# L_2015231EN.01001001.xml

| 4.9.2015 | EN | Official Journal of the European Union | L 231/10 |
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4.9.2015

EN

Official Journal of the European Union

L 231/10

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1492

of 3 September 2015

amending Regulation (EU) No 37/2010 as regards the substance ‘tylvalosin’

(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,

1

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

Whereas:

| (1) | Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (hereinafter ‘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 established in a regulation. |
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(1)

Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (hereinafter ‘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 established in a regulation.

| (2) | Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin. |
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(2)

Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

2

| (3) | Tylvalosin is currently included in that table as an allowed substance, for porcine and poultry species, applicable to muscle, skin and fat, liver and kidney in porcine species and to skin and fat and liver in poultry species, excluding animals producing eggs for human consumption. |
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(3)

Tylvalosin is currently included in that table as an allowed substance, for porcine and poultry species, applicable to muscle, skin and fat, liver and kidney in porcine species and to skin and fat and liver in poultry species, excluding animals producing eggs for human consumption.

| (4) | An application for the extension of the existing entry for tylvalosin to chicken eggs has been submitted to the European Medicines Agency (hereinafter ‘EMA’). |
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(4)

An application for the extension of the existing entry for tylvalosin to chicken eggs has been submitted to the European Medicines Agency (hereinafter ‘EMA’).

| (5) | The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use has recommended the establishment of a MRL for chicken eggs. |
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(5)

The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use has recommended the establishment of a MRL for chicken eggs.

| (6) | According to Article 5 of Regulation (EC) No 470/2009 the EMA 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. |
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(6)

According to Article 5 of Regulation (EC) No 470/2009 the EMA 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.

| (7) | The EMA has considered that the extrapolation of the MRLs for tylvalosin from chicken eggs to eggs of other poultry species is appropriate. |
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(7)

The EMA has considered that the extrapolation of the MRLs for tylvalosin from chicken eggs to eggs of other poultry species is appropriate.

| (8) | Regulation (EU) No 37/2010 should therefore be amended accordingly. |
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(8)

Regulation (EU) No 37/2010 should therefore be amended accordingly.

| (9) | It is appropriate to grant the stakeholders concerned a reasonable period of time to take measures that may be required to comply with the new MRL. |
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(9)

It is appropriate to grant the stakeholders concerned a reasonable period of time to take measures that may be required to comply with the new MRL.

| (10) | 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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(10)

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.

Official Journal of the European Union

It shall apply from 3 November 2015.

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

Done at Brussels, 3 September 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 'tylvalosin' 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 |
| --- | --- | --- | --- | --- | --- | --- |
| ‘Tylvalosin | Tylvalosin | Porcine | 50 μg/kg
  50 μg/kg
  50 μg/kg
  50 μg/kg | Muscle
  Skin and fat
  Liver
  Kidney | NO ENTRY | Anti-infectious agents/Antibiotics’ |
| Poultry | 200 μg/kg | Eggs |
| Sum of Tylvalosin and 3-0-acetyltylosin | Poultry | 50 μg/kg
  50 μg/kg | Skin and fat
  Liver |

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

‘Tylvalosin

Tylvalosin

Porcine

50 μg/kg

50 μg/kg

50 μg/kg

50 μg/kg

Muscle

Skin and fat

Liver

Kidney

NO ENTRY

Anti-infectious agents/Antibiotics’

Poultry

200 μg/kg

Eggs

Sum of Tylvalosin and 3-0-acetyltylosin

Poultry

50 μg/kg

50 μg/kg

Skin and fat

Liver

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