
Article 1 
The Annex I to Directive 2008/128/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 1 September 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, 17 January 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX

In Annex I to Directive 2008/128/EC the entry on E 160 d is replaced by the following:
'
(i) synthetic lycopene
Synonyms Lycopene from chemical synthesis
Definition Synthetic lycopene is a mixture of geometric isomeres of lycopenes and is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists predominantly of all-trans-lycopene together with 5-cis-lycopene and minor quantities of other isomers. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water- soluble powder.
Colour Index No 75125
EINECS 207-949-1
Chemical name Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene
Chemical formula C40H56
Molecular weight 536,85
Assay Not less than 96 % total lycopenes (not less than 70 % all-translycopene)E1 cm1 % at 465 - 475 nm in hexane (for 100 % pure all-translycopene) is 3 450
Description Red crystalline powder
Identification
Spectrophotometry A solution in hexane shows an absorption maximum at approximately 470 nm
Test for carotenoids The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid
Solubility Insoluble in water, freely soluble in chloroform
Properties of 1 % solution in chloroform Is clear and has intensive red-orange colour
Purity
Loss on drying Not more than 0,5 % (40 °C, 4 h at 20 mm Hg)
Apo-12’-lycopenal Not more than 0,15 %
Triphenyl phosphine oxide Not more than 0,01 %
Solvent residues Methanol not more than 200 mg/kg,Hexane, Propan-2-ol: Not more than 10 mg/kg each.Dichloromethane: Not more than 10 mg/kg (in commercial preparations only)
Lead Not more than 1 mg/kg
(ii) from red tomatoes
Synonyms Natural Yellow 27
Definition Lycopene is obtained by solvent extraction of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvent may be used:carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Besides the colour pigments the product may contain oil, fats, waxes and flavour components naturally occurring in tomatoes.
Colour Index No 75125
EINECS 207-949-1
Chemical name Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene
Chemical formula C40H56
Molecular weight 536,85
Assay E1 cm1 % at 465 - 475 nm in hexane (for 100 % pure all-translycopene) is 3 450.Content not less than 5 % total colouring matters
Description Dark red viscous liquid
Identification
Spectrophotometry Maximum in hexane at ca 472 nm
Purity
Solvent residues Propane-2-olHexaneAcetoneEthanolMethanolEthylacetateNot more than 50 mg/kg, singly or in combination
Sulphated ash Not more than 1 %
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
(iii) from Blakeslea trispora
Synonyms Natural Yellow 27
Definition Lycopene from Blakeslea trispora is extracted from the fungal biomass and purified by crystallisation and filtration. It consists predominantly of all-trans-lycopene. It also contains minor quantities of other carotenoids. Isopropanol and isobutyl acetate are the only solvents used in the manufacture. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder.
Colour Index No 75125
EINECS 207-949-1
Chemical name Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene
Chemical formula C40H56
Molecular weight 536,85
Assay Not less than 95 % total lycopenes and not less than 90 % all-translycopene of all colouring mattersE1 cm1 % at 465 - 475 nm in hexane (for 100 % pure all-translycopene) is 3 450
Description Red crystalline powder
Identification
Spectrophotometry A solution in hexane shows an absorption maximum at approximately 470 nm
Test of carotenoids The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid
Solubility Insoluble in water, freely soluble in chloroform
Properties of 1 % solution in chloroform Is clear and has intensive red-orange colour
Purity
Loss on drying Not more than 0,5 % (40 °C, 4 h at 20 mm Hg)
Other carotenoids Not more than 5 %
Solvent residues Propan-2-ol: Not more than 0,1 %Isobutyl acetate: Not more than 1,0 %Dichloromethane: Not more than 10 mg/kg (in commercial preparations only)
Sulphated ash Not more than 0,3 %
Lead Not more than 1 mg/kg'
