Scientific Consultancy, Animal Welfare, Neubiberg, Germany.
Altern Lab Anim. 2011 Dec;39(6):567-75. doi: 10.1177/026119291103900611.
Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.
纳米材料越来越多地被添加到食品处理和包装材料中，或者直接添加到人类食品和动物饲料中。为了确保这些工程纳米材料（ENMs）的安全性，欧洲食品安全局（EFSA）于 2011 年 5 月发布了一份关于在食品和饲料链中应用纳米科学和纳米技术的风险评估指南。该指南指出，风险评估应按照逐步程序进行。只要预计人类或动物会接触到纳米材料，一般的危害特征化方案就需要从体外遗传毒性、毒代动力学和重复剂量 90 天口服毒性研究中获取信息。在该指南中，针对纳米材料的特征及其危害和风险评估方面存在的许多普遍不确定性进行了讨论。本文从动物福利的角度出发，以 EFSA 关于食品和动物饲料中 ENMs 的风险评估指南为例，讨论了在何种程度的不确定性下，对于具有非医疗应用的产品的人类安全性评估应被认为是可接受的，以及对于此类产品是否应考虑动物试验在伦理上是否可接受。
