Missing CFR definitions: So what does “food-grade” actually mean?

Not food-grade...or is it?I was looking over the SQF code the other day and pondering the phrase “food-grade” for lubricants and chemicals, then I got home and noticed the “food-grade” sticker on my CO2 canister in my kegerator.

This is what we call nerd-sniping,  regulatory edition.

I sat down and started searching Title 21 of the Code of Federal Regulations, and in this case I was searching for a specific definition. After all, FDA uses the term “food-grade” in some of their guidance documents and individual chemical requirements, so they must have defined it, right?

…well maybe it was included in the original FD&C text, like some of those random standard of identities and definitions?

…well maybe they didn’t duplicate it, but it’s defined in Title 9 for USDA regulations then?

……well, crap. Well, if the bad bug book can cite wikipedia, then maybe FDA will include this blog post as a guidance document at some point.

If “food” is “food-grade”, then what is the term used for?

Since the term appears in the SQF and other codes, it’s usually a good assumption that you can find a definition in the codex alimentarius, maintained by the FAO and member nations. And if a US national standard doesn’t exist, it’s typically safe for manufacturers to refer to an international standard of some kind.

So, a quick search for “food-grade” in codex leads me to…

Okay, they use the term frequently for specific food additive standards (e.g. food grade salt, agar, and edible insects).

Maybe I’m overthinking this…maybe this is just a dictionary definition, and while I, as someone regulated under this standard, feel like it should have been codified, maybe I’m just supposed to take Oxford’s broad interpretation:

Of a quality suitable for human consumption, or for use in food production or storage.

I really don’t like attributing “food-grade” to just a substance that happens to be used in food production…that’s almost tautological. So in this case, I’m assuming I’m expected to examine each ingredient or food contact substance individually and make a judgement call based on standards that are or aren’t available, or just avoid anything hazardous that may somehow come with that ingredient. So where can we start?

The Food Chemicals Codex Standard (FCC)

The US Pharmacopeia (USP) is an organization that helps develop global public health standards and works closely with codex and helps publish the FCC monographs. These “monographs” are basically standards of purity necessary for specific uses of food ingredients. For example, salt has several levels of purity depending on use. Salt can be used in industrial chemistry in the petroleum industry or pesticide creation, it could be used as an ingredient or carrier in foods, or it could even be used as an inject-able substance in medicine. Each of those intended uses has a different purity standard, and you only want to do as much as necessary to make the ingredient safe for use. So, using this resource, items that hold the FCC purity standard would certainly be “food-grade”.

Back to the USA then, since we’re now operating outside of any sort of regulated definition of “food-grade” for foods in general. We can move past obvious foods and ingredients like produce, where “food-grade” would generally be assumed to be articles intended for human consumption that do not contain any poisonous or deleterious substances above any regulated threshold. We can also very easily find guidance for new food additives and functional ingredients that go through a normal review process.

What about the other stuff? Packaging, sanitizers, lubricants…

This really ends up being both easy and hard. You can certainly find products labeled food grade, and food packaging suppliers (selling to industry, not the public) will readily send you letters and specifications indicating that the plastic resins and other materials are safe for food contact. But establishing under what standard these items are held to is more difficult.

Food-Grade Packaging materials: FDA regulates substances used in food packaging and has migration standards to to make sure that anything in the material doesn’t transfer to the food in a significant way.

Food-Grade Lubricants and Maintenance Chemicals: In areas above food contact surfaces or in machinery that handles food, these chemicals are expected to occasionally enter food in small amounts. So they need to be safe for consumption in small amounts. FDA has a list of these materials and a general safety/purity standard. NSF has a great discussion of these standards and other international standards for lubricants, and provides certifications for these products that are very much accepted by both FDA and 3rd party auditors. NSF also helps approve food contact surfaces.

Food-Grade Sanitation Chemicals: FDA has a list for sanitizers and other “substances utilized to control the growth of microorganisms”, and includes the most common active ingredients as well as whether the sanitizer requires a rinse or not to make sure that no harmful residues are left behind. Once again, this is assuming that we aren’t feeding people these things, the SDS may still say they are toxic if swallowed, but in small amounts or “good manufacturing practice” they will be harmless.

Food-Grade Compressed Gasses: This is one that is very undefined. For example, FDA references Nitrogen’s GRAS status with this helpful note:

 The ingredient must be of a purity suitable for its intended use.

Very scientific FDA. So we have no domestic purity standard for compressed gases for food use, however we have established one for medical use. I spoke with a representative of Airgas over the phone, who stated that the only difference between gas cylinders sold with the “food grade” or “beverage grade” claim was their procedure for cleaning the tanks and tracking the gas by lot. This would make sense if they needed to follow a sanitation protocol or avoid/remove residues of any non-food grade lubricants used in industrial applications other than food, and if their typical “basic” gasses are already of high purity.

Internationally for the EU and European pharmacopeia there are standards for compressed gas purity, and in the US it would be assumed that “food grade” gasses would comply with the FCC monograph. An example one for Nitrogen can be found here.

So at the end of all this, is the answer simply that FDA could not come up with a “food-grade” standard that applied to all these types of materials? Or perhaps they thought that all these cases were already contained within their “adulteration” and “poisonous and deleterious substances” definitions. I still take issue with the fact that they use this phrase so heavily throughout the regulatory text that a definition should have been necessary. So, FDA, for your review, I submit the following definition:

As described in Fur, Farm, and Fork:

Food-Grade substance:  A substance that, when used within good manufacturing practice, is suitable for its intended use, does not introduce any poisonous or deleterious components to the food, and complies with any federally adopted purity standards

 

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