LegalizeCommission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council Text with EEA relevance
Article 1
Specifications for food additives
Specifications for food additives including colours and sweeteners listed in Annex II and III to Regulation (EC) No 1333/2008 are laid down in the Annex to this Regulation.
Article 2
Repeals
Directives 2008/60/EC, 2008/84/EC and 2008/128/EC are repealed with effect from 1 December 2012.
Article 3
Transitional measures
Foodstuffs containing food additives that have been lawfully placed on the market before 1 December 2012, but do not comply with this Regulation, may continue to be marketed until stocks are exhausted.
Article 4
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 December 2012.
However, the specifications laid down in the Annex for additives steviol glycosides (E 960) and basic methacrylate copolymer (E 1205) shall apply from the date of entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in the Member States.
ANNEX
Ethylene oxide may not be used for sterilising purposes in food additives.
No residue above 0,1 mg/kg, irrespective of its origin, of ethylene oxide (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide (1)) shall be present in food additives listed in Annexes II and III to Regulation (EC) No 1333/2008, including mixtures of food additives.
Aluminium lakes for use in colours only where explicitly stated.
| Definition: | Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulphate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product. |
|---|---|
| HCl insoluble matter | Not more than 0,5 % |
| ΝaΟΗ insoluble matter | Νot more than 0,5 %, for Ε 127 erythrosine only |
| Ether extractable matter | Not more than 0,2 % (under neutral conditions) Specific purity criteria for the corresponding colours are applicable. |
E 100 CURCUMIN
| Synonyms | CI Natural Yellow 3; Turmeric Yellow; Diferoyl Methane | ||
|---|---|---|---|
| Definition | Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallization. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occurring in turmeric may be present. Curcumin is also used as the aluminium lake; the aluminium content is less than 30 %. Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane, propan-2-ol. | ||
| Colour Index No | 75300 | ||
| Einecs | 207-280-5 | ||
| Chemical name | I 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione | ||
| Chemical formula | I C21H20O6 II C20H18O5 III C19H16O4 | ||
| Molecular weight | I. 368,39 | II. 338,39 | III. 308,39 |
| Assay | Content not less than 90 % total colouring matters 1 607 at ca. 426 nm in ethanol | ||
| Description | Orange-yellow crystalline powder | ||
| Identification | |||
| Spectrometry | Maximum in ethanol at ca. 426 nm | ||
| Melting range | 179 °C-182 °C | ||
| Purity | |||
| Solvent residues | Ethylacetate | Not more than 50 mg/kg, singly or in combination | |
| Not more than 50 mg/kg, singly or in combination | |||
| Acetone | |||
| n-butanol | |||
| Methanol | |||
| Ethanol | |||
| Hexane | |||
| Propan-2-ol | |||
| Dichloromethane: not more than 10 mg/kg | |||
| Arsenic | Not more than 3 mg/kg | ||
| Lead | Not more than 10 mg/kg | ||
| Mercury | Not more than 1 mg/kg | ||
| Cadmium | Not more than 1 mg/kg |
Aluminium lakes of this colour may be used.
E 101 (i) RIBOFLAVIN
| Synonyms | Lactoflavin; | |
|---|---|---|
| Definition | ||
| Colour Index No | ||
| Einecs | 201-507-1 | |
| Chemical name | 7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione; 7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine | |
| Chemical formula | C17H20N4O6 | |
| Molecular weight | 376,37 | |
| Assay | Content not less than 98 % on the anhydrous basis 328 at ca. 444 nm in aqueous solution | |
| Description | Yellow to orange-yellow crystalline powder, with slight odour | |
| Identification | ||
| Spectrometry | The ratio A375/A267 is between 0,31 and 0,33 | in aqueous solution |
| in aqueous solution | ||
| The ratio A444/A267 is between 0,36 and 0,39 | ||
| Maximum in water at ca. 375 nm | ||
| Specific rotation | [α]D 20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution | |
| Purity | ||
| Loss on drying | Not more than 1,5 % (105 °C, 4 hours) | |
| Sulphated ash | Not more than 0,1 % | |
| Primary aromatic amines | Not more than 100 mg/kg (calculated as aniline) | |
| Arsenic | Not more than 3 mg/kg | |
| Lead | Not more than 2 mg/kg | |
| Mercury | Not more than 1 mg/kg | |
| Cadmium | Not more than 1 mg/kg |
Aluminium lakes of this colour may be used.
E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE
| Synonyms | Riboflavin-5′-phosphate sodium | |
|---|---|---|
| Definition | These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate. | |
| Colour Index No | ||
| Einecs | 204-988-6 | |
| Chemical name | Monosodium(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate; monosodium salt of 5′-monophosphate ester of riboflavin | |
| Chemical formula | For the dihydrate form: C17H20N4NaO9P · 2H2O | |
| For the anhydrous form: C17H20N4NaO9P | ||
| Molecular weight | 514,36 | |
| Assay | Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P.2H2O 250 at ca. 375 nm in aqueous solution | |
| Description | Yellow to orange crystalline hygroscopic powder, with slight odour | |
| Identification | ||
| Spectrometry | The ratio A375/A267 is between 0,30 and 0,34 | in aqueous solution |
| in aqueous solution | ||
| The ratio A444/A267 is between 0,35 and 0,40 | ||
| Maximum in water at ca. 375 nm | ||
| Specific rotation | [α]D 20 between + 38° and + 42° in a 5 molar HCl solution | |
| Purity | ||
| Loss on drying | Not more than 8 % (100 °C, 5 hours in vacuum over P2O5) for the dihydrate form | |
| Sulphated ash | Not more than 25 % | |
| Inorganic phosphate | Not more than 1,0 % (calculated as PO4 on the anhydrous basis) | |
| Subsidiary colouring matters | Riboflavin (free): Not more than 6 % Riboflavine diphosphate: Not more than 6 % | |
| Primary aromatic amines | Not more than 70 mg/kg (calculated as aniline) | |
| Arsenic | Not more than 3 mg/kg | |
| Lead | Not more than 2 mg/kg | |
| Mercury | Not more than 1 mg/kg | |
| Cadmium | Not more than 1 mg/kg |
Aluminium lakes of this colour may be used.
E 102 TARTRAZINE
| Synonyms | CI Food Yellow 4 |
|---|---|
| Definition | Tartrazine is prepared from 4-amino-benzenesulphonic acid, which is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is then coupled with 4,5-dihydro-5-oxo-1-(4sulphophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted. |
| Colour Index No | 19140 |
| Einecs | 217-699-5 |
| Chemical name | Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate |
| Chemical formula | C16H9N4Na3O9S2 |
| Molecular weight | 534,37 |
| Assay | Content not less than 85 % total colouring matters calculated as the sodium salt 530 at ca. 426 nm in aqueous solution |
| Description | Light orange powder or granules |
| Appearance of the aqueous solution | Yellow |
| Identification | |
| Spectrometry | Maximum in water at ca. 426 nm |
| Purity | |
| Water insoluble matter | Not more than 0,2 % |
| Subsidiary colouring matters | Not more than 1,0 % |
| Organic compounds other than colouring matters: | |
| 4-hydrazinobenzene sulfonic acid | Total not more than 0,5 % |
| Total not more than 0,5 % | |
| 4-aminobenzene-1-sulfonic acid | |
| 5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid | |
| 4,4′-diazoaminodi(benzene sulfonic acid) | |
| Tetrahydroxysuccinic acid | |
| Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) |
| Ether extractable matter | Not more than 0,2 % under neutral conditions |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
Aluminium lakes of this colour may be used.
E 104 QUINOLINE YELLOW
| Synonyms | CI Food Yellow 13 |
|---|---|
| Definition | Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione or a mixture containing about two thirds 2-(2-quinolyl)indane-1,3-dione and one third 2-(2-(6-methylquinolyl))indane-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted. |
| Colour Index No | 47005 |
| Einecs | 305-897-5 |
| Chemical name | The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component) |
| Chemical formula | C18H9N Na2O8S2 (principal component) |
| Molecular weight | 477,38 (principal component) |
| Assay | Content not less than 70 % total colouring matters calculated as the sodium salt Quinoline Yellow shall have the following composition: Of the total colouring matters present: — not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates — not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates — not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate 865 (principal component) at ca. 411 nm in aqueous acetic acid solution |
| Description | Yellow powder or granules |
| Appearance of the aqueous solution | Yellow |
| Identification | |
| Spectrometry | Maximum in aqueous acetic acid solution of pH 5 at ca. 411 nm |
| Purity | |
| Water insoluble matter | Not more than 0,2 % |
| Subsidiary colouring matters | Not more than 4,0 % |
| Organic compounds other than colouring matters: | |
| 2-methylquinoline | Total not more than 0,5 % |
| Total not more than 0,5 % | |
| 2-methylquinoline-sulfonic acid | |
| Phthalic acid | |
| 2,6-dimethyl quinoline | |
| 2,6-dimethyl quinoline sulfonic acid | |
| 2-(2-quinolyl)indan-1,3-dione | Not more than 4 mg/kg |
| Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline) |
| Ether extractable matter | Not more than 0,2 % under neutral conditions |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
Aluminium lakes of this colour may be used.
E 110 SUNSET YELLOW FCF
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