Amazon ASTM F963 Pacifier Compliance Testing

Federal law mandates that pacifiers must comply with the Pacifier RegULation (16 CFR Part 1511) and other 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 (CPC) that the pacifiers conform to the Pacifier Regulation, relevant sections of ASTM F963, and any other applicable requirements based on the product's construction.

Applicable Standards

①　16 cfr 1511: Requirements for Pacifiers

②　ASTM F963: Standard Consumer Safety Specification for Toy Safety

What is a Pacifier?

Under the Pacifier Regulation issued by the U.S. Consumer Product Safety Commission (CPSC), a pacifier is an article consisting of a nipple-shaped component intended for a young child to suck on, not designed to facilitate liquid intake by an infant, and typically comprising a shield or guard and a handle or ring.

A shield or guard refers to the structure located at the base of the nipple-shaped component, designed to prevent the pacifier from being fully drawn into a child's mouth.

A handle or ring refers to the structure generally positioned near the shield or guard, used for holding or grasping the pacifier. A hinged handle or ring is one that can rotate freely about an axis parallel to the plane of the shield or guard.

Please note that pacifier clips are not included in the definition of a "pacifier" but must comply with separate children's product safety requirements, as outlined in the Frequently Asked Questions (FAQs) later in this document. Additionally, pacifiers must not be sold or distributed with any ribbons, cords, strings, chains, twines, leathers, yarns, or similar attachments.

What is the Purpose of the Pacifier Regulation?

The Pacifier Regulation aims to prevent infants from choking or suffocating on pacifiers. The regulation requires:

1. Pacifiers remain intact after undergoing certain tests; and

2. Pacifiers are designed and constructed with a guard or shield such that they cannot enter an infant's mouth and obstruct their throat.

What Are the Requirements for Pacifiers?

The key requirements for pacifiers are as follows:

①　Shield or Guard: Performance requirements mandate testing of the pacifier's shield or guard to ensure the entire pacifier cannot be swallowed by a child, while also ensuring adequate ventilation and breathability during use.

②　Protrusion Limitation: This test prevents the pacifier from being forcefully inserted into an infant's mouth in the event of a fall.

③　Structural Integrity: This section includes tests designed to simulate actual use and abuse by children. Physical and mechanical testing ensures pacifiers do not physically break apart, eliminating the risk of small-part choking hazards to children.

④　Prohibition of Ribbons, Cords, Strings, and Other Attachments: Pacifiers must not be sold or distributed with any ribbons, cords, strings, chains, twines, leathers, yarns, or similar attachments.

⑤　Labeling: All pacifiers must bear the statement: "WARNING - Do not tie pacifier around child's neck as this presents a strangulation hazard."

What Requirements Must Pacifiers Meet Under ASTM F963 (U.S. Toy Standard)?

In addition to complying with 16 CFR Part 1511, pacifiers must also meet the applicable requirements of ASTM F963, the U.S. toy safety standard. Specifically, Section 4.20 requires rubber nipples to comply with the nitrosamine requirements of ASTM F1313. Section 4.20 imposes additional requirements on pacifiers sold with toys or as part of a toy. Pacifiers are also subject to heavy element restrictions as specified in ASTM F963 Section 4.3.5.

Are There Regulations for Pacifier Clips?

Pursuant to 16 CFR §1511.6, pacifiers must not be sold or distributed with any ribbons, cords, strings, chains, twines, leathers, yarns, or similar attachments. Furthermore, for these types of products, CPSC staff recommends that the length of the clip not exceed that necessary for normal operation, with a preferRED total length of no more than 7–8 inches.

Pacifier clips must also comply with various CPSIA requirements, adhere to 16 CFR Part 1501 (the Small Parts Regulation), and undergo use and abuse testing as outlined in 16 CFR Part 1500.51 and 16 CFR Part 1500.52.

What Additional CPSIA Requirements Apply to Pacifiers?

Pacifiers are subject to surface coating requirements, lead and phthalate content restrictions, mandatory toy standard (ASTM F963) requirements, testing and certification, and tracking label requirements.

①　Surface Coating Restrictions: Pacifiers must not be painted with coatings containing lead in excess of 0.009% (90 ppm).

②　Lead Content Restrictions: The total lead content in any accessible component of a pacifier must not exceed 100 ppm (0.01%).

③　astm f963-17 Toy Standard: Pacifiers must comply with nitrosamine content limits specified in ASTM F963 Section 4.20 and ASTM F1313. They must also meet heavy metal element restrictions set forth in ASTM F963 Section 4.3.5.

④　Phthalate Content Restrictions: Plasticized components of pacifiers must not contain more than 0.1% of the following 8 designated phthalates: BIS(2-ethylhexyl) phthalate (DEHP), Dibutyl phthalate (DBP), Butyl benzyl phthalate (BBP), Diisononyl phthalate (DINP), Diisobutyl phthalate (DIBP), Di-n-pentyl phthalate (DPENP), Di-n-hexyl phthalate (DHEXP), and Dicyclohexyl phthalate (DCHP).

⑤　Testing and Certification: Like all products primarily designed or intended for children 12 years of age or younger, pacifiers must be tested by a CPSC-accepted third-party laboratory to ensure compliance with the Pacifier Regulation and all other applicable children's product safety rules. Based on this testing, the domestic pacifier manufacturer (or importer) must issue a Children's Product Certificate (CPC) listing each applicable rule and certifying that the product complies with such rules.

⑥　Tracking Label: Pacifiers must bear a tracking label or other distinguishing permanent mark on the product and its packaging. The tracking label should, to the extent feasible, be a permanent identifying mark on the product and packaging, and must include certain basic information, including the product's origin, production date, and relevant batch or run number.