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Threshold for Labeling Hydrolyzed Proteins in the US

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FosTerH0ME

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Posted 11 November 2024 - 05:50 PM

What degree of hydrolysis requires a protein to be labeled as hydrolyzed in the US? Specific context is for pea protein being referred to by a supplier as "partially hydrolyzed" but "not required to be labeled as hydrolyzed". I have been unable to locate a specific threshold even after reviewing the submissions to FDA for GRAS approval of various pea protein products.

 

Thank you for your time!


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kingstudruler1

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Posted 11 November 2024 - 10:00 PM

I spent a small amount of time looking.  

 

IMO the product should be labled as partially hydrolyzed pea protein.   It shouldnt be declared as hydrolyzed.   Ther is a difference.  Any advice otherwise should include refrence to a applicable regulation.   

 

I couldnt find the fda regulation referenced in the attached usda doc.     It suggests the cut off is 0.62 AN/TN.    

 

https://www.fsis.usd...1995-0001_0.pdf

 

1. Question: Can protein hydrolysates be grouped in the ingredients statement, e.g., "hydrolyzed vegetable
protein (corn, soy, wheat)"?
Answer: No, "hydrolyzed vegetable protein" is not established by FDA as a common or usual
name, nor is it established as an appropriate collective name for a variety of different protein
hydrolysates. The common or usual name of a protein hydrolysate should be specific to the
ingredient and shall include the identity of the source from which the protein was derived.
Hydrolyzed soy protein, hydrolyzed corn gluten, and hydrolyzed casein is examples of acceptable
names. The acceptable FDA designation is hydrolyzed corn protein, hydrolyzed soy protein, and
hydrolyzed wheat protein.
Question: What is the rule of thumb when the identity and function of a hydrolyzed substance is in
question?
Answer: According to FDA, appropriate standards exist to allow a distinction between
commercially available "highly" hydrolyzed protein hydrolysates and those variously termed
"partially," "mildly," or "lightly" hydrolyzed that are not used for flavor-related purpose.
According to the FDA, ‘highly" hydrolyzed proteins are declared as "hydrolyzed (source protein)"
and can be defined as those whose ratio of alpha-amino nitrogen (AN) to total nitrogen (TN) is
greater than 0.62 (AN:TN > 0.62). Proteins that are not highly hydrolyzed would have AN:TN of
less than 0.62 (AN:TN < 0.62) and may be declared by using such terms as "partially," "mildly," or
"lightly," e.g., "partially hydrolyzed (source protein)."
When a problem arises regarding whether a hydrolyzed substance used in the formulation of a meat
or poultry product is accurately identified and serving the primary function of flavoring, we
consider these definitions and the level of use of the substance in question. In our experience,
substances that have AN:TN > 0.62 would be used at less than 2 percent of the meat or poultry
product formulation when used for the primary purpose of flavoring. 

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FosTerH0ME

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Posted 12 November 2024 - 02:40 PM

Thank you for your response! It calls out "may". If it is not required, then would it just be labeled as pea protein or pea protein isolate if you elect not to employ the optional ""partially," "mildly," or "lightly,"" hydrolyzed?

 

Context: Application is a high protein extruded vegan crisp and not a meat product. Usage is >60% of the formulation. 


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kingstudruler1

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Posted 12 November 2024 - 03:35 PM

Thank you for your response! It calls out "may". If it is not required, then would it just be labeled as pea protein or pea protein isolate if you elect not to employ the optional ""partially," "mildly," or "lightly,"" hydrolyzed?

 

Context: Application is a high protein extruded vegan crisp and not a meat product. Usage is >60% of the formulation. 

 

I think the "MAY" refers to "partially," "mildly," or "lightly,"   You can pick one of them.  I cant find the exact regulation to verify the acceptability of  "lightly" and "mildly", I have only seen it labeled as "partially".   Thus, that is the one I would use.  

 

Are you trying to avoid any reference to "hydrolyzed"?  I dont think "Pea Protein" or "Pea Protein Isolate" "fits" this product.  If your supplier state that it is "partially hydrolyzed pea protein", i think you are stuck with it.  

 

Switch to non-hydrolyzed version? 


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FosTerH0ME

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Posted 12 November 2024 - 04:55 PM

Without getting too specific.... per the supplier "it is below the hydrolyzed percentage that requires being labelled as hydrolyzed". I don't agree with the supplier. I am in alignment with your suggestion to transition to a non-hydrolyzed version.

 

I am unable to "prove" the "experts" are mistaken to my internal team and would like to cite regulatory specifics as grounds to move to an alternative raw material. 


Edited by FosTerH0ME, 12 November 2024 - 04:55 PM.

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kingstudruler1

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Posted 12 November 2024 - 08:56 PM

Without getting too specific.... per the supplier "it is below the hydrolyzed percentage that requires being labelled as hydrolyzed". I don't agree with the supplier. I am in alignment with your suggestion to transition to a non-hydrolyzed version.

 

I am unable to "prove" the "experts" are mistaken to my internal team and would like to cite regulatory specifics as grounds to move to an alternative raw material. 

 

Does your supplier label it as just "Pea Protein"?   Or do they label it "Partially Hydrolyzed Pea Protein"?    I guess if the suppliers spec sheet and label state "Pea Protein", id be fine with that.   But is sounds like that is not what is happening and there is some kind of side discussion.   

 

I guess the info I gave you was the cut off for partial vs full.   I didnt see any info on where "pea protein" becomes "partially hydrolyzed pea protein".   

 

Im sorry, Ive been there.   Had to sit through a meeting once where:  MSG contains glutamate, tomatoes are natural and contain natural glutamates, therefor MSG is just "Natual Flavor".


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