Proposal for a Council Regulation amending Council 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
Date: 2002-07-08
Institutions: European Commission
Subjects: animal health, animal nutrition, food additive, food safety, foodstuffs legislation, public health, veterinary drug, withdrawal from the market

C 262 E/390

EN

Official Journal of the European Communities

29.10.2002

Proposal for a Council Regulation amending Council 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

(2002/C 262 E/24)

COM(2002) 367 final

(Submitted by the Commission on 8 July 2002)

EXPLANATORY MEMORANDUM

The purpose of this Regulation is to withdraw the authorisation for use as an additive in feedingstuffs of
the coccidiostat Nifursol, a histomonostat belonging to the nitrofuran group.

In October 2001 the Scientific Committee for Animal Nutrition adopted an opinion which concluded that,
on the basis of
the mutagenicity, genotoxicity and carcinogenicity studies provided by the person
responsible for putting the substance into circulation, it was not possible to derive an Acceptable Daily
Intake for the consumers.

The company submitted then a further set of data, which have been evaluated by the Scientific Committee
for Animal Nutrition. In its opinion of April 2002, the Committee has confirmed the previous one.

Therefore it is not possible to guarantee that the product is safe for the human health.

Article 9m of the Directive provides for the withdrawal of the authorisation of an additive if any of the
conditions as set out in Article 3a of Directive 70/524/EEC is no longer satisfied.

Under the procedure laid down in Article 23 of Council Directive 70/524/EEC, concerning additives in
feedingstuffs, the Commission sought the opinion of the Standing Committee on the Food Chain and
Animal Health on a draft Commission Regulation, which withdraws the authorisation of the additive
‘Nifursol’ belonging to the group of coccidiostats and other medicinal substances.

Owing to the fact that the Standing Committee on the Food Chain and Animal Health failed to deliver a
favourable opinion on 23 May 2002, the Commission is required, under the abovementioned Article, to
refer the proposed measures to the Council. The Council will have three months to decide. If the Council
fails to reach a decision, the Commission will adopt the measures, except where the Council has voted by a
simple majority against such measures.

This proposal has no financial impact on the budget of the European Communities.

It is based on an exclusive Community competence.

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the proposal from the Commission,

Having regard to the Treaty establishing the European
Community,

Whereas:

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as
(EC) No
last
2205/2001 (2), and in particular Article 9m thereof,

Commission

Regulation

amended

by

(1) The coccidiostat Nifursol, a nitrofuran, was authorised for
use as an additive in feedingstuffs for the first time by
Commission Directive 82/822/EEC (3). This authorisation
was linked to a person responsible for putting it into circu-
lation for a period of ten years by means of Commission
Regulation (EC) No 2430/1999 (4), without a re-evaluation.

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 297, 15.11.2001, p. 3.

(3) OJ L 347, 7.12.1982, p. 16.
(4) OJ L 296, 17.11.1999, p. 3.

29.10.2002

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Official Journal of the European Communities

C 262 E/391

(2) Article 9m provides for the withdrawal of the authorisation
of an additive if any of the conditions for its authorisation
set out in Article 3a of Directive 70/524/EEC is no longer
satisfied.

in food-producing animals of

(3) 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
the group of
products
substances known as nitrofurans. They concluded that it
was not possible, because of the genotoxicity and carcino-
genicity of the substance, to identify an Acceptable Daily
Intake (i.e. a level of intake by 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 nitrofurans were therefore inserted into
Annex IV of Council Regulation (EEC) No 2377/90, with
the effect of prohibiting throughout the Community the
administration
veterinary
these
medicinal products, to food-producing animals.

substances,

of

as

(4) The Commission therefore

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

to the

asked

(5) The SCAN adopted an opinion concerning Nifursol on 11
October 2001, which concluded that on the basis of the
mutagenicity, genotoxicity and carcinogenicity studies
provided by the person responsible for putting Nifursol
into circulation, and because of the lack of data on devel-
opmental
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.

toxicity,

(8) Consequently, as a condition laid down in Article 3a of
Directive 70/524/EEC is no longer met for the coccidiostat
Nifursol, the use of the substance as an additive in feed-
ingstuff 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.

(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,

HAS ADOPTED THIS REGULATION:

Article 1

1. Annex I to Commission Regulation (EC) No 2430/1999 is

amended as follows:

The entry relating to the additive E 769, Nifursol, is deleted.

2. Chapter II of Annex B to Directive 70/524/EEC is amended

as follows:

The following substance belonging to the group of cocci-
diostats and other medicinal substances shall be deleted:

— Nifursol.

Article 2

(6) It cannot be guaranteed that Nifursol does not present a

risk for human health.

This Regulation shall enter into force on the 7th day following
its publication in the Official Journal of the European Communities.

(7) Article 3a(b) states that 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 environment, nor harm the consumer
by impairing the characteristics of animal products.

It shall apply from 30 November 2002.

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