Any children’s toy or child care article, as defined at 16 C.F.R. § 1307.2, that contains concentrations of more than 0.1 % (1000 ppm) of the following phthalates in an accessible component part is prohibited:
- 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 when components are considered accessible for the purposes of phthalates regulation. For more information, visit our phthalates business guidance page.
The law that prohibits children's toys and child care articles that contain certain phthalates can be found in section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), Pub. L. No. 110-314, 122 Stat. 3016 (August 14, 2008), as amended by Section 5 of Public Law No. 112-28 (August 12, 2011), and codified at 15 U.S.C. § 2057c.
The Commission regulation concerning phthalates can be found at 16 C.F.R. part 1307.
An alternative plasticizer or a phthalate that is not one of the prohibited phthalates listed at 16 C.F.R. part 1307 may be used in a children's toy or child care article.
Manufacturers are responsible for ensuring that children's products do not contain hazardous substances. It is the manufacturer's obligation to ensure that any alternative plasticizer used is adequately tested and the manufacturer must be confident that the product does not pose a risk of injury or illness under normal use or reasonably foreseeable misuse. Children's products that are or contain a hazardous substance are banned hazardous substances per 16 C.F.R. § 1500.3(b)(15)(i)(A).
For the purposes of the prohibition concerning phthalates under section 108 of the CPSIA, a "children's toy" is defined as 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." This definition differs from the definition toy used to determine compliance with 16 C.F.R. part 1250, which incorporates by reference ASTM F963. Children’s products that are used while a child plays may not necessarily be a play thing but may still meet the definition of children’s toy under section 108 of the CPSIA. Examples of such products include inflatable bounce houses.
Any determination as to whether a particular product is designed or intended for use by a child 12 years of age or younger for use by a child while the child plays will be made after consideration of the following factors:
- Whether the intent of the product is for use by a child while the child plays, including a label on the product if such statement is reasonable
- Whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by the ages specified
- Whether the product is commonly recognized by consumers as being intended for use by a child of the ages specified
- The Age Determination Guidelines issued by the Commission staff in January 2020, and any successor to such guidelines
Child care articles are defined as a “consumer 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.”
Examples of child care articles include children's sleepwear, infant and toddler bottles, sippy cups, utensils, bibs, pacifiers, and teethers to be child care articles covered by the prohibition on phthalates.
Yes. For more information, visit our testing business guidance page and CPC business guidance page.
The phthalates regulation contains a provision that provides testing relief for qualifying and registered small batch manufacturers. For more information, visit our small batch manufacturer guidance page.
The prohibition concerning phthalates applies to any plasticized component part of a children’s toy or child care article or any other component part of a children’s toy or child care article that is made of other materials that may contain phthalates. Inaccessible component parts of children’s toys or child care articles are excluded from the prohibition concerning phthalates. A component part is considered inaccessible if that part is not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably foreseeable use and abuse of the product. Reasonably foreseeable use and abuse of the product includes swallowing, mouthing, breaking, or other children's activities, and the aging of the product.
The Commission has issued guidance on accessibility as it pertains to the phthalate regulation at 16 C.F.R. part 1199.
No. The Commission has stated that it is unnecessary to test and certify materials that are known not to contain phthalates or to certify that phthalates are absent from materials that are known not to contain phthalates.
The following materials do not require testing for compliance with the prohibition on phthalates, provided that they have not been treated or adulterated by a substance that may contain phthalates:
- Untreated/unfinished wood
- Metal
- Natural fibers
- Natural latex and mineral products
- Paper products
See the Commission's Notice of Requirements (76 FR 49286).
Additionally, 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)
These determinations do NOT provide an exemption from meeting the 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.
Yes, provided that certain conditions are satisfied.
The Commission issued a regulation regarding testing component parts. To the extent that a children's toy or child care article is required to be third party tested for phthalates, you can rely upon the test results or a certification from a component part supplier if the requirements in our regulation at 16 C.F.R. part 1109 are met.
That regulation requires that to rely upon test results or a certification from a supplier, you must use due care to ensure that the tests results or the certificate is valid and be given access to the underlying documentation, such as test results and attestations regarding how the testing was conducted and by whom. Certifications of a component part must contain the information listed at 16 C.F.R. § 1109.5(g) and be based on the results of testing from a third-party, CPSC-accepted laboratory. For more information, please visit our component part testing FAQs.
The test method currently approved by the Commission is CPSC-CH-C1001-09.4.
A failed test could indicate contamination from a number of sources and requires a thorough assessment of the manufacturing and shipping processes. For example, contamination could arise from recycled plastics, poorly cleaned manufacturing equipment, or even alternative plasticizers that contain trace amounts of the prohibited phthalates.
Packaging is generally not intended for use by children when they play, given that most packaging is discarded and is not used or played with as a children's toy or child care article; however, if the packaging is intended to be reused (e.g., for storage) or used in conjunction with a child care article or with a children's toy while playing, it would be subject to the phthalates regulation.
Shoes are not considered to be children's toys or child care articles; see CPSC's Office of the General Counsel advisory opinion 318. Although socks are not specifically mentioned in the advisory opinion, the same reasoning would apply.
Pool toys, beach balls, blow-up rafts, and inner tubes designed or intended for children 12 years of age or younger would be considered children's toys; therefore, they would be required to comply with the phthalates regulation.
Yes, if the mattress is primarily designed or intended for children 3 years of age and younger and has an accessible plasticized component. Examples of such components are vinyl layers for water resistance and buttons/snaps/zippers. Components surrounded by fabric may still be considered accessible; see 16 C.F.R. part 1199 for more information on accessibility regarding the phthalates regulation.