Do we have to announce formula changes with allergen additions?
Hi All,
I am new at a company currently in the middle of several formulation changes. In an effort to "clean up" the ingredient label, they are adding coconut oil. The oil is refined but not "highly refined," therefore, technically, an allergen is being added. It is in the ingredient list and contains statement of the new packaging but Marketing is not making any sort of real announcement or call out. Are there any regulations (FDA) that reference formula changes with allergen additions or are we legally compliant because the new packaging is correct to the new formula? Any insight is appreciated! Thanks!
As long as it's on the packaging you have no obligation to call it out as a change.
In many countries coconut is not considered an allergen. Botanically, coconut is classified as a fruit. While there have been allergic reactions to coconuts, they are usually very rare. You might want to check your countries allergens. Don't declare an allergen unless you have to.
Dear,
In Europe, coconut is not classified as a nut and therefor not subject to the allergen declaration legislation. However, the sources of vegetable oils and fats (for example: coconut, soya or palm) need to be declared on the product labels.
Kind regards,
Gerard Heerkens
Hi qaccount,
I'm not in USA but I assume that the "FDA" in yr OP refers to (US)FDA.
I also deduce that you believe yr coconut oil is classified in USA as containing a "major food allergen", eg via the 2 FDA links below -
https://www.fda.gov/...s/ucm059116.htm
http://nutrients.rea...2-allergen.html
(USA posters are welcome to correct me if my interpretation is invalid)
Unfortunately I have no idea what "reference formula" means, or the significance of such terminology in above context. USA posters hopefully will know.
Hi qaccount,
I'm not in USA but I assume that the "FDA" in yr OP refers to (US)FDA.
I also deduce that you believe yr coconut oil is classified in USA as containing a "major food allergen", eg via the 2 FDA links below -
https://www.fda.gov/...s/ucm059116.htm
http://nutrients.rea...2-allergen.html
(USA posters are welcome to correct me if my interpretation is invalid)
Unfortunately I have no idea what "reference formula" means, or the significance of such terminology in above context. USA posters hopefully will know.
Charles is correct in that Coconut is considered a "tree nut" and needs to be called out in compliance with FALCPA. I state again however, you don't need to do any special call out just because your formula didn't have it in the past, you just can't ship your new formula in old packaging which does not call out coconut.
Hi qaccount,
Coconuts are actually classified as tree nuts by the FDA - see this link https://www.fda.gov/...y/ucm238807.htm
I cannot comment on communication if you are supplying a finished product to retail - but if you are supplying the product to a wholesaler or manufacturer, I would strongly recommend reaching out and providing an updated specification sheet. If I were on the receiving end, it might keep me from a costly recall if I was not aware of the change.
Not legally obligated, but check with your customer agreements and contracts. Customers may have a specific requirement for it.
Didn't Luna bar change their formula a few years ago with the addition of an allergen? As I recall, they put the allergen declaration on their label, but regular consumers of the product didn't realize the addition of allergen. There were numerous allergic reactions reported, so Luna recalled the bars. If it was my company, I would take additional measures to let my customers know.
HI,
in the US coconut is an allergen (tree nut), but all highly refined oils are exempted from allergen labelling.
I have - some years ago - done are literature search on clinical studies. At that time it was only able to find reports on allergenic reactions. You will always find people reacting to....but not all these "allergens" are listed in food law for declaration (e.g. strawberries). In the US you have 8, in Eu 14....and in Japan are much more listed. This is a political decision on "local" requirements and awareness and posibilities to controll it on a reliable basis (SME).
Rgds
moskito