DIRECTIVES  
COMMISSION DIRECTIVE 2011/3/EU  
of 17 January 2011  
amending Directive 2008/128/EC laying down specific purity criteria on colours for use in 
foodstuffs  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Regulation (EC) No 1333/2008 of the 
European Parliament and of the Council of 16 December 
2008 on food additives (  1 ), and in particular Article 30(5) 
thereof,  
After consulting the European Food Safety Authority (EFSA),  
Whereas:  
(1) Commission Directive 2008/128/EC (  2 ) sets out the 
specific purity criteria concerning colours for use in 
foodstuffs, which colours are mentioned in European 
Parliament and Council Directive 94/36/EC of 30 June 
1994 on colours for use in foodstuffs (  3 ). 
(2) Under Article 30(4) of Regulation (EC) No 1333/2008 
specifications of the food additives covered under 
paragraphs 1 to 3 of that Article (which include also 
additives authorised under Directive 94/36/EC) shall be 
adopted, in accordance with Regulation (EC) No 
1331/2008 of the European Parliament and of the 
Council of 16 December 2008 establishing a common 
authorisation procedure for food additives, food enzymes 
and food flavourings (  4 ), at the moment those food 
additives are entered in the Annexes in accordance 
with those paragraphs.  
(3) Since the lists have not yet been drawn up, and in order 
to ensure that the modification of the Annexes to 
Directive 94/36/EC pursuant to Article 31 of Regulation 
(EC) No 1333/2008 is effective and that additives so authorised comply with safe conditions of use, Directive 
2008/128/EC should therefore be amended.  
(4) The European Food Safety Authority (hereinafter ‘the 
Authority’) has assessed the information on the safety 
in use of lycopene as a food colour from all sources in 
its opinion of 30 January 2008 (  5 ). The sources that were 
considered were the following: (a) E160d Lycopene 
obtained by solvent extraction of the natural strains of 
red tomatoes ( Lycopersicon esculentum  L.) with subsequent 
removal of the solvent, (b) synthetic lycopene and (c) 
lycopene from  Blakeslea trispora.  
(5) Current legislation lays down specifications only for 
lycopene of red tomatoes and needs to be modified 
respectively by including the other two sources. Specifi ­
cations of lycopene extracted from red tomatoes need 
also to be updated. Dichloromethane does not need to 
be listed in the list of the extraction solvents, as it is not 
used any more for lycopene of red tomatoes, according 
to the information received from stakeholders. Maximum 
limit for lead needs to be lowered due to safety reasons, 
and the reference on heavy metals is too generic and not 
relevant any more. In addition the reference on natural 
strains needs to be updated according to Regulation (EC) 
No 1829/2003 of the European Parliament and of the 
Council (  6 ). 
(6) Dichloromethane (methylene chloride) is being reported 
to be used for manufacturing ready-to-sale formulations 
of lycopene, mentioned also in the Authority's opinionEN 18.1.2011 Official Journal of the European Union L 13/59  
( 1 ) OJ L 354, 13.12.2008, p. 16.  
( 2 ) OJ L 6, 10.1.2009, p. 20.  
( 3 ) OJ L 237, 10.9.1994, p. 13.  
( 4 ) OJ L 354, 31.12.2008, p. 1.  ( 5 ) Scientific opinion of the panel on Food Additives, Flavourings, 
Processing Aids and Materials in Contact with Food on a request 
from the European Commission to provide a scientific opinion on 
the safety of use of 1. lycopene obtained from a fermentation 
process with  Blakeslea trispora  as a food colour in the food categories 
and use levels as proposed by the applicant and 2. synthetic 
lycopene as a food colour in the food categories listed in Annex 
III and Annex V, part 2 to Directive 94/36/EC on food colours for 
use in foodstuffs, 3. taking into account the various requests 
concerning lycopene currently under consideration including the 
re-evaluation of lycopene from tomatoes as part of the systematic 
re-evaluation of all food colours. The EFSA Journal (2008) 674, 
1-66.  
( 6 ) OJ L 268, 18.10.2003, p. 1.on Safety of ‘Lycopene Cold Water Dispersible Products 
from  Blakeslea trispora ’ of 4 December 2008 (  1 ). Similar 
products are produced also from synthetic lycopene, as 
mentioned in the Authority's opinion on safety of 
Synthetic Lycopene of 10 April 2008 (  2 ). As the 
Authority evaluated this specific use, it is necessary to 
authorise this use by the same residual levels that were 
considered during the evaluation.  
(7) It is necessary to take into account the specifications and 
analytical techniques for additives as set out in the Codex 
Alimentarius drafted by the Joint Expert Committee on 
Food Additives (JECFA). In particular, the specific purity 
criteria need to be adapted to reflect the limits for indi ­
vidual heavy metals of interest, where appropriate.  
(8) Directive 2008/128/EC should therefore be amended 
accordingly.  
(9) The measures provided for in this Directive are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health, and 
neither the European Parliament nor the Council has 
opposed them,  
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
The Annex I to Directive 2008/128/EC is amended in 
accordance with the Annex to this Directive.  Article 2  
Transposition  
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 BARROSOEN L 13/60 Official Journal of the European Union 18.1.2011  
( 1 ) Scientific opinion of the panel on Dietetic Products, Nutrition and 
Allergies on a request from European Commission to carry out an 
additional assessment for ‘Lycopene Cold Water Dispersible Products 
(CWD) from  Blakeslea Trispora ’ as a food ingredient in the context of 
Regulation (EC) No 258/97. The EFSA Journal (2008) 893, 1-15.  
( 2 ) Scientific opinion of the panel on Dietetic Products, Nutrition and 
Allergies on a request from the European Commission on safety of 
synthetic Lycopene. The EFSA Journal (2008) 676, 1-25.ANNEX  
In Annex I to Directive 2008/128/EC the entry on E 160 d is replaced by the following:  
‘E 160 D LYCOPENE 
(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-dotriacon ­
tatridecaene  
Chemical formula  C  40 H 56 
Molecular weight  536,85  
Assay  Not less than 96 % total lycopenes (not less than 70 % all-trans ­
lycopene) 
E 1 cm 1 % 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 prep ­
arations only)  
Lead  Not more than 1 mg/kgEN 18.1.2011 Official Journal of the European Union L 13/61(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-dotriacon ­
tatridecaene  
Chemical formula  C  40 H 56 
Molecular weight  536,85  
Assay  E  1 cm 1 % 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-ol 
Hexane 
Acetone 
Ethanol 
Methanol 
Ethylacetate 
Not 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.EN L 13/62 Official Journal of the European Union 18.1.2011Colour 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-dotriacon ­
tatridecaene  
Chemical formula  C  40 H 56 
Molecular weight  536,85  
Assay  Not less than 95 % total lycopenes and not less than 90 % all-trans ­
lycopene of all colouring matters 
E 1 cm 1 % 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 prep ­
arations only)  
Sulphated ash  Not more than 0,3 %  
Lead  Not more than 1 mg/kg’EN 18.1.2011 Official Journal of the European Union L 13/63