Zdrowie i gospodarka · 27.06.2014
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 or we) is announcing the availability of a 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 guidance explains 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 affect the identity of the food substance, impact the safety of the use of the food substance, change the regulatory status of the use of the food substance, or warrant a new regulatory submission to FDA.