Commission Regulation (EC) No 2037/2005 of  14 December 2005  amending the conditions for authorisation of a feed additive belonging to the group of coccidiostats Text with EEA relevance
Date: 2005-12-14
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, market approval, poultry, veterinary drug

15.12.2005

EN

Official Journal of the European Union

L 328/21

COMMISSION REGULATION (EC) No 2037/2005

of 14 December 2005

amending the conditions for authorisation of a feed additive belonging to the group of coccidiostats

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
the Council of 22 September
European Parliament and of
2003 on additives for use in animal nutrition (1) and in
particular Article 13(3) thereof,

Whereas:

(1)

(2)

(3)

(4)

The additive lasalocid A sodium (Avatec 15 %) was
authorised under certain conditions in accordance with
Council Directive 70/524/EEC (2). This
is
additive
currently authorised in the group ‘coccidiostats’
for
No
by
turkeys
(EC)
2430/1999 (3)
laying and
chickens for fattening by Commission Regulation (EC)
No 1455/2004 (4). This additive has been notified as
existing product on the basis of Article 10 of Regulation
(EC) No 1831/2003 and is subject to the verifications
and the procedures in application of that provision.

Commission
and chickens

Regulation
reared for

The company concerned submitted a new supplementary
dossier requesting a modification of existing carrier.

Regulation (EC) No 1831/2003 provides for the possi-
bility to modify the authorisation of an additive further
to an opinion of the European Food Safety Authority (the
Authority) on whether the authorisation still meets the
conditions set out in that Regulation.

The Commission asked the Authority to evaluate the
relevant data supporting the application for the change
of authorisation referred to in Regulations (EC) Nos

2430/1999 and 1455/2004 and to advise on the
possible harmful effects on safety and efficacy when
lasalocid A sodium is used by new carrier. Following
this request, the Authority has published on 26 August
2005 an opinion on the use of lasalocid A sodium in
feedingstuffs.

The opinion of the Authority concludes that the use of
the new formulation would not be expected to introduce
any additional risks or concerns for human, animal and
environmental safety and that the new formulation does
not adversely influence the stability of
lasalocid A
sodium.

(MRL)

A Maximum Residue
substance
Level
concerned has been established by Council Regulation
(EEC) No 2377/90 of 26 June 1990 (5) laying down a
establishment
Community
of
for
maximum residue
veterinary medicinal
products in foodstuffs of animal origin.

procedure

levels

the

for

of

Regulations (EC) Nos 2430/1999 and 1455/2004 should
therefore be amended accordingly.

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

opinion

the

the

of

(5)

(6)

(7)

(8)

HAS ADOPTED THIS REGULATION:

Article 1

In Annex I to Regulation (EC) No 2430/1999, the entry relating
to E 763, lasalocid A sodium, is replaced by the text in Annex I
to this Regulation.

(1) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(2) OJ L 270, 14.12.1970, p. 1. Directive repealed by Regulation (EC)

No 1831/2003.

(3) OJ L 296, 17.11.1999, p. 3.
(4) OJ L 269, 17.8.2004, p. 14.

The Annex to Regulation (EC) No 1455/2004 is replaced by
Annex II to this Regulation.

(5) OJ L 224, 18.8.1990, p. 1. Regulation as amended by Commission

Regulation (EC) No 712/2005 (OJ L 120, 12.5.2005, p. 3).

Article 2

L 328/22

EN

Official Journal of the European Union

15.12.2005

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

Article 3

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

Done at Brussels, 14 December 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

15.12.2005

EN

Official Journal of the European Union

L 328/23

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