Q&A: Why you should undertake a migration study as part of the FCN process

Q&A: Why you should undertake a migration study as part of the FCN process

What is a FCN?

Food contact notifications (FCNs) are one of the most popular methods of gaining FDA clearance for new food contact substances that are not currently regulated. Not only do they lead to proprietary approval, but are also a fast way to get authorization from the FDA as well.

When do you need a FCN?

  • If you have a new chemical substance that hasn’t previously been approved by the FDA
  • You have a substance that you want to put on the market that has been approved by someone else using a food contact notification that is proprietary to them, meaning you have to get your own one
  • You have a substance that has previously been approved by the FDA but you want to use it in a new application which is different to the application that it has previously been approved for
  • If you have changed a manufacturing process that will alter the chemical composition of a previously approved food contact substance.

What are the advantages of performing a migration study as part of an FCN submission?

  • You get accurate data from a migration study, whereas without a migration study you would have to provide estimates of dietary exposure which will always be an over-estimate of its true value
  • With accurate migration and exposure data you may be able to reduce the level of the toxicology study that you need to submit to the FDA. This can reduce the overall costs significantly
  • You find the limits of your material, allowing you to define where and how you can comfortably use your materials for various applications.

How can Smithers help?

We are able to advise on the most applicable exposure techniques and food simulants for your migration testing requirements, providing accurate data and support with the FCN process and submission to the FDA. With our advanced GC-MS and LC-MS equipment, we work with you to develop bespoke tests to suit your needs, finding out more about your materials and help make smarter choices for your food contact packaging materials, ultimately saving you time and money.

Find out more about our food contact regulatory support or get in touch with our experts for more information.

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