Council Regulation (EC) No 1756/2002 of 23 September 2002 amending Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of an additive and amending Commission Regulation (EC) No 2430/1999 (Text with EEA relevance)
Date: 2002-09-23
Institutions: Council of the European Union
Subjects: animal nutrition, food additive, foodstuffs legislation, veterinary drug, withdrawal from the market

3.10.2002

EN

Official Journal of the European Communities

L 265/1

I

(Acts whose publication is obligatory)

COUNCIL REGULATION (EC) No 1756/2002

of 23 September 2002

amending Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the
authorisation of an additive and amending Commission Regulation (EC) No 2430/1999

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), and in
particular Article 9m thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

(3)

The coccidiostat Nifursol, a nitrofuran, was authorised
for use as an additive in feedingstuffs for the first time
by Commission Directive 82/822/EEC (2). This authorisa-
tion was linked to a person responsible for putting it
into circulation for a period of ten years by means of
Commission Regulation (EC) No 2430/1999 (3), without
a re-evaluation.

Article 9m provides for the withdrawal of the authorisa-
tion of an additive if any of the conditions for its author-
isation set out in Article 3a of Directive 70/524/EEC is
no longer satisfied.

During the period between 1990 and 1995, both the
Joint FAO/WHO Expert Committee on Food Additives
(JECFA) and the Committee for Veterinary Medicinal
Products (CVMP) gave opinions on the use of veterinary
medicinal products in food-producing animals of the
group of
substances known as nitrofurans. They
concluded that it was not possible, because of the geno-
toxicity and carcinogenicity of the substance, to identify
intake by
an acceptable daily intake (i.e. a level of
humans of residues of the substances which could be
regarded as safe). Accordingly, it was not possible to set
maximum residue levels for the substances. All nitro-
furans were therefore inserted into Annex IV to Council

(4)

(5)

(6)

(7)

(8)

Regulation (EEC) No 2377/90 (4), with the effect of
prohibiting throughout the Community the administra-
tion of
as veterinary medicinal
products, to food-producing animals.

substances,

these

therefore

The Commission
Scientific
Committee for Animal Nutrition (SCAN) to make a new
scientific risk assessment of Nifursol, which belongs also
to the group of nitrofurans.

asked

the

The SCAN adopted an opinion concerning Nifursol on
11 October 2001, which concluded that on the basis of
and carcinogenicity
genotoxicity
the mutagenicity,
studies provided by the person responsible for putting
Nifursol into circulation, and because of the lack of data
on developmental toxicity, it was not possible to derive
an acceptable daily intake for the consumers. The SCAN
confirmed this opinion on 18 April 2002 after having
examined complementary data.

Therefore, it cannot be guaranteed that Nifursol does not
present a risk for human health.

that
Article 3a(b) of Directive 70/524/EEC states
Community authorisation of an additive shall be given
only if, taking into account the conditions of use, it does
not adversely affect human or animal health or the envir-
onment, nor harm the consumer by impairing the char-
acteristics of animal products.

the use of

Consequently, as a condition laid down in Article 3a of
for the coccidiostat
that Directive is no longer met
Nifursol,
the substance as an additive in
feedingstuff should no longer be permitted. Regulation
(EC) No 2430/1999 and the entry of this coccidiostat in
Chapter II of Annex B to Directive 70/524/EEC should
be amended accordingly.

(1) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commis-
sion Regulation (EC) No 2205/2001 (OJ L 297, 15.11.2001, p. 3).
(2) Forty-first Commission Directive 82/822/EEC of 19 November
1982 amending the Annexes to Council Directive 70/524/EEC
concerning additives in feedingstuffs (OJ L 347, 7.12.1982, p. 16).

(3) OJ L 296, 17.11.1999, p. 3.

(4) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down
a Community procedure for the establishment of maximum residue
limits of veterinary medicinal products in foodstuffs of animal origin
(OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commis-
sion Regulation (EC) No 1530/2002 (OJ L 230, 28.8.2002, p. 3).

L 265/2

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Official Journal of the European Communities

3.10.2002

(9)

In the absence of a favourable opinion of the Standing
Committee on the Food Chain and Animal Health, the
Commission has been unable to adopt the provisions it
envisaged under the procedure laid down in Article 23
of Directive 70/524/EEC,

In Chapter II of Annex B to Directive 70/524/EEC, the
2.
entry relating to Nifursol, a substance belonging to the group
of coccidiostats and other medicinal
shall be
deleted.

substances,

HAS ADOPTED THIS REGULATION:

Article 1

1.
In Annex I to Commission Regulation (EC) No 2430/
1999 the entry relating to the additive E 769, Nifursol, shall be
deleted.

Article 2

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

It shall apply from 31 March 2003.

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

Done at Brussels, 23 September 2002.

For the Council

The President

M. FISCHER BOEL