# L_2012338EN.01002001.xml

| 12.12.2012 | EN | Official Journal of the European Union | L 338/20 |
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12.12.2012

EN

Official Journal of the European Union

L 338/20

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COMMISSION IMPLEMENTING REGULATION (EU) No 1186/2012

of 11 December 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 phoxim

(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 of 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. |
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(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 MRLs 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). |
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(2)

Pharmacologically active substances and their classification regarding MRLs 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) | Phoxim is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for ovine species, applicable to muscle, fat and kidney, for porcine species, applicable to muscle, skin and fat, liver and kidney and for chicken, applicable to muscle, skin and fat, liver, kidney and eggs, excluding animals producing milk for human consumption. |
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(3)

Phoxim is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for ovine species, applicable to muscle, fat and kidney, for porcine species, applicable to muscle, skin and fat, liver and kidney and for chicken, applicable to muscle, skin and fat, liver, kidney and eggs, excluding animals producing milk for human consumption.

| (4) | An application for the extension of the existing entry for phoxim to include bovine species has been submitted to the European Medicines Agency. |
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(4)

An application for the extension of the existing entry for phoxim to include bovine species has been submitted to the European Medicines Agency.

| (5) | According to Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species. The Committee for Medicinal Products for Veterinary Use recommended establishing a MRL for phoxim for bovine species applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption, and the extrapolation of the MRLs for phoxim from ovine, bovine and porcine species, and chicken to all food-producing species except fin fish, applicable to muscle, fat, liver, kidney and eggs, excluding animals producing milk for human consumption. |
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(5)

According to Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species. The Committee for Medicinal Products for Veterinary Use recommended establishing a MRL for phoxim for bovine species applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption, and the extrapolation of the MRLs for phoxim from ovine, bovine and porcine species, and chicken to all food-producing species except fin fish, applicable to muscle, fat, liver, kidney and eggs, excluding animals producing milk for human consumption.

| (6) | The entry for phoxim in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include all food-producing species except fin fish. |
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(6)

The entry for phoxim in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include all food-producing species except fin fish.

| (7) | It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL. |
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(7)

It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL.

| (8) | 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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(8)

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 that of its publication in the Official Journal of the European Union.

It shall apply from 13 February 2013.

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

Done at Brussels, 11 December 2012.

For the Commission

The President

José Manuel BARROSO

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

1

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

2

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ANNEX

The entry corresponding to phoxim 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 |
| --- | --- | --- | --- | --- | --- | --- |
| ‘Phoxim | Phoxim | All food-producing species except fin fish. | 25  μg/kg | Muscle | For porcine and poultry species the fat MRL relates to “skin and fat in natural proportions”.
  Not for use in animals from which milk is produced for human consumption. | Antiparasitic agents/Agents against ectoparasites.’ |
| 550  μg/kg | Fat |
| 50  μg/kg | Liver |
| 30  μg/kg | Kidney |
| 60  μg/kg | Eggs |

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

‘Phoxim

Phoxim

All food-producing species except fin fish.

25  μg/kg

Muscle

For porcine and poultry species the fat MRL relates to “skin and fat in natural proportions”.

Not for use in animals from which milk is produced for human consumption.

Antiparasitic agents/Agents against ectoparasites.’

550  μg/kg

Fat

50  μg/kg

Liver

30  μg/kg

Kidney

60  μg/kg

Eggs

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