One final guidance addresses the agency's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics and food for animals, respectively.
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 and altering the look and feel of cosmetics.
"Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products," said FDA Commissioner
The three final guidance documents reflect the
The guidances are:
Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
The guidance outlines overarching considerations for all
Theguidance describes the
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 Color Additives
The 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 food substance, potentially warranting a regulatory submission to the
Draft Guidance for Industry: Use of Nanomaterials in Food for Animals
This draft guidance addresses issues related to the use of nanotechnology in food ingredients intended for use in food for animals. Public comments on this draft guidance are requested by
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