As a small business trying to comply with federal safety regulations, you know that it is essential that the children’s products you manufacture or import are tested for compliance by a CPSC-accepted third party laboratory. Those regulations will vary by product and by the materials you are using to manufacture the product. Based on those passing testing results, you must certify your product as compliant by issuing a Children’s Product Certificate.
CPSC-accepted third party laboratories are private organizations that are accredited to internationally accepted laboratory standards. As with any major purchase, it is prudent for you to seek out two to three estimates for the required testing services. Laboratories should provide you with an itemized list of the tests proposed for your product. You, as the manufacturer or importer, are ultimately responsible for the compliance of your product with federal safety standards and testing requirements. Therefore, you should: (1) ask detailed questions of the laboratories, and (2) compare the various estimates you receive, questioning the laboratories about any differences in the itemized lists they have provided you.
When you consider using a particular third party laboratory, you should ask the laboratory certain questions to make sure that the laboratory is a good match for your needs:
1. Is the third party laboratory accepted by CPSC to perform all the necessary tests for my children’s product(s)?
CPSC accepts the accreditation of third party laboratories on a test-by-test basis. Therefore, if your product requires testing for lead in paint, lead content, small parts, phthalates, and the toy standard, you must confirm that any laboratory that you use has been accepted by the CPSC for each one of those test methods. On the CPSC’s website, each test laboratory is listed with the names of the CPSC-accepted test methods for that laboratory. Usually, using a single laboratory for all of your testing needs is most cost effective, although, depending on your product, more than one laboratory may be necessary to meet your needs. CPSC has accepted the accreditation of more than 400 laboratories on six continents.
2. Is the particular test(s) in the laboratory’s cost estimate a requirement─federal, state, or other─or is it a recommendation?
Laboratories may provide you with an estimate that includes testing requirements for many jurisdictions, such as international and individual state jurisdictions. The estimate also may include tests that the laboratory recommends but that are not necessarily required under federal law. (Certain larger retailers may also have their own safety and performance testing requirements that may not be required by federal law.)
A laboratory should be able to explain whether a test is required by law, by which jurisdiction, and also be able to direct you to a copy of the relevant legal citation. For federal requirements, you can see CPSC’s website listing of regulations and overview of testing requirements. You must test your children’s product for compliance with all federal requirements relevant to that product at a CPSC-accepted laboratory. You should consult other jurisdictions for guidance for testing your products to their requirements. As the product’s certifier, you must understand each test for which you are agreeing to pay and why you are testing your product for compliance with a particular specification.
3. How can the laboratory help me reduce my testing costs through screening methods and other approved methods, like composite testing?
CPSC has accepted the following testing methods which may reduce some of your testing costs: (i) composite testing—which means using a single test for multiple colors of the same material at one time—for lead in paint and other surface coatings, lead content, and phthalate content, provided that certain conditions are met; (ii) a single screening test per component part for the content of eight heavy metals in toys; and (iii) X-ray fluorescence (XRF) testing for lead content of certain homogeneous materials.
The CPSC has also determined that third party testing is not required for lead content for many natural products and also some manufactured products, including most manufactured textiles and certain dye-like ink applications. In addition, certain small batch manufacturers who register with CPSC may be relieved of certain third party testing obligations—although those manufacturers must always make certain that all of their children’s products comply with the applicable federal safety regulations.
4. What are the measurement uncertainty levels at the laboratory?
There is always a degree of measurement uncertainty at every scientific laboratory. CPSC-accepted laboratories must estimate the uncertainty of their measurements. Laboratories’ customers should understand the reliability of the results, as well as the extent to which the test results indicate that untested production products are compliant with the applicable federal safety regulations. In order to certify your children’s products as being compliant—with a Children’s Product Certificate—the results of your testing, and the other knowledge you have about the manufacturing of your product, must provide you with a high degree of assurance that all of the products comply with applicable federal safety requirements. Laboratories should communicate these facts to their customers with every report.
Occasionally, testing variability may affect your ability to certify the compliance of your product, especially if the results of a chemical test are very close to the upper testing limit, such as 100 parts per million (ppm) with total lead content. For example, if your product’s test results are 90 ppm of lead with +/- limit of 20 ppm due to a laboratory’s measurement uncertainty, you may need to test additional samples and/or you may not be able to certify that your product complies because 90 ppm + 20 ppm laboratory uncertainty = 110 ppm, which is in excess of the federal requirements.
More often than not, when a product fails to comply with a chemical content requirement, measurement uncertainty is not to blame. CPSC has seen samples where 10 “identical” necklaces were collected for analysis, and the resulting tests showed that eight of these necklaces had no detectable lead in the clasp, while two clasps contained many hundreds of parts per million lead. Similarly, we have seen plastic wheels on toy cars, where one wheel had excessive lead, and the others did not. In these situations, the so-called “identical” parts were not identical and had real material differences. These situations may result from inconsistent supply chain management, manufacturing variability, non-representative sample selection, or other causes that are not the result of laboratory measurement uncertainty.
Accordingly, you must recognize the variability present in manufacturing and seek to control it. The best practice is always to design safety into your product and to source your materials so that your product’s ability to comply is not affected by the measurement uncertainty of your laboratory. You also must make certain that the samples you collect for analysis are identical in all material respects to those samples that are not tested, i.e., that they are representative samples. Be cautious of “golden samples” provided by distant manufacturers who later substitute noncompliant materials. Material substitutions will affect your ability to certify that a children’s product complies with CPSC regulations. You may wish to consider additional measures, including testing follow-up samples at a frequency you determine, to provide you with confidence in your manufacturer’s ability to continue to comply with applicable safety requirements. More frequent testing provides you with a baseline understanding about what is taking place at the factory over time. The less you know about your factory, the more frequently you should test your children’s products.
You, as the manufacturer or importer, are ultimately legally responsible for the compliance of your product with federal safety standards.
This document is a staff summary of CPSC regulations and is provided for general information purposes only. This document does not replace or supersede the requirements of 16 CFR Part 1107, 16 CFR Part 1109, or any other CPSC statute or regulation. This document does not, and is not intended to, constitute legal advice, has not been reviewed or approved by the Commission, and does not necessarily represent its views. Any views expressed in this communication may be changed or superseded by the Commission.