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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,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 nutritionnote, and in particular Article 9(2) thereof,Whereas:
(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECnote.
(2)A preparation of narasin (Monteban G100) (‘the preparation’) was authorised for 10 years in accordance with Directive 70/524/EEC as a feed additive for chickens for fattening by Commission Regulation (EC) No 1464/2004note. That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.
(3)In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation as a feed additive for chickens for fattening. The applicant requested the additive to be classified in the additive category ‘coccidiostats and histomonostats’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 3 October 2018note, 30 January 2024note and 28 January 2026note that the preparation is safe for the target species, as well as for consumers and the environment, when used in chickens for fattening at 70 mg/kg feed. It highlighted that narasin is toxic to horses, turkeys and rabbits at levels below those used in the prevention of coccidiosis in chickens and that the simultaneous use of the preparation and certain antibiotic drugs (e.g. tiamulin) is contraindicated. The Authority also concluded that the preparation is irritant to the eyes but no to the skin, has the potential to induce skin sensitisation and that inhalation exposure would pose a risk to persons handling the additive. The Authority further concluded that the use of the preparation at 60 mg/kg feed is efficacious in controlling coccidiosis in chickens for fattening. It considered that there is a need for specific requirements of post-market monitoring, recommending that field monitoring of Eimeria spp. resistance to narasin be undertaken, preferably during the latter part of the period of authorisation. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5)In view of the above, the Commission considers that the preparation satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised for chickens for fattening. It is appropriate to provide for post-market monitoring of the resistance of Eimeria spp. to narasin. It is appropriate to provide for indicating in the directions for use that the additive is dangerous for certain species and that its simultaneous use with certain medicinal substances can be contraindicated. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.
(6)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(7)As a consequence of the authorisation of the preparation as a feed additive for chickens for fattening, Regulation (EC) No 1464/2004 should be repealed.
(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Authorisation#
The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition for chickens for fattening, subject to the conditions laid down in that Annex.
Article 2Repeal#
Regulation (EC) No 1464/2004 is repealed.
Article 3Transitional measures#
1.The additive, as authorised by Regulation (EC) No 1464/2004 and premixtures containing that additive, which are produced and labelled before 19 February 2027 in accordance with the rules applicable before 19 August 2026 may continue to be placed on the market and used until the existing stocks are exhausted.
2.Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 19 August 2027 in accordance with the rules applicable before 19 August 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
Article 4Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
| Identification number of the additive | Name of the holder of authorisation | Name of the 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 feed with a moisture content of 12 % | ||||||||||
| Category: coccidiostats and histomonostats | ||||||||||
| 51765 | Elanco GmbH | Narasin 100 g/kg (Monteban G100) | Additive compositionPreparation ofnarasin: 95,0-107,5 g/kgfood grade mineral oil: 10-25 g/kgrice hulls qs 1 kg.Solid form.Characterisation of the active substanceNarasin granulated containing:Narasin: ≥ 100 g/kg, including:narasin A: (2R)-2-{(2R,3S,5S,6R)-6-[(2S,3S,4S,6R)-6-{(2S,5S,7R,9S,10S,12R,15R)-2-[(2R,5R,6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]-15-hydroxy-2,10,12-trimethyl-1,6,8-trioxadispiro[4.1.57.35]pentadec-13-en-9-yl}-3-hydroxy-4-methyl-5-oxooctan-2-yl]-3,5-dimethyltetrahydro-2H-pyran-2-yl}butanoic acid; C43H72O11; CAS number: 55134-13-9: ≥ 90 %,narasin B, D and I,Fermentation mass: 28 %,Dipotassium hydrogen phosphate: 6 %,Montmorillonite clay: 53 %.Produced by fermentation with Streptomyces spp. NRRL B-67771.Analytical methodsnoteFor the determination of narasin in the feed additive: High Performance Liquid Chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis).For the determination of narasin in the premixtures: High Performance Liquid Chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183.For the determination of narasin in compound feed:High Performance Liquid Chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183, orHigh Performance Liquid Chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299.For the determination of narasin in tissues: High Performance Liquid Chromatography coupled with tandem mass spectrometry (LC-MS/MS). | Chickens for fattening | — | 60 | 70 | 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.2. The additive shall be incorporated in compound feed in the form of a premixture.3. The additive shall not be used simultaneously with other coccidiostats.4. Indicate in the directions for use of the additive, premixtures and related feed: Dangerous for equines, turkeys and rabbits. This feed contains an ionophore: simultaneous use with certain medicinal substances, including tiamulin, is contra-indicated.5. A post-market monitoring programme on the resistance of Eimeria spp. to narasin shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008.6. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. | 19 August 2036 | 50 μg narasin/kg of all wet tissues |
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