# L_2016318EN.01000301.xml

| 24.11.2016 | EN | Official Journal of the European Union | L 318/3 |
| --- | --- | --- | --- |

24.11.2016

EN

Official Journal of the European Union

L 318/3

---

COMMISSION IMPLEMENTING REGULATION (EU) 2016/2045

of 23 November 2016

amending 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 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) | Article 17 of Regulation (EC) No 470/2009 requires that 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 established in a Regulation. |
| --- | --- |

(1)

Article 17 of Regulation (EC) No 470/2009 requires that 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 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. |
| --- | --- |

(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.

| (3) | Gamithromycin is already included in that table as an allowed substance for bovine species, applicable to fat, liver and kidney, excluding animals producing milk for human consumption and for porcine species, applicable to muscle, skin and fat, liver and kidney. |
| --- | --- |

(3)

Gamithromycin is already included in that table as an allowed substance for bovine species, applicable to fat, liver and kidney, excluding animals producing milk for human consumption and for porcine species, applicable to muscle, skin and fat, liver and kidney.

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

(4)

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

| (5) | 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. |
| --- | --- |

(5)

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.

| (6) | The EMA has considered that the extrapolation of the extended entry for gamithromycin to all ruminants except bovine is appropriate. |
| --- | --- |

(6)

The EMA has considered that the extrapolation of the extended entry for gamithromycin to all ruminants except bovine is appropriate.

| (7) | Regulation (EU) No 37/2010 should therefore be amended accordingly. |
| --- | --- |

(7)

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

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, |
| --- | --- |

(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.

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

Done at Brussels, 23 November 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

(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

---

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 | All ruminants except bovine | 50 μg/kg | Muscle | Not for use in animals producing milk for human consumption | Anti-infectious agents/Antibiotics’ |
| 50 μg/kg | Fat |
| 300 μg/kg | Liver |
| 200 μg/kg | Kidney |
| Bovine | 20 μg/kg | Fat |
| 200 μg/kg | Liver |
| 100 μg/kg | Kidney |
| Porcine | 100 μg/kg | Muscle | NO ENTRY |
| 100 μg/kg | Skin and fat in natural proportions |
| 100 μg/kg | Liver |
| 300 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

All ruminants except bovine

50 μg/kg

Muscle

Not for use in animals producing milk for human consumption

Anti-infectious agents/Antibiotics’

50 μg/kg

Fat

300 μg/kg

Liver

200 μg/kg

Kidney

Bovine

20 μg/kg

Fat

200 μg/kg

Liver

100 μg/kg

Kidney

Porcine

100 μg/kg

Muscle

NO ENTRY

100 μg/kg

Skin and fat in natural proportions

100 μg/kg

Liver

300 μg/kg

Kidney

---