FDA veröffentlicht Leitlinie zu Nanomaterialien in Tiernahrung
Die US-amerikanische Food and Drug Administration (DFA) hat die finale Version der Leitlinie zur Verwendung von Nanomaterialien in Tiernahrung veröffentlicht. Die Leitlinie ergänzt die bestehenden FDA Richtlinien zur Definitionsfrage, zur Sicherheit von Nanomaterialien in Kosmetika sowie zur Verwendung von Nanotechnologien in Lebensmitteln und -zusatzstoffen. Die neueste Leitlinie befasst sich mit Tiernahrung aus Nanomaterialien, Tiernahrung, welche Nanomaterialien enthält, sowie solche, welche mittels nanotechnologischer Verfahren hergestellt wurde. Sie enthält Empfehlungen zur Einreichung von Food Additive Petitions sowie zum Vorgehen bei Verwendung nanotechnologischer Verfahren.
The U.S. Food and Drug Administration has issued a final guidance for industry, 'Use of Nanomaterials in Food for Animals' (pdf), which is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology. This guidance is applicable to food ingredients intended for use in animal food which (1) consist entirely of nanomaterials, (2) contain nanomaterials as a component or (3) otherwise involve the application of nanotechnology.
This final guidance addresses the legal framework for adding nanomaterial substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient. This guidance also recommends manufacturers consult with FDA early in the development of their nanomaterial animal food ingredient and before submitting an FAP. At this time, we are not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is generally recognized as safe (GRAS).
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. These particles can have chemical, physical, and biological properties that differ from those of their larger counterparts, and nanotechnology has a broad range of potential applications.
Guidance documents represent the FDA’s current thinking on particular topics, policies, and regulatory issues. While “guidance for industry” documents are prepared primarily for industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of laws and policies.
Quelle: FDA
Bildquelle: Agricultural Research Service, United States Department of Agriculture