What certifications does custom silicone and rubber parts need?
Confidence 4/5 Established practice
Certification requirements for custom silicone and rubber parts:
Food-contact work needs FDA 21 CFR 177.2600 or EU 1935/2004 compliance, and medical or skin-contact work needs ISO 10993 biocompatibility testing rather than a generic "food grade" claim.
Sources
- Silicone and rubber moulding process guidance — Industry practice; cross-checked against made-in-China supplier data
- Rubber articles under HS 4016 — World Customs Organization HS nomenclature
- Food-contact material compliance — US FDA 21 CFR 177.2600
What goes wrong with custom silicone and rubber parts
- Suppliers quoting "food grade silicone" without a test report. Ask for the specific compliance document, not the phrase.
- Silicone colour matching is done by adding pigment; a tight Pantone match can shift between batches. Approve a physical sample and a tolerance.
- Hardness is specified in Shore A. Omitting it is the single most common cause of a part that feels wrong on arrival.
- Platinum-cure and peroxide-cure silicone behave differently and are not interchangeable for food or medical use.
Related questions people ask
Want this priced for your specification?
Send the requirement and any drawings. You get a supplier shortlist and one landed price, with the cost breakdown shown.