欧美食品用香料香精监管及安全评价体系研究

香料香精作为一种非常重要的食品添加剂,在食品行业中发挥着举足轻重的作用,但使用不当也会引起一定的食品安全隐患。目前国际上允许使用的食品用香料香精多达几千种,因此制定相关的法规标准进行监管及评价很有必要。美国及欧盟等相关国家和地区已经形成了较为完善的食品用香料香精的监管及安全评价体系,在国际香料监管及评估方面具有重要地位。重点介绍了欧美关于食品用香料香精的监管机构和组织:美国食品用香料香精主要由食品药品监督管理局(FDA)监管,但其将香料评价工作交由食品香料与萃取物制造者协会(FEMA)执行,FEMA主要工作是通过FEMA GRAS计划确保食品用香料的安全；欧盟食品用香料的监管工作主要由欧洲理事会(COE)和欧洲食品安全局(EFSA)负责,其中EFSA是制定食品安全法规的权威机构,主要公布欧盟许可的食品用香料名单。总结了欧美关于食品用香料香精安全性的评价方法,包括暴露量评估及毒理学评估方法。在美国,人均摄入量(PCI)×10法是最被认可的暴露量评估方法,每日最大摄入量(MSDI)法被EFSA认为是最适合一般使用的香料物质摄入量的评估方法。在毒理学评估方面,毒理学关注阈值(TTC)法是目前欧美基因毒性风险评估的主要方法。欧美对于香料香精的安全性评价体系具有高度相似性,可为我国食品用香料香精监管及评价体系的完善提供指导与借鉴。

Study on Supervision and Safety Assessment System of Food Flavorings in EU and USA

Flavorings play a pivotal role in food industry as an important kind of food additives. However, improper use of food flavorings can cause food safety risks. There are thousands of flavorings allowed using in food in the world at present. Therefore, it is necessary to formulate regulations and standards for supervision and safety assessment. Relatively perfect supervision and safety assessment systems for food flavorings has formed in EU and USA over the years, which played a vital role in international supervision and safety evaluation of flavorings. The regulatory agencies on food flavorings in EU and USA were reviewed. Regulations of food flavorings in USA were mainly conducted by the Food and Drug Administration (FDA). The safety assessment of flavorings was handed over to the Food Flavor and Extract Manufacturers Association (FEMA), which was mainly responsible for security of the food flavorings through the FEMA GRAS program. The supervision of food flavorings in EU was mainly performed by the Council of Europe (COE) and the European Food Safety Authority (EFSA). Wherein, EFSA was the authoritative organization that formulated food safety regulations and mainly published the list of EU-licensed food flavorings. In addition, safety assessment methods including exposure estimation and toxicological assessment were reviewed. The PCI×10 method was most acceptable for exposure estimation in USA, while the MSDI method was considered to be the most suitable method for intake estimation of general flavorings by EFSA. In terms of toxicological assessment, the threshold of toxicological concern (TTC) method was currently utilized for genotoxic risk assessment both in EU and USA. The safety evaluation systems of flavorings in EU and USA were highly similar, which could also provide guidance and reference for the improvement of the supervision and safety assessment system for food flavorings in China.