The Food and Drug Administration will change its food safety policy as 2025 progresses. Monday’s latest is the FDA issued a notice in the Federal Register that determined 35 food contact notifications (FCNs) related to per- and polyfluoroalkyl substances (PFAS) are no longer effective.
The FDA has determined that the uses of these 35 FCNs have been abandoned because the manufacturers or suppliers have ceased production, supply, or use of the food-contact substances. The 35 FCNs had previously authorized food-contact substances used for grease-proofing coatings applied to paper and paperboard packaging to prevent oil and water leaking.
At the same time, the FDA issued guidance on the action levels for lead in processed foods intended for babies and young children. The guidance supports the FDA’s initiative to reduce dietary exposure to contaminants in foods while maintaining access to nutritious food. The FDA also released labeling guidance documents for food allergens, food safety, and plant-based alternatives.
The guidelines’ contents, and what is most salient, are for food packagers. They are part of a larger effort to minimize exposure to contaminants and anticipate future regulation.
The applicable date for the FCN changes has determination as effective Jan. 6, with a compliance date of June 30.
The compliance date is for products produced, supplied, or used by the manufacturer or supplier before the effective date of this determination.
For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this document into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
In the Federal Register of March 22, 2024 (89 FR 20306), FDA issued a final rule to amend its regulations at § 170.105 (21 CFR 170.105) to provide additional reasons, other than safety, that may form the basis to determine that an FCN is no longer effective. It may determine that an FCN is no longer effective when the manufacturer or supplier has ceased or will cease the production, supply, or use of the food contact substance for its intended use authorized by the FCN (referred to as “abandonment”).
Several manufacturers or suppliers notified the FDA, through voluntary commitment letters that they have ceased producing, supplying, or using authorized FCSs for their intended food contact use in the United States. FDA received this information before issuing the final rule. After the final rule’s effective date of May 21, 2024, consistent with § 170.105(a)(2)(ii)(A), the FDA contacted the manufacturers or suppliers to inform them that their voluntary commitment letters demonstrate that they had ceased, and did not intend to resume in the future, producing, supplying, or using the subject FCSs for their intended food contact use.
The FDA provided the manufacturers or suppliers an opportunity to respond and received no responses that disagreed with its findings. Therefore, by § 170.105(a)(2)(ii)(B), the FDA determined that the FCNs are no longer effective based on abandonment. This notice constitutes the detailed summary of the basis for the FDA’s determination that these specific FCNs are no longer effective following § 170.105(b).
FCNs that are no longer effective and the FCSs no longer authorized by these FCNs, as of the publication date of this notice. Based on the end-of-sales dates provided by the manufacturers for the FCSs listed in FCNs in Table 1, the FDA expects any existing stocks of these FCSs to have already been exhausted from the U.S. market. For the FCSs listed in the FCNs in Table 2, the FDA provided a compliance date for existing stocks of products produced, supplied, or used by the manufacturer or supplier before Jan. 6. Based on the information provided in the voluntary commitment letters from that manufacturer, the FDA expects any existing stocks of these products to be exhausted by June 30, 2025.
The FDA has determined that a compliance date of June 30 to exhaust these existing stocks would protect public health. For this reason, following § 170.105(b), the FDA is establishing a compliance date of June 30 for the use of FCSs listed in Table 2 in food contact articles if the FCSs were produced, supplied, or used by the manufacturer or supplier before Jan. 6.
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