# L_2012040EN.01000401.xml

| 14.2.2012 | EN | Official Journal of the European Union | L 40/4 |
| --- | --- | --- | --- |

14.2.2012

EN

Official Journal of the European Union

L 40/4

---

COMMISSION IMPLEMENTING REGULATION (EU) No 123/2012

of 13 February 2012

amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance monepantel

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,

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

Whereas:

| (1) | The maximum residue limit (MRL) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry should be established in accordance with Regulation (EC) No 470/2009. |
| --- | --- |

(1)

The maximum residue limit (MRL) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry should be established in accordance with Regulation (EC) No 470/2009.

| (2) | Pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (2). |
| --- | --- |

(2)

Pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (2).

| (3) | Monepantel is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for ovine and caprine species, applicable to muscle, fat, liver, and kidney, excluding animals producing milk for human consumption. The provisional maximum residue limits for that substance set out for caprine species expired on 1 January 2012. |
| --- | --- |

(3)

Monepantel is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for ovine and caprine species, applicable to muscle, fat, liver, and kidney, excluding animals producing milk for human consumption. The provisional maximum residue limits for that substance set out for caprine species expired on 1 January 2012.

| (4) | Additional data were provided and assessed leading the Committee for Medicinal Products for Veterinary Use to recommend that the provisional MRLs for monepantel for caprine species should be set as definitive. |
| --- | --- |

(4)

Additional data were provided and assessed leading the Committee for Medicinal Products for Veterinary Use to recommend that the provisional MRLs for monepantel for caprine species should be set as definitive.

| (5) | The entry for monepantel in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly. |
| --- | --- |

(5)

The entry for monepantel in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly.

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

(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

The Annex to Regulation (EU) No 37/2010 is amended as set out in 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.

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

Done at Brussels, 13 February 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 152, 16.6.2009, p. 11.

1

(2)  
  OJ L 15, 20.1.2010, p. 1.

2

---

ANNEX

The entry monepantel in Table 1 of the Annex to Regulation (EU) No 37/2010 is replaced by the following:

| Pharmacologically active Substance | Marker residue | Animal Species | MRL | Target Tissues | Other Provisions
  (according to Article 14(7) of Regulation (EC) No 470/2009) | Therapeutic Classification |
| --- | --- | --- | --- | --- | --- | --- |
| ‘Monepantel | Monepantel-sulfone | Ovine, caprine | 700  μg/kg | Muscle | Not for use in animals producing milk for human consumption. | Antiparasitic agents/Agents acting against endoparasites’ |
| 7 000  μg/kg | Fat |
| 5 000  μg/kg | Liver |
| 2 000  μg/kg | Kidney |

Pharmacologically active Substance

Marker residue

Animal Species

MRL

Target Tissues

Other Provisions

(according to Article 14(7) of Regulation (EC) No 470/2009)

Therapeutic Classification

‘Monepantel

Monepantel-sulfone

Ovine, caprine

700  μg/kg

Muscle

Not for use in animals producing milk for human consumption.

Antiparasitic agents/Agents acting against endoparasites’

7 000  μg/kg

Fat

5 000  μg/kg

Liver

2 000  μg/kg

Kidney

---