4 replies to this topic

[darrenblack]

Hello all,

 

I am here to inquire about an allergen program. This is my first job as a QA manager and I was asked to get our bakery ready for a GMP audit. Luckily the QA guy before has almost all the systems need in place already, but one thing we do not have is an allergen program. I am being told that we list all the allergens we use on all of our product labels so that we do not require a allergen schedule. Is this an acceptable program? If so what does a example SOP with this type of system in place look like.

 

Thank you in advanced. Newbie all the way here so I definitely look forward to any help possible.

[Charles.C]

Hello all,

 

I am here to inquire about an allergen program. This is my first job as a QA manager and I was asked to get our bakery ready for a GMP audit. Luckily the QA guy before has almost all the systems need in place already, but one thing we do not have is an allergen program. I am being told that we list all the allergens we use on all of our product labels so that we do not require a allergen schedule. Is this an acceptable program? If so what does a example SOP with this type of system in place look like.

 

Thank you in advanced. Newbie all the way here so I definitely look forward to any help possible.

 

Hi darren,

 

I assume the listed allergenic items relate only to the intrinsic allergenic components in the ingredients of respective products.

 

If yr haccp program is intended to be acceptable to USFDA (???), I (not in USA) anticipate that the answer is No unless there is a self-evident risk of zero cross-contamination regarding non-intrinsic allergens. Is this the case ? (The demonstration may likely necessitates some allergen control program anyway).

 

There are several posted allergen control SOPs on this forum. Whether any are specifically for baking I don't recall offhand.

[Ryan M.]

It will not be accepted by the FDA under the FDA Allergen Program guidance.  The FDA requires best practices where possible in a facility.

 

I actually asked this question during a labeling workshop and a food lawyer told me..."You can, but you will still be liable for any allergen cross contact if it is not an ingredient in the product."  What this basically means is that the FDA does not recognize "potential allergen" warning labels on packaging.  So if you have cross contact you can still be found liable and it does not negate you from proper allergen changeover practices.

 

What you can do is put "processed on shared equipment with XXXX allergen".  However, this is more for customer in formation and still does not negate you from proper allergen changeover practices.

[scoot915]

I am also in bakery and have had 2 GMP audits.

 

If you just have one allergen or all the allergens are in all products you may just need allergen labeling (for consumer safety) since there is not a risk of cross contamination.

(someone correct me if I am wrong about this.)

 

If you have different allergens in different products you will have to do more.  Below is what we do.

 

Our products all have wheat and soy, 2 products also have egg.

We have a allergen program in place and it has been acceptable to the auditors.

 

Label and segregate the "egg" product ingredient (it is not fresh eggs) from other ingredients at receiving.

Schedule production runs so the egg products are run last.

Clean and test for allergen residue after producing allergen product.

Corrective action (clean,allergen test, new aprons etc.) should a egg allergen product be produced out of order.

Products labeled -- Contains: Wheat and Soy  OR  (for the egg allergen) Contains: Wheat, Soy and Egg 

Employees trained in allergen program.

All this is documented on various records.

 

This is what I am remembering quickly off the top of my head, I may have missed something but I think this is most of it.

 

Hope this helps !  Good luck with your audit.

[Charles.C]

I am also in bakery and have had 2 GMP audits.

 

If you just have one allergen or all the allergens are in all products you may just need allergen labeling (for consumer safety) since there is not a risk of cross contamination.

(someone correct me if I am wrong about this.)

 

If you have different allergens in different products you will have to do more.  Below is what we do.

 

Our products all have wheat and soy, 2 products also have egg.

We have a allergen program in place and it has been acceptable to the auditors.

 

Label and segregate the "egg" product ingredient (it is not fresh eggs) from other ingredients at receiving.

Schedule production runs so the egg products are run last.

Clean and test for allergen residue after producing allergen product.

Corrective action (clean,allergen test, new aprons etc.) should a egg allergen product be produced out of order.

Products labeled -- Contains: Wheat and Soy  OR  (for the egg allergen) Contains: Wheat, Soy and Egg 

Employees trained in allergen program.

All this is documented on various records.

 

This is what I am remembering quickly off the top of my head, I may have missed something but I think this is most of it.

 

Hope this helps !  Good luck with your audit.

 

Hi scoot,

 

Thks for the input.

 

As you/Ryan imply, the likely pervasive problem in many would-be "allegen evasive labelling" justifications is how to prove (to determined sceptics) a  zero risk of (allergen-relevant) cross-contamination. It can in theory be equated to demonstrating an "allergenX-free" stuation where X = anything but yr intrinsic allergens.

 

Vending machines spring to mind.

 

Hence the probably even more pervasive use of  "may contain traces of ...." etc zig-zags.