FDA vs LFGB vs RoHS vs REACH: Which Silicone Compliance Does Your Product Need?

For food-contact silicone sold in the USA you need FDA 21 CFR 177.2600. For food-contact silicone sold in the EU you need LFGB (German, recognized across the EU as the gold standard). RoHS and REACH are not food-contact tests — they restrict heavy metals and chemicals for electronics and general products, not for kitchenware. Mixing them up is the #1 reason buyers get rejected by Amazon or EU customs.

Why this matters

When a buyer sources a silicone spatula, baby teether, or kitchen mat from a Chinese factory, the compliance question that always comes up is: "Do you have FDA?" That is the wrong question. It conflates four different regulations with four different scopes, four different test methods, and four different markets. A factory can hold valid FDA, LFGB, RoHS and REACH test reports on paper and still fail an Amazon recall audit because the material tested in the report was not the same material that went into your product.

This article explains each regulation, what it actually covers, how to request the right document from your supplier, and what a real compliance file looks like.

The four regulations at a glance

What FDA 21 CFR 177.2600 actually tests

21 CFR 177.2600 is the US Federal Register section for rubber articles intended for repeated use in contact with food. For silicone, the standard test protocol runs the material through three simulants (distilled water, n-hexane, and a polar solvent), then measures:

1. Volume of soluble extractives in each simulant (must be below specified limits based on time and temperature of use)
2. Vinylidene chloride extractables if the formulation contains it
3. Peroxide residue for peroxide-cured systems

A valid FDA test report for silicone contains the material name, hardness (Shore A), cure system (peroxide vs platinum LSR), test date, lab name, and the exact simulants used. Without those five fields, the document is marketing, not a compliance file.

Why LFGB matters more than FDA for EU-bound kitchenware

The European Union does not have a single "silicone food-contact" regulation. The framework is EU 1935/2004 (general) plus EU 10/2011 (which officially covers plastics but is commonly extended to silicone). In practice, EU retailers — Aldi, Lidl, Carrefour, MediaMarkt — demand LFGB because:

• LFGB is the German national food and feed code, Paragraph 30 and 31
• It is strictly more comprehensive than EU 10/2011, including organoleptic testing (does the silicone smell or transfer taste to food?)
• German retailers require it as a condition of listing, and other EU retailers follow
• Amazon EU accepts LFGB as sufficient for food-contact silicone listing

Key difference: LFGB includes a sensory / organoleptic test that FDA does not. A silicone baking mat that smells like vinegar, transfers a soapy taste to butter, or discolors hot oil will pass FDA and fail LFGB.

RoHS is for electronics, not for kitchenware

This is the single most common confusion in B2B inquiries. RoHS restricts lead, cadmium, mercury, hexavalent chromium, PBB, PBDE, and four phthalates — because it was written to clean up electronics waste.

• A silicone spatula does not legally need RoHS. Asking for RoHS on a kitchen product wastes money.
• A silicone remote cover, keyboard keypad, or cable boot does need RoHS, because it is an electronics part.
• A silicone facial mask brush in an Amazon beauty listing does not legally need RoHS, but some EU buyers ask for it anyway as a general safety signal.

REACH is not a food-contact test — it is a chemical inventory

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is the EU's general chemical regulation. The parts that matter for product buyers are:

• SVHC candidate list — substances of very high concern, currently around 240 entries
• If a product contains >0.1% w/w of any SVHC, the buyer must be notified
• For silicone, the typical SVHC concerns are certain phthalates used as softeners, and sometimes specific catalysts

A real REACH declaration from a manufacturer should list the SVHCs tested, the method (usually GC-MS + ICP), and the test date. A one-line "REACH compliant" PDF from a supplier is not usable evidence for EU customs.

Prop 65: California's warning label rule

If you sell into California via Amazon, Shopify, or any US channel, Prop 65 applies regardless of FDA status. If any restricted substance is above the "safe harbor" level, you must place the Prop 65 warning on the product page or packaging. Most reputable silicone factories can test and certify Prop 65 in the same batch as FDA.

PFAS: the emerging addition

Since 2023, EU regulators and US states (Maine, Minnesota, California) have begun scrutinizing PFAS ("forever chemicals") in silicone products. The silicone polymer itself does not contain PFAS, but release agents, mold sprays, and certain additives can. For US-bound consumer products, request a PFAS screening report with identified analytes and method. CYES SILICONE provides PFAS screening on request, with the specific analytes, analytical method, and sample matrix documented.

How to request compliance documents from your supplier

Send this exact message to any silicone supplier:

"Please provide test reports for the exact material and hardness of my part, showing:
1. Material commercial name and supplier (e.g., Wacker ELASTOSIL LR 3003, Shin-Etsu KEG-2000)
2. Hardness Shore A
3. Cure system (peroxide vs platinum LSR)
4. FDA 21 CFR 177.2600 report (if US food-contact)
5. LFGB §30/31 report (if EU food-contact)
6. RoHS 2 + 2015/863 report (if electronics)
7. REACH SVHC declaration current to latest candidate list
8. PFAS screening (if US consumer product)
9. Test lab name and ISO 17025 accreditation"

If the supplier cannot produce all nine items for your specific material grade, the sample they showed you was made with a different compound. Ask them to retest on the actual production batch.

Common supplier traps

1. "We have FDA" — but the report is for a different hardness, a different colorant, or a different factory
2. "FDA approved" — FDA does not "approve" materials; it publishes regulations. Reports are issued by third-party labs (SGS, Intertek, TÜV, Bureau Veritas).
3. "We have LFGB" — but the report is from 2018 and the SVHC list has been updated 40 times since
4. "Everything is food-grade" — food-grade is a claim, not a test. Always ask for the specific report number, test lab, and date.

What a real compliance file looks like

A factory that does this properly provides, per product SKU:

• Material specification sheet (MSDS + TDS from silicone compound supplier)
• FDA / LFGB / EU 10/2011 / RoHS / REACH / PFAS reports, all dated within last 12 months
• Colorant compliance (each Pantone color is a separate compound)
• Print / ink compliance (if pad-printed or laser-marked)
• Packaging compliance (if retail boxed for food contact)

FAQ

Q: Do I need FDA and LFGB both?
A: Only if you sell into both the USA and the EU. A US-bound spatula needs FDA, not LFGB. An EU-bound spatula needs LFGB, not FDA. If you sell on both Amazon.com and Amazon.de, get both on the same production batch.

Q: Can a single FDA report cover all my products?
A: No. Each material grade, hardness, color, and cure system is a separate test. A silicone baby teether at Shore 40A in blue is a different compound from a silicone kitchen spatula at Shore 60A in red.

Q: How much does compliance testing cost?
A: FDA: ~$300–$600 per material. LFGB: ~$800–$1,500 per material. RoHS: ~$150–$300. REACH SVHC: ~$200–$400. PFAS: ~$500–$1,200. All five on one material typically totals $2,000–$3,500.

Q: How long does testing take?
A: FDA: 5–10 working days. LFGB: 10–15 working days. RoHS: 3–5 working days. Plan 3–4 weeks total if you need the full suite.

Q: Can the supplier's existing reports be reused for my product?
A: Only if the compound, hardness, color, and cure system are identical. If your design changes hardness or color, a new test is required.

Q: Is "medical grade" the same as "food grade"?
A: No. Medical grade silicone typically means USP Class VI or ISO 10993 biocompatibility tested. Food grade means FDA / LFGB. A medical-grade part is usually food-safe, but a food-grade part is not automatically medical-grade.

Q: What should I do if Amazon rejects my listing for compliance?
A: Request the exact rejection reason from Seller Support, then send it to your factory with the exact material spec. Ask them to re-issue the matching report within 7 days. Most rejections are not a product problem — they are a document mismatch.

Need to confirm the compliance scope for your product? See FDA & LFGB Testing for Silicone, or send your project and target market and we'll outline the exact testing you need.