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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of eight technological additives, including two Lactiplantibacillus plantarum (formerly Lactobacillus plantarum ) [CNCM I-3235 and CNCM I-3736/ DSM 11672], two Pediococcus acidilactici [CNCM I-3237 and CNCM I-4622/DSM 11673] , one Pediococcus pentosaceus [NCIMB 12455], one Acidipropionibacterium acidipropionici (formerly Propionibacterium acidipropionici ) [CNCM I-4661], one Lentilactobacillus buchneri (formerly Lactobacillus buchneri ) [NCIMB 40788/ CNCM I-4323], and the additive composed by the two active agents L. buchneri NCIMB 40788/ CNCM I-4323 and Lentilactobacillus hilgardii (formerly Lactobacillus hilgardii ) CNCM I-4785, as silage additives for use in forage for all animal species. The applicant has provided evidence that the additives currently on the market comply 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 concluded that the additives remain safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additives should be considered as respiratory sensitisers. In the absence of data, no conclusions could be drawn on the skin sensitisation, and skin and eye irritancy potential of the additives, with the exception for Pediococcus acidilactici CNCM I-4622/DSM 11673 (for which the Panel concluded that is non-irritant to skin and eyes). There is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of a tincture derived from Gentiana lutea L. (gentian tincture). It is intended to be used as a sensory additive for all animal species. The product is a water/ethanol solution, with a dry matter content of approximately 4.3% and it contains on average 0.0836% polyphenols (of which 0.0463% are flavonoids and 0.0027% xanthones) and 0.0022% gentiopicroside. The additive is intended for use in complete feed or drinking water up to a maximum level of 50 mg tincture/kg for all animal species, except horses, for which the proposed use is 200 mg/kg in complete feed. In a previous assessment, due to the genotoxic potential identified in vitro for xanthones (gentisin and isogentisin) and gentiopicroside the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for long-living animals and on risks of genotoxicity and carcinogenicity for dermal exposure of unprotected users. The additive did not raise safety concern for short-living animals, consumers and the environment. The applicant has provided information in the form of literature to address the previously identified genotoxic activity of xanthones and gentiopicroside and the risk for the user. Considering that the literature identified provided no new evidence, the FEEDAP Panel reiterated that it is not in a position to conclude on the safety of the additive for long-living and reproductive animals. No conclusions could be drawn on the potential of the additive to be a dermal/eye irritant or a skin sensitiser. When handling the tincture, exposure of unprotected users to xanthones (gentisin and isogentisin) and gentiopicroside cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Streptococcus salivarius DSM 13084/ATCC BAA 1024 as a technological additive (functional group: acidity regulators) in feed for dogs and cats. The additive is intended for use at a proposed minimum concentration of 1 × 10 11  CFU/l or kg liquid feed for dogs and cats. Due to the lack of adequate data, the FEEDAP Panel could not conclude on the safety of the additive for the target species. The additive was considered a respiratory sensitiser, but not irritant to skin. No conclusions could be drawn on the potential of the additive to be an eye irritant or a skin sensitiser. No environmental risk assessment is necessary for the use of the additive in feeds for pets. The Panel concluded that the additive has the potential to be efficacious in feeds for dogs and cats at the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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-d-mannanase (Hemicell® HT/HT-L) produced by a genetically-modified strain of Paenibacillus lentus (DSM 33618) as a zootechnical feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species to point of lay, pigs for fattening, piglets (weaned) and minor porcine species. The production strain was obtained from a Paenibacillus lentus recipient strain that has been evaluated previously by EFSA and considered to be safe. The genetic modification does not raise safety concerns and there were no antibiotic resistance genes from the genetic modification in the production strain. Viable cells and the DNA of the production strain were not found in the intermediate product used to formulate the additive. Hemicell® HT/HT-L produced by Paenibacillus lentus DSM 33618 is considered safe for the above-mentioned target species at the intended conditions of use. The use of Hemicell® HT/HT-L as a feed additive raises no concerns for the consumer or for the environment. Hemicell® HT/HT-L is not irritant to the skin and eyes but is regarded as a dermal sensitiser and a potential respiratory sensitiser. The additive has a potential to be efficacious at 32,000 U/kg in chickens for fattening, chickens reared for laying, minor poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species, and at 48,000 U/kg in turkeys for fattening, turkeys reared for breeding and weaned piglets., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 the authorisation of urea as nutritional feed additive. The additive is authorised for use in ruminants with functional rumen (3d1). The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been substantially modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the target species, consumer and for the environment when used as a source of non-protein nitrogen under current conditions of use, in ruminants with functional rumen. In the absence of new data, the FEEDAP Panel is not in the position to conclude on the user safety. The Panel retains that previously made conclusion on the efficacy remains valid., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH 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) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 as a nutritional feed additive for all animal species. The additive is produced by a genetically modified production strain. Although the production strain harbours some genes coding for resistance to antimicrobials, viable cells and DNA of the production strain were not detected in the final product. Therefore, the use of B. subtilis CGMCC 13326 to produce vitamin B2 does not raise safety concerns. The use of riboflavin 80% produced by B. subtilis CGMCC 13326 in animal nutrition does not represent a safety concern for the target species, consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential skin and eye irritation or potential toxicity by inhalation of the additive under assessment. Riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The additive under assessment is effective in covering the animals' requirements of vitamin B2 when administered via feed., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 × 10 8 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 × 10 8  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%., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a zinc(II)-betaine complex as nutritional additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion could be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded. The FEEDAP Panel concluded that the use of the zinc(II)-betaine complex in animal nutrition is of no concern for consumer safety provided that the maximum authorised total zinc levels in feed are respected. The additive is considered to be a skin and respiratory sensitiser due to the presence of nickel; it is irritant to the eyes, but not to the skin. The use of the additive in animal nutrition for terrestrial animals and land-based aquaculture at the proposed use levels is considered safe for terrestrial and aquatic ecosystems. The available data do not allow the conclusion to be made on the safety of the additive for the marine sediment when it is used in sea cages. Based on the deposition of zinc in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable zinc, comparable to the standard inorganic zinc source, and therefore, the additive is efficacious in meeting the birds zinc requirements. This conclusion can be extrapolated to all animal species and categories., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The additive Miya-Gold® consists of viable cells of Clostridium butyricum FERM BP-2789.The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and piglets of minor porcine species. The authorisation for chickens and minor poultry species for fattening and reared for laying is at a minimum level of 2.5 × 10 8  CFU/kg complete feed. The applicant has requested to lower this level to 1.25 × 10 8  CFU/kg feed. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) did not consider any of the five long-term trials and one pooled analysis of two of them as supporting evidence for the efficacy of the additive at the lower dose due to the incompliance of the husbandry conditions in which the chickens were reared with those indicated in Directive 2007/43/EC. Owing to the lack of adequate data, the Panel is not in the position to conclude on the efficacy of Miya-Gold® at 1.25 × 10 8  CFU/kg feed for the target species., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Locust bean gum (E 410) was re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to that assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of locust bean gum (E 410) for its uses as a food additive in food for infants below 16 weeks of age belonging to food category 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants). In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population, including the safety assessment for FC 13.1.5.1 and 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in directive 1999/21/EC). The process involved the publication of a call for data. Based on the received data, the Panel concluded that the technical data provided by the interested business operators support an amendment of the specifications for locust bean gum (E 410) laid down in Commission Regulation (EU) No 231/2012. The Panel identified a reference point of 1,400 mg/kg bw per day based on reduced blood zinc levels in a piglet study. It applied the margin of exposure (MoE) for the safety assessment of locust bean gum (E 410) when used as a food additive in FC 13.1.5.1 and 13.1.5.2. The Panel concluded that a MoE above 1 would not raise a safety concern. A MoE above 1 was obtained for some of the scenarios and exposure levels for infants. For toddlers (consumers only of food for special medical purposes), the MoE was above 1 for all exposure levels., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 × 10 8  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., (© 2023 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 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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2023 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 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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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. v ulgare 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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the aerial parts of Anethum graveolens L. (dill herb oil), when used as a sensory additive (flavouring) in feed for dogs and cats. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that dill herb oil is safe at use levels in complete feed of 7 mg/kg for dogs and 5 mg/kg for cats. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since the aerial parts of A. graveolens and its preparations are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat lasalocid A sodium (Avatec® 150G) for chickens for fattening and chickens reared for laying. Taking into account the results of all tolerance studies submitted for the re-evaluation of the additive, the FEEDAP Panel considers that lasalocid A sodium from Avatec® 150G is safe at a maximum content of 90 mg/kg complete feed for chickens for fattening. A margin of safety cannot be established. No conclusion on the safety of lasalocid for chickens reared for laying can be made. Three new floor pen studies showed efficacy of 90 mg lasalocid A sodium/kg complete feed reducing the adverse clinical consequences of an Eimeria infection in chickens for fattening. Considering also the previously reported positive floor pen study and the three positive anticoccidial sensitivity tests, the FEEDAP Panel can conclude on an efficient coccidiostatic level of 90 mg lasalocid A sodium/kg complete feed for chickens for fattening. This conclusion is extended to chickens reared for laying., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from gum resin of Ferula assa-foetida L. (asafoetida oil), when used as a sensory additive (flavouring) in feed for dogs and cats. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of asafoetida oil is safe at the proposed conditions of use of 1.5 mg/kg complete feed for dogs and 0.2 mg/kg complete feed for cats. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since F. assa-foetida and its preparations are recognised to flavour food, and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the target species of the coccidiostat halofuginone hydrobromide from STENOROL® when used as a feed additive for chickens for fattening and turkeys. In its previous assessment, the FEEDAP Panel could not conclude on the safety of STENOROL® for the target species at the highest proposed use level of 3 mg halofuginone hydrobromide/kg complete feed. On the basis of the new data provided, the FEEDAP Panel updates its previous conclusions on the safety for the target species as follows: halofuginone hydrobromide from STENOROL® is safe for chickens for fattening and for turkeys up to a maximum of 12 weeks of age at the highest proposed concentration of 3 mg/kg complete feed. For chickens for fattening, a margin of safety of about 1.3 can be established while for turkeys for fattening a margin of safety cannot be established., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of a product consisting of 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™ ABS1781 Bacillus subtilis and is not currently authorised in the EU. It is intended for use in complete feed for the target species at a minimum inclusion level of 1.5 × 10 8  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-67259 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 the treated or the control group in the two formerly submitted efficacy studies. The Panel concluded that the methodology was not able to discriminate between the strain under assessment and the background. Additionally, two new efficacy trials with chickens for fattening were provided to support the efficacy of the additive. However, none could be further considered since the husbandry conditions in which the birds were kept were non-compliant with Directive 2007/43/EC. Therefore, the FEEDAP Panel was not in the position to conclude on the efficacy of Correlink™ ABS1781 for all growing poultry species., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 the product Huvezym® neXo 100 G/L containing an endo-1,4-beta xylanase, an endo-1,4-beta-glucanase and a xyloglucan-specific-endo-beta-1,4-glucanase produced by a non-genetically modified strain of Trichoderma citrinoviride (DSM 33578) as a zootechnical additive for feed in all poultry species, ornamental birds and piglets (weaned and suckling). The information regarding the production strain did not allow to confirm its taxonomic identification. The batches used for the characterisation of the final formulations showed compliance with the minimum specifications of the additive in terms of enzyme activities but showed ratios between the enzymes lower than the ones specified for the additive. The FEEDAP Panel considered that the below-described conclusions would apply to the final formulations of the additive as per specifications with xylanase:glucanase, xylanase:xyloglucanase and glucanase:xyloglucanase ratios of 15, 15 and 1, respectively. Based on the data available, the Panel concluded that the additive is safe for the target species, consumers and the environment. Huvezym® neXo 100 G (granulated form) is neither skin corrosive nor eye irritant but should be considered a potential skin sensitiser. Huvezym® neXo 100 L (liquid) is neither skin corrosive nor sensitising and it is not an eye irritant. Due to lack of data, no conclusions can be drawn on the skin irritation of the final formulations of the additive. Due to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The FEEDAP Panel concluded that the additive has the potential to be efficacious in chickens for fattening, chickens reared for laying and breeding, and all growing poultry and ornamental birds at the minimum intended level of 1,500 EPU, 100 CU and 100 XGU/kg complete feed. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens and weaned piglets., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the fruit of Cuminum cyminum L. (cumin oil), when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of cumin oil up to the maximum proposed use levels in feed of 15 mg/kg complete feed is considered as safe for all animal species. The FEEDAP Panel considered the use in water for drinking as safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers were identified following the use of cumin oil up to the maximum proposed use level in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the essential oil, exposure of unprotected users to estragole (and dillapiole) cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of cumin oil at the proposed use level in feed is not expected to pose a risk to the environment. Since C. cyminum and its preparations are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 roots of Angelica sinensis (Oliv.) Diels (dong quai tincture) when used as a sensory additive in feed for horses, dogs and cats and in water for drinking for poultry species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for horses and dogs at the maximum proposed use level of 123 and 481 mg/kg complete feed, respectively. For cats, the calculated safe concentration is 184 mg/kg complete feed. For the poultry species, the calculated safe concentration in water for drinking is 79 mg/kg for chickens for fattening, 117 mg/kg for laying hens and 106 mg/kg for turkeys for fattening. No safety concern would arise for the consumer from the use of dong quai tincture up to the highest safe levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the dong quai tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the root of A. sinensis has flavouring properties and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an extract of condensed tannins from Schinopsis balansae Engl. and Schinopsis lorentzii (Griseb.) Engl. (red quebracho extract) when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is safe up to the maximum proposed use levels of 400 mg/kg for chickens for fattening and other growing poultry, 600 mg/kg for laying hens and other laying/breeding birds kept for egg production/reproduction, 540 mg/kg for turkeys for fattening, 720 mg/kg for piglets, 860 mg/kg for pigs for fattening and other growing Suidae, 1,050 mg/kg for sows, 1,680 mg/kg for veal calves (milk replacer), 1,580 mg/kg for cattle for fattening and other growing ruminants, 1,030 mg/kg for dairy cows and other dairy ruminants, 1,580 mg/kg for sheep, goats, horses, 630 mg/kg for rabbits, 1,810 mg/kg for salmonids and other fin fish, 1,900 mg/kg for dogs and 3,000 mg/kg for ornamental fish. For cats, the calculated safe concentration in feed is 317 mg/kg complete feed. For all the other minor species, the additive is considered safe at 317 mg/kg complete feed. The FEEDAP Panel considered the use in water for drinking as safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers were identified following the use of the additive at the maximum proposed use level in feed. The extract under assessment is not an eye irritant but in the absence of data, no conclusion can be drawn on its potential to be a skin irritant and a dermal and respiratory sensitiser. The use of the extract under the proposed conditions of use in feed was not expected to pose a risk for the environment. Since quebracho and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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 (pericarps and seeds) of Illicium verum Hook f. (star anise tincture) when used as a sensory feed additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.86%. The product contained on average 0.2588% polyphenols (of which 0.0229% were flavonoids, including 0.0036% rutin), anethole (0.018%) and estragole (0.00039%). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the star anise 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 star anise tincture up to the maximum proposed use levels in feed. Star anise tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the tincture, 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 star anise tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of I. verum and its preparations are recognised to provide flavour in food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Sodium carboxy methyl cellulose (E 466) was re-evaluated in 2018 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of E 466 for its uses as a food additive in food for infants below 16 weeks of age belonging to food categories (FC) 13.1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants) in line with Regulation (EC) No 1333/2008. In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the food additive when used in food for the general population, including the safety assessment for FC 13.1.5.1 and 13.1.5.2 (Dietary foods for babies and young children for special medical purposes as defined in directive 1999/21/EC). The process involved the publication of a call for data. Based on the received data, the Panel concluded that the technical data provided by the interested business operator support an amendment of the specifications for sodium carboxy methyl cellulose (E 466) laid down in Commission Regulation (EU) No 231/2012. The interested business operators declared that E 466 is not used in food for infants below 16 weeks of age and in FC 13.1.5.1. Due to the lack of data, an assessment has not been performed for this FC and age group. The interested business operators did not provide biological and toxicological data to support the uses of E 466 in FC 13.1.5.2. Due to the almost unchanged database compared to the situation before the call for data, the FAF Panel confirmed the previous EFSA ANS Panel conclusion according to which the available data did not allow for an adequate assessment of the safety of use of sodium carboxy methyl cellulose (E 466) in infants and young children consuming foods belonging to the FC 13.1.5.2. ©2022 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 renewal of the authorisation of endo-1,4-β-xylanase produced by Trichoderma reesei CBS 143953 and endo-1,3(4)-β-glucanase produced by T. reesei CBS 143945 (Axtra® XB 201 TPT/L) as a zootechnical feed additive (digestibility enhancers) for poultry and pigs. The endo-1,4-β-xylanase and endo-1,3(4)-β-glucanase are produced by a genetically modified strain of T. reesei and a non-genetically modified strain of T. reesei , respectively. The applicant also requested a reduction of the minimum recommended level for turkeys for fattening and the extension of use to other species/categories. The Panel concluded that the additive complies with the conditions of the current authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider previous conclusions on the safety of the additive. These conclusions apply also to the new target species/categories for which a request of use was made, suckling piglets. The Panel concluded that the additive should be considered irritant to eyes and a respiratory sensitiser. However, no conclusions could be drawn on the skin irritancy/sensitisation potential of the additive. No change in the authorisation conditions were requested for poultry species (other than turkeys), weaned piglets, pigs for fattening, sows and minor porcine species; therefore there was no need for an assessment on the efficacy of the additive for those species/categories. The Panel concluded that the additive has the potential to be efficacious in turkeys for fattening/reared for breeding and in suckling piglets (for the period in which solid feed is administered) at an intended level of 610 xylanase U/kg and 76 glucanase U/kg feed. However, the Panel noted that the actual effective level used in the studies supporting this conclusion was approximately 50% higher than the intended level., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 6-phytase produced by the genetically modified strain Trichoderma reesei CBS 146250 (Axtra® PHY GOLD 30L, Axtra® PHY GOLD 30 T and Axtra® PHY GOLD 65G) as a zootechnical feed additive for all poultry species and all pigs. 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 species and all pigs at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not give rise to concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel cannot conclude on the potential of the additive to be irritant to eyes or skin. Due to the proteinaceous nature of the active substance, it is considered a respiratory sensitiser. The panel concludes that the additive is efficacious in increasing the phosphorus utilisation when supplemented at 500 FTU/kg for all growing poultry species and all pigs, and at 300 FTU/kg in laying hens and other laying birds., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 feed additives prepared from Piper nigrum L.: black pepper oil and black pepper oleoresin for all animal species and a supercritical extract of black pepper for use in dogs and cats. The Panel concludes that black pepper oil is safe in complete feed up to 5 mg/kg for chickens for fattening and other growing poultry, 8 mg/kg for laying hens and other laying/breeding birds kept for egg production/reproduction, 7 mg/kg for turkeys for fattening, 9.5 mg/kg for piglets and other growing Suidae , 11.5 mg/kg for pigs for fattening, 14 mg/kg for sows and dairy cows (and other dairy ruminants), 8.5 mg/kg in rabbits and 20 mg/kg in veal calves, cattle for fattening (and other growing ruminants), sheep, goats, horses, salmonids (and other fin fish), dogs, cats and ornamental fish. For all the other species, the additive is considered safe at 5 mg/kg complete feed. The supercritical extract of black pepper is safe up to the maximum proposed use levels in complete feed of 1.5 mg/kg for cats and dogs. The black pepper oleoresin is safe in complete feed up to 12.5 mg/kg for veal calves, 11.5 for cattle for fattening and other growing ruminants, sheep/goats and horses, 14 mg/kg for dogs 13.5 for mg/kg for salmonids and other fin fish and 51.5 for ornamental fish. For the other species, the calculated safe concentrations in complete feed are 1 mg/kg for chickens for fattening and other growing poultry, 1.4 mg/kg for laying hens and other laying/breeding birds kept for egg production/reproduction, 1.3 for turkeys for fattening, 1.7 mg/kg for piglets and other growing Suidae , 2 mg/kg for pigs for fattening, 2.5 mg/kg for sows, 2.4 mg/kg for dairy cows and other dairy ruminants, 1.5 mg/kg for rabbits, 3.8 mg/kg for cats. For all the other species, the additive is considered safe at 1 mg/kg complete feed. No concerns for consumers and environment were identified following the use of the additives at the use levels considered safe for the target animals. The additives are irritant to skin and eyes, and act as dermal and respiratory sensitisers. The additives are recognised to flavour food and since their function in feed would be essentially the same, no further demonstration of efficacy is necessary., (© 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 vitamin B 2 in the form of riboflavin-5'-phosphate ester monosodium salt. The additive is manufactured by chemical synthesis from riboflavin 98%, produced by fermentation with a genetically modified strain of Bacillus subtilis (KCCM 10445). Riboflavin 98% has been previously evaluated by the FEEDAP Panel for its use as feed additive for all animal species. Since the additive under assessment contains the phosphate ester monosodium salt of a riboflavin (98%) preparation already considered safe, the FEEDAP Panel concluded that the addition of the salt does not add any toxicological property to the final additive. Therefore, the additive is safe for the target species, the consumer and the environment. The additive is not a skin/eye irritant and it is not considered a respiratory sensitiser. Riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The additive under assessment is effective in covering the animals' requirements for vitamin B2 when administered via feed and/or water for drinking., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the characterisation and safety of vitamin B 2 /riboflavin produced by fermentation with a genetically modified strain of Bacillus subtilis (KCCM 10445) as a nutritional additive in feed and water for drinking for all animal species. In 2021, the FEEDAP Panel issued an opinion on the safety and efficacy of vitamin B 2 98% and vitamin B 2 80% in the form of riboflavin produced by B. subtilis KCCM 10445. In that assessment, the Panel could not confirm the correspondence of the deposited strain under accession number KCCM 10445 with the strain used for production owing to discrepancies in the description of the genetic modification steps. Moreover, in the absence of data, no conclusions on the skin sensitisation potential of vitamin B 2 98% and vitamin B 2 80% nor on the possible risk by inhalation of vitamin B 2 98% could be reached. For the present assessment, the applicant provided supplementary information to partially address the limitations identified in that assessment. Based on the results of a bioinformatic analysis between the strain deposited under accession number KCCM 10445 with the strain used for production under assessment, the Panel confirmed the correspondence between the two strains. As no new data have been submitted on the safety of the additives, the conclusions from the Panel remain that the use of vitamin B 2 /riboflavin produced by B. subtilis KCCM 10445 is safe for the target species, the consumer and the environment. Vitamin B 2 80% is not hazardous by inhalation. In the absence of data, no conclusions on the possible risk by inhalation of vitamin B 2 98% could be reached. Neither the vitamin B 2 98% nor the vitamin B 2 80% are irritant to skin or eyes. In the absence of data, no conclusions on the skin sensitisation potential of the additives could be reached., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives to improve ensiling of forages consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum ) strains ATCC 55058 and ATCC 55942, respectively, for all animal species. Both additives are intended for use with all forages and for all animal species at a proposed minimum concentration of 5 × 10 6 colony forming units (CFU)/kg forage. In two previous opinions, the FEEDAP Panel could not conclude on their efficacy due to the absence of any significant evidence of nutrient preservation. Based on three new efficacy studies provided by the applicant as supplementary information, the FEEDAP Panel concluded that the addition of L. plantarum strains ATCC 55058 or ATCC 55942, have the potential to improve the ensiling process by reducing protein degradation in all type of forages as indicated by the reduction of ammonia production., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of glyceryl polyethyleneglycol ricinoleate (PEG castor oil) as technological feed additive for all animal species. PEG castor oil is safe at a maximum concentration in complete feed of 90 mg/kg for chickens for fattening and other minor growing poultry; 134 mg/kg for laying hens and other laying/breeding birds kept for egg production/reproduction; 121 mg/kg for turkeys for fattening; 162 mg/kg for piglets and other minor growing Suidae ; 194 mg/kg for pigs for fattening; 236 mg/kg for sows other minor reproductive Suidae ; 231 mg/kg for dairy cows and other dairy ruminants (other than sheep/goats); 142 mg/kg in rabbits and 377 mg/kg in veal calves; 356 mg/kg for cattle for fattening and other growing ruminants, sheep, goat, horses and cats; 427 mg/kg for dogs; 407 mg/kg for salmonids and other fin fish; and 1,584 mg/kg for ornamental fish. For other growing species and non-food producing animals, the additive is considered safe at 90 mg/kg complete feed. The use of PEG castor oil as feed additive for all animal species would be of no concern for the consumer. The FEEDAP Panel considered inhalation exposure of the user to the additive unlikely. PEG castor oil is not considered a skin sensitiser. The panel was not in the position to conclude on the potential of the additive to be a skin or eye irritant. The additive is a readily biodegradable substance and is not expected to pose a risk for the environment. The lack of sufficient data does not allow the FEEDAP Panel to conclude on the efficacy of PEG castor oil as an emulsifier in feedingstuffs., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives to improve ensiling of forages consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively, for all animal species. The additives are intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 10 7 colony forming units (CFU) of E. faecium ATCC 53519/kg forage or 5 × 10 6  CFU of E. faecium ATCC 55593/kg forage, respectively. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy owing to the lack of sufficient evidence for an improvement on the nutrient preservation during the ensiling process. The new data submitted by the applicant as supplementary information provided not enough weight of evidence on the effects of the additives on the ensiling of easy, moderately difficult and difficult to ensile material, and therefore, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive under the proposed conditions of use., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 assessment of the application for renewal of Lactiplantibacillus plantarum ssp. plantarum (formerly Lactobacillus plantarum ssp. plantarum ) DSM 8862 and Lactiplantibacillus plantarum ssp. argentoratensis (formerly Lactobacillus plantarum ssp. argentoratensis ) DSM 8866 as a technological additive to improve ensiling of forage for all animal species. 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, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not a skin irritant but no conclusions can be drawn on the eye irritancy potential of the additive nor to the skin sensitisation potential. The additive should be considered a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the re-evaluation of the safety and efficacy of carmine (sensory additive, functional group: colourants - substances that add or restore colour in feeds) for cats and dogs. The additive consists of aluminium lakes of carminic acid (carmines), which are complexes of aluminium and carminic acid. Carminic acid, produced from the female insect Dactylopius coccus Costa, is the colouring principle and is present in the final additive at 50%. The additive does not pose a risk concerning genotoxicity and is considered safe for dogs and cats at 264 and 220 mg Carmine/kg feed, respectively (which correspond to 132 and 110 mg carminic acid/kg feed, respectively). Due to the nature of the additive, the FEEDAP Panel concluded that allergic reactions may occur in the target species following the ingestion of feeds containing the additive. The FEEDAP Panel concluded that the exposure of users by inhalation is very likely, and that carmine is a respiratory and skin sensitiser; however, due to the lack of data, a conclusion cannot be reached on the potential skin and eye irritation of the additive. The additive is considered to be efficacious in feeds for dogs and cats under the proposed conditions of use., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf oil), when used as sensory additives (flavourings) in feed and water for drinking for all animal species. Owing to the presence of styrene in the essential oils under assessment, the FEEDAP Panel is not in the position to conclude on the safety for long-living animals and animals for reproduction. For 'short-living' animals, the FEEDAP Panel concluded that cinnamon bark oil and cinnamon leaf oil are considered as safe up to the maximum proposed use levels in complete feed. For 'short-living' animals, the Panel considered the use of cinnamon bark oil in water for drinking as safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. For cinnamon leaf oil, the proposed use level in water for drinking of 3 mg/L is considered as safe for 'short-living' animals. No concerns for consumers were identified following the use of the additives at the use level considered safe in feed for the target species. Based on the presence of safrole ≥0.1%, cinnamon leaf oil and bark oil are classified as carcinogen (category 1B) and handled accordingly. The use of the additives under the proposed conditions in animal feed was not expected to pose a risk for the environment. Since C. verum and its preparations are recognised to flavour food and its function in feed would be essentially the same, no further demonstration of efficacy is considered necessary for cinnamon essential oils., (© 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 Saccharomyces cerevisiae CNCM I-1079 when used as a zootechnical additive (gut flora stabilisers and physiological condition stabilisers) for calves, all other ruminant species and for camelids for rearing and for fattening. The product, manufactured in two forms, as a powder and an encapsulated form, is intended for use in complete feed at a minimum inclusion level of 1 × 10 9  CFU/kg complete feed. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the strain has been clearly established and the additive is composed mainly by dried cells of the active agent, the use of the additive in animal nutrition is considered safe for the target species, the consumer and the environment. The additive is not a skin or eye irritant, or a skin sensitiser, but should be considered a respiratory sensitiser. However, exposure by inhalation to the encapsulated form is unlikely. The Panel was not in the position to conclude on the efficacy of the additive for the target species., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of concentrated liquid l-lysine, l-lysine monohydrochloride and concentrated liquid l-lysine monohydrochloride produced by Escherichia coli NITE BP-02917 as nutritional and as sensory (flavouring compound) feed additives for all animal species. The production strain did not carry ■■■■■ antimicrobial resistance genes and no viable cells of the production strain were detected in the final products. ■■■■■ However, since no sequences of concern remained in the production strain, the potential presence of that DNA did not raise safety concerns. The use of the three forms of l-lysine produced by E. coli NITE BP-02917 in supplementing feed to compensate for l-lysine deficiency in feedingstuffs was safe for the target species. This conclusion would also cover the use as a sensory additive. The FEEDAP Panel identified risks of nutritional imbalances and hygienic concerns for amino acids when administered simultaneously in feed and in water for drinking. The use of the three forms of l-lysine produced by E. coli NITE BP-02917 in animal nutrition was considered safe for the consumers and for the environment. Concentrated liquid l-lysine, l-lysine HCl and concentrated liquid l-lysine HCl were not considered to have the potential to cause respiratory toxicity, or skin sensitisation. l-Lysine HCl and concentrated liquid l-lysine HCl were not considered skin and eye irritants. Concentrated liquid l-lysine, due to its high pH, might be corrosive for skin and eyes. The three forms were considered an efficacious source of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen. The three forms of the additive were also considered efficacious as feed flavouring compounds under the proposed conditions of use., (© 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 l-lysine monohydrochloride and l-lysine sulfate produced by Corynebacterium glutamicum CGMCC 17927, when used as a nutritional additive in feed and water for drinking for all animal species. The active substance is l-lysine, and it was produced in two different forms: monohydrochloride (HCl) or sulfate salts. The production strain was genetically modified. Neither viable cells nor recombinant DNA of the production strain were detected in the final products. Therefore, the Panel concluded that the additives did not pose any safety concern regarding the production strain. The use of l-lysine HCl and l-lysine sulfate produced by the strain C. glutamicum CGMCC 17927 in supplementing feed to compensate for l-lysine deficiency in feedingstuffs was safe for the target species. The FEEDAP Panel identified risks of nutritional imbalances and hygienic concerns for amino acids when administered simultaneously in feed and in water for drinking. The use of both forms of l-lysine produced by fermentation using C. glutamicum CGMCC 17927 in animal nutrition was considered safe for the consumers and for the environment. Exposure of users through inhalation to l-lysine HCl and l-lysine sulfate produced with C. glutamicum CGMCC 17927 was considered very likely. In absence of data, the FEEDAP Panel could not conclude on the potential of both forms of the additive to be irritant for skin and eyes or to be dermal sensitisers. l-Lysine HCl and l-lysine sulfate were considered as efficacious sources of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)