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Permissible count for botanical extracts
A client has an issue: they bought a botanical extract which they use at 0.01% in their formulas (shampoo, conditioner, and leave-on spray). The count for mold was up to 200 cfu/mL while their spec is less than 10 cfu/mL. Does this mold count put their products at risk at such low dosage? I have the experience that sometimes manufacturers’ specs are more strict than needed, so I want to know if that’s the case.
Since the availability of this ingredient put a launch under risk, I was trying to think outside the box (maybe too much outside that my proposal is silly, hehe), but I was thinking since those formulas all use Citric acid, that they could use a high load of that acid to mix it with the botanical extract, in order to reduce mold count, and leave it for a while before using it. Not sure if this would work, but wanted to know your opinion. The last thing I want is for them to launch an unsafe product, so we’ll be responsible. By the way, the preservative system of their products is EDTA/Phenoxyethanol/Sodium benzoate.
Thanks!
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5 Replies
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Why not just add edta/phenoxyethanol/sodium benzoate to the extract? I am assuming the supplier of the extract sells the extract unpreserved? Or, ask the supplier to preserve the extract.
No, I don’t think adding Citric Acid to the extract is going to help with mold contamination.
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Raw material spec is discretionary but to your concern, you don’t want the raw to put your finsihed product out of spec. If the spec on the material is 10/g - 200 puts it out of spec making it and any relevant product adulterated. 10/g for is pretty low for this kind of stuff.
Can you describe the raw material - a fluid extract? powder? and the finshed product shampoo? cream? pH? The “at least 200” here might mean the stuff is indeed moldy/adulterated - recall mold growing as colonies will not disperse well. As Mark said, citric acid is not going to help.
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Thank you @MarkBroussard and @PhilGeis . I was thinking to lower the pH of the botanical extract, but I understand thtat even at very low pH, that would only inhibit growth, but not reduce the population.
The extract is a liquid extract (solvents are water/propylene glycol). It doesn’t show anywhere which preservative system it’s being used). The manufacturer is called Nanofitotec (Brasil). I’m attaching some screenshots from the technical docs they gave my client. Weird thing is that their count for mold in the CoA is 10 cfu/mL, but in the technical sheet, it says 100 cfu/mL ????.
The products where the ingredients will be used (at a dose of 0.01%) are a conventional shampoo (pH 5.0-5.3), rinse-off conditioner (pH 4.0-4.5), leave-on spray (pH 4.0-4.5)…and that’s it.
Would it be possible then to use part of the preservative system (EDTA/Phenoxy/Sodium benzoate) in the botanical extract, prior to its final use?
Thanks a lot, I really appreciate this.
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You can’t clean up an OOS raw material.
Alot of naturals are effectively preserved by Aw with glycols - fungi being the remaining, moderate risk. Adding more preservative to an OOS material does not change its adulterated status and in this case prob won’t work.
Shampoos and conditioners very rarely have problems with fungi, but this is the supplier’s problem to fix, not yours to accept/attempt to control the risk as proxy for your customer - who owns the risk you take. Suppliers CDA specs - total aerobic count @ 100/g and fungi and “levaduros” (yeast) @ 10. Your 200 and greater shows these guys are not in control. Start up with this and you’ll be stuck with whatever they send - accept it or shut down production. They’ll say no one else complains - so get 3rd party lab data to support your complaint.
Decide what you’ll share with your customer.
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Got it @PhilGeis . Supplier will have to deal with his mess. I wouldn’t compomise product’s or consumer’s safety ????????
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