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Does FDA require allergen labeling for soy if the product tested and resulted 5 ppm for soy?

FDA FDAREQUIREMENT Soy Allergen labeling

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#1 Kubramiller

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Posted 23 April 2021 - 07:20 PM

Hi everyone, does FDA require allergen labeling for soy if the product tested and resulted 5 ppm for soy? What is the ppm range for soy to be on the allergen labeling? Thank you.



#2 kfromNE

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Posted 26 April 2021 - 11:34 AM

If it's an ingredient in the product then yes and it doesn't matter the ppm. The ppm range would help you with your allergen cleaning program.



#3 Spidey

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Posted 26 April 2021 - 08:27 PM

It's also important to note that Soy Lecithin is also required to be marked as a Soy Allergen, even though it's been processed so much that it will test negative.



#4 Timwoodbag

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Posted 27 April 2021 - 12:54 PM

If it's an ingredient in the product then yes and it doesn't matter the ppm. The ppm range would help you with your allergen cleaning program.

 

To finish that first thought, if Soy is NOT an ingredient, you should probably find out where that 5ppm is coming from....



#5 Xoinks

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Posted 27 April 2021 - 05:01 PM

Hi everyone, does FDA require allergen labeling for soy if the product tested and resulted 5 ppm for soy? What is the ppm range for soy to be on the allergen labeling? Thank you.

 

 

Great question.  The "Big 8" allergens are a zero tolerance for any testable limits.  If it can be detected by the test you are using, then it is contaminated.  If it's in an ingredient, like soy lecithin, then it must be declared even if a test doesn't find it.  (Except for certain highly refined oils, like many soybean oils.)  There are no established 'safe' limits for the Big 8 allergens in the United States. 

 

Some sensitizers, specifically sulfites, allow a limit of <10ppm - Though they still need to be declared if they're a functional ingredient in your product.  



#6 Kubramiller

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Posted 27 April 2021 - 05:50 PM

Thank you for all the answers and no we don’t use any ingredients that contains soybean oil or soy lechitin in our product. But from agricultural department .s random product allergen test for soy came 5 ppm. I tested other products we have and also did the swab test on the surfaces where it could be cross contact but all the soy test I had in the facility came negative. And since it is really low I was wondering if I can still call it soy free?
Thank you again



#7 Ryan M.

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Posted 27 April 2021 - 06:17 PM

You need to dig in with your supplier on this.  It could very well be a cross contact issue at your supplier.

 

Thank you for all the answers and no we don’t use any ingredients that contains soybean oil or soy lechitin in our product. But from agricultural department .s random product allergen test for soy came 5 ppm. I tested other products we have and also did the swab test on the surfaces where it could be cross contact but all the soy test I had in the facility came negative. And since it is really low I was wondering if I can still call it soy free?
Thank you again



#8 jkoratich712

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Posted 03 May 2021 - 05:45 PM

Do you use any wheat based ingredients? We had done an analysis of all of our raw materials with potential cross contact at the supplier level. We had 3 ingredients where soy was a potential for cross contact. We tested those ingredients at receipt and one tested positive for soy. As I started researching, the ingredient had wheat in it and there is a lot of information in regards to wheat testing positive for soy due to agriculture practices. 

 

Thank you for all the answers and no we don’t use any ingredients that contains soybean oil or soy lechitin in our product. But from agricultural department .s random product allergen test for soy came 5 ppm. I tested other products we have and also did the swab test on the surfaces where it could be cross contact but all the soy test I had in the facility came negative. And since it is really low I was wondering if I can still call it soy free?
Thank you again



#9 kfromNE

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Posted 03 May 2021 - 07:35 PM

Do you use any wheat based ingredients? We had done an analysis of all of our raw materials with potential cross contact at the supplier level. We had 3 ingredients where soy was a potential for cross contact. We tested those ingredients at receipt and one tested positive for soy. As I started researching, the ingredient had wheat in it and there is a lot of information in regards to wheat testing positive for soy due to agriculture practices. 

Good call. I never thought of that. I grew up on a farm and this doesn't surprise me at all.







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