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How to Successfully Submit a Food Contact Substance Notification in the USA - Quick Guide

Navigating the process of submitting a Food Contact Substance (FCS) Notification in the USA can be complex. This guide simplifies the process, covering everything from the initial administrative steps to the detailed technical dossier required by the Food and Drug Administration (FDA).

Understanding the Submission Process
Where and What to Submit: To ensure your FCS is considered for approval, you need to provide the FDA with comprehensive documentation. This includes submitting five hard copies and one electronic copy of your notification to:

Notifications Control Assistant, Office of Food Additive Safety, HFS-275, Center for Food Safety & Applied Nutrition, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740.

FDA's Response Time: Typically, the FDA will respond within 30 days of receiving your dossier, making timely and accurate submission crucial.

Crafting Your Technical Dossier
A well-prepared technical dossier is essential for a successful FCS notification. It should include:

  • A Comprehensive Summary (Section A): Provide a detailed overview and discussion supporting the safety of the FCS use.
  • Chemical Identity (Section B): Describe the chemical identity, impurities, and residuals related to the FCS, including formulas and CAS Registry Numbers.
  • Intended Conditions of Use (Section C): Detail the use conditions of the material(s), including temperature, contact type, and duration.
  • Intended Technical Effect (Section D): Explain the purpose of the FCS and present data supporting the minimum effective amount.
  • Estimation of Intake (Section E): Discuss residual reactants, impurities, and provide a cumulative estimated daily intake (CEDI) analysis.
  • Toxicity Information (Section F): Summarize toxicological data, including studies on genotoxicity, oral toxicity, and other relevant research.
  • Environmental Information (Section G): Provide an environmental assessment or a claim for exclusion.
  • FDA Form No. 3480 (Section H): Include a completed and signed copy of the form.


Understanding Tiered Toxicity Data Requirements
The FDA sets out specific toxicity data requirements based on the estimated exposure levels:

  • Exposure ≤ 0.5 ppb: No safety studies required, though information on potential carcinogenicity should be discussed.
  • Exposure > 0.5 ppb to ≤ 50 ppb: Requires gene mutation and chromosomal damage tests.
  • Exposure > 50 ppb to ≤ 1 ppm: Requires in vivo chromosomal damage tests and two subchronic oral toxicity tests.
  • Exposure > 1 ppm: Submission of a food additive petition is recommended, with requirements detailed within.


By meticulously preparing your notification dossier in accordance with these guidelines, you can streamline the approval process for your food contact substance in the USA. Remember, thoroughness and compliance with FDA recommendations are key to success.

For more details on compliance with food contact regulations in the USA, ensure to consult the relevant FDA guidelines and resources. We also recommend you to checkout this online training: Simplifying US FDA Regulations And Compliances Required For The Food Contact Materials