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EUROPEAN COMMISSION Brussels, XXX SANCO/xxx/2013 […](2013) XXX draft COMMISSION REGULATION (EU) No …/.. of XXX amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of certain food additives in food supplements for infants and young children (Text with EEA relevance) EN EN COMMISSION REGULATION (EU) No …/.. of XXX amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of certain food additives in food supplements for infants and young children (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 additives1, 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 flavourings2, 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 foods and their conditions of use. (2) That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application. (3) Several Member States have informed the Commission of the need to authorise the use of certain food additives for food supplements for infants and young children. Therefore, the Commission should take initiative to authorise the use of certain food additives in food supplements for infants and young children and create a separate food category for this type of food supplements in Annex II to Regulation (EU) No 1333/2008. (4) The food categories within the food categorisation system, basis of Annex II to Regulation (EU) No 1333/2008, are created with the sole purpose of listing the authorised additives and their conditions of use. Taking into account the specificity of both food category (food supplements) and age group (for infants and young children)3 that system needs to be adapted. (5) According to Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements4, substances may be added as ingredients in food supplements. Such substances may include vitamins, minerals and certain other categories of nutrients. 1 OJ L 354, 31.12.2008, p. 16. OJ L 354, 31.12.2008, p. 1. 'infants' means children under the age of 12 months; ‘young children’ means children aged between one and three years. OJ L 183, 12.7.2002, p. 51. 2 3 4 EN 2 EN (6) Several Member States endorse the intake of certain vitamins and minerals formulated as food supplements for reasons dictated by public health considerations, namely to improve the nutritional status of the population or specific population groups and/or tackle possible deficiencies in dietary intakes of vitamins or minerals. (7) [add recitals on the technological need for every food additive to be authorised]. (8) The Scientific Committee for Food considered it prudent that the number and amount of additives used in food for infants and young children should be kept at the minimum necessary.5 (9) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008. (10) As a result/In addition, only those additives for which their safety has been considered either by the Scientific Committee for Food or by the European Food Safety Authority will be authorised for use in food supplements for infants and young children. (11) the use of additives in food supplements for infants and young children should be restricted to the ones for which intake is advised by the Member States' national health authorities. (12) the opinion of EFSA/SCF for each food additive to be authorised and put the references in footnotes. As there are stricter rules for infants and young children you should have specific EFSA/SCF references that cover the use by infants and young children. If a certain FA is already allowed for use for infants and young children in another provision, you may refer to that use and its justification.] Therefore, the proposed use and use levels of those additives in food supplements for infants and young children is not liable to have an effect on human health. (13) Following all the above, it is appropriate to authorise the use of FA as a xxx in food supplements for infants and young children. (14) Regulation (EC) No 1333/2008 should therefore be amended accordingly. (15) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, HAS ADOPTED THIS REGULATION: Article 1 Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 5 EN Opinion on the applicability of the ADI (Acceptable Daily Intake) for food additives to infants (expressed on 17/09/1998). 3 EN This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President José Manuel BARROSO EN 4 EN ANNEX Annex II to Regulation (EC) No 1333/2008 is amended as follows: (1) Part D, Food Categories, is amended as follows: (a) the entry for food category 17. 'Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5) excluding food supplements for infants and young children' is replaced by the following: '17 Food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council' (b) the entry for food category 17.1 'Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms' is replaced by the following: '17.1 Food supplements, excluding those for infants and young children, supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms' (c) the entry for food category 17.2 'Food supplements supplied in a liquid form' is replaced by the following: '17.2 Food supplements, excluding those for infants and young children, supplied in a liquid form' (d) the entry for food category 17.3 'Food supplements supplied in a syrup-type or chewable form' is replaced by the following: '17.3 EN Food supplements, excluding those for infants and young children, in a syrup-type or chewable form' 5 EN (e) the following entry for food category 17.4 is inserted after the entry for food category 17.3 'Food supplements supplied in a syrup-type or chewable form': '17.4 Food supplements (as defined in Directive 2002/46/EC of the European Parliament and of the Council) for infants and young children' (2) Part E, food category 17. is amended as follows: (a) the following entries for "Food supplements (as defined in Directive 2002/46/EC) for infants and young children" are inserted after the entry for 17.3 'Food supplements supplied in a syrup-type or chewable form': ' List of FA The use of restrictions and/or exceptions is a possibility! e.g. only to vitamin D e.g. only food supplemments intended for infants of the age above 6 months e.g. only food supplemments … etc 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 Annexes to Directive 2006/141/EC EN E 163 Anthocyanins Food colours authorised at quantum satis E 170 Calcium carbonate quantum satis 6 only processed cereal-based foods and baby foods, only for pH adjustment EN EN E 260 Acetic acid quantum satis only processed cereal-based foods and baby foods, only for pH adjustment E 270 Lactic acid quantum satis only L(+)-form E 296 Malic acid quantum satis only processed cereal-based foods and baby foods, only for pH adjustment, L(+)-form only E 300 L-ascorbic acid 200 / 300 (18) only fat-containing cereal-based foods including biscuits and rusks and baby foods only fruit — and vegetable based drinks, juices and baby foods E 301 Sodium L-ascorbate 200 / 300 (18) only fat-containing cereal-based foods only fruit — and vegetable based drinks, juices and baby foods E 302 Calcium L-ascorbate 200/ 300 (18) only fat-containing cereal-based foods only fruit — and vegetable based drinks, juices and baby foods E 304(i) L-ascorbyl palmitate 10 / 100 (19) only fat-containing cereal-based foods E 306 Tocopherol-rich extract 10 / 100 (16) (19) only fat-containing cereal-based foods E 307 Alpha-tocopherol 10 / 100 (16) (19) E 308 Gamma-tocopherol 10 / 100 (16) (19) E 309 Delta-tocopherol 10 / 100 (16) (19) E 322 Lecithins 1 000 / 10 000 (14) E 327 Calcium lactate quantum satis 7 only biscuits and rusks, cereal-based foods, baby foods only processed cereal-based foods and baby foods, only for pH adjustment, L(+)-form only EN EN E 330 Citric acid quantum satis E 331 Sodium citrates 2 000 quantum satis E 333 Calcium citrates quantum satis E 334 Tartaric acid (L(+)-) 5 000 (42) only L(+)-form; only biscuits and rusks and baby foods E 339 Sodium phosphates 1 000 (1) (4) (15) (20) only cereals E 340 Potassium phosphates 1 000 (1) (4) (15) (20) only cereals E 341 Calcium phosphates 1 000 (4) (20) only cereals only in fruit-based desserts E 400 Alginic acid 500 (23) only desserts and puddings E 401 Sodium alginate 500 / 1 000 (23) only desserts and puddings From four months onwards in special food products with adapted composition, required for metabolic disorders and for general tubefeeding E 407 Carrageenan 300 (17) E 410 Locust bean gum 1 000/ 10 000 20 000 (17) (21) only processed cereal-based foods and baby food only gluten-free cereal-based foods From birth onwards in products for reduction of gastro-oesophageal reflux E 412 Guar gum 1 000/ 10 000 20 000 (17) (21) only where the liquid product contains partially hydrolysed proteins 8 only processed cereal-based foods and baby foods, only for pH adjustment (43) only processed cereal-based foods and baby foods, only for pH adjustment only processed cereal-based foods and baby foods, only for pH adjustment only low sugar fruit-based products EN only processed cereal-based foods and baby food only gluten-free cereal-based foods From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids EN E 414 Gum arabic (acacia gum) 10 000 / 20 000 (21) only processed cereal-based foods and baby only gluten-free cereal-based foods E 415 Xanthan gum 10 000 / 20 000 1 200 (21) only processed cereal-based foods and baby only gluten-free cereal-based foods From birth onwards for use in products based on amino acids or peptides for use with patients who have problems with impairment of the gastrointestinal tract, protein mal-absorption or inborn errors of metabolism E 440 Pectins 5 000/ 10 000 20 000 (21) only acidified follow-on formulae only processed cereal-based foods and baby only gluten-free cereal-based foods From birth onwards in products used in case of gastro-intestinal disorders E 450 Diphosphates 5 000 (4) (42) only biscuits and rusks E 460 Cellulose quantum satis E 462 Ethyl cellulose quantum satis E 465 Ethyl methyl cellulose quantum satis E 466 Carboxy methyl cellulose 10 000 E 470 salts of fatty acids quantum satis 9 From birth onwards in products for the dietary management of metabolic disorders EN EN NOT INCLUDED E 471 Mono- and diglycerides of fatty acids 4 000 / 5 000 (14) (22) only biscuits and rusks, cereal-based foods, From birth onwards in specialised diets, particularly those devoid of proteins 13.1.1 + 13.1.2 E 332, 338, 472c, E 473 Sucrose esters of fatty acids 120 (14) only products containing hydrolysed proteins, peptides or amino acids 13.1.3 – E 261, 262, 263, 325, 326, 332, 335, 336, 338, 354, 402, 404, 472a/b/c, 501, 503, 507, 526, 575, 920, 1410, 1412, 1413, 1414, 1420, 1422, E 500 Sodium carbonates quantum satis only as rising agent 13.1.4 – E 332, 338, 472 c, 501, 503, 507, 1410, 1412, 1413, 1414, 1420, 1422, E 524 Sodium hydroxide quantum satis only processed cereal-based foods and baby foods, only for pH adjustment 13.1.5 – E 332, 338, 405, 472c, 473, 501, 507, 526, E 525 Potassium hydroxide quantum satis only processed cereal-based foods and baby foods, only for pH adjustment E 551 Silicon dioxide 2 000 only Dry cereals E 903 Carnauba wax … glazing agent E 953 Isomalt Quantum satis (for purpose other than sweetening) 10 EN EN E 967 Xylitol Quantum satis (for purpose other than sweetening) E 1201 Polyvinylpyrrolidone quantum satis E 1404 Oxidized starch 50 000 only processed cereal-based foods and baby foods TOTAL FA: 39 E 1450 Starch sodium octenyl succinate 50 000 / 20 000 only processed cereal-based foods and baby PLEASE START HERE E xxx 11 EN EN 12 EN " EN 13 EN