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CPSC children'sUnited StatesPacifiers

Do pacifiers need a CPC?

Updated

Short answer

Yes.

A pacifier that does not meet 16 CFR part 1511 is a banned hazardous article under 16 CFR 1500.18(a)(8). Pacifiers are children's products and child care articles, so the 1511 tests, lead limits and phthalate limits must be verified at a CPSC-accepted third-party lab, and the importer issues a Children's Product Certificate (CPC) that is eFiled with the entry.

What changes the answer

  • What counts as a pacifier. 16 CFR 1511.2 defines it as a nipple a young child sucks on that is not designed to deliver fluid, usually with a guard or shield and a handle or ring. Feeding nipples are not pacifiers but are child care articles under the phthalate rule.
  • No cords. Under 1511.6, a pacifier may not be sold or distributed with any ribbon, string, cord, chain, yarn or similar attachment. Pacifier clips and holders sold separately are separate products with their own children's product requirements.
  • Required warning. 1511.7 requires the word "Warning" followed by "Do Not Tie Pacifier Around Child's Neck as it Presents a Strangulation Danger" on each individual package and on any retail display carton holding two or more pacifiers.
  • Pacifiers attached to plush. A pacifier attached to a stuffed animal still meets the 1511.2 definition if its nipple is meant for sucking, and the plush adds toy standard and small parts testing.
  • Small parts. Pacifiers are listed as exempt from the small parts rule in 16 CFR 1501.3. The 1511 structural tests cover parts coming loose instead.

What to do

  1. Have a CPSC-accepted lab test to 16 CFR 1511: guard or shield pull-through, protrusion limit of 0.63 inch, structural integrity of nipple and handle under the specified forces, and the other sections that apply.
  2. Test for the eight phthalates in 16 CFR 1307 and lead content and coatings in accessible parts.
  3. Print the 1511.7 warning on every package and display carton.
  4. Issue a CPC citing 1511, 1307 and the lead rules, and eFile it with the entry as required since July 8, 2026. Add tracking information to the pacifier where practicable and the packaging.
HTS line for pacifiers
  • 3926.90.16.00

    3926: Other articles of plastics and articles of other materials of headings 3901 to 3914

    Pacifiers

    Pacifiers of plastics. Rubber and silicone constructions may classify differently; check rulings.

    General rate
    3.1%
    Free or reduced under 17 programs

Next steps

Frequently asked questions

Can I sell a pacifier with a clip attached?
No. 16 CFR 1511.6 bars selling or distributing a pacifier with a ribbon, string, cord, chain or similar attachment. Sell clips separately, tested as their own children's product.
Are silicone pacifiers exempt from phthalate testing?
No. Silicone is not on CPSC's list of materials that need no phthalate testing. Test it or rely on component tests of the exact compound.
Do pacifiers need FDA clearance?
A standard pacifier is a CPSC-regulated consumer product under 16 CFR 1511. Products marketed with medical claims can fall under FDA, so keep claims to normal pacifier use.

Sources

  1. 16 CFR part 1511, Requirements for pacifiers, eCFR, National Archives
  2. 16 CFR 1511.7, Pacifier labeling, eCFR, National Archives
  3. 16 CFR 1307.3, Phthalate prohibitions, eCFR, National Archives
  4. Phthalates FAQ, U.S. Consumer Product Safety Commission
  5. Certificates of Compliance final rule (eFiling), published January 8, 2025, Federal Register

This is general information drawn from the official sources linked above. It is not legal advice. Rules change and often turn on the facts of your product, so confirm your test plan with an accredited lab and your obligations with qualified counsel before you import or sell.