Commission Directive 2010/67/EU (repealed)Show full title

ANNEX

Annex I to Directive 2008/84/EC is amended as follows:

1.

in the section on E 290 Carbon dioxide the subentry on ‘Oil content’ is replaced by the following:

‘Oil content

Not more than 5 mg/kg’;

2.

after the section on additive E 385, the following section on E 392 Extracts of rosemary is inserted:

‘E 392 EXTRACTS OF ROSEMARY

GENERAL SPECIFICATION
Synonym	Extract of rosemary leaf (antioxidant)
Definition	Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification
EINECS	283-291-9
Chemical name	Rosemary extract (Rosmarinus officinalis)
Description	Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardised
Identification
Reference antioxidative compounds: phenolic diterpenes	Carnosic acid (C20H28O4) and Carnosol (C20H26O4) (which comprise not less than 90 % of the total phenolic diterpenes)
Reference key volatiles	Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, Verbenone
Density	> 0,25 g/ml
Solubility	Insoluble in water
Purity
Loss on Drying	< 5 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 2 mg/kg

1. Extracts of rosemary produced from dried rosemary leaves by acetone extraction
Description	Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid
Identification
Content of reference antioxidative compounds	≥ 10 % w/w, expressed as the total of carnosic acid and carnosol
Antioxidant/Volatiles — Ratio	(Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, “GC-MSD”)
Residual Solvents	Acetone: not more than 500 mg/kg

2. Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide
Extracts of rosemary produced from dried rosemary leaves extracted by means of supercritical carbon dioxide with a small amount of ethanol as entrainer.
Identification
Content of reference antioxidative compounds	≥ 13 % w/w, expressed as the total of carnosic acid and carnosol
Antioxidant/Volatiles — Ratio	(Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, “GC-MSD”)
Residual Solvents	Ethanol: not more than 2 %

3. Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary
Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The extracts may be further purified, for example by treatment with active carbon and/or molecular distillation. The extracts may be suspended in suitable and approved carriers or spray dried.
Identification
Content of reference antioxidative compounds	≥ 5 % w/w, expressed as the total of carnosic acid and carnosol
Antioxidant/Volatiles — Ratio	(Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, “GC-MSD”)
Residual Solvents	Ethanol: not more than 500 mg/kg

4. Extracts of rosemary decolourised and deodorised, obtained by a two-step extraction using hexane and ethanol
Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/or molecular distillation. They may be suspended in suitable and approved carriers or spray dried.
Identification
Content of reference antioxidative compounds	≥ 5 % w/w, expressed as the total of carnosic acid and carnosol
Antioxidant/Volatiles — Ratio	(Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, “GC-MSD”)
Residual solvents	Hexane: not more than 25 mg/kg Ethanol: not more than 500 mg/kg’;

3.

in the section on E 426 Soybean Hemicellulose:

(a)

the entries on ‘Definition’ and ‘Description’ are replaced by the following:

‘Definition	Soybean Hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol
Description	Free flowing white or yellowish white powder’;

(b)

in the entry on ‘Purity’, the following subentry is added:

‘Ethanol

Not more than 2 %’;

4.

after the section on additive E 426, the following section on E 427 Cassia gum is inserted:

‘E 427 CASSIA GUM

Synonyms
Definition	Cassia gum is the ground purified endosperm of the seeds of Cassia tora and Cassia obtusifoli (Leguminosae) containing less than 0,05 % of Cassia occidentalis. It consists mainly of high molecular weight polysaccharides composed primarily of a linear chain of 1,4-β-D-mannopyranose units linked with 1,6-α-D-galactopyranose units. The ratio of mannose to galactose is about 5:1 In the manufacture the seeds are dehusked and degermed by thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with isopropanol
Assay	Not less than 75 % of Galactomannan
Description	Pale yellow to off-white, odourless powder
Identification
Solubility	Insoluble in ethanol. Disperses well in cold water forming a colloidal solution
Gel formation with borate	To an aqueous dispersion of the sample add sufficient sodium borate test solution (TS) to raise the pH to above 9; a gel is formed
Gel formation with xanthan gum	Weigh 1,5 g of the sample and 1,5 g of xanthan gum and blend them. Add this blend (with rapid stirring) into 300 ml water at 80 °C in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the temperature above 60 °C during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h A firm, viscoelastic gel forms after the temperature drops below 40 °C, but no such gel forms in a 1 % control solution of cassia gum or xanthan gum alone prepared in a similar manner
Viscosity	Less than 500 mPa.s (25 °C, 2h, 1 % solution) corresponding to an average molecular weight of 200 000-300 000 D
Purity
Acid insoluble matter	Not more than 2,0 %
pH	5,5-8 (1 % aqueous solution)
Crude fat	Not more than 1 %
Proteins	Not more than 7 %
Total ash	Not more than 1,2 %
Loss on drying	Not more than 12 % (5 h, 105 °C)
Total Anthraquinones	Not more than 0,5 mg/kg (detection limit)
Solvent residues	Not more than 750 mg/kg Isopropyl alcohol
Lead	Not more than 1 mg/kg
Microbiological criteria
Total plate count	Not more than 5 000 colony forming units per gram
Yeast and mould	Not more than 100 colony forming units per gram
Salmonella spp.	Absent in 25 g
E. Coli	Absent in 1 g’;

5.

in the section on E 463 Hydroxypropyl cellulose, the subentry on ‘Assay’ is replaced by the following:

‘Assay

Content not more than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis’;

6.

in the section on E 949 Hydrogen, in entry on ‘Purity’, the subentry on ‘Nitrogen’ is replaced by the following:

‘Nitrogen

Not more than 0,07 % v/v’;

7.

after the section on additive E 1201, the following section is inserted:

‘E 1203 POLYVINYL ALCOHOL

Synonyms	Vinyl alcohol polymer, PVOH
Definition	Polyvinyl alcohol is a synthetic resin prepared by the polymerisation of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characteristics of the product depend on the degree of polymerisation and the degree of hydrolysis
Chemical name	Ethenol homopolymer
Chemical formula	(C2H3OR)n where R = H or COCH3
Description	Odourless, tasteless, translucent, white or cream-coloured granular powder
Identification
Solubility	Soluble in water; sparingly soluble in ethanol
Precipitation reaction	Dissolve 0,25 g of the sample in 5 ml of water with warming and let the solution cool to room temperature. The addition of 10 ml of ethanol to this solution leads to a white, turbid or flocculent precipitate
Colour reaction	Dissolve 0,01 g of the sample in 100 ml of water with warming and let the solution cool to room temperature. A blue colour is produced when adding (to 5 ml solution) one drop of iodine test solution (TS) and a few drops of boric acid solution Dissolve 0,5 g of the sample in 10 ml of water with warming and let the solution cool to room temperature. A dark red to blue colour is produced after adding one drop of iodine TS to 5 ml of solution
Viscosity	4,8 to 5,8 mPa.s (4 % solution at 20 °C) corresponding to an average molecular weight of 26 000-30 000 D
Purity
Water insoluble matter	Not more than 0,1 %
Ester value	Between 125 and 153 mg KOH/g
Degree of hydrolysis	86,5 to 89,0 %
Acid value	Not more than 3,0
Solvent residues	Not more than 1,0 % Methanol, 1,0 % Methyl acetate
pH	5,0 to 6,5 (4 % solution)
Loss on drying	Not more than 5,0 % (105 °C, 3 H)
Residue in ignition	Not more than 1,0 %
Lead	Not more than 2,0 mg/kg’;

8.

the section on ‘Polyethylene glycol 6000’ is replaced by the following:

‘E 1521 POLYETHYLENE GLYCOLS

Synonyms	PEG, Macrogol, Polyethylene oxide
Definition	Addition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the molecular weight
Chemical name	alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol)
Chemical formula	HOCH2 - (CH2 - O - CH2)n - CH2OH
Average molecular weight	380 to 9 000 D
Assay	PEG 400: Not less than 95 % and not more than 105 % PEG 3000: Not less than 90 % and not more than 110 % PEG 3350: Not less than 90 % and not more than 110 % PEG 4000: Not less than 90 % and not more than 110 % PEG 6000: Not less than 90 % and not more than 110 % PEG 8000: Not less than 87,5 % and not more than 112,5 %
Description	PEG 400 is a clear, viscous, colourless or almost colourless hygroscopic liquid PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are white or almost white solids with a waxy or paraffin-like appearance
Identification
Melting point	PEG 400: 4-8 °C PEG 3000: 50-56 °C PEG 3350: 53-57 °C PEG 4000: 53-59 °C PEG 6000: 55-61 °C PEG 8000: 55-62 °C
Viscosity	PEG 400: 105 to 130 mPa.s at 20 °C PEG 3000: 75 to 100 mPa.s at 20 °C PEG 3350: 83 to 120 mPa.s at 20 °C PEG 4000: 110 to 170 mPa.s at 20 °C PEG 6000: 200 to 270 mPa.s at 20 °C PEG 8000: 260 to 510 mPa.s at 20 °C For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in water
Solubility	PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils PEG 3000 and PEG 3350: very soluble in water and in methylene chloride, very slightly soluble in alcohol, practically insoluble in fatty oils and in mineral oils PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils
Purity
Acidity or alkalinity	Dissolve 5,0 g in 50 ml of carbon dioxide-free water and add 0,15 ml of bromothymol blue solution . The solution is yellow or green. Not more than 0,1 ml of 0,1 M sodium hydroxide is required to change the colour of the indicator to blue
Hydroxyl value	PEG 400: 264-300 PEG 3000: 34-42 PEG 3350: 30-38 PEG 4000: 25-32 PEG 6000: 16-22 PEG 8000: 12-16
Sulphated ash	Not more than 0,2 %
1,4-Dioxane	Not more than 10 mg/kg
Ethylene oxide	Not more than 0,2 mg/kg
Ethylene glycol and diethylene glycol	Total not more than 0,25 % w/w individually or in combination
Lead	Not more than 1 mg/kg’.