NCHR Testimony to FDA in Preparation for the 2017 International Cooperation on Cosmetics Regulation (ICCR) Meeting

Megan Polanin, PhD, National Center for Health Research, May 25, 2017

Preparation for the 2017 International Cooperation on Cosmetics Regulation (ICCR) Meeting

May 25, 2017

Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a Senior Fellow at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from industry, so I have no conflicts of interest.

We continue to be concerned about the presence of endocrine disrupting chemicals in cosmetics and their effect on consumers’ health. Some hormone disruptors such as phthalates and parabens are found in a wide range of cosmetic products. Others are used in specific cosmetics, such as triclosan in toothpaste and UV filters in sunscreen. Children and adults are exposed to many different soaps, creams, and other cosmetic products every day and thus are exposed to multiple doses of different endocrine disruptors.

Low molecular weight phthalates such as DEP, DBP, DiBP, and DMP are still found in many cosmetics.[1]Prenatal exposure and as a young child are associated with increased behavior problems, decreased cognitive function, and more attention problems.[2]

Parabens are used in cosmetics as preservatives.[3] They are associated with oxidative stress, DNA damage of sperm, altered thyroid hormones, and increased risk of allergies. In addition, parabens are associated with breast cancer tumors and their growth. In at least some cases, the health effects are stronger when multiple parabens are present, such as from use of several cosmetic products.

Phthalates and parabens are found in virtually all adults.[4,5,6] They move into human placenta and milk, where they harm fetal and infant development.

Cosmetics substantially contribute to overall exposure to endocrine disruptors. A 2016 study of adolescent girls found that just changing the cosmetics that they used reduced the amount of specific phthalates, parabens, and other endocrine disruptors by 27% to 45%.[7] This study needs to be replicated, but it suggests that cosmetics provide a substantial exposure at a vulnerable age.

One of the problems with evaluating the impact of endocrine disrupting chemicals is that they can have an impact at very low concentrations and show a U-shaped dose response.[8] The National Institute of Environmental Health Sciences (NIEHS) has explained that smaller doses can have stronger effects than larger doses. This is particularly problematic in measuring the impact of exposure during critical developmental windows, such as during fetal development, as a young child, or during puberty.

We strongly urge the ICCR to have a thorough discussion about the issues of endocrine disruptors in cosmetic products as well as policies to reduce exposure. Not all phthalates and parabens are endocrine disruptors and eliminating all phthalates and parabens from cosmetics would not eliminate all exposure. However, changing known or suspected endocrine disrupting chemicals to safer alternatives would substantially reduce overall exposure for many adults and children. In products where these chemicals are necessary, they should be clearly labeled so that consumers have the option to avoid them. These actions would reduce the risks of endocrine disrupting chemicals on consumers’ health.

We support the ICCR’s attention this year to two such endocrine disruptors: mercury and 1, 4-dioxane. The Regulators-Industry Traces Working Group concluded that the maximum allowable mercury levels in cosmetic products should be kept below a target level of less than or equal to 1 ppm mercury.[9] In addition, the Trace Elements Working Group recommended lower levels of 1, 4-dioxane in finished cosmetic products to 25 ppm for phase 1 and 10 ppm for phase 2. However, 96% of products studied were already at this level, and 90% had less than 10 ppm.[10] This recommendation seems to be based on the status quo rather than sound science.

This issue is similar to the FDA’s recent recommendation for a maximum level of lead in cosmetic lip products.[11] No research was conducted to determine whether the FDA’s proposed recommendation is actually safe for consumers, but instead the chosen maximum level is consistent with lip products currently on the market. These recommendations would clearly create a disincentive for the cosmetic industry to reduce levels of these toxic chemicals in their products.

Consumers deserve to know about all the chemicals in cosmetic products so that they can make informed health decisions for themselves and their families. The ICCR and FDA have a responsibility to set high standards for manufacturers so consumers are not inadvertently exposed to products that harm them, particularly given that manufacturers do not have to disclose these toxic chemicals on cosmetic labels. They have failed to do so. This is especially discouraging since the ICCR and FDA are merely making recommendations with no enforcement mechanisms.

In summary, endocrine disrupting chemicals and other harmful substances are present in many cosmetics in the United States. These substances can harm the health of adults and children, and it is essential for the FDA and the ICCR to consider the growing evidence for their harm. We urge the FDA and ICCR to establish high standards for maximum levels of endocrine disruptors and require manufacturers to clearly label their presence in products.

Thank you for your time and consideration of our views.

References

  1. Guo, Y. & Kannan, K. (2013). A Survey of Phthalates and Parabens in Personal Care Products from the United States and Its Implications for Human Exposure. Environmental Science & Technology, 47(24): 14442-14449.
  2. Ejaredar, M., Nyanza, E.C., Eycke, K.T., & Dewey, D. (2015). Phthalate Exposure and Childrens Neurodevelopment: A Systematic Review. Environmental Research, 142: 51-60.
  3. Błędzka, D., Gromadzińska, J., & Wąsowicz, W. (2014). Parabens. From Environmental Studies to Human Health. Environment International, 67: 27-42.
  4. Philippat C., Bennett D., Calafat A.M., & Picciotto, I.H. (2015). Exposure to select phthalates and phenols through use of personal care products among Californian adults and their children. Environmental Research, 40: 369-376.
  5. Braun, J.M., Just, A.C., Williams, P.L., Smith, K.W., Calafat, A.M., & Hauser, R. (2014). Personal care product use and urinary phthalate metabolite and paraben concentrations during pregnancy among women from a fertility clinic. Journal of Exposure Science and Environmental Epidemiology, 24(5): 459-66.
  6. National Health and Nutrition Examination Survey (NHANES) (2014, October). Phthalates and Plasticizers Metabolites – Urine (PHTHTE_G): 2011 – 2012Data Documentation, Codebook, and Frequencies. Retreived from http://wwwn.cdc.gov/Nchs/Nhanes/2011-2012/PHTHTE_G.htm.
  7. Harley, K.G., Kogut, K., Madrigal, D.S., Cardenas, M., Vera, I.A., Meza-Alfaro, G., She, J., Gavin, Q., Zahedi, R., Bradman, A., Eskenazi, B., Parra, K.L. (2016). Reducing Phthalate, Paraben, and Phenol Exposure from Personal Care Products in Adolescent Girls: Findings from the HERMOSA Intervention Study. Environmental Health Perspectives, 124(10): 1600.
  8. Diamanti-Kandarakis, E., Bourquioqnon, J.P., Giudice, L.C., Hauser, R., Prins, G.S., Soto, A.M., Zoeller, R.T., Gore, A.C. (2009). Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement. Endocrine Reviews, 30(4): 293-342.
  9. International Cooperation on Cosmetics Regulation (ICCR) (2016, September 22). Joint Traces Working Group: Recommendation for Acceptable Trace Mercury Levels in Cosmetic Products. Retrieved from http://www.iccrnet.org/files/2914/7461/8872/ICCR_WG_report_Recommendation_for_Acceptable_Trace_Mercury_Levels_in_Cosmetic_Products.pdf.
  10. International Cooperation on Cosmetics Regulation (ICCR) (2017, January). Report of the ICCR Working Group: Considerations on Acceptable Trace Levels of 1, 4-Dioxane Cosmetic Products. Retrieved from http://www.iccrnet.org/files/2414/8717/1555/ICCR_14-Dioxane_Final_2017.pdf.
  11. Food and Drug Administration (FDA) (2016, August). Draft Guidance, Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level Guidance for Industry (Docket No. FDA-2014-D-2275). Retrieved from https://www.regulations.gov/document?D=FDA-2014-D-2275-0002.