LegalizeCommission Implementing Regulation (EU) 2016/973 of 17 June 2016 concerning the authorisation of zinc bislysinate as a feed additive for all animal species (Text with EEA relevance)
Article 1
The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, 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 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
| Identification number of the 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 |
|---|---|---|---|---|---|---|---|---|---|
| Content of element (Zn) in mg/kg of complete feed with a moisture content of 12 % | |||||||||
| Category of nutritional additives. Functional group: compounds of trace elements | |||||||||
| 3b613 | — | Zinc bislysinate | Characterisation of the additive Powder or granulate with a minimum content of 13,5 % zinc and a minimum content of 85,0 % lysine-HCl. Zinc in form of zinc chelate of bislysinate HCl: minimum 85 %. Characterisation of the active substance Zinc chelate of bislysinate HCl Chemical formula: Zn(C6H13N2O2)2 × 2HCl × 2H2O CAS number: 23333-98-4 Analytical methods (1) For the quantification of Lysine content in the feed additive and premixtures: — Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV/FD), or — VDLUFA 4.11.6 or EN ISO 17180. For the quantification of total zinc content in the feed additive and premixtures: — Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) — EN 15510, or — Inductively Coupled Plasma Atomic Emission Spectrometry after pressure digestion, (ICP-AES) — EN 15621. For the quantification of total zinc in the feed materials and compound feed: — Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) — EN 15510, or — Inductively Coupled Plasma Atomic Emission Spectrometry after pressure digestion, (ICP-AES) — EN 15621, or — Atomic Absorption Spectrometry (AAS) — Commission Regulation (EC) No 152/2009 (2). | All animal species | — | — | Dogs and cats: 200 (total) Salmonids and milk replacers for calves: 180 (total) Piglets, sows, rabbits and all fish other than salmonids: 150 (total) Other species and categories: 120 (total) | 1. The additive shall be incorporated into the feed in form of a premixture. 2. Zinc bislysinate may be placed on the market and used as an additive consisting of a preparation. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. | 8 July 2026 |
| (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 (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). |
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