6 replies to this topic

[Patricia326]

I have a question regarding allergen stickers on our pallets.  We do not have allergens in our manufacturing process, but we do have items we purchase and distribute that do contain allergens.  They always remain enclosed but we do store them in the warehouse using allergen storage guidelines.  We have a procedure for cleaning up allergens should there be a forklift accident or something else that would cause the allergens to spill.  My question is - what if the allergen in the ingredients is declared, then underneath there is a statement that says it may contain an additional allergen such as soy because lines are shared?  Does that mean I would label the pallet with the allergen ingredient AND the potential allergen (such as soy) that is not an ingredient but used on shared lines?  Currently I am counting the soy as an allergen as well although it is not specifically and ingredient in the product.  Is this overkill or am I reporting correctly?

 

Patricia 

[Scampi]

The general rule of thumb is that poor GMPs should not be the reason a "May contain" statement is applied to packaging

 

So if you have sound policies (and it sounds like a yes) then you do not have to declare the allergen that you only distribute

[jfrey123]

If I'm understanding, you've got finished good you distribute only and those items state "Contains: An Allergen - May contain a different allergen"

 

I would not sticker/label the finished good with the 'may contain' allergen.  It shouldn't contain that allergen (you used soy as the may contain example), so labeling it with soy stickers and stacking it amongst soy is introducing a hazard to those items that don't contain soy.  May contain is a craptastic attempt to be a catch-all to cover a company's butt if the sanitation is lacking, but it doesn't carry much efficacy.

[Tony-C]

Hi Patricia326,

 

As per previous posts I would only label the ones with confirmed allergen status and apply your allergen clean up procedures to those. If you have sound ‘clean as you go’ policies and clean up any other spillages I wouldn’t worry too much unless you are storing open products.

 

jfrey123, that is my word of the day: craptastic     

 

As you and Scampi have implied ‘may contain’ is overused and should be fully justified.

 

Kind regards,

 

Tony

[Patricia326]

I know that "may contains" is craptastic lol.  This is, for example, is a distribution item we have purchased that we store for a bit and distribute with our made items.  We don't make anything with allergens.  I hate this phrase but our supplier put it on the box ("shared lines with soy)" as an effort to make them not liable if their sanitation fails.  So my question is, does that pass the responsibility on to our plant, to make sure we store it as if it may contain soy?  Or are they liable since it's not an allergenic ingredient?

 

Patricia

[jfrey123]

You're not responsible and should not label it as containing soy in your plant.  To store a non-soy containing item in an area designated as soy allergen storage would be comingling and a violation of every allergen storage program I've ever seen.  If you're US based, 21 CFR 117.80(b)(1) requires you to protect this non-soy containing item from any actual soy containing items in your storage area.

 

Love that everyone is digging my craptastic description lol.  At the end of the day if soy is actually found in this craptastic "may contain soy" product, then the manufacturer are the ones who are facing a mandatory recall for an adulterated product and undeclared allergen.

Edited by jfrey123, 26 minutes ago.

[Patricia326]

Thanks.  This is very helpful.  Why are manufactures allowed to even put a "may contain" clause on their packaging?

 

Patricia