Commission Implementing Regulation (EU) 2017/1914 of 19 October 2017 concerning the authorisation of salinomycin sodium (Sacox 120 microGranulate and Sacox 200 microGranulate) as a feed additive for chickens for fattening and chickens reared for laying and repealing Regulations (EC) No 1852/2003 and (EC) No 1463/2004 (holder of authorisation Huvepharma NV) (Text with EEA relevance. )

Authorisation

Article 1

The preparations specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostas’ are authorised as a coccidiostat in animal nutrition, subject to the conditions laid down in the Annex.

Repeal of Regulation (EC) No 1852/2003

Article 2

Regulation (EC) No 1852/2003 is repealed.

Repeal of Regulation (EC) No 1463/2004

Article 3

Regulation (EC) No 1463/2004 is repealed.

Transitional measures

Article 4

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 9 May 2018 in accordance with the rules applicable before 9 November 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

Entry into force

Article 5

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

ANNEXSupplementary provisions

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 Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin mg of active substance/kg of complete feedingstuff with a moisture content of 12 % Coccidiostats and histomonostats 51766 Huvepharma NV. Salinomycin sodium 120 g/kg (Sacox 120 microGranulate) Salinomycin sodium 200 g/kg (Sacox 200 microGranulate) Additive composition (Sacox120 microGranulate):   Salinomycin sodium: 114-132 g/kg   Silicon dioxide: 10-100 g/kg   Calcium carbonate: 500-700 g/kg Solid form (Sacox 200 microGranulate):   Salinomycin sodium: 190-220 g/kg   Silicon dioxide: 50-150 g/kg   Calcium carbonate: 50-150 g/kg Solid form Characterisation of the active substance Salinomycin sodium, C 42 H 69 Na O 11 , CAS number: 55721-31-8, sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces azureus (DSM 32267) Related impurities: — ≤ 10 mg elaiophylin/kg salinomycin sodium. — ≤ 2 g 17-epi-20-desoxy-salinomycin/kg salinomycin sodium. — ≤ 10 g 20-desoxysalinomycin/kg salinomycin sodium. — ≤ 10 g 18,19-dihydrosalinomycin/kg salinomycin sodium. — ≤ 10 g methylated salinomycin/kg salinomycin sodium. Analytical method  ( 1 ) For the quantification of salinomycin in the feed additive: High Performance Liquid Chromatography using post-column derivatisation coupled to spectrophotometric detection (HPLC-PCD-UV-Vis). For the quantification of salinomycin in premixtures and feedingstuffs: High Performance Liquid Chromatography using post-column derivatisation coupled to spectrophotometric detection (HPLC-PCD-UV-Vis) — EN ISO 14183. Chickens for fattening — 50 70 1. The additives shall be incorporated in compound feed in the form of a premixture. 2. The following shall be indicated 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 contra-indicated’. 3. Salinomycin sodium shall not be mixed with other coccidiostats. 4. A post-market monitoring program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation. 5. Zero days of withdrawal time. 6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing, eyes and skin protections. 9 November 2027 150 μg salinomycin sodium/kg of liver; 40 μg salinomycin sodium/kg of kidney; 15 μg salinomycin sodium/kg of muscle, and 150 μg salinomycin sodium/kg. skin/fat. Chickens reared for laying 12 weeks 50 50 ( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports