Technical Spotlight – Phthalates Materials TestingNovember 23, 2015
What are Phthalates?
Phthalates are plasticizers used to soften rigid plastics and are also used as adhesives and solvents. These compounds are present in a wide variety of products such as children’s toys, cosmetics, medical devices, pharmaceuticals, and packaging materials just to name a few. There is concern that phthalates leach out of these products and can be absorbed by various means of contact. In the human body, there is serious concern that these compounds have possible adverse effects on human development and reproduction. The FDA has made recommendations on how to reduce exposure to DEHP from medical devices and has defined a high-risk patient group would be most sensitive to exposure.
Wal-Mart, Target, and Toys R Us proactively initiated phase out of products containing phthalates prior to the required date of enforcement.
Who needs to test for Phthlates?
Manufacturers, Importers, and Crafters of:
- Children’s toys: products intended for a child 12 years of age or younger for use when playing. General use balls, bath toys/books, dolls, and inflatable pool toys are examples of toys that are covered by the law.
- Child care articles: products that a child 3 years of age or younger would use for sleeping, feeding, sucking, or teething. Bibs, child placemats, child utensils, feeding bottles, cribs, booster seats, pacifiers and teethers are articles that are covered by the law.
Who is mandating testing for Phthalates?
U.S. Consumer Product Safety Commission (CPSC)
- Regulation of 6 phthalates – butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), di (2-ethylhexyl) phthalate (DEHP), diisodecyl phthalate (DIDP), diisononyl phthalate (DINP), and di-n-octyl phthalate (DnOP)
- Three phthalates (DEHP, DBP, and BBP) have been permanently banned in concentrations of more than 0.1% in children’s toys and child care articles.
U.S. Environmental Protection Agency (EPA)
- December 30, 2009, posted an Action Plan for phthalates
- Eight phthalates are listed on the Action Plan: BBP, DBP, DEHP, diisobutyl phthalate (DIBP), DIDP, DINP, DnOP, and di-n-pentyl phthalate (DnPP)
- EPA intends to initiate rulemaking in autumn 2010 to add the above eight phthalates to the Concern List under TSCA section 5(b)(4)as chemicals that present or may present an unreasonable risk of injury to health or the environment.
- In late 2010, EPA intends to initiate rulemaking to add the phthalates that have not been previously listed on the Toxics Release Inventory (TRI).
Individual U.S. States – bans and proposed laws
- California – Prop 65 list: BBP, DBP, DEHP (among first to be listed), DIDP, and Di-n-hexyl phthalate (DnHP)
- New Jersey
- New York
- Rhode Island
- West Virginia
- Europe – REACH; banned use of DEHP, DBP, and BBP children’s toys and childcare articles in concentrations over 0.1% by weight. Three additional phthalates (DINP, DIDP, and DnOP) have been prohibited in concentrations of more than 0.1% pending further study and review by the Commission and a group of outside experts. This interim prohibition applies to child care articles and toys that can be placed in a child’s mouth or brought to the mouth and kept in the mouth so that it can be sucked or chewed. There is an amendment (2007/47/EC) to Directive 93/42/EEC concerning phthalates and their use in medical devices (“Devices which contain phthalates, and which are intended to channel, transport or store medicines, body fluids or other substances for administration must be labeled to show presence of phthalates.”).
- Nine other countries including Japan, Argentina, Mexico