COMMISSION IMPLEMENTING REGULATION (EU) 2024/1194

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2024/1194 | 25.4.2024 ---|---|--- COMMISSION IMPLEMENTING REGULATION (EU) 2024/1194 of 24 April 2024 concerning the renewal of the authorisation of nicotinic acid and niacinamide as feed additives for all animal species and repealing Implementing Regulation (EU) No 642/2013 (Text with EEA relevance) 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 nutrition (1), 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 such an authorisation. ---|--- (2) | Niacin and niacinamide were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 642/2013 (2). ---|--- (3) | In accordance with Article 14(1) of Regulation (EC) No 1831/2003, two applications were submitted for the renewal of the authorisation of niacin and niacinamide 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. The Commission considers that the name of the additive ‘niacin’ used in the initial authorisation should be replaced by the name ‘nicotinic acid’ as the term ‘niacin’ is one of the generic names used for nicotinic acid but also for other substances such as nicotinamide and related derivatives. ---|--- (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 26 September 2023 (3) that the applicant provided evidence that nicotinic acid and niacinamide remain safe for all animal species, consumers and the environment under the conditions of use currently authorised. The Authority concluded that nicotinic acid and niacinamide remain efficacious as an effective source of niacin in animal nutrition and that nicotinic acid and niacinamide are not irritant to skin but irritant to eyes. The Authority further concluded that they are not dermal sensitisers and the exposure through inhalation is likely. It did not consider that there is a 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 method of analysis of nicotinic acid and niacinamide 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 378/2005 (4), an evaluation report of the Reference Laboratory is therefore not required. ---|--- (6) | In view of the above, the Commission considers that nicotinic acid and niacinamide satisfy the conditions for authorisation 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. ---|--- (7) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of nicotinic acid, 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 as a result of the change of the name of the additive ‘niacin’ by ‘nicotinic acid’. ---|--- (8) | As a consequence of the renewal of the authorisation of nicotinic acid and niacinamide, Implementing Regulation (EU) No 642/2013 should be repealed. ---|--- (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 1 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. Article 2 Repeal Implementing Regulation (EU) No 642/2013 is repealed. Article 3 Transitional measures 1\. The substance nicotinic acid specified in the Annex and premixtures containing that substance which are produced and labelled before 15 November 2024 in accordance with the rules applicable before 15 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted. 2\. Compound feed and feed materials containing the substance nicotinic acid specified in the Annex, which are produced and labelled before 15 May 2025 in accordance with the rules applicable before 15 May 2024 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\. Compound feed and feed materials containing the substance nicotinic acid specified in the Annex, which are produced and labelled before 15 May 2026 in accordance with the rules applicable before 15 May 2024 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 4 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. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 April 2024. For the Commission The President Ursula VON DER LEYEN * * * (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) Commission Implementing Regulation (EU) No 642/2013 of 4 July 2013 concerning the authorisation of niacin and niacinamide as feed additives for all animal species (OJ L 186, 5.7.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/642/oj). (3) EFSA Journal 2023;21(10):8359 and EFSA Journal 2023;21(10):8357. (4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/2005/378/oj). * * * ANNEX Identification number of the feed additive | 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 feedingstuff with a moisture content of 12 % Category: nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a314 | Nicotinic acid | Additive composition Nicotinic acid Characterisation of active substance Nicotinic acid Solid form Purity: ≥ 99 % Chemical name: nicotinic acid Chemical formula: C6H5NO2 CAS number: 59-67-6 Einecs number: 200-441-0 Analytical method (1) | — | For the determination of nicotinic acid in the feed additive: titration with sodium hydroxide; European Pharmacopoeia monograph 0459. ---|--- — | For the determination of nicotinic acid in premixtures, compound feed and water: Ion-pair Reversed Phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV). ---|--- All animal species | — | — | — | | 1. | Nicotinic acid may be used also via water for drinking. ---|--- 2. | In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment 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. ---|--- 15 May 2034 Identification number of the feed additive | 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 feedingstuff with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a315 | Niacinamide | Additive composition Niacinamide Characterisation of active substance Niacinamide Solid form Purity: ≥ 99 % Chemical name: niacinamide, nicotinamide Chemical formula: C6H6N2O CAS number: 98-92-0 Einecs number: 202-713 Analytical method (2) | — | For the determination of niacinamide (nicotinamide) in the feed additive: Titration with perchloric acid; European Pharmacopoeia monograph 0047. ---|--- — | For the determination of niacinamide (nicotinamide) in premixtures, compound feed and water: Ion-pair Reversed Phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV). ---|--- All animal species | — | — | — | | 1. | Niacinamide may be used also via water for drinking. ---|--- 2. | In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment 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. ---|--- 15 May 2034 * * * (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. * * * ELI: http://data.europa.eu/eli/reg_impl/2024/1194/oj ISSN 1977-0677 (electronic edition) * * *