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

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 .

ANNEX

ANNEX
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, oxidised, from hydrogenated tallow
yes
no
no
Only to be used in contact with non-fatty foods:
(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 ester, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol, C10-16 alkyl esters
yes
no
yes
5
Only to be used as an additive at up to 0,15 % w/w in polyolefins intended for contact with food 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 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.
(2)
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.
1092
1801863-42-2
amines, di-C14-C20-alkyl, oxidised, from hydrogenated vegetable oil
yes
no
no
Only to be used as an additive at up to 0,1 % w/w in polyolefins, which are to be 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 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.
(31)’
1096
1850357-57-1
wax, rice bran, oxidised, calcium salt
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.
(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.’

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

Schedules & Appendices

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