Regulation 13 Amendment of the principal Regulations

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/1.”;

(b)

in Part 1 (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 there shall be inserted at the end the following entries–

“

E 304 L-ascorbyl palmitate 10 mg/1
E 331 Sodium citrates } 2 g/l
E 332 Potassium citrates } Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC^f1
E 339 Sodium phosphates } 1 g/l 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/l, 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^f2
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 to Directive 91/321/EEC, as amended by Directive 96/4/EC
E 473 Sucrose esters of fatty acids 120 mg/l in products containing hydrolysed proteins, peptides or amino acids

”;

(c)

in Part 2 (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/l
E 331 Sodium citrates } 2 g/l
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/l 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 esters of mono- and diglycerides of fatty acids 7.5 g/l sold as power
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 to Directive 91/321/EEC, as amended by Directive 96/4/EC
E 473 Sucrose esters of fatty acids 120 mg/l in products containing hydrolysed proteins, peptides or amino acids

”;

(d)

in Part 3 (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–

“

(*)
The note in Part 4 does not apply.

E 333 Calcium citrates(*) Low-sugar fruit based products quantum satis
E 341 Tricalcium phosphate(*)^f3 Fruit based desserts 1 g/kg as P₂O₅
E 1451 Acetylated oxidised starch Weaning foods 50 g/kg

”;

(e)

in Part 4 (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 Maximum level Special conditions

E 401 Sodium alginate 1 g/l 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/l 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/l From birth onwards in products for reduction of gastro-oesophageal reflux
E 412 Guar gum 10 g/l 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/l 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/l From birth onwards in products used in case of gastro-intestinal disorders
E 466 Sodium carboxy methyl cellulose 10 g/l or kg From birth onwards in products for the dietary management of metabolic disorders
E 471 Mono- and diglycerides of fatty acids 5 g/l From birth onwards in specialised diets, particularly those devoid of proteins
E 1450 Starch sodium octenyl succinate 20 g/l In infant formulae and follow-on formulae

”.

EC No.	Name	Maximum level	Special conditions
E 401	Sodium alginate	1 g/l	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/l	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/l	From birth onwards in products for reduction of gastro-oesophageal reflux
E 412	Guar gum	10 g/l	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/l	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/l	From birth onwards in products used in case of gastro-intestinal disorders
E 466	Sodium carboxy methyl cellulose	10 g/l or kg	From birth onwards in products for the dietary management of metabolic disorders
E 471	Mono- and diglycerides of fatty acids	5 g/l	From birth onwards in specialised diets, particularly those devoid of proteins
E 1450	Starch sodium octenyl succinate	20 g/l	In infant formulae and follow-on formulae

Annotations

Footnotes

f1

OJ No. L175, 4.7.91, p. 35.

f2

OJ No. L49, 28.2.96, p. 12.

f3

(*)

The note in Part 4 does not apply.

E 304	L-ascorbyl palmitate	10 mg/1
E 331	Sodium citrates }	2 g/l
E 332	Potassium citrates }	Individually or in combination and in conformity with the limits set in Annex 1 to Directive 91/321/EEC^f1
E 339	Sodium phosphates }	1 g/l 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/l, 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^f2
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 to Directive 91/321/EEC, as amended by Directive 96/4/EC
E 473	Sucrose esters of fatty acids	120 mg/l in products containing hydrolysed proteins, peptides or amino acids

E 304	L-ascorbyl palmitate	10 mg/l
E 331	Sodium citrates }	2 g/l
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/l 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 esters of mono- and diglycerides of fatty acids	7.5 g/l sold as power
		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 to Directive 91/321/EEC, as amended by Directive 96/4/EC
E 473	Sucrose esters of fatty acids	120 mg/l in products containing hydrolysed proteins, peptides or amino acids

(*) The note in Part 4 does not apply.
E 333	Calcium citrates(*)	Low-sugar fruit based products	quantum satis
E 341	Tricalcium phosphate(*)^f3	Fruit based desserts	1 g/kg as P₂O₅
E 1451	Acetylated oxidised starch	Weaning foods	50 g/kg