Frequently Asked Questions on Food Contact Notifications: What Products can be Covered?

March 1, 2001

Can one file an FCN on components of packaging to hold food for irradiation?

FDA is proposing to accept FCNs on packaging to hold food for irradiation that is not already cleared for such use under Section 179.45.

How do recycling technologies fit into the FCN system?

There is no legal requirement to pre-clear recycled plastics with FDA, provided the underlying resin complies with existing clearances (regulations and FCNs) and provided the material is of a suitable purity for the intended use.

When requests for a status determination on a recycled polymer have been sought in the past, they have been for customer assurance purposes only. FDA has no current plans to accept FCNs for new recycling technologies. The agency will continue, upon request, to issue letters stating the agency's non-objection to the use of the technology. However, rather than refer to these letters as "no objection" letters, as the agency has done in the past, FDA is now referring to these as "opinion letters."

The agency has on several occasions noted its intent to publish rules that will specify a testing protocol for recycling processes that produce food-contact materials.

May notifications be filed for formulations?

FDA will permit FCNs for formulated products, extending even to semi-finished or finished food-contact articles, such as a film or molded package or part, where the article contains at least one otherwise uncleared food-contact substance. If the formulated product, however, contains more than one uncleared FCS, a separate FCN will be needed for each uncleared component.

FDA proposed a notification system for formulated products where all of the components are already cleared. In such a case, it appears that FDA will not commit to completing the review within 120 days, as such a notification is not legally required.

While FDA has published a form for such submissions, the agency's proposed rule reserves to FDA the right, in the future, to decline to accept FCNs for this type of product because of concerns regarding the potential burden these FCNs might place on FDA.

What kind of substance can be covered by an FCN?

A "food-contact substance" defined in Section 409(h)(6) of the act is "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food."

Notifications are only required for FCSs that are also food additives under Section 201(s) of the act. Thus, FCSs that are prior-sanctioned, generally recognized as safe (GRAS), or not reasonably expected to become a component of food do not require premarket clearance by FDA, as under the old Food Additive Petition process.

For example, a company might determine that a particular compound is not a "food additive" based on extraction studies demonstrating that the substance does not migrate to food under its intended conditions of use. Because the substance is not a "food additive," as that term is defined in Section 201(s) of the act, it does not require premarket clearance by FDA. However, an FCN can be filed for an otherwise unregulated FCS, regardless of whether it is a food additive. FDA properly has accepted FCNs on such materials.

The agency does not intend, however, to accept FCNs on compounds that are already permitted for the use under an applicable regulation (e.g., polymers otherwise listed under Part 177 for the particular use; prior sanctioned compounds under Part 181; or GRAS compounds listed in Parts 182, 184, or 186). Likewise, an FCN is not permitted for the use of a substance that is already covered by a Threshold of Regulation exemption.