12-04 :: April/May 2012

nanotimes News in Brief

The two draft guidance documents are: “Guidance for Industry: Assessing the Effects of Signifi- cant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regula- tory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.”

The food draft guidance describes the factors manufacturers should consider when determi- ning whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

• affect the identity of the food substance; • affect the safety of the use of the food substance; • affect the regulatory status of the use of the food substance; or warrant a regulatory submission to FDA.

The cosmetic product draft guidance discusses the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products. Key points include:

The legal requirements for cosmetics manufactured using nanomaterials are the same as those for any other cosmetics. While cosmetics are not subject to premarket approval, companies and individuals who market cosmetics are legally responsible for the safety of their products and they must be properly labeled.

To conduct safety assessments for cosmetic products containing nanomaterials, standard safety tests may need to be modified or new methods developed.

A new plasma process enables surfaces with a nano coatings to be applied more easily and cost- efficiently – on an industrial scale. Together with Plasmatreat GmbH, Dr. Jörg Ihde and Dr. Uwe Lommatzsch from the Fraunhofer Institute for Manufacturing Technology and Advanced Mate- rials IFAM in Bremen, Germany, developed a new kind of plasma coating process that works at ambi- ent pressure, that is to say, in an open atmosphere. “And that poses a major challenge”, explains Jörg Ihde. “Because the pressure is more than 10,000 times higher and the absence of a vacuum reactor, we had to stop unwanted particles from forming and embedding in the coating. That was the key to developing robust and efficient industrial processes using the new plasma system.

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Both guidances encourage manufacturers to con- sult with the agency before taking their 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.

http://www.fda.gov/Cosmetics/GuidanceCompli-

anceRegulatoryInformation/GuidanceDocuments/ ucm300886.htm

http://www.fda.gov/Food/GuidanceComplianceRegu-

latoryInformation/GuidanceDocuments/FoodIngredient- sandPackaging/ucm300661.htm