Commission Implementing Regulation (EU) 2026/2129 of 24 September 2026 concerning the renewal of the authorisation of L-cysteine hydrochloride monohydrate as a feed additive for cats and dogs and repealing Implementing Regulation (EU) 2015/2306

Official Journal EN of the European Union L series 2026/2129 25.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2129 of 24 September 2026 concerning the renewal of the authorisation of L-cysteine hydrochloride monohydrate as a feed additive for cats and dogs and repealing Implementing Regulation (EU) 2015/2306 (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 and renewing such an authorisation.

(2) L-cysteine hydrochloride monohydrate was authorised for 10 years as feed additive for cats and dogs by Commission Implementing Regulation (EU) 2015/2306(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 L-cysteine hydrochloride monohydrate for cats and dogs, requesting the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was 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 opinion of 18 November 2025(3) that the applicant has provided evidence that L-cysteine hydrochloride monohydrate remains safe for cats and dogs as well as for the users and the environment under the conditions of use currently authorised. The Authority further concluded that L-cysteine hydrochloride monohydrate should be considered an irritant to skin, eyes and mucous membranes.

Any exposure is considered a risk. 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 L-cysteine hydrochloride monohydrate 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.

(6) In view of the above, the Commission considers that L-cysteine hydrochloride monohydrate 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.

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

(2) Commission Implementing Regulation (EU) 2015/2306 of 10 December 2015 concerning the authorisation of L-cysteine hydrochloride monohydrate as a feed additive for cats and dogs (OJ L 326, 11.12.2015, p. 46, ELI: http://data.europa.eu/eli/reg_impl/ 2015/2306/oj).

(3) EFSA Journal2025;23:e9783, https://doi.org/10.2903/j.efsa.2025.9783.

(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 additive (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/2026/2129/oj 1/5EN OJ L, 25.9.2026

(7) The Commission considers that safety reasons do not require the setting of maximum content for L-cysteine hydrochloride monohydrate. In order to allow better control, the recommended maximum content should be indicated on the label of the additive. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned.

(8) As a consequence of the renewal of the authorisation of L-cysteine hydrochloride monohydrate, Implementing Regulation (EU) 2015/2306 should be repealed.

(9) Since a new requirement for the labelling of the additive is introduced by this Implementing Regulation, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet that new requirement resulting from the renewal of the authorisation.

(10) 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) 2015/2306 is repealed.

Article 3 Transitional measures

1. The feed additive L-cysteine hydrochloride monohydrate as authorised by Implementing Regulation (EU) 2015/2306 and premixtures containing that additive which are intended for cats and dogs, and which are produced and labelled before 15 April 2027 in accordance with the rules applicable before 15 October 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 intended for cats and dogs and which are produced and labelled before 15 October 2028 in accordance with the rules applicable before 15 October 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.

2/5 ELI: http://data.europa.eu/eli/reg_impl/2026/2129/ojEN OJ L, 25.9.2026 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 September 2026.

For the Commission The President Ursula VON DER LEYEN

ELI: http://data.europa.eu/eli/reg_impl/2026/2129/oj 3/5ANNEX Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, Maximum End of period of number of the category of Other provisions additive description, analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds.

2b920 L-cysteine Additive composition Cats and dogs — — — 1. The additive shall be incorporated 15 October hydrochloride into the feed in the form of a 2036 L-cysteine hydrochloride monohydrate monohydrate premixture.

Solid form

2. In the directions for use of the Characterisation of the active substance additive and premixtures, the L-cysteine hydrochloride monohydrate storage conditions and the stability to heat treatment shall be L-cysteine hydrochloride monohydrate indicated.

produced by hydrolysis of keratin from poultry feathers.

3. On the label of the additive the C H NO S·HClH O 3 7 2 2 following shall be indicated:

CAS number: 7048-04-6 ‘Recommended maximum

Purity: min. 98,5 % assay content of the active substance of complete feed with a moisture Analytical method(1) content of 12 %: 25 mg/kg.’ For the identification of L-cysteine monohydrochloride in the feed 4. The functional group, the

additive: identification number, the name — Food Chemical Codex ‘L-cysteine and the added amount of the monohydrochloride monograph’ active substance shall be indicated For the determination of cysteine in the on the label of the premixture

feed additive: where the use level on the label of — Ion-exchange chromatography the premixture would result in coupled with post-column exceeding the recommended derivatisation and optical detection maximum content referred to in (IEC-VIS/FLD) point 3.

4/5

ELI:

http://data.europa.eu/eli/reg_impl/2026/2129/oj EN OJ L,

25.9.2026Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, Maximum End of period of number of the category of Other provisions additive description, analytical method age mg of active substance/kg of authorisation additive animal complete feed with a moisture content of 12 % For the determination of cysteine in 5. For users of the additive and

premixtures: premixtures, feed business — Ion-exchange chromatography operators shall establish coupled with post-column operational procedures and derivatisation and optical detection organisational measures to (IEC-VIS) – Commission Regulation address the potential risks

(EC) No 152/2009(2) 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.

(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.

(2) Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1, ELI: http://data.europa.eu/eli/reg/ 2009/152/oj).

ELI:

http://data.europa.eu/eli/reg_impl/2026/2129/oj 5/5 OJ L,

25.9.2026 EN