Prováděcí nařízení Komise (EU) 2026/1017 ze dne 7. května 2026 o povolení L-threoninu z Escherichia coli CCTCC M 2024477 jako doplňkové látky 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 substance specified in the Annex, belonging to the additive category nutritional additives and to the functional group amino acids, their salts and analogues, is authorised as an additive 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 an authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-threonine produced with Escherichia coli CCTCC M 2024477. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of L-threonine produced with Escherichia coli CCTCC M 2024477 as a feed additive for use in feed and in water for drinking for all animal species, requesting that additive to be classified in the additive category nutritional additives and in the functional group amino acids, their salts and analogues.

(4) The European Food Safety Authority (the Authority) concluded in its opinion of 15 October 2025 EFSA Journal, 23 (10), e9678. https://doi.org/10.2903/j.efsa.2025.9678. that the use of L-threonine produced with Escherichia coli CCTCC M 2024477 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. Due to the risk of nutritional imbalances and hygienic reasons, the Authority has concerns on the of use L-threonine in water for drinking. The Authority also concluded that the use of L-threonine produced with Escherichia coli CCTCC M 2024477 in animal nutrition is safe for the consumers and the environment. In the absence of data, it could not conclude on the potential of the additive to be irritant to skin or eyes or on its potential to be a dermal sensitiser but identified an inhalation risk to endotoxins for the users of the additive. The Authority further concluded that the substance is regarded as an efficacious source of the amino acid L-threonine for all non-ruminant species. In order to be as efficacious in ruminants as in non-ruminant species, it should be protected from ruminal degradation. 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-threonine produced with Escherichia coli CCTCC M 2024477 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance as a feed additive should be authorised for all animal species. The Commission considers that possible hygiene risks related to the use of this amino acid in water for drinking, are to be addressed by feed businessRegulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/183/oj). laying down requirements for feed hygiene. When fed to ruminants, L-threonine produced with Escherichia coli CCTCC M 2024477 should be protected against degradation in the rumen. It is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids, in particular in the case of supplementation with L-threonine via water for drinking. 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.

(6) 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, 23 (10), e9678. https://doi.org/10.2903/j.efsa.2025.9678.

Article 1 Article 1 Authorisation

Article 2 Article 2 Entry into force

Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/183/oj).

HAS ADOPTED THIS REGULATION: