- Final 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 (the final foods guidance)
The final foods guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including changes involving nanotechnology, on the safety and regulatory status of food substances. This guidance also describes considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the use of the food substance, and potentially warrants a regulatory submission to FDA.
Nanotechnology is an emerging technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers – particles so small that they cannot be seen with a regular microscope. The technology has a broad range of potential applications, such as improving the packaging of food.
FDA will continue to pursue its ongoing scientific research and regulatory efforts and will consider new studies and data, as they become available, to determine future actions.
Please visit fda.gov for more information.