3. Regulatory Mode
As previously mentioned, FCS are subject to indirect food additives and are regulated by the FDA. The overall regulatory method for FCM is determined by the regulatory status of each FCS that constitutes the product. Hence, individual substances in food contact articles that migrate to food under their intended use must meet one of the following five categories.
3.1 Indirect Food Additives Approved by FDA
The FDA has formulated a list of substances approved in the production of FCM (including monomers, additives, adjuvants, etc.) in 21 CFR 174-179, which includes materials such as adhesives, coatings, paper and paperboard, polymers, rubber, etc. This list also specifies the chemical specification, purity, usage limits, and safety guidelines for the approved substances.
This list covers most of the FCM on the market, meeting the specifications and restrictions under the regulations without the need for further FDA approval. Substances not in the regulations or not meeting the requirements shall be further assessed to determine if they qualify for exemption from approval.
3.2 Prior-Sanctioned Substances
Before the official inclusion of food packaging under FDA regulation in 1958, the FDA had already approved certain substances and their specific conditions of application in response to manufacturers' inquiries about food packaging. These substances, approved before 1958, are known as prior-sanctioned substances and do not require pre-market approval from the FDA anymore. The list of prior-sanctioned substances can be searched in 21 CFR 181.
3.3 Generally Recognized as Safe (GRAS) Substances
GRAS substances refer to those assessed for safety by qualified experts through scientific training, and are widely considered safe under the conditions of their intended application. According to the regulations, substances recognized as GRAS under their intended conditions of application are not subject to food additives and do not require pre-market approval from the FDA.
The exemption from approval for GRAS substances is effective for all manufacturers. The list of GRAS substances can be searched in 21 CFR 182-186 and on the FDA website under GRAS notices.
3.4 Threshold of Regulation (TOR) Exemptions
TOR Exemptions are for FCM that are not known carcinogens, do not affect the food, do not damage the environment, and have daily dietary concentrations not exceeding 0.5 ppb, exempting them from pre-market regulatory approval requirements as food additives.
Substances approved by the TOR Exemptions review are published in the TOR Exemptions list on the FDA's official website, which includes the substance name, specific application and corresponding application restrictions. TOR Exemptions are broadly applicable. All manufacturers and suppliers can use or sell TOR Exemptions substances under the same substance characteristics and intended applications based on the list.
3.5 Effective Food Contact Substance Notification (FCN)
The list of effective Food Contact Substance Notification, reviewed and confirmed by the FDA, can be queried on the FDA's official website. The list includes information on food contact substances (FCS) such as names and CAS numbers, manufacturers or suppliers, intended uses, restrictions and specifications, effective dates, and their environmental impact statements.
It is important to note that an FCN is only valid for the manufacturer who submitted the notification and the substance in question. If other enterprises wish to use the substance listed in an FCN, they must submit a separate FCN or purchase the substance from an enterprise that has completed its notification.