Commission Regulation (EC) No 884/2007 of 26 July 2007 on emergency measures suspending the use of E 128 Red 2G as food colour (Text with EEA relevance)
Date: 2007-07-26
Institutions: European Commission
Subjects: consumer protection, food colouring, foodstuff, foodstuffs legislation, health risk, marketing restriction

L 195/8

EN

Official Journal of the European Union

27.7.2007

COMMISSION REGULATION (EC) No 884/2007

of 26 July 2007

on emergency measures suspending the use of E 128 Red 2G as food colour

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 178/2002 of the European
Parliament and the Council of 28 January 2002 laying down
the general principles and requirements of food law, establishing
and laying down
the European Food Safety Authority
food safety (1) and in particular
procedures
in matters of
Article 53(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

Under Article 53(1) of Regulation (EC) No 178/2002 the
Commission may suspend the placing on the market or
use of a food that is likely to constitute a serious risk to
human health, when such risk cannot be contained satis-
factorily by means of measures taken by the Member
States concerned.

European Parliament and Council Directive 94/36/EC of
for use in foodstuffs (2)
30 June 1994 on colours
authorises in its Annex I the use of the colour E 128
Red 2G in foodstuffs. Pursuant
that
Directive the colour E 128 Red 2G is permitted for use
in breakfast sausages with a minimum cereal content of
6 % and burger meat with a minimum vegetable and/or
cereal content of 4 %. In both foods a maximum level of
20 mg/kg is allowed.

to Annex IV of

The use of that colour has been permitted on the basis of
the opinion of
the Scientific Committee on Food
expressed on 27 June 1975 (3). That Committee
allocated an acceptable daily intake (ADI) of 0,1 mg/kg
body weight for E 128 Red 2G.

Food additives must be kept under continuous obser-
vation and must be re-evaluated whenever necessary in
the light of changing conditions of use and new scientific
information. As the original assessments of many of food
additives date back over a number of years, the European

(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(2) 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).

(3) SCF (1975). Reports of the Scientific Committee for Food (First

series), p. 17, 19, 24.

Commission considered that
there is a need for a
systematic re-evaluation of all authorised food additives
to verify whether the existing safety assessment remain
valid. Therefore, the Commission requested the European
Food Safety Authority (EFSA) to re-evaluate all currently
permitted food additives in the EU.

In this context
the EFSA Scientific Panel on food
additives, flavourings, processing aids and materials in
the
contact with food has re-evaluated the safety of
colour E 128 Red 2G and adopted an opinion (4) on
5 July 2007.

EFSA based its evaluation on the conclusions of
the
European Union risk assessment report (5) on aniline.
That report concluded that aniline should be considered
as a carcinogen for which a genotoxic mechanism cannot
be excluded. Since the colour E 128 Red 2G is readily
and extensively metabolised to aniline, EFSA concluded
that it would be prudent to regard that substance as
being of safety concern. Consequently, EFSA withdrew
the ADI for the colour E 128 Red 2G. EFSA, however,
considered that should the tumour inducing mechanism
of aniline be further elucidated, shown to be thresholded
and/or its relevance for man discounted, the colour E
128 Red 2G could be re-evaluated once again for use
as a food additive.

Considering that a food additive may only be used when
there is evidence that its use is not harmful to health,
Directive 94/36/EC should be amended to prohibit the
use of the colour E 128 Red 2G.

in order

In the interim, since the colour E 128 Red 2G is likely to
constitute a serious risk to human health,
it is appro-
priate,
to ensure the high level of health
protection chosen in the Community, to suspend with
immediate effect the use of the colour E 128 Red 2G in
food and the placing on the market and import of food
containing the colour E 128 Red 2G.

(5)

(6)

(7)

(8)

(9)

By virtue of Directive 94/36/EC, the colour E 128 Red
2G is legally authorised for use in all Member States.
Therefore, a Community-wide measure is necessary.

(4) EFSA (2007). Opinion of the Scientific Panel on Food Additives,
Flavourings, Processing aids and Materials in contact with Food
(AFC) on re-evaluation of food colours Red 2G (E 128).

(5) ECB, 2004, European Chemicals Bureau, Institute for Health and
Consumer Protection. European Union Risk Assessment Report on
Aniline. Volume 50.

27.7.2007

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Official Journal of the European Union

L 195/9

(10)

The Commission will keep this Regulation under regular
review taking into account new scientific information.

The placing on the market of food containing the colour

2.
E 128 Red 2G is suspended.

(11) Having regard to the nature of the risk, this Regulation

should enter into force immediately.

The import of food containing the colour E 128 Red 2G

3.
is suspended.

(12)

(13)

Taking account of technical and economic reasons, tran-
sitional periods should be laid down to cover breakfast
sausages and burger meat containing the colour E 128
in
Red 2G, which have been placed on the market
accordance with Directive 94/36/EC as well
as
consignments which were
from third
countries for the Community before the date of appli-
cation of this Regulation.

dispatched

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

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 2

1.
By derogation to Article 1(2), breakfast sausages and
burger meat containing the colour E 128 Red 2G which have
been placed on the market
in accordance with Directive
94/36/EC before the date of entry into force of this Regulation
their ‘use by’ date or their date of
may be marketed until
minimum durability.

2.
Article 1 shall not apply to consignments of breakfast
sausages and burger meat containing the colour E 128 Red
2G where the importer of such foodstuffs can demonstrate
third country
that
concerned and were en route to the Community before the
date of entry into force of this Regulation.

they had been dispatched from the

Article 1

Article 3

The use of the colour E 128 Red 2G in food, as referred

1.
to in Annex IV to Directive 94/36/EC, is suspended.

This Regulation shall enter into force the day following its
publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 26 July 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission