Commission Regulation (EU) 2025/2058 of 14 October 2025 amending Annexes II and III and correcting Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards foods intended for particular nutritional uses

Official Journal EN of the European Union L series 2025/2058 15.10.2025 COMMISSION REGULATION(EU) 2025/2058 of 14 October 2025 amending Annexes II and III and correcting Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards foods intended for particular nutritional uses (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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives(1), and in particular Article 10(3) thereof, Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings(2), and in particular Article 7(5) thereof,

Whereas:

(1) Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use. Part E of Annex II to Regulation (EC) No 1333/2008 includes, among others, food category 13 ‘Foods intended for particular nutritional uses as defined by Directive 2009/39/EC’.

(2) Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives including carriers approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use.

(3) Certain food categories, subcategories, provisions and conditions of use in Part E of Annex II to Regulation (EC) No 1333/2008 refer to Directive 2009/39/EC of the European Parliament and of the Council(3), which covered foods intended for particular nutritional uses, and to some Commission Directives on such foods. Since those Directives were repealed by Regulation (EU) No 609/2013 of the European Parliament and of the Council(4), those references should be updated

(4) As food category 13 refers to Directive 2009/39/EC, the reference should be replaced by a reference to Regulation

(EU) No 609/2013.

(5) As food categories 13.1.1 and 13.1.2 refer to Commission Directive 2006/141/EC(5)and this Directive was repealed by Regulation (EU) No 609/2013, the reference should be replaced by a reference to that Regulation.

(6) As footnotes 15, 43 and 44 to food categories 13.1.1 and 13.1.2 include references to repealed Directives, the references should be updated.

(1) OJ L 354, 31.12.2008, p. 16, ELI: http://data.europa.eu/eli/reg/2008/1333/oj.

(2) OJ L 354, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1331/oj.

(3) Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (OJ L 124, 20.5.2009, p. 21, ELI: http://data.europa.eu/eli/dir/2009/39/oj).

(4) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35, ELI: http:// data.europa.eu/eli/reg/2013/609/oj).

(5) Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/dir/2006/141/oj).

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 1/18EN OJ L, 15.10.2025

(7) Food category 13.1.3 refers to processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 2006/125/EC(6). These products are now defined by Regulation (EU) No 609/2013 and therefore the reference should be replaced.

(8) Food category 13.1.4 covers other foods for young children, namely milk-based products for young children other than foods mentioned in the other subcategories under food category 13. As these products are not within the scope of Regulation (EU) No 609/2013, it is appropriate to delete that category 13.1.4 and to create, only for the purposes of the Union food additives legislation, a new subcategory 01.10 of the food category 01. ‘Dairy products and analogues’ for those products. The list of food additives authorised for use and their conditions of use should however not be affected, and only references which appear irrelevant should be deleted.

(9) As food categories 13.1.5 and 13.2 and subcategory 13.1.5.2 refer to Commission Directive 1999/21/EC(7)and this Directive was repealed by Regulation (EU) No 609/2013, the references should be replaced by references to that Regulation. Furthermore, as food category 13.1.5 and subcategory 13.1.5.1 refer to ‘special formulae for infants’ and that concept is not used under Regulation (EU) No 609/2013, that expression should be deleted.

(10) Food category 13.3 covers dietary foods for weight control diets intended to replace the total daily food intake or an individual meal (the whole or part of the total daily diet). As Regulation (EU) No 609/2013 covers only total diet replacement for weight control, references to food category 13.3 should be amended accordingly and foods substituting one or two of the main daily meals of an energy restricted diet, with meal replacements contributing to weight loss or the maintenance of weight after weight loss should be moved to food category 18 as a new subcategory 18.2. Since the requirements on the composition of these foods allowed to bear the corresponding health claim are laid down in Commission Regulation (EU) No 432/2012(8), the title of this new subcategory should refer to that Regulation.

(11) Food category 13.4 covers foods suitable for people intolerant to gluten as defined by Commission Regulation (EC) No 41/2009(9). This Regulation was repealed by Regulation (EU) No 609/2013. Since category 13 covers foods for special purposes withing the scope of Regulation (EU) No 609/2013 and that Regulation does not cover foods suitable for people intolerant to gluten, this food category should be moved to food category 18 as a new subcategory 18.3.

(12) Due to the creation of new food categories 18.2 and 18.3, it is necessary to create a new food category 18.1 covering processed foods not covered by categories 18.2 and 18.3, excluding foods for infants and young children.

(13) It is also appropriate to correct the E code for food additive advantame in food categories 13.2 and 13.3.

(14) The changes to the food categories in Part E of Annex II to Regulation (EC) No 1333/2008 introduced by this Regulation should be reflected in Parts A and D of that Annex and in Part 5, Sections A and B, of Annex III to Regulation (EC) No 1333/2008. That Annex should therefore be amended accordingly.

(15) Regulation (EC) No 1333/2008 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 II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.

(6) Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16, ELI: http://data.europa.eu/eli/dir/2006/125/oj).

(7) Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29, ELI:

http://data.europa.eu/eli/dir/1999/21/oj).

(8) Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (OJ L 136, 25.5.2012, p. 1, ELI: http://data.

europa.eu/eli/reg/2012/432/oj).

(9) Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (OJ L 16, 21.1.2009, p. 3, ELI: http://data.europa.eu/eli/reg/2009/41/oj).

2/18 ELI: http://data.europa.eu/eli/reg/2025/2058/ojEN OJ L, 15.10.2025 Article 2 Annex III to Regulation (EC) No 1333/2008 is amended in accordance with Annex II to this Regulation.

Article 3 Annex II to Regulation (EC) No 1333/2008 is corrected in accordance with Annex III to this Regulation.

Article 4 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, 14 October 2025.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 3/18EN OJ L, 15.10.2025 ANNEX I Annex II to Regulation (EC) No 1333/2008 is amended as follows:

(1) in Part A, Table 1, entry 12 is replaced by the following: ‘12 Dry pasta, excluding gluten-free pasta (as food specially produced to reduce the gluten content of gluten-containing ingredients or substitute the gluten-containing ingredients), and pasta intended for hypoproteic diets’

(2) in Part A, Table 2, entry 30 is replaced by the following: ‘30 Milk-based drinks and similar products intended for young children(*)and foods for infants and young children as mentioned in Regulation (EU) No 609/2013, including foods for special medical purposes for infants and young children (*) Category of products established for the sole purpose of regulating the use of additives in the concerned food.’;

(3) in Part D, the following entry is inserted after the entry for category 01.9 (Edible caseinates): ‘01.10 Milk-based drinks and similar products intended for young children(*) (*) Category of products established for the sole purpose of regulating the use of additives in the concerned food.’;

(4) in Part D, the entries for category 13 (Foods intended for particular nutritional uses as defined by Directive 2009/39/EC) and its subcategories are replaced by the following: ‘13. Foods intended for specific groups as defined by Regulation (EU) No 609/2013

13.1 Foods for infants and young children

13.1.1 Infant formulae as defined by Regulation (EU) No 609/2013

13.1.2 Follow-on formulae as defined by Regulation (EU) No 609/2013

13.1.3. Processed cereal-based foods and baby foods as defined by Regulation (EU) No 609/2013

13.1.5 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants and young children

13.1.5.1 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants

13.1.5.2 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants as from four months of age and for young children

13.2 Foods for special medical purposes as defined by Regulation (EU) No 609/2013 (excluding products from food category 13.1.5)

13.3 Total diet replacement for weight control food as defined by Regulation (EU) No 609/2013’ 4/18 ELI: http://data.europa.eu/eli/reg/2025/2058/ojEN OJ L, 15.10.2025

(5) in Part D, the entry for category 18 (Processed foods not covered by categories 1 to 17, excluding foods for infants and young children) is replaced by the following: ‘18. Processed foods not covered by categories 1 to 17

18.1 Processed foods not covered by categories 18.2 and 18.3, excluding foods for infants and young children

18.2 Meal replacement for weight control as referred to in Commission Regulation (EU) No 432/2012(*)

18.3 Foods specially produced to reduce the gluten content of gluten-containing ingredients or substitute the gluten-containing ingredients (*) OJ L 136, 25.5.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/432/oj.’;

(6) in Part E, in category 0 (Food additives permitted in all categories of foods excluding foods for infants and young children, except where specifically provided for), the entries for E 290 (Carbon dioxide), E (938 (Argon), E 939

(Helium), E 941 (Nitrogen), E 942 (Nitrous oxide), E 948 (Oxygen) and E 949 (Hydrogen) are replaced by the

following: ‘E 290 Carbon dioxide quantum satis may be used in foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 938 Argon quantum satis may be used in foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 939 Helium quantum satis may be used in foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 941 Nitrogen quantum satis may be used in foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 5/18EN OJ L, 15.10.2025 E 942 Nitrous oxide quantum satis may be used in foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 948 Oxygen quantum satis may be used in foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 949 Hydrogen quantum satis may be used in foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II’

(7) in Part E, the following entry is inserted after the entry for category 01.9 (Edible caseinates): ‘01.10 Milk-based drinks and similar products intended for young children(*) The maximum levels of use indicated refer to foods ready for consumption prepared following manufacturers’ instructions

Note:For the manufacture of acidified milks, non-pathogenic L(+)-lactic acid producing cultures may be used E 270 Lactic acid quantum satis only L(+)-form E 304(i) L-ascorbyl 100 (19) palmitate E 306 Tocopherol-rich 100 (19) extract E 307 Alpha-tocopherol 100 (19) E 308 Gamma- 100 (19) tocopherol E 309 Delta-tocopherol 100 (19) E 322 Lecithins 10 000 (14) E 330 Citric acid quantum satis E 331 Sodium citrates 2 000 (1) 6/18 ELI: http://data.europa.eu/eli/reg/2025/2058/ojEN OJ L, 15.10.2025 E 332 Potassium citrates quantum satis (1) E 338 Phosphoric acid (1) (4) E 339 Sodium 1 000 (1) (4) phosphates E 340 Potassium 1 000 (1) (4) phosphates E 407 Carrageenan 300 E 410 Locust bean gum 10 000 (21) E 412 Guar gum 10 000 (21) E 414 Gum arabic (acacia 10 000 (21) gum) E 415 Xanthan gum 10 000 (21) E 440 Pectins 5 000 (21) E 471 Mono- and 4 000 (14) diglycerides of fatty acids E 472c Citric acid esters of 7 500 (14) only when sold as mono- and powder diglycerides of fatty acids E 472c Citric acid esters of 9 000 (14) only when sold as mono- and liquid where the diglycerides of products contain fatty acids partially hydrolysed proteins, peptides or amino acids E 473 Sucrose esters of 120 (14) only in products fatty acids containing hydrolysed proteins, peptides or amino acids E 500 Sodium carbonates quantum satis E 501 Potassium quantum satis carbonates E 503 Ammonium quantum satis carbonates

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 7/18EN OJ L, 15.10.2025 E 507 Hydrochloric acid quantum satis only for pH adjustment E 524 Sodium hydroxide quantum satis only for pH adjustment E 525 Potassium quantum satis only for pH hydroxide adjustment E 1404 Oxidized starch 50 000 E 1410 Monostarch 50 000 phosphate E 1412 Distarch 50 000 phosphate E 1413 Phosphated 50 000 distarch phosphate E 1414 Acetylated distarch 50 000 phosphate E 1420 Acetylated starch 50 000 E 1422 Acetylated distarch 50 000 adipate E 1450 Starch sodium 50 000 octenyl succinate

(1): The additives may be added individually or in combination

(4): The maximum level is expressed as P O 2 5

(14): If more than one of the substances E 322, E 471, E 472c and E 473 are added to a foodstuff, the maximum level established for that foodstuff for each of those substances is lowered with that relative part as is present in with the other substances together in that foodstuff

(19): E 304, E 306, E 307, E 308 and E 309 are authorised individually or in combination

(21): E 410, E 412, E 414, E 415 and E 440 are authorised individually or in combination (*) Category of products established for the sole purpose of regulating the use of additives in the concerned food.’;

8/18 ELI: http://data.europa.eu/eli/reg/2025/2058/ojEN OJ L, 15.10.2025

(8) in Part E, the entry for category 06.4.2 (Dry pasta) is replaced by the following: ‘06.4.2 Dry pasta Group I Additives only gluten-free pasta (as food specially produced to reduce the gluten content of gluten-containing ingredients or substitute the gluten-containing ingredients) and pasta intended for hypoproteic diets’

(9) in Part E, the heading of category 13 (Foods intended for particular nutritional uses as defined by Directive 2009/39/EC) is replaced by the following: ‘13 Foods intended for specific groups as defined by Regulation (EU) No 609/2013’

(10) in Part E, the entry for category 13.1 (Foods for infants and young children) is replaced by the following: ‘13.1 Foods for infants and young children INTRODUCTION PART, APPLIES TO ALL SUBCATEGORIES The maximum levels of use indicated refer to foods ready for consumption prepared following manufacturers’ instructions E 307, E 325, E 330, E 331, E 332, E 333, E 338, E 340, E 410, E472c and E 1450 shall be used in conformity with the limits set in the Annex to Regulation (EU) No 609/2013, in the Annexes to Commission Delegated Regulation (EU) 2016/127(*), in the Annexes to Commission Delegated Regulation (EU) 2016/128(**)and in the Annexes to Commission Directive 2006/125/EC(***) (*) OJ L 25, 2.2.2016, p. 1, ELI: http://data.europa.eu/eli/reg_del/2016/127/oj.

(**) OJ L 25, 2.2.2016, p. 30, ELI: http://data.europa.eu/eli/reg_del/2016/128/oj. (***)OJ L 339, 6.12.2006, p. 16, ELI: http://data.europa.eu/eli/dir/2006/125/oj.’;

(11) in Part E, the heading of category 13.1.1 (Infant formulae as defined by Directive 2006/141/EC) is replaced by the

following: ‘13.1.1 Infant formulae as defined by Regulation (EU) No 609/2013’

(12) in Part E, footnote (15) to categories 13.1.1 and 13.1.2 is replaced by the following: ‘(15): E 339 and E 340 are authorised individually or in combination and in conformity with the limits set in the Annex to Regulation (EU) No 609/2013 and in the Annexes to Delegated Regulation (EU) 2016/127’

(13) in Part E, footnote (43) to categories 13.1.1 and 13.1.2 is replaced by the following: ‘(43): E 331 and E 332 are authorised individually or in combination and in conformity with the limits set in the Annex to Regulation (EU) No 609/2013 and in the Annexes to Delegated Regulation (EU) 2016/127’

(14) in Part E, footnote (44) to categories 13.1.1 and 13.1.2 is replaced by the following: ‘(44): In conformity with the limits set in the Annex to Regulation (EU) No 609/2013 and in the Annexes to Delegated Regulation (EU) 2016/127’

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 9/18EN OJ L, 15.10.2025

(15) in Part E, the heading of category 13.1.2 (Follow-on formulae as defined by Directive 2006/141/EC) is replaced by

the following: ‘13.1.2 Follow-on formulae as defined by Regulation (EU) No 609/2013’

(16) in Part E, the heading of category 13.1.3 (Processed cereal-based foods and baby foods for infants and young children as defined by Directive 2006/125/EC) is replaced by the following: ‘13.1.3. Processed cereal-based foods and baby foods as defined by Regulation (EU) No 609/2013’

(17) in Part E, the entry for category 13.1.4 (Other foods for young children) is deleted;

(18) in Part E, the heading of category 13.1.5 (Dietary foods for infants and young children for special medical purposes as defined by Directive 1999/21/EC and special formulae for infants) is replaced by the following:

‘13.1.5 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants and young children’

(19) in Part E, the heading of category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) is replaced by the following: ‘13.1.5.1 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants’

(20) in Part E, the heading of category 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC) is replaced by the following: ‘13.1.5.2 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants as from four months of age and for young children’

(21) in Part E, the heading of category 13.2 (Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)) is replaced by the following: ‘13.2 Foods for special medical purposes as defined by Regulation (EU) No 609/2013 (excluding products from food category 13.1.5)’

(22) in Part E, the heading of category 13.3 (Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet)) is replaced by the following:

‘13.3 Total diet replacement for weight control food as defined by Regulation (EU) No 609/2013’

(23) in Part E, the entry for category 13.4 (Foods suitable for people intolerant to gluten as defined by Regulation (EC) No 41/2009) is deleted;

10/18 ELI: http://data.europa.eu/eli/reg/2025/2058/ojEN OJ L, 15.10.2025

(24) in Part E, the entry for category 18 (Processed foods not covered by categories 1 to 17, excluding foods for infants and young children) is replaced and new entries for categories 18.1 to 18.3 are inserted as follows:

‘18 Processed foods not covered by categories 1 to 17

18.1 Processed foods not covered by categories 18.2 and 18.3, excluding foods for infants and young children Group I Additives

18.2 Meal replacement for weight control as referred to in Regulation (EU) No 432/2012 Group I Additives Group II Colours at quantum quantum satis satis Group III Colours with 50 combined maximum limit Group IV Polyols quantum satis E 104 Quinoline Yellow 10 (61) E 110 Sunset Yellow 10 (61) FCF/Orange Yellow S E 124 Ponceau 4R, 10 (61) Cochineal Red A E 160d Lycopene 30 E 200-213 Sorbic acid – 1 500 (1) (2) potassium sorbate;

Benzoic acid – benzoates E 338-452 Phosphoric acid – 5 000 (1) (4) phosphates – di-, tri- and polyphosphates E 405 Propane-1, 2-diol 1 200 alginate E 432-436 Polysorbates 1 000 (1) E 473-474 Sucrose esters of 5 000 (1) fatty acids – sucroglycerides E 475 Polyglycerol esters 5 000 of fatty acids E 477 Propane-1,2-diol 1 000 esters of fatty acids

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 11/18EN OJ L, 15.10.2025 E 481-482 Stearoyl- 2 000 (1) 2-lactylates E 491-495 Sorbitan esters 5 000 (1) E 950 Acesulfame K 450 E 951 Aspartame 800 E 952 Cyclamic acid and 400 (51) its Na and Ca salts E 954 Saccharin and its 240 (52) Na, K and Ca salts E 955 Sucralose 320 E 959 Neohesperidine 100 DC E 960a – Steviol glycosides 270 (1) 960d (60) E 961 Neotame 26 E 962 Salt of aspartame- 450 (11)a acesulfame (49)

(50) E 969 Advantame 8

(1): The additives may be added individually or in combination

(2): The maximum level is applicable to the sum and the levels are expressed as the free acid

(4): The maximum level is expressed as P O 2 5

(11): Limits are expressed as (a) acesulfame K equivalent or (b) aspartame equivalent

(49): The maximum usable levels are derived from the maximum usable levels for its constituent parts, aspartame (E 951) and acesulfame-K (E 950)

(50): The levels for both E 951 and E 950 are not to be exceeded by use of the salt of aspartame-acesulfame, either alone or in combination with E 950 or E 951

(51): Maximum usable levels are expressed in free acid

(52): Maximum usable levels are expressed in free imide

(60): Expressed as steviol equivalents

(61): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III 12/18 ELI: http://data.europa.eu/eli/reg/2025/2058/ojEN OJ L, 15.10.2025

18.3 Foods specially produced to reduce the gluten content of gluten-containing ingredients or substitute the gluten-containing ingredients’ Products in this category can also use additives that are allowed in the corresponding food counterparts categories Group I Additives Including dry pasta Group II Colours at quantum quantum satis satis Group IV Polyols quantum satis E 338-452 Phosphoric acid – 5 000 (1) (4) phosphates – di-, tri- and polyphosphates In addition, all additives in the gluten containing counterparts are authorised

(1): The additives may be added individually or in combination

(4): The maximum level is expressed as P O ’ 2 5

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 13/18EN OJ L, 15.10.2025 ANNEX II Annex III to Regulation (EC) No 1333/2008 is amended as follows:

(1) in the definitions, point 1 is replaced by the following: ‘1. “nutrients” for the purposes of this Annex means vitamins, minerals and other substances added for nutritional purposes, as well as substances added for physiological purposes as covered by Regulation (EC) No 1925/2006 of the European Parliament and of the Council(*), Directive 2002/46/EC and Regulation (EU) No 609/2013.

_____________ (*) OJ L 404, 30.12.2006, p. 26, ELI: http://data.europa.eu/eli/reg/2006/1925/oj.’;

(2) in Part 5, Section A, the introductory wording is replaced by the following: ‘— Food additives added in nutrients except in nutrients intended to be used in foodstuffs listed in Part E, point

01.10, of Annex II and foodstuffs for infants and young children listed in Part E, point 13.1, of Annex II:’;

(3) in Part 5, Section B, the introductory wording is replaced by the following: ‘— Food additives added in nutrients intended to be used in foodstuffs listed in Part E, point 01.10, of Annex II and foodstuffs for infants and young children listed in Part E, point 13.1, of Annex II:’;

(4) in Part 5, Section B, the table is replaced by the following: ‘E number of Nutrient to which the Name of the food the food Maximum level food additive may be Food category additive additive added E 301 Sodium ascorbate 100 000 mg/kg in vitamin D Vitamin D Infant formulae and preparation and preparations follow-on formulae 1 mg/l maximum carry-over as defined by in final food Regulation (EU) No 609/2013 50 000 mg/kg in Microencapsulated Infant formula and microencapsulated vitamin A vitamin A follow-on formula as preparation and preparations defined by 1 mg/l maximum carry-over Regulation (EU) in final food No 609/2013 Total carry-over 75 mg/l Coatings of nutrient Foods for infants preparations and young children, containing and foods polyunsaturated mentioned in Part E, fatty acids point 01.10, of Annex II E 304(i) Ascorbyl For uses in nutrient All nutrients Foods for infants palmitate preparations under the and young children, condition that the maximum and foods level in foods mentioned in mentioned in Part E, Part E, points 01.10 point 01.10, of and 13.1, of Annex II is not Annex II exceeded E 306 Tocopherol-rich For uses in nutrient All nutrients Foods for infants E 307 extract preparations under the and young children, Alpha-tocopherol condition that the maximum and foods E 308 Gamma- level in foods mentioned in mentioned in Part E, E 309 tocopherol Part E, points 01.10 point 01.10, of Delta-tocopherol and 13.1, of Annex II is not Annex II exceeded 14/18 ELI: http://data.europa.eu/eli/reg/2025/2058/ojEN OJ L, 15.10.2025 ‘E number of Nutrient to which the Name of the food the food Maximum level food additive may be Food category additive additive added E 322 Lecithins For uses in nutrient All nutrients Foods for infants preparations under the and young children, condition that the maximum and foods level in foods mentioned in mentioned in Part E, Part E, points 01.10 point 01.10, of and 13.1, of Annex II is not Annex II exceeded E 330 Citric acid quantum satis All nutrients Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 331 Sodium citrates For uses in nutrient All nutrients Foods for infants preparations under the and young children condition that the maximum and foods level in foods mentioned in mentioned in Part E, Part E, points 01.10 point 01.10, of and 13.1, of Annex II is not Annex II exceeded and the conditions of use specified therein are respected E 332 Potassium citrates For uses in nutrient All nutrients Food for infants and preparations under the young children and condition that the maximum foods mentioned in level in foods mentioned in Part E, point 01.10, Part E, points 01.10 of Annex II and 13.1, of Annex II is not exceeded and the conditions of use specified therein are respected E 333 Calcium citrates Total carry-over 0,1 mg/kg All nutrients Foods for infants expressed as calcium and and young children, within the limit of calcium and foods level and calcium/ mentioned in Part E, phosphorus ratio as set for point 01.10, of the food category Annex II E 341(iii) Tricalcium Maximum carry-over of All nutrients Infant formulae and phosphate 150 mg/kg expressed as follow-on formulae P O and within the limit for as defined by 2 5 calcium, phosphorus, and Regulation (EU)

the calcium:phosphorus No 609/2013 ratio as set in Delegated Regulation (EU) 2016/127 Maximum level of 1 000 mg/ All nutrients Processed cereal- kg expressed as P O from all based foods and 2 5 uses in final food mentioned baby foods for in Part E, point 13.1.3, of infants and young Annex II is respected children as defined by Regulation (EU) No 609/2013

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 15/18EN OJ L, 15.10.2025 ‘E number of Nutrient to which the Name of the food the food Maximum level food additive may be Food category additive additive added E 401 Sodium alginate For uses in nutrient All nutrients Processed cereal- preparations under the based foods and condition that the maximum baby foods for level in foods mentioned in infants and young point 13.1.3 of Part E of children as defined Annex II is not exceeded by Regulation (EU) No 609/2013 E 402 Potassium For uses in nutrient All nutrients Processed cereal- alginate preparations under the based foods and condition that the maximum baby foods for level in foods mentioned in infants and young Part E, points 01.10 children as defined and 13.1.3, of Annex II is by Regulation (EU) not exceeded No 609/2013 E 404 Calcium alginate For uses in nutrient All nutrients Processed cereal- preparations under the based foods and condition that the maximum baby foods for level in foods mentioned in infants and young point 13.1.3 of Part E of children as defined Annex II is not exceeded by Regulation (EU) No 609/2013 E 414 Gum arabic 150 000 mg/kg in the All nutrients Foods for infants (acacia gum) nutrient preparation and young children, and 10 mg/kg carry-over in and foods final product mentioned in Part E, point 01.10, of Annex II E 415 Xanthan gum For uses in nutrient All nutrients Processed cereal- preparations under the based foods and condition that the maximum baby foods for level in foods mentioned in infants and young point 13.1.3 of Part E of children as defined Annex II is not exceeded by Regulation (EU) No 609/2013 E 421 Mannitol 1 000 times more than As carrier for Foods for infants vitamin B12, vitamin B12 and young children, 3 mg/kg total carry-over and foods mentioned in Part E, point 01.10, of Annex II E 440 Pectins For uses in nutrient All nutrients Follow-on formulae preparations under the and processed condition that the maximum cereal-based foods level in foods mentioned in and baby foods for point 13.1 of Part E of infants and young Annex II is not exceeded children as defined Regulation (EU) No 609/2013 16/18 ELI: http://data.europa.eu/eli/reg/2025/2058/ojEN OJ L, 15.10.2025 ‘E number of Nutrient to which the Name of the food the food Maximum level food additive may be Food category additive additive added E 466 Sodium carboxy For uses in nutrient All nutrients Food for special methyl cellulose, preparations under the medical purposes, as cellulose gum condition that the maximum defined by level in foods mentioned in Regulation (EU) point 13.1.5 of Part E of No 609/2013, Annex II is not exceeded intended for infants Only until 26 April 2027(1) and young children E 471 Mono- and For uses in nutrient All nutrients Foods for infants diglycerides of preparations under the and young children fatty acids condition that the maximum and foods level in foods mentioned in mentioned in Part E, Part E, points 01.10 point 01.10, of and 13.1, of Annex II is not Annex II exceeded and the conditions of use specified therein are respected E 472c Citric acid esters For uses in nutrient All nutrients Infant formulae and of mono- and preparations under the follow-on formulae diglycerides of condition that the maximum for infants and fatty acids level in foods mentioned in young children in Part E, points 01.10 good health and 13.1, of Annex II is not exceeded E 551 Silicon dioxide 10 000 mg/kg in nutrient Dry powdered Foods for infants preparations nutrient and young children preparations and foods mentioned in Part E, point 01.10, of Annex II E 1420 Acetylated starch For uses in nutrient All nutrients Processed cereal- preparations under the based foods and condition that the maximum baby foods for level in foods mentioned in infants and young point 13.1.3 of Part E of children as defined Annex II is not exceeded by Regulation (EU) No 609/2013 E 1450 Starch sodium Carry-over 100 mg/kg Vitamin Foods for infants octenyl succinate preparations and young children and foods Carry-over 1 000 mg/kg Polyunsaturated mentioned in Part E, fatty acid point 01.10, of preparations Annex II E 1451 Acetylated For uses in nutrient All nutrients Processed cereal- oxidised starch preparations under the based foods and condition that the maximum baby foods for level in foods mentioned in infants and young point 13.1.3 of Part E of children as defined Annex II is not exceeded by Regulation (EU) No 609/2013

(1) OJ L, 2025/666, 7.4.2025, ELI: http://data.europa.eu/eli/reg/2025/666/oj’.

ELI: http://data.europa.eu/eli/reg/2025/2058/oj 17/18EN OJ L, 15.10.2025 ANNEX III Annex II to Regulation (EC) No 1333/2008 is corrected as follows:

(1) in Part E, in category 13.2 (Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)), the entry for advantame is replaced by the following:

‘E 969 Advantame 10’

(2) in Part E, in category 13.3 (Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet)), the entry for advantame is replaced by the following:

‘E 969 Advantame 8’ 18/18 ELI: http://data.europa.eu/eli/reg/2025/2058/oj