When reviewing your composite formulations to determine compliance, consider each authorization to be composed of three parts: the identity of the substance, specifications including purity or physical properties and limitations on the conditions of use. It is the responsibility of the manufacturer of an FCS to ensure that food contact materials comply with the specifications and limitations in all applicable authorizations. FCNs are proprietary to the manufacturer for which the notification is effective, therefore, the FCS must be obtained from that manufacturer.

or an effective Food Contact Substance Notification (FCN).īe aware that Section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) states that an FCN is effective for the manufacturer, the Food Contact Substance (FCS), and the conditions of use identified in the notification and not effective for a similar or identical substance produced or prepared by a manufacturer other than a manufacturer identified in the prior notification.

a Threshold of Regulation (TOR) exemption request.

meeting the criteria for GRAS status (including but not limited to a GRAS regulation or GRAS notice).

a regulation listed in Title 21 Code of Federal Regulations.

The individual substance that is reasonably expected to migrate to food because of its intended use in the food contact material shall be covered by one of the following: The overall regulatory status of a food contact material is dictated by the regulatory status of each individual substance that comprises the article.

Components of a check