Assessment of the application for renewal of authorisation of Bactocell ® (Pediococcus acidilactici CNCM I-4622) as a feed additive for all fish and shrimps and its extension of use for all crustaceans

Bactocell \uae is the trade name for a feed additive based on viable cells of a strain of Pediococcus acidilactici. 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 Bactocell \uae  in the context of the renewal of the authorisation for shrimps, salmonids and fish other than salmonids. In addition, the applicant requested the extension of use for all crustaceans. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concludes that Bactocell \uae Aqua 10 Md/100 Md is safe under the current conditions of authorisation for the target species (all fish, shrimps and all crustaceans), consumers of products from animals fed the additive and the environment. Bactocell \uae Aqua 10 Md/100 Md is non-irritant to skin and eyes and is not a dermal sensitiser, but should be considered a potential respiratory sensitiser. Exposure of users by inhalation is very likely. There is no need for assessing the efficacy of Bactocell \uae in the context of the renewal of the authorisation. The Panel concludes that the additive at the minimum inclusion level of 1  7 10 9  CFU/kg feed has the potential to be efficacious in salmonids and in the new species proposed, i.e. all crustaceans

Safety and efficacy of lutein and lutein/zeaxanthin extracts from Tagetes erecta for poultry for fattening and laying (except turkeys)

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) evaluated (i) lutein from a saponified extract from Tagetes erecta obtained via extraction and saponification (lutein not less than 85% of total carotenoids (TC)) and (ii) lutein/zeaxanthin extract from Tagetes erecta obtained via extraction, saponification and isomerisation (lutein not less than 45% and zeaxanthin not less than 35% of TC). The maximum proposed use level of 80 mg TC from saponified Tagetes extract/kg complete feed for chickens for fattening and laying hens is safe for these animal categories. This conclusion can be extrapolated to minor poultry species for fattening and laying. The conclusions on saponified Tagetes extract for poultry for fattening and laying are extended to the saponified/isomerised Tagetes extract. The maximum use level of the saponified/isomerised Tagetes extract in breeding minor poultry should not exceed 50 mg TC/kg feed, considering the toxicological potential of zeaxanthin on reproduction. The saponified Tagetes extract is not genotoxic. This conclusion is extended to the saponified/isomerised Tagetes extract. Consumer exposure related to the consumption of animal products is very low compared to the exposure from other sources. The active substance is a viscous paste and may be irritant to skin and eyes; no exposure by inhalation is expected. In the absence of data, the Panel cannot conclude on the safety for the user of commercial preparations. The use of Tagetes extracts in poultry feed raised no concern for the environment. Tagetes extracts at levels up to the proposed maximum use level of 80 mg TC/kg complete feed have the potential to colour the egg yolk of laying hens and the skin of chickens for fattening. This conclusion is extended to minor poultry species for laying and for fattening. The use of the additive in feed and water for drinking is considered bioequivalent

Guidance on the assessment of the safety of feed additives for the environment

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment. (Table presented.)

Modification of the conditions of the authorisation of BioPlus® 2B (Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750) for turkeys for fattening

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of the authorisation of BioPlus\uae 2B (Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750) in feeds for turkeys for fattening to allow the simultaneous use with a battery of permitted coccidiostats (diclazuril, halofuginone, monensin sodium, robenidine hydrochloride, maduramicin ammonium, lasalocid sodium) and with the preservative formic acid. The proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of the additive. The additive is safe for the target species, consumers and the environment. The additive should be considered a potential respiratory sensitiser, but the Panel could not conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Conclusions previously drawn by the FEEDAP Panel on the compatibility of the additive for chickens for fattening apply to the current application provided that the maximum authorised concentration of the coccidiostats semduramycin, maduramicin ammonium, lasalocid sodium and the preservative formic acid for turkeys for fattening (when maximum authorised concentrations exist), are equal or lower than those for chickens for fattening. Considering the data submitted, the FEEDAP Panel concludes that BioPlus\uae 2B (B. licheniformis DSM 5749 and B. subtilis DSM 5750) is compatible with diclazuril and monensin sodium. Based on the data provided, no conclusion can be drawn for robenidine hydrochloride. In the absence of data, no conclusion can be drawn for halofuginone

Safety of erythrosine for ornamental fish

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of erythrosine for ornamental fish. Erythrosine is a sensory additive belonging to the functional group colourants. In 2015, the FEEDAP Panel calculated the safe concentration in complete feed of ornamental fish to be 59 mg/kg complete feed. Considering that erythrosine contains 56.5% iodine, the safe level in feed of ornamental fish was recalculated taking into account the currently authorised maximum content of total iodine in complete feed and resulted to be 35 mg erythrosine/kg complete feed. The applicant submitted a new tolerance study in rainbow trout to demonstrate the safety of erythrosine for ornamental fish at doses higher than 59 mg/kg complete feed. The FEEDAP Panel noted that the study shows several limitations: (i) blood biochemistry was not measured, although required according to the guidance on the assessment of the safety of feed additives for the target species (ii) a low number of replicates (3 per treatment) which does not permit to obtain a reliable estimate and may not be sufficient to evidence differences between the groups (with no indication on the a priori power of the study design), and (iii) the use level group was not included in the study design. Owing to these three limitations, the FEEDAP Panel is not in the position to change its previous conclusions that the safe level of erythrosine in ornamental fish is 59 mg/kg complete feed. This safe level is reduced to 35 mg erythrosine/kg complete feed, when considering the iodine content of erythrosine and the currently authorised maximum content of total iodine in complete feed for fish

Safety and efficacy of Calsporin ® (Bacillus subtilis DSM 15544) for all poultry species

The additive Calsporin \uae is a preparation of viable spores of Bacillus subtilis DSM 15544, at a minimum declared concentration of 1  7 10 10  colony forming units (CFU)/g additive. The additive is authorised as a zootechnical additive (functional group: gut flora stabiliser) for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, laying hens and ornamental fish, dogs, in sows and in suckling piglets. This opinion concerns a request for a modification of the terms of the authorisation, reducing the minimum content in complete feed for chickens for fattening from the authorised concentration of 5  7 10 8  CFU/kg feed to a concentration of 3  7 10 8  CFU/kg feed and for an authorisation for the use of the additive for all poultry species. The active agent fulfils 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, Calsporin \uae is considered safe for the target animals, the consumers and for the environment. The additive is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive in feedingstuffs for chickens for fattening at the level of 3  7 10 8  CFU/kg complete feed. Considering that efficacy at the same level has been shown in laying hens and turkeys, this conclusion is extrapolated to all poultry species and categories

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain 65 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maximum of 25% water), were assessed. Sodium formate was considered safe for all animal species at a maximum concentration of 10,000 mg formic acid equivalents/kg complete feed (with the exception of pigs, for which a maximum concentration of 12,000 mg formic acid equivalents/kg complete feed was considered safe). Sodium formate was also considered safe for the consumer and the environment. The Panel also concluded that sodium formate is corrosive. The Panel also concluded that \u2018for sodium formate, limited data are available to demonstrate their effects in feed\u2019. In the current opinion, additional data to demonstrate the efficacy of sodium formate liquid as a hygiene condition enhancer in feed for all animal species were assessed. The Panel concluded that sodium formate liquid has the potential to be efficacious as hygiene condition enhancer in feedingstuffs for all animal species at the proposed use level

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for turkeys for fattening

Monimax\uae is considered safe for turkeys for fattening at the highest use level of 50 mg monensin sodium and 50 mg nicarbazin/kg complete feed. The margin of safety is about 1.5. The simultaneous use of Monimax\uae and certain antibiotic drugs (i.e. tiamulin) is contraindicated. Nicarbazin (equimolar complex of dinitrocarbanilide (DNC) and 2-hydroxy-4,6-dimethylpyrimidine (HDP)) has no antimicrobial activity. For both compounds of Monimax\uae, the metabolic pathways in the chicken are similar to those in the turkey and rat. Monimax\uae does not represent a genotoxic risk. No safety concerns would arise from the nicarbazin impurities p-nitroaniline and methyl(4-nitrophenyl) carbamate. The lowest no observed effect level (NOEL) identified for monensin sodium in a developmental study in rabbits was 0.3 mg monensin sodium/kg body weight (bw) per day for maternal toxicity in rabbits. The lowest no observed adverse effect level (NOAEL) identified in a 52-week study in rat using DNC + HDP was 20 mg DNC + 8 mg HDP/kg bw per day. No significant interaction between monensin sodium and nicarbazin is expected from toxicological studies. The use of Monimax\uae at the highest proposed dose will not pose a risk to persons consuming animal products from treated turkeys for fattening. No withdrawal time is required for Monimax\uae in turkeys for fattening. Residue data comply with the established maximum residue limits (MRLs) for monensin and DNC. Monensin sodium presents a hazard by inhalation and may also be associated with dermal toxicity. Monimax\uae is not a skin irritant; however, no data are available for the eye irritation potential of monensin. Monimax\uae is not a skin sensitiser. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Monimax\uae for the environment. Monimax\uae has the potential to control coccidiosis in turkeys for fattening at a minimum concentration of 40 mg monensin sodium and 40 mg nicarbazin/kg complete feed

Safety and efficacy of Coxar® (nicarbazin) for turkeys for fattening

Coxar\uae 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\uae/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\uae. 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\uae for the environment. The efficacy of 100 mg nicarbazin from Coxar\uae/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\uae for turkeys for fattening can be drawn

Safety and efficacy of Avatec® 150G (lasalocid A sodium) for chickens for fattening and chickens reared for laying, and modification of the terms of authorisation for chickens for fattening, chickens reared for laying, turkeys for fattening, minor avian species (pheasants, guinea fowl, quails and partridges) except laying birds

Avatec\uae 150G is an anticoccidial feed additive containing 15% of the active ingredient lasalocid A sodium, an ionophore anticoccidial. The tolerance study indicated that oral administration of lasalocid A sodium via feed at doses at and above the targeted lasalocid dose of 125 mg/kg was not tolerated in chickens for fattening. Consequently, no safe dose can be established by the tolerance study submitted. Concurrent administration of lasalocid with tiamulin and certain other medicinal substances should be avoided. Lasalocid sodium has a selective antimicrobial activity against Gram-positive bacterial species while many Enterobacteriaceae are naturally resistant. Induction of resistance and/or cross-resistance was not observed in experimental conditions. Lasalocid A sodium is not genotoxic and not carcinogenic. The newly conducted cardiovascular study in dogs indicated an acute no-observed-adverse-effect level (NOAEL) of 1 mg/kg body weight (bw) per day. Since this NOAEL is above the lowest NOAEL of 0.5 mg/kg bw per day previously identified in a 2-year toxicity study in rats and a developmental study in rabbits, it is concluded that this NOAEL (0.5 mg/kg bw per day) is an appropriate base for establishing an Acceptable Daily Intake of 0.005 mg lasalocid sodium/kg bw. The use of lasalocid A sodium from Avatec\uae 150G at the highest proposed level of 125 mg/kg complete feed is safe for the consumer. For compliance with the maximum residue limits (MRLs), a withdrawal period of 3 days is necessary. No risk for the user is expected from the use of Avatec\uae 150G. The use of lasalocid A sodium from Avatec\uae 150G in feed for chickens for fattening and chickens reared for laying up to the highest proposed dose does not pose a risk for the environment. Insufficient evidence of the anticoccidial efficacy of lasalocid A sodium was provided in chickens for fattening/reared for laying