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How are "Cooking" and "Cooking Temperatures" Defined Under FDA Regulations?

April 30, 2013
Question 

I am looking for FDA definitions for "Cooking" and "Cooking Temperature." Could you please elaborate, including on the reference in 21 C.F.R. or any other FDA documents?

Answer 

The Food and Drug Administration (FDA) has not provided a definition of "cooking" or "cooking temperature" with respect to food-contact materials, per se. However, if you have a new food-contact material, a critical factor in establishing its FDA status is its intended use—including the maximum temperature at which it will be used. Condition of Use A is described as "High temperature heat-sterilized (e.g., over 212 deg.F)." Condition of Use J is described as "Cooking at temperatures exceeding 250 deg.F" on FDA's website. The description of Condition of Use A is also listed in Title 21 of the Code of Federal Regulations (C.F.R.), Section 176.170(c), Table 2.

The description of Condition of Use A in FDA's chemistry guidance for preparing food-contact notifications (FCN), "High temperature, heat sterilized or retorted (ca. 121 ºC (250 ºF))," varies with respect to the temperature listed. Although the regulation in 21 C.F.R. 176.170(c) is intended to cover use of a substance at any temperature above Condition of Use B (i.e., 212 ºF), whereas the guidance document is intended to describe the condition in relation to the migration testing needed to clear a food-contact substance (by way of an FCN) for Condition of Use A. Since retorting food in a container is normally done at 250 ºF and above, FDA was being more precise in the guidance document by referencing retort temperatures of 250 ºF. The chemistry guidance further clarifies that migration testing should be conducted at the maximum intended cooking temperature for the longest intended cooking time.

Since FDA did not conduct a regulatory proceeding when adopting Condition of Use J, it is only relevant in so far as it describes the types of testing data that the Agency requests for an FCN submission for a substance that is intended to be used in cooking applications exceeding 250o F (i.e., susceptor microwave applications).