美国FDA 指导原则 食品中使用的抗菌剂的微生物学问题工业指南 英文原版.pdfVIP

Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry Additional copies are available from: Office of Food Additive Safety Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20 740 (Tel) 240-402-1200 /guidance.html You may submit written or electronic comments regarding this guidance at any time. Submit written comments on the guidance to the Dockets Management Staff (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to . All comments should be identified with the title of the guidance document. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition September 2021 Table of Contents I. Introduction II. Questions and Answers A. What is an antimicrobial agent? B. What is FDA’s statutory authority with respect to antimicrobial agents used in food or in contact with food? C. Which other Federal agencies have authority over certain uses of antimicrobial agents in food applications? D. Why does FDA request microbiological data on the use of an antimicrobial agent? E. What types of data and information should be included in a submission to FDA to demonstrate that the use of an antimicrobial agent is safe and achieves the intended technical effect?