Hello,
validation that a plant is "allergen-free" - can this really be done? I wonder about the high numbers of "free from ..." statements on US products.
Ok, I am able to organize that procedures and specs signed are in place. Supplier have to guarantee that...what? -> same as I can do.
Proven evidence by analytics - impossible. Is under that circumstances validation possible where no limits exists? No, but we can have pre-requisites to reduce probability of occurrence of unintended contamination. You never will be able to demonstrate the ZERO=free from-level.
To demonstrate that products are "free from..." are really free from is scientifically impossible, even if you are taking many samples to increase confidence in statistics.
My position is clearly to state free from only in that cases where free from is defined e.g. gluten-free, perhaps in some countries lactose-free, alcohol-free i.e. where an accepted level + analytical method exists. Is this available for all "tree nuts" as defined by.... there are worldwide several legal definitions what tree nuts are. You have to take care about this too if you are exporting. Do you are able to get statements about pine contamination in supplied ingredients in Europe? Most companies stick to the "allergen profile" defined by local law.
In the case of allergens there is an individual dose-response curve - no accepted level. What free from ....allergens mean? Somethings else than 100% protection?
The Vital 2.0 concept (the basis was proposed by the Allergen Threshhold Group in the US) wants to protect most, not all consumers by using "may contain..." Information which is based on a certain level of an allergenic protein.
To finalize: In my opinion a validation of free from=ZERO-level is not possible on a scientific basis.
Rgds
moskito