Commission Implementing Regulation (EU) 2026/460 of 26 February 2026 concerning the renewal of the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/897
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 ↗
Renewal of the authorisation
The authorisation of the substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is renewed subject to the conditions laid down in that Annex.
Repeal of Implementing Regulation (EU) 2015/897
Implementing Regulation (EU) 2015/897 is repealed.
Transitional measures
1. The preparations of thiamine mononitrate, as authorised by Implementing Regulation (EU) 2015/897 and premixtures containing those additives which are intended for all animal species, and which are produced and labelled before 19 September 2026 in accordance with the rules applicable before 19 March 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. 2. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 19 March 2027 in accordance with the rules applicable before 19 March 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals. 3. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 19 March 2028 in accordance with the rules applicable before 19 March 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.
Entry 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 .
ANNEX Identification number of the additive Name of the 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 active substance/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a820 ‘Thiamine hydrocloride’ or ‘Vitamin B 1 ’ Additive composition Thiamine hydrochloride Solid form Characterisation of active substance Thiamine hydrochloride Chemical formula: C 12 H 17 ClN 4 OS•HCl CAS number: 67-03-8 Purity: minimum 98,5 % on anhydrous basis Produced by chemical synthesis Analytical method ( 1 ) For the characterisation of thiamine hydrochloride in the feed additive: — high performance liquid chromatography with UV detection (HPLC-UV) – US Pharmacopeia (‘thiamine hydrochloride’ monograph). For the quantification of thiamine hydrochloride in premixtures: — ion-exchange high performance liquid chromatography coupled to UV detector (HPLC-UV) – VDLUFA Bd. III, 13.9.1, or — reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) – decree 20.2.2006, Official Italian Journal No 50, 1.3.2006 . For the quantification of thiamine hydrochloride in compound feed: — reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) – decree 20.2.2006, Official Italian Journal No 50, 1.3.2006 . For the quantification of thiamine hydrochloride in water for drinking: — reversed phase high performance liquid chromatography with post-column derivatisation and fluorescence detection (HPLC-FLD). All animal species - - - 1. The additive may be used via water for drinking. 2. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. 3. 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, eye and skin protective equipment. 19.3.2036 Identification number of the additive Name of the 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 active substance/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a821 ‘Thiamine mononitrate’ or ‘Vitamin B 1 ’ Additive composition Thiamine mononitrate Solid form Characterisation of active substance Thiamine mononitrate Chemical formula: C 12 H 17 N 4 OS•NO 3 CAS number: 532-43-4 Purity: minimum 98 % on anhydrous basis Produced by chemical synthesis Analytical method ( 2 ) For the characterisation of thiamine mononitrate in the feed additive: — high performance liquid chromatography with UV detection (HPLC-UV) – US Pharmacopeia (‘thiamine mononitrate’ monograph). For the quantification of thiamine mononitrate in premixtures: — ion-exchange high performance liquid chromatography coupled to UV detector (HPLC-UV) – VDLUFA Bd. III, 13.9.1, or — reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) – decree 20.2.2006, Official Italian Journal No 50, 1.3.2006 . For the quantification of thiamine mononitrate in compound feed: — reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) – decree 20.2.2006, Official Italian Journal No 50, 1.3.2006 . For the quantification of thiamine mononitrate in water for drinking: — reversed phase high performance liquid chromatography with post-column derivatisation and fluorescence detection (HPLC-FLD). All animal species - - - 1. The additive may be used via water for drinking. 2. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. 3. 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, eye and skin protective equipment. 19.3.2036 ( 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 . ( 2 ) 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 .
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