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JeremyW(FoodSafetyFirst)

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Posted 24 November 2021 - 05:15 PM

Hello friends,

 

I am a co-manufacturer that typically produces many different products with a variety of allergens. Most products have different allergens compared to the others. We have an allergen management program including segregation of raw materials, color-coded utensils for allergenic ingredients during processing, wet-cleaning in between different product runs, Allersnap swabs post-cleaning, gluten line swabbing when appropriate, annual validation by testing finished product at 3rd party laboratory for allergens (eg. testing a product that contains soy only that is ran after a cleaning of product that contained soy, peanut, milk,) proper scheduling among other procedures. We have one potential product that is considered being ran and I would like to pose the question below. Any feedback would be greatly appreciated!

 

The new customer would like to produce a non-allergenic product that states on the product packaging 'Manufactured free from the top 8 allergens.' We would like to produce this on the same line that produces allergenic product. There would of course be a full wet-clean prior to the non-allergenic product. Are there any regulations that would prevent us from doing this? Do we need to take any special precautions? Should we test the non-allergenic product for allergens? Or is this a definite no-no. Any feedback would be greatly appreciated!

 

Thank you,

Jeremy W



olenazh

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Posted 24 November 2021 - 05:29 PM

Hi Jeremy, welcome to the forum! I'm from Canada and not familiar with US allergen regulations - however, even from the common sense standpoint that statement doesn't seem good as it's too vague. Here's CFIA statement regarding this "General "allergen-free" or "no allergens" claims

General claims stating only "allergen-free" or "no allergens" are considered to be too broad in nature and are therefore not acceptable. The list of potential food allergen sources is not restricted to the list of priority food allergens identified by Health Canada. There are over 200 food proteins that can cause adverse reactions to some segments of the population. Therefore, it is likely to create an erroneous impression to state that a product is free of allergens.



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JeremyW(FoodSafetyFirst)

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Posted 01 December 2021 - 03:34 PM

Thank you for the response! I do want to highlight that the claim does say 'from the top 8 allergens' implying FDA top 8 allergen list. I would be curious if this information would change your response? 

 

Thank you again!



olenazh

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Posted 01 December 2021 - 03:40 PM

Thank you for the response! I do want to highlight that the claim does say 'from the top 8 allergens' implying FDA top 8 allergen list. I would be curious if this information would change your response? 

 

Thank you again!

No, it wouldn't as it shall be clear to the consumers what exactly allergens your label refers to. Not many people are aware of them.



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Scampi

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Posted 01 December 2021 - 03:44 PM

I wouldn't touch this with a 10 foot pole

 

I would go back to the customer and ask them to be VERY specific about what they are expecting as an outcome---------are they expecting zero ppm of allergens to be detected?  or are they expecting 50 ppm or less?

 

Taking on this business is opening yourselves to a litigation nightmare if someone has a reaction to this product (and from what you have said, it's a likely possibility)

 

You cannot possibly (even with your best efforts) guarantee a product that is free from allergens in your facility


Please stop referring to me as Sir/sirs


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JeremyW(FoodSafetyFirst)

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Posted 01 December 2021 - 04:24 PM

I do not want to change the subject much from the original post as I would like to hear other opinions but I would like to add a bit more to the discussion.

 

If this 'Free from ... allergens' claim was not on the label then we would have no issue I believe. A may contains statement would be advisable but completely optional. 

 

Has anyone come across any FDA literature on making an allergen-free claim? 



MDaleDDF

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Posted 01 December 2021 - 05:13 PM

I wouldn't touch this with SCAMPI's 10 ft pole, lol.

I go out of my way to not make any claims whatsoever on a label.   I agree, you're asking for trouble with this.



Scampi

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Posted 01 December 2021 - 05:13 PM

Directly from the FDA's website (link below)

 

FALCPA's labeling requirements extend to retail and food-service establishments that package, label, and offer products for human consumption. However, FALCPA's labeling requirements do not apply to foods that are placed in a wrapper or container (such as paper or a box for a sandwich) following a customer’s order at the point of purchase.

Consumers may also see advisory statements such as “may contain [allergen] or “produced in a facility that also uses [allergen].” These are used to address “cross-contact,” which can occur when multiple foods with different allergen profiles are produced in the same facility using shared equipment or on the same production line, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.

FDA guidance for the food industry states that advisory statements should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading.

 

https://www.fda.gov/.../food-allergies

 

  1.  Does FALCPA require food manufacturers to label their products with advisory statements, such as "may contain [allergen]" or "processed in a facility that also processes [allergen]?"

    No. FALCPA does not address the use of advisory labeling, including statements describing the potential presence of unintentional ingredients in food products resulting from the food manufacturing process. FALCPA does require FDA to submit a report to Congress, a part of which assesses the use of, and consumer preferences about, advisory labeling. In earlier guidance, FDA advised that advisory labeling such as "may contain [allergen]" should not be used as a substitute for adherence to current Good Manufacturing Practices (cGMPs). In addition, any advisory statement such as "may contain [allergen]" must be truthful and not misleading.

  2.  Does FALCPA require FDA to set so-called thresholds for any food allergen?

    FALCPA does not require FDA to establish a threshold level for any food allergen. It is not unlikely, however, that FDA will at some point need to consider a threshold level for one or more food allergens in the context of reviewing a petition or a notification submitted to request that an ingredient be exempt from FALCPA's labeling requirements.https://www.fda.gov/...rgens-edition-4

 

https://www.fdareade...eling-allergens

Processed in a Facility That Also Processes…

It’s not uncommon to see an allergen statement like this on a packaged food. But what does it mean?

According to the FDA this is known as a May Contains claim. This type of claim is not required, nor is it recommended by the FDA.

So what if a food company produce their product in a facility that also processes other allergens? It shouldn’t matter that other allergens are present in the facility — proper cleaning and production should prevent any allergen cross contact.

A “may contains” claim doesn’t mean much — it is a tool to limit business liability for any allergens that show up in your product. But don’t rely on this type of claim to compensate for bad food processing practices. While it may stop someone with a food allergy from eating your product, it will not mean that a food business is exempt from liability related to allergens in your product.


Please stop referring to me as Sir/sirs


Scampi

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Posted 01 December 2021 - 05:15 PM

We all have 2 main functions in our jobs as Food Safety Professionals

 

1) Protect Consumers

 

2) Protect the business

 

Every decision we make needs to go through one or both channels above.............if you ask if this helps protect either group and the answer is NO----step away from that decision


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Jim E.

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Posted 09 December 2021 - 09:33 PM

Could not agree more to what has been said here, just the fact that you have allergens in your facility for other products there is no way to guarantee that this product will be allergen free.  You would need to be an allergen free facility to even tackle this product.



Dehydrated

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Posted 10 December 2021 - 03:33 AM

Hi Jeremy,

 

Our factory set up is very similar to the description you gave, in that we process a selection of allergens & use various allergen management tools to reduce risk of cross contact, verifying these are effective from time to time using external lab testing. We manufacture ingredients that will either me repacked or used in further processing by other manufacturers.

 

If a customer came to me with this proposal I would never agree. As others have said, it’s asking for trouble.

 

The only ‘free from’ claim I consider at request of a customer is ‘gluten free’. I’m in NZ and FSANZ define the criteria that must be met to make this claim, so it’s very clear & easier to show compliance with. If the customer tells us they wish to make a 'gluten free' claim on their finished product, we insist on sending a sample from each batch to a third-party lab for analysis to ensure it meets those criteria. It’s still only a sample, but we can at least show we’ve done the due diligence if a problem arose. So far this approach has worked well for us.

 



JeremyW(FoodSafetyFirst)

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Posted 19 May 2023 - 10:37 AM

Hello Everyone,

 

This issue has cropped up again at our facility. I am reposting to hopefully get more input. 

 

Thank you all



MDaleDDF

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Posted 19 May 2023 - 12:28 PM

The exact same issue?  If so, I don't know what more input you could want.   Start reading the thread again from the top, it's all there!   Lol.  Not being a smart ass, but I stand behind my original statement, wouldn't touch this with a 10 ft pole, and there seems to be most agreeing on that in the thread.....



JeremyW(FoodSafetyFirst)

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Posted 19 May 2023 - 01:42 PM

Hi MDaleDDF,

 

Not the exact same scenario but very similar with another customer. I am just hoping to revive this discussion and see if anyone else has more input (even if that input has already been mentioned by another user.) 

 

Thank you



JeremyW(FoodSafetyFirst)

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Posted 19 May 2023 - 06:48 PM

Furthermore there is a recent draft guidance from the FDA on this. Of course it does not contain much information so you have to guess their intentions which is the fun part of our jobs right? This is guidance intended for FDA staff. 

 

https://www.fda.gov/...168000/download - Page 8 Section 2 Sub-section E paragraph 2 Sec. 555.250 Major Food Allergen Labeling and Cross-contact Draft Compliance Policy Guide

 

Firms also may place voluntary statements to provide information to consumers that certain allergens are absent from the product (e.g., “allergen-free” claim). Other than the term “gluten-free” which is defined in 21 CFR 101.91,8 there are no regulations defining specific conditions (e.g., allergen levels) for a product to make a “free” claim from a major food allergen source. If voluntary allergen-free claims are used, they must be truthful and not misleading in accordance with section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)). For example, if a product label or labeling were to have a “milk-free” or similar claim, FDA would expect there to be no milk allergen in the product.



Gelato Quality Lead

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Posted 19 May 2023 - 07:13 PM

Hi Jeremy,

 

Keeping the sesame issues in mind (companies intentionally adding sesame to products that did not previously have sesame in lieu of ensuring the product is truly free from sesame in compliance with FALCPA and sesame being added as a major allergen), as well as the recent draft guidance, I would still go with the advice given in the previous posts.

 

It just sounds like too big of a risk to the customers and the business.


Edited by Gelato Quality Specialist, 19 May 2023 - 07:14 PM.


G M

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Posted 22 May 2023 - 09:48 PM

... For example, if a product label or labeling were to have a “milk-free” or similar claim, FDA would expect there to be no milk allergen in the product.

 

The US regulators don't recognize a maximum or safe threshold.  If any amount is detected, the claim is false or misleading. 

 

If your facility is not [fill in the blank]-free 100% of the time, I wouldn't even consider making a product that claimed to be [fill in the blank] allergen free.



AltonBrownFanClub

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Posted 25 May 2023 - 02:55 PM

Attached File  Allergen Limits 99 95 .png   151.33KB   0 downloadsPlease see the attached Table.

(Source:https://www.romerlab...g-your-assets/)

 

If you look at the "egg" row, you will see that 0.03mg of egg protein is the threshold to prevent 99% of egg reactions.

That is an incredibly small amount. Consider that a drop of water is 50mg. 

So at 0.03mg we are talking about 1/1600 of a water drop.

Even still, you have that last 1% of people who can have a reaction from even less protein.

 

Your company would be accepting an immense liability for that "xxxx-free" claim.

Even worse, the claim puts customers at risk. One reaction and this product would be considered adulterated as outlined above.





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