Everything You (Never) Wanted to Know About FDA-Compliance but Were Afraid to Ask

Recently, I received one of the more interesting inquiries from one of our customers regarding FDA compliance:

“When a resin has limitations as to Conditions of Use under 21 CFR 176.170(c), do you know what drives the limitations for the resin?”

The answer is quite simple… at least until it gets more complex. The simple answer is: the trigger is the level of chemicals which can be extracted under specific tests. We could leave it at that, but I know, dear Reader, you hunger for more information. (And remember: you asked for it.)

The exact wording in this section of the Code of Federal Regulations reads:

“The food-contact surface of the paper and paperboard in the finished form in which it is to contact food, when extracted with the solvent or solvents characterizing the type of food, and under conditions of time and temperature characterizing the conditions of its intended use as determined from tables 1 and 2 of this paragraph, shall yield net chloroform-soluble extractives (corrected for wax, petrolatum, mineral oil and zinc extractives as zinc oleate) not to exceed 0.5 milligram per square inch of food-contact surface as determined by the methods described in paragraph (d) of this section.”

Wait… what?!?

Let’s take a sample resin, and let’s assume that it is undergoing testing under Condition of Use A – that is, high temperature heat-sterilized (over 212°F, but less than 250°F). The specific food-simulating solvent for Food Types I (nonacid aqueous products), IV-B (dairy products and modifications in oil-in-water emulsions with high or low-fat) and VII-B (bakery products not included under Types VIII or IX with surface containing no free fat or oil) is water at 250° for two hours. (Yes, I’m aware that the boiling point of water is 212°F; I am guessing that the check extractables after the steam cools and becomes liquid again.) If, after that, the extracted chemicals do not exceed 0.5 milligram per square inch of food contact surface, then the material can be rightfully declared to be cleared for use under that specific Condition of Use for those specific food types. The material would then undergo similar tests for each Condition of Use down to H – remember, conditions I and J only apply if the resin has undergone Food Contact Notification certification through the FDA.

Eagle-eyed readers will note – especially if you review the actual tables – that not all food types are necessarily tested for each Condition of Use. While I admit I am not a food chemist (though I did stay at a Holiday Inn last night), I would assume this is because it is not expected that a food type not tested would be used in such applications, though I admit I don’t know how that determination is made.

I also believe it is safe to assume that certain resins are not tested for specific Conditions of Use due to temperature limitations of that resin. For example: if a resin has a melting point of 200°F, it is pointless to test it under Condition of Use A, since the resin itself would more than likely break down.

Who does this testing? Presumably the manufacturers themselves, or they would utilize the services of an independent lab for third-party testing. Once the resin has been tested, as long as the guidelines under the Code of Federal Regulations doesn’t change or the formulation of the resin doesn’t change, the test remains valid indefinitely.

If you absolutely, positively have to know more on the subject, you can find the specific portion of the Code here.
 – Authored by Christopher Thelen, Regulatory Specialist

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