Assessment of the feed additive consisting of l-tyrosine for all animal species for the renewal of its authorisation (BCF Life Sciences).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of l-tyrosine as a nutritional feed additive. The additive is authorised for use in all animal species (3c401). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed concluded that the use of the feed additive in animal nutrition remains safe for the target species, consumers, and the environment. As regards the safety for the user, l-tyrosine is not an irritant to skin or eyes. In the absence of data, the potential of l-tyrosine to be a dermal and respiratory sensitiser cannot be excluded. Exposure by inhalation of persons handling the additive is likely. The present application for renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and, therefore, there is no need for re-assessing the efficacy.

Consumer safety of feed additives containing selenium.

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

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

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

Safety and efficacy of a feed additive consisting of inactivated selenised yeast (Saccharomyces cerevisiae CCTCC M 2022402) for all animal species (Phytobiotics Futterzusatzstoffe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the selenised yeast (inactivated) Saccharomyces cerevisiae CCTCC M 2022402 (Plexomin® Se 3000, available in two forms: 'granules' and 'micro') as a nutritional feed additive for all animal species. Based on a tolerance-efficacy trial, the FEEDAP Panel concluded that the additive is safe for chickens for fattening at proposed conditions of use and this conclusion can be extrapolated to all animal species. In the absence of deposition data in all animal species and products, the FEEDAP Panel cannot conclude on the safety for the consumer. Plexomin® Se 3000 (granules) is dust-free; therefore, the exposure through inhalation is unlikely. Plexomin® Se 3000 (micro) presents a risk by inhalation. Both forms of the additive (granules and micro) are considered as respiratory sensitisers. Due to the lack of data, no conclusions can be drawn on the dermal and eye irritation potential of Plexomin® Se 3000 (granules). Plexomin® Se 3000 (micro) is not irritant to the skin and the eyes. No conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. The use of the additive in animal nutrition is considered safe for the environment. The additive is an efficacious source of selenium in feedingstuffs for all animal species.

Safety and efficacy of a feed additive consisting of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens CGMCC 21299 for all animal species (NHU Europe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B12 (cyanocobalamin) produced by fermentation with a non-genetically modified strain of Ensifer adhaerens (CGMCC 21299), when used as a nutritional additive for all animal species. No viable cells or DNA of the production strain were detected in the additive. Therefore, cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 does not raise safety concerns as regards to the production strain. The Panel on Additives and Products or Substances used in Animal Feed concluded that cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 is considered safe for all animal species, for the consumers and the environment. Due to the presence of nickel, the additive is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. Due to the lack of data, the Panel could not conclude on the potential of the additive to be an eye irritant. Cyanocobalamin produced by fermentation with E. adhaerens CGMCC 21299 is effective in meeting animal's nutritional requirements when administered via feed.

Assessment of the feed additive consisting of folic acid for all animal species for the renewal of its authorisation (Chr. Olesen A/S and DSM Nutritional Products Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of folic acid as a nutritional feed additive. The additive is authorised for use in feed and water for drinking for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the safety for the terrestrial species, consumers and for the environment. The use of folic acid in aquatic animal species to cover their nutritional needs is considered safe. However, the Panel is not in a position to set a maximum safe level for all fish and crustacean species. Considering the narrow margin between the requirement and the tolerated levels seen in some aquatic animal species, the FEEDAP Panel considers that supplementation should not exceed the requirements of the different aquatic animal species. The additive is neither a skin irritant nor a dermal sensitiser. The exposure through inhalation is likely. Due to the lack of data, the FEEDAP Panel is not in the position to conclude on the potential of folic acid to be harmful to the respiratory system and irritant to eyes. The Panel retains that the previously made conclusion on the efficacy remains valid.

Safety and efficacy of a feed additive consisting of copper(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

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 copper(II)-betaine as a nutritional additive for all animal species and on the safety for the marine sediment when the additive is used in sea cages. The FEEDAP Panel concluded that the risk to the marine sediment is acceptable when the additive is used in sea cages. The additional statistical analysis of the results of the efficacy study already assessed in the previous opinion did not allow the Panel to conclude on the efficacy of the additive.

Modification of the terms of authorisation of zinc-l-selenomethionine as a feed additive for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a new preparation of zinc-l-selenomethionine, with selenium content of 4%, as a nutritional feed additive for all animal species. Zinc-l-selenomethionine is already authorised for use in all animal species (3b818). Current authorisation defines the additive as 'Solid preparation of zinc-l-selenomethionine with a selenium content of 1-2 g/kg'. The applicant developed a new preparation of zinc-l-selenomethionine containing a minimum of 40 g Se/kg and seeks to modify the current authorisation. The FEEDAP Panel concluded that the newly proposed preparation is considered safe for all animal species. The FEEDAP Panel recommends adding, to the currently existing authorisation, a new preparation (40-46 g Se/kg) and not the range proposed by the applicant (1-46 g Se/kg), since no characterisation data on the intermediate preparation range (from 2 to 40 g Se/kg) have been provided. The use of the new preparation (minimum 40 g Se/kg) of zinc-l-selenomethionine in animal nutrition is of no concern for consumer safety. The newly proposed preparation presents a risk by inhalation; it is not irritant to eyes or skin. No conclusion can be reached regarding dermal sensitisation. The previous conclusion by the Panel on the safety for the environment remains unchanged. The Panel concluded that the modification request has no impact on efficacy.

Assessment of the feed additive consisting of niacinamide for all animal species for the renewal of its authorisation (Arxada Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of niacinamide as a nutritional additive for use in all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive is not irritant to skin but irritant to eyes. It is not a dermal sensitiser. Exposure through inhalation is likely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of iron(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, the EFSA 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 iron(II)-betaine complex as a nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chickens the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of iron in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum iron levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the iron(II)-betaine complex in animal nutrition at the maximum iron levels authorised for the animal species poses no concern to the safety of consumers. The additive is not a skin irritant, but it is an irritant to the eyes. Due to the traces of nickel, the additive is considered to be a respiratory and skin sensitiser. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals, land-based and sea cages aquaculture is considered safe under the proposed conditions of use. Based on the deposition of iron in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable iron, comparable to the standard inorganic iron source, and therefore, the additive is efficacious in meeting the birds iron requirements. This conclusion can be extrapolated to all animal species and categories.

Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for particles below 50 µm from 1% to 5%. The FEEDAP Panel considers that the proposed modifications do not introduce concern for the safety for the target species and that the additive remains safe for the target species and the consumers when used up to the maximum authorised levels. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land-based aquaculture is considered safe under the proposed conditions of use. The data available do not allow the FEEDAP Panel to reach a conclusion on the safety of the additive for marine sediment when it is used in sea cages. The additive is not corrosive to skin, but is an eye and skin irritant. Due to the nickel presence, it is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of l-valine produced by Corynebacterium glutamicum CGMCC 18932 for all animal species (Xinjiang Fufeng Biotechnologies Co., Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-valine produced by fermentation using a non-genetically modified strain of Corynebacterium glutamicum (CGMCC 18932). l-Valine is intended to be used in feed and water for drinking as a nutritional additive, functional group amino acids, their salts and analogues, for all animal species and categories. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that l-valine produced by C. glutamicum CGMCC 18932 is considered safe for the target species when supplemented to the diet in appropriate amounts according to the nutritional needs of the target species. The use of l-valine produced using C. glutamicum CGMCC 18932 in animal nutrition is considered safe for the consumer and for the environment. No conclusion could be drawn on the potential of l-valine produced using C. glutamicum CGMCC 18932 to be irritant to the skin or eyes, or a dermal sensitiser due to the lack of data. The FEEDAP Panel concluded that the l-valine produced by fermentation using C. glutamicum CGMCC 18932 is an efficacious source of the essential amino acid l-valine for non-ruminant nutrition. To be as efficacious in ruminants as in non-ruminants, supplemental l-valine requires protection against ruminal degradation. The FEEDAP Panel expressed concerns on the use of amino acids in water for drinking for hygienic reasons.

Safety and efficacy of a feed additive consisting of 25-hydroxycholecalciferol (produced by Pseudonocardia autotrophicaDSM 32858) for all pigs, all poultry for fattening and ornamental birds and other poultry species (Huvepharma NV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of 25-hydroxycholecalciferol (produced by Pseudonocardia autotrophica DSM 32858) for all pigs, all poultry for fattening and ornamental birds and other poultry species. The production strain P. autotrophica DSM 32858 is not genetically modified however, uncertainties remain on the possible presence of its viable cells in the final product. Due to the lack of adequate safety data and uncertainty on the presence of nano particles, the FEEDAP Panel cannot conclude on the safety of the additive for the target species and the consumer. The additive was shown not to be irritant to skin or eyes and it is not a skin sensitiser. Considering the low dusting potential of the additive, the FEEDAP Panel concluded that the exposure through inhalation is unlikely. However, the FEEDAP Panel considered that uncertainties remain on genotoxicity and on the possible presence of viable cells of P. autotrophica DSM 32858 in the final product which might have an impact on the safety for the users. The use of the feed additive is considered safe for the environment. The Panel concluded that the additive has a potential to be efficacious under the proposed conditions of use.

Safety and efficacy of a feed additive consisting of copper(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, the EFSA 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 a copper(II)-betaine complex as nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chicken, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of copper in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum copper levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the copper(II)-betaine complex in animal nutrition at the maximum copper levels authorised for the animal species poses no concern to the safety of consumers. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land-based aquaculture is considered safe under proposed conditions of use. The data available do not allow the conclusion to be made on the safety of the additive for marine sediment when it is used in sea cages. The additive is not a skin irritant, but it is an irritant to the eyes. Due to the traces of nickel, the additive is considered to be a respiratory and skin sensitiser. The Panel could not conclude on the efficacy of the product.

Assessment of the application for renewal of the authorization of a feed additive consisting of urea for ruminants (Borealis L.A.T. GmbH, SKW Stickstoffwerke Piesteritz GmbH and Yara France).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of urea as nutritional feed additive. The additive is authorised for use in ruminants with functional rumen (3d1). The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been substantially modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the target species, consumer and for the environment when used as a source of non-protein nitrogen under current conditions of use, in ruminants with functional rumen. In the absence of new data, the FEEDAP Panel is not in the position to conclude on the user safety. The Panel retains that previously made conclusion on the efficacy remains valid.

Safety and efficacy of a feed additive consisting of a zinc(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a zinc(II)-betaine complex as nutritional additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion could be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded. The FEEDAP Panel concluded that the use of the zinc(II)-betaine complex in animal nutrition is of no concern for consumer safety provided that the maximum authorised total zinc levels in feed are respected. The additive is considered to be a skin and respiratory sensitiser due to the presence of nickel; it is irritant to the eyes, but not to the skin. The use of the additive in animal nutrition for terrestrial animals and land-based aquaculture at the proposed use levels is considered safe for terrestrial and aquatic ecosystems. The available data do not allow the conclusion to be made on the safety of the additive for the marine sediment when it is used in sea cages. Based on the deposition of zinc in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable zinc, comparable to the standard inorganic zinc source, and therefore, the additive is efficacious in meeting the birds zinc requirements. This conclusion can be extrapolated to all animal species and categories.

Safety and efficacy of a feed additive consisting of concentrated liquid l-lysine, l-lysine monohydrochloride and concentrated liquid l-lysine monohydrochloride produced by Escherichia coliNITE BP-02917 for all animal species (Metex NoovistaGo).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of concentrated liquid l-lysine, l-lysine monohydrochloride and concentrated liquid l-lysine monohydrochloride produced by Escherichia coli NITE BP-02917 as nutritional and as sensory (flavouring compound) feed additives for all animal species. The production strain did not carry ■■■■■ antimicrobial resistance genes and no viable cells of the production strain were detected in the final products. ■■■■■ However, since no sequences of concern remained in the production strain, the potential presence of that DNA did not raise safety concerns. The use of the three forms of l-lysine produced by E. coli NITE BP-02917 in supplementing feed to compensate for l-lysine deficiency in feedingstuffs was safe for the target species. This conclusion would also cover the use as a sensory additive. The FEEDAP Panel identified risks of nutritional imbalances and hygienic concerns for amino acids when administered simultaneously in feed and in water for drinking. The use of the three forms of l-lysine produced by E. coli NITE BP-02917 in animal nutrition was considered safe for the consumers and for the environment. Concentrated liquid l-lysine, l-lysine HCl and concentrated liquid l-lysine HCl were not considered to have the potential to cause respiratory toxicity, or skin sensitisation. l-Lysine HCl and concentrated liquid l-lysine HCl were not considered skin and eye irritants. Concentrated liquid l-lysine, due to its high pH, might be corrosive for skin and eyes. The three forms were considered 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. The three forms of the additive were also considered efficacious as feed flavouring compounds under the proposed conditions of use.

Safety and efficacy of a feed additive consisting of Solanum glaucophyllum leaf extract for dairy cows and other dairy ruminants (Herbonis Animal Health Gmbh).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Solanum glaucophyllum leaf extract (SGE) as a nutritional additive for dairy cows and other dairy ruminants. However, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered the glycosides of 1,25-dihydroxycholecalciferol (1,25[OH]2D3) as the active substance and the bolus containing SGE-derived 1,25[OH]2D3 as the preparation of the additive. The product is intended to be administered to dairy ruminants during the pre-parturient (period from 9 days before calving to immediately before calving). The FEEDAP Panel concluded that the administration of one bolus, the preparation of the additive as applied in the animal studies evaluated, containing 500 µg of SGE-derived 1,25[OH]2D3 during the pre-parturient period is safe for cows. Owing to the lack of data, the Panel could not conclude on the safety for of a subsequent administration of a second bolus or on the safety of another SGE-derived 1,25[OH]2D3 preparation for use in dairy ruminants other than cows (Bos taurus). The Panel considered that, under the specified conditions of use, the product is safe for the consumer and the environment. The bolus, a preparation containing SGE, as a source of the active substance, is not irritating to skin and eyes and it is not a sensitiser. Exposure via inhalation is unlikely. The Panel concluded that the administration of the bolus, the preparation of the additive as applied in the animal studies evaluated, containing 500 µg of SGE-derived 1,25[OH]2D3 in a period from 9 days before calving to immediately before calving has the potential to prevent hypocalcaemia in dairy cows. Owing to the lack of data with another preparation, the Panel could not conclude on the efficacy in other dairy ruminants.

Safety and efficacy of a feed additive consisting of l-methionine produced by the combined activities of Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 for all animal species (CJ Europe GmbH).

Following a request from the European Commission, the FEEDAP Panel was asked to deliver a scientific opinion on the safety and efficacy of l-methionine ≥ 98.5% or ≥ 90% produced by the combined activities of Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246) as nutritional additive for all animal species. The two production strains are genetically modified. l-Methionine is intended to be used in feed or water for drinking for all animal species. Neither viable cells nor recombinant DNA of the production strains were detected in the final products. The additive does not pose any safety concern associated with the genetic modification of the production strains. The use of both products of l-methionine produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 in supplementing feed to compensate for l-methionine deficiency in feedingstuffs is safe for the target species. The FEEDAP Panel has concerns about the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of both products of l-methionine produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 in animal nutrition is considered safe for the consumers and for the environment. The additive, in either product, is not an irritant to skin/eyes and not a dermal sensitiser and shows no toxicity by inhalation. Considering the respiratory exposure to endotoxins, l-methionine ≥ 90% is a risk for the user. Both products of the additive produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 are 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.

Safety and efficacy of a feed additive consisting of manganous lysinate sulfate for all animal species (Phytobiotics Futterzusatzstoffe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganous lysinate sulfate as nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was assigned to this mandate. Based on the results of a tolerance study, the FEEDAP Panel concluded that manganous lysinate sulfate is safe for chickens for fattening when used up to the current maximum authorised levels of total manganese in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum manganese levels in complete feed authorised in the EU. The FEEDAP Panel concluded that the use of manganous lysinate sulfate in animal nutrition at the maximum manganese levels authorised for the animal species poses no concern to the safety of consumers and the environment. The Panel also concluded that manganous lysinate sulfate poses a risk to users by inhalation, is irritant to eyes and skin and should be considered a dermal sensitiser. Based on the results of a bioequivalence study, the FEEDAP Panel concluded that manganous lysinate sulfate is considered efficacious for chickens for fattening as a nutritional additive. This conclusion was extrapolated to all animal species and categories.