FDA, NSF, 3-A Sanitary, E-3A Sanitary, … how many of you have actually read the specs and requirements? By the way, I like milk, eggs, and beer. Let me explain…
True story. We have a pump and valve customer who came to us because of complaints he was getting from his end customer, a beer producer. The seals he was using were affecting the taste of the product. Now if it was yogurt or some green juice concoction, I probably wouldn’t have given it the proper urgency. But after all, this was beer! This was urgent!
In fact, there were minuscule particles of the seal material ingredients that, over time, were leaching and potentially affecting taste. The material was determined to be to spec and it met all the requirements and certifications, but it still affected the beer.
I bring up this story from time to time when I get into a discussion about FDA or NSF approvals, uh, I mean certifications, or standards… it can be confusing. Is there a difference? Yes!
Ever been asked to provide something FDA Certified? How about NSF Approved? In essence, the questioner is asking for something that meets the federal requirements, and knowledge of the difference between what’s approved, certified or just meeting the standard is sometimes blurry at best.
Here’s a quick tutorial (Thank you Parker O-Ring handbook to keep me straight too.)
The FDA does not approve end compounds. What they have done is created a list of ingredients that can be used in compounds that are neither toxic nor carcinogenic. If compounds are created using these ingredients and pass further extraction tests they then “meet the FDA requirements”. They are not “approved”. They are not “certified”. As Parker states, “It is the responsibility of the manufacturer to compound food grade materials from the FDA list of ingredients…”
Then there’s the NSF, National Sanitation Foundation. Here is where there are certifications. In this case, materials are submitted for certification and must pass very stringent tests. Once certified they can be promoted as being NSF 61 “listed” materials. There is also an NSF 51 standard. Applications vary and so do the appropriate materials. Consult your seal supplier (ESP) for the proper compound to the necessary certification. Oh, and then are multiple European and global standards that I won’t get into here (WRAS and such).
Confused yet? So what about 3-A Sanitary and E-3A requirements that were developed in cooperation with several agencies and no, despite popular assumptions, not the FDA. And by the way, there’s a crackdown to see who is and who isn’t in compliance. You’ve been warned. In short, the 3-A standards are intended for elastomers used in the dairy industry where there is product contact on dairy equipment. The E-3A, on the other hand, is intended where there is contact with egg processing equipment. Now the specifications are virtually the same but meant to establish criteria for the rubber material in how it holds up to frequent cleaning and anti-bacterial treatments to the equipment as well as being compatible with the product and process. As we know, cleaning agents can be hard on elastomers if you don’t have a compound that is compatible. Clean equipment also means good functioning seals.
Short and sweet but a few basics. There’s a lot more to these standards but it’s important to know the differences. After all, I don’t want an o-ring ruining my breakfast. And I really like the taste of my beer.