Invited lecture:
SAFETY ASSESSMENT AND REGULATORY UPDATE FOR NANODELIVERY SYSTEMS IN FOODS

The safety assessment of nanodelivery systems in foods is a critical but challenging task.  The small size and large surface area of nanosized particles create novel properties and thus unique applications as nanodelivery systems. These same novel properties can also result in altered biological properties with the potential to affect the safety of the material.  Challenges in assessing the safety of nanomaterials include the need for substantial characterization of the nanomaterial and an understanding of the effect of incorporating the nanomaterial into the food matrix on those characteristics.  Specific characteristics have been identified as “red flags” as they are often associated with increased toxicity and/or persistence in the body.

Unlike other routes of exposure to nanomaterials, oral exposure from consumption of nanodelivery systems in foods requires that the impact of the process of digestion on the nanomaterial also be considered.  Various digestion models have been developed to assess the changes in nanomaterials as they move through the digestive tract. The objective of these models is to predict degradation or changes in the material characteristics, and potential uptake of the nanomaterial and/or its effect on the gastrointestinal tract.

Both in vitro cell-based studies and in vivo animal studies have been utilized to assess the safety of the nanomaterials.  Consideration of the design, conduct, and reporting of the studies is critical to produce reliable and reproducible results.  We have developed an approach to assess the reliability of published toxicology studies of nanomaterials (1), which can also be used to guide the design of future studies.  At present, few studies on the safety of nanodelivery systems are in the published literature.

Regulatory agencies around the world are continuing to develop and refine approaches for regulation, safety assessment and approval of novel nanomaterials in foods.  A brief overview of the current regulatory landscape and future directions will be presented.

Principal investigator: Dr. Bernadene A. Magnuson  b.magnuson@utoronto.ca

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