A guidance for firms making antimicrobial food additives and food contact substances in designing studies to determine whether an antimicrobial food additive achieves its intended technical effect has been issued by the FDA. To demonstrate that an antimicrobial agent achieves its intended technical effect and that the proposed use level is the minimum level necessary to accomplish the intended technical effect, the following information is recommended at a minimum: (1) chemical or biological identity of the agent, (2) detailed description of intended microbial effect, (3) description of the conditions of use and any limitations on conditions of use, (4) efficacy studies, (5) sample of the label proposed for the food additive, and (6) for petitions, proposed wording for establishing or amending a food additive regulation.
SOURCE: FDA Guidance
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