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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 ROVABIO® ADVANCE (liquid and solid) which contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 as a zootechnical feed additive for weaned piglets at the recommended use level of 1800 U xylanase and 1250 U glucanase per kg feed. In a previous assessment, three long‐term trials in weaned piglets were submitted. Two of them were considered to support the efficacy of the additive while a third trial was not further considered due to the large number of veterinary treatments applied. A new trial was provided to support the efficacy of the additive, but it did not show a significant improvement of the performance parameters at the minimum recommended use level. Due to the lack of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive for the target species. [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 6‐phytase produced by the genetically modified strain Aspergillus oryzae DSM 33737 (HiPhorius™ 10, 40, 20L and 50L) as a zootechnical feed additive for all poultry, all Suidae and all fin fish. The FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry, all Suidae and all fin fish at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive is of no concern for the consumers and the environment. The liquid formulations of the additive are not skin or eye irritants. The two solid ones are not skin irritants but are eye irritants. Owing to the lack of data, the Panel cannot conclude on the skin sensitisation of the final formulations of the additive. Due to the proteinaceous nature of the active substance (6‐phytase), the additive is considered a respiratory sensitiser. The Panel concludes that the additive is efficacious when included in the diet of poultry for fattening or reared for laying/breeding, reproductive Suidae, and all fin fish. Due to the lack of sufficient data, the Panel could not conclude on the efficacy for laying and reproductive poultry and growing Suidae. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐β‐xylanase produced by Komagataella phaffii ATCC PTA‐127053 (Xygest™ HT) as a zootechnical feed additive (functional group: digestibility enhancers) for all Suidae at a recommended minimum level of 90,000 U/kg complete feed for pigs in the growing period and 45,000 U/kg complete feed for sows. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that the additive is safe at the minimum recommended use level for all growing Suidae and all sows in the lactating phase. Xygest™ HT was considered safe for the consumers and for the environment when used in feed for all Suidae. The additive was considered not to be irritant to eyes and skin, but was considered as a dermal and respiratory sensitiser. In the absence of sufficient data, the FEEDAP Panel was not in the position to conclude on the efficacy of Xygest™ HT for all Suidae. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. The product, manufactured in three formulations (microsphere, micropellet and powder), is intended for use in complete feed at a minimum inclusion level of 3 × 109 CFU/kg complete feed for horses, 4 × 108 CFU/kg complete feed for dairy cows and minor dairy species, 4 × 109 CFU/kg complete feed for calves, cattle for fattening, minor growing and fattening ruminants, piglets and pigs for fattening and minor porcine species and 6 × 109 CFU/kg complete feed for sows and minor porcine species for reproduction. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was conclusively established and, therefore, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive, in any formulation, is not irritant to the eyes and skin but should be considered a respiratory sensitiser. The Panel cannot conclude on the skin sensitisation potential of the additive. The Panel concluded that the additive has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs. However, the Panel was not in the position to conclude on the efficacy of the additive for calves, and neither for cattle for fattening, minor growing and fattening ruminants. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a pancreatic extract (Pan‐zoot) as a zootechnical additive for dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of Pan‐Zoot as a feed additive for dogs under the proposed conditions of use. The FEEDAP Panel could not conclude on the skin/eye irritancy potential of the additive or on the dermal sensitisation potential. Owing to its proteinaceous nature, the additive is considered a respiratory sensitiser. The additive may induce allergic reactions to the exposed users. The Panel concluded that there is no need for an environmental risk assessment. The FEEDAP Panel could not conclude on the efficacy of the product as a feed additive at the recommended conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525, Axtra® XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the ■■■■■ used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase. Moreover, the Panel could not conclude on the efficacy in laying hens. The applicant submitted some new information to address some of the limitations previously identified. Moreover, the applicant declared a change in the production strain of the protease, substituting B. subtilis ATCC SD‐2107 for B. subtilis CBS 148232. The Panel concluded that the additive is safe for the target species at the recommended use level (1,000 xylanase U, 100 amylase U and 2,000 protease U per kg feed). The additive is safe for the consumers of food products obtained from animals fed with the additive and raises no concerns for the environment. The Panel could not conclude on the skin/eye irritancy potential of the additive nor on its dermal sensitisation potential. Owing to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive 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 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level). 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 6‐phytase (VTR‐phytase) as zootechnical feed additive for all pigs and all avian species. The additive VTR‐phytase consists of 6‐phytase and it is available in solid and liquid forms. VTR phytase (liquid/solid) was produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.370). The genetic modification of the production strain does not give rise to safety concerns. Viable cells of the production strain and its DNA were not detected in the final products. The additive does not pose any safety concern regarding the production strain. VTR phytase (liquid/solid) produced by Komagataella phaffii CGMCC 7.370 is safe for all Suidae and all avian species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid VTR phytase and powder VTR phytase are non‐irritant to skin or eyes but should be considered skin and respiratory sensitisers. The additive has the potential to be efficacious in laying hens at 1,000 U phytase/kg complete feed. The conclusion can be extrapolated to other birds for egg production or breeding. The FEEDAP Panel cannot conclude on the efficacy of all pigs or growing poultry species. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) as a zootechnical additive for poultry species, pigs for fattening and minor porcine species. The production strain (CECT 13171) is genetically modified and was developed from a strain that had been previously assessed by the FEEDAP Panel. The genetic modifications present in K. phaffii CECT 13171 do not raise safety concerns and no recombinant DNA was detected in the final formulations of the additive (FSF10000/FLF1000). However, the Panel could not conclude on the identity of the production strain and uncertainty remained on the possible presence of viable cells of the production strain in the final formulations. Owing to these uncertainties, the FEEDAP Panel could not conclude on the safety of the additive regarding the production strain. The additive in either form is not irritant to eyes and skin, the liquid formulation is not a dermal sensitiser but the solid formulation is, and the two formulations should be considered potential respiratory sensitisers. The FEEDAP Panel concluded that the 3‐phytase present in the additive is safe for the target species at a level of 1,000 FTU/kg feed and that would not raise safety concerns for the environment. However, considering the uncertainties on the identification of the production strain and the possible presence of viable cells in the final formulations, the Panel could not conclude on the safety of the additive for the target species, consumer, users, and the environment. The FEEDAP Panel concluded that the additive is efficacious at 500 FTU/kg feed in poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species and at 1,000 FTU/kg feed in 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 the product EnzaPro containing viable cells/spores of strains of Bacillus velezensis (DSM 21836) and Bacillus licheniformis (ATCC 53757) and an endo‐1,4‐β‐xylanase produced by a genetically modified strain of Komagataella phaffii (DSM 33574) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. The strains B. velezensis DSM 21836 and B. licheniformis ATCC 53757 were considered to meet the qualified presumption of safety (QPS) requirements. The K. phaffii xylanase production strain is genetically modified. No viable cells and no recombinant DNA of the genetically modified production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the xylanase production strain. EnzaPro is safe for all poultry species for fattening or reared to the point of lay at the proposed conditions of use. The FEEDAP Panel concluded that the use of EnzaPro in animal nutrition is safe for the consumers and the environment. EnzaPro is not a skin irritant but should be considered an eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. Due to the lack of data, the FEEDAP Panel could not conclude on the efficacy of EnzaPro for the target species. EnzaPro is compatible with diclazuril, halofuginone and nicarbazin. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 6‐phytase produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.19) (Nutrase P) for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds. The additive is available in solid (Nutrase PD 100,000, Nutrase PG 10,000 and Nutrase PTS 10,000) and liquid (Nutrase PL 10,000) forms. In 2020, the FEEDAP Panel issued an opinion on the safety and efficacy of the product and concluded that uncertainties remained on the presence of viable cells and recombinant DNA of the production strain in two of the formulations (Nutrase PL 10,000 and Nutrase PD 100,000). Moreover, the Panel could not conclude on the safety and the efficacy of the additive for the target species at the recommended level of 250 FTU/kg complete feed. The applicant provided supplementary information to address the limitations identified in that assessment and requested to increase the minimum recommended use level to 500 FTU/kg complete feed. No viable cells and recombinant DNA of the production strain were detected in Nutrase PL 10,000 and Nutrase PD 100,000. Therefore, the Panel concluded that the additive, in any formulations, does not pose any safety concern with regard to the production strain. Based on the results of a new tolerance trial, the Panel concluded that Nutrase P is safe for the target species. The additive in any formulation is safe for the consumers and the environment, but should be considered a respiratory sensitiser. Considering the two long‐term trials in chickens for fattening previously evaluated and the new trial submitted, the Panel concluded that the additive is efficacious in chickens for fattening, other poultry species for fattening or reared for laying and ornamental birds at 1,500 FTU/kg complete feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO® ADVANCE (liquid and solid) which contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase. The enzymes present in the additive are produced by two strains of Talaromyces versatilis, one of them genetically modified. The additive is intended to be used as a feed additive for weaned piglets and pigs for fattening. Viable cells of the production strains and DNA of the genetically modified strain were not detected in the fermentation product used to formulate the additive. Based on the results of a tolerance trial in weaned piglets, the FEEDAP Panel concluded that ROVABIO® ADVANCE is safe for weaned piglets under the recommended conditions of use. This conclusion was extended to pigs for fattening. Based on the outcome of the toxicological studies performed, the Panel concluded that the additive is of no concern regarding consumer safety. ROVABIO® ADVANCE is not irritant to the skin or eyes but it is a skin and respiratory sensitiser. No risks to the environment are expected from the use of the additive in animal nutrition. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of ROVABIO® ADVANCE. [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. [ABSTRACT FROM AUTHOR]

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 dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non‐irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-b-xylanase (Beltherm MP/ML), produced by a genetically-modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panel concluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panel concluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panel concluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panel concluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panel could not conclude on the efficacy of the product for the target species for which the application was made. [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]

Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has requested for the authorisation in new species/categories. The Panel considered that the new use would not introduce hazards that have not already been considered. Therefore, it was concluded that the additive is safe for the consumers and the environment. Considering the safety for the user, the Panel concluded that the additive, in either form, is not toxic by inhalation or irritant for skin or eye but it is considered a potential respiratory sensitiser. The Panel could not conclude on the dermal sensitisation potential of the additive. In a trial with weaned piglets, the animals tolerated well a 200‐fold the level recommended in feed by the applicant; therefore, the Panel concluded that the additive is safe for weaned piglets, pigs for fattening and minor porcine species at the recommended level. Based on the data provided to support the efficacy of the additive in weaned piglets and pigs for fattening, the Panel concluded that the additive has the potential to be efficacious at the recommended level in those species/categories. The conclusions on the safety and efficacy for weaned piglets and pigs for fattening were extrapolated to minor porcine species. [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]

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]