1 reply to this topic

[vijaysai]

Hi everyone:

 

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=177.2480&SearchTerm=acetal

 

We like to know below things:

1. As we are not introducing any new material, do we need to still raise an FCN? 
2. 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?

 

 

Thank you,

Vijay

[Karenconstable]

Vijay,

 

The FDA does not certify equipment.  The process you are referring to (FCN) is what you have to do if you want to use a new type of material for food (beverage/water) contact purposes. 

 

If your materials are already listed in the FDA Code of Federal Regulations for food contact materials (indirect food additives) then you should not need to go through that Food Contact Notification Process.

 

There might be laws about hygienic design for the machines, depending on where you intend to sell them.  Hygienic Deisgn means things like using non-corroding materials, designing hoses, pipes and valves so there are no 'dead' spots where product can collect, designing for easy access to pumps for deep cleaning, making the units insect-proof so they don't become a cockroach breeding-ground, avoiding 'sharp' internal corners which are difficult to clean.... For hygienic design best practices, I urge you to consult the best practice hygienic design principles guidelines published (free) by EHEDG.  Poorly designed beverage dispensers are a food safety risk. 

 

If you intend to sell the units in Europe you need to be able to show that all the materials you use meet the appropriate EC regulations for food contact materials (EC 1935/2004) and I think (from memory) this includes traceability.  In USA your customers may ask you to provide a declaration that all your food contact parts are compliant with the FDA CFR 21 Chapter1 Parts 174?? - 178?? Indirect Food Additives (from memory).  

 

Certification for electricity compliance is compulsory but for food safety (eg. food-safe materials, hygienic design) certification is voluntary in most places as far as I am aware (I'm not a lawyer)... although NSF would have you believe otherwise.  However companies like McD's are unlikely to buy your equipment if it doesn't have some type of food safety certification. 

 

Certification companies that provide certifications for beverage dispensing equipment include NSF (US), UL (France), HACCP International (Global).

 

You're welcome to reach out to me on LinkedIn if you have more questions. 

 

Karen