Can Custom Baby Silicone Products Meet FDA & EN71 Safety Standards?

2025-10-07

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A Scientific Approach to Safety and Quality by LYA Silicone

In the world of infant care, safety is the soul of every product. Parents today are more aware and cautious than ever, demanding that every item touching their baby’s skin, mouth, or food meets global safety standards. For brands and OEM/ODM manufacturers, meeting these standards is not just a marketing claim — it’s a legal and ethical responsibility.

At LYA Silicone, a professional manufacturer specializing in custom liquid silicone molding for baby, medical, and lifestyle products, we make safety a measurable science. Our baby silicone teethers, pacifiers, bottle brushes, and feeding accessories are all engineered to comply with — and exceed — FDA and EN71 safety standards.

1. Understanding FDA and EN71: The Two Pillars of Global Safety

FDA Compliance: Ensuring Material Safety from the Inside Out

The U.S. Food and Drug Administration (FDA) regulates materials that come into contact with food and human tissue. For baby silicone products, FDA 21 CFR 177.2600 certification verifies that the silicone:

Does not release harmful chemicals when in contact with food or saliva.
Is free of BPA, PVC, lead, phthalates, and other endocrine-disrupting substances.
Remains stable under extreme temperatures — from boiling sterilization to freezing conditions.

EN71 Standard: The Safety Benchmark for Toys and Infant Goods

The EN71 European Toy Safety Directive applies to products designed for children under 14 years of age.
It covers multiple aspects:

EN71-1: Mechanical and physical properties (no sharp edges, choking hazards, or breakable parts).
EN71-2: Flammability resistance to ensure safety under accidental heat exposure.
EN71-3: Migration of certain elements — limiting heavy metals and toxic substances.

For silicone baby products, EN71 certification ensures that even under prolonged chewing or contact with saliva, no harmful substances migrate or leach out.

2. Material Science Behind LYA Silicone Baby Products

At LYA Silicone, our foundation is premium-grade, platinum-cured Liquid Silicone Rubber (LSR) — the same material used in medical implants and healthcare devices.
This high-performance material offers:

Biocompatibility – gentle and non-irritating to baby skin and gums.
Thermal stability – retains flexibility from -40°C to 230°C.
Antibacterial properties – resistant to microbial growth and easy to clean.
Durability – maintains elasticity and color even after thousands of sterilization cycles.

We source raw silicone from globally trusted suppliers such as Wacker, Dow, and Momentive, all with FDA/LFGB documentation.
Before entering production, every batch undergoes ROHS, REACH, and FDA material verification, ensuring full traceability from resin to finished product.

3. LYA Silicone’s Engineering and Production Excellence

Our in-house mold design and precision manufacturing enable complete control over product safety and performance.
Key production features include:

ISO 9001 & ISO 13485 Certified Facilities – ensuring consistent medical- and baby-grade process control.
100,000-Class Cleanroom Production – preventing contamination during molding, coloring, and assembly.
Liquid Injection Molding (LIM) and Compression Molding – achieving seamless structures with smooth edges and safe, burr-free surfaces.
Strict QC Protocols – every batch is tested for hardness, tensile strength, elongation, and migration properties.

We also perform third-party testing through accredited laboratories such as SGS, TUV, or Intertek, helping clients obtain FDA/EN71 test reports for their brands.

4. From Concept to Certification: LYA Silicone’s Customization Process

Each custom baby silicone product starts with your idea — and our engineering support transforms it into a certified product ready for global markets.

Our full-service workflow includes:

Product design & 3D prototyping
→ Support for ergonomic, baby-safe designs with optimal grip and texture.
Material selection & formulation
→ Choice of food-grade or medical-grade silicone, tailored hardness (Shore A 10–60).
Color matching & surface finish
→ Non-toxic colorants compliant with EN71-3 and FDA 21 CFR requirements.
Molding & production
→ Automated injection systems ensure precision and repeatability.
Testing & certification support
→ Assistance in third-party certification submission and compliance documentation.

This end-to-end service minimizes certification risks and shortens your time to market.

5. Why Choose LYA Silicone for FDA & EN71-Compliant Baby Products

✔ Over 20Years of Expertise in silicone molding for baby, beauty, and medical sectors
✔ Custom OEM/ODM Capabilities – from branding to packaging design
✔ Eco-Friendly Production – reusable molds, waste recycling, and sustainable packaging options
✔ Scientific Testing & Global Certification Support – for FDA, EN71, LFGB, CPSIA, and REACH compliance
✔ High Transparency in Quality Control – full material traceability and documented process flow

LYA Silicone is not just a manufacturer — we are a safety partner helping brands enter global markets with confidence.

6. The Science of Trust: Safety You Can See and Feel

Parents may not read certification numbers, but they feel trust in the quality of a soft, odorless, beautifully finished silicone teether or spoon. Behind that trust lies rigorous science — clean materials, precision molding, and verified compliance.

At LYA Silicone, we believe real safety comes from transparency, technology, and continuous testing.
Every certified product is not only a piece of silicone — it’s a promise of care, comfort, and protection for every child who uses it.

Partner with LYA Silicone Today

If your brand is looking to launch or upgrade a custom silicone baby product line, LYA Silicone provides the expertise, certification support, and production reliability to make it happen.

📞 Contact us today to discuss your custom project: