June 7, 2017 • Posted in Technical

FDA Conditions Of Use

A few weeks ago, I received a documentation request from one of our customers. They wanted to make sure that a few resins they bought from us met Food & Drug Administration (FDA) conditions of use B through H… and J.

Wait… what? I’ve been handling the regulatory desk here for nearly nine years now, and I had never heard of anything past H in terms of Conditions of Use.

Thus, boys and girls, it’s time for a little education on everyone’s favorite subject – FDA compliance! (No, seriously… wake up!)

Anyone who handles regulatory issues for their company – especially if they are manufacturing items meant to come into contact with food – is familiar with the “Conditions Of Use” that are specified in the US Code of Federal Regulations (CFR) – specifically, under 21 CFR 176.170(c), Table 2. As of the 2016 publication of this section of the CFR, the conditions of use are as follows:

  1. High-temperature or heat-sterilized (over 212°F)
  2. Boiling water sterilized (no higher than 212°F)
  3. Hot filled or pasteurized above 150°F
  4. Hot filled or pasteurized below 150°F
  5. Room temperature filled and stored, no thermal treatment in the container
  6. Refrigerated storage, no thermal treatment in the container
  7. Frozen storage, no thermal treatment in the container
  8. Frozen or refrigerated storage, ready-prepared foods intended to be reheated in the container at the time of use:
    1. Aqueous or oil-in-water emulsion of high- or low-fat
    2. Aqueous, high- or low-free oil or fat

These conditions of use go hand-in-hand with the portion of the CFR that applies to the specific material being used. It should be noted that the FDA does not actually certify the resins in these cases; all they do is set the guidelines the resins must meet in order to be called in compliance. The onus thus lies on the producer of the resin to guarantee that the material is in compliance.

However, in 1997, the FDA began establishing a food contact notification process, which would allow for faster review of food contact substances (FCS) that were food additives. (New food additives were required to be approved by the FDA beginning in 1958.) New food contact notifications were first accepted by the FDA in 2000, and the regulations were formally added to the CFR in 2002. (In this regard only does the FDA actually certify a material.)

If a resin is submitted for a FCS, all of the above conditions of use apply. However, two additional conditions now can apply:

  1. Irradiation
  2. Cooking at temperatures exceeding 250°F

These two additional conditions of use do not apply to materials simply having compliance declared by the resin manufacturer; there must be a Food Contact Notification published by the FDA for that particular material, and declared by the resin manufacturer. In the case of our customer, neither of the two resins they were asking about had any such notifications published, so Condition of Use J did not apply.

Be sure to read Chris’ previous regulatory related article Common Regulatory Questions You Should Ask.

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