# L_2008266EN.01000301.xml

| 7.10.2008 | EN | Official Journal of the European Union | L 266/3 |
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7.10.2008

EN

Official Journal of the European Union

L 266/3

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COMMISSION REGULATION (EC) No 976/2008

of 6 October 2008

amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of the feed additive ‘Clinacox’, 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 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 diclazuril (Clinacox 0,5 % Premix), belonging to the group of coccidiostats and other medicinal substances, was authorised under certain conditions in accordance with Council Directive 70/524/EEC (2). Commission Regulations (EC) No 2430/1999 (3), (EC) No 418/2001 (4) and (EC) No 162/2003 (5) authorised that additive for 10 years for use for chickens for fattening, turkeys for fattening and chickens reared for laying respectively, linking the authorisation to the person responsible for putting that additive into circulation. That additive was notified as an existing product in accordance with Article 10 of Regulation (EC) No 1831/2003. Since all the information required under that provision was submitted, that additive was entered into the Community Register of Feed Additives. |
| --- | --- |

(1)

The additive diclazuril (Clinacox 0,5 % Premix), belonging to the group of coccidiostats and other medicinal substances, was authorised under certain conditions in accordance with Council Directive 70/524/EEC (2). Commission Regulations (EC) No 2430/1999 (3), (EC) No 418/2001 (4) and (EC) No 162/2003 (5) authorised that additive for 10 years for use for chickens for fattening, turkeys for fattening and chickens reared for laying respectively, linking the authorisation to the person responsible for putting that additive into circulation. That additive was notified as an existing product in accordance with Article 10 of Regulation (EC) No 1831/2003. Since all the information required under that provision was submitted, that additive was entered into the Community Register of Feed Additives.

| (2) | Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority). The holder of the authorisation of the additive diclazuril (Clinacox 0,5 % Premix) has submitted an application with which it proposes changing the conditions of the authorisation by introducing a maximum residue limit (MRL) as evaluated by the Authority. At the same time it provided the necessary data to support that request. |
| --- | --- |

(2)

Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority). The holder of the authorisation of the additive diclazuril (Clinacox 0,5 % Premix) has submitted an application with which it proposes changing the conditions of the authorisation by introducing a maximum residue limit (MRL) as evaluated by the Authority. At the same time it provided the necessary data to support that request.

| (3) | In its opinion adopted on 16 April 2008 (6), the Authority concluded that no MRLs are required for chickens and turkeys for fattening. However, in case MRLs were considered necessary, it suggested values. Because it is possible that the chickens reared for laying enter in the food chain, not separately from the other chickens, it is necessary to consider the possibility to provide MRLs also for that animal category. It also considered that applying a withdrawal period of zero days would not compromise consumer safety. |
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(3)

In its opinion adopted on 16 April 2008 (6), the Authority concluded that no MRLs are required for chickens and turkeys for fattening. However, in case MRLs were considered necessary, it suggested values. Because it is possible that the chickens reared for laying enter in the food chain, not separately from the other chickens, it is necessary to consider the possibility to provide MRLs also for that animal category. It also considered that applying a withdrawal period of zero days would not compromise consumer safety.

| (4) | To ensure a high level of safety for the consumers and to improve the controls of the correct use of diclazuril, it is appropriate to establish MRLs as proposed by the Authority. Because there are no relevant physiological differences between the chickens for fattening and chickens reared for laying it is appropriate to establish the same MRLs also for the latter category. |
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(4)

To ensure a high level of safety for the consumers and to improve the controls of the correct use of diclazuril, it is appropriate to establish MRLs as proposed by the Authority. Because there are no relevant physiological differences between the chickens for fattening and chickens reared for laying it is appropriate to establish the same MRLs also for the latter category.

| (5) | Commission Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 should therefore be amended accordingly. |
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(5)

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

| (6) | 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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(6)

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 line for E 771 is replaced by the text in Annex I to this Regulation.

Article 2

Annex III to Regulation (EC) No 418/2001 is replaced by the text in Annex II to this Regulation.

Article 3

The Annex to Regulation (EC) No 162/2003 is replaced by the text in Annex III to this Regulation.

Article 4

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, 6 October 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  
  OJ L 270, 14.12.1970, p. 1.

2

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

3

(4)  
  OJ L 62, 2.3.2001, p. 3.

4

(5)  
  OJ L 26, 31.1.2003, p. 3.

5

(6)  Updated Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the Maximum Residue Limits for Clinacox 0,5 % (diclazuril) for turkeys for fattening, chickens for fattening and chickens reared for laying. The EFSA Journal (2008) 696, 1-12.

6

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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) in the relevant foodstuffs of animal origin |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff |
| Coccidiostats and other medicinal substances |
| ‘E 771 | Janssen Pharmaceutica nv | Diclazuril
  0,5 g/100 g
  (Clinacox 0,5 % Premix)
  Diclazuril
  0,2 g/100 g
  (Clinacox 0,2 % Premix) | | Additive composition: | Diclazuril: 0,5 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) in the relevant foodstuffs of animal origin

mg of active substance/kg of complete feedingstuff

Coccidiostats and other medicinal substances

‘E 771

Janssen Pharmaceutica nv

Diclazuril

0,5 g/100 g

(Clinacox 0,5 % Premix)

Diclazuril

0,2 g/100 g

(Clinacox 0,2 % Premix)

Additive composition:

Diclazuril: 0,5 g/100 g

| | Soybean meal: 99,25 g/100 g |
| --- | --- |

Soybean meal: 99,25 g/100 g

| | Polyvidone K 30: 0,2 g/100 g |
| --- | --- |

Polyvidone K 30: 0,2 g/100 g

| | Sodium hydroxide: 0,0538 g/100 g |
| --- | --- |

Sodium hydroxide: 0,0538 g/100 g

| | Diclazuril: 0,2 g/100 g |
| --- | --- |

Diclazuril: 0,2 g/100 g

| | Soybean meal: 39,7 g/100 g |
| --- | --- |

Soybean meal: 39,7 g/100 g

| | Polyvidone K 30: 0,08 g/100 g |
| --- | --- |

Polyvidone K 30: 0,08 g/100 g

| | Sodium hydroxide: 0,0215 g/100 g |
| --- | --- |

Sodium hydroxide: 0,0215 g/100 g

| | Wheat middling: 60 g/100 g |
| --- | --- |

Wheat middling: 60 g/100 g

| | Active substance: | Diclazuril
  C17H9Cl3N4O2,
  (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile, |
| --- | --- | --- |

Active substance:

Diclazuril

C17H9Cl3N4O2,

(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,

| | CAS number: 101831-37-2 |
| --- | --- |

CAS number: 101831-37-2

| | Related impurities: | Degradation compound (R064318): ≤ 0,2 % |
| --- | --- | --- |

Related impurities:

Degradation compound (R064318): ≤ 0,2 %

| | Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually |
| --- | --- |

Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually

| | Total impurities: ≤ 1,5 % |
| --- | --- |

Total impurities: ≤ 1,5 %

Chickens for fattening

—

1

1

—

30.9.2009

1 500 μg diclazuril/kg of wet liver

1 000 μg diclazuril/kg of wet kidney

500 μg diclazuril/kg of wet muscle

500 μg diclazuril/kg of wet skin/fat’

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ANNEX II

‘ANNEX III

| 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) in the relevant foodstuffs of animal origin |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff |
| Coccidiostats and other medicinal substances |
| E 771 | Janssen Pharmaceutica nv | Diclazuril
  0,5 g/100 g
  (Clinacox 0,5 % Premix)
  Diclazuril
  0,2 g/100 g
  (Clinacox 0,2 % Premix) | | Additive composition: | Diclazuril: 0,5 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) in the relevant foodstuffs of animal origin

mg of active substance/kg of complete feedingstuff

Coccidiostats and other medicinal substances

E 771

Janssen Pharmaceutica nv

Diclazuril

0,5 g/100 g

(Clinacox 0,5 % Premix)

Diclazuril

0,2 g/100 g

(Clinacox 0,2 % Premix)

Additive composition:

Diclazuril: 0,5 g/100 g

| | Soybean meal: 99,25 g/100 g |
| --- | --- |

Soybean meal: 99,25 g/100 g

| | Polyvidone K 30: 0,2 g/100 g |
| --- | --- |

Polyvidone K 30: 0,2 g/100 g

| | Sodium hydroxide: 0,0538 g/100 g |
| --- | --- |

Sodium hydroxide: 0,0538 g/100 g

| | Diclazuril: 0,2 g/100 g |
| --- | --- |

Diclazuril: 0,2 g/100 g

| | Soybean meal: 39,7 g/100 g |
| --- | --- |

Soybean meal: 39,7 g/100 g

| | Polyvidone K 30: 0,08 g/100 g |
| --- | --- |

Polyvidone K 30: 0,08 g/100 g

| | Sodium hydroxide: 0,0215 g/100 g |
| --- | --- |

Sodium hydroxide: 0,0215 g/100 g

| | Wheat middling: 60 g/100 g |
| --- | --- |

Wheat middling: 60 g/100 g

| | Active substance: | Diclazuril |
| --- | --- | --- |

Active substance:

Diclazuril

| | C17H9Cl3N4O2, |
| --- | --- |

C17H9Cl3N4O2,

| | (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile, |
| --- | --- |

(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,

| | CAS number: 101831-37-2 |
| --- | --- |

CAS number: 101831-37-2

| | Related impurities: | Degradation compound (R064318): ≤ 0,2 % |
| --- | --- | --- |

Related impurities:

Degradation compound (R064318): ≤ 0,2 %

| | Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually |
| --- | --- |

Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually

| | Total impurities: ≤ 1,5 % |
| --- | --- |

Total impurities: ≤ 1,5 %

Turkeys for fattening

12 weeks

1

1

—

28.2.2011

1 500 μg diclazuril/kg of wet liver

1 000 μg diclazuril/kg of wet kidney

500 μg diclazuril/kg of wet muscle

500 μg diclazuril/kg of wet skin/fat’

---

ANNEX III

‘ANNEX

| 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) in the relevant foodstuffs of animal origin |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff |
| Coccidiostats and other medicinal substances |
| E 771 | Janssen Pharmaceutica nv | Diclazuril
  0,5 g/100 g
  (Clinacox 0,5 % Premix)
  Diclazuril
  0,2 g/100 g
  (Clinacox 0,2 % Premix) | | Additive composition: | Diclazuril: 0,5 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) in the relevant foodstuffs of animal origin

mg of active substance/kg of complete feedingstuff

Coccidiostats and other medicinal substances

E 771

Janssen Pharmaceutica nv

Diclazuril

0,5 g/100 g

(Clinacox 0,5 % Premix)

Diclazuril

0,2 g/100 g

(Clinacox 0,2 % Premix)

Additive composition:

Diclazuril: 0,5 g/100 g

| | Soybean meal: 99,25 g/100 g |
| --- | --- |

Soybean meal: 99,25 g/100 g

| | Polyvidone K 30: 0,2 g/100 g |
| --- | --- |

Polyvidone K 30: 0,2 g/100 g

| | Sodium hydroxide: 0,0538 g/100 g |
| --- | --- |

Sodium hydroxide: 0,0538 g/100 g

| | Diclazuril: 0,2 g/100 g |
| --- | --- |

Diclazuril: 0,2 g/100 g

| | Soybean meal: 39,7 g/100 g |
| --- | --- |

Soybean meal: 39,7 g/100 g

| | Polyvidone K 30: 0,08 g/100 g |
| --- | --- |

Polyvidone K 30: 0,08 g/100 g

| | Sodium hydroxide: 0,0215 g/100 g |
| --- | --- |

Sodium hydroxide: 0,0215 g/100 g

| | Wheat middling: 60 g/100 g |
| --- | --- |

Wheat middling: 60 g/100 g

| | Active substance: | Diclazuril |
| --- | --- | --- |

Active substance:

Diclazuril

| | C17H9Cl3N4O2, |
| --- | --- |

C17H9Cl3N4O2,

| | (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile, |
| --- | --- |

(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,

| | CAS number: 101831-37-2 |
| --- | --- |

CAS number: 101831-37-2

| | Related impurities: | Degradation compound (R064318): ≤ 0,2 % |
| --- | --- | --- |

Related impurities:

Degradation compound (R064318): ≤ 0,2 %

| | Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually |
| --- | --- |

Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually

| | Total impurities: ≤ 1,5 % |
| --- | --- |

Total impurities: ≤ 1,5 %

Chickens reared for laying

16 weeks

1

1

—

20.1.2013

1 500  μg diclazuril/kg of wet liver

1 000  μg diclazuril/kg of wet kidney

500 μg diclazuril/kg of wet muscle

500 μg diclazuril/kg of wet skin/fat’

---