"Food-grade silicone" appears on nearly every supplier's website, and it means almost nothing on its own. What protects your product — and your importer — is a specific standard, a specific test report and a specific batch. Here is how the certifications actually work and what to write into your specification.
Quick answer
Food-grade means the finished article passes a food-contact standard such as FDA 21 CFR 177.2600 or German LFGB. Medical-grade means the material additionally passes biocompatibility testing (ISO 10993 or USP Class VI) under strict traceability. If your product touches food, specify LFGB when selling into Europe and FDA when selling into the US; if it enters the body or contacts broken skin, you need medical-grade with documented lot control.
1. What each standard actually tests
| Standard | Region | What it evaluates |
|---|---|---|
| FDA 21 CFR 177.2600 | United States | Permitted ingredients and extractable limits for rubber articles in repeated food contact |
| LFGB § 30/31 (BfR XV) | Germany / EU | Volatile matter, extractables, and a sensory test for odour and taste transfer |
| EU 1935/2004 + 10/2011 | EU | General food-contact framework and migration limits |
| ISO 10993 / USP Class VI | Global | Cytotoxicity, sensitisation, irritation and implantation biocompatibility |
| ISO 9001:2015 | Global | Quality management system — process control, not material safety |
2. Cure system matters more than most buyers realise
Peroxide-cured silicone leaves organic by-products that must be removed by post-curing; it can also carry a faint odour and slight colour shift. Platinum-cured silicone cures by addition with essentially no by-products, giving clearer material, lower volatiles and better taste and odour performance. For teethers, nipples, kitchenware and medical parts, platinum cure is the practical default.
Platinum systems are, however, sensitive to cure inhibition from sulfur, amines, tin catalysts and some plasticisers — one reason mixed tooling and mixed-material workshops need discipline.
3. Post-curing is where compliance is won or lost
A post-cure of about 200 °C for 2–4 hours in a circulating oven drives off residual volatiles, stabilises compression set and eliminates the "silicone smell" that fails LFGB sensory testing. It costs oven time and it is often the first thing a low bidder quietly removes from the process. Specify it explicitly and ask for the oven record.
4. What to write into your specification
- Material grade and supplier compound reference.
- Cure system: platinum or peroxide.
- Post-cure schedule: temperature and duration.
- Applicable standards and required test reports with issue date.
- Colourant compliance — pigments must be food-contact approved too.
- Batch traceability: raw material lot recorded against production lot.
- Re-test interval — many buyers require annual re-testing.
5. Common compliance mistakes
- Accepting a certificate for a different compound than the one being molded.
- Certifying the silicone but ignoring the pigment or the printed logo ink.
- Assuming FDA compliance satisfies EU customers — it does not cover LFGB sensory testing.
- Approving a sample that was post-cured, then buying production that was not.
- No traceability, so a single complaint forces a full recall instead of a lot recall.
Related reading: manufacturing silicone baby teethers and choosing your molding process.
Working with Tongsheng
Dongguan Tongsheng Electronic Technology Co., Ltd. has manufactured silicone rubber molds and silicone products since 2014. We run in-house CNC tooling, compression and liquid silicone injection molding, and a testing lab, from a 2,000+ sqm ISO 9001:2015 certified factory in Humen Town, Dongguan, with 100+ staff and 15 engineers. Food-grade (FDA / LFGB), medical-grade and industrial-grade compounds, Shore A 10–80, Pantone and RAL color matching.
Send 2D/3D drawings (STP, IGS, PDF) and we quote within 24 hours — request a quote, email coraycn@gmail.com, or message us on WhatsApp.