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
Date: 2025-10-14
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: baby food, consumer protection, dietary product, food additive, food inspection, food safety, foodstuff, human nutrition, labelling




L_202502058EN.000101.fmx.xml












Official Journal of the European Union


EN
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 Since those Directives were repealed by Regulation (EU) No 609/2013 of the European Parliament and of the Council (4), those references should be updated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.












(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.


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
            





(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).

(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).




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 (*1) 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














(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 (*2)















(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’














(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 (*3)





18.3


Foods specially produced to reduce the gluten content of gluten-containing ingredients or substitute the gluten-containing ingredients














(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




 


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
 (*4)





 


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 palmitate


100 


(19)


 




 


E 306


Tocopherol-rich extract


100 


(19)


 




 


E 307


Alpha-tocopherol


100 


(19)


 




 


E 308


Gamma-tocopherol


100 


(19)


 




 


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)


 




 


E 332


Potassium citrates



quantum satis



(1)


 




 


E 338


Phosphoric acid


 


(1) (4)


 




 


E 339


Sodium phosphates


1 000 


(1) (4)


 




 


E 340


Potassium phosphates


1 000 


(1) (4)


 




 


E 407


Carrageenan


300 


 


 




 


E 410


Locust bean gum


10 000 


(21)


 




 


E 412


Guar gum


10 000 


(21)


 




 


E 414


Gum arabic (acacia gum)


10 000 


(21)


 




 


E 415


Xanthan gum


10 000 


(21)


 




 


E 440


Pectins


5 000 


(21)


 




 


E 471


Mono- and diglycerides of fatty acids


4 000 


(14)


 




 


E 472c


Citric acid esters of mono- and diglycerides of fatty acids


7 500 


(14)


only when sold as powder




 


E 472c


Citric acid esters of mono- and diglycerides of fatty acids


9 000 


(14)


only when sold as liquid where the products contain partially hydrolysed proteins, peptides or amino acids




 


E 473


Sucrose esters of fatty acids


120 


(14)


only in products containing hydrolysed proteins, peptides or amino acids




 


E 500


Sodium carbonates



quantum satis



 


 




 


E 501


Potassium carbonates



quantum satis



 


 




 


E 503


Ammonium carbonates



quantum satis



 


 




 


E 507


Hydrochloric acid



quantum satis



 


only for pH adjustment




 


E 524


Sodium hydroxide



quantum satis



 


only for pH adjustment




 


E 525


Potassium hydroxide



quantum satis



 


only for pH adjustment




 


E 1404


Oxidized starch


50 000 


 


 




 


E 1410


Monostarch phosphate


50 000 


 


 




 


E 1412


Distarch phosphate


50 000 


 


 




 


E 1413


Phosphated distarch phosphate


50 000 


 


 




 


E 1414


Acetylated distarch phosphate


50 000 


 


 




 


E 1420


Acetylated starch


50 000 


 


 




 


E 1422


Acetylated distarch adipate


50 000 


 


 




 


E 1450


Starch sodium octenyl succinate


50 000 


 


 




 


 








(1):


The additives may be added individually or in combination








 


 








(4):


The maximum level is expressed as P2O5









 


 








(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


















(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 (*5), in the Annexes to Commission Delegated Regulation (EU) 2016/128 (*6) and in the Annexes to Commission Directive 2006/125/EC (*7)















(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’


















(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;










(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 satis




quantum satis



 


 




 


Group III


Colours with combined maximum limit


50 


 


 




 


Group IV


Polyols



quantum satis



 


 




 


E 104


Quinoline Yellow


10 


(61)


 




 


E 110


Sunset Yellow FCF/Orange Yellow S


10 


(61)


 




 


E 124


Ponceau 4R, Cochineal Red A


10 


(61)


 




 


E 160d


Lycopene


30 


 


 




 


E 200-213


Sorbic acid – potassium sorbate; Benzoic acid – benzoates


1 500 


(1) (2)


 




 


E 338-452


Phosphoric acid – phosphates – di-, tri- and polyphosphates


5 000 


(1) (4)


 




 


E 405


Propane-1, 2-diol alginate


1 200 


 


 




 


E 432-436


Polysorbates


1 000 


(1)


 




 


E 473-474


Sucrose esters of fatty acids – sucroglycerides


5 000 


(1)


 




 


E 475


Polyglycerol esters of fatty acids


5 000 


 


 




 


E 477


Propane-1,2-diol esters of fatty acids


1 000 


 


 




 


E 481-482


Stearoyl-2-lactylates


2 000 


(1)


 




 


E 491-495


Sorbitan esters


5 000 


(1)


 




 


E 950


Acesulfame K


450 


 


 




 


E 951


Aspartame


800 


 


 




 


E 952


Cyclamic acid and its Na and Ca salts


400 


(51)


 




 


E 954


Saccharin and its Na, K and Ca salts


240 


(52)


 




 


E 955


Sucralose


320 


 


 




 


E 959


Neohesperidine DC


100 


 


 




 


E 960a – 960d


Steviol glycosides


270 


(1) (60)


 




 


E 961


Neotame


26 


 


 




 


E 962


Salt of aspartame-acesulfame


450 


(11)a (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 P2O5









 


 








(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









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 satis




quantum satis



 


 




 


Group IV


Polyols



quantum satis



 


 




 


E 338-452


Phosphoric acid – phosphates – di-, tri- and polyphosphates


5 000 


(1) (4)


 




 


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 P2O5’














(*1)  Category of products established for the sole purpose of regulating the use of additives in the concerned food.’;

(*2)  Category of products established for the sole purpose of regulating the use of additives in the concerned food.’;

(*3)  
            OJ L 136, 25.5.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/432/oj.’;

(*4)  Category of products established for the sole purpose of regulating the use of additives in the concerned food.’;

(*5)  
            OJ L 25, 2.2.2016, p. 1, ELI: http://data.europa.eu/eli/reg_del/2016/127/oj.

(*6)  
            OJ L 25, 2.2.2016, p. 30, ELI: http://data.europa.eu/eli/reg_del/2016/128/oj.

(*7)  
            OJ L 339, 6.12.2006, p. 16, ELI: http://data.europa.eu/eli/dir/2006/125/oj.’;





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 (*1), Directive 2002/46/EC and Regulation (EU) No 609/2013.





(*1)  
                                       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 the food additive


Name of the food additive


Maximum level


Nutrient to which the food additive may be added


Food category




E 301


Sodium ascorbate


100 000  mg/kg in vitamin D preparation and
1 mg/l maximum carry-over in final food


Vitamin D preparations


Infant formulae and follow-on formulae as defined by Regulation (EU) No 609/2013




50 000  mg/kg in microencapsulated vitamin A preparation and
1 mg/l maximum carry-over in final food


Microencapsulated vitamin A preparations


Infant formula and follow-on formula as defined by Regulation (EU) No 609/2013




Total carry-over 75 mg/l


Coatings of nutrient preparations containing polyunsaturated fatty acids


Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II




E 304(i)


Ascorbyl palmitate


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded


All nutrients


Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II




E 306
E 307
E 308
E 309


Tocopherol-rich extract
Alpha-tocopherol
Gamma-tocopherol
Delta-tocopherol


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded


All nutrients


Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II




E 322


Lecithins


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded


All nutrients


Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II




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 preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded and the conditions of use specified therein are respected


All nutrients


Foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II




E 332


Potassium citrates


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded and the conditions of use specified therein are respected


All nutrients


Food for infants and young children and foods mentioned in Part E, point 01.10, of Annex II




E 333


Calcium citrates


Total carry-over 0,1 mg/kg expressed as calcium and within the limit of calcium level and calcium/phosphorus ratio as set for the food category


All nutrients


Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II




E 341(iii)


Tricalcium phosphate


Maximum carry-over of 150 mg/kg expressed as P2O5 and within the limit for calcium, phosphorus, and the calcium:phosphorus ratio as set in Delegated Regulation (EU) 2016/127


All nutrients


Infant formulae and follow-on formulae as defined by Regulation (EU) No 609/2013




Maximum level of 1 000  mg/kg expressed as P2O5 from all uses in final food mentioned in Part E, point 13.1.3, of Annex II is respected


All nutrients


Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013




E 401


Sodium alginate


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded


All nutrients


Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013




E 402


Potassium alginate


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1.3, of Annex II is not exceeded


All nutrients


Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013




E 404


Calcium alginate


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded


All nutrients


Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013




E 414


Gum arabic (acacia gum)


150 000  mg/kg in the nutrient preparation and 10 mg/kg carry-over in final product


All nutrients


Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II




E 415


Xanthan gum


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded


All nutrients


Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013




E 421


Mannitol


1 000  times more than vitamin B12,
3 mg/kg total carry-over


As carrier for vitamin B12


Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II




E 440


Pectins


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded


All nutrients


Follow-on formulae and processed cereal-based foods and baby foods for infants and young children as defined Regulation (EU) No 609/2013




E 466


Sodium carboxy methyl cellulose,
cellulose gum


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.5 of Part E of Annex II is not exceeded
Only until 26 April 2027 (1)



All nutrients


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




E 471


Mono- and diglycerides of fatty acids


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded and the conditions of use specified therein are respected


All nutrients


Foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II




E 472c


Citric acid esters of mono- and diglycerides of fatty acids


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded


All nutrients


Infant formulae and follow-on formulae for infants and young children in good health




E 551


Silicon dioxide


10 000  mg/kg in nutrient preparations


Dry powdered nutrient preparations


Foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II




E 1420


Acetylated starch


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded


All nutrients


Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013




E 1450


Starch sodium octenyl succinate


Carry-over 100 mg/kg


Vitamin preparations


Foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II




Carry-over 1 000  mg/kg


Polyunsaturated fatty acid preparations




E 1451


Acetylated oxidised starch


For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded


All nutrients


Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013










(*1)  
            OJ L 404, 30.12.2006, p. 26, ELI: http://data.europa.eu/eli/reg/2006/1925/oj.’;”


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





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’


 


 











ELI: http://data.europa.eu/eli/reg/2025/2058/oj
ISSN 1977-0677 (electronic edition)