What does FDA 21 CFR 177.2600 mean for a silicone mat?
21 CFR 177.2600 is the US FDA rule for "rubber articles intended for repeated use" in contact with food, and silicone rubber falls under it. It does two things: it lists the ingredients a rubber may be made from, and it limits how much material can be pulled out of the finished rubber by a solvent and by water. A silicone mat tested to it has shown that very little of the material comes off on what touches it.
The full text is on the government's own site: ecfr.gov, 21 CFR 177.2600.
What the test actually does
The lab takes a sample of the rubber and extracts it under reflux (heated, with the liquid continuously recirculating):
- In n-hexane for 7 hours, then a further 2 hours. Hexane stands in for fatty foods: it pulls out anything oily or fat-soluble.
- In distilled water for 7 hours, then a further 2 hours. Water stands in for watery foods.
What comes out is weighed and reported per square inch of rubber surface. The rule sets a limit for each.
The limits, and what our silicone scored
The silicone our mat is made from was tested by SGS, an accredited test lab, in January 2026 (report CANEC25032504501).
| Extraction | Limit | Result |
|---|---|---|
| n-Hexane, 7 hours | 175 mg/in² | 11.9 mg/in² |
| n-Hexane, further 2 hours | 4 mg/in² | 0.5 mg/in² |
| Distilled water, 7 hours | 20 mg/in² | Not detected |
| Distilled water, further 2 hours | 1 mg/in² | Not detected |
Four extractions, four passes. The first hexane result is about one-fifteenth of the limit; nothing came out in water at all.
What it does not mean
Three things a clinic should know before repeating the phrase "FDA approved":
- The FDA does not approve or certify individual products under this rule. A manufacturer tests the material against it. The accurate wording is "tested to" or "meets the extraction limits of" 21 CFR 177.2600.
- It is a food-contact rule. A reconstitution mat is a work surface, not a medical device, and the rule says nothing about medical use. It is the closest US standard for a silicone surface people handle every day, which is why it is the one to ask for.
- It tests the material. Our report covers the silicone the mat is made from, and the maker confirms in writing that the mat is made from that platinum-cured silicone.
Why ask for it at all
Because "food-grade silicone" on a listing is a phrase, and a lab report is a document. A supplier who has tested the material will send the report. The US rule is also only half the picture: Germany's LFGB tests for things the FDA rule does not. LFGB vs FDA covers the other half.
Questions
What is 21 CFR 177.2600?
The section of the US Code of Federal Regulations that governs rubber articles intended for repeated use in contact with food. It sets which ingredients may be used and limits how much can be extracted from the finished rubber.
What does "total extractives" measure?
How much material comes out of the rubber when it is soaked in a solvent (n-hexane) and in distilled water under set conditions. The result is given in milligrams per square inch of surface, against a limit for each liquid.
Does FDA approve silicone mats?
No. The FDA does not approve or certify individual products under this rule. A manufacturer tests the material against it, usually through an accredited lab. Ask for the lab report.
