Short answer: they are not interchangeable, and neither of them is a certificate. FDA 21 CFR 177.2600 is a US regulation that measures how much matter extracts out of the rubber; LFGB is German law whose §30 and §31 tests add a trained sensory panel; EU 1935/2004 is a framework regulation that has no harmonised measure for silicone at all. What decides which report your programme needs is the destination market and the retailer’s own specification — not the folder of logos a supplier sends you. Here is what each document actually proves, what it leaves out, and how to check that the report in front of you names the compound and the colour you are buying.
The short answer, by market
United States — an FDA 21 CFR 177.2600 extraction report from an ISO/IEC 17025-accredited laboratory, issued for your compound and your pigments. Germany — an LFGB §30/§31 report that includes the sensory panel and cites BfR Recommendation XV. Rest of the EU — a Declaration of Compliance under Regulation (EC) 1935/2004 with GMP Regulation (EC) 2023/2006 and a REACH statement, backed by a national test protocol. Toys and childcare articles — the same set plus EN 71-1, -2 and -3. If you sell into more than one market you need more than one report: none of them substitutes for another.
What each document actually is
FDA 21 CFR 177.2600 — a rule, not an approval
Part 177 of Title 21 is the indirect food additive regulation: the substances that may be used in materials contacting food. Section 177.2600 covers rubber articles intended for repeated use, which is where silicone sits. It lists permitted ingredients and sets extraction limits — the finished article is refluxed in distilled water and again in n-hexane, and the extracted matter is weighed against limits expressed per square inch of food-contact surface. The aqueous limit most often quoted for repeated-use articles is 20 mg/in²; the n-hexane limit is much higher, because a fat solvent pulls more out of any rubber.
What does not exist is an FDA certificate. The FDA does not approve, certify or register silicone spatulas. Compliance is declared by the manufacturer on the basis of test data, and the agency’s involvement is post-market. So the paper you receive is a laboratory report, and its worth depends on two things: whether the laboratory is accredited to ISO/IEC 17025 for that method, and whether the report names the compound and the pigment that will actually be moulded for your order.
LFGB §30 and §31 — law, plus a panel of noses
Germany’s Food and Feed Code asks a different question. Section 30 prohibits substances harmful to health from passing into food; section 31 requires that a material must not change the food in an unacceptable way — composition, smell or taste. That second obligation is why the German protocol always carries a sensory test: a trained panel assesses odour and taste on the migration contact, following DIN 10955. On top of the statute sits BfR Recommendation XV for silicone, which limits volatile organic content and extractable matter.
This is the difference buyers underestimate. A part can sit comfortably inside an extraction limit and still fail LFGB, because five people can taste it. Peroxide-cured silicone with an incomplete post-cure is the classic case: the residual volatiles are exactly what the panel detects. Platinum-cured compound with a full post-cure is usually clean here, which is one reason the curing system belongs in the written specification rather than in the factory’s discretion.
EU 1935/2004 — a framework with a hole where silicone should be
Framework Regulation (EC) No 1935/2004 sets the principle for every food-contact material in the EU: no transfer of constituents in quantities that endanger health, and no unacceptable change in the food. Regulation (EC) No 2023/2006 adds good manufacturing practice. What the framework does not do is give silicone a harmonised measure of its own. Plastics have (EU) No 10/2011, ceramics have 84/500/EEC, recycled plastics have (EU) 2022/1616 — silicone has nothing at EU level.
In practice the gap is filled by national rules and by the buyer’s specification. Germany applies BfR XV; France applies the arrêté du 25 novembre 1992 on elastomers and rubber in contact with food; Italy applies its own ministerial decree for rubber. The document that travels with the goods is the Declaration of Compliance: which articles it covers, which regulation it declares against, which test reports support it, and the conditions of use. REACH runs alongside — SVHC screening at 0.1% by weight, and a SCIP notification where an article contains a listed substance above that threshold.
Side by side
| Question | FDA 21 CFR 177.2600 | LFGB §30/§31 + BfR XV | EU 1935/2004 |
|---|---|---|---|
| Legal status | US federal regulation for indirect food additives | German national statute plus a BfR recommendation | EU framework regulation, with no silicone-specific measure |
| The question it answers | Do permitted ingredients extract beyond the limit? | Does anything harmful — or anything detectable by smell or taste — pass into the food? | Is the article safe, inert and traceable across the EU? |
| Test media | Distilled water at reflux, then n-hexane at reflux | Aqueous, acidic and fatty simulants plus a sensory contact | Whatever the chosen national protocol requires |
| Sensory panel | Not required | Required — odour and taste, trained panel, DIN 10955 | Inherited from the national protocol |
| How the limit is expressed | Milligrams of extract per square inch of surface | Percentage of volatiles, and migration per area | By reference to the national measure |
| Document you actually receive | An accredited laboratory test report | A test report that includes the sensory page | A Declaration of Compliance plus the reports behind it |
| Tied to a colour? | Yes — to a compound and a pigment | Yes — to a compound and a pigment | The declaration must list the articles and their reports |
| Who asks for it | US retail QA, marketplace compliance portals, importers | German and EU retail QA, discounter tenders, IFS/BRCGS auditors | Every EU importer, as part of due diligence |
| Main renewal trigger | Formulation, pigment or supplier change | The same, plus a change in the article’s use conditions | The same, plus a change in the applicable national rule |
Why an FDA report does not satisfy a German buyer
The two protocols answer different questions, so the numbers cannot be converted from one to the other. The US test asks how much matter comes out of the rubber into water and into hexane, and weighs it. The German test asks what migrates into food simulants under defined time and temperature, at what concentration, and whether a trained panel can detect a change. A buyer’s QA reads the first page for the regulation cited, then turns straight to the conditions table. Four things give a report away as incomplete:
- No n-hexane result on an “FDA” report. If only an aqueous extraction appears, the fatty-contact case was never tested.
- An “LFGB” report with no sensory page. The §31 obligation is the reason that test exists in that market.
- Conditions that do not match the claim. A report run at 175 °C for two hours does not support an oven-safe claim to 230 °C.
- A compound code your purchase order does not use. Common when a supplier forwards a report from a different programme.
A test report belongs to a compound and a colour
Silicone is a formulation, not a commodity: base polymer, filler, pigment masterbatch and curing system. Change the pigment and the migration profile changes, which is why a report is issued against a specific compound code and specific colours. Two consequences follow for a private-label programme. A new colour is a new test rather than a photocopy — put it on the calendar, because it sits on the critical path to the first shipment. And a “family” report is only valid if it lists the colour you actually ordered.
This is also where the difference between a factory and a middleman stops being a slogan and becomes a document. A manufacturer with its own mixing room and its own presses can point to the batch record that ties your order to the compound named on the report. A trading company has to ask a third party for that link, and often cannot produce it at all. If the compound code on the certificate cannot be traced back to the batch that made your goods, the certificate is describing somebody else’s production.
What to request, market by market
| Market | Ask for | Who will ask you for it |
|---|---|---|
| United States | An FDA 21 CFR 177.2600 extraction report, per compound and colour, with the test conditions stated | Retail QA, marketplace compliance portals, the importer’s broker |
| Germany | An LFGB §30/§31 report including the sensory panel, citing BfR XV | Retail QA, discounter tender, IFS or BRCGS auditor |
| EU, other member states | A Declaration of Compliance to (EC) 1935/2004 with GMP 2023/2006, the national protocol named, and a REACH SVHC statement | The importer, and the retailer behind them |
| United Kingdom | A Declaration of Compliance to the Food Contact Materials Regulations 2008, which mirror 1935/2004 | The UK importer and the retailer’s technical team |
| Toys and childcare | The food-contact set plus EN 71-1, -2 and -3; a Children’s Product Certificate for the US | Toy buyer, the marketplace toys category, a notified body |
A report is only valid for the conditions it names
Every migration result is produced at a temperature, a time and a contact type. If the report was run at 175 °C for two hours against a fatty simulant and your packaging claims oven-safe to 230 °C, the report does not cover the claim. The same logic applies at the cold end: freezer use to −40 °C does not change migration, but it does stress the compound, and a wall chosen for a 40 Shore A mould can craze after repeated cycles if the material was never specified for it. Write the intended use into the brief, then check that the conditions table matches. This is why one generic report, bought once and reused across an entire catalogue, quietly stops being compliance somewhere in the second season.
What to send so the right test gets booked first time
Most testing delays are specification delays. Five items close the loop:
- 1
Destination markets
List every country the SKU will be sold in, including the country the marketplace ships from.
- 2
Compound and colours
Platinum or peroxide cure, Shore A hardness, and every pigment in the range — including the ones added later in the season.
- 3
Contact and conditions
Aqueous, acidic, fatty or dry; maximum temperature and time; oven, freezer, microwave, dishwasher.
- 4
The retailer’s own spec
Send their questionnaire if one exists — it usually names a specific regulation and a maximum age for the report.
- 5
Toy, childcare or medical status
If the item is marketed to children, EN 71 and a Children’s Product Certificate change the test plan.
Five statements we correct most weeks
- “FDA approved this silicone.” Nothing was approved. There is a test report and a manufacturer’s declaration.
- “We have LFGB.” Ask for the report and turn to the sensory page. Without it, it is not an LFGB test.
- “The report never expires.” It has no formal expiry date, but it is tied to a formulation: a new compound, pigment or cure makes it historical.
- “One report covers the whole range.” Only where the compound and every pigment are identical across all SKUs.
- “FDA is stricter than LFGB.” They test different things. LFGB adds the sensory panel; the hexane extraction is the harder limit for some compounds. Neither dominates.
How this runs inside our own plant
Shenzhen Jewelives Industrial Co., Ltd is a manufacturer with its own factory in Longgang, Shenzhen — not a trading company. Compounding, moulding, assembly and packing run on our own lines, under ISO 9001, ISO 14001 and ISO 13485 quality systems and IATF 16949, with BSCI and Disney FAMA social audits; items are tested to FDA and LFGB, with CE, REACH and EN 71-2/3 reports where the product calls for them. OEM, ODM and private label all run in-house, which is what turns the link between a test report and a production batch into a one-plant question instead of a three-company correspondence. See how we manufacture — including where the mould shop and the QC stations sit on the line.
Send the destination market, the compound, the colours and the use conditions and you get a straight answer on which reports apply and which have to be booked — normally within 24 hours. Start from the 26-piece catalogue if the shapes are already decided, or send the requirement directly.