September 6, 2019
The U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) is announcing the launch of an online submission assembly module to improve the submission building process for industry users who send petitions or notifications for food ingredient and food packaging material to CFSAN’s Office of Food Additive Safety (OFAS).
This electronic module is known as the CFSAN Online Submission Module (COSM). COSM is a web-based tool that walks users through a step-by-step process to assemble and send fully electronic submissions to the agency, thereby eliminating the need for printing and mailing of paper submissions.
Submitters will use a new link to log into COSM and assemble their submissions following a traditional question-and-answer form. This form will guide system users through developing and organizing the documents in the appropriate manner for submission through the FDA Electronic Submissions Gateway or via CD/DVD. Information on how to register, use COSM, and send submissions is provided in the help guides on the COSM website.
Submitters can use COSM to provide the following petitions and notifications to OFAS:
- Biotechnology Notification File (BNF)
- Color Additive Petition (CAP)
- Food Additive Petition (FAP)
- Food Contact Notification (FCN)
- Generally Recognized as Safe Notice (GRN)
- New Protein Consultation (NPC)
- Pre-Notification Consultation (PNC) for a food contact substance
- Food Master File (FMF) for food additives
- Food Master File (FMF) for a food contact substance
- Color Master File (CMF) for color additives
For questions regarding food ingredient and packaging material submissions, please contact the Office of Food Additive Safety by email at Premarkt@fda.hhs.gov or call 240-402-1200.
OFAS will continue to accept paper submissions of petitions and notifications.
- Food Ingredients & Packaging
- Food Additives & Petitions
- Generally Recognized as Safe (GRAS)
- Submissions on Bioengineered New Plant Varieties
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety
- Guidance for Industry: Preparation of Food Contact Notifications (Administrative)