Frequently Asked Questions on Food Contact Notifications: The FCN Program in General
What is the Food-Contact Notification program?
The Food and Drug Administration Modernization Act of 1997, which was signed into law by President Clinton on Nov. 21, 1997, amended the Federal Food, Drug, and Cosmetic Act to provide for the submission of notifications for food-contact substances in lieu of Food Additive Petitions and threshold of regulation submissions.
Under the FCN system, a manufacturer or supplier of a food-contact material may submit an FCN to FDA regarding the identity and use of a new food-contact substance (FCS), along with information supporting the conclusion that the substance is safe for the intended use. If FDA does not object within 120 days to the substance's use based on safety grounds, in writing, the submitter and its customers may market the substance.
Unlike Food Additive Petitions, notifications are proprietary and may be relied upon only by the submitter and its customers. On Jan. 18, 2000, FDA formally began accepting FCNs to permit the use of new food-contact materials and new uses of food-contact materials.
What types of data are required for FCN filings?
The requirements for an FCN are substantially similar to those for a Food Additive Petition. Generally speaking, the notification should include information on:
- The composition, specifications, and method of manufacture for a substance;
- Its intended conditions of use;
- The quantity and identity of substances likely to become components of foods under the intended use conditions;
- An estimate of the concentration of the additive in the daily diet; and
- Toxicology data demonstrating the safety of this intake level.
One new requirement is that submitters must calculate the cumulative estimated dietary intake (CEDI) to potential migrants from all sources, not just the product in question, and provide supporting toxicology studies for exposures above 0.5 ppb in the diet.
What types of toxicity data must be submitted?
Where the cumulative estimated dietary intake:
- Is below 0.5 ppb? - no toxicity data need be generated, but all relevant known toxicity data available must be submitted;
- Is between 0.5 ppb and 50 ppb? - two genotoxicity studies (a bacterial mutagenicity assay plus an in vitro cytogenetic damage or mouse lymphoma assay) must be submitted;
- Exceeds 50 ppb but is below 1 ppm? - a third genotoxicity study (in addition to the two noted above) in the form of an in vivo chromosomal aberration study is recommended, as well as two subchronic studies (two different species) are required for these exposures;
- Is in excess of 1 ppm? - a full range of toxicity studies is generally required, including chronic (two-year) toxicity/carcinogenicity studies in rats and mice, a one-year feeding study in dogs, and multigeneration reproductive studies in rats.
Where cumulative dietary exposure exceeds this 1 ppm level, FDA may request the filing of a Food Additive Petition instead of an FCN.
When is environmental impact data required?
FDA requires submitters to include an analysis of the potential environmental impact resulting from the production, use, and disposal of the food-contact substance.
Effective Aug. 24, 2000, the agency has adopted the same categorical exclusions from the need to file an environmental assessment (EA) to notifications that had applied to petitions and Threshold of Regulation submissions. The exclusions eliminate the need for environmental assessments in the case of notifications for substances that are 5% or less of finished articles, components of coatings, and components of repeated-use articles.
Where can I find information about data requirements?
Details regarding FDA's data requirements can be found in FDA's guidance documents implementing the FCN program, available on FDA's Web page as follows:
"Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations" (made final, April 2002, updated December 2007) is found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081818.htm
"Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations" (April 2002), is found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081825.htm
"Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Administrative" (June 2000, updated May 2002), is found at "Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Administrative" (June 2000, updated May 2002), is found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081807.htm