2001L0050 — EN — 01.08.2001 — 000.001 — 1
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►B COMMISSION DIRECTIVE 2001/50/EC
of 3 July 2001
amending Directive 95/45/EC laying down specific purity criteria concerning colours for use in
foodstuffs
(Text with EEA relevance)
(OJ L 190, 12.7.2001, p. 14)
Corrected by:
►C1Corrigendum, OJ L 217, 11.8.2001, p. 18 (2001/50/EC)
▼B
COMMISSION DIRECTIVE 2001/50/EC
of 3 July 2001
amending Directive 95/45/EC laying down specific purity criteria
concerning colours for use in foodstuffs
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988
on the approximation of the laws of the Member States concerning food
additives authorised for use in foodstuffs intended for humanconsumption(
1), as amended by Directive 94/34/EC of the European
Parliament and of the Council(2) and in particular Article 3(3)(a)
thereof,
After consulting the Scientific Committee for Food,
Whereas:
(1)►C1Directive 94/36/EC of the European Parliament and of the
Council◄of 30 June 1994 on colours for use in foodstuffs(3)
lists those substances which may be used as colours in foodstuffs.
(2)►C1CommissionDirective 95/45/EC ◄of 26 July 1995 laying
down specific purity criteria concerning colours for use in
foodstuffs(4), as amended by Directive 1999/75/EC(5), sets out
the purity criteria for the colours mentioned in Directive 94/36/EC.
(3)It is necessary, in the light of technical progress, to amend thepurity criteria set out inDirective 95/45/EC for mixed caroten es(E160a(i)) and beta-carotene (E160a(ii)).
(4)It is necessary to take into account the specifications andanalytical techniques for additives as set out in the Codex
alimentarius as drafted by the Joint FAO/WHO Expert
Committee onFood Additives (JECFA).
(5)It is consequently necessary to adapt Directive 95/45/EC.
(6)The measures provided for inthis Directive are inaccordan cewith the opinion of the Standing Committee on Foodstuffs,
HAS ADOPTED THIS DIRECTIVE:
Article 1
In part B of the Annex to Directive 95/45/EC, the text concerning mixed
carotenes (E160a(i)) and beta-carotene (E160a(ii)) is replaced by thetext of the Annex to this Directive.
Article 2
Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive before30 June 2002. They shall immediately inform the Commission thereof.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such reference atthe time of their official publication. The procedure for such referenceshall be adopted by Member States.2001L0050 — EN — 01.08.2001 — 000.001 — 2
(1) OJ L 40, 11.2.1989, p. 27.
(2) OJ L 237, 10.9.1994, p. 1.
(3) OJ L 237, 10.9.1994, p. 13.
(4) OJ L 226, 22.9.1995, p. 1.
(5) OJ L 206, 5.8.1999, p. 19.
▼B
Article 3
This Directive shall enter into force on the 20th day following its
publicationinthe Official Journal of the European Communities .
Article 4
This Directive is addressed to the Member States.2001L0050 — EN — 01.08.2001 — 000.001 — 3
▼B
ANNEX
‘E 160a (i)MIXED CAROTENES
1.Plant carotenes
Synonyms CI food orange 5
Definition Mixed carotenes are obtained by solvent extraction of natural
strains of edible plants, carrots, vegetable oils, grass, alfalfa
(lucerne) and nettle
The main colouring principle consists of carotenoids of which
β-carotene accountes for the major part. α, γ-carotene and
other pigments may be present. Besides the colour pigments,
this substance may contain oils, fats and waxes naturally
occurring in the source material
Only the following solvents may be used in the extraction:
acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol,
hexane (*), dichloromethane and carbon dioxide
Class CarotenoidColour index No 75130
Einecs 230-636-6
Chemical formula β-carotene: C
40H56
Molecular weight β-carotene: 536,88
Assay Content of carotenes (calculated as β-carotene) is not less than
5 %. Forproducts obtained by extraction of vegetables oils: not
less than0,2 % inedible fats
E1%
1c m2 500 at approximately 440 nm to 457 nm in
cyclohexane
Identification
A. Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to
486 nm
Purity
Solvent residues Acetone/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Not more than50 mg/kg,
singly or in combinationMethyl ethyl ketone
Methanol
Propan-2-ol
HexaneEthanol
Dichloromethane Not more than 10 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than5 mg/kg
Mercury Not more than1 mg/kg
Cadmium Not more than1 mg/kg
2.Algal carotenes
Synonyms CI food orange 5
Definition Mixed carotenes may also be produced from natural strains of
the algae Dunaliella salina , growninlarge salin e lakes located
inWhyalla, South Australia. β-carotene is extracted using an
essential oil. The preparation is a 20 to 30 % suspension in
edible oil. The ratio of trans-cis isomers is in the range of 50/
50 to 71/29
The main colouring principle consists of carotenoids of which
β-carotene accounts for the major part. α-carotene, lutein,
zeaxanthin and β-cryptoxanthin may be present. Besides the
colour pigments, this substance may contain oils, fats and
waxes naturally occurring in the source material
Class Carotenoid
Colour Index No 751302001L0050 — EN — 01.08.2001 — 000.001 — 4
▼B
Chemical formula β-Carotene: C40H56
Molecular weight β-Carotene: 536,88
Assay Content of carotenes (calculated as β-carotene) is not less than
20 %
E1%
1c m2 500 at approximately by 440 nm to 457 nm in
cyclohexane
Identification
A. Spectrometry Maximum in cyclohexane at 448 nm to 457 nm and 474 nm to
486 nm
Purity
Natural tocopherols inedible oil Not more than0,3 %
Arsenic Not more than 3 mg/kg
Lead Not more than5 mg/kgMercury Not more than1 mg/kg
Cadmium Not more than1 mg/kg
E 160a (ii)BETA-CAROTENE
1.Beta-carotene
Synonyms CI food orange 5
Definition These specifications apply predominantly to all trans isomer of
β-carotene together with minor amounts of other carotenoids.
Diluted and stabilised preparations may have different trans-cis
isomer ratios
Class Carotenoid
Colour index No 40800Einecs 230-636-6
Chemical names β-carotene, β,β-carotene
Chemical formula C
40H56
Molecular weight 536,88
Assay Not less than96 % total colourin g matters (expressed as β-
carotene)
E1%
1c m2 500 at approximately by 440 nm to 457 nm in
cyclohexane
Description Red to brownish-red crystals or crystalline powder
Identification
A. Spectrometry Maximum in cyclohexane at 453 nm to 456 nm
Purity
Sulphated ash Not more than0,2 %
Subsidiary colouring matters Carotenoids other than β-carotene: not more than 3,0 % of total
colouring matters
Arsenic Not more than 3 mg/kgLead Not more than5 mg/kg
Mercury Not more than1 mg/kg
Cadmium Not more than1 mg/kg
2.Beta-carotene from Blakeslea
trispora
Synonyms CI food orange 5
Definition Obtained by a fermentation process using a mixed culture of
the two sexual mating types (+) and (–) of natural strains of the
fungusBlakeslea trispora . The β-carotene is extracted from the
biomass with ethyl acetate and crystallised. The crystallised
product consists mainly of trans β-carotene. Because of the
natural process approximately 3 % of the product consists of
mixed carotenoids, which is specific for the product2001L0050 — EN — 01.08.2001 — 000.001 — 5
▼B
Class Carotenoid
Colour Index No 40800
Einecs 230-636-6
Chemical names β-carotene, β,β-carotene
Chemical formula C40H56
Molecular weight 536,88Assay Not less than96 % total colourin g matters (expressed as β-
carotene)
E
1%
1c m2 500 at approximately 440 nm to 457 nm in
cyclohexane
Description Red to brownish-red crystals or crystalline powder
Identification
A. Spectrometry Maximum in cyclohexane at 453 nm to 456 nm
Purity
Solvent residues Ethyl acetate/C148/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C150Not more than0,8 %,
singly or in combination Ethanol
Sulphated ash Not more than0,2 %Subsidiary colouring matters Carotenoids other than β-carotene: not more than 3,0 % of total
colouring matters
Arsenic Not more than 3 mg/kgLead Not more than5 mg/kg
Mercury Not more than1 mg/kg
Cadmium Not more than1 mg/kgAflatoxinB1 Absen t
Mycotoxins:
T2/C148/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C150Absent Ochratoxin
Zearalenone
Microbiology:Moulds Not more than100/g
Yeasts Not more than100/g
Salmonella Absent in 25 g
Escherichia coli Absent in 5 g
(*) Benzene not more than 0,05 % v/v.’2001L0050 — EN — 01.08.2001 — 000.001 — 6