Does LYASILICONE use silicone that is completely free of BPA, phthalates, PVC, and latex?

2025-10-27

Contents

At LYASILICONE we manufacture baby, maternal and pet silicone products using medical-/food-grade silicone formulations that do not contain BPA, phthalates, PVC or natural-rubber latex. We offer platinum-cured LSR options and support third-party testing and biocompatibility certification (FDA food-contact guidance, ISO 10993, USP/USP Class VI, LFGB) so customers and brands can verify safety and traceability.

Why material purity matters for baby & maternal products

Parents and caregivers choose silicone because—unlike some plastics—silicone is an inorganic polymer whose basic backbone (silicon–oxygen) does not require BPA or phthalate-based plasticizers. That chemistry makes correctly formulated food-grade and medical-grade silicones inherently free of BPA, phthalates, PVC and natural-rubber latex fillers when produced to the right specifications. Independent industry guidance and suppliers routinely state that food-grade silicone is produced without these harmful additives.

For buyers, this translates into two practical benefits:

Low migration risk: properly cured, high-purity silicones have very low extractables and leachables compared with many plastics.
Hypoallergenic profile: because silicone contains no natural-rubber proteins (the cause of latex allergy), it avoids that specific allergy risk when processed and tested appropriately.

How LYASILICONE ensures the silicone is safe and “additive-free”

At LYASILICONE we use a layered approach to guarantee product safety and to give B2B customers the documentation they need:

1) Raw material selection – food & medical-grade LSR / RTV
We source silicone compounds specified as food-grade or medical-grade that are formulated without BPA, phthalates, PVC or latex fillers. These base materials are designed to meet food-contact and skin-contact applications.

2) Preferred curing chemistry — platinum (addition) cure options
Where purity is critical (baby nipples, teethers, medical contact parts), we recommend platinum-cured silicones. Platinum (addition) curing produces fewer by-products and generally yields a higher-purity elastomer than some peroxide-cured alternatives — an advantage for low-extractables and food/medical uses.

3) In-process controls & traceability
Every production batch is tracked (raw material lot → mixing → molding → cure → QC). LYASILICONE can support COAs and batch traceability so importers and brands can run audits or trace a part back to its source.

4) Third-party testing & recognized standards
We support and can facilitate testing and documentation to internationally recognized frameworks: FDA food-contact requirements and guidance, ISO 10993 biological evaluation for skin/contact devices, and USP biocompatibility (Class VI) testing where required. These tests are the accepted ways to demonstrate safety for human contact and food contact products.

The science behind the claims (concise)

Silicone chemistry ≠ BPA/phthalates: BPA and phthalates are used as monomers or plasticizers in certain plastics (polycarbonate, PVC). Silicone elastomers are silicon-oxygen polymers made from silica-derived monomers and do not require those plasticizers. Properly formulated food-grade silicones therefore do not include BPA or phthalate ingredients.
Platinum cure → low by-products: addition (platinum) cure systems create fewer residual by-products than some other cure systems; this helps lower extractables that could otherwise migrate from the part. That’s why platinum-cured silicones are often specified for infant and medical contact products.
Regulatory routes exist for food contact & biocompatibility: the FDA evaluates food contact substances and provides guidance; ISO 10993 and USP test methods are the standard frameworks for assessing biological risk and cytotoxicity for medical/skin-contact parts. Brands looking to sell in the U.S. or EU commonly request these reports.

What LYASILICONE can provide to buyers (documentation & services)

Material Declaration (raw material spec: no BPA, no phthalates, no PVC, no latex).
COA (Certificate of Analysis) for each lot.
SGS / third-party lab test reports (LFGB, FDA food contact support, extractables/leachables where requested).
Biocompatibility testing support (ISO 10993, USP Class VI) for medical or prolonged skin-contact applications.
Platinum-cured LSR options, custom colorants that are food-grade, and low-outgassing formulations for critical use.
(If you need a copy of a test report or want a custom testing scope for your market—US, EU or other—LYASILICONE can coordinate that.)

FAQ (concise & shareable)

Q1 — Does LYASILICONE’s silicone contain BPA, phthalates, PVC or latex?
A: No. We source food- and medical-grade silicone compounds formulated without BPA, phthalates, PVC or natural-rubber latex. Material declarations and COAs are available upon request.

Q2 — How can I verify that a batch is additive-free?
A: Request the COA and third-party test reports (SGS, LFGB, FDA-related documentation). For medical/skin-contact parts we can support ISO 10993 and USP biocompatibility testing.

Q3 — Is platinum-cured silicone always better?
A: Platinum-cured silicones typically have higher purity and fewer by-products, making them preferred for food and medical contact parts. However, final selection depends on mechanical requirements, colorants, and cost tradeoffs. We’ll recommend the best cure system for your application.

Q4 — Can LYASILICONE supply documentation for Amazon/retail compliance?
A: Yes. We can provide test reports and declarations commonly required by platforms and retailers (e.g., material safety, LFGB/testing for EU/German markets, FDA food-contact support).

Q5 — What if I want custom color or additives?
A: We only use food-grade/colorants and evaluate colorant migration. Any additives are qualified to meet your target market compliance; we provide migration/extractable test options on request.

Final note — how LYASILICONE helps your brand

Safety and traceability are non-negotiable for baby, maternal and pet products. LYASILICONE combines food/medical-grade material sourcing, platinum-cure expertise, batch traceability and third-party testing support so you can bring safe, compliant silicone products to market with confidence.

Interested in samples or test documentation for your SKU? Contact our sales team with your product spec and market (US/EU/others) and we’ll provide the appropriate COA and testing plan.

Sources & further reading (select)

Why food contact substances are regulated — FDA. U.S. Food and Drug Administration
Food-grade silicone does not contain BPA, phthalates, PVC or latex — industry guidance.
ISO 10993 and biocompatibility evaluation for skin/contact devices (FDA guidance).
Platinum-cured vs peroxide-cured silicone — purity and by-products.
USP Class VI / biocompatibility testing overview.

Conclusion

With LYA Silicone, you get scientifically tested, platinum-cured LSR that’s clean, stable, odor-free, and compliant with global safety standards. Our expertise ensures consistent quality, advanced mold design, and long-term product performance — from baby teethers .