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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of Saccharomyces cerevisiae CNCM I‐1077 as a zootechnical feed additive for several animal species. The additive, existing in a not‐coated and a coated form, is currently authorised for use in feed for calves, cattle for fattening, dairy cows, dairy goats and dairy sheep, lambs, all minor ruminant species for fattening and rearing, horses and camelids for fattening and rearing. This application regards the request for the extension of use in all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses, and the modification of the authorisation for lambs to reduce the minimum use level. The identity of the active agent as S. cerevisiae was confirmed. Based on the qualified presumption of safety approach and since no concerns are expected from other components, the additive is considered safe for the target species, consumers and the environment. The not‐coated form of the additive is not irritant to skin or eyes. The additive in both formulations should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. No conclusion could be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive has the potential to be efficacious when used in feed for all ruminants and camelids reared for milk production/suckling/reproduction at the minimum proposed use level of 5 × 108 CFU (colony forming unit)/kg complete feed, all minor (young) ruminant species and camelids for fattening and lambs at 1 × 109 CFU/kg complete feed, and in all Equidae species other than horses at 3 × 109 CFU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Loigolactobacillus coryniformis DSM 34345 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with all fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. coryniformis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Loigolactobacillus coryniformis DSM 34345 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Loigolactobacillus coryniformis DSM 34345 has the potential to improve the production of silages prepared from all fresh plant materials at a minimum concentration of 1 × 108 CFU/kg fresh material.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of diclazuril (Clinacox® 0.5%) as a coccidiostat for chickens for fattening and chickens reared for laying. The additive currently on the market complies with the existing conditions of authorisation. The additive remains safe for the target species and the consumer under the authorised conditions of use. The additive is irritant to skin, eyes and respiratory tract but is not a skin sensitiser. Exposure by inhalation cannot be excluded. The FEEDAP Panel cannot conclude on the safety for the environment of diclazuril from Clinacox® 0.5% due to lack of data. Diclazuril from Clinacox® 0.5% at a concentration of 1 mg diclazuril/kg complete feed has the potential to control coccidiosis in chickens for fattening. This conclusion is extended to chickens reared for laying. Development of resistance to diclazuril of field Eimeria spp. strains isolated from chickens should be monitored.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use in weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive AveMix® XG 10 with calcium carbonate + wheat flour and AveMix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal FEED (FEEDAP) noted that no data were submitted to support compliance of the formulation of AveMix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both formulations of the additive (powder and liquid) remain safe for the target species, consumers and the environment, and that the extension of use to suckling piglets would not affect these conclusions. AveMix® XG 10 formulated with calcium carbonate + sepiolite and AveMix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in all its formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 4000 XU and 900 BGU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactococcus lactis DSM 34262 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in easy and moderately difficult to ensile fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. lactis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Lactococcus lactis DSM 34262 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Lactococcus lactis DSM 34262 has the potential to improve the fermentation of the silage prepared from fresh plant material with a DM range of 30–35% at a minimum concentration of 1 × 108 CFU/kg fresh material.

Abstract 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 a preparation of dried cells of Saccharomyces cerevisiae CNCM I‐4407 (Actisaf® Sc 47) as a zootechnical additive for rabbits for fattening and non‐food producing rabbits. The applicant provided evidence that the additive currently in the market complies with the existing terms of the authorisation. The Panel concluded that the additive remains safe for the target species, consumers and the environment. Regarding the safety for the user, the additive is not a skin or eye irritant. However, it should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

Abstract This guidance document is intended to assist the applicant in preparing and presenting an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the efficacy of feed additives.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755), endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) and polygalacturonase (produced with Aspergillus fijiensis CBS 589.94) (AveMix® 02 CS/ AveMix® 02 CS L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use with weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There was no new evidence that would lead the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions that the additive is safe for weaned piglets, the consumer and the environment under the authorised conditions of use. This conclusion applied also to the new target species (suckling piglets) for which a request for an extension of use was made. The additive in both formulations (powder and liquid) is not irritant to skin or eyes but should be considered a dermal and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 2140 XU, 1230 BGU and 46 PGLU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactiplantibacillus plantarum DSM 34271 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in easy and moderately difficult to ensile fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Lactiplantibacillus plantarum DSM 34271 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Lactiplantibacillus plantarum DSM 34271 has the potential to improve the fermentation of the silage prepared from fresh plant material with a DM range of 30%–35% at a minimum concentration of 1 × 108 CFU/kg fresh material.

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

Abstract 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 Quillaja saponaria powder and Yucca schidigera powder (Magni‐Phi®) for all avian species (to slaughter age/weight, or to the point of lay) and ornamental birds, as a zootechnical additive (digestibility enhancer and other zootechnical additives). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening at the level of 250 mg/kg complete feed with a margin of safety of 20 assuming that the additive contains 3.58% of saponins. This conclusion was extrapolated to all growing poultry species and ornamental birds. The Panel concluded that the use of the feed additive in animal nutrition at 250 mg/kg complete feed is of no concern for the safety for the consumer and the environment. The Panel also concluded that the additive is not irritant to skin, but irritant to the eyes and to the respiratory system. Due to the lack of data, the FEEDAP Panel could not conclude on the skin sensitisation potential of the additive. The FEEDAP Panel was not in the position to conclude on the efficacy of the additive for all poultry species and ornamental birds.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tinctures obtained from the dried leaves of Ginkgo biloba L. (ginkgo tinctures) when used as sensory additives. The tinctures are water/ethanol solutions with a dry matter content of 5.7% (tincture A) and 3.0% (tincture B). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additives under assessment are safe for the target species at the following concentrations in complete feed: (i) ginkgo tincture A at 240 mg/kg for horses and 750 mg/kg for dogs; (ii) ginkgo tincture B at 600 mg/kg for horses and 50 mg/kg for all other animal species. No safety concern would arise for the consumer from the use of ginkgo tinctures up to the maximum proposed use level in feed for the target species. The tinctures should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of ginkgo tinctures at the proposed use levels in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that ginkgo tinctures would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additives.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of citronella oil obtained from the leaves of Cymbopogon nardus (L.) Rendle, when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that citronella oil from C. nardus is of low concern for long‐living and reproductive animals at the use levels in complete feed of 3.5 mg/kg for laying hens and rabbits, 6 mg/kg for sows and dairy cows, 9.5 mg/kg for sheep/goats and horses, 2.0 mg/kg for cats and 10 mg/kg for dogs. For short‐living animals (species for fattening), the additive was considered of no concern at concentrations of 18 mg/kg in chickens for fattening, 24 mg/kg in turkeys for fattening, 20 mg/kg for piglets, pigs for fattening, veal calves (milk replacer), cattle for fattening, sheep/goats for meat production, horses for meat production and rabbits for meat production, and 30 mg/kg for salmonids. The conclusions were extrapolated to physiologically related minor species. For any other species, the additive is considered of low concern at 2.0 mg/kg complete feed. The use of citronella oil in animal feed is expected to be of no concern for the consumers and for the environment. The essential oil under assessment should be considered as irritant to skin and eyes and as a dermal sensitiser. When handling the essential oil, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of C. nardus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat salinomycin sodium (Sacox®) for rabbits for fattening. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of salinomycin sodium (SAL‐Na) from Sacox® does not raise safety concerns for the target species, consumers, users and the environment with regard to the production strain. In the absence of adequate tolerance studies, the FEEDAP Panel could not conclude on the safety of SAL‐Na from Sacox® for rabbits for fattening. The FEEDAP Panel concluded that the additive is safe for the consumer when it is used at the proposed maximum level of 25 mg SAL‐Na/kg complete feed for rabbits and a withdrawal period of 1 day is respected. The following maximum residue limits (MRL) are proposed for the marker residue compound salinomycin (SAL): 0.2 and 0.03 mg SAL/kg for liver and kidney, respectively. The additive is not irritant to skin and eyes but should be considered a potential dermal and respiratory sensitiser. A risk for inhalation toxicity could not be excluded. The use of the SAL‐Na from Sacox® in feed for rabbits for fattening up to the highest proposed level will not pose a risk for the terrestrial and aquatic compartment and ground water. The risk of secondary poisoning can be excluded for worm‐eating birds and mammals, while it cannot be excluded for fish‐eating birds and mammals. The FEEDAP Panel concludes that SAL‐Na from Sacox® at the minimum concentration of 20 mg SAL‐Na/kg complete feed has the potential to control coccidiosis in rabbits for fattening. Development of resistance to SAL‐Na of field Eimeria spp. strains isolated from rabbits for fattening should be monitored.

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

Abstract 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.

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 6‐phytase (Quantum® Blue) as a zootechnical feed additive for fin fish. The additive is authorised for use in poultry and pigs. The additive is available in solid and liquid forms, and the 6‐phytase contained in the product is produced by fermentation with a genetically modified strain of Trichoderma reesei. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that 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 FEEDAP Panel concluded that, based on the data available, the additive tested is safe for fin fish at the highest recommended level of 2500 phytase activity unit (FTU)/kg complete feed. The Panel concluded that Quantum® Blue is not an irritant to skin and eyes nor a skin sensitiser. Owing to the proteinaceous nature of the active substance, 6‐phytase (Quantum® Blue) is considered a respiratory sensitiser. The use of Quantum® Blue as a feed additive is considered safe for the environment. The additive is considered to be efficacious as a zootechnical additive for salmonids and ornamental fish at 500 FTU/kg complete feed and other fin fish at 2500 FTU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of muramidase produced with Trichoderma reesei DSM 32338 (Balancius™) as a feed additive for laying hens. The additive is already authorised as a zootechnical additive (functional group: other zootechnical additives) for chickens, turkeys and minor poultry species for fattening or reared for breeding, and for weaned piglets. The enzyme is produced by fermentation with a genetically modified strain of Trichoderma reesei; viable cells of the production strain and its recombinant DNA were not detected in the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not give rise to safety concerns regarding the genetic modification of the production strain. Based on the data available from a sub‐chronic oral toxicity study, the Panel concluded that the additive is safe for laying hens at the maximum recommended level of 60,000 LSU(F) (muramidase activity units)/kg feed. The Panel also concluded that the additive is safe for the consumers and the environment. The liquid formulation of the additive is considered not irritant to the skin or eyes. The solid formulation of the additive is considered not irritant to the skin. The Panel cannot conclude on the potential of the additive (both formulations) to be a dermal sensitiser or on the potential of the solid formulation to be irritant to the eyes. Due to the proteinaceous nature, both forms of the additive should be considered respiratory sensitisers. The additive has the potential to be efficacious as a zootechnical additive for laying hens at 30,000 LSU(F)/kg feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DSM 34246 as a zootechnical feed additive for dogs and cats. The additive, with the trade name Canobios‐BL, is intended for use in feed for cats and dogs at a proposed minimum inclusion level of 5 × 109 CFU/kg complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and the additive is composed by dried cells of the active agent and an emulsifier, that are not expected to introduce any risk, the additive is considered safe for the target species. Canobios‐BL is not a skin or eye irritant but should be considered a skin and respiratory sensitiser. Canobios‐BL is considered to be efficacious in feedingstuffs for dogs and cats at the use level 5 × 109 CFU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.460 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain is not genetically modified. Viable cells of the production strain were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. The use of l‐tryptophan (≥ 98%) produced with E. coli CGMCC 7.460 to supplement feed is safe for non‐ruminant species. There may be a risk for an increased production of toxic metabolites when unprotected tryptophan is used in ruminants. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns on the safety of the simultaneous oral administration of l‐tryptophan via water for drinking and feed due to possible amino acid imbalances and hygienic reasons. The use of l‐tryptophan produced with E. coli CGMCC 7.460 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive in combination with the high dusting potential may represent a risk of exposure by inhalation to endotoxins for users. The additive l‐tryptophan is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Saccharomyces cerevisiae CNCM I‐4407 (Actisaf® Sc47) as a zootechnical feed additive (functional group: gut flora stabiliser) in cattle for fattening. The additive is already authorised for use in feed for dairy cows, calves for rearing, lambs for fattening, dairy goats, dairy sheep and dairy buffaloes. In a previous opinion, the EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that Actisaf® Sc47 was safe for cattle for fattening, the consumers and the environment. Additionally, the Panel considered that Actisaf® Sc47 is not a skin irritant, and no conclusions could be drawn on the additive's eye irritancy and dermal sensitisation potential. Due to the lack of adequate data, the Panel could not conclude on the efficacy of the additive in cattle for fattening at the proposed conditions of use. In the current application, the applicant submitted three trials to support the efficacy in cattle for fattening. However, two of them were not considered for the assessment. The other trial showed an improved zootechnical performance of the animals at the proposed use level of 4 × 109 CFU/kg complete feed. Considering the additive is authorised in dairy cows and calves for rearing and the requirements of the current Guidance on the assessment of the efficacy of feed additives, no further demonstration of efficacy is necessary to extrapolate the conclusions previously reached to all ruminants. The significant positive effect shown in one trial in cattle for fattening supports the above extrapolation. Therefore, the FEEDAP Panel concludes that Actisaf® Sc47 is efficacious as a zootechnical additive for cattle for fattening at the proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive obtained from the dried leaves of Ginkgo biloba L. (ginkgo extract) when used as a sensory additive in feed for horses, dogs, cats, rabbits and guinea pigs. Ginkgo extract contains ≥ 24% total flavonoids, ≥ 6% total terpene lactones and ≤ 1 mg/kg ginkgolic acids. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ginkgo extract is safe for the target species at the following concentrations in complete feed: 2.8 mg/kg for horses and cats, 1.1 mg/kg for rabbits and guinea pigs, and 3.3 mg/kg for dogs. No safety concern would arise for the consumers from the use of ginkgo extract up to the highest level in feed which is considered safe for food‐producing species (horses and rabbits). The additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the additive at the proposed level in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that the ginkgo extract would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additive.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Patent Blue V as a sensory feed additive for non‐food‐producing animals. The additive is already authorised for use with non‐food‐producing animals. The applicant has not provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel cannot conclude whether the additive remains safe for the target species due to the non‐compliance with the specifications and the lack of adequate data on the potential aneugenicity of the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a dermal and eye irritant nor a dermal and respiratory sensitiser. Since the potential genotoxicity of the additive was not ruled out, the exposure to the additive of the unprotected users should be minimised. The Panel retains that the previously made conclusion on the efficacy remains valid.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lanthanum carbonate octahydrate as a zootechnical feed additive for dogs. The additive is already authorised for use in feed for cats. The FEEDAP Panel concluded that the additive lanthanum carbonate octahydrate is safe for adult dogs at the maximum recommended level of 7500 mg/kg complete feed. The additive is not irritant to skin or eyes, is not a skin sensitiser and exposure by inhalation is considered to be unlikely. The Panel also concluded that lanthanum carbonate octahydrate is efficacious in the reduction of phosphorus bioavailability in adult dogs at the minimum inclusion level of 1500 mg/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs. However, the Panel was not in the position to conclude on the efficacy of BioCell® for calves, and, consequently, for other ruminants for fattening or rearing. The applicant provided three additional efficacy trials in veal calves to support the efficacy of BioCell® for ruminants for fattening or rearing. The three studies showed positive effects of the supplementation with the additive at 1.7 × 109 colony forming unit (CFU)/kg complete feed on the performance of veal calves. Considering the previously submitted studies in dairy cows and the new submitted trials, the FEEDAP Panel concluded that the additive has the potential to be efficacious for all ruminants at the proposed condition of use: 4.0 × 108 CFU/kg complete feed for dairy ruminants and 4.0 × 109 CFU/kg complete feed for ruminants for fattening and rearing.

Abstract 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.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as a nutritional feed additive for use in feed and in water for drinking for all animal species. The production strain is non‐genetically modified, qualifies for the QPS approach to safety assessment when used for production purposes, is susceptible to the relevant antibiotics and contains no antimicrobial resistance genes of concern. No viable cells of the production strain were detected in the final product. The additive does not give rise to any safety concern regarding the production strain. l‐Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered safe for the target species, the consumer and the environment. Regarding the use in water, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reiterates its concerns over the safety for the target species of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. In the absence of data, the FEEDAP Panel is not in a position to conclude on the potential of l‐isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the high dusting potential, exposure by inhalation is likely. l‐Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered as an efficacious source of the essential amino acid l‐isoleucine for non‐ruminant animal species. For the supplemental l‐isoleucine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

Abstract 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.

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

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat narasin (Monteban® G100) for chickens for fattening. In a previous opinion, uncertainties remained on the identification and characterisation of the non‐genetically modified production strain of the active substance narasin. The Panel could not conclude either on the safety of Monteban® G100 for chickens for fattening or on the efficacy of the additive at the minimum applied concentration. The FEEDAP Panel excluded risks for environment but the risk for sediment compartment could not be assessed. The applicant provided supplementary information to cover the data gaps and substituted the narasin production strain from Streptomyces spp. NRRL 8092 to Streptomyces spp. NRRL B‐67771. The information submitted to taxonomically identify the production strain did not allow to assign it to any described microbial species. Based on the information provided, the Panel concluded that the use of Monteban® G100 did not raise safety concerns as regards the production strain for the target animal, consumer, user and environment. The Panel concluded that 70 mg narasin/kg complete feed was safe for chickens for fattening with a margin of safety of 1.4; narasin from Monteban® G100 was unlikely to increase shedding of Salmonella Enteritidis, Salmonella Typhimurium and Campylobacter jejuni. Narasin, when used in chickens for fattening at 70 mg/kg feed, was not expected to pose a risk to the aquatic compartment and to sediment, while a risk for the terrestrial compartment could not be excluded. No risk for groundwater was expected, nor for secondary poisoning via the terrestrial food chain, but the risk of secondary poisoning via the aquatic food chain could not be excluded. The Panel concluded that 60 mg narasin/kg feed was efficacious in controlling coccidiosis in chickens for fattening.

Abstract 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 a feed additive consisting of carvacrol (Nimicoat®) as a zootechnical feed additive for weaned piglets at the recommended use level of 250 mg/kg complete feed. In a previous assessment, three efficacy trials and one tolerance–efficacy trial were assessed. Only one of the efficacy trials was considered to support the efficacy at the recommended use level. The applicant provided amendments to two previously submitted studies and a new trial. The amendments to the previously submitted studies did not change the conclusions from the previous assessment. The new efficacy study showed a significant improvement of the zootechnical parameters. Two studies showed positive and significant effects on the performance of the weaned piglets when the additive was administered at 250 mg/kg feed. Due to the lack of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive for the target species.

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 6‐phytase produced by the genetically modified strain Aspergillus oryzae DSM 33737 (HiPhorius™ 10, 40, 20L and 50L) as a zootechnical feed additive for all poultry, all Suidae and all fin fish. The FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry, all Suidae and all fin fish at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive is of no concern for the consumers and the environment. The liquid formulations of the additive are not skin or eye irritants. The two solid ones are not skin irritants but are eye irritants. Owing to the lack of data, the Panel cannot conclude on the skin sensitisation of the final formulations of the additive. Due to the proteinaceous nature of the active substance (6‐phytase), the additive is considered a respiratory sensitiser. The Panel concludes that the additive is efficacious when included in the diet of poultry for fattening or reared for laying/breeding, reproductive Suidae, and all fin fish. Due to the lack of sufficient data, the Panel could not conclude on the efficacy for laying and reproductive poultry and growing Suidae.

Abstract 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 sodium bisulphate (SBS) as a feed additive for all terrestrial animal species (category: technological additive; functional group: preservative), and for all terrestrial animal species other than cats, mink, pets and other non‐food‐producing animals (category: technological additive; functional group: acidity regulator). EFSA has also been asked to assess the new use of the product as an acidity regulator and flavouring compound in all pets and other non‐food‐producing animals except aquatic animals. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all terrestrial animal species, consumer and the environment under the authorised conditions of use. The FEEDAP Panel considers that the proposed new use would not introduce risks not already considered in the previous assessment and therefore the same conclusions on all terrestrial animal species, consumers of products from animals fed the additive and the environment would apply. Regarding user safety, the additive is irritant to the skin, eyes and the respiratory tract, and should be considered a skin and respiratory sensitiser. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation. The Panel considers that the additive has the potential to be efficacious as an acidity regulator and sensory additive (flavouring compound) in feed for pet and non‐food‐producing animals (except aquatic animals).

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a zootechnical feed additive (functional group: digestibility enhancers) for all Suidae at a recommended minimum level of 90,000 U/kg complete feed for pigs in the growing period and 45,000 U/kg complete feed for sows. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that the additive is safe at the minimum recommended use level for all growing Suidae and all sows in the lactating phase. Xygest™ HT was considered safe for the consumers and for the environment when used in feed for all Suidae. The additive was considered not to be irritant to eyes and skin, but was considered as a dermal and respiratory sensitiser. In the absence of sufficient data, the FEEDAP Panel was not in the position to conclude on the efficacy of Xygest™ HT for all Suidae.

Abstract 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 Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening, chickens reared for laying, other poultry species for fattening or reared for laying, and ornamental birds. The additive is available in two formulations: Lactiferm WS200 and Lactiferm Basic 50. The FEEDAP Panel concluded that the use of the additive is safe for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying, and ornamental birds. The Panel also concluded that the use of the feed additive is safe for consumers, and the environment. Lactiferm WS200 is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It was not possible, however, to conclude on the irritancy potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both formulations of the additive to cause skin sensitisation. The efficacy studies submitted did not allow to draw a conclusion on the efficacy of the additive for the target species. Lactiferm® is considered compatible with the coccidiostats monensin sodium and decoquinate.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Pediococcus pentosaceus DSM 23689 as a technological additive, silage additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers, and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation, and skin and eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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 Bacillus velezensis ATCC PTA‐6737 as a zootechnical additive (functional group: gut flora stabilisers) in regard to the renewal of the authorisation for weaned piglets, weaned minor porcine species, sows and minor reproductive Suidae species, and its extension of use for all Suidae. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. The Panel concluded that there is no new evidence that would lead it to reconsider the previous conclusions; the additive is safe for the target species, consumers and the environment under the authorised conditions of use. This conclusion also applies to the target species/categories for which a request for an extension of use is made. The Panel concluded that B. velezensis ATCC PTA‐6737 is not irritant to skin or eyes but should be considered a respiratory sensitiser due to its proteinaceous nature. No conclusions could be drawn on the skin sensitisation potential of the additive. The Panel concluded that the additive has the potential to be efficacious in all growing Suidae (suckling, weaned and fattening Suidae) at the minimum inclusion level of 1 × 107 CFU/kg of complete feed and in sows and minor reproductive Suidae species at 1 × 108 CFU/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of phenylcapsaicin (aXiphen®) as a zootechnical additive (functional group: physiological condition stabilisers) in feed for chickens for fattening. The additive under assessment, phenylcapsaicin, is safe for chickens for fattening up to the maximum proposed use level of 15 mg/kg complete feed. A margin of safety could not be established. Phenylcapsaicin is not genotoxic. The reference point for phenylcapsaicin derived from a 90‐day repeated dose oral toxicity study in rats is 37.2 mg/kg body weight (bw) per day, the lowest of the model averaged BMDL20 values for alanine aminotransferase increase in plasma. The metabolic similarity in the laboratory animals and the target species was not demonstrated and the identity of the marker residue could not be established. In the absence of such data, the safety for the consumers could not be evaluated. The inhalation exposure of phenylcapsaicin (as liquid) for the user was considered unlikely. The FEEDAP Panel considered the additive irritant to the eyes but not to the skin and it is not a dermal sensitiser. In the absence of appropriate data, the environmental risk assessment for phenylcapsaicin could not be performed. It is unlikely that phenylcapsaicin bioaccumulates in the environment and the risk of secondary poisoning is considered low. The FEEDAP Panel could not conclude on the efficacy of the additive in chickens for fattening at the proposed conditions of use.

Abstract 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.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of benzoic acid (Kalama®) as a zootechnical feed additive for weaned piglets at a level of 5000 mg/kg complete feed and for pigs for fattening at a minimum content of 5000 mg/kg and a maximum content of 10,000 mg/kg complete feed. The FEEDAP Panel concluded that benzoic acid is safe for weaned piglets at 5000 mg/kg complete feed and for pigs for fattening at 10,000 mg/kg complete feed. The Panel considered the use of benzoic acid under the proposed conditions of use to be of no concern for consumer safety and the environment. Benzoic acid poses a risk by inhalation, it is irritant to skin and corrosive to eyes, but no conclusions can be drawn on dermal sensitisation. The additive, benzoic acid, is efficacious as a zootechnical feed additive for weaned piglets and for pigs for fattening at the proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of natrolite–phonolite obtained from volcanic rock from Kaiserstuhl as a technological additive (functional group: anticaking) for all animal species. According to the conventional risk assessment, due to the lack of adequate data, the Panel is not in a position to conclude on the safety of the additive for the target species under the proposed conditions of use. However, from the tolerance studies in cattle for fattening and weaned piglets, effects observed in animal performance and blood clinical biochemistry suggest adverse effects on the animals supplemented with the additive. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and, therefore, of concern for the consumer. The FEEDAP Panel is not in the position to conclude on the potential of the additive to be a skin and eye irritant. The additive is considered a respiratory and dermal sensitiser. In the absence of suitable data, the presence of small/nanoparticles cannot be excluded. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles for the target species, the consumer and the user could not be assessed. Due to the lack of sufficient data, the Panel is not in a position to conclude on the efficacy of the additive.

Abstract 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.

Abstract 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 zinc chloride hydroxide monohydrate as a nutritional feed additive for all animal species (3b609). The applicant reported changes in the production process and requested a change in the specification of the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) confirms that the use of the additive under the current authorised conditions of use is safe for the target species and the consumers. The use of the additive in animal nutrition at the proposed use levels for the terrestrial species and land‐based aquaculture systems is considered safe for the environment. The FEEDAP Panel cannot conclude on the safety of the additive for marine sediment compartment, when it is used in sea cages. The additive is an eye irritant, but not irritant to the skin and not a skin sensitiser. The exposure through inhalation is likely, but in the absence of data, the Panel is not in a position to conclude on the risk of exposure by inhalation. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract 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.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Availa®Cr (active compound: chromium chelate of dl‐methionine) as a feed additive for dairy cows. In a previous opinion, the FEEDAP Panel concluded that Availa®Cr at a maximum recommended use level of 0.5 mg Cr(III) (8 mg Cr from Availa®Cr/cow per day) was safe for dairy cows and the consumers. Additionally, the FEEDAP Panel considered that the additives posed a risk to the user by inhalation, it was not irritant to skin and eyes, and it should be considered a skin sensitiser. The Panel could not conclude on the efficacy of the additive at the proposed conditions of use. Since the new information provided in the current application is lacking sufficient evidence, the FEEDAP Panel is still not in the position to conclude on the efficacy of chromium dl‐methionine from Availa®Cr.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zeolites (≥ 50%) obtained from Neapolitan Yellow Tufa as a technological additive (functional group: anticaking) for all animal species. The additive is specified to contain not less than 50% of zeolites, namely phillipsite, chabazite and analcime. Neapolitan Yellow Tufa originates from the volcanic activity of Campi Flegrei, Italy. According to the conventional risk assessment, due to a lack of adequate data, the safety of the additive for the target species cannot be established. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and, therefore, of concern for the consumer. The additive poses a risk by inhalation. It is not irritant to the skin. The Panel cannot conclude on the eye irritancy and on the dermal and respiratory sensitisation potential of the additive. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles for the target species, the consumer and the user could not be assessed. The additive is safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species at 20,000 mg/kg complete feed.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the mixture of Sepiolite and Kieselguhr (diatomaceous earth) (Anpro) as a technological feed additive for all terrestrial animal species. According to the conventional risk assessment, due to lack of adequate data, the safety of the additive Anpro for the target species cannot be established. Based on current knowledge, there is no indication of substantial absorption of the components of the additive and therefore no concern for the consumer. The additive poses a risk by inhalation. It is not irritant to the skin or eyes but should be considered as skin sensitiser. As no suitable data in line with the requirements of the Guidance on risk assessment of nanomaterials were provided by the applicant, the potential risks associated with the presence of nanoparticles could not be assessed for the target species, the consumer and the user. The additive is safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of the additive for all terrestrial animal species.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Weizmannia faecalis (formerly identified as Bacillus coagulans) DSM 32016 (TechnoSpore50®) as a zootechnical feed additive for poultry reared for breeding/laying/fattening, ornamental birds and suckling and weaned Suidae piglets. The additive is authorised for use in feed for poultry for fattening, ornamental birds and suckling and weaned Suidae piglets. This application sought the extension of use in feed for poultry reared for breeding/laying and the new authorisation in water for drinking for suckling and weaned Suidae piglets, poultry for fattening, reared for breeding/laying and ornamental birds. Moreover, the applicant requested the authorisation of simultaneous use in feed for poultry reared for breeding and laying with coccidiostats. The identity and the lack of toxigenic activity of the active agent was confirmed, and it did not show resistance to relevant antibiotics; therefore, the strain was presumed safe for the target species, consumers and the environment. Since other components did not introduce concerns, TechnoSpore50® was also considered safe for the target species, consumers and the environment. The additive is not a skin/eye irritant but is a respiratory sensitiser. No conclusions could be drawn on the skin sensitisation potential of the additive. TechnoSpore50® was considered to be efficacious in feed for poultry reared for laying/breeding at 1 × 109 CFU/kg and in water for drinking for poultry reared for fattening, poultry reared for laying/breeding, ornamental birds and for suckling and weaned Suidae piglets at 5 × 108 CFU/L. TechnoSpore50® is compatible with halofuginone, diclazuril, monensin sodium, robenidine hydrochloride, salinomycin sodium and monensin sodium + nicarbazin, but not with narasin or narasin + nicarbazin. No conclusions could be drawn on the compatibility of TechnoSpore50® with decoquinate, lasalocid A sodium, semduramicin sodium, nicarbazin or amprolium hydrochloride.