Compliance
Food-contact rules for teethers
Core position: a teether is a toy and a mouth-contact product at the same time. The food-contact layer is separate from the toy layer, uses different tests, and is frequently missing from supplier files. We supply material declarations and test evidence; we do not describe any material as "FDA approved".
For the walkthrough, see food-contact rules for wooden teethers.
Two layers, one product
| Layer | US | EU |
|---|---|---|
| Toy safety | ASTM F963-23, CPSIA, 16 CFR 1501, 16 CFR 1510 | EN 71-1/-2/-3 and the toy legislation |
| Mouth contact | FDA food-contact framework, 21 CFR Parts 174–178 | National food-contact law; 10/2011 for plastics only |
A report covering EN 71-3 or F963 answers the toy question. It does not answer the food-contact question, because the extraction conditions and legal basis are different.
The US framework
| Material | Applicable framework | Evidence to request |
|---|---|---|
| Silicone rubber | 21 CFR 177.2600, rubber articles for repeated use | Extraction test report with conditions stated |
| Wood | General food-contact framework, 21 CFR 174–178, no dedicated regulation for wood | Material declaration plus extraction or migration data |
| Coatings and inks | Food-contact surface if they contact the mouth | Composition declaration and migration data |
| Adhesives | Food-contact surface where used at a mouth-contact joint | Composition declaration |
What 21 CFR 177.2600 covers
Section 177.2600 covers rubber articles intended for repeated use, which includes silicone rubber. It sets limits on extractables — residues released into distilled water and into n-hexane under specified conditions, with different limits for repeated-use articles depending on the food type and contact conditions.
For a teether, the practical items to confirm in a report:
- The material is identified specifically (silicone, not "rubber" generically).
- The extraction conditions are stated (medium, time, temperature).
- The results are compared with the limits, not just reported as numbers.
- The tested sample is the finished component, not only the raw compound.
Wood falls outside 177.2600. It is assessed through the general framework, which in practice means a combination of material identity, suitability for food contact, and extraction or migration data. There is no dedicated FDA regulation that says "this wood is food-contact compliant".
The EU framework
Regulation (EU) 10/2011 applies to plastic materials and articles in contact with food. It does not apply to silicone elastomers: the European Commission's Joint Research Centre has stated that elastic materials are excluded from its scope.
For wood, there is no EU-wide food-contact material regulation. Requirements fall to national law. Germany is the most commonly referenced example: LFGB §30 and §31 set the general safety requirement and the prohibition on transfer that endangers health, with the BfR recommendations providing the technical detail. France, Italy and other member states have their own frameworks.
So an EU teether file typically contains:
- Toy compliance under EN 71 and the toy legislation.
- Food-contact evidence for each mouth-contact material under the applicable national framework.
- A material declaration from the silicone, coating and adhesive suppliers.
If a supplier presents "EU 10/2011" as evidence for a silicone teether, ask which test method and which national framework the report was written against. The regulation does not cover the material.
Claim language
| Avoid | Use instead |
|---|---|
| "FDA approved", "FDA food grade" | "Food-contact-grade material; extraction testing to 21 CFR 177.2600 available" |
| "Food safe" without a report | "Food-contact evidence available on request for the destination market" |
| "BPA free" without data | "Tested for restricted substances under [the applicable framework]" |
| "Non-toxic", "100% safe" | Describe the material and the test, not the conclusion |
The reason for this discipline is not style. "FDA approved" cannot be substantiated for a toy or a food-contact material, and it is a claim that a marketplace or a competitor can act on.
What we supply, and what stays with the buyer
| Item | We supply | Buyer does |
|---|---|---|
| Material declaration per component | Yes | Files with the technical documentation |
| Extraction test reports where they exist | Yes, per material and model | Assesses against the destination market |
| Test scoping with a laboratory | Yes | Commissions and owns the report |
| Composition of coatings, inks and adhesives | From material suppliers, on request | Confirms suitability |
| "FDA approved" claim | No | Not used by either party |
FAQ
Q: Are wooden teethers FDA approved?
No. The FDA does not approve toys or teethers. Food-contact materials are assessed against regulatory requirements; approval is not the mechanism.
Q: Does 21 CFR 177.2600 apply to the wood part?
No. It applies to rubber articles for repeated use, including silicone. Wood is assessed through the general food-contact framework, without a dedicated regulation.
Q: Is EU 10/2011 relevant to teethers at all?
Only where a plastic material is in contact with food or the mouth. Silicone is outside its scope, and wood is covered by national law.
Q: Which German rules are usually referenced?
LFGB §30 and §31, with the BfR recommendations. Confirm the applicable recommendation with the laboratory and your EU importer.
Q: Do we need food-contact testing if the teether is sealed?
A sealed surface is still a mouth-contact surface. Whether it needs separate migration data depends on the finish composition and the destination market; ask the lab to scope it rather than assume.
Related pages: US CPSIA and the CPC. For the cleaning side of the same materials, see how to clean wooden baby toys. To ask for material-level evidence on a model, use the quote form.
This is a commercial explainer, not legal advice. Certification is model-specific and market-specific.
Tell us the model and the market
We confirm whether a report exists, or whether testing can be commissioned.