Commission Implementing Regulation (EU) 2026/352 of 18 February 2026 concerning the authorisation of L-arginine produced with Escherichia coli CCTCC M 20231961 as a feed additive for all animal species
Date: 2026-02-18
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: amino acid, animal feedingstuffs, drinking water, food additive, market approval, microorganism








L_202600352EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/352


19.2.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/352
of 18 February 2026
         
concerning the authorisation of L-arginine produced with Escherichia coli CCTCC M 20231961 as a feed additive for all animal species
(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 such an authorisation.












(2)


In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-arginine produced with Escherichia coli CCTCC M 20231961. 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-arginine produced with Escherichia coli CCTCC M 20231961 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 21 July 2025 (2) that, under the proposed conditions of use, L-arginine produced with Escherichia coli CCTCC M 20231961 is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. However, due to the risk of nutritional imbalances and hygienic reasons, the Authority has concerns on the of use L-arginine in water for drinking. The Authority also concluded that the use of L-arginine produced with Escherichia coli CCTCC M 20231961 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 substance to be an irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The Authority further concluded that the substance is regarded as an efficacious source of the amino acid L-arginine for non-ruminant nutrition. For the supplemental L-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen. 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-arginine produced with Escherichia coli CCTCC M 20231961 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. The Commission considers that the safe use of this amino acid in water for drinking, with regard to possible hygiene risks, is to be considered within the scope of Regulation (EC) No 183/2005 of the European Parliament and of the Council (3) laying down requirements for feed hygiene. When fed to ruminants, L-arginine produced with Escherichia coli CCTCC M 20231961 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-arginine 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,





HAS ADOPTED THIS REGULATION:



Article 1

Authorisation

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.


Article 2

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, 18 February 2026.


For the Commission


The President

Ursula VON DER LEYEN
            





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

(2)  
            EFSA Journal 2025;23(8);e9609, https://doi.org/10.2903/j.efsa.2025.9609.

(3)  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).




ANNEX













Identification number of the additive


Name of the additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




mg/kg of complete feed with 12 % moisture content





Category: nutritional additives. Functional group: amino acids, their salts and analogues





3c366i


L-arginine



Additive composition

L-arginine
Solid form

Characterisation of the active substance

L-arginine ≥ 98,5 % (on a dry matter basis) produced with Escherichia coli CCTCC M 20231961
IUPAC name: (2S)-2-amino-5-(diaminomethylideneamino)pentanoic acid
Chemical formula: C6H14N4O2

CAS number: 74–79-3

Analytical method
 (1)

For the identification of L-arginine in the feed additive:






—


Food Chemical Codex ‘L-arginine monograph’




For the determination of arginine in the feed additive:






—


Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD or IEC-VIS)




For the determination of arginine in premixtures:






—


Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS/FLD) or










—


Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (2)





For the determination of arginine in compound feed:






—


Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS) – Regulation (EC) No 152/2009




For the determination of arginine in water for drinking:






—


Ion-exchange chromatography coupled to post-column derivatisation and optical detection (IEC-VIS)






All animal species


—


—


—








1.


In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and in water for drinking shall be indicated.










2.


The additive may be used via water for drinking.










3.


Feed business operators shall ensure that L-arginine is rumen protected, when fed to ruminants.










4.


The moisture content shall be indicated on the label of the additive.










5.


The label of the additive and premixtures shall indicate the following: ‘The supplementation with L-arginine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances.’










6.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin and eye protective equipment.






11 March 2036






(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/2026/352/oj
ISSN 1977-0677 (electronic edition)