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Was there something wrong with the preservative? Should I sue?
OK, I know that I have a thread on this already, but I wanted to start a new thread to gauge your opinions. I acquired a sample of Microcare SB and made some samples of skin cream using 1% MSB. They were fine and passed PET. I then bought a 25 kg pail of MSB and scaled up. Unfortunately, the cream containing this new batch of preservative burnt the skin. I contacted the manufacturers who suggested I add the MSB at the aqueous stage. I did this, all fine, no burning. However, I’ve gone back after 2 weeks and every single jar of cream is full of mould!
At this stage, I am seriously considering suing the manufacturers. There must be a problem with the preservative first by burning the skin and secondly by allowing the cream to go mouldy. Here is my formulation, I would welcome your views on whether you think there could be a problem with the batch of preservative I bought. I have since changed the formula, but I am stuck with 60 kg of mouldy cream and have lost two contracts because of it. Thanks in advance for your help and advice.
INGREDIENTS (%):
Water - 64.4
Aloe Vera Powder 0.5
Solagum Tara - 0.3
Coconut Oil - 18
Olyvoyl Emulsifier - 3.8
Shea Butter - 8
Floraesters K100 - 2
Vegelane - 1
Soya Lecithin - 0.5
Microcare SB - 1
Lavender EO - 0.5
Citric Acid to pH 5.8. -
100 Replies
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If you have some Microcare SB left, you could have it analysed. Do you have the analysis certificates of the old and new batches?If you’re unlucky, your fist batch simply hadn’t contact with the resistant mould now thriving in your product.Your product is prone to spoilage, only using benzoate/sorbate is a tightrope walk.BTW what is olyvoyl emulsifier? Your LOI would be more useful (to me) if it were proper INCI names.And suing people because it was probably you who messed up… did you actually negotiate/talk to the manufacturer? See, using a pH 5.8 for your preservative blend is playing with fire. Benzoic and sorbic acid are also known irritants. Furthermore, sorbic acid is heat sensitive and scaling up usually increases cool down time and hence there’s a higher possibility for sorbic acid to degrade in bigger batches. -
One major problem I see is that Microcare SB is a mix of sodium benzoate and potassium sorbate. They are much less effective when the pH is greater than 5.0.
If I were the ingredient supplier, that would be the first thing I would say.
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It is also possible that when you have scaled up you have also used a different batch of one of your raw materials and it is contaminated. You are using a number of natural materials (aloe vera, solagum tara and soy lecithin) which are all prone to microbial contamination.You will probably find a clause in the sales contract that they are not responsible for how you use the product or something similar.The best you could possibly hope for is for the manufacturer/supplier of the preservative to take back the unused product and refund you but even this is probably unlikely. -
Also, did you conduct PET/Challenge Testing of your product through a third-party lab? Was the Formulation tested in its final form or did you make changes after PET testing? Not to be skeptical, but I would not have sent this preservative at that pH for testing and wonder how it may have passed. -
It was the manufacturers who told me to get the pH to 5.8. Previously it was 3.65-3.95 and they claimed this was the reason for the skin burning (it wasn’t).
The emulsifier is Olivoyl Hydrolyzed Wheat Protein, Cetearyl Alcohol, Glyceryl Oleate, Glyceryl Stearate, Potassium Hydroxide, Potassium Sorbate, Sodium Benzoate.
Yes, we did the PET through a respected lab in the UK.
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So it could be the Aloe Vera, Tara Gum or Lecithin causing the mould. I can take out Aloe Vera and Lecithin and I might be able to switch to Xanthan Gum.
Any ideas why the MSB was causing burning to the skin previously?
I need to get to the bottom of this. The loss for me is >$100k and we are a small business so pretty devastating really.
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The problem with the skin burning is most likely from the Potassium Sorbate causing a flushing reaction. This is common in many people with product containing Potassium Sorbate.
The problem with the preservation is that you are at the very upper limit on the effectiveness of this preservative combination (max 6.0, but really more around 5.0) and with Lecithin and Aloe Vera in your formula you are inadequately preserved against yeast/mold. Also note that you do not have a chelating agent in your formula which would help with preservation. I would have suspected you would have failed the PCT.
No offense, but it appears that the problem is not the preservative per-se, but the choice of preservative and a formula that is inadequately preserved given the ingredients.
I don’t think you have much of a case regarding filing suit against the manufacturer of the preservative.
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Thanks Mark.
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OK, so given your advice, I will do this:
- Switch to a different preservative (Benzyl Alcohol in this case)
- Ditch the Aloe Vera
- Ditch the Soya Lecithin
- Bring the pH down to <5.Is that looking better? Thanks.
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Oh, also:
- Add Naticide 0.6%.
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I think those changes will go a long way towards solving your problem. Perhaps you should submit samples of your new formula to more than one lab to ensure the PCT results are all positive.
When you submitted your samples to the lab with a pH of 5.8 and Benzoate/Sorbate as the sole preservative, it should have raised some eyebrows.
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Sorry Mark, just to clarify, when we did the PET the pH for all our products was between 3.65-3.95. It was only when we had the burning problem with the SB that the manufacturers told us the pH was too low and that we should raise it to 5.8. At which point the mould appeared.
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I still don’t understand why we didn’t have the burning problem with the sample, only with the full pail. And it was bad. I am happy to PM some pictures if anybody is interested.
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How comes, no offence but a serious question @GabyD, that someone who develops and produces cosmetics for third parties doesn’t know the basics.At least to me this issue seems to have a higher priority than itchy skin.
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Pharma, I don’t produce cosmetics for third parties. I make it and sell it.
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… and sure, it’s a bigger issue, but both are issues that need addressing. Which is why I am here seeking help. If you have any constructive advice with regard to these issues, I would be very open to hearing it.
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I see … so you did a PCT with the product at a pH of 3.9, but then raised the pH to 5.8, but did not do another PCT. So, you actually did not pass a PCT at pH 5.8? … that makes more sense.
Gaby, you really should have a professional chemist advise you to make sure that all is in order before you make your next scale-up batch. You are unfortunately learning the hard way from some mistakes on issues that are the most fundamental basics … You must always run a PCT on a sample of the product that you are actually going to manufacture. If you run a PCT, but then make a change to the formula, particularly adjusting the pH up, you need to run another PCT to verify that the revised formula passes PCT.
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GabyD said:I still don’t understand why we didn’t have the burning problem with the sample, only with the full pail. And it was bad. I am happy to PM some pictures if anybody is interested.
The burning sensation is likely caused by sorbic acid. (See page 26 of this safety report 0 https://pdfs.semanticscholar.org/bbbe/1de833dfb7ebaf3959eaace0762e9b9ffb9b.pdf )
When the product has a pH of 3.9 you actually had more sorbic acid in the formula than the potassium sorbate. When you raised the pH to 5.8 you shifted the equilibrium so you had more potassium sorbate and less active sorbic acid. You reduced the irritation potential but also reduced the effectiveness of the ingredient as a preservative.
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Thanks Mark and Perry. That all makes sense. The formula was done by a professional chemist. I then employed another chemist when the first chemist when AWOL (another story!). I have also been in constant contact with one of the preservative manufacturer’s senior chemists. So this whole process has been managed by people far more experienced than me.
However, it seems that neither really understood what was going on. For that reason, I am very grateful to this site.
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In that case, let me rephrase my advice to you … have a competent professional chemist review everything before you scale up your next batch.
Were your chemist consultants aware that you were scaling-up without running a PCT on the sample at pH 5.8? That’s the only reasonable scenario that makes sense, because all of this is very basic.
That you were going to have preservation problems popped right out upon first reviewing your list of ingredients.
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GabyD said:…I contacted the manufacturers who suggested I add the MSB at the aqueous stage……If you have any constructive advice……Benzyl Alcohol… …Naticide 0.6%…First of all, I wasn’t going to insult you (well, probably I did but it wasn’t my intention). See, I’m supposed to be very intelligent and what I do is giving free hugs waiting for good karma to kick in whilst you may not know as much but make good money from it. Who’s now the smarter one of us? My question was probably more a rhetorical one to the universe…Now back to topic: Do I understand you right that you first added MSB to the oil phase and did a PCT, everything was fine and you scaled up but now people got skin burn. At that point you changed to adding it to the aqueous phase and raised pH, trading in skin burn for mould?Your solution is now benzyl alcohol and Naticide? BA requires a low pH and is only useful against bacteria. Naticide requires also a low pH and seems (from hearsay on the internet, not personal experience or anything) to be poor against mould but great in irritating skin.It looks like, obviously, that your main issue is mould. Hence, you need something strong against mould. I have the impression you’re going full natural. Therefore, the best I could find against mould (again, not based on personal experience) are p-anisic acid (low pH required) and Cosphaderm Magnolia Extract 98.
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OK, just to clarify some of the detail, this is what happened…
Dec 2017:
I undertook a Cosmetic Chemistry course with a view to launching my own skincare range. I have a science degree and an MBA and a background in retail.May 2018:
I approached a cosmetic chemist “Carol” and asked her to formulate an organic palm oil-free emulsion for me. She is well-qualified and teaches this subject. She came up with the recipe above with Microcare DB as the only preservative. We made the samples and ran PET and Stability. It passed.July 2018:
I received an order for a large quantity of skin cream, based on this formula. Unfortunately, the client did not want MDB so we switched to Potassium Sorbate & Sodium Benzoate. Ran PET & Stability again. All good.Sep 2018:
I was unable to find a manufacturer to make the cream within a time frame and at an MOQ that worked for me, so I decided to grow upon my limited knowledge and make it myself. By now, Carol the Chemist had started ghosting me and to this day I have no idea why. She ignored my increasingly desperate emails and then phonecalls, however I noticed she still posted on Instagram so was obviously fine. I have since discovered that she has form for this kind of behaviour.Feb 2019:
I received another large order based on the original samples we sent out. I now had two very large orders to fulfill.March 2019:
I retained the services of another cosmetic chemist “Rachel” to review our formulas and formulate some more products for us. She advised that as we were using Potassium Sorbate and Sodium Benzoate, that we should switch to Microcare SB as it is basically the same. We got samples from the manufacturers and all was fine. The pH at this time was 3.65-3.95, as advised by Carol.April 2019:
Bought a 25 kg pail of MSB. As the samples had been fine we proceeded to scale up to 60 kg. From that batch, we experienced the skin burning. I approached the manufacturers who told me to bring the pH up to 5.8. We did. All looked good, so made another 60 kg. All went mouldy.July 2019:
The company who placed the second order have pulled out and the company who placed the first order are now demanding their deposit back. Right now, I need a miracle.I just want to add that I am hugely grateful for the support and expertise on this forum and I hope that my experiences can help others.
Gaby
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So, the bottom line is: You adjusted the pH to 5.8, but never ran a PCT on the product that was adjusted to pH 5.8?
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@Mark, I was advised by a Senior Chemist at the Manufacturers that it would be completely fine. I trusted them.
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Not to be defeatist, but you likely will have to write-off any loss to life experience.
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