Pacifiers, feeding nipples and teethers go straight into a baby's mouth, so the silicone they are made from and the way it is molded must clear strict food-contact and child-safety standards. This 2026 guide explains which material and standards apply to baby and maternal silicone products, and the molding steps that keep them safe, soft and odor-free.
Only platinum-cured (addition-cure) food-grade liquid silicone rubber is appropriate for baby products. Platinum-cured LSR leaves no peroxide by-products, is free of BPA, PVC, latex and phthalates, and is naturally taste- and odor-neutral after post-cure. It also tolerates repeated steam sterilization and boiling. Peroxide-cured silicone is avoided for baby-contact parts because it can leave volatile residues that affect taste and safety.
Several food-contact and child-safety frameworks apply, and export markets often require more than one. The table summarizes the key ones buyers ask for.
|
Standard / regulation |
Region |
What it covers |
|
FDA 21 CFR 177.2600 |
USA |
Rubber articles for repeated food contact |
|
LFGB (Sec. 30/31) |
Germany / EU |
Food-contact safety, incl. taste/odor test |
|
EU 10/2011 & Reg. 1935/2004 |
EU |
Food-contact materials framework |
|
EN 14350 |
EU |
Child-use drinking equipment safety |
|
EN 1400 |
EU |
Soothers (pacifiers) for babies |
|
CPSIA / Prop 65 |
USA |
Lead, phthalates and chemical limits |
Because post-curing is what makes silicone truly taste- and odor-free and compliant. Freshly molded LSR contains small amounts of residual volatile siloxanes. A post-cure, typically around 200 C for up to 4 hours in a batch oven, drives these volatiles off. This step is mandatory for LFGB taste/odor requirements and for parts that contact food or a baby's mouth. Skipping it leaves a faint smell or taste that fails inspection and upsets end users.
Anti-colic nipples rely on a precisely molded valve or micro-slit that vents air so the baby swallows less of it. This demands tight control of thin-wall thickness (often well under 1 mm), consistent slit geometry, and low variation cavity-to-cavity. LSR is ideal because its low viscosity fills fine features cleanly, and platinum cure gives high tear strength so the thin valve survives repeated use and sterilization. A cold-runner, multi-cavity tool with vacuum keeps these small parts consistent and flash-free.
Softness, safety and durability all matter together. The typical targets are:
Contamination control is a core part of baby-product molding because you cannot inspect purity back into a part. Reputable production runs food-grade LSR in a clean, segregated area, often a controlled or cleanroom environment, with covered material feed, filtered air, and automated take-out to avoid hand contact. Automated demolding and inline vision inspection reduce both contamination and defects such as flash on mouth-contact edges.
TYM provides LSR injection molding machines, precision multi-cavity silicone molds and automated production systems configured for infant-care products such as pacifiers, feeding nipples and teethers. TYM's solutions cover food-grade material handling, precise thin-wall and micro-valve tooling, integrated post-cure planning and automated flashless take-out, helping brands meet FDA, LFGB and EN requirements with efficient, intelligent production.
A: Yes, when it is platinum-cured, food-grade liquid silicone rubber that is post-cured. This material is free of BPA, PVC, latex and phthalates, is taste- and odor-neutral, and withstands boiling and steam sterilization. It should meet food-contact and child-safety standards such as FDA 21 CFR 177.2600, LFGB and EN 14350 or EN 1400.
A: Platinum-cured (addition-cure) silicone leaves no by-products, is purer, and is taste- and odor-free after post-cure, which is why it is used for baby and medical parts. Peroxide-cured silicone can leave volatile residues affecting taste and safety, so it is avoided for mouth-contact baby products.
A: Post-curing, typically about 200 C for up to 4 hours, removes residual volatile siloxanes so the part is fully taste- and odor-free. It is required to pass LFGB taste/odor testing and to ensure food-contact safety. Without post-cure, parts can retain a faint smell or taste that fails inspection.
A: It depends on the market. The USA typically requires FDA 21 CFR 177.2600 plus CPSIA and Prop 65 limits; the EU requires food-contact compliance (Reg. 1935/2004, EU 10/2011), often LFGB, and product standards such as EN 14350 for drinking equipment or EN 1400 for soothers. Many brands certify to several at once.
