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HHS/FDA RIN: 0910-AB94 Publication ID: Spring 2002 
Title: Food Additives: Food Contact Substances Notification System 
Abstract: In November 1997, Congress amended the Federal Food, Drug, and Cosmetic Act (FFD&C) to establish a notification process whereby manufacturers and suppliers of components of food contact materials may notify FDA 120 days prior to marketing a new food contact substance. If FDA does not object to the notification within 120 days, the substance may be marketed with the same status as a regulated food additive. FDA is authorized to publish regulations outlining the information required to be submitted in premarket notifications for food-contact substances submitted to the agency. FDA is also authorized to publish regulations that identify when a food additive petition is required in lieu of a premarket notification. FDA is not required to accept a premarket notification in any fiscal year for which an appropriation is not specifically made for this program. FDA expects that the majority of food-contact substances that are currently the subject of food additive petitions will be the subject of premarket notifications. FDA also expects that substances currently reviewed under the agency's threshold of regulation process will be reviewed as premarket notifications under the new process. Unlike food additive regulations, premarket notifications will be specific to the notifier. The proposed use of a similar or identical substance produced by another manufacturer will require a separate premarket notification submission. Also, unlike food additive petitions, the existence of the notification and any otherwise releasable data within the notification is not publicly available until the 120-day period has expired. FDA maintains a publicly available list of effective premarket notifications to assist manufacturers, distributors, and users of food packaging and other food-contact materials. FDA published a proposed rule on the notification process for food contact substances on July 13, 2000. The comment period on the proposed rule ended on September 26, 2000. Three comments were received on the proposed rule. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 20.100    21 CFR 58.3    21 CFR 170.3    21 CFR 170.100    21 CFR 170.101    21 CFR 170.102    21 CFR 170.103    21 CFR 170.104    21 CFR 170.105    21 CFR 171.1    21 CFR 171.4    21 CFR 174.5    21 CFR 179.25    21 CFR 170.106    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 321 et seq   
Legal Deadline:  None
Action Date FR Cite
NPRM  07/13/2000  65 FR 43269   
Final Rule  05/00/2002    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Mitchell Alan Cheeseman
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-205, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway,
College Park, MD 20704
Phone:301 436-1589

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