Certification and Registration
16 CFR 1511: US. Requirements for Pacifiers
Category:
CPC
Federal law requires that pacifiers comply with the Pacifier Regulation (16 CFR Part 1511) and other requirements, including those in the Consumer Product Safety Improvement Act of 2008 (CPSIA).
Manufacturers and importers of pacifiers must… Children’s Product Certificate (CPC) The certificate confirms that the pacifier complies with the provisions of the Pacifier Regulation, the relevant sections of ASTM F963, and any other requirements applicable to the product’s design.
Applicable Standards
16 CFR 1511 Requirements for Pacifiers
ASTM F963 Standard Consumer Safety Specification for Toy Safety
What is a pacifier?
According to the U.S. Consumer Product Safety Commission’s regulations on pacifiers, a pacifier is an article shaped like a nipple that infants and young children suck on, but not intended to deliver liquid; it typically consists of a shield or guard and a handle or ring.
A shield or guard is a structure located at the base of the nipple, designed to prevent the pacifier from being fully sucked into the child’s mouth.
A handle or ring refers to a structure typically located near the shield or guard, designed for grasping or holding 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 pacifier clips are not considered part of the “pacifier” definition, but they must comply with separate child‑product safety requirements, as outlined in the FAQs below. Additionally, pacifiers may not be sold or distributed with any ribbons, cords, strings, chains, twine, leather, yarn, or similar attachments.
What is the purpose of the pacifier regulation?
The purpose of the pacifier regulation is to prevent infants from choking or suffocating on pacifiers. The regulation requires…
1.The pacifier remains intact after undergoing tests; and
2.The design and construction of pacifiers must include a protective device or shield to prevent the pacifier from entering the infant’s mouth and obstructing the airway.
What are the requirements for pacifiers?
The main requirements for a pacifier are:
The main requirements for a pacifier are:
● Shield or guard – Performance requirements: The pacifier’s shield or guard shall be tested to ensure the entire pacifier cannot be swallowed by a child, while also ensuring adequate ventilation and breathability during use.
● Protrusion restrictions – This test prevents the pacifier from being forcibly inserted into the baby’s mouth in the event of a fall.
● Structural integrity – This section includes tests designed to simulate real‑world use and abusive conditions by children. Physical and mechanical testing ensures the pacifier does not break and does not pose a choking hazard from small parts.
● Prohibition of ribbons, cords, ropes, and other attachments – Pacifiers shall not be sold or distributed with any ribbons, cords, strings, chains, twine, leather, yarn, or similar attachments.
● Tag – All pacifiers must bear the following warning: “Warning – Do not attach a pacifier to a child’s neck, as it may cause strangulation.”
According to U.S. toy standard ASTM F963, what requirements must a pacifier meet?
In addition to meeting 16 CFR Part 1511, pacifiers must also meet applicable requirements of the U.S. toy standard ASTM F963. Specifically, paragraph 4.20 requires rubber nipples to comply with ASTM F1313 nitrosamine requirements. Article 4.20 has additional requirements for pacifiers sold with toys or as part of a toy. According to ASTM F963 4.3.5, pacifiers must also comply with heavy metal restrictions.
Are there any regulations regarding pacifier clips?
According to 16 CFR §1511.6, pacifiers may not be sold or distributed with any ribbons, cords, ropes, chains, twine, leather, yarn, or similar attachments. Furthermore, for these products, CPSC staff recommend the clip’s length not exceed what is necessary for proper operation, and ideally the overall length should not surpass 7‑8 inches.
The pacifier clip must also comply with various CPSIA requirements, as well as 16 CFR Part 1501 (small parts regulations), and must undergo use and abuse testing as outlined in 16 CFR 1500.51 and 1500.52.
What additional CPSIA requirements are there for pacifiers?
Pacifiers must comply with surface coating requirements, limits on lead and phthalate content, mandatory toy standard (ASTM F963) requirements, testing and certification, and traceability labeling requirements.
● Surface Coating Restrictions
Pacifiers must not contain lead levels exceeding 0.009% (90 ppm) in paint.
● Lead Content Limitation
The total lead content of any accessible part of a pacifier shall not exceed 100 ppm (0.01%).
●ASTM F963-17 Toy Standards
Pacifiers must comply with ASTM F963 4.20 and ASTM F1313 nitrosamine limits, and also with ASTM F963 4.3.5 heavy metal limits.
● Phthalate content limits
The plasticizing components of pacifiers shall not contain more than 0.1% of the following 8 specified phthalates: DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, and DCHP.
● Testing and Certification
Pacifiers and all products primarily designed for children aged 12 or younger must be tested by a CPSC‑accredited third‑party laboratory to ensure compliance with the pacifier regulation and all other applicable child product safety standards. Based on these test results, domestic manufacturers (or importers) must issue a Children’s Product Certificate (CPC) specifying each applicable rule and demonstrating compliance.
● Tracking tag
Pacifiers must bear a traceability label or other permanent marking on the product and its packaging. To the extent practicable, the label shall serve as a permanent identifier on both the product and packaging and must include essential information such as origin, date of manufacture, and batch or production‑run number.
The U.S. market exhibits strong demand for infant and child products, yet regulatory oversight is equally stringent. SATISFY can provide compliance guidance for infant and child products. Please contact SATISFY customer service for more details.
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