Safe by Design.
Certified for Every Market.
YMS specializes in food-contact baby products engineered to meet FDA, LFGB, EN 14350, CPSIA, and REACH requirements. From material selection to batch-level traceability, every component is designed, tested, and documented for global compliance.
Food-Grade LSR Silicone Nipple
Food Grade
Module 02 · Scope
Applicable Feeding Product Categories.
Our food-contact compliance program covers every category where silicone touches an infant's food, saliva, or oral cavity. Each category has dedicated test protocols and migration standards.
Bottles & Nipples
Silicone bottles, nipples, bottle sleeves, and anti-colic valves.
Cups & Straws
Training cups, sippy cups, silicone straws, and spill-proof lids.
Bowls & Plates
Divided plates, suction bowls, snack cups, and placemats.
Utensils
Spoons, forks, training chopsticks, and feeding sets.
Teethers & Pacifiers
Teething toys, pacifiers, chew beads, and soothers.
Food Storage
Freezer trays, snack boxes, pouches, and ice molds.
Bibs
Silicone bibs with crumb catcher and food-contact surfaces.
Multi-Material
Silicone + PP, silicone + stainless steel overmold assemblies.
Module 03 · Materials
Material & Color Information.
Every batch starts with 100% food-grade silicone raw material, paired with pigment masterbatches that have passed heavy-metal and primary aromatic amine testing. Transparent documentation is prepared for each project.
Base Silicone
Platinum-cured LSR or HTV, Dow / Shin-Etsu / Wacker food-grade grades with full COA and migration certificates.
Pigment Masterbatch
Pantone-matched food-grade color pastes; heavy-metal screened per EN 71-3 and CPSIA Lead/Cadmium limits.
Secondary Components
PP, Tritan, PCTG, stainless steel 304/316 -- each paired with its own food-contact declaration.
Standard Color Palette
Pantone / RAL custom matching available. Translucent, pearl, and glow-in-the-dark variants on request -- each with its own compliance dossier.
Module 04 · Contact & Scenarios
Contact Modes & Usage Scenarios.
How a product interacts with food directly determines the migration test matrix. We classify every project by contact type, temperature, duration, and food simulant category before any lab work begins.
Prolonged Contact
> 24 hours -- storage containers, freezer trays, overnight pouches.
Simulants: 10% Ethanol · 3% Acetic Acid · Olive Oil
Short Repeated Contact
< 30 minutes per use -- spoons, cups, bowls, plates.
Simulants: Distilled Water · 3% Acetic Acid
Mouthing Contact
Teethers, pacifiers, nipples -- saliva and oral exposure.
EN 1400 · EN 14350 · Saliva Simulant
High Heat / Sterilization
Boiling, steam, UV, dishwasher, microwave validated up to 230°C.
Freezing & Cold Chain
Validated to -40°C for breast-milk storage and freezer trays.
Fatty / Acidic / Aqueous
Simulant matrix selected per EU 10/2011 and FDA 21 CFR 177.
Module 05 · Markets
Target Market Testing Requirements.
Compliance is market-specific. Tell us where you sell -- we map the exact regulatory matrix and test package required for lawful placement.
North America
- ✦FDA 21 CFR 177.2600
- ✦CPSIA (Lead / Phthalates)
- ✦CPC Certification
- ✦California Prop 65
Europe
- ✦LFGB §30/§31 (DE)
- ✦EU 10/2011 Framework
- ✦EN 14350 / EN 1400
- ✦REACH SVHC · UKCA
Oceania
- ✦AS 2070 Food Contact
- ✦AS/NZS 8124 Toy Safety
- ✦ACCC Mandatory Standards
Asia & Rest of World
- ✦JFSL (Japan)
- ✦KFDA (Korea)
- ✦GB 4806 (China)
- ✦Mercosur · GCC
Module 06 · Sample Prep
Test Sample Preparation.
Representative samples are the foundation of a defensible compliance file. We follow strict protocols for mold trials, material lot tracking, and conditioning before samples are released to the lab.
Material Lot Lock
Dedicated raw-material batch reserved, labeled, and sealed with full COA chain.
Pilot Mold Trial
Production-equivalent tooling, cure cycle, and secondary processes replicated 1:1.
Post-Cure Conditioning
200°C / 4h secondary cure to drive off volatiles before migration testing.
Chain-of-Custody Pack
Tamper-evident packaging with sample ID, lot code, and shipment to accredited lab.
Module 07 · Third-Party Labs
Accredited Testing & Document Support.
We partner with globally recognized ISO 17025 laboratories to deliver legally defensible reports. Our team manages test scoping, lab liaison, and final document packaging -- including Declaration of Compliance (DoC).
Full Test Reports
Migration, physical, mechanical, and chemical results in English, with raw data appendix.
Declaration of Compliance
EU 10/2011 DoC prepared and signed by our regulatory team for each SKU.
Technical File
Material specs, process flow, GMP evidence, and migration modeling bundled for customs clearance.
Regulatory Updates
Proactive alerts when standards change (e.g. REACH SVHC additions, new LFGB methods).
Module 08 · Variants
Product Difference Assessment.
Not every SKU needs its own full test. Our regulatory team analyzes variants against the "worst-case representative sample" principle to minimize test cost while preserving legal defensibility.
Module 09 · Traceability
Report & Batch Management.
Each production batch is linked to its material lot, cure parameters, and corresponding test report via a unique traceability code -- ensuring every carton can be traced back to its compliance evidence within minutes.
10yr
Document retention
100%
Batch traceability
<24h
Report retrieval SLA
ISO 9001
QMS certified
Batch Record · Example
LIVEModule 10 · Start Here
Submit Your Food-Contact Project.
Tell us your target markets, product category, and compliance goals. Our regulatory team will respond within one business day with a tailored test and development roadmap.