About Food Contact Testing of Rubber Materials

Rubber materials are used in a wide variety of food contact materials from storage containers to cooking utensils. The FDA requires that rubber articles intended for use in food contact applications must meet certain requirements for identity and extractable content.  This method covers part (e) and (f) of 21 CFR 177.2600. 

Approach

1.       Samples must be identified by FTIR analysis and compared with the list of approved materials in 21 CFR 177.2600.

2.       If the article is intended for repeated use in contact with aqueous food, then the extractables content in distilled water must be determined.  No more than 20 mg/in2 shall be extracted in the first 7 hours.  No more than 1 mg/in2 shall be extracted in the succeeding 2 hours.

3.       If the article is intended for repeated use in contact with fatty food, then the extractables content in n-hexane must be determined.  No more than 175 mg/in2 shall be extracted in the first 7 hours.  No more than 4 mg/in2 shall be extracted in the succeeding 2 hours.

Sample Considerations

10 grams of material are required to complete this testing.