# Commission Regulation (EU) 2020/771 of 11 June 2020 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of Annatto, Bixin, Norbixin (E 160b) (Text with EEA relevance), Division: ‘E 160 b (i) ANNATTO BIXIN

Extent: E+W+S+N.I.

Synonyms
Annatto B, Orlean, Terre orellana, L. Orange, CI Natural Orange 4
Definition
Solvent-extracted bixin is obtained by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following food grade solvents: acetone, methanol, hexane, ethanol, isopropyl alcohol, ethyl acetate, alkaline alcohol or supercritical carbon dioxide. The resulting preparation may be acidified, followed by the removal of the solvent, drying and milling.
Solvent-extracted bixin contains several coloured components; the major colouring principle is cis-bixin, a minor colouring principle is trans-bixin; thermal degradation products of bixin may also be present as a result of processing.
Colour Index No
75120
Einecs
230-248-7
Chemical name
cis-Bixin: Methyl (9-cis)-hydrogen-6,6'-diapo-Ψ,Ψ-carotenedioate
Chemical formula
cis-Bixin: C25H30O4
Molecular weight
394,5
Assay
Not less than 85 % colouring matter (expressed as bixin)
E1 % 1cm 3090 at ca. 487 nm in tetrahydrofuran and acetone
Description
Dark red-brown to red-purple powder
Identification
Solubility
Insoluble in water, slightly soluble in ethanol
Spectrometry
The sample in acetone shows absorbance maxima at about 425, 457 and 487 nm
Purity
Norbixin
Not more than 5 % of total colouring matters
Residual Solvents
Acetone: Not more than 30 mg/kg
Methanol: Not more than 50 mg/kg
Hexane: Not more than 25 mg/kg
Ethanol:
Isopropyl alcohol:
Ethyl acetate:
not more than 50 mg/kg, singly or in combination
Arsenic
Not more than 2 mg/kg
Lead
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 0,5 mg/kg
Synonyms
Annatto E, Orlean, Terre orellana, L. Orange, CI Natural Orange 4
Definition
Aqueous-processed bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) by abrading the seeds in the presence of cold, mildly-alkaline water. The resultant preparation is acidified to precipitate bixin which is then filtered, dried and milled.
Aqueous-processed bixin contains several coloured components; the major colouring principle is cis-bixin, a minor colouring principle is trans-bixin; thermal degradation products of bixin may also be present as a result of processing.
Colour Index No
75120
Einecs
230-248-7
Chemical name
cis-Bixin: Methyl (9-cis)-hydrogen-6,6'-diapo-Ψ,Ψ-carotenedioate
Chemical formula
cis-Bixin: C25H30O4
Molecular weight
394,5
Assay
Not less than 25 % colouring matter (expressed as bixin)
E1 % 1cm 3090 at ca. 487 nm in tetrahydrofuran and acetone
Description
Dark red-brown to red-purple powder
Identification
Solubility
Insoluble in water, slightly soluble in ethanol
Spectrometry
The sample in acetone shows absorbance maxima at about 425, 457 and 487 nm
Purity
Norbixin
Not more than 7 % of total colouring matters
Arsenic
Not more than 2 mg/kg
Lead
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 0,5 mg/kg

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Source: https://www.legislation.gov.uk/eur/2020/771/annex/II/division/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2020-771/annex-II/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.