US FDA Food Contact Approvals: The Use Is the Key
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, e.g., 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 determine 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 higher than what in fact is extracted).
After performing the requisite 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.
For more information, contact the Ibex Global team at info@ibexglobal.net or visit us on the web at www.ibexglobal.net or www.ibexglobal.co.il.
* This document is not intended 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.
Related Tags: israel, food, center, safety, israeli, fda, food contact notification, fcn, additives, ibex global
Copyright 2007 by Ibex Global LLC, all rights reserved.
Tom Page teaches international and comparative environmental and public health law and regulation at the Hebrew University of Jerusalem Faculty of Law. He also serves as global regulatory affairs director for a multinational high-tech company and as a consultant to Ibex Global Environmental & Medical Technology Consulting LLC.
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