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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 HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, turkeys for fattening, laying hens, minor poultry species for fattening and laying, weaned piglets, pigs for fattening and carps. The applicant has now requested to extend the authorisation to sows in order to have benefit in piglets. The FEEDAP Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected. Considering the safety for the user, it was concluded that the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. A tolerance study was submitted to support the safety of the additive in the new target species/category. The results showed that sows tolerated well a 100‐fold the recommended enzyme activity level in feed. Consequently, the FEEDAP Panel concluded that the additive is safe for sows at 1,500 EPU/kg feed. A total of four studies were submitted to support the efficacy of the additive, one of which was not considered further in the assessment due to the high mortality registered in piglets. In the other three, a significant and positive effect on a relevant parameter was found in only one trial. Therefore, the Panel concluded that there is insufficient information to conclude on the efficacy of the additive.

Abstract The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the FEEDAP Panel concluded that the additive is safe for chickens for fattening, weaned piglets and pigs for fattening and that the use of this product as a feed additive raises no concerns for consumers of food products obtained from animals receiving it or for the environment. The FEEDAP Panel also concluded that the additive is not irritant to skin or eyes but should be considered as a potential skin and respiratory sensitiser. The Panel evaluated the efficacy of the additive and concluded that it has a potential to be efficacious in pigs for fattening at 1,500 EPU/kg feed. However, the Panel could not conclude regarding the efficacy of the additive for chickens for fattening and weaned piglets due to insufficient data/information. The applicant has now provided supplementary information in order to complement the information available supporting the efficacy of the additive. With the newly submitted efficacy studies and clarifications, the Panel concluded that the additive has a potential to be efficacious in chickens for fattening and weaned piglets at 1,500 EPU/kg feed.

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 a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. In previous opinions the identity of the strains has been clearly established and no antibiotic resistance of concern was detected. Therefore, the use of the strains 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, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered a potential respiratory sensitiser. In a previous application, three studies involving both strains used in combination at the same concentration were made with samples of whole crop maize with varied dry matter content. The same studies have been submitted in this application. The Panel reiterates its previous conclusions that Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri NCIMB 40788/CNCM I‐4323 at 1.5 × 108 CFU of each active agent per kg of fresh forage, equivalent to 3 x 108 CFU total lactobacilli/kg of forage significantly improve the aerobic stability of the silage.

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 authorisation of lecithins as a feed additive for all animal species. Lecithins are currently authorised for use in feed for all animal species (Commission Implementing Regulation (EU) 2017/2325). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion of the additive lecithins in 2016. The Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as emulsifier. The requested modification refers to the alignment of the specifications of the feed additive to the specifications set for lecithins when used as food additives, and the inclusion in the authorisation of rapeseed among the botanical sources of hydrolysed and de‐oiled lecithins and of de‐oiled hydrolysed soybean lecithins as an additional form of the additive. Based on the data available, all the lecithins of different botanical origin and their forms under application meet the specifications set for the use of lecithins as a food additive. The Panel therefore recommended applying the specifications set for food additive to the lecithins under application. In its previous opinion, the Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as an emulsifier. The Panel is not aware of any information related to the use of rapeseed as an additional source of hydrolysed liquid lecithins and de‐oiled lecithin powder that would modify the previous conclusions.

Abstract l‐Arginine is considered as a non‐essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. l‐Arginine produced by fermentation with Escherichia coli NITE BP‐02186, genetically modified to enhance the production of l‐arginine, is intended to be used in feed and water for drinking for all animal species and categories. The product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. Its use as a nutritional additive is safe for target species when supplemented to diets in appropriate amounts. The use of l‐arginine as a feed flavouring agent is unlikely to pose any concern. No risks are expected for the consumer from the use of the product under assessment as a feed additive. It is not irritant to skin or eyes, nor a skin sensitiser. Although the presence of endotoxin activity is of no concern, the available exposure and toxicological data indicate that the additive may pose a risk to users by inhalation. The use of this additive in animal nutrition does not pose a risk to the environment. The additive is an effective source of arginine for all species. l‐Arginine is considered efficacious when used as a flavouring compound in animal nutrition.

Abstract Amylofeed® is a feed additive that contains glucanase, xylanase and amylase activities, and it is intended to be used as a zootechnical additive for weaned piglets and minor porcine species. In previous assessments, the additive was characterised and the safety for the target species, consumers and environment was established. Considering the safety for the user, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive should be considered as a potential skin and eye irritant and a potential skin and respiratory sensitiser. Furthermore, the Panel concluded that the additive has a potential to be efficacious in the target species. However, the efficacy at the recommended enzyme activities could not be established. In order to overcome this limitation, the applicant proposed to modify the specifications of the additive whilst keeping the recommended level of addition of 500 mg additive/kg feed. The Panel evaluated the new specifications and their impact on the relevant aspects of the safety and efficacy of the additive. The newly proposed specifications of the additive were supported by analytical data. The Panel considered that the modification proposed by the applicant on the specifications would not have an impact on the safety aspects related to the consumer, user and environment. Therefore, the conclusions previously drawn would still apply. Moreover, it was considered that the tolerance trial previously evaluated would still support the safety for the target species. The addition of the additive with the new specifications would result in higher enzyme activities than those that were found in the efficacy studies that supported the efficacy of the product. Therefore, the additive has the potential to be efficacious at the newly proposed level of enzyme activities.

Abstract The additive under assessment consists of a natural mixture, mainly composed of dolomite (~ 30%), magnesite (~ 20%) and magnesium‐phyllosilicates (talc (~ 35%) and chlorite (~ 15%)). In 2016, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of natural mixture of dolomite plus magnesite and magnesium‐phyllosilicates. In this opinion, the Panel concluded that 20,000 mg additive/kg complete feed is considered safe for dairy cows and for piglets (weaned). This conclusion was extended to pigs for fattening while no conclusion could be drawn on the safety for poultry or any other species/categories. Following this opinion, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species. The new tolerance studies submitted with cattle for fattening and chickens for fattening showed tolerance of these animal categories to the additive up to approximately fivefold the highest recommended use level. The FEEDAP Panel therefore concluded that 20,000 mg additive/kg complete feed is safe for cattle for fattening and chickens for fattening. The additive at the same dietary concentration was already considered safe in an earlier opinion for piglets and dairy cows. Since the additive at 20,000 mg/kg complete feed is considered safe for four animal categories (three major animal species) with a comparable margin of safety, the conclusion on safety is extrapolated to all animal species. At the safe dietary concentration the additive did not affect the digestibility of the feed (including feed additives).

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 Lactobacillus acidophilus D2/CSL when used in feed for cats and dogs at a minimum dose of 5 × 109 colony forming units (CFU)/kg complete feedingstuffs. The additive is a preparation of viable cells of Lactobacillus acidophilus CECT 4529. This species is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety (QPS) approach to establishing safety for the target species and the environment. The safety of L. acidophilus CECT 4529 was assessed by EFSA in 2014. Following the QPS approach to safety assessment, L. acidophilus CECT 4529 is assumed to be safe for the target species and the environment without the need for further studies. No concerns are expected from other excipients present in the product, so Lactobacillus acidophilus D2/CSL is also considered safe for target animals, including cats and dogs, and the environment. The safety of the additive for the user was also considered in that opinion. The FEEDAP Panel is unaware of any new data that would lead it to revise its conclusions that the additive should be considered to be an eye/skin irritant and a skin/respiratory sensitiser. Lactobacillus acidophilus D2/CSL has some potential to reduce the moisture of stools from dogs and cats receiving the additive at 5 x 109 CFU/kg feed. However, the biological relevance of the magnitude of the effect detected is questionable.

Abstract Fumonisin esterase produced from a genetically modified strain of Komagataella phaffi is intended to degrade fumonisin mycotoxins contaminants in feeds for pigs and poultry. The production strain and its recombinant genes are not present in the final product. The applicant selected 300 U/kg feed to represent a likely upper limit. This concentration showed to be safe for piglets, chickens and turkeys for fattening and laying hens; the additive is thus safe for those categories. This conclusion is extended to all pigs, chickens reared for laying and turkeys reared for breeding and extrapolated to all other poultry species for growing and laying and to minor porcine species. No evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity from a repeated‐dose oral toxicity study; the residue assessment did not identify any concern. The use of the additive is, thus, considered safe for consumers. 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 a dermal sensitiser. No risks for the environment are expected following the use of the additive in feeds under the proposed condition of use. The additive has the capacity to degrade fumonisin contaminants in feed of marketable quality when used at the minimum recommended dose of 10 U/kg complete feed, as shown in studies with chickens for fattening, laying hens and weaned piglets. Since the mode of action of the additive can be reasonably assumed to be the same in animal species for which the application is made, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the additive efficacious for all poultry and all pigs.

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 cumin tincture (Cuminum cyminum L.) when used as a sensory feed additive for all animal species. The product is a water ethanol ■■■■■ solution, which contains 0.002–0.003% of 4‐isopropylbenzaldehyde (cuminaldehyde). The FEEDAP Panel concludes that the additive cumin tincture is safe at the maximum proposed use level (30 μL/kg complete feed or water for drinking) for all animal species. No safety concern would arise for the consumer from the use of cumin tincture up to the highest safe level in feeds. No specific data were provided by the applicant regarding the safety of the additive for users. In the absence of data, no conclusions can be drawn on the additive's potential to be a dermal/eye irritant or a skin sensitiser. The use of cumin tincture at the maximum proposed dose is not considered to be a risk for the environment. Since the major components of the additive are recognised to provide flavour in food and its function in feed would be essentially the same, no demonstration of efficacy is considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening, based on a dossier submitted for the modification of the terms of authorisation of the additive. The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000 mg/kg complete feedingstuffs. The applicant proposed the introduction of an additional manufacturing process, which introduces an impurity (dimethylamino‐ethanol (DMAE)) in the additive at concentrations up to 0.09%. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the proposed modification would not substantially affect the previous assessment as related to the safety of the environment and the efficacy of the product. Since the safety of the active substance was established, the current assessment has dealt with the impurity DMAE. Considering the toxicological profile of DMAE, the estimated intake by the target animal and consumers, and making use of the Threshold of Toxicological Concern (TTC) approach, the Panel concluded that Taminizer D, manufactured by the DMAE route, is safe for both chickens for fattening and consumers, up to the maximum level of 1,000 mg/kg feed. The FEEDAP Panel extends its conclusions about Taminizer D produced by the original method to cover also Taminizer D produced by the new DMAE method. There is minimal risk to users from dust produced as a result of normal handling of the additive. Taminizer D is not irritant to skin but may be irritant to eyes; it is regarded as a potential skin sensitiser. The FEEDAP Panel recommended to set a specification for the DMAE content in the additive.

Abstract l‐Arginine is considered to be a non‐essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l‐arginine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (KCCM 10741P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations at or below thresholds specified by EFSA; thus, C. glutamicum KCCM 10741P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded 99.8%, and no impurities of concern were detected. The use of l‐arginine produced by C. glutamicum KCCM 10741P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. l‐Arginine produced by C. glutamicum KCCM 10741P is considered corrosive to skin and eyes and therefore poses a risk by inhalation. The additive is an effective source of arginine for all species. For the supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against microbial degradation in the rumen.

Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the efficacy of feed additives. Draft Endorsed by the FEEDAP Panel 28 November 2018 Submitted for public consultation 4 December 2017 End of public consultation 28 January 2018 Adoption by the FEEDAP Panel 17 April 2018 Implementation date 1 September 2018

Abstract Hemicell® HT/HT‐L is an additive that presents endo‐1,4‐β‐mannanase produced by a genetically modified strain of Paenibacillus lentus. This additive is aimed to be used as a feed additive for chickens for fattening/reared for laying, turkeys for fattening/reared for breeding, weaned piglets, pigs for fattening and minor poultry and porcine species. In a previous assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) established the safety of the additive regarding the production strain, target species, consumer and user. However, limitations on the data regarding the absence of the production strain and its DNA did not permit to conclude on the safety of the additive for the environment. In that assessment, the Panel considered that the additive has a potential to be efficacious in the target species with the exception of pigs for fattening and in minor porcine species. The applicant provided new data to address the limitations identified. New data provided allowed the FEEDAP Panel to conclude that production strain and its recombinant DNA are not detected in the intermediate product used to formulate the additive. Therefore, the Panel concluded that the additive does not pose any environmental safety concern. Regarding the efficacy in pigs for fattening, the applicant provided a new analysis of the trials previously assessed which allowed the Panel to conclude that the additive has a potential to improve the feed to gain ratio at 32,000 U/kg feed. No data was provided regarding the efficacy in minor porcine species. However, considering the data available in major porcine species and that the mode of action of enzymes is well‐known and can be reasonably be considered to be similar among porcine species the Panel extrapolated the conclusion drawn in pigs for fattening to minor porcine species for fattening.

Abstract l‐Glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na4) (Kelforce®) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce® is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA‐Na4, respectively. Kelforce® is safe for chickens for fattening at the maximum level of 1,000 mg GLDA‐Na4/kg complete feed. Based on the toxicological profile of GLDA‐Na4 and the consumer exposure to GLDA‐Na4 and to nitrilotriacetic acid trisodium salt (NTA‐Na3; an impurity of the additive), the use of Kelforce® at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA‐Na4 is unlikely to pose a risk by inhalation. However, owing to the high‐dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce® is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance.

Abstract The additive consists of single strains of Bacillus subtilis and Aspergillus oryzae, to be used in combination as a technological additive (proposed functional group: Substances for the reduction of anti‐nutritional factors) in feed materials for all animal species. An opinion on the two microorganisms was published previously. At this time, the safety of the B. subtilis strain for target animals, consumers, users and the environment was established, but no conclusions could be draw on the safety of the strain of A. oryzae for the target species and consumers or on the efficacy of the additive in reducing anti‐nutritional factors. This opinion considers new information intended to address the identified deficiencies in the previous opinion. An extensive analytical search for secondary metabolites was made of the A. oryzae component of the additive and 15 metabolites were detected and quantified. Of the 15 metabolites, 13 occurred in ng/g additive concentrations and were considered not to be of concern. The remaining two compounds, cyclic dipeptides (2,5‐diketopiperazines), were detected at concentrations up to 1.5 mg/kg. Both have been identified in a wide range of foods and beverages and there appears to be no reports of adverse reactions to such cyclic dipeptides in processed food. Consequently, none of the metabolites detected were considered likely to cause adverse effects in target animals fed treated feed material or in consumers of products derived from such animals. Data from the analysis of 18 batches of soybean before and after treatment with the two strains were presented in support of the efficacy of the additive. Two classes of anti‐nutritional factors were considered; oligosaccharides of the raffinose series and trypsin inhibitor. The microbial strains in combination were able to substantially reduce the concentration of oligosaccharides and trypsin inhibitor naturally present in soybean. Other feed materials were not considered.

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 EB15 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus subtilis intended for use in feed at the proposed dose of 5 × 108 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108 CFU/L. The additive exists in two forms, EB15 and EB15 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010 CFU/g additive, respectively. The two formulations are considered equivalent when used to deliver the same dose. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, the additive can be presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. Insufficient evidence was provided to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species.

Abstract A total of 11 enzymes were assessed including alpha‐amylase, endo‐1,4‐beta‐glucanase, endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase as silage additives for all animal species. These enzymes are obtained by fermentation of bacterial or fungi non‐genetically modified production strains. Throughout information regarding the production strains of each product were provided, including the origin and history of modifications and allowing their identification. The identification was conclusive for 8 of 10 production strains. For three of the strains, more information/data would still be required in order to conclude. Three of the amylases are produced by bacterial strains that belong to a species that is considered by EFSA to be suitable for the Qualified Presumption of Safety approach to safety assessment. The identity of the strains has been established and the qualifications were met, and consequently, those products were regarded as safe. For the products derived from fungal strains, the strains or resulting products were tested for the presence of secondary metabolites which could be of toxicological concern. These were found to be below the limits of detection or the strain not capable of producing them. Considering all the information provided by the applicant, the Panel concluded that these products can be regarded as safe for the target species, consumer and the environment. In the absence of data, the Panel could not conclude on the skin and eye irritancy or skin sensitisation potential of the products under evaluation. These products should be considered to have the potential to be a respiratory sensitiser. For some of the products under evaluation, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that they have a potential to improve the characteristic of the silage material; for some other products, the Panel could not conclude on their efficacy.

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 ZM16 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens intended for use in feed at the proposed dose of 5 × 108 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108 CFU/L. The additive exists in two forms, ZM16 and ZM16 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010 CFU/g additive, respectively. The two formulations are considered equivalent when used to deliver the same dose. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, the additive can be presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Insufficient evidence was provided to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species.

Abstract The coccidiostat Coxar® is safe for turkeys for fattening at the use level of 100 mg nicarbazin/kg complete feed, with a margin of safety of about 1.25. Nicarbazin, when ingested, is rapidly split in its two components 2‐hydroxy‐4,6‐dimethylpyrimidine (HDP) and dinitrocarbanilide (DNC), which behave independently. HDP‐related residues are much lower than those of DNC. DNC is the marker residue. Liver is the target tissue. Nicarbazin is not genotoxic. The primary toxicity resulting from the oral use of nicarbazin is renal toxicity. The lowest no observed adverse effect level (NOAEL) identified in a 52‐week study in rat using DNC+HDP is 20 mg DNC + 8 mg HDP/kg body weight (bw) per day based on the absence of microcrystals in urine and related microscopic renal observations. The use of 100 mg nicarbazin from Coxar®/kg complete feed for turkeys for fattening will not pose a risk to consumers, provided that maximum contents in nicarbazin of 0.1% p‐nitroaniline (PNA) and 0.4% methyl(4‐nitrophenyl) carbamate (M4NPC) would be respected. No withdrawal time is required. Residue data comply with the established maximum residue limits (MRLs). Nicarbazin is not a skin or eye irritant and not a skin sensitiser. These conclusions also apply to the additive Coxar®. Inhalation toxicity of nicarbazin is limited; the granulated additive has a low dusting potential. No risk for users is identified. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Coxar® for the environment. The efficacy of 100 mg nicarbazin from Coxar®/kg feed was demonstrated in three anticoccidial sensitivity tests (AST), but only in one floor pen study. The floor pen study with 75 mg nicarbazin failed to demonstrate evidence of efficacy. No final conclusions on the efficacy of nicarbazin from Coxar® for turkeys for fattening can be drawn.

Abstract The additive, ‘Zinc‐l‐selenomethionine’ (Zn‐l‐SeMet) is intended to be used as a source of selenium for all animal species. The applicant intends to market the active compound blended with inert carriers (Availa®Se). Zn‐l‐SeMet is a safe source of selenium for chickens for fattening; the conclusion is extended to all animal species. Selenium from Zn‐l‐SeMet does not elicit any adverse effects not expected for a selenium compound. The use of Zn‐l‐SeMet in animal nutrition is expected to result in a similar increase in selenium deposition in animal tissues/products as that resulting from other sources of SeMet. The use of the additive up to the maximum selenium supplementation level established for other sources of organic selenium (0.2 mg/kg complete feed) and complying with the maximum authorised total selenium content is safe for consumers. The additive is hazardous upon inhalation; owing to the high dusting potential, persons handling Availa®Se are at risk by inhalation. Availa®Se is not an irritant to the skin. In the absence of data, no conclusion on the eye irritation and skin sensitisation can be drawn. The use of Zn‐l‐SeMet in feed does not pose an additional risk to the environment, compared with other sources of selenium for which it will substitute, as long as the maximum authorised content in complete feed is not exceeded. Zn‐l‐SeMet is an effective source of selenium in chickens for fattening and laying hens; this conclusion is extended to all animal species. The maximum contribution of zinc in total feed deriving from the use of the additive (

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Coxiril® for pheasants. Coxiril®, containing 0.5% diclazuril, is intended for the prevention of coccidiosis in pheasants at a dose range of 1.0–1.2 mg/kg of complete feed. Diclazuril from Coxiril® is considered safe for pheasants at a level of 1.2 mg/kg complete feed. The conclusion was made by extrapolating the results of a tolerance study with turkeys for fattening. The FEEDAP Panel considered that the residues in pheasant tissues and eggs would be of the same magnitude as those measured in the physiologically similar major species chickens and turkeys for fattening. The use of diclazuril at a maximum concentration of 1.2 mg/kg complete fed for pheasants would be safe for the consumer, provided that the maximum residue limits (MRLs) established for poultry would not be exceeded. The conclusions on the safety of the additive for the target species and the consumer are made under the provision that Coxiril® is not fed to laying birds. Coxiril® is considered as a non‐irritant to eyes and skin. It is not a potential skin sensitiser. User inhalation exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. The use of diclazuril from Coxiril® in pheasants does not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of the additive in acid soil cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. The FEEDAP Panel concluded that diclazuril from Coxiril® at a minimum dose of 1 mg/kg complete feed has the potential to control coccidiosis in pheasants.

Abstract The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked by the European Commission to deliver a scientific opinion on the safety and efficacy of benzoic acid as feed flavouring for piglets (suckling, weaned), pigs for fattening, sows (for reproduction, in order to have benefit in piglets), minor porcine species, chickens (for fattening, reared for laying), hens (laying, breeding), turkeys (for fattening, for breeding purposes, reared for breeding) and minor poultry species. Benzoic acid is safe for weaned piglets at 2,500 mg/kg feed, and for laying hens, turkeys and chickens for fattening at 500 mg/kg feed; no conclusions could be drawn for suckling piglets and sows. The conclusions on weaned piglets can be extended to pigs for fattening and extrapolated to growing minor porcine species. The conclusions on chickens/turkeys for fattening can be extended to chickens reared for laying and turkeys reared for breeding and extrapolated to minor poultry species up to the point of lay. In the absence of safety margin in laying hens, no conclusions can be reached for minor poultry species for laying/breeding. The use of the additive is not expected to pose a risk to consumer, considering that the additive is rapidly metabolised with very low deposition, if any, in edible tissues of pigs and poultry and that foods of animal origin provide a very minor contribution, if any, to the overall dietary intake of benzoic acid. Owing to the unlikelihood of exposure, no risk to users upon inhalation of the additive is expected; the additive is not a skin sensitiser, but is a skin/ eye irritant. The proposed use of the additive does not pose environmental risks. Benzoic acid is authorised as food flavouring and its function in feed is essentially the same; no further demonstration of efficacy is necessary.

Abstract The additive is a natural mixture of talc and chlorite (NTMC) that contains at least 75% of talc and chlorite as main components. The additive is intended for use as a technological additive (functional groups: (i) anticaking agents) in premixtures and feedingstuffs for all animal species at use levels of 1,000–50,000 mg/kg. No safe dietary level of NMTC could be identified for piglets, chickens for fattening and dairy cows. The use of NMTC in animal nutrition is considered not to pose a risk for the consumer of animal tissues and products from animals fed the additive. Talc could cause serious lung disease if repeatedly inhaled in large quantities over a long period. Talc is not irritant to skin and eyes. In the absence of data, no conclusion can be drawn on the skin sensitisation potential of the product. The components of the additive (talc, chlorite, dolomite and magnesite) are ubiquitous in the environment, being natural components of soil. Therefore, it is not expected that its use as a feed additive would adversely affect the environment. The additive NMTC is efficacious as an anticaking agent.

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 Coxiril® (diclazuril) for chickens reared for laying. Coxiril®, containing 0.5% diclazuril, is intended for the prevention of coccidiosis in chickens reared for laying at a dose range of 0.8–1.2 mg diclazuril/kg of complete feed up to a maximum age of 12 weeks. Derived from data already assessed for chickens and turkeys for fattening, diclazuril from Coxiril® is safe for chickens reared for laying up to 1.2 mg/kg complete feed when applied until 12 weeks of age. The FEEDAP Panel extended its previous assessment of consumer safety for the use of diclazuril from Coxiril® in chickens for fattening to chickens reared for laying. No measurable diclazuril residues were found in the first eggs laid from chickens reared for laying fed diclazuril from Coxiril® at 1.2 mg/kg complete feed until 12 weeks of age. Coxiril® was considered as a non‐irritant to eyes and skin. It is not a potential skin sensitiser. User inhalation exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. The use of diclazuril from Coxiril® in chickens reared for laying at the highest proposed feed concentration would not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril® cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. Derived from data already assessed for chickens for fattening, diclazuril from Coxiril® has the potential to control coccidiosis in chickens reared for laying at a minimum concentration of 0.8 mg/kg complete feed.

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 a strain of Pediococcus pentosaceus when used as a technological additive intended to improve ensiling at a proposed application rate of 5 × 107 CFU kg/fresh matter. The species P. pentosaceus is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than the absence of resistance to antibiotics of human and veterinary significance. As the identity of the strain was clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed treated silage and the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy of the additive. The additive should be considered a potential respiratory sensitiser. Pediococcus pentosaceus DSM 32291 at a minimum dose of 5 × 107 CFU/kg has the potential to improve the production of silage from easy and moderately difficult to ensile materials by decreasing dry matter loss and protein degradation during ensiling.

Abstract Sodium saccharin is intended to be used as a sweetener in feed and water for drinking for piglets, pigs for fattening and veal calves. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the proposed maximum use level of 150 mg sodium saccharin/kg feed as safe for calves and pigs for fattening. For piglets (sucking and weaned piglets), a lower level of 100 mg sodium saccharin/kg complete feed is considered safe. The corresponding maximum safe concentrations in water for drinking are 30 mg/L for piglets and 50 mg/L for pigs for fattening, respectively. The maximum safe concentrations of sodium saccharin in feed and water for drinking are derived under the premise that only one source, feed or water for drinking, contains the additive. The FEEDAP Panel concludes that no concern for the consumer would result from the use of sodium saccharin in feed and water for drinking at the dose considered safe for the target species. The precautions for handling the product proposed by the applicant are considered to be sufficient to ensure user safety. The FEEDAP Panel concludes that the use of sodium saccharin at the dose considered safe for target species is unlikely to have detrimental effects on the terrestrial and freshwater compartments. The high mobility and relative persistence of saccharin and the high persistency of its degradation product 4‐hydroxysaccharin indicate that groundwater contamination above 0.1 μg/L is likely to occur. Since the function of sodium saccharin in feed for the target species is essentially the same as that in food, the FEEDAP Panel concludes that no demonstration of efficacy is necessary.

Draft Endorsed by the FEEDAP Panel * 18 May 2017 Submitted for public consultation 15 June 2017 End of public consultation 15 September 2017 Adopted by the FEEDAP Panel 21 February 2018 Implementation date 1 September 2018 * Sections 3.1 and 3.2 were also endorsed by the EFSA Panel on Genetically Modified Organisms (GMO), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) and EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) on 18 May (GMO) and 7 June (CEF and ANS) 2017. Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the characterisation of microorganisms used as feed additives or as production organisms.

Abstract Sacox® microGranulates, containing salinomycin sodium (SAL‐Na), for chickens for fattening and chickens reared for laying have been recently re‐evaluated by Panel on Additives and Products or Substances used in Animal Feed. Following an urgent request from the European Commission, the safety and efficacy of the product when fed to rabbits for fattening was assessed based on the available data submitted by the applicant at the beginning of the assessment. SAL‐Na is largely absorbed and metabolised. Metabolites have a reduced ionophoric activity. SAL is the marker residue. SAL‐Na is not genotoxic and not a carcinogen. A no observed adverse effect level (NOAEL) of 0.5 mg/kg body weight (bw) per day is derived from a study in dogs. Only data on feed intake and body weight were available to conclude on the safety of SAL for rabbits. Levels of 35 mg SAL/kg feed and higher were not tolerated by growing rabbits. The Panel considers the available data indicate that the additive is tolerated by rabbits for fattening up to 25 mg/kg. The safety of SAL in rabbits for fattening needs to be established by a tolerance study compliant with the current standards. Adverse effects on breeding does cannot be excluded. The simultaneous use of SAL‐Na with certain medicinal substances (e.g. tiamulin and valnemulin) and bentonite is contraindicated. Consumer exposure to residues of toxicological concern complies with the acceptable daily intake (ADI) of 0.005 mg/kg bw, after 1‐day withdrawal. A provisional maximum residue limit (MRL) of 0.01 mg/kg liver would ensure consumer safety. A 5‐day withdrawal period as proposed by the applicant is supported. SAL‐Na in feed for rabbits will not pose a risk for the aquatic environment. A risk for the terrestrial ecosystem is considered unlikely. Efficacy and effective dose of SAL‐Na under present farming conditions could not be established.

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Alterion NE® when used in feed for chickens for fattening and chickens reared for laying. Alterion NE® is a preparation containing viable spores of Bacillus subtilis DSM 29784 intended for use in feed for the target species at the recommended dose of 1 × 108 CFU/kg complete feedingstuffs. B. subtilis 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, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of a previous opinion 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 same opinion, the FEEDAP Panel concluded that Alterion NE® is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion could be drawn on the dermal sensitisation of the additive. Alterion NE® at the recommended dose 1 × 108 CFU/kg feed has the potential to be efficacious in minor poultry species for fattening and reared for laying. B. subtilis DSM 29784 is compatible with the coccidiostats monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, robenidine hydrochloride and decoquinate at the respective authorised levels.

Abstract ECONASE® XT is an enzyme preparation with endo‐1,4‐β‐xylanase which is authorised as a feed additive for 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. The authorisation of the additive for pigs for fattening is at 24,000 BXU/kg feed. The applicant asked for a modification on the conditions of use in pigs for fattening, which consists in the reduction of the minimum recommended level from 24,000 BXU/kg feed to 16,000 BXU/kg feed. In previous opinions, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the safety of the product when used as a feed additive and concluded that the use of the product raises no concerns for consumer safety and no risks for the environment are expected. The Panel also concluded that the additive is non‐irritant to the skin, and the liquid form is non‐irritant to the eyes and is not a dermal sensitiser; however, it is considered a respiratory sensitiser. Regarding the use of the additive in pigs for fattening, the Panel concluded that under the conditions of use, the additive is safe for pigs for fattening and that it can be efficacious at 24,000 BXU/kg. In the current application, the applicant provided three efficacy trials to support the efficacy at 16,000 BXU/kg feed. Two of these studies had been previously evaluated by the FEEDAP Panel and supported the efficacy at 16,000 BXU/kg feed. The third study revealed a significant effect of the additive on the feed to gain ratio in pigs for fattening at 20,000 BXU/kg feed (analysed content). The FEEDAP Panel concluded that the additive has a potential to be efficacious in pigs for fattening as a zootechnical additive at the dose of 20,000 BXU/kg 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 3‐phytase FLF1000 as a feed additive for chickens reared for laying and minor poultry species. Safety aspects regarding the use of this additive in feed including the safety for the consumer, for the users and for the environment have been previously evaluated by EFSA. The FEEDAP Panel considered that the new use requested by the applicant would not modify those conclusions. In the previous assessment, the Panel evaluated the safety and efficacy for chickens for fattening and laying hens. In the current evaluation, no new studies were submitted to support the safety and the efficacy in new species/categories. Therefore, the data on the tolerance and efficacy in major species previously evaluated was taken into consideration for this assessment. The results of the tolerance trial in chickens for fattening previously evaluated showed that chickens tolerated well 10‐fold the maximum recommended dose. The Panel extended the conclusion reached in chickens for fattening to chickens reared for laying and extrapolated it to minor poultry species for fattening purposes or reared for laying/breeding. In the previous assessment, the FEEDAP Panel concluded that the additive has a potential to be efficacious in chickens for fattening at 500 FTU/kg feed. The Panel extended the conclusion on the efficacy in chickens for fattening to chickens reared for laying and extrapolated it to minor poultry species for fattening purposes or reared for laying/breeding.

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 Bacillus subtilis DSM 28343 when used in feed for calves for rearing. The additive is a preparation containing viable spores of a strain of B. subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. The strain was found to meet the criteria for the QPS approach in the context of a previous opinion and since concerns are not expected from other components of the additive, the additive is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. In the same opinion, the FEEDAP Panel concluded that Bacillus subtilis DSM 28343 is not an eye/skin irritant but should be considered a potential respiratory sensitiser and that no conclusion could be drawn on its skin sensitisation potential. These conclusions apply also to the current application. Insufficient evidence was provided to conclude on the efficacy of the additive in calves for rearing.

Abstract Butylated hydroxyanisole (BHA) is a waxy solid consisting for > 98.5% of the active substance, a mixture of 3‐tert‐butyl‐4‐hydroxyanisole and 2‐tert‐butyl‐4‐hydroxyanisole. It is intended to be used as an antioxidant in feedingstuffs for all animal species and categories. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered BHA up to 150 mg/kg complete feed as safe for all animal species except for cats, for which a safe dose could not be established from the tolerance data. BHA is rapidly absorbed from the gastrointestinal tract; it is metabolised rapidly and excreted as such and as metabolites in the urine and faeces. The proportions of the different metabolites vary depending on species and dose. No accumulation of BHA or metabolites was observed in tissues. The Panel concluded that no concern for consumer safety would arise from the use of BHA as a feed additive at the maximum concentration of 150 mg/kg feed. The additive should be considered a skin, eye irritant and a potential skin sensitiser. Exposure of the user via inhalation was considered unlikely; therefore, a risk is not expected. The use of BHA at the maximum concentration proposed is unlikely to pose a risk to the environment. BHA is authorised as an antioxidant for food use at comparable use levels, therefore, no studies were required to demonstrate the efficacy of BHA as an antioxidant in feedingstuffs for all animal species.

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 proposed modification of the terms of the authorisation regarding the formulation of the product Lactococcus lactis NCIMB 30160. The applicant has proposed to modify the manufacturing process by replacing one ingredient in the freeze‐drying step with polyethylene glycol (PEG 4000), a product authorised in the EU as a food additive. The use of PEG 4000 as an excipient in formulations with Lactococcus lactis NCIMB 30160 would not change the previous conclusions regarding the safety for the target animals, consumers and users. The FEEDAP Panel concludes that the additive is safe for target species and for consumers of products from animals fed the treated silage. The additive is not a skin irritant but is a potential skin/respiratory sensitiser. In the absence of data, the Panel is unable to conclude on the safety for the environment of the proposed use of PEG 4000 as excipient in formulations of the additive. The FEEDAP Panel sees no reason to reconsider the conclusions on efficacy previously drawn that the additive containing L. lactis NCIMB 30160 has the potential to improve the production of silage from all forages by increasing lactic acid content and the preservation of dry matter, by reducing the pH and moderately the loss of protein, as determined by ammonia‐N.

Abstract The European Commission asked EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to deliver a scientific opinion on the safety and efficacy of ADRY+®. ADRY+® consists of hydroxy analogue of methionine (HMTBa) and its calcium salt (HMTBa‐Ca), both precursors of l‐methionine. HMTBa and HMTBa‐Ca are currently authorised for use as a nutritional additives, under the functional group ‘amino acids, their salts and analogues’. ADRY+® is produced by chemical synthesis and it is intended to be used in feed for all animal species and categories. The FEEDAP Panel concluded that ADRY+® is safe for the target animals. The use of the additive in animal nutrition is not expected to result in an accumulation of HMTBa or its metabolites in edible tissues and animal products. Therefore, its use does not raise safety concerns for the consumer. ADRY+® is irritant to eyes and not irritant to the skin. The FEEDAP Panel cannot conclude on the skin sensitisation potential of this additive. The exposure of the users to the additive by inhalation is expected to be low. The use of this product as a feed additive does not represent a risk to the environment. ADRY+® is an effective source of methionine for protein synthesis in non‐ruminant animals and fish, although HMTBa may show a lower bioefficacy than dl‐methionine. In ruminants, HMTBa is more slowly degraded in the rumen than dl‐methionine.

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 Bacillus subtilis DSM 28343 when used in feed for weaned piglets. The additive is a preparation containing viable spores of a strain of B. subtilis. This species is 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, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of a previous opinion 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 same opinion, the FEEDAP Panel concluded that Bacillus subtilis DSM 28343 is not an eye/skin irritant but should be considered as a potential respiratory sensitiser and that no conclusion could be drawn on its skin sensitisation potential. These conclusions apply also to the current application. Bacillus subtilis DSM 28343 at 1 × 109 CFU/kg feedingstuffs has the potential to be efficacious in weaned piglets.

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 ponceau 4R for cats, dogs and ornamental fish. The following ponceau 4R concentrations in complete feed were considered safe: 31 mg/kg for cats, 37 mg/kg for dogs and 137 mg/kg for ornamental fish. Inhalation exposure of ponceau 4R is regarded as hazardous. In the absence of data, the Panel cannot conclude on the irritancy potential of ponceau 4R to skin or eyes. No conclusion could be made on the skin sensitisation of ponceau 4R. Ponceau 4R is effective in adding colour to feedingstuffs.

Abstract Cylactin® is the trade name for a feed additive based on dehydrated cells of Enterococcus faecium. It is marketed in three forms: Cylactin® LBC ME10 and Cylactin® LBC ME20 Plus – which contain the microencapsulated bacterium in concentrations of 1 × 1010 CFU/g and 2 × 1010 CFU/g, respectively – and Cylactin® LBC G35, a granulated form with a guaranteed content of 3.5 × 1010 CFU/g. In 2012, EFSA was requested by the European Commission to re‐evaluate the product when used as a zootechnical additive in feed for weaned piglets, sows and pigs for fattening. In the opinion delivered in 2015, the safety of the additive for consumers, users, the environment and target animals and its efficacy for piglets and sows were established. However, since only two efficacy studies with pigs for fattening could be considered and showed positive results, the Panel could not conclude on the efficacy for this target species due to insufficient data. The applicant has produced three additional feeding trials in pigs for fattening receiving the additive at the proposed inclusion level of 3.5 × 108 CFU/kg feedingstuffs, which are the subject of this assessment. None of these studies showed a significant effect on the performance of pigs for fattening. The data on average daily gain and feed to gain ratio of the three new studies and of the two from the previous opinion were pooled. Based on the results of this pooled analysis of five studies, but not supported by four out of the five individual studies, the EFSA Panel on Additives and Products or Substances used in Animal Feed concludes that Cylactin® has some potential to improve performance of pigs for fattening at 3.5 × 108 CFU/kg feed.

Abstract Riboflavin (80%) is a feed additive produced by fermentation of a genetically modified Bacillus subtilis strain. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of riboflavin (80%) based on a dossier supplied by the applicant. The Panel concluded that neither the production strain nor its recombinant DNA was detected in the final product, and therefore, the additive does not give rise to any safety concern with regard to the genetic modification of the production strain. The Community Reference Laboratory on Feed additives, in the context of an official control, reported on the presence of recombinant DNA in samples of the additive. The European Commission asked EFSA to deliver a new opinion on the safety of Vitamin B2 (80%) based on the new data, complementing the former one. The analysed samples contained DNA belonging to the production strain, including the genetic modification. Moreover, one of the samples contained viable cells from the production strain. Because the production strain carries antimicrobial resistance genes introduced by the genetic modification, the FEEDAP Panel considers that Riboflavin (80%) poses a risk for the spread of viable cells and DNA of a genetically modified strain‐harbouring genes coding for resistance to antimicrobials.

Abstract ECONASE® XT is an enzyme preparation with endo‐1,4‐β‐xylanase which is authorised as a feed additive for 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. The authorisation of the additive for laying hens is at 24,000 BXU/kg feed. The applicant asked for a modification on the conditions of use in laying hens, which consists in the reduction of the minimum recommended level from 24,000 BXU/kg feed to 12,000 BXU/kg feed. In previous opinions, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the safety of the product when used as a feed additive and concluded that the use of the product as a feed additive raises no concerns for consumer safety and no risks for the environment are expected. The Panel also concluded that the additive is non‐irritant to the skin, and the liquid form is non‐irritant to the eyes and is not a dermal sensitiser; however, it is considered a respiratory sensitiser. Regarding the use of the additive in laying hens, the Panel concluded that under the conditions of use the additive is safe for laying hens and that it can be efficacious at 24,000 BXU/kg. The results of the studies previously assessed showed in two cases improvements on the efficacy at the dose of 12,000 BXU/kg or below. The applicant provided two new studies which showed improvements at the new recommended dose on the performance of the laying hens in one trial and on the energy content in another trial. Therefore, the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in laying hens at the dose of 12,000 BXU/kg feed.

Abstract Following a request from the European Commission, the European Food Safety Authority (EFSA) Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Calsporin® when used in feed for pigs for fattening. The additive contains viable spores of a single strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment. This approach requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of previous opinions and since concerns are not expected from other components of the additive, Calsporin® is presumed safe for all target species, including pigs, consumers of products derived from animals treated and for the environment. In a previous opinion, the Panel also concluded that the additive is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. The use of the additive in pigs for fattening is considered unlikely to introduce hazards for users of the product not already considered as part of the first assessment. Therefore, the conclusions reached apply to the current application. Based on the results of the pooled analysis of four studies, the Panel on additives and products or substances used in animal feed (FEEDAP) concludes that Calsporin® has the potential to improve performance of pigs for fattening at 1.5 × 108 CFU/kg feed.

Abstract To meet the general requirement for transparency in EFSA's work, all its scientific assessments must consider uncertainty. Assessments must say clearly and unambiguously what sources of uncertainty have been identified and what is their impact on the assessment conclusion. This applies to all EFSA's areas, all types of scientific assessment and all types of uncertainty affecting assessment. This current Opinion describes the principles and methods supporting a concise Guidance Document on Uncertainty in EFSA's Scientific Assessment, published separately. These documents do not prescribe specific methods for uncertainty analysis but rather provide a flexible framework within which different methods may be selected, according to the needs of each assessment. Assessors should systematically identify sources of uncertainty, checking each part of their assessment to minimise the risk of overlooking important uncertainties. Uncertainty may be expressed qualitatively or quantitatively. It is neither necessary nor possible to quantify separately every source of uncertainty affecting an assessment. However, assessors should express in quantitative terms the combined effect of as many as possible of identified sources of uncertainty. The guidance describes practical approaches. Uncertainty analysis should be conducted in a flexible, iterative manner, starting at a level appropriate to the assessment and refining the analysis as far as is needed or possible within the time available. The methods and results of the uncertainty analysis should be reported fully and transparently. Every EFSA Panel and Unit applied the draft Guidance to at least one assessment in their work area during a trial period of one year. Experience gained in this period resulted in improved guidance. The Scientific Committee considers that uncertainty analysis will be unconditional for EFSA Panels and staff and must be embedded into scientific assessment in all areas of EFSA's work.

Abstract Uncertainty analysis is the process of identifying limitations in scientific knowledge and evaluating their implications for scientific conclusions. It is therefore relevant in all EFSA's scientific assessments and also necessary, to ensure that the assessment conclusions provide reliable information for decision‐making. The form and extent of uncertainty analysis, and how the conclusions should be reported, vary widely depending on the nature and context of each assessment and the degree of uncertainty that is present. This document provides concise guidance on how to identify which options for uncertainty analysis are appropriate in each assessment, and how to apply them. It is accompanied by a separate, supporting opinion that explains the key concepts and principles behind this Guidance, and describes the methods in more detail.

Abstract ENZY CARBOPLUS® is an additive available in liquid and solid forms that contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase which are produced by two genetically modified strains of Komagataella pastoris. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the production strains are safe and the genetic modifications raise no safety concerns. The Panel also concluded that the additive is safe for the target species at the recommended dosages and that its use as a feed additive raises no concern for consumers. The additive in either form is not a skin or eye irritant nor a dermal sensitiser; however, it is considered as a potential respiratory sensitiser. The production strains and their recombinant DNA were not detectable in the additive; moreover, the active substances of the additive will be degraded/inactivated during passage through the digestive tract of animals or in the environment, consequently, the Panel concluded that the additive poses no concerns to the environment. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in chickens for fattening at 4,000 LXU and 375 LGU per kg feed, in turkeys for fattening at 1,400 LXU and 120 LGU per kg feed, and in weaned piglets at 700 LXU and 60 LGU per kg feed. The Panel extended these conclusions to chickens reared for laying and turkeys reared for breeding at the corresponding doses. Since the mode of action of xylanase and glucanase can be reasonably assumed to be the same within avian or within porcine species, the Panel extrapolated the conclusions on the efficacy to all avian species up to the point of lay and to all porcine species. Owing to the lack of data, no conclusions could be drawn on the efficacy of the additive in laying hens.

Abstract VevoVitall® is a feed additive consisting of benzoic acid. It is currently authorised as a zootechnical additive for weaned piglets and pigs for fattening. This opinion concerns the renewal of the authorisation of benzoic acid as a zootechnical additive in feed. In 2005 and 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted two opinions on the safety and efficacy of VevoVitall® as a feed additive for weaned piglets and pigs for fattening, respectively. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. Furthermore, according to the information provided in the technical dossier, no new evidence has been identified that would make the FEEDAP Panel reconsidering the previous conclusions on the safety of the additive. The Panel confirms that the additive is safe at the maximum authorised concentrations of 5,000 and 10,000 mg/kg feed for weaned piglets and pigs for fattening, respectively; a margin of safety cannot be determined for weaned piglets while a margin of safety of less than 1.5 is established for pigs for fattening. The use of VevoVitall® in feeds for weaned piglets and pigs for fattening at the maximum authorised concentrations does not pose any safety concern for consumers and the environment. The use of VevoVitall® does not pose a risk by inhalation to users and is not a skin sensitiser. The new available data confirm that the additive is a skin irritant and a severe eye irritant. A recommendation concerning the potential toluene residues in the additive has been posted.

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 an essential oil from Origanum vulgare subsp. hirtum var Vulkan (DOS 00001) when used as a sensory feed additive for all animal species. Analysis of the oil identified 34 components accounting for > 99% of the oil, with carvacrol being the most prevalent (> 60%). Five tolerance studies in three species (chickens for fattening, weaned piglets and dairy cows) were made to assess the safety for the target species. The recommended use level of 150 mg additive/kg feed was shown to be safe for chickens for fattening and weaned piglets and this conclusion is extended to all poultry and porcine species grown for meat production. A dose of 500 mg additive/head and day (equivalent to ~ 25 mg/kg complete feed) was also demonstrated safe for the dairy cow. The Panel concluded that since the recommended use level differs between the dairy cow and the non‐ruminants tested the lower use level of 25 mg additive/kg feed could be applied to all target animals not included above. Residue studies (meat, liver, fat milk and eggs) showed that the exposure of consumers to products from animals given the additive at the recommended use level did not raise safety concerns. The additive should be considered as an irritant to skin and eyes, and to have a potential for sensitisation of susceptible individuals. Use in animal production of the essential oil extracted from O. vulgare is not expected to pose a risk for the environment. Since oregano and its extracts is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

Abstract The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) received a request from the European Commission to assess the safety and efficacy of bentonite when used as a technological feed additive (substances for reduction of the contamination of feed by mycotoxins) for all animal species. The applicant, EUBA aisbl (European Bentonite Association) representing six companies, submitted to EFSA a technical dossier to support the application. The applicant proposes to use bentonite at the maximum level of 20,000 mg/kg complete feed. The additive apparently interferes with the analysis of aflatoxin B1 in feed. The safety of the additive was already evaluated by the Panel in an opinion delivered in 2012. Bentonites are safe for all animal species, the consumers and the environment when used at a maximum level of 20,000 mg/kg complete feed. The results of a new genotoxicity study reinforced the previous conclusion that smectites are non‐genotoxic. Bentonites are not skin irritants but might be mildly irritant to the eye; based on a new study submitted, the additive is not a skin sensitiser. Owing to its silica content, the additive is a hazard by inhalation for the users. The in vitro study showed that the di‐ and tri‐octahedral smectites tested can adsorb aflatoxin B1 at different concentrations and at pH 5; however, no adequate in vivo studies were available. Therefore, the Panel cannot draw conclusions on the additive's efficacy. The Panel further considers the safety and efficacy conclusions to apply equally to the di‐ and tri‐octahedral smectites under assessment. The FEEDAP Panel posted some recommendations regarding the maximum content of other minerals in the additive and the incompatibilities of the additive with other medicinal substances. The Panel also drew a remark concerning the denomination of the additive and the current regulatory definition of Bentonite.