LegalizeCommission Implementing Regulation (EU) 2019/913 of 29 May 2019 concerning the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats and repealing Regulation (EC) No 163/2008 (holder of authorisation Bayer HealthCare AG) (Text with EEA relevance.)
Article 1
The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is renewed subject to the conditions laid down in that Annex.
Article 2
Regulation (EC) No 163/2008 is repealed.
Article 3
This Regulation shall enter into force on the twentieth 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
| Identification number of the feed additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
|---|---|---|---|---|---|---|---|---|---|
| mg of additive/kg of complete feedingstuff with a moisture content of 12 % | |||||||||
| Category: zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine) | |||||||||
| 4d1 | Elanco GmbH | Lanthanum carbonate octahydrate | Additive composition Lanthanum carbonate octahydrate At least 85 % lanthanum carbonate octahydrate as active substance. Characterisation of the active substance Lanthanum carbonate octahydrate La2(CO3)38H2O CAS number 6487-39-4 Analytical method* (1) For the quantification of carbonate in the feed additive: Union method, introduced by Commission Regulation (EC) No 152/2009 (2). For the quantification of lanthanum in the feed additive and compound feed: Inductively coupled plasma-atomic emission spectrometry (ICP-AES). | Cats | — | 1 500 | 7 500 | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The additive shall only be fed to adult cats. 3. In the directions for use of the additive, the following shall be indicated: ‘For adult cats. Avoid simultaneous use of feeds with high level of phosphorus.’. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address 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 protective equipment. | 25 June 2029 |
| (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en. (2) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/152/oj). |
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