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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of liquid l‐lysine base produced with a genetically modified strain of Corynebacterium glutamicum as a nutritional feed additive for all animal species. The l‐lysine base liquid produced with C. glutamicum NRRL B‐67535 and NRRL B‐67439 is currently authorised as a nutritional additive for all animal species. The present application is aimed at modifying the current authorisation to include C. glutamicum NRRL B‐68248 as a production strain. The new production strain qualifies for the qualified presumption of safety approach when used for production purposes. It was unambiguously identified as C. glutamicum and was shown not to harbour acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. All the introduced sequences or mutations were considered to be safe, and no viable cells or DNA of the NRRL B‐68248 strain was detected in the final product. Therefore, the final product does not pose any safety concern associated with the production strain. l‐Lysine base produced using C. glutamicum NRRL B‐68248 does not represent a risk for the target species, the consumer or the environment. The additive was considered to be neither irritant to skin or the eyes, nor a dermal sensitiser. l‐Lysine base produced with C. glutamicum NRRL B‐68248 is considered to be an efficacious source of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the characterisation of the feed additive consisting of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens (CGMCC 19596). The additive is intended to be used as a nutritional additive for all animal species. In a previous opinion, the FEEDAP Panel could not conclude on the characterisation of the production strain, due to uncertainties on whether the production strain E. adhaerens CGMCC 19596 was genetically modified. However, since viable cells and DNA were not detected in the product, the FEEDAP Panel concluded that vitamin B12 (cyanocobalamin), produced with E. adhaerens CGMCC 19596 would not raise safety concerns as regards the production strain. In the present submission, the applicant provided supplementary information regarding the origin and history of modifications of the strain. Based on the data provided, the FEEDAP Panel concluded on the characterisation of the production strain E. adhaerens CGMCC 19596, which can be considered not to be genetically modified. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae CNCM I‐1079 as a zootechnical feed additive for dogs and all other Canidae. The additive is intended for use in feed for dogs and all other Canidae at a proposed minimum inclusion level of 1 × 109 CFU per kg of complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and no concerns are expected from other components of the product, the additive is considered safe for the target species. Since the additive is intended to be used only in feed for dogs and other non‐food‐producing animals, an assessment of the safety for the consumer and the environment is not needed. The non‐coated form of the additive was shown to be non‐irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both forms, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Panel was not in the position to conclude on the efficacy of Saccharomyces cerevisiae CNCM I‐1079 at the proposed conditions of use. [ABSTRACT FROM AUTHOR]

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 ROVABIO® ADVANCE (liquid and solid) which contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 as a zootechnical feed additive for weaned piglets at the recommended use level of 1800 U xylanase and 1250 U glucanase per kg feed. In a previous assessment, three long‐term trials in weaned piglets were submitted. Two of them were considered to support the efficacy of the additive while a third trial was not further considered due to the large number of veterinary treatments applied. A new trial was provided to support the efficacy of the additive, but it did not show a significant improvement of the performance parameters at the minimum recommended use level. Due to the lack of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive for the target species. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Bacillus subtilis FERM BP‐07462, Enterococcus lactis FERM BP‐10867 and Clostridium butyricum FERM BP‐10866 (BIO‐THREE®) as a zootechnical feed additive to be used as a gut flora stabiliser for chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, and all avian species for rearing/fattening or reared for laying/breeding. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of BIO‐THREE® for the target species at the proposed conditions of use. The applicant has provided a new study in chickens for fattening as supplementary information to support the efficacy of BIO‐THREE® for the target species. Considering the previously submitted studies and the new submitted trial, the Panel concluded that the additive is efficacious for chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, and all avian species for rearing/fattening or reared for laying/breeding under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6‐phytase produced by Komagataella phaffii CGMCC 7.19 (Nutrase P) as a zootechnical feed additive for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds. In a previous opinion, the FEEDAP Panel concluded on the efficacy of Nutrase P for the target species at the level of 1,500 phytase units (FTU)/kg but could not conclude at the minimum recommended use level of 500 FTU/kg complete feed. The applicant has provided supplementary information, consisting in the statistical re‐analysis of the long‐term study assessed in the original opinion, in order to support the efficacy of the additive at the minimum recommended level of 500 FTU/kg complete feed. Considering the previously submitted studies and the re‐analysis of the long‐term study, the Panel concluded that the additive has a potential to be efficacious for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the characterisation of the feed additive consisting of vitamin B 12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens (CGMCC 19596). The additive is intended to be used as a nutritional additive for all animal species. In a previous opinion, the FEEDAP Panel could not conclude on the characterisation of the production strain, due to uncertainties on whether the production strain E. adhaerens CGMCC 19596 was genetically modified. However, since viable cells and DNA were not detected in the product, the FEEDAP Panel concluded that vitamin B 12 (cyanocobalamin), produced with E. adhaerens CGMCC 19596 would not raise safety concerns as regards the production strain. In the present submission, the applicant provided supplementary information regarding the origin and history of modifications of the strain. Based on the data provided, the FEEDAP Panel concluded on the characterisation of the production strain E. adhaerens CGMCC 19596, which can be considered not to be genetically modified., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha-amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non-irritant to the skin and the solid form was shown to be non-irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DSM 34246 as a zootechnical feed additive for dogs and cats. The additive, with the trade name Canobios-BL, is intended for use in feed for cats and dogs at a proposed minimum inclusion level of 5 × 10 9 CFU/kg complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and the additive is composed by dried cells of the active agent and an emulsifier, that are not expected to introduce any risk, the additive is considered safe for the target species. Canobios-BL is not a skin or eye irritant but should be considered a skin and respiratory sensitiser. Canobios-BL is considered to be efficacious in feedingstuffs for dogs and cats at the use level 5 × 10 9 CFU/kg complete feed., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 6-phytase produced by the genetically modified strain Aspergillus oryzae DSM 33737 (HiPhorius™ 10, 40, 20L and 50L) as a zootechnical feed additive for all poultry, all Suidae and all fin fish. The FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry, all Suidae and all fin fish at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive is of no concern for the consumers and the environment. The liquid formulations of the additive are not skin or eye irritants. The two solid ones are not skin irritants but are eye irritants. Owing to the lack of data, the Panel cannot conclude on the skin sensitisation of the final formulations of the additive. Due to the proteinaceous nature of the active substance (6-phytase), the additive is considered a respiratory sensitiser. The Panel concludes that the additive is efficacious when included in the diet of poultry for fattening or reared for laying/breeding, reproductive Suidae , and all fin fish. Due to the lack of sufficient data, the Panel could not conclude on the efficacy for laying and reproductive poultry and growing Suidae ., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Huvezym® neXo 100 G/L, a product containing endo-1,4-β-xylanase, endo-1,4-β-glucanase and xyloglucan-specific-endo-β-1,4-glucanase activities produced by a non-genetically modified strain of Trichoderma citrinoviride (DSM 33578), as a zootechnical additive for all Suidae . The applicant provided information confirming the taxonomic identification of the production strain. The batches used for the characterisation of the final formulations showed compliance with the minimum specifications of the additive in terms of enzyme activities (> 15,000 EPU, > 1000 CU, > 1000 XGU per g) but not for the ratio of the enzymes, which is lower (ca. 7:1:1) than the ones specified (15:1:1). The Panel could not conclude on the representativeness of the test item used in the toxicological and tolerance studies with respect to the final formulations. Therefore, the conclusions are limited to the product with a minimum enzyme activity of 15,000 EPU, 1000 CU, 1000 XGU per g and a xylanase:glucanase:xyloglucanase ratio of 15:1:1. The Panel concluded that the additive is safe for the target species, consumers and the environment. Huvezym® neXo 100 G is not an irritant to the skin and eyes but should be considered a skin sensitiser. Huvezym® neXo 100 L is neither an irritant to the skin and eyes nor a skin sensitiser. Due to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive has the potential to be efficacious in all reproductive Suidae at the minimum proposed use level. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for Suidae for fattening or reared for reproduction., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6-phytase produced by Komagataella phaffii CGMCC 7.19 (Nutrase P) as a zootechnical feed additive for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds. In a previous opinion, the FEEDAP Panel concluded on the efficacy of Nutrase P for the target species at the level of 1,500 phytase units (FTU)/kg but could not conclude at the minimum recommended use level of 500 FTU/kg complete feed. The applicant has provided supplementary information, consisting in the statistical re-analysis of the long-term study assessed in the original opinion, in order to support the efficacy of the additive at the minimum recommended level of 500 FTU/kg complete feed. Considering the previously submitted studies and the re-analysis of the long-term study, the Panel concluded that the additive has a potential to be efficacious for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds under the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 safety and efficacy of a feed additive consisting of two bacilli strains (tradename: BioPlus® 2B) when used in suckling piglets, calves for fattening and other growing ruminants. BioPlus® 2B is composed of viable cells of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749. In the course of the current assessment, the latest strain was reclassified as Bacillus paralicheniformis . BioPlus® 2B is intended for use in feedingstuffs and water for drinking for the target species at the minimum inclusion level of 1.3 × 10 9  CFU/kg feed and 6.4 × 10 8  CFU/l water, respectively. B. paralicheniformis and B. subtilis are considered eligible for the qualified presumption of safety (QPS) approach. The identity of the active agents was established, and the qualifications regarding the lack of acquired antimicrobial resistance genes, toxigenic potential and bacitracin production ability were complied with. Following the QPS approach, B. paralicheniformis DSM 5749 and B. subtilis DSM 5750 are presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, BioPlus® 2B was also considered safe for the target species, consumers and the environment. BioPlus® 2B is not irritant to the eyes or skin but should be considered a respiratory sensitiser. The Panel could not conclude on the skin sensitisation potential of the additive. BioPlus® 2B when supplemented at 1.3 × 10 9  CFU/kg complete feed and 6.4 × 10 8  CFU/l water for drinking has the potential to be efficacious in suckling piglets, calves for fattening and other growing ruminants (e.g. sheep, goat, buffalo) at the same developmental stage., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 zearalenone hydrolase (ZenA) produced by Escherichia coli DSM 32731 when used as a feed additive for all terrestrial animals. The production strain E. coli DSM 32731 is genetically modified and harbours a kanamycin resistance gene. No viable cells of the production strain were detected in the final product, but uncertainty remains on the presence of recombinant DNA in the final product. The ZenA contained in the additive is safe for all terrestrial animal species up to the maximum use levels of (in U/kg complete feed): 100 U/kg in chickens for fattening; 150 U/kg in laying hens, turkeys for fattening and rabbits; 200 U/kg in pigs; 250 U/kg in dairy cows; 400 U/kg in veal calf (milk replacer), cattle for fattening, sheep, goats, horses and cats; and 450 U/kg in dogs. Based on the ADME and toxicological data, the FEEDAP Panel considers that the use of the ZenA contained in the additive in animal nutrition is safe for the consumers. The endotoxin content in the additive poses a risk by inhalation for users handling the additive. The additive is not a skin/eye irritant nor a skin sensitiser. Due to its proteinaceous nature, the additive should be considered as a potential respiratory sensitiser. The ZenA contained in the additive and the resulting breakdown products of its enzymatic activity do not represent a safety concern for the environment. The production strain harbours an antimicrobial resistance gene and uncertainties remain on the possible presence of its recombinant DNA in the final product; therefore, the FEEDAP Panel cannot conclude on safety of the additive for the target species, the consumer, the user and the environment., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 safety and efficacy of selenium-enriched yeast ( Saccharomyces cerevisiae CNCM I-3060) for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised as selenomethionine produced by S. cerevisiae CNCM I-3060 as a nutritional additive (compound of trace elements) with a minimum selenium content of 2,000 mg/kg. The applicant proposed the inclusion of an additional formulation with a minimum content of selenium in the additive of 3,000 mg/kg. Considering (i) that the main changes in the manufacturing of the product compared to the former application involve the drying phase (spray-drying vs drum drying), which has led to slightly different values of the dusting potential and particle size, and (ii) the conditions of use already authorised, the FEEDAP Panel stated that the modification requested would only affect the safety for the target animals and the users, without impacting the safety for the consumers, safety for the environment or the efficacy of the additive. The FEEDAP Panel concluded that there are no concerns for the safety of the target animals based on its previous assessment and an additional study on homogeneity of the additive. The additive is hazardous by inhalation, is not irritant for the eyes, skin and is not a dermal sensitiser., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 safety and efficacy of iron (II) chelate of amino acids hydrate for all animal species, brand name Availa ® Fe, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 9% iron. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to include a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (iron), with an inclusion level of 9-10%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/2330. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust, it is not possible to make the assessment of the exposure by inhalation., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 safety and efficacy of zinc chelate of amino acids hydrate, brand name Availa ® Zn, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein with a minimum content of 10% zinc. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 17%; (iii) to introduce a tighter specification of the zinc content of 10-11%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2016/1095. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 safety and efficacy of copper (II) chelate of amino acids hydrate, brand name Availa ® Cu, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 10% copper. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (copper), with an inclusion level of 10-11%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2018/1039. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 safety and efficacy of manganese chelate of amino acids hydrate, brand name Availa ® Mn, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 8% manganese. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 17%; and (iii) to introduce a tighter specification on the mineral content (manganese), with an inclusion level of 8-9%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/1490. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 safety and efficacy of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum ) DSM 26571 when used as a technological additive intended to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed application rate of 1 × 10 8 colony forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. The additive is not irritant to skin or eyes and is not a skin sensitiser but should be considered a potential respiratory sensitiser. The FEEDAP Panel concluded that the addition of Lactiplantibacillus plantarum DSM 26571 at a minimum concentration of 1 × 10 8 CFU/kg may improve the production of silage from easy, moderately difficult and difficult to ensile forage material., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of copper chelate of hydroxy analogue of methionine (Mintrex ® Cu) for all animal species. The FEEDAP Panel has delivered two opinions (in 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Copper chelate of hydroxy analogue of methionine' containing 18% copper, 79.5-81% (2-hydroxy-4-methylthio)butanoic acid (DL-methionine hydroxy analogue, HMTBa) and 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 16% copper and ≥ 78% HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Mintrex ® Cu is considered as a skin and eye irritant and a skin sensitiser; the risk of respiratory sensitisation is considered low. The present application did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive; therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 assessment of the application for renewal of authorisation of the feed additive consisting of dimethylglycine sodium salt (trade name: Taminizer D) as a zootechnical additive for chickens for fattening. In 2011, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive, and subsequently, the additive was authorised in the EU. In 2018, a second scientific assessment was made based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is authorised as 'dimethylglycine sodium salt with a purity of at least 97%' for chickens for fattening under the category 'zootechnical additives' and functional group 'other zootechnical additives (improvement of zootechnical parameters)'. The evidence provided by the applicant indicated that the additive currently in the market, produced by the two manufacturing routes, complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. The FEEDAP Panel concludes that Taminizer D is not a skin irritant but may be an eye irritant and a skin sensitiser; although uncertainty remains on the presence of formaldehyde, exposure is considered extremely low. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of chromium propionate (KemTRACE™ Chromium; KemTRACE-Cr) as zootechnical feed additive for all growing poultry species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. Based on two tolerance studies submitted, the Panel concluded that the additive is safe for chickens for fattening at the maximum recommended supplementation level of 0.4 mg Cr/kg feed from KemTRACE-Cr, but a margin of safety cannot be established; this conclusion can be extended to chickens reared for laying/breeding, but cannot be extrapolated to other growing poultry species. The FEEDAP Panel considered that the use of KemTRACE-Cr in animal nutrition at the proposed conditions of use is safe for the consumer. No concerns for users following any inhalation exposure during the handling of the additive are expected; the additive was shown to be corrosive to the eyes but not irritant to skin or a skin sensitiser. The use of KemTRACE-Cr in animal nutrition according to the proposed conditions of use will not significantly alter the concentration in the receiving environmental compartments of concern; therefore, no safety concern is expected for the environment. Based on three efficacy studies, the FEEDAP Panel concluded that KemTRACE-Cr has the potential to be efficacious as a zootechnical additive in chickens for fattening at the supplementation level of 0.4 mg Cr/kg feed; this conclusion could be extended to chickens reared for laying and chickens reared for breeding, and extrapolated to other poultry species for fattening and reared for laying/breeding., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelate of ethylenediamine (Copper-EDA-Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) identified several issues related to the data provided concerning the chemical characteristics of the additive and, based on the information provided from an in vitro dissociation study, considered it unlikely that the additive consists only of copper mono-chelate of EDA but of several coexisting (copper) species. Therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation of the additive. The FEEDAP Panel concludes that the additive is safe for chickens for fattening and reared for laying/breeding but cannot conclude on the safety for other animal species/categories. The FEEDAP Panel cannot conclude on the safety of the additive for the consumer or the environment. The FEEDAP Panel concludes that handling the additive poses a risk to users by inhalation. The additive should be considered as non-irritant for the skin but corrosive for the eyes and a skin sensitiser. The Panel notes the uncertainties on the genotoxicity potential of the additive that might have an impact on the conclusions on the safety for the user. The FEEDAP Panel concludes that the additive is efficacious in providing copper to meet the nutritional requirements of this trace element in all animal species., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of iron chelate of ethylenediamine (Iron-EDA-Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of iron monochelate of EDA, but of several coexisting (iron) species; therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation. The FEEDAP Panel concludes that the additive is safe for poultry for fattening and reared for laying/breeding, but cannot conclude on the safety for other animal species/categories. The FEEDAP Panel cannot conclude on the safety of the additive for the consumer or the environment. The FEEDAP Panel concludes that handling the additive poses a risk to users by inhalation. The additive should be considered as non-irritant for the skin but irritant for the eyes and skin sensitiser. The FEEDAP Panel cannot conclude on the efficacy of the additive., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zinc chelate of ethylenediamine (Zinc-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of zinc mono-chelate of EDA, but of several coexisting (zinc) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelate of ethylenediamine (Manganese-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of manganese mono-chelate of EDA, but of several coexisting (manganese) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (trade name: B-Act ® ) when used in feed for laying hens, minor poultry species for laying and for breeding purposes and ornamental birds. B. licheniformis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes or has toxigenic potential. Following the QPS approach, B. licheniformis DSM 28710 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, B-Act ® is also considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B-Act ® is considered a respiratory sensitiser. B-Act ® when supplemented at 1.6 × 10 9 CFU/kg complete feed has the potential to be efficacious in laying hens. Considering also that the efficacy of the product was already shown in chickens and turkeys for fattening, the Panel concludes that the additive has the potential to be efficacious in minor poultry species for laying, poultry species for breeding purposes and for ornamental birds at the same inclusion level. The conclusions on the compatibility of B-Act ® with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal or lower than those for chickens., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following a request from the European Commission (EC), the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the users of the feed additive consisting of ferric citrate chelate (CI-FER™) when used as a zootechnical additive for suckling and weaned piglets and minor porcine species. The EC request follows a previous opinion of the FEEDAP Panel. In that opinion, the Panel identified several risks for the users of the additive; it was listed that it posed a risk to users by inhalation, should be considered as an irritant to skin, eyes and mucous membranes, and also that, due to its nickel content, should be considered as a dermal and respiratory sensitiser. The applicant provided additional data including information on the manufacturing process of the additive and data supporting the safety of the additive for the users to address those concerns. Some changes have been applied to the original manufacturing process which led to a dust-free additive, with the following specifications: total iron ≤ 23%, iron (III) ≥ 16.5% and moisture ≤ 10.0%. The FEEDAP Panel concluded that CI-FER™ does not pose a risk by inhalation and is classified as non-irritant to the skin. The additive should be classified as a skin sensitiser. In the absence of new data, the FEEDAP Panel reiterates its previous conclusion that the additive should be considered irritant to eyes., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 ECONASE ® XT, an enzyme based on endo-1,4-β-xylanase produced by a genetically modified strain of Trichoderma reesei CBS 114044. The additive is currently authorised for use in chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, minor poultry species, piglets (weaned) and pigs for fattening. ECONASE ® XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. In a previous opinion, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches of the additive. The applicant has submitted data to support the absence of recombinant DNA derived from the production organism in recent product batches. The FEEDAP Panel confirms that the data provided support the absence of recombinant DNA of Trichoderma reesei CBS 114044 in the additive and thus, no safety concern was identified., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine (Mintrex ® Zn) for all animal species. The FEEDAP Panel has delivered three opinions (during 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Zinc chelate of hydroxy analogue of methionine' containing 17.5-18 % zinc, 81 % (2-hydroxy-4-methylthio)butanoic acid (dl-methionine hydroxy analogue, HMTBa) and maximum 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 17 % zinc and ≥ 79 % HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Owing to the zinc and nickel content of Mintrex ® Zn, the handling of the additive poses a risk to users by inhalation; the additive is not a skin or eye irritant but is considered a skin sensitiser. The present application did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive; therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of manganese chelate of hydroxy analogue of methionine (Mintrex ® Mn) for all animal species. The FEEDAP Panel has delivered three opinions (in 2008, 2009 and 2010) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Manganese chelate of hydroxy analogue of methionine' containing 15.5-17 % manganese, 77-78 % (2-hydroxy-4-methylthio)butanoic acid (dl-Methionine Hydroxy Analogue, HMTBa) and maximum 1% mineral oil. Following some modifications in the manufacturing process the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 14 % manganese and ≥ 76 % HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Owing to the manganese and nickel content of Mintrex ® Mn, the handling of the additive poses a risk to users by inhalation; the additive is not a skin or eye irritant but is considered as a skin sensitiser. The present application did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive; therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 safety and efficacy of fumonisin esterase from Komagataella phaffii DSM 32159 as a technological feed additive for all animal species. The product has been already assessed by the FEEDAP Panel for use in pigs and poultry feed as technological additive and was granted with an authorisation in the EU for this use. In the current application, the additive is intended to be used in fermenting feeds with the purpose to reduce the contamination of feed by fumonisins. New data provided showed that no recombinant DNA could be detected in three batches of the product. The evidence provided - based on the data submitted in the previous and the current application - allowed the FEEDAP Panel to conclude that the additive is safe for the target animals under the proposed conditions of use. The Panel also considered valid the previous conclusions in which the safety of the additive for consumers and the environment was established. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non-irritant to skin and eyes and is not considered as a dermal sensitiser. The additive has the capacity to degrade fumonisins in fermenting feed (with a fumonisin content within the guidance limits operating in the EU) when used at the minimum recommended dose of 40 U/kg feed. The FEEDAP Panel notes that the efficacy has been demonstrated only in silages, not in other fermenting feeds like e.g. liquid feeds., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of l-methionine produced by fermentation with Corynebacterium glutamicum KCCM 80184 and Escherichia coli KCCM 80096 for all animal species. The two producing microorganisms were obtained by genetic modification. l-Methionine is intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains, nor their recombinant DNA were detected in the final product. The additive does not pose any safety concern associated with the genetic modification of the production strains. l-methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096. The additive is considered safe for the target species, for the consumer and for the environment. l-Methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096 is considered not toxic by inhalation, non-irritant to skin or eyes and not a dermal sensitiser. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety of l-methionine for target species when administered via water for drinking owing to the risk of nutritional imbalances and hygienic reasons. l-Methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096 is considered as an efficacious source of the essential amino acid l-methionine for non-ruminant animal species. For the supplemental l-methionine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The additives under assessment are lactic acid and calcium lactate. In 2015, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of lactic acid and calcium lactate. The FEEDAP Panel could not conclude on the safety of lactic acid in pre-ruminants and poultry. Following this opinion, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species. Based on the studies submitted in chickens for fattening and laying hens, no safe concentration of lactic acid and calcium lactate in complete feed for these species could be identified. Owing to the absence of data on tolerated dietary levels of d-lactic acid, no conclusion on the safety of lactic acid in milk replacer for pre-ruminants is possible. Since a safe concentration of lactic acid (and calcium lactate) was established only for pigs and cattle, and not for a third major animal species, no extrapolation to any other species is possible., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)