Food Contact Notification (FCN) Support
Exponent’s Center for Chemical Regulation and Food Safety specializes in timely, high-quality, creative, and practical solutions to problems that affect our clients' ability to conduct business globally. Our experienced staff includes both technical and regulatory consultants who are experienced in dealing with pesticide and non-pesticide products, including conventional chemicals, biochemicals, agrichemicals, microbials, antimicrobials, consumer products, and products of biotechnology. We draw upon expertise in a variety of backgrounds, including epidemiology, biostatistics, toxicology, ecotoxicology, environmental sciences, and risk modeling, to best meet our clients’ needs.
About Food Contact Notifications
Food contact substances (FCS) are materials intended to come into contact with food, such as processing equipment, packaging and containers, and containers used in transport. Common types of food contact substances include coatings, plastics, paper, adhesives, colorants, antimicrobials, and antioxidants. Because molecules can migrate from the food contact material to the food, many countries regulate FCS.
In the U.S., the FDA has established a Food Contact Notification (FCN) Program within the Center for Food Safety and Applied Nutrition's (CFSAN) Office of Food Additive Safety, which regulates FCS. All FCS must be approved by the U.S. FDA through the process of FCN.
How Exponent Can Help
Exponent’s Chemical Regulation and Food Safety group works with FCS manufacturers with their submittals to the U.S. FDA. Our staff have expertise in all disciplines needed to support the requisite regulatory and technical aspects of Food Contact Notification (FCN) to the U.S. FDA.
Our experienced consultants provide:
- Customized strategy for submission of your FCN
- Guidance and interpretation of current food contact regulations
- Liaison with U.S. FDA
- Coordination of pre-notification meetings
- Assistance with presentations to U.S. FDA
- Technical discussion with U.S. FDA to address FCN strategy
- Recording and finalizing meeting minutes
- Facilitation of chemical testing and analysis including design of migration testing protocols, and migration study placement, monitoring, and technical troubleshooting
- Human health safety and FCS exposure assessment
- Systematic and thorough literature search
- Review of toxicity studies and identified publically available literature
- Safety assessment of FCS at proposed use levels
- Tailored strategy to meet safe dose benchmarks
- Environmental impact assessment in accordance with FCN requirements
- Preparation and submission of the complete FCN package
- Follow-up with U.S. FDA as needed.