Safety and efficacy of Bacillus subtilis DSM 28343 for pigs for fattening

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 pigs for fattening. The additive is a preparation containing viable spores of a strain of Bacillus 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 a previous opinion, the FEEDAP Panel concluded that Bacillus subtilis DSM 28343 is not an eye/skin irritant but should be considered as a potential respiratory sensitizer 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 2 × 108 CFU/kg complete feed has the potential to be efficacious in pigs for fattening

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

Safety of the feed additive consisting of manganese chelates of lysine and glutamic acid for all animal species (Zinpro Animal Nutrition)

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 for target animals of manganese chelates of lysine and glutamic acid (Manganese-LG) as a nutritional feed additive for all animal species. The European Commission request followed an opinion of the FEEDAP Panel published in 2020; in that opinion, the FEEDAP Panel could conclude on the safety of the additive for chickens for fattening, but not for the rest of the target animals. The applicant submitted additional information to allow the FEEDAP Panel to complete its assessment; these additional data, comprising two tolerance studies (one with chickens for fattening and one with laying hens), were the subject of this opinion. The tolerance study in laying hens was not considered for the assessment since the housing conditions of the animals were not appropriate according to the relevant EU provisions. The results of the tolerance study in chickens for fattening showed that Manganese-LG at the highest level tested – 800 mg Mn/kg feed – is safe for these target animals. The FEEDAP Panel also considered a previous tolerance study in chickens for fattening. Taking all the evidence together the Panel concluded that Manganese-LG is safe for chickens for fattening at 150 mg Mn/kg feed, with a margin of safety of 5.5. This conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total manganese in feed are not exceeded

Efficacy of a feed additive consisting of endo-1,4-beta-xylanase produced by Trichoderma citrinoviride (IMI SD 135) (HOSTAZYM® X) for sows in order to have benefits in piglets (Huvepharma NV)

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 efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefits in piglets. This additive consists of endo-1,4-β-xylanase produced by a non-genetically modified strain of Trichoderma citroviride. The additive is to be used in sows at 1,500 EPU/kg feed. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. The applicant provided new efficacy data to complete the assessment of the efficacy of the additive. Based on the previously assessed data and the newly submitted one, the Panel could not conclude on the efficacy of the additive

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 APSA PHYTAFEED® 20,000 GR/L (6-phytase) as a feed additive for chickens for fattening, chickens reared for laying and minor growing poultry species

APSA PHYTAFEED\uae 20,000 GR/L is a preparation of 6-phytase which is presented in solid and liquid forms. This additive is intended to be used as a zootechnical additive in chickens for fattening or reared for laying/breeding and minor poultry species for fattening or reared for laying/breeding. The 6-phytase present in the additive is produced by a genetically modified strain of Komagataella phaffii. The production strain and its recombinant DNA were not detected in intermediate products used to produce the additive. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding. The FEEDAP Panel concluded that the use of APSA PHYTAFEED\uae 20,000 GR/L as a feed additive gives rise to no concern for consumers. The additive, in either form, is not toxic by inhalation or irritant for skin or eyes and it is not a dermal sensitizer, but it is considered a potential respiratory sensitizer. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel evaluated three efficacy trials in which the retention of the phosphorus was studied. The data showed that the additive has the potential to improve the retention of phosphorus in the diets in chickens for fattening at 250 U/kg feed. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding

Safety and efficacy of copper chelates of lysine and glutamic acid as a feed additive for all animal species

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelates of lysine and glutamic acid (Copper-LG) as a nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that, owing to safety considerations, Copper-LG should not be used in water for drinking. Copper-LG is safe for chickens for fattening; this conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total copper in feed are not exceeded. No increases in the copper content of animal tissues/products are expected from the use of Copper-LG in animal nutrition. There is no indication that the toxicity of Copper-LG is essentially different from that of inorganic divalent copper. The use of Copper-LG in animal nutrition is of no concern for consumer safety provided that the maximum authorised total copper in feed is respected. Owing to the copper and nickel content of Copper-LG, the handling of the additive, poses a risk to users by inhalation. The additive is considered as a skin and respiratory sensitiser; it is corrosive to the eye while it is non-irritant to skin. The additive is intended to be a substitute for other authorised copper additives and will not further increase the environmental burden of copper; therefore, the FEEDAP Panel considers that the use of the additive in animal nutrition would not pose an additional risk for the environment. Copper-LG is a bioavailable source of copper, comparable to the standard inorganic copper source, and therefore, the additive is efficacious in meeting the birds copper requirements; this conclusion can be extrapolated to all animal species/categories. The FEEDAP Panel posed a recommendation concerning the description of the additive

Efficacy of the feed additive containing Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I-3740 (Biacton\uae) for chickens for fattening, turkeys for fattening and laying hens (ChemVet dk A/S)

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 efficacy of the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I-3740 (tradename: Biacton\uae) for chickens for fattening, turkeys for fattening and laying hens. The additive is a preparation containing viable cells of C. farciminis CNCM I-3740 at the minimum concentration of 1  7 109 CFU/g additive. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in these target species. The Panel concluded that based on the qualified presumption of safety of the active agent, and the lack of concerns deriving from other components of the additive, Biacton\uae was presumed safe for the target animals, consumers and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive did not allow drawing conclusions on the efficacy of the additive in any of the target species. The additional information submitted with chickens for fattening and laying hens did not provide sufficient evidence to conclude on the efficacy of Biacton\uae for these target species. No new information was provided that would lead the Panel to reconsider the conclusions already reached on the use of the additive with turkeys for fattening. The FEEDAP Panel, based on the available data, cannot conclude on the efficacy of Biacton\uae in chickens for fattening, turkeys for fattening and laying hens