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Abstract The European Commission (EC) asked EFSA to assess the genotoxicity of beauvericin (BEA). Relevant information, including that which has become available since the 2014 Scientific Opinion on the risks to human and animal health related to the presence of BEA and enniatins in food and feed, was reviewed. In the previous Opinion the Panel concluded that in vitro genotoxicity data were equivocal and there were no in vivo genotoxicity data available. New in vitro studies in mammalian cell lines provided no convincing evidence for induction of chromosomal damage by BEA as measured by micronucleus and chromosome aberration tests or an increase of DNA strand breaks as assessed by the Comet assay. In these studies, no concentration‐dependent effects or potential for interference from associated cytotoxicity were observed. In addition, DNA double‐strand breaks as measured by γ‐H2AX analysis were only observed following exposure to highly cytotoxic BEA concentrations. In vivo studies (Comet and Pig‐a assays, micronucleus test) with BEA were negative. In vitro gene expression studies showed no indication of a DNA damage response and (quantitative) structure activity relationship analysis was also not indicative of genotoxic potential. Some effects of BEA might play an indirect role in the formation of DNA strand breaks. These include increased reactive oxygen species, induction of cell cycle arrest and apoptosis, associated with interference in mitochondrial function and cell signalling. There was no compelling evidence of inflammatory and immunosuppressive effects. Taken together, the available data indicate that BEA is devoid of genotoxic potential.

Abstract The European Commission asked EFSA to update its 2012 risk assessment on brominated phenols and their derivatives in food, focusing on five bromophenols and one derivative: 2,4,6‐tribromophenol (2,4,6‐TBP), 2,4‐dibromophenol (2,4‐DBP), 4‐bromophenol (4‐BP), 2,6‐dibromophenol (2,6‐DBP), tetrabrominated bisphenol S (TBBPS), tetrabromobisphenol S bismethyl ether (TBBPS‐BME). Based on the overall evidence, the CONTAM Panel considered in vivo genotoxicity of 2,4,6‐TBP to be unlikely. Effects in liver and kidney were considered as the critical effects of 2,4,6‐tribromophenol (2,4,6‐TBP) in studies in rats. A BMDL10 of 353 mg/kg body weight (bw) per day for kidney papillary necrosis in male rats was identified and was selected as the reference point for the risk characterisation. The derivation of a health‐based guidance value was not considered appropriate due to major limitations in the toxicological database. Instead, the margin of exposure (MOE) approach was applied to assess possible health concerns. Around 78,200 analytical results for 2,4,6‐TBP in food were used to estimate dietary exposure for the European population. Considering the resulting MOE values, all far above an MOE of 6000 that does not raise a health concern, and accounting for the uncertainties affecting the exposure and hazard assessments, the CONTAM Panel concluded with at least 95% probability that the current dietary exposure to 2,4,6‐TBP does not raise a health concern. Due to lack of occurrence data, no risk assessment could be performed for breastfed or formula‐fed infants. No risk characterisation could be performed for any of the other brominated phenols and derivatives included in the assessment, due to lack of data both on the toxicity and occurrence.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of diclazuril (Clinacox® 0.5%) as a coccidiostat for chickens for fattening and chickens reared for laying. The additive currently on the market complies with the existing conditions of authorisation. The additive remains safe for the target species and the consumer under the authorised conditions of use. The additive is irritant to skin, eyes and respiratory tract but is not a skin sensitiser. Exposure by inhalation cannot be excluded. The FEEDAP Panel cannot conclude on the safety for the environment of diclazuril from Clinacox® 0.5% due to lack of data. Diclazuril from Clinacox® 0.5% at a concentration of 1 mg diclazuril/kg complete feed has the potential to control coccidiosis in chickens for fattening. This conclusion is extended to chickens reared for laying. Development of resistance to diclazuril of field Eimeria spp. strains isolated from chickens should be monitored.

Abstract EFSA performs dietary exposure assessments for food‐producing and non‐food‐producing animals to deliver risk assessment for mandates on the presence of contaminants in feed. The CONTAM and FEEDAP Panels identified the need to update the animal dietary exposure assessment model used in those assessments in CONTAM Scientific Opinions since 2011 in cases where insufficient occurrence data are available on species specific compound feeds. The Panels proposed in this statement a series of model diets based on groups of feed materials with the possibility to use different feed materials in their formulation. The Panels considered that the currently proposed model diets cover the need of the CONTAM Panel to assess the dietary exposure of animals to contaminants in feed.

Abstract This guidance document is intended to assist the applicant in preparing and presenting an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the efficacy of feed additives.

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 monensin sodium (Coxidin®) as a coccidiostat for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. The additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Coxidin® remains safe for turkeys for fattening (up to 16 weeks) and extends this conclusion to turkeys reared for breeding (up to 16 weeks). The Panel was not in the position to confirm that the current maximum authorised level of 125 mg monensin sodium/kg complete feed remains safe for chickens for fattening and chickens reared for laying. The use of monensin sodium from Coxidin® at the corresponding maximum authorised/proposed use levels in the target species is safe for the consumer. The existing maximum residue levels (MRLs) for poultry tissues ensure consumer safety. No withdrawal time is necessary. Both formulations of Coxidin® pose a risk by inhalation. The formulation with wheat bran as a carrier was neither irritant to the skin nor a skin sensitiser but it was irritant to the eyes. In the absence of data, no conclusions could be made on the potential of the formulation containing calcium carbonate to be irritant to skin and eyes and to be a skin sensitiser. The use of monensin sodium from Coxidin® in complete feed for the target species poses no risk for the terrestrial compartments and for sediment. No risk for groundwater is expected. For chickens for fattening the risk for aquatic compartment cannot be excluded, but no risks are expected for the other animal categories. There is no risk of secondary poisoning. Coxidin® is efficacious in controlling coccidiosis at a level of 100 mg/kg complete feed for chickens for fattening and at 60 mg/kg complete feed for turkeys for fattening. These conclusions are extended to chickens reared for laying and turkeys reared for breeding. The Panel noted that there are signs of development of resistance of Eimeria spp. to monensin sodium.

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 In 2004, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks to animal health and transfer from feed to food of animal origin related to the presence of ochratoxin A (OTA) in feed. The European Commission requested EFSA to assess newly available scientific information and to update the 2004 Scientific Opinion. OTA is produced by several fungi of the genera Aspergillus and Penicillium. In most animal species it is rapidly and extensively absorbed in the gastro‐intestinal tract, binds strongly to plasma albumins and is mainly detoxified to ochratoxin alpha (OTalpha) by ruminal microbiota. In pigs, OTA has been found mainly in liver and kidney. Transfer of OTA from feed to milk in ruminants and donkeys as well as to eggs from poultry is confirmed but low. Overall, OTA impairs function and structure of kidneys and liver, causes immunosuppression and affects the zootechnical performance (e.g. body weight gain, feed/gain ratio, etc.), with monogastric species being more susceptible than ruminants because of limited detoxification to OTalpha. The CONTAM Panel considered as reference point (RP) for adverse animal health effects: for pigs and rabbits 0.01 mg OTA/kg feed, for chickens for fattening and hens 0.03 mg OTA/kg feed. A total of 9,184 analytical results on OTA in feed, expressed in dry matter, were available. Dietary exposure was assessed using different scenarios based on either model diets or compound feed (complete feed or complementary feed plus forage). Risk characterisation was made for the animals for which an RP could be identified. The CONTAM Panel considers that the risk related to OTA in feed for adverse health effects for pigs, chickens for fattening, hens and rabbits is low.

Abstract Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat monensin sodium (Elancoban® G200) when used as a feed additive for chickens for fattening and turkeys. Based on the new data provided, the Panel updates its previous conclusions as follows: monensin sodium is produced by fermentation by a non‐genetically modified strain of Streptomyces sp. NRRL B‐67924. Genome analysis suggests the production strain may belong to a new species within the genus Streptomyces. The production strain and its DNA were not detected in the final additive. The product is free of antimicrobial activity other than monensin. The FEEDAP Panel cannot conclude on the safety of monensin sodium from Elancoban® G200 in feed for chickens for fattening and chickens reared for laying at the proposed maximum use level due to a dose‐related reduction of the final body weight. The toxicological profile of monensin sodium was evaluated in studies made with the product obtained from the parental strain ATCC 15413. Based on a comparison of the genomes of the two strains, the FEEDAP Panel concludes that toxicological equivalence has been established, thus the conclusions already drawn on Elancoban® G200 are valid for the product obtained with the new production strain concluding that the additive is safe for the consumer and the environment; the production strain does not represent an additional risk when safety for the user is considered. Monensin sodium from Elancoban® G200 is safe for turkeys up to 16 weeks of age at the concentration of 100 mg monensin sodium/kg feed and has the potential to control coccidiosis at the minimum concentration of 60 mg/kg complete feed.

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.

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 feed additive consisting of robenidine hydrochloride (Cycostat® 66G) for rabbits for breeding and rabbits for fattening for the renewal of its authorisation. Since the potential aneugenic activity of robenidine hydrochloride cannot be excluded, the FEEDAP Panel is not in the position to conclude on the safety of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety of robenidine hydrochloride for the environment. Robenidine hydrochloride has potential for bioaccumulation; however, a risk for secondary poisoning for worm/fish‐eating birds and mammals is not likely to occur. No concern for groundwater is expected. Robenidine hydrochloride is not a skin or eye irritant and not a skin sensitiser. Due to the lack of data on the genotoxicity (aneugenicity) of the substance, the exposure to the additive of the unprotected users should be minimised. Owing to the lack of sufficient data, the FEEDAP Panel cannot conclude that robenidine hydrochloride from Cycostat® 66G is still efficacious against recent Eimeria spp. strains in rabbits.

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 Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of the coccidiostat nicarbazin (Coxar®) when used in feed for turkeys for fattening. On the basis of the new data provided, the FEEDAP Panel updated its previous conclusions on the efficacy of Coxar® as follows: the two new floor pen studies showed efficacy of nicarbazin from Coxar® reducing the adverse clinical consequences of an Eimeria infection in turkeys. Overall, when considering also the positive floor pen study previously reported and the three positive anticoccidial sensitivity tests, the FEEDAP Panel concludes that Coxar® has the potential to be efficacious against coccidiosis of turkeys for fattening at 100 mg nicarbazin/kg complete feed.

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.