14 replies to this topic

[vkul84]

Hi! I have a question about setting internal requirements for gluten testing. I have looked everywhere and can't find a solid answer to this. 

 

We make herbs and spices and recently had a recall due to a supplier letting us know a spice they provided to us contained gluten. We tested it and the results were around 500 ppm gluten so we did a voluntary recall since gluten was not declared on the label. 

 

I am now looking into which spices are considered high risk for gluten contamination and I am going to add a gluten testing requirement to our spec when approving the raw materal. We are not a gluten free company and make no gluten free claims on our label, but I want to avoid having to do a recall like this again for items that are considered high risk. (I am basing high risk items off various studies done on spices and which ones commonly came back with poisitive gluten results)

 

The issue is, I can't find any solid information about what our requirements are for testing and labelling if we are not saying our product is gluten free. Do we need to test all incoming items, or just ones we consider high risk? And for the ones we are testing (or requiring a gluten test from our supplier) what level do we set? I know <20 ppm in considered gluten free, so do we use this level even if we are not making gluten free claims? Or is there a different limit set if not making gluten free claims?

 

Or are we not required to test at all if the products are not usualy souces of gluten and we are not claiming gluten free?

 

It is so hard to find any kind of guidance on this. We even asked CFIA about this when we were communicating our recall information to them and they couldn't give us an answer either. 

 

Any help would be greatly appreciated!

[Scampi]

It seems to me that the most straightforward way out of your particular dilemma is to put a "may contain gluten" statement on your packaging

 

cheaper, and true

 

It's amazing to me that CFIA did not refer to you to the information below

Food allergen cross-contamination (or precautionary) statements

A cross-contamination statement is a declaration on the label of a prepackaged product that alerts consumers of the possible presence of an allergen in the food.

Cross-contamination statements may be declared by food manufacturers and importers when, despite all reasonable measures, there is the unintended presence of food allergens in the food. Cross-contamination statements are not a substitute for good manufacturing practices.

https://inspection.c...s-and-gluten#c4

[vkul84]

It seems to me that the most straightforward way out of your particular dilemma is to put a "may contain gluten" statement on your packaging

 

cheaper, and true

 

It's amazing to me that CFIA did not refer to you to the information below

Food allergen cross-contamination (or precautionary) statements

A cross-contamination statement is a declaration on the label of a prepackaged product that alerts consumers of the possible presence of an allergen in the food.

Cross-contamination statements may be declared by food manufacturers and importers when, despite all reasonable measures, there is the unintended presence of food allergens in the food. Cross-contamination statements are not a substitute for good manufacturing practices.

https://inspection.c...s-and-gluten#c4

 

Putting a "may contain gluten" statement was something we talked about this morning actually........but I'm not sure yet if that is the route we will go.

 

We did specially ask the CFIA about what level of gluten is ok if we are not stating gluten free and our inspector told us "off the top of his head, he wasn't sure". They didn't mention the above but maybe it was because we asked such a specific question. 

[SQFconsultant]

Wow, 500ppm was off the charts.

 

We used to offer consulting on the Gluten-Free Food Program certification that covers the US, Canada and earth-wide and their testing requirement for GF was less than 5PPM.

 

When GF really took off it was less than 20 - but because there are so many possible secondary contributors for gluten (such as the glue on packaging for instance that could have Gluten or an employee that introduces gluten on clothing, etc) the requirement for certification on a product-to-product basis is now less than 5ppm  -- wording:
 

Each product licensed under the GFFP must be tested to confirm 5 ppm (parts-per-million) (that is from their website)  There are only a small handful of companies that produce a test kit that will detect that low, thus I believe GFFP makes a lists of companies that has them available.

 

Unless you are making a claim on your labeling that your product is Gluten-Free there would be no reason to test and as Scampi noted from the Canada regulations the key word is "MAY" indicating to me might want to but don't have too.

 

Back to the less than 20 - I have had friends that are Gluten-intolerant and have had reactions at 10ppm.

 

For reference:

https://glutenfreefo...-manufacturing/

[Scampi]

 

We did specially ask the CFIA about what level of gluten is ok if we are not stating gluten free and our inspector told us "off the top of his head, he wasn't sure". They didn't mention the above but maybe it was because we asked such a specific question. 

 

That's because zero is what you should be targeting. If you CANNOT BE SURE that your spices do not contain wheat and it's derivatives, and testing is cost prohibitive, then you MUST include the may contain statement

 

The issue isn't that your not claiming gluten free, the issue is it IS present in your product and you are not declaring it

[G M]

That's because zero is what you should be targeting. If you CANNOT BE SURE that your spices do not contain wheat and it's derivatives, and testing is cost prohibitive, then you MUST include the may contain statement

 

The issue isn't that your not claiming gluten free, the issue is it IS present in your product and you are not declaring it

 

I cannot be sure than my popcorn doesn't contain purple unicorn robots, but no one has declared "may contain purple unicorn robots" on the package.  You can rarely prove negatives.

 

The underlying issue is the supplier verification program, not gluten, or testing.  Your supplier notified you of a problem, this raised the question "do I have other problems I am not aware of".  The way to resolve this without driving yourself nuts over "how many people is it OK to kill with imaginary gluten" is to instead review your supplier approval program for weaknesses.

[SQFconsultant]

Scampi wrote in part -  " then you MUST include the may contain statement"

 

I was reading the Canada requirements and did not see where it said MUST, shall, etc - did I miss something.

[TimG]

I was wondering the same thing, FOUND IT!

Allergens and gluten sources labelling - Canada.ca

[jfrey123]

I don't know that the hazard can be easily dismissed in this circumstance.  Herbs and spices are specifically identified as at risk for food fraud in the US due to potential for economic motivated adulteration, where flour and other plant based debris are ground and blended into the product.  

Spice and Herb Frauds: Types, Incidence, and Detection: The State of the Art

Economically Motivated Adulteration (Food Fraud) | FDA

 

Beyond purposeful adulteration, a lot of the plants that run mills will grind flour and various spices, and a lack of sanitation after is obviously a potential problem.  The spice industry is dirty at best having started my career there.

 

Kudos to your supplier for being proactive in notifying you.  For me, next step would be to figure out if they manufacture the spices (better process controls in theory, but also higher concern about how the gluten got in there) vs if they're a distributor or purchase pre-ground spices for their own packaging (because they'd need some robust supplier controls to control the fraud risk).  I'd opt for requesting a COA from your spice supplier showing gluten levels as part of a corrective action, and I'd consider sending random samples of other spices from other manufacturers.

[GMO]

Wow... As others have said, it's worth understanding 500ppm is really high.  It's indicative of gross contamination, either deliberate or from significant cross contact.  This is not just a few wheat ears in a field or trays here. 

 

I'm not familiar with Canadian law but as spices are routinely exported, UK law would not treat this as a voluntary recall situation, it would be a compulsory one.  Also while so called "alibi labelling" is permitted, it doesn't excuse you of defining what is in your product.  UK law permits up to 20ppm for gluten free products but it's a misunderstanding that means up to 20ppm is ok not to label for non declared products.  The only reason that rule is there is the admission that things like field contamination are really hard to avoid.

 

Your aim should be absence of allergens which are not declared.  But also in addition to your "voluntary recall" I'd be letting, particularly any business to business customers know (and the competent authorities) that there is a risk of presence of gluten.  For a while in the UK there was a similar risk flagged about mustard in wheat from Italy for example.  But the question in my mind should be whether you should be supplying this spice until you know what the root causes were of this gross and significant error.  Gluten allergies are not necessarily mild and it's possible to have anaphylaxis to wheat...  

[Scampi]

Wow... As others have said, it's worth understanding 500ppm is really high.  It's indicative of gross contamination, either deliberate or from significant cross contact.  This is not just a few wheat ears in a field or trays here. 

 

I'm not familiar with Canadian law but as spices are routinely exported, UK law would not treat this as a voluntary recall situation, it would be a compulsory one.  Also while so called "alibi labelling" is permitted, it doesn't excuse you of defining what is in your product.  UK law permits up to 20ppm for gluten free products but it's a misunderstanding that means up to 20ppm is ok not to label for non declared products.  The only reason that rule is there is the admission that things like field contamination are really hard to avoid.

 

Your aim should be absence of allergens which are not declared.  But also in addition to your "voluntary recall" I'd be letting, particularly any business to business customers know (and the competent authorities) that there is a risk of presence of gluten.  For a while in the UK there was a similar risk flagged about mustard in wheat from Italy for example.  But the question in my mind should be whether you should be supplying this spice until you know what the root causes were of this gross and significant error.  Gluten allergies are not necessarily mild and it's possible to have anaphylaxis to wheat...  

 

 

Quoting UK law isn't really helpful here........the legislation is different in each country and that is what must be followed. End of discussion

 

Which is why I (correctly) stated that the OP must declare wheat/gluten on the label UNLESS they are willing to change suppliers

 

Folks who are celiac rely on the labelling to be correct. Period

[GMO]

Quoting UK law isn't really helpful here........the legislation is different in each country and that is what must be followed. End of discussion

 

Which is why I (correctly) stated that the OP must declare wheat/gluten on the label UNLESS they are willing to change suppliers

 

Folks who are celiac rely on the labelling to be correct. Period

 

No, understood.  I suppose I wasn't trying to make a point re law but make a point as per the food safety of the ingredient but also how an ingredient like a spice can end up in a sub ingredient of another sub ingredient and that can be worldwide.  (This was the case with the sudan dye contamination, it ended up in worcestershire sauce, which, at the time, was a sub ingredient into lots of prepared savoury products.)

 

I agree that labelling must be correct but the point I was perhaps inarticulately trying to make is that why on earth is the op even thinking of supplying this as a product, whether labelled as "contains gluten" or not until you understand what has gone wrong?  This is severe and gross contamination which is either indicative of a major failure or a deliberate attempt to "pad out" the spice with other ingredients. You cannot put gluten on the ingredients list without knowing what the source of it is!  

 

So to my mind, it's not a labelling issue, it's a food safety one.  You now have an ingredient with a potential food safety risk which you now do not trust the supply chain on.

 

By the way, a friend of mine once did a trial where they sent a known contaminant level of an allergen to 10 different labs.  All underestimated the level of contamination.  Some by a significant margin.  Unless it's a known matrix, the lab can't be confident that's even the correct level of gluten, it could be far higher.

 

Why are you thinking about selling that spice (and probably even from that supplier) until you do trust it?

[vkul84]

I don't know that the hazard can be easily dismissed in this circumstance.  Herbs and spices are specifically identified as at risk for food fraud in the US due to potential for economic motivated adulteration, where flour and other plant based debris are ground and blended into the product.  

Spice and Herb Frauds: Types, Incidence, and Detection: The State of the Art

Economically Motivated Adulteration (Food Fraud) | FDA

 

Beyond purposeful adulteration, a lot of the plants that run mills will grind flour and various spices, and a lack of sanitation after is obviously a potential problem.  The spice industry is dirty at best having started my career there.

 

Kudos to your supplier for being proactive in notifying you.  For me, next step would be to figure out if they manufacture the spices (better process controls in theory, but also higher concern about how the gluten got in there) vs if they're a distributor or purchase pre-ground spices for their own packaging (because they'd need some robust supplier controls to control the fraud risk).  I'd opt for requesting a COA from your spice supplier showing gluten levels as part of a corrective action, and I'd consider sending random samples of other spices from other manufacturers.

 

Unfortunately no kudos to our supplier. They have been disqualified by us due to this.

 

In our invesitgation we would out the following details: They found out about the issue in October, and did not tell us until we asked for more of the same lot and then told us it was on hold due to gluten. They are refusing to release their testing results to us stating "in house testing results were inconclusive and non-repeatable" and that they have not sent the sample for 3rd party testing. We obviously find this hard to believe since they knew about it since October. They also told us they have not made a decsion about recalling since the level of gluten could not be determined........but they havent' sent it for testing. They are also being very vague about their investigation and said their supplier mentioned unoffically they think it's due to drift from other fields, which previous posters have mentioned does not seem likely due to the high level.

[vkul84]

No, understood.  I suppose I wasn't trying to make a point re law but make a point as per the food safety of the ingredient but also how an ingredient like a spice can end up in a sub ingredient of another sub ingredient and that can be worldwide.  (This was the case with the sudan dye contamination, it ended up in worcestershire sauce, which, at the time, was a sub ingredient into lots of prepared savoury products.)

 

I agree that labelling must be correct but the point I was perhaps inarticulately trying to make is that why on earth is the op even thinking of supplying this as a product, whether labelled as "contains gluten" or not until you understand what has gone wrong?  This is severe and gross contamination which is either indicative of a major failure or a deliberate attempt to "pad out" the spice with other ingredients. You cannot put gluten on the ingredients list without knowing what the source of it is!  

 

So to my mind, it's not a labelling issue, it's a food safety one.  You now have an ingredient with a potential food safety risk which you now do not trust the supply chain on.

 

By the way, a friend of mine once did a trial where they sent a known contaminant level of an allergen to 10 different labs.  All underestimated the level of contamination.  Some by a significant margin.  Unless it's a known matrix, the lab can't be confident that's even the correct level of gluten, it could be far higher.

 

Why are you thinking about selling that spice (and probably even from that supplier) until you do trust it?

 

Just to clairfy we are definately NOT supplying this product with this level. It has been recalled. And I posted above, this supplier has been disqulified. 

 

I am wanting to require testing on all high risk spices, I just am having trouble finding guidance on what level is ok. I'm going with the assumption that we should require a gluten test of <20 ppm, but am getting push back from upper management that those levels are too strict since those are the limits for labelling food as gluten free and that is not something we are trying to do.

 

I just want to make sure that our products are safe, and a review of our supplier approval program and risk assessment for our different products is in process. 

[GMO]

Ah now I get you.

 

As Scampi has pointed out, I'm not familiar with Canadian law, however, the "accepted levels" of allergen is a developing area of research and legislation, one which has not been pinned down well in any country I would suggest.

 

Again, with no experience of working in Canada, from a food safety point of view, this is what I'd suggest:

 

• Alibi labelling is now so widespread in so many countries it's widely ignored even by allergenic consumers.  (My child's consultant even advised this as it's virtually impossible to avoid.)
• Gluten or cereals containing gluten are a food safety risk to some consumers and can cause anaphylaxis in some (its not "just" coeliac disease).
• The problem will come I'd argue once you know.  So for example, you have a test result of 40ppm (or even 20ppm to be honest) and send it out or test after despatch and not recall.  You have then knowingly sent out a product which is a potential risk to someone with a wheat allergy or coeliac disease with only a "may contain" type statement.  I would think that would be a difficult position to defend if defence was required.
• What I think you want to do is specify <20ppm gluten with your suppliers and positive release batches into your process.  But there could be consequences to that including stopping lines and your supplier has got to agree to it of course.  But also remember while it was gluten today, it could be nut or mustard or a-n-other thing tomorrow and contamination may not be homogeneous.  But as devil's advocate, it does give you a level of due diligence.  If you do decide to do this, make sure you test either the ingredient or product before release to the market.  That way you won't be recalling (although as batches of the supply could be large, other products on the marketplace may be impacted.)
• What I'd really want to do is find out where the original source of the previous issue was from (they could be using the same supply into them and your new supplier after all) and also understand your supplier's controls.  This will be a better preventive action than the testing.

 

I don't know if you know the story about Cadbury's in the UK?  Since bought out by Kraft and renamed "Mondelez", they had a huge Salmonella incident in the early 00s.  

 

It turned out they had a contamination issue in their crumb plant.  Testing had found the issue but a decision was made at a senior level that they would start to accept "some" Salmonella in their product.  There was no scientific basis for this and other people within confectionery were well aware that any level of Salmonella positive was not safe.

 

They put three kids in hospital.  One was lucky to survive.  Fined £1 million.  

 

My point in sharing this is that with what they felt was an absence of evidence that low levels of Salmonella were dangerous, (we're talking single digit numbers of viable microorganisms here, Salmonella is strange in chocolate, the typical levels of contamination aren't required).  Not knowing this or not believing it, they set their own "safe limit".  Don't be tempted to set a "safe limit" when you have no evidence for it would be my suggestion.