Assessment of the feed additive consisting of Lactiplantibacillus plantarum (previously Lactobacillus plantarum) DSM 19457 for all animal species for the renewal of its authorisation (Biomin GmbH).

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 assessment of the application for renewal of authorisation of Lactiplantibacillus plantarum (previously Lactobacillus plantarum) DSM 19457 as a technological additive for use in forage for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive is not irritant to skin or eyes but owing to its proteinaceous nature, it should be considered a respiratory sensitiser. In the absence of data, no conclusions could be drawn on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of Lentilactobacillus diolivorans (formerly Lactobacillus diolivorans) DSM 33625 as a silage additive for all animal species (Lactosan GmbH & Co.KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lentilactobacillus diolivorans (formerly Lactobacillus diolivorans) DSM 33625 when used as a technological additive to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg forage. The bacterial species L. diolivorans is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive is not a skin or an eye irritant. In the absence of data, no conclusion can be drawn on the skin sensitisation of the additive. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The FEEDAP Panel concluded that Lentilactobacillus diolivorans DSM 33625 at a minimum concentration of 1 × 108 CFU/kg forage may extend the aerobic stability of silage prepared from easy and moderately difficult to ensile forage material with a DM range of 32-65%.

Safety and efficacy of a feed additive consisting of endo-1,3(4)-beta-glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG).

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 endo-1,3(4)-beta-glucanase produced by Aspergillus fijiensis CBS 589.94 (RONOZYME® VP (CT/L)) as a zootechnical feed additive for chickens for fattening and weaned piglets. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats and the tolerance trials provided, the additive was considered safe for chickens for fattening and weaned piglets at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not rise concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel could not conclude on the potential of the additive to be irritant to skin and eyes or on its potential as a dermal sensitiser. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The Panel concluded that the additive is efficacious as a zootechnical additive in chickens for fattening and weaned piglets at the minimum recommended level of 10 FBG/kg feed.

Efficacy of a feed additive consisting of 6-phytase produced by Komagataella phaffii CGMCC 12056 (APSA PHYTAFEED® 20,000 GR/L) for pigs for fattening (Andrés Pintaluba S.A).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6-phytase produced by the genetically modified strain Komagataella phaffii CGMCC 12056 (APSA PHYTAFEED® 20,000 GR/L) as a zootechnical feed additive (functional group: digestibility enhancers) for pigs for fattening at a minimum recommended level of 1,000 U /kg feed. In a previous assessment, three trials were submitted; one of them showed significant improvements on zootechnical parameters supporting the efficacy of the additive. The other two trials evaluating apparent faecal phosphorus digestibility and bone mineralisation, showed no improvements on phosphorus retention in bone and, therefore, the FEEDAP Panel could not conclude on the efficacy of the additive. The applicant submitted two new efficacy studies in pigs for fattening evaluating the animal's zootechnical performance, apparent faecal phosphorus digestibility and bone mineralisation. One of the trials was not considered due to high rates of mortality, culling of animals and medical treatments applied. In the other trial, significant improvements on final body weight and apparent total track phosphorus digestibility were found in the animals that received the phytase at 1,000 U/kg complete feed. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of the additive in pigs for fattening.

Assessment of the feed additive consisting of Lactiplantibacillus plantarumLMG P-21295 for all animal species for the renewal of its authorisation (Chr. Hansen A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum LMG P-21295, a technological additive to improve ensiling of fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. The Panel is not in the position to conclude on the skin and eye irritation potential of the additive. No conclusions can be drawn on the potential of the additive to cause skin sensitisation, but it is considered to be a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Petroselinum crispum (Mill.) Fuss (parsley tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, 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 a tincture derived from the fruit of Petroselinum crispum (Mill.) Fuss (parsley tincture) when used as a sensory feed additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 0.82%. The product contained 0.0198% polyphenols (of which 0.0085% were flavonoids), apiole (0.0083%), elemicin (0.0015%) and myristicin (0.0011%). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the parsley tincture is safe at the maximum proposed use levels of 200 mg/kg complete feed for horses and 50 mg/kg complete feed for all other animal species. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount which is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of parsley tincture up to the maximum proposed use levels in feed. Parsley tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to apiole, elemicin and myristicin cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of parsley tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of P. crispum and its preparations were recognised to provide flavour in food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Foeniculum vulgare Mill. ssp. vulgare var. dulce (sweet fennel tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the fruit of Foeniculum vulgare Mill. ssp. vulgare var. dulce (sweet fennel tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 2.16%. The product contained 0.0586% polyphenols (of which 0.0052% were flavonoids), anethole (0.0006%), anisaldehyde (0.0035%) and estragole (0.0006%). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that sweet fennel tincture is safe at the maximum proposed use levels of 200 mg/kg complete feed for horses and 50 mg/kg complete feed for all other animal species. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount which is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of sweet fennel tincture up to the maximum proposed use levels in feed. Sweet fennel tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to estragole cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. F. vulgare is native to Europe. The use of sweet fennel tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of F. vulgare and its preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Efficacy of the feed additive consisting of Bacillus velezensis NRRL B-67257 (Correlink™ ABS747) as a feed additive for all growing poultry species (Elanco GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of a product consisting of viable spores of Bacillus velezensis NRRL B-67257 as a zootechnical additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species. The additive has the tradename Correlink™ ABS747 Bacillus subtilis and is not currently authorised in the European Union. It is intended for use in complete feed for the target species at a minimum inclusion level of 1.5 × 108 CFU/kg complete feed. In a previous opinion the FEEDAP Panel could not conclude on the efficacy of the additive for the poultry species due to the potential cross-contamination of the control diets in two of the three studies provided. The applicant has provided supplementary information to exclude this possibility. The new data showed that the gene used as marker in the previous analyses is non-specific of the NRRL B-67257 strain, which precluded the adequate quantification of the active agent in the feeds used in the studies. Moreover, in a second analysis, the active agent could not be isolated from the field excreta samples collected from either from the treated or the control group of one of the formerly submitted efficacy studies. The Panel concluded that the methodology was not able to discriminate between the strain under assessment and the background. Therefore, the FEEDAP Panel was not in the position to conclude on the efficacy of Correlink™ ABS747 for all growing poultry species based on the data newly provided.

Safety and efficacy of the feed additive consisting of 6-phytase (produced by Aspergillus oryzaeDSM 33699) (RONOZYME® Hiphos GT/L) for poultry, pigs for fattening, weaned piglets and sows (DSM Nutritional Products Ltd).

The additive RONOZYME® Hiphos (GT/L) contains 6-phytase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae, it is currently authorised for poultry, pigs for fattening, weaned piglets and sows. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 22594 for A. oryzae DSM 33699. RONOZYME® Hiphos (GT/L), manufactured with the production strain A. oryzae DSM 33699, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its recombinant DNA were detected in an intermediate product representative of both final forms of the additive. RONOZYME® Hiphos (GT/L) was considered safe for poultry, pigs for fattening, weaned piglets and sows at the recommended inclusion levels of 500-4,000 FYT/kg complete feed. The use of RONOZYME® Hiphos GT and L manufactured with the production strain A. oryzae DSM 33699 raised no concerns for consumers. In the absence of data on the final formulations, the Panel could not conclude on the potential of the additive to be irritant to eyes or skin, or a skin sensitiser. Due to the proteinaceous nature of the active substance, the additive was considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33699 raises no safety concerns for the environment. The additive has the potential to be efficacious in poultry, pigs for fattening, weaned piglets and sows at 500 FYT/kg complete feed.

Assessment of the efficacy of a feed additive consisting of ferrous lysinate sulfate for all animal species (Phytobiotics Futterzusatzstoffe GmbH).

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 ferrous lysinate sulfate for all animal species. The safety of the additive for the target species, consumer, user and the environment has already been assessed previously, however the efficacy remained inconclusive due to limitations in the study with chickens for fattening. In the present assessment, the applicant submitted a new efficacy study in weaned piglets. After the assessment of the new data submitted by the applicant, the FEEDAP Panel could not conclude on the efficacy of ferrous lysinate sulfate in weaned piglets.

Efficacy of a feed additive consisting of Bacillus subtilis strains CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 for all animal species (MiXscience).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of the preparation consisting of viable cells of Bacillus subtilis CNCM I-4606, B. subtilis CNCM I-5043, B. subtilis CNCM I-4607 and Lactococcus lactis CNCM I-4609 when used as a technological additive (hygiene condition enhancer) for all animal species. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for the target species, consumers and the environment. The Panel also considered the additive to be non-irritant to skin and eyes, nor a dermal sensitiser, but a respiratory sensitiser. Moreover, the data provided were not sufficient to conclude on the efficacy of the additive to significantly reduce the growth of Salmonella Typhimurium or Escherichia coli in feed. In the current assessment, the applicant provided supplementary information to address these flaws and limited the claimed effect to 'prevent (re)contamination by Salmonella Typhimurium'. Based on the new studies, the Panel concluded that the additive at a minimum proposed inclusion level of 1 × 109 colony forming units (CFU) B. subtilis and 1 × 109 CFU L. lactis per litre showed potential to reduce Salmonella Typhimurium growth in feeds with high moisture content (60-90% moisture).

Safety of 27 flavouring compounds providing a milky-vanilla flavour and belonging to different chemical groups for use as feed additives in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 27 compounds to provide a milky-vanilla flavour belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fifteen of the 27 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. No adverse effects were observed in the tolerance studies at 10-fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 15 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 12 compounds, read-across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 12 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer from the use of the 27 compounds up to the highest levels considered safe for target animals. No new data were submitted on the safety for the user that would allow the FEEDAP Panel to change its previous conclusion for 5-methylhept-2-en-4-one [07.139], 5-methylfurfural [13.001] and 4-phenylbut-3-en-2-one [07.024]. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Anethum graveolens L. (dill tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the fruit of Anethum graveolens L. (dill tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 0.9%. The product contained 0.0247% polyphenols (of which 0.0137% were flavonoids) and 0.003% carvone. Estragole was present at concentrations between the limit of detection and the limit of quantification in the five batches examined. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the dill tincture is safe at the maximum proposed use levels of 200 mg/kg complete feed for horses and 50 mg/kg complete feed for all other animal species. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount which is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of dill tincture up to the maximum proposed use levels in feed. Dill tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to estragole cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of dill tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of A. graveolens and its preparations were recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety of a feed additive consisting of sodium saccharin for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sodium saccharin as a sensory feed additive (flavouring compound) for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening. In a previous assessment, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) could not conclude on the safety of the additive for the environment because concentrations of the additive or its degradation product 4-hydroxysaccharin in groundwater above 0.1 µg/L were likely to occur. In addition, regarding user safety, sodium saccharin was considered to be potentially harmful by inhalation or by contact to skin and eyes. In the current opinion, the applicant restricted the use to suckling and weaned piglets and up to a use level of 5 mg/kg complete feed. In relation to the user safety, the additive was neither a skin or eye irritant, nor a dermal sensitiser. In the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be toxic by inhalation. Regarding the safety of the additive for the environment, the new conditions of use describe a maximum use level of 5 mg sodium saccharin/kg feed. The applicant indicated that a restriction to a lower use level due to environmental safety would be accepted and submitted an environment risk assessment based on a use level of 1.13 mg sodium saccharin/kg feed. This use level cannot be considered safe. The estimated use level that would result in a concentration in groundwater below 0.1 µg/L is of 0.022 mg sodium saccharin/kg feed. The available data do not allow to conclude on the potential effect of the degradation product 4-hydroxysaccharin in ground water.

Safety and efficacy of a feed additive consisting 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 (Genencor international B.V.).

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.

Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of ammonium chloride (Amoklor™) as a zootechnical additive for all ruminants, dogs and cats and its extension of use in sows for urinary health. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for ruminants other than lambs for fattening, lambs for fattening, cats and dogs, consumers and the environment under the current authorised conditions of use. Inhalation exposure of the additive is considered very likely. Amoklor™ should be considered a potential respiratory sensitiser but not a skin sensitiser. The additive is not irritant to the skin, but the Panel could not conclude on its eye irritation potential. 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 the context of the renewal of the authorisation. Regarding the extension of use in sows, the FEEDAP Panel concludes that the additive is safe and efficacious for sows at the inclusion level of 5,000 mg/kg feedingstuffs from week 9th to 11th of gestation and from week 15th of gestation to 1st of lactation.

Safety and efficacy of a feed additive consisting of Bacillus velezensis ATCC PTA-6737 (Bacillus velezensis PB6) for turkeys for fattening, turkeys reared for breeding, laying hens, minor poultry species for laying, piglets (weaned), weaned minor porcine species and sows (Kemin Europe N.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bacillus subtilis ATCC PTA-6737 (Bacillus subtilis PB6) when used as a feed additive for turkeys for fattening, turkeys reared for breeding, laying hens, minor poultry species for laying, piglets (weaned), weaned minor porcine species and sows. With this application, the company requested the modification of the current authorisations as regards the strain taxonomy from B. subtilis ATCC PTA-6737 to Bacillus velezensis ATCC PTA-6737. The FEEDAP Panel concluded that the active agent of B. subtilis PB6 should be taxonomically designated as B. velezensis ATCC PTA-6737. The Panel also concluded that Bacillus velezensis PB6 is presumed safe for the target species, consumers and the environment and is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. The Panel reiterated the previous conclusions reached on the efficacy of the additive when used with the target species.

Safety of feed additives consisting of ß-damascone [07.083] and (E)-ß-damascone [07.224] belonging to chemical group 8 for use in all animal species (FEFANA asbl).

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 supplementary information submitted on the safety of ß-damascone [07.083] and (E)-ß-damascone [07.224] belonging to chemical group 8, when used as sensory additives (flavourings) in feed for all animal species. The additives are already authorised for use in all animal species. According to previous assessments, the additives were considered safe for the target species, the consumer and the freshwater environment. For the marine environment, the safe use level for the two substances was estimated to be 0.05 mg/kg feed. Hazards for skin and eye contact, and respiratory exposure were recognised for the majority of the compounds belonging to chemical group 8. In the absence of ecotoxicity data, the FEEDAP Panel could not conclude on the safety of ß-damascone [07.083] and (E)-ß-damascone [07.224] for the terrestrial compartment. The applicant has provided new data (a chronic toxicity test on earthworms) to address the issue previously identified regarding the environmental safety of ß-damascone [07.083] for the terrestrial compartment. The use of ß-damascone [07.083] and (E)-ß-damascone [07.224] as feed additives is considered safe for the terrestrial and freshwater environment.

Safety of 37 feed additives consisting of flavouring compounds belonging to different chemical groups for use in all animal species (FEFANA asbl).

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 supplementary information submitted on the safety of 37 compounds belonging to different chemical groups, when used as sensory additives (flavourings) in feed for all animal species formerly assessed by the Panel in the context of the re-evaluation of these feed additives. The FEEDAP Panel concludes that ethyl oleate [09.192] and benzyl cinnamate [09.738] are safe at the proposed use level of 5 mg/kg complete feed for all animal species, the consumer and the environment; ethyl salicylate [09.748] is safe up to the maximum proposed use level of 5 mg/kg complete feed for all animal species and the consumer. No new data were submitted on the safety for the user that would allow the FEEDAP Panel to change its previous conclusion for 26 out of the 37 compounds under assessment. The use of 4-terpinenol [02.072], linalyl butyrate [09.050], linalyl formate [09.080], linalyl propionate [09.130], linalyl isobutyrate [09.423], isopulegol [02.167] and 1,2-dimethoxy-4-(prop-1-enyl)-benzene [04.013] as flavouring additives at the proposed use level of 5 mg/kg in feed for all animal species is considered safe for the environment. The use of 3-methyl-2-cyclopenten-1-one [07.112] at 0.5 mg/kg and methyl dihydrojasmonate [09.520] at 5 mg/kg in feed for all animal species except marine animals is considered safe for the environment.

Safety and efficacy of a feed additive consisting of 6-phytase (produced by Komagataella phaffii DSM 23036) (OptiPhos®) for poultry for fattening, chickens reared for laying, laying hens, turkeys reared for breeding, weaned piglets, pigs for fattening and sows for the renewal of their authorisation and for the new use in breeding hens and turkeys, ornamental birds, suckling piglets and minor pig species for fattening and breeding (Huvepharma EOOd).

OptiPhos® is the trade name of the feed additive under assessment containing 6-phytase produced by a genetically modified strain of Komagataella phaffii. It is authorised for use in chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, other avian species for fattening, laying hens, weaned piglets, pigs for fattening and sows. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation and the extension of use to breeding hens, turkeys for breeding purposes, ornamental birds, minor pig species for fattening or breeding and suckling piglets for the period when solid feed is given. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider previous conclusions that the additive remains safe for the animal species/categories, the consumer and the environment under the authorised conditions of use. This conclusion applies also to the new target species/categories for which a request of extension of use is made. The additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. There was no need for assessing the efficacy of the additive for the authorised species/categories. The additive has the potential to be efficacious at 125 OTU/kg complete feed in all poultry species other than turkeys, ornamental birds, pigs for fattening, sows and minor pig species for fattening or breeding; and in turkeys for fattening, reared for breeding and for breeding purposes, weaned piglets and suckling piglets (for the period when solid feed is given) at 250 OTU/kg feed.