Commission Implementing Regulation (EU) 2024/1193 of 24 April 2024 concerning the renewal of the authorisation of sodium hydroxide as a feed additive for cats, dogs and ornamental fish and repealing Implementing Regulation (EU) No 161/2013

Official Journal EN of the European Union L series 2024/1193 25.4.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1193 of 24 April 2024 concerning the renewal of the authorisation of sodium hydroxide as a feed additive for cats, dogs and ornamental fish and repealing Implementing Regulation (EU) No 161/2013 (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 2003on 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 and renewing such authorisation.

(2) Sodium hydroxide was authorised for a period of 10 years as a feed additive for cats, dogs and ornamental fish by Commission Implementing Regulation (EU) No 161/2013(2).

(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of sodium hydroxide as a feed additive for cats, dogs and ornamental fish, requesting the additive to be classified in the additive category ‘technological additives’ and in the functional group ‘acidity regulators’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 September 2023(3)that sodium hydroxide remains safe for the target species under the conditions of use currently authorised, provided that the resulting total sodium concentration in feed does not compromise the overall electrolyte balance. It reiterated its previous conclusion that the additive is corrosive and also indicated that there is no need for assessing the efficacy of the additive as 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.

(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 sodium hydroxide 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(4), an evaluation report of the Reference Laboratory is therefore not required.

(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 161/2013 of 21 February 2013 concerning the authorisation of a preparation of sodium hydroxide as a feed additive for cats, dogs and ornamental fish (OJ L 49, 22.2.2013, p. 52). ELI: http://data.europa.eu/eli/ reg_impl/2013/161/oj).

(3) EFSA Journal 2023;21(9):8249.

(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).

ELI: http://data.europa.eu/eli/reg_impl/2024/1193/oj 1/4EN OJ L, 25.4.2024

(6) In view of the above, the Commission considers that sodium hydroxide 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 sodium hydroxide as a feed additive, Implementing Regulation (EU) No 161/2013 should be repealed accordingly.

(8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of sodium hydroxide, 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 ‘technological additives’ and to the functional group ‘acidity regulators’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal of Implementing Regulation (EU) No 161/2013 Implementing Regulation (EU) No 161/2013 is repealed.

Article 3 Transitional measures

1. The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 15 November 2024in accordance with the rules applicable before 15 May 2024may continue to be placed on the market and used until the existing stocks are exhausted.

2. Compound feed and feed materials containing the substance specified in the Annex, which are produced and labelled before 15 May 2026in accordance with the rules applicable before 15 May 2024may continue to be placed on the market and used until the existing stocks are exhausted.

2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/1193/ojEN OJ L, 25.4.2024 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

ELI: http://data.europa.eu/eli/reg_impl/2024/1193/oj 3/4ANNEX Identifica- Minimum Maximum tion Species or content content Composition, chemical formula, Maximum End of period of number of Additive category Other provisions description, analytical method age authorisation the feed of animal mg/kg of complete feedingstuff additive with a moisture content of 12 %

Category: technological additives. Functional group: acidity regulators 1j524 Sodium hydroxide Additive composition Cats, - - - 1. Indicate in the directions for 15 May 2034 Sodium hydroxide 50 % w/w dogs and use of the additive and pre­ orna­ mixtures:

(water solution) mental ‘The resulting total sodium fish concentration in feed shall ———————— not compromise the overall Characterisation of the active substance electrolyte balance’.

Sodium hydroxide ≥ 98,0 % total alkali

2. For users of the additive and (calculated as NaOH) premixtures, feed business operators shall establish op­ NaOH CAS No.: 1310-73-2 erational procedures and or­ Produced by chemical synthesis ganisational measures to ad­ ————————— dress potential risks resulting Analytical method(1) from their use. Where those Determination of sodium hydroxide in risks cannot be eliminated by

feed additive: Titrimetry – FAO JECFA such procedures and mea­ Combined Compendium for Food sures, the additive and pre­ Additive Specifications, Monograph mixtures shall be used with No 1 (2006) ‘sodium hydroxide’. personal skin, eye and breathing protective equip­ ment.

(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_en.

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ELI:

http://data.europa.eu/eli/reg_impl/2024/1193/oj EN OJ L,

25.4.2024