First things first, parabens are a family of preservatives that are widely used in the food, pharmaceutical and cosmetic industries. Preservatives are an important part of many products, including personal care, as they help to protect against potentially harmful microbes as well as prolonging product shelf life. When it comes to designing a product, it’s a tricky task to find a preservative that is not only effective at preventing or eliminating the growth of bacteria or fungi but is also non-toxic, which is why parabens are so widely used – they tick both boxes! Parabens are not only effective against the full range of microbes across a wide temperature and pH range, but they’re also harmless to people at the concentrations that they are used.[1,2]
Fun fact: naturally occurring parabens can be found in trace amounts in fruits and vegetables such as blueberries and carrots. When it comes to cosmetics, they’re mostly found in topical products such as washes, lotions and creams, while in pharmaceuticals they’re part of various formulations such as nasal solutions and intradermal injections. The most commonly used parabens include methylparaben, ethylparaben, propylparaben and butylparaben [3,4] (try saying that five times!).
In order to achieve good antimicrobial activity, usually a combination of two or three parabens are used for preservation. Concentrations of at least 0.4% (4g/kg) for a single paraben molecule and a maximum of 0.8% (8g/kg) for multiple parabens are used in cosmetic products.[3,4]
So why parabens? What are the advantages when compared to other preservatives?
There are plenty of great reasons why parabens are such a popular option when it comes to preservatives. They are known to have:
· A broad range of activity against bacteria, moulds and yeasts
· Chemical stability over a wide temperature and pH range
· A very good safety profile
· Sufficient water solubility
· A lack of odour, taste and colour
· Stability; not causing changes in colouration or consistency of products
Why the negative press around parabens?
Parabens are rapidly absorbed and metabolised when applied topically or consumed orally, and therefore, are present in low levels in human tissues however they do not present any cause for concern.[5,6] Although some worries have been raised regarding the potential for parabens to mimic the estrogen hormone in the body, their activity has been found to be significantly lower than natural hormones in the body.[2,6] Parabens have been used since their invention in the 1920s and are widely considered safe by regulatory bodies around the world when used within the permitted concentrations:[2,8,9]
Various industry bodies around the world have done their own assessments of parabens, including:
· Australia: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has assessed parabens and concluded that: “the available data do not indicate any risks associated with exposure”. Methylparaben is listed as a “substance considered not to require control by scheduling”,[2,10] which means that it is considered safe enough to not even need rigorous oversight.
· Europe: The European Medicines Agency (EMA) concluded that methylparaben and propylparaben pose no toxicological concern at their current usage levels in oral medications and further restriction was deemed “not necessary due to the absence of sufficient clinical evidence of parabens related effects in humans”.[2,11]
· USA: Food and Drug Administration (FDA) scientists continue to review published studies and scientific data on the safety of parabens. Their ongoing research of parabens shows that they are safe to use: “At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human health”.
· Canada: Health Canada agrees with the FDA position on parabens and “reaffirms the safety of parabens as preservatives in the present practices of use and concentration in cosmetics”.
Parabens: Non-Allergen of the Year 2019
Following the unsupported negative press around paraben safety, the ingredient has been replaced in many products (you may have noticed ‘paraben free’ being called out a lot) with preservatives that have far greater allergenic potential.
For this reason, in 2019, the American Contact Dermatitis Society chose parabens as the Non-Allergen of the Year to draw attention to their low rate of associated contact allergy, highlight their confidence in the safety of parabens, and to encourage their continued use despite high public interest in limiting exposure to parabens.[14,15]
The parting words on parabens
Science, safety and sustainability is at the core of etchðos and we look to the decades of expert research when it comes to formulating products. This research, along with the opinions of both the international scientific and health communities, show that parabens are one of the safest, most effective preservative systems used in pharmaceutical and cosmetic products, plus there is no link to any adverse health effects when used appropriately.
1. Elder DP, Crowley PJ. Antimicrobial preservatives Part One: choosing a preservative system [Internet]. Available from: https://www.americanpharmaceuticalreview.com/Featured-Articles/38886-Antimicrobial-Preservatives-Part-One-Choosing-a-Preservative-System/. (Accessed: 15 November 2021).
2. Medisca. Parabens: the importance and safety of preservatives [Internet]. Available from: https://www.medisca.com/Pages/Studies/pdf-files/white-papers/Parabens%20White%20Paper.pdf. (Accessed: 15 November 2021).
3. Petric Z, Ružić J, Žuntar I. The controversies of parabens - an overview nowadays. Acta Pharm. 2021; 71(1):17-32.
4. Garner N, Siol A, Eilks I. Parabens as preservatives in personal care products. Chem Action. 2014; 103:36-43.
5. Francisco A, Fonseca AP. Parabens paradoxes in cosmetic formulations: a review. International Journal of Medical Research and Pharmaceutical Sciences. 2016; 3(8):1-11.
6. Golden R, Gandy J, Vollmer G. A review of the endocrine activity of parabens and implications for potential risks to human health. Crit Rev Toxicol. 2005; 35(5):435-458.
7. Lincho J, Martins RC, Gomes J. Paraben compounds - Part I: An overview of their characteristics, detection, and impacts. Applied Sciences. 2021; 11(5):2307.
8. Final amended report on the safety assessment of methylparaben, ethylparaben, propylparaben, isopropylparaben, butylparaben, isobutylparaben, and benzylparaben as used in cosmetic products. Int J Toxicol. 2008; 27(Suppl 4):1-82.
9. Cherian P, Zhu J, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG Jr, Shank RC, Slaga TJ, Snyder PW, Heldreth B. Amended safety assessment of parabens as used in cosmetics. Int J Toxicol. 2020; 39(1_suppl):5S-97S.
10. National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Parabens: Human health tier II assessment 2015 [Internet]. Available from: https://www.industrialchemicals.gov.au/sites/default/files/Parabens_Human%20health%20tier%20II%20assessment.pdf. (Accessed: 15 November 2021).
11. European Medicines Agency (EMA). Science Medicines Health. Reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use 2015 [Internet]. Available from: https://www.ema.europa.eu/en/use-methyl-propylparaben-excipients-human-medicinal-products-oral-use. (Accessed: 15 November 2021).
12. U.S. Food and Drug Administration (FDA). Parabens in cosmetics 2016 [Internet]. Available from: https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics. (Accessed: 15 November 2021).
13. Government of Canada. Parabens [Internet]. Available from: https://www.canada.ca/en/health-canada/services/chemicals-product-safety/parabens.html. (Accessed: 15 November 2021).
14. Fransway AF, Fransway PJ, Belsito DV, Warshaw EM, Sasseville D, Fowler JF Jr, DeKoven JG, Pratt MD, Maibach HI, Taylor JS, Marks JG, Mathias CGT, DeLeo VA, Zirwas JM, Zug KA, Atwater AR, Silverberg J, Reeder MJ. Parabens. Dermatitis. 2019; 30(1):3-31.
15. Reeder M, Atwater AR. Parabens: the 2019 nonallergen of the year. Cutis. 2019; 103(4):192-193.