# L_2006325EN.01000601.xml

| 24.11.2006 | EN | Official Journal of the European Union | L 325/6 |
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24.11.2006

EN

Official Journal of the European Union

L 325/6

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COMMISSION REGULATION (EC) No 1729/2006

of 23 November 2006

amending Annexes I and III to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards firocoxib and triclabendazole

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (1), and in particular Article 2 and the third paragraph of Article 4 thereof,

Having regard to the opinions of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,

Whereas:

| (1) | All pharmacologically active substances used in the Community in veterinary medicinal products intended for food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90. |
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(1)

All pharmacologically active substances used in the Community in veterinary medicinal products intended for food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90.

| (2) | Following examination of an application for the establishment of maximum residue limits for firocoxib in Equidae and in order to allow for the completion of minor scientific validation of studies, it is considered appropriate to include firocoxib in Annex III to Regulation (EEC) No 2377/90 for Equidae species. |
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(2)

Following examination of an application for the establishment of maximum residue limits for firocoxib in Equidae and in order to allow for the completion of minor scientific validation of studies, it is considered appropriate to include firocoxib in Annex III to Regulation (EEC) No 2377/90 for Equidae species.

| (3) | The substance triclabendazole is included in Annex I to Regulation (EEC) No 2377/90 for bovine and ovine for muscle, kidney and liver, excluding animals producing milk for human consumption. Following examination of an application for the modification of those maximum residue limits, it is considered appropriate to include triclabendazole in that Annex for all ruminants for muscle, fat, liver and kidney, excluding animals producing milk for human consumption amending the maximum residue limits values. |
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(3)

The substance triclabendazole is included in Annex I to Regulation (EEC) No 2377/90 for bovine and ovine for muscle, kidney and liver, excluding animals producing milk for human consumption. Following examination of an application for the modification of those maximum residue limits, it is considered appropriate to include triclabendazole in that Annex for all ruminants for muscle, fat, liver and kidney, excluding animals producing milk for human consumption amending the maximum residue limits values.

| (4) | Regulation (EEC) No 2377/90 should therefore be amended accordingly. |
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(4)

Regulation (EEC) No 2377/90 should therefore be amended accordingly.

| (5) | An adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any necessary adjustment in the light of this Regulation to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (2). |
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(5)

An adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any necessary adjustment in the light of this Regulation to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (2).

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, |
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(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and III to Regulation (EEC) No 2377/90 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

It shall apply from 21 January 2007.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 November 2006.

For the Commission

Günter VERHEUGEN

Vice-President

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(1)  
  OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1451/2006 (OJ L 271, 30.9.2006, p. 37).

1

(2)  
  OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

2

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ANNEX

A.   The following substance is inserted in Annex I to Regulation (EEC) No 2377/90:

2.   Antiparasitic agents

2.1.   Agents acting against endoparasites

2.1.3.   Benzimidazoles and pro-benzimidazoles

| Pharmacologically active substance(s) | Marker residue | Animal species | MRLs | Target tissues |
| --- | --- | --- | --- | --- |
| ‘Triclabendazole | Sum of extractable residues that may be oxidised to ketotriclabendazole | All ruminants (1) | 225  μg/kg | Muscle |
| 100  μg/kg | Fat |
| 250  μg/kg | Liver |
| 150  μg/kg | Kidney |

Pharmacologically active substance(s)

Marker residue

Animal species

MRLs

Target tissues

‘Triclabendazole

Sum of extractable residues that may be oxidised to ketotriclabendazole

All ruminants (1)

225  μg/kg

Muscle

100  μg/kg

Fat

250  μg/kg

Liver

150  μg/kg

Kidney

B.   The following substance is inserted in Annex III to Regulation (EEC) No 2377/90:

5.   Anti-inflammatory agents

5.1.   Non-steroidal anti-inflammatory agents

5.1.4.   Sulfonated phenyl lactones

| Pharmacologically active substance(s) | Marker residue | Animal species | MRLs | Target tissues |
| --- | --- | --- | --- | --- |
| ‘Firocoxib
   (2) | Firocoxib | Equidae | 10  μg/kg | Muscle |
| 15  μg/kg | Fat |
| 60  μg/kg | Liver |
| 10  μg/kg | Kidney |

Pharmacologically active substance(s)

Marker residue

Animal species

MRLs

Target tissues

‘Firocoxib
   (2)

Firocoxib

Equidae

10  μg/kg

Muscle

15  μg/kg

Fat

60  μg/kg

Liver

10  μg/kg

Kidney

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(1)  Not for use in animals producing milk for human consumption.’

1

(2)  Provisional MRLs expire on 1 July 2007.’

2

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