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) (c. 45)

ANNEX U.K.

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 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
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 407a PROCESSED 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 907 HYDROGENATED 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 1517 GLYCERYL 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 1519 BENZYL 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’