Posted: 10 Aug 2015 03:32 AM PDT
By Riëtte van Laack –
On August 5, 2015, FDA announced the availability of a guidance document regarding nanomaterials in food for animals. The guidance contains no surprises as it is virtually identical to the draft guidance (based on the docket, it appears that FDA did not receive any comments to the draft guidance) and is in agreement with FDA’s guidance regarding use of nanomaterials in human food (see our previous post here).
At the outset, FDA clarifies that the guidance is applicable only to feed ingredients for which the size has been deliberately manipulated with the goal to produce specific effects. Materials that naturally occur or naturally contain substances in nanoscale range or contain particles in nanoscale range as a result of conventional manufacturing processes are not within the scope of the guidance.
FDA does not question the regulatory status of products that naturally contain nanosize substances and have already been determined to be generally recognized as safe (GRAS) or approved as a food additive. However, FDA concludes that animal food ingredients that have been engineered to be nanosize are not GRAS and, therefore, will be food additives subject to premarket review and approval by FDA. The guidance details FDA’s recommendations for a food additive petition for nanomaterial food ingredients. Throughout the guidance, FDA encourages companies contemplating the use of nanomaterials in animal food to consult FDA.
On August 5, 2015, FDA announced the availability of a guidance document regarding nanomaterials in food for animals. The guidance contains no surprises as it is virtually identical to the draft guidance (based on the docket, it appears that FDA did not receive any comments to the draft guidance) and is in agreement with FDA’s guidance regarding use of nanomaterials in human food (see our previous post here).
At the outset, FDA clarifies that the guidance is applicable only to feed ingredients for which the size has been deliberately manipulated with the goal to produce specific effects. Materials that naturally occur or naturally contain substances in nanoscale range or contain particles in nanoscale range as a result of conventional manufacturing processes are not within the scope of the guidance.
FDA does not question the regulatory status of products that naturally contain nanosize substances and have already been determined to be generally recognized as safe (GRAS) or approved as a food additive. However, FDA concludes that animal food ingredients that have been engineered to be nanosize are not GRAS and, therefore, will be food additives subject to premarket review and approval by FDA. The guidance details FDA’s recommendations for a food additive petition for nanomaterial food ingredients. Throughout the guidance, FDA encourages companies contemplating the use of nanomaterials in animal food to consult FDA.
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