Prováděcí nařízení Komise (EU) 2026/1150 ze dne 28. května 2026 o obnovení povolení neohesperidindihydrochalkonu jako doplňkové látky pro selata, výkrm prasat, telata, ovce, ryby určené k produkci potravin, okrasné ryby a psy a o zrušení prováděcího nařízení (EU) 2015/264

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 nutritionOJ L 268, 18.10.2003, p. 29 , ELI: http://data.europa.eu/eli/reg/2003/1831/oj. , and in particular Article 9(2) thereof,

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.

OJ L 268, 18.10.2003, p. 29 , ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(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) 2015/264Commission 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 378/2005Commission 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,

Implementing Regulation (EU) 2015/264 is repealed.

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).

Article 1 Article 1 Renewal of the authorisation

Article 2 Article 2 Repeal

Article 3 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. 3.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 Article 4 Entry into force

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.

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.

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.

EFSA Journal 2025;23:e9358, https://doi.org/10.2903/j.efsa.2025.9358.

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

EFSA Journal 2025;23:e9681, https://doi.org/10.2903/j.efsa.2025.9681.

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).

HAS ADOPTED THIS REGULATION: