16 CFR Part 1511——Requirements for Pacifiers

Pacifiers are products that infants directly insert into their mouths and use for extended periods. If not designed properly, they can lead to: The entire pacifier being swallowed, which can block the airway.

The shield/panel dimensions are inadequate, or ventilation holes are missing, causing the infant to inhale the entire nipple into their mouth, or the ventilation holes becoming stuck in the lips/teeth.

Defects in the design of the pull tab or handle could cause it to snag onto a baby’s clothing, potentially leading to strangulation.

A nipple that is too long or too soft can lead to suffocation or interfere with oral development.

Scope of application:

This regulation applies to all pacifiers designed or intended for use by infants.

Definition: A pacifier is defined as a nipple-like device used to satisfy an infant’s desire to suckle, typically comprising a nipple tip, a cover/shield, and a pull ring/handle.

Excluded: Pacifiers used for feeding infants (which are typically governed by another standard or general food contact material regulation).

Core security requirements:

Protective cover/panel requirements (to prevent ingestion)

Nipple head restrictions (to prevent suffocation and oral injuries)

Rings/handles strength

Overall integrity testing

Material safety

Packaging and labeling

Overview of key testing items:

To verify compliance with 16 CFR Part 1511, products typically need to undergo the following tests in a CPSC-approved laboratory: Cover size and ventilation hole test: Confirm that the diameter of the cover and the size and number of ventilation holes are compliant.

Nipple Head Length Test: Measure the distance from the base of the cover to the end of the nipple head.

Nipple Head Retention/Tensile Strength Test: Hold the nipple head and pull it outward to check if it breaks or detaches from the cover.

Buckle/Handle Retention Test: Apply tension to the buckle to ensure a secure connection.

Torque Test: Apply torque to various components to simulate a child’s biting action. Drop Test/Impact Test: Simulate falls during everyday use to check if the product has cracked, resulting in sharp edges or small parts.

Nipple Head Retention Test (for nipple heads): Simulate infant chewing to check for cracks or tears.

Requirements for manufacturers and importers:

Design Verification: During the design phase, it is essential to ensure that the cover diameter is sufficiently large and that there are symmetrically positioned ventilation holes. The length of the nipple tip must be strictly controlled and should not be excessively long.

Material Selection: It is imperative to choose food-grade silicone or rubber that is resistant to tearing, durable, and safe.

Structural Integrity: The pull tab, decorative components (if any), must be seamlessly integrated with the main body or undergo rigorous tensile testing to prevent detachment.

Label Compliance: The warning language on the packaging must comply with regulatory requirements and should not be altered or omitted arbitrarily.