We manufacture our own platinum-cured silicone and our own molds. That means the material in every mold we ship comes from a supply chain we control end to end — from raw silicone through pigment matching to the finished mold.

This page documents the testing and standards behind that material.

Material Testing

SGS Test Report — FDA 21 CFR 177.2600

Testing bodySGS
Report numberCANEC1700522801
StandardFDA 21 CFR 177.2600 — Total extractive residues, distilled water extraction
ResultPASS — distilled water extraction, below the regulatory limit
Report date19 January 2017

US FDA 21 CFR 177.2600 sets the requirements for rubber articles intended for repeated food contact. The test measures how much material transfers out of the silicone under extraction conditions. The tested sample was below the permitted limit for the distilled water extraction. This report covers the distilled water extraction only; n-hexane extraction was not included in this test.

Download the full report (PDF)

Scope of this report

This report covers the distilled water extraction only. If your specification requires n-hexane extraction or other conditions, contact us and we will arrange the testing.

The tested sample was a platinum-cured silicone in one pigment formulation. Because different colour pigments use different formulations, testing does not automatically extend across every custom colour we produce.

If you need documentation for a specific colour, batch or finished mold — particularly for food-contact applications — contact us and we will arrange the appropriate testing.

Material Safety

Safety Data Sheet (SDS/MSDS)

Our platinum-cured silicone SDS covers composition, handling, storage, transport classification and disposal.

Download SDS (PDF)

What We Control In-House

Our compliance position rests on vertical integration rather than on supplier declarations:

Because we control each stage, we can trace a finished mold back to the material batch it was made from, and we can arrange testing on any specific formulation a customer requires.

Requesting Documentation

Certification and test documentation is available on request. When contacting us, please specify:

Contact: info@bksilicone.com

Frequently Asked Questions

What does the SGS report cover for food-contact use?

A cured sample of our platinum silicone passed SGS testing for total extractives (distilled water) per FDA 21 CFR 177.2600 (2017). The report covers that tested sample and those test conditions. For a specific food-contact application, contact us with your colour and product requirements so we can confirm what documentation applies.

Do you have current test reports?

The report published here is dated 2017. If your procurement process requires recent testing, contact us — we can arrange updated testing to your specification.

Can you test a custom colour?

Yes. Because pigment formulations vary, custom colours are tested individually when documentation is required. Contact us with your Pantone reference.

What is FDA 21 CFR 177.2600?

It is the US Food and Drug Administration regulation covering rubber articles intended for repeated use in contact with food. It sets limits on how much material may extract from the rubber under specified test conditions.

Download TDS / Test Report

BK Silicone Technical Document Downloads (D11)