FDA compliance for Ultraviolet Electron Beam EB Coatings and Adhesives

FDA compliance for Ultraviolet Electron Beam (EB) Coatings and Adhesives 

3) Prior sanctioned substances (prior to 1958, issued by either the FDA or the USDA. 

Any food additive that is not within these exclusions is required to be the subject of a FCN according to section 409 of the FDCA. However, there are other evaluation options by which food contact substances can be determined to be exempt from or compliant with FDA regulations (Statutory Exemption). Food contact substance is defined as any substance intended for use as a component of materials used in manufacturing, packaging, packing, transportation, or holding food if such use is not intended to have a technical effect in food . Provided next is a list of mechanisms by which a statutory exemption can be established (i.e., the substance is not reasonably expected to become a component of food)  

1) Threshold of Regulation Letter-. Prior to the implementation of the FCN, FDA would issue opinion letters as to whether or not a particular substance represented a significant dietary exposure. Previously issued letters will still be in effect. 

2) No Migration / No Food Additive Determination This determination, often referred to as the no migration exemption, is the most significant escape clause, for it provides the most-used premise for self-determination that a food packaging material need not be subject to FDA s review. 

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