Home Cosmetic Science Talk Formulating Hurdle Technology Approach

  • Hurdle Technology Approach

    Posted by SoapyWays on May 24, 2023 at 11:42 am

    I 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 10 months, 2 weeks ago 7 Members · 53 Replies
  • 53 Replies
  • PhilGeis

    Member
    May 24, 2023 at 6:55 pm

    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

    • This reply was modified 11 months, 1 week ago by  PhilGeis. Reason: spelling
  • ozgirl

    Member
    May 25, 2023 at 5:38 pm
  • mikethair

    Member
    May 26, 2023 at 5:46 pm

    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.

    • PhilGeis

      Member
      May 26, 2023 at 7:12 pm

      Your soap solutions? Do you have in-use data?

      • mikethair

        Member
        May 26, 2023 at 9:29 pm

        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?

        • PhilGeis

          Member
          May 29, 2023 at 1:00 am

          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

          • mikethair

            Member
            May 29, 2023 at 3:14 am

            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.

            • ketchito

              Member
              May 29, 2023 at 7:18 am

              @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?

            • mikethair

              Member
              May 29, 2023 at 8:47 pm

              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.

            • PhilGeis

              Member
              May 29, 2023 at 11:31 am

              Not sure I’d call hurdle - reliance on soap formulation. Were there other factors?

            • mikethair

              Member
              May 29, 2023 at 9:09 pm

              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.

    • Abdullah

      Member
      May 26, 2023 at 9:09 pm

      What happened after march 2023?

      • mikethair

        Member
        May 26, 2023 at 9:30 pm

        I retired. I’m now in my early 70s.

        • Abdullah

          Member
          May 28, 2023 at 7:20 pm

          Ok

          Thanks

        • Perry44

          Administrator
          May 30, 2023 at 9:14 am

          Congratulations!

  • PhilGeis

    Member
    May 30, 2023 at 5:53 am

    That’s a stretch - “soap” a single factor of product formulation - and maybe EO - is “hurdle. Suppose a bottle of chlorine bleach is hurdle.

    • mikethair

      Member
      May 30, 2023 at 7:16 am

      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?

      • PhilGeis

        Member
        May 30, 2023 at 8:06 am

        “Saponified oils” - it’s simply soap. “Hurdle ” here is pretentious.

        • This reply was modified 11 months ago by  PhilGeis.
      • Perry44

        Administrator
        May 30, 2023 at 9:18 am

        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.

        • mikethair

          Member
          May 30, 2023 at 8:07 pm

          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.

          • Perry44

            Administrator
            May 31, 2023 at 8:29 am

            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.

            • mikethair

              Member
              May 31, 2023 at 9:24 pm

              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

            • ketchito

              Member
              June 1, 2023 at 7:00 am

              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.

            • mikethair

              Member
              June 1, 2023 at 10:11 pm

              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

            • PhilGeis

              Member
              June 2, 2023 at 4:41 pm

              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.

  • ketchito

    Member
    June 2, 2023 at 12:22 am

    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 😀

    • mikethair

      Member
      June 2, 2023 at 1:58 am

      Hi again ketchito,

      Thanks for the clarification. Noted.

      Kind regards,

      Mike

      • Perry44

        Administrator
        June 3, 2023 at 9:31 am

        Here are the relevant reports. Lots to read.

        CIR - original paraben opinion
        https://www.dropbox.com/s/oyq0dw1grjxi60i/paraben-report-original.pdf?dl=0

        CIR - re-review of latest data
        https://www.dropbox.com/s/5zwi9k5arwujzij/paraben-report-latest.pdf?dl=0

        SCCS - Opinion on parabens
        https://www.dropbox.com/s/v7a6px5w7nuyx02/SCCS-opinion%20on%20parabens.pdf?dl=0

        While 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.

        • mikethair

          Member
          June 3, 2023 at 9:23 pm

          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

          • PhilGeis

            Member
            June 4, 2023 at 8:41 am

            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

            • mikethair

              Member
              June 4, 2023 at 10:17 pm

              Hi PhilGeis…. good question.

              Yes indeed, the endocrine-disruption properties have been the focus of researchers for decades still remain a focus for research.

              And the reason? Science circles back on itself. Successive investigations will lead back to the same question but at deeper and deeper levels. And contexts never remain static.

              For example, a study in 2021 showed the levels of human exposure to parabens were higher in the U.S.
              and EU countries than in China and India. But this level of exposure will change with the
              increasing production of parabens in China and India. Thus this 2021 review
              provides context for future studies to connect paraben exposure levels
              with human health effects.

              So, in effect, we may never see a definitive response to your question “what do you see as the open question re. parabens that current risks assessments have not addressed?

              As a scientist, I’m comfortable with this. It’s how science works.

            • PhilGeis

              Member
              June 6, 2023 at 6:29 am

              Good point Mike - as a scientific question -safety in any aspect is and will always be open for discovery. Parabens have been the most investigated of preservatives and SCCS is reportedly in process of addressing additional data that offered in support of methyl paraben safety.

              It’s also worth noting that many of the replacement preservatives are not approved and the subjects of limited to no safety testing.

              chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://health.ec.europa.eu/system/files/2022-02/sccs2022_q_001.pdf

            • mikethair

              Member
              June 6, 2023 at 10:06 pm

              Yes indeed. The alternative/replacement preservatives have very limited safety testing. Of course, these are nicely greenwashed and labeled “innovative.” It’s all driven by the marketing gurus…

    • PhilGeis

      Member
      June 2, 2023 at 5:17 pm

      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.

  • SoapyWays

    Member
    June 6, 2023 at 9:17 am

    I wanted to jump back in here and thank everyone for the wealth of knowledge that has been shared thus far. It has honestly been more than I was initially expecting, to say that I have been fascinated with the discussion would be a drastic understatement. Some people want to sit at a table with their favorite actors, musicians, etc. In my relatively young chemistry learning experience, it would be astonishing to round table with the minds here and witness an open debate.. the wealth of knowledge you all hold is something to aspire to. The counterpoints and different perspectives are simply fascinating. Absolutely love all the backup studies and references, I have been sifting through and absorbing it all!

    To those whom are in support of parabens, formaldehyde.. To pinpoint where I am coming from, all I’ve ever known since growing up is parabens=bad bad bad, which is where I assume the general mindset of the average consumer is at.. So to those in support of the data behind parabens, formaldehyde.. do you put this pressure on the company/brands to educate the consumer to say “hey don’t believe the fear mongering.. here’s the facts, here are the studies, here is what you should know to make your own decision”.. Or do you realize that a product with parabens simply won’t move units and focus on a different preservation approach?

    I realize it depends on the formulation and product, so keeping with shampoo based around more natural surfactant alternatives such as glucosides, what would be the next top tier researched preservative without a bad stigma against it? This has been a big issue for me as well, finding alternative preservatives that actually have a mountain of research and data behind it, parabens are bountiful in this regard.

    I personally feel that a reversal in the mindset of the average consumer is such a mountain to climb, simply because the stigma existed for so many years. Does anyone know if there are any major brands doing such a thing?

    I find myself somewhere between the two points being brought up here. I enjoy Mike’s take and also sympathize with knowing someone with issues endocrine disruption, etc. Without diving too far into detail, it’s what started my chemist journey and set me on the path I am on today. But I find saponification works great for body wash and the like, but it absolutely destroys my hair/their hair.. I find potassium cocoate particularly drying, from our perspective.

    So to you Mike, if you were to formulate, again sticking with typical shampoo, have you found any preservatives that worked for your wife, held up, and have sufficient data behind them?

    Between the greenwashing.. misinformation that is out there.. fear mongering.. It makes it incredibly difficult to research and cherry pick ingredients that aren’t mutagens, endocrine disruptors, carcinogenic. There’s just so much to learn! Again, can’t thank you all enough for all knowledge shared here. I have a bunch more questions but feel I’ve said enough for now. Thank you 🙏

    • This reply was modified 10 months, 3 weeks ago by  SoapyWays. Reason: layout jumbled oddly, had to fix spacing
    • Perry44

      Administrator
      June 6, 2023 at 12:20 pm

      First, you’d be surprised how little the average consumer thinks about this stuff. For most consumers, if it is sold at a store it’s fine. They really don’t look at the ingredient lists. In fact, paraben remain the most popular preservative used in cosmetics. They’ve dropped a lot in volume but most consumers don’t care.

      But some consumers do care and from a marketing standpoint it’s generally better to cater to consumers that care about a topic because the ones who don’t will just buy whatever is on sale. So, marketers & retailers care more about what you put in than the average consumer.

      In reality, the cosmetic industry is controlled by Marketing departments. The R&D folks make what they are asked to make (if possible). We’ll grumble about being hamstrung & creating products that aren’t as good as they could be, but ultimately, Marketing & Sales can override any R&D complaints. Consumers also don’t really care either.

      There really is little benefit to a company to educate consumers about what is true in the beauty business. Nearly the entire industry is built on fantasy and story telling. Safety, sustainability, natural, active ingredients, antiaging…they’re all just stories needed to convince people to buy products they probably don’t really need. “Truth-telling” also becomes a marketing story that can work for some brands but not others. Chemical fear mongering is just another story telling technique for getting consumers to buy your product rather than your competitor’s.

      In truth, I think consumers should bother worrying about chemicals in their beauty products. Products are safe. Unless you have an interest in becoming a Toxicologist, learning about mutagens, EDs, carcinogens, etc. researching on your own is a waste of time. If you are not an expert, you will most likely be mislead by your personal beliefs. You will cherry pick studies that support what you want to believe & ignore the things that don’t support it.

      • Perry44

        Administrator
        June 6, 2023 at 12:22 pm

        My advice. Find products that work for you & are at a price you can afford.
        Don’t worry about anything else.

    • mikethair

      Member
      June 6, 2023 at 10:25 pm

      Hi SoapyWays,

      Yes, endocrine disruption from preservatives is real to those who suffer and non-existent to those who don’t suffer. It’s that simple. And there is plenty of scientific/medical literature (more than 10,000 papers) discussing the effects on those who suffer.

      And re your comment “But I find saponification works great for body wash and the like, but it absolutely destroys my hair/their hair.. I find potassium cocoate particularly drying, from our perspective.

      OK, what we have found is that your hair is full of the ingredients from your synthetic shampoo. And the saponified product needs time to clean these from your hair. Over the years various customers have reported that this can take a few days to two weeks. And if your hair is still dry after this transition period, then a hair oil applied overnight works wonders.

      • PhilGeis

        Member
        June 7, 2023 at 6:12 am

        Endocrine disruption from preservatives is real in consumer context? Don’t think this is consistent with CIR, SCCS and FDA opinion. Can you elaborate?

        • This reply was modified 10 months, 3 weeks ago by  PhilGeis.
        • mikethair

          Member
          June 7, 2023 at 9:45 pm

          <div>Yes indeed, endocrine disruption from preservatives is VERY REAL for consumers. But it is a case where if you suffer from endocrine disruption from preservatives, you suffer seriously. And those who don’t suffer have zero effects from preservatives.</div><div>

          I also note that there are around 10,000 papers in the peer-reviewed scientific and medical literature.

          </div><div>

          So this group in effect suffers in silence. And are not recognized. Within this context, it is not aligned with CIR, SCCS, and FDA opinions.

          </div><div>

          Feel free to get back to me with further questions.

          </div>

          • PhilGeis

            Member
            June 8, 2023 at 4:59 am

            Please share the data - the specific consumer health data that these scientists directly responsible for consumer health have apparently not seen.

            • mikethair

              Member
              June 8, 2023 at 8:25 pm

              There is zero data.

            • Perry44

              Administrator
              June 9, 2023 at 8:09 am

              So what makes you think your assertion that preservatives are causing health problems? Without data, isn’t a more rational explanation is that the problems are more psychosomatic & not caused by preservatives?

              It just doesn’t seem that you’ve come to your conclusions based on science. It’s also not something that the independent experts of the SCCS have identified either. The EU has no problem banning anything that’s even a suspected harm inducer. They don’t even require completed studies. Even they don’t support the concerns you are raising about parabens.

              What evidence would convince you parabens are safe?

            • mikethair

              Member
              June 9, 2023 at 10:08 pm

              Hi Perry,

              With respect, what concerns me is the research cited in scientific literature. For example:

              • 2021 Jul 15;778:146150.

                doi: 10.1016/j.scitotenv.2021.146150.

                Epub 2021 Feb 27. Parabens as chemicals of emerging concern in the environment and humans: A review.

              • 2019 Jan/Feb;30(1):32-45.

                doi: 10.1097/DER.0000000000000428. Paraben Toxicology

              • 2022 Nov;87(5):389-405.

                doi: 10.1111/cod.14181.

                Epub 2022 Jul 18. Preservatives in non-cosmetic products: Increasing human exposure requires action for protection of health

              • 2022 Oct;29(49):73648-73674.

                doi: 10.1007/s11356-022-22895-z.

                Epub 2022 Sep 9. Environmental contamination status with common
                ingredients of household and personal care products exhibiting
                endocrine-disrupting potential

              • 2010 Sep;15(3):190-6.

                Toxic effects of the easily avoidable phthalates and parabens

              • And the list goes on. I should add that these are from peer-assessed papers and the scientists do not have any allegiance to cosmetics companies.

                Further, if the check the following link, there are listed 100+ scientific papers (including those I have cited above):

                https://pubmed.ncbi.nlm.nih.gov/?term=paraben%20concerns%20cosmetics

                And what evidence would convince me that parabens are safe? Similar to what I have provided above citing peer-assessed papers saying that parabens are safe.

            • PhilGeis

              Member
              June 10, 2023 at 5:07 am

              Mike please - I doubt you’ve read these papers or have the expertise to develop an informed risk assessment.

              Please read the CIR, SCCS, etc. assessments whose authors have both the toxicologic expertise and have considered all the literature in arriving at a conclusion of safety in use.

              In use is the context - not absolute safety - the process is risk assessment not the impossibility of risk elimination. You might also consider the absence of data for most of the compounds folks use in place of parabens.

              • This reply was modified 10 months, 3 weeks ago by  PhilGeis.
            • mikethair

              Member
              June 10, 2023 at 5:18 am

              Hi PhilGeis,

              With great respect, I have read all of the papers I have cited. As a scientist and formulator, it’s what I do.

              Call me old-fashioned if you like (OK, I’m in my 70s), but the papers I have cited are of concern to me. I have listed 100+ scientific papers listing concerns. That’s too many for me.

              And again, I have gone through all of these papers.

            • PhilGeis

              Member
              June 10, 2023 at 5:36 am

              I’ve not called you old fashioned, and suggest we avoid ad hominem including re. authorship of publications. In fact, you’ll see little from industry in the literature. That they hire experts in the field to execute assessments is to their credit, and I take your comment as a personal insult. I’ve worked in this industry for four decades never once saw the cynicism you suggest.

              I’m not aware you have toxicologic expertise having seen nothing to that effect in your publications. I do not have that expertise. However, I know many of the folks at CIR having provided data and perspective regarding preservatives they have rejected. I greatly respect their expertise and conclusions.

              Again, read the assessments better to understand their conclusion of safety in use.

            • mikethair

              Member
              June 10, 2023 at 9:00 pm

              Hi PhilGeis,

              I think that your response shows that we are communication from different sides of the pond.

              In my case, as a scientist, my reference point has and always will be the scientific/medical literature. And based on my understanding this scientific literature I formulate. I maintained this approach for more than two decades as a co-founder and managing director of a cosmetics manufacturing company that provided products to brands globally.

              And now I understand from your perspective from within the cosmerics industry “That they hire experts in the field to execute assessments is to their credit…”

              This perspective you have explained is very illustrative to me. So thanks for that.

              I’m not suggesting that one approach is better than the other. And I believe they can co-exist.

              My phrase “call me old fashioned” is what I guess we call an idiom. And there are no suggestion here that you called me old-fashioned.

  • PhilGeis

    Member
    June 6, 2023 at 10:44 am

    To your question re. education or conversion - for most major brands - neither, yet.

    Companies and the cosm industry are not equipped and not willing to attempt education Don’t view companies as monoliths - they exist in internal conflict with marketing as the driver that can/will only sell.

    Micro is part of the efficiency drives global formulas - with global preservative systems 1) legal in all regions incl EU and 2) effective in high speed manufacturing and in-use. Conventional preservatives satisfy these - alternatives do not.

    “Yet”- industry lost out on recent fed legislation. The bill they supported would prevent states from banning preservatives - the bill that passed does not. States will ban - Washington st. just banned formaldehyde releasers. For alternatives - there’s not much safety data for most and no one is trying to get the new ones into the EU directive. So there’s going to be a squeeze.

  • ketchito

    Member
    June 10, 2023 at 6:13 pm

    Dear @MikeThair,

    With all due respect, I doubt you actually read those references. Just few comments on the ones you mentioned:

    1) Parabens as chemicals of emerging concern in the environment and humans: A review: this one has many biased comments, like saying that preservatives use will increase in the comming years because consumers want products with higher shelf life (if that was the case, many of the newer “natural options” wouldn’t be even considered). They also mention many times the works from Darbre and how he showed a relationship with breast cancer (studies that were heavily criticized by many experts, due to the poor study protocols; similar -but correcting Dabre’s flaws- studies conducted later on showed no link).

    2) Paraben Toxicology: in its very abstract, they actually are IN FAVOR of keeping parebens: “Based on currently available scientific information, claims that parabens are involved in the genesis or propagation of these controversial and important health problems are premature. Haste to remove parabens from consumer products could result in their substitution with alternative, less proven, and potentially unsafe alternatives, especially given the compelling data supporting the lack of significant dermal toxicity of this important group of preservatives.

    3) Preservatives in non-cosmetic products: Increasing human exposure requires action for protection of health: reading that paper, I was shocked by the mention of Bronopol (risk of nitrosamine formation) and Formaldehyde as the most used preservatives…but then I noticed the paper was about non-cosmetic products, hehe. Weird thing that they talk about preservatives for non-cosmetic use, but they use cosmetic regulations to show their permitted level.

    While it’s nice to have a peer-reviewing process to filter information in a scientific paper, this process is not always correct. You might want to read this: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1420798/. We’ve seen so many times flawed studies being published in BJM, Nature, NEJM and few more of the big journals, that had to be retracted, or that were found to use very weak evidence to draw conclusions. This is why having specialists (I cannot stress this word more) in the CIR or SCCS to review the evidence and take only the one that has a stong methodoly and less risk of bias, is crucial.

    • mikethair

      Member
      June 10, 2023 at 9:05 pm

      Hi ketchito,

      Yes, I have read all of these papers. As a scientist, that’s what I do.

      And yes, there are flaws in these papers and the peer review system. But what is the alternative?

      • PhilGeis

        Member
        June 11, 2023 at 1:23 pm

        The alternative to reading “100” papers you know to be flawed and reaching a conclusion regarding subject not in your expertise? Reminds of the EIC for Dabre’s infamous breast cancer hit piece admitted her work was “flawed” but published it anyway.

        Not an alternative but the best assessment exists in the SCCS, CIR and FDA by which expert toxicologists review all the data. Not the f lawed 100 effectively anonymous folks who carry no responsibility for the work but individuals whose careers and reputations rest on their rigor nd the resulting safety impact of their conclusions.

        • PhilGeis

          Member
          June 11, 2023 at 2:08 pm

          For perspective - the 2020 CIR assessment for methyl parabens included 197 citations - the great majority of which were published after its 2008 assessment.

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