Are Parabens Really Dangerous?

Parabens are sometimes regarded as the boogeyman of skincare. The Environmental Working Group has parabens listed as a part of their dirty dozen food additives1. However, parabens are used far more frequently in cosmetics, and at greater concentrations, which is mainly where there is controversy, leading many companies to use “paraben-free” as marketing in its own right. This month, we fact check this controversy, and whether the fear is really warranted.

*We follow the works of The Health Controversies of Parabens, published in Skin Therapy Letter, as well as other studies and summaries on this topic, which will be listed at the end of the article for readers who would like to delve deeper.

Background: What are Parabens anyway and what are they used for?

Parabens are not a singular entity, but a family of chemical products derived from parahydroxybenzoic acid, also known as 4-hydroxybenzoic acid, the main parabens in question being methylparaben, ethylparaben, propylparaben, and butylparaben2. Parabens are widely used as preservatives in cosmetic products that range from toothpaste to shampoo, moisturizers, and deodorants. They control mould and yeast growth very effectively, and some parabens also have some antibacterial properties3. These properties are also used in food additives for the same reason--to preserve it for longer, although they are used in much lower concentrations4. In cosmetics, parabens have been used for over 80 years, as a low cost preservative with a high safety profile, and one that has a relatively low chance of triggering skin irritation and allergic reactions (although the chances are never zero).

What is the controversy or concern?

A 2004 study, Concentrations of Parabens in Human Breast Tumour, published in the Journal of Applied Toxicology, found parabens in the breast tissue of patients with breast cancer. Breast cancer is a very common and serious cancer that affects a large number of women. Given the pervasiveness of parabens in our life, this caused a deluge of questions and concerns among consumers, chemists, and regulators. The primary concerns that were raised:

  • There are a large amount of everyday products that contain parabens: Soap, Body lotion, Shampoo, Foundations, Lipstick, Sunscreen, Mascara, Hair Spray, as well as food additives. The ubiquity of parabens makes any potential for toxicity a serious concern. Parabens have been used since the 1930s, and possibly the late 1920s, largely replacing formaldehyde for its preservative properties.
  • Parabens are so ubiquitous in products we use that traces have been found in various environments such as streams, agriculture fields, rivers and drinking water sources, and even in house dust5. Their concentrations, however, are low.
  • Parabens have also been found in the human body. They can be absorbed through the skin (for cosmetic products), and ingested (when in food). The body metabolizes parabens, but they have been found in breast milk and urine. The most concerning was the finding that they were found in the breast tissue of patients with breast cancer.

The primary concerns among some scientists is that given how often parabens are used in cosmetics, and that our bodies can absorb them, we should investigate possible effects of long-term exposures. Given that we have been using parabens for 80 years, it does not have acute toxicity at the levels we are exposed to normally. Like a game of telephone, by the time it reaches some people, it can turn into exaggerated “poison the public” panics, or like the autism/vaccination conspiracy, dangerous misinformation. That said, examining the long-term effects of exposure of something like parabens is important, given how we often we are exposed to it through everyday products.

The Big Question: Toxicity

There is no acute toxicity in parabens, at least from levels of exposures that we are subjected to. While this should be clear from the fact that parabens have been used widely for over 80 years, it’s still important to clarify that the studies and concerns are related to long-term effects of chronic exposure5. The main concerns with parabens are:

  • Estrogenic activity: First identified in 1998, and validated in vitro and in vivo (using mice uterus assays). However, the estrogenic activity is extremely weak (10,000 to 1,000,000 times weaker than estradiol)6.
  • Effect on male reproductive system have also been studied, but its findings are conflicting. In the end no correlation between sperm count and fertility, and parabens were found8.
  • Allergic reactions: The most common reaction to parabens, is eczematous rashes, and the rates are between 0.5% and 3.5%. These rates are the lowest among alternative preservatives.

Have there been studies on parabens and what’s the verdict?

Since the 2004 study, Concentrations of Parabens in Human Breast Tumour was published, concerns were raised, and grabbed widespread public attention, many studies have looked into parabens and their potential long-term effect. Government regulatory agencies in Europe and North America were quick to investigate current usage and safety for obvious reasons.

The most concerning aspect of the controversy--that of possible connection to breast cancer (since this is a very common cancer in women), at least at this time, appears to be thin in reliable evidence. Notably, the study into parabens in breast tissue of patients had no comparison with normal controls.

Europe: The European Union has set limits on paraben use based on the recommendation of the European Scientific Committee of Consumer Products (SCCP) at 0.4% per individual paraben (there are many parabens), and 0.8% in total.

United States: The FDA’s current position is that at this time, there is no evidence to suggest that parabens are harmful to humans at the concentrations that we are exposed to currently. The Cosmetic Ingredient Review (CIR) has recommended a maximum concentration of 0.4% for any individual paraben and a maximum total of 0.8% for total parabens. This recommendation is following a 2006 recommendation from the European Scientific Committee on Consumer Products (SCCP). It should be noted, however, that these are only guidelines, and manufacturers are not required by law to follow them.

Canada: Health Canada has followed the same guidelines with the United States FDA, and CIR. Similarly, these are recommended guidelines, and manufacturers are not required by law to follow them.

Pragmatically What Should you do?

Given that regulatory agencies on health matters are quite conservative when it comes to public safety, the current evidence seems to suggest that they are safe. This said, science is always evolving, and things that were considered safe in the past, were replaced when they were found to have adverse effects that were unknown at a later time, or when better alternatives were found.

The practical question that many people consider is, why not play it safe, and avoid it if there’s any uncertainty whatsoever? This is certainly a reasonable stance, and there is a niche in cosmetic products that avoid parabens altogether. The wider challenge is that preservatives are absolutely necessary in cosmetic products to ensure that they are safe over time. The air contains a ton of fungi, bacteria, yeasts, and molds which can land on your cosmetic product anytime it’s opened and exposed to air, and build a home where there is plenty of moisture and what they consider food. The alternatives to parabens, both natural and synthetic, which are both cost-effective, and have been time-tested, have more serious drawbacks in terms of efficacy, irritation, or allergic reactions. Research on the effects of parabens will surely continue, but at this time, in terms of relative risk, parabens look like the way to go. Ultimately, however, you as the consumer have the power of choice, and there are a wide range of products out there that use alternative preservatives if you choose to avoid parabens.

6Routledge EJ, Parker J, Odum J, et al. Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicol Appl Pharmacol. 1998 Nov;153(1):12-9.
7Barr L, Metaxas G, Harbach CA, et al. Measurement of paraben concentrations in human breast tissue at serial locations across the breast from axilla to sternum. J Appl Toxicol. 2012 Mar;32(3):219-32.
9Cosmetic Ingredient Review Expert Panel. 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.