
Article 1 
Annex I to Directive 2008/84/EC is amended in accordance with the Annex to this Directive.
Article 2 

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3 
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4 
This Directive is addressed to the Member States.
Done at Brussels, 20 October 2010.
For the Commission
The President
José Manuel BARROSO
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:
'

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/kgEthanol: 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:
'
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 5:1In 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 hA 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:
'
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 solutionDissolve 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:
'
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 liquidPEG 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 °CPEG 3000: 50-56 °CPEG 3350: 53-57 °CPEG 4000: 53-59 °CPEG 6000: 55-61 °CPEG 8000: 55-62 °C
Viscosity PEG 400: 105 to 130 mPa.s at 20 °CPEG 3000: 75 to 100 mPa.s at 20 °CPEG 3350: 83 to 120 mPa.s at 20 °CPEG 4000: 110 to 170 mPa.s at 20 °CPEG 6000: 200 to 270 mPa.s at 20 °CPEG 8000: 260 to 510 mPa.s at 20 °CFor 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 oilsPEG 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 oilsPEG 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: 264-300PEG 3000: 34-42PEG 3350: 30-38PEG 4000: 25-32PEG 6000: 16-22PEG 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'.
