COMMON POSITION (EC) No 26/98 adopted by the Council on 23 March 1998 with a view to adopting Directive 98/.../EC of the European Parliament and of the Council of ... amending Directive 95/2/EC on food additives other than colours and sweeteners
27. 5. 98 EN Official Journal of the European Communities C 161/29 COMMON POSITION (EC) No 26/98 adopted by the Council on 23 March 1998 with a view to adopting Directive 98/. /EC of the European Parliament and of the Council of. amending Directive 95/2/EC on food additives other than colours and sweeteners (98/C161 /03) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), Whereas specific provisions on thiabendazole have been laid down in Council Directive 95/38/EC of 17 July 1995 amending Annexes I and II to Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels (7); whereas the entry on thiabendazole should now be repealed, Having regard to the opinion of the Economic and Social Committee (2), HAVE ADOPTED THIS DIRECTIVE: Acting in accordance with the procedure referred to in Article 189b of the Treaty (3), Article 1 Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (4), and in particular Article 3(2) thereof, Directive 95/2/EC is hereby amended as follows: 1. Article 1(1) shall be replaced by the following: Whereas there have been technical developments in the field of food additives since the adoption of Directive 95/2/EC (5); ‘1. This Directive is a specific Directive forming a part of the comprehensive Directive, within the meaning of Article 3 of Directive 89/107/EEC, and applies than colours and sweeteners. It does not apply to enzymes other than those mentioned in the Annexes,’; to additives other Whereas Directive 95/2/EC should be adapted to take account of these developments; 2. Article 2(1) shall be replaced by the following: Whereas the Scientific Committee for Food, set up by Decision 74/234/EEC (6), was consulted before the adoption of provisions liable to have an effect on public health; (1) OJ C 76, 11. 3. 1997, p. 34, and OJ C 77, 12. 3. 1998, p. 7. (2) OJ C 75, 10. 3. 1997, p. 1. (3) Opinion of the European Parliament of 23 October 1997 (OJ C 339, 10. 11. 1997, p. 1), Council common position of 23 March 1998 and Decision of the European Parliament of. (not yet published in the Official Journal). (4) OJ L 40, 11. 2. 1989, p. 27. Directive as last amended by Directive 94/34/EC of the European Parliament and of the Council (OJ L 237, 10. 9. 1994, p. 1). (5) OJ L 61, 18. 3. 1995, p. 1. Directive as amended by Directive 96/85/EC (OJ L 86, 28. 3. 1997, p. 4). (6) OJ L 136, 20. 5. 1974, p. 1. ‘1. Only substances listed in Annexes I, III, IV and V may be used in foodstuffs for the purposes mentioned in Article 1(3) and Article 1(4),’; 3. Article 2(2) shall be replaced by the following: foodstuffs, Food additives listed in Annex I are permitted ‘2. in in Article 1(3) and Article 1(4), with the exception of those foodstuffs listed in Annex II, following the “quantum satis” principle,’; the purposes mentioned for 4. The fifth indent of Article 2(3)(a) shall be replaced by: (7) OJ L 197, 22. 8. 1995, p. 14. C 161/30 EN Official Journal of the European Communities 27. 5. 98 They shall forthwith inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States. States 2. Member the shall Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive. communicate to Article 3 This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. Article 4 This Directive is addressed to the Member States. Done at Brussels,. For the European Parliament For the Council The President The President ‘— pasteurised and sterilised (including UHT) milk (including plain, skimmed and semi-skimmed) and plain pasteurised cream,’; 5. The eleventh replaced by: indent of Article 2(3)(a) shall be ‘— dry pasta, excluding gluten-free and/or pasta intended for hypoproteic diets, in accordance with Directive 89/398/EEC,’; 6. The tables of the Annexes shall be amended in accordance with the provisions contained in the Annex to this Directive. Article 2 1. Member States shall, where necessary, amend their laws, regulations and administrative provisions in order to: — authorise trade in products conforming with this Directive, by. (1) at the latest, — prohibit trade in products not conforming with this Directive from. (2). However, products placed on the market or labelled before that date which do not comply with the Directive may be marketed until stocks are exhausted. (1) 18 months after the entry into force of this Directive. (2) 24 months after the entry into force of this Directive. 27. 5. 98 EN Official Journal of the European Communities C 161/31 ANNEX 1. In Annex I, the following additives shall be added: ‘E 469 Enzymatically hydrolysed carboxy methyl cellulose E 920 L-Cysteine (*) E 1103 Invertase E 1451 Acetylated oxidised starch (*) May be used only as a flour treatment agent. ’ 2. In Annex II: (a) the list of additives and the maximum level for ‘Jam, jellies and marmalades as defined in Directive 79/693/EEC and other similar fruit spreads including low-calorie products’ shall be supplemented as follows: ‘E 471 Mono and diglycerides of fatty acids quantum satis’ (b) the table concerning ‘Sterilised, pasteurised and UHT cream, low-calorie cream and pasteurised low-fat cream’ shall be replaced by the following: ‘Plain pasteurised cream E 401 Sodium alginate E 402 Potassium alginate E 407 Carrageenan E 466 Sodium carboxy methyl cellulose E 471 Mono- and diglycerides of fatty acids quantum satis’ (c) the designation ‘Frozen and deep-frozen unprocessed fruit and vegetables’ shall be amended as follows: ‘Frozen and deep-frozen unprocessed fruit and vegetables; prepacked, refrigerated unprocessed fruit and vegetables ready for consumption and prepacked unprocessed and peeled potatoes. ’; (d) the following table shall be inserted after the table concerning ‘Non-emulsified oils and fats of animal or vegetable origin’: ‘Non-emulsified oils and fats of animal or vegetable origin (except virgin oils and olive oils) specifically intended for cooking and/or frying purposes or for the preparation of gravy Fatty acid esters of ascorbic acid Lactic acid E 270 E 300 Ascorbic acid E 304 E 306 Tocopherol-rich extract E 307 Alpha-tocopherol E 308 Gamma-tocopherol E 309 Delta-tocopherol quantum satis E 322 Lecithins E 471 Mono- and diglycerides of fatty acids 30 g/l 10 g/l E 472c Citric acid esters of mono- and quantum satis’ diglycerides of fatty acids E 330 Citric acid E 331 E 332 E 333 Calcium citrates Sodium citrates Potassium citrates C 161/32 EN Official Journal of the European Communities 27. 5. 98 (e) the list of additives and the maximum level for ‘Mozzarella and whey cheese’ shall be supplemented as follows. ‘E 260 Acetic acid quantum satis’ (f) the list of additives and the maximum level for ‘Canned and bottled fruit and vegetables’ shall be supplemented as follows: ‘E 296 Malic acid quantum satis’ (g) the list of additives and the maximum level for ‘Gehakt’ shall be supplemented as follows: ‘E 300 Ascorbic Acid E 301 Sodium ascorbate E 302 Calcium ascorbate quantum satis’ (h) the following table shall be added at the end of the Annex: ‘Pineapple and passion fruit juices and nectars Sliced and grated ripened cheese E 440 Pectins 3 g/l E 170 Calcium carbonates E 504 Magnesium carbonates E 509 Calcium chloride E 575 Glucono-delta-lactone E 460 Celluloses quantum satis Soured-cream butter E 500 Sodium carbonates quantum satis’ 3. In Annex III, Part A: (a) the maximum levels for ‘Olives and olive-based preparations’, ‘Emulsified sauces with a fat content of 60 % or more’ and ‘Emulsified sauces with a fat content less than 60 %’ shall be replaced by the following: ‘Olives and olive-based preparations 1 000 500 1 000 Emulsified sauces with a fat content of 60 % or more 1 000 500 1 000 Emulsified sauces with a fat content less than 60 % 2 000 1 000 2 000’ (b) at the end of this part, the following table shall be added: ‘Foodstuff Maximum level (mg/kg or mg/l as appropriate) Sa Ba PHB Sa + Ba Sa + PHB Sa + Ba + PHB. Mehu and Makeutettu. Mehu 500 200 Analogues of meat, fish, crustaceans and cephalopods and cheese based on protein 2 000 Dulce de membrillo 1 000 27. 5. 98 EN Official Journal of the European Communities C 161/33 Foodstuff Marmelada Ostkaka Pasha Semmelknödelteig Maximum level (mg/kg or mg/l as appropriate) Sa Ba PHB Sa + Ba Sa + PHB Sa + Ba + PHB 1 500 2 000 1 000 2 000 Cheese and cheese analogues (surface treatment only) quantum satis Cooked red beet 2 000 Collagen-based casings with a water activity greater than 0,6 quantum satis’ 4. In Annex III, Part B: (a) the presentation of the following foodstuffs and maximum levels: ‘Crustaceans and cephalopods — fresh, frozen and deep-frozen crustaceans, panaeidae solenceridae, aristeidae family: — up to 80 units — between 80 and 120 units — over 120 units — cooked (1) In edible parts. ’ shall be as follows: ‘Crustaceans and cephalopods: — fresh, frozen and deep-frozen — crustaceans, panaeidae solenceridae, aristeidae family: — up to 80 units — between 80 and 120 units — over 120 units — cooked (*) In edible parts. ’. 150 (1) 150 (1) 200 (1) 300 (1) 50 (1) 150 (*) 150 (*) 200 (*) 300 (*) 50 (*) (b) the maximum level for the entry ‘Sugars as defined in Directive 73/437/EEC except glucose syrup, whether or not dehydrated’ shall be replaced by the following: ‘Sugars as defined in Directive 73/437/EEC except glucose syrup, whether or not dehydrated 10’ (c) the following foodstuffs and maximum levels: ‘Vegetable and cereal- protein-based meat, fish and crustacean analogues 200’ C 161/34 EN Official Journal of the European Communities 27. 5. 98 shall be replaced by the following: ‘Analogues of meat, fish and crustaceans based on protein 200’ (d) at the end of this Part, the following foodstuffs and maximum levels shall be added: ‘Marinated nuts Vacuum packed sweet corn Distilled alcoholic beverages containing whole pears 50 100 50’ 5. In Annex III, Part C: (a) the following foodstuff and maximum level shall be added to E 234: ‘E 234 Nisin (1) Mascarpone 10 mg/kg’ (b) the following foodstuffs and maximum levels shall be added to E 251 and E 252: ‘E 251 E 252 Sodium nitrate Potassium nitrate (*) Expressed as Na NO3. ’; Foie gras, foie gras entier, blocs de foie gras 50 (*) (c) the following foodstuffs and maximum levels shall be added to E 280, E 281, E 282 and E 283: ‘E 280 Propionic acid E 281 E 282 E 283 Sodium propionate Calcium propionate Potassium propionate prepacked pølsebrød, boller and dansk flutes Cheese and cheese analogues (surface treatment only) 2 000 mg/kg, expressed as propionic acid quantum satis’ (d) the following table shall be deleted: ‘E 233 Thiabendazole Surface treatment of: — citrus fruit — bananas 6 mg/kg 3 mg/kg’ 6. The designation ‘Dehydrated granulated potatoes’ contained in the table in Annex III parts B and D in the foodstuffs column shall be replaced by ‘Dehydrated potatoes’. 7. In Annex IV: (a) the designation ‘Instant tea powder’ concerning E 297 Fumaric acid and the maximum level of 1 g/l shall be replaced by ‘Instant products for preparation of flavoured tea and herbal infusions with the maximum level: 1 g/kg’. 27. 5. 98 EN Official Journal of the European Communities C 161/35 (b) the table concerning E 338 to E 452 shall be replaced by the following: ‘In the following applications the levels of phosphoric acid and the phosphates E 338, E 339, E 340, E 341, E 343, E 450, E 451 and E 452 may be added individually or in combination (expressed as P2O5): indicated maximum E 338 Phosphoric acid Non-alcoholic flavoured drinks Sterilised and UHT milk Candied fruits Fruit preparations E 339 Sodium phosphates Partly dehydrated mild with less than 28 % solids 700 mg/l 1 g/l 800 mg/kg 800 mg/kg 1 g/kg i) Monosodium phosphate Partly dehydrated milk with more than 28 % solids 1,5 g/kg ii) Disodium phosphate Dried milk and dried skimmed milk 2,5 g/kg iii) Trisodium phosphate Pasteurised, sterilised and UHT creams Whipped cream and vegetable analogues fat 5 g/kg 5 g/kg Unripened cheese (except Mozzarella) 2 g/kg E 340 Potassium phosphates Processed cheese and processed cheese analogues i) Monopotassium Meat products phosphate 20 g/kg 5 g/kg ii) Dipotassium phosphate Sport drinks and prepared table waters 0,5 g/l iii) Tripotassium phosphate Dietary supplements quantum satis Salt and its substitutes Vegetable protein drinks E 341 Calcium phosphates Beverage whiteners i) Monocalcium phosphate Beverage whiteners for vending machines ii) Dicalcium phosphate Edible ices iii) Tricalcium phosphate Desserts Dry powdered dessert mixes E 343 Magnesium phosphates Fine bakery wares i) Monomagnesium Flour phosphate ii) Dimagnesium phosphate Flour, self raising Soda bread Liquid egg (white, yolk or whole egg) E 450 Diphosphates Sauces i) Disodium diphosphate Soups and broths ii) Trisodium diphosphate Instant tea and instant herbal infusions 10 g/kg 20 g/l 30 g/kg 50 g/kg 1 g/kg 3 g/kg 7 g/kg 20 g/kg 2,5 g/kg 20 g/kg 20 g/kg 10 g/kg 5 g/kg 3 g/kg 2 g/kg 2 g/l iii) Tetrasodium diphosphate v) Tetrapotassium diphosphate Cider and perry Chewing gum quantum satis vi) Dicalcium diphosphate Chocolate and malt dairy-based drinks 2 g/l Dried powdered foodstuffs 10 g/kg C 161/36 EN Official Journal of the European Communities 27. 5. 98 vii) Calcium dihydrogen diphosphate Alcoholic drinks (excluding wine and beer) E 451 Triphosphates i) Pentasodium triphosphate Breakfast cereals Snacks Surimi Fish and crustacean paste (syrups Toppings pancakes, flavoured syrups for milkshakes and ice cream; similar products) for ii) Pentapotassium triphosphate Special formulae for particular nutritional uses Glazings for meat and vegetable products E 452 Polyphosphates Sugar confectionery i) Sodium polyphosphate Icing sugar ii) Potassium polyphosphate iii) Sodium calcium polyphosphate iv) Calcium polyphosphates Noodles Batters Fillets of unprocessed fish, frozen and deep-frozen Unprocessed and processed molluscs and crustaceans frozen and deep-frozen Processed potato products (including frozen, deep-frozen, chilled and dried processed products) and pre-fried frozen and deep-frozen potatoes Spreadable fats excluding butter Soured-cream butter Canned crustaceans products Waterbased emulsion sprays for coating baking tins 1 g/l 5 g/kg 5 g/kg 1 g/kg 5 g/kg 3 g/kg 5 g/kg 4 g/kg 5 g/kg 10 g/kg 2 g/kg 12 g/kg 5 g/kg 5 g/kg 5 g/kg 5 g/kg 2 g/kg 1 g/kg 30 g/kg Coffee based drinks machines for vending 2 g/l’ (c) the following additive shall be added: ‘E 468 Crosslinked sodium carboxy methyl cellulose Solid dietary supplements 30 g/kg’ (d) the designation ‘Minarine’ concerning E 385 shall be amended as follows: ‘Spreadable fats as defined in Annexes B and C of Regulation (EC) No 2991/94 (*) having a fat content of 41 % or less 100 mg/kg (*) OJ L 316, 9. 12. 1994, p. 2. ’; (e) the following foodstuff and maximum level shall be added to E 405: ‘E 405 Propane-1, 2-diol alginate Cider excluding cidre bouché 100 mg/l’ 27. 5. 98 EN Official Journal of the European Communities C 161/37 (f) the designation in the 12th section, third column, concerning E 442, shall be amended as follows: ‘Cocoa and chocolate products as defined in Directive 73/241/EEC including fillings’ ‘Confectionary based on these products’; (g) the following foodstuff and maximum level shall be added to E 445: ‘E 445 Glycerolesters of wood rosins Surface treatment of citrus fruit 50 mg/kg’ (h) the following foodstuffs and maximum levels shall be added to E 473 and E 474: ‘E 473 Sucrose esters of fatty acids Cream analogues E 474 Sucroglycerides Sterilised cream and sterilised cream with reduced fat content 5 g/kg 5 g/kg’ (i) the designation ‘Low and very low fat spreads and dressings’ concerning E 476 shall be amended as follows: ‘E 476 Polyglycerol polyricinoleate Spreadable fats as defined in Annexes A, B and C of Regulation (EC) No 2991/94 having a fat content of 41 % or less Similar spreadable products with a fat content of less than 10 % fat Dressings 4 g/kg 4 g/kg 4 g/kg’ (j) the following foodstuffs and maximum levels concerning E 551 to E 559 shall be added: ‘Seasonings Confectionery excluding chocolate (surface treatment only) (*) 30 g/kg quantum satis Tin-greasing products 30 g/kg (*) The designation ‘Confectionery excluding chocolate (surface treatment only)’ replaces ‘Moulded jelly sweets (surface treatment only)’ in Directive 95/2/EC. ’; (k) the designation ‘Sliced hard cheese and sliced processed cheese’ concerning E 551 to E 559 shall be amended as follows: ‘Sliced or grated hard, semi-hard and processed cheese Sliced cheese or analogues and processed cheese analogues grated 10 g/kg’ (l) the following foodstuff and maximum level shall be added to E 900: ‘E 900 Dimethyl polysiloxane Cider excluding cidre bouché 10 mg/l’ C 161/38 EN Official Journal of the European Communities 27. 5. 98 (m) the following foodstuffs and maximum levels shall be added to E 901, E 902, E 903 and E 904: ‘E 901 Beeswax, white and yellow E 902 E 903 E 904 Candelilla wax Carnauba wax Shellac Peaches and pineapples (surface treatment only) quantum satis’ (n) the following foodstuffs and maximum levels shall be added to E 912 and E 914: ‘E 912 E 914 Montanic acid esters Oxidised polyethylene wax Fresh melon, mango, papaya, avocado and pineapple (surface treatment only) quantum satis’ (o) the following foodstuffs and maximum levels shall be added to E 957: ‘E 957 Thaumatin Water-based flavoured non- alcoholic drinks Desserts — dairy and non dairy 0,5 mg/l 5 mg/kg (as flavour enhancer only)’ (p) the designation ‘Margarine’ and ‘Minarine’ concerning E 959 shall be amended as follows: ‘E 959 Neohesperidine DC Spreadable fats as defined in Annexes B and C of Regulation (EC) No 2991/94 5 mg/kg’ (q) the following foodstuff and maximum level shall be added to E 999: ‘E 999 Quillaia extract Cider excluding cidre bouché (r) the following table shall be added: ‘E 905 Microcrystalline wax Surface treatment of — confectionery excluding chocolate — chewing gum — melons, papaya, mango and avocado 200 mg/l calculated as anhydrous extract’ quantum satis E 1518 Glyceryl triacetate (triacetin) Chewing gum quantum satis’ (s) the following table shall be added: ‘E 459 Beta-cyclodextrine Foodstuffs in tablet and coated tablet form quantum satis E 425 Konjac (*) (i) Konjac gum (ii) Konjac glucomannane Foodstuffs those referred 2(3)) in general (except in Article to 10 g/kg individually or in combination (*) These substances may not be used to produce dehydrated foodstuffs intended to rehydrate on ingestion. ’. 27. 5. 98 EN Official Journal of the European Communities C 161/39 8. In Annex V, the following tables shall be added: ‘E 322 Lecithins E 432-E 436 Polysorbates glazing agents for fruit E 470a E 471 Sodium, potassium and calcium salts of fatty acids Mono and diglycerides of fatty acids E 491-E 495 Sorbitans E 570 E 900 E 425 Fatty acids Dimethylpolysiloxane Polyethyleneglycol 6000 sweeteners Konjac (i) Konjac gum (ii) Konjac glucomannane E 459 Beta-cyclodextrine 1 g/kg E 1451 Acetylated oxidised starch E 468 Cross linked sodium carboxy methyl cellulose sweeteners E 469 Enzymatically hydrolysed carboxy methyl cellulose’ 9. In Annex VI: (a) the first subparagraph of the introductory note shall be replaced by the following: ‘Formulae and weaning foods for infants and young children may contain E 414 (acacia gum, gum arabic) and E 551 (silicon dioxide) resulting from the addition of nutrient preparations containing not more than 150 g/kg of E 414 and 10 g/kg of E 551, as well as E 421 (mannitol) when used as a carrier for vitamin B12 (not less than 1 part vitamin B12 to 1 000 parts mannitol). The carry over of E 414 in the product ready for consumption should not be more than 10 mg/kg. Formulae and weaning foods for infants and young children may contain E 301 (sodium L-ascorbate), used at QS level in coatings of nutrient preparations containing polyunsaturated fatty acids. The carry over of E 301 in the product ready for consumption should not be more than 75 mg/l. ’; (b) in Part 1, note 2 shall be replaced by the following: ‘2. 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 of the other substances together in that foodstuff. ’; C 161/40 EN Official Journal of the European Communities 27. 5. 98 (c) in Part 1, the following table shall be added: ‘E 304 L-ascorbyl palmitate 10 mg/l E 331 E 332 E 339 E 340 Sodium citrates 2 g/l Potassium citrates Individually or in combination and in conformity with the in Annex I to Directive 91/321/EEC limits set Sodium phosphates 1 g/l expressed as P2O5 Potassium phosphates Individually or in combination and in conformity with the in Annex I to Directive 91/321/EEC limits set E 412 Guar gum E 472c Citric acid esters of mono- and diglycerides of fatty acids 1 g/l, where the liquid product contains partially hydrolysed proteins and is in conformity with the conditions set in Annex IV of Directive 91/321/EEC, as amended by Directive 96/4/EC 7,5 g/l sold as powder 9 g/l sold as liquid where the products contain partially hydrolysed proteins, peptides or amino acids and are in conformity with the conditions set in Annex IV of Directive 91/321/EEC, as amended by Directive 96/4/EC E 473 Sucrose esters of fatty acids 120 mg/l proteins, peptides or amino acids’ in products containing hydrolysed (d) in Part 2, note 2 shall be replaced by the following: ‘2. If more than one of the substances E 322, E 471, E 472c and 473 is 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 of the other substances together in that foodstuff. ’; (e) in Part 2, the following table shall be added: ‘E 304 L-ascorbyl palmitate 10 mg/l E 331 E 332 E 339 E 340 Sodium citrates 2 g/l Potassium citrates Individually or in combination and in conformity with the in Annex I to Directive 91/321/EEC limits set Sodium phosphates 1 g/l expressed as P2O5 Potassium phosphates Individually or in combination and in conformity with the in Annex I to Directive 91/321/EEC limits set E 472c Citric acid esters of mono- and diglycerides of fatty acids 7,5 g/l sold as powder 9 g/l sold as liquid where the products contain partially hydrolysed proteins, peptides or amino acids and are in conformity with the conditions set in Annex IV of Directive 91/321/EEC, as amended by the Directive 96/4/EC E 473 Sucrose esters of fatty acids 120 mg/l proteins, peptides or amino acids’ in products containing hydrolysed 27. 5. 98 EN Official Journal of the European Communities C 161/41 (f) in Part 3, the following table shall be added: ‘E 333 Calcium citrates (*) In low-sugar fruit based products quantum satis E 341 Tricalcium phosphate (*) In fruit based desserts 1 g/kg as P2O5 E 1451 Acetylated oxidised starch Weaning foods 50 g/kg (*) The note in part 4 does not apply. ’; (g) in Part 4, the following table shall be added: ‘E number Name Maximum level Special conditions E 401 Sodium alginate 1 g/l E 405 Propane 1,2-diolalginate 200 mg/l E 410 Locust bean gum 10 g/l E 412 Guar gum 10 g/l E 415 Xanthan gum 1,2 g/l E 440 Pectins 10 g/l E 466 Sodium carboxy methyl cellulose 10 g/l or kg E 471 Mono- and diglycerides of fatty acids 5 g/l products with From 4 months onwards in special food adapted composition, required for metabolic disorders and for general tube- feeding From 12 months onwards in specialised diets intendes for young children who have cow’s milk intolerance or inborn errors of metabolism From birth onwards in products for reduction of gastro-oesophageal reflux liquid From birth onwards in products in containing formulae hydrolysed proteins, peptides or amino acids in conformity with the conditions set Annex IV of Directive 91/321/EEC, as amended by Directive 96/4/EC From birth onwards for use in products based on amino acids or peptides for use with patients who have problems with impairments of the gastrointestinal tract, protein mal-absorption or inborn errors of metabolism From birth onwards in products used in case of gastro-intestinal disorders From birth onwards in products for the dietary management of metabolic disorders From birth onwards in spesialised diets, particularly those devoid of proteins E 1450 Starch sodium octenyl succinate 20 g/l In infant formulae and follow-on formulae’ C 161/42 EN Official Journal of the European Communities 27. 5. 98 STATEMENT OF THE COUNCIL’S REASONS I. INTRODUCTION 1. On 4 September 1996, the Commission submitted to the Council a proposal for a Directive of the European Parliament and of the Council based on Article 100a of the EC Treaty amending Directive 95/2/EC of the European Parliament and of the Council on food additives other than colours and sweeteners (1). 2. Further to the European Parliament’s opinion delivered at first reading on 23 October 1997 (2), the Commission submitted an amended proposal (3) to the Council on 16 January 1998. 3. The Economic and Social Committee delivered its opinion on 18 December 1996 (4). 4. The Council adopted on 23 March 1998 its common position in accordance with Article 189b of the Treaty. II. PURPOSE 5. The aim of the draft Directive is to adapt Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (5) to recent scientific and technical developments taking account of the requirements of both industry and consumers. To that end, draft amended Directive 95/2/EC aims to authorise: — the use of certain additives, which are already authorised, in certain new categories of foodstuffs not yet included in the Directive, — certain foodstuffs manufactured with certain additives in the ‘new’ Member States, which are not covered by the existing Directive, — certain new food additives at present prohibited which, following assessment by the Scientific Committee for Food, have been deemed fit for human consumption. As a result the draft Directive constitutes a necessary measure to help ensure proper operation of the internal market in the foodstuffs sector. III. ANALYSIS OF THE COMMON POSITION A. General comments 6. In the light of the amended Commission proposal, the Council endorsed the Commission’s approach with respect to the European Parliament’s amendments by: — taking over as they stand or in principle amendments 13, 20, 21, 23 to 25, 28, 33 and 34, — rejecting amendments 1 to 5, 15, 16, 18, 26, 29 and 42. (1) OJ C 76, 11. 3. 1997, p. 34. (2) OJ C 339, 10. 11. 1997, p. 136. (3) OJ C 77, 12. 3. 1998, p. 7. (4) OJ C 75, 10. 3. 1997, p. 1. (5) OJ L 61, 20. 2. 1995, p. 1. 27. 5. 98 EN Official Journal of the European Communities C 161/43 On the other hand, the Council departed from the Commission’s amended proposal by: — accepting amendments 8, 9, 17 and 19 (in part) which the Commission had rejected, — endorsing two of the three parts of amendment 10 only one part of which the Commission had accepted, — accepting partially amendment 14 which the Commission had adopted as it stood. In addition, the Council made a number of other amendments to the Commission proposal which concerned both the substance and the form of the text. The Commission accepted all these amendments. The amendments made by the Council to the amended Commission proposal require the following specific comments: B. Specific comments 7. Amendments accepted (as they stood or in part) by the Council and rejected (as they stood or in part) by the Commission — Amendment 8 (point 2(e) of the Annex to the common position): the Council accepted this amendment as it thought there was no technological need for the use of hydrochloric acid to be permitted in the manufacture of Mozzarella. — Amendment 9 (point 4(b)): given that practice in the sugar industry is to use not more than 10 mg of SO2 per kg of sugar, the Council agreed with the European Parliament and reduced the maximum level for this additive, where sugar is concerned, to 10 mg. — Amendment 10 (point 4(d)): only the third part of this amendment (addition of alcoholic beverages containing whole pears) was accepted by the Commission. The Council adopted that part as well as another point, namely the deletion of dehydrated apples and pears with a moisture content of more than 12 %; however, the Council did not see fit also to delete the reference to marinated nuts. — Amendment 17 (point 7(o)): the Council agreed with the European Parliament and authorised two new uses for thaumatin as a flavour enhancer (water-based flavoured drinks and desserts) although it reduced the maximum level permitted in desserts to 5 mg (amendment 17: 10 mg). — Amendment 19 (point 7(r)): the Council agreed with the European Parliament and deleted glazed rice from the list of foods which may be treated with microcrystalline wax; however, it went along with the Commission where triacetin was concerned and did not delete that heading as the European Parliament wished. 8. Amendment adopted by the Commission and accepted in part by the Council — Amendment 14 (point 7(f)): the Council considered that it was justifiable to extend the use of ammonium phosphatides to fillings of cocoa and chocolate products, but not to all confectionery. 9. Other amendments made to the Commission proposal The Council introduced other changes to the Commission proposal, in particular to take account of new technological developments and the needs of the food industry. These amendments include: C 161/44 EN Official Journal of the European Communities 27. 5. 98 — the inclusion of flour treatment agents in the scope of the Directive and the exclusion of enzymes (Article 1(1), (2) and (3)); the Commission undertook to examine the problems connected with the latter and to submit appropriate proposals, — repeal of the entry on thiabendazole which is now covered by Council Directive 95/38/EC on pesticide residues (1) (fourth recital and point 5(d)), — authorisation to treat Mascarpone with nisin (point 5(a)) and peaches and pineapples with wax (point 7(m)). 10. Comments on a number of the European Parliament’s other amendments Of the amendments accepted by the Commission and the Council, with respect to amendment 28 on additives authorised in food products for infants and young children for particular medical purposes (Annex VI, Part 4) the following comment seems required: the Council accepted this amendment while adopting, as did the Commission, the maximum level recommended by the Scientific Committee on Food for the first three substances; it also followed the advice of that Committee in laying down more specific special conditions for the use of the additives concerned (point 9(g)). IV. CONCLUSIONS The Council considers that the common position at one and the same time substantially meets the wishes expressed by the European Parliament and takes sufficient account of recent technological requirements and developments. The Council is of the opinion that the common position reflects a sound balance between the technological requirements of the industry and consumer expectations. (1) OJ L 197, 22. 8. 1995, p. 14