Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae CNCM I-1079 for dogs and all other Canidae (Danstar Ferment AG).

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

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

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

Modification of the terms of authorisation regarding the maximum inclusion level of a feed additive consisting of nonanoic acid for all pigs and poultry species (Anitox Corporation).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation regarding the maximum inclusion level of a feed additive consisting of nonanoic acid for all pigs and poultry species. Nonanoic acid is currently authorised for use as a sensory additive (functional group: flavouring compounds) for all animal species at a recommended maximum content of 5 mg/kg complete feed. The applicant is requesting a modification of the authorisation to increase the recommended maximum content of the active substance from 5 to 100 mg/kg complete feed for all poultry and pig species. In support of the safety of the additive at the new proposed level, the applicant provided tolerance trials in the target species. The FEEDAP Panel concludes that nonanoic acid is safe for all growing poultry species and Suidae at 100 mg/kg feed. The Panel cannot conclude on the safety of the new proposed level (100 mg/kg complete feed) for laying hens, turkeys for breeding, minor poultry species for laying/breeding and reproductive Suidae. However, FEEDAP Panel considered that nonanoic acid is safe at 10 mg/kg complete feed in laying hens, turkeys for breeding, minor poultry species for laying/breeding and 20 mg/kg complete feed for reproductive Suidae. The use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for the consumer and the environment. Due to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant neither a dermal nor respiratory sensitiser. No further demonstration of efficacy is necessary.

Safety and efficacy of a feed additive consisting of Pediococcus acidilactici CNCM I-4622 for all insect species (Danstar Ferment AG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Pediococcus acidilactici CNCM I-4622 as a zootechnical additive (functional group: physiological condition stabilisers) for all insects. The active agent used in the additive is already authorised for use in all animal species as a technological additive, and as a zootechnical additive in all Suidae species for fattening and for breeding, other than sows, all avian species, all fish species and all crustaceans. The active agent has been identified as a strain of P. acidilactici and consequently meets the qualifications required by the qualified presumption of safety (QPS) approach. The use of the additive is considered safe for all insect species, consumers and the environment. The additive is considered non-irritant to skin and eyes but a respiratory sensitiser. No conclusions can be drawn regarding its skin sensitisation potential. In the absence of adequate data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive as a physiological condition stabiliser for honeybees nor for all insect species.

Efficacy of the feed additive consisting of 6-phytase (produced by Komagataella phaffiiCGMCC 7.19) (Nutrase P) for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds (Nutrex N.V.).

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

Safety and efficacy of a feed additive consisting of endo-1,4-beta-xylanase (produced by Aspergillus oryzae DSM 33700) (RONOZYME® WX (CT/L)) for all poultry species and all Suidae (DSM nutritional products ltd).

The additive RONOZYME® WX (CT/L) contains endo-1,4-beta-xylanase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae; the additive is currently authorised for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 26372 with A. oryzae DSM 33700, and to extend the use of the additive to all poultry species and all Suidae. RONOZYME® WX (CT/L), manufactured with the production strain A. oryzae DSM 33700, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its DNA were detected in an intermediate product representative of both final formulations of the additive. RONOZYME® WX (CT/L) was considered safe for all poultry species and all Suidae at the recommended inclusion levels. The use of RONOZYME® WX CT and L manufactured with the production strain A. oryzae DSM 33700 raised no concerns for consumers. RONOZYME® WX L is not an eye irritant; however, no conclusions could be drawn on the potential of RONOZYME® WX CT to be an eye irritant. Both formulations are not irritant to the skin, but due to the lack of data, the FEEDAP Panel was not able to conclude on the potential of both formulations of the additive to be skin sensitisers. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33700 raises no safety concerns for the environment. The additive has the potential to be efficacious in all poultry species and all Suidae at 100 and 200 FXU/kg complete feed, respectively.

Efficacy of a feed additive consisting of Saccharomyces cerevisiae MUCL 39885 (Biosprint®) for cats (Prosol S.p.A).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Saccharomyces cerevisiae MUCL 39885 (Biosprint®) as a zootechnical additive for cats. The additive is already authorised for use in sows, dairy cows, horses, weaned piglets, dogs, cattle and minor ruminants for fattening and minor ruminants for dairy production. In a previous opinion, the FEEDAP Panel concluded that Biosprint® is safe when used in feeds for cats and dogs. However, based on the data available, the FEEDAP Panel was unable to conclude on the efficacy of the additive when administered to cats. In the current application, the applicant provided an additional efficacy trial in cats. Based on the previously and newly submitted data, the FEEDAP Panel concluded that Biosprint® has the potential to be efficacious as a zootechnical additive for cats under the proposed conditions of use.

Safety of 41 flavouring compounds providing a herbal flavour and belonging to different chemical groups for use as feed additives in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 41 compounds to provide a Herbal flavour and belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fourteen out of the 41 compounds were tested in tolerance studies in chickens for fattening, piglets, cattle for fattening and Atlantic salmon. No adverse effects were observed in the tolerance studies at 10-fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 14 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 27 compounds, read-across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 27 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer and the environment from the use of the 41 compounds up to the maximum proposed use level in feed.

Safety and efficacy of the feed additive consisting of protease produced by Bacillus licheniformis DSM 33099 (ProAct 360) for use in poultry species for fattening or reared for laying/breeding (DSM Nutritional Products Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a protease (ProAct 360) produced by a genetically modified strain of Bacillus licheniformis (DSM 33099) as a zootechnical feed additive for poultry species for fattening or reared for laying/breeding. The production strain and its recombinant DNA were not detected in an intermediate concentrated product representative of the final formulation. The final product did not trigger a safety concern with regard to the genetic modification. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ProAct 360 is considered safe for all growing poultry species at the recommended inclusion level of 30,000 NFP/kg complete feed. The use ProAct 360 as a feed additive did not give rise to concerns for the consumers or the environment. The additive is not an eye or a dermal irritant but should be considered a respiratory sensitiser. In the absence of data, no conclusions could be reached on the skin sensitisation potential of the additive. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 30,000 NFP/kg complete feed for all poultry species for fattening or reared for laying/breeding.

Safety and efficacy of a feed additive consisting of a preparation of essential oils of thyme and star anise, and quillaja bark powder (BIOSTRONG® 510 all natural) for all poultry species (Delacon Biotechnik GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation consisting of essential oils of thyme and star anise, and quillaja bark powder (BIOSTRONG® 510 all natural) as a zootechnical feed additive (functional groups: digestibility enhancer; other zootechnical additives) for all poultry species. BIOSTRONG® 510 all natural is a preparation of partially microencapsulated essential oils, quillaja bark powder, dried herbs and dried spices. The additive contains estragole (up to ■■■■■. For short-living animals, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concerns when the additive is used at the recommended level of 150 mg/kg complete feed for chickens for fattening and other poultry species for fattening. For long-living animals, the use of the additive was considered of concern owing to the presence of estragole. No safety concern would be expected for the consumer and the environment from the use of the additive at the recommended use level in feed. The Panel concluded that the additive is corrosive to the eyes but not irritant to skin. It may be a respiratory irritant or dermal or respiratory sensitiser. When handling the additive, exposure of unprotected users to estragole ■■■■■ may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The additive BIOSTRONG® 510 all natural was considered efficacious for chickens for fattening at the use level 150 mg/kg complete feed. This conclusion was extrapolated to all poultry species for fattening or reared for laying/breeding. ■■■■■.

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 Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® extra) for all poultry species (excluding laying and breeding birds) (Phytobiotics Futterzusatzstoffe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) when used as a zootechnical feed additive (functional group: other zootechnical additives) for all poultry species (excluding laying and breeding birds). The additive is standardised to contain a concentration of the sum of the four alkaloids sanguinarine, chelerythrine, protopine and allocryptopine of 1.25%, with 0.5% sanguinarine. Owing to the presence of the DNA intercalators sanguinarine and chelerythrine, a concern for genotoxicity was identified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concerns when the additive is used at the recommended level of 150 mg/kg complete feed (corresponding to 0.750 mg sanguinarine/kg complete feed) for chickens for fattening and other poultry species for fattening. No conclusion can be drawn for poultry reared for laying/breeding. The use of Sangrovit® Extra in poultry species for fattening at the maximum recommended level was considered of low concern for consumers. The additive was shown to be irritant to the eyes but not irritant to skin or a skin sensitiser. The FEEDAP Panel could not exclude the potential of the additive to be a respiratory sensitiser. When handling the additive, exposure of unprotected users to sanguinarine and chelerythrine may occur. Therefore, to reduce the risk, the exposure of users should be reduced. The use of Sangrovit® Extra as a feed additive under the proposed conditions of use was considered safe for the environment. The additive Sangrovit® Extra had the potential to be efficacious in improving performance of chickens for fattening at 45 mg/kg complete feed. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all poultry species for fattening or reared for laying/breeding.

Safety and efficacy of feed additives consisting of sodium ferrocyanide and potassium ferrocyanide for all animal species (Eusalt a.i.s.b.l.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium and sodium ferrocyanide as technological feed additives for all animal species. The additives sodium- and potassium ferrocyanide are intended to be used in sodium chloride with a maximum content of 80 mg ferrocyanide anion (anhydrous)/kg salt. The FEEDAP Panel concluded that the use of sodium ferrocyanide and potassium ferrocyanide is safe, when added to sodium chloride at a maximum content of 80 mg ferrocyanide anion/kg for: turkey for fattening and laying hens and other laying/breeding birds; all porcine species and categories, all ruminant species and categories, rabbit, horse, salmonids and other minor fin fish, dogs and cats. In the absence of a margin of safety, the use of sodium and potassium chloride according to the proposed conditions of use is not considered to be safe for chickens for fattening and other poultry species for fattening or reared for laying/breeding other than turkeys. In the absence of information on the use of sodium chloride in the diets for any other animal species, no conclusion on a potentially safe level of sodium chloride, supplemented with 80 mg ferrocyanide anions (anhydrous)/kg, could be made. The use of sodium and potassium ferrocyanide in animal nutrition under the conditions of use proposed is of no concern for consumer safety. The results of in vivo studies showed that sodium and potassium ferrocyanide are not irritant to skin and eye and are not skin sensitisers. However, owing to the presence of nickel, sodium ferrocyanide, is considered a dermal and respiratory sensitiser. No conclusions could be reached on the safety of the user exposed via inhalation for potassium ferrocyanide. The use of sodium and potassium ferrocyanide as feed additives is considered safe for the environment. The additives are considered to be efficacious as anticaking agents in sodium chloride at the proposed use level.

Safety and efficacy of a feed additive consisting of 6-phytase produced by Komagataella phaffiiCGMCC 7.370 (VTR-phytase powder/liquid) for all pigs and all avian species (Victory Enzymes GmbH).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 6-phytase (VTR-phytase) as zootechnical feed additive for all pigs and all avian species. The additive VTR-phytase consists of 6-phytase and it is available in solid and liquid forms. VTR phytase (liquid/solid) was produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.370). The genetic modification of the production strain does not give rise to safety concerns. Viable cells of the production strain and its DNA were not detected in the final products. The additive does not pose any safety concern regarding the production strain. VTR phytase (liquid/solid) produced by Komagataella phaffii CGMCC 7.370 is safe for all Suidae and all avian species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid VTR phytase and powder VTR phytase are non-irritant to skin or eyes but should be considered skin and respiratory sensitisers. The additive has the potential to be efficacious in laying hens at 1,000 U phytase/kg complete feed. The conclusion can be extrapolated to other birds for egg production or breeding. The FEEDAP Panel cannot conclude on the efficacy of all pigs or growing poultry species.

Safety and efficacy of a feed additive consisting of tocopheryl phosphate mixture (TPM) for all animal species (Avecho biotechnology limited).

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 tocopheryl phosphate mixture (TPM) as nutritional feed additive for all animal species. The additive has not been authorised for use in animal nutrition. TPM is produced by chemical synthesis and is a mixture of two different phosphorylated tocopheryl compounds in approximate 2:1 weight ratio: all-rac-α-tocopheryl di-hydrogen phosphate (TP) and all-rac-di-α-tocopheryl hydrogen phosphate (T2P). It is intended to be used as nutritional additive (as a source of vitamin E) in feed for all animal species and categories. Considering the limited information on the ADMER for the components of the additive and the uncertainties on the potential aneugenicity and clastogenicity of the additive, the Panel cannot conclude on the safety of the additive for the target species and for the consumer. TPM is not a skin irritant nor a skin sensitiser but should be considered irritant to the eyes and the upper respiratory tract. Owing to the uncertainty on the potential aneugenicity and clastogenicity of the additive, it is not possible to conclude on safety for the user. The FEEDAP Panel cannot conclude on the safety of TPM for the environment due to lack of data on environmental impact of T2P. TPM is a bioavailable source of α-tocopherol. The data available, however, do not allow the Panel to establish the relative bioequivalence of TPM as vitamin E. Therefore, the Panel is not in the position to conclude on the efficacy of TPM for all animal species.