In the US 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 the food contact substance is not already regulated, a number of options exist for achieving FDA clearance:
- Submission of a Food Contact Notifications (FCN)
- Submission of a Food Additive Petition (FAP)
- Submission of a Threshold of Regulation Exemption (ToR)
- Use of the No Migration Exemption.
Submitting a FCN is the most commonly used route; it has the twin advantages of leading to proprietary approval and being a quick process once the notification is with the FDA.
The process for an FCN involves carrying out a migration study – either by migration testing or by calculation/mathematical modelling – which calculates the cumulative estimated dietary intake (CEDI). If the CEDI is between 0.5 ppb and 1 ppm, toxicology studies are required. Below 0.5 ppb a toxicology literature search is required, whilst above 1ppm a FAP must be submitted.
Food Additive Petition (FAP)
FAP's are only undertaken 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 FCNs. Due to the toxicology data required, it can be an expensive process and is slower than a Food Contact Notification. FAPs lead to generic approval which anyone can use.
Threshold of Regulation Exemption (ToR)
ToR exemption is applicable when the CEDI is less than 0.5 ppb, but a wide range of applications or generic approval is required. It is a relatively fast process.
No Migration Exemption
If the new food contact substance is not detected in a migration study, it is possible to claim a no migration exemption. Suitable detection limits for this are either 10 ppb or 50 ppb of migration, depending on the nature of the subject and application. If no migration is detected than there is no requirement to notify the substance to the FDA because it will not become a component in food.
We can help you:
- Identify the best route for your food contact substance and application
- Undertake migration testing to assess the level of consumer exposure, customised to your substance and application
- Advice on the migration study route required – whether calculated, modelled or analytical
- Provide study data to enable clients to complete the dossier submission.
Download a brochure for more information: