Pacifiers Business Guidance

CPSC business guidance for manufacturers and importers regarding compliance with the pacifier regulation and with additional requirements, including those of the Consumer Product Safety Improvement Act of 2008 (CPSIA).

Federal law requires that pacifiers comply with the pacifier regulation 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 regulation and the additional requirements after the pacifiers have been tested for compliance at a CPSC-accepted, third party laboratory. These requirements are reviewed in greater detail at www.cpsc.gov/cpsia.

What is a pacifier?

A pacifier is an article with a nipple, intended for a young child to suck on, but that is not designed to help a baby obtain fluid. A pacifier usually has a guard or shield at the base of the nipple that keeps the pacifier from being sucked completely into a child's mouth. It also has a handle or ring, usually on the opposite side of the guard or shield from the nipple, which is used to hold or grasp the pacifier.

 

What is the purpose of the pacifier rule?

This rule aims to keep babies from choking or suffocating on pacifiers.

 

Where can I find the requirements for pacifiers?

The pacifier regulation is published in the Code of Federation Regulations at 16 CFR Part 1511. This summary also describes a variety of other statutory and regulatory mandates applicable to pacifiers, including regulations on surface coatings, lead and phthalate content limits, requirements for testing and certification, and tracking labels.

 

What does the pacifier rule require?

The rule requires that

  1. the shield not be so small or flexible that it can be sucked completely into a child's mouth;
  2. the pacifier not have handles or other protrusions that are long enough to force the pacifier into the child's mouth if the child falls or lies face down;
  3. pacifiers are labeled to warn caregivers not to tie the pacifier around the child's neck; and
  4. pacifiers not produce small parts when tested.

 

How do you test a pacifier's guard or shield to make sure that it cannot suffocate a child?

Center the nipple in the opening of the pacifier test fixture. Gradually pull on the nipple until you reach a force of 2 lbs. Hold the 2-lb. force for 10 seconds. If the shield pulls completely through the fixture from the applied force, the pacifier fails.

pacifier test fixture diagram

Figure 1 - Pacifier Test Fixture

 

Are there other requirements for shields and guards?

The pacifier guard or shield must have at least two holes, one on either side of the nipple. Each hole must be at least 0.2 inches wide and cannot be closer than 0.2 inch from the outside edge of the shield or guard. These holes allow a child to continue breathing, even if the child sucks the pacifier guard completely into his or her mouth.

 

What does the standard say about protrusions?

Parts cannot stick out more than 0.63 inches from the face of the guard or shield on the side opposite the nipple. To test for a protrusion, clamp the pacifier by its nipple so that it will not move. Place an object with a flat surface, such as a piece of wood or hard plastic, directly on any handle, ring, or other part that protrudes from the shield or guard on the other side of the nipple. Gradually push the object toward the nipple, allowing the protrusion you are testing to bend or, if it is a hinged handle or ring, to move. Make sure that you apply the force in the direction that follows the length of the nipple. Once you reach a force of 2 pounds, measure the distance between the guard or shield and the surface of the test object.

 

Are there other requirements for pacifier strength?

Yes. There is a pull test. The pacifier must not come apart if you hold the handle or guard and gradually pull on the nipple in any possible direction for 5 seconds until you reach 10 pounds. Hold that force for 10 more seconds. The handle or ring must pass the same test. Both the nipple and the handle or ring must also pass these same tests after the pacifier has been boiled and cooled six times. Boiling the pacifier simulates how parents sterilize pacifiers in the home. If any pieces come off during the pull tests, test the parts to see if they fit entirely into the "small parts" test cylinder. (The cylinder approximates the size of a child's throat. If any part fits, the pacifier is banned because a child could choke on the part.)

pacifier test fixture diagram

Figure 2 - Small Parts Test Cylinder

 

Are there any other requirements for pacifiers?

Yes. To prevent a child from strangling, a pacifier cannot be sold or distributed with any ribbon, string, cord, chain, twine, leather, yarn, or similar attachment. In addition, pacifier packages must be clearly labeled on the front: "Warning - Do Not Tie Pacifier Around Child's Neck as it Presents a Strangulation Danger." Pacifiers also may not have sharp points or edges. (See 16 CFR §1500.48 and 16 CFR §1500.49. Third party testing is not required for these requirements.)

What are the additional requirements for pacifiers required by the Consumer Product Safety Improvement Act?

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

  • 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.
  • Phthalate Content Limits Pacifiers cannot contain more than 0.1% of the following phthalates: di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). Pacifiers also may not contain more than 0. 1 percent of (diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP) while an interim statutory ban of these phthalates remains in effect. In addition, Section 4.22 of ASTM F963 contains a provision on pacifiers requiring that rubber nipples shall not contain more than 20 ppb. total nitrosamines.
  • F963 Toy Standard: Section 4.22 of ASTM F963 contains a provision on pacifiers requiring that rubber nipples shall not contain more than 20 ppb. total nitrosamines. See ASTM F1313, Standard Specification for Volatile N-Nitrosamine Levels in Rubber Nipples on Pacifiers, for more details on nitrosamine testing. In addition, ASTM F 963 prohibits pacifiers from containing any of the following heavy metals in surface coatings or substrate materials in excess of the limits listed in the standard: antimony, arsenic, barium, cadmium, chromium, lead, mercury, and selenium.
  • Testing and Certification Pacifiers, like all products that are designed or intended primarily intended for children 12 years of age or younger, must be tested by an accredited third party laboratory accepted by the CPSC 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. 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 (1) name of the manufacturer or private label, (2) the location and date of manufacture, and (3) 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 Education, Global Outreach, & Small Business Ombudsman (Assistance in Understanding and Complying with CPSC Regulations): e-mail: Business@cpsc.gov; telephone: (301) 504-7999.
  • Office of Compliance (Enforcement Inquires): e-mail: sect15@cpsc.gov; telephone: (301) 504-7520.

To obtain copies of the Standard Consumer Safety Specification on Toy Safety (ASTM F963) and Volatile n-Nitrosamine Levels in Rubber Nipples on Pacifiers (ASTM F1313), contact ASTM International at: www.astm.org or via telephone: (610) 832-9585.