Animal dietary exposure in the risk assessment of contaminants in feed.

EFSA performs dietary exposure assessments for food-producing and non-food-producing animals to deliver risk assessment for mandates on the presence of contaminants in feed. The CONTAM and FEEDAP Panels identified the need to update the animal dietary exposure assessment model used in those assessments in CONTAM Scientific Opinions since 2011 in cases where insufficient occurrence data are available on species specific compound feeds. The Panels proposed in this statement a series of model diets based on groups of feed materials with the possibility to use different feed materials in their formulation. The Panels considered that the currently proposed model diets cover the need of the CONTAM Panel to assess the dietary exposure of animals to contaminants in feed.

Evolving patterns and clinical outcome of genetic studies performed at diagnosis in acute myeloid leukemia patients: Real life data from the PETHEMA Registry.

BACKGROUND: There are no studies assessing the evolution and patterns of genetic studies performed at diagnosis in acute myeloid leukemia (AML) patients. Such studies could help to identify potential gaps in our present diagnostic practices, especially in the context of increasingly complex procedures and classifications. METHODS: The REALMOL study (NCT05541224) evaluated the evolution, patterns, and clinical impact of performing main genetic and molecular studies performed at diagnosis in 7285 adult AML patients included in the PETHEMA AML registry (NCT02607059) between 2000 and 2021. RESULTS: Screening rates increased for all tests across different time periods (2000-2007, 2008-2016, and 2017-2021) and was the most influential factor for NPM1, FLT3-ITD, and next-generation sequencing (NGS) determinations: NPM1 testing increased from 28.9% to 72.8% and 95.2% (p < .001), whereas FLT3-ITD testing increased from 38.1% to 74.1% and 95.9% (p < .0001). NGS testing was not performed between 2000-2007 and only reached 3.5% in 2008-2016, but significantly increased to 72% in 2017-2021 (p < .001). Treatment decision was the most influential factor to perform karyotype (odds ratio [OR], 6.057; 95% confidence interval [CI], 4.702-7.802), and fluorescence in situ hybridation (OR, 2.273; 95% CI, 1.901-2.719) studies. Patients ≥70 years old or with an Eastern Cooperative Oncology Group ≥2 were less likely to undergo these diagnostic procedures. Performing genetic studies were associated with a favorable impact on overall survival, especially in patients who received intensive chemotherapy. CONCLUSIONS: This unique study provides relevant information about the evolving landscape of genetic and molecular diagnosis for adult AML patients in real-world setting, highlighting the increased complexity of genetic diagnosis over the past 2 decades.

Consumer safety of feed additives containing selenium.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the consumer of products from animals fed diets with feed additives containing selenium as an active substance. Based on the limited data set available and the several uncertainties, the FEEDAP Panel concluded that the use of organic selenium at the currently maximum authorised use level of 0.2 mg supplemented selenium from organic sources/kg complete feed (within a maximum of 0.5 mg total selenium/kg complete feed) leads to an exceedance of the UL for all the population categories (except elderly and very elderly), suggesting a concern for consumer safety. It was not possible to conclude on the safety of the currently maximum use level of 0.5 mg total selenium/kg complete feed for all consumer categories. Additional data from studies specifically designed to measure deposition of selenium in tissues and products from animal origin resulting from the use of the different sources of selenium would be required to perform a proper risk assessment.

Amanitin determination in bile samples by UHPLC-MS: LR-MS and HR-MS analytical performance.

Consumption of misidentified foraged mushrooms containing bicyclic amanitin octapeptides is a worldwide public health and veterinary problem, being considered one of the deadliest accidental human and canine food ingestion due to acute liver failure (ALF). Reversal of advanced ALF and complete clinical recovery can be achieved following definitive removal of accumulated amatoxin laden bile from the gallbladder. An accurate means of quantifying amanitin content in aspirated bile is, therefore, urgently needed. Building on our prior work validating a method to detect and quantify amanitin in hepatic autopsy tissue, the development of an accurate method of measuring α- and ß-amanitin in aspirated gallbladder bile was performed to evaluate the efficiency of this emergency procedure applied as a clinical treatment for intoxicated patients. A solid-phase extraction (SPE) procedure was optimized followed by detection based on ultra-high performance liquid chromatography coupled with mass spectrometry (UHPLC-MS). Low resolution mass spectrometry (LRMS) was compared with high resolution (HRMS) by the validation of UHPLC-MS/MS (triple quadrupole MS) and UHPLC-ToF-MS (time-of-flight MS). Both methods were able to detect amatoxins in bile with limits of detection and quantification ranging from 2.71 to 3.46 µg.kg-1, and 8.36-9.03 µg.kg-1 for α-amanitin and, 0.32-1.69 µg.kg-1 and 0.55-5.62 µg.kg-1 for ß-amanitin, respectively. Validation was completed with the evaluation of linearity, specificity, robustness, recovery, and precision following the ICH guidelines and CIR 808/2021. The validated methods were finally applied to bile samples obtained 48-96 hours + post-ingestion from 4 amatoxin poisoning patients who underwent gallbladder drainage procedures in Vietnam, Canada, and California. Gallbladder bile from patients with amatoxin mushroom poisoning contained significant amanitin content, even when aspirated several days post-ingestion, thus confirming the important role of enterohepatic circulation in amatoxin hepatotoxicity. This work represents a high and unique analytical throughput in amanitin poisoning allowing to efficiently respond to this fatal health problem.

Safety and efficacy of a feed additive consisting of a tincture derived from the flowers of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove tincture) for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried flower bud of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■) solution, with a dry matter content of ~ 1.66%. The product contains on average 0.511% phenolic acids (of which 0.0344% were flavonoids), 0.039% eugenol, 0.00019% methyleugenol and 0.00008% estragole. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove tincture is very unlikely to be of safety concern for the target species up to the maximum proposed use level of 50 mg clove tincture/kg complete feed for all animal species, except for horses, for which the proposed use level is 200 mg/kg complete feed. The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered very unlikely to be of safety concern when consumed via feed alone. No safety concern would arise for the consumer and the environment from the use of clove tincture up to the maximum proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the flower buds of S. aromaticum and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the wood of Juniperus deppeana Steud. (cedarwood Texas oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the wood of Juniperus deppeana Steud. (cedarwood Texas oil), when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for veal calves (milk replacer), cattle for fattening, sheep, goats, horses, dogs, salmonids and ornamental fish. For the other species, the calculated safe concentrations in complete feed were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 10 mg/kg for piglets, 12 mg/kg for pigs for fattening, 14 mg/kg for sows and dairy cows, 8.5 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 4 mg/kg complete feed. The use of cedarwood Texas oil in water for drinking was considered safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the maximum proposed use level in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. Since the individual components of cedarwood Texas oil are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) for suckling and weaned piglets and other growing Suidae (Phytobiotics Futterzusatzstoffe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) as a zootechnical feed additive for suckling and weaned piglets and other growing Suidae. The additive is standardised to contain a concentration of the sum of the four alkaloids sanguinarine, chelerythrine, protopine and allocryptopine of 1.25%, with 0.5% sanguinarine. Owing to the presence of the DNA intercalators sanguinarine and chelerythrine, a concern for genotoxicity was identified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concerns for the target species when the additive is used at the recommended level of 0.750 mg sanguinarine/kg complete feed for suckling and weaned piglets and other growing Suidae. Since in all consumer categories the exposure to sanguinarine and chelerythrine via the use of Sangrovit® Extra exceeds the threshold of toxicological concern of 0.0025 µg/kg bw per day for DNA reactive mutagens and/or carcinogens, the FEEDAP Panel could not conclude on the safety for the consumers. The additive was shown to be irritant to the eyes but not irritant to skin or a skin sensitiser. The FEEDAP Panel could not exclude the potential of the additive to be a respiratory sensitiser. When handling the additive, exposure of unprotected users to sanguinarine and chelerythrine may occur. Therefore, to reduce the risk, the exposure of users should be reduced. The use of Sangrovit® Extra as a feed additive under the proposed conditions of use was considered safe for the environment. The additive Sangrovit® Extra had the potential to be efficacious in improving performance of weaned piglets at 0.600 mg sanguinarine/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae.

Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of Eucalyptus globulus Labill. (eucalyptus tincture) for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves of Eucalyptus globulus Labill. (eucalyptus tincture) when used as a sensory additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of ~ 1.86%, which contains on average 0.454% phenolic acids and flavonoids (of which 0.280% was gallic acid), 0.0030% 1,8-cineole and 0.00012% methyleugenol. In the absence of analytical data on the occurrence of mono- or diformylated adducts of acylphloroglucinols with terpenes in the tincture and in the absence of toxicity data, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the use of eucalyptus tincture for long-living and reproductive animals. For short-living animals (species for fattening), the additive was considered of no concern at 4 mg/kg complete feed for chickens for fattening, 5 mg/kg for turkeys for fattening, 6 mg/kg for piglets and rabbits for meat production, 7 mg/kg for pigs for fattening, 16 mg/kg for veal calves (milk replacer), 14 mg/kg for cattle for fattening, sheep/goats and horses for fattening, and 15 mg/kg for salmonids. These levels were extrapolated to physiologically related minor species. No safety concern would arise for the consumer from the use of eucalyptus tincture up to the levels in feed considered of no concern. Eucalyptus tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of eucalyptus tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the leaves of E. globulus and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Safety and efficacy of feed additives consisting of ginkgo tinctures obtained from the leaves of Ginkgo biloba L. for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tinctures obtained from the dried leaves of Ginkgo biloba L. (ginkgo tinctures) when used as sensory additives. The tinctures are water/ethanol solutions with a dry matter content of 5.7% (tincture A) and 3.0% (tincture B). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additives under assessment are safe for the target species at the following concentrations in complete feed: (i) ginkgo tincture A at 240 mg/kg for horses and 750 mg/kg for dogs; (ii) ginkgo tincture B at 600 mg/kg for horses and 50 mg/kg for all other animal species. No safety concern would arise for the consumer from the use of ginkgo tinctures up to the maximum proposed use level in feed for the target species. The tinctures should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of ginkgo tinctures at the proposed use levels in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that ginkgo tinctures would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additives.

The different effects of a sensorimotor grounding on AoA between bilingual concepts.

Introduction: Psycholinguistic studies have argued for the age of acquisition (AoA) of words as a marker of concept learning, showing that the semantic features of concepts themselves influence the age at which their labels are learned. However, empirical evidence suggests that semantic features such as imageability and linguistic phenomena such as frequency do not adequately predict AoA. The present study takes the developmental approach of embodied cognition and investigates the effects of sensorimotor experiences on the ease of acquisition of the concept acquired in bilinguals. Specifically, we investigated (1) whether the sensorimotor experience can explain AoA beyond frequency; (2) and whether these patterns are consistent across L1 Chinese and L2 English. Methods: We conducted sensorimotor rating measures in both Chinese and English on 207 items in which Chinese-English bilingual adults were requested to evaluate the extent to which they experienced concepts by employing six perceptual senses and five effectors for actions located in various regions of the body. Meanwhile, data on AoA and frequency were collected. Results: The present study showed the sensorimotor experience was closely linked with AoAs in both languages. However, the correlation analysis revealed a trend of higher correlations between AoAs for the same concepts and L1 Chinese, relative to L2 English for the present Chinese-English bilinguals. Importantly, the hierarchical regression analysis demonstrated that after controlling for frequency, sensorimotor experience explained additional variance in L1 AoA. However, L2 sensorimotor experience did not explain the variance in L2 AoA. Sensorimotor experience explained more share of variance in L1 AoA but frequency accounted for more variance in L2 AoA. Discussion: The findings suggest that concept acquisition should consider the grounding in appropriate sensorimotor experience beyond linguistic phenomena like frequency.

Assessment of the feed additive consisting of Lactiplantibacillus plantarum ATCC 55944 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) ATCC 55944 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumer and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum ATCC 55944 should be considered a potential skin and respiratory sensitiser, and that any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarum ATCC 55943 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) ATCC 55943 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum ATCC 55943 should be considered a potential skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarum DSM 18113 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 18113 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum DSM 18113 should be considered a potential skin and respiratory sensitiser, and that any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

EDA-Graph: Graph Signal Processing of Electrodermal Activity for Emotional States Detection.

The continuous detection of emotional states has many applications in mental health, marketing, human-computer interaction, and assistive robotics. Electrodermal activity (EDA), a signal modulated by sympathetic nervous system activity, provides continuous insight into emotional states. However, EDA possesses intricate nonstationary and nonlinear characteristics, making the extraction of emotion-relevant information challenging. We propose a novel graph signal processing (GSP) approach to model EDA signals as graphical networks, termed EDA-graph. The GSP leverages graph theory concepts to capture complex relationships in time-series data. To test the usefulness of EDA-graphs to detect emotions, we processed EDA recordings from the CASE emotion dataset using GSP by quantizing and linking values based on the Euclidean distance between the nearest neighbors. From these EDA-graphs, we computed the features of graph analysis, including total load centrality (TLC), total harmonic centrality (THC), number of cliques (GNC), diameter, and graph radius, and compared those features with features obtained using traditional EDA processing techniques. EDA-graph features encompassing TLC, THC, GNC, diameter, and radius demonstrated significant differences (p<0.05) between five emotional states (Neutral, Amused, Bored, Relaxed, and Scared). Using machine learning models for classifying emotional states evaluated using leave-one-subject-out cross-validation, we achieved a five-class F1 score of up to 0.68.

Assessment of the feed additive consisting of Lactiplantibacillus plantarum ATCC PTA-6139 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) ATCC PTA-6139 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum ATCC PTA-6139 should be considered a potential skin and respiratory sensitiser, and that any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarum DSM 18112 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 18112 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum DSM 18112 should be considered a potential skin and respiratory sensitiser, and that any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Lactiplantibacillus plantarum DSM 18114 for all animal species for the renewal of its authorisation (Pioneer Hi-Bred International, Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 18114 as a technological additive (functional group: silage additive) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumer and the environment. Regarding user safety, the Panel concluded that owing to the nature of the additive, Lactiplantibacillus plantarum DSM 18114 should be considered a potential skin and respiratory sensitiser, and that any exposure through the skin and respiratory tract is considered a risk. The Panel could not conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of l-cystine for all animal species for the renewal of its authorisation (Bretagne Chimie Fine [BCF Life Sciences]).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of l-cystine as nutritional feed additive. The additive is authorised for use in all animal species (3c391). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed concluded that the use of the feed additive in animal nutrition remains safe for the target species, the consumers and the environment. As regards the safety for the user, l-cystine is not an irritant to skin or eyes and is not a skin sensitiser. Exposure by inhalation of persons handling the additive cannot be excluded. The present application for the renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and therefore there is no need for reassessing the efficacy.

Efficacy of a feed additive consisting of ferrous lysinate sulfate for all animal species (Phytobiotis Futterzusatzstoffe GmbH).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of ferrous lysinate sulfate (Plexomin® L-Fe) for all animal species. The additive has not been previously authorised as a feed additive in the European Union (EU). The safety of the additive for the target species, consumer, user and the environment has already been assessed in previous opinions. However, the efficacy remained inconclusive due to the absence of evidence of the bioavailability of the iron contained in the additive in the trials submitted either with chickens for fattening or with weaned piglets. For the present assessment, the applicant submitted a recalculation of the previous data on weaned piglets, which did not show evidence of bioavailability. Therefore, in the absence of adequate data, the FEEDAP Panel could not conclude on the efficacy of ferrous lysinate sulfate for all animal species.

Safety and efficacy of a feed additive consisting of muramidase produced with Trichoderma reesei DSM 32338 (Balancius™) for laying hens (DSM nutritional products).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of muramidase produced with Trichoderma reesei DSM 32338 (Balancius™) as a feed additive for laying hens. The additive is already authorised as a zootechnical additive (functional group: other zootechnical additives) for chickens, turkeys and minor poultry species for fattening or reared for breeding, and for weaned piglets. The enzyme is produced by fermentation with a genetically modified strain of Trichoderma reesei; viable cells of the production strain and its recombinant DNA were not detected in the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not give rise to safety concerns regarding the genetic modification of the production strain. Based on the data available from a sub-chronic oral toxicity study, the Panel concluded that the additive is safe for laying hens at the maximum recommended level of 60,000 LSU(F) (muramidase activity units)/kg feed. The Panel also concluded that the additive is safe for the consumers and the environment. The liquid formulation of the additive is considered not irritant to the skin or eyes. The solid formulation of the additive is considered not irritant to the skin. The Panel cannot conclude on the potential of the additive (both formulations) to be a dermal sensitiser or on the potential of the solid formulation to be irritant to the eyes. Due to the proteinaceous nature, both forms of the additive should be considered respiratory sensitisers. The additive has the potential to be efficacious as a zootechnical additive for laying hens at 30,000 LSU(F)/kg feed.