Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 32505 as a nutritional additive in feed or water for drinking for all animal species and categories. The production strain is genetically modified. None of the genetic modifications raised a safety concern. Viable cells or DNA of the production strain were not detected in the final product. The use of l‐isoleucine produced with C. glutamicum CGMCC 32505 in feed was considered safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs. The FEEDAP Panel had concerns on the use of amino acids in water for drinking. The use of l‐isoleucine (≥ 98.0%) produced with C. glutamicum CGMCC 32505 in animal nutrition was considered safe for the consumers and the environment. Regarding the safety for the user, owing to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes and to be a potential skin sensitiser. The additive was regarded as an effective source of the amino acid l‐isoleucine for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation.
Keywords: amino acids, their salts and analogues, Corynebacterium glutamicum CGMCC 32505, l‐isoleucine, nutritional additives, safety
1. INTRODUCTION
1.1. Background and Terms of Reference
Regulation (EC) No 1831/2003 1 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any person seeking authorisation for a feed additive or for a new use of feed additive shall submit an application in accordance with Article 7.
The European Commission received a request from Xinjiang Fufeng Biotechnologies Co., Ltd. represented in the European Union by Seres Biotech B.V. 2 for the authorisation of the additive consisting of L‐isoleucine produced with the genetically modified strain Corynebacterium glutamicum CGMCC 32505, when used as a feed additive for all animal species (category: nutritional additives; functional group: amino acids, their salts and analogues).
According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 4(1) (authorisation of a feed additive or new use of a feed additive). The dossier was received on 20 November 2025, and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2025‐00654. The particulars and documents in support of the application were considered valid by EFSA as of 27 February 2026.
According to Article 8 of Regulation (EC) No 1831/2003, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the feed additive consisting of L‐isoleucine produced with the genetically modified strain C. glutamicum CGMCC 32505, when used under the proposed conditions of use (see Section 3.1.4 ).
1.2. Additional information
The additive consists of l‐isoleucine produced with C. glutamicum CGMCC 32505. It has not been previously authorised as a feed additive in the European Union. l‐isoleucine produced by fermentation using different production strains is currently authorised for its use in all animal species as a nutritional additive. 3
The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has issued a series of scientific opinions on the safety and efficacy of l‐isoleucine produced by fermentation using different production strains for all animal species. 4
2. DATA AND METHODOLOGIES
2.1. Data
The present assessment is based on data submitted by the applicant in the form of a technical dossier 5 in support of the authorisation request for the use of l‐isoleucine produced with C. glutamicum CGMCC 32505 as a feed additive.
In accordance with Article 38 of the Regulation (EC) No 178/2002 6 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation, and of the Decision of EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality, 7 a non‐confidential version of the dossier has been published on Open.EFSA.
According to Article 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 26 June 2026 to 17 July 2026 for which no comments were received.
The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 4 March 2026 to 4 June 2026. No comments were received.
EFSA has verified the European Union Reference Laboratory (EURL) report as it relates to the methods used for the control of the active substance in animal feed. 8
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety and the efficacy of l‐isoleucine produced with C. glutamicum CGMCC 32505 is in line with the principles laid down in Regulation (EC) No 429/2008 9 and the relevant guidance documents: Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017a), Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017b), Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017c), Guidance on the characterisation of microorganisms used as feed additives or as production organisms (EFSA FEEDAP Panel, 2018), Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019), Guidance on the assessment of the safety of feed additives for the users (EFSA FEEDAP Panel, 2023), EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA, 2024) and Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2024).
3. ASSESSMENT
l‐isoleucine (≥ 98.5% l‐isoleucine on a dry matter [DM] basis) is produced by fermentation with a genetically modified strain of C. glutamicum (CGMCC 32505). It is intended to be used as nutritional additive (functional group: amino acids, their salts and analogues) in feed and water for drinking for all animal species.
3.1. Characterisation
3.1.1. Characterisation of the production microorganism
l‐Isoleucine is produced with a genetically modified strain of C. glutamicum which is deposited in the China General Microbiological Culture Collection Center (CGMCC) with accession number 32505. 10
The taxonomic identification of the production strain CGMCC 32505 as C. glutamicum was confirmed by bioinformatic analysis of its whole genome sequence (WGS) data. 11 ■■■■■
The antimicrobial susceptibility of the production strain to antimicrobials was tested using a broth microdilution method against the battery of antibiotics recommended by the FEEDAP Panel (EFSA FEEDAP Panel, 2018). 12 All the minimum inhibitory concentration (MIC) values were equal or fell below the corresponding cut‐off values for ‘Corynebacterium and other Gram‐positive’. Therefore, the production strain is considered susceptible to all relevant antibiotics.
The WGS data of the production strain was interrogated for the presence of antimicrobial resistance (AMR) genes against ■■■■■ databases. 13 The search resulted in ■■■■■ (EFSA, 2024). ■■■■■ (EFSA BIOHAZ Panel, 2023) ■■■■■ Therefore, the FEEDAP Panel concludes that the strain harbours no acquired AMR genes.
3.1.1.1. Characterisation of the parental or recipient microorganism and genetic modification description
The parental strain is the type strain C. glutamicum ATCC 13032T.
The genetic modifications described below, aimed at increasing the production of l‐isoleucine, were introduced to obtain the production strain under assessment.
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3.1.2. Manufacturing process
l‐Isoleucine is produced by fermentation with C. glutamicum CGMCC 32505. 14 ■■■■■. 15
The applicant stated that no antimicrobial substances are used in the manufacturing process. 16
3.1.3. Characterisation of the additive
l‐Isoleucine (International Union of Pure and Applied Chemistry (IUPAC)) name: (2S,3S)‐2‐amino‐3‐methylpentanoic acid, a compound identified by Chemical Abstracts Service (CAS) No 73‐32‐5, and European Inventory of Existing Commercial Chemical Substances (EINECS) No 200‐798‐2, has a molecular weight of 131.17 g/mol; the molecular formula is C6H13NO2 and its structural formula is given in Figure 1.
FIGURE 1.
Structural formula of l‐isoleucine.
The additive is specified to contain ≥ 98.5% l‐isoleucine on DM basis and a maximum content of moisture of 2.0%. 17
The data provided by the applicant on the batch‐to‐batch variation 18 of the additive are reported in Table 1. Data on impurities 19 and physicochemical and technological properties 20 are reported in Appendix A.
TABLE 1.
Data on the batch‐to‐batch variation of the l‐isoleucine. The data presented are average values and (range) for batch‐to‐batch variation, and ranges for all other parameters. The number of batches analysed per parameter, or group of parameters are indicated in [].
| Specifications | |
| l‐isoleucine (%, on DM basis) 1 | ≥ 98.5% |
| Loss on drying (%) | ≤ 2 |
| Specific optical rotation (°) 2 | +38.9° to +41.8° |
| Batch‐to‐batch variation | [5] |
| l‐isoleucine (%, on DM basis) | 100 (100–100) |
| Loss on drying (%) | 0.86 (0.7–1.0) |
| Specific optical rotation (°) | +38.92 (+38.91 to +38.93) |
Abbreviation: DM, dry matter.
Analytical method to determine l‐isoleucine was EN ISO 17180:2013.
In accordance to USP 781S.
As supporting evidence, endotoxin activity was analysed in three batches of the final product and in all cases the result was < 300 IU/g (limit of detection (LOD)). 21 The FEEDAP Panel notes that endotoxins are not expected in Gram‐positive microorganisms.
The data provided showed compliance with the specifications set by the applicant. The FEEDAP Panel considers that the microbial contamination and the amounts of the impurities analysed are of no concern.
The presence of viable cells of the production strain was investigated in three independent production batches of the additive analysed in triplicate (1 g per sample). 22 Methodology, incubation conditions and controls were performed according to the requirements set by the EFSA FEEDAP Panel (EFSA FEEDAP Panel, 2018). No viable cells of the production strain were found in any of the test samples.
The presence of DNA from the production strain was analysed by PCR in three independent production batches of the additive in triplicate (1 g per sample). 23 ■■■■■ all relevant controls in the analysis were included. The limit of detection in samples spiked with total DNA of the production strain was 0.1 ng per gram of product. No DNA from the production strain was detected in any of the samples.
3.1.4. Conditions of use
l‐Isoleucine is intended to be used in feed or water to achieve an adequate amino acid profile and meet the requirements on l‐isoleucine for all animal species and categories. It is proposed to be added directly to complete feed, through complementary feed, premixtures and water for drinking. No inclusion levels have been proposed by the applicant, as the requirements in quantitative terms depend on the species, the physiological state of the animal, the performance level and the environmental conditions, as well as the amino acid composition of the unsupplemented diet. 24
3.2. Safety
3.2.1. Safety of the production microorganism
The production strain belongs to a species, C. glutamicum, that qualifies for the qualified presumption of safety (QPS) when used for production purposes (EFSA BIOHAZ Panel, 2026). The genetic modifications performed to obtain the production strain C. glutamicum CGMCC 32505 have the purpose to increase the production of l‐isoleucine. The taxonomic identification of the production strain was unequivocally established, and evidence that the strain does not carry acquired AMR genes coding for resistance to therapeutic antimicrobials was provided. The genetic modification does not raise safety concerns. No viable cells nor DNA of the production strain were detected in the final product. Therefore, the FEEDAP Panel concludes that the additive does not pose any safety concern regarding the production strain.
3.2.2. Safety for the target species, consumers and the environment
The l‐isoleucine requirements of the target animal species and the safety of this essential amino acid in non‐ruminant and ruminant nutrition are well known by feed formulators and available in general publications on animal nutrition.
The additive is produced by fermentation with a genetically modified C. glutamicum (CGMCC 32505), and no safety concerns were identified for the production strain (see Section 3.2.1 ), the fermentation process and its residues/metabolites. Moreover, the resulting product is highly purified (≥ 98.5% amino acid on a dry matter basis). l‐isoleucine produced with C. glutamicum CGMCC 32505 is safe for the target species when used to supplement the diet in appropriate amounts to satisfy the animal requirements. However, due to the risk of nutritional imbalances and hygienic reasons associated with the use of amino acids via water for drinking (EFSA FEEDAP Panel, 2010), the FEEDAP Panel has concerns on the safety of the use of l‐isoleucine via water for drinking.
The absorption and metabolic fate of l‐isoleucine in the animals is well known. The amino acid l‐isoleucine, supplemented to feed, will be incorporated into proteins of tissues and/or products of animal origin and any of its potential excess will be metabolised and excreted. Therefore, the composition of tissues and products of animal origin will not be affected using l‐isoleucine in animal nutrition. Therefore, the Panel considers that the use of the additive in animal nutrition is safe for the consumer.
The amino acid l‐isoleucine is a physiological and natural component of animals and plants. It is not excreted as such, but as urea/uric acid and carbon dioxide. The use of the product l‐isoleucine in animal nutrition would not lead to any localised increase in the concentration in the environment. The use of the additive in water for drinking, when given in addition to complete diets with a well‐balanced amino acid profile, would disturb the nitrogen balance and increase nitrogen excretion via urine. The Panel concludes that the use of l‐isoleucine produced by fermentation with C. glutamicum CGMCC 32505 as a feed additive does not represent a risk for the environment.
3.2.3. Safety for the user
No specific information was submitted to support the safety for the user. In absence of information, the FEEDAP Panel is not in the position to conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal sensitiser.
3.3. Efficacy
Efficacy studies are not required for amino acids that occur naturally in plant and animal proteins. The nutritional role of the amino acid l‐isoleucine is well established in the scientific literature. l‐Isoleucine produced by fermentation with C. glutamicum CGMCC 32505 is regarded as an efficacious source of the essential amino acid l‐isoleucine for non‐ruminant nutrition. For the amino acid l‐isoleucine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.
3.4. Post‐market monitoring
The FEEDAP Panel considers that there is no need for specific requirements for a post‐market monitoring plan other than those established in the Feed Hygiene Regulation 25 and Good Manufacturing Practice.
4. CONCLUSIONS
The production strain C. glutamicum CGMCC 32505 does not raise safety concerns. No viable cells or DNA of the production strain are detected in the final product. Therefore, the FEEDAP Panel concludes that the additive does not pose any safety concern regarding the production strain.
The use of l‐isoleucine in feed produced by fermentation with C. glutamicum CGMCC 32505 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. The FEEDAP Panel has concerns on the use of l‐isoleucine in water for drinking.
The use of l‐isoleucine produced by fermentation with C. glutamicum CGMCC 32505 in animal nutrition is considered safe for the consumers and for the environment.
Regarding the user safety, in the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal sensitiser.
The additive l‐isoleucine produced by fermentation with C. glutamicum CGMCC 32505 is regarded as an effective source of the amino acid l‐isoleucine for all non‐ruminant species. For the supplemental l‐isoleucine to be as efficacious in ruminants as in non‐ruminants species, it requires protection against degradation in the rumen.
ABBREVIATIONS
- AMR
antimicrobial resistance
- ANI
average nucleotide identity
- CAS
Chemical Abstracts Service
- CGMCC
China General Microbiological Culture Collection Center
- DM
dry matter
- EINECS
European Inventory of Existing Chemical Substances
- EURL
European Union Reference Laboratory
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- FLAVIS
The EU Flavour Information System
- IUPAC
International Union of Pure and Applied Chemistry
- JECFA
The Joint FAO/WHO Expert Committee on Food Additives
- LOD
limit of detection
- MIC
minimum inhibitory concentration
- nDL‐PCBs
non‐dioxin‐like PCBs
- PCBs
polychlorinated biphenyls
- PCDDs
polychlorinated dibenzo‐p‐dioxins
- PCDFs
polychlorinated dibenzofurans
- QPS
qualified presumption of safety
- RH
relative humidity
- TEQ
toxic equivalent factors for dioxins, furans and dioxin‐like PCBs
- WGS
whole genome sequence
- WHO
World Health Organization
REQUESTOR
European Commission
QUESTION NUMBER
EFSA‐Q‐2025‐00654
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PANEL MEMBERS
Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Giovanna Martelli, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Katerina Theodoridou.
LEGAL NOTICE
The published scientific output implements EFSA’s decision on the confidentiality requests submitted on specific information items. Information items awarded confidential status by EFSA and included in the relevant scientific output have been withheld from public disclosure by redaction.
ACKNOWLEDGEMENTS
The Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last name): Jaume Galobart. EFSA wishes to acknowledge contribution from the following consortium members under the Framework Partnership Agreement GP/EFSA/FIP/2022/01: Raúl Domínguez‐Perles, Pablo S. Fernandez‐Escamez, Sonia Medina and Paula M. Periago‐Bayonas.
APPENDIX A. Impurities and physicochemical and technological properties of the additive
TABLE A.1 Data on impurities and physicochemical and technological properties of the product. The data presented are ranges for all parameters. The number of batches analysed are indicated in [].
| Impurities | [3] |
| Lead (mg/kg) | < 0.01 |
| Mercury (mg/kg) | < 0.002 |
| Cadmium (mg/kg) | < 0.002 |
| Arsenic (mg/kg) | < 0.01 |
| Dioxins and furans (upper bound) 1 | [3] |
| PCDD/Fs (ng WHO2005‐TEQ/kg) | 0.137 |
| PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg) | 0.269 |
| nDL‐PCBs (μg/kg) | 0.132 |
| Mycotoxins (μg/kg) | [3] |
| Aflatoxins | < 0.05 |
| Zearalenone | < 17 |
| Citrinin | < 15.0 |
| Deoxynivalenol | < 134 |
| Fumonisine B1 + B2 + B3 | < 250 |
| Ochratoxin A | < 2.8–3.9 |
| Microbial contamination | [3] |
| Salmonella spp. (per 25 g) | Not detected |
| Escherichia coli (per 25 g) | Not detected |
| Enterobacteriaceae (per 10 g) | Not detected |
| Yeast and moulds (per 25 g) | Not detected |
| Physical properties | |
| Bulk density (kg/m3) | 574 [5] |
| pH | 4.9 [5] |
| Dusting potential (Stauber Heubach) (mg/m3) | 1818 [3] |
| Shelf‐life (% recovery) | [3] |
| Room temperature, 6 months (%) | 101 |
| Stability in premixtures (% recovery) | [3] |
| Vitamin‐mineral premix ‐ Room temperature, 6 months (%) | 113 |
| Stability in feed (% recovery) | [3] |
| Meal – Room temperature, 3 months (%) | 104 |
| Pelleted – Room temperature, 3 months (%) | 104 |
| Stability in water (% recovery) | [3] |
| 8–10°C, 48 h | 98 |
|
Homogeneity (coefficient of variation of 10 subsamples, %) Total isoleucine in feed (pelleted) |
6.7 [1] |
Abbreviations: nDL‐PCBs, non‐dioxin‐like PCBs; PCBs, polychlorinated biphenyls; PCDDs, polychlorinated dibenzo‐p‐dioxins; PCDFs, polychlorinated dibenzofurans; RH, relative humidity; TEQ, toxic equivalent factors for dioxins, furans and dioxin‐like PCBs established by WHO in 2005 (Van den Berg et al., 2006); WHO, World Health Organization.
Upper bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification. Values are expressed per kg of additive with 88% dry matter content.
<, below the limit of detection.
EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Villa, R. E. , Azimonti, G. , Bonos, E. , Christensen, H. , Durjava, M. , Dusemund, B. , Gehring, R. , Glandorf, B. , Kouba, M. , López‐Alonso, M. , Marcon, F. , Martelli, G. , Nebbia, C. , Pechová, A. , Prieto‐Maradona, M. , Theodoridou, K. , Anguita, M. , Innocenti, M. L. , Tarrés‐Call, J. , & García‐Cazorla, Y. (2026). Safety and efficacy of a feed additive consisting of l‐isoleucine produced with Corynebacterium glutamicum CGMCC 32505 for all animal species (Xinjiang Fufeng Biotechnologies Co., Ltd). EFSA Journal, 24(8), e10291. 10.2903/j.efsa.2026.10291
Adopted: 24 July 2026
Correspondence: Ask a Question
The declarations of interest of all scientific experts active in EFSA's work are available at https://open.efsa.europa.eu/experts.
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the council of 22 September 2003 on the additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
Xinjiang Fufeng Biotechnologies co., Ltd. (Ganquan Pu, Industrial Park, Urumqi, Xinjiang 830000, China) represented in the EU by Seres Biotech B.V. (B. Verderlaan 11 Utrecht, Netherlands).
European Commission food and feed additives portal. Available online: https://ec.europa.eu/food/food‐feed‐portal/screen/feed‐additives/search.
Available online in EFSA Journal: https://efsa.onlinelibrary.wiley.com/journal/18314732.
Dossier reference: FEED‐2025‐36602.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, p. 1–48.
Decision available at: https://www.efsa.europa.eu/en/corporate‐pubs/transparency‐regulation‐practical‐arrangements.
Evaluation report received on 21/4/2026 and available on the EU Science Hub https://joint‐research‐centre.ec.europa.eu/eurl‐fa‐eurl‐feed‐additives/eurl‐fa‐authorisation/eurl‐fa‐evaluation‐reports_en.
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5.2008, p. 1.
2.2.1.2.a Certificate of deposition of the strain.
2.2.1.2.c1 Bioinformatics P1873R2205.
2.2.2.2.a MIC P1873R2194.
2.2.1.2.c1 Bioinformatics P1873R2205.
Technical dossier text ‐ Sect_1.2.
2.3.1.a Manufacturing and flow chart_Consolidated 260513, 2.3.1.b Raw materials used in the production process_Consolidated 260513.
2.3.1.c Statement no antibiotic use.
Sect_2.1–2.2_Consolidated 260114.
2.1.5.b COA Optical rotation density, 2.1.3.b Statement Independent samples.
2.1.3.a BtB stability impurities 148,781, 2.1.4.a Dioxins PCBs, Sect_2.6_Consolidated 260513.
2.1.5.a Dust, Sect_2.4_Consolidated 260,114, 2.4.1.b Stability premix feed homogeneity.
2.1.4.d Endotoxins.
2.1.4.b Absence viable cells P1873R2203.
2.1.4.c Absence DNA P1873R2235.
Sect_2.5.
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.
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