Food Contact Notifications That Are No Longer Effective, 653-655 [2024-31692]
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653
Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Notices
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Margaret Dugan,
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[FR Doc. 2024–31554 Filed 1–3–25; 8:45 am]
BILLING CODE 6820–34–P
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.
The Food and Drug
Administration (FDA or we) is
announcing its determination that the
khammond on DSK9W7S144PROD with NOTICES
SUMMARY:
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
§ 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
§ 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 § 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 § 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 § 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
FCN No.
59 ................
VerDate Sep<11>2014
FCS
Manufacturer/supplier
Glycine, N,N-bis[2-hydroxy-3-(2-propenyloxy)propyl]-, monosodium salt, reaction products with ammonium hydroxide and pentafluoroiodoethane-tetrafluoroethylene telomer (CAS Reg. No. 220459–70–1).
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BASF Corporation.
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Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Notices
TABLE 1—FOOD CONTACT NOTIFICATIONS (FCNS) NO LONGER EFFECTIVE AS OF JANUARY 6, 2025—Continued
FCN No.
FCS
187 ..............
Fluorinated polyurethane anionic resin (CAS Reg. No. 328389–91–9) prepared by reacting perfluoropolyether
diol (CAS Reg. No. 88645–29–8), isophorone diisocyanate (CAS Reg. No. 4098–71–9), 2,2dimethylolpropionic acid (CAS Reg. No. 4767–03–7), and triethylamine (CAS Reg. No. 121–44–8).
Diphosphoric acid, polymers with ethoxylated reduced Me esters of reduced polymerized 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).
Copolymer of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate ...
195 ..............
206 ..............
255 ..............
311 ..............
314 ..............
3-cyclohexane-1-carboxylic acid, 6-((di-2-propenylamino)carbonyl)-,(1R,6R), reaction products with
pentafluoroiodoethane-tetrafluoroethylene telomer, ammonium salts.
Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate ..
338 ..............
2-Propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178–90–3).
Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate ..
398 ..............
Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991–62–4), ammonium salt ..............................................
416 ..............
Diphosphoric acid, polymers with ethoxylated reduced methyl esters of reduced polymerized 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).
2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178–90–3).
2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No 464178–90–3).
Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991–62–4), ammonium salt ..............................................
487 ..............
518 ..............
538 ..............
542 ..............
628 ..............
646 ..............
746 ..............
783 ..............
820 ..............
827 ..............
885 ..............
888 ..............
933 ..............
940 ..............
962 ..............
1027 ............
1044 ............
1097 ............
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Manufacturer/supplier
1360 ............
1451 ............
1493 ............
VerDate Sep<11>2014
2-propen-1-ol, reaction products 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).
Copolymer of 2-perfluoroalkylethyl acrylate, 2-(dimethylamino)ethyl methacrylate, and oxidized 2(dimethylamino)ethyl methacrylate (CAS Reg. No. 479029–28–2).
Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate,
acrylic acid, and methacrylic acid (CAS Reg. No. 870465–08–0).
2-propen-1-ol, reaction products 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.
2-propen-1-ol, reaction products 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.
2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl ester, polymer with a-(1-oxo-2-propen-1-yl)-whydroxypoly(oxy-1,2-ethanediyl).
2-propenoic acid, 2-hydroxyethyl ester, polymer with a-(1-oxo-2-propen-1-yl)-w-hydroxypoly(oxy-1,2ethanediyl), a-(1-oxo-2-propen-1-yl)-w-[(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).
2-propenoic acid, 2-methyl-, polymer with 2-(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).
2-propenoic acid, 2-hydroxyethyl ester, polymer with a-(1-oxo-2-propen-1-yl)-w-hydroxypoly(oxy-1,2ethanediyl), a-(1-oxo-2-propen-1-yl)-w-[(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).
2-propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 2-methyl-2-propenoate, a-(1-oxo-2-propen-1-yl)-whydroxypoly(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).
Hexane, 1,6-diisocyanato-, homopolymer, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanol-blocked (CAS Reg.
No. 357624–15–8).
Diphosphoric acid, polymers with ethoxylated reduced methyl esters of reduced polymerized 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).
2-propenoic acid, 2-methyl-, polymer with 2-(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).
2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester polymer with 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).
Hexane, 1,6-diisocyanato-, homopolymer, a-[1-[[[3-[[3 (dimethylamino)propyl]amino]propyl]amino]carbonyl]1,2,2,2-tetrafluoroethyl]-w-(1,1,2,2,3,3,3-heptafluoropropoxy)poly[oxy[trifluoro(trifluoromethyl)-1,2-ethanediyl]]blocked (CAS Reg. No. 1279108–20–1).
2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, 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).
2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, 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).
Copolymer of 2-(dimethylamino) ethyl methacrylate with 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate, N-oxide, acetate (CAS Reg. 1440528–04–0).
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Solvay Specialty Polymers Italy
S.p.A.
Solvay Specialty Polymers Italy
S.p.A.
DuPont Chemical Solutions Enterprise.
BASF Corporation.
DuPont Chemical Solutions Enterprise.
Solenis LLC.
DuPont Chemical Solutions Enterprise.
Solvay Specialty Polymers Italy
S.p.A.
Solvay Specialty Polymers Italy
S.p.A.
Solenis LLC.
Solenis LLC.
Solvay Specialty Polymers Italy
S.p.A.
Solenis LLC.
Clariant Corporation.
Dupont Chemical Solutions Enterprise.
Solenis LLC.
Solenis LLC.
Daikin America, Inc.
Daikin America, Inc.
The Chemours Company FC, LLC.
Daikin America, Inc.
Daikin America, Inc.
The Chemours Company FC, LLC.
Solvay Specialty Polymers USA,
LLC.
The Chemours Company FC, LLC.
Daikin America, Inc.
Archroma U.S., Inc.
Daikin America, Inc.
Daikin America, Inc.
Archroma Management GmbH.
655
Federal Register / Vol. 90, No. 3 / Monday, January 6, 2025 / Notices
TABLE 2—FOOD CONTACT NOTIFICATIONS (FCNS) NO LONGER EFFECTIVE AS OF JANUARY 6, 2025 WITH A COMPLIANCE
DATE OF JUNE 30, 2025
FCN No.
599 ..............
604 ..............
1186 ............
1676 ............
FCS
Copolymer of perfluorohexylethyl methacrylate, 2-N,N-diethylaminoethyl methacrylate, 2-hydroxyethyl methacrylate, and 2,2’-ethylenedioxydiethyl dimethacrylate, acetic acid salt (CAS Reg. No. 863408–20–2) or
malic acid salt (CAS Reg. No. 1225273–44–8).
Copolymer of perfluorohexylethyl methacrylate, 2-N,N-diethylaminoethyl methacrylate, 2-hydroxyethyl methacrylate, and 2,2’-ethylenedioxydiethyl dimethacrylate, acetic acid salt (CAS Reg. No. 863408–20–2) or
malic acid salt (CAS Reg. No. 1225273–44–8).
Butanedioic acid, 2-methylene-, polymer with 2-hydroxyethyl, 2-methyl-2-propenoate, 2-methyl-2-propenoic
acid and 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).
2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8tridecafluorooctyl 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-nolonger-effective.
We also updated our Inventory of
Effective Food Contact Notifications
accordingly at https://www.hfpapp
external.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).
khammond on DSK9W7S144PROD with NOTICES
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.
19:04 Jan 03, 2025
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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/marketphase-out-grease-proofing-substancescontaining-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5889]
Request for Nominations of Voting
Members on a Public Advisory
Committee; National Mammography
Quality Assurance Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
II. Analysis of Environmental Impact
VerDate Sep<11>2014
Manufacturer/supplier
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the National Mammography
Quality Assurance Advisory Committee
in the Center for Devices and
Radiological Health. Nominations will
be accepted for current and upcoming
vacancies effective February 1, 2025,
with this notice. FDA seeks to include
the views of women and men, members
of all racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
SUMMARY:
PO 00000
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Asahi Glass Co., Ltd. (Manufacturer)
and AGC Chemicals Americas, Incorporated.
Asahi Glass Co., Ltd. (Manufacturer)
and AGC Chemicals Americas, Incorporated.
Asahi Glass Co., Ltd.
AGC Chemicals Americas, Inc.
Asahi Glass Co., Ltd.
AGC Chemicals Americas, Inc.
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before March 7, 2025, will be given first
consideration for membership on the
National Mammography Quality
Assurance Advisory Committee.
Nominations received after March 7,
2025, will be considered for nomination
to the committee as later vacancies
occur.
ADDRESSES: All nominations for
membership should be submitted
electronically by logging into the FDA
Advisory Nomination Portal at https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership: James P. Swink, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5211,
Silver Spring, MD 20993, 301–796–
6313, James.Swink@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the National Mammography Quality
Assurance Advisory Committee.
I. General Description of the Committee
Duties
The National Mammography Quality
Assurance Advisory Committee advises
the Commissioner of Food and Drugs
(the Commissioner) or designee on: (1)
developing appropriate quality
standards and regulations for
mammography facilities; (2) developing
appropriate standards and regulations
E:\FR\FM\06JAN1.SGM
06JAN1
]]>Agencies
[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
