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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. [ABSTRACT FROM AUTHOR]

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 of 3‐phytase FLF1000/FSF10000 as a feed additive for pigs for fattening and minor porcine species for growing. This additive contains 3‐phytase produced by a genetically modified strain of Komagataella phaffii and it is authorised in its liquid FLF1000 and solid form FSF10000 as a feed additive for chickens for fattening, laying hens, chickens reared for laying and for minor poultry species for fattening or reared for laying or for breeding. The FEEDAP Panel has adopted an opinion regarding the use of this product as a feed additive in pigs for fattening and minor porcine species for growing. In that opinion, the FEEDAP Panel concluded that the use of the product as a feed additive would raise no concerns for the consumer safety nor for the environment but that the additive should be regarded as a potential respiratory sensitizer. The Panel also concluded that the additive has a potential to be efficacious in improving the phosphorus utilisation in the target species. However, the Panel could not conclude on the safety for the target species due to the limitations identified in the data provided. The applicant has now complemented the information and made it available to the Panel. The tolerance trial was done in weaned piglets in which the animals received up to 10 times the recommended dose of 1,000 FTU/kg feed. The results showed no adverse effects of the phytase on the performance of the animals or on the haematological and biochemical parameters measured in blood. Therefore, the Panel concluded that the additive (3‐phytase FLF1000 and FSF10000) is safe for pigs for fattening and minor growing porcine species at the recommended dose of 1,000 FTU/kg feed. [ABSTRACT FROM AUTHOR]

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 Axtra®XAP 104 TPT as a zootechnical feed additive (digestibility enhancers) for poultry species. The additive contains three enzyme activities (endo‐1,4‐beta‐xylanase, protease and alpha‐amylase) produced by three different genetically modified strains. Viable cells and recombinant DNA of the strains producing the protease and amylase were not detected in the final product. Owing to the insufficient data, uncertainty remained on the presence in the additive of viable cells of the strain producing the xylanase. The results obtained in the genotoxicity and subchronic oral toxicity studies performed with the three fermentation products did not indicate safety concerns resulting from the fermentation products used in the formulation/manufacturing. However, uncertainties remain on the suitability of the test item used in the studies conducted with the xylanase; therefore, the Panel was not in the position to conclude on the toxicological potential of AXTRA®XAP 104 TPT. Consequently, the Panel could not conclude on the safety of the additive for the target species, consumers and users. Owing to the uncertainty on the presence of viable cells of one of the production strains in the additive, the Panel could not conclude on the safety for the environment. The FEEDAP Panel concluded that AXTRA®XAP 104 TPT is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 U xylanase, 200 U amylase and 4,000 U protease per kg feed. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens. [ABSTRACT FROM AUTHOR]

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 APSA PHYTAFEED® 20,000 GR/L (6‐phytase) as a zootechnical feed additive for laying hens and other poultry species for laying. 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 three 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 irritant to skin or eyes or a dermal sensitiser but it should be considered as a respiratory sensitiser. The Panel considered that the new use in laying hens and other poultry species for laying would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial in laying hens and a subchronic oral toxicity study were made available to support the safety of the additive for the target species/categories subject of this new application; from the results obtained, the Panel concluded that the additive is safe for laying hens at the recommended level of use (300 U/kg feed) with a wide margin of safety and therefore the conclusion was extrapolated to other laying birds. The FEEDAP Panel concluded that the additive has the potential to be efficacious in laying hens at the level of 300 U/kg feed and this conclusion was extrapolated to other laying birds. [ABSTRACT FROM AUTHOR]

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 Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets and for all porcine species. This additive contains endo‐1,4‐β‐xylanase produced by a genetically modified strain of Bacillus subtilis and it is authorised in the European Union as a feed additive for poultry for fattening, weaned piglets and pigs for fattening. The applicant requested the extension of use of the additive to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of Belfeed B MP/ML in all Suidae species. The additive is not irritant for skin or eye but it should be considered a potential respiratory sensitiser for the users, the Panel could not conclude on the potential of the additive as a potential dermal sensitiser. Considering the results from a tolerance trial done in weaned piglets, those in a subchronic oral toxicity study and the nature/origin of the product under assessment the Panel concluded that the additive is safe for all porcine species at any developmental stage. The data previously assessed in piglets and pigs for fattening allowed to conclude that the additive is efficacious at 10 IU/kg feed in suckling piglets and all Suidae species from suckling to slaughter. The data submitted to support the efficacy for sows was considered insufficient and therefore the Panel could not conclude on the efficacy in sows. [ABSTRACT FROM AUTHOR]

PHYZYME®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®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. [ABSTRACT FROM AUTHOR]

The additive Hemicell®‐L is a liquid preparation of endo‐1,4‐β‐mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and considered to be safe. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) evaluated the genetic modification and concluded that the sequences introduced to obtain the production strain did not raise safety concerns. The production strain and its DNA were not detected in the additive. The Panel concluded that the additive is safe for chickens for fattening and turkeys for fattening at the recommended level. These conclusions were extended or extrapolated to the other target species under application. The Panel concluded that the results obtained in the toxicological studies performed with the fermentation products of the recipient strain and of another genetically modified strain obtained from the same recipient strain could support the safety for the consumer of the product obtained with the new production strain. The additive is not a dermal or eye irritant and it is not a dermal sensitiser. However, considering that the active substance is a protein, the additive should be regarded as a potential sensitiser. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for the target species at 79,200 U/kg. [ABSTRACT FROM AUTHOR]

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® X as a feed additive for rabbits for fattening. HOSTAZYM® 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. [ABSTRACT FROM AUTHOR]

The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the FEEDAP Panel concluded that the additive is safe for chickens for fattening, weaned piglets and pigs for fattening and that the use of this product as a feed additive raises no concerns for consumers of food products obtained from animals receiving it or for the environment. The FEEDAP Panel also concluded that the additive is not irritant to skin or eyes but should be considered as a potential skin and respiratory sensitiser. The Panel evaluated the efficacy of the additive and concluded that it has a potential to be efficacious in pigs for fattening at 1,500 EPU/kg feed. However, the Panel could not conclude regarding the efficacy of the additive for chickens for fattening and weaned piglets due to insufficient data/information. The applicant has now provided supplementary information in order to complement the information available supporting the efficacy of the additive. With the newly submitted efficacy studies and clarifications, the Panel concluded that the additive has a potential to be efficacious in chickens for fattening and weaned piglets at 1,500 EPU/kg feed. [ABSTRACT FROM AUTHOR]

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® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in 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, pigs for fattening and carps. The applicant has now requested to extend the authorisation to sows in order to have benefit in piglets. 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. The FEEDAP Panel concluded 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. A tolerance study was submitted to support the safety of the additive in the new target species/category. The results showed that sows tolerated well a 100‐fold the recommended enzyme activity level in feed. Consequently, the FEEDAP Panel concluded that the additive is safe for sows at 1,500 EPU/kg feed. A total of four studies were submitted to support the efficacy of the additive, one of which was not considered further in the assessment due to the high mortality registered in piglets. In the other three, a significant and positive effect on a relevant parameter was found in only one trial. Therefore, the Panel concluded that there is insufficient information to conclude on the efficacy of the additive. [ABSTRACT FROM AUTHOR]

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 muramidase produced by Trichoderma reesei DSM 32338 (Balancius™) as a feed additive for weaned piglets. The additive has been previously assessed by the FEEDAP Panel in the context of other applications, and in the current assessment the applicant requests for an extension of use. Based on the data available in a sub-chronic oral toxicity study, the Panel concluded that the additive is safe for weaned piglets at the maximum recommended level of 65,000 LSU(F)/kg feed. The additive is safe for the consumers and the environment but should be considered a potential respiratory sensitiser. The Panel could not conclude on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive has the potential to be efficacious as a zootechnical additive for weaned piglets at the dose of 50,000 LSU(F)/kg feed., (© 2021 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 Axtra ® XAP 104 TPT as a zootechnical feed additive (digestibility enhancers) for poultry species. The additive contains three enzyme activities (endo-1,4-beta-xylanase, protease and alpha-amylase) produced by three different genetically modified strains. Viable cells and recombinant DNA of the strains producing the protease and amylase were not detected in the final product. Owing to the insufficient data, uncertainty remained on the presence in the additive of viable cells of the strain producing the xylanase. The results obtained in the genotoxicity and subchronic oral toxicity studies performed with the three fermentation products did not indicate safety concerns resulting from the fermentation products used in the formulation/manufacturing. However, uncertainties remain on the suitability of the test item used in the studies conducted with the xylanase; therefore, the Panel was not in the position to conclude on the toxicological potential of AXTRA ® XAP 104 TPT. Consequently, the Panel could not conclude on the safety of the additive for the target species, consumers and users. Owing to the uncertainty on the presence of viable cells of one of the production strains in the additive, the Panel could not conclude on the safety for the environment. The FEEDAP Panel concluded that AXTRA ® XAP 104 TPT is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 U xylanase, 200 U amylase and 4,000 U protease per kg feed. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens., (© 2020 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 APSA PHYTAFEED ® 20,000 GR/L (6-phytase) as a zootechnical feed additive for laying hens and other poultry species for laying. 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 three 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 irritant to skin or eyes or a dermal sensitiser but it should be considered as a respiratory sensitiser. The Panel considered that the new use in laying hens and other poultry species for laying would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial in laying hens and a subchronic oral toxicity study were made available to support the safety of the additive for the target species/categories subject of this new application; from the results obtained, the Panel concluded that the additive is safe for laying hens at the recommended level of use (300 U/kg feed) with a wide margin of safety and therefore the conclusion was extrapolated to other laying birds. The FEEDAP Panel concluded that the additive has the potential to be efficacious in laying hens at the level of 300 U/kg feed and this conclusion was extrapolated to other laying birds., (© 2020 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 (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Natugrain ® TS/TS L. The additive is a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by two genetically modified strains of Aspergillus niger, and it is authorised for use in piglets (weaned) and pigs for fattening, poultry species and ornamental birds. The applicant requested the extension of use of the additive to sows at 560 TXU and 250 TGU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of the additive in sows. The additive should be considered a potential respiratory sensitiser for the users. Considering the results from a subchronic oral toxicity study and the tolerance study in lactating sows, the Panel concluded that the additive is safe for sows at the recommended dose. The data submitted to support the efficacy for sows allowed the Panel to conclude that the additive is efficacious in lactating sows, data on gestating sows were not given, and therefore, the Panel could not conclude on the efficacy of the additive in that physiological stage., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

AMAFERM ® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for cows. This scientific opinion concerns the renewal of the authorisation of this additive for its use in dairy cows. In its former opinion, the EFSA Panel on Additives and Product or Substances used in Animal Feed (FEEDAP), based on the data and knowledge available at that time, concluded that the additive is safe for cows, for the consumers and the environment. In that assessment, the Panel also concluded that the additive is non-irritant or a dermal sensitiser but should be considered a potential respiratory sensitiser. The applicant provided new information regarding the characterisation of the additive in terms of enzyme activities as well as information concerning the production strain. Regarding the enzyme activities in the fermentation product, weaknesses and limitations in the methods of analysis were noted. The information regarding the production strain did not permit to confirm its taxonomic classification, moreover uncertainty remains regarding the presence of viable cells/spores in the final product. Therefore, the FEEDAP Panel could not confirm the previously drawn conclusions regarding the safety of the production strain and consequently could not confirm the safety for the target species and consumers. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

PHYZYME ® 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 ® 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., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Natuphos ® is a feed additive that contains 3-phytase which is produced ■■■■■ 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., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The additive Hemicell ® -L is a liquid preparation of endo-1,4-β-mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and considered to be safe. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) evaluated the genetic modification and concluded that the sequences introduced to obtain the production strain did not raise safety concerns. The production strain and its DNA were not detected in the additive. The Panel concluded that the additive is safe for chickens for fattening and turkeys for fattening at the recommended level. These conclusions were extended or extrapolated to the other target species under application. The Panel concluded that the results obtained in the toxicological studies performed with the fermentation products of the recipient strain and of another genetically modified strain obtained from the same recipient strain could support the safety for the consumer of the product obtained with the new production strain. The additive is not a dermal or eye irritant and it is not a dermal sensitiser. However, considering that the active substance is a protein, the additive should be regarded as a potential sensitiser. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for the target species at 79,200 U/kg., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Natugrain ® Wheat TS is the trade name for a feed additive that contains endo-1,4-beta-xylanase produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, turkeys for fattening or reared for breeding, ducks, ornamental birds and minor avian species (except ducks and laying birds). This scientific opinion concerns the renewal of the authorisation of this additive for those species. 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 Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment under the authorised conditions of use. The additive is safe for the target species for which there is an authorisation, the consumers and the environment. The additive is a potential skin and dermal sensitiser. The present 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., (© 2019 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 (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM ® X as a feed additive for rabbits for fattening. HOSTAZYM ® 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., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The product Bergazym ® P100 contains a xylanase which is produced by a non-genetically modified strain of Trichoderma reesei . The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the FEEDAP Panel concluded that the additive is safe for chickens for fattening, weaned piglets and pigs for fattening and that the use of this product as a feed additive raises no concerns for consumers of food products obtained from animals receiving it or for the environment. The FEEDAP Panel also concluded that the additive is not irritant to skin or eyes but should be considered as a potential skin and respiratory sensitiser. The Panel evaluated the efficacy of the additive and concluded that it has a potential to be efficacious in pigs for fattening at 1,500 EPU/kg feed. However, the Panel could not conclude regarding the efficacy of the additive for chickens for fattening and weaned piglets due to insufficient data/information. The applicant has now provided supplementary information in order to complement the information available supporting the efficacy of the additive. With the newly submitted efficacy studies and clarifications, the Panel concluded that the additive has a potential to be efficacious in chickens for fattening and weaned piglets at 1,500 EPU/kg feed., (© 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 (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM ® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM ® X contains endo-1,4-beta-xylanase and is available in 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, pigs for fattening and carps. The applicant has now requested to extend the authorisation to sows in order to have benefit in piglets. 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. The FEEDAP Panel concluded 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. A tolerance study was submitted to support the safety of the additive in the new target species/category. The results showed that sows tolerated well a 100-fold the recommended enzyme activity level in feed. Consequently, the FEEDAP Panel concluded that the additive is safe for sows at 1,500 EPU/kg feed. A total of four studies were submitted to support the efficacy of the additive, one of which was not considered further in the assessment due to the high mortality registered in piglets. In the other three, a significant and positive effect on a relevant parameter was found in only one trial. Therefore, the Panel concluded that there is insufficient information to conclude on the efficacy of the additive., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The additive under assessment is a muramidase from Trichoderma reesei DSM 32338 which is to be used as a zootehcnical additive in feed for chickens for fattening and minor poultry species. The production strain is a genetically modified microorganism. The introduced genetic sequences do not give rise to safety concerns and no viable cells and no DNA of the production strain were detected in the additive. The results of a tolerance trial in chickens for fattening showed that the birds tolerated well 10-fold the highest recommended level of 45,000 LSU(F)/kg feed. Therefore, the Panel concluded that the additive is safe for chickens for fattening and extrapolated the conclusion to minor poultry species for fattening. The enzyme filtrate used to formulate the additive was tested in genotoxicity studies and in a subchronic oral toxicity study. The results of these tests did not indicate any reason for concern for consumer safety arising from the use of the product as a feed additive. Therefore, the Panel concluded that the additive is safe for the consumers. The Panel could not conclude on the potential of the additive for skin/eye irritancy or for its skin sensitisation potential. Owing to the proteinaceous nature of the active substance, the additive is considered to have potential for respiratory sensitisation. The FEEDAP Panel concluded that the use of this product as a feed additive poses no risks to the environment. The additive is to be used as a zootechnical additive, functional group other additives. To support the efficacy, the applicant submitted three efficacy studies with comparable design. The results showed significant and positive improvements on the feed to gain ratio of the birds receiving the additive at the lowest recommended level (25,000 LSU(F)/kg feed). This conclusion was extrapolated to minor poultry species for fattening., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Hemicell ® HT/HT-L is an additive that presents endo-1,4-β-mannanase produced by a genetically modified strain of Paenibacillus lentus . This additive is aimed to be used as a feed additive for chickens for fattening/reared for laying, turkeys for fattening/reared for breeding, weaned piglets, pigs for fattening and minor poultry and porcine species. In a previous assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) established the safety of the additive regarding the production strain, target species, consumer and user. However, limitations on the data regarding the absence of the production strain and its DNA did not permit to conclude on the safety of the additive for the environment. In that assessment, the Panel considered that the additive has a potential to be efficacious in the target species with the exception of pigs for fattening and in minor porcine species. The applicant provided new data to address the limitations identified. New data provided allowed the FEEDAP Panel to conclude that production strain and its recombinant DNA are not detected in the intermediate product used to formulate the additive. Therefore, the Panel concluded that the additive does not pose any environmental safety concern. Regarding the efficacy in pigs for fattening, the applicant provided a new analysis of the trials previously assessed which allowed the Panel to conclude that the additive has a potential to improve the feed to gain ratio at 32,000 U/kg feed. No data was provided regarding the efficacy in minor porcine species. However, considering the data available in major porcine species and that the mode of action of enzymes is well-known and can be reasonably be considered to be similar among porcine species the Panel extrapolated the conclusion drawn in pigs for fattening to minor porcine species for fattening., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

A total of 11 enzymes were assessed including alpha-amylase, endo-1,4-beta-glucanase, endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase as silage additives for all animal species. These enzymes are obtained by fermentation of bacterial or fungi non-genetically modified production strains. Throughout information regarding the production strains of each product were provided, including the origin and history of modifications and allowing their identification. The identification was conclusive for 8 of 10 production strains. For three of the strains, more information/data would still be required in order to conclude. Three of the amylases are produced by bacterial strains that belong to a species that is considered by EFSA to be suitable for the Qualified Presumption of Safety approach to safety assessment. The identity of the strains has been established and the qualifications were met, and consequently, those products were regarded as safe. For the products derived from fungal strains, the strains or resulting products were tested for the presence of secondary metabolites which could be of toxicological concern. These were found to be below the limits of detection or the strain not capable of producing them. Considering all the information provided by the applicant, the Panel concluded that these products can be regarded as safe for the target species, consumer and the environment. In the absence of data, the Panel could not conclude on the skin and eye irritancy or skin sensitisation potential of the products under evaluation. These products should be considered to have the potential to be a respiratory sensitiser. For some of the products under evaluation, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that they have a potential to improve the characteristic of the silage material; for some other products, the Panel could not conclude on their efficacy., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

ECONASE ® XT is an enzyme preparation with endo-1,4-β-xylanase which is authorised as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. The authorisation of the additive for laying hens is at 24,000 BXU/kg feed. The applicant asked for a modification on the conditions of use in laying hens, which consists in the reduction of the minimum recommended level from 24,000 BXU/kg feed to 12,000 BXU/kg feed. In previous opinions, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the safety of the product when used as a feed additive and concluded that the use of the product as a feed additive raises no concerns for consumer safety and no risks for the environment are expected. The Panel also concluded that the additive is non-irritant to the skin, and the liquid form is non-irritant to the eyes and is not a dermal sensitiser; however, it is considered a respiratory sensitiser. Regarding the use of the additive in laying hens, the Panel concluded that under the conditions of use the additive is safe for laying hens and that it can be efficacious at 24,000 BXU/kg. The results of the studies previously assessed showed in two cases improvements on the efficacy at the dose of 12,000 BXU/kg or below. The applicant provided two new studies which showed improvements at the new recommended dose on the performance of the laying hens in one trial and on the energy content in another trial. Therefore, the Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in laying hens at the dose of 12,000 BXU/kg feed., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

ECONASE ® XT is an enzyme preparation with endo-1,4-β-xylanase which is authorised as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. The authorisation of the additive for pigs for fattening is at 24,000 BXU/kg feed. The applicant asked for a modification on the conditions of use in pigs for fattening, which consists in the reduction of the minimum recommended level from 24,000 BXU/kg feed to 16,000 BXU/kg feed. In previous opinions, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the safety of the product when used as a feed additive and concluded that the use of the product raises no concerns for consumer safety and no risks for the environment are expected. The Panel also concluded that the additive is non-irritant to the skin, and the liquid form is non-irritant to the eyes and is not a dermal sensitiser; however, it is considered a respiratory sensitiser. Regarding the use of the additive in pigs for fattening, the Panel concluded that under the conditions of use, the additive is safe for pigs for fattening and that it can be efficacious at 24,000 BXU/kg. In the current application, the applicant provided three efficacy trials to support the efficacy at 16,000 BXU/kg feed. Two of these studies had been previously evaluated by the FEEDAP Panel and supported the efficacy at 16,000 BXU/kg feed. The third study revealed a significant effect of the additive on the feed to gain ratio in pigs for fattening at 20,000 BXU/kg feed (analysed content). The FEEDAP Panel concluded that the additive has a potential to be efficacious in pigs for fattening as a zootechnical additive at the dose of 20,000 BXU/kg feed., (© 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 (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., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

ENZY CARBOPLUS ® is an additive available in liquid and solid forms that contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase which are produced by two genetically modified strains of Komagataella pastoris . The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the production strains are safe and the genetic modifications raise no safety concerns. The Panel also concluded that the additive is safe for the target species at the recommended dosages and that its use as a feed additive raises no concern for consumers. The additive in either form is not a skin or eye irritant nor a dermal sensitiser; however, it is considered as a potential respiratory sensitiser. The production strains and their recombinant DNA were not detectable in the additive; moreover, the active substances of the additive will be degraded/inactivated during passage through the digestive tract of animals or in the environment, consequently, the Panel concluded that the additive poses no concerns to the environment. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in chickens for fattening at 4,000 LXU and 375 LGU per kg feed, in turkeys for fattening at 1,400 LXU and 120 LGU per kg feed, and in weaned piglets at 700 LXU and 60 LGU per kg feed. The Panel extended these conclusions to chickens reared for laying and turkeys reared for breeding at the corresponding doses. Since the mode of action of xylanase and glucanase can be reasonably assumed to be the same within avian or within porcine species, the Panel extrapolated the conclusions on the efficacy to all avian species up to the point of lay and to all porcine species. Owing to the lack of data, no conclusions could be drawn on the efficacy of the additive in laying hens., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Natuphos ® E is a feed additive that contains a 6-phytase available in powder, granulated and liquid forms which is intended to be used as a feed additive for avian and porcine species. The production strain of the phytase present in the product is a genetically modified strain of Aspergillus niger . The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the genetic modification of the production strain does not give rise to safety concerns. The production strain and its DNA were not detected in the concentrate used to formulate the products. 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. The Panel also concluded that the use of the product as a feed additive does not give rise to concerns for consumers. Evidence was provided showing that the additive is not toxic by inhalation or irritant for skin or eyes, however, it should be regarded as a dermal sensitiser and a potential respiratory sensitiser. The use of the additive as a feed additive poses no risks to the environment. Based on the efficacy studies provided, the Panel concluded that the additive has the potential to be efficacious in chickens for fattening, turkeys for fattening, piglets, pigs for fattening and sows. These conclusions were extended to chickens reared for laying, turkeys reared for breeding and extrapolated to minor poultry species and other avian species for fattening and to the point of lay and to minor porcine species. The Panel considered that there was insufficient information to conclude on the efficacy in laying hens., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

RONOZYME ® WX is an additive that contains endo-1,4-β-xylanase which is authorised for use as a feed additive in poultry for fattening, weaned piglets and pigs for fattening. The applicant has requested for an extension of the use to laying hens. The Panel on additives and Products or Substances used in Animal Feed (FEEDAP) delivered in 2012 an opinion on the safety and efficacy of RONOZYME ® WX when used as a feed additive for poultry, piglets (weaned) and pigs for fattening and another one in 2016 on the change of the production strain proposed by the applicant. In those opinions, the FEEDAP Panel concluded that the use of the product as a feed additive raises no concerns for consumer safety or for the environment. Considering the safety for the user, the Panel concluded that the additive is not a skin or eye irritant but could not conclude on its skin sensitisation potential; however, the additive was considered a potential respiratory sensitiser. The Panel considered that the new use of RONOZYME ® WX would not modify those conclusions. The applicant submitted a tolerance study in laying hens the results of which permitted the Panel to conclude that the additive is safe for laying hens at the recommended dose of 100 FXU/kg feed. In order to support the efficacy of the additive in laying hens, the applicant submitted three long-term trials. In all three trials, the groups receiving the xylanase at the recommended dose showed a lower feed intake and a better feed to egg mass ratio. However, in one of the three trials, these reductions were seen concurrently with a decrease in the laying rate. This result casts doubts on the efficacy of the additive, and therefore, the Panel considered that there was not sufficient evidence to conclude on the efficacy of the product., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

FRA ® Octazyme C Dry is a product that presents α-galactosidase, α-amylase, endo-1,3(4)-β-glucanase, endo-1,4-β-glucanase, mannan-endo-1,4-β-mannosidase, pectinase, protease and endo-1,4-β-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 six 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 ® 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 ® Octazyme C Dry as a feed additive poses no risks to the environment., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Beltherm MP/ML is a feed additive that contains endo-1,4-beta-xylanase to be used as a zootechnical additive in poultry species. The production strain of the xylanase is a genetically modified strain of Bacillus subtilis . This species is considered by EFSA to qualify for the qualified presumption of safety (QPS) approach to safety assessment. The strain was unequivocally identified and qualifications were met. The genetic modification along with the results on the investigations regarding the presence? of the production strain and its DNA in the product were evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and raised no safety concerns. The FEEDAP Panel also concluded that the additive is safe for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species at 100 ADXU/kg feed with a wide margin of safety. The Panel also concluded that no toxicological concerns for the consumer would arise from the use of Beltherm as a feed additive. The additive is considered a potential respiratory sensitiser for users. The Panel concluded that the use of the product as a feed additive raises no safety concerns for the environment. The additive has the potential to improve the performance of chickens for fattening, chickens reared for laying and minor growing poultry species at the dose of 100 ADXU/kg feed. The Panel could not conclude on the efficacy of the product in turkeys for fattening or reared for breeding or in turkeys for breeding purposes., (© 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 (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM ® X. The additive HOSTAZYM ® X is a preparation of endo-1,4-β-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 Panel adopted 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 ( Cyprinus carpio ). 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. The FEEDAP Panel concluded 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 1,050 endo-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 1,050 EPU/kg feed., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Amylofeed ® is a preparation of endo-1,3(4)-β-glucanase, endo-1,4-β-xylanase and α-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., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The additive OPTIPHOS ® is a preparation of 6-phytase that is authorised for use in avian species, weaned piglets, pigs for fattening and sows. The applicant seeks for an extension of use of the product to finfish, at a dose range between 250 and 1,000 OTU/kg feed. The FEEDAP Panel concluded in a previous opinion that there are no concerns for consumer safety and no risks for the environment are expected from the use of the product as feed additive. Moreover, it was concluded that the additive is not a skin/eye irritant or a skin sensitiser, but has the potential to be a respiratory sensitiser. The Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. The results of a tolerance study performed in juvenile rainbow trout ( Oncorhynchus mykiss ) showed no negative effects of the additive on the fish when offered up to 100 times the maximum recommended dose. Therefore, the Panel concluded that the additive is safe for the rainbow trout and extrapolated this conclusion to all finfish. The Panel evaluated three efficacy trials, two performed in rainbow trout and one in Atlantic salmon ( Salmo salar ). In these studies, the performance of the fish was monitored as well as phosphorus digestibility and phosphorus retention parameters. In the three trials, the performance and the phosphorus retention were improved by the additive at the lowest tested dose (in rainbow trouts at 250 OTU/kg feed and in Atlantic salmon at 500 OTU/kg feed). The FEEDAP Panel concluded that the additive has a potential to be efficacious in rainbow trout and salmon at 500 OTU/kg. The Panel extrapolated the conclusion to all finfish species., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Endofeed ® DC is a preparation of endo-1,3(4)-β-glucanase and endo-1,4-β-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., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Bergazym ® P is a preparation of endo-1,4-β-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., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Hemicell ® HT is a feed additive with endo-1,4-β-d-mannanase as the main enzymatic activity that is available in solid (HT) and liquid (HT-L) forms. The production strain of the enzyme is a genetically modified strain of Paenibacillus lentus . The recipient strain is considered to be safe, the sequences introduced to obtain the production strain do not raise safety concerns. The absence of the production strain and of recombinant DNA in the product was not proven. The additive is safe for the target species at the corresponding recommended doses. The use of Hemicell ® HT as a feed additive does not give rise to concerns for consumers. Hemicell ® HT and Hemicell ® HT-L are not irritant to the skin and eyes; Hemicell ® HT is a skin sensitiser. No specific data were provided on the effects on the respiratory system; however, considering the nature of the active substance, the additive is considered a potential respiratory sensitiser. The active substance of the additive is a protein, and as such, it will be degraded/inactivated during passage through the digestive tract of the animals or in the environment. However, uncertainty remains on the absence of the production strain and of recombinant DNA in the product, consequently, the EFSA FEEDAP Panel could not conclude on the environmental safety of the product with regard to the genetically modified production strain. The additive has the potential to be efficacious in chickens for fattening at 32,000 U/kg feed and at 48,000 U/kg feed in turkeys for fattening and weaned piglets. These conclusions were extended to chickens reared for laying and turkeys reared for breeding and extrapolated to minor poultry species for fattening or reared for laying/breeding. The Panel could not conclude on the efficacy of the product in pigs for fattening or in minor porcine species., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)