```

[Federal Register Volume 90, Number 3 (Monday, January 6, 2025)]
[Notices]
[Pages 653-655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31692]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0403]

Food Contact Notifications That Are No Longer Effective

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing its 
determination that the Food Contact Notifications (FCNs) listed in this 
notice are no longer effective. Several manufacturers notified FDA in 
writing that they ceased producing, supplying, or using the listed food 
contact substances (FCSs) for their intended use in the United States. 
We are taking this action in accordance with the process set out in our 
regulations, by which FDA may determine that an FCN is no longer 
effective.

DATES: Applicable date: This determination for the FCNs listed in table 
1 and table 2 is effective January 6, 2025.
    Compliance date: June 30, 2025, is the compliance date for the FCSs 
listed in table 2 that were produced, supplied, or used by the 
manufacturer or supplier prior to the effective date of this 
determination.

ADDRESSES: 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, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lillian Mawby, Office of Food Chemical 
Safety, Dietary Supplements, and Innovation, Human Foods Program, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-
796-4041 or Carrol Bascus, Office of Policy, Regulations and 
Information, Human Foods Program, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 22, 2024 (89 FR 20306), FDA issued 
a final rule to amend its regulations at Sec.  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. One reason we 
may determine that an FCN is no longer effective is 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 FDA, through voluntary 
commitment letters (Ref. 1), 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 Sec.  170.105(a)(2)(ii)(A), we 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. We provided the manufacturers 
or suppliers an opportunity to respond and did not receive any 
responses that disagreed with our findings. Therefore, in accordance 
with Sec.  170.105(a)(2)(ii)(B), we determined that the FCNs are no 
longer effective based on abandonment. This notice constitutes the 
detailed summary of the basis for FDA's determination that these 
specific FCNs are no longer effective in accordance with Sec.  
170.105(b).
    Tables 1 and 2 identify FCNs that are no longer effective, as well 
as 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, we expect 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, we are 
providing a compliance date for existing stocks of products that were 
produced, supplied, or used by the manufacturer or supplier before 
January 6, 2025. Based on the information provided in the voluntary 
commitment letter from that manufacturer, we expect any existing stocks 
of these products to be exhausted by June 30, 2025. We have determined 
that providing a compliance date of June 30, 2025, to exhaust these 
existing stocks would be protective of public health. For this reason, 
in accordance with Sec.  170.105(b) we are establishing a compliance 
date of June 30, 2025, 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 January 6, 2025.

  Table 1--Food Contact Notifications (FCNs) No Longer Effective as of
                             January 6, 2025
------------------------------------------------------------------------
                                                         Manufacturer/
     FCN No.                      FCS                      supplier
------------------------------------------------------------------------
59...............  Glycine, N,N-bis[2-hydroxy-3-(2-   BASF Corporation.
                    propenyloxy)propyl]-, monosodium
                    salt, reaction products with
                    ammonium hydroxide and
                    pentafluoroiodoethane-
                    tetrafluoroethylene telomer (CAS
                    Reg. No. 220459-70-1).

[[Page 654]]

 
187..............  Fluorinated polyurethane anionic   Solvay Specialty
                    resin (CAS Reg. No. 328389-91-9)   Polymers Italy
                    prepared by reacting               S.p.A.
                    perfluoropolyether diol (CAS
                    Reg. No. 88645-29-8), isophorone
                    diisocyanate (CAS Reg. No. 4098-
                    71-9), 2,2-dimethylolpropionic
                    acid (CAS Reg. No. 4767-03-7),
                    and triethylamine (CAS Reg. No.
                    121-44-8).
195..............  Diphosphoric acid, polymers with   Solvay Specialty
                    ethoxylated reduced Me esters of   Polymers Italy
                    reduced polymerized oxidized       S.p.A.
                    tetrafluoroethylene (CAS Reg.
                    No. 200013-65-6). This substance
                    is also known as: phosphate
                    esters of ethoxylated
                    perfluoroether, prepared by
                    reaction of ethoxylated
                    perfluoroether diol (CAS Reg.
                    No. 162492-15-1) with
                    phosphorous pentoxide (CAS Reg.
                    No. 1314-56-3) or pyrophosphoric
                    acid (CAS Reg. No. 2466-09-3).
206..............  Copolymer of 2-                    DuPont Chemical
                    perfluoroalkylethyl acrylate, 2-   Solutions
                    N,N-diethylaminoethyl              Enterprise.
                    methacrylate, and glycidyl
                    methacrylate.
255..............  3-cyclohexane-1-carboxylic acid,   BASF Corporation.
                    6-((di-2-propenylamino)carbonyl)-
                    ,(1R,6R), reaction products with
                    pentafluoroiodoethane-
                    tetrafluoroethylene telomer,
                    ammonium salts.
311..............  Copolymers of 2-                   DuPont Chemical
                    perfluoroalkylethyl acrylate, 2-   Solutions
                    N,N-diethylaminoethyl              Enterprise.
                    methacrylate, and glycidyl
                    methacrylate.
314..............  2-Propen-1-ol, reaction products   Solenis LLC.
                    with pentafluoroiodoethane-
                    tetrafluoroethylene telomer,
                    dehydroiodinated, reaction
                    products with epichlorohydrin
                    and triethylenetetramine (CAS
                    Reg. No. 464178-90-3).
338..............  Copolymers of 2-                   DuPont Chemical
                    perfluoroalkylethyl acrylate, 2-   Solutions
                    N,N-diethylaminoethyl              Enterprise.
                    methacrylate, and glycidyl
                    methacrylate.
398..............  Perfluoropolyether dicarboxylic    Solvay Specialty
                    acid (CAS Reg. No. 69991-62-4),    Polymers Italy
                    ammonium salt.                     S.p.A.
416..............  Diphosphoric acid, polymers with   Solvay Specialty
                    ethoxylated reduced methyl         Polymers Italy
                    esters of reduced polymerized      S.p.A.
                    oxidized tetrafluoroethylene
                    (CAS Reg. No. 200013-65-6). This
                    substance is also known as
                    phosphate esters of ethoxylated
                    perfluoroether, prepared by
                    reaction of ethoxylated
                    perfluoroether diol (CAS Reg.
                    No. 162492-15-1) with
                    phosphorous pentoxide (CAS Reg.
                    No. 1314-56-3) or pyrophosphoric
                    acid (CAS Reg. No. 2466-09-3).
487..............  2-propen-1-ol, reaction products   Solenis LLC.
                    with pentafluoroiodoethane-
                    tetrafluoroethylene telomer,
                    dehydroiodinated, reaction
                    products with epichlorohydrin
                    and triethylenetetramine (CAS
                    Reg. No. 464178-90-3).
518..............  2-propen-1-ol, reaction products   Solenis LLC.
                    with pentafluoroiodoethane-
                    tetrafluoroethylene telomer,
                    dehydroiodinated, reaction
                    products with epichlorohydrin
                    and triethylenetetramine (CAS
                    Reg. No 464178-90-3).
538..............  Perfluoropolyether dicarboxylic    Solvay Specialty
                    acid (CAS Reg. No. 69991-62-4),    Polymers Italy
                    ammonium salt.                     S.p.A.
542..............  2-propen-1-ol, reaction products   Solenis LLC.
                    with 1,1,1,2,2,3,3,4,4,5,5,6,6-
                    tridecafluoro-6-iodohexane,
                    dehydroiodinated, reaction
                    products with epichlorohydrin
                    and triethylenetetramine (CAS
                    Reg. No. 464178-94-7).
628..............  Copolymer of 2-                    Clariant
                    perfluoroalkylethyl acrylate, 2-   Corporation.
                    (dimethylamino)ethyl
                    methacrylate, and oxidized 2-
                    (dimethylamino)ethyl
                    methacrylate (CAS Reg. No.
                    479029-28-2).
646..............  Copolymers of 2-                   Dupont Chemical
                    perfluoroalkylethyl acrylate, 2-   Solutions
                    N,N-diethylaminoethyl              Enterprise.
                    methacrylate, glycidyl
                    methacrylate, acrylic acid, and
                    methacrylic acid (CAS Reg. No.
                    870465-08-0).
746..............  2-propen-1-ol, reaction products   Solenis LLC.
                    with 1,1,1,2,2,3,3,4,4,5,5,6,6-
                    tridecafluoro-6-iodohexane,
                    dehydroiodinated, reaction
                    products with epichlorohydrin
                    and triethylenetetramine (CAS
                    Reg. No. 464178-94-7) as
                    manufactured in accordance with
                    the description in the FCN.
783..............  2-propen-1-ol, reaction products   Solenis LLC.
                    with 1,1,1,2,2,3,3,4,4,5,5,6,6-
                    tridecafluoro-6-iodohexane,
                    dehydroiodinated, reaction
                    products with epichlorohydrin
                    and triethylenetetramine (CAS
                    Reg. No. 464178-94-7) as
                    manufactured in accordance with
                    the description in the FCN.
820..............  2-Propenoic acid,                  Daikin America,
                    3,3,4,4,5,5,6,6,7,7,8,8,8-         Inc.
                    tridecafluorooctyl ester,
                    polymer with [alpha]-(1-oxo-2-
                    propen-1-yl)-[omega]-
                    hydroxypoly(oxy-1,2-ethanediyl).
827..............  2-propenoic acid, 2-hydroxyethyl   Daikin America,
                    ester, polymer with [alpha]-(1-    Inc.
                    oxo-2-propen-1-yl)-[omega]-
                    hydroxypoly(oxy-1,2-ethanediyl),
                    [alpha]-(1-oxo-2-propen-1-yl)-
                    [omega]-[(1-oxo-2-propen-1-
                    yl)oxy]poly(oxy-1,2-ethanediyl)
                    and 3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-propenoate
                    (CAS Reg. No. 1012783-70-8).
885..............  2-propenoic acid, 2-methyl-,       The Chemours
                    polymer with 2-                    Company FC, LLC.
                    (diethylamino)ethyl 2-methyl-2-
                    propenoate, 2-propenoic acid and
                    3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-methyl-2-
                    propenoate, acetate (CAS Reg.
                    No. 1071022-26-8).
888..............  2-propenoic acid, 2-hydroxyethyl   Daikin America,
                    ester, polymer with [alpha]-(1-    Inc.
                    oxo-2-propen-1-yl)-[omega]-
                    hydroxypoly(oxy-1,2-ethanediyl),
                    [alpha]-(1-oxo-2-propen-1-yl)-
                    [omega]-[(1-oxo-2-propen-1-
                    yl)oxy]poly(oxy-1,2-ethanediyl)
                    and 3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-propenoate
                    (CAS Reg. No. 1012783-70-8).
933..............  2-propenoic acid, 2-methyl-,       Daikin America,
                    polymer with 2-hydroxyethyl 2-     Inc.
                    methyl-2-propenoate, [alpha]-(1-
                    oxo-2-propen-1-yl)-[omega]-
                    hydroxypoly(oxy-1,2-ethanediyl)
                    and 3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-propenoate
                    sodium salt (CAS Reg. No.
                    1158951-86-0).
940..............  Hexane, 1,6-diisocyanato-,         The Chemours
                    homopolymer,                       Company FC, LLC.
                    3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluoro-1-octanol-blocked
                    (CAS Reg. No. 357624-15-8).
962..............  Diphosphoric acid, polymers with   Solvay Specialty
                    ethoxylated reduced methyl         Polymers USA,
                    esters of reduced polymerized      LLC.
                    oxidized tetrafluoroethylene
                    (CAS Reg. No. 200013-65-6). This
                    substance is also known as
                    phosphate esters of ethoxylated
                    perfluoroether, prepared by
                    reaction of ethoxylated
                    perfluoroether diol (CAS Reg.
                    No. 162492-15-1) with
                    phosphorous pentoxide (CAS Reg.
                    No. 1314-56-3) or pyrophosphoric
                    acid (CAS Reg. No. 2466-09-3).
1027.............  2-propenoic acid, 2-methyl-,       The Chemours
                    polymer with 2-                    Company FC, LLC.
                    (diethylamino)ethyl 2-methyl-2-
                    propenoate, 2-propenoic acid and
                    3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-methyl-2-
                    propenoate, acetate (CAS Reg.
                    No. 1071022-26-8).
1044.............  2-propenoic acid, 2-methyl-, 2-    Daikin America,
                    hydroxyethyl ester polymer with    Inc.
                    1-ethyenyl-2-pyrrolidinone, 2-
                    propenoic acid and
                    3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-propenoate
                    sodium salt (CAS Reg. No.
                    1206450-10-3).
1097.............  Hexane, 1,6-diisocyanato-,         Archroma U.S.,
                    homopolymer, [alpha]-[1-[[[3-[[3   Inc.
                    (dimethylamino)propyl]amino]prop
                    yl]amino]carbonyl]-1,2,2,2-
                    tetrafluoroethyl]-[omega]-
                    (1,1,2,2,3,3,3-
                    heptafluoropropoxy)poly[oxy[trif
                    luoro(trifluoromethyl)-1,2-
                    ethanediyl]]-blocked (CAS Reg.
                    No. 1279108-20-1).
1360.............  2-Propenoic acid, 2-methyl-, 2-    Daikin America,
                    (dimethylamino)ethyl ester,        Inc.
                    polymer with 1-ethenyl-2-
                    pyrrolidinone and
                    3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-propenoate,
                    acetate (CAS Reg. No. 1334473-84-
                    5).
1451.............  2-Propenoic acid, 2-methyl-, 2-    Daikin America,
                    (dimethylamino)ethyl ester,        Inc.
                    polymer with 1-ethenyl-2-
                    pyrrolidinone and
                    3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-propenoate,
                    acetate (CAS Reg. No. 1334473-84-
                    5).
1493.............  Copolymer of 2-(dimethylamino)     Archroma
                    ethyl methacrylate with            Management GmbH.
                    3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl methacrylate,
                    N-oxide, acetate (CAS Reg.
                    1440528-04-0).
------------------------------------------------------------------------

[[Page 655]]

  Table 2--Food Contact Notifications (FCNs) No Longer Effective as of
         January 6, 2025 With a Compliance Date of June 30, 2025
------------------------------------------------------------------------
                                                         Manufacturer/
     FCN No.                      FCS                      supplier
------------------------------------------------------------------------
599..............  Copolymer of perfluorohexylethyl   Asahi Glass Co.,
                    methacrylate, 2-N,N-               Ltd.
                    diethylaminoethyl methacrylate,    (Manufacturer)
                    2-hydroxyethyl methacrylate, and   and AGC Chemicals
                    2,2'-ethylenedioxydiethyl          Americas,
                    dimethacrylate, acetic acid salt   Incorporated.
                    (CAS Reg. No. 863408-20-2) or
                    malic acid salt (CAS Reg. No.
                    1225273-44-8).
604..............  Copolymer of perfluorohexylethyl   Asahi Glass Co.,
                    methacrylate, 2-N,N-               Ltd.
                    diethylaminoethyl methacrylate,    (Manufacturer)
                    2-hydroxyethyl methacrylate, and   and AGC Chemicals
                    2,2'-ethylenedioxydiethyl          Americas,
                    dimethacrylate, acetic acid salt   Incorporated.
                    (CAS Reg. No. 863408-20-2) or
                    malic acid salt (CAS Reg. No.
                    1225273-44-8).
1186.............  Butanedioic acid, 2-methylene-,    Asahi Glass Co.,
                    polymer with 2-hydroxyethyl, 2-    Ltd.
                    methyl-2-propenoate, 2-methyl-2-  AGC Chemicals
                    propenoic acid and                 Americas, Inc.
                    3,3,4,4,5,5,6,6,7,7,8,8,8-
                    tridecafluorooctyl 2-methyl-2-
                    propenoate, sodium salt (CAS
                    Reg. No. 1345817-52-8).
1676.............  2-propenoic acid, 2-methyl-, 2-    Asahi Glass Co.,
                    hydroxyethyl ester, polymer with   Ltd.
                    2-propenoic acid and              AGC Chemicals
                    3,3,4,4,5,5,6,6,7,7,8,8,8-         Americas, Inc.
                    tridecafluorooctyl 2-methyl-2-
                    propenoate, sodium salt (CAS
                    Reg. No. 1878204-24-0).
------------------------------------------------------------------------

    To reflect these changes in status of the affected FCNs, we 
established an Inventory of Food Contact Notifications That are No 
Longer Effective on FDA's website. The Inventory may be viewed at 
https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=FCN-no-
longer-effective.
    We also updated our Inventory of Effective Food Contact 
Notifications accordingly at https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=FCN.
    A food additive is deemed unsafe unless that substance and its use 
conform with a regulation issued under section 409 of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348) or there is an FCN 
submitted under section 409(h) of the FD&C Act that is effective 
(section 409(a) of the FD&C Act). An effective FCN is specific only to 
the intended use of the substance prepared by the manufacturer or 
supplier identified in the FCN (section 409(h)(1)(C)).
    Our determination that an FCN is no longer effective does not 
preclude any manufacturers or suppliers from submitting a new FCN for 
the same FCS, including for the same intended use, after FDA has 
determined that an FCN is no longer effective, unless the intended use 
of the FCS is authorized by a food additive regulation or the subject 
of an issued threshold of regulation exemption, per 21 CFR 170.105(c).

II. Analysis of Environmental Impact

    We have determined under 21 CFR 25.32(m) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. References

    The following references are on display at the Dockets Management 
Staff, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500 and are available for viewing 
by interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they also are available electronically at https://www.regulations.gov. 
Although FDA has verified the website addresses in this document, 
please note that websites are subject to change over time.

1. FDA, Market Phase-Out of Grease-Proofing Substances Containing 
PFAS, Commitment Letters from Industry available at: https://www.fda.gov/food/process-contaminants-food/market-phase-out-grease-proofing-substances-containing-pfas.

    Dated: December 30, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31692 Filed 1-3-25; 8:45 am]
BILLING CODE 4164-01-P
```