Hello all I am hoping to get guidance on a Raw Material questions.
We purchase spices from a broker, and that broker has a dedicated spice dealer. We've gotten spices from this company for years with no issue. Upon receiving some a spice, we noticed that the COA had a new specification on it for both Peanut and Gluten allergies. The gluten allergen showed less than 5ppm, but the peanut allergy showed 6ppm, with the testing threshold being less than 2.5ppm. We have placed the shipment on hold and are arguing with the broker and now supplier. They said that this amount doesn't pose a public threat, and that everyone else is accepting it. I have explained multiple times to them that the FDA does not establish limits and if I see a test showing positive, to me that means the garlic contains peanuts and I must declare a peanut allergen if I use it.
I know that <25ppm is technically not a threat to the public in general, but to me anything above the testing threshold should be considered as containing an allergen.
Am I crazy here? Is this a thing now? Do I need to keep standing my ground on this?
Does anyone have any guidance, or references I can consult.
Contractual Product specifications IMEX require formal/signed acceptance by both parties otherwise the contract is "indeterminate".
I suggest yr first technical priority is to be aware of US legal, I assume FDA, requirements. As you indicate, operationally, it's all about the labelling.
IIRC, (1) FDA non-zero limits do exist but solely for gluten and sulphites within FALCPA-"related" items. (2) Otherwise the tolerance is "zero", ie no detection using a reference methodology(s) unless labelled.
Even for (1) there are a variety of caveats to any quoted values within the legal limit(s) as previously discussed/referenced here (somewhere).
My guess is that this is all detailed on the FARRP website, eg -
PS - ppm level is not necessarily the ultimate criterion for safety, see section 7 (et al) in this (non-USA action levels) attachment -
Peanut was the first food to be formally examined to establish threshold doses. The lowest reported threshold doses for peanut appear to be below or near 1 milligram. The differences in the levels of threshold dose in these studies may relate to the preparation method of the peanut source used and standardised, multi-centred studies are underway. Nevertheless, one thing is clear; a really tiny piece of a peanut can be a threat to a peanut allergic patient. An average scaled peanut weighs between 500 and 1000 mg. This means that 1/1000 of a peanut is enough to trigger a reaction in some patients.
PPS - some more background in this post/thread -
Edited by Charles.C, 18 July 2019 - 12:24 AM.