We are usually not given over to dramatics particularly in
the choice of a jot title but “hidden dangers” aptly describes the current
situation with phthalates.
What are phthalates?
Phthalates (pronounced “thal-ates”) are esters of phthalic
acid (or benzene-1,2-dicarboxylic acid, to the chemically inclined). They
include di-ethyl phthalate (DEP), di-isobutyl phthalate (DIBP), di-n-butyl
phthalate (DBP), and di-n-octyl phthalate (DOP), to name a few.
Commonly used as plasticizers to make plastics more flexible
and easier to process, phthalates occur in a wide range of products such as
vinyl shower curtains, upholstery, plastic toys, paints, adhesives, and yes,
cosmetics too. (BTW, that new car smell that some of us find so pleasant -
that’s probably phthalates at work.) In the realm of cosmetics and personal
care, phthalates are used in nail polish to render it chip resistant, and in
hairsprays to create pliable coatings so your beautifully styled hair won’t
feel crunchy. The presence of phthalates in these products should be indicated
on the ingredients list on the label. They could be hidden, however, if they
are used in fragrances as solvents or fixatives. Manufacturers are not required
to disclose the ingredients of fragrances because of their proprietary nature;
hence, the consumer would only see “fragrance” on the ingredients list. (To be
fair to the cosmetics industry, phthalates are also “hidden” in a host of other
products that do not require an ingredients label, such as shower curtains,
intravenous bags, and plastic bottles.)
So what’s the danger?
Because of their ubiquitous nature, we are constantly
exposed to and consequently harboring phthalates in our bodies. A study by
the U.S. Centers for Disease Control (CDC) in 2000 found metabolites associated
with phthalate exposure in every single of the 289 people tested, with the
highest levels recorded in women of reproductive age .
This finding is particularly worrisome, as phthalates have
been shown to be reproductive and developmental toxins - and may
contribute to what is known as “testicular dysgenesis syndrome”: increasing
incidence of birth defects of the male reproductive tract such as undescended testis,
and lower sperm count . (Phthalates are believed to inhibit testosterone
synthesis during the critical period of fetal development when masculine traits
are beginning to form.) While a lot of attention has been focused on the "demasculation" of boys by phthalates, women are not immune to their effects. Phthalates are implicated in premature puberty in girls , and in
animal studies, they appear to suppress estradiol production, prolong estrous
cycles, and cause anovulation (no egg released in the cycle), a common cause of
infertility . Furthermore recent studies suggest that
prenatal phthalate exposure may be linked to lower birth weight in newborns 
and disruptive behavior in offspring .
What’s being done?
The use of a number of phthalates in cosmetics has been
banned in the EU, Japan, Taiwan, and other countries. No such restrictions
exist yet in the U.S. where the FDA has not taken regulatory action, citing insufficient evidence of causality. The Cosmetic Ingredient Review (CIR; a trade panel that
reviews cosmetics ingredient safety) has asserted that phthalates are safe as
used in cosmetics, the argument being that they are used in much smaller
quantities than doses shown to cause adverse effects (yes, but there are risks
of bioaccumulation from repeated exposure). Phthalate chemical producers cite
the decades long history of use as evidence for their safety and say any
alternative would be less tested and less safe. Their stance is not surprising;
however to maintain the status quo in light of mounting evidence that phthalates are not benign would be a huge disservice to us and our children .
Changes are coming, albeit slowly. Congress has banned
the use of three types of phthalates (DBP, DEHP, and BBP) in children’s toys
effective March 2010. Pressure from environmental and consumer advocacy groups
has caused several cosmetics companies (OPI, Orly, Sally Hansen) to reformulate
their nail polishes without phthalates. The EPA announced in its Chemical Action Plan in December 2009 that it will evaluate the risks of 8 phthalates “because
of their toxicity and the evidence of pervasive human and environmental
exposure to these chemicals.”  EPA intends to add them in autumn 2010 to the Concern List under
the 1976 Toxic Substances Control Act “as chemicals that present
or may present an unreasonable risk of injury to health or the environment.”
What we are doing
We talked about parabens in an earlier jot, and if we were to
compare these two suspected endocrine disruptors, we would put phthalates as higher risk (rest assured they are both excluded from our products). We are
mindful that they may be hidden in fragrances; hence we use only phthalate-free
fragrances in our bath and home scent lines. Products that are expected to
linger on the skin, e.g. lotions, lip balms, and deodorants, are scented with
natural essential oils, absolutes, and oleoresins. These are all natural fragrances
that we invest a considerable amount of effort and expense into procuring and
using. We are also in the process of reducing (and eventually eliminating) the use of shrink wrap in our
products. You may find changes in the packaging of some of
our products in the weeks ahead as we remove shrink wrapping and add tamper-evident paper seals. While the shrink wrap does not contact the
products directly (and should not transfer to you), we feel we should not potentially add to the phthalate load
in the environment.
At home, we have switched to fabric shower curtain
liners and are happy to realize that they can be laundered and reused. We also avoid storing and heating food in plastic containers, and our cars, because of their age, no longer have the new car smell.
1. Blount et al. Levels of Seven Urinary Phthalate Metabolites in a Human Reference
Population. Environmental Health Perspectives. 108 979-982 (2000)
2. Park et al. The plasticizer diethylhexyl phthalate
induces malformations by decreasing fetal testosterone synthesis during sexual
differentiation in the male rat. Toxicological Sciences. 58339-349 (2000)
3. Barlow et al. Male reproductive tract lesions at 6, 12, and 18 months of age
following in utero exposure to di(n-butyl) phthalate. Toxicologic Pathology.32 79-90
4. Gray et al. Perinatal exposure to the phthalates DEHP, BBP,
and DINP, but not DEP, DMP, or DOTP, alters sexual differentiation of the male
rat. Toxicological Sciences.58 350-365 (2000)
5. Swan et al. Decrease in anogenital distance among male
infants with prenatal phthalate exposure. Environmental Health Perspectives. 113 1056-1061 (2005)
6. Skakkebæk et al. Testicular dysgenesis syndrome: an
increasingly common developmental disorder with environmental aspects. Human
Reproduction. 16 (972-978)
7. Chou et al. Phthalate exposure in girls during early
puberty. Journal of Pediatric Endocrinology & Metabolism.22 69-77 (2009)
8. Lovekamp-Swan et al. Mechanisms of phthalate ester toxicity in the female
reproductive system.Environmental Health Perspectives. 111 139-145 (2003)
9. Zhang et al. Phthalate levels and low birth weight: A nested
case-control study of Chinese newborns. The Journal of Pediatrics.155 500-504 (2009)
10. Engel et al. Prenatal
phthalate exposure is associated with childhood behavior and executive
functioning. Environmental Health Perspectives. In Press (2010)
Over the past few years, we have seen news articles reporting an association between parabens and breast cancer. These reports suggest that parabens can cause breast cancer by acting like estrogen, a female sex hormone, through a process called endocrine distruption. Advocacy groups such as the Campaign for Safe Cosmetics and the Environmental Working Group have cautioned against the use of paraben-containing products, giving parabens a hazard score of 8 on a scale of 1-10. (Phthalates get a scary 10 – more on that in a future jot.)
But what are parabens and are they worth avoiding?
Parabens and Cosmetics
Parabens are a class of preservatives that are used in a variety of foods, drugs, and cosmetics to prevent the growth of harmful microorganisms. Chemically, parabens are esters of p-hydroxybenzoic acid. The most common parabens used in cosmetic products are methyl paraben, propyl paraben, and butyl paraben. Parabens are typically used at levels ranging from 0.01 to 0.3% (per paraben).
Parabens have been used for decades as preservatives in the cosmetic industry and is recognized as safe by the U.S. Food and Drug Administration (FDA). Additionally, a report by the Cosmetic Ingredient Review (CIR) Expert Panel issued on June 19, 2006, concluded that methyl paraben, ethyl paraben, propyl paraben, isopropyl paraben, butyl paraben, isobutyl paraben, and benzyl paraben are safe as used in cosmetics. (Note: the CIR is an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature.)
How Do Parabens End Up in the Body?
Up to 60 percent of topically applied chemicals in cosmetics, lotions, and other personal care products may be absorbed through the skin. In addition to this dermal route, parabens can enter the body through the ingestion of food that contains parabens. However, orally ingested parabens are believed to be metabolized rapidly. A third potential route is via inhalation of parabens in the air. A recent study reported the detection of parabens in indoor air and house dust, probably due to the prevalence of parabens in household and personal care products (Rudel et al., 2009).
The Paraben Fuss
Concerns about parabens stem from studies showing measurable levels of parabens in human tissue, including breast tumors (Darbre et al., 2004; Soni et al., 2001). While parabens are believed to not bioaccumulate, once in the body, they could act as weak estrogen mimics (Kang et al., 2002; Routledge et al., 1998). The danger of estrogen mimics lies in their potential to disrupt normal hormonal balance and physiological functions. Oishi has found that the administration of parabens to male rats resulted in lowered testosterone and sperm production (Oishi, 2001).
The link to breast cancer is more tenuous. While estrogenic activity is associated with certain forms of breast cancer, and estrogenic suppression is important in the treatment of these cancers, it has been argued that the estrogenic activity of parabens is 10,000-to 100,000-fold less than naturally occurring estradiol (a form of estrogen) and also less than that of phytoestrogens naturally found in foods, e.g. flavonoids in soy.
FDA has also pointed out that current studies have not established causality between parabens and breast cancer. Considering the low levels used in cosmetics, “FDA believes that at the present time there is no reason for consumers to be concerned about the use of cosmetics containing parabens. However, the agency will continue to evaluate new data in this area.” (see FDA statement issued on March 24, 2006)
Although there is no direct evidence linking parabens to breast cancer, there is similarly no evidence that permits us to conclude with certainty that parabens are safe. Their long-term health impact is unknown at this point. We understand that such research is difficult and lengthy in undertaking, and while we sit tight and wait for new data, we believe it is prudent to not unnecessarily expose ourselves and our customers to potentially hazardous chemicals. And yes, while we understand that it is frequently the dose that makes the poison, and one might argue that parabens are used at such low levels to pose no harm, we need to remember that they are often used in combination – a product may contain more than 1 type of paraben bringing the total concentration closer to 1% – and are ubiquitous in household and personal care products such that one’s exposure could add up quite quickly. Research has also shown that repeated applications of paraben-containing product may increase the quantities of parabens crossing the skin barrier (El Hussein, 2007).
We have no issue with other companies using parabens in their products. They are FDA approved preservatives that are highly effective and economical. However, we cannot in good conscience use parabens knowing that alternatives are available. In line with our philosophy, we want to avoid “iffy” chemicals, so until we know what’s the real deal with parabens, we will continue to keep them out of our products.
1. Darbre, P.D. et al. Concentrations of parabens in human breast tumours. Journal of Applied Toxicology.24 5–13 (2004)
2. El Hussein, S. et al. Assessment of principal parabens used in cosmetics after their passage through human-epidermis layers (ex-vivo study). Experimental Dermatology.16 (10) 830-836 (2007)
3. Kang, K.S. et al. Decreased sperm number and motile activity on the F1 offspring maternally exposed to butyl p-hydroxybenzoic acid (butylparaben). The Journal of Veterinary Medical Science.64 (3) 227–235 (2002)
4. Oishi S. Effects of butyl paraben on the male reproductive system in rats. Toxicology and Industrial Health.17 (1)31-39 (2001)
5. Routledge, E.J. et al. Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicology and Applied Pharmacology. 153 (1) 12–19 (1998)
6. Soni, M.G. et al. Safety assessment of propyl paraben: a review of the published literature. Food and Chemical Toxicology.39 (6) 513–532 (2001)
7. Rudel et al. Endocrine disrupting chemicals in indoor and outdoor air. Atmospheric Environment.43 170–181 (2009)
8. FDA statement on March 24, 2006: http://www.fda.gov/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/ucm128042.htm