Help Print this page 

Document 32018R0722

Title and reference
Commission Implementing Regulation (EU) 2018/722 of 16 May 2018 amending Regulation (EU) No 37/2010 to classify the substance eprinomectin as regards its maximum residue limit (Text with EEA relevance. )

C/2018/2797
  • Date of entry into force unknown (pending notification) or not yet in force., Date of effect: 06/06/2018
OJ L 122, 17.5.2018, p. 8–10 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

ELI: http://data.europa.eu/eli/reg_impl/2018/722/oj
Languages, formats and link to OJ
BG ES CS DA DE ET EL EN FR GA HR IT LV LT HU MT NL PL PT RO SK SL FI SV
HTML html BG html ES html CS html DA html DE html ET html EL html EN html FR html HR html IT html LV html LT html HU html MT html NL html PL html PT html RO html SK html SL html FI html SV
PDF pdf BG pdf ES pdf CS pdf DA pdf DE pdf ET pdf EL pdf EN pdf FR pdf HR pdf IT pdf LV pdf LT pdf HU pdf MT pdf NL pdf PL pdf PT pdf RO pdf SK pdf SL pdf FI pdf SV
Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal Display Official Journal
 To see if this document has been published in an e-OJ with legal value, click on the icon above (For OJs published before 1st July 2013, only the paper version has legal value).
Multilingual display
Text

17.5.2018   

EN

Official Journal of the European Union

L 122/8


COMMISSION IMPLEMENTING REGULATION (EU) 2018/722

of 16 May 2018

amending Regulation (EU) No 37/2010 to classify the substance eprinomectin as regards its maximum residue limit

(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 (‘EMA’) 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.

(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 all ruminants, applicable to muscle, fat, liver, kidney and milk.

(4)

An application for the extension of the existing entry for eprinomectin to fin fish has been submitted to EMA.

(5)

EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for eprinomectin in fin fish.

(6)

According to Article 5 of Regulation (EC) No 470/2009, 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)

EMA has considered that the extrapolation of the entry for eprinomectin to the tissues of horses and rabbits is appropriate.

(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.

(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.

It shall apply from 16 July 2018.

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

Done at Brussels, 16 May 2018.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 152, 16.6.2009, p. 11.

(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).


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

MRLs

Target Tissues

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

Therapeutic Classification

‘Eprinomectin

Eprinomectin B1a

All ruminants, equidae

50 μg/kg

Muscle

NO ENTRY

Antiparasitic agents/Agents acting against endo- and ectoparasites’

250 μg/kg

Fat

1 500 μg/kg

Liver

300 μg/kg

Kidney

20 μg/kg

Milk

Fin fish

50 μg/kg

Muscle and skin in natural proportions

Rabbits

50 μg/kg

Muscle

250 μg/kg

Fat

1 500 μg/kg

Liver

300 μg/kg

Kidney


Top