Zdrowie i gospodarka · 25.04.2012
Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food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; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and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." The draft guidance, when finalized, will explain FDA's current thinking on the factors to be considered when determining whether changes in manufacturing process, including the intentional reduction in particle size to the nanoscale, for a food substance already in the market affects the safety and regulatory status of the food substance, and whether a new regulatory submission to FDA is warranted.