, and periodic test results; or
iii. 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.)
4. 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.