Chemical Manufacture - Safety of preservatives

LuisJavierLuisJavier Member
edited December 2019 in Change my view
I recently watched a video by BASF about their efforts in minimising ethylene oxide residues in various of their products such as SLES and other ethoxylated ingredients. They were aiming for a level of about 1ppm or less, in addition to explaining potentially new legislation requiring lower ethylene oxide residues. The reason I bring up this information is because it had me thinking about other chemicals, ethoxylated or not and their undesirable and potentially hazardous to health in even very small quantities, whether that be a long-term concern or not.

Am I wrong in thinking that if BASF is making big efforts in reducing the EO residues in some of their products as well as notifying us of formulations that will have to change to be compliant with potentially new legislation as a result of EO residues, that surely this is a topic for the formulator to give moral thought to?

I do not desire to just hand-wave any critical thought/analysis of these chemicals and their impurities because of CIR saying that as of present, these chemicals are safe for use at the accepted usage levels, or because of the argument that these chemicals are in such tiny percentages. No, firstly, tiny levels of these residues is still a concern for me and many others due to knowledge that a product (e.g. a face cream) is not just used once in a lifetime or once a month, but often as frequently as everyday or every other day. Concern over these impurities is possibly the only worry that I share with the 'natural-only' crowd on the internet.

Secondly, I appreciate CIR and other such organisations' research on these topics, but I desire more knowledge of the thought-process behind their decisions when they state something to be 'safe for use at 0.5% in a leave-on product'. I have read many CIR safety assessments but still have so many questions. I understand that testing data is used to come to such conclusions, but often this is for acute effects. I'm more interested in the long-term effects of the impurities of the said product. For example, if CIR make a safety assessment of 2-phenoxyethanol, they review the acute effects of phenoxethanol and not ethylene oxide. Ethylene oxide residues would like have a long-term effect due to their tiny %.
 
Benzyl alcohol if introduced to the eyes, can cause corneal necrosis. My phenoxyethanol supplier lists in their MSDS for the chemical that it has a maximum phenol content of 10ppm and I am unaware of the ethylene oxide content, but I'm sceptical about it being EO free. I also found out that ethylene oxide can penetrate the skin and is also readily soluble in water as well as being denser than air, so I do not hope very much that in a formulation, that it will just evaporate away before the product (e.g. face cream) is applied. Caprylhydroxamic acid in Spectrastat may have hydroxylamine residues which is at least a suspected human carcinogen.

Sodium benzoate can form benzene if it reacts with ascorbic acid at even room temperature. Now, I will admit, the kind of face creams that I formulate, I do not have a worry about benzene formulation because I do not use ascorbic acid or its derivatives and the oils and butters that I use, as far as I'm aware, don't contain vitamin C, and even if they did, it would not only be a small amount, but for that small amount to react with the already tiny amount of sodium benzoate in the product, in the presence of an emulsion, is something that I would not really worry about. I am however quite averse to formaldehyde releasers due to client reactions to these kinds of chemicals.
 
Sodium anisate and sodium levulinate do not seem so cost-effective due to their effective usage levels, and they seem difficult to incorporate due to their very small pH window for adequate efficacy. Potassium sorbate is a chemical that so far I have not really read up anything negative about except skin reddening due to the sorbic acid on capillaries on the face, and the rather low pH for it's efficacy.
 
So, after everything I've written above, if I have said anything that you think is logically inconsistent or factually wrong, please let me know. If you feel that some information would be useful to me in regards to the above, please point me in the right direction or just let me know. Alternatively, you can let me know of a preservative system that you think I would not object to.  Thank you!

*Edited for formatting (PR)

Comments

  • PerryPerry Administrator, Professional Chemist

    I’ve got more to say but let’s start with this…

    1.  BASF ethylene oxide - I think you’re mistaken about BASF’s motivation. They are not worried about regulations and it’s not being done for safety reasons. It’s simply being done for PR reasons. This is something they can do easily now, they can get some good press, so they do it. It’s similar to P&G removing (perfectly safe) phthalates and J&J removing perfectly safe preservatives from their products. This does not make the products more safe but consumers think it does.

    2.  Regulations - These are not made based solely on scientific data. If they were, there would be no differences in regulations anywhere in the world. If safety was the highest concern, professional toxicologists would be the only people involved in deciding what ingredients are safe and at what level. But it’s not done that way. Non-scientists & industry are involved in creating regulations and they come to conclusions that are not necessarily science based.

    ...more to come.

  • I see. So BASF is doing it for PR reasons but in doing so, it seems to be aiding the fear-mongering people on the internet. Well, I guess if it will increase their profits, okay. I was a little bit puzzled by them mentioning legislation in regards to all this as it made ethylene oxide reduction from 5ppm to 1ppm or under seem like an actual safety concern. That did seem quite misleading or at least obscure enough to mislead many people who are not as well-read on this topic.

    I'm really rummaging through my mind right now thinking of whether to use a phenoxyethanol + sodium benzoate + potassium sorbate blend in my face cream formula or maybe sodium benzoate, potassium sorbate and whatever else except phenoxyethanol or a formaldehyde releaser, without including something at a ridiculously high level like ethanol or glycerin. I do not know if pentylene glycol or hexanediol could be used at small percentages for substantial preservative efficacy. Lastly, I can use Spectrastat OEL. Do you have any insight into this?

      
  • PerryPerry Administrator, Professional Chemist
    Many companies don't really mind the fear-mongering. In fact, many embrace it because it is an effective marketing strategy. When you can't create a product that is measurably different than a competitor's, you revert to fear marketing to dissuade people from buying your competitor.

    Sulfate free shampoos are not better for hair. They are just more expensive and don't work as well. But if you make consumers afraid of sulfates, they'll switch to a non-sulfate version even though it costs more & doesn't work as well.

    You're really putting too much thought into your preservative. Phenoxyethanol is probably fine. There is no evidence that using it at the levels to be effective in your product represents any health hazard. It is a preservative that has been tested & proven in cosmetics for decades. If safety is your concern, use phenoxyethanol. (parabens & formaldehyde donors are safe and effective too).

    Fear marketing is the only reason people have moved away from traditional, safe and effective preservatives. Unfortunately, the alternatives like Sodium anisate and sodium levulinate are just not as safe & reliable.
  • Bill_TogeBill_Toge Member, Professional Chemist
    Perry said:
    2.  Regulations - These are not made based solely on scientific data. If they were, there would be no differences in regulations anywhere in the world. If safety was the highest concern, professional toxicologists would be the only people involved in deciding what ingredients are safe and at what level. But it’s not done that way. Non-scientists & industry are involved in creating regulations and they come to conclusions that are not necessarily science based.

    ...more to come.

    don't know about the rest of the world, but in Europe any proposed change to the legislation must first be reviewed by the Scientific Committee for Consumer Safety, a panel of expert doctors and toxicologists from all over Europe, and any changes must be made in accordance with their advice
    this makes European cosmetics legislation exceptionally resistant to lobbying, and is the reason why it's still legal (though impractical and commercially suicidal) to use formaldehyde as a preservative in Europe; within the usage limits dictated by Annex V, it's been found to be safe for use

    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • LuisJavierLuisJavier Member
    edited December 2019
    Thank you Perry for your response. The issue of ethylene oxide impurity is the crux of the matter for me. I fully understand that on the whole, at accepted usage levels, phenoxyethanol is very safe in cosmetics, but I have a lingering thought: 'For cancer, all it takes is possibly one mutation, and if EO is carcinogenic, and even if it is in a tiny percentage in a bottle of phenoxyethanol, then the risk for that mutation to occur only increases as application of this preservative is maintained.

    I admit, I do have to consider that the impurity percentage is further minimised when you take into account the percentage of the preservative in the entire cosmetic product, so yes, this preservative really isn't the worst thing out there.

    In regards to my concern in the third sentence, is this concern one of exaggeration? I'm not certain but I remember reading that even car exhaust contains small amounts of carcinogens too, as well as a tiny percentage of asbestos fibres that make up the air we breathe here in the UK. Finally, I'm open to a response to the concern I've mentioned in regards sustained exposure to tiny levels of EO, and I will take up your advice and just use phenoxyethanol, probably in combination with sodium benzoate (and potassium sorbate?). Many thanks again. 
  • But do you realize that anything can cause that mutation? Radiation can cause mutation that would lead to cancer and bananas, for example, contain isotopes of radioactive potassium. Do you avoid bananas? Same and even more about sun exposure. You have many more chances to get cancer from walking outside on a lovely summer day rather than from using modern cosmetics. 
  • I didn't know bananas contain radioactive potassium. Do you have any papers on this?
  • PerryPerry Administrator, Professional Chemist
    A good place to start is here. 
    https://en.wikipedia.org/wiki/Banana_equivalent_dose

    But basically, a certain percentage of naturally occurring potassium is radioactive. Bananas incorporate natural potassium in their fruits and some percentage of that is radioactive.
  • PerryPerry Administrator, Professional Chemist
    "For cancer, all it takes is possibly one mutation, and if EO is carcinogenic, and even if it is in a tiny percentage in a bottle of phenoxyethanol, then the risk for that mutation to occur only increases as application of this preservative is maintained."

    There are actually a couple of things mistaken about this statement.

    1.  Cancer is much more complicated than one single mutation. On average it takes about 4 mutations before cancer develops

    2.  It employs the flawed "gambler's fallacy" logic.  Basically, each exposure is an independent event and increasing the number of exposures will not increase the chances of causing a mutation. If it is 1 in a million chance with one exposure, the next exposure will still be 1 in a million.
  • I did not know that the average number of mutations needed for cancer to develop is 4.  I'm a bit puzzled by how I fell into that fallacy; I do not mean that the probability of getting cancer at each subsequent stage increases from the last, but that if a person is put into a situation where he/she adds a risk factor and maintains it as a routine, like smoking, then by the end of 20 years, it could be sargued that developing cancer is more likely for this person than for a person who only smoked 1 cigarette in their life (when you consider a large population demographic of course). 
  • Applying a moisturizer with extremely low amounts of dioxane isn’t an equivalent of smoking a cigarette. Smoking even one cigarette exposes the smoker to a significant amount of harmful components. Meaning 1 cigarette is harmful. Harmful *20 years = very harmful. Non-harmul *20 years is still not harmful.
  • That's a good point. I could agree that cigarette smoking seems to be far more harmful than tiny levels of dioxane.
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