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Commission Implementing Regulation (EU) 2021/967 of 16 June 2021 concerning the renewal of the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species, and repealing Regulation (EU) No 350/2010 (Text with EEA relevance)

Commission Implementing Regulation (EU) 2021/967 of 16 June 2021 concerning the renewal of the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species, and repealing Regulation (EU) No 350/2010 (Text with EEA relevance)

Implementing Regulation (EU) 2021/967 · Regulation · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

The authorisation of the additive specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is renewed subject to the conditions laid down in that Annex.

Article 2

1.   Manganese chelate of hydroxy analogue of methionine and premixtures containing this additive, which are produced and labelled before 7 January 2022 in accordance with the rules applicable before 7 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted. 2.   Feed materials and compound feed containing manganese chelate of hydroxy analogue of methionine, which are produced and labelled before 7 July 2022 in accordance with the rules applicable before 7 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3.   Feed materials and compound feed containing manganese chelate of hydroxy analogue of methionine, which are produced and labelled before 7 July 2023 in accordance with the rules applicable before 7 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3

Regulation (EU) No 350/2010 is repealed.

Article 4

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

Supplementary provisions

ANNEXSupplementary provisions

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 (Mn) in mg/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: compounds of trace elements 3b510 - Manganese chelate of hydroxy analogue of methionine Characterisation of the additive : Manganese chelate of hydroxy analogue of methionine containing 14 % manganese and 76 % (2-hydroxy-4-methylthio) butanoic acid. Maximum content of nickel: 170 ppm. Solid form. Analytical method  ( 1 ) : For the quantification of the hydroxy analogue of methionine content in the feed additive: — Titrimetry, potentiometric titration after oxidation reduction reaction; For the quantification of total manganese in the feed additive and premixtures: — Atomic Absorption Spectrometry,AAS (EN ISO 6869); or — 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 manganese in feed materials and compound feed: — Atomic Absorption Spectrometry, AAS (Commission Regulation (EC) No 152/2009, Annex IV-C); or — Atomic Absorption Spectrometry, AAS (EN ISO 6869); or — Inductively Coupled Plasma – Atomic Emission Spectrometry, ICP-AES (EN 15510); or — Inductively Coupled Plasma – Atomic Emission Spectrometry after pressure digestion, ICP-AES (EN 15621). All species - - Fish: 100 (total) Other species: 150 (total) 1. The additive shall be incorporated into feed in the form of a premixture. 2. Manganese chelate of hydroxy analogue of methionine 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, in particular due to the content of heavy metals including nickel. 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. 7 July 2031 ( 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

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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