FDA vs LFGB Silicone Certification: What’s the Difference?

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    Silicone products show up in all kinds of daily items. In real use, though, performance always comes after one thing: safety. If a silicone product is meant to touch food, there’s no room for shortcuts.

    When you start selling into different markets, especially the U.S. and Europe, food contact certification becomes unavoidable. Among all the standards out there, FDA and LFGB are the two names buyers mention most often.

    Based on our experience with food-grade silicone products, this guide breaks down what FDA and LFGB really mean, how they are different in practice, where each one is accepted, and what actually helps a silicone product pass the tests.

    Why Do Silicone Products Need Food Contact Certification?

    Silicone is a high-performance polymer. It handles heat well, stays flexible, and remains stable over time. On paper, it looks like an ideal material for food contact.

    But in real production, things are not always that simple.

    If the raw material is poorly selected, or if the curing and post-curing process is not well controlled, the finished silicone part can still release low-molecular substances or carry an unpleasant smell. These issues may not be obvious at first, but they become a problem once the product is used with hot food or long-term contact.

    That’s why food-grade silicone needs to be verified through proper testing. Certification from recognized laboratories helps confirm that the material won’t release harmful substances, and that it won’t affect the taste or smell of food, even under high temperatures and repeated use.

    silicone product 1

    What Are FDA and LFGB Certifications?

    FDA Certification

    FDA refers to the U.S. Food and Drug Administration. In day-to-day business, when people talk about FDA for silicone, they’re usually referring to the food contact rules under CFR 21.

    From a practical point of view, FDA testing is mainly about material compliance. The question it tries to answer is simple:

    Are the ingredients used in this silicone formulation allowed, and are they clean enough for food contact?

    FDA testing focuses on:

    • Whether the raw materials are on the FDA-approved list
    • Whether extractables and residues stay within allowed limits during normal use

    If the formulation is clean and well controlled, FDA compliance is usually achievable. That’s why FDA is often considered the baseline requirement for food-grade silicone, especially in the U.S. market.

    LFGB Certification

    LFGB comes from Germany and stands for Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch. In practice, it’s widely recognized as one of the strictest food contact standards for silicone products.

    LFGB follows EU food contact regulations, such as EU 1935/2004 and EU 10/2011, but its testing approach goes a step further.

    Besides checking chemical safety, LFGB also looks at something many standards don’t pay much attention to:

    whether the silicone changes the taste or smell of food.

    This is where many silicone products struggle. Even if a material is technically safe, residual odors, incomplete curing, or certain additives can still cause problems in LFGB sensory tests. That’s why LFGB testing is often more demanding than FDA, especially for products used with hot food or long contact times.

    silicone bowl and spoon 1

    What’s the Difference Between FDA and LFGB Certifications?

    Both FDA and LFGB set safety standards for food-grade silicone, but they focus on different things. FDA looks at material safety and ingredient compliance. LFGB goes further—it also checks if the product affects food’s taste or smell, and uses stricter test conditions.

    Here’s a side-by-side look at how their testing methods compare.

    Test CategoryFDA (U.S. Food and Drug Administration)LFGB (German Food and Feed Code)
    Legal Basis• CFR 21 Part 177.2600 (Rubber articles for repeated use)• LFGB Code (German law)
    • EU Regulation 1935/2004
    • EU Regulation 10/2011
    • BfR Recommendation XV (for silicone)
    Main GoalEnsures materials don’t release harmful substances into food.Ensures materials are safe and don’t change food’s smell or taste.
    Overall Migration Test• Called Extraction Test or TNVR (Total Nonvolatile Residue)
    • Uses deionized water, n-hexane, 10% ethanol
    • Limited test conditions (e.g. 100°C for 8h or 24h)
    • Has defined limits
    • Uses water, 3% acetic acid, 10% ethanol, olive oil, or synthetic fat
    • Tested under stricter, varied conditions (e.g. 60°C/10 days, 175°C/2h)
    • Limit usually 10 mg/dm²
    Specific Migration Test• Focus on heavy metals (like lead, cadmium) and certain additives• Includes lead, cadmium, arsenic, mercury
    • Focus on volatile siloxanes (D4, D5, D6)
    • Checks peroxide by-products like benzoic acid
    • Tests for organotin compounds (like TBT, DMT)
    • Covers plasticizers, antioxidants, etc.
    Sensory TestNot required• Mandatory
    • Assesses if the material causes food to smell or taste unusual
    • Usually tested by trained assessors
    Material Compliance• Materials and additives must be listed in CFR 21.177.2600
    • Purity and limit values must be followed
    • Also focuses on limits for specific chemicals
    • Has clear rules for colorant migration
    Test Reports• Manufacturers self-declare, supported by internal or third-party test reports• Reports must be from an authorized third-party lab
    silicone test 1

    Where Are FDA and LFGB Certifications Accepted?

    FDA: Your ticket to the U.S. market

    • FDA certification is a must if you want to sell silicone products in the United States.
    • It is also widely accepted in Canada, South America, and many Middle Eastern countries.
    • For global brands, FDA approval builds strong trust at a basic level.

    LFGB: Essential for Germany and the EU

    • In Germany, LFGB testing is almost always required by customers.
    • While not legally mandatory in other EU countries, it is widely recognized.
    • EU consumers often care more about taste, smell, and clean contact with food.

    Recommendation: Go for both to reach high-end markets

    • Getting both FDA and LFGB certifications helps open doors to global sales.
    • It also boosts brand credibility, especially for baby products and premium kitchenware.
    FactorFDALFGBFDA + LFGB
    Target marketUnited States, AmericasGermany, EUGlobal / premium markets
    Legal requirementMandatory in the U.S.Strongly expected in GermanyOften requested by international brands
    Product typeGeneral food contact itemsHigh-sensitivity food contactBaby products, bakeware, premium kitchenware
    Odor & taste controlNot testedStrictly testedFully covered
    Material toleranceHigherLowerLowest risk
    Brand positioningStandardHigh qualityPremium / professional
    silicone test2 1

    How Can Silicone Products Pass FDA and LFGB Tests?

    From our experience, passing FDA or LFGB is rarely about one single factor. Most failures come from small issues adding up.

    Material choice, process control, and testing preparation all matter. If any of these are handled loosely, problems usually show up at the lab stage.

    The good news is that once the right habits are in place, passing both FDA and LFGB becomes much more predictable.

    Control the Materials: Problems Usually Start at the Source

    Everything begins with raw materials. If the base silicone is wrong, no process can fully fix it later.

    In most food-contact applications, platinum-cured, food-grade silicone is the safer choice. Compared with peroxide-cured systems, it leaves fewer by-products after curing and has much lower odor. In practice, this makes a big difference when facing LFGB sensory tests and FDA residue limits.

    Additives are another common risk point. Certain substances, such as organotin compounds or benzene-related chemicals, can easily cause compliance issues. Before purchasing any material, it’s worth carefully reviewing the supplier’s MSDS and food contact compliance statement. This step is boring, but it prevents many problems down the line.

    Manage the Process: Good Materials Still Need Proper Handling

    Even with qualified materials, poor process control can ruin the final result.

    Post-curing is not optional. After molding, silicone parts should be baked at high temperatures, typically 150°C to 200°C for several hours. This step helps drive off low-molecular volatile substances like D4, D5, and D6, reduces residual odor, and lowers migration risks. In real testing, proper post-curing often makes the difference between passing and failing LFGB.

    Clean production conditions also matter more than many expect. Molds should be kept clean, and only food-grade, low-residue release agents should be used. Contamination from molds or processing aids is a common reason for unexpected test failures.

    Work with Certified Labs: Let Testing Confirm the Results

    In the end, compliance has to be confirmed by a qualified third-party laboratory.

    Preparation helps a lot. Submitting representative samples along with a clear ingredient list allows the lab to test more efficiently and reduces back-and-forth questions.

    It’s also important to work with recognized testing organizations, such as SGS, Intertek, or TÜV. Their reports are widely accepted and trusted in international markets.

    Finally, timing matters. FDA and LFGB testing usually takes 7–15 working days, depending on the product and test scope. It’s best to plan this into the production and shipping schedule early, rather than rushing testing at the last minute.

    food grade silicone lid mat spoon spatula mold

    What Do FDA and LFGB Compliance Really Mean?

    FDA Compliance

    In reality, the FDA itself does not issue certificates for silicone products or food contact materials.

    What the market usually calls an FDA certificate is actually:

    • A third-party laboratory test report
    • The report confirms that the silicone material complies with FDA regulations, mainly CFR 21 requirements for food contact substances
    • The lab tests whether the material formulation, extractables, and residues meet FDA limits

    In other words, FDA compliance is regulation-based, not license-based.

    The responsibility lies with the manufacturer to ensure materials meet FDA rules, and a qualified lab verifies this through testing.

    LFGB Compliance

    LFGB works in a similar way.

    • LFGB is a German food contact regulation, not a government-issued certificate
    • Testing is carried out by accredited third-party laboratories
    • The lab confirms compliance with LFGB and related EU food contact regulations

    So whether it’s FDA or LFGB, what customers receive is a compliance test report, not an official government-issued certificate.

    Understanding this difference helps avoid confusion during purchasing, customs clearance, and customer audits.

    FDA silicone test

    FDA & LFGB Certification – Frequently Asked Questions

    Is LFGB better than FDA?

    Not exactly. LFGB is stricter in testing conditions, especially for odor, taste, and migration. FDA focuses more on material formulation and safety limits. They serve different regulatory systems.

    If a product passes LFGB, does it automatically pass FDA?

    In most cases, yes. However, documentation and reporting formats may still need adjustment to meet FDA compliance expectations.

    Why can a product pass FDA but fail LFGB?

    This usually happens because:

    • The silicone has residual odor
    • Post-curing was insufficient
    • Additives or colorants release substances under LFGB’s stricter conditions

    Does color affect FDA or LFGB testing?

    Yes. Dark colors and certain pigments increase the risk of failing LFGB migration or sensory tests. Transparent or natural silicone generally has the lowest risk.

    How long are FDA and LFGB test reports valid?

    There is no fixed legal expiration date, but:

    • Most buyers accept reports within 1–3 years
    • Any change in material, color, supplier, or process requires re-testing

    Can one test report be used for all silicone products?

    No. Certification is product- and material-specific. Different colors, formulations, or production processes may require separate testing.

    Is certification enough to guarantee product safety?

    Certification confirms food contact compliance, but it does not replace:

    • Proper product design
    • Correct usage instructions
    • Ongoing quality control during mass production
    clean silicone mold 1

    Conclusion

    Understanding and using FDA and LFGB certifications the right way does more than open global markets. It helps build customer trust and grow your brand. In today’s competitive silicone market, safety and compliance are a must—not a choice. And it all starts with proper certification.

    We have rich experience in food-grade silicone production. We know the FDA and LFGB rules inside and out. From picking safe materials to passing lab tests, we’ll guide you every step of the way. Reach out now to get expert advice and move forward with confidence.

    About Author: Ruiyang Silicone

    Ruiyang Silicone, established in 2012, specializes in manufacturing high-quality, environmentally friendly silicone products compliant with FDA standards. They focus on silicone baby products, kitchenware, and toys, ensuring safety and non-toxicity. The company offers a wide range of wholesale items like silicone spoons, spatulas, baby bibs, and pacifiers. They provide OEM customization services, allowing for product tailoring according to customer designs.

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