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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 and renewing such an authorisation.
(2)Thiamine hydrochloride and thiamine mononitrate were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) 2015/897note.
(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, two applications were submitted for the renewal of the authorisation of thiamine hydrochloride and thiamine mononitrate and for one preparation of thiamine mononitrate as feed additives for all animal species, requesting the additives to be classified in the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. One of the applicants, requesting the authorisation of the preparation of thiamine mononitrate as a feed additive for all animal species, withdrew its application for the preparation.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 18 March 2025note and 4 April 2025note that the applicants have provided evidence that thiamine hydrochloride and thiamine mononitrate remain safe for all animal species, as well as for the consumers, the users and the environment under the conditions of use currently authorised. The Authority further concluded that thiamine hydrochloride and thiamine mononitrate are skin and eye irritants and are considered skin and respiratory sensitisers. Any dermal and respiratory exposure is considered a risk. The Authority stated that the applications for renewal of the authorisation do not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives. Therefore, it concluded that there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation. The Authority considered that there is no need for specific requirements of post-market monitoring.
(5)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the methods of analysis of thiamine hydrochloride and thiamine mononitrate as feed additives in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005note, the evaluation reports of the Reference Laboratory are therefore not required.
(6)In view of the above, the Commission considers that thiamine hydrochloride and thiamine mononitrate satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives should be renewed. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additives. Those protective measures should be without prejudice to other workers’ safety requirements under Union law.
(7)As a consequence of the renewal of the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives, Implementing Regulation (EU) 2015/897 should be repealed.
(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation resulting from the fact that the preparations of thiamine mononitrate as feed additives for all animal species are not renewed, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
(9)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 1Renewal 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.
Article 2Repeal of Implementing Regulation (EU) 2015/897#
Implementing Regulation (EU) 2015/897 is repealed.
Article 3Transitional 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.
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 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 B1’ | Additive compositionThiamine hydrochlorideSolid formCharacterisation of active substanceThiamine hydrochlorideChemical formula: C12H17ClN4OS•HClCAS number: 67-03-8Purity: minimum 98,5 % on anhydrous basisProduced by chemical synthesisAnalytical methodnoteFor 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, orreversed 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 B1’ | Additive compositionThiamine mononitrateSolid formCharacterisation of active substanceThiamine mononitrateChemical formula: C12H17N4OS•NO3CAS number: 532-43-4Purity: minimum 98 % on anhydrous basisProduced by chemical synthesisAnalytical methodnoteFor 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, orreversed 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 |
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