FDA Approval: Rules and Regulations

Federal Register

Vol.66 No.123

Tuesday, June 26,2001

PART 173-SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

AUTHORITY:21 U.S.C. 321,342,348

Sec. 173.368 Ozone

On June 26, 2001 the U.S. FDA approved the use of ozone as an antimicrobial agent in the gas or liquid phases for direct contact with foods. In this paper, the author will discuss and interpret specific wordings of the FDA approval in terms of several food uses of ozone and existing safety regulations. This will be followed by discussions of gas- and liquid-phase applications of ozone in food and agricultural applications, and recommendations for determining appropriate dosages of ozone that should be applied to specific foodstuffs. Ozone has been approved for use under "Good Manufacturing Practices", meaning "exposure of foods to sufficient ozone (concentrations and times of exposure) to accomplish its intended purpose."

上文翻譯如下 :

2001年6月26日，美國食品藥物管理局(FDA)在第66卷第123號法案中批准「氣態或液態的臭氧( O₃ ， CAS Reg No. 10028-15-6)可當成直接處理食物的抗菌劑使用」。在該篇173.368章節裡，細述了FDA批准 O₃ 可應用在數項食物處理的說明與符合現有的安全規範。接著討論氣相或液相的 O₃ 於食物及農業各種的應用與需要提供處理特定食品的適當用量建議。 O₃ 在 GMP規範下通過批准使用，也就是說， " 要完成對食物特定目的之處理是需要足夠適量的 O₃ (濃度與使用時間) " 。