Latest Research on The Truth About Parabens

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Latest Research on The Truth About Parabens It is hugely important that skincare be produced in a safe manner and that the product is kept free of microbial contamination. There are several methods to test the efficacy of preservatives (no matter the origin) in a finished product. Independent bacteriology laboratories usually complete this testing using a method called the "British Pharmacopia Standard Method". This process tests the finished creams over a period of time for the ability to kill a variety of bacteria, yeast and fungi. Regardless of the professed preservative, the finished cream must be able to kill the following that they are exposed to in this test. Peninillium funiculosum, penicillium citreonigrum, cladosporium cladosporoides, bacillus sp, gram-negative rods (pseudomonas sp). Several companies who use synthetic preservatives seem to assume and state publicly that Living Nature does not do this type of testing. Of course we do, it has been essential to the development of our natural preservative system, as well as a regular check of all of our raw materials. The issue about preservatives should not be confused with the argument about the preference for natural ingredients (that is just our choice). The issue is whether the preservative used is harmful or not to the human organism. It hardly seems logical to be using lots of nutritious ingredients and then using a dangerous preservative. We became tired of all the arguments about the pros and cons of parabens, and had an independent Government laboratory at Hort Research do a series of tests on many ingredients (positive and negative) and included all of the parabens in these tests. The testing process was carried out by Dr. Iona Weir and used the method of Flow Cytometry. A way of testing live cells for oxidative stress, toxicity, DNA damage and inflammatory response. The paraben research results were as follows: 1. Does not cause inflammation 2. Creates intense oxidative stress 3. Is not toxic, which means it doesn't cause the cell membrane to break. 4. Severe DNA damage. What this means is that the parabens can cause unsuspected long-term damage, because they don't irritate the skin or create a toxic effect. Hence the damaged DNA can still replicate, this combined with oxidative stress (which creates intense damage in the cell) could combine to cause abnormalities in cell reproduction. This is where we can get cancerous cells forming. Pretty scary when you think of how many people with melanomas are putting on suspect sunscreens that contain parabens. Most of the studies carried out by cosmetic companies are about the toxic and inflammatory effects of parabens, and this is of course how many skincare ingredients are tested. However there is more our DNA is one of the main controlling factors of whether the cell replicates healthily. Once it is damaged then we don't know what the final effect could be. We do know cancers form when the DNA does not replicate correctly. SOURCES OF PARABENS There are lots of arguments about commercial production of parabens, and not much information around. They are produced from a petroleum derivative, toluene. The following process is used:

Page 2 Latest Research on The Truth About Parabens 1. Obtained originally from coal tar toluene is prepared. Please note from Merck index (Myeltoxic potential: L. Greenburg et al J. Am. Med. Assoc. 118, 573 (1942). Comparison with benzene of effects on hematopiesis and bone marrow metabolism). 2. Toluene is reacted with oxygen at temperature around 200 oc with the presence of Cobalt and Manganese salts as catalysts or by alkyl substituted benzene which is oxidised to benzoic acid by hot potassium permanganate. 3. A strong hydroxide reaction (could be using any of the hydroxides like sodium hydroxide) to produce the alkyl esters which are methyl, butyl, ethyl and propyl parabens. Parabens could also be produced from Gum benzoin, but would cost over 450 times the price. I also do not know of any natural companies whose product pricing reflects that they are derived from gum benzoin. However, regardless of the form of extraction, they have the same effect on the cell. As a company we have found natural parabens present in several plants, but have removed them from our line once we realised this. We now test all of our ingredients for natural or synthetic parabens before using them. REPLY TO A TYPICAL INDUSTRY RESPONSE ABOUT NATURAL PRODUCTS AND PARABENS. Living Nature's replies are in italic. "Put succinctly, there is no such thing as all-natural, pure cosmetics. They don't exist and if they did, they would not automatically be good for the skin. Whatever preconceived or advertising-induced fiction that you may have heard regarding natural ingredients being better for the skin has no basis in fact or scientific legitimacy. Not only is the definition of "all natural" hazy, but the term isn't even regulated, so each cosmetics company can use it to mean something different. If a company wants to call their products natural, it can, and it doesn't matter what they contain." I certainly agree that many producers definition of the term "all natural" is hazy, but it is very outdated to say that there is no such thing as all natural cosmetics! There are at least 5 or 6 companies I know of! "So what is all natural? It can mean anything and nothing. For most cosmetics companies it means including plant extracts in their formulations. The ingredient list may include aqueous extracts with a long list of plant names following. Even if an all-natural product did exist, you wouldn't want to use it on your skin anyway. Think about a bunch of plants, fruits, or vegetables sitting in your bathroom. What would happen in a very brief period of time if they didn't contain preservatives? They would become mouldy and disgusting in just a few days. Skin-care products contain very unnatural sounding preservatives, and that's great. According to many cosmetic chemists, a reliable preservative system helps avoid the risk of microbial contamination, which could cause problems for the eyes, lips, and skin. For most people, the possibility of an allergic reaction to a preservative is the lesser of the two evils. So-called all natural ingredients can themselves cause allergies, irritation, and skin sensitivities. Just think of how many people have hay fever, and you will start to realise just how unfriendly certain natural ingredients may sometimes be." There are allergic reactions to many things synthetic or otherwise. Everyone making natural cosmetics preserve them, they just use preservatives that are not damaging or harmful to the skin.

Page 3 Latest Research on The Truth About Parabens If we look for an argument about synthetic versus plant source, then look at orthodox medicine, how many medical complications occur each year using synthetic medication, often ending in death. What we need to address is individual ingredients and their merit, the issue is far more complex. "The notion that all natural equals good skin care or better makeup will waste your money and probably hurt your skin. I'm not sure if the majority of women who buy cosmetics are ever going to be able to believe this. The pressure to believe the lie about all natural products being better for the skin is hard to resist, and women want to believe it. Cosmetics companies spend lots of money to reinforce their message about the benefit of natural ingredients through their ads, sales force, and brochures. Despite the corroboration from countless physicians, cosmetic chemists, and other scientists in a variety of academic research, it still isn't easy to counter the hype surrounding products claiming to be all-natural or pure. It gets even more confounding as the natural sources become more exotic and eccentric, such as sea plants or foliage from the rain forest or herbs from India." It is the responsibility of all manufacturers regardless of the source of their ingredients, to test their products for safety and efficacy. Living Nature does this using Flow cytometry on live skin cells. Any ingredients, even natural ones, are not used unless they show a positive effect. There are many commonly used synthetics and natural extracts that are not beneficial for the skin. "What makes this natural craze so annoying and undesirable is that it perpetuates myths that can hurt a woman's skin. The label might say pure and natural but you could be buying a purely irritating product that might cause an allergic reaction. All natural ingredients are one of the most bogus, misleading components of the cosmetics industry because they focus attention on the wrong information." Gross generalisation. I have found the most misleading information about natural ingredients in the advertising of synthetic based multi-nationals, rather than the serious organic and natural skincare manufacturers. The reason for this, is they see it as a money spinner. The reason it is a money spinner is that human beings PREFER using natural plant and mineral based products. The consumer should have a choice, and accurate information, so they can make an informed decision. "We are not saying there aren't some natural-sounding ingredients that are good for the skin, because there are, but the idea that they are still natural once they have been extracted from their source and mixed into a cosmetic is ludicrous. One of the more potent examples of how the natural craze gets in the way of good skin care and good information concerns alpha hydroxy acids. AHAs have gotten a lot of press over the past several years, and many women know that AHAs work as effective exfoliants for sun-damaged skin. Of the several AHAs used in cosmetics, lactic acid and glycolic acid are the most popular and the most researched. AHAs have been promoted as being natural because lactic acid is derived from milk and glycolic acid is derived from sugarcane, but derived from doesn't mean the original ingredient has anything to do with the extracted ingredient. Milk and sugarcane are not the same as lactic acid and glycolic acid. Rubbing milk or sugarcane on your face won't have the same effect as applying a product with lactic or glycolic acid, rubbing mouldy bread on your body isn't the same as taking penicillin, even though penicillin is derived from mouldy bread. Again individual skin care companies make choices on individual ingredients. Living Nature would not use AHA's because we have found them to be damaging long term. However we are happy using l-lactic acid, and have seen benefits, and are happy about the manufacture method.

Page 4 Latest Research on The Truth About Parabens "Companies like Aveda companies based on an all-natural concept do list the technicalsounding ingredients along with the natural sources. Although this appears to be helpful information, it still leads consumers in the wrong direction. For example, ammonium lauryl sulfate, a standard detergent cleansing agent, is listed on the Aveda ingredient label as being derived from coconut oil. Doesn't that make it sound pure and pleasant? Ammonium lauryl sulfate is the salt of a sulfuric acid compound, neutralised with an ingredient like triethonalamine. None of that is bad for the skin, and we wouldn't tell anyone to avoid ammonium lauryl sulfate, but it is the more accurate description of that ingredient. Associating it with coconut oil, a far-removed organic source, just makes for better (though misleading) marketing lingo." While some of the above paragraph is true, we would not use Ammonium lauryl sulfate because our tests show the end result is damaging and irritating on skin. It is directly derived from coconut. It goes through several synthetic stages to arrive at its final structure, but is definitely derived from coconut. Again the real argument is whether the extract is good for you or not. "Next time you're faced with marketing claims about all natural being better for the skin, remember the following": 1. Food-type ingredients in products increase the need for additional preservatives to decrease mould and bacteria contamination." This depends on the ingredient combination and the expected shelf life. Personally I prefer things that are food for the skin, and blended correctly and responsibly can be beneficial. 2. "Food can feed the bacteria present in skin, increasing risk of breakouts." That's if people were just rubbing food on their skin! 3. "Plant extracts are no longer plants." Not really worth commenting on! 4. "Yeast or bacteria cultures (from products that do not contain preservatives) in cosmetics can exacerbate rosacea and psoriasis." Again natural companies are not suggesting no preservative be used, but safe naturally derived ones. "By law, a cosmetic product must contain a preservative system designed to retard microbial growth. This is to protect the consumer from bacterial infections which could result in serious health problems, such as blindness. The law doesn't state what system must be used, but it does specify that the preservative system keep the microbial growth within a certain range. We use parabens, simply because they are the most effective and widely used in cosmetic products today. In addition, they have been thoroughly studied for effectiveness and safety." As explained in the introduction, we use and have passed the British Standard Preservative Test, and responsible natural manufacturers should do the same. "The preservatives are listed as all of the 'parabens' and Phenoxyethanol. All parabens fall under the category of preservatives. Preservatives are ingredients which prevent or retard microbial growth and thus protect cosmetic products from spoilage. Cosmetic products may support the growth of micro organisms. The use of preservatives is required to prevent product

Page 5 Latest Research on The Truth About Parabens damage caused by micro organisms and to protect the product from inadvertent contamination by the consumer during use. The use of more than one preservative can sometimes increase efficacy due to synergism." We use over 7 different plant extracts and fractions to preserve our products. This blend varies from product to product, depending on the requirements. "Basically, if you don't have a preservative in the product to retard microbial contamination, you run the risk of early spoilage of the product and in worst case scenarios, bacterial infections that result in blindness." Again the point has been missed, natural companies are using preservatives. Confusion occurs when some countries have a list of ingredients that can be called preservatives. If you are using something not on the list, then you can say your product is preservative free (meaning you're not using any of the ones on the initial list). Parabens are the esters p-hydroxybenzoic acid (PHBA). They are prepared by esterification of PHBA with the corresponding alcohol in the presence of a catalyst. Parabens are generally oil soluble and poorly soluble in water. Water solubility decreases as the ester chain length increases. As mentioned above they are derived from toluene and coal tar. "Parabens are used as preservatives in over 13,000 cosmetic formulations at concentrations almost exclusively less than 5 percent. They are most commonly used at concentrations up to 1 percent. Parabens preserve fats, proteins, oils, and gums in cosmetics. Products containing Parabens contact all surfaces of the body as well as ocular, oral, and vaginal mucosae. Duration of application may be continuous and may extend over a period of years. Certain Parabens are also used as preservative in foods (up to 0.1 percent as GRAS ingredient), pharmaceutical's (as inactive or safe and effective OTC ingredients), and other products. Parabens are quickly absorbed from the blood and gastrointestinal tract hydrolysed to p- hydroxybenzoic acid, conjugated, and the conjugate excreted in the urine. Data obtained from chronic administration studies (over 348 have been performed) indicate that Parabens do not accumulate in the body. Serum concentrations of Parabens even after intravenous administration, quickly decline and remain low. Varying amounts of Parabens are passed in the faeces depending on which paraben is administered and the size of the dose. Little or no unchanged Paraben is excreted in the urine. Most of an administered dose can be recovered within 5 to 72 hours as p-hydroxybenzoic acid or its conjugates. Parabens appear to be rapidly absorbed through intact skin." Good to hear this stated, as so many companies for so long have been saying that parabens do not absorb through the skin, despite models that have been quoted. The study quoted above does not account for parabens applied in the normal method continually to skin. I would definitely be interested in a study that measured the amount applied in a daily moisturiser to what is excreted in the urine. We know that residues can be left in skin tissue. However there are quite a few experiences of parabens being found in tumours, especially breast and lymph glands. Perhaps they were trapped in these after going through the skin on the way to the kidneys???? "The antimicrobial activity of the Parabens increases with increasing ester chain length. Their effect is more microbiostatic than microbiocidal. Parabens are effective within a ph range of 4

Page 6 Latest Research on The Truth About Parabens to 8. Parabens act as microbiostatic agents by increasing cell wall permeability and thereby disrupting transport. Parabens also alter cellular respiration, electron transport, and oxidative enzyme systems of microbes. Both the ester-linkage and the para-hydroxy group of the Paraben molecule have been implicated as active sites." If they do this to microbes which have much tougher cell walls than humans, what are they doing to our cell membranes??? We know that they are getting through and damaging our DNA! "In summary, a number of acute, subchronic, and chronic toxicity tests have been performed (almost 400) on the Parabens using a wide variety of routes of administration. From this data, it is readily apparent that these ingredients are non-toxic and must certainly be considered safe for cosmetic use in the usual quantities employed as a preservative." Please note that the scientific word "toxic" relates to whether the cell membrane bursts, therefore killing the cell. We have shown in our studies that this does not happen, therefore allowing the damaged cell to replicate. "For more information regarding the safety of the Parabens please read: "Final report on the safety assessment of Methylparaben, Ethylparaben, Propylparaben and Butylparaben" Journal of the American College of Toxicology. Vol. 3, No. 5, 1984. "Final report on the Safety Assessment of Isobutylparaben and Isopropylparaben." Journal of the American College of Toxicology 14(5):364372, Lippincott-Raven Publishers, Philadelphia. 1995 Cosmetic Ingredient Review." Both of these studies have determined that parabens are quickly absorbed through the skin. That they do not create an inflammatory response (which we know) and are not toxic, i.e. don't burst the cell membrane. Neither study has looked at the oxidative stress or the effect on DNA. I do hope you find these answers helpful and please comment if you have any further information. Suzanne Hall NZCS (chem), MBThANZ suzanne@livingnature.com