Piperine (E,E-) is a naturally occurring pungent and spicy constituent of black pepperand is also used as an added flavoring ingredient to foods and beverages. Piperine has been determined safe under conditions of intended use as a flavoring substance by regulatory and scientific expert bodies. While concurring with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and Flavor and Extract Manufacturers Association (FEMA) Expert Panel on the safety of piperine, the European Food Safety Authority (EFSA) requested additional toxicological data. The results of a 90-day GLPcompliant dietary study, conducted in Sprague-Dawley rats at target doses of 0, 5, 15, or 50 mg/kg bw/day, to respond to this request are presented herein. No adverse effects were found attributable to ingestion of piperine. Statistically significant changes in food consumption, body weight gain, and plasma cholesterol levels were not considered adverse as discussed in this paper. Therefore, the oral no-observed-adverse-effect level (NOAEL) was determined to be the highest dose tested of 50 mg/kg bw/day. EFSA derived a lower NOAEL of 5 mg/kg bw/day based on increased plasma cholesterol levels which still affords an adequate margin of safety of over 48,000 and concluded that piperine is not of safety concern.

胡椒碱（E，E-）是黑胡椒的一种天然刺激性和辛辣成分，还用作食品和饮料中的添加调味成分。胡椒和胡椒已被监管和科学专家机构确定在拟用作调味品的条件下是安全的。欧洲食品安全局（EFSA）同意粮农组织/世卫组织食品添加剂联合专家委员会（JECFA）和调味料和提取物制造商协会（FEMA）胡椒碱安全性专家小组的意见，同时要求提供其他毒理学数据。本文介绍了在Sprague-Dawley大鼠中进行的为期90天的GLP饮食研究的结果，其目标剂量为0、5、15或50 mg / kg bw /天，以响应此要求。没有发现归因于胡椒碱的摄入造成的不利影响。食物消费有统计上的显着变化，如本文所述，体重增加和血浆胆固醇水平不被认为是不利的。因此，口服未观察到的不良反应水平（NOAEL）被确定为50 mg / kg bw /天的最高测试剂量。基于血浆胆固醇水平的升高，EFSA得出的NOAEL较低，为5 mg / kg bw /天，仍然可以提供超过48,000的足够安全裕度，并得出结论胡椒碱与安全无关。