# Commission Regulation (EC) No 500/2007 of 7 May 2007 amending Regulation (EC) No 1463/2004 as regards the introduction of a maximum residue limit for the feed additive ‘Sacox 120 microGranulate’, belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)

EU Regulation No 500/2007 · adopted 7 May 2007

Commission Regulation (EC) No 500/2007 of 7 May 2007 amending Regulation (EC) No 1463/2004 as regards the introduction of a maximum residue limit for the feed additive ‘Sacox 120 microGranulate’, belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)

## Introductory text

Commission Regulation (EC) No 500/2007
of 7 May 2007
amending Regulation (EC) No 1463/2004 as regards the introduction of a maximum residue limit for the feed additive ‘Sacox 120 microGranulate’, belonging to the group of coccidiostats and other medicinal substances
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 13(3) thereof,
Whereas:
(1)
The additive salinomycin sodium (Sacox 120 microGranulate) was authorised under certain conditions in accordance with Council Directive 70/524/EEC. Commission Regulation (EC) No 1463/2004 authorised that additive for 10 years for use for chickens for fattening, linking the authorisation to the person responsible for putting that additive into circulation. That additive was notified as an existing product on the basis of Article 10 of Regulation (EC) No 1831/2003. Since all the information required under that provision was submitted, that additive was entered into the Community Register of Feed Additives.
(2)
Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority). The holder of the authorisation of the additive salinomycin sodium (Sacox 120 microGranulate) has submitted an application which proposes changing the conditions of the authorisation by introducing a maximum residue limit (MRL) as evaluated by the Authority.
(3)
In its opinion adopted on 30 June 2004, the Authority proposed to establish an MRL of 5 μg/kg for the active substance concerned. It may be necessary to review that MRL in the light of the results of a future evaluation of that active substance by the European Agency for the Evaluation of Medicinal Products.
(4)
Regulation (EC) No 1463/2004 should therefore be amended accordingly.
(5)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:

## 1 

The Annex to Regulation (EC) No 1463/2004 is replaced by the text in the Annex to this Regulation.

## 2 

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

## Signature

This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 May 2007.
For the Commission
Markos Kyprianou
Member of the Commission

## 

Registration number of additive
Name and registration number of person responsible for putting additive into circulation
Additive(Trade name)
Composition, chemical formula, description
Species or category of animal
Maximum age
Minimum content
Maximum content
Other provisions
End of period of authorisation
Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
Coccidiostats and other medicinal substances
E 766
Huvepharma NV Belgium
Salinomycin sodium 120 g/kg
(Sacox 120 microGranulate)
Additive composition:
Salinomycin sodium ≥ 120 g/kg
Silicon dioxide 10-100 g/kg
Calcium carbonate 350-700 g/kg
Active substance:
Salinomycin sodium,
C42H69O11Na,
CAS number: 55 721-31-8,
Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (DSM 12217)
Related impurities:
< 42 mg elaiophylin/kg salinomycin sodium.
< 40 g 17-epi-20-desoxy-salinomycin/kg salinomycin sodium
Chickens for fattening
—
60
70
Use prohibited at least one day before slaughter.
Indicate in the instructions for use:
‘Dangerous for equines and turkeys’;
‘This feedingstuff contains an ionophore:
simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated’
21.8.2014
5 μg of Salinomycin/kg for all wet tissues

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Source: https://www.legislation.gov.uk/eur/2007/500 (the official version)
Page: https://openlegislation.uk/eu-regulation-2007-500
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.