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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 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.

Abstract 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.

Abstract 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.

Abstract 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.

Abstract 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.

Abstract 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.

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 6‐phytase produced by Trichoderma reeseiCBS 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.

Abstract 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.

Abstract 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.

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 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.

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 renewal of the authorisation of Bacillus subtilisPB6, 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 velezensisATCC 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. velezensisATCC 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.

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 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 velezensisNRRL 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. velezensisNRRL 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.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Lactobacillus parafarraginis DSM 32962 when used as a technological additive intended to improve the production of silage at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The bacterial species L. parafarraginis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive is not an eye or dermal irritant but should be considered a potential respiratory sensitiser. No conclusions can be drawn on the skin sensitisation potential of the additive. Three studies with laboratory‐scale silos were made using samples of easy and moderately difficult to ensile forage. In each case, replicate silos containing untreated forage were compared with identical silos containing the same forage to which Lactobacillus parafarraginis DSM 32962 was added to reach an intended concentration of 1 × 108 CFU/kg fresh matter. The results showed that the addition of the additive improves significantly the aerobic stability of the silage tested.

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 fumonisin esterase from Komagataella phaffii DSM 32159 as a technological feed additive for all animal species. The product has been already assessed by the FEEDAP Panel for use in pigs and poultry feed as technological additive and was granted with an authorisation in the EU for this use. In the current application, the additive is intended to be used in fermenting feeds with the purpose to reduce the contamination of feed by fumonisins. New data provided showed that no recombinant DNA could be detected in three batches of the product. The evidence provided – based on the data submitted in the previous and the current application – allowed the FEEDAP Panel to conclude that the additive is safe for the target animals under the proposed conditions of use. The Panel also considered valid the previous conclusions in which the safety of the additive for consumers and the environment was established. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non‐irritant to skin and eyes and is not considered as a dermal sensitiser. The additive has the capacity to degrade fumonisins in fermenting feed (with a fumonisin content within the guidance limits operating in the EU) when used at the minimum recommended dose of 40 U/kg feed. The FEEDAP Panel notes that the efficacy has been demonstrated only in silages, not in other fermenting feeds like e.g. liquid feeds.

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 Lactobacillus buchneri DSM 29026 when used as a technological additive to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 108 colony‐forming units (CFU)/kg forage if used alone, or 5 × 107 CFU/kg forage if used in combination with other authorised microorganisms. The bacterial species L. buchneri is considered by the EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The FEEDAP Panel concluded that Lactobacillus buchneri DSM 29026 at a minimum concentration of 5 × 107 CFU/kg may improve the production of silage from easy and moderately difficult to ensile forage material.

Abstract In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of ammonium, calcium and sodium formate when used as a technological additive (preservative) for all animal species. Sodium formate was considered safe for all animal species at a maximum concentration of 10,000 mg formic acid equivalents/kg complete feed (with the exception of pigs, for which a maximum concentration of 12,000 mg formic acid equivalents/kg complete feed was considered safe). Sodium formate was also considered safe for the consumer and the environment. The Panel also concluded that sodium formate is non‐irritant to the skin, but mildly irritant to the eyes, and is a respiratory irritant with a potential for sensitisation. The Panel also concluded that ‘Sodium formate or solid sodium formate had no discernible effects on microbial numbers in the feed materials examined. The preservative effect of the three formate salts in water for drinking was not demonstrated’. In the current opinion, additional data to demonstrate the efficacy of sodium formate as a preservative in feed for all animal species were assessed. The Panel concluded that sodium formate has the potential to be efficacious as a preservative in feedingstuffs for all animal species at the proposed use level. In the absence of data, the Panel cannot conclude on the efficacy of the use of the additive in water for drinking.

Abstract The additive perlite (sodium potassium aluminium silicate) is intended to be used as a technological additive (functional group: anticaking agents) for ruminants and poultry. 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 user, 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 perlite as a technological additive for ruminants and poultry.

Abstract Following a request from European Commission, the Panel on Additives and Products or Substances used in animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of authorisation of montmorillonite‐illite (FIMIX 1g557) for all animal species. The FEEDAP Panel adopted in 2014 an opinion on the safety and in 2015 on the efficacy of this additive. The additive montmorillonite‐illite (FIMIX 1g557) is currently authorised for use in feedingstuffs for all animal species as an anticaking agent with a minimum and a maximum content of 20,000 mg/kg. The applicant proposed to use the additive in premixtures and complementary feeds for all animal species and categories at a minimum concentration of 20,000 mg/kg premixture and 10,000 mg/kg complementary feeds. The FEEDAP Panel considers that the proposed modification (reduction of the inclusion level in feed) would not affect the conclusions reached in the previous assessment as related to the safety for the target species, consumers, users and the environment. Montmorillonite‐illite is efficacious as an anticaking agent in premixtures for all animal species at inclusions levels starting at 20,000 mg/kg premixture and in complementary feeds at inclusions levels starting at 10,000 mg/kg. When the premixtures or complementary feeds are incorporated into complete feed, the concentration of montmorillonite‐illite would range from 50 to 100 mg/kg complete feed for poultry and all other animal species, respectively. There is no evidence that the anticaking effect of the additive will persist at these concentrations in complete feed. In the absence of specific data, the FEEDAP Panel is not in the position to comment on the efficacy of the additive at these concentrations when used in complete feed.

Abstract In 2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of calcium formate when used as a technological additive (preservative) for all animal species. Calcium formate was considered safe for all animal species at a maximum concentration of 10,000 mg formic acid equivalents/kg complete. Calcium formate was also considered safe for the consumer and the environment. The Panel also concluded that calcium formate is non‐irritant to skin but causes severe adverse effects in eyes. It is likely that handling the additive could result in skin reactions and in the production of respirable dust that could present a risk to unprotected workers. The Panel also concluded that ‘Data submitted do not provide convincing evidence of the efficacy of the additive when used as a preservative for compound feed or feed materials’. In the current opinion, additional data to demonstrate the efficacy of calcium formate as a preservative in feed for all animal species were assessed. The Panel concluded that calcium formate has the potential to be efficacious as a preservative in feedingstuffs for all animal species at the proposed use level.

Abstract 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.

Abstract 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.

Abstract 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.

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 l‐cysteine monohydrochloride monohydrate produced by fermentation using two non‐genetically modified strains of Escherichia coli K12 (E. coli KCCM 80109 and E. coli KCCM 80197) 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 the use of l‐cysteine hydrochloride monohydrate produced by E. coli KCCM 80109 and KCCM 80197 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. Based on the results of the studies provided, it should be classified as skin irritant and that it causes serious eye damage. l‐Cysteine hydrochloride monohydrate is not a dermal sensitiser. Since l‐cysteine hydrochloride monohydrate is used in food as flavourings, 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.

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 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.

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 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.

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 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.

Abstract The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of l‐methionine produced by fermentation with Corynebacterium glutamicum KCCM 80184 and Escherichia coli KCCM 80096 for all animal species. The two producing microorganisms were obtained by genetic modification. l‐Methionine is intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains, nor their recombinant DNA were detected in the final product. The additive does not pose any safety concern associated with the genetic modification of the production strains. l‐methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096. The additive is considered safe for the target species, for the consumer and for the environment. l‐Methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096 is considered not toxic by inhalation, non‐irritant to skin or eyes and not a dermal sensitiser. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety of l‐methionine for target species when administered via water for drinking owing to the risk of nutritional imbalances and hygienic reasons. l‐Methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096 is considered as an efficacious source of the essential amino acid l‐methionine for non‐ruminant animal species. For the supplemental l‐methionine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

Abstract ECONASE® XT is an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei ■■■■■. The additive is currently authorised for use in chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. This scientific opinion concerns the renewal of the authorisation of the additive when used in weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. ECONASE® XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. The current application also comprises three new less concentrated formulations. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches. However, since no sequences of concern have been introduced in the production strain, the potential presence of recombinant DNA in the final product does not raise any safety concern. No new evidence has been produced that would lead the Panel to reconsider its previous conclusions on the safety of the product for target species, consumers, users and the environment under the authorised conditions of use. Therefore, the FEEDAP Panel confirms that ECONASE® XT is safe for the target species, consumers of products from animals fed the additive and the environment. ECONASE® XT is non‐irritant to the skin, the liquid form is non‐irritant to the eyes and is not a dermal sensitiser, but the additive in all forms 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.

Abstract Bacillus subtilis DSM 28343 is a preparation of viable spores of a single strain of B. subtilis intended to be used as a zootechnical additive (functional group: gut flora stabilizer) in feed for calves for rearing to increase growth. In 2018, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Bacillus subtilis DSM 28343 as a feed additive for calves for rearing. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. In that opinion, the FEEDAP Panel was unable to conclude on the efficacy of the additive, under the condition of use as proposed by the applicant, due to insufficient data provided. In the current opinion, additional data to demonstrate the efficacy of Bacillus subtilis DSM 28343 were assessed. Based on one study of this application and two studies submitted in the previous application, the Panel concluded that Bacillus subtilis DSM 28343 has the potential to be efficacious as gut flora stabiliser used in feed for calves for rearing at the proposed use level.

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 Natuphos® E (6‐phytase) as a feed additive for laying hens, minor poultry and other avian species for laying. The additive Natuphos® E consists of 6‐phytase (phytase; Enzyme Commission Number 3.1.3.26) and is intended to be used as a feed additive for laying hens, minor poultry and other avian species for laying as a zootechnical additive, functional group of digestibility enhancers. This additive was previously assessed by the FEEDAP Panel in 2017 for avian and porcine species. The production strain of the phytase present in the product is a genetically modified strain of Aspergillus niger. Based on the previous opinion, the FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. The production strain and its DNA were not detected in the concentrate used to formulate the products. The FEEDAP Panel previously concluded that the additive was safe for the target species, consumers and the environment when used at 200 FTU/kg feed. The additive Natuphos® E is not considered to be toxic by inhalation or irritant for skin or eye; however, it should be regarded as a dermal sensitiser and a potential respiratory sensitiser. The additive has the potential to be efficacious in improving the performance and/or the phosphorus utilisation in laying hens at 200 FTU/kg feed; the conclusions drawn in laying hens can be extrapolated to all minor poultry and other avian species for laying.

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 modification of the terms of the authorisation of BioPlus® 2B (Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750) in feeds for turkeys for fattening to allow the simultaneous use with a battery of permitted coccidiostats (diclazuril, halofuginone, monensin sodium, robenidine hydrochloride, maduramicin ammonium, lasalocid sodium) and with the preservative formic acid. The proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of the additive. The additive is safe for the target species, consumers and the environment. The additive should be considered a potential respiratory sensitiser, but the Panel could not conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Conclusions previously drawn by the FEEDAP Panel on the compatibility of the additive for chickens for fattening apply to the current application provided that the maximum authorised concentration of the coccidiostats semduramycin, maduramicin ammonium, lasalocid sodium and the preservative formic acid for turkeys for fattening (when maximum authorised concentrations exist), are equal or lower than those for chickens for fattening. Considering the data submitted, the FEEDAP Panel concludes that BioPlus® 2B (B. licheniformis DSM 5749 and B. subtilis DSM 5750) is compatible with diclazuril and monensin sodium. Based on the data provided, no conclusion can be drawn for robenidine hydrochloride. In the absence of data, no conclusion can be drawn for halofuginone.

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 of erythrosine for ornamental fish. Erythrosine is a sensory additive belonging to the functional group colourants. In 2015, the FEEDAP Panel calculated the safe concentration in complete feed of ornamental fish to be 59 mg/kg complete feed. Considering that erythrosine contains 56.5% iodine, the safe level in feed of ornamental fish was recalculated taking into account the currently authorised maximum content of total iodine in complete feed and resulted to be 35 mg erythrosine/kg complete feed. The applicant submitted a new tolerance study in rainbow trout to demonstrate the safety of erythrosine for ornamental fish at doses higher than 59 mg/kg complete feed. The FEEDAP Panel noted that the study shows several limitations: (i) blood biochemistry was not measured, although required according to the guidance on the assessment of the safety of feed additives for the target species (ii) a low number of replicates (3 per treatment) which does not permit to obtain a reliable estimate and may not be sufficient to evidence differences between the groups (with no indication on the a priori power of the study design), and (iii) the use level group was not included in the study design. Owing to these three limitations, the FEEDAP Panel is not in the position to change its previous conclusions that the safe level of erythrosine in ornamental fish is 59 mg/kg complete feed. This safe level is reduced to 35 mg erythrosine/kg complete feed, when considering the iodine content of erythrosine and the currently authorised maximum content of total iodine in complete feed for fish.

Abstract The product under assessment is a preparation containing single strains of Saccharomyces cerevisiae, Lactobacillus plantarum and Lactobacillus casei to be used as a technological additive to improve the ensiling process. EFSA has been previously requested by the European Commission to evaluate this product. The safety of the additive for consumers, users, the environment and target animals was established at that time. There was, evidence for improved aerobic stability in forage materials with dry matter contents varying between 30% and 70%. Fluorescence in situ hybridisation methods were also introduced and a different culture medium to better characterise the additive but the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) remains unable to identify a minimum specification for the product or a minimum effective dose.

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.