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Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Protural® (sodium benzoate) when used as a zootechnical additive in feed for weaned piglets and other growing Suidae at 4,000 mg/kg feedingstuff. Protural® consists of sodium benzoate without any carrier materials and is currently authorised for use in weaned piglets. This opinion concerns the renewal of the authorisation of Protural® for weaned piglets and the evaluation of the new use in other growing Suidae. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Protural® is safe under the current conditions of authorisation for the target species, consumers of products from animals fed the additive and the environment. Protural® was not considered as irritant to skin and eyes but a skin sensitiser. Based on dusting potential data, the FEEDAP Panel considered that the powder formulation of the additive represented a risk by inhalation. There was no need for assessing the efficacy of Protural® in the context of the renewal of the authorisation for weaned piglets. The efficacy data previously evaluated allowed the FEEDAP Panel to conclude that the additive has the potential to be efficacious at the level of 4,000 mg/kg feedingstuff in other growing Suidae. A conclusion cannot be reached for the efficacy in pigs for fattening.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Lacticaseibacillus paracasei (formerly Lactobacillus paracasei) DSM 16245 as a technological additive for all animal species. The additive aims to improve the production of silage and is currently authorised at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new 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 L. paracasei DSM 16245 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser.

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 Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 16774 as a technological additive to improve ensiling of 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 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 Lentilactobacillus buchneri DSM 16774 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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 Lacticaseibacillus rhamnosus (formerly Lactobacillus rhamnosus) IMI 507023 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 109 colony-forming units (CFU)/kg fresh material. The bacterial species L. rhamnosus is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been 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 and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 109 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.

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 Pediococcus pentosaceus IMI 507025 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 109 colony forming units (CFU)/kg fresh material. The bacterial species P. pentosaceus is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 109 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.

The additive Biosprint® contains viable cells of Saccharomyces cerevisiae MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to all pigs (other than sows and weaned piglets) and other minor porcine species at a minimum inclusion level of 3 × 109 CFU/kg feed. S. cerevisiae is considered by EFSA to have qualified presumption of safety (QPS) status and consequently is considered safe for the target species, the consumers and the environment. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. In previous evaluations, the FEEDAP Panel concluded that the additive is efficacious in sows and weaned piglets. In the current application, these conclusions are extrapolated to all pigs (other than sows and weaned piglets) and to other minor porcine species.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium diformate (Formi™ LHS) as a technological feed additive for piglets (weaned) and pigs for fattening. The FEEDAP Panel concluded that potassium diformate is safe for weaned piglets and for pigs for fattening at the level of 6,000 mg/kg complete feed, with no margin of safety. The use of potassium diformate in weaned piglets and pigs for fattening nutrition under the conditions of use proposed is of no concern for consumer safety. Potassium diformate does not raise concern regarding the effects on respiratory system and the skin but is an eye irritant. The use of potassium diformate as a feed additive is considered safe for the environment. The additive is considered to be efficacious as acidity regulator in feedingstuffs for weaned piglets and pigs for fattening at the minimum proposed concentration of 6,000 mg/kg complete feed.

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 an essential oil from the fruits of Litsea cubeba (Lour.) Pers. (litsea berry oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that litsea berry oil is safe up to the maximum proposed use level of 125 mg/kg complete feed for ornamental fish. For the other species, the calculated safe concentration in complete feed are 11 mg/kg for chicken for fattening, 16 mg/kg for laying hen, 14 mg/kg for turkey for fattening, 19 mg/kg for piglet, 23 mg/kg for pig for fattening, 28 mg/kg for lactating sow, 48 mg/kg for veal calf (milk replacer), 43 mg/kg for cattle for fattening, sheep, goat and horse, 28 mg/kg for dairy cow, 17 mg/kg for rabbit, 47 mg/kg for salmon, 50 mg/kg for dog and 8.5 mg/kg for cat. The FEEDAP Panel also concluded that the use of litsea berry oil at the maximum proposed use level in water for drinking of 1 mg/kg is safe for all animal species. Simultaneous use in feed and water for drinking may lead to the maximum safe dose being exceeded. No concerns for consumer safety were identified following the use of the additive up to the highest safe use level in feed for the target animals. The essential oil under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the additive in animal feed under the proposed conditions was not expected to pose a risk for the environment. Litsea berry oil is recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

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 (formerly Lactobacillus plantarum) DSM 21762, as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but is considered a skin and respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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 the feed additive consisting of dimethylglycine sodium salt (trade name: Taminizer D) as a zootechnical additive for chickens for fattening. In 2011, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive, and subsequently, the additive was authorised in the EU. In 2018, a second scientific assessment was made based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is authorised as ‘dimethylglycine sodium salt with a purity of at least 97%’ for chickens for fattening under the category ‘zootechnical additives’ and functional group ‘other zootechnical additives (improvement of zootechnical parameters)’. The evidence provided by the applicant indicated that the additive currently in the market, produced by the two manufacturing routes, complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. The FEEDAP Panel concludes that Taminizer D is not a skin irritant but may be an eye irritant and a skin sensitiser; although uncertainty remains on the presence of formaldehyde, exposure is considered extremely low. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation.

The present opinion deals with an updated safety assessment of the food additive titanium dioxide(E 171) based on new relevant scientific evidence considered by the Panel to be reliable, includingdata obtained with TiO2nanoparticles (NPs) and data from an extended one-generation reproductivetoxicity (EOGRT) study. Less than 50% of constituent particles by number in E 171 have a minimumexternal dimension30 nm) up to the highest dose tested of100 mg/kg bw per day. No effects on reproductive and developmental toxicity were observed up to adose of 1,000 mg E 171/kg bw per day, the highest dose tested in the EOGRT study. However,observations of potential immunotoxicity and inflammation with E 171 and potential neurotoxicity withTiO2NPs, together with the potential induction of aberrant crypt foci with E 171, may indicate adverseeffects. With respect to genotoxicity, the Panel concluded that TiO2particles have the potential toinduce DNA strand breaks and chromosomal damage, but not gene mutations. No clear correlationwas observed between the physico-chemical properties of TiO2particles and the outcome of eitherin vitroorin vivogenotoxicity assays. A concern for genotoxicity of TiO2particles that may be presentin E 171 could therefore not be ruled out. Several modes of action for the genotoxicity may operate inparallel and the relative contributions of different molecular mechanisms elicited by TiO2particles arenot known. There was uncertainty as to whether a threshold mode of action could be assumed. Inaddition, a cut-off value for TiO2particle size with respect to genotoxicity could not be identified. Noappropriately designed study was available to investigate the potential carcinogenic effects of TiO2NPs. Based on all the evidence available, a concern for genotoxicity could not be ruled out, and giventhe many uncertainties, the Panel concluded that E 171 can no longer be considered as safe whenused as a food additive.©2021 European Food Safety Authority. EFSA Journalpublished by John Wiley and Sons Ltd on behalfof European Food Safety Authority.Keywords:Titanium dioxide, E 171, CAS No 13463-67-7EFSA Journal 2021;19(5):6585www.efsa.europa.eu/efsajournal

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‐histidine monohydrochloride (HCl) monohydrate produced by fermentation with Escherichia coli (NITE SD 00268) when used as a nutritional additive or as a feed flavouring compound in feed for all animal species. The active substance of the additive is l‐histidine. The production strain has been modified by conventional mutagenesis and it does not raise safety concerns. The additive under assessment is safe for the target species when used as a nutritional additive to supplement the diet in appropriate amounts to cover the requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements. This conclusion would cover its use as flavouring compound. l‐Histidine HCl monohydrate produced by E. coli NITE SD 00268, when used at the proposed conditions of use, is safe for the consumer and for the environment. l‐Histidine HCl monohydrate produced using E. coli NITE SD 00268 is not a skin irritant. In the absence of data, it is not possible to conclude on the potential of the additive to be toxic by inhalation, irritant to eyes or a skin sensitiser. The additive l‐histidine HCl monohydrate is regarded as an effective source of the amino acid l‐histidine when used as a nutritional additive. For the supplemental l‐histidine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. l‐Histidine is efficacious as a flavouring compound.

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 concentrated liquid l‐lysine (base) and l‐lysine monohydrochloride (HCl) produced using Corynebacterium glutamicum KCCM 80183 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l‐lysine. Concentrated liquid l‐lysine (base) and l‐Lysine HCl produced by the strain C. glutamicum KCCM 80183 do not pose any safety concern as regards the genetic modification of the production strain. The use of the additives under assessment in supplementing feed to compensate for l‐lysine deficiency in feedingstuffs is safe for the target species. The FEEDAP Panel has concerns about the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of both forms of l‐lysine produced by fermentation using C. glutamicum KCCM 80183 in animal nutrition is considered safe for the consumers and for the environment. Concentrated liquid l‐lysine (base) produced by C. glutamicum KCCM 80183 is considered hazardous by inhalation, not irritant to skin and eyes and it is not a skin sensitiser. l‐Lysine HCl produced by C. glutamicum KCCM 80183 is considered hazardous by inhalation, it is not irritant to skin but mildly irritant to eyes and it is not a skin sensitiser. The additives under assessment are 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.

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 a dried extract prepared from the leaves of Ginkgo biloba L. (G. biloba dry extract) when used as a sensory additive in feed for cats and dogs. G. biloba dry extract is specified to contain at least 24% flavonol glycosides, at least 6% terpene lactones and less than 5 ppm ginkgolic acids. Since uncertainty remains concerning the nature of up to 75% of the extract, the additive is not sufficiently characterised to allow an assessment based on the individual components. In view of the indication of potential carcinogenicity from the results of studies by the National Toxicology Program of the USA, obtained with a G. biloba extract comparable with the additive under assessment, the FEEDAP Panel concludes that the additive cannot be considered safe for cats and dogs. In the absence of data, no conclusions can be drawn on the safety for the user. In the absence of evidence that the extract acts as a flavour in animal feed or has an effect on palatability, the FEEDAP Panel was unable to conclude on the efficacy of the additive.

Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is to be used in to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. This additive consists of endo-1,4-β-xylanase produced by a genetically modified strain of Bacillus subtilis (LMG S-15136). In a previous opinion, the FEEDAP Panelcould not conclude on the safety of the additive for the users regarding the potential of the additive as dermal sensitiser and on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. In the absence of new information, the FEEDAP Panelretained its previous conclusion that the additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a dermal sensitiser. The applicant provided new efficacy data and complementary information regarding a previous study. Based on the previously assessed data and the newly submitted ones, the Panelconcludes that although the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period at the level of 10 IU/kg feed, the data are considered not sufficient to conclude on a beneficial effect on the performance of the litters.

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 feed additive Vitamin B2/Riboflavin produced by Eremothecium ashbyi CCTCCM 2019833 for all animal species and categories. The additive contains a minimum content of riboflavin of 5%. The production strain has been characterised and data showed that viable cells are not present in the final additive. The additive is not a skin or eye irritant nor a skin sensitiser, but it is considered to be a respiratory sensitiser. The lack of data on the toxicological profile of the additive, including its genotoxic potential, did not allow the Panel to conclude on the safety of the additive for the target species, consumers and users. The FEEDAP Panel concluded that the use of the product as a feed additive poses no concerns for the environment. The additive under assessment is effective in covering the animals’ requirements for vitamin B2 when administered via feed.

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 additive consisting of Ligilactobacillus animalis (formerly known as Lactobacillus animalis) ATCC PTA‐6750 when used as a technological additive (acidity regulator, preservative and hygiene condition enhancer) in feed and water for drinking for all animal species. The product is intended for use as a single strain at a minimum inclusion level of 5 × 106 CFU/L or CFU/kg in water, liquid and dry feeds. No minimum inclusion level is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species L. animalis is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. The Panel is not in the position to conclude on the efficacy of L. animalis ATCC PTA‐6750 when used in animal nutrition as an acidity regulator, preservative or hygiene condition enhancer due to lack of data. The studies provided showed that L. animalis ATCC PTA‐6750 when used in combination with Propionibacterium freudenreichii ssp. shermanii ATCC PTA‐6752 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditions.

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 the additive consisting of Enterococcus faecium DSM 7134 (trade name: Bonvital®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening. The additive is produced in powder and granulate (microencapsulated) forms. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of Bonvital® under the current authorised conditions of use is safe for the target species, the consumers and the environment. Bonvital® is not irritant to skin and eyes but should be considered a potential skin sensitiser and a respiratory sensitiser. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation. The FEEDAP Panel reiterates its previous conclusions that E. faecium DSM 7134 is compatible with the coccidiostats robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelate of ethylenediamine (Manganese‐EDA‐Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of manganese mono‐chelate of EDA, but of several coexisting (manganese) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser.

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 ECONASE ® XT, an enzyme based on endo‐1,4‐β‐xylanase produced by a genetically modified strain of Trichoderma reesei CBS 114044. The additive is currently authorised for use in chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, minor poultry species, piglets (weaned) and pigs for fattening. ECONASE ® XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. In a previous opinion, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches of the additive. The applicant has submitted data to support the absence of recombinant DNA derived from the production organism in recent product batches. The FEEDAP Panel confirms that the data provided support the absence of recombinant DNA of Trichoderma reesei CBS 114044 in the additive and thus, no safety concern was identified.

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the renewal of the authorisation of additives for use in animal nutrition. Draft Endorsed by the FEEDAP Panel 14 November 2019 Submitted for public consultation 29 November 2019 End of public consultation 26 January 2020 Adoption by the FEEDAP Panel 19 November 2020 Implementation date 27 March 2021, This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-1996/full

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‐valine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (CGMCC 7.358). The additive is intended to be used in feed and water for drinking for all animal species and categories. The production strain meets the qualifications for the qualified presumption of safety (QPS) approach to safety assessment and is considered safe. l‐Valine produced using C. glutamicum CGMCC 7.358 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species, for the consumer and for the environment. No conclusion could be drawn on the potential of l‐valine produced using C. glutamicum CGMCC 7.358 to be toxic by inhalation, irritant to the skin or eyes, or a dermal sensitiser due to the lack of data. The product l‐valine produced by fermentation using C. glutamicum CGMCC 7.358 is regarded as an efficacious source of the essential amino acid l‐valine for non‐ruminant nutrition. For the supplemental l‐valine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

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 BioWorma® (Duddingtonia flagrans NCIMB 30336) when used as a zootechnical feed additive for all grazing animals. Duddingtonia flagrans belongs to a group of nematophagous fungi that physically entrap nematodes through an adhesive hyphal net. The additive contains the fungus in the form of chlamydospores and is intended to control pathogenic nematodes on pasture, with subsequent benefits for grazing animals. No conclusions could be drawn on the safety for the target species due to lack of data. ■■■■■ As it is not possible to exclude the presence of secondary metabolites (other than flagranones) produced during fermentation and their potential carry‐over into animal products, safety for the consumer could not be established. The Panel concluded that the additive is not irritant to skin and eyes but is irritant to the respiratory tract and a respiratory sensitiser. No conclusion could be drawn on its skin sensitisation potential. Since D. flagrans is a naturally inhabiting soil organism of world‐wide distribution, the Panel considered that use of an additive based on this organism does not pose a risk for the environment under the intended conditions of use. The strain under application reduced the number of parasitic nematodes on pasture to the benefit of grazing animals when used at the recommended application rate of 3 × 104 chlamydospores/kg bodyweight and day.

© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of STABILFLOR® (zinc ethylenediaminetetraacetic acid (Zn-EDTA) and copper diammonium EDTA (Cu-EDTA) dried on chicory pulp and supplemented with zinc oxide and copper oxide), as a zootechnical additive for pigs. STABILFLOR® is intended to be used in feed for pigs for fattening at a minimum and maximum levels of 500 and 1,000 mg/kg complete feed, respectively. The Panel could not conclude on the safety of STABILFLOR® for pigs for fattening owing to the lack of adequate data. At the proposed used levels in feed the additive may exert antimicrobial activity in the gut microbiota. The use of the additive resulted neither in residues of Zn-EDTA, Cu-EDTA or EDTA nor on an increase in total zinc and copper deposition in edible tissues; Zn-EDTA and Cu-EDTA had not a genotoxic potential; the Panel concluded that STABILFLOR® at 1,000 mg/kg complete feed for pigs does not pose any concern to the safety of consumers. The handling of STABILFLOR® will lead to a copper exposure of the users that poses a risk by inhalation; the additive is not a skin irritant or a skin sensitiser but is a severe eye irritant. Regarding environmental safety, no concern was expected for the terrestrial compartment. A risk for groundwater was highlighted for Zn-EDTA. Due to the absence of data, the risk for the aquatic compartment could not be assessed. Only one efficacy study showed positive effects of STABILFLOR® in pigs for fattening at 1,000 mg/kg complete feed; a conclusion on the efficacy of STABILFLOR® could not be drawn. The minimum use level of 500 mg STABILFLOR®/kg complete feed was not tested.

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 turmeric extract, turmeric oil, turmeric oleoresin and turmeric tincture from Curcuma longa L. rhizome when used as sensory additives in feed and in water for drinking for all animal species. The FEEDAP Panel concludes that the additives under consideration are safe at the maximum proposed use levels: (i) turmeric extract at 15 mg/kg complete feed (or in water for drinking at comparable exposure) for all animal species; (ii) turmeric essential oil at 80 mg/kg feed for veal calves (milk replacer) and 20 mg/kg complete feed (or 20 mg/L) for all other species; (iii) turmeric oleoresin at 30 mg/kg complete feed (or 30 mg/L) for chickens for fattening and laying hens and 5 mg/kg complete feed (or 5 mg/L) for pigs, veal calves, cattle for fattening and dairy cows, sheep, goats, horses, rabbits and fish; (iv) turmeric tincture at 0.8 mL/L water for drinking for poultry, 6 mL per head and day for horses and 0.05 mL tincture/kg complete feed for dogs. No concerns for consumers were identified following the use of the additives at the proposed use level in animal nutrition. Turmeric extract, turmeric oil, turmeric oleoresin and turmeric tincture should be considered as irritants to skin and eyes and the respiratory tract and as skin sensitisers. The use of the additives in feed is not expected to pose a risk for the environment. Since turmeric and its preparations are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

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 propyl gallate as feed additive for all animal species. Propyl gallate is neither genotoxic nor carcinogenic. Propyl gallate a is safe for veal calves, cattle for fattening, dairy cows, sheep, goats, sows, horses and salmonids at the proposed maximum use level of 40 mg/kg and for ornamental fish at the proposed maximum use level of 100 mg/kg. The following concentrations (mg/kg complete feed) are considered safe for the other target species: 15 for chickens for fattening; 20 for turkeys for fattening, laying hens and rabbits; 27 for piglets and pigs for fattening and 71 for dogs. The Panel cannot conclude on a safe level for cats. The exposure of the consumer to propyl gallate and its metabolites cannot be estimated owing to the absence of reliable data on residues of propyl gallate and its metabolites in edible tissues and products. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for the consumer of propyl gallate, when used as a feed additive for all food‐producing animal species. Propyl gallate is irritant to skin and eyes and a dermal sensitiser. Exposure via inhalation is possible and it is considered a hazard. The use of the additive in animal nutrition does not pose a risk for the environment. The FEEDAP Panel concludes that propyl gallate has the potential to act as an antioxidant in feedingstuffs. The Panel did not see a reason for the use of propyl gallate as an antioxidant in water for drinking.

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 Capsozyme SB Plus as a zootechnical feed additive (digestibility enhancers) for poultry species and ornamental birds. The additive contains two enzyme activities (α‐galactosidase and endo‐1,4‐β‐xylanase) and it is presented in solid form. The α‐galactosidase is produced by a non‐genetically modified strain of Aspergillus tubingensis and the xylanase is produced by a non‐genetically modified strain of Trichoderma longibrachiatum. Based on the results obtained in a tolerance trial performed in chickens for fattening, the FEEDAP Panel concluded that the additive is safe for the target species at the recommended levels. The mixture of the two enzyme concentrates that are used to formulate the additive, did not show any potential for a genotoxic effect in a bacterial reverse mutation assay and an in vitro mammalian cell micronucleus test. However, owing to the limitations identified in the subchronic oral toxicity study, the Panel could not conclude on the toxicological potential of the additive. No studies were submitted by the applicant to address the safety aspects related to the user. Therefore, the Panel could not conclude on the skin or eye irritation potential of the additive nor on its skin sensitisation potential. Owing to the proteinaceous nature of the additive it should be regarded as a potential respiratory sensitiser, but the exposure is presumed to be limited due to the low dusting potential. The Panel considered that the product, used as feed additive, poses no risks to the environment and no further environmental risk assessment is required. The Panel considered a total of five efficacy trials, however, the limited evidence of the efficacy provided by those studies did not allow the Panel to conclude on the efficacy.

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 GalliPro® Fit (Bacillus subtilis DSM 32324, B. subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840) when used as a zootechnical additive in feed and water for drinking for all poultry species for fattening or reared for laying/breeding. The two bacterial species present in the additive are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agents was established and the lack of toxigenic potential confirmed. The strains did not show resistance to relevant antibiotics. Therefore, the additive was presumed safe for the target species, consumers and the environment. In the absence of data, no conclusions could be drawn on the skin/eye irritancy or skin sensitisation of the additive. Due to the proteinaceous nature of the active agents, the additive was considered a respiratory sensitiser. The Panel concluded that GalliPro® Fit is compatible with diclazuril, decoquinate and halofuginone. However, the data provided did not allow to conclude on the compatibility of the additive with other coccidiostats. The Panel concluded that the additive has a potential to be efficacious in chickens for fattening at 1.6 × 109 CFU/kg feed and at 5.4 × 108 CFU/L water for drinking. The conclusion was extrapolated to all other poultry species for fattening or reared for laying/breeding. The results from the study in turkeys support this conclusion.

Panavital feed is a preparation of d‐glyceric acid intended to be used as a zootechnical additive in chickens for fattening. The active substance (d‐glyceric acid) of the additive ■■■■■ by fermentation with Gluconobacter frateurii. The additive is intended to be used in chickens for fattening at a concentration from ■■■■■. The FEEDAP Panel notes that the data provided for the characterisation of the active substance are incomplete and that data on the characterisation of the formulated additive are not provided. Based on the information available, the FEEDAP Panel cannot assess the qualitative and quantitative composition of Panavital feed. Due to lack of data, the safety of the production strain claimed to be used to produce the active substance cannot be evaluated. Based on the data provided by the applicant, the FEEDAP Panel cannot conclude on the safety of Panavital feed for the target species, the consumer, the user and the environment and on the efficacy of Panavital feed when used as feed additive.

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 AveMix® XG 10 (endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase) for chickens for fattening. The applicant has 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 the target species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not considered to be a dermal or eye irritant but it is a dermal and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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 Lactobacillus rhamnosus CNCM I‐3698 and Lactobacillus farciminis CNCM I‐3699 when used as a silage additive in forage for all animal species. The additive is the result from the fermentation of milk‐based broth with L. rhamnosus CNCM I‐3698 and L. farciminis CNCM I‐3699. It is intended to be used in easy and moderately difficult to ensile materials at a minimum proposed application rate of 2.5 × 107 and maximum 8 × 107 VFU/kg complete feed for all animal species. The data provided do not allow a full characterisation of the additive, and therefore, uncertainty remains on the nature of the product in terms of viability, on the ratio between the active agents and on the shelf‐life of the additive. Both strains fulfil the requirements of the Qualified Presumption of Safety (QPS) approach to the assessment of safety and consequently, are presumed safe for the target animals, consumers of products from animals receiving the additive and the environment. The additive should be considered a respiratory sensitiser. In the absence of data, no conclusions can be drawn on the irritancy of the additive to skin and eyes or on its dermal sensitisation potential. No conclusions can be drawn on the efficacy of the additive to improve the ensiling process of easy and moderately difficult to ensile materials.

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‐cystine produced using Pantoea ananatis NITE BP‐02525 when used as a nutritional additive (amino acid) or as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. l‐Cystine is a dispensable sulfur‐containing amino acid, naturally occurring in proteins of plants and animals. The amino acid l‐cystine produced by fermentation with P. ananatis NITE BP‐02525 is safe for all animal species, if the requirements for sulfur‐containing amino acids are respected. The maximum amount of l‐cystine that can be safely added to the diet will depend on the levels of other sulfur amino acids. This conclusion would also cover its use as a sensory additive. The use of l‐cystine produced by fermentation with P. ananatis NITE BP‐02525 in animal nutrition raises no safety concerns to consumers of animal products. The additive under assessment is considered slightly irritating by inhalation, not irritating to the skin or eyes and is not a skin sensitiser. There is no risk for persons handling the additive from the exposure to endotoxins by inhalation. The use of the l‐cystine produced by fermentation with P. ananatis NITE BP‐02525 as a feed additive does not represent a risk to the environment. l‐Cystine is considered efficacious in partially meeting the requirements of sulfur‐containing amino acids in all animal species. For the supplemental l‐cystine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. It is also considered efficacious as a feed flavouring compound under the proposed conditions of use.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelates of lysine and glutamic acid (Manganese‐LG) as nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. The Panel concluded that, owing to safety considerations, the simultaneous use of both feed and water supplemented with Manganese‐LG should be avoided. Manganese‐LG showed to be safe for chickens for fattening up to the maximum authorised levels in the EU for manganese in feed (150 mg/kg); however, since a margin of safety could not be derived, the conclusions could not be extrapolated/extended to other categories/species. The data showed that Manganese‐LG does not increase nor change the patterns of manganese tissue deposition when administered up to the maximum level allowed in the EU; therefore, the Panel concluded that the additive is safe for consumers of tissues and products from animals fed the additive up to the total manganese content in feed authorised in the EU. Owing to the manganese and nickel content of Manganese‐LG, the Panel concluded that the handling of the additive poses a risk to users by inhalation and shall be considered as a skin and respiratory sensitiser; the data showed that the additive is irritant to eye and non‐irritant to skin. Manganese‐LG, intended to substitute other authorised manganese additives, will not further increase the environmental burden of manganese; the Panel considered that the use of the additive in animal nutrition would not pose an additional risk for the environment. The Panel concluded that the additive is efficacious in chickens for fattening; this conclusion can be extrapolated/extended to other categories/species. The FEEDAP Panel posed a recommendation concerning the description of the additive.

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‐isoleucine produced by Escherichia coli FERM ABP‐10641 (i) to renew the authorisation and to extend the use of the additive in water for drinking when used as a nutritional additive for all animal species and (ii) to evaluate a new use as a flavouring additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. l‐Isoleucine does not give rise to any safety concern regarding the production strain and its genetic modification. Considering that the production process has not been substantially modified and that no adverse effects have been reported in the literature search, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in previous assessments. Therefore, the Panel considers that the additive l‐isoleucine produced by E. coli FERM ABP‐10641 remains safe for the target species, consumer and for the environment when used as a nutritional additive in feed. The Panel extends these conclusions to the use of the additive as a flavouring compound. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety for the target species of l‐isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. l‐Isoleucine is not irritant to skin and eyes and is not a dermal sensitiser but is hazardous by inhalation. The Panel confirms the previous conclusions that the additive is considered as a source of available isoleucine for non‐ruminant animal species when used as a nutritional additive. It requires protection against degradation in the rumen to be as efficacious in ruminants as in non‐ruminant species. The Panel considers the use of the additive in water for drinking to be equally effective than the use in feed when used as a nutritional additive. Since l‐isoleucine is used in food as a flavouring compound, and its function in feed is essentially the same as that in food no further demonstration of efficacy is necessary.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of butylated hydroxy anisole (BHA) for all animal species. In 2018, the Panel delivered an Opinion on the safety and efficacy of BHA. The Panel concluded that ‘a weight of evidence of the limited data supports that 150 mg BHA/kg complete feed would be a safe dose for all animal species. However, a possible exception could be cat, with its known lower capacity for glucuronidation of phenolic compounds and for which no specific data were available’. The Applicant submitted a review of the metabolism of phenolic compounds in cats and an in vivo study with cats. No specific information on metabolic fate of BHA has been made available for the feline species. The lack of knowledge is of particular relevance considering the additional load of phenolic compounds by dietary BHA for the full lifetime expectancy of cats. Owing the shortcomings in the design and reporting, the in vivo study could not be used to conclude on the safety of BHA for cats. Consequently, the Panel reiterates that no safe concentration of BHA in complete feed for cats could be established.

© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the additional data submitted on Lancer® when used as a feed additive for weaned piglets. The FEEDAP Panel considered that uncertainty still remains on possible developmental neurotoxicity of Lancer® since it was unable to identify a no observed adverse effect level (NOAEL) for this specific endpoint applying a read-across strategy from the studies provided by the applicant. However, the FEEDAP Panel considered that the exposure to La and Ce from products of animals treated with Lancer® at 250 mg/kg feed would not add a significant contribution to the background exposure of these elements. The FEEDAP Panel concluded that the use of Lancer® in feed for weaned piglets (up to 120 days) according to the proposed conditions of use, does not represent a safety concern for the consumer and for the environment.

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 additional data submitted for ethyl ester of β‐apo‐8‐carotenic acid (β‐apo‐8‐ester) when used as a feed additive for poultry for fattening and poultry for laying. The proposed maximum content for β‐apo‐8‐ester of 40 mg/kg complete feed is safe for laying hens with a margin of safety of at least two. The following dietary concentrations are considered safe for the adult consumers, including the age classes adults, elderly and very elderly: 15 mg β‐apo‐8‐ester/kg complete feed for chickens for fattening, 5 mg β‐apo‐8‐ester/kg complete feed for laying hens and 40 mg β‐apo‐8‐ester/kg complete feed for laying hens only intended to the production of liquid eggs which will be only used by the pasta industry for the production of egg pasta. Concerns would arise for the age classes infants, toddlers, other children and adolescents in those countries where dietary surveys showed higher consumption of egg and egg‐derived products (Bulgaria, Spain, the UK, the Netherlands, Greece, the Czech Republic and Italy) and higher consumption of egg pasta (Bulgaria, Spain, the UK, the Netherlands, Germany, Denmark, Greece, Austria, the Czech Republic, France, Latvia, Sweden and Italy) assuming that the egg pasta is manufactured with liquid eggs from laying hens treated with 40 mg β‐apo‐8‐ester/kg complete feed.

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of l‐methionine produced by fermentation with Corynebacterium glutamicum KCCM 80184 and Escherichia coli KCCM 80096 for all animal species. The two producing microorganisms were obtained by genetic modification. l‐Methionine is intended to be used in feed or water for drinking for all animal species and categories. Neither viable cells of the production strains, nor their recombinant DNA were detected in the final product. The additive does not pose any safety concern associated with the genetic modification of the production strains. l‐methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096. The additive is considered safe for the target species, for the consumer and for the environment. l‐Methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096 is considered not toxic by inhalation, non‐irritant to skin or eyes and not a dermal sensitiser. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety of l‐methionine for target species when administered via water for drinking owing to the risk of nutritional imbalances and hygienic reasons. l‐Methionine produced by C. glutamicum KCCM 80184 and E. coli KCCM 80096 is considered as an efficacious source of the essential amino acid l‐methionine for non‐ruminant animal species. For the supplemental l‐methionine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase, EC 3.2.1.1) is produced with a non‐genetically modified Aspergillus oryzae (strain DP‐Bzb41) by Danisco US Inc. (USA). The α‐amylase food enzyme is intended to be used in baking, brewing, distilled alcohol production and starch processing for the glucose syrup production. Based on the maximum use levels for baking and brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 2.59 mg TOS/kg body weight (bw) per day. Since residual amounts of TOS are removed during distilled alcohol production and by the purification steps applied during starch processing, dietary exposure for these processes was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 1,000 mg TOS/kg bw per day, the highest dose tested. Comparison with the estimated dietary exposure, results in a margin of exposure of at least 386. Similarity of the amino acid sequence to those of known allergens was searched and one match to respiratory allergen was found (an amylase from another strain of A. oryzae). The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

The food enzyme β‐d‐galactosidase galactohydrolase (EC 3.2.1.23) is produced with Bacillus sp. strain M3‐1 by GenoFocus Inc. The food enzyme β‐galactosidase is intended to be used in the manufacture of galactooligosaccharides (GOS). Since residual amounts of total organic solids are removed by the purification steps applied during the production of GOS, toxicological studies were considered not necessary and no dietary exposure was calculated. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

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 RONOZYME ® WX CT/L as a feed additive for sows for reproduction. This additive contains endo‐1,4‐β‐xylanase produced by a genetically modified strain of Aspergillus oryzae and it is authorised in the EU as a feed additive for poultry for fattening, weaned piglets and pigs for fattening. The applicant requests the extension of use of the additive to sows for reproduction at 200 FXU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of RONOZYME ® WX in sows. The FEEDAP Panel concluded that the additive is not a skin or eye irritant, but it should be considered a respiratory sensitiser, but could not conclude on the skin sensitisation potential of the additive. A tolerance trial in lactating sows and two toxicological studies were made available to support the safety of the target species. Based on the data available, the FEEDAP Panel concluded that the additive is safe for sows for reproduction at the recommended level with a wide margin of safety. Three efficacy studies in lactating sows were evaluated. Sows that received RONOZYME ® WX showed improvements on the apparent faecal digestibility of the energy in the three trials. The enzyme activity in feed that showed efficacy ranged from 124 to 287 FXU/kg feed, and the FEEDAP Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in lactating sows at a level of approximately 250 FXU/kg feed. No data has been provided in gestating sows, and consequently, the Panel could not conclude on this physiological stage of the productive cycle.

The food enzyme, a maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133), is produced with a genetically modified Escherichia coli strain BLASC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This maltogenic amylase is intended to be used in baking and brewing processes and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups; consequently, dietary exposure was not calculated for this food process. For baking and brewing processes, based on the maximum use levels recommended for food processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.107 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose tested of 838 mg TOS/kg bw per day that, compared with the estimated dietary exposure, resulted in a sufficiently high margin of exposure (at least 7,800). Similarity of the amino acid sequence to those of known allergens was searched and one match was found with respiratory allergen produced by Aspergillus oryzae. The Panel considered that, under the intended conditions of use, the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reaction to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

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 Bergazym® P100 (endo‐1,4‐β‐xylanase, produced by a non‐genetically modified strain of Trichoderma reesei) as a feed additive for other birds for fattening, ornamental birds and other growing Suidae. Considering the high margin of safety observed in the tolerance studies in chickens for fattening and in weaned piglets, and that the recommended level is the same, the Panel extrapolates the conclusions reached in chickens for fattening to all poultry species for fattening and ornamental birds and extrapolates the conclusions reached in weaned piglets to other growing Suidae species. Therefore, Bergazym® P100 containing endo‐1,4‐β‐xylanase as active substance is considered safe in other birds for fattening, ornamental birds and other growing Suidae at the recommended dose of 1,500 EPU/kg feed. The additive is considered safe for the consumer and the environment. The additive is not irritant to the eyes and the skin, but it is considered a potential skin and respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive, functional group ‘digestibility enhancers’, in other birds for fattening, ornamental birds and other growing Suidae at the recommended dose of 1,500 EPU/kg feed.

The additive (trade name Biomin®DC-P) is a blend of five individual compounds (carvacrol, thymol, d-carvone, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for various poultry species at a minimum concentration of 65mg/kg complete feed and a recommended maximum level of 105mg/kg complete feed. The results of a tolerance study show that Biomin® DC-P is safe for chickens for fattening at the maximum recommended application rate of 105 mg/kg complete feed; this conclusion is extended to include chickens reared for laying and extrapolated to minor poultry species The active components of a previously evaluated additive (Biomin®DC-C) were shown to be not genotoxic; owing to the similarity on composition, this conclusion can be also applied to Biomin®DC-P. Notwithstanding the uncertainties identified in the residue study, after applying a worst-case scenario to calculate potential exposure of consumers to menthol and carvone, and since that the components of the additive are considered safe for their use as food and feed flavourings, the FEEDAP Panelconcludes that the use of the additive in animal nutrition is considered safe for consumers. The FEEDAP Panelconsidered that exposure of users by inhalation is unlikely, but cannot conclude on the effects of Biomin®DC-P on skin and eyes. The use of Biomin®DC-P is not expected to pose a risk for the environment. Biomin®DC-P has a potential to increase the growth performance of chickens for fattening when incorporated into feed at a minimum application rate of 65mg/kg complete feed; the conclusion can be extended to chickens reared for laying and extrapolated to minor poultry species reared up to the point of lay.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the product Biosprint® (Saccharomyces cerevisiae MUCL 39885) as a feed additive for sows. S. cerevisiae is considered by EFSA to have qualified presumption of safety (QPS) status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel confirms that the use of Biosprint® under the current authorised conditions of use is safe for sows, the consumers and the environment. The additive is considered as a potential skin and eye irritant and skin/respiratory sensitiser. There is no need to assess the efficacy of Biosprint® in the context of the renewal of the authorisation.

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‐tryptophan produced by fermentation using Escherichia coli KCCM 80152 when used as nutritional additive in feed and water for drinking for all animal species. The production strain and its recombinant DNA were not detected in the additive. l‐Tryptophan, manufactured by fermentation with E. coli KCCM 80152, does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l‐tryptophan produced using E. coli KCCM 80152 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non‐ruminant target species. Using unprotected forms of tryptophan in ruminants can be a risk. The use of l‐tryptophan produced by fermentation using E. coli KCCM 80152 in animal feed presents no concerns to consumers of animal products. Due to the content of endotoxins, the additive poses a risk for persons handling the additive when exposed by inhalation. The additive is not considered irritant for skin or eyes and is not considered a skin sensitiser. The additive under assessment is safe for the environment. The additive under assessment is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. If l‐tryptophan is intended for use in ruminants, it should be protected from ruminal degradation.

APSA PHYTAFEED ® 20,000 GR/L is a preparation of 6‐phytase which is presented in solid and liquid forms. This additive is intended to be used as a zootechnical additive in chickens for fattening or reared for laying/breeding and minor poultry species for fattening or reared for laying/breeding. The 6‐phytase present in the additive is produced by a genetically modified strain of Komagataella phaffii. The production strain and its recombinant DNA were not detected in intermediate products used to produce the additive. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding. The FEEDAP Panel concluded that the use of APSA PHYTAFEED ® 20,000 GR/L as a feed additive gives rise to no concern for consumers. The additive, in either form, is not toxic by inhalation or irritant for skin or eyes and it is not a dermal sensitizer, but it is considered a potential respiratory sensitizer. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel evaluated three efficacy trials in which the retention of the phosphorus was studied. The data showed that the additive has the potential to improve the retention of phosphorus in the diets in chickens for fattening at 250 U/kg feed. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding.

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 an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species. The essential oil under assessment obtained ■■■■■ is specified to contain carvacrol ■■■■■ and thymol (7%). The remaining 30% of the composition remains uncharacterised. In the absence of these data, the FEEDAP Panel was unable to make a risk assessment of the additive for the target species, the consumer and the user. Use in animal production of the essential oil extracted from O. vulgare ssp. hirtum (Link) leetsw. is not expected to pose a risk for the environment. Since oregano and its extracts are universally recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detected in the final additive, but recombinant DNA from the production strain was detected. Considering that the production strain does not carry genetic sequences of concern, the presence of DNA was considered per se of no safety concern by the Panel. The safety of the additive for the target species, consumers and environment was established, but the Panel concluded that the additive should be considered as a respiratory sensitiser. Regarding the efficacy, it was concluded that the additive has a potential to be efficacious in chickens for fattening and extended/extrapolated the conclusion to chickens reared for laying and minor poultry species for fattening. However, the Panel could not conclude on the efficacy of the additive in turkeys for fattening, reared for breeding or for breeding purposes. The Panel concluded, based on the new guidance on the efficacy for feed additives, that the conclusion on the efficacy in chickens for fattening can be extrapolated to turkeys for fattening/reared for breeding purposes. New data in turkeys for fattening would support the extrapolation. No data has been provided to support the efficacy in turkeys for breeding purposes and therefore no conclusion could be drawn. Finally, the applicant has proposed, in the current submission, a modification of the manufacturing process to remove the presence of DNA from the production strain in the final product, the removal was confirmed by analyses.

Bonvital ® is the trade name for a feed additive based on Enterococcus faecium DSM 7134 currently authorised for use in piglets, pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. This opinion concerns the renewal of the authorisation of Bonvital ® as a zootechnical additive for weaned piglets and pigs for fattening. The applicant is proposing to increase the minimum and maximum inclusion level of the additive in feed for weaned piglets and the maximum for pigs for fattening. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. E. faecium DSM 7134 does not belong to the hospital-associated clade and does not express resistance to the antibiotics tested; therefore, its use in animal nutrition is considered safe for the target animals and consumers of animal products. Bonvital ® is also considered safe for the target animals and consumers. In previous opinions, Bonvital ® was found to be non-irritant to skin and eyes, but a potential skin/respiratory sensitiser and safe for the environment. No new evidence has been identified that would make the Panel reconsider the previous conclusions on the safety of the additive. The conclusions reached before are considered to cover the higher maximum application rates proposed by the applicant. Therefore, the Panel concludes that Bonvital ® used under the proposed conditions of use is safe for weaned piglets and pigs for fattening, consumers of products derived from animals fed Bonvital ® and the environment. Bonvital ® is considered a potential skin/respiratory sensitiser. The additional studies provided confirm that Bonvital ® has the potential to be efficacious in weaned piglets at 1 × 10 9 colony forming unit (CFU)/kg feed and in pigs for fattening at 2 × 10 8 CFU/kg feed.