I. Introduction
II. Regulatory Framework for Food Substances
A. Industry’s Responsibility Regarding the Safe and Lawful Use of Food Substances
B. Food Additive Provisions of the Act
C. Color Additive Provisions of the Act
III. Safety Assessment of a Food Substance
A. Identity
B. Technical Effect
C. Self-limiting Levels of Use
D. Safety Studies
E. Manufacturing Process, including Nanotechnology
IV. Discussion
A. Considerations for Assessing the Impact of a Significant Manufacturing Process Change on the Safety and Regulatory Status of a Food Substance
B. Recommendations
V. References
Appendix 1. Examples of FDA’s Previous Consideration of Changes in Manufacturing Process
A. Carrageenan (21 CFR 172.620)
B. Xanthan Gum (21 CFR 172.695 and GRAS Notice No. GRN 000121)
C. Tartaric Acid (21 CFR 184.1099 and GRAS Notice No. GRN 000187)
Appendix 2. Descriptions of the Principal Regulatory Submissions for Food Substances
A. Petition Process for Premarket Approval of a Food Additive
B. Premarket Notification Program for a Food Contact Substance
C. “Threshold of Regulation” Program for a Substance Used in a Food Contact Article
D. Program to Notify FDA of a Determination that a Use of a Substance is Generally Recognized as Safe
E. Petition Process for Listing a Color Additive
II. Regulatory Framework for Food Substances
A. Industry’s Responsibility Regarding the Safe and Lawful Use of Food Substances
B. Food Additive Provisions of the Act
C. Color Additive Provisions of the Act
III. Safety Assessment of a Food Substance
A. Identity
B. Technical Effect
C. Self-limiting Levels of Use
D. Safety Studies
E. Manufacturing Process, including Nanotechnology
IV. Discussion
A. Considerations for Assessing the Impact of a Significant Manufacturing Process Change on the Safety and Regulatory Status of a Food Substance
B. Recommendations
V. References
Appendix 1. Examples of FDA’s Previous Consideration of Changes in Manufacturing Process
A. Carrageenan (21 CFR 172.620)
B. Xanthan Gum (21 CFR 172.695 and GRAS Notice No. GRN 000121)
C. Tartaric Acid (21 CFR 184.1099 and GRAS Notice No. GRN 000187)
Appendix 2. Descriptions of the Principal Regulatory Submissions for Food Substances
A. Petition Process for Premarket Approval of a Food Additive
B. Premarket Notification Program for a Food Contact Substance
C. “Threshold of Regulation” Program for a Substance Used in a Food Contact Article
D. Program to Notify FDA of a Determination that a Use of a Substance is Generally Recognized as Safe
E. Petition Process for Listing a Color Additive