ANNEX
The Annex I to Directive 2008/84/EC is amended as follows:
The text concerning E 234 nisin is replaced by the following:
‘E 234 NISIN
Definition | Nisin consists of several closely related polypeptides produced during the fermentation of a milk or sugar medium by certain natural strains of Lactococcus lactis subsp.lactis |
Einecs | 215-807-5 |
Chemical formula | C143H230N42O37S7 |
Molecular weight | 3 354,12 |
Assay | Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk proteins or fermented solids and a minimum sodium chloride content of 50 % |
Description | White powder |
Purity | |
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Loss on drying | Not more than 3 % when dried to constant weight at 102 °C to 103 °C |
Arsenic | Not more than 1 mg/kg |
Lead | Not more than 1 mg/kg |
Mercury | Not more than 1 mg/kg’ |
The text concerning E 400 alginic acid is replaced by the following:
‘E 400 ALGINIC ACID
The text concerning E 401 sodium alginate is replaced by the following:
‘E 401 SODIUM ALGINATE
Definition | |
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Chemical name | Sodium salt of alginic acid |
Chemical formula | (C6H7NaO6)n |
Molecular weight | 10 000-600 000 (typical average) |
Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222) |
Description | Nearly odourless, white to yellowish fibrous or granular powder |
Identification | |
Positive test for sodium and alginic acid | |
Purity | |
Loss on drying | Not more than 15 % (105 °C, 4 hours) |
Water-insoluble matter | Not more than 2 % on the anhydrous basis |
Formaldehyde | Not more than 50 mg/kg |
Arsenic | Not more than 3 mg/kg |
Lead | Not more than 5 mg/kg |
Mercury | Not more than 1 mg/kg |
Cadmium | Not more than 1 mg/kg |
Total plate count | Not more than 5 000 colonies per gram |
Yeast and moulds | Not more than 500 colonies per gram |
E. coli | Absent in 5 g |
Salmonella spp. | Absent in 10 g’ |
The text concerning E 402 potassium alginate is replaced by the following:
‘E 402 POTASSIUM ALGINATE
Definition | |
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Chemical name | Potassium salt of alginic acid |
Chemical formula | (C6H7KO6)n |
Molecular weight | 10 000-600 000 (typical average) |
Assay | Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238) |
Description | Nearly odourless, white to yellowish fibrous or granular powder |
Identification | |
Positive test for potassium and for alginic acid | |
Purity | |
Loss on drying | Not more than 15 % (105 °C, 4 hours) |
Water-insoluble matter | Not more than 2 % on the anhydrous basis |
Formaldehyde | Not more than 50 mg/kg |
Arsenic | Not more than 3 mg/kg |
Lead | Not more than 5 mg/kg |
Mercury | Not more than 1 mg/kg |
Cadmium | Not more than 1 mg/kg |
Total plate count | Not more than 5 000 colonies per gram |
Yeast and moulds | Not more than 500 colonies per gram |
E. coli | Absent in 5 g |
Salmonella spp. | Absent in 10 g’ |
The text concerning E 403 ammonium alginate is replaced by the following:
‘E 403 AMMONIUM ALGINATE
Definition | |
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Chemical name | Ammonium salt of alginic acid |
Chemical formula | (C6H11NO6)n |
Molecular weight | 10 000-600 000 (typical average) |
Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217) |
Description | White to yellowish fibrous or granular powder |
Identification | |
Positive test for ammonium and alginic acid | |
Purity | |
Loss on drying | Not more than 15 % (105 °C, 4 hours) |
Sulphated ash | Not more than 7 % on the dried basis |
Water-insoluble matter | Not more than 2 % on the anhydrous basis |
Formaldehyde | Not more than 50 mg/kg |
Arsenic | Not more than 3 mg/kg |
Lead | Not more than 5 mg/kg |
Mercury | Not more than 1 mg/kg |
Cadmium | Not more than 1 mg/kg |
Total plate count | Not more than 5 000 colonies per gram |
Yeast and moulds | Not more than 500 colonies per gram |
E. coli | Absent in 5 g |
Salmonella spp. | Absent in 10 g’ |
The text concerning E 404 calcium alginate is replaced by the following:
‘E 404 CALCIUM ALGINATE
Synonyms | Calcium salt of alginate |
Definition | |
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Chemical name | Calcium salt of alginic acid |
Chemical formula | (C6H7Ca1/2O6)n |
Molecular weight | 10 000-600 000 (typical average) |
Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219) |
Description | Nearly odourless, white to yellowish fibrous or granular powder |
Identification | |
Positive test for calcium and alginic acid | |
Purity | |
Loss on drying | Not more than 15,0 % (105 °C, 4 hours) |
Formaldehyde | Not more than 50 mg/kg |
Arsenic | Not more than 3 mg/kg |
Lead | Not more than 5 mg/kg |
Mercury | Not more than 1 mg/kg |
Cadmium | Not more than 1 mg/kg |
Total plate count | Not more than 5 000 colonies per gram |
Yeast and moulds | Not more than 500 colonies per gram |
E. coli | Absent in 5 g |
Salmonella spp. | Absent in 10 g’ |
The text concerning E 405 propane-1,2-diol alginate is replaced by the following:
‘E 405 PROPANE-1,2-DIOL ALGINATE
Synonyms | Hydroxypropyl alginate 1,2-propanediol ester of alginic acid Propylene glycol alginate |
Definition | |
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Chemical name | Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule |
Chemical formula | (C9H14O7)n (esterified) |
Molecular weight | 10 000-600 000 (typical average) |
Assay | Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2 of carbon dioxide |
Description | Nearly odourless, white to yellowish brown fibrous or granular powder |
Identification | |
Positive test for 1,2-propanediol and alginic acid after hydrolysis | |
Purity | |
Loss on drying | Not more than 20 % (105 °C, 4 hours) |
Total propane-1,2-diol content | Not less than 15 % and not more than 45 % |
Free propane-1,2-diol content | Not more than 15 % |
Water-insoluble matter | Not more than 2 % on the anhydrous basis |
Formaldehyde | Not more than 50 mg/kg |
Arsenic | Not more than 3 mg/kg |
Lead | Not more than 5 mg/kg |
Mercury | Not more than 1 mg/kg |
Cadmium | Not more than 1 mg/kg |
Total plate count | Not more than 5 000 colonies per gram |
Yeast and moulds | Not more than 500 colonies per gram |
E. coli | Absent in 5 g |
Salmonella spp. | Absent in 10 g’ |
The text concerning E 407 carrageenan is replaced by the following:
‘E 407 CARRAGEENAN
Synonyms | Products of commerce are sold under different names such as: Irish moss gelose Eucheuman (from Eucheuma spp.) Iridophycan (from Iridaea spp.) Hypnean (from Hypnea spp.) Furcellaran or Danish agar (from Furcellaria fastigiata) Carrageenan (from Chondrus and Gigartina spp.) |
Definition | Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaeceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded. Formaldehyde may be present as an adventitious impurity up to a maximum level of 5 mg/kg |
Einecs | 232-524-2 |
Description | Yellowish to colourless, coarse to fine powder which is practically odourless |
Identification | |
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Positive tests for galactose, for anhydrogalactose and for sulphate | |
Purity | |
Methanol, ethanol, propane-2-ol content | Not more than 0,1 % singly or in combination |
Viscosity of a 1,5 % solution at 75 °C | Not less than 5 mPa.s |
Loss on drying | Not more than 12 % (105 °C, four hours) |
Sulphate | Not less than 15 % and not more than 40 % on the dried basis (as SO4) |
Ash | Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C |
Acid-insoluble ash | Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid) |
Acid-insoluble matter | Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid) |
Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) | Not more than 5 % |
Arsenic | Not more than 3 mg/kg |
Lead | Not more than 5 mg/kg |
Mercury | Not more than 1 mg/kg |
Cadmium | Not more than 2 mg/kg |
Total plate count | Not more than 5 000 colonies per gram |
Yeast and moulds | Not more than 300 colonies per gram |
E. coli | Absent in 5 g |
Salmonella spp. | Absent in 10 g’ |
The text concerning E 407a processed eucheuma seaweed is replaced by the following:
‘E 407a PROCESSED EUCHEUMA SEAWEED
The text concerning E 412 guar gum is replaced by the following:
‘E 412 GUAR GUM
After the entry E 503(ii), the following text concerning E 504(i) is added:
‘E 504(i) MAGNESIUM CARBONATE
The text concerning E 526 calcium hydroxide is replaced by the following:
‘E 526 CALCIUM HYDROXIDE
The text concerning E 529 calcium oxide is replaced by the following:
‘E 529 CALCIUM OXIDE
The text concerning E 901 beeswax is replaced by the following:
‘E 901 BEESWAX
The text concerning E 905 microcrystalline wax is replaced by the following:
‘E 905 MICROCRYSTALLINE WAX
The text concerning E 230 and E 233 is deleted.