Please Explain the Testing Conditions Required for FDA Condition of Use
There appears to be contradicting statements in FDA’s "Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations," Appendix II, Section 11 (Special Cooking Applications), paragraph A (Microwave-Only Containers). The second half of the paragraph states:
"Typical cooking conditions have been generally observed to not exceed 130ºC (266ºF). Test performed for broad coverage in packaging under the protocol for condition of use H (above) will also be adequate to model migration for microwave only containers. However, for those sponsors that propose use of a food contact article specifically in microwave containers, migration testing should be performed in a food oil, or fatty food simulant, at 130ºC (266ºF) for 15 minutes and in an aqueous food simulant at 100ºC (212ºF) for 15 minutes."
So first, it states that tests performed for coverage under condition of use H would be adequate to model microwave only containers. Then it goes on to say that you should test a fatty food simulant at 266ºF and an aqueous simulant at 212ºF, both for 15 minutes. We confirmed with the material supplier that the material was tested at 212ºF for 2 hours to achieve condition H status. Can you clarify if the existing declaration is adequate, and if not, what else would be needed?
The different testing requirements are based on the final use of a microwave-only containers (i.e., reheating versus cooking food). In its “Guidance for Industry, Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations,” FDA confirmed that tests performed for broad coverage under the protocol for Condition of Use H (reheating ready-to-eat, prepared foods) is adequate to cover microwave-only containers in addition to conventional oven reheating of ready-to-eat, prepared foods. However, where such containers are intended to cook food in a microwave, then the Agency expects the testing to be conducted in accordance with the admonition noted above, which in this case is use of a food oil, or fatty-food simulant, at 130ºC (266º F) for 15 minutes and an aqueous food simulant at 100º C (212º F) for 15 minutes.