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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]