5 replies to this topic

[Snickerdoodle]

I worked for a small chocolate manufacturing factory and we handle tree nuts on our site. We are currently validating our tree nut allergen purging procedure. We do not have a dedicated line for tree nut containing products so our purging process is really extensive between changeovers. We use cocoa butter and/or liquor to purge our tanks and pipes but this is very costly  even if we rework them into like products. We are using an Elisa allergen test but we are still getting high allergen protein results after we purge them using hundreds of kilos of cocoa butter. I believe the Lowest detectable limit that the laboratory can test is 2.5 ppm but this is simply not achievable for us. We'd like to set an internal limit between 10 to 100 ppm maximum. Is this acceptable? Our label has an allergen warning of "May Contain Tree Nuts" on our dark Chocolates.  

 

I'd appreciate any info/guidance/procedures you can share with us. Thank you so much. 

[jfrey123]

FDA is working on some guidelines talking about establishing a threshold for allergen testing limits.

 

Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (fda.gov)

 

They're showing some issues with blanket declarations of x ppm, and instead shooting for some conversation around the lowest observed adverse effect level (LOAEL).  P54 they've got a table showing LOAEL for Tree Nuts of 0.02 to 7.5 mg protein, and despite desperate googling I can't find a way to convert that to a PPM that makes sense to me (or even whether that conversion is possible).  This doesn't answer your question, only to suggest that the lowest detection limit you can get your hands on and returning a negative is one of the safest bets at this point.

[MDaleDDF]

Buy some form of tree nut powder and just add enough to spread the allergen to all formulations, and put nuts on the ingredient statement.  No more special cleaning, etc.   We have 4 allergens in my building, and every product has those four and only those four.   I will not add other allergens to my building, nor will I make anything a customer wants one of those allergens left out of.    Super easy.

 

And we all know around here what the 'may contain' statement does for us.    Nada.

[G M]

... 0.02 to 7.5 mg protein, and despite desperate googling I can't find a way to convert that to a PPM that makes sense to me ...

 

It's actually very straightforward. 

 

1ppm = 1mg/kg 

 

and the next tier down is 

 

1ppb = 1ug/kg

[G M]

 

... the Lowest detectable limit that the laboratory can test is 2.5 ppm but this is simply not achievable for us. We'd like to set an internal limit between 10 to 100 ppm maximum. Is this acceptable? ...

 

Probably not.  Most regulators have not set acceptable limits, including the US FDA, so without a # to put in the statement "#ppm or lower is acceptable" the only officially acceptable level is ZERO.  If you know there is allergenic material in the product that is not in the ingredient list, then it is adulterated with undeclared allergens.

 

"May Contain" is not a substitute for effective GMPs or cleaning processes.  The hazards are still expected to be controlled.

 

Even by Japanese regulatory standards for allergens (one of the few that has picked a number), detectable levels are required to be under 10ppm.  

[kingstudruler1]

FDA is working on some guidelines talking about establishing a threshold for allergen testing limits.

 

Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (fda.gov)

 

They're showing some issues with blanket declarations of x ppm, and instead shooting for some conversation around the lowest observed adverse effect level (LOAEL).  P54 they've got a table showing LOAEL for Tree Nuts of 0.02 to 7.5 mg protein, and despite desperate googling I can't find a way to convert that to a PPM that makes sense to me (or even whether that conversion is possible).  This doesn't answer your question, only to suggest that the lowest detection limit you can get your hands on and returning a negative is one of the safest bets at this point.

 

It makes sense to know what actually cause an adverse effect and try and legislate around that.   However, I'm not sure i'm understanding what they are accomplishing.  If you take the lowest LOAELs from the table and a serving size of a cookie (30g) -  the PPM result is already really low and close to or below current ppm detection levels (0.66 - 33.3 ppm - soy is 2933 ppm).   Then, what do you do regarding the person that ingests 2x, 5x, 10x the RACC?   I dont see how you can change from anything other than zero tolerance.  

 

Maybe my math is wrong or I'm missing something..........  someone correct me.