For custom silicone products intended to contact food or skin—such as baby bottle nipples, silicone baby bibs, kitchen spatulas, or dental accessories—compliance with strict safety standards is paramount. The two industry-leading certifications are US FDA (Federal Food and Drug Administration) and European LFGB (Lebensmittel- und Futtermittelgesetzbuch).
1. FDA Food Grade Silicone
The FDA regulations under CFR 177.2600 dictate the testing standards for rubber articles intended for repeated use in contact with food. This testing focuses primarily on the extraction thresholds in water and n-hexane solvents.
- Standard: Accepted in the United States and many global regions.
- Catalyst: Often processed using peroxide-based vulcanization, which is cost-effective but requires high-temperature post-curing to eliminate residual volatile organic compounds (VOCs).
2. LFGB Food Grade Silicone (Platinum-Cured)
LFGB is the German national food contact standard, widely recognized as the strictest in Europe. The test procedures are significantly tougher than FDA. It includes sensory testing (taste and smell transfer) and overall organic migration limits.
- Standard: Required for Germany, France, and preferred across the entire European Union.
- Catalyst: Always processed using premium Platinum-Cured silicone. Platinum-catalyzed silicone does not produce toxic byproducts, boasts zero sensory transfer, and yields absolute clarity and ultra-high tear strength.
3. Export Guidelines: How to Target Your Market
If you are developing food or baby supplies, understanding these guidelines prevents customs rejections:
If exporting primarily to the North American market, FDA compliance is fully legally compliant. However, if your target market is **Europe (Germany, France, UK)** or you are aiming for a **super-premium market positioning**, you must specify **LFGB Compliance** (Platinum-Cured).