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Allergen Spices Threshold Garlic Peanut China SQF FDA Limit

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#1 YNA QA

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Posted 17 July 2019 - 05:18 PM

Hello all I am hoping to get guidance on a Raw Material questions. 

 

We purchase spices from a broker, and that broker has a dedicated spice dealer.  We've gotten spices from this company for years with no issue.  Upon receiving some a spice, we noticed that the COA had a new specification on it for both Peanut and Gluten allergies.  The gluten allergen showed less than 5ppm, but the peanut allergy showed 6ppm, with the testing threshold being less than 2.5ppm.  We have placed the shipment on hold and are arguing with the broker and now supplier.  They said that this amount doesn't pose a public threat, and that everyone else is accepting it.  I have explained multiple times to them that the FDA does not establish limits and if I see a test showing positive, to me that means the garlic contains peanuts and I must declare a peanut allergen if I use it.  

 

I know that <25ppm is technically not a threat to the public in general, but to me anything above the testing threshold should be considered as containing an allergen. 

 

Am I crazy here? Is this a thing now?  Do I need to keep standing my ground on this?

 

Does anyone have any guidance, or references I can consult.

 

TIA

 

 



#2 Lynette1125

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Posted 17 July 2019 - 05:23 PM

If the spice should not have gluten or peanut, then it seems that they might not be ensuring their equipment is free of allergens when producing a non-allergen product. I wouldn't take the risk of putting the ingredient in a product and possibly contaminating the whole finished product. 

I would look into purchasing those spices from another supplier in the future. 



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#3 SQFconsultant

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Posted 17 July 2019 - 05:51 PM

Don't buy their risk.

Processors should contact customers on major changes in specs and peanut amd gluten regardless how small are MAJOR changes. The next red flag is anyone making the statement that everybody has accepted it and its not just a matter of declarations on labels it will also be how allergens are receieved, stored etc.

It says to me, the processor is running with sheer disregard for proper sanitation between runs and the broker as well as the processor has no standards.

We consult on gluten-free and from experience a 5ppm for only 1 ingredient that should not have sny gluten to begin with is way too much.

There is a solution here - if they can not pinpoint the issue or at least work on a solution to resolve, you will need to find another supplier otherwise you have to buy that risk... and no one can accept that.


Warm regards,

 

 

Glenn Oster

Glenn Oster Consulting, LLC

 

SQF Development & Implementation Consultants

Hampton, VA (USA) & La Cruz, Costa Rica

http://glennostercon...ixsite.com/ogfc

+1-800-793-7042 (Earth Wide)

 

We help small-to-midsize food, food contact packaging & food logistic businesses to co-develop entire SQF systems and provide consulting audits on facilities and operations to ensure SQF compliance in order to get certified as quickly as possible, so that your company can retain customers and gain new customers that expect certification from their suppliers.

 

Development of SQF Systems - Implementation of SQF - eConsultant - FSVP Development - Internal Auditor Training - this is what we do 24/7


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#4 zanorias

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Posted 17 July 2019 - 07:16 PM

Hi Ashley,

The supplier should notify you when you a spec changes (put that in writing in your agreement if not already), especially significant changes such as allergens that will effect your product and your customer.

It's worrying not only that the product now contains allergens, but the suppliers attitude... I wouldn't be surprised if "everyone else" aren't aware of the change. I would keep the stock on hold and add precautions to future deliveries - ask for the processors testing cert or test a sample if feasible. Changing supplier may be necessary. It needs to be contained and rectified before implications are made with your product and customers.

Is the garlic sourced from China by any chance? There has been some issue recently with peanut contamination in garlic from China. We test ours as a precaution and have had customers querying it too.

P.s you aren't crazy, and welcome to the forum :welcome:



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#5 YNA QA

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Posted 17 July 2019 - 08:42 PM

Hi Ashley,

The supplier should notify you when you a spec changes (put that in writing in your agreement if not already), especially significant changes such as allergens that will effect your product and your customer.

It's worrying not only that the product now contains allergens, but the suppliers attitude... I wouldn't be surprised if "everyone else" aren't aware of the change. I would keep the stock on hold and add precautions to future deliveries - ask for the processors testing cert or test a sample if feasible. Changing supplier may be necessary. It needs to be contained and rectified before implications are made with your product and customers.

Is the garlic sourced from China by any chance? There has been some issue recently with peanut contamination in garlic from China. We test ours as a precaution and have had customers querying it too.

P.s you aren't crazy, and welcome to the forum :welcome:

 

 

Yes! It is from China, and I am also worried about his attitude.  This was their email response:

 

18. [Added December, 2005] Is a major food allergen that has been unintentionally added to a food as the result of cross-contact subject to FALCPA's labeling requirements?

No. FALCPA's labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, "cross-contact " occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment.

 

I think they are using this quote out of context, but explaining that to others is difficult.



#6 Marshenko

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Posted 17 July 2019 - 09:34 PM

21 CFR 117.80
 
Sec. 117.80 Processes and controls.
 
(a) General. (1) All operations in the manufacturing, processing, packing, and holding of food (including operations directed to receiving, inspecting, transporting, and segregating) must be conducted in accordance with adequate sanitation principles.
 
(2) Appropriate quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable.
 
(3) Overall sanitation of the plant must be under the supervision of one or more competent individuals assigned responsibility for this function.
 
(4) Adequate precautions must be taken to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source.
 
(5) Chemical, microbial, or extraneous-material testing procedures must be used where necessary to identify sanitation failures or possible allergen cross-contact and food contamination.
 
(6) All food that has become contaminated to the extent that it is adulterated must be rejected, or if appropriate, treated or processed to eliminate the contamination.

Edited by Marshenko, 17 July 2019 - 09:34 PM.


#7 Charles.C

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Posted 17 July 2019 - 11:00 PM

Hello all I am hoping to get guidance on a Raw Material questions. 

 

We purchase spices from a broker, and that broker has a dedicated spice dealer.  We've gotten spices from this company for years with no issue.  Upon receiving some a spice, we noticed that the COA had a new specification on it for both Peanut and Gluten allergies.  The gluten allergen showed less than 5ppm, but the peanut allergy showed 6ppm, with the testing threshold being less than 2.5ppm.  We have placed the shipment on hold and are arguing with the broker and now supplier.  They said that this amount doesn't pose a public threat, and that everyone else is accepting it.  I have explained multiple times to them that the FDA does not establish limits and if I see a test showing positive, to me that means the garlic contains peanuts and I must declare a peanut allergen if I use it.  

 

I know that <25ppm is technically not a threat to the public in general, but to me anything above the testing threshold should be considered as containing an allergen. 

 

Am I crazy here? Is this a thing now?  Do I need to keep standing my ground on this?

 

Does anyone have any guidance, or references I can consult.

 

TIA

 

Hi Ashley,

 

Contractual Product specifications IMEX require formal/signed acceptance by both parties otherwise the contract is "indeterminate".

 

I suggest yr first technical priority is to be aware of US legal, I assume FDA, requirements. As you indicate, operationally, it's all about the labelling.

 

IIRC, (1) FDA non-zero limits do exist but solely for gluten and sulphites within FALCPA-"related" items. (2) Otherwise the tolerance is "zero", ie no detection using a reference methodology(s) unless labelled.

 

Even for (1) there are a variety of caveats to any quoted values within the legal limit(s) as previously discussed/referenced here (somewhere).

 

My guess is that this is all detailed on the FARRP website, eg -

 

https://farrp.unl.ed...-food-allergens

 

PS - ppm level is not necessarily the ultimate criterion for safety, see section 7 (et al) in this (non-USA action levels) attachment -

Attached File  VITAL-2-0-QA-May2012.pdf   756.42KB   11 downloads

 

and -

 

Peanut was the first food to be formally examined to establish threshold doses. The lowest reported threshold doses for peanut appear to be below or near 1 milligram. The differences in the levels of threshold dose in these studies may relate to the preparation method of the peanut source used and standardised, multi-centred studies are underway. Nevertheless, one thing is clear; a really tiny piece of a peanut can be a threat to a peanut allergic patient. An average scaled peanut weighs between 500 and 1000 mg. This means that 1/1000 of a peanut is enough to trigger a reaction in some patients.

http://research.bmh....food/?FoodId=38

 

PPS - some more background in this post/thread -

 

https://www.ifsqn.co...nt/#entry144185


Edited by Charles.C, 18 July 2019 - 12:24 AM.
expanded

Kind Regards,

 

Charles.C


#8 larissaj

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Posted 18 July 2019 - 12:50 PM

Some things I have done is always review the specs with the ingredient statement. If I see that it contains peanuts but peanuts are not in the ingredients I ask why, where did it come from? I have told the purchasing manager to not order from certain suppliers due to allergens. In one product it has wheat starch and in other suppliers they dont use it so if possible, I say switch.

 

I never care about how much of an allergen is in a product, if its in the suppliers statement, I list it as an allergen in my statement.



#9 AmeliaJacobs

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Posted 24 July 2019 - 01:28 PM

Oddly specific, but what is your testing method's margin of error?

We once had a positive for sulfites, put a ton of material on hold, questioned our supplier and lost a potential order, only to realize that the margin of error for the test our lab had done was much larger than the result... If I remember correctly the margin of error was like 10ppm, the test was read in >5ppm and our results were 6-8. Irresponsible to sell a test that can't reliably detect at that level you're reporting if you ask me, but there it is. I would never have thought to check but a co-worker had had a similar experience.

 

 



#10 Charles.C

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Posted 24 July 2019 - 03:02 PM

Oddly specific, but what is your testing method's margin of error?

We once had a positive for sulfites, put a ton of material on hold, questioned our supplier and lost a potential order, only to realize that the margin of error for the test our lab had done was much larger than the result... If I remember correctly the margin of error was like 10ppm, the test was read in >5ppm and our results were 6-8. Irresponsible to sell a test that can't reliably detect at that level you're reporting if you ask me, but there it is. I would never have thought to check but a co-worker had had a similar experience.

 

Hi Amelia,

 

Hopefully the standard deviation of the average would enable a more "confident" assessment albeit also depending on how the official method for assessing legality/maximum level was set up.


Kind Regards,

 

Charles.C


#11 Skyhawk

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Posted 24 July 2019 - 11:12 PM

Hi Ashley,

 

Contractual Product specifications IMEX require formal/signed acceptance by both parties otherwise the contract is "indeterminate".

 

I suggest yr first technical priority is to be aware of US legal, I assume FDA, requirements. As you indicate, operationally, it's all about the labelling.

 

IIRC, (1) FDA non-zero limits do exist but solely for gluten and sulphites within FALCPA-"related" items. (2) Otherwise the tolerance is "zero", ie no detection using a reference methodology(s) unless labelled.

 

Even for (1) there are a variety of caveats to any quoted values within the legal limit(s) as previously discussed/referenced here (somewhere).

 

My guess is that this is all detailed on the FARRP website, eg -

 

https://farrp.unl.ed...-food-allergens

 

PS - ppm level is not necessarily the ultimate criterion for safety, see section 7 (et al) in this (non-USA action levels) attachment -

attachicon.gif VITAL-2-0-QA-May2012.pdf

 

and -

 

 

PPS - some more background in this post/thread -

 

https://www.ifsqn.co...nt/#entry144185

 

Great to see some reference to the Allergen Bureau Vital programme.

Though I will add that there are more freely available resources on the Allergen Bureau website.

And the Allergen Bureau has the VITAL Online Calculator (http://allergenbureau.net/vital/) which can be used for carrying out a Risk Assessment. 

 

Incidents of Allergen contamination in spices and other agricultural products are increasing due to "Good Agricultural Practices" of crop rotation, etc.

So the Allergen Bureau has just started an Agricultural Cross contact Working Group to understand how allergen risks occur, and investigate options to improve & educate the agricultural sector on best practise as relates to Allergens. The outcomes of this working group will published on the Allergen Bureau website as it progresses.



#12 moskito

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Posted 25 July 2019 - 04:41 PM

Hi,

 

just a short addition: Vital 3.0 is on the way with some changes in ED1.

Have a look under fams2019 http://allergenburea...-presentations/

Have a look to the presentation of Kirsten Grinter from Nestle  http://allergenburea...O-VITAL-3.0.pdf

 

Rgds

moskito







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