14 July 2016 EMA/CVMP/453264/2016 Committee for Medicinal Products for Veterinary Use

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits Procedure no: EMEA/V/MRL/003298/MODF/0004 Name of the substance: Aluminium salicylate, basic (INN) Basis for the opinion Pursuant to Article 3 of Regulation (EC) No 470/2009 of 6 May 2009, COOPHAVET submitted to the European Medicines Agency on 30 January 2013 an application for the modification of maximum residue limits for aluminium salicylate, basic to allow the establishment of a maximum residue limit in bovine milk. On 13 June 2013 the Committee for Medicinal Products for Veterinary Use adopted a list of questions to be addressed by the applicant. The response to the list of questions was submitted on 10 July 2014. On 9 October 2014 the Committee for Medicinal Products for Veterinary Use adopted an opinion recommending the establishment of provisional maximum residue limits for aluminium salicylate, basic for tissues in bovine and caprine species, Equidae and rabbits and for milk in bovine and caprine species and Equidae and adopted a list of questions to be addressed by the applicant. Commission Implementing Regulation (EU) 2015/1308 of 29 July 2015 established provisional maximum residue limits for aluminium salicylate, basic in bovine and caprine species, Equidae and rabbits. The provisional maximum residue limits expire on 31 December 2016. COOPHAVET submitted, on 24 March 2016, the responses to the list of questions further to the establishment of provisional maximum residue limits for bovine and caprine species, Equidae and rabbits.

Recommendation The Committee, having considered the response to the list of questions after the establishment of the provisional maximum residue limits, recommends by consensus the removal of the provisional status of the maximum residue limits for aluminium salicylate, basic in bovine, caprine, Equidae and rabbit and the modification of the entry for aluminium salicylate, basic in Table 1 (Allowed substances) of the Annex to Regulation (EU) No 37/2010 as follows: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

Pharmaco-

Marker

Animal

logically

residue

species

Salicylic acid

Bovine,

Target

Other

Therapeutic

tissues

provisions

classification

200 µg/kg

Muscle

NO ENTRY

Antidiarrhoeal and

MRLs

active substance Aluminium salicylate,

caprine,

500 µg/kg

Fat

anti-inflammatory

basic

Equidae,

1500 µg/kg

Liver

agents

rabbit

1500 µg/kg

Kidney

Bovine,

9 µg/kg

Milk

caprine, Equidae NOT APPLICABLE

All food

No MRL

NOT

For topical

producing

required

APPLICABLE

use only

species except bovine, caprine, Equidae, rabbit and fin fish

The Norwegian CVMP member agrees with the above-mentioned recommendation of the Committee. The scientific conclusions of the Committee are presented in the European public MRL assessment report (EPMAR), provided in Annex I of this opinion. The preliminary analytical method for monitoring of residues is appended to this opinion. The present opinion is forwarded to the European Commission and to the applicant together with its appendices. London, 14 July 2016

Signature on file

Dr David Murphy Chair, on behalf of the CVMP

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits EMA/CVMP/453264/2016

Page 2/2

Annex I European public MRL assessment report (EPMAR)

Opinion of the Committee for Medicinal Products for Veterinary Use on ...

Send a question via our website www.ema.europa.eu/contact ... The scientific conclusions of the Committee are presented in the European public MRL ...

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