Jump to content

  • Quick Navigation
Photo

Allergen Free Labeling

Allergen-free claim Allergen free claim allergen free labeling

  • You cannot start a new topic
  • Please log in to reply
10 replies to this topic

JeremyW(FoodSafetyFirst)

    Grade - Active

  • IFSQN Active
  • 5 posts
  • 0 thanks
0
Neutral

  • United States
    United States

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

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,087 posts
  • 342 thanks
331
Excellent

  • Canada
    Canada
  • Gender:Female
  • Location:Toronto
  • Interests:My job, church, reading, gym, horror movies

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.



Thanked by 1 Member:

JeremyW(FoodSafetyFirst)

    Grade - Active

  • IFSQN Active
  • 5 posts
  • 0 thanks
0
Neutral

  • United States
    United States

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

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,087 posts
  • 342 thanks
331
Excellent

  • Canada
    Canada
  • Gender:Female
  • Location:Toronto
  • Interests:My job, church, reading, gym, horror movies

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.



Thanked by 1 Member:

Scampi

    Fellow

  • IFSQN Fellow
  • 4,492 posts
  • 1242 thanks
991
Excellent

  • Canada
    Canada
  • Gender:Not Telling

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


Thanked by 1 Member:

JeremyW(FoodSafetyFirst)

    Grade - Active

  • IFSQN Active
  • 5 posts
  • 0 thanks
0
Neutral

  • United States
    United States

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

    Grade - MIFSQN

  • IFSQN Member
  • 240 posts
  • 84 thanks
176
Excellent

  • United States
    United States

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

    Fellow

  • IFSQN Fellow
  • 4,492 posts
  • 1242 thanks
991
Excellent

  • Canada
    Canada
  • Gender:Not Telling

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

    Fellow

  • IFSQN Fellow
  • 4,492 posts
  • 1242 thanks
991
Excellent

  • Canada
    Canada
  • Gender:Not Telling

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


Please stop referring to me as Sir/sirs


Jim E.

    Grade - MIFSQN

  • IFSQN Member
  • 158 posts
  • 23 thanks
9
Neutral

  • Canada
    Canada
  • Gender:Male
  • Location:Alberta, Canada
  • Interests:Sports of course.
    Food safety for all things eaten not just what we make.
    Being able to see my kids grow up in healthy environment.

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

    Grade - Active

  • IFSQN Active
  • 3 posts
  • 0 thanks
0
Neutral

  • New Zealand
    New Zealand

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.

 







Also tagged with one or more of these keywords: Allergen-free claim, Allergen free claim, allergen free, labeling

0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users