The document, which provides guidance on the use of nanoparticles in processing practices and food contact substances (FCS), details safety concerns that have not been an issue with traditionally manufactured products.
The guidance was detailed in the FDA document, Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Colour Additives.
It pinpoints factors that should be considered when trying to determine whether manufacturing processing changes create significant changes in food substances.
Nanotechnology, which involves the use of materials at a scale measured in nanometres, has a broad range of potential applications, including in the packaging of food.
Once finalised, the draft guidance will represent the FDA’s current thinking on the topic.
New safety issues
“As with any other manufacturing technologies applied to food, nanotechnology and other emerging technologies may introduce issues that warrant additional or different evaluation during a safety assessment of a food substance,” said the published document.
“For example, so called nano-engineered food substances can have significantly altered bioavailability and may, therefore, raise new safety issues that have not been seen in their traditionally manufactured counterparts.”
The guidance added the recent advances in nanotechnology have resulted in new properties not traditionally seen in manufactured food.
This may “merit” examination, said the guidance.
“However, FDA does not categorically judge all products containing nano-materials or otherwise involving application of nanotechnology as intrinsically benign or harmful,” said the guidance.
Particle size, surface area, aggregation, or shape may impact the absorption, distribution, metabolism and excretion characteristics, said the document. This could potentially affect the safety of nano-engineered food substances.
Future consequences
The document added that the consequences – both to consumers and the food industry – of distributing a substance, later recognised to present a safety concern, could be significant.
“Any manufacturing change has the potential to be significant, and this remains true for changes or novel products, involving nanotechnology,” the FDA paper added.
“Alterations in particle size distributions on the nanometer scale, which alter the physical and/or chemical properties of food ingredients and FCSs, can sometimes be significant manufacturing changes.”
“The discussion in this document of nanotechnology – in particular intentional alterations of particle size distribution on the nanometer scale – primarily addresses circumstances in which there has been a manufacturing change to a food substance already used in food,” it added.