# L_2016148EN.01000101.xml

| 4.6.2016 | EN | Official Journal of the European Union | L 148/1 |
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4.6.2016

EN

Official Journal of the European Union

L 148/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/885

of 3 June 2016

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

(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) | 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.

| (3) | Eprinomectin is already included in that table as an allowed substance, for bovine, ovine and caprine species, applicable to muscle, fat, liver, kidney and milk. The provisional MRLs for that substance set out for ovine and caprine species, applicable to muscle, fat, liver, kidney and milk expire on 30 June 2016. |
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(3)

Eprinomectin is already included in that table as an allowed substance, for bovine, ovine and caprine species, applicable to muscle, fat, liver, kidney and milk. The provisional MRLs for that substance set out for ovine and caprine species, applicable to muscle, fat, liver, kidney and milk expire on 30 June 2016.

| (4) | Additional data was provided and assessed by the Committee for Medicinal Products for Veterinary Use, who recommended that the provisional MRLs for eprinomectin in ovine and caprine species should be set as definitive. |
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(4)

Additional data was provided and assessed by the Committee for Medicinal Products for Veterinary Use, who recommended that the provisional MRLs for eprinomectin in ovine and caprine species should be set as definitive.

| (5) | According to Article 5 of Regulation (EC) No 470/2009, the European Medicines Agency (hereinafter ‘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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(5)

According to Article 5 of Regulation (EC) No 470/2009, the European Medicines Agency (hereinafter ‘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 existing entry for eprinomectin to all ruminants is appropriate. |
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(6)

The EMA has considered that the extrapolation of the existing entry for eprinomectin to all ruminants is appropriate.

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

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

Done at Brussels, 3 June 2016.

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 ‘eprinomectin’ 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 |
| --- | --- | --- | --- | --- | --- | --- |
| ‘Eprinomectin | Eprinomectin B1a | All ruminants | 50 μg/kg
  250 μg/kg
  1 500 μg/kg
  300 μg/kg
  20 μg/kg | Muscle
  Fat
  Liver
  Kidney
  Milk | NO ENTRY | Antiparasitic agents/Agents against endo- and ectoparasites’ |

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

‘Eprinomectin

Eprinomectin B1a

All ruminants

50 μg/kg

250 μg/kg

1 500 μg/kg

300 μg/kg

20 μg/kg

Muscle

Fat

Liver

Kidney

Milk

NO ENTRY

Antiparasitic agents/Agents against endo- and ectoparasites’

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