U.S. – CPSC Issues Final Rule to Modify and Expand the Ban on Phthalates in Toys and Child Care Articles
Vol. 996 | October 23, 2017
On October 18, 2017, the U.S. Consumer Product Safety Commission (CPSC) voted to approve a Final Rule modifying and expanding the existing CPSC regulation limiting certain phthalates (plastic softeners) in toys and child care articles. The new Rule will go into effect in approximately six months’ time (180 days from official publication in the Federal Register). At the same hearing, CPSC Commissioner Joseph P. Mohorovic announced his resignation from the agency effective October 20, 2017.
Culminating a more than eight-year process of review of the scientific literature regarding long-term health effects of human exposure to phthalates by a panel of scientists known as a Chronic Hazard Advisory Panel (CHAP), this Final Rule follows the CHAP’s recommendation to remove the federal limit of 1,000 parts-per-million (ppm), or 0.1% for two specific phthalates and adds four additional phthalates to those that may not exceed the 1,000 ppm level in covered children’s products. Specifically, the Final Rule:
- Drops the 1,000 ppm limit for di-n-octyl phthalate (DNOP) and diisodecyl phthalate (DIDP);
- Imposes new 1,000 ppm limits on diisobutyl phthalate (DIBP); Di-n-pentyl phthalate (DPENP); di-n-hexyl phthalate (DHEXP) and dicyclohexyl phthalate (DCHP);
- Expands the limit on the now 8 specified phthalates to accessible components of all toys, from the current limit on only those toys that are “mouthable” (have any dimension less than 5 cm);
- Maintains the statutory definition of “toy” to mean “a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by a child when s/he plays” (noting that this definition is slightly different from the scope of the mandatory CPSC Toy Safety Standard, which includes play products for children under 14 years of age);
- Maintains the current definition of “child care articles” to include all products for children 3 years and younger (under 4 years) that are intended to facilitate sleep or feeding, or to help such children with sucking or teething (e.g., teething rings and pacifiers); and
- Maintains the current limitation of the phthalates limits to only “plasticized” component parts of a toy or child care article components of a product that are accessible to the child through normal use and abuse of the product.
Note that the expanded CPSC list of phthalates subject to the 1,000 ppm limit is different than the list of California Proposition 65 phthalates. For companies intending to avoid either the CPC or Proposition 65 list of phthalates, the combined includes 9 phthalates: CPSC: DEHP; DBP; BBP; DINP; DIBP; DPENP; DHEXP; DCHP and the additional Proposition 65-listed phthalate DIDP.
Also note that the CPSC recently expanded its so-called “Determinations List” of materials in toys and child care articles that do not require third party testing (but must nevertheless remain compliant with the limits) as they do not typically contain phthalates, and has recently proposed to further expand that list to include manufactured woods. (See Intertek Insight bulletins Vol. 984 and Vol. 995).
While not yet officially published in the Federal Register, the Final Rule “staff package” (including the actual rule text at pages 177 – 179) may be found at: https://www.cpsc.gov/s3fs-public/Final%20Rule%20-%20Phthalates%20-%20September%2013%202017.pdf?nArsRDzq81e90J4Re2BFAzjdQHxq8Mh_