
Article 1 
The 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 13 February 2010 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, 13 February 2009.
For the Commission
Androulla VASSILIOU
Member of the Commission
ANNEX

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

1.. The text concerning E 234 nisin is replaced by the following:
'
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
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'
2.. The text concerning E 400 alginic acid is replaced by the following:
'
Definition Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)
Einecs 232-680-1
Chemical formula (C6H8O6)n
Molecular weight 10 000-600 000 (typical average)
Assay Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculated on equivalent weight basis of 200)
Description Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless
Identification

A. Solubility
 Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate

B. Calcium chloride precipitation test
 To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum

C. Ammonium sulphate precipitation test
 To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch

D. Colour reaction
 Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple
Purity
pH of a 3 % suspension Between 2,0 and 3,5
Loss on drying Not more than 15 % (105 °C, 4 hours)
Sulphated ash Not more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution) Not more than 2 % on the anhydrous basis insoluble matter
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'
3.. The text concerning E 401 sodium alginate is replaced by the following:
'
Definition
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'
4.. The text concerning E 402 potassium alginate is replaced by the following:
'
Definition
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'
5.. The text concerning E 403 ammonium alginate is replaced by the following:
'
Definition
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'
6.. The text concerning E 404 calcium alginate is replaced by the following:
'
Synonyms Calcium salt of alginate
Definition
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'
7.. The text concerning E 405 propane-1,2-diol alginate is replaced by the following:
'
Synonyms Hydroxypropyl alginate1,2-propanediol ester of alginic acidPropylene glycol alginate
Definition
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'
8.. The text concerning E 407 carrageenan is replaced by the following:
'
Synonyms Products of commerce are sold under different names such as:Irish moss geloseEucheuman (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
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'
9.. The text concerning E 407a processed eucheuma seaweed is replaced by the following:
'
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. Formaldehyde may be present as an adventitious impurity up to a maximum level of 5 mg/kg.
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 °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 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 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'
10.. The text concerning E 412 guar gum is replaced by the following:
'
Synonyms Gum cyamopsisGuar flour
Definition Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobur (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as a galactomannan. The gum may be partially hydrolysed by either heat treatment, mild acid or alkaline oxidative treatment for viscosity adjustment.
Einecs 232-536-0
Molecular weight Consists mainly of a high molecular weight hydrocolloidal polysaccharide (50 000-8 000 000)
Assay Galactomannan content not less than 75 %
Description A white to yellowish-white, nearly odourless powder
Identification

A. Positive tests for galactose and for mannose
 

B. Solubility
 Soluble in cold water
Purity
Loss on drying Not more than 15 % (105 °C, 5 hours)
Ash Not more than 5,5 % determined at 800 °C
Acid-insoluble matter Not more than 7 %
Protein (N × 6,25) Not more than 10 %
Starch Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution (no blue colour is produced)
Organic peroxides Not more than 0,7 meq active oxygen/kg sample
Furfural Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Arsenic Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg'
11.. After the entry E 503(ii), the following text concerning E 504(i) is added:
'
Synonyms Hydromagnesite
Definition Magnesium carbonate is a basic hydrated or a monohydrated magnesium carbonate or a mixture of the two
Chemical name Magnesium carbonate
Chemical formula MgCO3.nH2O
Einecs 208-915-9
Assay Not less than 24 % and not more than 26,4 % of Mg
Description Odourless, light, white friable masses or as a bulky white powder
Identification

A. Solubility
 Practically insoluble both in water or ethanol

B. Positive tests for magnesium and for carbonate
 
Purity
Acid insoluble matter Not more than 0,05 %
Water soluble matter Not more than 1 %
Calcium Not more than 0,4 %
Arsenic Not more than 4 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg'
12.. The text concerning E 526 calcium hydroxide is replaced by the following:
'
Synonyms Slaked lime, hydrated lime
Definition
Chemical name Calcium hydroxide
Einecs 215-137-3
Chemical formula Ca(OH)2
Molecular weight 74,09
Assay Content not less than 92 %
Description White powder
Identification

A. Positive tests for alkali and for calcium
 

B. Solubility
 Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Acid insoluble ash Not more than 1,0 %
Magnesium and alkali salts Not more than 2,7 %
Barium Not more than 300 mg/kg
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 6 mg/kg'
13.. The text concerning E 529 calcium oxide is replaced by the following:
'
Synonyms Burnt lime
Definition 
Chemical name Calcium oxide
Einecs 215-138-9
Chemical formula CaO
Molecular weight 56,08
Assay Content not less than 95 % on the ignited basis
Description Odourless, hard, white or greyish white masses of granules, or white to greyish powder
Identification

A. Positive test for alkali and for calcium
 

B. Heat is generated on moistening the sample in water
 

C. Solubility
 Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Loss on ignition Not more than 10 % (ca. 800 °C to constant weight)
Acid insoluble matter Not more than 1 %
Barium Not more than 300 mg/kg
Magnesium and alkali salts Not more than 3,6 %
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 7 mg/kg'
14.. The text concerning E 901 beeswax is replaced by the following:
'
Synonyms White wax, yellow wax
Definition Yellow beeswax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matterWhite beeswax is obtained by bleaching yellow beeswax
Einecs 232-383-7 (beeswax)
Description Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour
Identification

A. Melting range
 Between 62 °C and 65 °C

B. Specific gravity
 About 0,96

C. Solubility
 Insoluble in waterSparingly soluble in alcoholVery soluble in chloroform and ether
Purity
Acid value Not less than 17 and not more than 24
Saponification value 87-104
Peroxide value Not more than 5
Glycerol and other polyols Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxes Absent
Fats, Japan wax, rosin and soaps Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg'
15.. The text concerning E 905 microcrystalline wax is replaced by the following:
'
Synonyms Petroleum wax, hydrocarbon wax, Fischer-Tropsch wax, synthetic wax, synthetic paraffin
Definition Refined mixtures of solid, saturated hydrocarbons, obtained from petroleum or synthetic feedstocks
Description White to amber, odourless wax
Identification

A. Solubility
 Insoluble in water, very slightly soluble in ethanol

B. Refractive Index
 nD100 1,434-1,448Alternative: nD120 1,426-1,440
Purity
Molecular weight Average not less than 500
Viscosity Not less than 1,1 × 10-5 m2 s-1 at 100 °CAlternative: Not less than 0,8 × 10-5 m2 s-1 at 120 °C, if solid at 100 °C
Residue on ignition Not more than 0,1 wt %
Carbon number at 5 % distillation point Not more than 5 % of molecules with carbon number less than 25
Colour Passes test
Sulphur Not more than 0,4 wt %
Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Polycyclic aromatic compounds The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:
Nm Maximum absorbance per cm path length
280-289 0,15
290-299 0,12
300-359 0,08
360-400 0,02Alternative, if solid at 100 °CPAC method as per 21 CFR& 175.250;Absorbency at 290 nm in decahydronaphthalene at 88 °C: Not exceeding 0,01'
16.. The text concerning E 230 and E 233 is deleted.
