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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., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 × 10 7  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 × 10 7  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., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Sodium and potassium alginate are intended to be used as technological additives (functional groups: emulsifiers, stabilisers, thickeners, gelling agents and binders). Sodium alginate is intended to be used in feedingstuffs for pets, other non food-producing animals and fish, with no maximum recommended use level. Potassium alginate is intended to be used in feedingstuffs for cats and dogs at levels up to 40,000 mg/kg feed (on dry matter). Since the functional properties of the additives are determined by the alginate content, sodium and potassium alginate were considered equivalent. The maximum dose considered safe for cats, dogs, other non food-producing animals, salmonids and other fish is 40,000 mg alginates (sodium and potassium salts)/kg complete feed. The use of alginates in feedingstuffs for fish is of no concern for the consumer. Alginates are reported not to be irritant to the skin but mildly irritant to the eyes. They are considered as potential sensitisers to the skin and the respiratory tract. Alginates are high-molecular-weight polymers naturally occurring in brown algae. Their use in feedingstuffs for fish does not pose a risk for the aquatic environment. Alginates are effective as stabilisers, thickeners, gelling agent and binders. No conclusion could be drawn on the efficacy of alginates as emulsifiers., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 a strain of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 10 8 colony forming units (CFU)/kg fresh material. The bacterial species L. buchneri is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, 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. Three studies with laboratory-scale silos were made using samples of easy, moderately difficult and difficult to ensile material. In each case, replicate silos containing untreated forage were compared with identical silos containing the same forage treated with the combination of Lactobacillus buchneri NRRL B-50733 at an intended concentration of 1 × 10 8  CFU/kg fresh matter. The results showed that the addition of Lactobacillus buchneri NRRL B-50733 at 1 × 10 8  CFU/kg fresh material has the potential to improve the aerobic stability of silage with a dry matter content ranging from 30% to 73%., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 a specific strain of Pediococcus parvulus when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 10 8  CFU/kg fresh matter. The species P. parvulus 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 or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Five studies with laboratory-scale silos were made using forage of differing water-soluble carbohydrate content. Replicate silos containing forages treated at the proposed application rate were compared to identical silos containing the same but untreated forage. The minisilos were then stored for 90-103 days at 20-24°C. After opening, the contents of the silos were analysed. Results showed that Pediococcus parvulus DSM 28875 at 5 × 10 7  CFU/kg forage has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing dry matter loss and enhancing protein preservation., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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   casei when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 10 8  CFU (when used alone) or 5 × 10 7  CFU (when used in combination) kg/fresh matter. The species L .  casei 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 to have the potential to be a respiratory sensitiser. Five studies with laboratory-scale silos were made using forage of differing water-soluble carbohydrate content. Replicate silos containing forages treated at the proposed application rate were compared to identical silos containing the same but untreated forage. The mini-silos were stored for 90 days at 20-24°C. At the end of the ensiling period, the content of the silos was analysed and dry matter losses determined. Results showed that the L .  casei strain applied at a minimum dose of 5 × 10 7  CFU/kg has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing dry matter loss and enhancing protein preservation., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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   rhamnosus when used as a technological additive intended to improve ensiling at a proposed application rate of 5.0 × 10 7  colony-forming units (CFU)/kg fresh material. The bacterial species L .  rhamnosus is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Seven studies with laboratory-scale silos were made using samples of forage of differing dry matter and water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing dry matter loss and enhancing protein preservation. This was shown at the proposed application rate of 5 × 10 7  CFU/kg forage., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following a request from the European Commission, the EFSA FEEDAP Panel (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 a strain of Lactobacillus plantarum when used as a technological additive intended to improve the ensiling process at a minimum proposed dose of 5.0 × 10 7  colony-forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Seven studies with laboratory-scale silos were made using samples of forage of differing dry matter and water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing the pH and increasing lactic acid concentration and protein preservation. This was shown at the proposed application rate of 5 × 10 7  CFU/kg forage., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)