# L_2006343EN.01006601.xml

| 8.12.2006 | EN | Official Journal of the European Union | L 343/66 |
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8.12.2006

EN

Official Journal of the European Union

L 343/66

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COMMISSION REGULATION (EC) No 1805/2006

of 7 December 2006

amending Annex I 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 thiamphenicol, fenvalerate and meloxicam

(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 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) | The substance thiamphenicol is included in Annex I to Regulation (EEC) No 2377/90 for bovine species for muscle, fat, liver, kidney and milk as well as for chicken for muscle, skin and fat, liver and kidney, excluding animals which produce eggs for human consumption. Thiamphenicol is also included in Annex III to that Regulation for porcine species for muscle, skin and fat, liver and kidney. Following examination of the information provided by the applicant for the establishment of final maximum residues limits for thiamphenicol in porcine species, it is considered appropriate to modify the entry of thiamphenicol in Annex I to Regulation (EEC) No 2377/90 to all food-producing species for muscle, fat, liver, kidney and milk, excluding animals which produce eggs for human consumption. The maximum residue limits for fat, liver and kidney should not apply to fin fish. |
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(2)

The substance thiamphenicol is included in Annex I to Regulation (EEC) No 2377/90 for bovine species for muscle, fat, liver, kidney and milk as well as for chicken for muscle, skin and fat, liver and kidney, excluding animals which produce eggs for human consumption. Thiamphenicol is also included in Annex III to that Regulation for porcine species for muscle, skin and fat, liver and kidney. Following examination of the information provided by the applicant for the establishment of final maximum residues limits for thiamphenicol in porcine species, it is considered appropriate to modify the entry of thiamphenicol in Annex I to Regulation (EEC) No 2377/90 to all food-producing species for muscle, fat, liver, kidney and milk, excluding animals which produce eggs for human consumption. The maximum residue limits for fat, liver and kidney should not apply to fin fish.

| (3) | The substance fenvalerate is included in Annex III to Regulation (EEC) No 2377/90 for bovine for muscle, fat, liver, kidney and milk. Those provisional maximum residue limits expire on 1 July 2006. Following examination of the information provided by the applicant for the establishment of final maximum residues for fenvalerate limits for bovine species, it is considered appropriate to include fenvalerate in Annex I to Regulation (EEC) No 2377/90 for bovine species for muscle, fat, liver, kidney and milk. |
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(3)

The substance fenvalerate is included in Annex III to Regulation (EEC) No 2377/90 for bovine for muscle, fat, liver, kidney and milk. Those provisional maximum residue limits expire on 1 July 2006. Following examination of the information provided by the applicant for the establishment of final maximum residues for fenvalerate limits for bovine species, it is considered appropriate to include fenvalerate in Annex I to Regulation (EEC) No 2377/90 for bovine species for muscle, fat, liver, kidney and milk.

| (4) | The substance meloxicam is included in Annex I to Regulation (EEC) No 2377/90 for bovine, porcine and equidae species for muscle, liver and kidney as well as for bovine species for milk. Following examination of an application for the establishment of maximum residues limits for meloxicam in rabbits and caprine species for milk, it is considered appropriate to modify the entry of meloxicam in that Annex for rabbits and caprine species for muscle, liver and kidney as well as to caprine species for milk. |
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(4)

The substance meloxicam is included in Annex I to Regulation (EEC) No 2377/90 for bovine, porcine and equidae species for muscle, liver and kidney as well as for bovine species for milk. Following examination of an application for the establishment of maximum residues limits for meloxicam in rabbits and caprine species for milk, it is considered appropriate to modify the entry of meloxicam in that Annex for rabbits and caprine species for muscle, liver and kidney as well as to caprine species for milk.

| (5) | Regulation (EEC) No 2377/90 should therefore be amended accordingly. |
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(5)

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

| (6) | An adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any adjustment which may be necessary 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) to take account of the provisions of this Regulation. |
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(6)

An adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any adjustment which may be necessary 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) to take account of the provisions of this Regulation.

| (7) | 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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(7)

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

Annex I to Regulation (EEC) No 2377/90 is 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 8 February 2007.

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

Done at Brussels, 7 December 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 1729/2006 (OJ L 325, 24.11.2006, p. 6).

1

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

2

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ANNEX

The following substance is inserted in Annex I to Regulation (EEC) No 2377/90 (List of pharmacologically active substances for which maximum residue limits have been fixed):

1.   Anti-infectious agents

1.2.   Antibiotics

1.2.5.   Florfenicol and related compounds

| Pharmacologically active Substance(s) | Marker residue | Animal species | MRLs | Target tissues |
| --- | --- | --- | --- | --- |
| ‘Thiamphenicol | Thiamphenicol | All food producing species (1) | 50 μg/kg | Muscle (2) |
| 50 μg/kg | Fat (3) |
| 50 μg/kg | Liver |
| 50 μg/kg | Kidney |
| 50 μg/kg | Milk |

Pharmacologically active Substance(s)

Marker residue

Animal species

MRLs

Target tissues

‘Thiamphenicol

Thiamphenicol

All food producing species (1)

50 μg/kg

Muscle (2)

50 μg/kg

Fat (3)

50 μg/kg

Liver

50 μg/kg

Kidney

50 μg/kg

Milk

2.   Anti-parasitic agents

2.2.   Agents acting against ectoparasites

2.2.3.   Pyrethroids

| Pharmacologically active Substance(s) | Marker residue | Animal species | MRLs | Target tissues |
| --- | --- | --- | --- | --- |
| ‘Fenvalerate | Fenvalerate (sum of RR, SS, RS and SR isomers) | Bovine | 25 μg/kg | Muscle |
| 250 μg/kg | Fat |
| 25 μg/kg | Liver |
| 25 μg/kg | Kidney |
| 40 μg/kg | Milk’ |

Pharmacologically active Substance(s)

Marker residue

Animal species

MRLs

Target tissues

‘Fenvalerate

Fenvalerate (sum of RR, SS, RS and SR isomers)

Bovine

25 μg/kg

Muscle

250 μg/kg

Fat

25 μg/kg

Liver

25 μg/kg

Kidney

40 μg/kg

Milk’

4.   Anti-inflammatory agents

4.1.   Non-steroidal anti-inflammatory agents

4.1.4.   Oxicam derivatives

| Pharmacologically active Substance(s) | Marker residue | Animal species | MRLs | Target tissues |
| --- | --- | --- | --- | --- |
| ‘Meloxicam | Meloxicam | Porcine, equidae, rabbit | 20 μg/kg | Muscle |
| 65 μg/kg | Liver |
| 65 μg/kg | Kidney |
| Bovine, caprine | 20 μg/kg | Muscle |
| 65 μg/kg | Liver |
| 65 μg/kg | Kidney |
| 15 μg/kg | Milk’ |

Pharmacologically active Substance(s)

Marker residue

Animal species

MRLs

Target tissues

‘Meloxicam

Meloxicam

Porcine, equidae, rabbit

20 μg/kg

Muscle

65 μg/kg

Liver

65 μg/kg

Kidney

Bovine, caprine

20 μg/kg

Muscle

65 μg/kg

Liver

65 μg/kg

Kidney

15 μg/kg

Milk’

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(1)  Not for use in animals from which eggs are produced for human consumption, MRLs for fat, liver and kidney do not apply to fin fish.

1

(2)  For fin fish muscle relates to “muscle and skin in natural proportions”.

2

(3)  For porcine and poultry species this MRL relates to “skin and fat in natural proportions”.’

3

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