Jump to content

  • Quick Navigation
Photo

Do we have to announce formula changes with allergen additions?


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

#1 qaccount

qaccount

    Grade - Active

  • IFSQN Active
  • 10 posts
  • 0 thanks
0
Neutral

  • Earth
    Earth

Posted 19 September 2017 - 06:50 PM

Hi All,

 

I am new at a company currently in the middle of several formulation changes.  In an effort to "clean up" the ingredient label, they are adding coconut oil.  The oil is refined but not "highly refined," therefore, technically, an allergen is being added.  It is in the ingredient list and contains statement of the new packaging but Marketing is not making any sort of real announcement or call out.  Are there any regulations (FDA) that reference formula changes with allergen additions or are we legally compliant because the new packaging is correct to the new formula?  Any insight is appreciated!  Thanks!



#2 FurFarmandFork

FurFarmandFork

    QA Manager/FS Blogger

  • IFSQN Fellow
  • 1,064 posts
  • 482 thanks
84
Excellent

  • United States
    United States
  • Gender:Male
  • Location:USA

Posted 19 September 2017 - 08:22 PM

As long as it's on the packaging you have no obligation to call it out as a change.


QA Manager and food safety blogger in Oregon, USA.

 

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

Subscribe to have one post per week delivered straight to your inbox.

 


#3 Snookie

Snookie

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,625 posts
  • 265 thanks
167
Excellent

  • United States
    United States
  • Gender:Female

Posted 19 September 2017 - 10:42 PM

In many countries coconut is not considered an allergen.  Botanically, coconut is classified as a fruit.  While there have been allergic reactions to coconuts, they are usually very rare.  You might want to check your countries allergens.  Don't declare an allergen unless you have to.  


Posted Image
Live Long & Prosper

#4 Gerard H.

Gerard H.

    Grade - SIFSQN

  • IFSQN Senior
  • 298 posts
  • 102 thanks
12
Good

  • France
    France
  • Gender:Male

Posted 20 September 2017 - 11:58 AM

Dear,

 

In Europe, coconut is not classified as a nut and therefor not subject to the allergen declaration legislation. However, the sources of vegetable oils and fats (for example: coconut, soya or palm) need to be declared on the product labels.

 

Kind regards,

 

Gerard Heerkens



#5 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 13,963 posts
  • 3849 thanks
456
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 20 September 2017 - 07:20 PM

Hi qaccount,

 

I'm not in USA but I assume that the "FDA" in yr OP refers to (US)FDA.

 

I also deduce that you believe yr coconut oil is classified in USA as containing a "major food allergen", eg  via the 2 FDA links below - 

 

https://www.fda.gov/...s/ucm059116.htm

http://nutrients.rea...2-allergen.html

(USA posters are welcome to correct me if my interpretation is invalid)

 

Unfortunately I have no idea what "reference formula" means, or the significance of such terminology  in above context. USA posters hopefully will know.


Kind Regards,

 

Charles.C


#6 FurFarmandFork

FurFarmandFork

    QA Manager/FS Blogger

  • IFSQN Fellow
  • 1,064 posts
  • 482 thanks
84
Excellent

  • United States
    United States
  • Gender:Male
  • Location:USA

Posted 20 September 2017 - 08:47 PM

Hi qaccount,

 

I'm not in USA but I assume that the "FDA" in yr OP refers to (US)FDA.

 

I also deduce that you believe yr coconut oil is classified in USA as containing a "major food allergen", eg  via the 2 FDA links below - 

 

https://www.fda.gov/...s/ucm059116.htm

http://nutrients.rea...2-allergen.html

(USA posters are welcome to correct me if my interpretation is invalid)

 

Unfortunately I have no idea what "reference formula" means, or the significance of such terminology  in above context. USA posters hopefully will know.

Charles is correct in that Coconut is considered a "tree nut" and needs to be called out in compliance with FALCPA. I state again however, you don't need to do any special call out just because your formula didn't have it in the past, you just can't ship your new formula in old packaging which does not call out coconut.


QA Manager and food safety blogger in Oregon, USA.

 

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

Subscribe to have one post per week delivered straight to your inbox.

 


#7 teaks

teaks

    Grade - MIFSQN

  • IFSQN Member
  • 89 posts
  • 31 thanks
8
Neutral

  • United States
    United States
  • Gender:Female

Posted 20 September 2017 - 08:52 PM

Hi qaccount,

 

Coconuts are actually classified as tree nuts by the FDA  - see this link https://www.fda.gov/...y/ucm238807.htm

 

I cannot comment on communication if you are supplying a finished product to retail - but if you are supplying the product to a wholesaler or manufacturer, I would strongly recommend reaching out and providing an updated specification sheet.  If I were on the receiving end, it might keep me from a costly recall if I was not aware of the change.



#8 Ryan M.

Ryan M.

    Grade - SIFSQN

  • IFSQN Senior
  • 474 posts
  • 202 thanks
34
Excellent

  • United States
    United States
  • Gender:Male
  • Location:Birmingham, AL
  • Interests:Reading, crosswords, passionate discussions, laughing at US politics.

Posted 20 September 2017 - 09:22 PM

Not legally obligated, but check with your customer agreements and contracts.  Customers may have a specific requirement for it.



#9 rchare1

rchare1

    Grade - Active

  • IFSQN Active
  • 5 posts
  • 0 thanks
0
Neutral

  • United States
    United States

Posted 20 September 2017 - 10:18 PM

Didn't Luna bar change their formula a few years ago with the addition of an allergen? As I recall, they put the allergen declaration on their label, but regular consumers of the product didn't realize the addition of allergen. There were numerous allergic reactions reported, so Luna recalled the bars. If it was my company, I would take additional measures to let my customers know.



#10 moskito

moskito

    Grade - SIFSQN

  • IFSQN Senior
  • 258 posts
  • 50 thanks
7
Neutral

  • Germany
    Germany
  • Gender:Male

Posted 30 September 2017 - 04:42 PM

HI,

 

in the US coconut is an allergen (tree nut), but all highly refined oils are exempted from allergen labelling.

I have - some years ago - done are literature search on clinical studies. At that time it was only able to find reports on allergenic reactions. You will always find people reacting to....but not all these "allergens" are listed in food law for declaration (e.g. strawberries). In the US you have 8, in Eu 14....and in Japan are much more listed. This is a political decision on "local" requirements and awareness and posibilities to controll it on a reliable basis (SME).

 

Rgds

 

moskito






0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users

EV SSL Certificate