Search

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 FROM AUTHOR]

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 Cylactin® as a zootechnical feed additive for cats and dogs. The active agent of the additive is Enterococcus lactis NCIMB 10415 and the micro‐encapsulated formulation, Cylactin® LBC ME5 PET, was assessed. 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 cats and dogs. Regarding user safety, the additive was not shown to be skin and eye irritant, but it should be considered a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

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.

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 FROM AUTHOR]

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 FROM AUTHOR]

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 Cylactin® as a zootechnical feed additive for cats and dogs. The active agent of the additive is Enterococcus lactis NCIMB 10415 and the micro‐encapsulated formulation, Cylactin® LBC ME5 PET, was assessed. 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 cats and dogs. Regarding user safety, the additive was not shown to be skin and eye irritant, but it should be considered a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation. 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, 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 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.

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 the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I‐3740 (tradename: Biacton®) for chickens for fattening, turkeys for fattening and laying hens. The additive is a preparation containing viable cells of C. farciminis CNCM I‐3740 at the minimum concentration of 1 × 109 CFU/g additive. It is intended to be used as a zootechnical additive in feed for chickens for fattening, turkeys for fattening and laying hens at the recommended application level of 5 × 108 CFU/kg complete feed. In the context of previous opinions, no conclusions could be drawn on the efficacy of the additive in any of the target species based on the data provided. As regards chickens for fattening, in the former opinions the supplementation of the additive at the recommended level showed a significantly greater weight or weight gain compared to birds in the control group only in two studies. New statistical analysis data of one efficacy trial were submitted. The results showed that Biacton® supplemented at 8.5 × 108 CFU/kg feed or at higher levels significantly improved the feed to gain ratio of chickens for fattening compared to control birds or to birds receiving the additive at the recommended level. Therefore, the Panel concluded that Biacton® has the potential to be efficacious in chickens for fattening at the concentration of 8.5 × 108 CFU/kg complete feed. This conclusion was extrapolated to turkeys for fattening. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. The product, manufactured in three formulations (microsphere, micropellet and powder), is intended for use in complete feed at a minimum inclusion level of 3 × 109 CFU/kg complete feed for horses, 4 × 108 CFU/kg complete feed for dairy cows and minor dairy species, 4 × 109 CFU/kg complete feed for calves, cattle for fattening, minor growing and fattening ruminants, piglets and pigs for fattening and minor porcine species and 6 × 109 CFU/kg complete feed for sows and minor porcine species for reproduction. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was conclusively established and, therefore, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive, in any formulation, is not irritant to the eyes and skin but should be considered a respiratory sensitiser. The Panel cannot conclude on the skin sensitisation potential of the additive. The Panel 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 the additive for calves, and neither for cattle for fattening, minor growing and fattening ruminants. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed for weaned piglets to improve their performance. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 viable‐forming units (VFU)/g additive. However, in that opinion, the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address the missing information for the characterisation of the additive. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. Sorbiflore® ADVANCE is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of four bacteriophages infecting Salmonella enterica ser. Gallinarum B/00111, intended to be used as a zootechnical additive (functional group: other zootechnical additives) for all avian species. The additive (tradename Bafasal®) is not currently authorised in the European Union. Bafasal® is intended to be used in water for drinking and liquid complementary feed to guarantee a minimum daily dose of 2 × 106 PFU/bird, to reduce the Salmonella spp. contamination of poultry carcasses and load in the environment, and to improve the zootechnical performance of the treated animals. In a previous opinion, the FEEDAP Panel could not conclude on the additive's potential to be irritant or a dermal sensitiser, or on its efficacy for any avian species due to insufficient data. The applicant provided supplementary information to address these data gaps. The new data showed that Bafasal® is not a skin or eye irritant. No conclusions could be drawn on its skin sensitisation potential. The Panel was not in the position to conclude on the efficacy of Bafasal® to improve the zootechnical performance of the target species based on the available data. The additive showed the potential to decrease the counts of two strains of Salmonella Enteritidis in boots swabs and caecal digesta of chickens for fattening. No conclusions could be drawn on the capacity of Bafasal® to reduce the contamination of other Salmonella enterica strains, serovars or other species of Salmonella. The potential of Bafasal® to reduce the Salmonella spp. contamination poultry carcasses and/or the environment is limited. The FEEDAP Panel recommended a post‐market monitoring plan to address the potential selection and spread of resistant variants of Salmonella to Bafasal®. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp.CNCM I‐3699 intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed for chickens for fattening to improve their performance. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 viable forming units (VFU)/g additive. However, in that opinion, the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address the missing information for the characterisation of the additive. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. Sorbiflore® ADVANCE is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential of the additive. [ABSTRACT FROM AUTHOR]

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 authorisation of ammonium chloride (Amoklor™) as a zootechnical additive for all ruminants, dogs and cats and its extension of use in sows for urinary health. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for ruminants other than lambs for fattening, lambs for fattening, cats and dogs, consumers and the environment under the current authorised conditions of use. Inhalation exposure of the additive is considered very likely. Amoklor™ should be considered a potential respiratory sensitiser but not a skin sensitiser. The additive is not irritant to the skin, but the Panel could not conclude on its eye irritation potential. The present application for renewal of the authorisation does 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. Regarding the extension of use in sows, the FEEDAP Panel concludes that the additive is safe and efficacious for sows at the inclusion level of 5,000 mg/kg feedingstuffs from week 9th to 11th of gestation and from week 15th of gestation to 1st of lactation. [ABSTRACT FROM AUTHOR]

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 the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I‐3740 (tradename: Biacton®) for chickens for fattening, turkeys for fattening and laying hens. The additive is a preparation containing viable cells of C. farciminis CNCM I‐3740 at the minimum concentration of 1 × 109 CFU/g additive. It is intended to be used as a zootechnical additive in feed for chickens for fattening, turkeys for fattening and laying hens at the recommended application level of 5 × 108 CFU/kg complete feed. In the context of previous opinions, no conclusions could be drawn on the efficacy of the additive in any of the target species based on the data provided. As regards chickens for fattening, in the former opinions the supplementation of the additive at the recommended level showed a significantly greater weight or weight gain compared to birds in the control group only in two studies. New statistical analysis data of one efficacy trial were submitted. The results showed that Biacton® supplemented at 8.5 × 108 CFU/kg feed or at higher levels significantly improved the feed to gain ratio of chickens for fattening compared to control birds or to birds receiving the additive at the recommended level. Therefore, the Panel concluded that Biacton® has the potential to be efficacious in chickens for fattening at the concentration of 8.5 × 108 CFU/kg complete feed. This conclusion was extrapolated to turkeys for fattening.

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. The product, manufactured in three formulations (microsphere, micropellet and powder), is intended for use in complete feed at a minimum inclusion level of 3 × 109 CFU/kg complete feed for horses, 4 × 108 CFU/kg complete feed for dairy cows and minor dairy species, 4 × 109 CFU/kg complete feed for calves, cattle for fattening, minor growing and fattening ruminants, piglets and pigs for fattening and minor porcine species and 6 × 109 CFU/kg complete feed for sows and minor porcine species for reproduction. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was conclusively established and, therefore, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive, in any formulation, is not irritant to the eyes and skin but should be considered a respiratory sensitiser. The Panel cannot conclude on the skin sensitisation potential of the additive. The Panel 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 the additive for calves, and neither for cattle for fattening, minor growing and fattening ruminants.

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 safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp. CNCM I‐3699 intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed for weaned piglets to improve their performance. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 viable‐forming units (VFU)/g additive. However, in that opinion, the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address the missing information for the characterisation of the additive. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. Sorbiflore® ADVANCE is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential 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 a product consisting of four bacteriophages infecting Salmonella enterica ser. Gallinarum B/00111, intended to be used as a zootechnical additive (functional group: other zootechnical additives) for all avian species. The additive (tradename Bafasal®) is not currently authorised in the European Union. Bafasal® is intended to be used in water for drinking and liquid complementary feed to guarantee a minimum daily dose of 2 × 106 PFU/bird, to reduce the Salmonella spp. contamination of poultry carcasses and load in the environment, and to improve the zootechnical performance of the treated animals. In a previous opinion, the FEEDAP Panel could not conclude on the additive's potential to be irritant or a dermal sensitiser, or on its efficacy for any avian species due to insufficient data. The applicant provided supplementary information to address these data gaps. The new data showed that Bafasal® is not a skin or eye irritant. No conclusions could be drawn on its skin sensitisation potential. The Panel was not in the position to conclude on the efficacy of Bafasal® to improve the zootechnical performance of the target species based on the available data. The additive showed the potential to decrease the counts of two strains of Salmonella Enteritidis in boots swabs and caecal digesta of chickens for fattening. No conclusions could be drawn on the capacity of Bafasal® to reduce the contamination of other Salmonella enterica strains, serovars or other species of Salmonella. The potential of Bafasal® to reduce the Salmonella spp. contamination poultry carcasses and/or the environment is limited. The FEEDAP Panel recommended a post‐market monitoring plan to address the potential selection and spread of resistant variants of Salmonella to Bafasal®.

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 safety and efficacy of Sorbiflore® ADVANCE, a feed additive consisting of Lacticaseibacillus rhamnosus CNCM I‐3698 and Companilactobacillus sp.CNCM I‐3699 intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed for chickens for fattening to improve their performance. In a previous opinion, the additive was described as containing viable but not cultivable cells of the two strains in a 1:1 ratio, with a minimum of total lactic acid bacteria counts of 5 × 108 viable forming units (VFU)/g additive. However, in that opinion, the Panel could not fully characterise the additive or conclude on its dermal/ocular irritancy or sensitisation potential. In the current assessment, the applicant provided supplementary information to address the missing information for the characterisation of the additive. The proposed methodology to discriminate and individually quantify the two strains composing the additive still presented limitations. Therefore, the Panel concluded that the data available do not allow to fully characterise the additive. The Panel was not in the position to conclude on the taxonomical identification of the strain CNCM I‐3699, and consequently, on its eligibility for the application of the qualified presumption of safety (QPS) approach. Therefore, the previous conclusions on the safety of the additive based on the QPS approach could not be confirmed. The Panel was not in the position to conclude on the safety of the additive for the target species, consumer and the environment. Sorbiflore® ADVANCE is not irritant to skin. The Panel could not conclude on the eye irritancy or skin sensitisation potential 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 authorisation of ammonium chloride (Amoklor™) as a zootechnical additive for all ruminants, dogs and cats and its extension of use in sows for urinary health. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for ruminants other than lambs for fattening, lambs for fattening, cats and dogs, consumers and the environment under the current authorised conditions of use. Inhalation exposure of the additive is considered very likely. Amoklor™ should be considered a potential respiratory sensitiser but not a skin sensitiser. The additive is not irritant to the skin, but the Panel could not conclude on its eye irritation potential. The present application for renewal of the authorisation does 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. Regarding the extension of use in sows, the FEEDAP Panel concludes that the additive is safe and efficacious for sows at the inclusion level of 5,000 mg/kg feedingstuffs from week 9th to 11th of gestation and from week 15th of gestation to 1st of lactation. The use of the additive in sows is regarded as safe for the consumers and the environment.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an aqueous extract of Citrus limon (L.) Osbeck (Citrozest®) when used as a zootechnical additive in feed for weaned piglets and all growing poultry species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is safe for the target species up to the maximum proposed use level of 1,000 mg/kg complete feed. No concerns for consumers were identified following the use of additive up to the highest safe level in feed. The additive should be considered a skin and eye irritant, and a potential corrosive. The use of Citrozest® as a feed additive is considered safe for the environment. In the absence of adequate data, the FEEDAP Panel could not conclude on the efficacy of Citrozest® as a zootechnical additive for weaned piglets and all growing poultry species under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an aqueous extract of Citrus limon (L.) Osbeck (Citrozest®) when used as a zootechnical additive in feed for weaned piglets and all growing poultry species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is safe for the target species up to the maximum proposed use level of 1,000 mg/kg complete feed. No concerns for consumers were identified following the use of additive up to the highest safe level in feed. The additive should be considered a skin and eye irritant, and a potential corrosive. The use of Citrozest® as a feed additive is considered safe for the environment. In the absence of adequate data, the FEEDAP Panel could not conclude on the efficacy of Citrozest® as a zootechnical additive for weaned piglets and all growing poultry species under the proposed conditions of use.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of carvacrol, thymol, d‐carvone, methyl salicylate and l‐menthol (Biomin® DC‐P) for all poultry species. The additive is authorised for use in feed for chickens for fattening, chickens reared for laying and minor poultry species reared to the point of lay. The safety and efficacy of the additive for those species have been previously evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive for all poultry species under the same conditions of use (recommended level ranging between 65 and 105 mg/kg complete feed). The FEEDAP Panel concluded that the additive Biomin® DC‐P is safe for poultry species for fattening or reared for laying, but in the absence of adequate data cannot conclude on the safety for laying/breeding birds. The use of Biomin® DC‐P in feed for all poultry species under the proposed conditions of use was considered safe for consumers and the environment. The FEEDAP Panel considered that exposure of users by inhalation is unlikely. In the absence of data, the Panel could not conclude on the effects of Biomin® DC‐P on skin and eyes. Biomin® DC‐P has the potential to be efficacious in poultry species for fattening or reared for laying when incorporated into feed at a minimum concentration of 65 mg/kg complete feed. In the absence of sufficient data, the Panel could not conclude on the efficacy for laying hens or for other poultry species for laying/breeding. [ABSTRACT FROM AUTHOR]

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 carvacrol, thymol, d‐carvone, methyl salicylate and l‐menthol (Biomin® DC‐P) for all poultry species. The additive is authorised for use in feed for chickens for fattening, chickens reared for laying and minor poultry species reared to the point of lay. The safety and efficacy of the additive for those species have been previously evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive for all poultry species under the same conditions of use (recommended level ranging between 65 and 105 mg/kg complete feed). The FEEDAP Panel concluded that the additive Biomin® DC‐P is safe for poultry species for fattening or reared for laying, but in the absence of adequate data cannot conclude on the safety for laying/breeding birds. The use of Biomin® DC‐P in feed for all poultry species under the proposed conditions of use was considered safe for consumers and the environment. The FEEDAP Panel considered that exposure of users by inhalation is unlikely. In the absence of data, the Panel could not conclude on the effects of Biomin® DC‐P on skin and eyes. Biomin® DC‐P has the potential to be efficacious in poultry species for fattening or reared for laying when incorporated into feed at a minimum concentration of 65 mg/kg complete feed. In the absence of sufficient data, the Panel could not conclude on the efficacy for laying hens or for other poultry species for laying/breeding.

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 assessment of the application for renewal of authorisation of the feed additive consisting of ammonium chloride (tradename: Ammonium chloride AF) as a zootechnical additive for ruminants, cats and dogs. In 2012, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive and subsequently the additive was authorised in the EU. The additive is authorised as 'ammonium chloride with a content of ammonium chloride ≥ 99% and sodium chloride ≤ 0.5% in the active substance' for ruminants, cats and dogs under the category 'zootechnical additives' and functional group 'other zootechnical additives'. The evidence provided by the applicant indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsider its previous conclusions on the safety for target species, consumers and environment. The FEEDAP Panel concludes that ammonium chloride is considered an eye and skin irritant and a potential respiratory sensitiser, but is not a dermal sensitiser. The present application for renewal of the authorisation does 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. [ABSTRACT FROM AUTHOR]

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 assessment of the application for renewal of authorisation of the feed additive consisting of ammonium chloride (tradename: Ammonium chloride AF) as a zootechnical additive for ruminants, cats and dogs. In 2012, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive and subsequently the additive was authorised in the EU. The additive is authorised as ‘ammonium chloride with a content of ammonium chloride ≥ 99% and sodium chloride ≤ 0.5% in the active substance’ for ruminants, cats and dogs under the category ‘zootechnical additives’ and functional group ‘other zootechnical additives’. The evidence provided by the applicant indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsider its previous conclusions on the safety for target species, consumers and environment. The FEEDAP Panel concludes that ammonium chloride is considered an eye and skin irritant and a potential respiratory sensitiser, but is not a dermal sensitiser. The present application for renewal of the authorisation does 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.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lanthanum carbonate octahydrate (Lanthan One) as a zootechnical feed additive for cats. The FEEDAP Panel concluded that lanthanum carbonate octahydrate is safe for cats at the maximum proposed use level of 7,500 mg/kg complete feed. The additive is not irritant to skin or eyes, is not a skin sensitiser and exposure of users by inhalation is considered unlikely. The Panel also concluded that the additive is efficacious as a phosphate binder in adult cats at the minimum proposed conditions of use (1,500 mg/kg complete feedingstuffs). [ABSTRACT FROM AUTHOR]

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 (Lanthan One) as a zootechnical feed additive for cats. The FEEDAP Panel concluded that lanthanum carbonate octahydrate is safe for cats at the maximum proposed use level of 7,500 mg/kg complete feed. The additive is not irritant to skin or eyes, is not a skin sensitiser and exposure of users by inhalation is considered unlikely. The Panel also concluded that the additive is efficacious as a phosphate binder in adult cats at the minimum proposed conditions of use (1,500 mg/kg complete feedingstuffs).

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 the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I‐3740 (tradename: Biacton®) for chickens for fattening, turkeys for fattening and laying hens. The additive is a preparation containing viable cells of C. farciminis CNCM I‐3740 at the minimum concentration of 1 × 109 CFU/g additive. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in these target species. The Panel concluded that based on the qualified presumption of safety of the active agent, and the lack of concerns deriving from other components of the additive, Biacton® was presumed safe for the target animals, consumers and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive did not allow drawing conclusions on the efficacy of the additive in any of the target species. The additional information submitted with chickens for fattening and laying hens did not provide sufficient evidence to conclude on the efficacy of Biacton® for these target species. No new information was provided that would lead the Panel to reconsider the conclusions already reached on the use of the additive with turkeys for fattening. The FEEDAP Panel, based on the available data, cannot conclude on the efficacy of Biacton® in chickens for fattening, turkeys for fattening and laying hens.

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 assessment of the application for renewal of authorisation of the feed additive consisting of dimethylglycine sodium salt (trade name: Taminizer D) as a zootechnical additive for chickens for fattening. In 2011, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive, and subsequently, the additive was authorised in the EU. In 2018, a second scientific assessment was made based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is authorised as ‘dimethylglycine sodium salt with a purity of at least 97%’ for chickens for fattening under the category ‘zootechnical additives’ and functional group ‘other zootechnical additives (improvement of zootechnical parameters)’. The evidence provided by the applicant indicated that the additive currently in the market, produced by the two manufacturing routes, complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. The FEEDAP Panel concludes that Taminizer D is not a skin irritant but may be an eye irritant and a skin sensitiser; although uncertainty remains on the presence of formaldehyde, exposure is considered extremely low. There is no need to assess 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 chromium propionate (KemTRACE™ Chromium; KemTRACE‐Cr) as zootechnical feed additive for all growing poultry species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. Based on two tolerance studies submitted, the Panel concluded that the additive is safe for chickens for fattening at the maximum recommended supplementation level of 0.4 mg Cr/kg feed from KemTRACE‐Cr, but a margin of safety cannot be established; this conclusion can be extended to chickens reared for laying/breeding, but cannot be extrapolated to other growing poultry species. The FEEDAP Panel considered that the use of KemTRACE‐Cr in animal nutrition at the proposed conditions of use is safe for the consumer. No concerns for users following any inhalation exposure during the handling of the additive are expected; the additive was shown to be corrosive to the eyes but not irritant to skin or a skin sensitiser. The use of KemTRACE‐Cr in animal nutrition according to the proposed conditions of use will not significantly alter the concentration in the receiving environmental compartments of concern; therefore, no safety concern is expected for the environment. Based on three efficacy studies, the FEEDAP Panel concluded that KemTRACE‐Cr has the potential to be efficacious as a zootechnical additive in chickens for fattening at the supplementation level of 0.4 mg Cr/kg feed; this conclusion could be extended to chickens reared for laying and chickens reared for breeding, and extrapolated to other poultry species for fattening and reared for laying/breeding.

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 the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I‐3740 (tradename: Biacton®) for chickens for fattening, turkeys for fattening and laying hens. The additive is a preparation containing viable cells of C. farciminisCNCM I‐3740 at the minimum concentration of 1 × 109CFU/g additive. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in these target species. The Panel concluded that based on the qualified presumption of safety of the active agent, and the lack of concerns deriving from other components of the additive, Biacton® was presumed safe for the target animals, consumers and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive did not allow drawing conclusions on the efficacy of the additive in any of the target species. The additional information submitted with chickens for fattening and laying hens did not provide sufficient evidence to conclude on the efficacy of Biacton® for these target species. No new information was provided that would lead the Panel to reconsider the conclusions already reached on the use of the additive with turkeys for fattening. The FEEDAP Panel, based on the available data, cannot conclude on the efficacy of Biacton® in chickens for fattening, turkeys for fattening and laying hens. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the feed additive consisting of dimethylglycine sodium salt (trade name: Taminizer D) as a zootechnical additive for chickens for fattening. In 2011, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive, and subsequently, the additive was authorised in the EU. In 2018, a second scientific assessment was made based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is authorised as 'dimethylglycine sodium salt with a purity of at least 97%' for chickens for fattening under the category 'zootechnical additives' and functional group 'other zootechnical additives (improvement of zootechnical parameters)'. The evidence provided by the applicant indicated that the additive currently in the market, produced by the two manufacturing routes, complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. The FEEDAP Panel concludes that Taminizer D is not a skin irritant but may be an eye irritant and a skin sensitiser; although uncertainty remains on the presence of formaldehyde, exposure is considered extremely low. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of chromium propionate (KemTRACE™ Chromium; KemTRACE‐Cr) as zootechnical feed additive for all growing poultry species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. Based on two tolerance studies submitted, the Panel concluded that the additive is safe for chickens for fattening at the maximum recommended supplementation level of 0.4 mg Cr/kg feed from KemTRACE‐Cr, but a margin of safety cannot be established; this conclusion can be extended to chickens reared for laying/breeding, but cannot be extrapolated to other growing poultry species. The FEEDAP Panel considered that the use of KemTRACE‐Cr in animal nutrition at the proposed conditions of use is safe for the consumer. No concerns for users following any inhalation exposure during the handling of the additive are expected; the additive was shown to be corrosive to the eyes but not irritant to skin or a skin sensitiser. The use of KemTRACE‐Cr in animal nutrition according to the proposed conditions of use will not significantly alter the concentration in the receiving environmental compartments of concern; therefore, no safety concern is expected for the environment. Based on three efficacy studies, the FEEDAP Panel concluded that KemTRACE‐Cr has the potential to be efficacious as a zootechnical additive in chickens for fattening at the supplementation level of 0.4 mg Cr/kg feed; this conclusion could be extended to chickens reared for laying and chickens reared for breeding, and extrapolated to other poultry species for fattening and reared for laying/breeding. [ABSTRACT FROM AUTHOR]

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 Biacton® when used as a feed additive for weaned piglets. Biacton® is a preparation of viable cells of Lactobacillus farciminis CNCM I‐3740 intended to be incorporated into feed for weaned piglets at a minimum recommended application level of 1 × 109 CFU/kg complete feed. L. farciminis is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. Biacton® is not irritant to skin, eyes or to the respiratory tract, but should be considered a prespiratory sensitiser. In the absence of data, no conclusions could be drawn on the potential skin sensitisation potential of the additive. No conclusion can be drawn on the efficacy of Biacton® for weaned piglets based on the data available.

Abstract Panavital feed is a preparation of d‐glyceric acid intended to be used as a zootechnical additive in chickens for fattening. The active substance (d‐glyceric acid) of the additive ■■■■■ by fermentation with Gluconobacter frateurii. The additive is intended to be used in chickens for fattening at a concentration from ■■■■■. The FEEDAP Panel notes that the data provided for the characterisation of the active substance are incomplete and that data on the characterisation of the formulated additive are not provided. Based on the information available, the FEEDAP Panel cannot assess the qualitative and quantitative composition of Panavital feed. Due to lack of data, the safety of the production strain claimed to be used to produce the active substance cannot be evaluated. Based on the data provided by the applicant, the FEEDAP Panel cannot conclude on the safety of Panavital feed for the target species, the consumer, the user and the environment and on the efficacy of Panavital feed when used as feed additive.

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 Biacton® when used as a feed additive for chickens for fattening, turkeys for fattening and laying hens. Biacton® is a preparation of viable cells of Lactobacillus farciminis CNCM I‐3740 intended for use in feed for chickens for fattening, turkeys for fattening and laying hens at a minimum recommended application level of 5 × 108 CFU/kg complete feedingstuffs. L. farciminis is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment, and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In the absence of data, no conclusions can be drawn on the irritancy of Biacton® to skin and eyes or on its dermal sensitisation potential. The additive should be considered a respiratory sensitiser. Due to poor reporting and significant limitations in the data available, the FEEDAP Panel cannot conclude on the efficacy of the additive for chickens for fattening, turkeys for fattening and laying hens.

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 safety and efficacy Nimicoat® (carvacrol), as a zootechnical additive for weaned piglets. The additive is composed by carvacrol (≥ 40 %) as an active substance encapsulated with high‐melting lipids. Nimicoat® is intended to be used in feed for weaned piglets at a minimum recommended dose of 250 mg/kg complete feed and at a maximum recommended dose of 1,000 mg/kg complete feed corresponding to a minimum and maximum of 100 and 400 mg carvacrol/kg complete feed, respectively. Based on a tolerance study, the FEEDAP Panel concluded that the use of Nimicoat® in feed for weaned piglet at the maximum recommended dose of 1,000 mg/kg feed is safe for the target animal; however, a precise figure for the margin of safety cannot be defined. Nimicoat® used in feed for weaned piglets at the maximum recommended concentration does not pose a safety concern for consumers. The additive is corrosive to eyes, skin and the respiratory mucosae. Concerning safety for the environment a Phase II was required; taking into consideration the data provided, the FEEDAP Panel concluded that the additive does not pose any risk to the terrestrial and aquatic compartments and that bioaccumulation potential for carvacrol is low and risk for secondary poisoning for worm/fish eating birds and mammals is not likely to occur. Only one study positively supporting efficacy of the additive was available; therefore, the FEEDAP Panel is not in a position to conclude on the efficacy of Nimicoat®.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Availa®Cr (active compound: chromium chelate of DL‐methionine) as a feed additive for dairy cows. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. The tolerance study did not show adverse effects with respect to body weight, milk yield, haematology and blood biochemistry up to the 10‐fold overdose of chromium from Availa®Cr; however, owing to deficiencies in design and reporting of the study, it provided only supportive evidence on the safety of the additive. A safe level for dairy cows could be derived from a toxicological study with laboratory rodents. Taking all together, the FEEDAP Panel considers the maximum recommended use level (8 mg Cr from Availa®Cr/cow per day; about 0.4 mg Cr/kg complete feed) as safe. Chromium DL‐Met shows a genotoxic activity in vitro that is not expressed in vivo after systemic exposure; although no data on genotoxicity at the site of contact are available, the Panel notes that chromium(III) is not carcinogenic and concludes that chromium DL‐Met is unlikely to pose a carcinogenic risk at levels occurring in the diet. The use of Availa®Cr in feed of dairy cows up to the recommended supplementation level would not measurably increase consumer exposure to chromium(III), and therefore is safe for consumers. The additive poses a risk to users by inhalation, it is not an irritant to skin and eyes and should be considered a sensitiser. The use of the additive is not expected to pose a risk to the environment. Since only one study could be considered for the efficacy assessment, and three studies are required, the FEEDAP Panel cannot conclude on the efficacy of Availa®Cr for dairy cows.

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 Biacton® when used as a feed additive for weaned piglets. Biacton® is a preparation of viable cells of Lactobacillus farciminis CNCM I‐3740 intended to be incorporated into feed for weaned piglets at a minimum recommended application level of 1 × 109 CFU/kg complete feed. L. farciminis is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. Biacton® is not irritant to skin, eyes or to the respiratory tract, but should be considered a prespiratory sensitiser. In the absence of data, no conclusions could be drawn on the potential skin sensitisation potential of the additive. No conclusion can be drawn on the efficacy of Biacton® for weaned piglets based on the data available. [ABSTRACT FROM AUTHOR]

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 Biacton® when used as a feed additive for chickens for fattening, turkeys for fattening and laying hens. Biacton® is a preparation of viable cells of Lactobacillus farciminis CNCM I‐3740 intended for use in feed for chickens for fattening, turkeys for fattening and laying hens at a minimum recommended application level of 5 × 108CFU/kg complete feedingstuffs. L. farciminis is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment, and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In the absence of data, no conclusions can be drawn on the irritancy of Biacton® to skin and eyes or on its dermal sensitisation potential. The additive should be considered a respiratory sensitiser. Due to poor reporting and significant limitations in the data available, the FEEDAP Panel cannot conclude on the efficacy of the additive for chickens for fattening, turkeys for fattening and laying hens. [ABSTRACT FROM AUTHOR]

Panavital feed is a preparation of d‐glyceric acid intended to be used as a zootechnical additive in chickens for fattening. The active substance (d‐glyceric acid) of the additive ■■■■■ by fermentation with Gluconobacter frateurii. The additive is intended to be used in chickens for fattening at a concentration from ■■■■■. The FEEDAP Panel notes that the data provided for the characterisation of the active substance are incomplete and that data on the characterisation of the formulated additive are not provided. Based on the information available, the FEEDAP Panel cannot assess the qualitative and quantitative composition of Panavital feed. Due to lack of data, the safety of the production strain claimed to be used to produce the active substance cannot be evaluated. Based on the data provided by the applicant, the FEEDAP Panel cannot conclude on the safety of Panavital feed for the target species, the consumer, the user and the environment and on the efficacy of Panavital feed when used as feed additive. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy Nimicoat® (carvacrol), as a zootechnical additive for weaned piglets. The additive is composed by carvacrol (≥ 40 %) as an active substance encapsulated with high‐melting lipids. Nimicoat® is intended to be used in feed for weaned piglets at a minimum recommended dose of 250 mg/kg complete feed and at a maximum recommended dose of 1,000 mg/kg complete feed corresponding to a minimum and maximum of 100 and 400 mg carvacrol/kg complete feed, respectively. Based on a tolerance study, the FEEDAP Panel concluded that the use of Nimicoat® in feed for weaned piglet at the maximum recommended dose of 1,000 mg/kg feed is safe for the target animal; however, a precise figure for the margin of safety cannot be defined. Nimicoat® used in feed for weaned piglets at the maximum recommended concentration does not pose a safety concern for consumers. The additive is corrosive to eyes, skin and the respiratory mucosae. Concerning safety for the environment a Phase II was required; taking into consideration the data provided, the FEEDAP Panel concluded that the additive does not pose any risk to the terrestrial and aquatic compartments and that bioaccumulation potential for carvacrol is low and risk for secondary poisoning for worm/fish eating birds and mammals is not likely to occur. Only one study positively supporting efficacy of the additive was available; therefore, the FEEDAP Panel is not in a position to conclude on the efficacy of Nimicoat®. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Availa®Cr (active compound: chromium chelate of DL-methionine) as a feed additive for dairy cows. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. The tolerance study did not show adverse effects with respect to body weight, milk yield, haematology and blood biochemistry up to the 10-fold overdose of chromium from Availa®Cr; however, owing to deficiencies in design and reporting of the study, it provided only supportive evidence on the safety of the additive. A safe level for dairy cows could be derived from a toxicological study with laboratory rodents. Taking all together, the FEEDAP Panel considers the maximum recommended use level (8 mg Cr from Availa®Cr/cow per day; about 0.4 mg Cr/kg complete feed) as safe. Chromium DL-Met shows a genotoxic activity in vitro that is not expressed in vivo after systemic exposure; although no data on genotoxicity at the site of contact are available, the Panel notes that chromium(III) is not carcinogenic and concludes that chromium DL-Met is unlikely to pose a carcinogenic risk at levels occurring in the diet. The use of Availa®Cr in feed of dairy cows up to the recommended supplementation level would not measurably increase consumer exposure to chromium(III), and therefore is safe for consumers. The additive poses a risk to users by inhalation, it is not an irritant to skin and eyes and should be considered a sensitiser. The use of the additive is not expected to pose a risk to the environment. Since only one study could be considered for the efficacy assessment, and three studies are required, the FEEDAP Panel cannot conclude on the efficacy of Availa®Cr for dairy cows. [ABSTRACT FROM AUTHOR]

Abstract The additive (trade name Biomin®DC‐P) is a blend of five individual compounds (carvacrol, thymol, d‐carvone, methyl salicylate and l‐menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for various poultry species at a minimum concentration of 65 mg/kg complete feed and a recommended maximum level of 105 mg/kg complete feed. The results of a tolerance study show that Biomin® DC‐P is safe for chickens for fattening at the maximum recommended application rate of 105 mg/kg complete feed; this conclusion is extended to include chickens reared for laying and extrapolated to minor poultry species The active components of a previously evaluated additive (Biomin®DC‐C) were shown to be not genotoxic; owing to the similarity on composition, this conclusion can be also applied to Biomin®DC‐P. Notwithstanding the uncertainties identified in the residue study, after applying a worst‐case scenario to calculate potential exposure of consumers to menthol and carvone, and since that the components of the additive are considered safe for their use as food and feed flavourings, the FEEDAP Panel concludes that the use of the additive in animal nutrition is considered safe for consumers. The FEEDAP Panel considered that exposure of users by inhalation is unlikely, but cannot conclude on the effects of Biomin®DC‐P on skin and eyes. The use of Biomin®DC‐P is not expected to pose a risk for the environment. Biomin®DC‐P has a potential to increase the growth performance of chickens for fattening when incorporated into feed at a minimum application rate of 65 mg/kg complete feed; the conclusion can be extended to chickens reared for laying and extrapolated to minor poultry species reared up to the point of lay.

Abstract 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 VevoVitall® (benzoic acid) as a zootechnical feed additive for pigs for fattening. The additive is currently authorised for pigs for fattening with the effect of ‘urinary pH decrease’ at the minimum and maximum use of 5,000 and 10,000 mg/kg complete feed, respectively. The current application intends to support the use of the additive with the specific effect of ‘improvement of performance parameters’ at the minimum dose of 3,000 mg additive/kg complete feed, and keeping the same other conditions as for the use already authorised. The FEEDAP Panel assessed already the safety of the product when used in pigs for fattening in 2007 and 2017. The Panel confirms its former assessments that VevoVitall® used as a feed additive in pigs for fattening at the maximum level of 10,000 mg/kg is considered as safe for pigs for fattening, consumers of food derived from pigs fed the additive and the environment. VevoVitall® does not pose a risk by inhalation to users and is not a skin sensitiser but is a skin irritant and a severe eye irritant. Based on the results of three efficacy studies, the FEEDAP Panel concluded that VevoVitall® has the potential to increase the performance in pigs for fattening at the level of 3,000 mg/kg complete feed.

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 safety and efficacy of muramidase produced by Trichoderma reesei DSM 32338. The additive is considered safe for turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding up to the maximum recommended dose of 45,000 LSU(F)/kg feed. The additive is considered safe for the consumer and the environment. No conclusions can be reached on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive should be considered a potential respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive in turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding when added to feed at 25,000 LSU(F)/kg feed.

Abstract Bactocell® is the trade name for a feed additive based on viable cells of a strain of Pediococcus acidilactici. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on Bactocell® in the context of the renewal of the authorisation for shrimps, salmonids and fish other than salmonids. In addition, the applicant requested the extension of use for all crustaceans. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concludes that Bactocell® Aqua 10 Md/100 Md is safe under the current conditions of authorisation for the target species (all fish, shrimps and all crustaceans), consumers of products from animals fed the additive and the environment. Bactocell® Aqua 10 Md/100 Md is non‐irritant to skin and eyes and is not a dermal sensitiser, but should be considered a potential respiratory sensitiser. Exposure of users by inhalation is very likely. There is no need for assessing the efficacy of Bactocell® in the context of the renewal of the authorisation. The Panel concludes that the additive at the minimum inclusion level of 1 × 109 CFU/kg feed has the potential to be efficacious in salmonids and in the new species proposed, i.e. all crustaceans.

Abstract The additive (trade name Biomin® DC‐C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l‐menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were exposed to feed containing up to an intended 1,250 mg additive/kg complete feed showed that additive is safe for piglets at the maximum recommended level with at least a sixfold margin of safety. The active components of the additive are not genotoxic and from the available residue study, based on the detection of five marker compounds, no measurable exposure of the consumers is foreseen; consequently, the use of the additive is considered safe for consumers of animal products. The FEEDAP Panel considered that exposure to users by inhalation is unlikely; in the absence of data, the Panel cannot conclude on the effects of Biomin® DC‐C on skin and eyes. The use of the additive in animal production is not expected to pose a risk for the terrestrial or aquatic environments. Based on the results of three efficacy studies in which positive benefits were seen, the additive has a potential to improve the growth performance of weaned piglets at a minimum application rate of 75 mg/kg complete feed.

Abstract Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The available evidence, including the results of the post‐market monitoring plan, confirms that the use of Lantharenol® in cat food at the maximum authorised concentration of 7.5 g/kg of complete feed is safe for cats. In the absence of new data, the FEEDAP Panel reiterates its previous conclusion that Lantharenol® does not pose a risk by inhalation and is not an irritant to skin or eye and not a dermal sensitiser. The FEEDAP Panel considers that there is no need for a continuation of a specific post‐market monitoring plan.