CPSC Phthalates Rule (16 CFR 1307): What Amazon Sellers of Toys, Teethers and Baby Feeding Products Must Meet

The CPSC phthalates rule, 16 CFR part 1307, prohibits making for sale, selling, distributing or importing any children’s toy or child care article that contains more than 0.1 percent (1,000 ppm) of any of eight phthalates: DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP and DCHP. The limit applies to each accessible plasticized component part. Covered products need third-party testing at a CPSC-accepted lab unless the material is on a CPSC exempt list, and a Children’s Product Certificate citing “16 C.F.R. part 1307 – Phthalates” (CPSC and 16 CFR, data checked 2026-10-13).

On Amazon that reaches PVC bath toys, vinyl inflatables, soft plastic figures, teethers, pacifiers, bottles and bibs. This guide sets out CPSC’s criteria so you can run the check on your own product; it does not decide whether any specific product is covered or compliant.

Sources: CPSC Phthalates business guidance, CPSC Phthalates FAQs, 16 CFR parts 1307, 1308, 1199, 1252 and 1253 (edition revised as of January 1, 2025, via govinfo), and the 2017 final rule. Data checked 2026-10-13.

What 16 CFR 1307 Prohibits

Section 1307.1 covers “the manufacture for sale, offer for sale, distribution in commerce or importation into the United States” of any children’s toy or child care article containing the listed phthalates. A listing is an offer for sale and an FBA shipment from an overseas factory is an importation, so both ends of a private-label chain are inside the wording.

Section 1307.3 sets one limit for all eight: concentrations of “more than 0.1 percent.”

Section 1307.3(c) applies the limit “to any plasticized component part” and to any other part “made of other materials that may contain phthalates.” The test is per component part, not an average across the product.

The final rule states: “The rule will become effective on April 25, 2018.” It also dropped the old interim bans on DIDP and DNOP, concluding that continuing them “is not necessary to ensure a reasonable certainty of no harm to children.” A supplier report built on the old list, testing DIDP and DNOP but not DIBP, DPENP, DHEXP or DCHP, does not cover the current rule.

Is Your Product a Children’s Toy or Child Care Article?

Section 1307.2 takes both definitions from the CPSIA:

• Children’s toy: “a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays.”
• Child care article: “a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.”

CPSC’s FAQ lists child care article examples: “children’s sleepwear, infant and toddler bottles, sippy cups,” “utensils, bibs, pacifiers, and teethers.” It also settles several edge cases:

So a reusable PVC case sold with a toy set is in the question, and a feeding product for a 4-year-old is not a child care article, though a toy for that child still is a children’s toy. Intended age shows in your listing copy, images and age grading; our Children’s Product Certificate guide covers how that call is made.

Which Parts Count: Accessibility Under 16 CFR 1199

CPSC points to 16 CFR part 1199 for accessibility. Under § 1199.1(b) a part is not accessible “if it is not physically exposed, by reason of a sealed covering or casing, and does not become physically exposed through reasonably foreseeable use and abuse of the product.” Inaccessible parts are outside the prohibition.

• Probes. The sharp point and edge probes at 16 CFR 1500.48-1500.49 are used; a part is accessible “if it can be contacted by any portion of the specified segment of the accessibility probe.”
• Use and abuse. The tests at 16 CFR 1500.50 to 1500.53 for the product’s age band apply, excluding the bite tests.
• Coatings do not seal. Part 1199 says “paint, coatings, and electroplating may not be considered a barrier.”
• Fabric can, with a size limit. A fabric-covered part that passes use and abuse is inaccessible “unless the product or part of the product, in one dimension, is smaller than 5 centimeters.”
• Baby mattresses are the exception. Vinyl-covered sleep surfaces for children 3 and younger “are considered accessible” even under sheets or pads.
• Older kids with tools. Disassembly by children older than 8 using tools is not considered.

Part 1199’s opening paragraph dates from 2013 and still describes the interim list with DIDP and DnOP. Cite it for the accessibility method; the current list is the eight in § 1307.3.

Third-Party Testing and the Lab Method

To “Is third party testing and certification required for the phthalates regulation?” CPSC’s FAQ answers “Yes.” Section 1308.1 says covered materials “must comply with the third party testing requirements of section 14(a)(2) of the Consumer Product Safety Act (CPSA), unless listed in § 1308.2.”

The lab must be CPSC-accepted for this rule; CPSC published the phthalates lab requirements notice on October 27, 2017. Check that a lab’s acceptance scope lists phthalates, not only lead or ASTM F963. The method: “The test method currently approved by the Commission is CPSC-CH-C1001-09.4.”

From the FAQ:

• Small batch. The rule “provides testing relief for qualifying” and “registered small batch manufacturers”; registration with CPSC is the condition.
• Suppliers. You “can rely upon the test results or a certification from a component part supplier” if “the requirements in our regulation at 16 C.F.R. part 1109 are met.”
• Unintended failures. Contamination “could arise from recycled plastics, poorly cleaned manufacturing equipment,” or “alternative plasticizers that contain trace amounts of the prohibited phthalates.” A supplier’s “we use DOTP” does not replace a test.

Materials That Skip Testing, and What Still Applies

CPSC has determined that certain materials do not exceed the limits “with a high degree of assurance.” Accessible parts made only from them need no third-party phthalate testing. The business page adds that this “testing exemption does NOT provide an exemption from meeting the underlying phthalate requirement,” and firms may still be responsible if “the end product as received by a consumer is found to have a regulated phthalate in excess of 0.1%.”

The FAQ adds untreated, unfinished wood, metal, natural fibers, natural latex and mineral products, and paper products, provided they have not been treated with a substance that may contain phthalates (citing Notice of Requirements 76 FR 49286).

Check the definitions. “Unfinished” engineered wood has no surface treatments at manufacture, with “paint or similar surface coating materials, wood glue, or metal fasteners” given as examples. An unfinished manufactured fiber has “no chemical additives beyond those required to manufacture the fiber,” so dyed polyester plush falls outside § 1253.2(c).

PVC and other flexible vinyls are not on the § 1308.2 list, so a vinyl bath toy or PVC-coated bib has to be tested.

What the CPC Must Cite

CPSC’s business page says the CPSA “requires manufacturers and importers of children’s products subject to a regulation, standard, or ban” to certify in a Children’s Product Certificate. For this rule, section 2 of the CPC cites “16 C.F.R. part 1307 – Phthalates,” usually beside the toy standard and lead content.

Exempt materials do not remove the certificate. CPSC’s FAQ: “Firms are still expected to certify compliance with the phthalate requirement in a Children’s Product Certificate (CPC).” When every accessible part is exempt, the CPC rests on the § 1308.2, § 1252.3 or § 1253.2 determination instead of a lab report.

Who issues the CPC, its required elements and record keeping are in our CPC guide; importers also need CPSC eFiling.

What This Means for an Amazon Listing

Amazon can request a CPC and test reports for children’s products; our Manage Your Compliance guide shows where those requests appear. Have a report ready that covers all eight phthalates, uses CPSC-CH-C1001-09.4, comes from a lab accepted for this rule and matches the ASIN’s model.

CPSC’s phthalates page does not address platform or reseller duties, penalties or record retention. If a product exceeds the limit after sale, see our Section 15(b) reporting guide and Amazon product recalls for sellers. Small-parts labeling is a separate rule: choking hazard warnings for toy listings.

Common Mistakes

1. Testing the finished toy as one sample. The limit applies per accessible component part.
2. Using a report built on the pre-2018 list. It skips DIBP, DPENP, DHEXP and DCHP.
3. Assuming paint seals PVC. Part 1199 says coatings are not a barrier.
4. Treating “phthalate-free” as a test. CPSC lists contamination routes even when nothing was added.
5. Reading a testing exemption as a compliance exemption. The limit and the CPC still apply.
6. Forgetting reusable packaging. A storage case sold with the toy can be in scope.
7. Adding an unlisted additive to PP or PE. § 1308.2 exempts them only with the named additives.

Pre-Listing Checklist

1. Decide whether the product is a children’s toy (12 and under) or a child care article (3 and under: sleep, feeding, sucking, teething).
2. List every component part, including reusable packaging.
3. Mark each part accessible or inaccessible under 16 CFR 1199 for the age band.
4. Mark each accessible part test-exempt (§ 1308.2, § 1252.3(c), § 1253.2(c), or the FAQ’s untreated natural materials) or test-required.
5. Test the rest at a lab accepted for phthalates, method CPSC-CH-C1001-09.4, all eight phthalates.
6. Issue a CPC citing “16 C.F.R. part 1307 – Phthalates.”
7. If you import, confirm the certificate is eFiled.

Frequently Asked Questions

What is the phthalate limit for children’s toys?

Under 16 CFR 1307.3, no more than 0.1 percent of DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP or DCHP in an accessible plasticized component part. CPSC states it as 0.1% (1000 ppm) (data checked 2026-10-13).

Do teethers and baby bottles fall under the phthalates rule?

Yes, if designed for children 3 and younger. CPSC’s FAQ lists bottles, sippy cups, pacifiers and teethers as child care articles.

Do I need a lab test if my toy is polypropylene?

Not if it uses only the additives listed in 16 CFR 1308.2(a)(1). It still has to meet the limit and be covered by a CPC citing part 1307.

Does the phthalates rule apply to adult products?

No. Part 1307 covers children’s toys and child care articles. For products marketed to both, the manufacturer’s design and intent decide, so check your listing’s age claims.

Conclusion

The phthalates rule is one limit applied part by part. Confirm the product type, find the accessible parts, separate test-exempt materials, test the rest for all eight phthalates at an accepted lab, and hold a CPC citing 16 C.F.R. part 1307.