EFSA Publishes Nanotechnology Guidance for Food

The European Food Safety Authority (EFSA; Parma, Italy) today published guidance for assessing the risk of nanomaterials in food and feed products. EFSA calls the guidance “the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.”

The document provides guidance on several fronts:

• First, the data needed to physically and chemically characterize nanomaterials used in applications including food additives, enzymes, flavorings, food-contact materials, novel foods, feed additives, and pesticides. The guidance says nanomaterials should be characterized at five stages: when manufactured (pristine state), when delivered for use in food/feed products, when present in the food/feed matrix, when used in toxicity testing, and when present in biological fluids and tissues.

• Second, the guidance outlines testing approaches to use to examine parameters including in vitro genotoxicity, absorption, distribution, metabolism and excretion, and repeated-dose, 90-day oral toxicity studies in rodents, keeping in mind how these parameters are influenced by the size, shape, solubility, surface charge, and surface reactivity of nanomaterials. Notably, the guidance says that when there is “convincing evidence” that a nanomaterial will not migrate from food-contact materials or will completely degrade or dissolve in the gastrointestinal tract without being absorbed, that there may be no need for additional testing. However, if such data is not available, then tests should follow EFSA’s guidance.

Notably, the guidance also recognizes the uncertainties that currently exist due to any knowledge gaps when it comes to nanotechnology use in food and feed. “A thorough characterization of the engineered nanomaterials followed by adequate toxicity testing is essential for the risk assessment of these applications,” said professor Vittorio Silano, chair of EFSA’s scientific committee. “Yet we recognize uncertainties related to the suitability of certain test methodologies and the availability of data for engineered nanomaterial applications in food and feed.”

EFSA says the guide is practical by providing six scenarios that outline different toxicity testing approaches and indicating the type of testing required. EFSA built its guidance through public consultation as well as more than 256 industry comments received.