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Ingredients Factsheet The truth about preservatives Several of our skincare formulations are preservative-free. In others, we use a wide range of different types of safe, effective, broad-spectrum preservatives. Why are preservatives needed in skincare and are there any dangers associated with their use? In particular, parabens have had a very bad press - why is this and should we be concerned? This factsheet has been written to provide accurate information for anyone concerned about these issues. Understanding parabens Parabens are a family of ingredients widely found in nature, especially in foods such as fruits. They are esters of para-hydroxybenzoic acid, hence their name, and include methylparaben (E 218), and propylparaben (E 216). These compounds and their salts have been used since the early 1920s as broad-spectrum preservatives in both food and skincare as they have excellent bacteriocidal and fungicidal properties. In nature, they are the reason some fruits stay fresh longer than others, such as blueberries compared to raspberries. We eat them in foods such as apples, blackcurrants, carrots, onions, grapes, yeast extract, wine vinegar and cheese. Studies show parabens are present in foods at a level of around 600 ppm (parts per million). Natural vanilla extract is especially high in methyl paraben as it is one of its four main flavour components (it is also a natural component of plant lignin). Although paraben preservatives are created synthetically (it would be too expensive to extract the small amounts found in foods), the compounds are nature identical. This means that the paraben molecules synthesized and used as preservatives are absolutely identical on every level - molecular, structural and biochemical - to those found in fruits and other plants. Many plants and some insects contain parabens and one interesting aspect of this is their ability to increase biodegradability in soils, ditch and drain water, river water and sludge treatment works. Studies by E. G. Beveridge et al show that the esters of methyl, ethyl, n-propyl, iso-propyl, n-butyl and iso-butyl parabens all assist in the breakdown and cleansing of water and are intrinsic to all aerobic and anaerobic plant and animal life. Parabens are frequent in nature and can be considered to be ‘green’, biodegradable and natural. Are parabens safe? Unlike some other preservative systems, parabens have a long established history of safety and are highly effective, which is why they are so widely used in the food, pharmaceutical and beauty industries. They are considered safe because of their low toxicity as well as being rapidly metabolised and excreted when eaten in foods: i.e. they don’t accumulate or get stored in the tissues of the body. Traces of parabens’ breakdown products are normally found in the urine of healthy people as they are a natural by-product of the amino acid tyrosine (found in many foods and some health food supplements) being broken down by the digestive process. Studies show that the presence of parabens and their breakdown products in urine is perfectly normal and the parabens could be there as a result of food and not necessarily from absorption through the skin of skincare products. Far from being dangerous, the main precursor of the parabens 4-hydroxybenzoic acid is actually also a precursor for ubiquinones (Co-enzyme Q10) which is essential for healthy oxygenation of our bodies (some people take additional dietary supplements of Co-enzyme Q10 to help increase energy levels). On the skin, parabens are generally non-irritating and non-sensitising unless you have a specific paraben allergy. So why the negative publicity? The reason for the bad press comes from both misinterpretation and flawed scientific studies: a study in 1998 by Dr Routledge et al reported mild oestrogenic activity in some paraben esters (no activity was discovered in methyl paraben). However, the activity was so weak it was almost undetectable, being 100,000 times weaker than oestradiol (the reference standard against which all oestrogenic activity is measured). Some oestrogens are known to increase the growth of tumours, although that is not the case here as the mutagenic activity of oestrogens depends on different free radical chemistry. However, this first study then led to further work by researchers attempting to find parabens in breast cancer tissue. The reason for this study was that the researchers believed parabens to be present in most underarm deodorants and anti-perspirants. In fact, parabens are not and never have been ingredients in the vast majority of underarm toiletries. This is because preservatives are not generally required in these types of formulations (they are either aerosols or generally contain alcohol and other ingredients such as aluminium or zirconium salts and so do not require further preservation). There are a few brands which previously contained parabens, and a handful that still do, but 95% of the market are formulated without parabens and always have been. Despite the rumours, they were not subsequently removed en masse following this study as they were not present in the majority in the first instance. These researchers found traces of parabens in a study of 20 breast cancer tissues. However, parabens were also found in the blank controls - in fact, one of the ‘blank’ controls contained more total parabens than 12 of the tissue samples and the second highest ‘blank’ contained more parabens than 9 of the tissue samples. So, parabens were present in both the breast cancer tissue samples and the blank controls! Peer-review has shown this to be a highly-flawed study and instead of being present in the breast cancer tissue, it is more likely that the parabens (measured in parts per billion) were actually already present on the glassware. Ingredients Factsheet Later reviews of this trial now conclude that the presence of parabens in the tumour tissues is most likely to have come from contamination of the laboratory apparatus used in the trial. Other studies quoted to discredit parabens include a trial where an adverse oestrogenic effect on fish was discovered by injecting fish with very large amounts of parabens, at levels of 100-300mg/kg bodyweight (not something that is likely to occur either in fish or in humans). Studies on rats and mice have also shown some disruption to sperm to be ‘preservative free’ that some may not actually be so. For example, some certification organisations allow preservatives such as parabens to be used within the herbal ingredients and this may not be declared on the label (known as the INCI listing). Alcohol (either plant-derived or synthetic) can also be used as a preservative, but this needs to be used in fairly high quantities in order to be effective (at least 12%). We would consider this in some body treatments, but not in sensitive skin formulas for the face. likely to eat the vast amounts of parabens involved and many Skincare advice toxicologists do not accept these findings as either relevant or valid. Keep in mind that you do need to take care when using un-preserved Such is the misinformation and mythology surrounding parabens as skincare, especially if you have a low immune system. It is ironic ingredients that, in skincare, some products now declare themselves that cancer patients may be advised by well-meaning natural to be ‘parabens free’, as if this is a virtue. This highlights the dangers health advocates to opt for ‘natural’ skincare that is more likely to be to consumers of some companies supporting inaccurate information un-preserved. This is dangerous advice for someone with a damaged by feeding them large quantities of parabens, but again, we are not and is one of the reasons why this factsheet has been compiled. Safe, effective skincare is a priority So what about other preservatives? At Liz Earle Naturally Active Skincare, we use a wide range of different preservatives. In some cases, products may not even need to be preserved at all. Our preservative-free formulations include Superbalm and Superskin Concentrate. It has always been our company policy to use the lowest safe and effective levels of a range of broad-spectrum preservative systems, such as phenoxyethanol (used in contact lens solutions) and potassium sorbate. When testing our skincare for safety, we carry out what is known as challenge testing. This involves taking a sample of the product and injecting it with a wide variety of common bugs, such as bacteria, moulds and fungi, and testing for how well the preservative system deals with these. We then age this sample over 6 weeks in a warm environment (around 30 degrees). The aged sample is then re-tested and we look for the same safety levels as we would find in a freshly made sample. We test and re-test, always making sure that we reduce the preservatives we use to just the right levels - not too much and not too little. We never simply top up our formulations with the maximum allowable as this technique (although easier) can lead to excessive use of preservatives. immune system. Warnings were issued by the Universitari del Mar Hospital in Barcelona in January 2008 when moisturising body lotions used in patient care transmitted deadly bugs to critically-ill patients. Five intensive care patients contracted a life-threatening infection caused by the bacteria Burkholderia cepacia which was present in the lotion before the containers were opened. According to leading British dermatologist Professor Michael Cork, using un-preserved or poorly-preserved skincare could be fatal. His clinical trial completed in 2007 showed 53% of emollients (ointments and creams) tested to contain bacterial contamination. These included 25% contaminated with Staphylococcus aureus (one of the triggers for eczema), 11% with coliforms and enterococci (from faeces) and 17% with general skin bacteria. Professor Cork even found the deadly ‘superbug’ MRSA in several skin creams. In addition to those with lowered immune systems, those who also need to be especially careful include the very young (especially babies and toddlers), the elderly and anyone with damaged skin or open wounds, such as psoriasis, eczema, cuts or grazes. A last word… The safety of parabens, and the risk of using skincare not properly preserved, are at last starting to be appreciated by well-researched media. However, many scare stories are fed by commercial companies We constantly search for and test new preservatives, including or organisations with their own agenda. They may also be fuelled by many of the so-called ‘more natural’ options. We do not use broadcasters or newspapers seeking higher ratings or sales figures. grapefruit seed extract as not only is this not a natural ingredient The news that parabens are both natural and safe to use is not exactly (it is significantly chemically adapted) but we have also found it not an exciting headline, but the good news is that you can continue to to be effective enough in protecting against contamination when enjoy both eating parabens in foods such as fruits and using parabens challenged. Be aware when buying products that declare themselves in skincare without fear. Ingredients Factsheet Want to know more? References These websites are useful to bookmark as they tend to offer balanced and credible viewpoints, backed with detailed peer-reviewed research on all kinds of health and beauty myths: Beveridge E.G. and Hart A.; Int. Biodetn. Bull., 1970, 6 (1), 9. www.thefactsabout.co.uk An excellent and informative website run by the Cosmetic, Toiletry and Perfumery Association in the UK. Worth checking for a balanced and legally accurate view whenever there is a scare story in the media. www.senseaboutscience.org.uk A UK charity for scientific information written by leading scientists. Golden R., Gandy J. and Vollmer G. A review of endocrine activity of parabens and implications for potential risks to human health. Critical Reviews in Toxicology. Vol. 35, No. 5, pp. 435-458 2005. Soni M.G., Carabin I.G. and Burdock G.A. Safety assessment of esters of p-hydroxybenzoic acid (parabens). Food and Chemical Toxicology (2005), 43(7), 985-1015. Cashman A.L. and Warshaw E.M. Parabens: a review of epidemiology, www.colipa.eu The European Cosmetics Association website, which contains useful information on EU legislation and product labelling. structure, allergenicity, and hormonal properties. Dermatitis. 2005 www.acsh.org/healthissues An American website run by the American Council on Sciences and Health, a consumer education consortium. Routledge E.J. et al. Some Alkyl Hydroxy Benzoate www.personalcarecouncil.org A very good American website run by the Personal Care Products Council (they tend to issue response statements following scares). www.fda.gov The main American Food and Drug Administration website is tricky to navigate, but it does have a good question and answer section on skincare ingredients, and more. www.cancer.gov The main cancer information website in America. A good selection of risk assessment papers can be downloaded at www.cancer.gov/cancertopics/factsheet/Risk Jun;16(2):57-66; quiz 55-6. Preservatives (Parabens) Are Estrogenic. Toxicology and Applied Pharmacology. 153(1), 12-19. 1998. Darbre P.D., Aljarrah A., Miller W.R., Coldham N.G., Sauer M.J. and Pope G.S. Concentrations of parabens in human breast tumours. J Appl Toxicol. 2004 Jan-Feb;24(1):5-13. Na’was T. and Alkofahi A. Microbial contamination and preservative efficacy of topical creams. Journal of Clinical Pharmacy and Therapeutics (1994) 19, 41-46. Alvarez-Lerma F. et al. Moisturising body milk as a reservoir of Burkholderia cepacia: outbreak of nosocomial infection in a multidisciplinary intensive care unit. Critical Care. 2008 Jan ISSN 1364-8535. www.snopes.com An American website dedicating to solving all kinds of internet and media myths, e-mail scares and round-robin hoaxes. A handy reference site that helps debunk all kinds of urban legends. Contact customer care for skincare and product advice 01983 813913 Email [email protected] Visit lizearle.com Call 01983 813913 Liz Earle Naturally Active Skincare is a trading name of Liz Earle Beauty Co. Limited. Registered in England and Wales No. 3070395. Registered address: Nunn Mills Road, Northampton, NN1 5PA. All Liz Earle products mentioned are trademarks of Liz Earle Beauty Co. Limited. Liz Earle ® Liz Earle Beauty Co. Limited is not responsible for the content of external websites. © Liz Earle Beauty Co. Limited 2012. All rights reserved.