I. Federal Regulatory Action

A. US Environmental Protection Agency (EPA)

• Set a drinking water standard for DEHP (6 ppb).8

• Listed DEHP and DBP as hazardous air pollutants and as substances on the Toxic Release Inventory that must be reported to EPA if released into any media.8

• Listed phthalates as hazardous waste if discarded as commercial chemical products under the Resource Conservation and Recovery Act.8

• Recently designated 5 phthalates (DnBP, DiBP, BBzP, DEHP, and DCHP) as high-priority substances for risk evaluation under the Toxic Substances Control Act.9

B. US Consumer Product Safety Commission

• Banned 8 ortho-phthalates from use in children’s toys and childcare articles: DEHP, DBP, BBzP, DINP, DiBP, DPENP, DHEXP, and DCHP.10 The regulation is under legal challenge by the National Association of Manufacturers, the American Chemistry Council, and other industry groups.11

C. US Food and Drug Administration (FDA)

• Set maximum concentration of DEHP in bottled water at the same concentration that EPA had set in drinking water.12

• Issued guidelines (but not regulation) recommending that DBP and DEHP be avoided as excipients in prescription and nonprescription products,13 advised manufacturers to label medical devices that contain DEHP,14 and concluded that exposure to DEHP received by some infants from medical device–related sources could be substantially greater than the agency’s estimate of the Tolerable Intake.15

• Approved use of 28 phthalates as food additives in food contact articles.16,17 Uses include as plasticizers, binders, coating agents, defoamers, and gasket closures, in materials such as cellophane, paper and paperboard, and plastics.

• Has failed to meet the statutory deadline for final decisions on 3 recently submitted petitions that could substantially reduce dietary exposure to phthalates.17 o Two were submitted by 11 environmental and public health organizations and requested that FDA strike from its existing regulations its approvals of all 28 phthalates as food additives in food contact articles, as the agency could no longer conclude that such use is safe, as is required by law.17

o The third petition was submitted by the Flexible Vinyl Alliance and requested that FDA revoke its approval of 24 phthalates that the Alliance claims are no longer used as food additives in food contact applications.17 The industry petition did not include several approved uses of these phthalates and continued the approval of DEHP, DINP, DCHP, and DIDP as food additives.

II. Examples of Voluntary Action by Retailers and Manufacturers

• Home Depot’s safer chemicals policy includes restrictions on phthalates as a class in vinyl flooring and wall-to-wall carpet.18,19

• Lowe’s, Lumber Liquidators, and Menards have taken action to remove phthalates as a class from vinyl flooring.19,20

• Apple has removed phthalates as a class from almost all products.21

• Hewlett Packard has removed multiple phthalates from commercial personal computer products and a lesser number from other products.22

• IKEA has removed phthalates from a number of its products.23

• Mohawk,24 Tarkett,24 SC Johnson,25 and Steelcase26 have restricted use of phthalates in some products, including household products.

• Ahold Delhaize, the fourth largest grocery chain in the United States (with 2000 stores including Food Lion, Giant Food, Giant/Martin’s, Hannaford, and Stop & Shop) recently announced restrictions on phthalates and other chemicals in its own branded products in the following categories: all grocery, baby food and infant formula, and formulated laundry products, as well as personal care, cosmetic, and baby products.27,28

• CVS Health,29 Loblaw,29 Rite Aid,30 and Walmart31 are also reducing the use of phthalates in beauty and personal care products and household products with the goal of elimination.

• Sephora set a goal to reduce high-priority chemicals including 8 phthalates by 50% over the next 3 years.32,33

• Panera Bread has replaced vinyl gloves, which must be softened with phthalates or other plasticizers, with safer alternatives such as polyethylene gloves that require no such chemical additives.33

III. Examples of Health Care Organization and Medical Supplier Actions

• Dignity Health,34 Hackensack Meridian Health,35 and Kaiser Permanente36 have a stated preference for products made without phthalates.

• Warner Chilcott recently brought a new product to market, Delzicol (mesalamine), which does not contain DBP in the medication coating.37

In totality, these examples demonstrate the feasibility of reformulating a vast array of products to remove phthalates. Cited references can help inform steps necessary in selection of safer alternatives when replacing phthalates.38–40

Note. BBzP = butylbenzyl phthalate; DBP = dibutyl phthalate; DCHP = dicyclohexl phthalate; DEHP = di-2-ethylhexyl phthalate; DHEXP = di-n-hexyl phthalate; DiBP = diisobutyl phthalate; DIDP = di-isodecyl phthalate; DINP = diisononyl phthalate; DnBP = di-n-butyl phthalate; DPENP = di-n-pentyl phthalate; and ppb = parts per billion.