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FDA issues two draft Guidance Documents for Nanotechnology

The United States Food and Drug Administration (FDA) today released documentation related to the safety aspects of nanomaterials for the food and cosmetics industries, and has asked for input from stakeholders. The report Guidance for Industry: Safety of Nanomaterials in Cosmetic Products is solely concerned with nanotechnology, whilst Guidance for Industry: Assessing the Effect of Significant Manufacturing Process Changes...on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances considers the impact of nanotech amongst other emerging technologies.

According to the FDA's news release, 'the cosmetic product draft guidance discusses the FDA's current thinking on the safety assessment of nanomaterials when used in cosmetic products'. The draft document states that several areas should be addressed by safety assessments, including the physio-chemical characteristics, agglomeration, size distribution, and potential product exposure levels; the document also hints that currently-used safety tests may need to be modified or replaced by newer ones to be able to fully assess nano-based cosmetics. A further key fact stakeholders are reminded of is that the 'legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics', meaning that there is no special pre-market approval process.

The food safety draft guidance highlights nanotechnology activities twice in its key section, 'recommendations for assessing the effect of a significant manufacturing process change on the safety and regulatory status of a food substance'. The first mention is in 'the use of food contact substances for which there is an effective food contact notification', where the guidance highlights that an alteration in the manufacturing of a notified food contact substance to 'either produce components on the nanometer scale or increase the proportion of nanometer scale components' can be considered a substantial change, and therefore the FDA would need to be informed of such changes. The second mention is in 'use of a food substance for which there is an existing determination that a use of a food substance is GRAS (Generally Recognized as Safe)', where the documentation insinuates that nanotech applications in food substances would not currently be eligible for GRAS status due to 'questions related to the technical evidence of safety as well as the general recognition of that safety'.

The draft guidance materials have been released so that manufacturers can consult with the FDA, thus allowing it to make amendments before the final documentation is published. Comments on the drafts are due by 24 July 2012.


Follow this link to read the FDA's draft guidance on cosmetics and on food. Alternatively follow this link to read the press release announcing the availability of the documents.

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