US FDA Food Contact Approvals: The Use Is the Key


When it comes to understanding what it takes to be Approved as a “food contact substance,” the key question is what kind of use the substance willhave. The skies Different kind of food contact substances are Twofold: Food additives, sem Actually enter Into the food in what Oftel are rather minimal quantities; and food contact materials, such as packaging and cooking utensils.

The key questions for food contact substances That are not food additives are how much of Them Actually become combined with the food Itself and what are the Conditions of the use of the food contact materials, eg, for liquid foods, acidic foods, hot foods, cold foods, etc.

Based on the classification of the food contact material as an additive or simply a substance That will come Into contact with food, as well as the kind of contact That Will occur, US Food & Drug Administration (“FDA”) Regulations specify exact kind of “extraction” testing that must be conducted in order to determiner exactly what quantities of the food contact substances Actually Will be extruded Into the food Itself or, Alternatively, the Regulations Provide for Calculations of extraction without the need for testing (where the Estimated extraction of materials is usually in a higher than what in fact is extracted).

After performing the requisites extraction testing, as well as providing the Appropriate physical data and use description of the food contact material, a Food Contact Notification may be filed with the US FDA That Will take up to 90 days to be Approved. The key is reading the highly technical guidelines about what data to submit and in what form.

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* This document is not superintended to Provide legal-regulatory advice but merely as a general overview of the subject matter. For specific issues and products, Consultation with a regulatory expert is advisable.


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