Legalize / European Union / Implementing Regulation

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

Type Implementing Regulation

Publication 2015-03-11

State In force

Text As published

Department European Commission

Source EUR-Lex

articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API


11.3.2015	EN	Official Journal of the European Union	L 66/1

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) 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 to be established in accordance with Regulation (EC) No 470/2009.

(2) Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 ².

(3) Tulathromycin is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine, porcine, ovine and caprine species, applicable to muscle, fat (skin and fat for porcine species), liver and kidney, excluding animals producing milk for human consumption. The provisional MRLs for that substance set out for bovine and porcine species expire on 1 January 2015.

(4) Additional data was provided and assessed by the Committee for Medicinal Products for Veterinary Use who recommended that the provisional MRLs for tulathromycin in bovine and porcine species should be set as definitive.

(5) In accordance with Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency 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. The Committee for Medicinal Products for Veterinary Use concluded that the extrapolation to other food producing species cannot be supported for this substance.

(6) The entry for tulathromycin in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly.

(7) 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, 10 March 2015.

For the Commission

The President

Jean-Claude JUNCKER

OJ L 152, 16.6.2009, p. 11.

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 ‘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’
‘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	250 μg/kg	Fat	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	5 400 μg/kg	Liver	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	1 800 μg/kg	Kidney	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	Bovine	300 μg/kg	Muscle	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	Bovine	200 μg/kg	Fat	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	Bovine	4 500 μg/kg	Liver	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	Bovine	3 000 μg/kg	Kidney	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	Porcine	800 μg/kg	Muscle	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	Porcine	300 μg/kg	Skin and fat in natural proportions	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	Porcine	4 000 μg/kg	Liver	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’
‘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	Porcine	8 000 μg/kg	Kidney	Not for use in animals from which milk is produced for human consumption	Anti-infectious agents/Antibiotics’

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.