Prováděcí nařízení Komise (EU) 2026/1012 ze dne 7. května 2026 o povolení L-cysteinu, L-cystein-hydrochloridu monohydrátu a L-cystein-hydrochloridu jako doplňkových látek pro všechny druhy zvířat

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 substances specified in the Annex, belonging to the additive category sensory additives and to the functional group flavouring compounds, are authorised as additives in animal nutrition, 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 such authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) That application concerns the authorisation of L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride, requesting those additives to be classified in the additive category nutritional additives and the functional group amino acids, their salts and analogues and in the additive category sensory additives and the functional group flavouring compounds. The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of flavouring compounds for use in water for drinking. Therefore, the use of those additives in water for drinking should not be allowed insofar as they are classified in the functional group flavouring compounds. The applicant later withdrew the application for the authorisation of L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride in the additive category nutritional additives and the functional group amino acids, their salts and analogues.

(4) The European Food Safety Authority (the Authority) concluded in its opinion of 17 September 2025 EFSA Journal 2025;23:e9689, https://doi.org/10.2903/j.efsa.2025.9689. that, under the proposed conditions of use, L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride are safe for all animal species as well as for consumers and the environment. The Authority also concluded that L-cysteine is not considered a skin and eye irritant nor a skin sensitiser. The substances L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride are considered to be corrosive to eyes and respiratory tract, but no conclusion could be reached on their skin irritation potential. The Authority further concluded that, as L-cysteine, L-cysteine hydrochloride, and L-cysteine hydrochloride monohydrate are used in food as flavouring compounds, it is expected that they can provide a similar function in feed and no further demonstration of their efficacy is necessary. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) In view of the above, the Commission considers that L-cysteine, L-cysteine hydrochloride monohydrate and L-cysteine hydrochloride satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of those substances should be authorised for all animal species. 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.

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

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

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:e9689, https://doi.org/10.2903/j.efsa.2025.9689.

Article 1 Article 1 Authorisation

Article 2 Article 2 Entry into force

HAS ADOPTED THIS REGULATION: