Food Contact Materials




Article Posted in I 3 CONSULTING website in INDIA by Mrs. Jeyadevi on June 12th 2016
This article is for informational purposes only and is not intended to provide regulatory advice or technical / scientific advice. Interpretations and questions regarding Food Contact Substance (FCS) should be directed to US FDA regulatory compliance department by email enquiry@i3cglobal.com






Compliance to the FDA regulations

According to the Section 409 of the FD&C Act, Food contact substances (FCS) is any substance that is intended to come into contact with food as a component of material used during its production, processing, storage, preparation and serving. This includes direct or indirect contact. According to the USFDA these substances are classified into three categories as below:

  • Direct Food Additive: Components added directly into the food for preservation, flavor or appearance.
  • Secondary Direct Food Additive: Components that are added for food treatment.
  • Indirect food additive: Substances that come in contact due to packaging or processing equipment, storage or preparation.

The regulatory status of the Food contact substance is determined by the status of each individual substance that the substance is made of. Based on the substance’s intended use and migration to the food, it has to be covered by one of the below:

  • 21 CFR Regulation 174-179
  • Substance meets the GRAS Status Criteria
  • Prior sanction letter
  • Threshold of Regulation (TOR) exemption request
  • Food Contact Substance Notification (FCN)

Responsibilities of the manufacturer
It lies in the responsibility of the manufacturer of an Food Contact Substance, to ensure that the materials are in compliance with the specifications and limitations as laid out in the FDA regulations and applicable authorizations. While determining compliance manufacturers need to analyse the substance for its identity, specifications including purity and physical properties and limitations of use. Also, a manufacturer can issue a letter of Guaranty in compliance with Section 303 c(2) of the act confirming the product is acceptable for use in contact with food.

How to determine compliance of your FCS?
There are several ways by which a substance can be determined if complies with the FDA regulation. As a first step, determine if the substance falls in the 21 CFR regulations 174-179. These substances include General Indirect food additives, Adhesives and Components of coatings, Paper and paperboard components, Polymer, Adjuvants Production aids and Sanitisers, Irradiation in the production, processing and handling. If the substance falls into any of these categories then, there is no need for any further review with the FDA. Verification on the GRAS status in compliance with 21 CFR 182-186 and list of GRAS notices would help to determine compliance. The next step would be to check if the substance has been sanctioned through a letter of Compliance in line with 21 cfr 181. Also consult the listing of Threshold of Regulation (TOR) exemption request in compliance with the 21 cfr 170.39 or the listings of Food Contact Substance Notification (FCN) determine the regulatory status of the substance. 

Food Contact Formulation notification
When an individual is doubtful if the substance in the food contact formulation is complying or not, a notification to review and confirm if the substance can be legally used or not and authorize a new food contact substance. These notifications need not require any safety information as the sole purpose is to determine the regulatory status of the substance. The notifier is required to submit FDA form 3479 and any documentation required to establish that the components are intended for its specific use. Manufacturer can rely on the notification to establish compliance.

Thanks for reading this article.
Mrs. Jeyadevi. [Senior Consultant]
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