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Hurdle Technology Approach
Posted by SoapyWays on May 24, 2023 at 11:42 amI was hoping someone could very simply explain to me the Hurdle Technology Approach, more out of curiosity rather than anything else…
1. Example, in a shampoo formulation how would one use Hurdle Technology?
2. Is this method frequently used in cosmetics/shampoos?
3. What are the upsides and downsides to such a method?
Thank you!!!
PhilGeis replied 2 hours, 58 minutes ago 7 Members · 31 Replies -
31 Replies
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In concept, preservation by a combination of factors none of which has a primary antimicrobial effect - e.g. mildly acidic or basic pH, Aw <0.9, low % alcohol, etc. Maybe toss in a pump packaged.
Shampoos? Don’t bet on it. Don’t waste your time
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This reply was modified 1 week, 3 days ago by
PhilGeis. Reason: spelling
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This reply was modified 1 week, 3 days ago by
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Yes, Hurdle Technology worked for us.
We ran a GMP Certified factory for 20 years until March 2023 and employed Hurdle Technology for our shampoo, face wash, and body wash products. The main component of Hurdle Technology was the high pH of these products (around 9.5 pH). And appropriate packaging.
And over the 20 years, we manufactured for various Private Label customers around the world which required validation and Notifiaction in various countries, including the EU.
I should also mention that our factory had its own in-house laboratory, and results were regularly validated by external labs.
And on top of this, we were regularly inspected by the GMP Certifying authority.
So yes, Hurdle Technology can work.
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No.
In all of the cosmetics compliance parameters globally that we have complied with, “in-use data” is not a requirement.
Can you provide an example where “in-use data” is a requirement?
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Can you describe your hurdle technology? Is this in context of the soap base you mentioned before.
“In-use” as in the articles below. The major manufacturers put product in hands of consumers to confirm the basic efficacy of their systems . This has been shown generally conventional systems and would be esp important with hurdle. “Compliance” is rudimentary - gov folks know crap all about cosmetic microbiology and as I think you noted before -your guys did not ask for data.
https://academic.oup.com/jambio/article-abstract/128/2/598/6714996
https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987
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Yes, we use Hurdle Technology on our liquid shampoo, face wash, and body washes I have mentioned before.
And yes, like other manufacturers, our test batches go to our test consumers to confirm the basic product efficacy. This can take a lot of time. And we have spent upwards of 12 + months to get the test batches where we want them. And liked by our test consumers, before the formulation is finalized.
So yes, we do ask for data from our test consumers.
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@mikethair just a follow-up on @PhilGeis question, when he talks about in-use test, that means that consumers (ca. 30 subjects) use the products you manufactured in normal conditions for certain time (in one of the references, it’s between 2 to 3 weeks), then return those same products to the lab, so the micro testing is done. Is thay the type of in-use test you perform?
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Generally, what you describe are the protocols we adopted.
And after 20+ years of producing the same products, it’s a well-trodden path from our side.
Our overseas Private Label customers usually prefer to do the microbial testing themselves in-country and email the results for our records.
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Not sure I’d call hurdle - reliance on soap formulation. Were there other factors?
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The soap formulation adopts the main elements of Hurdle Technology. And by definition, our approach combines a number of bacteria-inhibiting factors. With our liquid face wash, body wash, and shampoo include pH, heat treatment (71 to 100 C), and appropriate packaging, in our case pump bottles.
Also, some of the essential oils we used in finished products may have had bacteria-inhibiting factors. But these were never tested as the bases themselves all displayed bacteria-inhibiting factors.
And it is worth remembering the simplicity of our bases……shampoo is only potassium cocoate, and face wash potassium olivate. Our body washes a mixture of potassium cocoate, potassium palmate, and potassium soyate.
So, in our opinion, the reliance on our soap formulation is in fact Hurdle Technology.
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That’s a stretch - “soap” a single factor of product formulation - and maybe EO - is “hurdle. Suppose a bottle of chlorine bleach is hurdle.
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With the greatest respect PhilGeis, we never implied “soap as a single factor of product formulation.” And we never identified EO as part of the hurdle.
And as we mentioned, our hurdle approach combined a number of bacteria-inhibiting factors. These included pH, heat treatment (71 to 100 C), and appropriate packaging. So we see three combined hurdles working in unison. And our early trialing indicated that if we eliminate one of these factors, the bacteria-inhibiting falls into a heap.
Is it the simplicity of our approach using just saponified oils that is troubling you?
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I can’t speak for @PhilGeis, but I think the objection would be that your experience would encourage other manufacturers to stop using proven preservatives & start using (normally inadequate) hurdle strategies instead. It also encourages preservative-phobia, validating unreasonable fears of ingredients that have been proven safe. Additionally, it undermines the message that formulas need to be preserved.
While your experience demonstrates that it is possible, for the vast majority of product makers, using a preservative is the safer option.
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Thanks, Perry, I appreciate your response.
Perhaps you should relay the same message to Mike Bronner, the current President of Dr. Bronner’s. This company was founded in 1948 by Emanuel Bronner. They saponify plant oils, as we do, to produce a wide range of bathroom and household cleaners.
After 150 years in operation, I think the damage has been done to “encourage other manufacturers to stop using proven preservatives.” Dr. Bronner’s is a very well-established brand globally. And in saying this, I am not encouraging non-safe products.
And in response to your comment “While your experience demonstrates that it is possible, for the vast majority of product makers, using a preservative is the safer option,” there is absolutely no question about the safety of our products without preservatives, and using Hurdle.
And you may also know that many preservatives are endocrine disruptors. We cater to this sector of the market. My wife suffers from endocrine disruption caused by preservatives.
Again, I appreciate your comment, Perry. Thanks.
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I appreciate your response also.
Text is really an inefficient way to communicate as it’s easy to misunderstand. Just to clarify…
I don’t doubt the safety of your products (or Dr Bronner’s). I also don’t think companies are willfully trying to make unsafe products.
Products like Dr. Bronner’s are based on old technology & quite frankly don’t meet the performance expectations of the vast majority of consumers. While they are beloved by a niche consumer group, at about $200 million in yearly sales they are a tiny sliver of the market. https://www.sdbj.com/retail/dr-bronners-hits-188m-revenue-2020/
Most companies want to make products that appeal to the greatest number of consumers. You can’t do that with saponification technology. They just don’t perform as well.
And when a naive entrepreneur or marketer looks at brands that claim to avoid preservatives, they start demanding products that perform like modern technologies without preservatives.
I think we could both agree, in general, that can’t be done. Unfortunately, this hasn’t stopped some companies from making and selling unsafe products like these.
As the endocrine disruption goes, I’m not a doctor so won’t comment on anyone’s health conditions. But what I will point out is that Dr Bronner’s sells products with Tea Tree and Soy based ingredients both of which have been implicated in endocrine disruption. A strange thing to do for a company who markets themselves as safer-than-others.
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Hi again Perry,
Thanks for your response, I really appreciate it. We may have to agree to disagree. And why not. I think divergent points of view in our industry are healthy. And as long as safety and cosmetic compliance standards are never compromised.
In my world, I see a place for niche products, and I see Dr Bronner’s in that category. As were our own products and those I formulated for our global Private Label customers.
Yes, they may not be everybody’s cup of tea, but there is a demand there, albeit a lot less than the giants of our industry. And I should add that the profit margins on saponified products are a lot less than the conventional skincare products. So yes, a $200 million annual profit is small in the big scheme of things.
As a scientist, I am guided by the published medical literature in peer-reviewed scientific journals. And there is certainly a solid body of evidence around endocrine disruption from the synthetics used in skincare, especially the preservatives. The fact is that nobody, apart from scientists like myself, reads these journals. And as a scientist, something that I have done for years is to write plain English blogs that can be understood by the general public.
OK, Perry, thanks again for your comments. Very much appreciated.
Kind regards,
Mike
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Would you kindly share some of those peer-reviewed papers showing the endocrine disruption from preservatives in cosmetics? My understanding is that in the case of preservatives, the conversation goes the other way. If you check CIR and SCCS reports, they review avalialble evidence for, among other things, endocrine activity, and put it in perspective (they model exposure). Here’s the CIR report for parabens: https://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/PRS746.pdf. In page 36S (very weird way to number pages) there’s the endocrine activity part. You’ll see that not only parabens have a very weak binding affinity to endocrine receptors (Methylparaben’s binding affinity is not even detectable), but they have thousands of times less potency than natural E2 (again, Methylparaben even fails to show any activity in some studies). This is the type of information safety reviewers check before recommending the safe use of (in this case) parabens as cosmetic preservatives. I understand we can have different opinions, but when there’s clear evidence about some hot topic, we need to show consensous….otherwise, fear mongering and missinformation will win the battle.
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Hi ketchito,
With respect, I’m not confident the report/s you have cited are unbiased reviews. After all, the Personal Care Products Council is a national trade association representing global cosmetics and personal care product companies. So, hardly unbiased.
As a scientist, I rely on the published scientific/medical literature. These papers are published in peer-reviewed journals, and these scientists have no links to cosmetics and personal care product companies.
I have provided a link below to 100 scientific papers using the search keywords “endocrine disruptors preservatives cosmetics.”
Any questions, please feel free to get back to me.
Kind regards,
Dr. Mike Thair
https://pubmed.ncbi.nlm.nih.gov/?term=endocrine+disruptors+preservatives+cosmetics
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That two terms are associated in a publication does not mean they report or confirm cause and effect. You might also research to meaning of endocrine disruption. The working definition (binding to estrogen receptors) would find many phytoestrogens such as are commonly found in diets profoundly more effective. Lastly - take anything authored by Darbre with caution - tho’ as a scientist you might enjoy her profoundly flawed methodologies.
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Hi Mike,
Apparently the PCPC is hosting the reports from CIR, but the image I uploaded is from the CIR report for parabens, you might want to take a look to confirm. As I mentioned, both the CIR and SCCS reports are amongst the most trusted source of information when it comes to evaluating safety of ingredients. They for sure looked at the hundreds of reports you mentioned and selected the ones that had less risk of bias and had the strongest methodology. It’s a very fun read 😀
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Hi again ketchito,
Thanks for the clarification. Noted.
Kind regards,
Mike
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Here are the relevant reports. Lots to read.
CIR - original paraben opinion
https://www.dropbox.com/s/oyq0dw1grjxi60i/paraben-report-original.pdf?dl=0CIR - re-review of latest data
https://www.dropbox.com/s/5zwi9k5arwujzij/paraben-report-latest.pdf?dl=0SCCS - Opinion on parabens
https://www.dropbox.com/s/v7a6px5w7nuyx02/SCCS-opinion%20on%20parabens.pdf?dl=0While the CIR relies of the cosmetic industry for funding, the group is made up of independent scientists, the FDA, and consumer advocates. They also follow an open process where all meeting minutes, reports and supporting research are available for anyone to inspect.
But even if you remain skeptical of CIR, the SCCS performs the same service in the EU (reviewing ingredient safety data). They are NOT industry funded but rather supported by the government. They have no conflict of interest. Interestingly, they came to the same conclusions as the CIR. Parabens are safe as used in cosmetics.
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Hi Perry,
Thanks very much for the clarification, it’s much appreciated.
The Paraben question, it’s ongoing. Some scientists still have questions regarding relative safety. So we will need to wait this one out. It won’t be quick.
Kind regards,
Mike
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Mike, whereas the scare mongering may have made the question academic, what do you see as the open question re. parabens that current risks assessments have not addressed?
https://www.sciencedirect.com/science/article/abs/pii/S027323002100146X
https://www.cir-safety.org/sites/default/files/paraben_web.pdf
https://journals.sagepub.com/doi/full/10.1177/1091581820925001
https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics
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Analogous - one can find >750,000 citations for combined search terms formaldehyde and cancer. Yet the same sources CIR, FDA, SCCS have determined and confirmed safety in use for formaldehyde releasing preservatives in cosmetics. As correctly noted by J&J researchers when they grudgingly removed Dowicil from their baby shampoo - there’s more formaldehyde in a plum than their product.
Be aware- CIR, SCCS, FDA work on risk assessment rather than an attempt at risk elimination - consistent with Paracelsus caution - the poison is in the dose.
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