FDA Food Contact Notification - FCN 1811
Food Contact Notification (FCN) 1811 is for using electrolytically generated hypochlorous acid
as an antimicrobial agent in an aqueous solution in the production and preparation of whole
or cut meat and poultry; processed and preformed meat and poultry; fish and seafood; fruits and vegetables; and shell eggs. A potable water rinse is not required after use.
What is a Food Contact Notification (FCN)?
A food contact notification (FCN) is the primary method by which the Food and Drug Administration (FDA) regulates food additives that are food contact substances (FCSs). An FCS is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.
Notifications for an FCS must contain sufficient scientific information to demonstrate that the substance that is the subject of the notification is safe for the intended use (sec. 409(h) of the Act). Because the safety standard is the same for all food additives, whether subject to the petition process or the FCN process, information in an FCN should be comparable to that recommended for inclusion in a food additive petition or in a "Threshold of Regulation" submission (See 21 CFR 170.39).
According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
FDA Stance on "GRAS" Substances
What does "GRAS" mean?
"GRAS" is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.
What are the criteria for GRAS status?
Under 21 CFR 170.30(b), general recognition of safety through scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive and ordinarily is based upon published studies, which may be corroborated by unpublished studies and other data and information.
In what way are the criteria for the use of a substance to be GRAS similar to that for the approved use of a food additive?
Regardless of whether the use of a substance is a food additive use or is GRAS, there must be evidence that the substance is safe under the conditions of its intended use. FDA has defined "safe" (21 CFR 170.3(i)) as a reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. The specific data and information that demonstrate safety depend on the characteristics of the substance, the estimated dietary intake, and the population that will consume the substance.
Must FDA approve GRAS substances?
No. If the use of a food substance is GRAS, it is not subject to the premarket review and approval requirement by FDA.