New rules proposed by the FDA in 2022 would allow the FDA to revoke the effective status of the FCN for reasons other than safety concerns.

  Previously, 21 C.F.R.§ 170.105 & other; FDA determines FCN is no longer effective ” It allows the FDA to revoke the effective status of the FCN due to material safety concerns. The new Regulation proposes to amend this section and section 170.102 (e), which will include:

  A manufacturer or supplier may plead before FDA determines that a Food Contact Notice (FCN) is no longer valid; In addition, the FDA is allowed to use reasons other than safety as a basis for determining that the FCN is no longer valid.

  Other reasons the FDA has determined that FCN is no longer effective include:

  The production, supply, or use of food contact substances has stopped or is about to stop.

  Food contact substances authorized in the FCN are covered by the Food Additives regulations or exempt from the TOR (threshold of regulations).

  The proposal will be published in the Federal Register for comment until April 11, 2022.