Commission Regulation (EC) No 249/2006 of  13 February 2006  amending Regulations (EC) No 2430/1999, (EC) No 937/2001, (EC) No 1852/2003 and (EC) No 1463/2004 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: 2006-02-13
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval, medicinal product

L 42/22

EN

Official Journal of the European Union

14.2.2006

COMMISSION REGULATION (EC) No 249/2006

of 13 February 2006

amending Regulations (EC) No 2430/1999, (EC) No 937/2001, (EC) No 1852/2003 and (EC) No
the authorisation of certain additives in feedingstuffs
1463/2004 as regards the terms of

belonging to the group 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)

(4)

(5)

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 halofuginone hydrobromide 6
g/kg (Stenorol) belonging to the group of ‘Coccidiostats
and other medicinal substances’ was authorised for 10
years for chickens for laying 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 salinomycin sodium 120 g/kg
‘Coccidiostats
(Sacox 120) belonging to the group of
and other medicinal substances’ was authorised for 10
years for rabbits for fattening by Commission Regulation
(EC) No 937/2001 (3). The authorisation was linked to
the person responsible for putting the additive into circu-
lation.

and other medicinal

The use of the additive salinomycin sodium 120 g/kg
(Sacox 120 microGranulate) belonging to the group of
substances’ was
‘Coccidiostats
authorised for 10 years for chickens reared for laying
by Commission Regulation (EC) No 1852/2003 (4). The
authorisation was linked to the person responsible for
putting the additive into circulation.

The use of the additive salinomycin sodium 120 g/kg
(Sacox 120 microGranulate) belonging to the group of
‘Coccidiostats
substances’ was
authorised for 10 years for chickens for fattening by
Commission Regulation (EC) No 1463/2004 (5). The
authorisation was linked to the person responsible for

and other medicinal

putting the additive into circulation and replaced the
previous authorisation of this additive which was not
linked to any specific person.

The holder of the authorisations, Hoechst Roussel Vet
International BV, have submitted
GmbH and Intervet
applications pursuant
to 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 5. With the appli-
cation they have submitted data showing that
the
marketing rights for those additives have been transferred
to Huvepharma NV with effect from 1 August 2005.

Assigning the authorisation of an additive linked to a
person responsible for putting it
into circulation to
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.

is necessary to change the name of

To allow Huvepharma NV to exploit its ownership rights,
it
the person
responsible for putting the additives into circulation
accordingly.

Regulations (EC) No 2430/1999,
(EC) No 937/2001,
(EC) No 1852/2003 and (EC) No 1463/2004 should
therefore be amended accordingly.

(6)

(7)

(8)

(9)

(10)

is appropriate to provide for a transitional period

It
during which existing stocks may be used up.

(11)

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 1

In column 2 of the entry for E 764 of the Annex I to Regu-
lation (EC) No 2430/1999, the words ‘Hoechst Roussel Vet
GmbH’ are replaced by the words ‘Huvepharma nv’.

(1) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Com-
mission 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 Council

Regulation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).

(3) OJ L 130, 12.5.2001, p. 25.
(4) OJ L 271, 22.10.2003, p. 13.
(5) OJ L 270, 18.8.2004, p. 5.

Article 2

In column 2 of the entry for E 766 of Annex IV to Regulation
(EC) No 937/2001, the words ‘Intervet International BV’ are
replaced by the words ‘Huvepharma NV’.

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Official Journal of the European Union

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Article 3

Article 5

In column 2 of the entry for E 766 of the Annex to Regulation
(EC) No 1852/2003, the words ‘Intervet International BV’ are
replaced by the words ‘Huvepharma 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 31 July
2006.

Article 4

Article 6

In column 2 of the entry for E 766 of the Annex to Regulation
(EC) No 1463/2004, the words ‘Intervet International BV’ are
replaced by the words ‘Huvepharma NV’.

This Regulation shall enter into force on the third 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, 13 February 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission