If you think you may have made a material change to your children's product, you must have samples of the product or component part of the product tested by a CPSC-accepted third party lab. After the testing, you must issue a new Children's Product Certificate (CPC).
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.
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.
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.
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.