Commission Implementing Regulation (EU) 2015/394 of 10 March 2015 amending the Annex to Regulation (EU) No 37/2010 as regards the substance ‘tulathromycin’ Text with EEA relevance

• CELEX: Implementing Regulation (EU) 2015/394
• Articles: 3

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 .

Schedules & Appendices

ANNEX

ANNEX

In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘tulathromycin’ 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

‘Tulathromycin

(2R,3S,4R,5R,8R,10R,11R,12S, 13S,14R)-2-ethyl-3,4,10,13-tetra-hydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethy-lamino)-ß-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopent-decan-15-one expressed as tulathromycin equivalents

Ovine, caprine

450 μg/kg

Muscle

Not for use in animals from which milk is produced for human consumption

Anti-infectious agents/Antibiotics’

250 μg/kg

Fat

5 400 μg/kg

Liver

1 800 μg/kg

Kidney

Bovine

300 μg/kg

Muscle

200 μg/kg

Fat

4 500 μg/kg

Liver

3 000 μg/kg

Kidney

Porcine

800 μg/kg

Muscle

300 μg/kg

Skin and fat in natural proportions

4 000 μg/kg

Liver

8 000 μg/kg

Kidney