Defining a Material Change after Product Certification

/in /by

December 7,2011 by Bill Jacoby

CPSIA Testing, Labeling and Certification – Part 3 Material Change

In 2012 companies will quickly have to deal with the final ruling issued by the CPSC under 16 CFR 1107 as mandated by the CPSIA Section 102.  In this new ruling the CPSC has outlined standards for manufacturers/importers to show compliance with existing safety rules, bans and standards for the products they produce.  The rule can be broken out into five (5) major areas; the types and frequency of testing, what constitutes a material change in a product, the requirements and procedures and training for an undue influence program,  general recordkeeping requirements and label requirements for products complying with consumer safely rules under the CPSA.

In the third part of this article we will look at the requirements for manufacturers/importers under the Material Change part of the rule.

Material Change

After the initial certification of a product, a “material change” in the product is a change that “could affect the product’s ability to comply with applicable rules, standards or regulations.”  This could occur based on a change in product design, manufacturing process or the sourcing of component parts where the manufacturer/importer knows or should know could affect the products ability to comply with all applicable children’s product safety rules.  At this point the manufacturer/importer must submit sufficient samples of the product to a CPSC accredited laboratory to test for compliance.

A manufacturer/importer whose product has undergone a material change cannot issue a new Children’s Product Certificate until  this testing is done.  Changes that cause a children’s product safety rule to no longer apply to a children’s product are not considered material changes.  The extent of testing needed depends on the extent of the material change.

For example, if the children’s product was a cotton sweater with metal buttons that were certified under the lead limits of Section 101 of the CPSIA and were changed to wooden buttons would this be classified as a material change?  Yes and No, changing to wooden buttons would eliminate the need to show continued compliance for lead limits under Section 101 of the CPSIA as natural wood is exempt from lead testing.  However for other children’s product safety rules, such as small parts the change may be a material change.

The three major categories of material change are;

  • product design, which includes all component parts , their composition, and their interaction and functionality when assembled.  The manufacturer/importer should evaluate the product as received or assembled by the consumer when examining product design
  • manufacturing process, is a change in how the children’s product is made which could affect the finished products ability to comply with the applicable safety rules.  For each change in the manufacturing process, the manufacture/importer should carefully evaluate the product to ensure it still meets all applicable safety rules or if the change results in new rules being applied to it.
  • sourcing of component parts, is a change that results when the replacement of one component part of a product with another component part that could affect compliance.  This includes, but is not limited to, changes in composition, part supplier, or the use of a different component part from the same supplier who provided the initial component part.

For a domestic manufacturer, there would be a special knowledge of its production design, components and, production processes not found with importers of record using foreign manufacturers.  For example, a domestic manufacturer would know whether a new solvent contains any of the prohibited chemicals such as lead and phthalates, or a replacement mold is made from the same specifications as the previously compliant mold.  Such changes would not be examples of “material change” and unless the importer of record has a very close working relationship with the foreign manufacturer, would not know.

2012 is weeks away …. is your company ready? Need help in deciphering the law as it pertains to you? Jacoby Solutions can review your testing process to make sure it contains all the elements as outlined under 1107 including record keeping. We also can provide services for Sourcing/Project Management  testing for any new products you have in development or act as a liaison between you and your factory. Contact us today and see how we can save you money!

Bill Jacoby is the founder principal at Jacoby Solutions and developed the CORE Audit™ (Compliance Operations Readiness Engagement Audit), the company’s proprietary approach to business operations readiness A one-stop shop for manufacturing and distribution companies in need of a solutions partner who can help them evolve their business while keeping an eye on compliance, Jacoby Solutions saves companies time, money and resources while helping them become CPSIA ready.