Commission Implementing Regulation (EU) 2023/2583 of 20 November 2023 concerning the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80185 as a feed additive for all animal species
Commission Implementing Regulation (EU) 2023/2583of 20 November 2023concerning the authorisation of L-isoleucine produced by Corynebacterium glutamicum KCCM 80185 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 nutritionOJ L 268, 18.10.2003, p. 29., 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-isoleucine produced by Corynebacterium glutamicum KCCM 80185. 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-isoleucine produced by Corynebacterium glutamicum KCCM 80185 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 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 opinions of 10 November 2021EFSA Journal 2021;19(12):6977. and of 21 March 2023EFSA Journal 2023;21(4):7957. that, under the proposed conditions of use, L-isoleucine produced by Corynebacterium glutamicum KCCM 80185 is safe for the target species, consumers and the environment. It also concluded that the additive is hazardous by inhalation for persons handling the additive. The Authority further concluded that the additive is an efficacious source of the essential amino acid isoleucine for non-ruminant animals and that for the supplemental L-isoleucine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority expressed concerns on the simultaneous oral administration of the amino acid via water for drinking and feed. However, the Authority did not propose a maximum content for L-isoleucine. Thus, in the case of supplementation with L-isoleucine via water for drinking, it is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids. 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-isoleucine produced by Corynebacterium glutamicum KCCM 80185 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that additive should be authorised. 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 1The 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 2This 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, 20 November 2023.For the CommissionThe PresidentUrsula von der LeyenANNEX
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_enCommission 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).
Identification number of the additiveAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisation
mg/kg of complete feed with 12 % moisture content
Category: nutritional additives. Functional group: amino acids, their salts and analogues
3c384L-isoleucineAdditive compositionPowder with a minimum content of L-isoleucine of 90 % (on a dry matter basis)Characterisation of the active substanceL-isoleucine produced by fermentation with Corynebacterium glutamicum KCCM 80185IUPAC name: (2S,3S)-2-amino-3-methylpentanoic acidChemical formula: C6H13NO2CAS number: 73-32-5Analytical methodFor the identification of L-isoleucine in the feed additive:Food Chemical Codex "L-isoleucine monograph"For the quantification of isoleucine in the feed additive:ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) orion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS)For the quantification of isoleucine in premixtures:ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) orion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F)For the quantification of isoleucine in compound feed:ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS) – Regulation (EC) No 152/2009 (Annex III, F)For the quantification of isoleucine in water:ion-exchange chromatography coupled to post-column derivatisation and photometric detection (IEC-VIS)All animal species--1.In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and in water shall be indicated.2.The additive may be used via water for drinking.3.Declaration to be made on the label of the additive and premixture:"The supplementation with L-isoleucine, in particular via water for drinking, shall take into account all essential and conditionally essential amino acids in order to avoid imbalances."L-isoleucine content.4.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 breathing protective equipment.11 December 2033