Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 (AfB1) binder for all animal species; the additive is composed of bentonite feed grade and algae belonging to Ulva spp. The European Commission request follows an opinion of the FEEDAP Panel published in 2016; in that opinion, the FEEDAP Panel could not conclude on the efficacy of the additive. The applicant has submitted additional information to allow the FEEDAP Panel to complete its assessment; these additional data, related to the efficacy of the additive, are the subject of this opinion. In the efficacy study provided, the use of the additive reduced the AfM1 in milk, although this effect seemed to be not consistent over time; this study presented some weaknesses and limitations (incomplete data analysis, reporting and lack of determination of the active substance of the additive in feed) which do not allow the FEEDAP Panel to draw any conclusion on the efficacy of the additive. Due to insufficient evidence, the FEEDAP Panel cannot conclude on the efficacy of the algae interspaced bentonite as a technological feed additive for all animal species

Safety and efficacy of TYFER\u2122 (Ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFERTM (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFERTM/kg complete feed; this conclusion can be extended to chickens reared for laying/breeding and extrapolated to turkeys and all minor poultry species for fattening or reared for laying/breeding. No concerns for consumer safety are expected from the use of the additive in poultry nutrition. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the additive poses a risk to users by inhalation, and should also be considered as an irritant to skin, eyes and mucous membranes. Due to the presence of nickel, ferric tyrosine chelate should also be considered as a dermal and respiratory sensitiser. The supplementation of feed with the additive is not expected to pose an environmental risk. TYFERTM used at the minimum recommended level (20 mg/kg feed) in chickens diets has the potential to improve zootechnical parameters of birds. The additive at 20 mg/kg feed has the potential to reduce the caecal load Campylobacter spp. by at least 1 log10-units in chickens for fattening, thus with a potential impact to reduce the risk of human campylobacteriosis; however, the Panel notes that the load of Campylobacter in the chickens caecum is one of the multiple factors that contribute to Campylobacter load in carcases-meat. The conclusions on the efficacy of the additive can be extended to chickens reared for laying/breeding and extrapolated to turkeys and all minor poultry species for fattening or reared for laying/breeding. The Panel recommends including a specification for maximum lithium content in a potential authorisation of the additive

Safety and efficacy of an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species

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 an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species. The essential oil under assessment obtained is specified to contain carvacrol and thymol (7%). The remaining 30% of the composition remains uncharacterised. In the absence of these data, the FEEDAP Panel was unable to make a risk assessment of the additive for the target species, the consumer and the user. Use in animal production of the essential oil extracted from O. vulgare ssp. hirtum (Link) leetsw. is not expected to pose a risk for the environment. Since oregano and its extracts are universally recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary

Assessment of the application for renewal of the authorisation of PHYZYME® XP 10000 TPT/L (6-phytase) as a feed additive for all avian species and all swine species

PHYZYME\uae XP 10000 TPT/L is a feed additive that contains 6-phytase produced by a genetically modified strain of Schizosaccharomyces pombe. The applicant requested for the renewal of the authorisation for PHYZYME\uae XP 10000 TPT and L to be used as a feed additive for avian species for fattening/laying, weaned piglets, pigs for fattening and sows and for an extension of use to avian species reared for laying/breeding, suckling piglets and minor porcine species. To support the request or the renewal of the authorisation, the applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment. The application for renewal of the authorisation did not include a proposal for amending the conditions of use in those species for which an authorisation exists that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. Regarding the new species/categories, the Panel concluded that the additive is safe and has a potential to be efficacious in avian species reared for laying/breeding at 250 FTU/kg feed and for suckling piglets and minor porcine species at 500 FTU/kg feed

Safety and efficacy of Levucell SC® (Saccharomyces cerevisiae CNCM I-1077) as a feed additive for calves and minor ruminant species and camelids at the same developmental stage

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 Levucell® SC when used in feed for calves and minor ruminant species and camelids at the same developmental stage. The additive consists of viable cells of Saccharomyces cerevisiae. 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. 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, Levucell® SC is presumed safe for all target species, consumers of products derived from animals fed the additive and for the environment. The Panel considers these conclusions to apply also in the current assessment. In a previous opinion, the Panel also concluded that the additive is considered an eye irritant but not a dermal irritant or sensitiser and that inhalation exposure is unlikely. Since the use of the additive in calves and minor ruminant species and camelids at the same developmental stage is considered unlikely to introduce hazards for users of the product not already considered as part of the first assessment, these conclusions are still considered valid. Levucell SC® has the potential to be efficacious in calves at the minimum inclusion level of 1 × 109 CFU/kg complete feed. The conclusion on efficacy for calves can be extrapolated to minor ruminant species and camelids at the same developmental stage

Safety and efficacy of FRA® Octazyme C Dry (endo-1,4-β-xylanase, mannan-endo-1,4-β-mannosidase, α-amylase, endo-1,3(4)-β-glucanase, pectinase, endo-1,4-β-glucanase, protease, α-galactosidase) as a feed additive for weaned piglets and chickens for fattening

The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non-supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species

Assessment of the application for renewal of authorisation of GalliPro ® (Bacillus subtilis DSM 17299) for chickens for fattening

GalliPro \uae is the trade name for a feed additive based on viable cells of a strain of Bacillus subtilis intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. The product is currently authorised for use in chickens for fattening. This opinion concerns the renewal of this authorisation. Bacillus subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish the safety for the target species, consumers and the environment. The identity of the strain present in the additive was established and evidence was provided on the lack of toxigenic potential as well as acquired antibiotic resistance determinants to antibiotics of human and veterinary importance. Accordingly, this strain is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, GalliPro \uae is considered safe for the target species, consumers and the environment. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel confirms its previous conclusions that GalliPro \uae is safe for the target species; consumers of products from animals fed the additive and the environment. GalliPro \uae should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential of GalliPro \uae for skin and eyes irritancy and dermal sensitisation

Safety and efficacy of Biomin \uae DC-C as a zootechnical feed additive for weaned piglets

The additive (trade name Biomin \uae DC-C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were exposed to feed containing up to an intended 1,250 mg additive/kg complete feed showed that additive is safe for piglets at the maximum recommended level with at least a sixfold margin of safety. The active components of the additive are not genotoxic and from the available residue study, based on the detection of five marker compounds, no measurable exposure of the consumers is foreseen; consequently, the use of the additive is considered safe for consumers of animal products. The FEEDAP Panel considered that exposure to users by inhalation is unlikely; in the absence of data, the Panel cannot conclude on the effects of Biomin \uae DC-C on skin and eyes. The use of the additive in animal production is not expected to pose a risk for the terrestrial or aquatic environments. Based on the results of three efficacy studies in which positive benefits were seen, the additive has a potential to improve the growth performance of weaned piglets at a minimum application rate of 75 mg/kg complete feed

Safety and efficacy of Biomin ® DC-C as a zootechnical feed additive for weaned piglets

The additive (trade name Biomin \uae DC-C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were exposed to feed containing up to an intended 1,250 mg additive/kg complete feed showed that additive is safe for piglets at the maximum recommended level with at least a sixfold margin of safety. The active components of the additive are not genotoxic and from the available residue study, based on the detection of five marker compounds, no measurable exposure of the consumers is foreseen; consequently, the use of the additive is considered safe for consumers of animal products. The FEEDAP Panel considered that exposure to users by inhalation is unlikely; in the absence of data, the Panel cannot conclude on the effects of Biomin \uae DC-C on skin and eyes. The use of the additive in animal production is not expected to pose a risk for the terrestrial or aquatic environments. Based on the results of three efficacy studies in which positive benefits were seen, the additive has a potential to improve the growth performance of weaned piglets at a minimum application rate of 75 mg/kg complete feed

Safety and efficacy of Biomin\uae DC-P as a zootechnical feed additive for chickens for fattening, chickens reared for laying and minor avian species to the point of lay

The additive (trade name Biomin\uaeDC-P) is a blend of five individual compounds (carvacrol, thymol, d-carvone, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for various poultry species at a minimum concentration of 65 mg/kg complete feed and a recommended maximum level of 105 mg/kg complete feed. The results of a tolerance study show that Biomin\uae DC-P is safe for chickens for fattening at the maximum recommended application rate of 105 mg/kg complete feed; this conclusion is extended to include chickens reared for laying and extrapolated to minor poultry species The active components of a previously evaluated additive (Biomin\uaeDC-C) were shown to be not genotoxic; owing to the similarity on composition, this conclusion can be also applied to Biomin\uaeDC-P. Notwithstanding the uncertainties identified in the residue study, after applying a worst-case scenario to calculate potential exposure of consumers to menthol and carvone, and since that the components of the additive are considered safe for their use as food and feed flavourings, the FEEDAP Panel concludes that the use of the additive in animal nutrition is considered safe for consumers. The FEEDAP Panel considered that exposure of users by inhalation is unlikely, but cannot conclude on the effects of Biomin\uaeDC-P on skin and eyes. The use of Biomin\uaeDC-P is not expected to pose a risk for the environment. Biomin\uaeDC-P has a potential to increase the growth performance of chickens for fattening when incorporated into feed at a minimum application rate of 65 mg/kg complete feed; the conclusion can be extended to chickens reared for laying and extrapolated to minor poultry species reared up to the point of lay