Food Contact Notifications

We can help you with notifications for a wide range of new food contact substances. Our experts are on hand to explain the process and the support we offer.

In the U.S. a number of options exist for gaining the necessary clearance for new food contact substances. Firstly, the substance may already be regulated by the FDA, under a relevant Part of the Title 21 of the Code of Federal Regulations.

If not already regulated, a number of options exist for achieving FDA clearance:

  • Submission of a Food Contact Notification (FCN)
  • Submission of a Food Additive Petition (FAP)
  • Submission of a Threshold of Regulation Exemption (ToR)
  • Use of the No Migration Exemption
Food Contact Notification (FCN)

The most commonly used route is the submission of a FCN. This has the twin advantages of leading to a proprietary approval and being a quick process once the notification is with the FDA. It involves carrying out a migration study, either experimentally or by calculation/mathematical modelling, which is used to calculate the cumulative estimated dietary intake (CEDI). Toxicology studies are then necessary if the CEDI is between 0.5 ppb and 1 ppm and as always the higher the exposure the more studies are needed and the higher the cost. Below 0.5 ppb a toxicology literature search is required rather than experimental toxicology saving considerable money, whilst above 1ppm a FAP must be submitted.

How we can help:
Smithers Pira will help you find the most cost effective route through the various studies and will provide as much help as is needed with the notification itself from passing all the data to you right through to notifying on your behalf. 
Contact our featured expert for more information.

Food Additive Petition (FAP)

FAP's are only done when the CEDI is greater than 1 ppm or when the applications for the new Food Contact substance are too broad for a reasonable number of FCN's. It is an expensive process requiring extensive toxicological data, quite slow relative to an FCN and only leads to a generic approval which anyone can use.

Threshold of Regulation Exemption (ToR) 

An application for a ToR exemption can be a useful route to notifying a new Food Contact substance when the CEDI is less than 0.5 ppb, but a wide range of applications or a generic approval is the required outcome. It is a relatively fast process


How we can help: 
Smithers Pira can partner you through the process

 
No Migration Exemption

Finally it is possible to claim a no migration exemption if the new Food Contact substance is not detected in a migration study. Suitable detection limits for this are either 10 ppb or 50 ppb of migration depending on the nature of the subject and the application. If no migration is detected then there is no requirement to notify the substance to the FDA because it will not become a component of food.


How we can help:
A letter of opinion from Smithers Pira will be sufficient to satisfy your customers of the safety of the substance.