Commission Regulation (EU) 2025/2058

Contents

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^note, 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^note, 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^note, 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 Since those Directives were repealed by Regulation (EU) No 609/2013 of the European Parliament and of the Council^note, those references should be updated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(5)As food categories 13.1.1 and 13.1.2 refer to Commission Directive 2006/141/EC^note and this Directive was repealed by Regulation (EU) No 609/2013, the reference should be replaced by a reference to that Regulation.

(6)As footnotes 15, 43 and 44 to food categories 13.1.1 and 13.1.2 include references to repealed Directives, the references should be updated.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

Annex I

(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

(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

(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 609/201313.1 | Foods for infants and young children13.1.1 | Infant formulae as defined by Regulation (EU) No 609/201313.1.2 | Follow-on formulae as defined by Regulation (EU) No 609/201313.1.3. | Processed cereal-based foods and baby foods as defined by Regulation (EU) No 609/201313.1.5 | Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants and young children13.1.5.1 | Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants13.1.5.2 | 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 children13.2 | 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 1718.1 | Processed foods not covered by categories 18.2 and 18.3, excluding foods for infants and young children18.2 | Meal replacement for weight control as referred to in Commission Regulation (EU) No 432/201218.3 | 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):^note‘01.10Milk-based drinks and similar products intended for young children^noteThe maximum levels of use indicated refer to foods ready for consumption prepared following manufacturers’ instructionsNote: For the manufacture of acidified milks, non-pathogenic L(+)-lactic acid producing cultures may be usedE 270Lactic acidquantum satisonly L(+)-formE 304(i)L-ascorbyl palmitate100(19)E 306Tocopherol-rich extract100(19)E 307Alpha-tocopherol100(19)E 308Gamma-tocopherol100(19)E 309Delta-tocopherol100(19)E 322Lecithins10000(14)E 330Citric acidquantum satisE 331Sodium citrates2000(1)E 332Potassium citratesquantum satis(1)E 338Phosphoric acid(1) (4)E 339Sodium phosphates1000(1) (4)E 340Potassium phosphates1000(1) (4)E 407Carrageenan300E 410Locust bean gum10000(21)E 412Guar gum10000(21)E 414Gum arabic (acacia gum)10000(21)E 415Xanthan gum10000(21)E 440Pectins5000(21)E 471Mono- and diglycerides of fatty acids4000(14)E 472cCitric acid esters of mono- and diglycerides of fatty acids7500(14)only when sold as powderE 472cCitric acid esters of mono- and diglycerides of fatty acids9000(14)only when sold as liquid where the products contain partially hydrolysed proteins, peptides or amino acidsE 473Sucrose esters of fatty acids120(14)only in products containing hydrolysed proteins, peptides or amino acidsE 500Sodium carbonatesquantum satisE 501Potassium carbonatesquantum satisE 503Ammonium carbonatesquantum satisE 507Hydrochloric acidquantum satisonly for pH adjustmentE 524Sodium hydroxidequantum satisonly for pH adjustmentE 525Potassium hydroxidequantum satisonly for pH adjustmentE 1404Oxidized starch50000E 1410Monostarch phosphate50000E 1412Distarch phosphate50000E 1413Phosphated distarch phosphate50000E 1414Acetylated distarch phosphate50000E 1420Acetylated starch50000E 1422Acetylated distarch adipate50000E 1450Starch sodium octenyl succinate50000

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

(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

(4):The maximum level is expressed as P₂O₅

(8)in Part E, the entry for category 06.4.2 (Dry pasta) is replaced by the following:06.4.2 | Dry pastaGroup 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

(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:‘18Processed foods not covered by categories 1 to 1718.1Processed foods not covered by categories 18.2 and 18.3, excluding foods for infants and young childrenGroup IAdditives18.2Meal replacement for weight control as referred to in Regulation (EU) No 432/2012Group IAdditivesGroup IIColours at quantum satisquantum satisGroup IIIColours with combined maximum limit50Group IVPolyolsquantum satisE 104Quinoline Yellow10(61)E 110Sunset Yellow FCF/Orange Yellow S10(61)E 124Ponceau 4R, Cochineal Red A10(61)E 160dLycopene30E 200-213Sorbic acid – potassium sorbate; Benzoic acid – benzoates1500(1) (2)E 338-452Phosphoric acid – phosphates – di-, tri- and polyphosphates5000(1) (4)E 405Propane-1, 2-diol alginate1200E 432-436Polysorbates1000(1)E 473-474Sucrose esters of fatty acids – sucroglycerides5000(1)E 475Polyglycerol esters of fatty acids5000E 477Propane-1,2-diol esters of fatty acids1000E 481-482Stearoyl-2-lactylates2000(1)E 491-495Sorbitan esters5000(1)E 950Acesulfame K450E 951Aspartame800E 952Cyclamic acid and its Na and Ca salts400(51)E 954Saccharin and its Na, K and Ca salts240(52)E 955Sucralose320E 959Neohesperidine DC100E 960a – 960dSteviol glycosides270(1) (60)E 961Neotame26E 962Salt of aspartame-acesulfame450(11)a (49) (50)E 969Advantame8

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

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

(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

(4):The maximum level is expressed as P₂O₅’

(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

18.3Foods 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 categoriesGroup IAdditivesIncluding dry pastaGroup IIColours at quantum satisquantum satisGroup IVPolyolsquantum satisE 338-452Phosphoric acid – phosphates – di-, tri- and polyphosphates5000(1) (4)In addition, all additives in the gluten containing counterparts are authorised

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

Annex II

(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^note, Directive 2002/46/EC and Regulation (EU) No 609/2013.

^note

(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 categoryE 301 | Sodium ascorbate | 100000 mg/kg in vitamin D preparation and1 mg/l maximum carry-over in final food | Vitamin D preparations | Infant formulae and follow-on formulae as defined by Regulation (EU) No 609/201350000 mg/kg in microencapsulated vitamin A preparation and1 mg/l maximum carry-over in final food | Microencapsulated vitamin A preparations | Infant formula and follow-on formula as defined by Regulation (EU) No 609/2013Total 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 IIE 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 IIE 306E 307E 308E 309 | Tocopherol-rich extractAlpha-tocopherolGamma-tocopherolDelta-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 IIE 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 IIE 330 | Citric acid | quantum satis | All nutrients | Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex IIE 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 IIE 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 IIE 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 IIE 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 609/2013Maximum level of 1000 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 609/2013E 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 609/2013E 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 609/2013E 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 609/2013E 414 | Gum arabic (acacia gum) | 150000 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 IIE 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 609/2013E 421 | Mannitol | 1000 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 IIE 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 609/2013E 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 exceededOnly until 26 April 2027 | All nutrients | Food for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants and young childrenE 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 IIE 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 healthE 551 | Silicon dioxide | 10000 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 IIE 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 609/2013E 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 IICarry-over 1000 mg/kg | Polyunsaturated fatty acid preparationsE 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

Annex III to Regulation (EC) No 1333/2008 is amended as follows:

III

(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 | |

Annex II to Regulation (EC) No 1333/2008 is corrected as follows:

Article 1#

Article 2#

Article 3#

Article 4#