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)
Date: 2001-07-03
Institutions: European Commission
Subjects: food chemistry, foodstuffs legislation, natural food colouring

L 190/14

EN

Official Journal of the European Communities

12.7.2001

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,

HAS ADOPTED THIS DIRECTIVE:

Article 1

In part B of
concerning mixed carotenes
(E160a(ii))
Directive.

the Annex to Directive 95/45/EC,

the text
(E160a(i)) and beta-carotene
the Annex to this

is replaced by the text of

Article 2

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive before 30 June 2002. They shall immediately inform
the Commission thereof.

these provisions,

When Member States adopt
these shall
contain a reference to this Directive or shall be accompanied by
such reference at the time of their official publication. The
procedure for such reference shall be adopted by Member
States.

Article 3

This Directive shall enter into force on the 20th day following
its publication in the Official Journal of the European Communities.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 3 July 2001.

For the Commission

David BYRNE

Member of the Commission

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 human consumption (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)

(2)

(3)

(4)

(5)

(6)

Council Directive 94/36/EC of the European Parliament
and of Council of 30 June 1994 on colours for use in
foodstuffs (3) lists those substances which may be used
as colours in foodstuffs.

Commission Directive 94/45/EC of 26 July 1995 laying
down specific purity criteria concerning colours for use
in foodstuffs (4),
amended by Directive 1999/
75/EC (5), sets out the purity criteria for the colours
mentioned in Directive 94/36/EC.

as

in the light of technical progress, to
It is necessary,
amend the purity criteria set out in Directive 95/45/EC
for mixed carotenes
and beta-carotene
(E160a(ii)).

(E160a(i))

It is necessary to take into account the specifications and
analytical techniques for additives as set out in the Codex
alimentarius as drafted by the Joint FAO/WHO Expert
Committee on Food Additives (JECFA).

It is consequently necessary to adapt Directive 95/45/EC.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Foodstuffs,

(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.

12.7.2001

EN

Official Journal of the European Communities

L 190/15

‘E 160 a (i) MIXED CAROTENES

1. Plant carotenes

Synonyms

Definition

Class

Colour index No

Einecs

Chemical formula

Molecular weight

Assay

Identification

A. Spectrometry

Purity

ANNEX

CI food orange 5

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-caro-
tene 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

Carotenoid

75130

230-636-6

β-carotene: C

40H56

β-carotene: 536,88

Content of carotenes (calculated as β-carotene) is not less than 5 %. For
products obtained by extraction of vegetables oils: not less than 0,2 %
in edible fats

E 1 %

1 cm 2 500 at approximately 440 nm to 457 nm in cyclohexane

Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to
486 nm

Solvent residues

Acetone

Arsenic

Lead

Mercury

Cadmium

2. Algal carotenes

Synonyms

Definition

Methyl ethyl ketone

Methanol

Propan-2-ol

Hexane

Ethanol

Not more than 50 mg/kg, singly or
in combination

Dichloromethane

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

CI food orange 5

Mixed carotenes may also be produced from natural strains of the algae
Dunaliella salina, grown in large saline lakes located in Whyalla, 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-caro-
tene 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

L 190/16

EN

Official Journal of the European Communities

12.7.2001

Class

Colour Index No

Chemical formula

Molecular weight

Assay

Identification

A. Spectrometry

Purity

Carotenoid

75130

β-Carotene: C40

H

56

β-Carotene: 536,88

Content of carotenes (calculated as β-carotene) is not less than 20 %

E 1 %

1 cm 2 500 at approximately by 440 nm to 457 nm in cyclohexane

Maximum in cyclohexane at 448 nm to 457 nm and 474 nm to
486 nm

Natural tocopherols in edible oil

Not more than 0,3 %

Arsenic

Lead

Mercury

Cadmium

E 160 a (ii) BETA-CAROTENE

1. Beta-carotene

Synonyms

Definition

Class

Colour index No

Einecs

Chemical names

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

CI food orange 5

These specifications apply predominantly to all trans isomer of β-caro-
tene together with minor amounts of other carotenoids. Diluted and
stabilised preparations may have different trans-cis isomer ratios

Carotenoid

40800

230-636-6

β-carotene, β,β-carotene

C40

H

56

536,88

Not less than 96 % total colouring matters (expressed as β-carotene)

E 1 %

1 cm 2 500 at approximately by 440 nm to 457 nm in cyclohexane

Red to brownish-red crystals or crystalline powder

A. Spectrometry

Maximum in cyclohexane at 453 nm to 456 nm

Purity

Sulphated ash

Not more than 0,2 %

Subsidiary colouring matters

Carotenoids other than β-carotene: not more than 3,0 % of
colouring matters

total

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

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Official Journal of the European Communities

L 190/17

2. Beta-carotene from Blakeslea trispora

Synonyms

Definition

CI food orange 5

Obtained by a fermentation process using a mixed culture of the two
sexual mating types (+) and (–) of natural strains of the fungus Blakeslea
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 product

Class

Colour Index No

Einecs

Chemical names

Chemical formula

Molecular weight

Assay

Description

Identification

Carotenoid

40800

230-636-6

β-carotene, β,β-carotene

C40H56

536,88

Not less than 96 % total colouring matters (expressed as β-carotene)

E 1 %

1 cm 2 500 at approximately 440 nm to 457 nm in cyclohexane

Red to brownish-red crystals or crystalline powder

A. Spectrometry

Maximum in cyclohexane at 453 nm to 456 nm

Purity

Solvent residues

Ethyl acetate

Ethanol

Not more than 0,8 %,
singly or in combination

Sulphated ash

Not more than 0,2 %

Subsidiary colouring matters

Carotenoids other than β-carotene: not more than 3,0 % of
colouring matters

total

Arsenic

Lead

Mercury

Cadmium

Aflatoxin B1

Mycotoxins:

T2

Ochratoxin

Zearalenone

Microbiology:

Moulds

Yeasts

Salmonella

Escherichia coli

(*) Benzene not more than 0,05 % v/v.’

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Absent

Absent

Not more than 100/g

Not more than 100/g

Absent in 25 g

Absent in 5 g