Scientific opinion on the safety and efficacy of Natugrain^® TS (endo-1,4-beta-xylanase and endo-1,4-beta-glucanase) as a feed additive for pigs for fattening

Natugrain® TS is an enzyme preparation that contains endo-1,4-beta-xylanase and endo-1,4-beta-glucanase, produced by two genetically modified strains of Aspergillus niger. This product is currently authorised for use in piglets (weaned), poultry species and ornamental birds as a zootechnical additive under the functional group of digestibility enhancers. The applicant is now seeking for the extension of its use as a zootechnical additive for pigs for fattening at a dose range of 560 to 840 TXU (thermostable xylanase units) and 250 to 375 TGU (thermostable glucanase units) per kg feed. Since the product has been demonstrated to be  safe in piglets at the maximum recommended dose, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that this conclusion can be extended to pigs for fattening, provided that the same maximum dose applies. In two long-term trials, Natugrain® TS significantly improved the performance of the pigs for fattening at the minimum recommended dose (560 TXU and 250 TGU/kg feed). In a balance trial, the metabolisable energy content of the diet was significantly improved by the addition of Natugrain® TS in feed at the minimum recommended dose. Therefore, the FEEDAP Panel concludes that Natugrain® TS at the minimum recommended dose (560 TXU and 250 TGU/kg feed) has the potential to be efficacious in pigs for fattening

Scientific Opinion on the safety and efficacy of <em>Lactobacillus paracasei</em> (NCIMB 30151) as a silage additive for all animal species

Lactobacillus paracasei is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1.0 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species L. paracasei is considered by the European Food Safety Authority 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 in the production of silage is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. A total of seven studies with laboratory-scale silos were made using samples of forage of differing 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, moderately difficult and difficult to ensile forage species by reducing the pH and increasing the preservation of dry matter. This was most consistently shown at application rates of 5 × 107 and 1 × 108 CFU/kg forage

Scientific Opinion on the safety and efficacy of <em>Lactobacillus plantarum</em> (NCIMB 40027) as a silage additive for all animal species

The strain of Lactobacillus plantarum is intended to improve the ensiling process at proposed doses ranging from 1 x 108 to 1 x 109 CFU/kg fresh material. This speciesis considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is presumed safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The active agent is not an eye or skin irritant or a skin sensitiser. Given the proteinaceous nature of the active agent and the high dusting potential of the product tested, the FEEDAP Panel considers it prudent to treat this additive as a respiratory sensitiser. A total of 20 laboratory-scale ensiling studies were conducted with L. plantarum applied at 1 x 109 or 1 x 108 CFU/kg forage. In all the studies, forage containing the additive was compared with untreated control materials, and the duration of the studies was at least 90 days. L. plantarum has the potential to improve the production of silage by increasing lactic acid content and the preservation of dry matter, by reducing the pH and protein degradation. This was demonstrated in a range of easy and moderately difficult to ensile forage materials at a minimum concentration of 1 x 108 CFU/kg fresh material and also in difficult to ensile forage materials when added at a concentration of 1 x 109 CFU/kg fresh material

Scientific opinion on the safety and efficacy of CAROPHYLL^® Red 10% (preparation of canthaxanthin) for all poultry for breeding purposes (chickens, turkeys and other poultry)

No abstract availabl

Scientific Opinion on the safety and efficacy of <em>Lactobacillus brevis</em> (DSMZ 16680) as a silage additive for all species

Lactobacillus brevis is a technological additive intended to improve the ensiling process at a proposed minimum dose of 1.0 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species L. brevis is considered by the European Food Safety Authority 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 in the production of silage is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser and should be treated accordingly. The FEEDAP Panel concluded that L. brevis has the potential to increase aerobic stability of the treated silage at the minimum recommended dose of 1.0 × 108 CFU/kg fresh material. This was demonstrated in forage materials with a dry matter content of 29–46 %

Scientific Opinion on the safety and efficacy of formaldehyde for all animal species based on a dossier submitted by Regal BV

The additive formaldehyde is an aqueous solution containing 35 % formaldehyde and 14 % methanol. It is intended for use in all animal species at concentrations between 200 and 1000 mg active substance/kg complete feed. Free and reversibly bound formaldehyde is readily absorbed in the gastrointestinal tract and joins the pool of endogenous formaldehyde. It is rapidly oxidised to formic acid further on to carbon dioxide and water. Formaldehyde is a carcinogen by inhalation. While local irritation is expected to strongly promote carcinogenesis, lower local concentrations of formaldehyde are known to produce DNA adducts. Therefore, the FEEDAP Panel deems it prudent not to consider the exposure to non-irritant concentration as totally riskless. Moreover, on the basis of the present knowledge, a causal association between formaldehyde exposure and leukaemia cannot be ruled out. The FEEDAP Panel estimated the oral intake of formaldehyde of consumers from food of animal origin to be 4 mg per person per day. A reliable additional exposure of consumers to formaldehyde from supplementing feedingstuffs cannot be calculated. However, the FEEDAP Panel considers that the proposed use of formaldehyde as a feed additive would not increase consumer exposure and consequently would not pose an additional risk for the consumer. A safe feed concentration for all animal species and categories could not be determined. Formaldehyde is a strong irritant, a potent skin and respiratory sensitiser. Measures should be taken to ensure that the respiratory tract, skin and eyes of any person handling the product are not exposed to any dust, mist or vapour generated by the use of formaldehyde. The use of formaldehyde in animal nutrition is not expected to pose a risk for the environment. Formaldehyde in concentrations between 200 and 1000 mg/kg feed (compound feed and/or feed material) has the potential to be an efficacious preservative

Scientific Opinion on the safety and efficacy of <em>Pediococcus pentosaceus</em> (NCIMB 30068) as a silage additive for all animal species

Pediococcus pentosaceus is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1 × 108 colony-forming units (CFU)/kg fresh material. The P. pentosaceus strain was found to be resistant to tetracycline by an unidentified mechanism and thus may pose a risk for the spread of genes coding for resistance to an antibiotic of human and veterinary importance. Thus, the additive containing this strain is not considered safe for the target animals and consumers of products from animals fed the treated silage. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. Since the P. pentosaceus strain carries an uncharacterised resistance to tetracycline, the FEEDAP Panel cannot conclude on its safety for the environment. A total of four studies with laboratory-scale silos were made using samples of forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. Although the additive showed a tendency to increase lactic acid production and reduce pH in the ensiled material, overall there was insufficient evidence of a beneficial effect on the preservation of nutrients

Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additive for all animal species: Zinc oxide, based on a dossier submitted by Grillo Zinkoxid GmbH/EMFEMA

Zinc oxide is a safe source of zinc for all animal species and no concerns for consumer safety are expected from the use of zinc oxide in animal nutrition, considering the maximum contents for total zinc in feedingstuffs set by EU legislation. Zinc oxide is not an irritant to skin and eyes; it is not a skin sensitiser. The zinc oxide under application is considered a compound with high dusting potential, which may result in a critical exposure of users by inhalation, affecting the respiratory system. The authorised use of zinc oxide as a feed additive does not pose a direct concern for the agricultural soil compartment. However, there is a potential environmental concern related to groundwater, drainage and the run-off of zinc to surface water. Acid sandy soils are most vulnerable to these processes. In order to draw a final conclusion, some further refinement to the assessment of zinc-based feed additives in livestock needs to be considered, for which additional data would be required. The use of zinc-containing additives in aquaculture up to maximum authorised zinc level in feeds is not expected to pose an appreciable risk to the environment. Zinc oxide is efficacious in meeting animal zinc requirements

Scientific Opinion on the safety and efficacy of AveMix^® XG 10 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) as a feed additive for turkeys for fattening

The additive AveMix® XG 10 is an enzyme preparation of endo-1,4-beta-xylanase (xylanase) and endo-1,3(4)-beta-glucanase (glucanase), produced by two strains of Trichoderma reesei. This product is currently authorised for use in chickens for fattening, laying hens, minor poultry species and weaned piglets as a zootechnical additive, under the functional group of digestibility enhancers. The applicant is now seeking an extension of the authorisation to turkeys for fattening at a recommended dose of 4 000 XU (xylanase units) and 900 BGU (glucanase units) per kg complete feed. The results obtained in a tolerance study in turkeys for fattening showed that the birds tolerated well a 100-fold overdose of the recommended dose. Therefore, the additive is safe for turkeys for fattening when used at the recommended dose. Three efficacy studies carried out in turkeys for fattening showed that the additive has the potential to be efficacious at the dose of 4 000 XU and 900 BGU/kg complete feed

Scientific Opinion on the safety and efficacy of vitamin A (retinyl acetate, retinyl palmitate and retinyl propionate) as a feed additive for all animal species and categories

No abstract availabl