Phenoxyethanol 101: Is This Ingredient Dangerous or Unfairly Demonized In Cosmetics?
Is phenoxyethanol safe in cosmetics?
Whether you are a small brand owner choosing ingredients for your next launch, or just want to make informed decisions about the ingredients you put on your skin, we provide an overview of phenoxyethanol in simple terms.
Our in-depth guide below critically evaluates the latest research into the safety of phenoxyethanol in cosmetic products. We explain what phenoxyethanol is, how it’s used, and the maximum limit for safe use in beauty products.
Plus, we discuss what governing health and safety bodies legally require and recommend when it comes to using phenoxyethanol in cosmetics.
What Is Phenoxyethanol? What Are The Benefits Of Using Phenoxyethanol In Cosmetic Formulas?
With rising concerns about the safety of parabens in cosmetics, the beauty industry searched for an alternative low-cost, versatile, and powerful yet safe preservative to increase the shelf life and improve the stability of personal care products.
Enter phenoxyethanol! As explained by Nowak et al. phenoxyethanol is one of the most popular alternatives to parabens in cosmetic formulas. This affordable, flexible, and effective preservative has been a staple in beauty and personal care products for decades now. It’s also used in the medical field and many personal hygiene products including hand soap.
Phenoxyethanol is typically added to cosmetics for its antimicrobial activity properties. Not only is it effective against yeasts, but it also prevents the development of many gram-negative bacteria and gram-positive bacteria in products over time. Plus, it doesn’t cause much disturbance to the skin’s natural flora.
How common is this preservative ingredient in cosmetics? Very! According to a 2017 Spanish study, 43% of cosmetics sold only in pharmacies, 23.29% of beauty products sold in supermarkets, and 14.1% of cosmetics available in herbal shops contain phenoxyethanol.
How Does Phenoxyethanol Work?
Gelmetti and colleagues explain that phenoxyethanol is an ether and aromatic alcohol, and is also known chemically as 2-phenoxyethanol, ethylene glycol monophenyl ether, phenoxytol, 1-hydroxy-2-phenoxyethane, and (2-hydroxyethoxy) benzene.
To get technical for a moment, as outlined in Gelmetti and colleagues’ study phenoxyethanol provides antimicrobial benefits through uncoupling oxidative phosphorylation from respiration and competitively inhibiting malate dehydrogenase.
What Is The Controversy Around Phenoxyethanol? Is It Unsafe?
Phenoxyethanol is a glycol ether. Some other glycol ethers, such as ethylene glycol ethyl ether, are linked to potential reproductive issues and are listed as ‘substances of very high concern’ on the EU’s European Chemicals Agency website. Unlike ethylene glycol ethyl ether, phenoxyethanol is not linked to reproductive issues.
However, the potential health risks of ethylene glycol ethyl ether and ethylene glycol methyl ether raised concerns about all other glycol ethers - including phenoxyethanol.
As explained in the adverse drug reaction journal Reactions Weekly, alarm bells rang over phenoxyethanol in 2008 when the FDA released a statement warning consumers not to use the product ‘Mommy’s Bliss Nipple Cream’.
This product contained both chlorphenesin and phenoxyethanol, and there was some suspicion that these ingredients could be potentially harmful to infants. No reports of injury were made, however, the FDA was concerned about the potential for the formula to cause respiratory depression, vomiting, and diarrhea in infants.
Was phenoxyethanol to blame?
The best way to learn about the real impact of phenoxyethanol on human health is to evaluate the latest academic research. Several peer-reviewed studies testing the safety of phenoxyethanol in cosmetics followed the 2008 FDA report.
Studies Analyzing The Safety Risks Of Phenoxyethanol
Multiple studies have investigated speculative links between phenoxyethanol and cancer, reproductive issues, and endocrine issues.
Does Phenoxyethanol Cause Cancer?
To examine the potential carcinogenic (cancer-causing) properties of phenoxyethanol, researchers fed a high oral dose of phenoxyethanol to rats or mice.
The researchers concluded that no potential carcinogenic effects of phenoxyethanol were found in either case. (Phenoxyethanol up to 1% is allowed in the EU - after all)
However, consuming large amounts of phenoxyethanol resulted in mild toxic effects on the kidneys in male rats and some phospholipid and cholesterol issues in mice. It’s important to note that the dose was well over the recommended limit for cosmetics, and the phenoxyethanol was consumed orally (not topically).
Is Phenoxyethanol A Reproductive Toxic Substance?
Several studies investigated the impact of phenoxyethanol (consumed orally or applied dermally) on animal reproductive and developmental health.
This research included a two-generation reproductive study in mice and two developmental toxicity studies in rabbits. Summaries are available on pages 41 - 46 of the European Commission report on the safety of phenoxyethanol.
In each case, no impact on reproductive and developmental parameters was found.
Is Phenoxyethanol An Endocrine Disruptor?
To assess the impact of phenoxyethanol on pregnancy, researchers examined a cohort of 3,421 pregnant women before 19 weeks of gestation and an additional cohort of 2,002 pregnant women before their 24th week of amenorrhoea. Exposure to phenoxyethanol was measured using urine levels of phenoxyethanol metabolites.
Using this data, researchers failed to find plausible links between phenoxyethanol and endocrine-disrupting capabilities.
The first study conducted by Botton et al. did not find an association between phenoxyacetic acid in the urine (the primary metabolite of phenoxyethanol) and cryptorchidism or hypospadias.
Although a longer time to pregnancy was reported for the phenoxyethanol group in Labat and colleagues’ study, the authors state that a confounding ingredient could be causing the issue - not phenoxyethanol.
Board-certified dermatologist Dr. Dray further critiques the study as only one urine sample per woman was collected and only a randomly selected sample was analyzed to save costs.
Is Phenoxyethanol Banned In The US or The EU? What Is The Maximum Percentage Limit?
Based on the studies discussed above (and more research), a review of the currently available literature concludes that phenoxyethanol is safe when used as a preservative in cosmetic products at a concentration of up to 1%.
Phenoxyethanol is not banned in the EU or the US. The safety agencies in both jurisdictions regularly revise their recommendations in line with the latest safety research.
Updates from the US:
In June 2015, the U.S. Environmental Protection Agency (US-EPA) listed phenoxyethanol as a substance with no oestrogenic activity (meaning it’s not likely to influence estrogen hormones).
Updates from the EU:
The EU lists all of the preservatives allowed for use in cosmetic products under Annex V of Cosmetics Regulation (EC) No. 1223/2009, which includes phenoxyethanol.
Phenoxyethanol is not classified as a reproductive toxic substance under the EU’s Regulation (EC) No 1272/2008. However, the EU places a maximum limit on the amount of phenoxyethanol legally allowed in a cosmetic formula.
The EU’s Scientific Committee on Consumer Safety (SCCS) assessed the safety of phenoxyethanol as a preservative in cosmetics in 2016. They concluded that phenoxyethanol is safe for use as a preservative in cosmetics (including on children) if limited to a maximum concentration of 1%.
As outlined in the EU safety report, an objection was raised by The French National Agency for the Safety of Medicines and Health Products (ANSM), which argued that phenoxyethanol should not be used as a preservative in products specifically designed for the diaper area of children under 3 years old.
The EU Commission also received reports from EU member states concerned about the use of phenoxyethanol on children.
Who Should Avoid Phenoxyethanol?
Given the child safety concerns raised by the French ANSM, and the previous (speculative) potential infant safety risks linked to nipple balms containing phenoxyethanol, consider adopting a cautious approach toward phenoxyethanol in any formula designed for very young children or pregnant and breastfeeding women.
People with a confirmed or suspected allergy to phenoxyethanol should avoid all cosmetics and personal care products that contain this ingredient and should consult a medical professional for further advice.
There are some documented cases of allergic reactions involving phenoxyethanol, including a 2016 study that linked a contact dermatitis response with phenoxyethanol and parabens in ultrasound gel.
Thankfully, studies show that allergies to phenoxyethanol (when formulated at safe levels) are rare.
A multi-year patch-test study of 6,932 people by Uter et al. found that sensitization to 1% phenoxyethanol was found in just 0.24% of cases. A more recent review of patch test studies by Scognamiglio et al. showed that allergic reactions range from a low of 0% to a high of 0.2%.
Although allergies to phenoxyethanol are rare, it is possible to become allergic to any ingredient in cosmetic products.
How To Formulate Products With Phenoxyethanol
Now that we have established phenoxyethanol is safe to add at low concentrations in most cosmetics, let’s talk about how you can use it to improve your products.
Phenoxyethanol is a good preservative choice for cosmetics as it’s both inexpensive and safe on human skin at low concentrations. Part of its appeal is also its versatility – you will find phenoxyethanol in everything from moisturizers, face masks, shampoo, body polish, serums, and lip gloss, to hand soap.
Given these benefits, it’s not a surprise that phenoxyethanol is commonly found in some of the most popular products on the market. For example, phenoxyethanol is listed as an ingredient in over 20,520 products in EWG’s database alone.
At Genie Supply, our clean private label catalog is formulated without many common paraben preservatives, animal products, petroleum derivatives, and over 2,000+ other ingredients that are potentially harmful to human skin.
To avoid paraben use, phenoxyethanol (at a safe concentration level) is a key preservative in many of our preformulated bulk/private label products. This includes our water cream, oil-free facial moisturizer, body butter, sugar scrub, and gentle daily moisturizer.
We also offer a custom formulating service and can make your products with or without phenoxyethanol depending on your preferences. Learn more about our manufacturing services here.
Is phenoxyethanol a safe ingredient?
Phenoxyethanol is a cost-effective, versatile, and widely available preservative for cosmetic products
An academic review of the phenoxyethanol literature to date and the EU’s Scientific Committee concluded that it is safe in cosmetics at concentration levels less than 1%
There is some concern that it could be potentially harmful to infants under 3 years old when used in the diaper area or to breastfeeding infants when phenoxyethanol is used in nipple balms
There is no strong evidence that phenoxyethanol causes cancer, damages reproductive health, or is an endocrine disruptor
Are you ready to formulate a new skin care or color cosmetics line with a professional lab specializing in small home-to-lab businesses like yours? We would love to work with your brand! Get in touch via email: customerservice@geniesupply.com or call: (812) 329-1105 for more information.
