Allergen Statement Refined Soybean Oil (RBD
Currently commissioning a new Soybean Oil Refinery.
Refined Soybean Oil (RBD) is the only production line and sold product (by-products are spent bleaching earth and Free Fatty Acids). We are selling in bulk (tanker truckloads).
I understand that the “Food Allergen Labeling and Consumer Protection Act of 2004, Sec. 203, subsection 7, part C.c.1.qq.2.1” under Conforming Amendments, states that highly refined oils are exempted as major food allergens, thus we do not need to list Soy or Soybeans as an allergen since our product is defined as a highly refined oil.
However, many facilities follow the practice of including a statement such as "manufactured in a facility that process [tree nuts]…". With that example, our facility uses crude soybean oil (this facility does not crush the bean or extract the oil, that is done by a separate, near-by facility on the same property but different building), should we include an allergen statement or not? If so, what should it look like (say)? - Thanks!
You still have to declare the type or source of the refined oil - which is soybeans.
Are you sure no other major allergen can be obtained from supplied materials? check your suppliers.
The 'processed in a plant...' statement is to cover the small, but realistic possibility of cross-contamination. In your case, there does not appear to be any other allergens of concern - do follow gud2ya's advice about due diligence on suppliers. Given FDA's stance on allergens in highly refined oils, you should not have to put any allergen statement on the label. I do not see any statements like that on soybean oils my plants get.
KTD
I agree with the above comments. Even though it is highly refined and has denatured the protein, you still need to state soy on your allergen statement. You should include a statement saying the soy is highly refined. I did quite a it of research in my previous job on soy allergies. . In doing my research I found that soy allergies are not very prevalent and since soy is mostly highly refined, it's risk was minute.
I agree with the above comments. Even though it is highly refined and has denatured the protein, you still need to state soy on your allergen statement. You should include a statement saying the soy is highly refined. I did quite a it of research in my previous job on soy allergies. . In doing my research I found that soy allergies are not very prevalent and since soy is mostly highly refined, it's risk was minute.
I respectfully disagree. I believe gud2ya's suggestion was regarding declaration of the source of the oil on the label (must be named "soybean oil" or the like), but IMEX declaring soy in an allergen statement is optional - especially if the oil is refined in a different building and has only a remote risk of cross-contamination and can be validated (do you perform allergen testing on equipment and end product?).
I've had customers in the past that request that we declare soy as an allergen in products that contain only soybean oil just for CYA. IMO a bit ridiculous when the FDA itself declares soybean oil a non-allergen.
We had a robust allergen program at my previous job, but still claimed on the label as we did not perform a wash out when we ran like products...it allowed us to run continuous for the day without down time. If the supplier listed on the allergen statement then we called it out on the label...even if it was highly refined.
At my current job we do not test for allergens and soybean oil and only soybean oil is used in our facility. We still make a call out on all our labeling for soy allergy.
It's an oxymoron as the US calls out soy as one of the major allergens, yet highly refined is non-allergenic.