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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 Actisaf Sc47 as a zootechnical additive for lambs for fattening, minor dairy ruminants, horses and pigs for fattening. In 2006, 2007 and 2008, the FEEDAP Panel adopted opinions on the safety and efficacy of Actisaf Sc47 when used in lambs for fattening, minor dairy ruminants, horses and pigs for fattening. Actisaf Sc47 is the trade name for a feed additive based on viable cells of Saccharomyces cerevisiae CNCM I-4407 with no carrier . It is currently authorised for use in sows, piglets, pigs for fattening, cattle for fattening, calves for rearing, dairy cows, dairy buffaloes, lambs for fattening, dairy sheep, dairy goats, horses, rabbits for fattening and non-food producing rabbits. Actisaf Sc47 is marketed in three forms: standard, powder and HR. All of them are authorised with a declared minimal concentration of viable yeast cells in the additive of 5 9 109 CFU/g. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. In previous opinions, Actisaf Sc47 was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Additionally, it was not found to be a skin or eye irritant. No new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions on the safety of Actisaf Sc47. Therefore, the Panel considers that the additive Actisaf SC47 remains safe under the approved conditions for lambs for fattening, minor dairy ruminants, horses and pigs for fattening, the consumer, user and the environment. [ABSTRACT FROM AUTHOR]

The feed additive Aviax 5%, containing the active substance semduramicin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 20-25 mg/kg complete feed. Semduramicin sodium is present in Aviax 5% in its mycelial form and is produced by fermentation of Actinomadura spp. (ATCC 53664). Semduramicin sodium is active against certain Gram-positive bacteria, while Gram-negative bacteria are resistant; its use as a feed additive is unlikely to increase shedding of Salmonella, Escherichia coli and Campylobacter and to induce resistance and cross-resistance to antimicrobials used of human and animal relevance. In the absence of a tolerance study in chickens for fattening performed according to the current EU standards, the FEEDAP Panel cannot conclude on the safety of Aviax 5%, containing semduramicin mycelium. Semduramicin sodium in the feed is not compatible with the concurrent use of tiamulin. Mycelial semduramicin sodium is not genotoxic. There is no evidence that the mycelial semduramicin is more toxic than the crystalline by oral administration. The acceptable daily intake (ADI) of 0.00125 mg/kg set for the crystalline semduramicin is applicable to mycelial semduramicin. The use of semduramicin sodium is safe for the consumer provided a withdrawal time of 24 h is respected. No conclusions can be made on the irritancy of Aviax 5% to skin and eye and on the potential for dermal and respiratory sensitisation. Model calculations on inhalation exposure of persons handling the additive indicate a serious risk. Aviax 5% used in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for the terrestrial compartment. A risk for the aquatic compartment and for groundwater pollution cannot be excluded. Aviax 5% at a minimum dose of 20 mg/kg feed has the potential to effectively control coccidiosis in chickens for fattening. [ABSTRACT FROM AUTHOR]

Cyanocobalamin is a synthetic form of vitamin B12 used in pharmaceuticals, supplements and as a food additive. It is intended to be used in feed for all animal species and categories. 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 cyanocobalamin produced by fermentation with Ensifer adhaerens strains SCM 2034 or CICC 11008s or Ensifer fredii strain CMCC (B) 70000. Since relevant data were not provided by the applicant that would allow a proper identification and characterisation of the production strains, the Additives and Products or Substances used in Animal Feed (FEEDAP) Panel cannot conclude on the safety of the use of vitamin B12 produced using E. adhaerens CICC 11008s and E. fredii CMCC (B) 70000 in animal nutrition for the target animals, the consumer, the user and the environment. Due to significant uncertainties on the identity and safety of the production strain E. adhaerens SCM 2034, including the presence of antibiotic resistance genes, the absence of viable cells of the production strain or their DNA in the product, the FEEDAP Panel cannot conclude on the safety of the use of vitamin B12, produced by E. adhaerens SCM 2034 in animal nutrition for the target species, consumers and the environment. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, vitamin B12 produced by E. adhaerens SCM2034 is considered to pose a risk to user safety. Vitamin B12 additives produced by Ensifer spp. are regarded as effective in meeting animals' requirements. [ABSTRACT FROM AUTHOR]

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 a riboflavin-based additive (minimum 80%) produced by a genetically modified strain of Ashbya gossypii ( ). It is intended to be used in feed for all animal species and categories. The additive under assessment does not give rise to safety concerns on the genetic modification of the production strain. The additive contains 80% of riboflavin (vitamin B2) and 20% of spent growth medium. The additive is safe for target animals with a wide margin of safety. The use of riboflavin 80% produced by A. gossypii in animal nutrition does not represent a safety concern for consumers. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot draw a final conclusion on the risk posed for the user by inhalation of riboflavin produced by A. gossypii and on the potential to be irritant to skin or eyes. The product under assessment is not a skin sensitiser; however, riboflavin is a known photosensitiser. The use of riboflavin produced by A. gossypii in animal nutrition does not pose a risk to the environment. The additive is regarded as an effective source of riboflavin in covering the animal's requirement when administered via feed. The FEEDAP Panel made recommendations on the description of the additive. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of betaine anhydrous produced as a nutritional additive to be used in feed for all food-producing animal species except rabbits. Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous tissues of vertebrates as an osmolyte ensuring osmoprotection. Betaine anhydrous (97%, 96% or 91%) is considered safe for the target species at a maximum supplementation rate of 2,000 mg betaine/kg complete feed. The use of betaine anhydrous (97%, 96% and 91%) as a feed additive up to a supplementation of 2,000 mg/kg complete feed does not pose concerns to consumer safety. The betaine liquid product contains a high proportion of unknown material (about 30% on dry matter basis). The FEEDAP Panel therefore cannot conclude on the safety of the liquid form of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety for the user. The supplementation of feed with betaine anhydrous does not pose a risk to the environment. Betaine has a potential to become efficacious in food-producing animal species and categories when administered via feed, especially when methyl groups from methionine or choline are limiting. The FEEDAP Panel made a recommendation on the use of the additive in premixtures without choline chloride. [ABSTRACT FROM AUTHOR]

The additive under assessment is a muramidase from Trichoderma reesei DSM 32338 which is to be used as a zootehcnical additive in feed for chickens for fattening and minor poultry species. The production strain is a genetically modified microorganism. The introduced genetic sequences do not give rise to safety concerns and no viable cells and no DNA of the production strain were detected in the additive. The results of a tolerance trial in chickens for fattening showed that the birds tolerated well 10-fold the highest recommended level of 45,000 LSU(F)/kg feed. Therefore, the Panel concluded that the additive is safe for chickens for fattening and extrapolated the conclusion to minor poultry species for fattening. The enzyme filtrate used to formulate the additive was tested in genotoxicity studies and in a subchronic oral toxicity study. The results of these tests did not indicate any reason for concern for consumer safety arising from the use of the product as a feed additive. Therefore, the Panel concluded that the additive is safe for the consumers. The Panel could not conclude on the potential of the additive for skin/eye irritancy or for its skin sensitisation potential. Owing to the proteinaceous nature of the active substance, the additive is considered to have potential for respiratory sensitisation. The FEEDAP Panel concluded that the use of this product as a feed additive poses no risks to the environment. The additive is to be used as a zootechnical additive, functional group other additives. To support the efficacy, the applicant submitted three efficacy studies with comparable design. The results showed significant and positive improvements on the feed to gain ratio of the birds receiving the additive at the lowest recommended level (25,000 LSU(F)/kg feed). This conclusion was extrapolated to minor poultry species for fattening. [ABSTRACT FROM AUTHOR]

Calsporin is the trade name for a feed additive based on Bacillus subtilis DSM 15544. It is currently authorised for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, and ornamental fish. This opinion concerns the renewal of the authorisation of Calsporin® as a zootechnical additive for chickens for fattening. In 2006 and 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted two opinions on the safety and efficacy of Calsporin® when used in chickens for fattening, and the active agent was further characterised in an opinion from 2015. 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 reconsider the previous conclusions on the safety of the additive. The FEEDAP Panel confirms its previous conclusion that Calsporin® is safe for the target species, consumers of products from animals fed the additive, users and the environment. [ABSTRACT FROM AUTHOR]

The coccidiostat amprolium hydrochloride from COXAM® is considered safe for chickens for fattening at 125 mg/kg complete feed. The margin of safety is at least 5. This conclusion is extended to chickens reared for laying. Amprolium hydrochloride does not possess any significant antibacterial activity. The applicant provided no information on the absorption, distribution, metabolism and excretion (ADME) and on the toxicology of the additive or active substance. Reference was made to the Committee for Medicinal Products for Veterinary Use (CVMP) summary reports from 1999 and 2001 citing studies used for the establishment of maximum residue limits (MRLs) for amprolium. However, the original data used in these assessments were not provided and the literature review covering the subsequent period was not made. Thus, the FEEDAP Panel cannot independently evaluate all data relevant to the current application and is therefore unable to conclude on the safety for the consumer of amprolium when used as a feed additive in chickens for fattening and chickens reared for laying. COXAM® is considered to be a skin and respiratory sensitiser. Inhalation exposure to dust from COXAM® may present a risk for the user. The use of amprolium hydrochloride from COXAM® in feed for chickens for fattening up to 125 mg/kg complete feed does not pose a risk for the environment. This conclusion can be extended to chickens reared for laying because of the lower predicted concentration in soil. COXAM® was effective as a coccidiostat in three floor pen studies and in two anticoccidial sensitivity tests. Since three anticoccidial sensitivity tests showing positive effects of the treatment are required, the FEEDAP Panel is not in the position to conclude on the efficacy of COXAM® for chickens for fattening under EU farming conditions. Consequently, a conclusion on the efficacy for chickens reared for laying is also not possible. [ABSTRACT FROM AUTHOR]

Abstract: Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the 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 FROM AUTHOR]

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 FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 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 FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 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 × 108CFU/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 FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 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 FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 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 FROM AUTHOR]

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 FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 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 FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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 FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Draft Endorsed by the FEEDAP Panel*18 May 2017Submitted for public consultation15 June 2017End of public consultation15 September 2017Adopted by the FEEDAP Panel21 February 2018Implementation date1 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. 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.This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1389/full [ABSTRACT FROM AUTHOR]