Commission Regulation (EC) No 552/2008 of 17 June 2008 amending Regulations (EC) No 2430/1999, (EC) No 2380/2001 and (EC) No 1289/2004 as regards the terms of the authorisations of certain additives for use in animal nutrition (Text with EEA relevance)
Date: 2008-06-17
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, market approval, veterinary drug

18.6.2008

EN

Official Journal of the European Union

L 158/3

COMMISSION REGULATION (EC) No 552/2008

of 17 June 2008

amending Regulations (EC) No 2430/1999, (EC) No 2380/2001 and (EC) No 1289/2004 as regards
the terms of the authorisations of certain additives for use in animal nutrition

(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:

Alpharma (Belgium) BVBA has submitted an application
under Article 13(3) of Regulation (EC) No 1831/2003
proposing to change the name of the holder of the auth-
orisation as regards Commission Regulations (EC) No
2430/1999 (2),
(EC) No 2380/2001 (3) and (EC) No
1289/2004 (4). Those Regulations authorise the use of
certain additives. The authorisations are linked to the
holder of the authorisation.

In the case of
the additives robenidine hydrochloride
66 g/kg (Cycostat 66G) and maduramicin ammonium
alpha 1 g/100g (Cygro 1 %) listed in Annex I to Regu-
lation (EC) No 2430/1999 the holder of the authoris-
ation is Roche Vitamins Europe Ltd.

(1)

(2)

(3)

referred to in recitals 2 and 3. With the application
Alpharma (Belgium) BVBA has submitted appropriate
documents showing that the marketing rights for those
additives have been transferred to Alpharma (Belgium)
BVBA together with additional supporting documents
from the original holders as named in those authoris-
ations.

The proposed change of the terms of the authorisations
is purely administrative in nature and does not entail a
fresh assessment of
concerned. The
European Food Safety Authority was informed of the
application.

additives

the

To allow the applicant to exploit its marketing rights
is
it
under the name of Alpharma (Belgium) BVBA,
necessary to change the terms of the authorisations.

Regulations (EC) No 2430/1999,
(EC) No 2380/2001
and (EC) No 1289/2004 should therefore be amended
accordingly.

is appropriate to provide for a transitional period

It
during which existing stocks may be used up.

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

opinion

the

the

of

(5)

(6)

(7)

(8)

(9)

In the case of additives maduramicin ammonium alpha
1 g/100g (Cygro 1 %) listed in the Annex to Regulation
(EC) No 2380/2001 and decoquinate 60,6 g/kg (Deccox)
listed in the Annex to Regulation (EC) No 1289/2004
the holder of the authorisation is Alpharma AS.

HAS ADOPTED THIS REGULATION:

(4)

The applicant claims that Alpharma (Belgium) BVBA is
the legal successor of the holders of the authorisations

(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 last amended by Regu-

lation (EC) No 1519/2007 (OJ L 335, 20.12.2007, p. 15).

(3) OJ L 321, 6.12.2001, p. 18.
(4) OJ L 243, 15.7.2004, p. 15.

Article 1

In Annex I to Regulation (EC) No 2430/1999, in column
1.
2 of the entry for E758 and E770, the words ‘Roche Vitamins
Europe Ltd’ are replaced by the words ‘Alpharma (Belgium)
BVBA’.

2.
in
In the Annex to Regulation (EC) No 2380/2001,
column 2 of the entry for E770, the words ‘Alpharma AS’
are replaced by the words ‘Alpharma (Belgium) BVBA’.

L 158/4

EN

Official Journal of the European Union

18.6.2008

In the Annex to Regulation (EC) No 1289/2004,

3.
‘Alpharma AS’ are replaced by the words ‘Alpharma (Belgium) BVBA’.

in column 2 of the entry for E756, the words

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 September 2008.

Article 2

This Regulation shall enter into force on the 20th 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, 17 June 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission