Paul Brown & Stephanie Fox-Rawlings, PhD
Phthalates are synthetic chemicals found in everyday plastic products, including toys, children’s care products, medical tubes and saline or blood bags, and food packaging. They are used to make plastic flexible. They are also used in many personal care products that smell good, such as shampoo and creams, as well as air fresheners. The use of some phthalates is being restricted in some products; however, they are still very common. Phthalates can leach out of the plastic to cause health problems, especially for young children.
Q: Animals exposed to phthalates are more likely to develop serious diseases and health problems, such as liver cancer, kidney cancer, and male reproductive organ damage1, but have any studies shown that phthalates cause health problems in humans?
A: Yes, studies by Harvard researchers have shown that phthalates may damage human sperm DNA, reduce sperm numbers, and reduce its mobility2, and another study from several major medical centers has found that phthalates may cause genital changes for boys.3 Mount Sinai researchers found that girls exposed to more phthalates were more likely to be overweight.[end Wolff MS. (2012, January).Associations between phthalate metabolite urinary concentrations and body size measures in New York City children. Environmental Research 112:186-193] Other studies have shown that being exposed to phthalates increases the chance of developing asthma, allergies and bronchial obstruction.4
Q: Can phthalate exposure affect a child’s behavior?
A: Yes, prenatal exposure to phthalates and/or as a young child increases the chances of cognitive and behavior problems.5 Higher levels of phthalates have been associated with attention and memory problems, increased aggression and law-breaking behaviors, as well as poor social skills.
Q: Have scientists representing the European Union concluded that phthalates are safe?
A: No, in 2006, the European Union banned the use of 6 phthalates in toys that may be placed in the mouth by children younger than 3.6 The banned phthalates are DINP, DEHP, DBP, DIDP, DNOP, and BBzP. More recently the European Union banned the use of DEHP, BBP, DBP and BiBP in electronic equipment starting in 2019. The chemicals cause environmental and health hazards during recycling or disposal.7
Q: How are phthalates regulated in the US?
A: As of February 2009, U.S. law bans children’s toys and child care products related to sleep or feeding that contain the phthalates BBP, DBP, or DEHP. Toys or items that can be placed in a child’s mouth cannot contain DIDP, DINP, or DnOP.8 In 2014, the Chronic Hazard Advisory Panel recommended banning DIBP, DPENP, DHEXP, DCHP, and DIOP.9 The Consumer Protection and Safety Commission (CPSC) followed with a proposed a rule to ban DIBP, DPENP, DHEXP, and DCHP in children’s toys and care products.10 However a final rule (and thus the ban) has not been published. The Environmental Protection Agency (EPA) has planned to assess seven phthalates under the Toxic Substances Control Act, which could limit their use in all kinds of products.11 These are DBP, DIBP, BBP, DEHP, DnOP, DINP, and DIDP. However, it is unclear when assessment will occur.
Q: If phthalates are banned, will the toy industry start using unsafe alternatives?
A: No, federal legislation requires that alternatives to the banned phthalates are not hazardous under the Federal Hazardous Substance Act.8 Manufactures are also required to sufficiently test their product to insure it will not cause injury through normal use or predictable misuse.
Q: Should the Consumer Product Safety Commission (CPSC) establish federal regulations for phthalates that preempt state laws?
A: That would be a bad idea because some States have better laws than the federal government. The CPSC is a small agency that has a hard time keeping up with reports of unsafe products that are sold in the U.S. In 2015, CPSC recalled more than 600 distinct products, including 52 for children and babies.11 The states of California and Washington have passed strong laws to protect adults and children from unsafe products, and it would be inappropriate for federal laws to interfere. California has listed six phthalates (DBP, DEHP, BBP, DINP, DIDP, and DNHP) on their Prop 65 lists of chemicals known to cause cancer, birth defects or reproductive harm.12 In Washington state, the definition of “children’s product” is broader that that used by the CPSC. Therefore, there are some children’s products that cannot be sold in the state of Washington but are not banned by the CPSC. Examples include children’s cosmetics or clothing that are not packaged as toys.13
- Vastag, B., (2001, April). CDC Unveils First Report on Toxins in People, JAMA, Volume 285(14), pp 1827-1828. ▲
- Duty, S. M., M. J. Silva, et al., (2003). Phthalate exposure and human semen parameters. Epidemiology 14(3): 269-77. Duty, S. M., N. P. Singh, et al., (2003). The relationship between environmental exposures to phthalates and DNA damage in human sperm using the neutral comet assay. Environ Health Perspect 111(9): 1164-9. Duty, S. M., A. M. Calafat, et al., (2004). The relationship between environmental exposure to phthalates and computer-aided sperm analysis motion parameters. J Androl 25(2): 293-302. Duty, S. M., A. M. Calafat, et al., (2005). Phthalate exposure and reproductive hormones in adult men. Hum Reprod 20(3): 604-10. ▲
- Swan et al., (2005). Decrease in Anogenital Distance Among Male Infants with Prenatal Phthalate Exposure, Environmental Health Perspectives, National Institute of Environmental Health Sciences. ▲
- Jaakkola JJ, Knight TL (2008 July). The Role of exposure to phthalates from polyvinyl chloride products in the development of asthma and allergies: a systematic review and meta-analysis. Environ Health Perspect, 116(7): 845-53. Kanazawa A, Kishi R (2009 May). Potential risk of indoor semivolatile organic compounds indoors to human health. Nippon Eiseigaku Zasshi, 64(3): 672-82. Hsu NY, Lee CC, Wang JY, et al. (2012). Predicted risk of childhood allergy, asthma, and reported symptoms using measured phthalate exposure in dust and urine. Indoor Air. 22(3): 189-99. ▲
- Ejaredar M, Nyanza EC, Eycke KT, Dewey D (2015). Phthalate exposure and childrens neurodevelopment: A systematic review. Environ Res 142:51-60. ▲
- Sathyanarayana S, Swan SH et al., (2008, February). Baby Care Products: Possible Sources of Infant Phthalate Exposure, Pediatrics, Vol. 121, No. 2. ▲
- European Commission (2015, March). Commission Delegated Directive: amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances. http://ec.europa.eu/transparency/regdoc/rep/3/2015/EN/3-2015-2067-EN-F1-1.PDF ▲
- CPSC (2015 July). Phthalates. http://www.cpsc.gov/en/Business–Manufacturing/Business-Education/Business-Guidance/Phthalates-Information/#p-5 ▲
- CPSC (2014). Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives. http://www.cpsc.gov/PageFiles/169902/CHAP-REPORT-With-Appendices.pdf ▲
- CPSC (2014, December). Proposed Rule: Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates. https://www.federalregister.gov/articles/2014/12/30/2014-29967/prohibition-of-childrens-toys-and-child-care-articles-containing-specified-phthalates#h-12 ▲
- CPSC (2016). Recent Recalls. http://www.cpsc.gov/en/Recalls. ▲
- OEHHA (2016 April). Proposition 65: Current Proposition 65 List. http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html ▲
- State of Washington Department of Ecology (2016 February). Children’s Safe Product Act – RCW 70.240.020 Lead, Cadmium, and Phthalates. http://www.ecy.wa.gov/programs/hwtr/RTT/cspa/pdf/LeadCadmiumPhthalatesenforcement.pdf ▲