# L_2005328EN.01002101.xml

| 15.12.2005 | EN | Official Journal of the European Union | L 328/21 |
| --- | --- | --- | --- |

15.12.2005

EN

Official Journal of the European Union

L 328/21

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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 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) | The additive lasalocid A sodium (Avatec 15 %) was authorised under certain conditions in accordance with Council Directive 70/524/EEC (2). This additive is currently authorised in the group ‘coccidiostats’ for turkeys by Commission Regulation (EC) No 2430/1999 (3) and chickens reared for 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. |
| --- | --- |

(1)

The additive lasalocid A sodium (Avatec 15 %) was authorised under certain conditions in accordance with Council Directive 70/524/EEC (2). This additive is currently authorised in the group ‘coccidiostats’ for turkeys by Commission Regulation (EC) No 2430/1999 (3) and chickens reared for 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.

| (2) | The company concerned submitted a new supplementary dossier requesting a modification of existing carrier. |
| --- | --- |

(2)

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

| (3) | Regulation (EC) No 1831/2003 provides for the possibility 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. |
| --- | --- |

(3)

Regulation (EC) No 1831/2003 provides for the possibility 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.

| (4) | 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. |
| --- | --- |

(4)

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.

| (5) | 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. |
| --- | --- |

(5)

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.

| (6) | A Maximum Residue Level (MRL) for substance concerned has been established by Council Regulation (EEC) No 2377/90 of 26 June 1990 (5) laying down a Community procedure for the establishment of maximum residue levels of veterinary medicinal products in foodstuffs of animal origin. |
| --- | --- |

(6)

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

| (7) | Regulations (EC) Nos 2430/1999 and 1455/2004 should therefore be amended accordingly. |
| --- | --- |

(7)

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

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. |
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(8)

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

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.

Article 2

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

Article 3

This Regulation shall enter into force on the third 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, 14 December 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(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 270, 14.12.1970, p. 1. Directive repealed by Regulation (EC) No 1831/2003.

2

(3)  
  OJ L 296, 17.11.1999, p. 3.

3

(4)  
  OJ L 269, 17.8.2004, p. 14.

4

(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).

5

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ANNEX I

| Registration number of additive | Name and registration number of person responsible for putting additive into circulation | Additive
  (Trade name) | Composition, chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation | Maximum Residue Limits
  (MRLs) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff |
| Coccidiostats and histomonostats |
| E 763 | Alpharma (Belgium) BVBA | Lasalocid A sodium 15 g/100 g
  (Avatec 15 % cc) | | Additive composition: | Lasalocid A sodium: 15 g/100 g |

Registration number of additive

Name and registration number of person responsible for putting additive into circulation

Additive

(Trade name)

Composition, chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Maximum Residue Limits

(MRLs)

mg of active substance/kg of complete feedingstuff

Coccidiostats and histomonostats

E 763

Alpharma (Belgium) BVBA

Lasalocid A sodium 15 g/100 g

(Avatec 15 % cc)

Additive composition:

Lasalocid A sodium: 15 g/100 g

| | Corn cob meal: 80,95 g/100 g |
| --- | --- |

Corn cob meal: 80,95 g/100 g

| | Lecithin: 2 g/100 g |
| --- | --- |

Lecithin: 2 g/100 g

| | Soya oil: 2 g/100 g |
| --- | --- |

Soya oil: 2 g/100 g

| | Ferric oxide: 0,05 g/100 g |
| --- | --- |

Ferric oxide: 0,05 g/100 g

| | Active substance:

  Lasalocid A sodium, C34H53O8Na,
  CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)
  Related impurities:
  Lasalocid sodium B-E: ≤ 10 % |
| --- | --- |

Active substance:

Lasalocid A sodium, C34H53O8Na,

CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)

Related impurities:

Lasalocid sodium B-E: ≤ 10 %

Turkeys

12 weeks

90

125

Use prohibited at least five days before slaughter. Indicate in the instructions for use:

| | ‘Dangerous for equine species’ |
| --- | --- |

‘Dangerous for equine species’

| | ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated’. |
| --- | --- |

‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated’.

30.9.2009

Regulation (EEC) No 2377/90

Lasalocid A sodium 15 g/100 g

(Avatec 150 G)

| | Additive composition: | Lasalocid A sodium: 15 g/100 g |
| --- | --- | --- |

Additive composition:

Lasalocid A sodium: 15 g/100 g

| | Calcium sulphate dihydrate: 80,9 g/100 g |
| --- | --- |

Calcium sulphate dihydrate: 80,9 g/100 g

| | Calcium lignosulphonate 4 g/100 g |
| --- | --- |

Calcium lignosulphonate 4 g/100 g

| | Ferric oxide: 0,1 g/100 g |
| --- | --- |

Ferric oxide: 0,1 g/100 g

| | Active substance:

  Lasalocid A sodium, C34H53O8Na,
  CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)
  Related impurities:
  Lasalocid sodium B-E: ≤ 10 % |
| --- | --- |

Active substance:

Lasalocid A sodium, C34H53O8Na,

CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)

Related impurities:

Lasalocid sodium B-E: ≤ 10 %

Turkeys

12 weeks

90

125

Use prohibited at least five days before slaughter. Indicate in the instructions for use:

| | ‘Dangerous for equine species’ |
| --- | --- |

‘Dangerous for equine species’

| | ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated’. |
| --- | --- |

‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated’.

30.9.2009

Regulation (EEC) No 2377/90

---

ANNEX II

| Registration number of additive | Name and registration number of person responsible for putting additive into circulation | Additive
  (Trade name) | Composition, chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation | Maximum Residue Limits
  (MRLs) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff |
| Coccidiostats and histomonostats |
| E 763 | Alpharma (Belgium) BVBA | Lasalocid A sodium 15 g/100 g
  (Avatec 15 % cc) | | Additive composition: | Lasalocid A sodium: 15 g/100 g |

Registration number of additive

Name and registration number of person responsible for putting additive into circulation

Additive

(Trade name)

Composition, chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Maximum Residue Limits

(MRLs)

mg of active substance/kg of complete feedingstuff

Coccidiostats and histomonostats

E 763

Alpharma (Belgium) BVBA

Lasalocid A sodium 15 g/100 g

(Avatec 15 % cc)

Additive composition:

Lasalocid A sodium: 15 g/100 g

| | Corn cob meal: 80,95 g/100 g |
| --- | --- |

Corn cob meal: 80,95 g/100 g

| | Lecithin: 2 g/100 g |
| --- | --- |

Lecithin: 2 g/100 g

| | Soya oil: 2 g/100 g |
| --- | --- |

Soya oil: 2 g/100 g

| | Ferric oxide: 0,05 g/100 g |
| --- | --- |

Ferric oxide: 0,05 g/100 g

| | Active substance:

  Lasalocid A sodium, C34H53O8Na,
  CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)
  Related impurities:
  Lasalocid sodium B-E: ≤ 10 % |
| --- | --- |

Active substance:

Lasalocid A sodium, C34H53O8Na,

CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)

Related impurities:

Lasalocid sodium B-E: ≤ 10 %

Chickens for fattening

—

75

125

Use prohibited at least five days before slaughter. Indicate in the instructions for use:

| | ‘Dangerous for equine species’ |
| --- | --- |

‘Dangerous for equine species’

| | ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra-indicated’. |
| --- | --- |

‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra-indicated’.

20.8.2014

Regulation (EEC) No 2377/90

Chickens reared for laying

16 weeks

75

125

20.8.2014

Lasalocid A sodium 15 g/100 g

(Avatec 150 G)

| | Additive composition: | Lasalocid A sodium: 15 g/100 g |
| --- | --- | --- |

Additive composition:

Lasalocid A sodium: 15 g/100 g

| | Calcium sulphate dihydrate: 80,9 g/100 g |
| --- | --- |

Calcium sulphate dihydrate: 80,9 g/100 g

| | Calcium lignosulphonate 4 g/100 g |
| --- | --- |

Calcium lignosulphonate 4 g/100 g

| | Ferric oxide: 0,1 g/100 g |
| --- | --- |

Ferric oxide: 0,1 g/100 g

| | Active substance:

  Lasalocid A sodium, C34H53O8Na,
  CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)
  Related impurities:
  Lasalocid sodium B-E: ≤ 10 % |
| --- | --- |

Active substance:

Lasalocid A sodium, C34H53O8Na,

CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)

Related impurities:

Lasalocid sodium B-E: ≤ 10 %

Chickens for fattening

—

75

125

Use prohibited at least five days before slaughter. Indicate in the instructions for use:

| | ‘Dangerous for equine species’ |
| --- | --- |

‘Dangerous for equine species’

| | ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra-indicated’. |
| --- | --- |

‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contra-indicated’.

20.8.2014

Regulation (EEC) No 2377/90

Chickens reared for laying

16 weeks

75

125

20.8.2014

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