U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. 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
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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 June 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0490
Issued by:
Guidance Issuing Office
Human Foods Program

This document provides guidance to manufacturers of food ingredients and food contact substances (FCSs), and end users2 of food ingredients and FCSs, including food ingredients that are color additives.  In the remainder of this document, we use the term “food substance” as a general term addressing food ingredients and FCSs.

This guidance is intended to describe the factors you should consider when determining whether a significant change in manufacturing process for a food substance already in the market:

  • Affects the identity of the food substance;
  • Affects the safety of the use of the food substance;
  • Affects the regulatory status of the use of the food substance; and
  • Warrants a regulatory submission to FDA.

The manufacturing process for a food substance may evolve, for example, to use a more efficient catalyst, to replace an expensive solvent with a more cost-effective solvent, or to introduce a treatment to reduce the presence of contaminants such as lead. Some of these changes in a manufacturing process may be considered significant, and it is these significant changes in manufacturing process that are the subject of this guidance (some examples of significant changes in manufacturing process are provided in section IV.A. below).

This guidance provides our current thinking regarding considerations for assessing the impact of a significant manufacturing process change on the safety and regulatory status of a food substance. In addition, the guidance provides relevant recommendations for assessing the effect of a significant manufacturing process change on the safety and regulatory status of food substances, including those that are the subject of a food additive or color additive regulation, a food contact substance notification, or a generally recognized as safe (GRAS) determination.

As with all food substances, this guidance also is intended to recommend that you consult with us regarding a significant manufacturing process change for a food substance already in the market, irrespective of your conclusion about whether that change affects the safety or regulatory status of the food substance.  It is prudent practice for you to do so, particularly when the manufacturing process change involves emerging technologies, such as nanotechnology.  Food substances may be used in a wide array of products manufactured, distributed and sold at retail by a large number of firms. The consequences (to consumers and to the food industry) of broadly distributing a food substance that is later recognized to present a safety concern have the potential to be significant.

Download the Guidance

Related Information

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0490.

Back to Top