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Who Is Responsible for Compliance Testing?

November 19, 2019
Question 

If I’m the supplier for an additive and I’ve certified that it is FDA compliant (for example §176.170), do my clients need to conduct migration testing to make sure their product is FDA compliant rather than reply on our statement? 

Answer 

It is not usual for a customer to rely on the assurance provided by its supplier on the compliance of its product. However, it is important to recognize exactly what the compliance statement covers. If the statement is intended to assert compliance with the compositional requirements of a regulation, that is usually the supplier’s responsibility. However, many regulations have end test extractive limitations that need to be conducted by the customer as the testing will need to be done on the finished article.

For example, Title 21 Code of Federal Regulations (C.F.R.) §176.170, “Components of paper and paperboard in contact with aqueous and fatty foods,” contains two lists of substances that are cleared to be used as components of paper and paperboard in contact with aqueous and fatty foods. Substances in the first group do not require end tests when they comply with the specified limitations. However, substances in the second group must meet extractive end test limitations when the prescribed testing is conducted on the finished product.

Extraction or end tests are generally the responsibility of the producer of the finished item; however, a packaging manufacturer may request that their suppliers conduct testing to establish compliance with the specification in a regulation or an effective FCN.