# L_2015026EN.01001001.xml

| 31.1.2015 | EN | Official Journal of the European Union | L 26/10 |
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31.1.2015

EN

Official Journal of the European Union

L 26/10

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/150

of 30 January 2015

amending the Annex to Regulation (EU) No 37/2010 as regards the substance ‘gamithromycin’

(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 is to 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 is to 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 (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 (2).

| (3) | Gamithromycin is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance for bovine species, applicable to fat, liver and kidney, excluding animals producing milk for human consumption. |
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(3)

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

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

An application for the extension of the existing entry for gamithromycin to porcine species has been submitted to the European Medicines Agency.

| (5) | In accordance with 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 concluded that the extrapolation to other food producing species cannot be supported for this substance. |
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(5)

In accordance with 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 concluded that the extrapolation to other food producing species cannot be supported for this substance.

| (6) | The entry for gamithromycin in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for porcine species. |
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(6)

The entry for gamithromycin in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for porcine species.

| (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 twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 April 2015.

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

Done at Brussels, 30 January 2015.

For the Commission

The President

Jean-Claude JUNCKER

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

1

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

2

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ANNEX

In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘gamithromycin’ is replaced by the following:

| Pharmacologically active Substance | Marker residue | Animal Species | MRLs | Target Tissues | Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009) | Therapeutic Classification |
| --- | --- | --- | --- | --- | --- | --- |
| ‘Gamithromycin | Gamithromycin | Porcine | 100 μg/kg | Muscle | NO ENTRY | Anti-infectious agents/Antibiotics’ |
| 100 μg/kg | Skin and fat in natural proportions |
| 100 μg/kg | Liver |
| 300 μg/kg | Kidney |
| Bovine | 20 μg/kg | Fat | Not for use in animals producing milk for human consumption. |
| 200 μg/kg | Liver |
| 100 μg/kg | Kidney |

Pharmacologically active Substance

Marker residue

Animal Species

MRLs

Target Tissues

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

Therapeutic Classification

‘Gamithromycin

Gamithromycin

Porcine

100 μg/kg

Muscle

NO ENTRY

Anti-infectious agents/Antibiotics’

100 μg/kg

Skin and fat in natural proportions

100 μg/kg

Liver

300 μg/kg

Kidney

Bovine

20 μg/kg

Fat

Not for use in animals producing milk for human consumption.

200 μg/kg

Liver

100 μg/kg

Kidney

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