Safety and efficacy of a feed additive consisting of acacia gum (gum Arabic) for all animal species (A.I.P.G. Association for International Promotion of Gums).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of acacia gum (gum Arabic) as a feed additive for all animal species. Acacia gum is safe up to approximately 280 mg/kg complete feed for chickens for fattening, 375 mg/kg complete feed for turkeys for fattening, 400 mg/kg complete feed for rabbit, 500 and 600 mg/kg complete feed for piglets and pigs for fattening, respectively, 1,100 mg/kg complete feed for cattle for fattening and 1,250 mg/kg complete feed for veal calves and salmonids. No conclusions can be reached on the safety for long living and reproductive animal, until the genotoxic potential of the additive is fully assessed in the framework of its use as a feed additive. No exposure of the consumer to the additive or its metabolites is expected. Therefore, the use of the additive in animal nutrition is considered safe for the consumers. Acacia gum is a potential dermal and respiratory sensitiser. No conclusion can be reached on the irritating potential to the skin or eyes. The use of acacia gum in animal nutrition is considered safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of acacia gum.

Safety and efficacy of a feed additive consisting of guar gum for all animal species (A.I.P.G. Association for International Promotion of Gums).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of guar gum as a feed additive for all animal species. Owing the absence of information, the genotoxic potential of the additive could not be fully assessed. From the results of tolerance studies, the FEEDAP Panel concluded that guar gum is safe for salmonids at a maximum concentration of 3,000 mg/kg complete feed. Guar gum is safe up to ~ 280 mg/kg complete feed for chickens for fattening, 375 mg/kg complete feed for turkeys for fattening, 400 mg/kg complete feed for rabbits, 500 and 600 mg/kg complete feed for piglets and pigs for fattening, respectively, 1,100 mg/kg complete feed for cattle for fattening and 1,150 mg/kg complete feed for veal calves. No conclusions can be reached on the safety for long living and reproductive animals, until the genotoxic potential of the additive is fully assessed in the framework of its use as a feed additive. The use of the additive in animal nutrition is considered safe for the consumer and the environment. In the absence of data, no conclusions could be drawn on the safety of the additive for the user. Guar gum is efficacious as a gelling agent, thickener, and contributes to stabilise canned pet feed. No conclusion can be drawn on the additive as an emulsifier.

Safety and efficacy of a feed additive consisting of carrageenan for pets and other non-food-producing animals (Marinalg International).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of carrageenan as a feed additive for pets and other non-food-producing animals. The additive is manufactured in two forms, refined and semi-refined carrageenan. Owing the lack of information, the FEEDAP Panel is not in the position to conclude on safety of the additives for pets and other non-food-producing animals and for the user. The FEEDAP Panel concludes that the additive is efficacious as a gelling agent, thickener and contributes to stabilise canned pet feed. No conclusion can be drawn on the efficacy of the additive as a binder and emulsifier.

Safety and efficacy of a feed additive consisting of agar for pets and non-food-producing animals (Hispanagar).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of agar as a feed additive for pets and non-food-producing animals. Owing the lack of information, the FEEDAP Panel is not in the position to conclude on the safety of agar for pets and other non-food-producing animals and for the user. The FEEDAP Panel concludes that the additive is efficacious as a gelling agent, thickener and contributes to stabilise canned pet feed. No conclusion can be drawn on the efficacy of the additive as a binder.

Safety and efficacy of a feed additive consisting of copper chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelate of ethylenediamine (Copper-EDA-Cl) as a feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) identified several issues related to the data provided concerning the chemical characteristics of the additive and, based on the information provided from an in vitro dissociation study, considered it unlikely that the additive consists only of copper mono-chelate of EDA but of several coexisting (copper) species. Therefore, in the absence of adequate experimental data and owing to the uncertainties identified, the Panel cannot conclude on its identity and characterisation of the additive. The FEEDAP Panel concludes that the additive is safe for chickens for fattening and reared for laying/breeding but cannot conclude on the safety for other animal species/categories. The FEEDAP Panel cannot conclude on the safety of the additive for the consumer or the environment. The FEEDAP Panel concludes that handling the additive poses a risk to users by inhalation. The additive should be considered as non-irritant for the skin but corrosive for the eyes and a skin sensitiser. The Panel notes the uncertainties on the genotoxicity potential of the additive that might have an impact on the conclusions on the safety for the user. The FEEDAP Panel concludes that the additive is efficacious in providing copper to meet the nutritional requirements of this trace element in all animal species.

Statement on the safety and efficacy of the feed additive consisting on tragacanth gum for all animal species (Association for International Promotion of Gums).

The additive tragacanth gum is intended to be used as a technological additive (category: technological additive; functional groups: emulsifier, stabiliser, thickener, gelling agent) for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the characterisation and identification, the safety for the target species and the efficacy of the additive. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive tragacanth gum as a technological additive for all animal species.

Safety for the user of the feed additive consisting of ferric citrate chelate (CI-FER™) for suckling and weaned piglets and minor porcine species (Akeso Biomedical, Inc.).

Following a request from the European Commission (EC), the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the users of the feed additive consisting of ferric citrate chelate (CI-FER™) when used as a zootechnical additive for suckling and weaned piglets and minor porcine species. The EC request follows a previous opinion of the FEEDAP Panel. In that opinion, the Panel identified several risks for the users of the additive; it was listed that it posed a risk to users by inhalation, should be considered as an irritant to skin, eyes and mucous membranes, and also that, due to its nickel content, should be considered as a dermal and respiratory sensitiser. The applicant provided additional data including information on the manufacturing process of the additive and data supporting the safety of the additive for the users to address those concerns. Some changes have been applied to the original manufacturing process which led to a dust-free additive, with the following specifications: total iron ≤ 23%, iron (III) ≥ 16.5% and moisture ≤ 10.0%. The FEEDAP Panel concluded that CI-FER™ does not pose a risk by inhalation and is classified as non-irritant to the skin. The additive should be classified as a skin sensitiser. In the absence of new data, the FEEDAP Panel reiterates its previous conclusion that the additive should be considered irritant to eyes.

Assessment of the application for renewal of authorisation of 6-phytase produced by Trichoderma reeseiCBS 122001 as a feed additive for pigs and poultry, from Roal Oy.

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 6-phytase produced by Trichoderma reesei CBS 122001 (brand name: Finase® EC). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel concludes that the additive remains safe for poultry for fattening, breeding and laying, and all pigs, the consumer and the environment under the authorised conditions of use. Regarding user safety, the Panel reiterates that the additive is not a skin or eye irritant or sensitiser but should be considered a potential respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. These conclusions also apply to the new proposed liquid formulation Finase® EC 5 L.

Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species.

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine (Mintrex®Zn) for all animal species. The FEEDAP Panel has delivered three opinions (during 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Zinc chelate of hydroxy analogue of methionine' containing 17.5-18 % zinc, 81 % (2-hydroxy-4-methylthio)butanoic acid (dl-methionine hydroxy analogue, HMTBa) and maximum 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 17 % zinc and ≥ 79 % HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Owing to the zinc and nickel content of Mintrex®Zn, the handling of the additive poses a risk to users by inhalation; the additive is not a skin or eye irritant but is considered a skin sensitiser. The present application 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.

Assessment of the application for renewal of authorisation of manganese chelate of hydroxy analogue of methionine for all animal species.

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of manganese chelate of hydroxy analogue of methionine (Mintrex®Mn) for all animal species. The FEEDAP Panel has delivered three opinions (in 2008, 2009 and 2010) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Manganese chelate of hydroxy analogue of methionine' containing 15.5-17 % manganese, 77-78 % (2-hydroxy-4-methylthio)butanoic acid (dl-Methionine Hydroxy Analogue, HMTBa) and maximum 1% mineral oil. Following some modifications in the manufacturing process the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 14 % manganese and ≥ 76 % HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Owing to the manganese and nickel content of Mintrex®Mn, the handling of the additive poses a risk to users by inhalation; the additive is not a skin or eye irritant but is considered as a skin sensitiser. The present application 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.

Safety and efficacy of Nutrase P (6-phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds.

Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6-phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.

Safety and efficacy of Correlink™ ABS747 Bacillus subtilis (Bacillus velezensis NRRL B-67257) as a feed additive for all growing poultry species.

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 Correlink™ ABS747 Bacillus subtilis (hereafter designated as Correlink™ ABS747) when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and minor growing poultry species. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis, which in the course of the current assessment, was reclassified as Bacillus velezensis NRRL B-67257. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NRRL B-67257 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Correlink™ ABS747 is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. Correlink™ ABS747 is not irritant to skin and eyes or a skin sensitiser but is a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of Correlink™ ABS747 for the target species due to lack of data.

Safety and efficacy of Correlink™ ABS1781 Bacillus subtilis (Bacillus velezensisNRRL B-67259) as a feed additive for all growing poultry species.

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 Correlink™ ABS1781 Bacillus subtilis (hereafter designated as Correlink™ ABS1781) when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and minor growing poultry species. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis, which in the course of the current assessment, was reclassified as Bacillus velezensis NRRL B-67259. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NRRL B-67259 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Correlink™ ABS1781 is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. Correlink™ ABS1781 is not irritant to skin and eyes or a skin sensitiser but is a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of Correlink™ ABS1781 for the target species due to lack of data.

Safety and efficacy of Bacillus subtilisPB6 (Bacillus velezensisATCC PTA-6737) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species (except for laying purposes), ornamental, sporting and game birds.

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 renewal of the authorisation of Bacillus subtilis PB6, the extension of use to ornamental, sporting and game birds and a modification on the concentration of the said additive. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis. During the course of the current assessment, the active agent has been redesignated as Bacillus velezensis ATCC PTA-6737. The bacterial species B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent is established and the compliance with the other qualifications confirmed. Therefore, B. velezensis ATCC PTA-6737 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. The additive is not a dermal/eye irritant or a skin sensitiser. Exposure via inhalation is unlikely. In the previous assessments performed by the FEEDAP Panel, the additive showed to be efficacious as a zootechnical additive in feedingstuffs for chickens for fattening and chickens reared for laying at the level of 1 × 107 CFU/kg. Considering that efficacy at the same level has been shown, this conclusion is extrapolated to ornamental, sporting and gaming birds.

Safety and efficacy of l-cysteine hydrochloride monohydrate produced by fermentation using Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 as a flavouring additive for all animal species.

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 l-cysteine monohydrochloride monohydrate produced by fermentation using two genetically modified strains of Escherichia coli K12 (Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181) as a flavouring additive for all animal species. No safety concerns are derived from the use of these strains as production strains of the additive. The FEEDAP Panel concludes that l-cysteine hydrochloride monohydrate, produced by E.coli KCCM 80180 and KCCM 80181 at concentrations up to 25 mg/kg complete feed, is safe for the target species, for the consumer and for the environment. The product is proposed to be classified as respiratory irritant; however, exposure by inhalation is unlikely. l-Cysteine hydrochloride monohydrate produced by E.coli KCCM 80180 and E.coli KCCM 80181 was shown to be a skin and eye irritant but not a skin sensitiser. Since l-cysteine hydrochloride monohydrate is used in food as flavouring, it is to be expected that it can provide a similar function in feed and no further demonstration of efficacy is necessary when used at concentrations up to 25 mg/kg complete feed and the corresponding concentration in water.

Assessment of the application for renewal of authorisation of l-isoleucine produced by Escherichia coli FERM ABP-10641 as a nutritional additive, its extension of use in water for drinking and a new use as flavouring additive for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-isoleucine produced by Escherichia coli FERM ABP-10641 (i) to renew the authorisation and to extend the use of the additive in water for drinking when used as a nutritional additive for all animal species and (ii) to evaluate a new use as a flavouring additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. l-Isoleucine does not give rise to any safety concern regarding the production strain and its genetic modification. Considering that the production process has not been substantially modified and that no adverse effects have been reported in the literature search, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in previous assessments. Therefore, the Panel considers that the additive l-isoleucine produced by E. coli FERM ABP-10641 remains safe for the target species, consumer and for the environment when used as a nutritional additive in feed. The Panel extends these conclusions to the use of the additive as a flavouring compound. Regarding the use in water, the FEEDAP Panel 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. l-Isoleucine is not irritant to skin and eyes and is not a dermal sensitiser but is hazardous by inhalation. The Panel confirms the previous conclusions that the additive is considered as a source of available isoleucine for non-ruminant animal species when used as a nutritional additive. It requires protection against degradation in the rumen to be as efficacious in ruminants as in non-ruminant species. The Panel considers the use of the additive in water for drinking to be equally effective than the use in feed when used as a nutritional additive. Since l-isoleucine is used in food as a flavouring compound, and its function in feed is essentially the same as that in food no further demonstration of efficacy is necessary.

Assessment of the application for renewal of authorisation of AveMix®XG 10 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) for chickens for fattening.

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 AveMix® XG 10 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) for chickens for fattening. The applicant has 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 the target species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not considered to be a dermal or eye irritant but it is a dermal and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Statement on the safety and efficacy of phosphoric acid 60% on silica carrier (UD60) for all animal species.

The additive UD60 (phosphoric acid 60% on silica carrier) is intended to be used as a technological additive (functional group: preservative) for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the characterisation, the safety for the target species and the efficacy of the additive. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive UD60 (phosphoric acid 60% on silica carrier) as a technological additive for all animal species.

Statement on the safety and efficacy of Shellac for all animal species.

The additive Shellac is intended to be used as a technological additive (functional group: stabiliser) for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the description of the additive/efficacy, and safety of the additive. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the request from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive Shellac as a technological additive for all animal species.

Statement on the safety and efficacy of lignosulphonate of magnesium (Caimabond) for all animal species.

The additive lignosulphonate of magnesium is intended to be used as a technological additive (functional group: binders) for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the absence and/or incompleteness of information needed in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the format requirements of the application and the structure of the dossier. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive lignosulphonate of magnesium as a technological additive for all animal species.