Is Allergen to be included as the fourth hazard in the study?
Bibi,
Generally, allergen is currently addressed under an allergen management program i.e. Label Notification, Cross Contamination Protection through en effective cleaning programme etc. How deep do you wish to go? You may actually write up an "Allergen Management Programme" as part of your integral GMP System and this will go down extremely well with the auditor and would certainly more than comply with BRC & ISO 22K as part of your system update.
Come to think of it, allergen should be equally rank as unforeseen hazard but of course being unforeseen, you cannot really deal with the issue until it happens right. However in the case of allergens, there is at least a known list to deal with................but then again, did you know that they have recently made "Kiwi Fruit / Puree" an allergenic substance
Yes thats how crazy it is. So how far do you wish to go and will you have an information update program on this stuff called "Allergens"
Personally, I just make notes of nuts, milk, seeds and stuff like these that are part of the known list of substances....am not bothered with the rest unless its a regulatory requirement under country specifics when exporting.
Just my view
Charles