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Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat salinomycin sodium (Sacox®) for rabbits for fattening. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of salinomycin sodium (SAL‐Na) from Sacox® does not raise safety concerns for the target species, consumers, users and the environment with regard to the production strain. In the absence of adequate tolerance studies, the FEEDAP Panel could not conclude on the safety of SAL‐Na from Sacox® for rabbits for fattening. The FEEDAP Panel concluded that the additive is safe for the consumer when it is used at the proposed maximum level of 25 mg SAL‐Na/kg complete feed for rabbits and a withdrawal period of 1 day is respected. The following maximum residue limits (MRL) are proposed for the marker residue compound salinomycin (SAL): 0.2 and 0.03 mg SAL/kg for liver and kidney, respectively. The additive is not irritant to skin and eyes but should be considered a potential dermal and respiratory sensitiser. A risk for inhalation toxicity could not be excluded. The use of the SAL‐Na from Sacox® in feed for rabbits for fattening up to the highest proposed level will not pose a risk for the terrestrial and aquatic compartment and ground water. The risk of secondary poisoning can be excluded for worm‐eating birds and mammals, while it cannot be excluded for fish‐eating birds and mammals. The FEEDAP Panel concludes that SAL‐Na from Sacox® at the minimum concentration of 20 mg SAL‐Na/kg complete feed has the potential to control coccidiosis in rabbits for fattening. Development of resistance to SAL‐Na of field Eimeria spp. strains isolated from rabbits for fattening should be monitored.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat narasin (Monteban® G100) for chickens for fattening. In a previous opinion, uncertainties remained on the identification and characterisation of the non‐genetically modified production strain of the active substance narasin. The Panel could not conclude either on the safety of Monteban® G100 for chickens for fattening or on the efficacy of the additive at the minimum applied concentration. The FEEDAP Panel excluded risks for environment but the risk for sediment compartment could not be assessed. The applicant provided supplementary information to cover the data gaps and substituted the narasin production strain from Streptomyces spp. NRRL 8092 to Streptomyces spp. NRRL B‐67771. The information submitted to taxonomically identify the production strain did not allow to assign it to any described microbial species. Based on the information provided, the Panel concluded that the use of Monteban® G100 did not raise safety concerns as regards the production strain for the target animal, consumer, user and environment. The Panel concluded that 70 mg narasin/kg complete feed was safe for chickens for fattening with a margin of safety of 1.4; narasin from Monteban® G100 was unlikely to increase shedding of Salmonella Enteritidis, Salmonella Typhimurium and Campylobacter jejuni. Narasin, when used in chickens for fattening at 70 mg/kg feed, was not expected to pose a risk to the aquatic compartment and to sediment, while a risk for the terrestrial compartment could not be excluded. No risk for groundwater was expected, nor for secondary poisoning via the terrestrial food chain, but the risk of secondary poisoning via the aquatic food chain could not be excluded. The Panel concluded that 60 mg narasin/kg feed was efficacious in controlling coccidiosis in chickens for fattening.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of benzoic acid (Kalama®) as a zootechnical feed additive for weaned piglets at a level of 5000 mg/kg complete feed and for pigs for fattening at a minimum content of 5000 mg/kg and a maximum content of 10,000 mg/kg complete feed. The FEEDAP Panel concluded that benzoic acid is safe for weaned piglets at 5000 mg/kg complete feed and for pigs for fattening at 10,000 mg/kg complete feed. The Panel considered the use of benzoic acid under the proposed conditions of use to be of no concern for consumer safety and the environment. Benzoic acid poses a risk by inhalation, it is irritant to skin and corrosive to eyes, but no conclusions can be drawn on dermal sensitisation. The additive, benzoic acid, is efficacious as a zootechnical feed additive for weaned piglets and for pigs for fattening at the proposed conditions of use.

Abstract Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat halofuginone hydrobromide (STENOROL®) when used as a feed additive for chickens for fattening and turkeys for fattening/reared for breeding. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the safety for turkeys for fattening established in its previous opinion can be extended to turkeys for breeding up to 12 weeks of age. Based on the new data provided on the safety for consumer, environment and efficacy, the Panel updates its previous conclusions as follows: halofuginone hydrobromide is not genotoxic. Applying an uncertainty factor of 100 to the lowest no observed adverse effect level (NOAEL) of 0.03 mg/kg body weight (bw) per day, an acceptable daily intake (ADI) of 0.3 μg halofuginone/kg bw is established. The chronic exposure of consumers to residues of halofuginone would amount to 6–19% of the ADI after 3 days of withdrawal. Therefore, the Panel considers that the additive is safe for the consumer of tissues obtained from chickens for fattening and turkeys for fattening fed the additive at a maximum level of 3 mg/kg complete feed at a 3‐day withdrawal time. For control purposes, the Panel recommends the setting of the following maximum residue limits (MRLs): liver, 50 μg/kg; kidney, 40 μg/kg; muscle, 3 μg/kg; skin/fat, 10 μg/kg wet tissue. Based on an updated environmental risk assessment, no concern for groundwater is expected. Halofuginone is unlikely to bioaccumulate and the risk of secondary poisoning is not likely to occur. No safety concerns are expected for terrestrial and aquatic environments. The additive has the potential to control coccidiosis in chickens for fattening and turkeys for fattening/reared for breeding up to 12 weeks of age at a minimum level of 2 mg/kg complete feed.

The recent European Union (EU) Regulations on clinical trial on medicinal products (MPs) (2014/536) and on medical devices (MD) (2017/745) represent potential improvement for the European health system and may offer advantages to the citizens. As Regulations, they are immediately applicable in Member States overruling national laws, being an advantage for stakeholders (e.g. sponsors and investigators) and Europe becomes de facto one homogeneous place for research and development of medicines and medical devices. This perspective commentary focuses on the most relevant methodological and regulatory aspects of the recent Regulation on clinical trials for drug development and how it may indirectly impact on substance-based medical devices (SBMD). The article highlights the innovations associated with the 2017/745 Regulation, especially to the area of SBMD, which represent a novelty among MDs. Since SBMDs share some aspects of medicines, they will increasingly undergo research in the future related to the performance and safety claims, via post-marketing surveillance. Importantly, SBMD’s Consumers are rapidly increasing due to their usage to treat some common symptoms, which not necessarily need conventional medicines. “Frontiers in Drug Safety and Regulation” created a section to reflect this rapidly-changing scenario and host reports on SBMD in a scientific environment. This initiative is also a reflection of the recent regulation on SBMDs. Thus, the improvement of clinical research through the new EU Regulation on clinical trials may become useful also to the new requirements for SBMD. A novel editorial initiative will further contribute to implement the EU Regulation providing adequate scientific dissemination.

Abstract 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.

Abstract 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.

Abstract Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety of the coccidiostat Aviax 5% (semduramicin sodium) when used in feed for chickens for fattening. In a previous assessment, the FEEDAP Panel could not conclude on the taxonomical identification of the production strain at species level and on the absence of genetic determinants for antimicrobial resistance. In addition, the Panel could not conclude on the safety for the target animals and could not set maximum residue limits to protect consumers. Regarding the safety for the environment, although the use of the additive was considered safe for the terrestrial compartment, a risk for the aquatic compartment and for groundwater pollution could not be excluded. Based on the new data provided, the FEEDAP Panel concludes that there are no safety concerns for the target animals, consumer, user and environment regarding the production strain of semduramicin sodium. Based on the results in the tolerance trial, the FEEDAP Panel concludes that the additive is safe for chickens for fattening up to the maximum recommended level (25 mg/kg complete feed), but no margin of safety can be established. The use of semduramicin sodium at a maximum level of 25 mg/kg complete feed for chickens for fattening is safe for consumers with no withdrawal time. Based on the new data provided and the current requirements for environmental risk assessment, the use of semduramicin sodium from Aviax 5% in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for groundwater nor for aquatic and sediment compartments, while a risk for the terrestrial compartment cannot be excluded. The bioaccumulation and the risk for secondary poisoning are considered to be low.

Abstract 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 Allura Red AC for small non‐food‐producing mammals and ornamental birds when used as an additive that add or restore colour in feedingstuffs. The use of Allura Red AC up to the proposed conditions of use of 500 mg/kg complete feed is considered safe for guinea pig, chinchilla, degu, hamster, gerbil and chipmunk. The following maximum safe levels (mg/kg complete feed) apply to the following species: ferrets 99, rabbits 123, canaries, budgerigars, mynah and toucans 45, lovebirds 51, cockatiels 79, cockatoos 115, amazons 145, parrots 147, yellow breast macaw 150, blue‐throated macaw 173 and hyacinth macaw 214. The maximum safe level of Allura Red AC for other small non‐food‐producing mammal is 99 mg/kg feed and for other ornamental birds is 45 mg/kg feed. Inhalation exposure of Allura Red is regarded as hazardous. In the absence of data, the Panel cannot conclude on the potential of Allura Red to be a skin/eye irritant or a skin sensitiser. The FEEDAP Panel cannot conclude on the efficacy of the additive.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ECONASE® XT (endo‐1,4‐β‐xylanase) produced by a genetically modified strain of Trichoderma reesei (CBS 140027) as a zootechnical feed additive for piglets (weaned), pigs for fattening, chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding and minor poultry species. The recipient strain and the production strain T. reesei CBS 140027 are considered safe. The additive is safe for chickens for fattening and weaned piglets at the maximum recommended doses (16,000 and 24,000 BXU/kg feed, respectively) with a wide margin of safety (100‐fold and 50‐fold, respectively). These conclusions are extended to chickens reared for laying and to pigs for fattening at 16,000 and 24,000 BXU/kg feed, respectively. The additive is safe for turkeys for fattening or reared for breeding at 16,000 BXU/kg feed. The FEEDAP Panel cannot conclude on the safety of the additive for laying hens and for minor poultry species for laying at the proposed conditions of use. The information provided does not allow to conclude on the safety of the use of ECONASE XT® P/L produced by T. reesei CBS 140027 in animal nutrition for the consumers. The use of the additive under assessment in animal nutrition does not raise safety concerns for the environment. ECONASE® XT L is non‐irritant to the skin or to the eyes. In absence of data, the FEEDAP Panel cannot conclude on the potential of the solid product to be irritant to skin and eyes and on the potential of the additive in all forms to be a dermal sensitiser. All forms of the additive should be considered as respiratory sensitisers. All forms of the additive are considered efficacious at the minimum recommended levels for the target species.

Abstract Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.

Abstract 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 Avatec® 150G (lasalocid A sodium) for chickens for fattening and chickens reared for laying. In 2017, the FEEDAP Panel was not able to conclude on a safe dose for chickens for fattening and chickens reared for laying and no conclusion could be drawn on the anticoccidial efficacy of the additive at the lowest proposed used level (75 mg lasalocid A sodium/kg feed) in these species. In the present assessment, the applicant submitted new tolerance and efficacy studies in chickens for fattening to address the concerns identified by the FEEDAP Panel in its former opinion. In addition, the applicant proposed to decrease the maximum of the dose range from 125 to 100 mg lasalocid A sodium/kg complete feed. Based on the additional information, the FEEDAP Panel concludes that no safe level of lasalocid A sodium from Avatec® 150G in feed for chickens for fattening can be identified. The FEEDAP Panel is not in the position to conclude on the coccidiostatic efficacy of Avatec® 150G for chickens for fattening at the lowest proposed dose level of 75 mg lasalocid A sodium/kg complete feed due to the insufficient number of studies with positive results. The conclusions are extended to chickens reared for laying.

Abstract 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.

Abstract 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 Sorbiflore® ADVANCE when used as a zootechnical feed additive for chickens for fattening. Sorbiflore® ADVANCE is an additive resulting from the fermentation of milk‐based broth with Lactobacillus rhamnosus CNCM I‐3698 and Lactobacillus farciminis CNCM I‐3699. Sorbiflore® ADVANCE is intended for use in feed for chickens for fattening at the minimum concentration of 5 × 107 Viable Forming Units (VFU)/kg and the maximum concentration of 2 × 108 VFU/kg complete feed. The data submitted did 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 stability and homogeneity of the additive. The active agents fulfil the requirements of the Qualified Presumption of Safety (QPS) approach to the assessment of safety and no concerns are expected from other components of the additive. Consequently, Sorbiflore® ADVANCE is presumed to be 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 Sorbiflore® ADVANCE to skin and eyes and on its dermal sensitisation potential. Sorbiflore® ADVANCE at 2 × 108 VFU/kg feed has the potential to be efficacious in chickens for fattening.

Abstract 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 Sorbiflore® ADVANCE when used as a zootechnical feed additive for weaned piglets. Sorbiflore® ADVANCE results from the fermentation of milk based‐broth with Lactobacillus rhamnosus CNCM I‐3698 and Lactobacillus farciminis CNCM I‐3699. The additive is intended for use in feed for weaned piglets at the minimum concentration of 1.25 × 108 viable forming units (VFU)/kg and the maximum concentration of 5 × 108 VFU/kg complete feed. The data submitted did 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 stability of the additive. The active agents fulfil the requirements of the qualified presumption of safety (QPS) approach to the assessment of safety and no concerns are expected from other components of the additive. Consequently, Sorbiflore® ADVANCE is presumed to be 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 could be drawn on the irritancy of Sorbiflore® ADVANCE to skin and eyes and on its dermal sensitisation potential. Sorbiflore® ADVANCE at 1.25 × 108 VFU/kg feed has the potential to be efficacious in weaned piglets.

Abstract 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 l‐glutamine (≥ 98.0%) produced by fermentation using a genetically modified strain of Corynebacterium glutamicum (NITE BP‐02524). It is intended to be used in feed for all animal species and categories as nutritional additive (amino acid) and as sensory additive (flavouring compound). Viable cells of the production strain and its recombinant DNA were not detected in the additive. l‐Glutamine manufactured by fermentation using C. glutamicum NITE BP‐02524 does not give rise to any safety concern with regard to the genetic modification of the production strain. The use of l‐glutamine produced by fermentation using C. glutamicum NITE BP‐02524 in animal nutrition is considered safe for all animal species when applied as a nutritional additive to achieve an adequate amino acid profile in feed and to overcome potential glutamine shortages during critical periods of life. The proposed use level (25 mg/kg feed) when used as sensory additive (flavouring compound) is safe for all animal species. The uses of l‐glutamine produced using C. glutamicum NITE BP‐02524 as nutritional additive or as flavouring compound are considered safe for the consumer. l‐Glutamine produced using C. glutamicum NITE BP‐02524 is not toxic by inhalation, is non‐irritant to skin and eyes and is not a skin sensitiser. l‐Glutamine produced using C. glutamicum NITE BP‐02524 is considered safe for the environment. l‐glutamine is a non‐essential amino acid and it plays a physiological role as such. Recent evidence shows that glutamine may act as conditionally essential amino acid mainly in growing animals and has some specific effects e.g. in improving intestinal development and immune response. This amino acid produced by fermentation using C. glutamicum NITE BP‐02524 is regarded as an efficacious source of glutamine for all animal species. For supplemental l‐glutamine to be as efficacious in ruminants as in non‐ruminants, it would require protection against degradation in the rumen. The use of l‐glutamine as sensory additive at 25 mg/kg feed is considered efficacious.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Natugrain® TS/TS L. The additive is a preparation of endo‐1,4‐beta‐xylanase and endo‐1,4‐beta‐glucanase produced by two genetically modified strains of Aspergillus niger, and it is authorised for use in piglets (weaned) and pigs for fattening, poultry species and ornamental birds. The applicant requested the extension of use of the additive to sows at 560 TXU and 250 TGU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of the additive in sows. The additive should be considered a potential respiratory sensitiser for the users. Considering the results from a subchronic oral toxicity study and the tolerance study in lactating sows, the Panel concluded that the additive is safe for sows at the recommended dose. The data submitted to support the efficacy for sows allowed the Panel to conclude that the additive is efficacious in lactating sows, data on gestating sows were not given, and therefore, the Panel could not conclude on the efficacy of the additive in that physiological stage.

Abstract 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 CI‐FER™ (ferric citrate chelate) as zootechnical feed additive for suckling and weaned piglets and minor porcine species. The additive is safe for weaned piglets at the recommended level of 500 mg/kg complete feed. This conclusion can be extended to sucking piglets for the period in which solid feed is given and extrapolated to all minor porcine species. No concerns for consumer safety are expected from the use of the additive in piglets and minor porcine species. The FEEDAP Panel considers that the compound under assessment poses a risk to users by inhalation. The product should also be considered as an irritant to skin, eyes and mucous membranes. Due to the presence of nickel, CI‐FER™ should also be considered as a dermal and respiratory sensitiser. The supplementation of feed with the additive is not expected to pose an environmental risk. CI‐FER™ used at the minimum recommended level of 500 mg/kg feed has the potential to improve zootechnical parameters of weaned piglets. This conclusion can be extended to sucking piglets for the period in which solid feed is given and extrapolated to all minor porcine species.

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

Abstract PHYZYME® XP 5000 G/L is a feed additive that contains 6‐phytase produced by a genetically modified strain of Schizosaccharomyces pombe. The applicant requested for the renewal of the authorisation for PHYZYME® XP 5000 G and L to be used as a feed additive in chickens for fattening, laying hens, turkeys for fattening, ducks for fattening, piglets (weaned), pigs for fattening and sows. This scientific opinion concerns the renewal of the authorisation of the additive for those species. To support the request, the applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment. The application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

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

Abstract Natuphos® is a feed additive that contains 3‐phytase which is produced by a genetically modified strain of Aspergillus niger. The product is currently authorised for use as a feed additive in chickens for fattening, piglets (weaned) and pigs for fattening, laying hens and turkeys for fattening, ducks, sows, all minor avian species other than ducks and ornamental birds. This scientific opinion concerns the renewal of the authorisation of this additive for those species. The application also included chickens reared for laying/breeding, turkeys reared for breeding and breeding hens. The applicant provided evidence that the additive in the market complies with the conditions of authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reconsider the previous conclusions regarding the safety for the target species, consumer and environment under the authorised conditions of use. The additive is a respiratory sensitiser and a potential skin sensitiser. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in for those species for which an authorisation exists. The Panel also considered that the additive is safe and has a potential to be efficacious in chickens reared for laying/breeding, turkeys reared for breeding, breeding hens and suckling piglets at the corresponding recommended doses.

Abstract 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 × 109 colony forming unit (CFU)/kg feed and in pigs for fattening at 2 × 108 CFU/kg feed.

Abstract Following a request from the European Commission, the European Food Safety Authority 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 Probiotic Lactina® for chickens for fattening and rabbits. The additive is a preparation containing viable cells of six strains of lactic acid bacteria intended for use in feed at the proposed dose of 2.5 × 109 CFU/kg complete feedingstuffs. The identity of all of the component strains of Probiotic Lactina® was established in a previous opinion, five of which qualify for the qualified presumption of safety (QPS) approach to safety assessment. As no antibiotic resistance of concern was detected in these strains, following the QPS approach, the use of these five strains in feedingstuffs is presumed safe for target species; consumers of products from animals fed the additive and the environment. The identity and safety of the sixth strain, Enterococcus faecium NBIMCC 8270, was also established in the previous and current opinions. The FEEDAP Panel concludes that Probiotic Lactina® is safe for rabbits (suckling and weaned) at the recommended inclusion level of 2.5 × 109 CFU/kg feed and reiterates its former conclusion that the product is safe for chickens for fattening at 1 × 1010 CFU/kg feed. The FEEDAP Panel considers Probiotic Lactina® to be safe for consumers of products derived from treated animals when used at the conditions proposed. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of Probiotic Lactina® to skin and eyes or on its dermal sensitisation. Owing to the proteinaceous nature of the active agents, the additive is considered to be a potential respiratory sensitiser. No conclusions can be drawn on the efficacy of Probiotic Lactina® for chickens for fattening and rabbits (suckling/weaned).

Abstract Natugrain® Wheat TS is the trade name for a feed additive that contains endo‐1,4‐beta‐xylanase produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, turkeys for fattening or reared for breeding, ducks, ornamental birds and minor avian species (except ducks and laying birds). This scientific opinion concerns the renewal of the authorisation of this additive for those species. The applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment under the authorised conditions of use. The additive is safe for the target species for which there is an authorisation, the consumers and the environment. The additive is a potential skin and dermal sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Abstract The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be established and evidence that they lack toxigenic potential and acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. The identity of the three active agents is established and the lack of toxigenic potential confirmed. The two B. amyloliquefaciens strains do not show resistance to relevant antibiotics, and are presumed safe for the target species, consumers and the environment. The B. subtilis strain showed a low level of resistance to streptomycin, for which acquired resistance genes were not identified. Therefore, it also complies with the QPS qualifications and is presumed safe for the target species, consumer and the environment. Since no other component give rise to concerns, Cinergy® Life B3 HiCon is also considered safe for the target species, consumers and the environment. In the absence of data, no conclusions can be made on the skin or eye irritancy or the potential for dermal sensitisation of the additive. Owing to the proteinaceous nature of the active agents, the additive is considered a potential respiratory sensitiser. However, the low dusting potential makes it unlikely that additive poses a risk for the respiratory system. Cinergy® Life B3 HiCon showed a potential to improve the feed to gain ratio in pigs for fattening given the additive at a minimum inclusion level of 1.5 × 108 CFU/kg complete feed. This conclusion is extrapolated to minor porcine species at the same application rate and for an equivalent growth phase.

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

Abstract 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 Lactobacillus reuteri NBF‐2 when used in feed for cats at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32264. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach establishing safety for the target species and the environment. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, in the absence of concerns form other components of the additives, Lactobacillus reuteri NBF‐2 is presumed safe for the target animals and the environment. Lactobacillus reuteri NBF‐2 should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or on its dermal sensitisation. The FEEDAP the Panel is not in the position to conclude on the efficacy of Lactobacillus reuteri NBF‐2 for cats.

Abstract The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared for laying/breeding, laying hens and minor poultry species for fattening or reared for laying/breeding. Therefore, in this assessment, the new formulation of the product has been characterised and its safety and efficacy has been evaluated. The production strain and its DNA were not detected in the solid formulation. Therefore, the additive poses no concerns with regard to the genetic modification of the production strain. The Panel concluded, based on studies conducted with the liquid formulation, that the additive 3‐phytase FSF10000 is safe for the target species at 1,000 FTU/kg feed. Also, considering the production strain and composition of the final additive the Panel concluded that the additive raises no safety concerns for the consumer of products obtained from animals fed the additive or for the environment. The additive 3‐phytase FSF10000 is not irritant to skin and eyes but it is a skin dermal sensitiser and is considered to be a respiratory sensitiser. Based on studies conducted with the liquid formulation, the Panel concluded that the 3‐phytase FSF10000 has a potential to be efficacious in chickens for fattening or reared for laying and in minor poultry species for fattening or reared for laying/breeding at 500 FTU/kg feed and in laying hens at 1,000 FTU/kg feed.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys for fattening, laying hens, minor poultry species for fattening and laying, weaned piglets, pigs for fattening and carps. The applicant has now requested to extend the authorisation to rabbits for fattening. The FEEDAP Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. There are no concerns for consumer safety and no risks for the environment are expected from the use of the additive as a feed additive. Regarding the safety for the user, the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. A subchronic oral toxicity study in rats was submitted to support the safety of the additive when administered to rabbits for fattening. The maximum safe enzyme activity in feed for the rabbits for fattening was derived from the data obtained in the subchronic oral toxicity study in rats; considering the maximum safe intake derived for rabbits from the toxicological data, the FEEDAP Panel concluded that the additive is safe for rabbits for fattening at the recommended use level. Two efficacy studies were submitted to support the efficacy of the additive; a significant effect of the additive in a relevant parameter was found in only one trial. Due to the insufficient evidence the Panel could not conclude on the efficacy of the additive in rabbits for fattening.

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strain to be established and evidence that it is not toxigenic and does not show acquired resistance to relevant antibiotics. In a previous opinion, the strain was found to meet the criteria for the QPS approach. Since no concerns are expected from other components of the additive, B‐Act® is presumed safe for the target species, consumers and the environment. In the same opinion, no conclusions could be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B‐Act® was considered a potential respiratory sensitiser. Since the use of B‐Act® with the target species is considered unlikely to introduce hazards for users of the product not already considered, the conclusions previously reached apply to the current application. B‐Act® at the recommended dose of 1.6 × 109 colony forming units (CFU)/kg feed has the potential to be efficacious in turkeys for fattening. Since the same dose is proposed for the minor poultry species for fattening or raised for laying, the conclusions can be extended/extrapolated to these species. The conclusions on the compatibility of B‐Act® with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal/lower than those for chickens.

Abstract 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 Lactobacillus reuteri NBF‐1 when used in feed for dogs at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32203. This species is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety (QPS) approach establishing safety for the target species and the environment. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, in the absence of concerns from other components of the additive, Lactobacillus reuteri NBF‐1 is presumed safe for the target animals and the environment. Lactobacillus reuteri NBF‐1 should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or on its dermal sensitisation. The FEEDAP Panel is not in the position to conclude on the efficacy of Lactobacillus reuteri NBF‐1 for dogs.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, turkeys for fattening, laying hens, minor poultry species for fattening and laying, weaned piglets, pigs for fattening and carps. The applicant has now requested to extend the authorisation to sows in order to have benefit in piglets. The FEEDAP Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected. Considering the safety for the user, it was concluded that the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. A tolerance study was submitted to support the safety of the additive in the new target species/category. The results showed that sows tolerated well a 100‐fold the recommended enzyme activity level in feed. Consequently, the FEEDAP Panel concluded that the additive is safe for sows at 1,500 EPU/kg feed. A total of four studies were submitted to support the efficacy of the additive, one of which was not considered further in the assessment due to the high mortality registered in piglets. In the other three, a significant and positive effect on a relevant parameter was found in only one trial. Therefore, the Panel concluded that there is insufficient information to conclude on the efficacy of the additive.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. In previous opinions the identity of the strains has been clearly established and no antibiotic resistance of concern was detected. Therefore, the use of the strains as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered a potential respiratory sensitiser. In a previous application, three studies involving both strains used in combination at the same concentration were made with samples of whole crop maize with varied dry matter content. The same studies have been submitted in this application. The Panel reiterates its previous conclusions that Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri NCIMB 40788/CNCM I‐4323 at 1.5 × 108 CFU of each active agent per kg of fresh forage, equivalent to 3 x 108 CFU total lactobacilli/kg of forage significantly improve the aerobic stability of the silage.

Abstract 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 modification of the terms of authorisation of lecithins as a feed additive for all animal species. Lecithins are currently authorised for use in feed for all animal species (Commission Implementing Regulation (EU) 2017/2325). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion of the additive lecithins in 2016. The Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as emulsifier. The requested modification refers to the alignment of the specifications of the feed additive to the specifications set for lecithins when used as food additives, and the inclusion in the authorisation of rapeseed among the botanical sources of hydrolysed and de‐oiled lecithins and of de‐oiled hydrolysed soybean lecithins as an additional form of the additive. Based on the data available, all the lecithins of different botanical origin and their forms under application meet the specifications set for the use of lecithins as a food additive. The Panel therefore recommended applying the specifications set for food additive to the lecithins under application. In its previous opinion, the Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as an emulsifier. The Panel is not aware of any information related to the use of rapeseed as an additional source of hydrolysed liquid lecithins and de‐oiled lecithin powder that would modify the previous conclusions.

Abstract l‐Arginine is considered as a non‐essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. l‐Arginine produced by fermentation with Escherichia coli NITE BP‐02186, genetically modified to enhance the production of l‐arginine, is intended to be used in feed and water for drinking for all animal species and categories. The product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. Its use as a nutritional additive is safe for target species when supplemented to diets in appropriate amounts. The use of l‐arginine as a feed flavouring agent is unlikely to pose any concern. No risks are expected for the consumer from the use of the product under assessment as a feed additive. It is not irritant to skin or eyes, nor a skin sensitiser. Although the presence of endotoxin activity is of no concern, the available exposure and toxicological data indicate that the additive may pose a risk to users by inhalation. The use of this additive in animal nutrition does not pose a risk to the environment. The additive is an effective source of arginine for all species. l‐Arginine is considered efficacious when used as a flavouring compound in animal nutrition.

Abstract The additive under assessment consists of a natural mixture, mainly composed of dolomite (~ 30%), magnesite (~ 20%) and magnesium‐phyllosilicates (talc (~ 35%) and chlorite (~ 15%)). In 2016, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of natural mixture of dolomite plus magnesite and magnesium‐phyllosilicates. In this opinion, the Panel concluded that 20,000 mg additive/kg complete feed is considered safe for dairy cows and for piglets (weaned). This conclusion was extended to pigs for fattening while no conclusion could be drawn on the safety for poultry or any other species/categories. Following this opinion, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species. The new tolerance studies submitted with cattle for fattening and chickens for fattening showed tolerance of these animal categories to the additive up to approximately fivefold the highest recommended use level. The FEEDAP Panel therefore concluded that 20,000 mg additive/kg complete feed is safe for cattle for fattening and chickens for fattening. The additive at the same dietary concentration was already considered safe in an earlier opinion for piglets and dairy cows. Since the additive at 20,000 mg/kg complete feed is considered safe for four animal categories (three major animal species) with a comparable margin of safety, the conclusion on safety is extrapolated to all animal species. At the safe dietary concentration the additive did not affect the digestibility of the feed (including feed additives).

Abstract 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 Lactobacillus acidophilus D2/CSL when used in feed for cats and dogs at a minimum dose of 5 × 109 colony forming units (CFU)/kg complete feedingstuffs. The additive is a preparation of viable cells of Lactobacillus acidophilus CECT 4529. This species is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety (QPS) approach to establishing safety for the target species and the environment. The safety of L. acidophilus CECT 4529 was assessed by EFSA in 2014. Following the QPS approach to safety assessment, L. acidophilus CECT 4529 is assumed to be safe for the target species and the environment without the need for further studies. No concerns are expected from other excipients present in the product, so Lactobacillus acidophilus D2/CSL is also considered safe for target animals, including cats and dogs, and the environment. The safety of the additive for the user was also considered in that opinion. The FEEDAP Panel is unaware of any new data that would lead it to revise its conclusions that the additive should be considered to be an eye/skin irritant and a skin/respiratory sensitiser. Lactobacillus acidophilus D2/CSL has some potential to reduce the moisture of stools from dogs and cats receiving the additive at 5 x 109 CFU/kg feed. However, the biological relevance of the magnitude of the effect detected is questionable.

Abstract 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 cumin tincture (Cuminum cyminum L.) when used as a sensory feed additive for all animal species. The product is a water ethanol ■■■■■ solution, which contains 0.002–0.003% of 4‐isopropylbenzaldehyde (cuminaldehyde). The FEEDAP Panel concludes that the additive cumin tincture is safe at the maximum proposed use level (30 μL/kg complete feed or water for drinking) for all animal species. No safety concern would arise for the consumer from the use of cumin tincture up to the highest safe level in feeds. No specific data were provided by the applicant regarding the safety of the additive for users. In the absence of data, no conclusions can be drawn on the additive's potential to be a dermal/eye irritant or a skin sensitiser. The use of cumin tincture at the maximum proposed dose is not considered to be a risk for the environment. Since the major components of the additive are recognised to provide flavour in food and its function in feed would be essentially the same, no demonstration of efficacy is considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening, based on a dossier submitted for the modification of the terms of authorisation of the additive. The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000 mg/kg complete feedingstuffs. The applicant proposed the introduction of an additional manufacturing process, which introduces an impurity (dimethylamino‐ethanol (DMAE)) in the additive at concentrations up to 0.09%. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the proposed modification would not substantially affect the previous assessment as related to the safety of the environment and the efficacy of the product. Since the safety of the active substance was established, the current assessment has dealt with the impurity DMAE. Considering the toxicological profile of DMAE, the estimated intake by the target animal and consumers, and making use of the Threshold of Toxicological Concern (TTC) approach, the Panel concluded that Taminizer D, manufactured by the DMAE route, is safe for both chickens for fattening and consumers, up to the maximum level of 1,000 mg/kg feed. The FEEDAP Panel extends its conclusions about Taminizer D produced by the original method to cover also Taminizer D produced by the new DMAE method. There is minimal risk to users from dust produced as a result of normal handling of the additive. Taminizer D is not irritant to skin but may be irritant to eyes; it is regarded as a potential skin sensitiser. The FEEDAP Panel recommended to set a specification for the DMAE content in the additive.

Abstract l‐Arginine is considered to be a non‐essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l‐arginine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (KCCM 10741P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations at or below thresholds specified by EFSA; thus, C. glutamicum KCCM 10741P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded 99.8%, and no impurities of concern were detected. The use of l‐arginine produced by C. glutamicum KCCM 10741P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. l‐Arginine produced by C. glutamicum KCCM 10741P is considered corrosive to skin and eyes and therefore poses a risk by inhalation. The additive is an effective source of arginine for all species. For the supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against microbial degradation in the rumen.

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

Abstract l‐Glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na4) (Kelforce®) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce® is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA‐Na4, respectively. Kelforce® is safe for chickens for fattening at the maximum level of 1,000 mg GLDA‐Na4/kg complete feed. Based on the toxicological profile of GLDA‐Na4 and the consumer exposure to GLDA‐Na4 and to nitrilotriacetic acid trisodium salt (NTA‐Na3; an impurity of the additive), the use of Kelforce® at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA‐Na4 is unlikely to pose a risk by inhalation. However, owing to the high‐dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce® is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance.

Abstract The additive consists of single strains of Bacillus subtilis and Aspergillus oryzae, to be used in combination as a technological additive (proposed functional group: Substances for the reduction of anti‐nutritional factors) in feed materials for all animal species. An opinion on the two microorganisms was published previously. At this time, the safety of the B. subtilis strain for target animals, consumers, users and the environment was established, but no conclusions could be draw on the safety of the strain of A. oryzae for the target species and consumers or on the efficacy of the additive in reducing anti‐nutritional factors. This opinion considers new information intended to address the identified deficiencies in the previous opinion. An extensive analytical search for secondary metabolites was made of the A. oryzae component of the additive and 15 metabolites were detected and quantified. Of the 15 metabolites, 13 occurred in ng/g additive concentrations and were considered not to be of concern. The remaining two compounds, cyclic dipeptides (2,5‐diketopiperazines), were detected at concentrations up to 1.5 mg/kg. Both have been identified in a wide range of foods and beverages and there appears to be no reports of adverse reactions to such cyclic dipeptides in processed food. Consequently, none of the metabolites detected were considered likely to cause adverse effects in target animals fed treated feed material or in consumers of products derived from such animals. Data from the analysis of 18 batches of soybean before and after treatment with the two strains were presented in support of the efficacy of the additive. Two classes of anti‐nutritional factors were considered; oligosaccharides of the raffinose series and trypsin inhibitor. The microbial strains in combination were able to substantially reduce the concentration of oligosaccharides and trypsin inhibitor naturally present in soybean. Other feed materials were not considered.

Abstract 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 EB15 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus subtilis intended for use in feed at the proposed dose of 5 × 108 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108 CFU/L. The additive exists in two forms, EB15 and EB15 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010 CFU/g additive, respectively. The two formulations are considered equivalent when used to deliver the same dose. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, the additive can be presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. Insufficient evidence was provided to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species.

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

Abstract 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 ZM16 10 for weaned piglets and minor porcine species. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens intended for use in feed at the proposed dose of 5 × 108 CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108 CFU/L. The additive exists in two forms, ZM16 and ZM16 10, which contain the bacterium in concentrations of 1.25 × 109 CFU/g additive and 1.25 × 1010 CFU/g additive, respectively. The two formulations are considered equivalent when used to deliver the same dose. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements of the QPS approach to the assessment of safety. Consequently, the additive can be presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Insufficient evidence was provided to conclude on the efficacy of the additive in weaned piglets or minor weaned porcine species.

Abstract The coccidiostat Coxar® is safe for turkeys for fattening at the use level of 100 mg nicarbazin/kg complete feed, with a margin of safety of about 1.25. Nicarbazin, when ingested, is rapidly split in its two components 2‐hydroxy‐4,6‐dimethylpyrimidine (HDP) and dinitrocarbanilide (DNC), which behave independently. HDP‐related residues are much lower than those of DNC. DNC is the marker residue. Liver is the target tissue. Nicarbazin is not genotoxic. The primary toxicity resulting from the oral use of nicarbazin is renal toxicity. The lowest no observed adverse effect level (NOAEL) identified in a 52‐week study in rat using DNC+HDP is 20 mg DNC + 8 mg HDP/kg body weight (bw) per day based on the absence of microcrystals in urine and related microscopic renal observations. The use of 100 mg nicarbazin from Coxar®/kg complete feed for turkeys for fattening will not pose a risk to consumers, provided that maximum contents in nicarbazin of 0.1% p‐nitroaniline (PNA) and 0.4% methyl(4‐nitrophenyl) carbamate (M4NPC) would be respected. No withdrawal time is required. Residue data comply with the established maximum residue limits (MRLs). Nicarbazin is not a skin or eye irritant and not a skin sensitiser. These conclusions also apply to the additive Coxar®. Inhalation toxicity of nicarbazin is limited; the granulated additive has a low dusting potential. No risk for users is identified. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Coxar® for the environment. The efficacy of 100 mg nicarbazin from Coxar®/kg feed was demonstrated in three anticoccidial sensitivity tests (AST), but only in one floor pen study. The floor pen study with 75 mg nicarbazin failed to demonstrate evidence of efficacy. No final conclusions on the efficacy of nicarbazin from Coxar® for turkeys for fattening can be drawn.