Phthalates are chemicals that are most often, but not always, used to make plastics softer and/or more pliable. In this use, phthalates function as plasticizers. One example of a product that may contain phthalates is a children's rubber duck; the flexible plastic feel of the rubber duck may be the result of using phthalates in the manufacturing process.
Section 108 of the Consumer Product Safety Improvement Act, codified at 15 U.S.C. § 2057c and 16 C.F.R. part 1307, prohibits the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States children’s toys and child care articles that contain more than 0.1% (1000 ppm) of the following phthalates in an accessible plasticized component:
- Di-(2-ethylhexyl) phthalate (DEHP)
- Dibutyl phthalate (DBP)
- Benzyl butyl phthalate (BBP)
- Diisononyl phthalate (DINP)
- Diisobutyl phthalate (DIBP)
- Di-n-pentyl phthalate (DPENP)
- Di-n-hexyl phthalate (DHEXP)
- Dicyclohexyl phthalate (DCHP)
16 C.F.R. part 1199 provides guidance on accessibility for the phthalate regulation.
A “children’s toy” is a “consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays”.
A “child care article” is a “product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething”.
Exemptions from Testing
The Commission has determined that certain materials are exempt from testing for phthalates:
- Certain untreated and unfinished engineered wood products listed at 16 C.F.R. § 1252.3(c)
- Untreated and unfinished fibers listed at 16 C.F.R. § 1253.2(c)
- Certain plastics with the noted additives as listed at 16 C.F.R. § 1308.2(a)
This testing exemption does NOT provide an exemption from meeting the underlying phthalate requirement. Firms are still expected to certify compliance with the phthalate requirement in a Children’s Product Certificate (CPC). Further, if the end product as received by a consumer is found to have a regulated phthalate in excess of 0.1% (1000 ppm), the firm may still be held responsible for noncompliance.
Certification
Section 14(a)(2) of the Consumer Product Safety Act (CPSA) requires manufacturers and importers of children’s products subject to a regulation, standard, or ban enforced by the CPSC to certify that those products meet the requirements of the standard by issuing a CPC. For children’s products subject to the phthalate requirement, the citation to use in section 2 of the CPC is “16 C.F.R. part 1307 – Phthalates”. For more information on creating a CPC, visit our CPC business guidance page.
Additional Information
Contact
- SBO contact form
- Toll-free: (888) 531-9070
- Email: SBO@cpsc.gov