ASTM F963 Teether Compliance Testing

As an essential companion for infants and young children during their growth, teethers not only help relieve gum pain and swelling during teething but also promote the development of their chewing ability and hand-eye coordination. With the booming development of cross-border e-commerce, an increasing number of teether products are seeking to enter the huge U.S. Amazon marketplace.

What is a Teether?

A teether, also known as a teething stick, teething device, or teething trainer, is an oral toy designed for babies aged 6 months to 2 years during the teething period. Most teethers are made of safe and non-toxic silicone, while some are crafted from soft plastic, featuring diverse shapes such as fruits, animals, pacifiers, and cartoon characters.

The designs of teethers vary according to the characteristics of different teething stages in infants and young children:

①　Emergence stage: Refrigerable teethers can effectively relieve gum pain and swelling before teething.

②　At 6 months: When the primary mandibular central incisors begin to erupt, frozen teethers are suitable for massaging the tender primary central incisors.

③　When four upper and lower teeth have erupted: Pacifier-shaped teethers are lightweight and easy to grasp, capable of massaging the gums around new teeth.

④　At 1–2 years: During the growth of primary molars, molar teethers that can reach the back teeth area should be selected.

High-quality teethers not only massage the gums but also help babies practice chewing and biting, contributing to the healthy development of teeth. Sucking and biting teethers can also promote the coordination of infants' mouths and hands, thereby furthering intellectual development.

Compliance Standards for Teethers Listed on Amazon U.S.

Children's products sold in the U.S. market are subject to strict regulation. As an oral product, teethers are governed by even more stringent safety standards. Amazon requires that all children's products must be accompanied by a Children's Product Certificate (CPC) to prove compliance with relevant U.S. regulations.

The core compliance framework includes:

①　ASTM F963 Standard: A mandatory U.S. toy safety standard covering requirements for physical and mechanical properties, flammability, and chemical toxicity.

②　cpsia Regulations: The U.S. Consumer Product Safety Improvement Act, which imposes strict limits on lead and phthalate content.

③　CPC Certificate: A compliance statement issued by the manufacturer or importer based on test reports.

Amazon mandates that sellers provide a CPC certificate, which must be based on test reports issued by CPSC-accredited third-party laboratories. For infant teethers, compliance with the U.S. Food and Drug Administration (FDA) requirements for food contact materials is also required.

It should be noted that test reports meeting policy requirements must be issued by ISO 17025-accredited laboratories with relevant testing capabilities and qualifications.

Detailed Explanation of ASTM F963 Teether Test Items

ASTM F963 is a mandatory U.S. toy safety standard, with its latest version being ASTM F963-23. This standard ensures the safety of toy products across multiple dimensions, with particularly stringent testing requirements for teethers.

Physical and Mechanical Performance testing

Physical and mechanical testing aims to prevent injuries such as cuts and suffocation caused by structural defects of toys. Specific items include:

①　Small Parts Test: Ensures that teethers and their components do not produce small parts after abuse testing, preventing choking and swallowing by children.

②　Sharp Edges and Tips Test: Accessible edges of teethers must not contain unreasonable sharp edges.

③　Puncture Resistance Test: For liquid-filled teethers, testing is required to check for easy rupture and liquid leakage.

④　Bite Resistance Test: Ensures that teethers do not break or suffer component damage after repeated biting.

The structural safety of teethers is critical. If any tips or ends are overly thin and long, they may penetrate deep into the throat during sucking, posing a suffocation risk.

Chemical Performance Testing

Chemical testing is a top priority for teether inspection, as the products directly contact infants' and young children's oral cavities. Main test items include:

Soluble Heavy Metals Test: Testing the migration levels of eight heavy metals (antimony, arsenic, barium, cadmium, chromium, lead, mercury, selenium), with the following limit requirements:

①　Phthalate Testing: Restricts the content of 8 phthalates (DEHP, DBP, BBP, DINP, DIDP, DNOP, DIBP, DPENP), with each not exceeding 0.1%.

②　Other Chemical Substances: Including BISphenol A (BPA) (≤0.1% required by some states) and formaldehyde, among others.

Other Test Items

Depending on the characteristics and functions of teethers, additional testing may be required, such as microbiological testing (especially for water-filled teethers), flammability testing, and electrical performance testing (if teethers are equipped with electronic components).

ASTM F963 Teether Compliance Process

Completing ASTM F963 compliance testing for teether products requires a systematic process, with the key steps outlined below:

1. Select a CPSC-Accredited Laboratory – JJR LAB

Testing must be conducted by a third-party conformity assessment body accredited by the U.S. Consumer Product Safety Commission (CPSC). Prior to selection, verify that the laboratory possesses relevant testing capabilities and ISO 17025 accreditation.

2. Prepare Samples and Documentation

Prepare a sufficient quantity of teether samples (typically 3–5 units) for laboratory testing. Simultaneously, prepare supporting documents including product instructions, manufacturer information, and product ingredient lists.

3. Conduct Sample Testing

The laboratory will perform comprehensive physical, mechanical, and chemical testing on the samples to ensure compliance with all applicable requirements of the astm f963 standard. The testing cycle is generally 5–10 working days, which can be shortened to 3–5 working days under expedited conditions.

4. Obtain Test Report

Upon completion of testing, the laboratory will issue a detailed test report specifying test items, methods, and results. The report must clearly indicate whether the product meets the standard requirements.

5. Issue CPC Certificate

Based on the qualified test report, the manufacturer or importer must issue a Children's Product Certificate (CPC) confirming that the product complies with all applicable safety regulations. The CPC certificate must include elements such as product description, applicable regulatory standards, and testing laboratory information.

6. Product Labeling and Listing

The product and its packaging must be marked with a tracking label containing manufacturer information, production date, and batch number. Additionally, safety information such as applicable age warnings must be added. Only after completing the above steps may the product be sold on the Amazon platform.

Latest Interpretation of Amazon's TIC Audit Policy

Starting in 2025, Amazon has strengthened compliance audits for children's products and launched the TIC (Testing, Inspection, and Certification) Verified Program. This policy change has had a significant impact on teether sellers.

The core change of the TIC audit is that sellers can no longer upload test reports independently; instead, verification must be completed through Amazon-accredited TIC bodies. These bodies submit verification results directly to Amazon to ensure the authenticity and reliability of data.

JJR LAB, China provides astm f963 testing services for teethers, as well as TIC verification and audit services. Welcome to inquire.