Project: We are currently developing a beverage dispensing mechanical equipment. These equipment parts are made up of food-grade raw materials. As this is consumable, do we have to get this prototype certified by FDA? If so, what are the steps involved?
I have seen the below FDA Certification Process on website:
Firstly, we would raise a request for a food contact notification (FCN) to FDA.
A "phase one" review meeting is held within the first three weeks after receipt of the FCN to ensure that the basic data and informational elements are present, and that the submission meets the administrative requirements set forth in the FD&C Act and FDA's regulations.
During "phase two" the team evaluates the safety of the food contact substance as it is proposed for use.
When we prepare a package to FDA to obtain a certification, we need to provide a breakdown of the list of P/N’s, and their raw materials. Then provide the supporting documentation and their compliance if these materials are already existing in FDA website.
Example of a component:
The material Acetal we are using to produce the Quick Disconnector is FDA compliant.
We like to know below things:
- As we are not introducing any new material, do we need to still raise an FCN?
- FDA is the agency that certifies the entire unit? Or can it be made for certifying it to NSF requirements. So, FDA would be providing us with the final signature?
Please find the link for the FCN process:
Guidance for Industry: Preparation of Food Contact Substance Notifications (Administrative) | FDA
Packaging & Food Contact Substances (FCS) > Regulatory Report: FDA's Food Contact Substance Notification Program (archive-it.org)
Can anyone please provide me with your insights on where to start for our project needs?
I like to know approaching NSF or FDA this process would be easier?