Recent U.S. FDA guidance provides updated expectations for demonstrating that food-contact silicone articles comply with 21 CFR 177.2600. The guidance emphasizes extractables testing, cure completeness and documentation of the formulation used in finished tubing.

Implications for buyers

Procurement and quality teams should request up-to-date extraction study data and a declaration of compliance from tubing suppliers. Platinum-cured silicone with verified low extractables remains the recommended option for direct food and beverage contact.

Rekky's food-grade tubing is manufactured to these requirements and is supported by FDA and USP Class VI documentation on request.