Amendment of the principal Regulations
13. In Schedule 8 (miscellaneous additives permitted in foods for infants and young children)—
(a)there shall be substituted for the first introductory note the following introductory notes—
“1. 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 1000 parts mannitol). The carry over of E 414 in the product ready for consumption shall not be more than 10 mg/kg.
1A. Formulae and weaning foods for infants and young children may contain E 301 (sodium L-ascorbate), used at quantum satis level in coatings of nutrient preparations containing polyunsaturated fatty acids. The carry over of E 301 in the product ready for consumption shall not be more than 75 mg/l.”;
(b)in Part I (miscellaneous additives permitted in infant formulae for infants in good health)—
(i)there shall be substituted for note (b) the following note—
“(b)if more than one of the substances E 322, E 471, E 472c and E 473 is added to a food, the maximum level established for that food for each of those substances is lowered by that relative part as is present of the other substances together in that food.”;
(ii)in the table where there shall be inserted at the end the following entries—
| “E 304 | L-ascorbyl palmitate | 10 mg/1 |
| E 331 | Sodium citrates | 2 g/1 |
| E 332 | Potassium citrates | Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/ EEC(1) |
| E 339 | Sodium phosphates | 1 g/1 expressed as P2O5 |
| E 340 | Potassium phosphates | Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC |
| E 412 | Guar gum | 1 g/1, where the liquid product contains partially hydrolysed proteins and is in conformity with the conditions set in Annex IV to Directive 91/321 EEC, as amended by Directive 96/4/EC(2) |
| E472c | Citric acid esters of mono-and diglycerides of fatty acids | 7.5 g/1 sold as powder |
| g/1 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 to Directive 91/321/EEC, as amended by Directive 96/4/EC | ||
| E 473 | Sucrose esters of fatty acids | 120 mg/1 in products containing hydrolysed proteins, peptides or amino acids”; |
(c)in Part II (miscellaneous additives permitted in follow-on formulae for infants in good health)—
(i)there shall be substituted for note (b) the following note—
“(b)if more than one of the substances E 322, E 471, E 472c and E 473 is added to a food, the maximum level established for that food for each of those substances is lowered by that relative part as is present of the other substances together in that food.”;
(ii)in note (c) there shall be substituted for the words “lowered with” the words “lowered by”;
(iii)in the table there shall be inserted at the end the following entries—
| “E 304 | L-ascorbyl palmitate | 10 mg/1 |
| E 331 | Sodium citrates | 2 g/1 |
| E 332 | Potassium citrates | Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC |
| E 339 | Sodium phosphates | 1 g/1 expressed as P2O5 |
| E 340 | Potassium phosphates | Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC |
| E 472c | Citric acid testers of mono-and diglycerides of fatty acids | 7.5 g/1 sold as powder. 9 g/1 sold as liquid where the products contain partially hydrolised proteins, peptides or amino acids and are in conformity with the conditions set in Annex IV to Directive 91/321/EEC, as amended by Directive 96/4/EC |
| E 473 | Sucrose esters of fatty acids | 120 mg/1 in products containing hydrolysed proteins, peptides or amino acids”; |
(d)in Part III (miscellaneous additives permitted in weaning foods for infants and young children in good health) in the table there shall be inserted at the end the following entries—
(e)in Part IV (miscellaneous additives permitted in foods for infants and young children for special medical purposes) there shall be inserted at the end the following table—
| “EC No. | Name | Max. level | Special Conditions |
|---|---|---|---|
| E 401 | Sodium alginate | 1 g/1 | From 4 months onwards in special food products with adapted composition, required for metabolic disorders and for general tube feeding |
| E 405 | Propane 1, 2-diolalginate | 200 mg/1 | From 12 months onwards in specialised diets intended for young children who have cows' milk intolerance or inborn errors of metabolism |
| E 410 | Locust bean gum | 10 g/1 | From birth onwards in products for reduction of gastro-oesophageal reflux |
| E 412 | Guar gum | 10 g/1 | From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids in conformity with the conditions set in Annex IV to Directive 91/321/EEC, as amended by Directive 96/4/EC |
| E 415 | Xanthan gum | 1.2 g/1 | From birth onwards for use in products based on amino acids or peptides for use with patients who have problems with impairment of the gastro-intestinal tract, protein mal-absorption or inborn errors of metabolism |
| E 440 | Pectins | 10 g/1 | From birth onwards in products used in case of gastro-intestinal disorders |
| E 466 | Sodium carboxy methyl cellulose | 10g/1 or kg | From birth onwards in products for the dietary management of metabolic disorders |
| E 471 | Mono-and diglycerides of fatty acids | 5 g/1 | From birth onwards in specialised diets, particularly those devoid of proteins |
| E 1450 | Starch sodium octenyl succinate | 20 g/1 | In infant formulae and follow-on formulae”. |
O.J. No. L175, 4.7.91, p. 35
O.J. No. L49, 28.2.96, p. 12