Commission Regulation (EC) No 1519/2007 of 19 December 2007 amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of certain additives in feedingstuffs belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance )
Date: 2007-12-19
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, veterinary drug

20.12.2007

EN

Official Journal of the European Union

L 335/15

COMMISSION REGULATION (EC) No 1519/2007

of 19 December 2007

amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the
the authorisation of certain additives in feedingstuffs belonging to the group of
terms of

coccidiostats and other medicinal substances

(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
European Parliament and of
the Council of 22 September
2003 on additives for use in animal nutrition (1), and in
particular Article 13(3) thereof,

Whereas:

(1)

(2)

(3)

Article 13(3) of Regulation (EC) No 1831/2003 provides
for the possibility of changing the terms of authorisation
of an additive further to an application from the holder
of the authorisation.

The use of the additive diclazuril 0,5 g/100 g (Clinacox
0,5 % Premix), diclazuril 0,2 g/100 g (Clinacox 0,2 %
Premix), belonging to the group of ‘Coccidiostats and
other medicinal substances’ was authorised for 10 years
for chickens for fattening by Commission Regulation
(EC) No 2430/1999 (2). The authorisation was linked to
the person responsible for putting the additive into circu-
lation.

The use of the additive diclazuril 0,5 g/100 g (Clinacox
0,5 % Premix), diclazuril 0,2 g/100 g (Clinacox 0,2 %
‘Coccidiostats and
Premix) belonging to the group of
other medicinal substances’ was authorised for 10 years
for turkeys for fattening by Commission Regulation (EC)
No 418/2001 (3). The authorisation was linked to the
person responsible for putting the additive into circu-
lation.

(4)

The use of the additive diclazuril 0,5 g/100 g (Clinacox
0,5 % Premix), diclazuril 0,2 g/100 g (Clinacox 0,2 %

(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 296, 17.11.1999, p. 3. Regulation as amended by Regulation

(EC) No 249/2006 (OJ L 42, 14.2.2006, p. 22).

(3) OJ L 62, 2.3.2001, p. 3.

‘Coccidiostats and
Premix) belonging to the group of
other medicinal substances’ was authorised for 10 years
for chickens reared for laying by Commission Regulation
(EC) No 162/2003 (4). The authorisation was linked to
the person responsible for putting the additive into circu-
lation.

(5)

(6)

(7)

The holder of the authorisations, Janssen Animal Health
BVBA, has submitted an application under Article 13(3)
of Regulation (EC) No 1831/2003 proposing to change
the name of
the person responsible for putting into
circulation the additives referred to in recitals 2 to 4 of
this Regulation. With the application they have submitted
data showing that
those
additives have been transferred to Janssen Pharmaceutica
NV, its Belgian parent company, with effect from 2 July
2007.

the marketing rights

for

Assigning the authorisation of an additive linked to a
into circulation to
person responsible for putting it
another person is based on a purely administrative
procedure and did not entail a fresh assessment of the
additives. The European Food Safety Authority was
informed of the application.

its
To allow Janssen Pharmaceutica NV to exploit
it is necessary
ownership rights from 2 July 2007 on,
to change the name of the person responsible for putting
the additives into circulation, with effect from 2 July
2007. Therefore,
it is necessary for this Regulation to
apply retroactively.

(8)

Regulations (EC) No 2430/1999, (EC) No 418/2001 and
amended
(EC) No 162/2003 should therefore be
accordingly.

(9)

is appropriate to provide for a transitional period

It
during which existing stocks may be used up.

(10)

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

opinion

the

the

of

(4) OJ L 26, 31.1.2003, p. 3.

L 335/16

EN

Official Journal of the European Union

20.12.2007

HAS ADOPTED THIS REGULATION:

Article 2

Article 1

In Annex I to Regulation (EC) No 2430/1999, in column
1.
2 of the entry for E 771, the words ‘Janssen Animal Health
BVBA’ are replaced by the words ‘Janssen Pharmaceutica NV’.

Existing stocks which are in conformity with the provisions
applicable before the entry into force of this Regulation may
continue to be placed on the market and used until 30 April
2008.

2.
In Annex III to Regulation (EC) No 418/2001, in column
2 of the entry for E 771, the words ‘Janssen Animal Health
BVBA’ are replaced by the words ‘Janssen Pharmaceutica NV’.

Article 3

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

3.
In the Annex to Regulation (EC) No 162/2003, in column
2 of the entry for E 771, the words ‘Janssen Animal Health
BVBA’ are replaced by the words ‘Janssen Pharmaceutica NV’.

It shall apply from 2 July 2007.

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

Done at Brussels, 19 December 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission