Commission Directive 2004/47/EC of 16 April 2004 amending Directive 95/45/EC as regards mixed carotenes (E 160 a (i)) and beta-carotene (E 160 a (ii)) (Text with EEA relevance)
Date: 2004-04-16
Institutions: European Commission
Subjects: food chemistry, food colouring, foodstuff, foodstuffs legislation, human nutrition

L 113/24

EN

Official Journal of the European Union

20.4.2004

COMMISSION DIRECTIVE 2004/47/EC

of 16 April 2004

amending Directive 95/45/EC as

regards mixed carotenes

(E 160 a (i)) and beta-carotene

(E 160 a (ii))

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Article 2

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/107/EEC of 21
the
December 1988 on the approximation of
Member States concerning food additives authorised for use in
foodstuffs intended for human consumption (1), and in particu-
lar Article 3(3)(a) thereof,

the laws of

After consulting the Scientific Committee for Food,

Whereas:

(1)

(2)

(3)

(4)

(5)

Commission Directive 95/45/EC of 26 July 1995 laying
down specific purity criteria concerning colours for use
in foodstuffs (2) sets out
the
colours mentioned in Directive 94/36/EC of the Euro-
pean Parliament and of the Council of 30 June 1994 on
colours for use in foodstuffs (3).

the purity criteria for

in the light of technical progress, to
It is necessary,
amend the purity criteria set out in Directive 95/45/EC
for mixed carotenes
(E 160 a (i)) and beta-carotene
(E 160 a (ii)).

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

techniques for additives as set out

Directive 95/45/EC should therefore be amended accord-
ingly.

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 1 April 2005 at the latest. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this Direc-
tive.

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such
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

Products on the market or labelled before 1 April 2005 which
do not comply with this Directive may be marketed until
stocks are exhausted.

Article 4

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

Article 5

This Directive is addressed to the Member States.

HAS ADOPTED THIS DIRECTIVE:

Done at Brussels, 16 April 2004.

Article 1

The Annex to Directive 95/45/EC is amended in accordance
with the Annex to this Directive.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(2) OJ L 226, 22.9.1995, p. 1. Directive as last amended by Directive

2001/50/EC (OJ L 190, 12.7.2001, p. 14).

(3) OJ L 237, 10.9.1994, p. 13. Directive as amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

20.4.2004

EN

Official Journal of the European Union

L 113/25

In the Annex, the text concerning mixed carotenes (E 160 a (i)) and beta-carotene (E 160 a (ii)) is replaced by the
following:

ANNEX

‘E 160 a (i) MIXED CAROTENES

1. Plant carotenes

Synonyms

Definition

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 beta-carotene accounts
for the major part. Alpha, gamma-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

Carotenoid

Colour index No

75130

EINECS

230-636-6

Chemical formula

Beta-carotene: C40H56

Molecular weight

Beta-carotene: 536,88

Assay

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

E1 %
1 cm 2 500 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

Methyl ethyl ketone

Methanol

Propan-2-ol

Hexane

Ethanol

9

>>>>>>>>>>>>>>>>>>=
>>>>>>>>>>>>>>>>>>;

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

Dichloromethane

Not more than 10 mg/kg

Lead

Not more than 5 mg/kg

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

L 113/26

EN

Official Journal of the European Union

20.4.2004

2. Algal carotenes

Synonyms

Definition

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. Beta-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 beta-carotene accounts
for the major part. Alpha-carotene, lutein, zeaxanthin and beta-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

75130

Chemical formula

Beta-carotene: C40H56

Molecular weight

Beta-carotene: 536,88

Assay

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

E1 %
1 cm 2 500 at approximately 440 nm to 457 nm in cyclohexane

Identification

A. Spectrometry

Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm

Purity

Natural tocopherols in
edible oil

Not more than 0,3 %

Lead

Not more than 5 mg/kg

E 160 a (ii) BETA-CAROTENE

1. Beta-carotene

Synonyms

Definition

CI Food Orange 5

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

Class

Colour index No

EINECS

Carotenoid

40800

230-636-6

Chemical names

Beta-carotene, beta,beta-carotene

Chemical formula

Molecular weight

C40H56

536,88

Assay

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

E1 %
1 cm 2 500 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 to 456 nm

Purity

Sulfated ash

Not more than 0,2 %

Subsidiary colouring matters Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters

Lead

Not more than 2 mg/kg

20.4.2004

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Official Journal of the European Union

L 113/27

2. Beta-carotene from Blakeslea trispora

Synonyms

Definition

Class

Colour index No

EINECS

Chemical names

Chemical formula

Molecular weight

Assay

Description

Identification

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 beta-carotene is
extracted from the biomass with ethyl acetate, or isobutyl acetate followed by
isopropyl alcohol, and crystallised. The crystallised product consists mainly of trans
beta-carotene. Because of the natural process, approximately 3 % of the product
consists of mixed carotenoids, which is specific for the product.

Carotenoid

40800

230-636-6

Beta-carotene, beta,beta-carotene

C40H56
536,88

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

E1 %
1 cm 2 500 at approximately 440 nm to 457 nm in cyclohexane
Red, brownish-red or purple-violet crystals or crystalline powder (colour varies
according to extraction solvent used and conditions of crystallisation)

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

Isobutyl acetate: Not more than 1,0 %

Isopropyl alcohol: Not more than 0,1 %

Sulfated ash

Not more than 0,2 %

Subsidiary colouring matters Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters

Lead

Mycotoxins:

Aflatoxin B1

Trichothecene (T2)

Ochratoxin

Zearalenone

Microbiology:

Moulds

Yeasts

Salmonella

Escherichia coli

Not more than 2 mg/kg

Absent

Absent

Absent

Absent

Not more than 100/g

Not more than 100/g

Absent in 25 g

Absent in 5 g’