FDA sub-ingredients: how many generations do we need to declare?
Hi everyone, this has brother me for a while. In Canada, it is clearly stated that from the 3rd generation of sub-ingredients, it is no longer required to declare its components. But I couldn't find anything of similar nature in the US regulations. For example, if we use a marinated meat as an ingredients, which contains a sauce as a component. Then the sauce contains a pickled vegetable, that contains vinegar, do we still need to declare the components of the vinegar?
Thank you for all your input.
No, "3rd gen" is not required. However, it cannot contribute significantly to the nutritional analysis, and must follow allergen/intolerance substance declaration.
No, "3rd gen" is not required. However, it cannot contribute significantly to the nutritional analysis, and must follow allergen/intolerance substance declaration.
Thank you, do you have a regulatory reference for that?
Thank you, but this does not say that the 3rd gen are exempted to be declared. I am a little concern if an inspector challenging us for not expand the 3rd gen components.
You are correct, 3rd gen is not specified in the code, so the two options for sub ingredient components are options (i) or (ii). There are a few exemptions for some sub ingredients (i.e. "enzymes" "culture", etc.) which can probably be found here:
Food-Labeling-Guide-(PDF).pdf 8.53MB 2 downloads
Of course, as I mentioned [OP] all ingredients are still subject to nutritional, allergen/intolerance substance labeling law.
If an auditor wants to "over-interpret" US Food Code, then get your legal council involved.
The FDA law may not be as black a white as you wish. If the ingredient is present in small/incidental amounts and it does not have a techinical of functional effect in the final product, it does not need to be declared.
If you feel like your in for a headache or are not sure, just list everyting.
https://www.accessda....cfm?fr=101.100
(3) Incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food. For the purposes of this paragraph (a)(3), incidental additives are:
(i) Substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect.
7. Is it necessary to declare ingredients in “trace”, i.e., incidental amounts? Can sulfites be considered incidental additives? Answer: FDA does not define “trace amounts”, however, there are some exemptions for declaring ingredients present in “incidental” amounts in a finished food. If an ingredient is present at an incidental level and has no functional or technical effect in the finished product, then it need not be declared on the label. An incidental additive is usually present because it is an ingredient of another ingredient. Note that major food allergens (as discussed on pages 20-24), regardless of whether they are present in the food in trace amounts, must be declared. Sulfites added to any food or to any ingredient in any food and that has no technical effect in that food are considered to be incidental only if present at less than 10 ppm. 21 CFR 101.100(a)(3) & (4)