Description
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance at the phone number listed on the title page.
Scope & Applicability
Product Classes
4Substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food; referred to as FCS throughout the guidance; The potential for genetic toxicity is an important consideration in the safety evaluation of FCSs.; toxicological recommendations for FCS
Approved substances for direct addition to food
Substance intended to exempt microbial toxicity with specific CEDI limits
A particular mixture of two or more food contact substances.
Stakeholders
3Entity responsible for submitting NDINs
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
The manufacturer or distributor submitting the notification; The person or firm submitting the NDIN
Regulatory Context
Attributes
6CEDI > 1 ppm threshold for determining submission type
Estimate of the amount of a substance that can be consumed daily over a lifetime without risk (ADI).; The daily intake of a substance that, during the human lifetime, appears to be without appreciable risk.
Estimated level of dietary exposure to transformation products
Sum of the estimated daily intakes of the FCS; CEDI level for toxicological concern
FCN should include chemical and structural formulas and CAS Registry No.
The amount of an NDI expected to be consumed based on labeling (EDI).; The highest possible total daily intake level of an NDI determined from proposed conditions of use.
Related CFR Sections (6)
- 21CFR170.39§ 170.39 Threshold of regulation for substances used in food-contact articles.
(a) A substance used in a food-contact article (e.g., food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food will be exempted from regulation as a food additive because it becomes a component of food at levels that are below the threshold of regulatRead full regulation →
- 21CFR170.100§ 170.100 Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA).
(a) An FCN is effective for the food contact substance manufactured or prepared by the manufacturer or supplier identified in the FCN submission. If another manufacturer or supplier wishes to market the same food contact substance for the same use, that manufacturer or supplier must also submit an FRead full regulation →
- 21CFR171.1§ 171.1 Petitions.
(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submRead full regulation →
- 21CFR170.101§ 170.101 Information in a premarket notification for a food contact substance (FCN).
An FCN must contain the following:Read full regulation →
- 21CFR170.102§ 170.102 Confidentiality of information related to premarket notification for a food contact substance (FCN).
(a) During the 120-day period of the Food and Drug Administration (FDA) review of an FCN, FDA will not disclose publicly any information in that FCN.Read full regulation →
- 21CFR170.106§ 170.106 Notification for a food contact substance formulation (NFCSF).
(a) In order for the Food and Drug Administration (FDA) to accept an NFCSF, any food additive that is a component of the formulation must be authorized for its intended use in that NFCSF.Read full regulation →
Related Warning Letters (2)
- 2022-06-28
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
- 2020-05-05
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
See Also (8)
- Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations) (Status: Final)
- Guidance for Industry: Antimicrobial Food Additives (Status: Final)
- Guidance for Industry: Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact Articles (Status: Final)
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (Status: Draft)
- 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 (Status: Final)
- Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations) (Status: Final)
- Guidance for Industry: Microbiological Considerations for Antimicrobial Agents Used in Food Applications (Status: Final)