12 replies to this topic

[MDaleDDF]

I've mentioned on this forum before that in my facility, we only have 4 allergens.   Wheat, milk, egg, and soy.   I have all 4 allergens in everything we make, so there's no chance of cross contamination.   We still have special bulk storage, open ingredient storage, special scoops, etc, for the allergens.   

I'm wanting to stop doing all of this babysitting of the allergens, because it just seems silly to me.   Where is the risk?   Everything is guaranteed to contain all four allergens.    I'm doing a risk analysis, but I wanted some input from all you guys out there, since you're always such a help.

I've been FSSC 22k certed for like 13 years, so this kind of worries me, as we're passing fine now.   I don't want to do something an inspector will get upset over and write me up, where I've never had an issue.  However, I really feel that all this special care just isn't needed.  Am I missing something here?

Lemme know what you guys think....

Thanks!

 

[Gelato Quality Lead]

In your situation, the only case that I can think of that would be a reason for continuing allergen control would be if there is any possibility of a new product in the pipeline which does not contain all of the allergens. Then, in order to make that product, you would have to buy all new ingredients since you wouldn't be certain that they haven't been exposed to cross-contamination.

 

Apart from that, I'm pretty sure you can conduct thorough risk analyses and show these to an auditor.

[jfrey123]

CFR 117.80 (b) 8 states raw materials that are food allergens must be held in a manner that prevents cross-contamination.  How you do that and satisfy an auditor is completely up to you, but even with stringent risk analysis I think you'd have a hard time completely exempting yourself from any GFSI code requirements. 

 

eCFR :: 21 CFR 117.80 -- Processes and controls.

[olenazh]

Agree with Gelato QS: it's up to you how to control your allergens as soon as it does not compromise your existing or new products.

[MDaleDDF]

CFR 117.80 (b) 8 states raw materials that are food allergens must be held in a manner that prevents cross-contamination.  How you do that and satisfy an auditor is completely up to you, but even with stringent risk analysis I think you'd have a hard time completely exempting yourself from any GFSI code requirements. 

 

eCFR :: 21 CFR 117.80 -- Processes and controls.

Something like this is exactly what I'm worried about.   However, my 'manner that prevents cross contamination', is that they're all in everything, lol.   They're cross contaminated on purpose...   So I don't know how an auditor could argue that.   I don't see the risk, but I do see your point, and that's why I'm asking you guys, so thanks for that.   Honestly, I'm not as worried about the FDA.   They're generally very common sense when they're in here.   It's NSF auditors that have been......'difficult', we'll say....

 

(and I have had one auditor that sided with semantics over common sense, which was very frustrating.   She wrote me up for path testing a raw ingredient for something that wasn't on their spec sheet, and said I can only test for what the vendor tests for.   I actually complained and NSF did remove that ding off me.  She literally wrote me up for too much path testing, lmao)

 

Still, to me, this is silly.   Cross contamination isn't possible with what we do here.   I've been through every spec sheet of every raw ingredient we have in house, all safe.

And no, I will never add another allergen to the building, but if I do, it's going into everything we make....

[Bansal]

I agree with MdaleDDF, if all the allergens are going in all the products then there should not be question of cross contamination as every product contains all the Allergens

i would say, if you are super confident that no new product (which doesn't have any of the above or having only three of the above) will be introduced, i think its not required to work on prevention of cross contamination..

[SQFconsultant]

Sorry, but as a former Auditor you will have a very difficult time explaining to an auditor what you decided to do because you dont like all the babysitting.

[olenazh]

Sorry, but as a former Auditor you will have a very difficult time explaining to an auditor what you decided to do because you dont like all the babysitting.

But there is NO actual cross-contamination - so, why to do the unnecessary/redundant work? Shouldn't it be common sense? Of course, MD would need to do the risk assessment, clearly explaining all reasons for cutting that stuff out.

[Kara S.]

I did something similar at a bakery I worked for in the past. We did not consider wheat an allergen because it was in EVERY product we made. We also had harmonized lines which reduced some allergen changeover cleaning. We put the definition for allergen and unique allergen in our policies. We illustrate that we know what the 9 major allergens are, how it all must be adequately labeled on finished product. Then discuss unique allergens, allergens that are not in every product and would need to adhere to allergen management policy like you described with color coding, separation, etc.

 

As long as you have it documented - like keep an allergen matrix so an auditor can visualize that there are no unique allergens, everything is on the labels, and in the formulas - i dont see the issue with discontinuing the program, unless you have a situation like Gelato Specialist said below. Get confirmation from marketing/ R&D folks that there are no plans in the near future with new products.

 

In your situation, the only case that I can think of that would be a reason for continuing allergen control would be if there is any possibility of a new product in the pipeline which does not contain all of the allergens. Then, in order to make that product, you would have to buy all new ingredients since you wouldn't be certain that they haven't been exposed to cross-contamination.

 

Apart from that, I'm pretty sure you can conduct thorough risk analyses and show these to an auditor.

[G M]

CFR 117.80 (b) 8 states raw materials that are food allergens must be held in a manner that prevents cross-contamination.  How you do that and satisfy an auditor is completely up to you, but even with stringent risk analysis I think you'd have a hard time completely exempting yourself from any GFSI code requirements. 

 

eCFR :: 21 CFR 117.80 -- Processes and controls.

 

'Cross-contamination' implies that ingredients are getting into a product they would otherwise not be in, but all products leaving this facility have all of the allergens entering the facility as ingredients. 

 

The allergens can't be counted as cross contamination, but other things still can (presuming the products aren't just process variants).  

[jfrey123]

'Cross-contamination' implies that ingredients are getting into a product they would otherwise not be in, but all products leaving this facility have all of the allergens entering the facility as ingredients.

The allergens can't be counted as cross contamination, but other things still can (presuming the products aren't just process variants).

Since section b refers directly to raw materials and other ingredients, and finished products are covered separately in section c (with the additional requirement finished goods be protected from allergens specifically under ©2), I’d stand on my statement that the law here is requiring allergen segregation from other raw ingredients.

Granted, I wholeheartedly think it’s absurd in a case such as our OP’s, but the trick will be to convince a GFSI auditor expecting a company to follow US regulations on the matter. It sounds like something I would have tried to do before being handed my rear in my early days of defending my programs lol.

If it were my plant, I’d be doing the absolute minimum here: use GMP program to explain no allergens are to be opened/sampled in the storage area, keep like allergens stacked over like allergens, a single pallet width of dead space between allergens and other raw goods, and a monthly check in my GMP audit to demonstrate compliance. With a risk assessment that allergen cross contamination is extremely low risk due to all being in all products, I can’t see an auditor having a serious problem with that.

[MDaleDDF]

Glen's response is exactly what I would expect from an auditor....lol.   I appreciate your honesty Glen, but this shows exactly my point.  An auditor response like that is outside all common sense to me.  

I have zero question that what I'm doing is 100% safe, but an auditor will hang me out to dry on semantics..... I want to avoid that.

I've talked to past inspectors that I keep in touch with that tell me this would be fine, and another that says no  way.   IMHO that's the biggest problem with these systems.   There should be no leeway for two separate auditors to reach two different conclusions, on the exact same issue.   What's ok with one auditor, will get you in trouble with another.   And that's really not right, imho.

Edited by MDaleDDF, 31 August 2022 - 12:59 PM.

[Mulan1010]

   I agree, it does not sound like special procedures such as the color coding of utensils during the manufacturing of the products would be needed for your case.  However, you would still need to implement the basics of allergen controls such as reviewing incoming raw materials for possible non-like allergens, allergens should be stored separately and appropriate, proper labeling controls and controls in place to prevent cross-contamination from employee's lunches/snacks; just a good practice.  It is the special procedures implemented for production that you should be able to eliminate. 

  I would think you could keep your Allergen Control program as is but add a simple statement that if all products being produced contain the same allergens that no separation or special procedures during the manufacturing of the products are required.  Your risk assessment would support that.  If a new allergenic raw material is introduced you would need to review your HACCP and Allergen Program anyway to ensure procedures would be adequate based on the new ingredient but the basics would still be in place.