Commission Directive 2004/45/EC of 16 April 2004 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
Status:
This is the original version (as it was originally adopted).
ANNEX
The Annex to Directive 96/77/EC is amended as follows:
1.
The texts concerning E 407 Carrageenan and E 407a Processed Eucheuma Seaweed are replaced by the following:
‘E 407CARRAGEENAN
| 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 |
| EINECS | 232-524-2 |
| Description | Yellowish to colourless, coarse to fine powder which is practically odourless |
| Identification |
|---|
A. 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 oC | Not less than 5 mPa.s |
| Loss on drying | Not more than 12 % (105 oC, 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 oC |
| 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 1 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 | Negative in 5 g |
| Salmonella spp. | Negative in 10 g |
E 407aPROCESSED EUCHEUMA SEAWEED
| Synonyms | PES (acronym for processed eucheuma seaweed) |
| Definition | Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consist chiefly of the potassium salt of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded |
| Description | Tan to yellowish, coarse to fine powder which is practically odourless |
| Identification |
|---|
A. Positive tests for galactose, for anhydrogalactose and for sulphate | |
B. Solubility | Forms cloudy viscous suspensions in water. Insoluble in ethanol |
| Purity |
|---|
| Methanol, ethanol, propane-2-ol content | Not more than 0,1 % singly or in combination |
| Viscosity of a 1,5 % solution at 75 oC | Not less than 5 mPa.s |
| Loss on drying | Not more than 12 % (105 oC, 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 oC |
| Acid-insoluble ash | Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid) |
| Acid-insoluble matter | Not less than 8 % and not more than 15 % 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 1 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 | Negative in 5 g |
| Salmonella spp. | Negative in 10 g’ |
2.
The following text concerning E 907 Hydrogenated poly-1-decene is inserted after E 905 Microcrystalline wax:
‘E 907HYDROGENATED POLY-1-DECENE
| Synonyms | Hydrogenated polydec-1-ene
Hydrogenated poly-alpha-olefin
|
| Definition |
|---|
| Chemical formula | C10nH20n+2 where n = 3 — 6 |
| Molecular weight | 560 (average) |
| Assay | Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution:
C30: 13 — 37 %
C40: 35 — 70 %
C50: 9 — 25 %
C60: 1 — 7 %
|
| Description | Colourless, odourless, viscous liquid |
| Identification |
|---|
A. Solubility | Insoluble in water; slightly soluble in ethanol; soluble in toluene |
B. Burning | Burns with a bright flame and a paraffin-like characteristic smell |
| Purity |
|---|
| Viscosity | Between 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 °C |
| Compounds with carbon number less than 30 | Not more than 1,5 % |
| Readily carbonisable substances | After 10 minutes shaking in a boiling water bath, a tube of sulfuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour |
| Nickel | Not more than 1 mg/kg |
| Lead | Not more than 1 mg/kg’ |
3.
The following text concerning E 1517 Glyceryl diacetate and E 1519 Benzyl alcohol is added:
‘E 1517GLYCERYL DIACETATE
| Synonyms | Diacetin |
| Definition | Glyceryl diacetate consists predominantly of a mixture of the 1,2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters |
| Chemical names | Glyceryl diacetate
1,2,3-propanetriol diacetate
|
| Chemical formula | C7H12O5 |
| Molecular weight | 176,17 |
| Assay | Not less than 94,0 % |
| Description | Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour |
| Identification |
|---|
A. Solubility | Soluble in water. Miscible with ethanol |
B. Positive tests for glycerol and acetate | |
C. Specific gravity | d20 20: 1,175 — 1,195 |
D. Boiling range | Between 259 and 261 °C |
| Purity |
|---|
| Total ash | Not more than 0,02 % |
| Acidity | Not more than 0,4 % (as acetic acid) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
E 1519BENZYL ALCOHOL
| Synonyms | Phenylcarbinol
Phenylmethyl alcohol
Benzenemethanol
Alpha-hydroxytoluene
|
| Definition |
|---|
| Chemical names | Benzyl alcohol
Phenylmethanol
|
| Chemical formula | C7H8O |
| Molecular weight | 108,14 |
| Assay | Not less than 98,0 % |
| Description | Colourless, clear liquid with a faint, aromatic odour |
| Identification |
|---|
A. Solubility | Soluble in water, ethanol and ether |
B. Refractive index | [n]D 20:1,538 – 1,541 |
C. Specific gravity | d25 25: 1,042 — 1,047 |
D. Positive test for peroxides | |
| Purity |
|---|
| Distillation range | Not less than 95 % v/v distils between 202 and 208 °C |
| Acid value | Not more than 0,5 |
| Aldehydes | Not more than 0,2 % v/v (as benzaldehyde) |
| Lead | Not more than 5 mg/kg’ |
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