LegalizeCommission Regulation (EC) No 109/2007 of 5 February 2007 concerning the authorisation of monensin sodium (Coxidin) as a feed additive (Text with EEA relevance )
Article 1
The substance, specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
This Regulation shall enter into force on the 20th 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
| Identification number of the additive | Name of the holder of authorisation | Additive (Trade name) | Composition, chemical formula, description, analytical method | 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the additive | Name of the holder of authorisation | Additive (Trade name) | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation | Provisional maximum residue limits (MRLs) in the relevant foodstuffs of animal origin | ||||||
| Identification number of the additive | Name of the holder of authorisation | Additive (Trade name) | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats | Coccidiostats and histomonostats |
| 51701 | Huvepharma NV Belgium | Monensin sodium (Coxidin) | Additive composition Monensin sodium technical substance equivalent to monensin activity: 25 % Perlite: 15 – 20 % Wheat bran 55 – 60 % Active substance C36H61O11Na Sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis 28682, LMG S-19095 in powder form Factor composition Monensin A: not less than 90 % Monensin A + B: not less than 95 % Monensin C: 0,2 – 0,3 % Analytical method [^E0004] Method for determination of the active substance: high performance liquid chromatography (HPLC) with post-column derivatisation and UV detection (λ = 520nm) | Chickens for fattening | — | 100 | 125 | Other provisions | End of period of authorisation | Provisional maximum residue limits (MRLs) in the relevant foodstuffs of animal origin | 1. Use prohibited at least 1 day before slaughter. 2. The additive shall be incorporated in compound feedingstuffs in form a premixture. 3. Maximum permitted dose of monensin sodium in complementary feedingstuffs: — 625 mg/kg for chickens for fattening, — 500 mg/kg for turkeys. 4. Monensin sodium shall not be mixed with other coccidiostats. 5. 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’. 6. Wear suitable protective clothing, gloves and eye/face protection. In case of insufficient ventilation in the premise, wear suitable respiratory equipments. | 6.2.2017 | 25 μg monensin sodium/kg of wet skin + fat 8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle | |||
| 51701 | Huvepharma NV Belgium | Monensin sodium (Coxidin) | Additive composition Monensin sodium technical substance equivalent to monensin activity: 25 % Perlite: 15 – 20 % Wheat bran 55 – 60 % Active substance C36H61O11Na Sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis 28682, LMG S-19095 in powder form Factor composition Monensin A: not less than 90 % Monensin A + B: not less than 95 % Monensin C: 0,2 – 0,3 % Analytical method [^E0004] Method for determination of the active substance: high performance liquid chromatography (HPLC) with post-column derivatisation and UV detection (λ = 520nm) | Turkeys | 16 weeks | 60 | 100 | |||||||||
| 51701 | Huvepharma NV Belgium | Monensin sodium (Coxidin) | Additive composition Monensin sodium technical substance equivalent to monensin activity: 25 % Perlite: 15 – 20 % Calcium Carbonate: qs. 100 % Active substance C36H61O11Na Sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis 28682, LMG S-19095 in powder form Factor composition Monensin A: not less than 90 % Monensin A + B: not less than 95 % Monensin C: 0,2 – 0,3 % Analytical method [^E0004] Method for determination of the active substance: high-performance liquid chromatography (HPLC) with post-column derivatisation and UV-VIS detection (EN ISO standard method 14183:2008) | Chickens for fattening | — | 100 | 125 | 1. Use prohibited at least 1 day before slaughter. 2. The additive shall be incorporated in compound feedingstuffs in form of a granulated premixture. 3. Monensin sodium shall not be mixed with other coccidiostats. 4. 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’. 5. Wear suitable protective clothing, gloves and eye/face protection. In case of insufficient ventilation in the premise, wear suitable respiratory equipments. | 10.6.2021 | 25 μg monensin sodium/kg of wet skin + fat 8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle | 1. Use prohibited at least 1 day before slaughter. 2. The additive shall be incorporated in compound feedingstuffs in form a premixture. 3. Maximum permitted dose of monensin sodium in complementary feedingstuffs: — 625 mg/kg for chickens for fattening, — 500 mg/kg for turkeys. 4. Monensin sodium shall not be mixed with other coccidiostats. 5. 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’. 6. Wear suitable protective clothing, gloves and eye/face protection. In case of insufficient ventilation in the premise, wear suitable respiratory equipments. | 6.2.2017 | 25 μg monensin sodium/kg of wet skin + fat 8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle | |||
| 51701 | Huvepharma NV Belgium | Monensin sodium (Coxidin) | Additive composition Monensin sodium technical substance equivalent to monensin activity: 25 % Perlite: 15 – 20 % Calcium Carbonate: qs. 100 % Active substance C36H61O11Na Sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis 28682, LMG S-19095 in powder form Factor composition Monensin A: not less than 90 % Monensin A + B: not less than 95 % Monensin C: 0,2 – 0,3 % Analytical method [^E0004] Method for determination of the active substance: high-performance liquid chromatography (HPLC) with post-column derivatisation and UV-VIS detection (EN ISO standard method 14183:2008) | Turkeys | 16 weeks | 60 | 100 | 1. Use prohibited at least 1 day before slaughter. 2. The additive shall be incorporated in compound feedingstuffs in form of a granulated premixture. 3. Monensin sodium shall not be mixed with other coccidiostats. 4. 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’. 5. Wear suitable protective clothing, gloves and eye/face protection. In case of insufficient ventilation in the premise, wear suitable respiratory equipments. | 10.6.2021 | 25 μg monensin sodium/kg of wet skin + fat 8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle |
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
[^E0002]: (2) Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on a request from the European Commission of the coccidiostat COXIDIN (monensin sodium), adopted on 20 October 2005, The EFSA Journal (2005) 283, p. 1-53.
[^E0003]: (3) Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the Maximum Residues Limits for monensin sodium for chicken and turkeys for fattening, adopted on 21 November 2006, The EFSA Journal (2006) 413, p. 1-13. See also opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety of COXIDIN (monensin sodium), adopted on 12 July 2006, The EFSA Journal (2006) 381, p. 1-10.
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