LegalizeCommission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs (Text with EEA relevance)
COMMISSION REGULATION (EC) No 600/2005
of 18 April 2005
concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs
(Text with EEA relevance)
Article 1
The preparation belonging to the group ‘Coccidiostats and other medicinal substances’, as specified in Annex I, is authorised for use for 10 years as additive in animal nutrition under the conditions laid down in that Annex.
Article 2
The preparation belonging to the group ‘Micro-organisms’, as specified in Annex II, is authorised provisionally for four years as an additive in animal nutrition under the conditions laid down in that Annex.
Article 3
The preparations belonging to the group ‘Micro-organisms’, as specified in Annex III, are authorised for use without a time limit as additives in animal nutrition under the conditions laid down in that Annex.
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 I
| 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 | Zoetis Belgium SA | Salinomycin sodium 120 g/kg (Salinomax 120G) | Additive composition: Salinomycin sodium 120 g/kg Calcium lignosulfonate: 40 g/kg Calcium sulphate dihydrate to 1 000 g/kg Active substance: Salinomycin sodium, C42H69O11Na, Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (ATCC 21838/US 9401-06), CAS No: 55 721-31-8 Related impurities: < 42 mg elaiophylin/kg salinomycin sodium. < 40 g 17-epi-20 desoxysalinomycin/kg salinomycin sodium | Chickens for fattening | — | 50 | 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” | 22.4.2015 | 5 μg of Salinomycin/kg for all wet tissues’ |
ANNEX II
| No (or EC No) | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of complete feedingstuff | ||||||||
| Micro-organisms | ||||||||
| ‘25 | Lactobacillus acidophilus DSM 13241 | Preparation of Lactobacillus acidophilus containing a minimum of: 1 × 1011 CFU/g additive | Dogs | — | 6 × 109 | 2 × 1010 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. For use in dry feed with a water content at or below 2 %. | 22.4.2009 |
| Cats | — | 3 × 109 | 2 × 1010 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. For use in dry feed with a water content at or below 2 %. | 22.4.2009’ |
ANNEX III
| EC No | Additive | Chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|
| CFU/kg of complete feedingstuff | ||||||||
| Micro-organisms | ||||||||
| ‘E 1709 | Enterococcus faecium ATCC 53519 Enterococcus faecium ATCC 55593 (In a 1/1 ratio) | Mixture of encapsulated Enterococcus faecium and Enterococcus faecium containing a minimum of 2 × 108 CFU/g additive. (i.e. a minimum of 1 × 108 CFU/g of each bacterium) | Chickens for fattening | — | 1 × 108 | 1 × 108 | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. May be used in compounded feed containing coccidiostats: decoquinate, halofuginone, lasalocid sodium, maduramicin ammonium, monensin sodium, narasin, narasin/nicarbazin, and salinomycin sodium. | Without a time limit |
| ————— | ||||||||
| ————— |