Assessment of the application for renewal of authorisation of PHYZYME® XP 5000 G/L (6-phytase) for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening, weaned piglets, pigs for fattening and sows for reproduction

PHYZYME\uae XP 5000 G/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 5000 G and L to be used as a feed additive in chickens for fattening, laying hens, turkeys for fattening, ducks for fattening, piglets (weaned), pigs for fattening and sows. This scientific opinion concerns the renewal of the authorisation of the additive for those species. To support the request, 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 or supplementing the conditions of the original authorisation 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

Assessment of the application for renewal of the authorisation of Natuphos (3-phytase) as a feed additive for poultry and pigs

Natuphos \uae is a feed additive that contains 3-phytase which is produced \u25a0\u25a0\u25a0\u25a0\u25a0 The product is currently authorised for use as a feed additive in chickens for fattening, piglets (weaned) and pigs for fattening, laying hens and turkeys for fattening, ducks, sows, all minor avian species other than ducks and ornamental birds. This scientific opinion concerns the renewal of the authorisation of this additive for those species. The application also included chickens reared for laying/breeding, turkeys reared for breeding and breeding hens. The applicant provided evidence that the additive in the market complies with the conditions of authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reconsider the previous conclusions regarding the safety for the target species, consumer and environment under the authorised conditions of use. The additive is a respiratory sensitiser and a potential skin sensitiser. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in for those species for which an authorisation exists. The Panel also considered that the additive is safe and has a potential to be efficacious in chickens reared for laying/breeding, turkeys reared for breeding, breeding hens and suckling piglets at the corresponding recommended doses

Safety and efficacy of OptiPhos\uae PLUS for suckling and weaned piglets, pigs for fattening, sows, other minor pig species for fattening and other minor reproductive pig 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 OptiPhos\uae PLUS (6-phytase) as a zootechnical feed additive for suckling and weaned piglets, pigs for fattening, sows, other minor pig species for fattening and other minor reproductive pig species. The additive is a preparation of 6-phytase produced by a genetically modified strain of Komagataella phaffii and has been previously assessed by the FEEDAP Panel in the context of two applications for its use in different species/categories. The Panel concluded in those opinions that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be skin irritant but was found to be a dermal sensitiser. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. Owing to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. Based on the tolerance studies provided, the Panel concluded that the additive is safe for the target species under the conditions of use with a wide margin of safety and therefore the conclusion were extended to suckling piglets and extrapolated to other minor pig species for fattening and to other minor reproductive pig species. The FEEDAP Panel concluded that the additive has the potential to be efficacious in weaned piglets, pigs for fattening and in sows at the level of 250 FTU/kg feed and this conclusion were extended to suckling piglets and extrapolated to other minor pig species for fattening and to other minor reproductive pig species

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

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 HOSTAZYM\uae X as a feed additive for rabbits for fattening. HOSTAZYM\uae X contains endo-1,4-beta- xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys for fattening, laying hens, minor poultry species for fattening and laying, weaned piglets, pigs for fattening and carps. The applicant has now requested to extend the authorisation to rabbits for fattening. The FEEDAP Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. There are no concerns for consumer safety and no risks for the environment are expected from the use of the additive as a feed additive. Regarding the safety for the user, the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. A subchronic oral toxicity study in rats was submitted to support the safety of the additive when administered to rabbits for fattening. The maximum safe enzyme activity in feed for the rabbits for fattening was derived from the data obtained in the subchronic oral toxicity study in rats; considering the maximum safe intake derived for rabbits from the toxicological data, the FEEDAP Panel concluded that the additive is safe for rabbits for fattening at the recommended use level. Two efficacy studies were submitted to support the efficacy of the additive; a significant effect of the additive in a relevant parameter was found in only one trial. Due to the insufficient evidence the Panel could not conclude on the efficacy of the additive in rabbits for fattening

Safety and efficacy of Amylofeed® (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase and α‐amylase) as a feed additive for piglets and minor porcine species

Amylofeed\uae is a preparation of endo-1,3(4)-b-glucanase, endo-1,4-b-xylanase and a-amylase aimed to be used as a feed additive for piglets and young minor porcine species. In a previous assessment, the safety of the additive for the target species, user and environment were established. However, the safety for the consumer and the efficacy of the product could not be established. In that previous assessment, the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided did not allow the Panel to conclude on the safety for the consumer. The applicant has now provided new data/information to assess the safety for the consumer and also new studies in order to support the efficacy of the additive in the target species. The enzymes present in the product are obtained from two different strains and from two different fermentation processes. In the current assessment, the applicant provided complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products. New genotoxicity studies were submitted by the applicant and the results showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study performed and previously submitted were valid for the current assessment; the results showed no evidence for adverse effects. Consequently, the Panel concluded that the additive is safe for the consumers when used as a feed additive. For the evaluation of the efficacy of the additive, the Panel considered four long-term trials done in weaned piglets. Based on these data, the Panel concluded that the additive has a potential to be efficacious in weaned piglets at the nominal dose of 500 mg/kg feed and extrapolated this conclusion to growing minor porcine species

Safety and efficacy of HOSTAZYM((R)) X (endo-1,4--xylanase) as a feed additive for carps

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM((R)) X. The additive HOSTAZYM((R)) X is a preparation of endo-1,4--xylanase available in different liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, turkeys for fattening, laying hens, minor poultry species for fattening and laying, weaned piglets and pigs for fattening. The FEEDAP Paneladopted two opinions on the safety and efficacy of the product as a feed additive for poultry and pigs, and another one for its use as a feed additive in chickens reared for laying and minor poultry species reared for laying. The applicant has now requested to extend the authorisation to carps (Cyprinuscarpio). The FEEDAP Panelconsidered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. The FEEDAP Panelconcluded that there are no concerns for consumer safety and no risks for the environment are expected. Considering the safety for the user, it was concluded that the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. The data in a tolerance trial performed with carps showed that the additive is safe for carp at 1,050endo-pentosanase units (EPU)/kg feed. The results in three efficacy trials showed that the additive has the potential to improve the performance of the carps at 1,050EPU/kg feed

Safety and efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, weaned piglets and pigs for fattening

Bergazym (R) P is a preparation of endo-1,4-beta-xylanase (xylanase) that is intended to be used as a zootechnical additive in feed for chickens for fattening, weaned piglets and pigs for fattening at a dose of 1,500 EPU/kg feed. The xylanase is produced by a non-genetically modified strain of Trichoderma reesei. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded from the tolerance studies submitted that the additive is safe for chickens for fattening and weaned piglets at 1,500 EPU/kg feed. The conclusions were extended to pigs for fattening. The results obtained with the enzyme concentrate used to formulate the additive in the genotoxicity studies and in the sub-chronic oral toxicity study do not indicate any reason for concern for consumer safety arising from the use of the product as feed additive. From the data provided on the enzyme concentrate used to formulate the additive, the Panel concluded that the additive is not irritant to skin or eyes but it is considered a potential skin sensitiser. Owing to the proteinaceous nature of the active substance, the additive is considered a potential respiratory sensitiser. The FEEDAP Panel concluded that no risks to the environment are expected. To support the efficacy of the additive, the applicant submitted five trials in chickens for fattening, five in weaned piglets and three in pigs for fattening. The FEEDAP Panel could not conclude on the efficacy of the additive in chickens for fattening and weaned piglets, but concluded that the additive has the potential to be efficacious in pigs for fattening at the recommended dose

Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens reared for laying and minor poultry species

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 3-phytase FLF1000 as a feed additive for chickens reared for laying and minor poultry species. Safety aspects regarding the use of this additive in feed including the safety for the consumer, for the users and for the environment have been previously evaluated by EFSA. The FEEDAP Panel considered that the new use requested by the applicant would not modify those conclusions. In the previous assessment, the Panel evaluated the safety and efficacy for chickens for fattening and laying hens. In the current evaluation, no new studies were submitted to support the safety and the efficacy in new species/ categories. Therefore, the data on the tolerance and efficacy in major species previously evaluated was taken into consideration for this assessment. The results of the tolerance trial in chickens for fattening previously evaluated showed that chickens tolerated well 10-fold the maximum recommended dose. The Panel extended the conclusion reached in chickens for fattening to chickens reared for laying and extrapolated it to minor poultry species for fattening purposes or reared for laying/breeding. In the previous assessment, the FEEDAP Panel concluded that the additive has a potential to be efficacious in chickens for fattening at 500 FTU/kg feed. The Panel extended the conclusion on the efficacy in chickens for fattening to chickens reared for laying and extrapolated it to minor poultry species for fattening purposes or reared for laying/breeding

Safety of Endofeed® DC (endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species

Endofeed\uae DC is a preparation of endo-1,3(4)-b-glucanase and endo-1,4-b-xylanase to be used as a feed additive for chickens for fattening, laying hens, pigs for fattening and minor poultry and porcine species. In a previous assessment, the safety of the additive for the target species, user and environment as well as the efficacy were established. In that assessment, the applicant provided in order to address the safety for the consumer, a bacterial reverse mutation assay and an in vitro micronucleus test, and a subchronic oral toxicity study. However, considering the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided, the Panel could not conclude on the safety for the consumer. The applicant provided new data/information on the manufacturing process, characterisation of the additive and new toxicological studies, to support the safety for the consumer, which was the main subject of this opinion. Complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products were provided. With the new information on the manufacturing and on the test items used in the toxicological studies evaluated in 2013, the Panel identified the need for new genotoxicity studies, while confirmed the appropriateness of the test item used in the subchronic oral toxicity study. New genotoxicity studies were submitted by the applicant and the results of the tests showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study previously submitted can be considered valid; the results showed no evidence for adverse effects. Therefore, the Panel concluded that the additive is safe for the consumers when used as a feed additive

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

FRA\uae Octazyme C Dry is a product that presents a-galactosidase, a-amylase, endo-1,3(4)-b-glucanase, endo-1,4-b-glucanase, mannan-endo-1,4-b-mannosidase, pectinase, protease and endo-1,4-b- xylanase. It is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. The enzymes present in the additive are obtained from different fermentation processes with four different microorganisms, Trichoderma citroviride, Aspergillus niger, Bacillus licheniformis and Bacillus amyloliquefaciens. In the tolerance and efficacy trials done in the target species, major limitations on the analysed enzyme activities in the feed were identified. These limitations did not permit the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to conclude on the safety and efficacy of FRA\uae Octazyme C Dry for the target species. The Panel concluded that the additive raises no concerns for the consumers of food products obtained from animals fed with the additive. No specific data were submitted to address the safety for the user, in the absence of such data the FEEDAP Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties. Owing to the nature of the active substances, the additive should be considered a potential respiratory sensitiser. The use of FRA\uae Octazyme C Dry as a feed additive poses no risks to the environment