13 replies to this topic

[MDaleDDF]

I have a question, a bit of an odd one.

How much of an ingredient has to be in a formulation to be a real input?

 

Example:   We do everything here by percentage.   Every formula equals 100%, then it's easy to convert to pounds for production.   Let's say I want to have egg in a product that doesn't contain egg, for allergen issues (all other products in the plant contain eggs).

What's the smallest amount of egg I can put in?    .01?   .001? .0001?

 

Is ANY amount considered acceptable?

[jfrey123]

Assuming this formulation thing is calculating in Excel?  Can you not just have the egg line for that recipe be 0%?  Adding it at .0001% would be effectively meaningless for your purposes and get the job done, but if an auditor noticed your formulation calls for egg period and it's not on the label or in the food, they could argue it shows you're not following your own recipe.

[MDaleDDF]

Assuming this formulation thing is calculating in Excel?  Can you not just have the egg line for that recipe be 0%?  Adding it at .0001% would be effectively meaningless for your purposes and get the job done, but if an auditor noticed your formulation calls for egg period and it's not on the label or in the food, they could argue it shows you're not following your own recipe.

No, it would be in our software, like all formulations, ERP/MRP stuff.

I don't want to put zero egg in, I'm just wondering at what percentage the auditor of FDA would say "That's not enough" to consider it an ingredient.   Or even if there is a threshold?   I don't know.   I mean if I were making it allergen free, the threshold would be 0, so it seems anything above that would be ok?

I just want to put just enough in the formulation to list it on the ingredient statement and allergen statement.   But obviously if I do .001%  it's way cheaper than like .10.....  when you start talking about millions of pounds of product per year, and look at the price of eggs...

[Shrimper]

Not sure if this is a dumb response, but any amount of an allergen like eggs would have to be put on the label and included as an allergen. If the goal is to say there is eggs in the product, any amount of eggs will do. I think the formulation more so depends on the end result of the mixture/solution. If you put too much eggs it becomes "eggy." Is there a limit on how the mixture comes out? If you put none is it the same as putting a lot? If that's the case, put a little. 

 

On the other hand, if you do not want it to say eggs are in the product, then you cannot put eggs in the product without properly labeling it so. 

 

Hope this makes sense!

 

Cheers,

Shrimper

[MDaleDDF]

I guess really what I want to know is if there's a minimum?   I didn't think so, but I'm starting to think so low on a number that I figured an auditor may say "that's not enough to count" because if I'm putting a gram into a 10k batch, well, you see....lol.

Thanks for the responses.

[Scampi]

My question would be one of blending

 

So you add 1 gram to a 10k batch.......are you sure that you produce a fully homogeneous mix?

[GMO]

I get your point.  A friend of mine used to have a plant and every recipe had x amount of butter in it because he didn't want to declare a product without milk as then he'd go through the pain of validating for the milk, cross contamination risk etc.

 

It's kinda cheeky but also completely valid.  Egg is a right b**** to get off equipment so I'd be keen to have to avoid that validation process if I could.

 

What's the minimum?  Any amount I'd assume.  But I suppose if there is a genuine risk of blending of batches from time to time so sometimes there is high egg concentration and sometimes it's a trace?  Gut feel is you'd want to avoid that if you can.  But I can't really pin down why?   I suppose theoretically you could have someone with a mild egg allergy who decides to take the risk and eats your product without reaction.  Then next time there's a lot more egg there.  Doesn't honestly feel really likely though.

[kingstudruler1]

That is a bit of an odd one.   I dont think there is a reg that covers that.   There are items that are added at very small percentages.  In the past, Ive added things like vitamins to fluid milk or colors (red 40, yellow 5, yellow 6, etc) in flavors in very small percentages.   (100 - 150  ius of Vitamin D in 8 ozs of whole milk isnt much / mcg's per 8 oz.)

 

granted those have a "function"   

[GMO]

I have thought on a bit more and come up with why I feel a little uneasy.  While it's not law, it's some retailer practice and I'd say best practice overall to only include an allergen if it has a function in the product.  It's always been something I've tried to do when I've gone into a new business, i.e. remove allergens which are there for no good reason.  This has though in most cases derisked my process which it doesn't sound like it would for yours.

 

In the case I shared before though the product contained pastry so it was reasonable to assume butter may be present.  Is it reasonable to assume egg might be present in the product you're thinking of including it in at low level?  

 

This is going to sound shocking to you but I know (from experience) that allergenic consumers do not always read back of pack.  I know...  And I know this because my child has an allergy (look I really know) but his allergy is to one, unusual, tree nut.  If I'm buying a bag of oven chips, I will honestly not check back of pack to see if they contain that one tree nut (and not a "may contain" either but as an ingredient as his allergy is, so far, mild).  So I'd be wary of including it in something where it would be odd to be there.  

 

If, say, for example, your item is in a batter coating, I think anyone with an allergy would check as that will often be there.  The same with baked goods.  If it's something where it's not obvious, like a soft drink or something bizarre like that, I don't think even allergenic consumers would check.

 

Legally though I think either are fine.   Ethically, and actual risk to consumers from their behaviour though is a different thing.

[MDaleDDF]

Thanks for the responses all.   Interesting stuff.   

 

We have hundreds of sku's, all add water only products like pancake mix, etc.    We did the allergen stack thing years ago, like 20 years ago(?), with the idea of totally mitigating cross contamination, which has been a huge success in keeping things around here easier, and safer for our customers, though we still have color coded scoops, special allergen storage procedures, etc.    Still, what percent of recalls in the marketplace are due to undeclared allergens?   We have totally taken ourselves out of that, which has been great, and honestly, I don't know why more companies don't do it, although obviously it's not tenable for every situation, plant, etc.

 

As far as how homogeneously it's mixed into a batch, do I honestly care?    All I want is for people with an egg allergy to be aware there's egg in the product, which is on the label, due to the smallest amount being in there.  I have other products where it's not the egg in question, and I add a small amount of whatever allergen is missing in the product, such as wheat.   I have formulations that have .01% wheat added, just so I can put it on the label and allergen statement.

I have looked and looked and I would have to concur there is no minimum amount of a formulation input.   I just wondered the thoughts of my fellow professionals on this.    Much appreciated feedback yall.   Thank you.

Edited by MDaleDDF, 17 February 2025 - 01:40 PM.

[emportllc]

I think the closest parallel here is sesame. When sesame got added as major allergen, some bakeries decided to add negligible amounts of sesame to ALL their products (vs taking steps to prevent cross-contact).

 

FDA doesn't love it as a practice — but so far it's in limbo and not explicitly forbidden. For now, treating egg similarly in your facility seems (to me) to be a solution that seems easy on its face — but may cause major headaches down the line. Strengthening your allergen management program might be more work up front but smoother sailing going forward.

 

FDA's May 2023 guidance here:

https://www.fda.gov/...d-cross-contact

 

Bimbo Bakeries response here:

https://www.bakingbu...edient-labeling

[MDaleDDF]

I think the closest parallel here is sesame. When sesame got added as major allergen, some bakeries decided to add negligible amounts of sesame to ALL their products (vs taking steps to prevent cross-contact).

 

FDA doesn't love it as a practice — but so far it's in limbo and not explicitly forbidden. For now, treating egg similarly in your facility seems (to me) to be a solution that seems easy on its face — but may cause major headaches down the line. Strengthening your allergen management program might be more work up front but smoother sailing going forward.

 

FDA's May 2023 guidance here:

https://www.fda.gov/...d-cross-contact

 

Bimbo Bakeries response here:

https://www.bakingbu...edient-labeling

 

If you read the post before yours you'll see I've been doing it more than 20 years, this isn't new.   And every program in my facility is strong af, lol, but thank you.

You are right about the sesame thing though, I know companies have been responding to the allergen addition thusly.   I don't see how the FDA can forbid the practice, it would be interesting to see them write that up...and even more interesting to see them enforce it, since they're already buried and hugely behind.

 

I think it's funny that they dislike the practice honestly.   What's the difference?  If a company wants to add sesame to their product instead of adding a huge disruption to their facility, what does the FDA care?   It would seem to me that all it does is kill the chance of having a recall due to allergen cross contamination, which accounts for around 30% of all recalls.   If you could turn that number to 0, how much money would be saved?  How much waste would end?

Edited by MDaleDDF, 17 February 2025 - 06:56 PM.

[emportllc]

If you read the post before yours you'll see I've been doing it more than 20 years, this isn't new.   And every program in my facility is strong af, lol, but thank you.

You are right about the sesame thing though, I know companies have been responding to the allergen addition thusly.   I don't see how the FDA can forbid the practice, it would be interesting to see them write that up...and even more interesting to see them enforce it, since they're already buried and hugely behind.

 

I think it's funny that they dislike the practice honestly.   What's the difference?  If a company wants to add sesame to their product instead of adding a huge disruption to their facility, what does the FDA care?   It would seem to me that all it does is kill the chance of having a recall due to allergen cross contamination, which accounts for around 30% of all recalls.   If you could turn that number to 0, how much money would be saved?  How much waste would end?

You're right, I totally misread your last response — if you're already doing this for other allergens, I'm not aware of any reason to treat egg any differently than any other allergens.

 

More generally, the thinking behind my response is: if your allergen practices are on point and there's still sporadic cross-contact, you're a perfect case for precautionary labeling. If they're on point and you're not seeing cross-contact, is limiting the recall risk worth bringing yourself into the middle of an ongoing debate? 

[G M]

Any amount above zero.  If someone can measure it accurately, then dilute it out to .000001, you still know its in there.

 

This is effectively how most of our allergens work.  They go in at some objectively measurable amount, then get diluted out at a couple intermediate stages to such a low level they are undetectable.  It still shows on the label because we recorded putting it in.