21 CFR 177.2600: silicone food-contact procurement
For repeated-use rubber food-contact articles, check the formulation, intended use and applicable extractives requirements in 21 CFR 177.2600. A cure-system label is insufficient.
Confirm the scope first
Identify the article, food types, contact temperature, duration and repeated-use conditions. Do not assume every pacifier, teether or medical component is governed by this food-contact rule. Product classification and the destination market determine additional requirements.
Read the full test conditions
The regulation addresses permitted substances and finished-article requirements. Water and n-hexane extraction provisions have separate conditions and limits, including successive extraction periods. Ask the laboratory to identify the applicable subsections and record all relevant results; a generic “FDA compliant” statement is not a substitute.
US and European evidence are different
German LFGB requirements, BfR recommendations and the EU food-contact framework should be considered for their own scope. Passing one test program does not automatically demonstrate compliance in another market. BfR explains that its recommendations are not themselves binding law.
Before requesting a quote
Send the drawing revision, application, material preference, critical dimensions, annual quantity, delivery market and required evidence. Feasibility, testing, price and timing need written project review.
Buyer questions
Does platinum cure automatically comply?
No. Confirm the grade, additives, processing and finished-part results. Some peroxide-cured grades can also meet food-contact requirements under specified processing and use conditions.