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Expert needed: validation of claim iron and B12, what to expect?

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Madam A. D-tor

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Posted 02 January 2018 - 02:29 PM

Lately visited a manufacturer that produces vegan meat replacers.

The product is labeled with "with iron", "with vitamin B12", "rich on fibers" and "rich on proteins".

I asked for validation of these claims.

I received a report, dated 1 week before the audit, which stated that "rich on fibers" and "rich on proteins" claims were calculated and in line with EG directive 1924/2006.

For "with iron", which was claimed in nutritional value table as 2,1 mg/100 gram, validation was only "added in recipe".

For "with vitamin B12", which was claimed in nutritional value table as 0,38ug/100 gram, validation was also "added in recipe".

There are no analysis reports verifying the quantity of iron and B12.

The QA manager explained that B12 analyses has a very high uncertainty (up to 75%) and therefore it is not possible to validate with analyses.

For Iron it is also hard to analyse amounts with certainty, is said.

 

Is there any expert here, that can:

-  conform to me that indeed analyses of B12 and iron are no useful;

- explain what I can expect (and accept) as validation for these claims.

 

(note: for vitamin C claims, I use to ask for analyses results end of shelf life to conform that the claimed amount of vit C is still present in the product.)


Kind Regards,

Madam A. D-tor

Madam A. D-tor

    Grade - PIFSQN

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  • Interests:meat, meat products, ready to eat, food safety, QMS, audits, hazard analyses, IFS, BRC, SQF, HACCP, ISO 9001, ISO 22000

Posted 02 January 2018 - 02:46 PM

added (not able to edit previous post):

For iron it is hard to analyse the quantity because all the natural ingredients has iron contents that variates in the seasons and per variety. Ingredients are mainly soy and vegetables.


Kind Regards,

Madam A. D-tor

FurFarmandFork

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Posted 02 January 2018 - 03:47 PM

I get that ingredients will have variability for seasonality in crops, however if you're making the claim on the label, I would expect it to meet the stated nutritional content. If they're the one making the claim, the product needs to meet the claim, not just when the crop happens to be at that level...

 

That said, if they confirm the purity of their fortified ingredients (iron and b12) and they know for certain that they are adding sufficient amounts to meet the standard, that may perhaps do it. 

 

If this was my company in the US, I would do one of two options to validate the claims:

1. Use testing to confirm purity of the incoming salt/vitamin and demonstrate how I can verify the proper amount was added during production, even with testing variance I can guarantee it was actually added to the product. But...

 

2. If my product is tested in the marketplace and doesn't meet the claim I'm in trouble anyway, I would replicate what the government would do to "test" the claim in the marketplace to make sure my product measures up.

 

As far as variance in the testing itself..I challenge that a bit. It seems like B12 testing has issues in clinical patients, but not so much in food. Seems like they need to talk to some different labs about methodology or perform some repeated testing, companies love to blame seasonal "crop variance" on nutritional variation, but they don't get to then make claims on the label that the crop is always at it's most nutritious values and have it both ways. :)


Austin Bouck
Owner/Consultant at Fur, Farm, and Fork.
Consulting for companies needing effective, lean food safety systems and solutions.

Subscribe to the blog at furfarmandfork.com for food safety research, insights, and analysis.



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