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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

Regulation (EU) 2025/2058 · Regulation · 7 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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

Article 2

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

Article 3

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

Article 4

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEX ISupplementary provisions

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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 P 2 O 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 (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 P 2 O 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 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 P 2 O 5 ’ ( *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 IISupplementary provisions

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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 P 2 O 5 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 P 2 O 5 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 IIISupplementary provisions

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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’

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