Phthalates

What are “Phthalates”?

Phthalates are materials that are derived from the organic chemical phthalic acid. Although Phthalates are used primarily as plasticizers in plastics, meaning they are used to give flexibility to rubber, plastic, or resin, they are also used in just about every major product category such as construction, automotive, household, apparel, toys, packaging, and medicinal materials. Because Phthalates are widely used in many consumer products, their use has been extensively researched and reviewed. Phthalates are a broad class of ingredients; each has its own benefits and toxicological profile, so each must be considered for use separately.

Why are Phthalates used in personal care products?

Phthalates are used in cosmetic products as solubulizers (an agent that something is dissolved in), plasticizers, or denaturants (makes the product bitter to the taste). The Phthalate that is most frequently used in cosmetics and personal care products is Diethyl Phthalate [DEP]. Dimethyl Phthalate [DMP] may also have some uses in cosmetics and personal care products. Dibutyl Phthalate [DBP] is an ingredient that has been found to be safe and effective for use in making nail polish flexible and resistant to chipping. However, since DBP has been banned in some countries, the use of the ingredient has been discontinued by most manufacturers. Diethylhexyl Phthalate [DEHP] is no longer used in the manufacturing of cosmetic and personal care including nail products.

Link to FDA statement on Phthalates and Cosmetic Products : http://www.fda.gov/cosmetics/productandingredientsafety/selectedcosmetic...

Link to SCCNFP Report for DEP: http://ec.europa.eu/food/fs/sc/sccp/out168_en.pdf

DEP is most commonly used as a solubulizer in perfumes and as a denaturant in alcohol. The use of DEP also prolongs the scent of perfumes and, as a denaturant, renders alcoholic products unfit for oral consumption. The use of DEP as an alcohol denaturant also continues to be approved by the US Alcohol Tax & Trade Bureau (formerly the BATF).

What about the safety of Phthalates?

Although the U.S. Food and Drug Administration (FDA) has chosen not to take regulatory action against the use of DBP and DEHP in cosmetics, in 2004 the European Union [EU] prohibited the manufacture and/or sale of cosmetics containing these specific Phthalates. Additionally, in 2005 the state of California listed DEHP and DBP as chemicals that are known to the state to cause reproductive or developmental toxicity and require label warnings when these substances are present at higher than designated amounts. In 1988, DEHP was listed as a chemical known to the state to cause cancer. DEP has a long and safe history of use, and consumers are routinely exposed to DEP in the air, water, food, plastics, medical devices and drugs. The FDA has conducted its own studies to determine whether exposure to DEP contained in cosmetics products presents a human health risk. Based upon its test results and current toxicological data, the FDA concluded that no health hazard exists with DEP’s use in cosmetics and fragrances.

See FDA comments at the following link: http://www.fda.gov/cosmetics/productandingredientsafety/selectedcosmetic...

There have been some reports about the detection, using sophisticated analytical techniques, of very low levels of phthalates in cosmetics and personal care products. The presence of trace levels is not surprising and likely comes from product packaging. Scientific experts have concluded that these trace levels “do not indicate a risk to the health of the consumer.”

Link to the European SCCP Opinion on Phthalates in Cosmetics: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_106.pdf

What does FDA require for cosmetic products containing Phthalates?

DEP has a long and safe history of use, and consumers are routinely exposed to DEP in the air, water, food, plastics, medical devices and drugs. The FDA continues to evaluate whether exposure to DEP contained in cosmetics products presents a human health risk. To date, the FDA has concluded that the currently available evidence does not support a concern about DEP’s use in cosmetics and fragrances. Because of its excellent, long-term safety record, DEP continues to be internationally accepted by global regulatory authorities for these purposes. In the 2005 report to which a link is provided above, the U.S. Food and Drug Administration (FDA) stated that it is not clear what effect, if any, Phthalates have on health and that the Agency has found insufficient evidence to take regulatory action against the use of Phthalates in cosmetics. The FDA explained that at the present time, it does not have compelling evidence that phthalates, as used in cosmetics, pose a safety risk.

More information about Phthalates:

For more information on Phthalates and Phthalates in relation to cosmetics, the reader is encouraged to contact the following Web sites:

• Food and Drug Administration (FDA) at, http://www.fda.gov/

• Environmental Protection Agency (EPA) at, http://www.epa.gov/

• Center for Disease Control and Prevention (CDC) at, http://www.cdc.gov/

• National Institute of Health (NIH) at, http://www.nih.gov/

• California’s Office of Environmental Health and Hazard Assessment (OEHHA) at, http://www.oehha.ca.gov

• European Commission at, http://ec.europa.eu/index_en.htm

Cosmetic Ingredient Review (CIR) at, http://www.cir-safety.org/

• American Chemistry Council at, http://www.americanchemistry.com/s_acc/index.asp

• Cosmetics Europe at, https://cosmeticseurope.eu/safety-and-science-cosmetics-europe/products-...

• Research Institute for Fragrance Material (RIFM) at, http://www.rifm.org/

• Stats at George Mason University, http://www.stats.org

REFERENCES 1. Hauser R. et al. 2004. Medications as a source of human exposure to phthalates. Environ. Health Perspect., 112:751-753. 2. Doul, J. et al. 1999. A cancer risk assessment of di(2-ethylhexyl)phthalate: Application of the new U.S. EPA risk assessment guidelines. Regul. Toxicol. Pharmacol., 29:327-357. 3. Melnick, R.L. 2001. Is peroxisome proliferation an obligatory precursor step in the carcinogenicity of di(2-ethylhexyl)phthalate (DEHP)? Environ. Health Perspect., 109:437-442. 4. Scott, R.C., et al. 1987. In vitro absorption of some o-phthalate diesters through human and rat skin. Environ. Health Perpect., 74:223-227. 5. Hubinger, J.C. and D.C. Havery. 2006. Analysis of consumer cosmetic products for phthalate esters. J. Cosmet. Sci., 57(2):127-137. 6. Koo, H.J. and B.M. Lee. 2004. Estimated exposure to phthalates in cosmetics and risk assessment. J. Tox. Environ. Health, Part A, 67:1901-1014. 7. CIR Re-review. 2005. Int. J. Toxicol. 24(Suppl. 1): 1-102.