Two Frameworks, Two Different Jobs
A buyer in Chicago asks for an FDA certificate. A buyer in Hamburg asks for LFGB. Both want evidence that a silicone part is safe in contact with food, and both requests arrive with the same assumption that one document can be swapped for the other. It cannot. The two systems test different media at different temperatures, and a report produced under one framework says very little about the other.
The distinction carries commercial weight at the quotation stage. A 40 Shore A spatula molded from kitchenware LSR and a 3 mm baking mat are different articles under both systems, and the ratio of exposed surface to part weight moves the pass or fail outcome further than most formula changes a buyer is likely to request.
What FDA 21 CFR 177.2600 Covers
Section 177.2600 is the United States rule for rubber articles intended for repeated use in food contact. It sits inside Title 21, Part 177, which lists indirect food additives. The section names permitted base polymers and compounding ingredients, then defines an extraction protocol that the finished article has to survive.
The protocol runs two media. Distilled water under reflux for 7 hours, and n-hexane under reflux for 2 hours. Extractives are reported as milligrams per square inch of exposed food-contact surface, with limits of 20 mg per square inch for the aqueous extraction and 175 mg per square inch for the hexane extraction in 21 CFR 177.2600(c)(4). A second extraction sequence applies to repeated-use articles. Read the current regulation text before signing a test request, because the figures printed in older laboratory templates do not always match it.
Two operational consequences follow. The result depends on how the laboratory calculates surface area, and on whether the part is measured on one face or both. A baking mat tested on one face can pass where the same mat tested on both faces fails, and no laboratory will flag the choice unless the request states it.
What LFGB and BfR XV Require
Germany's LFGB is a framework law. Articles 30 and 31 prohibit the transfer of substances that are harmful to health or that alter the sensory character of food. The technical detail for silicone comes from BfR Recommendation XV, which lists permitted components and limits volatile organic content, together with the overall migration conditions in the EN 1186 series.
The sensory requirement catches exporters more often than the migration numbers do. A trained panel evaluates odor and taste after contact with a defined simulant. A part with acceptable extractive results can still fail when it is demolded with an external release agent, or when it is packed warm in a polyethylene bag and takes on the odor of the bag.
BfR XV also constrains volatile organic constituents, which pushes production toward a post-cure. Anysil runs a 4 hour post-cure at 200 °C on food-contact LSR before packing. The volatile reduction from that step is usually larger than any formula change a buyer is in a position to negotiate.
Side by Side
|
Item |
FDA 21 CFR 177.2600 |
LFGB with BfR XV |
|
Legal basis |
Indirect food additive rule for rubber in repeated use |
National framework law with a BfR recommendation for silicone |
|
Primary evidence |
Extractive limits in water and n-hexane |
Overall and specific migration plus a sensory panel |
|
Test media |
Distilled water, n-hexane |
Simulants per EN 1186, for example 3 percent acetic acid, 10 percent ethanol, olive oil |
|
Conditions |
Reflux times defined in the section |
Exposure chosen from food type, temperature and contact time |
|
Result basis |
Milligrams per square inch of contact surface |
Milligrams per square decimetre, or per kilogram of food |
|
What a pass proves |
Formula and cure state meet US extractive limits |
Article suits the declared food type and temperature |
|
What a pass omits |
Acidic or fatty food at high temperature |
US additive listing and extractive limits |
|
Document issued |
Laboratory report plus supplier declaration |
Laboratory report plus declaration of compliance |
The last two rows carry the argument. A US report on a coffee machine gasket and a German report on the same gasket answer different questions, and no laboratory will accept one as a substitute for the other.
Why an FDA Certificate Is Not a Certificate
The United States does not issue certificates for food-contact articles. There is no registration number, no federal mark, and no expiry date. What exists is a test report from an accredited laboratory that applied the section's methods, supported by a supplier declaration of compliance.
A supplier offering a numbered FDA certificate for a silicone part is offering a document with no legal counterpart. The position in Europe is similar, where the declaration of compliance carries the legal weight and the test report supports it. The declaration identifies the article, the intended use, the restricted substances and the basis for compliance.
Where Silicone Sits in European Law
Regulation (EU) No 10/2011 governs plastic materials and articles. Silicone elastomers are not plastics under that regulation, so a quotation for a 10/2011 test on a silicone spatula is quoting the wrong framework. The European reference for silicones is Resolution AP(2004)5 of the Council of Europe, applied through national measures such as LFGB in Germany and the French order of 25 November 1992 for elastomers.
The error is common enough to have a pattern. A trading company buys a 10/2011 report because the buyer's specification mentions European food contact, the container arrives, and the retailer rejects the document because the material category is wrong. The money is gone and the shipment sits in a warehouse.
Writing a Test Request That Produces Usable Evidence
A request that names only the material grade produces a report nobody can file. Five items decide whether the evidence survives an audit.
Article description with the wall thickness range. An 0.8 mm wall and a 6 mm wall do not release the same way, because thin sections are governed by the surface to volume ratio.
Food contact type, stated as aqueous, acidic, fatty or alcoholic. Fatty food at 100 °C is the hardest case for a spatula and the easiest case to test badly.
Maximum service temperature and cumulative contact time. A baking mat at 230 °C for 60 minutes follows a different exposure than a baby care bottle teat at 40 °C.
Surface area method, written into the request. One face or both, measured or calculated from the drawing.
Whether a post-cure is applied before testing, and the profile used. This item is missing from most purchase orders.
The fifth item is the one suppliers leave out. Testing a part straight off the press and testing it after a 4 hour post-cure can move the hexane extractive result far enough to turn a marginal pass into a comfortable one, and the report does not say which state was tested.
Sequencing Tests on a New Tool
Order the tests by market first, then by article. Commissioning both frameworks at once on a new tool doubles the cost before the tool has proven its dimensions.
For a United States launch, run the 177.2600 extraction on the production tool with the production cure, not on a trial cavity.
For a European launch, run overall migration and the sensory panel first, then add specific migration only where the formula carries a restricted substance.
Run both sets only when the same article ships to both markets, and release against the stricter of the two results.
Repeat the full set after any change of base polymer supplier, pigment masterbatch or post-cure profile.
A pigment change is the most frequent re-test trigger that buyers forget to budget. A 1.0 percent letdown of a new masterbatch shifts extractive results even when the pigment itself is compliant, because the carrier and the dispersion aid take part in migration.
|
One detail that decides marginal cases. The laboratory needs the actual exposed area, so Anysil supplies a dimensioned drawing with the food-contact faces marked and the number of pieces per condition, usually 6 for the aqueous medium and 6 for hexane. Parts are cut from the same lot and post-cured together, and the report carries the lot number. Without that link between report and lot, a buyer has evidence for a material and nothing for the shipment. |
Next Step
Send the part drawing with wall thickness, the destination market, and the food type with maximum service temperature, and Anysil will return a quotation with the correct test scope attached. Extraction reports for the current food-contact LSR grade ship with the sample set, so the document and the material arrive together.