-
Just curious…with the new green push….what is the PET failure rate?
Didn’t know if anyone had a friend in the business, or an ear to the ground… I was just curious if the PET failure rates had sky rocketed with the green push on preservatives?
Not so much talking about the few mommy bloggers sending stuff in…but more the semi-professional formulators, who know what they are doing….but are bypassing the F releasers and parabens.
Aloha.
I had seen on some other forums…some of what appeared to be competent people getting some failures with some reasonable alternatives. (I am not talking Leucidal folks….but reasonable alternatives with hurdle techniques.)
-
22 Replies
-
While on the topic…is someone knows any of these approximate factoids…I’d love to hear the information.
What is the failure rate (PET) of professional formulas?
What is the failure rate (PET) of semi-professional formulators?
What is the failure rate (PET) of home-crafters?
I guess will toss in the twist…where they are trying to meet green expectations.
-
@Graillotion: Interesting question. Following.
-
I don’t know the statistics, but I’m sure the failure rate is low. I follow the local market and nowadays hardly anyone uses parabens and formaldehyde donors, except from companies focused on selling cosmetics in pharmacies.
Other companies, even the large ones (I mean companies selling their cosmetics throughout the country in the most popular retailers, of course they are not comparable to the largest companies from the US) mainly use Sodium Benzoate with Potassium Sorbate or Phenoxyethanol with Ethylhexylglycerin.
At the moment, I have never found a cosmetic that would be preserved with anything other than a ready-to-use blend. I’m convinced that these companies do the challenge test because that test is very cheap here and is for sure checked during the inspection. -
@grapefruit22 Big companies (like P&G, Unilever, L’oreal) are the ones still relying on the high performing preservatives (formaldehyde donors, benzoate/phenoxy/benzyl alcohol combo, and even isothiazolinones mixture). They for sure conduct proper microbiological testing. While small companies are the ones mostly using the newer “more natural” blends. Don’t believe they conduct proper micro studies, but in the recall reports, I see many products with these systems fail.
-
Every formula in FDA enforcement reports passed PET - USP 51. Passing the test means little and garbage systems - esp. “natural” and the contrivance of “hurdle” - readily pass.
As ketchito said, those working to the purpose of preservation - protecting the consumer in use, - maintain the traditional systems despite the market pressures driven by EWG BS, “clean beauty”, priority lists, Ecocert head fakes, etc.
-
@ketchito Everything I described was about local brands (I’m not from US). Sometimes it’s hard to specify what I mean saying big / small company, as I wrote, they are definitely not companies like Unilever, but if they sell their products in several or several dozen countries, they are also not small. Let’s say they are medium. Maybe they only do a basic test, like the USP 51, I don’t know that. But I’m pretty sure that they do at least this test.
It’s not that someone wants to use natural preservatives. If you use Phenoxyethanol, then you don’t really want to be natural. It’s more about how these cosmetics are tested. If you can use a poor preservative, you pass the tests, and then the product is recalled, it’s pretty obvious that the test is not reliable.
I follow new products released by big companies quite closely and I haven’t seen a new skin care product with parabens or formaldehyde donors in the last year, so I would say that the largest companies are adapting to the “new standards”. Maybe it means that such preservation systems are good enough?
-
the largest companies are not “adapting to the new standards”. To the extent they’re using other preservatives - they are still using the standard of consumer use and not USP 51. I’m familiar with some of the seemingly “lesser” systems and those are the product of a lot of effort and carefully controlled to meet the corp standards. That doesn’t mean some corp (advertsing or marketing) VP didn’t decide to take a risk for specific sku’s.
-
Writing about the standard, I meant of course the types of preservatives, not the testing method, I’m aware that they perform something more than USP 51. The conclusion was that maybe just by performing appropriate tests and taking appropriate precautions at each stage of production, it is possible to create safe and reliable product without parabens and formaldehyde donors. At least, I came to this conclusion by analyzing new products from big companies and the fact that none of those I know uses parabens and formaldehyde donors anymore (in new products).
-
@PhilGeis What do you mean by “the standard of consumer use”? How is something like this done?
-
It is possible - the issue in addition to efficacy is the effort needed to qualify each product preservative application separately as opposed to a system that carries over from product to product.
-
@PhilGeis Could you please say something more about “the standard of consumer use”? I know that some companies, when ordering clinical tests, ask for the product to be returned after the test is completed by the probands. Do you mean testing such “leftovers” or more testing various combinations and concentrations of the preservative and checking them for efficiency after 1,3,7 days in laboratory? If the latter, is the complete elimination after three days or seven days satisfactory?
-
@grapefruit22
Each company has it’s own protocol and returns from consumer (rather than clinical testing are a typical part. Global countries have to consider different cultural practices - e.g. a single use (in US) sachet of shampoo may be used for months in other countries.
The test itself may also calibrated - e.g. https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987Others rely as heavily on in use testing as challenge. Don’t have a link to the paper cited but these guys showed failing challenge results were irrelevant to the micro quality through consumer use
Schnittger, S., J. Sabourin, and D. King. “Preservation of water-in-silicone emulsions.” JOURNAL OF COSMETIC SCIENCE 53.1 (2002): 78-80. -
Mixed results here.
I am developing toothpaste, which admittedly has a low water activity and adds to the inherent preservation and aside from some essential oils there for flavour (but seem to contribute to antimicrobial activity) our toothpaste is self-preserving and we can back this up with PET testing results conducted to British Pharmacopoeial standards.
Those products that have failed BP PET testing have been the newer silica gel based toothpastes.
That said, those gels that failed BP PET have also passed USP and ISO PET standards showing that our products are safe without additional preservatives needed. However, testing to BP is the gold standard - and those products that failed BP test methods do have some preservatives in them.
-
There is no gold technical standard - in a regulatory sense these tests are validated in their respective authority.
-
PhilGeis said:There is no gold technical standard - in a regulatory sense these tests are validated in their respective authority.
Fair comment re gold standard. However, meeting BP is tougher to meet than USP or ISO
-
Thanks @PhilGeis, interesting article. Now I understand why the challenge test alone may be insufficient.
Packaging seems to be crucial. Earlier, it seemed to me that first of all the customer should not have access to the product, as it is for example when the product is in a jar. Now I can see there are more problems. For example, I noticed that I regularly forget to close packaging with a disc top closure. And if the product comes with a dropper, sometimes in a hurry I just put it back and don’t screw it on tightly. Not always, but for sure it happened to me 1-2 times and I’m probably not the only person in the world who did it.
Does it make sense to include it somehow in the challenge test? For example, leave the disc top open for a day? Or a bottle that is not tightly closed. Would it make any sense? -
@Herbnerd - reasonable thought butnone of the compendial methods meet what most major manuf’s expect either in protocol, efficacy or both.
@grapefruit22
Take a look at these for closure perspective
https://journals.asm.org/doi/abs/10.1128/aem.56.5.1476-1479.1990
https://www.sciencedirect.com/science/article/abs/pii/S0002939414708323
https://www.aptar.com/wp-content/uploads/2022/04/Overview-of-microbial-integrity-tests-for-preservative-free-nasal-spray-pumps-and-multidose-eyedroppers.pdfSome folks have offered protocols, but with the objective of protecting consumers through millions of units over years, prob the best for major guys is large(geographic)-based in-use evaluation.
Wish I could access the Schnittger (Este Lauder ) paper for you. The product failed challenge but in-use found no contamination. The dynamic was its water-in-oil formula. Inoculum in challenge droplets never found the formula water droplets with preservative so very little efficacy. Similarly, in-use bugs never found any water where they might grow.
Water in oil emulsions are generally more hostile for that.You prob shouldn’t have asked, I get carried away.
-
@MarkBroussard interested in your perspective since you formulate in the natural product space… hope you don’t mind me tagging you!
-
Well, there are many variables here that can have an effect/impact. The products could be poorly formulated, improperly or insufficiently preserved, packaged in containers that may facilitate contamination in use or a combination of all of these factors. So, you would really need to look at the recalls on a case-by-case basis to understand the potential reasons for the failure and I don’t think you can generalize conclusions unless there is some obvious trend with a particular preservative ingredient being a common component of the failed products. Since preservation is more than simply adding a preservative(s) ingredient to a formula, you don’t know if that is also a contributing factor.
But generally, I think if you take a look at the number of products that are recalled as a percentge of the total number of products out in the marketplace it is probably a very small fraction of a percent.
The other factor is that it is possible for virtually anyone to get a cosmetic product on the market with no registration required with the FDA. So, you have a lot of products on the marketplace formulated by people who may not really know what they are doing, nor the regulations and perhaps those products were not properly preserved nor properly tested. For instance, in another thread there was a discussion of the recall of a nipple cream for nursing mothers that was preserved with phenoxyethanol and chlorsphenesin. That product should never have been on the market as it allowed for infants to ingest the preservatives orally.
-
Please recall - FDA enforcement only addresses manufacturing contamination and recalls are voluntary. Many - perhaps most - contaminations are not reported.
Consumer contamination is much more common and obscure. -
@PhilGeis Thanks for the articles. I found a link to the Schnittger paper in this discussion: https://www.researchgate.net/post/When-should-I-add-preservatives-in-W-O-Emulsions-heating-or-cooling
But why exactly did they not find bacteria in the product that was handled with the contaminated hand?
-
Presume the bacteria found no water in which to grow - just the silicone continuous phase. Some might survive but not enough to recover.
Log in to reply.