# L_2008158EN.01000301.xml

| 18.6.2008 | EN | Official Journal of the European Union | L 158/3 |
| --- | --- | --- | --- |

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 establishing the European Community,

Having regard to Regulation (EC) No 1831/2003 of the 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) | 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 authorisation 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. |
| --- | --- |

(1)

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 authorisation 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.

| (2) | 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 Regulation (EC) No 2430/1999 the holder of the authorisation is Roche Vitamins Europe Ltd. |
| --- | --- |

(2)

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 Regulation (EC) No 2430/1999 the holder of the authorisation is Roche Vitamins Europe Ltd.

| (3) | 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. |
| --- | --- |

(3)

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.

| (4) | The applicant claims that Alpharma (Belgium) BVBA is the legal successor of the holders of the authorisations 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 authorisations. |
| --- | --- |

(4)

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

| (5) | The proposed change of the terms of the authorisations is purely administrative in nature and does not entail a fresh assessment of the additives concerned. The European Food Safety Authority was informed of the application. |
| --- | --- |

(5)

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

| (6) | To allow the applicant to exploit its marketing rights under the name of Alpharma (Belgium) BVBA, it is necessary to change the terms of the authorisations. |
| --- | --- |

(6)

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

| (7) | Regulations (EC) No 2430/1999, (EC) No 2380/2001 and (EC) No 1289/2004 should therefore be amended accordingly. |
| --- | --- |

(7)

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

| (8) | It is appropriate to provide for a transitional period during which existing stocks may be used up. |
| --- | --- |

(8)

It is appropriate to provide for a transitional period during which existing stocks may be used up.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(9)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

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

3.   In the Annex to Regulation (EC) No 1289/2004, in column 2 of the entry for E756, the words ‘Alpharma AS’ are replaced by the words ‘Alpharma (Belgium) BVBA’.

Article 2

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 3

This Regulation shall enter into force on the 20th day following that of 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, 17 June 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

(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).

1

(2)  
  OJ L 296, 17.11.1999, p. 3. Regulation as last amended by Regulation (EC) No 1519/2007 (OJ L 335, 20.12.2007, p. 15).

2

(3)  
  OJ L 321, 6.12.2001, p. 18.

3

(4)  
  OJ L 243, 15.7.2004, p. 15.

4

---