# L_2007161EN.01002801.xml

| 22.6.2007 | EN | Official Journal of the European Union | L 161/28 |
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22.6.2007

EN

Official Journal of the European Union

L 161/28

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COMMISSION REGULATION (EC) No 703/2007

of 21 June 2007

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 Dihydrostreptomycin and Streptomycin

(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 opinion 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 Dihydrostreptomycin is included in Annex I to Regulation (EEC) No 2377/90 for all ruminants for muscle, fat, liver, kidney and milk as well as for porcine for muscle, skin and fat, liver and kidney. Following examination of an application for the extension to rabbits of the existing entry for Dihydrostreptomycin, it is considered appropriate to modify the entry for Dihydrostreptomycin to include rabbits. |
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(2)

The substance Dihydrostreptomycin is included in Annex I to Regulation (EEC) No 2377/90 for all ruminants for muscle, fat, liver, kidney and milk as well as for porcine for muscle, skin and fat, liver and kidney. Following examination of an application for the extension to rabbits of the existing entry for Dihydrostreptomycin, it is considered appropriate to modify the entry for Dihydrostreptomycin to include rabbits.

| (3) | The substance Streptomycin is included in Annex I to Regulation (EEC) No 2377/90 for bovine and ovine for muscle, fat, liver, kidney and milk as well as for porcine for muscle, skin and fat, liver and kidney. Following examination of the application for the extension to rabbits of the existing entry for Dihydrostreptomycin and taking account that the safety evaluation of the above referred two substances had been initially carried out together on the basis of their similarity in chemical structure and biological activity, it is also considered appropriate to modify the entry for Streptomycin to include rabbits for muscle, fat, liver and kidney. It was equally considered appropriate to modify the current entry of Streptomycin for bovine and ovine by a new entry for all ruminants for muscle, fat, liver, kidney and milk. |
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(3)

The substance Streptomycin is included in Annex I to Regulation (EEC) No 2377/90 for bovine and ovine for muscle, fat, liver, kidney and milk as well as for porcine for muscle, skin and fat, liver and kidney. Following examination of the application for the extension to rabbits of the existing entry for Dihydrostreptomycin and taking account that the safety evaluation of the above referred two substances had been initially carried out together on the basis of their similarity in chemical structure and biological activity, it is also considered appropriate to modify the entry for Streptomycin to include rabbits for muscle, fat, liver and kidney. It was equally considered appropriate to modify the current entry of Streptomycin for bovine and ovine by a new entry for all ruminants for muscle, fat, liver, kidney and milk.

| (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 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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(5)

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.

| (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

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 21 August 2007.

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

Done at Brussels, 21 June 2007.

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 287/2007 (OJ L 78, 17.3.2007, p. 13).

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

The following substances are replaced in Annex I (List of pharmacologically active substances for which maximum residue limits have been fixed):

1.   Anti-infectious agents

1.2.   Antibiotics

1.2.10.   Aminoglycosides

| Pharmacologically active substance(s) | Marker residue | Animal species | MRLs | Target issues |
| --- | --- | --- | --- | --- |
| ‘Dihydrostreptomycin | Dihydrostreptomycin | All ruminants | 500 μg/kg | Muscle |
| 500 μg/kg | Fat |
| 500 μg/kg | Liver |
| 1 000 μg/kg | Kidney |
| 200 μg/kg | Milk |
| Porcine | 500 μg/kg | Muscle |
| 500 μg/kg | Skin + fat |
| 500 μg/kg | Liver |
| 1 000 μg/kg | Kidney |
| Rabbits | 500 μg/kg | Muscle |
| 500 μg/kg | Fat |
| 500 μg/kg | Liver |
| 1 000 μg/kg | Kidney |
| Streptomycin | Streptomycin | All ruminants | 500 μg/kg | Muscle |
| 500 μg/kg | Fat |
| 500 μg/kg | Liver |
| 1 000 μg/kg | Kidney |
| 200 μg/kg | Milk |
| Porcine | 500 μg/kg | Muscle |
| 500 μg/kg | Skin + fat |
| 500 μg/kg | Liver |
| 1 000 μg/kg | Kidney |
| Rabbits | 500 μg/kg | Muscle |
| 500 μg/kg | Fat |
| 500 μg/kg | Liver |
| 1 000 μg/kg | Kidney’ |

Pharmacologically active substance(s)

Marker residue

Animal species

MRLs

Target issues

‘Dihydrostreptomycin

Dihydrostreptomycin

All ruminants

500 μg/kg

Muscle

500 μg/kg

Fat

500 μg/kg

Liver

1 000 μg/kg

Kidney

200 μg/kg

Milk

Porcine

500 μg/kg

Muscle

500 μg/kg

Skin + fat

500 μg/kg

Liver

1 000 μg/kg

Kidney

Rabbits

500 μg/kg

Muscle

500 μg/kg

Fat

500 μg/kg

Liver

1 000 μg/kg

Kidney

Streptomycin

Streptomycin

All ruminants

500 μg/kg

Muscle

500 μg/kg

Fat

500 μg/kg

Liver

1 000 μg/kg

Kidney

200 μg/kg

Milk

Porcine

500 μg/kg

Muscle

500 μg/kg

Skin + fat

500 μg/kg

Liver

1 000 μg/kg

Kidney

Rabbits

500 μg/kg

Muscle

500 μg/kg

Fat

500 μg/kg

Liver

1 000 μg/kg

Kidney’

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