3 replies to this topic

[Emily_B]

My company ordered refined oil from a vendor, and they had (mistakenly) sent unrefined oil. The unrefined oil that we received, the packaging and label does not state that there is an allergen in the product but their documentation (allergen statement) states that there is an allergen in the unrefined oil.  

 

When I raised concern to our vendor about the label and allergen, they stated "Because the common name “Sesame” is on the drum as a single ingredient, it is already labeled as the FDA mandates.  The “contains” label in not required when “the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived”.

 

For a company that sells both refined and unrefined oils, does this portion of the law relate to them or their products?

I know refined oil is exempt from claiming allergens, and that is why I feel not labeling unrefined oil allergens is misleading. I have found a website that state "Refined, bleached, deodorized soybean oil is not a food allergen since the protein chain that causes allergic reactions is destroyed in the manufacturing process. Highly refined oils are the only FALCPA exemption from allergen declaration. However, soy lecithin does contain some intact soy protein chains, thus, is to be treated as a regulated allergen. In addition, the source of the lecithin must be declared on the ingredient declaration, “soy lecithin.”(1). 

 

How come the labeling requirements of unrefined sesame oil would not be the same as the soy lecithin, where the common name is in the product name but the allergen still needs to be identified?

 

If anyone can help me understand, I would appreciated it very much!  

 

 

Source:

https://www.qualitya...ntial-allergen/

Edited by Emily_B, 23 October 2023 - 07:45 PM.

[smgendel]

Emily,

 

Regardless of the regulations that apply to single substance bulk ingredients, if you use this non-refined oil in your product you DO need to have it declared.  It can either be listed in the ingredient deck or in a "contains" statement (or both).  If you use a contains statement for other major food allergens, then you need to add sesame to that statement. That is, all the allergens present must be listed in that statement. 

 

Without knowing more about your product and labeling system, it is hard to say more than that.

 

Steve

[Emily_B]

Hi Steve,

Thank you for responding.

I wanted to clarify that we are not using the unrefined oil in our product, and if we were we would 100% claim it, especially having the allergen statement. In this case, we are returning the unrefined oil for RBD oil.

 

What I mostly want to know, does our vendor need to claim the allergen on their the one ingredient product?

 

 Thanks, Emily 

[SerenityNow!]

Oils need to be identified from where they are derived whether they are refined or not. Just as with vegetable oils, the source must be identified. there are different ways to call them out, for example: Sesame Oil, Soybean Oil, Vegetable Oil (soy), Vegetable Oils (sunflower, soy) - the source must always be identified.

 

How exactly is the product labeled?  If it says Sesame Oil, it is identified properly with respect to standards of identity.  

 

But, I get where you're coming from.  Two different sesame oils, one is refined one isn't.  They would both be identified properly by being called Sesame Oil because sesame is called out.  With that said, the company should take an additional step to further identify the product on whether it's highly refined or not as part of their allergen control, product control and labeling control processes, and order fulfillment as it's sold as two different items and should have two different specifications/controls.  Their allergen controls should be tightened, better labeled, segregated, training, additional label alerts and such.