Commission Directive 2006/33/EC of  20 March 2006  amending Directive 95/45/EC as regards sunset yellow FCF (E 110) and titanium dioxide (E 171)   (Text with EEA relevance)
Date: 2006-03-20
Institutions: European Commission
Subjects: food colouring, food safety, foodstuffs legislation

L 82/10

EN

Official Journal of the European Union

21.3.2006

COMMISSION DIRECTIVE 2006/33/EC

of 20 March 2006

amending Directive 95/45/EC as regards sunset yellow FCF (E 110) and titanium dioxide (E 171)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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

the laws of

(4)

After consulting the European Food Safety Authority,

Whereas:

(1)

(2)

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

Sunset yellow FCF (E 110) is authorised under Directive
94/36/EC as a colour for use in certain foodstuffs. There
is scientific evidence that under certain circumstances,
Sudan I (1-(phenylazo)-2-naphthalenol) may be formed
as an impurity during the production of sunset yellow.
Sudan I
is an unauthorised colour and an undesired
substance in food. Its presence in sunset yellow should
therefore be restricted to an amount below the limit of
i.e. 0,5 mg/kg. The purity criteria for sunset
detection,
should therefore be amended
yellow FCF (E 110)
accordingly.

Committee on Food Additives (JECFA). JECFA began the
implementation of a systematic programme to replace
the test for heavy metals (as lead) in all existing food
additive specifications with appropriate limits for indi-
vidual metals of concern. These limits for sunset yellow
FCF (E 110) should therefore be amended accordingly.

in the anatase or

Titanium dioxide (E 171) is authorised under Directive
for use in certain foodstuffs.
94/36/EC as a colour
can be manufactured to obtain
Titanium dioxide
crystals
in the rutile form. The
platelet form of rutile titanium dioxide differs from the
anatase form in structure and optical properties (pear-
lescence). There is a technological need for the use of
the platelet form of rutile titanium dioxide as a colour in
foodstuffs and in film coatings for food supplement
tablets. On 7 December 2004 the European Food
Safety Authority stated that the use of rutile titanium
dioxide in the platelet or amorphous forms would not
pose any safety concerns. The purity criteria for titanium
dioxide (E 171) should therefore be amended in order to
include both the anatase and the rutile form of
the
substance.

Directive 95/45/EC should
accordingly.

therefore be

amended

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

(5)

(6)

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

(3)

should be taken of

the specifications and
Account
analytical techniques for additives set out in the Codex
Alimentarius as drafted by the Joint FAO/WHO Expert

Article 2

(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

2004/47/EC (OJ L 113, 20.4.2004, p. 24).

(3) OJ L 237, 10.9.1994, p. 13. Directive as amended by Regulation

(EC) No 1882/2003.

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 10 April 2007 at the latest. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

21.3.2006

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Official Journal of the European Union

L 82/11

When Member States adopt those provisions, they shall contain a reference to this Directive or be accom-
panied 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.

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

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 20 March 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 82/12

EN

Official Journal of the European Union

21.3.2006

ANNEX

In the Annex to Directive 95/45/EC, Part B is amended as follows:

(1) The text concerning sunset yellow FCF (E 110) is replaced by the following:

‘E 110 SUNSET YELLOW FCF

Synonyms

Definition

Class

Colour Index No

EINECS

Chemical names

Chemical formula

Molecular weight

Assay

Description

Identification

A. Spectrometry

CI Food Yellow 3, Orange Yellow S

Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-
(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary
colouring matters together with sodium chloride and/or sodium
sulfate as the principal uncoloured components.

Sunset Yellow FCF is described as the sodium salt. The calcium
and the potassium salt are also permitted.

Monoazo

15985

220-491-7

Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-
sulfonate

C16H10N2Na2O7S2

452,37

Content not less than 85 % total colouring matters calculated as
the sodium salt

E1 %
1 cm 555 at ca 485 nm in aqueous solution at pH 7

Orange-red powder or granules

Maximum in water at ca 485 nm at pH 7

B. Orange solution in water

Purity

Water insoluble matter

Not more than 0,2 %

Subsidiary colouring matters

Not more than 5,0 %

1-(Phenylazo)-2-naphthalenol (Sudan I)

Not more than 0,5 mg/kg

Organic compounds other than colouring
matters:

4-aminobenzene-1-sulfonic acid

3-hydroxynaphthalene-2,7-disulfonic acid

6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-disulfonic acid
4,4′-diazoaminodi(benzene sulfonic acid)
6,6′-oxydi(naphthalene-2-sulfonic acid)

9

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

Total not more than 0,5 %

Unsulfonated primary aromatic amines

Not more than 0,01 % (calculated as aniline)

Ether extractable matter

Not more than 0,2 % under neutral conditions

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg’

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Official Journal of the European Union

L 82/13

(2) The text concerning titanium dioxide (E 171) is replaced by the following:

‘E 171 TITANIUM DIOXIDE

Synonyms

Definition

CI Pigment White 6

Titanium dioxide consists essentially of pure anatase and/or rutile
titanium dioxide which may be coated with small amounts of
alumina and/or silica to improve the technological properties of
the product.

Class

Colour Index No

EINECS

Chemical names

Chemical formula

Molecular weight

Assay

Description

Identification

Solubility

Purity

Loss on Drying

Loss on Ignition

Inorganic

77891

236-675-5

Titanium dioxide

TiO2

79,88

Content not less than 99 % on an alumina and silica-free basis

White to slightly coloured powder

Insoluble in water and organic solvents. Dissolves slowly in
hydrofluoric acid and in hot concentrated sulfuric acid.

Not more than 0,5 % (105 oC, 3 hours)

Not more than 1,0 % on a volatile matter free basis (800 oC)

Aluminum oxide and/or silicon dioxide

Total not more than 2,0 %

Matter soluble in 0,5 N HCl

Not more than 0,5 % on an alumina and silica-free basis and, in
addition, for products containing alumina and/or silica, not more
than 1,5 % on the basis of the product as sold.

Water soluble matter

Not more than 0,5 %

Cadmium

Antimony

Arsenic

Lead

Mercury

Zinc

Not more than 1 mg/kg

Not more than 50 mg/kg by total dissolution

Not more than 3 mg/kg by total dissolution

Not more than 10 mg/kg by total dissolution

Not more than 1 mg/kg by total dissolution

Not more than 50 mg/kg by total dissolution.’.