Food Contact Substance Notifications and Conditions of Use

A food contact substance is used as a component of materials involved in manufacturing, packing, transporting or holding food without an intended technical effect in the food. Migration and the conditions of contact are relevant to the regulatory question. A finished package’s trade name does not identify the legal status of every constituent. Part 170.

The FCN route concerns a specified substance and intended use, with manufacturer or supplier limitations under the statute and regulations. A user must establish that the actual supply chain and use fall within the effective notification. Another company’s notification for a chemically similar material is not automatically available to every supplier. FDA inventory conditions.

The notification process considers information supporting safety under intended conditions, including exposure and toxicological considerations. Relevant migration and use information connects the chemistry of the material with likely food exposure. A generic declaration that an ingredient is food grade does not answer every question about concentration, temperature, duration or food type. FDA explanation.

A regulatory file should preserve the FCN number, identified notifier or supplier, substance identity and conditions of use. The inventory also addresses notifications that are no longer effective. Its current status must therefore be checked, rather than relying solely on a historical supplier statement or an old screen capture of an entry. Effective FCN inventory.

Food-contact uses can rely on applicable food-additive regulations, an effective FCN or another legally appropriate basis such as a qualifying exemption. The basis must actually cover the substance and use. None of these routes removes the need to assess the finished article’s intended conditions or obligations applicable to other constituents. Regulatory framework.

Identify every relevant constituent, the supplying manufacturer and the proposed food-contact conditions. Match those facts to the authorization and retain the supporting specification and declaration. Check limits involving food type, temperature, duration and concentration rather than accepting the phrase FDA approved without qualification. Use FDA’s current inventory and source regulation for the precise basis. FDA inventory.