The Paraben Paradox: Are These Cosmetic Ingredients Worth Preserving?
Contract Manufacturer G.S. Cosmeceutical USA Weighs in on the Controversy

May 18, 2010, Livermore, California – When a group of British researchers analyzed a small sample of breast cancer tumors and discovered parabens in 18 of the 20 samples, their 2004 published study set off a public outcry against the preservatives found commonly in topical cosmetics and body care products.
As a result of the study, manufacturers scrambled to reformulate their cosmetic products. Parabens, such as methylparaben, propylparaben, ethylparaben and butylparaben, as well as their iso derivatives, were stricken from INCI lists and replaced with paraben-free preservative systems. Companies parlaying a paraben-containing shampoo, conditioner, facial moisturizer or cleanser were black-listed by some cosmetic bloggers, and consumers scoured cosmetic labels for the “P” word.
Despite the implications of that Journal of Applied Toxicology study, many questions remain today. Are parabens really that hazardous to our health, or are these once-popular preservatives just getting a bad rap?

The Paraben Paradox
On one hand, the UK-based study demonstrated that parabens are capable of penetrating the skin and accumulating in the body’s tissue fully intact. In general, parabens are known to exert weak estrogen-like activity and may lead to gene expression that causes breast tumor cells to grow.
However, the British study did not examine potential paraben levels in normal tissue. And while it is true that parabens can mimic estrogen activity, a 1998 Toxicology and Applied Pharmacology study concluded that the most potent paraben, butylparaben, demonstrated 10,000- to 100,000-fold less activity than naturally occurring estradiol. Furthermore, a 2005 Critical Reviews in Toxicology report found that parabens — even at maximum daily exposure estimates — could not increase the risk associated with estrogenic chemicals.

Parabens and Alternative Preservatives
Since the 1920s, parabens have been used widely as highly effective preservative systems in cosmetics to maintain product shelf life and to protect consumers against microbial growth.
These broad-spectrum preservatives can be found in a wide variety of food and products. They are found naturally in blueberries and even the human bloodstream as a byproduct of the amino acid tyrosine.
In cosmetics, parabens are used at low levels – generally at less than 0.2%, though they are often used in combination and, as demonstrated by the British study, may bioaccumulate in the body.
With all of the questions surrounding parabens, more contract manufacturers such as Livermore, California-based G.S. Cosmeceutical USA, Inc., are now offering safe, alternative preservatives as an option to maintain product safety, stability and shelf life.
According to G.S. Cosmeceutical CEO and Chief Scientific Officer Gogi Sangha, several variables, including a product’s pH level and water content, help determine the preservative system best suited for any given product.
Where parabens are not an option, one good alternative is a preservative system that incorporates phenoxyethanol, a synthetic preservative with a chemical makeup based on a natural antibacterial chemical found in the sage plant.
Ethylhexylglycerin is another choice, though this synthetic compound also must be paired with another preservative to maintain a high enough efficacy of microbial protection.
In recent years, the organic and natural ingredient movement has sparked a demand for food-grade and organic preservatives. Grain alcohol, for instance, is available in an organic version and can work independently in a formulation. Grain alcohol is also accepted by many associations, including the Natural Products Association (NPA).
The only downside is the perception of the word “alcohol,” which many equate with drying of the skin, though this can be countered by increasing the moisturizing ingredients in the formula.
Sodium dehydroacetate, potassium sorbate and sodium benzoate are popular “food-grade” choices. While these popular “safe enough to eat” choices tell a great marketing story, it’s important that consumers and skincare companies know that they can be ineffective in some formulations, particularly water-based products where the potential for microbial growth is much higher than anhydrous formulations. In those cases, “natural” is not always best. While you might have a cream or serum that’s free of parabens, the product could pose even greater danger to a consumer’s health if it’s contaminated with microbial organisms!
To date, major U.S. health, regulatory and cancer organizations, including the FDA and the American Cancer Society, have not found enough evidence to warrant a ban on parabens.
Nevertheless, the preliminary findings offer some cause for concern, and most agree that larger studies are needed to elucidate the long-term implications of parabens as cosmetic preservatives and what effect they might have on our health.

Filed under: Contract Manufacturing, Cosmeceutical Manufacturing, Cosmetic Chemistry and Formulation, Cosmetics, Health and Wellness, OTC Drug Manufacturing, Personal Care Products, Skincare Technology