Commission Implementing Regulation (EU) 2026/1150of 28 May 2026concerning the renewal of the authorisation of neohesperidine dihydrochalcone as a feed additive for piglets, pigs for fattening, calves, sheep, food-producing finfish, ornamental finfish and dogs and repealing Implementing Regulation (EU) 2015/264(Text with EEA relevance)

Commission Implementing Regulation (EU) 2026/1150 of 28 May 2026 concerning the renewal of the authorisation of neohesperidine dihydrochalcone as a feed additive for piglets, pigs for fattening, calves, sheep, food-producing finfish, ornamental finfish and dogs and repealing Implementing Regulation (EU) 2015/264 (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 OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. , 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) Neohesperidine dihydrochalcone was authorised for 10 years as a feed additive for piglets, pigs for fattening, calves, sheep, fish and dogs by Commission Implementing Regulation (EU) 2015/264 Commission Implementing Regulation (EU) 2015/264 of 18 February 2015 concerning the authorisation of neohesperidine dihydrochalcone as a feed additive for sheep, fish, dogs, calves and certain categories of pigs (OJ L 45, 19.2.2015, p. 10, ELI: http://data.europa.eu/eli/reg_impl/2015/264/oj). . (3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, two applications were submitted for the renewal of the authorisation of neohesperidine dihydrochalcone for piglets, pigs for fattening, calves, sheep, food-producing finfish, ornamental finfish and dogs, requesting the additive to be classified in the additive category sensory additives and in the functional group flavouring compounds. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. (4) The European Food Safety Authority (the Authority) concluded in its opinions of 19 March 2025 EFSA Journal 2025;23:e9358, https://doi.org/10.2903/j.efsa.2025.9358. and 16 September 2025 EFSA Journal 2025;23:e9681, https://doi.org/10.2903/j.efsa.2025.9681. that the applicants have provided evidence that neohesperidine dihydrochalcone remains safe for the target species as well as for the consumers and the environment under the conditions currently authorised. The Authority further stated that neohesperidine dihydrochalcone is not irritant to the eyes and the skin, it is not a skin sensitiser but the exposure through inhalation is likely. The Authority stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, it concluded that there is no need for assessing the efficacy of the additive 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 method of analysis of neohesperidine dihydrochalcone as a feed additive 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 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 additive (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/2005/378/oj). , evaluation reports of the Reference Laboratory are therefore not required. (6) In view of the above, the Commission considers that neohesperidine dihydrochalcone satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive 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 additive. 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 neohesperidine dihydrochalcone, Implementing Regulation (EU) 2015/264 should be repealed. (8) Since certain labelling conditions related to the storage conditions and stability have been modified and, in addition, the reference to certain animal species, 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 1

Renewal of the authorisation The authorisation of the substance specified in the Annex, belonging to the additive category sensory additives and to the functional group flavouring compounds, is renewed subject to the conditions laid down in that Annex.

Article 2

Repeal Implementing Regulation (EU) 2015/264 is repealed.

Article 3

Transitional measures

1. The feed additive neohesperidine dihydrochalcone as authorised by Implementing Regulation (EU) 2015/264 and premixtures containing that additive which are intended for piglets, pigs for fattening, calves, sheep, fish and dogs, and which are produced and labelled before 18 December 2026 in accordance with the rules applicable before 18 June 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 additive referred to in paragraph 1, which are produced and labelled before 18 June 2027 in accordance with the rules applicable before 18 June 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.

1. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 18 June 2028 in accordance with the rules applicable before 18 June 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 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, 28 May 2026. For the Commission The President Ursula von der Leyen

Annex

ANNEX 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_en. Identification number of the additiveName of the additiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg of active substance/kg of complete feed with a moisture content of 12 %Category: Sensory additives. Functional group: Flavouring compounds2b959Neohesperidine dihydrochalcone Additive composition Neohesperidine dihydrochalcone Solid form Ethanol ≤ 5000 mg/kg Characterisation of the active substance Neohesperidine dihydrochalcone C28H36O15 CAS No: 20702-77-6 Purity: minimum 96 % (dried basis) Produced by chemical synthesis: by catalytic hydrogenation of the flavanone glycoside neohesperidine extracted from the immature fruit of bitter orange (Citrus aurantium), by the conversion of naringin and further condensation with isovanillin. Naringin may be extracted from grapefruit (Citrus paradisi) or from pomelo (Citrus maxima). Analytical method For the determination of neohesperidine dihydrochalcone in the feed additive: High-Performance Liquid Chromatography coupled with optical detection (HPLC-UV) – European Pharmacopoeia monograph 1547. For the determination of neohesperidine dihydrochalcone in premixtures and compound feed: High-Performance Liquid Chromatography coupled with optical detection (HPLC-DAD). Piglets——35

1. The directions for use of the additive and premixtures shall indicate the storage conditions and the stability to heat treatment.
2. 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 protective equipment. 18 June 2036 Pigs for fattening——35Calves——35Sheep——35Food-producing finfish——35Ornamental finfish——35Dogs——35