Date: 2026-07-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2026/1756 of 20 July 2026 concerning the authorisation of L-valine produced from Corynebacterium glutamicum KCCM 80366, in the form of an inactivated fermentation product, as a feed additive for all animal species
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Implementing Regulation (EU) 2026/1756 authorizes L-valine produced from *Corynebacterium glutamicum* KCCM 80366 as a nutritional feed additive for all animal species. The regulation, enacted on 20 July 2026, enters into force in August 2026 and sets an authorization expiry date of 10 August 2036. It establishes specific labeling, safety, and formulation requirements to ensure animal health and user safety.
**Key Points / Main Content**
**Authorization and Classification**
* **Additive Identification:** The substance is L-valine (identification number 3c375) produced from *Corynebacterium glutamicum* KCCM 80366.
* **Category:** Classified as a ‘nutritional additive’ within the functional group ‘amino acids, their salts and analogues.’
* **Target Species:** Authorized for use across all animal species.
**Product Specifications**
* **Composition:** An inactivated fermentation product in solid form with a minimum L-valine content of 72% (on a dry matter basis).
* **Analytical Method:** For determination of valine in the additive, premixtures, and feed, the required method is ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC—VIS).
**Usage Requirements**
* **Ruminant Efficacy:** To ensure efficacy in ruminants, the additive must be protected against degradation in the rumen.
* **Instructions for Use:** Directions must clearly indicate storage conditions and the stability of the additive regarding heat treatment.
**Labeling Mandates**
* **Moisture Content:** The specific moisture content must be indicated on the additive's label.
* **Nutritional Warning:** Labels for the additive and premixtures must state: "The supplementation with L-valine shall take into account all essential and conditionally essential amino acids in order to avoid nutritional imbalances."
**Safety and Health Measures**
* **Risk Identification:** The additive is recognized as a potential skin and respiratory sensitizer.
* **Risk Management:** Users must establish operational procedures and organizational measures to address risks. Where risks cannot be eliminated, personal protective equipment (PPE) for skin, eyes, and breathing is mandatory.
**Impact Analysis**
**Feed Business Operators**
**Impact**
Operators are granted the right to market and use this specific L-valine source within the EU, provided they comply with strict formulation and labeling standards.
**Action Required**
Must ensure that L-valine is rumen-protected when intended for ruminant feed. They must update product labels to include moisture content, heat stability, and the mandatory nutritional imbalance warning.
**Users of the Additive (Manufacturers and Farm Workers)**
**Impact**
Users are exposed to potential health risks, specifically skin and respiratory sensitization, during the handling of the additive and premixtures.
**Action Required**
Must implement formal operational procedures and use appropriate PPE (protective equipment for skin, eyes, and respiratory tract) if exposure risks cannot be otherwise mitigated.
**Regulatory and Monitoring Bodies**
**Impact**
Responsible for ensuring the additive on the market meets the purity and concentration standards (minimum 72% L-valine).
**Action Required**
Utilize the specified ion-exchange chromatography (IEC—VIS) analytical methods for official controls and market surveillance.
Key Entities Referenced
Regulation (EC) No 1831/2003: The primary legal framework governing the authorisation, placement on the market, and use of additives in animal nutrition.
L-valine produced from Corynebacterium glutamicum KCCM 80366: The specific nutritional feed additive authorised by this regulation for use in animal nutrition for all animal species.
European Food Safety Authority: The regulatory body that conducted the scientific assessment and provided the safety and efficacy opinion for the feed additive.
Standing Committee on Plants, Animals, Food and Feed: The expert committee that provided a favorable opinion on the measures adopted in this regulation.
Official Journal EN
of the European Union L series
2026/1756 21.7.2026
COMMISSION IMPLEMENTING REGULATION(EU) 2026/1756
of 20 July 2026
concerning the authorisation of L-valine produced from Corynebacterium glutamicumKCCM 80366,
in the form of an inactivated fermentation product, 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-valine produced from Corynebacterium glutamicum KCCM 80366, in the form of an inactivated fermentation
product. 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-valine produced from Corynebacterium glutamicumKCCM 80366, in
the form of an inactivated fermentation product, as a feed additive 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 18 November 2025(2)that L-valine
produced using Corynebacterium glutamicum KCCM 80366 is safe for all animal species when supplemented in
appropriate amounts to the diet according to their nutritional needs. The Authority also concluded that the use of
L-valine produced using Corynebacterium glutamicumKCCM 80366 in animal nutrition is safe for the consumers and
the environment. It further concluded that the additive should not be considered a skin irritant but should be
considered a skin and respiratory sensitiser. It could not make any conclusions regarding the eye irritancy potential
of the additive. The Authority further concluded that the substance is regarded as an efficacious source of the
essential amino acid L-valine for all animal species but, in order to be as efficacious in ruminants as in non-
ruminants, 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-valine produced from Corynebacterium glutamicum KCCM
80366, in the form of an inactivated fermentation product, 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.
When fed to ruminants, L-valine produced from Corynebacterium glutamicum KCCM 80366, in the form of an
inactivated fermentation product, 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 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,
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Journal 23(12), e9782, https://doi.org/10.2903/j.efsa.2025;9782.
ELI: http://data.europa.eu/eli/reg_impl/2026/1756/oj 1/4EN
OJ L, 21.7.2026
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, 20 July 2026.
For the Commission
The President
Ursula VON DER LEYEN
2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/1756/ojANNEX
Identifica Minimum Maximum
tion Species or content content End of period
Composition, chemical formula, Maximum
number of Name of the additive category Other provisions of
description, analytical method age
the of animal mg/kg of complete feed with authorisation
additive 12 % moisture content
Category: nutritional additives. Functional group: amino acids, their salts and analogues
3c375 L-valine Additive composition All — — — 1. In the directions for use of 10 August
animal the additive and premixtures, 2036
Fermentation product consisting of
species the storage conditions and
inactivated cells of Corynebacterium
the stability to heat treatment
glutamicumKCCM 80366 with a
shall be indicated.
minimum L-valine content of 72 %
(on a dry matter basis). 2. Feed business operators shall
ensure that L-valine is rumen
Solid form.
protected, when fed to
Characterisation of the active substance ruminants.
L-valine produced from 3. The moisture content shall
Corynebacterium glutamicumKCCM be indicated on the label of
80366 the additive.
IUPAC name: (2S)-2-amino- 4. The label of the additive and
3-methylbutanoic acid premixtures shall indicate
the following: ‘The
Chemical formula: C H NO
5 11 2 supplementation with
CAS number: 72-18-4 L-valine shall take into
account all essential and
Analytical method(1)
conditionally essential
For the determination of valine in the amino acids in order to avoid
feed additive: nutritional imbalances.’
— Ion-exchange chromatography
coupled with post-column
derivatisation and optical
detection (IEC—VIS)
ELI:
http://data.europa.eu/eli/reg_impl/2026/1756/oj
3/4
OJ
L,
21.7.2026
ENIdentifica Minimum Maximum
tion Species or content content End of period
Composition, chemical formula, Maximum
number of Name of the additive category Other provisions of
description, analytical method age
the of animal mg/kg of complete feed with authorisation
additive 12 % moisture content
Category: nutritional additives. Functional group: amino acids, their salts and analogues
For the determination of valine in 5. For users of the additive and
premixtures and compound feed: premixtures, feed business
— Ion-exchange chromatography operators shall establish
coupled with post-column operational procedures and
derivatisation and optical organisational measures to
detection (IEC—VIS), address potential risks
Commission Regulation resulting from their use.
(EC) No 152/2009(2) Where those risks cannot be
eliminated by such
procedures and measures,
the additive and premixtures
shall be used with personal
skin, eye and breathing
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).
4/4
ELI:
http://data.europa.eu/eli/reg_impl/2026/1756/oj
EN
OJ
L,
21.7.2026