Federal law requires that pacifiers comply with the pacifier regulation (16 CFR part 1511) and with additional requirements, including those of the Consumer Product Safety Improvement Act of 2008 (CPSIA).

Manufacturers and importers of pacifiers must certify in a Children's Product Certificate that the pacifiers comply with the pacifier regulation, relevant sections of ASTM F963, and additional requirements, as applicable, based upon the construction of the product. Additional business guidance information can be found at: https://business.cpsc.gov/robot and www.cpsc.gov/BusinessEducation.

 

What is a pacifier?

According to CPSC’s pacifier regulation, a pacifier is an article that consists of a nipple that is intended for a young child to suck upon, but is not designed to facilitate a baby's obtaining fluid, and usually includes a guard or shield and a handle or ring.

  • Guard or shield means the structure located at the base of the nipple used to prevent the pacifier from being completely drawn into the child's mouth.
  • Handle or ring means the structure usually located adjacent to the guard or shield used for holding or grasping the pacifier. A hinged handle or ring is one that is free to pivot about an axis parallel to the plane of the guard or shield.

Please note, pacifier clips or “lovies” do not fall under the definition of “pacifiers,” but must meet separate children’s product safety requirements, as outlined in a later FAQ.  Additionally, pacifiers cannot be sold or distributed with any ribbon, string, cord, chain, twine, leather, yarn, or similar attachments.

 

What is the purpose of the pacifier regulation?

The pacifier regulation is intended to prevent infants from choking or suffocating on pacifiers. The rule requires that:

  1. a pacifier stay in one piece after certain tests; and
  2. a pacifier must be designed and constructed with a guard or shield so that it cannot enter an infant's mouth and block his or her throat.

 

What are the requirements for pacifiers?

The principal requirements for pacifiers are:

  • Guard or shield – The performance requirements test the guard or shield of the pacifier to ensure that the whole pacifier cannot be swallowed by the child, and also to ensure that the pacifier has sufficient ventilation and breathability while in use.
  • Protrusion limitations – This test protects against the pacifier being forced into the baby’s mouth if the baby falls on their face.
  • Structural Integrity – This section includes tests designed to simulate realistic use and abuse from a child. The physical and mechanical tests ensure that the pacifier will not physically break apart and cause a small-parts choking hazard for the child.
  • Prohibition of ribbons, strings, cords, and other attachments - A pacifier must not be sold or distributed with any ribbon, string, cord, chain, twine, leather, yarn, or similar attachments.
  • Labeling - All pacifiers must be labeled with the following statement:

“WARNING - DO NOT TIE PACIFIER AROUND CHILD'S NECK AS IT PRESENTS STRANGULATION DANGER.”

For more information on the requirements the full regulation is published in the Code of Federation Regulations at 16 CFR Part 1511

 

What requirements do pacifiers need to meet under the U.S. Toy Standard, ASTM F963?

In addition to meeting requirements under 16 CFR part 1511, pacifiers must also meet applicable requirements under the ASTM F963 U.S. Toy Standard. Specifically, section 4.20 requires that rubber nipples comply with the nitrosamine requirements under ASTM F1313. Section 4.20 has additional requirements for pacifiers sold with or as part of a toy. Pacifiers are also subject to heavy elements limits, as specified in section 4.3.5 of ASTM F963.

 

Are there regulations for pacifier clips?

A pacifier cannot be sold or distributed with any ribbon, string, cord, chain, twine, leather, yarn, or similar attachments under 16 CFR §1511.6. Additionally, for these type of products, CPSC staff recommends that the length of the clip be no longer than is necessary to function properly, and preferably no longer than 7-8 inches in total length.

The pacifier clip will also need to comply with various requirements under the CPSIA (as outlined in the next FAQ), as well as comply with 16 CFR part 1501, Small Parts Regulation, and must undergo use and abuse testing, as outlined in sections 16 CFR § 1500.51 and 16 CFR § 1500.52.

 

What are the additional requirements for pacifiers required by the CPSIA?

Pacifiers are subject to surface coating requirements, lead and phthalate content limits, requirements under the mandatory toy standard (ASTM F963), testing and certification, and tracking label requirements. These requirements are discussed below and at: www.cpsc.gov/BusinessEducation:

  • Surface Coating Limit Pacifiers may not be painted with paint that contains more than 0.009 percent lead.
  • Lead Content Limit Pacifiers cannot contain greater than 100 ppm (0.01 percent) of total lead content in any accessible component part.
  • ASTM F963-17 Toy Standard.  Pacifiers must meet limits on nitrosamine levels, as specified in section 4.20 of ASTM F963, and in ASTM F1313. Pacifiers are also subject to heavy elements limits, as specified in section 4.3.5 of ASTM F963.
  • Phthalate Content Limits Plasticized components of pacifiers must not contain more than 0.1 percent of the following eight specified phthalates: di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP), diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP).
  • Testing and Certification Pacifiers, like all products that are designed or intended primarily for children 12 years of age or younger, must be tested by an accredited and CPSC-accepted, third party laboratory for compliance with the pacifier regulation and all other applicable children's product safety rules. Based on that testing, a domestic manufacturer (or importer) of pacifiers must issue a Children's Product Certificate specifying each applicable rule and indicating that the product complies with those rules.
  • Tracking Labels Pacifiers must have a tracking label or other distinguishing permanent mark affixed to the product and its packaging. The tracking label shall be a permanent distinguishing mark on the product and its packaging, to the extent practicable, and must contain certain basic information, including the source of the product, the date of manufacture, and cohort information, such as a batch or run number.

 

Where can I find additional information?

For more information on the requirements for pacifiers, contact the U.S. Consumer Product Safety Commission:

  • Office of Compliance (for specific enforcement inquires): e-mail: sect15@cpsc.gov; telephone: (800) 638-2772
  • Small Business Ombudsman (for general assistance understanding and complying with CPSC regulations): e-mail: Please use our Contact Form, which is the best way to get a fast response; telephone: (888) 531-9070.

To obtain copies of ASTM F963, contact ASTM International at: www.astm.org or via telephone: (610) 832-9585.

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