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Official Journal EN
of the European Union L series
2026/245 3.2.2026
COMMISSION REGULATION(EU) 2026/245
of 2 February 2026
amending Annex I to Regulation (EU) No 10/2011 as regards the authorisation or the conditions of
use of several substances
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC(1),
and in particular Article 5(1), second subparagraph, points (a), (d), (e) and (i), and Article 11(3) thereof,
Whereas:
(1) Commission Regulation (EU) No 10/2011(2)lays down specific rules as regards plastic materials and articles intended
to come into contact with food. In particular, Annex I to that Regulation establishes a Union list of authorised
substances that may be intentionally used in the manufacture of plastic materials and articles intended to come into
contact with food.
(2) On 6 March 2024, the European Food Safety Authority (‘the Authority’) adopted a scientific opinion(3)on the use of
the substance phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol,
C10–16 alkyl esters. The Authority concluded that the substance is not of safety concern for the consumer if used as
an additive at up to 0,15 % w/w in polyolefin materials and articles intended for contact with all food types except for
infant formula and human milk, for long-term storage at room temperature and below, including hot-fill and/or
heating up to 100 °C for up to 2 hours, if the migration of the total of phosphite and phosphate species does not
exceed 5 mg/kg food, and if its low molecular weight fraction (LMWF) (< 1 000 Da) is not higher than 13 % w/w.
The Authority also indicated that the fat consumption reduction factor applies.
(3) It is therefore appropriate to authorise the substance phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexa
nedimethanol and polypropylene glycol, C10–16 alkyl esters (CAS No 1821217-71-3, FCM No 1084) accordingly.
(4) On 13 March 2024, the Authority adopted a scientific opinion(4) on the use of the substance calcium tert-
butylphosphonate. The Authority concluded that the substance is not of a safety concern for the consumer if it is
used as a nucleating agent up to 0,15 % w/w in polyolefin materials and articles intended for contact with all types
of food for storage above 6 months at room temperature and below, including at temperatures up to 100 °C for
maximum 2 hours and up to 130 °C for short durations, except for infant formula and human milk.
(5) It is therefore appropriate to authorise the substance calcium tert-butylphosphonate (CAS No 81607-35-4, FCM
No 1089) accordingly.
(1) OJ L 338, 13.11.2004, p. 4, ELI: http://data.europa.eu/eli/reg/2004/1935/oj.
(2) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with
food (OJ L 12, 15.1.2011, p. 1, ELI: http://data.europa.eu/eli/reg/2011/10/oj).
(3) EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids) (2024). Safety assessment of the substance
‘phosphorous acid, triphenyl ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10–16 alkyl esters’, for use
in food contact materials (EFSA Journal2024; 22(4), e8694 (https://doi.org/10.2903/j.efsa.2024.8694)).
(4) EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids) (2024). Safety assessment of the substance
calcium tert-butylphosphonate for use in food contact materials (EFSA Journal 2024; 22(4), e8705 (https://doi.org/10.2903/
j.efsa.2024.8705)).
ELI: http://data.europa.eu/eli/reg/2026/245/oj 1/6EN
OJ L, 3.2.2026
(6) On 16 April 2024, the Authority adopted a scientific opinion(5) on the use of the substance amines,
di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil. The Authority concluded that the substance is not of
safety concern for the consumer if it is used as an additive at 0,1 % w/w in the manufacture of polyolefin food
contact materials intended to be in contact with foods simulated by food simulants A, B, C and E, except for infant
formula and human milk, for storage above 6 months at room temperature and below, including hot-fill conditions
and heating up to 100 °C for 2 hours.
(7) It is therefore appropriate to authorise the substance amines, di-C14-C20-alkyl, oxidised, from hydrogenated
vegetable oil (CAS No 1801863-42-2, FCM No 1092) accordingly.
(8) In its opinion on the substance amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil, the Authority
proposed renaming the substance amines, bis(hydrogenated tallow alkyl) oxidised, by including the precision
‘di-C14-C20-alkyl’. This change of name was suggested as this substance contains C14- and C20- alkyl chains.
Moreover, the authority recommended removing the note of verification of compliance in column 11 of Table 1 of
Annex I for this substance as no substance’s specific value exists to verify its compliance.
(9) It is therefore appropriate to change the name of the substance amines, bis(hydrogenated tallow alkyl) oxidised (FCM
No 768) and remove the reference to the note on the verification of compliance accordingly. In addition, the
restriction for the uses of this substance should be made consistent with the definition of ‘non-fatty foods’ in
Regulation (EU) No 10/2011.
(10) On 3 July 2024, the Authority adopted a scientific opinion(6)on the use of the substances wax, rice bran, oxidised,
and wax, rice bran, oxidised, calcium salt. The Authority concluded that these two substances are not of safety
concern for the consumer if used as additives up to 0,3 % w/w in polyethylene terephthalate (PET), polylactic acid
(PLA) and rigid poly(vinyl chloride) (PVC) materials and articles intended for contact with all food types except for
fatty foods, for long-term storage at room temperature and below, including hot-fill and/or heating up to 100 °C for
up to 2 hours.
(11) It is therefore appropriate to authorise substances wax, rice bran, oxidised (CAS No 1883583-80-9, FCM No 1093),
and wax, rice bran, oxidised, calcium salt (CAS No 1850357-57-1, FCM No 1096) accordingly.
(12) On 6 November 2024, the Authority adopted a scientific opinion(7) on the use of the substance 2,2′-
oxydiethylamine. The Authority concluded that the substance is not of safety concern for the consumer at any time
and temperature conditions if used as a comonomer at up to 14 % w/w with adipic acid and caprolactam, or with
homologues of those two substances that have longer C chains, to manufacture polyamide films with a thickness of
up to 25 μm, provided that the migration of the substance does not exceed 0,05 mg/kg food, that the final films are
not in contact with infant formula and human milk, that the migration of oligomers with a molecular weight below
1 000 Da that contain the substance does not exceed 5 mg/kg food and that, where the homologues of adipic acid
and caprolactam are used as starting substances, only homologues authorised in accordance with Regulation (EU)
No 10/2011 are used.
(13) It is therefore appropriate to authorise the substance 2,2′-oxydiethylamine (CAS number No 2752-17-2, FCM
No 1094) accordingly.
(5) EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids) (2024). Safety assessment of the substance
amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil, for use in food contact materials (EFSA Journal 2024; 22(5),
e8769 (https://doi.org/10.2903/j.efsa.2024.8769)).
(6) EFSA FCM Panel (EFSA Panel on Food Contact Materials) (2024). Safety assessment of the substances ‘wax, rice bran, oxidised’ and
‘wax, rice bran, oxidised, calcium salt’ for use in food contact materials (EFSA Journal 2024; 2(8), e8960 (https://doi.org/10.2903/
j.efsa.2024.8960)).
(7) EFSA FCM Panel (EFSA Panel on Food Contact Materials) (2024). Safety assessment of the substance 2,2′-oxydiethylamine for use in
plastic food contact materials (EFSA Journal2024; 22(12), e9105 (https://doi.org/10.2903/j.efsa.2024.9105)).
2/6 ELI: http://data.europa.eu/eli/reg/2026/245/ojEN
OJ L, 3.2.2026
(14) In its assessment of the substance 2,2′-oxydiethylamine, the Authority also considered the available migration data
and the instability of the substance in 10 % ethanol (simulant A) under the applied migration test conditions, and
recommended the use of water as the simulant to test compliance with the migration limit. Given the substance’s
high solubility in water and the possibility for testing at 60 °C instead of 40 °C, the Authority determined that
contact with water represented the worst-case scenario for the migration of 2,2′-oxydiethylamine and recommended
to indicate in a note on the verification of compliance that water is to be used for compliance verification purposes
instead of food simulants.
(15) Regulation (EU) No 10/2011 should therefore be amended accordingly.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 February 2026.
For the Commission
The President
Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg/2026/245/oj 3/6ANNEX
Annex I to Regulation (EU) No 10/2011 is amended as follows:
(1) Table 1 is amended as follows:
(a) entry 768 is replaced by the following:
‘768 34850 0143925-92-2 amines, di-C14-C20-alkyl, yes no no Only to be used in contact with non-fatty
oxidised, from hydrogenated foods:
tallow (a) at 0,1 % w/w in polyolefins
(b) at 0,25 % w/w in PET’
(b) the following entries are added:
‘1084 1821217-71-3 phosphorous acid, triphenyl yes no yes 5 Only to be used as an additive at up to (2)
ester, polymer with 0,15 % w/w in polyolefins intended for
1,4-cyclohexanedimethanol contact with food at room temperature and
and polypropylene glycol, below, including hot-fill and/or heating up
C10-16 alkyl esters to 100 °C for up to 2 hours.
Not to be used in the manufacture of
articles intended for contact with infant
formula (7), and human milk.
The fraction with a molecular weight below
1 000 Da shall not exceed 13 % w/w of the
substance.
The SML applies to the total of phosphite
and phosphate species.
1089 81607-35-4 calcium tert-butylphosphonate yes no no Only to be used as a nucleating agent at up
to 0,15 % w/w in polyolefins intended for
contact with food at room temperature and
below, including temperatures up to 100 °C
for maximum 2 hours and up to 130 °C for
less than 15 minutes.
Not to be used in materials and articles
intended for contact with infant formula (7),
and human milk.
4/6
ELI:
http://data.europa.eu/eli/reg/2026/245/oj
EN
OJ
L,
3.2.20261092 1801863-42-2 amines, di-C14-C20-alkyl, yes no no Only to be used as an additive at up to
oxidised, from hydrogenated 0,1 % w/w in polyolefins, which are to be
vegetable oil used only in contact with non-fatty foods at
room temperature and below, including
hot-fill and/or heating up to 100 °C for up
to 2 hours.
Not to be used in the manufacture of
materials and articles intended for contact
with infant formula (7), and human milk.
1093 1883583-80-9 wax, rice bran, oxidised yes no no Only to be used as an additive at up to
0,3 % w/w in polyethylene terephthalate,
polylactic acid and rigid poly(vinyl
chloride) materials and articles intended for
contact with non-fatty foods, at room
temperature and below, including hot-fill
and/or heating up to 100 °C for up to 2
hours.
1094 2752-17-2 2,2′-oxydiethylamine no yes no 0,05 Only to be used as a comonomer at up to (31)’
14 % w/w with adipic acid and
caprolactam, or with authorised
homologues of these two substances with a
longer C chain, to manufacture polyamide
films with a thickness of up to 25 μm.
The migration of oligomers containing the
substance with a molecular weight below
1 000 Da shall not exceed 5 mg/kg food.
Not to be used in the manufacture of
materials and articles intended for contact
with infant formula (7), and human milk.
1096 1850357-57-1 wax, rice bran, oxidised, yes no no Only to be used as an additive at up to
calcium salt 0,3 % w/w in polyethylene terephthalate,
polylactic acid and rigid poly(vinyl
chloride) materials and articles intended for
contact with non-fatty foods, at room
temperature and below, including hot-fill
and/or heating up to 100 °C for up to 2
hours.
ELI:
http://data.europa.eu/eli/reg/2026/245/oj
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EN(2) in point 3, Table 3, the following entry is added:
‘(31) Water shall be used for verification of compliance instead of food simulants listed in Table 1 of Annex III.’
6/6
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