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Document 02004R1356-20190219
Commission Regulation (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive Elancoban in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)Text with EEA relevance
Consolidated text: Commission Regulation (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive Elancoban in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)Text with EEA relevance
Commission Regulation (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive Elancoban in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)Text with EEA relevance
02004R1356 — EN — 19.02.2019 — 003.001
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COMMISSION REGULATION (EC) No 1356/2004 of 26 July 2004 concerning the authorisation for 10 years of the additive ‘Elancoban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (OJ L 251 27.7.2004, p. 6) |
Amended by:
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Official Journal |
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No |
page |
date |
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L 31 |
4 |
6.2.2007 |
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L 298 |
5 |
7.11.2008 |
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COMMISSION IMPLEMENTING REGULATION (EU) 2019/138 of 29 January 2019 |
L 26 |
1 |
30.1.2019 |
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COMMISSION REGULATION (EC) No 1356/2004
of 26 July 2004
concerning the authorisation for 10 years of the additive ‘Elancoban’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances
(Text with EEA relevance)
Article 1
Chapter I of Annex B to Directive 70/524/EEC is amended as follows:
The additive monensin sodium, belonging to the group ‘Coccidiostats and other medical substances’, shall be deleted.
Article 2
The additive Elancoban belonging to the group ‘Coccidiostats and other medical substances’, as set out in the Annex to the present Regulation is authorised for use in animal nutrition under the conditions laid down in that Annex.
Article 3
A period of six months from the date of entry into force of this Regulation is permitted to use up the existing stocks of monensin sodium.
Article 4
This Regulation shall enter into force on the third 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.
ANNEX
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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 |
Provisional maximum residue limits (MRLs) in the relevant foodstuffs of animal origin |
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mg of active substance/kg of complete feedingstuff |
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Coccidiostats and other medicinal substances |
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E 757 |
►M3 Elanco GmbH ◄ |
Monensin sodium (Elancoban G100, Elancoban 100, Elancogran 100, Elancoban G200, Elancoban 200) |
Active substance C36H61O11Na sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis, ATCC 15413 in granular form. Factor composition: Monensin A: not less than 90 % Monensin A + B: not less than 95 % Additive composition Granular monensin (dried fermentation product) equivalent to Monensin activity 10 % w/w Mineral oil 1-3 % w/w Limestone granular 13-23 % w/w Rice hulls or limestone granular qs 100 % w/w Granular monensin (dried fermentation product) equivalent to Monensin activity 20 % w/w Mineral oil 1-3 % w/w Rice hulls or limestone granular qs 100 % w/w |
Chickens for fattening |
— |
100 |
125 |
Use prohibited at least one day before slaughter. Indicate in the instructions for use: ‘Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances’ |
30.7.2014 |
25 μg/kg monensin sodium of wet skin + fat 8 μg/kg monensin sodium of wet liver, wet kidney and wet muscle. |
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Chickens reared for laying |
16 weeks |
100 |
120 |
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Turkeys |
16 weeks |
60 |
100 |
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