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FDA sub-ingredients: how many generations do we need to declare?

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Sean Xia

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Posted Today, 04:31 PM

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.



Slab

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Posted Today, 05:28 PM

No, "3rd gen" is not required. However, it cannot contribute significantly to the nutritional analysis, and must follow allergen/intolerance substance declaration.


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Sean Xia

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Posted 59 minutes ago

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?



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Posted 40 minutes ago

21 CFR 101.4(b)(2)

 

Your ingredient list will either fall under (i) or (ii)


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Sean Xia

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Posted 36 minutes ago

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. 





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