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IATP submitted this comment to the Office of Additive Safety, U.S. Food and Drug Administration (FDA) regarding the “[Draft] Guidance for Industry:  Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, On the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives" Docket number: FDA-2011-D-0490.

There is currently no pre-marketing testing for the use of Engineered Nanoscale Materials (ENMs) used in food ingredients and food-contact surfaces. Because of political and industry pressures against regulation, IATP believes that FDA’s draft voluntary guidelines offers a non-prejudicial way for industry to consult with the agency about these applications under FDA’s authority. Given the many unknowns about the effects of  ENMs in food substances on human health, pre-market testing should be required.


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