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Call for new tests of nanotech safety

23rd April 2012

The United States' drug regulator has issued new guidelines on the use of nanotechnology in the food and cosmetic industries.

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The Food and Drug Administration (FDA) warned manufacturers of food and cosmetics that while they do not need to prove their products are safe before bringing them to market, they are still legally responsible for the products they manufacture.

It said nanotechnology, which allows the manipulation of materials on a sub-microscopic scale that has to be measured in nanometers, was still an emerging science.

In two draft guidance documents for the food and cosmetics industries, the agency said that such technology has a broad range of potential applications in the packaging of food or in altering the way that cosmetics look and feel.

Aimed at food manufacturers using nanomaterials in food ingredients, particularly colour additives, and at cosmetics makers who use them to add shine and texture, the guidelines warn that any changes in manufacturing processes should be thoroughly investigated for potential health and safety implications before bringing products to market.

Such significant changes may affect the identity of food substances, affect their safety, or their regulatory status, or warrant a regulatory submission to the FDA, the guidelines warn.

It called on cosmetics manufacturers to conduct safety assessments for any cosmetics containing nanomaterials.

"Standard safety tests may need to be modified, or new methods developed," the FDA said in a news release on Monday.

It also called on manufacturers to consult with FDA experts before bringing products to market.

"Such consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status," the administration said in a statement carried on its website.

It said it was investing in a nanotechnology regulatory science programme to further identify the properties of nanomaterials and the effect they might have on humans and manufactured products.

FDA Commissioner Margaret A. Hamburg characterised the agency's approach as "prudent," saying it would assess products on their own merits and refrain from making general assumptions about the safety of nanomaterials.

She said the FDA was currently in the process of strengthening its scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices.

The guidelines were still in draft form, and the administration called for relevant and substantive comments to aid the publication of the final guidance documents, the statement said.


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