Safety of a feed additive consisting of xanthan gum (produced with Xanthomonas campestris strains ATCC SD‐7012, DSM 23730, CNCM I‐4861 and ■■■■■ for all animal species with the exception of cats and aquatic species (BIOPOLYMER International)

TL;DR

The paper confirms that xanthan gum, produced with specific strains, is safe for animal feed in most species, with no major safety concerns.

Contribution

The study provides a comprehensive safety evaluation of xanthan gum as a feed additive for non-feline and non-aquatic animals.

Findings

Xanthan gum production strains do not pose safety concerns.

The additive is safe for target animals, consumers, and the environment.

No skin irritation or sensitization risks were identified.

Abstract

Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the safety of xanthan gum as a technological feed additive for all animal species, with the exception of cats and aquatic species. Xanthan gum, produced with Xanthomonas campestris ATCC SD‐7012, CNCM I‐4861, DSM 23730 and ■■■■■, does not pose any safety concern associated with the production strains. The FEEDAP Panel concluded that the additive is safe for all target animal species under application. The use of xanthan gum in animal nutrition did not pose any concern for consumer safety. Additionally, the use of this additive was considered safe for the environment. Regarding the user safety, the additive is not a skin irritant or a skin sensitiser. The FEEDAP Panel cannot conclude on the eye irritation potential due to the lack of data.

Tables

TABLE 1. Description of the additive

Category of additive	Technological additives
Functional group of additive	– Stabilisers
	– Thickeners
Description	Xanthan gum
Target animal category	All animal species with the exception of cats and aquatic species
Applicant	BIOPOLYMER International
Type of request	New opinion

TABLE 2. Maximum safe concentration of xanthan gum in complete feed for the target species.

Target animal	Default values for daily feed intake (g dry matter/kg)	Safe concentration in feed (mg/kg complete feed) 1
Chicken for fattening	79	56
Laying hen	53	83
Turkey for fattening	59	75
Piglet	44	100
Pig for fattening	37	120
Sow lactating	30	146
Veal calf (milk replacer)	19	250
Cattle for fattening	20	220
Dairy cow	31	143
Sheep/goat	20	220
Horse	20	220
Rabbit	50	88
Dog	17	264

Full text

INTRODUCTION

1

Background and Terms of Reference as provided by the requestor

1.1

Regulation (EC) No 1831/2003 establishes the rules governing the Community authorisation of additives for use in animal nutrition and, in particular, Article 9 thereof defines the terms of the authorisation by the Commission.

The applicant, BIOPOLYMER International, is seeking a Community authorisation of xanthan gum as a feed additive to be used as stabiliser and thickener, for all animal species with the exception of cats and aquatic species (Table 1).

On 24 June 2021, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of the European Food Safety Authority (EFSA), in its opinion on the safety and efficacy of the product, could not conclude on the safety of the additive.

The Commission gave the possibility to the applicant to submit supplementary information and data in order to complete the assessment and to allow a revision of the EFSA's opinion. The new data have been received on 22 February 2023 and the applicant has been requested to transmit them to EFSA as well.

In view of the above, the Commission asks EFSA to deliver a new opinion on xanthan gum as a feed additive, for all animal species with the exception of cats and aquatic species based on the supplementary information and data submitted by the applicant, in accordance with Article 29(1)(a) of Regulation (EC) No 178/2002.

Additional information

1.2

Xanthan gum is currently listed in the EU Register of Feed Additives as a technological additive (functional group: emulsifying and stabilising agents, thickeners and gelling agents) for use in feed for all animal species.1

The additive is xanthan gum produced by fermentation with Xanthomonas campestris strains ATCC SD‐7012, DSM 23730, CNCM I‐4861 and ■■■■■. EFSA issued one opinion for the re‐evaluation of this product when used in feed for all animal species (EFSA FEEDAP Panel, 2021).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of supplementary information2 to a previous application on the same product.3

In accordance with Article 38 of the Regulation (EC) No 178/20024 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,5 a non‐confidential version of the supplementary information has been published on Open.EFSA.

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and efficacy of xanthan gum is in line with the principles laid down in Regulation (EC) No 429/20086 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 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), EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA, 2021) and Guidance on the assessment of the safety of feed additives for the users (EFSA FEEDAP Panel, 2023).

ASSESSMENT

3

The additive under assessment is xanthan gum produced with different strains of Xanthomonas campestris intended to be used as a technological additive (functional groups: stabilisers and thickeners) in feedingstuffs for all animal species with the exception of cats and aquatic species.

In a previous opinion (EFSA FEEDAP Panel, 2021), the identity of the strains producing xanthan gum was not unambiguously established, data on antimicrobial susceptibility were incomplete and it was not possible to exclude the presence in the additive of viable cells/DNA of the production strains. This, together with the lack of adequate data on the safety, did not allow the Panel to conclude on the safety of xanthan gum for the target species, consumers, users and the environment.

For the current evaluation, the applicant submitted new data on the identity of the production strain (Section 3.1.1), additional information/data on the toxicology of xanthan gum, on the safety for the user and environment (Section 3.2) to address the limitations previously identified by the Panel. The new data are assessed below.

Characterisation

3.1

The additive consists of pure xanthan gum and was characterised in the previous opinion in terms of composition, impurities and physical and physico‐chemical properties (EFSA FEEDAP Panel, 2021). The applicant has provided new data to allow the characterisation of the production strains.

Characterisation of the production strains

3.1.1

The additive under assessment is produced by four manufacturing companies, each using a different production strain belonging to the species X. campestris.7

X. campestris ATCC SD‐7012

3.1.1.1

The production strain is deposited in the American Type Culture Collection (ATCC) under the accession number ATCC SD‐7012.8 ■■■■■.9

The taxonomical identification of the strain ATCC SD‐7012 was confirmed by average nucleotide identity (ANI) determination of the whole genome sequence (WGS) data.10 The results of this analysis showed an ANI value of 98.64% with the type strain X. campestris ATCC 33913^T^.

The antimicrobial susceptibility of the strain was tested against the battery of antibiotics recommended by the EFSA FEEDAP Panel (EFSA FEEDAP Panel, 2018).11 All the minimum inhibitory concentration (MIC) values were equal to or fell below the corresponding cut‐off values for Enterobacteriaceae, except for ampicillin, gentamicin and ciprofloxacin. The MIC value for ampicillin and gentamicin exceeded the EFSA cut‐off value by one dilution step (16 vs. 8 mg/L and 4 vs. 2 mg/L, respectively). Exceedance of the cut‐off value by one dilution is considered to be within the normal range of variation and thus, not a matter of concern. The MIC value for ciprofloxacin exceeded the EFSA cut‐off value by more than two dilution steps (0.48 vs. 0.06 mg/L). Therefore, the strain ATCC SD‐7012 is susceptible to all the relevant antibiotics, except to ciprofloxacin.

The WGS data of the strain were interrogated for the presence of antimicrobial resistance (AMR) genes by a search against four databases, using equal or lower thresholds as indicated in the EFSA Statement (EFSA, 2021).12 The FEEDAP Panel only considered the results obtained from the three maintained databases, NCBI Bacterial Antimicrobial Resistance Reference Gene Database, ResFinder and MEGARes. No hits of concern were identified; therefore, the FEEDAP Panel concludes that the strain does not harbour acquired AMR genes and does not raise safety concerns. Although the strain was resistant to ciprofloxacin, since no acquired AMR genes were found in the WGS, the resistance to ciprofloxacin does not raise safety concerns.

The WGS data of the production strain were also interrogated for the presence of known virulence factor genes against the Virulence Factor database (VFDB) and the ecoli_vf database.13 No hits were identified.

The presence of viable cells of the production strain X. campestris ATCC SD‐7012 was investigated in three batches of the additive, each tested in triplicate.14 For each sample, 1 g was plated onto TSA (Tryptic Soy Agar) medium and incubated at 30°C for 6 days. Positive controls were included. No viable cells of the production strain were detected.

X. campestris CNCM I‐4861

3.1.1.2

The production strain is deposited in the Collection Nationale de Cultures de Microorganismes (CNCM) under the accession number CNCM I‐4861.15 It derives from X. campestris ■■■■■ and was obtained using selective pressure to ensure bacteriophage resistance. Therefore, X. campestris CNCM I‐4861 is not genetically modified.16

The taxonomical identification of the strain CNCM I‐4861 was confirmed by ANI determination of the WGS data.17 The results of this analysis showed an ANI value of 98.62% with the type strain X. campestris ATCC 33913^T^.

The antimicrobial susceptibility of the strain to the relevant antibiotics was tested against the list of antibiotics described for Enterobacteriaceae as per the aforementioned guidance.18 All the MIC values were equal to or fell below the corresponding cut‐off values, except for ciprofloxacin, whose value exceeded the EFSA cut‐off value by more than two dilution steps (> 0.25 vs. 0.06 mg/L). Therefore, the strain CNCM I‐4861 is susceptible to the relevant antibiotics, except for ciprofloxacin.

The WGS data of the strain were interrogated for the presence of AMR genes by a search against CARD and NCBI Bacterial Antimicrobial Resistance Reference Gene databases, using equal thresholds as indicated in the EFSA Statement (EFSA, 2021).19 No hits of concern were identified; therefore, the FEEDAP Panel concludes that the strain does not harbour acquired AMR genes and does not raise safety concerns. Although the strain was resistant to ciprofloxacin, since no acquired AMR genes were found in the WGS, the resistance to ciprofloxacin does not raise safety concerns.

The presence of viable cells of the production strain X. campestris CNCM I‐4861 was investigated in three batches of the additive, each tested in triplicate.20 For each sample, 1 g of xanthan gum was plated onto plates of a selective medium (plate count agar with a colour indicator (tetrazolium chloride), facilitating the identification of the X. campestris colonies, and bile salts). The plates were incubated at 30°C for 6 days. Positive controls were included. One colony was detected in one replicate of one of the batches tested. The isolate did not belong to the species X. campestris, as confirmed by MALDI‐TOF mass spectrometry. Therefore, the presence of viable cells of the production strain was excluded.

X. campestris DSM 23730

3.1.1.3

The production strain is deposited in the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ) under the accession number DSM 23730.21 It derives from X. campestris ■■■■■ and has been obtained by chemical mutagenesis. Therefore, X. campestris DSM 23730 is not genetically modified.22

The taxonomical identification of the strain DSM 23730 was confirmed by digital DNA–DNA hybridisation (dDDH) using the WGS data. The dDDH value obtained was 88.0% with the type strain X. campestris ATCC 33913^T^.23

The antimicrobial susceptibility of the strain to relevant antibiotics was tested against the list of antibiotics described for Enterobacteriaceae as per the aforementioned guidance.24 All the MIC values were equal to or fell below the corresponding cut‐off values, except for ampicillin and ciprofloxacin. The MIC values for ampicillin and ciprofloxacin exceeded the EFSA cut‐off values by more than two dilution steps (> 32 vs. 8 mg/L and > 0.25 vs. 0.06 mg/L, respectively). Therefore, the DSM 23730 strain is susceptible to the relevant antibiotics, except for ampicillin and ciprofloxacin.

The WGS data of the strain were interrogated for the presence of AMR genes by a search against three databases, using below thresholds as indicated in the EFSA Statement (EFSA, 2021).25 The FEEDAP Panel only considered the results obtained from the two maintained databases, Resfinder and the National Database of Antibiotic Resistant Organisms (NDARO). No hits of concern were identified; therefore, the FEEDAP Panel concludes that the strain does not harbour acquired AMR genes and does not raise safety concerns. Although the strain was resistant to ampicillin and ciprofloxacin, since no acquired AMR genes were found in the WGS, the resistance to ampicillin and ciprofloxacin does not raise safety concerns.

The presence of viable cells of the production strain DSM 23730 was investigated in three batches of the additive, tested in triplicate. For each sample, 1 g of xanthan gum was plated onto plates of TSA with a colour indicator (tetrazolium chloride) that facilitates the identification of the X. campestris colonies.26 The plates were incubated at 30°C for 6 days. Positive controls were included. A total of five colonies were detected in different batches; these were purified and identified using MALDI‐TOF analysis. None of these belong to the species X. campestris; therefore, the presence of viable cells of the production strain was excluded.

X. campestris ■■■■■

3.1.1.4

The production strain was originally deposited in the Collection des Bactéries de l'Institut Pasteur (CIP) under the accession number ■■■■■.27 ■■■■■.28 During the assessment, the applicant provided evidence that the strain is also deposited in the Belgian Coordinated Collection of Microorganisms (BCCM/LMG) under the accession number ■■■■■.29 The taxonomical identification of the strain ■■■■■ was confirmed by ANI determination of the WGS data.30 The results of this analysis showed an ANI value of 98.94% with the type strain X. campestris ATCC 33913^T^.

The antimicrobial susceptibility of the strain to relevant antibiotics was tested against the list of antibiotics described for Enterobacteriaceae as the aforementioned guidance.31 All the MIC values were equal to or fell below the corresponding cut‐off values, except for streptomycin and ciprofloxacin, which exceeded the EFSA cut‐off values by more than two dilution steps both (> 512 vs. 16 mg/L and > 0.25 vs. 0.06 mg/L, respectively). Therefore, the ■■■■■ strain is susceptible to the relevant antibiotics, except for streptomycin and ciprofloxacin.

The WGS data of the strain were interrogated for the presence of AMR genes by a search against four databases, using equal thresholds as indicated in the EFSA Statement (EFSA, 2021).32 The FEEDAP Panel only considered the results obtained from the three maintained databases, NCBI Bacterial Antimicrobial Resistance Reference Gene Database, ResFinder and MEGARes. No hits of concern were identified; therefore, the FEEDAP Panel concludes that the strain harbours no acquired AMR genes and raises no safety concerns. Although the strain was resistant to ciprofloxacin and streptomycin, since no acquired AMR genes were found in the WGS, the resistance to streptomycin and ciprofloxacin does not raise safety concerns.

The WGS data of the production strain were also interrogated for the presence of known virulence factor genes against VFDB, EcOH and ecoli_vf databases.33 No hits were identified.

The presence of viable cells of the production strain ■■■■■ was investigated in three batches of the additive, tested in triplicate.34 For each sample, 1 g of xanthan gum was plated onto plates of TSA. The plates were incubated at 30°C for 6 days. Positive controls were included. Six colonies were isolated from two batches, but the assignment to the production strain was excluded by PCR analysis. Therefore, the presence of viable cells of the production strain was excluded.

Conditions of use

3.1.2

The additive is intended to be used in feedingstuffs for all animal species (except cats and aquatic animals), without a minimum or maximum content. The applicant proposed a typical range of use levels of 100–10,000 mg/kg feed.35

Safety

3.2

Safety of the production strains

3.2.1

The production strains belong to a species, X. campestris, that qualifies for the QPS approach to safety assessment when used for production purposes (EFSA BIOHAZ Panel, 2023). The taxonomic identification of the production strains was unequivocally established, and evidence has been provided that the strains do not show acquired antimicrobial determinants for antibiotics of human and veterinary importance. No viable cells of the production strains have been detected in the additive. Consequently, the FEEDAP Panel concludes that the additive does not pose any safety concern regarding the strains ATCC SD‐7012, CNCM I‐4861, DSM 23730 and ■■■■■.

Toxicological studies

3.2.2

The FEEDAP Panel considered that xanthan gum is not absorbed in the gastrointestinal tract (GIT) and that after partial fermentation, it is metabolised into non‐hazardous short‐chain fatty acids (EFSA FEEDAP Panel, 2021). Possible genotoxic effects at the site of contact are not expected due to the nature of the additive itself (high molecular weight polysaccharide). In addition, based on the new data submitted, the production strains qualify for the QPS status.

In the previous FEEDAP opinion (EFSA FEEDAP Panel, 2021), reference was made to a number of published studies on the toxicity of xanthan gum in dogs and rats. In that opinion, it was noted that these studies showed several limitations in the design or reporting. No new toxicological studies were provided for the current assessment. However, the full reports of three repeated dose toxicity studies submitted in the context of the previous application (EFSA FEEDAP Panel, 2021) and included in the opinion on the re‐evaluation of xanthan gum as a food additive (EFSA ANS Panel, 2017) were made available.

In a 2‐year chronic toxicity,36 Charles River CD rats (30 males and females per group) were administered xanthan gum at dietary levels of 0, 250, 500 and 1000 mg/kg body weight (bw) per day. Weekly assessments of body weight and feed intake were conducted, alongside periodic haematological and biochemical analyses. Survival rates after 104 weeks were comparable across the control (48%), 250 (52%), 500 (63%) and 1000 mg/kg bw per day (52%) groups. Body weight gains showed no significant differences, while soft stools were more common in higher dose groups but not statistically significant. Haematological changes at the end of the study were minor and not dose‐related. Neoplasm incidence did not differ significantly between groups. A no observed adverse effects level (NOAEL) of 1000 mg/kg bw per day (the highest dose tested) was identified from this study.

In a carcinogenicity study,37 groups of four male and four female beagle dogs, aged between 4 and 8 months, were fed xanthan gum at doses of 0, 250, 500 and 1000 mg/kg bw per day for 107 weeks. No adverse effects were observed. The FEEDAP Panel considered that this study is not adequate for the risk assessment due to the limited number of animals used in the study.

In a three‐generation reproductive toxicity study,38 albino rats were fed xanthan gum at dietary levels of 0, 250 and 500 mg/kg bw per day. The study, which predates current OECD 421 and 443 guidelines, involved mating pairs to produce two litters per generation, with subsequent generations selected from the second litters' weanlings. Parameters evaluated included survival, body weights, general health, behaviour, reproductive performance, litter size, live births, weaning weights and survival of offspring, as well as examinations for fetal resorption, malformations and histopathological assessments. Although treated groups exhibited slightly lower body weights than controls in each generation, there were no significant differences in survival, appearance, reproductive outcomes or litter health metrics. Autopsy and organ weight comparisons between treated and control groups showed no abnormalities. Histopathological examinations did not reveal any xanthan gum‐related effects. A NOAEL of 500 mg/kg bw per day (the highest dose tested) was identified from this study.

The FEEDAP Panel also noted that, in the opinion on the re‐evaluation of xanthan gum as food additive (E 415) by the ANS Panel (EFSA ANS Panel, 2017), it was concluded that there was no need for a numerical acceptable daily intake (ADI) for this substance. Additionally, taking into account the information on structure–activity relationships and considering that xanthan gum has a molecular weight far above the threshold for absorption, according to absorption, distribution, metabolism and excretion (ADME) data, it is not degraded in the intestine and is slightly fermented to non‐hazardous short‐chain fatty acids by the gut microbiota. Based on this, the ANS Panel concluded that xanthan gum (E 415) does not give rise to concerns for genotoxicity.

Finally, xanthan gum has been recently evaluated by the EFSA Panel on Food Additives and Flavourings (FAF) for its use in formulae for infants below 16 weeks of age (EFSA FAF Panel, 2023). The FAF Panel identified a NOAEL of 750 mg/kg bw per day from the available piglet studies based on histopathological changes in the intestine in the high‐dose group and concluded that the use of xanthan gum in formulae for infants below 16 weeks of age up to a concentration of 1200 mg/L does not raise concerns. However, the FEEDAP Panel considers that, based on the experimental design (duration, animal species), this study is not suitable to identify a NOAEL on which to base the safety of the additive under the proposed conditions of use.

In summary, the FEEDAP Panel considers that:

• –The repeated dose toxicity studies available are old and not conducted in line with the current OECD TG requirements;
• –The studies presented some limitations in the design (e.g. number of animals, parameters evaluated, not compliant with the current OECD guidelines) and reporting;
• –No adverse effects were observed in the studies in rats and dogs at the highest dose tested (500–1000 mg/kg bw per day).
• –Cases of soft stools have been reported, but this effect was observed at higher doses only and was not considered adverse;
• –Gums are not absorbed and therefore systemic toxicity is not expected;
• –Possible genotoxic effects at the site of contact are not expected due to the nature of the additive itself (polysaccharide).

Conclusions on toxicological studies

3.2.2.1

The FEEDAP Panel concludes that xanthan gum does not pose a concern for genotoxicity and, based on the 2‐year chronic study in rats, a NOAEL of 1000 mg/kg bw per day is identified.

Safety for the target species

3.2.3

In the previous opinion (EFSA FEEDAP Panel, 2021), the Panel was unable to draw conclusions on the safety of xanthan gum produced with X. campestris strains for the target species due to the lack of specific tolerance studies conducted on the target species with the additive under assessment or adequate toxicity studies from which a reliable NOAEL could be derived. Moreover, the safety of the production strains had not been established.

In the current assessment, the applicant provided a chronic toxicity study39 in rats which allowed the Panel to derive a NOAEL of 1000 mg/kg bw per day. Applying an uncertainty factor (UF) of 200 to the NOAEL derived from a chronic study, to take into account the limitations identified in the study, the maximum safe feed concentration was calculated following the methodology described in the Guidance of the safety for the target species (EFSA FEEDAP Panel, 2017c).

The FEEDAP Panel considers that the use of xanthan gum is safe for the target species up to the maximum concentration in complete feed summarised in Table 2.

These levels are extrapolated to physiologically related species. For any other target species under application the FEEDAP Panel concludes that a maximum concentration of 56 mg xanthan gum/kg complete feed is considered safe.

Safety for the consumer

3.2.4

Considering that xanthan gum is not absorbed in the GIT of the target species, its deposition in animal tissues is unlikely. In addition, xanthan gum is currently authorised as a food additive (E 415) in many food categories.40 Based on the new data submitted on the production strains (see Section 3.1.1), these belong to the species X. campestris and qualify for the QPS approach when used for production purposes.

Therefore, the FEEDAP Panel considered that the use of xanthan gum produced with X. campestris ATCC SD‐7012, CNCM I‐4861, DSM 23730 and ■■■■■ in animal nutrition at the proposed use levels is safe for the consumers.

Safety for the user

3.2.5

Based on the highest dusting potential measured (17.4 g/m^3^) (EFSA FEEDAP Panel, 2021), the FEEDAP Panel considers that the exposure of users through inhalation is likely.

The skin irritation potential of the additive was tested in a study performed according to OECD TG 439,41 which showed that the additive is not irritant to the skin (UN GHS ‘No Category’).

The skin sensitisation potential of the additive was tested in two studies performed according to OECD TG 442C and OECD TG 442E, which showed that the additive is not a skin sensitiser.42

Conclusions on safety for the user

3.2.5.1

The additive is not a skin irritant or a skin sensitiser. The FEEDAP Panel cannot conclude on the eye irritation potential due to the lack of data.

Safety for the environment

3.2.6

In the previous opinion (EFSA FEEDAP Panel, 2021), the Panel could not conclude on the safety for the environment due to insufficient information regarding xanthan gum metabolism in ruminants, potential environmental impact, safety of production strains and presence of viable cells or DNA in the final product. Moreover, concerns were raised about the bacteria's pathogenicity to plants, further complicating assessments of its environmental safety.

In the current assessment, the applicant submitted a ready biodegradability study using the manometric respirometry test, in accordance with GLP and OECD Test Guideline 301F (1992).43 The study was considered acceptable and showed that xanthan gum biodegradation was 65% at day 14 and 78% at day 28. Xanthan gum thus fulfils the criteria for ready biodegradability.

Several references from the literature were submitted by the applicant which demonstrate that xanthan gum can be completely biodegraded by a number of organisms present in soil and water (Ahlgren, 1993; Ashraf et al., 2017; Ashraf et al., 2018; Berninger et al., 2021; Cadmus et al., 1982; Chen et al., 2014; Hashimoto et al., 1998; Hou et al., 1986; Hovland, 2015; Liu et al., 2005; Muchová et al., 2009; Nankai et al., 1999; Ruijssenaars et al., 2000; Sutherland, 1987).

The production strains belong to the species X. campestris, qualifying for the QPS approach. The strains do not possess acquired antimicrobial determinants for antibiotics important to human and veterinary health. No viable cells of the production strains were detected in the final additive.

Based on the above evidence, the FEEDAP Panel concludes that xanthan gum produced with X. campestris ATCC SD‐7012, CNCM I‐4861, DSM 23730 and ■■■■■ strains is deemed safe for the environment.

CONCLUSIONS

4

The xanthan gum produced with X. campestris ATCC SD‐7012, CNCM I‐4861, DSM 23730 and ■■■■■ does not pose any safety concern associated with the production strains.

The FEEDAP Panel concludes that xanthan gum produced with X. campestris ATCC SD‐7012, CNCM I‐4861, DSM 23730 and ■■■■■ is safe for all animal species (with the exception of cats and aquatic species) at the respective maximum proposed use levels detailed in the table below:Animal categoriesConcentration (mg/kg complete feed)1 Turkeys for fattening75Chickens for fattening and minor poultry for fattening or reared for laying/reproduction and ornamental birds56Laying hens and other laying/reproductive birds83Piglets and other porcine species for meat production or reared for reproduction100Pigs for fattening120Sows and other porcine species for reproduction146Veal calves (milk replacer)250Sheep/goats220Cattle for fattening, other ruminants for fattening or reared for milk production/reproduction and camelids at the same physiological stage220Dairy cows and other ruminants and camelids for milk production or reproduction143Horses and other equids220Rabbits and other leporids88Dogs264Other species (with the exception of cats and aquatic species)56 ^1^ Complete feed containing 88% DM, milk replacer 94.5% DM.

The use of xanthan gum produced with X. campestris ATCC SD‐7012, CNCM I‐4861, DSM 23730 and ■■■■■ in animal nutrition under the proposed conditions of use is considered safe for the consumers and the environment.

Regarding the user safety, the additive is not irritant to the skin and is not a skin sensitiser. No conclusions could be reached on its potential to be an eye irritant.

ABBREVIATIONSADIacceptable daily intakeADMEabsorption, according to absorption, distribution, metabolism, and excretionAMRantimicrobial resistanceANSEFSA Scientific Panel on Additives and Nutrient Sources added to FoodBWbody weightCFUcolony‐forming unitFAFPanel on Food Additives and FlavouringsFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedGLPGood laboratory practiceMICminimum inhibitory concentrationNOAELno observed adverse effect levelOECDOrganization for Economic Co‐operation and DevelopmentUFuncertainty factorWGSwhole genome sequence

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2023‐00078

COPYRIGHT FOR NON‐EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source

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, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe, and Katerina Theodoridou.

LEGAL NOTICE

Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by EFSA. The full output has been shared with the European Commission, EU Member States (if applicable) and the applicant. The blackening may be subject to review once the decision on the confidentiality requests is adopted by EFSA and in case it rejects some of the confidentiality requests.