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tspinnanger

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Posted 23 May 2024 - 03:21 PM

Good morning! I have searched this site and seen this topic come up several times, but I am still looking for a detail I cannot find. I understand that water typically needs to be included on a food item's list of ingredients but per CFR if it is used as a processing aid and later removed by baking or some other means OR used to reconstitute another ingredient OR present in "insignificant levels" it may not need to be declared. 

 

I work in the cannabis industry and we make an edible "gummy", the recipe includes water, sugar, pectin, etc but we do not list the water as an ingredient on the label as we assumed it was cooked off during the manufacturing process. After some discussions I am being told the final gummy may contain 20% water and the water activity is around 0.6, though I am unsure if any of these numbers have been officially calculated or that they even matter...

 

We are conflicted as to whether the water needs to be added to the labels. Based on the CFR language it seems like the water could be a "processing aid" and/or only used to "reconstitute" an ingredient and therefore possibly unnecessary to declare, however I am not seeing actual numbers anywhere and "insignificant levels" is so vague! 

 

Does an actual standard and/or calculation exist that tells us above some threshold it is required to list the water? Is the first snip below the calculation we need to perform? If so, can someone explain what is meant by "single strength" and how we'd know exactly which ingredients we're reconstituting- is it all the dry ingredients or only certain ones? If this is incorrect, can anyone help us make this decision?!

 

Thank you in advance for any help or insight!

 

© When water is added to reconstitute, completely or partially, an ingredient permitted by paragraph (b) of this section to be declared by a class name, the position of the ingredient class name in the ingredient statement shall be determined by the weight of the unreconstituted ingredient plus the weight of the quantity of water added to reconstitute that ingredient, up to the amount of water needed to reconstitute the ingredient to single strength. Any water added in excess of the amount of water needed to reconstitute the ingredient to single strength shall be declared as "water" in the ingredient statement.

 

 

Subpart G - Exemptions From Food Labeling Requirements

(ii) Processing aids, which are as follows:

(a ) Substances that are added to a food during the processing of such food but are removed in some manner from the food before it is packaged in its finished form.

 

(c ) Substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food

 

 



Scampi

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Posted 23 May 2024 - 03:48 PM

are you making CBD or THC gummies?


Please stop referring to me as Sir/sirs


jfrey123

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Posted 23 May 2024 - 05:20 PM

Went and checked my kids' fruit snack supplies in the pantry.  Couple different fruit snack and gummies in there, all listing water as the third or fourth ingredient.  I'm useless as to whether FDA has labeling requirements for a product that remains illegal at the Federal level here in the US...



SQFconsultant

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Posted 23 May 2024 - 06:42 PM

Your assumptions are going to get you in trouble.

 

Put it on the label - but first you need to nail down that assumption, as a fact not a "well is may or may not."


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rhare

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Posted 31 May 2024 - 06:43 PM

Interesting. You are trying to comply with 21 CFR 101 regulations for labeling, but do you follow any regs for manufacturing?



Madam A. D-tor

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Posted 02 June 2024 - 01:29 PM

Dear tspinnanger,

 

- Check your recipe.

- Water as processing aid, is mostly not added in the recipe. This is for example water for rinsing, water that is sprayed on the product, glazing water, etc.

- water to reconstiture is for example when you use dried vegetables. The amount of water that is absorbed by the dried to bring it back more or less to the original product is not to be declared. If you add more water, than it should be declared. Which ingredient in your recipe are you reconstitutioning?


Kind Regards,

Madam A. D-tor



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