9 replies to this topic

[Padfoot]

Hell everyone! We currently have soy as one of the allergens in our plant. Some of these items list soy as an allergen because IE shortening has refined soybean oil. We know a refined oil allergen is not considered an allergen and have a letter from our vendor that also confirms this. We have been talking about removing soy as an allergen for these products but the problem is that we have other plants in the corporation that use soy in the same products and our labeling is universal for all plants. I know that it is a problem to have an allergen and not declare it in the allergen statement but what if we had the allergen in our statement but not consider it an allergen when changing products. In other words if we were to run something that had refined soybean oil in it and changeover to a product that didn't have it we would clean the production line. Would this be a problem for us? 

[jdpaul]

Since highly refined soybean oil would not be declared on the ingredient statement (FALCPA does not require the labelling of highly refined oils from any of the major allergen categories), have you ever considered looking into research on protein residue leftover from refined soybean oil? I know the amount of allergen protein is so minute it doesn't trigger an allergic response in individuals which is partly why it doesn't have to be declared. 

 

You could also do a change over and validate the soybean protein using a kit from Neogen. That would be your validation and evidence for not performing cleaning and sanitizing of the line after running products that contain highly refined soybean oil

Edited by jdpaul, 10 December 2020 - 09:11 PM.

[Padfoot]

Since highly refined soybean oil would not be declared on the ingredient statement (FALCPA does not require the labelling of highly refined oils from any of the major allergen categories), have you ever considered looking into research on protein residue leftover from refined soybean oil? I know the amount of allergen protein is so minute it doesn't trigger an allergic response in individuals which is partly why it doesn't have to be declared. 

 

You could also do a change over and validate the soybean protein using a kit from Neogen. That would be your validation and evidence for not performing cleaning and sanitizing of the line after running products that contain highly refined soybean oil

Wow I didn't think of this! I actually have some soy test kits from Neogen 

[Padfoot]

But now, if I prove that there is no soy residue in refined soybean oil would it be a problem if we still declared it in our allergens for our sister plants that have the same product and actually use Soy but not treat it like an allergen just in our plant? 

[Ryan M.]

Am I interpreting this correctly?  The product you run does not have soy allergen (refined oil), but a separate plant runs the same product and has a soy allergen?

[jdpaul]

Sounds like you need two different labels but if FALCPA did not require the labelling of highly refined soybean oil why did you have it in there in the first place? You have

 

 

• Sister formula label: soy in the ingredient and allergen statement and removing highly refined soybean oil
• Other formula label: no soy and removing highly refined soybean oil

Edited by jdpaul, 10 December 2020 - 09:22 PM.

[Padfoot]

Am I interpreting this correctly?  The product you run does not have soy allergen (refined oil), but a separate plant runs the same product and has a soy allergen?

Yes I'm in the middle of figuring out why exactly they have to have it in our sister plant but that's the information ive had

[Ryan M.]

Yes I'm in the middle of figuring out why exactly they have to have it in our sister plant but that's the information ive had

 

You need to dig further into this.  If you can't get the information you seek it is a bit tricky because technically it is mislabeling, but it does not necessarily present any safety hazard to the consumer.  I believe the FDA could force your hand for you with the labeling if/when they find out about the discrepancy because it is not accurate.

 

You should have all your ducks in a row though to show an auditor or inspector the reasoning of the labeling.  Including all information and communication you have with the sister plant.  If you don't do allergen type controls for it you need to prove the product is soy allergen free.

[kfromNE]

I would find out why they would label it in the first place. I would think having one less allergen to deal with would be a blessing. Maybe they are unaware of the rules.

[Padfoot]

I conducted an allergen test on the IE shortening for soy using the neogen test and it was negative.

 

Since highly refined soybean oil would not be declared on the ingredient statement (FALCPA does not require the labelling of highly refined oils from any of the major allergen categories), have you ever considered looking into research on protein residue leftover from refined soybean oil? I know the amount of allergen protein is so minute it doesn't trigger an allergic response in individuals which is partly why it doesn't have to be declared. 

 

You could also do a change over and validate the soybean protein using a kit from Neogen. That would be your validation and evidence for not performing cleaning and sanitizing of the line after running products that contain highly refined soybean oil