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Labeling requirements - must declare minute amounts ?


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#1 Arpagano2

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Posted 16 September 2019 - 07:22 PM

I am looking to get some FDA interpreted guidance on the ingredient legend on a label.  I keep hearing the term "under 2%"or "processing aid" internally regarding sub ingredients.  My understanding has always been if it is in the product, it must be declared on the label.  For example, if sub ingredient contains polysorbate or dicalcium phosphate, no matter how much,must be declared on the label.  Any specific reference to the regulations would be extremely helpful. 



#2 QAGB

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Posted 17 September 2019 - 12:28 PM

Hi Arpagano2,

 

Check out this link, as there are several posts describing the difference between a processing aid and an ingredient. 

 

 

https://www.ifsqn.co...processing-aid/

 

I'm not sure where the "under 2%" is coming from, because to my knowledge there isn't an actual quantification by the FDA for a processing aid other than to say it can only be present in "insignificant amounts" (and also must fall under one of three specific categories). I do know that ingredients on your label which are less than 2% of your finished goods don't have to be listed in descending order of concentration, but they still must be listed. See CFR 21 101.4, as below. 

 

(a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with 101.36 need not be repeated in the ingredient list. Paragraph (g) of this section describes the ingredient list on dietary supplement products.

(2) The descending order of predominance requirements of paragraph (a)(1) of this section do not apply to ingredients present in amounts of 2 percent or less by weight when a listing of these ingredients is placed at the end of the ingredient statement following an appropriate quantifying statement, e.g., "Contains _ percent or less of ___" or "Less than _ percent of ___." The blank percentage within the quantifying statement shall be filled in with a threshold level of 2 percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying phrase applies may be present in an amount greater than the stated threshold.


Edited by QAGB, 17 September 2019 - 12:28 PM.


#3 Arpagano2

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Posted 17 September 2019 - 12:37 PM

Thank you so much!  This is exactly what I was looking for!  






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