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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 ZM16 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens (DSM 25840). This product is available in two forms, ZM16 and ZM16 10, which contain the bacterium in concentrations of 1.25 × 10 9  CFU/g additive and 1.25 × 10 10 CFU/g additive, respectively. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in weaned piglets. The Panel concluded that the active agent fulfils the requirements of the qualified presumption of safety (QPS) approach to the assessment of safety. Consequently, the additive is presumed safe for the target animals, consumers of products from animals fed with the additive and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a potential respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive was not sufficient to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species. The applicant provided supplementary information to complement the data, including a statistical analysis pooling data from different studies. Based on the newly submitted data, the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in weaned piglets at a level of 5 × 10 8 CFU/kg complete feed or in water for drinking at 1.7 × 10 8 CFU/L. This conclusion was extrapolated to minor porcine species at the same developmental stage., (© 2019 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 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 EB15 10 for all pigs. The additive is a preparation containing viable spores of a strain of Bacillus   subtilis intended for use in feed at the proposed dose of 5 × 10 8  CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 10 8 CFU/L. The additive exists in two forms, EB15 and EB15 10, and has been previously characterised by the FEEDAP Panel. B .  subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements, and consequently, the additive was presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. The data made available by the applicant allowed the Panel to conclude that the additive in either form has a potential to be efficacious as a zootechnical additive when added to feed for piglets (suckling and weaned), pigs for fattening and sows (excluding a benefit from sows to suckling piglets) at 5 × 10 8  CFU/kg (corresponding to 1.7 × 10 8  CFU/L water) The conclusions on the efficacy were extrapolated to all Suidae species., (© 2019 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 a l-lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l-lysine (base, minimum 50%) produced by genetically modified strains of Corynebacterium glutamicum (NRRL-B-67439 or NRRL B-67535). They are intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains C. glutamicum strains NRRLB-67439 or NRRL B-67535; nor their recombinant DNA were detected in the final products. Therefore, those products do not pose any safety concern associated with the genetic modification of the production strains. l-Lysine HCl and concentrated liquid l-lysine (base) produced by C. glutamicum strains NRRLB-67439 or NRRL B-67535 are considered safe for the target species, for the consumer and for the environment. l-Lysine HCl produced by C. glutamicum strains NRRL B-67439 or NRRL B-67535 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l-lysine HCl produced by C. glutamicum strains NRRL B-67439 or NRRL B-67535. Concentrated liquid l-lysine (base) produced by C. glutamicum strains NRRL B-67439 or NRRL B-67535, due to its high pH (10.7 and 10.9, respectively) is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l-Lysine HCl and concentrated liquid l-lysine (base) produced by C. glutamicum strains NRRLB-67439 or NRRL B-67535 are considered as efficacious sources 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., (© 2019 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 Panel) was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat Monimax ® (monensin sodium and nicarbazin) when used in feed for turkeys or chickens for fattening. In previous assessments (2017, 2018), the FEEDAP Panel could not conclude on the safety of Monimax ® for the environment due to concerns on monensin sodium and 4,4'-dinitrocarbanilide (DNC, one of the moieties of nicarbazin). The applicant provided additional information that has been assessed. The use of monensin sodium from Monimax ® in complete feed for chickens for fattening, chickens reared for laying and turkeys for fattening poses no risk for the aquatic compartment, the terrestrial compartment or for sediment. The bioaccumulation potential of monensin in the environment is low. No concerns would arise for the 4,6-dimethylpyrimidin-2-ol (HDP) moiety of nicarbazin excreted from chickens for fattening, chickens reared for laying and turkeys fed Monimax ® . The use of DNC moiety of nicarbazin from Monimax ® in complete feed for chickens for fattening, chickens reared for laying and turkeys for fattening poses no risk for the aquatic compartment, the terrestrial compartments or for sediment. The bioaccumulation potential of DNC in the environment is low and the risk for secondary poisoning is not likely to occur., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following a request from 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 for the environment of the proposed modification of the terms of the authorisation regarding the formulation of the additive Lactococcus lactis NCIMB 30160. The applicant has proposed to modify the manufacturing process by adding polyethylene glycol (PEG 4000) in the list of potential cryoprotectants that can be used in the freeze-drying step, up to a maximum concentration of 0.025 mg PEG 4000/kg silage. The use of PEG 4000 as an excipient in formulations with Lactococcus lactis NCIMB 30160 would not change the previous conclusions regarding the safety for the target animals, consumers and users. No safety concerns are expected for the environment when PEG 4000 is used as a cryoprotectant in the additive Lactococcus lactis NCIMB 30160 up to a maximum concentration of 0.025 mg PEG 4000/kg silage., (© 2019 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 l-histidine monohydrochloride (HCl) monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80179 when used as a nutritional additive (amino acid) and as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is not genetically modified. No viable cells of the production strain were detected in the final product. The use of l-histidine monohydrochloride monohydrate produced by fermentation using C. glutamicum KCCM 80179 is safe for the target species when used as a nutritional additive to supplement the diet in appropriate amounts to cover the requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. This conclusion would also cover the use as a sensory additive. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 supplemented at levels appropriate for the requirements of species and life stage is considered safe for the consumer. l-Histidine HCl monohydrate produced using C. glutamicum KCCM 80179 is not irritant to skin, is mildly irritant to eyes, and it is not a skin sensitiser. The additive does not pose a risk to users by inhalation. The use of l-histidine HCl monohydrate produced by C. glutamicum KCCM 80179 in animal nutrition is not expected to represent a risk to the environment. l-Histidine HCl monohydrate is considered an efficacious source of the essential amino acid l-histidine for non-ruminant animal species. For the supplemental l-histidine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen. It is also considered efficacious as a feed flavouring compound under the proposed conditions of use., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

An essential oil from Origanum vulgare subsp. hirtum var. Vulkan (DOS 00001) is intended to be used as a sensory additive in feed for all animal species. In a previous opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the Panel concluded that the recommended use level of 150 mg additive/kg feed was safe for chickens for fattening and weaned piglets and this conclusion was extended to all poultry and porcine species grown for meat production. The Panel also concluded that the dose of 500 mg additive/head and day (equivalent to ~25 mg/kg complete feed) was safe for dairy cows. Since the recommended use level differs between the dairy cow and the non-ruminants tested, the lower use level of 25 mg additive/kg feed was applied to all target animals not included above. The Panel also concluded that the additive was safe for the consumers and the environment, but should be considered as an irritant to skin and eyes and a potential skin and respiratory sensitiser in susceptible individuals. In the present application, the applicant has provided a new tolerance study in dairy cows to support the safety of a higher use level of 150 mg/kg for all animal species. Data on residues in milk from dairy cows fed the additive at the maximum recommended use level where also provided to assess consumer exposure. The Panel concluded that the essential oil under assessment is safe for cows at the recommended use level of 150 mg additive/kg feed. Since safety has been demonstrated in three major species with a comparable margin of safety, this conclusion on safety is extrapolated to all animal species. No concerns for consumer safety were identified following the application of the additive at the proposed use level in animal nutrition., (© 2019 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 an application for the authorisation of AviPlus ® , an additive containing a mixture of sorbic acid, citric acid, thymol and vanillin, for use in turkeys for fattening and for breeding at a recommended dose range of 200-500 mg/kg complete feed and in suckling piglets at 1,000-3,000 mg/kg complete feed. AviPlus ® is considered safe for turkeys for fattening and turkeys reared for breeding up to the maximum recommended dose of 500 mg/kg complete feed. For suckling piglets, the additive is safe up to the maximum recommended dose of 3,000 mg/kg complete feed. The additive is considered safe for the consumer and the environment. The additive is considered a potential skin/eye irritant and a skin sensitiser. The additive has the potential to be efficacious as a zootechnical additive in turkeys for fattening, turkeys reared for breeding at a minimum dose of 200 mg/kg complete feed. For suckling piglets, AviPlus ® has the potential to be efficacious at a minimum dose of 1,000 mg/kg complete feed., (© 2019 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 Bergazym ® P100 (endo-1,4-β-xylanase, produced by a non-genetically modified strain of Trichoderma reesei ) as a feed additive for other birds for fattening, ornamental birds and other growing Suidae. Considering the high margin of safety observed in the tolerance studies in chickens for fattening and in weaned piglets, and that the recommended level is the same, the Panel extrapolates the conclusions reached in chickens for fattening to all poultry species for fattening and ornamental birds and extrapolates the conclusions reached in weaned piglets to other growing Suidae species. Therefore, Bergazym ® P100 containing endo-1,4-β-xylanase as active substance is considered safe in other birds for fattening, ornamental birds and other growing Suidae at the recommended dose of 1,500 EPU/kg feed. The additive is considered safe for the consumer and the environment. The additive is not irritant to the eyes and the skin, but it is considered a potential skin and respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive, functional group 'digestibility enhancers', in other birds for fattening, ornamental birds and other growing Suidae at the recommended dose of 1,500 EPU/kg feed., (© 2019 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 l-tryptophan produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (KCCM 80176) when used as a nutritional additive in feed and water for drinking for all animal species. Viable cells of the production strain and its recombinant DNA were not detected in the additive. l-Tryptophan manufactured by fermentation using C .  glutamicum KCCM 80176 does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l-tryptophan produced using C .  glutamicum KCCM 80176 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non-ruminant target species and in ruminants when a rumen-protected form is used. The use of l-tryptophan produced by C .  glutamicum KCCM 80176 in animal nutrition presents no safety concerns to consumers of animal products. l-Tryptophan produced by C .  glutamicum KCCM 80176 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. l-Tryptophan produced by C .  glutamicum KCCM 80176 is safe for the environment. l-Tryptophan produced by C .  glutamicum KCCM 80176 is regarded as an effective source of the amino acid l-tryptophan for all non-ruminant species. If l-tryptophan is intended for use in ruminants, it should be protected from ruminal degradation., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

l-Arginine is an amino acid that is conditionally essential for mammalian neonates, some strict carnivores, birds and fish. The subject of this opinion is a request for renewal of authorisation of l-arginine produced by a strain of Corynebacterium glutamicum . The strain designation has changed to its new deposition number, NITE SD 00285, but the strain is otherwise unchanged from the previous opinion. It is not genetically modified and possesses no antibiotic resistance of safety concern. Minor changes in downstream processing following fermentation have been made. The FEEDAP Panel notes that two out of five batches did not meet the specification of the current authorisation (minimum 98% on a dry matter basis). The FEEDAP Panel concludes that l-arginine produced by fermentation to C. glutamicum NITE SD 00285 remains safe for the target species, consumers of products from animals fed the additive and the environment under the approved conditions of authorisation. The additive is considered as irritant to skin, corrosive to eyes and poses a risk by inhalation., (© 2019 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 assessment of the application for renewal of authorisation of the product Biosprint ® ( Saccharomyces cerevisiae MUCL 39885) as a feed additive for sows. S. cerevisiae is considered by EFSA to have qualified presumption of safety (QPS) status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel confirms that the use of Biosprint ® under the current authorised conditions of use is safe for sows, the consumers and the environment. The additive is considered as a potential skin and eye irritant and skin/respiratory sensitiser. There is no need to assess the efficacy of Biosprint ® in the context of the renewal of the authorisation., (© 2019 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 Bactocell ® ( Pediococcus acidilactici CNCM I-4622) in the context of the renewal of the authorisation for weaned piglets, pigs for fattening, minor porcine species (weaned and for fattening), chickens for fattening, laying hens and minor avian species for fattening and for laying when used as a zootechnical feed additive (gut flora stabiliser) in feed or in water for drinking. In addition, the applicant requested the extension of use for suckling piglets, minor pig species (growing/for fattening), chickens reared for laying, chickens reared for breeding purposes, chickens for breeding purposes, turkeys and minor avian species (including non-food producing/ornamental birds) reared for laying/breeding purposes and for breeding purposes when used as in feed or in water for drinking. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The additive is safe for the target species, consumers and the environment as well. The additive is non-irritant to skin and eyes and is not a dermal sensitiser but should be considered a respiratory sensitiser. Considering the high dusting potential of the formulations, exposure of users by inhalation is very likely. The additive, at the level of 1 × 10 9  CFU/kg feed (5 × 10 8 when delivered in water), has the potential to be efficacious in the new species proposed: chickens reared for laying, chickens reared for breeding purposes, chickens for breeding purposes, turkeys and minor avian species reared for laying/breeding purposes and for breeding purposes (including non-food producing/ornamental birds) and in suckling piglets and minor porcine species (growing/for fattening)., (© 2019 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 l-tryptophan produced by fermentation using Escherichia coli KCCM 80135 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain and its recombinant DNA were not detected in the additive. l-Tryptophan produced by fermentation with E. coli KCCM 80135 does not raise any safety concern with regard to the genetic modification of the production strain. The use of l-tryptophan produced using E. coli KCCM 80135 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non-ruminant target species. Using unprotected forms of tryptophan in ruminants can be a risk. The use of l-tryptophan produced by fermentation using E. coli KCCM 80135 in animal nutrition presents no safety concerns to consumers of animal products. l-Tryptophan produced by E. coli KCCM 80135 is not toxic by inhalation. The additive is not an irritant to skin and eyes, and it is not a skin sensitiser. The additive under assessment is considered safe for the environment. It is regarded as an effective source of the amino acid l-tryptophan for all non-ruminant species. If the additive l-tryptophan is intended for use in ruminants, it should be protected from ruminal degradation., (© 2019 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 l-leucine produced by fermentation with Escherichia coli NITE BP-02351 when used as nutritional additive or as feed flavouring compound in feed and water for drinking for all animal species. The product under assessment is l-leucine produced by fermentation with a genetically modified strain of E. coli (NITE BP-02351). The production strain and its recombinant DNA were not detected in the final products. l-Leucine, manufactured by fermentation with E. coli NITE BP-02351, does not give rise to any safety concern to the production strain. The use of l-leucine produced with E. coli NITE BP-02351 is safe for the target species when used to supplement the diet in appropriate amounts. It is safe at the proposed use level of 25 mg/kg when used as flavouring compound for all animal species. The use of l-leucine produced by fermentation with E. coli NITE BP-02351 in animal nutrition raises no safety concerns for consumers of animal products. The additive is not irritating to the skin or eyes and is not a skin sensitiser. There is a risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of l-leucine produced by  E. coli NITE BP-02351 as feed additive does not represent a risk to the environment. The additive l-leucine produced by E. coli NITE BP-02351 is regarded as an effective source of the amino acid l-leucine when used as nutritional additive. For the supplemental l-leucine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen. It is also considered efficacious as feed flavouring compound under the proposed conditions of use., (© 2019 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 muramidase produced by Trichoderma reesei DSM 32338. The additive is considered safe for turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding up to the maximum recommended dose of 45,000 LSU(F)/kg feed. The additive is considered safe for the consumer and the environment. No conclusions can be reached on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive should be considered a potential respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive in turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding when added to feed at 25,000 LSU(F)/kg feed., (© 2019 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 l-arginine produced by fermentation with a genetically modified strain of Corynebacterium glutamicum KCCM 80182 when used as a nutritional additive in feed and water for drinking for all animal species categories. Viable cells of the production strain and its recombinant DNA were not detected in the additive. The product l-arginine, manufactured by fermentation with C. glutamicum , KCCM 80182, does not give rise to any safety concern with regard to the production strain. l-Arginine produced using C. glutamicum KCCM 80182 is considered safe for the target species. The FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of l-arginine via water for drinking and feed. l-Arginine produced using C. glutamicum KCCM 80182 is safe for the consumer and for the environment. The additive is not hazardous by inhalation, is not a skin sensitiser, but is corrosive to skin and eyes. The product under assessment is considered an efficacious source of the amino acid l-arginine for all animal species. For l-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against microbial 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.)

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 Levucell ® SB when used in feed for turkeys for fattening. The additive is intended for use as a zootechnical additive (functional group: other additives) for the reduction of Salmonella contamination on carcasses through its decrease in faeces. In the context of a previous opinion, the identity of the strain was confirmed, and according to the Qualified Presumption of Safety (QPS) approach to safety assessment, it was presumed safe for the target species, consumers and the environment. Since no concerns are expected from other components of the additive, Levucell ® SB is also considered safe for the target species, consumers and the environment. The additive is not a skin or eye irritant or a skin sensitiser. Considering the data on the dusting potential, the user can be exposed to the additive by inhalation when handling it. The additive in non-encapsulated form should be considered as a respiratory sensitiser. The coated formulation is not considered to pose a risk by inhalation. The efficacy of Levucell ® SB for the same purpose was previously established in chickens for fattening. The FEEDAP Panel concluded that there was some evidence that the addition of Levucell ® SB at 2 × 10 10 CFU/kg feed has a potential to aid the reduction of carcass contamination with Salmonella spp. Since the mechanism of action of the additive can be reasonably assumed to be same, Levucell ® SB can be presumed efficacious in turkeys for fattening at a dose of 2 × 10 10 CFU/kg feed without the need for additional studies., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment. [Table: see text]., (© 2019 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 l-lysine monohydrochloride and l-lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l-lysine and it is produced in two different forms (monohydrochloride or sulfate). Owing to the uncertainties regarding the possible genetic modification of the strain used to obtain the production strain C. glutamicum CCTCC M 2015595 and on the possible presence of viable cells and DNA of the production strain in the final product, the FEEDAP Panel cannot conclude on the safety of the additives l-lysine HCl and l-lysine sulfate produced with C. glutamicum CCTCC M 2015595 for the target species, the consumers, the users and the environment. For both products, the FEEDAP Panel has concerns regarding the safety for the target species when the additives are administered via water for drinking. In the absence of data, the FEEDAP Panel cannot conclude on the safety of the additive for the user. The products under assessment are considered efficacious sources of the amino acid l-lysine for all animal species. For these products to be as efficacious in ruminants as in non-ruminant species, they 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.)

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 l-tryptophan produced by fermentation with Escherichia coli CGMCC 11674 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain did not raise safety concerns. The FEEDAP Panel cannot conclude on the safety of l-tryptophan produced by E. coli CGMCC 11674 for the target species and for the consumer due to the tryptophan-related impurities such as 1,1'-ethylidene-bis-l-tryptophan (EBT). The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of l-tryptophan via water for drinking and feed. Using unprotected forms of tryptophan in ruminants can be a risk. The FEEDAP Panel cannot conclude on the dermal or ocular irritation and skin sensitisation of l-tryptophan produced by E. coli CGMCC 11674. The additive poses a risk by inhalation from the exposure to endotoxins for people handling the additive. The use of l-tryptophan produced by E. coli CGMCC 11674 in animal nutrition does not pose a risk to the environment. The additive under assessment is regarded as an effective source of the amino acid l-tryptophan for all non-ruminant species. If the product l-tryptophan is intended for use in ruminants, it should be protected from ruminal degradation., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions is the subject of this assessment. The active substance is considered to be CLA (t10,c12) methyl ester (ME). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA previously issued an opinion on the safety and efficacy of the product, in which it could not conclude on the efficacy of this additive for sows for reproduction and for cows for reproduction. The European Commission asked EFSA to deliver an opinion on the efficacy of this additive for sows and cows for reproduction, based on additional data submitted by the applicant. The FEEDAP Panel has performed the assessment of the new data following an approach in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents. In relation to the data on efficacy in sows for reproduction, owing to methodological shortcomings of the study submitted, including the duration of the study and the limited biological relevance of the effect observed, the FEEDAP Panel cannot conclude on the efficacy of CLA (t10,c12)-ME for sows for reproduction. The data related to dairy cows indicate that dietary CLA (t10,c12)-ME supplementation in the late dry period and/or lactation period showed an increase of the probability of pregnancy and a reduction of time to conception in the same reproductive cycle. However, considering that the minimum duration of efficacy studies for reproductive parameters is of at least two reproductive cycles, the FEEDAP Panel is not in a position to conclude on the efficacy of the additive for cows for reproduction., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The product subject of this assessment is l-valine produced by fermentation with a strain of Corynebacterium glutamicum (CGMCC 11675). It is intended to be used in feed and water for drinking for all animal species and categories. Owing to the uncertainties regarding the possible genetic modification of the original production strain, the FEEDAP Panel cannot conclude on the safety of the additive l-valine produced with C .  glutamicum CGMCC 11675 for the target species, the consumers, the users and the environment. The FEEDAP Panel has concerns on the safety for the target animals of the simultaneous oral administration of valine-containing additives via feed and water for drinking. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l-valine produced with C. glutamicum CGMCC 11675 to be toxic by inhalation, irritant to skin or eyes, or on its potential to be a dermal sensitiser. The product is considered an efficacious source of the amino acid l-valine for all animal species. The supplemental l-valine requires protection against rumen degradations in order to be as efficacious in ruminant as in non-ruminant species., (© 2019 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 l-threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ when used as nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l-threonine produced by fermentation with a genetically modified strain of C. glutamicum (■■■■■). The production strain and its recombinant DNA were not detected in the additive. The product l-threonine, manufactured by fermentation with C. glutamicum , ■■■■■ does not give rise to any safety concern with regard to the production strain. l-Threonine produced using C. glutamicum ■■■■■ is considered safe for the target species. The FEEDAP Panel has concerns regarding the safety of the simultaneous oral administration of l-threonine via water for drinking and feed. l-Threonine produced using C. glutamicum ■■■■■ is safe for the consumer. The additive is not a skin or eye irritant and is not a skin sensitiser. Although the workers can be exposed by inhalation, the results of an acute inhalation study showed that risk of adverse effects by inhalation is low. l-Threonine produced using C. glutamicum ■■■■■ is safe for the environment. The product under assessment is considered an efficacious source of the amino acid l-threonine for all animal species. For l-threonine to be as efficacious in ruminants as in non-ruminant species, it requires 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.)

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 l-tryptophan produced by fermentation with a genetically modified strain of Escherichia coli CGMCC 7.248 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli CGMCC 7.248 and its recombinant DNA were not detected in the final product. The product l-tryptophan, manufactured by fermentation with E. coli CGMCC 7.248, does not give rise to any safety concern with regard to the genetic modification of the production strain. l-Tryptophan produced by E. coli CGMCC 7.248 is safe for non-ruminant target species. The use of unprotected l-tryptophan in ruminant feed should be avoided. l-Tryptophan produced by fermentation by E. coli CGMCC 7.248 is safe for the consumer. The level of endotoxins present in the product and its dusting potential indicate an inhalation risk for the user. l-Tryptophan produced by E. coli CGMCC 7.248 is not a skin or eye irritant but it is a dermal sensitiser. The use of l-tryptophan produced by E. coli CGMCC 7.248 in animal nutrition does not pose a risk to the environment. The product under assessment is regarded as an effective source of the amino acid l-tryptophan for all non-ruminant species. For the supplemental l-tryptophan to be as efficacious in ruminants as in non-ruminant species, it requires 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 European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l-lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l-lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum (NRRL B-50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. glutamicum NRRL B-50775 nor its recombinant DNA was detected in the final product. Therefore, the product does not pose any safety concern associated with the genetic modification of the production strain. l-Lysine HCl and concentrated liquid l-lysine (base) produced by C. glutamicum NRRL B-50775 are considered safe for the target species, for the consumer and for the environment. l-Lysine HCl produced by C .  glutamicum NRRL B-50775 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l-lysine HCl produced by C. glutamicum NRRL B-50775. Concentrated liquid l-lysine (base) produced by C. glutamicum NRRL B-50775, due to its high pH (11) it is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l-Lysine HCl and concentrated liquid l-lysine (base) produced by C. glutamicum NRRL B-50775 are considered as efficacious sources 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., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l-lysine (base), l-lysine monohydrochloride (HCl) and l-lysine sulfate products manufactured using different strains of Corynebacterium glutamicum . New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic modification does not introduce any safety concern and no introduced antibiotic resistance genes remain in its genome. Even if uncertainty remains concerning the absence/presence of the production strain and/or its recombinant DNA in the final products, these would not raise safety concerns. The liquid l-lysine (base) and l-lysine HCl produced by C. glutamicum KCTC 12307BP or C. glutamicum KCCM 11117P; and l-lysine HCl produced by C. glutamicum NRRL B-50547 are considered safe for the target species, consumers and the environment. Regarding the safety for the user, concentrated liquid l-lysine (base) and l-lysine HCl produced by C. glutamicum KCTC 12307BP, C. glutamicum NRRL B-50547 or C. glutamicum KCCM 11117P are not irritant to skin or eyes and they are not skin sensitisers. l-Lysine HCl is not hazardous by inhalation. The use of C. glutamicum DSM 24990 in the production of l-lysine sulfate is considered safe for the target species, consumers, users or the environment. No negative effects are to be expected for the target species within the proposed inclusion levels of 0.5-30 g lysine sulfate/kg complete feed provided that the total S intake complies with the recommendations of established scientific bodies. The use of C. glutamicum KCCM 10227 in the production of l-lysine sulfate is considered safe for the target species, consumers, users and the environment with regard to antimicrobial resistance. No negative effects are to be expected for the target species within common inclusion levels provided that the total S intake complies with the recommendations of established scientific bodies., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The product subject of this assessment is l-valine produced by fermentation using a non-genetically modified strain of Corynebacterium   glutamicum (KCCM 11201P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations below thresholds specified by EFSA, thus C .  glutamicum KCCM 11201P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C .  glutamicum were detected in the final product. The amount of identified material exceeded ■■■■■% on 'as is' basis, and no impurities of concern were detected. The use of l-valine produced by C .  glutamicum KCCM 11201P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. The product l-valine produced by C .  glutamicum (KCCM 11201P) is considered not to be an irritant or a dermal sensitiser, and does not cause acute inhalation toxicity. The additive is an effective source of valine for all species. For the supplemental l-valine to be as efficacious in ruminants as in non-ruminant species, it requires protection against microbial 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 Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D 3 /kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment, the 2017 opinion did not address the potential effects of the proposed increase in the maximum authorised levels of vitamin D 3 on the safety for the user and the environment. The NFSA has submitted additional data and the European Commission has requested EFSA to deliver a new opinion on the safety for the environment of vitamin D 3 as a nutritional additive for salmonids. Planktonic microalgae, inhabiting the sea, are a large group of photosynthetic organisms that contain both vitamin D 3 and provitamin D 3 . Marine phytoplankton is distributed throughout the sea serving as the basis for all marine food webs. Therefore, since it is produced by phytoplankton, vitamin D 3 may also be considered as being ubiquitous in the aquatic environment. Considering the different sources of vitamin D 3 already present in the marine environment, the FEEDAP Panel considers that an increase in concentration of vitamin D 3 when used as a feed additive in compound feed for salmonids up to a maximum of 1.5 mg/kg is not expected to pose a risk for the environment., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The product subject of this assessment is l-threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l-threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the genetic modification of the production strain. l-Threonine produced using E. coli CGMCC 7.232 is considered safe for the target species. The FEEDAP Panel has concerns regarding the safety of the simultaneous administration of l-threonine via water for drinking and feed. l-Threonine produced using E. coli CGMCC 7.232 is safe for the consumer. In absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and eyes or to be a skin sensitiser. There is a risk from the inhalation exposure to endotoxins for persons handling the additive. l-Threonine produced using E. coli CGMCC 7.232 is safe for the environment. The product under assessment is considered an efficacious source of the amino acid l-threonine for all animal species. For l-threonine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Cyanocobalamin is a synthetic form of vitamin B 12 used in pharmaceuticals, supplements and as a food additive. It is intended to be used in feed for all animal species and categories. 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 cyanocobalamin produced by fermentation with Ensifer adhaerens strains SCM 2034 or CICC 11008s or Ensifer fredii strain CMCC (B) 70000. Since relevant data were not provided by the applicant that would allow a proper identification and characterisation of the production strains, the Additives and Products or Substances used in Animal Feed (FEEDAP) Panel cannot conclude on the safety of the use of vitamin B 12 produced using E. adhaerens CICC 11008s and E. fredii CMCC (B) 70000 in animal nutrition for the target animals, the consumer, the user and the environment. Due to significant uncertainties on the identity and safety of the production strain E. adhaerens SCM 2034, including the presence of antibiotic resistance genes, the absence of viable cells of the production strain or their DNA in the product, the FEEDAP Panel cannot conclude on the safety of the use of vitamin B 12 , produced by E. adhaerens SCM 2034 in animal nutrition for the target species, consumers and the environment. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, vitamin B 12 produced by E. adhaerens SCM2034 is considered to pose a risk to user safety. Vitamin B 12 additives produced by Ensifer spp. are regarded as effective in meeting animals' requirements., (© 2018 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 a riboflavin-based additive (minimum 80%) produced by a genetically modified strain of Ashbya gossypii (■■■■■). It is intended to be used in feed for all animal species and categories. The additive under assessment does not give rise to safety concerns on the genetic modification of the production strain. The additive contains 80% of riboflavin (vitamin B 2 ) and 20% of spent growth medium. The additive is safe for target animals with a wide margin of safety. The use of riboflavin 80% produced by A. gossypii ■■■■■ in animal nutrition does not represent a safety concern for consumers. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot draw a final conclusion on the risk posed for the user by inhalation of riboflavin produced by A. gossypii ■■■■■ and on the potential to be irritant to skin or eyes. The product under assessment is not a skin sensitiser; however, riboflavin is a known photosensitiser. The use of riboflavin produced by A. gossypii ■■■■■ in animal nutrition does not pose a risk to the environment. The additive is regarded as an effective source of riboflavin in covering the animal's requirement when administered via feed. The FEEDAP Panel made recommendations on the description of the additive., (© 2018 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 betaine anhydrous produced ■■■■■ as a nutritional additive to be used in feed for all food-producing animal species except rabbits. Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous tissues of vertebrates as an osmolyte ensuring osmoprotection. Betaine anhydrous (97%, 96% or 91%) is considered safe for the target species at a maximum supplementation rate of 2,000 mg betaine/kg complete feed. The use of betaine anhydrous (97%, 96% and 91%) as a feed additive up to a supplementation of 2,000 mg/kg complete feed does not pose concerns to consumer safety. The betaine liquid product contains a high proportion of unknown material (about 30% on dry matter basis). The FEEDAP Panel therefore cannot conclude on the safety of the liquid form of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety for the user. The supplementation of feed with betaine anhydrous does not pose a risk to the environment. Betaine has a potential to become efficacious in food-producing animal species and categories when administered via feed, especially when methyl groups from methionine or choline are limiting. The FEEDAP Panel made a recommendation on the use of the additive in premixtures without choline chloride., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

l-Arginine is considered to be a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l-arginine produced by fermentation using a non-genetically modified strain of Corynebacterium glutamicum (KCCM 10741P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations at or below thresholds specified by EFSA; thus, C. glutamicum KCCM 10741P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded 99.8%, and no impurities of concern were detected. The use of l-arginine produced by C. glutamicum KCCM 10741P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. l-Arginine produced by C. glutamicum KCCM 10741P is considered corrosive to skin and eyes and therefore poses a risk by inhalation. The additive is an effective source of arginine for all species. For the supplemental l-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against microbial degradation in the rumen., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

l-Arginine is considered as a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. l-Arginine produced by fermentation with Escherichia coli NITE BP-02186, genetically modified to enhance the production of l-arginine, is intended to be used in feed and water for drinking for all animal species and categories. The product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. Its use as a nutritional additive is safe for target species when supplemented to diets in appropriate amounts. The use of l-arginine as a feed flavouring agent is unlikely to pose any concern. No risks are expected for the consumer from the use of the product under assessment as a feed additive. It is not irritant to skin or eyes, nor a skin sensitiser. Although the presence of endotoxin activity is of no concern, the available exposure and toxicological data indicate that the additive may pose a risk to users by inhalation. The use of this additive in animal nutrition does not pose a risk to the environment. The additive is an effective source of arginine for all species. l-Arginine is considered efficacious when used as a flavouring compound in animal nutrition., (© 2018 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 Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to deliver a scientific opinion on the safety and efficacy of ADRY+ ® . ADRY+ ® consists of hydroxy analogue of methionine (HMTBa) and its calcium salt (HMTBa-Ca), both precursors of l-methionine. HMTBa and HMTBa-Ca are currently authorised for use as a nutritional additives, under the functional group 'amino acids, their salts and analogues'. ADRY+ ® is produced by chemical synthesis and it is intended to be used in feed for all animal species and categories. The FEEDAP Panel concluded that ADRY+ ® is safe for the target animals. The use of the additive in animal nutrition is not expected to result in an accumulation of HMTBa or its metabolites in edible tissues and animal products. Therefore, its use does not raise safety concerns for the consumer. ADRY+ ® is irritant to eyes and not irritant to the skin. The FEEDAP Panel cannot conclude on the skin sensitisation potential of this additive. The exposure of the users to the additive by inhalation is expected to be low. The use of this product as a feed additive does not represent a risk to the environment. ADRY+ ® is an effective source of methionine for protein synthesis in non-ruminant animals and fish, although HMTBa may show a lower bioefficacy than dl-methionine. In ruminants, HMTBa is more slowly degraded in the rumen than dl-methionine., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The product subject of this assessment is l-threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 11473). It is intended to be used in feed and water for drinking for all animal species and categories. It was not possible to characterise the genetic modification with the information provided. Uncertainty remained on the possible presence of cells from the production strain and their recombinant DNA in the product. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the product l-threonine, produced by fermentation with Escherichia coli CGMCC 11473 for the target species, consumers and the environment. The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of threonine containing additives via water for drinking and feed. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be an irritant for skin and eyes or to be a skin sensitiser. There is a risk from the exposure by inhalation to endotoxins for persons handling the additive. The product under assessment is considered an efficacious source of the amino acid l-threonine for all animal species. For l-threonine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

During 2012-2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued three opinions on the safety and efficacy of vitamin D 3 for all animal species and concluded that no safety concern was identified for the use of vitamin D 3 for fish at the maximum authorised content of 0.075 mg/kg feed. The Norwegian Food Safety Authority made available to the Commission some studies on the safety of vitamin D 3 for fish and consumers at substantially higher levels (1.5 mg/kg feed) than those proposed by EFSA. The European Commission asked EFSA to review the information provided to estimate if it would be possible to increase the current levels of vitamin D 3 in feed for fish. The increasing use of plant-based feed materials in aquaculture feeds could induce a decrease in vitamin D 3 content in feedingstuffs. However, there is no evidence that the current total (background + supplemented) maximum EU content of vitamin D 3 may cause any appreciable risk of deficiency in salmonids. The possible contribution of vitamin D 2 in plant-based ingredients to the total vitamin D intake is considered to be low, although it cannot be reliably estimated. The FEEDAP Panel concludes that a total level of 1.5 mg vitamin D 3 /kg compound feed is safe for salmonids with a margin of safety of at least 10. For other fish, insufficient data are available to conclude on the safety of a total level of 1.5 mg vitamin D 3 /kg feed. Although the assessment of safety for the consumer is impaired by uncertainties concerning the transfer of vitamin D 3 from feed to fish flesh, it was concluded that an increase of total vitamin D content in fish feeds up to 1.5 mg/kg feed would not lead the tolerable upper intake level to be exceeded even in high consumers., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

We compiled information on the distribution of ticks in the western Palearctic (11°W, 45°E; 29°N, 71°N), published during 1970-2010. The literature search was filtered by the tick's species name and an unambiguous reference to the point of capture. Records from some curated collections were included. We focused on tick species of importance to human and animal health, in particular: Ixodes ricinus, Dermacentor marginatus, D. reticulatus, Haemaphysalis punctata, H. sulcata, Hyalomma marginatum, Hy. lusitanicum, Rhipicephalus annulatus, R. bursa, and the R. sanguineus group. A few records of other species (I. canisuga, I. hexagonus, Hy. impeltatum, Hy. anatolicum, Hy. excavatum, Hy. scupense) were also included. A total of 10,280 records was included in the data set. Almost 42 % of published references are not adequately referenced (and not included in the data set), host is reported for only 61 % of records and a reference to time of collection is missed for 84 % of published records. Ixodes ricinus accounted for 44.3 % of total records, with H. marginatum and D. marginatus accounting for 7.1 and 8.1 % of records, respectively. The lack of homogeneity of the references and potential pitfalls in the compilation were addressed to create a digital data set of the records of the ticks. We attached to every record a coherent set of quantitative descriptors for the site of reporting, namely gridded interpolated monthly climate and remotely sensed data on vegetation (NDVI). We also attached categorical descriptors of the habitat: a standard classification of land biomes and an ad hoc classification of the target territory from remotely sensed temperature and NDVI data. A descriptive analysis of the data revealed that a principal components reduction of the environmental (temperature and NDVI) variables described the distribution of the species in the target territory. However, categorical descriptors of the habitat were less effective. We stressed the importance of building reliable collections of ticks with specific references as to collection point, host and date of capture. The data set is freely downloadable.