Food Additives; Food Contact Substances Notification System

OMB 0910-0495

Food contact substances must be preapproved by FDA for marketing. Respondents to the collection are manufacturers who must provide information, including: (1) the identity and intended use of the food contact substance and (2) the basis for the manufacturer's or supplier's determination that the food contact substance is safe. FDA uses the information to determine whether a food contact substance should be preapproved.

The latest form for Food Additives; Food Contact Substances Notification System expires 2022-03-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0495 FCN FRIA Docket FDA-2021-N-0403.pdf Supplementary Document
FCN Final Rule 0495 Rev 2024 SSA for RIN AI01.docx Supporting Statement A
21 CFR 170.106 (Category A) Form and Instruction
Determination that a FCN is no longer effective
Preparation for FCS in contact w/infant formula and/or human milk Other-Agency Guidance
Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance) Instruction
Prenotification Consultation or Master File (concerning a food contact substance) Form
Use of Recycled Plastics in Food Packaging Other-guidance document
21 CFR 170.1 Indirect Food Additives
21 CFR 170.101 (Category E) Form
21 CFR 170.101 (Category D) Form
21 CFR 170.101 (Category C) Form
21 CFR 170.101 (Category B) Instruction

All Historical Document Collections

202403-0910-008 Approved without change	Revision of a currently approved collection	2024-04-01
202301-0910-004 Comment filed on proposed rule and continue	Revision of a currently approved collection	2023-01-05
202201-0910-011 Approved without change	Extension without change of a currently approved collection	2022-02-14
201902-0910-013 Approved without change	Revision of a currently approved collection	2019-02-28
201602-0910-004 Approved without change	Extension without change of a currently approved collection	2016-02-04
201211-0910-009 Approved with change	Revision of a currently approved collection	2012-11-30
201208-0910-008 Improperly submitted and continue	Revision of a currently approved collection	2012-08-30
201205-0910-009 Withdrawn and continue	Extension without change of a currently approved collection	2012-05-31
200812-0910-002 Approved with change	Extension without change of a currently approved collection	2008-12-10
200606-0910-004 Approved without change	No material or nonsubstantive change to a currently approved collection	2006-06-27
200510-0910-004 Approved without change	Extension without change of a currently approved collection	2005-10-20
200208-0910-003 Approved with change	New collection (Request for a new OMB Control Number)	2002-08-26

OMB Details

21 CFR 170.106 (Category A)

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 3479

NOTIFICATION FOR A FOOD CONTACT

Fillable Fileable

Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.