Safety and efficacy of Deccox® (decoquinate) for chickens for fattening.

Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20-40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial action. Decoquinate is not genotoxic and not carcinogenic. Deccox® is safe for the consumer under the proposed conditions of use. No withdrawal period is required to ensure consumer safety. No maximum residue limits are considered necessary. The inhalation risk for users is considered negligible since inhalation toxicity and exposure are very low. Deccox® is not an irritant to skin and eyes and has no sensitisation potential. The ratios predicted environmental concentration/predicted no effect concentration (PEC/PNEC) for terrestrial, aquatic compartment and sediment are below 1, indicating that decoquinate used in chickens for fattening up to the highest proposed dose, does not pose a risk for these compartments; as well, no risk is expected neither for secondary poisoning nor for groundwater contamination. Due to insufficient evidence, the potential of decoquinate to prevent coccidiosis in chickens for fattening cannot be established.

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening.

Following a request from 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 Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz® 66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a margin of safety of approximately 2.5. This conclusion is extrapolated to turkeys for fattening. Robenidine HCl is active against Gram-positive but not against Gram-negative bacteria. It is not expected that the use of robenidine HCl as a feed additive would induce resistance or cross-resistance to antimicrobials used in human and animal therapy. The use of robenidine HCl from Robenz® 66G at the highest proposed level of 36 mg/kg complete feed in chickens and turkeys for fattening is considered safe for the consumer. The existing maximum residues limits for both avian species are confirmed. Robenidine HCl is not a skin or eye irritant and not a skin sensitiser. The risk via inhalation is considered negligible. The use of robenidine HCl from Robenz® in feed for chickens for fattening and turkeys for fattening up to 36 mg/kg complete feed does not pose a risk to either the terrestrial or the aquatic compartment. A risk for bioaccumulation cannot be excluded. The risk for secondary poisoning is not likely to occur. The FEEDAP Panel concludes that 36 mg robenidine HCl/kg complete feed from Robenz® 66G has the potential to effectively control coccidiosis of chickens for fattening under field conditions but cannot conclude on the efficacy of robenidine HCl in turkeys for fattening. The existing 5-day withdrawal period to avoid off-flavours in edible tissues should be maintained.

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: see text].

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying.

The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC) and 2-hydroxy-4,6-dimethylpyrimidine (HDP) which behave independently. Monimax® 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 is 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 based on the absence of microcrystals in urine and related microscopic renal observations. No significant interaction between monensin sodium and nicarbazin is expected from toxicological studies. The use of Monimax® at the highest proposed dose will not pose a risk to persons consuming animal products from treated chickens for fattening. This conclusion is extended to chickens reared for laying. No withdrawal time is required for Monimax® in chickens for fattening. Residue data comply with the established maximum residue limits (MRLs) for monensin and DNC. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Monimax® for the environment. Monimax® has the potential to control coccidiosis in chickens for fattening at a minimum concentration of 40 mg monensin and 40 mg nicarbazin/kg complete feed.

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening.

The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60-70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for antimicrobial resistance in Streptomyces spp. under assessment. Based on the available data set, the FEEDAP Panel cannot conclude on the safety of Monteban® G100 for chickens for fattening. The simultaneous use of Monteban® G100 and certain antibiotic drugs (e.g. tiamulin) is contraindicated. Narasin is not genotoxic. No indication of carcinogenicity or developmental toxicity was found at the doses tested in the mouse, rat and rabbit. The lowest no observed effect level (NOEL) identified in the oral toxicity studies was 0.5 mg/kg body weight (bw) per day for the neuropathy seen in a one-year dog study. The acceptable daily intake (ADI) derived from this NOEL is 0.005 mg narasin/kg bw applying a uncertainty factor of 100. Monteban® G100 is safe for the consumer. Maximum residue limits (MRLs) of 50 µg narasin/kg for all wet tissues ensure consumer safety. Monteban® G100 is irritatant to the eyes but not to the skin. It has the potential to induce skin sensitisation. Inhalation exposure would pose a risk to persons handling the additive. Narasin, when used as a feed additive for chickens for fattening at 70 mg/kg feed, is not expected to pose a risk to the environment. The risk for sediment compartment cannot be assessed. The FEEDAP Panel cannot conclude on the efficacy of Monteban® at the minimum applied dose of 60 mg narasin/kg complete feed for chickens for fattening.

Safety and efficacy of Monteban® G100 (narasin) for ducks 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 safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60-70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed with a margin of safety of about 4. The FEEDAP Panel assumes that the residues in duck tissues would be of the same magnitude as those measured in the physiologically similar major species, chickens for fattening. The use of Monteban® G100 at a maximum concentration of 70 mg/kg complete feed for ducks for fattening is safe for the consumer without applying a withdrawal period, provided the maximum residue limit (MRL) of 50 µg narasin/kg for all wet tissues would not be exceeded. Monteban® G100 is irritant to the eyes but not to the skin. It has the potential to induce skin sensitisation. The acute systemic toxicity following dermal application is low. Inhalation exposure would pose a risk to persons handling the additive. Narasin, when used as feed additive for ducks for fattening at 70 mg/kg feed, is not expected to pose a risk to the environment. The risk for sediment compartment cannot be assessed. Narasin is not considered to have a bioaccumulation potential. Insufficient data were provided to allow a conclusion on the efficacy of Monteban® G100 in ducks.

Safety and efficacy of Coxiril® (diclazuril) for chickens reared for laying.

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 Coxiril® (diclazuril) for chickens reared for laying. Coxiril®, containing 0.5% diclazuril, is intended for the prevention of coccidiosis in chickens reared for laying at a dose range of 0.8-1.2 mg diclazuril/kg of complete feed up to a maximum age of 12 weeks. Derived from data already assessed for chickens and turkeys for fattening, diclazuril from Coxiril® is safe for chickens reared for laying up to 1.2 mg/kg complete feed when applied until 12 weeks of age. The FEEDAP Panel extended its previous assessment of consumer safety for the use of diclazuril from Coxiril® in chickens for fattening to chickens reared for laying. No measurable diclazuril residues were found in the first eggs laid from chickens reared for laying fed diclazuril from Coxiril® at 1.2 mg/kg complete feed until 12 weeks of age. Coxiril® was considered as a non-irritant to eyes and skin. It is not a potential skin sensitiser. User inhalation exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. The use of diclazuril from Coxiril® in chickens reared for laying at the highest proposed feed concentration would not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril® cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. Derived from data already assessed for chickens for fattening, diclazuril from Coxiril® has the potential to control coccidiosis in chickens reared for laying at a minimum concentration of 0.8 mg/kg complete feed.

Safety and efficacy of Coxiril® (diclazuril) for pheasants.

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 Coxiril® for pheasants. Coxiril®, containing 0.5% diclazuril, is intended for the prevention of coccidiosis in pheasants at a dose range of 1.0-1.2 mg/kg of complete feed. Diclazuril from Coxiril® is considered safe for pheasants at a level of 1.2 mg/kg complete feed. The conclusion was made by extrapolating the results of a tolerance study with turkeys for fattening. The FEEDAP Panel considered that the residues in pheasant tissues and eggs would be of the same magnitude as those measured in the physiologically similar major species chickens and turkeys for fattening. The use of diclazuril at a maximum concentration of 1.2 mg/kg complete fed for pheasants would be safe for the consumer, provided that the maximum residue limits (MRLs) established for poultry would not be exceeded. The conclusions on the safety of the additive for the target species and the consumer are made under the provision that Coxiril® is not fed to laying birds. Coxiril® is considered as a non-irritant to eyes and skin. It is not a potential skin sensitiser. User inhalation exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. The use of diclazuril from Coxiril® in pheasants does not pose a risk to the environment for neutral/alkaline soils (pH ≥ 7). A final conclusion on the risk resulting from the use of the additive in acid soil cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. The FEEDAP Panel concluded that diclazuril from Coxiril® at a minimum dose of 1 mg/kg complete feed has the potential to control coccidiosis in pheasants.

Safety and efficacy of sodium saccharin when used as a feed flavour for piglets, pigs for fattening, calves for rearing and calves for fattening.

Sodium saccharin is intended to be used as a sweetener in feed and water for drinking for piglets, pigs for fattening and veal calves. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the proposed maximum use level of 150 mg sodium saccharin/kg feed as safe for calves and pigs for fattening. For piglets (sucking and weaned piglets), a lower level of 100 mg sodium saccharin/kg complete feed is considered safe. The corresponding maximum safe concentrations in water for drinking are 30 mg/L for piglets and 50 mg/L for pigs for fattening, respectively. The maximum safe concentrations of sodium saccharin in feed and water for drinking are derived under the premise that only one source, feed or water for drinking, contains the additive. The FEEDAP Panel concludes that no concern for the consumer would result from the use of sodium saccharin in feed and water for drinking at the dose considered safe for the target species. The precautions for handling the product proposed by the applicant are considered to be sufficient to ensure user safety. The FEEDAP Panel concludes that the use of sodium saccharin at the dose considered safe for target species is unlikely to have detrimental effects on the terrestrial and freshwater compartments. The high mobility and relative persistence of saccharin and the high persistency of its degradation product 4-hydroxysaccharin indicate that groundwater contamination above 0.1 µg/L is likely to occur. Since the function of sodium saccharin in feed for the target species is essentially the same as that in food, the FEEDAP Panel concludes that no demonstration of efficacy is necessary.

Safety and efficacy of Sacox® microGranulate (salinomycin sodium) for rabbits for fattening.

Sacox ® microGranulates, containing salinomycin sodium (SAL-Na), for chickens for fattening and chickens reared for laying have been recently re-evaluated by Panel on Additives and Products or Substances used in Animal Feed. Following an urgent request from the European Commission, the safety and efficacy of the product when fed to rabbits for fattening was assessed based on the available data submitted by the applicant at the beginning of the assessment. SAL-Na is largely absorbed and metabolised. Metabolites have a reduced ionophoric activity. SAL is the marker residue. SAL-Na is not genotoxic and not a carcinogen. A no observed adverse effect level (NOAEL) of 0.5 mg/kg body weight (bw) per day is derived from a study in dogs. Only data on feed intake and body weight were available to conclude on the safety of SAL for rabbits. Levels of 35 mg SAL/kg feed and higher were not tolerated by growing rabbits. The Panel considers the available data indicate that the additive is tolerated by rabbits for fattening up to 25 mg/kg. The safety of SAL in rabbits for fattening needs to be established by a tolerance study compliant with the current standards. Adverse effects on breeding does cannot be excluded. The simultaneous use of SAL-Na with certain medicinal substances (e.g. tiamulin and valnemulin) and bentonite is contraindicated. Consumer exposure to residues of toxicological concern complies with the acceptable daily intake (ADI) of 0.005 mg/kg bw, after 1-day withdrawal. A provisional maximum residue limit (MRL) of 0.01 mg/kg liver would ensure consumer safety. A 5-day withdrawal period as proposed by the applicant is supported. SAL-Na in feed for rabbits will not pose a risk for the aquatic environment. A risk for the terrestrial ecosystem is considered unlikely. Efficacy and effective dose of SAL-Na under present farming conditions could not be established.

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

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.

Safety and efficacy of cumin tincture (Cuminum cyminum L.) when used as a sensory additive for all animal species.

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.

Safety and efficacy of COXAM® (amprolium hydrochloride) for chickens for fattening and chickens reared for laying.

The coccidiostat amprolium hydrochloride from COXAM ® is considered safe for chickens for fattening at 125 mg/kg complete feed. The margin of safety is at least 5. This conclusion is extended to chickens reared for laying. Amprolium hydrochloride does not possess any significant antibacterial activity. The applicant provided no information on the absorption, distribution, metabolism and excretion (ADME) and on the toxicology of the additive or active substance. Reference was made to the Committee for Medicinal Products for Veterinary Use (CVMP) summary reports from 1999 and 2001 citing studies used for the establishment of maximum residue limits (MRLs) for amprolium. However, the original data used in these assessments were not provided and the literature review covering the subsequent period was not made. Thus, the FEEDAP Panel cannot independently evaluate all data relevant to the current application and is therefore unable to conclude on the safety for the consumer of amprolium when used as a feed additive in chickens for fattening and chickens reared for laying. COXAM ® is considered to be a skin and respiratory sensitiser. Inhalation exposure to dust from COXAM ® may present a risk for the user. The use of amprolium hydrochloride from COXAM ® in feed for chickens for fattening up to 125 mg/kg complete feed does not pose a risk for the environment. This conclusion can be extended to chickens reared for laying because of the lower predicted concentration in soil. COXAM ® was effective as a coccidiostat in three floor pen studies and in two anticoccidial sensitivity tests. Since three anticoccidial sensitivity tests showing positive effects of the treatment are required, the FEEDAP Panel is not in the position to conclude on the efficacy of COXAM ® for chickens for fattening under EU farming conditions. Consequently, a conclusion on the efficacy for chickens reared for laying is also not possible.

Scientific Opinion on the safety and efficacy of Aviax 5% (semduramicin sodium) for chickens for fattening.

The feed additive Aviax 5%, containing the active substance semduramicin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 20-25 mg/kg complete feed. Semduramicin sodium is present in Aviax 5% in its mycelial form and is produced by fermentation of Actinomadura spp. (ATCC 53664). Semduramicin sodium is active against certain Gram-positive bacteria, while Gram-negative bacteria are resistant; its use as a feed additive is unlikely to increase shedding of Salmonella, Escherichia coli and Campylobacter and to induce resistance and cross-resistance to antimicrobials used of human and animal relevance. In the absence of a tolerance study in chickens for fattening performed according to the current EU standards, the FEEDAP Panel cannot conclude on the safety of Aviax 5%, containing semduramicin mycelium. Semduramicin sodium in the feed is not compatible with the concurrent use of tiamulin. Mycelial semduramicin sodium is not genotoxic. There is no evidence that the mycelial semduramicin is more toxic than the crystalline by oral administration. The acceptable daily intake (ADI) of 0.00125 mg/kg set for the crystalline semduramicin is applicable to mycelial semduramicin. The use of semduramicin sodium is safe for the consumer provided a withdrawal time of 24 h is respected. No conclusions can be made on the irritancy of Aviax 5% to skin and eye and on the potential for dermal and respiratory sensitisation. Model calculations on inhalation exposure of persons handling the additive indicate a serious risk. Aviax 5% used in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for the terrestrial compartment. A risk for the aquatic compartment and for groundwater pollution cannot be excluded. Aviax 5% at a minimum dose of 20 mg/kg feed has the potential to effectively control coccidiosis in chickens for fattening.

Safety and efficacy of Sacox® microGranulate (salinomycin sodium) for chickens for fattening and chickens reared for laying.

Salinomycin sodium (SAL-Na) is active against certain Gram-positive bacteria, while Gram-negative species are resistant. SAL-Na at the proposed concentration is unlikely to increase shedding of Salmonella, Escherichia coli and Campylobacter and or induce resistance and cross-resistance to antimicrobials important in human and animal therapy. SAL-Na is safe for chickens for fattening at 70 mg/kg complete feed, for chickens reared for laying at 50 mg/kg complete feed in the first 12 weeks of life. The simultaneous use of SAL-Na and certain antibiotic drugs (e.g. tiamulin) is contraindicated. SAL-Na is absorbed and extensively metabolised. Metabolites have reduced ionophoric activity. SAL is the marker residue (MR). No residues in eggs are expected. SAL-Na is not genotoxic and not a carcinogen. A NOAEL of 0.5 mg/kg body weight (bw) per day is derived from a cardiovascular study in dogs as well as from a 12-month dog study. Consumer exposure complies with an acceptable daily intake of 0.005 mg SAL/kg bw after 1 h withdrawal. A withdrawal time and maximum residue limits are not considered necessary. SAL-Na from Sacox® is not an irritant to skin and eyes; it is a potential sensitiser to skin and the respiratory tract. A toxicological risk by inhalation for persons handling the additive cannot be excluded. SAL-Na in feed for chickens will not pose a risk for the aquatic environment. A risk for the terrestrial ecosystem is considered unlikely due to metabolisation and the rapid degradation of SAL in the environment. SAL-Na at a minimum concentration of 50 mg/kg complete feed is an effective coccidiostat for chickens for fattening. This conclusion is extended to chickens reared for laying. SAL-Na in Sacox® 120 microGranulate and Sacox® 200 microGranulate is considered bioequivalent with respect to its anticoccidial effect.

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

The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for turkeys for fattening at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. The simultaneous use of Monimax® and certain antibiotic drugs (i.e. tiamulin) is contraindicated. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC) and 2-hydroxy-4,6-dimethylpyrimidine (HDP) which behave independently. Monimax® 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® 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® in turkeys for fattening. Residue data comply with the established maximum residue limits for monensin and DNC. Monensin sodium presents a hazard by inhalation and may also be associated with dermal toxicity. Monimax® is not a skin irritant; however, no data are available for the eye irritation potential of monensin. Monimax® is not a skin sensitiser. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Monimax® for the environment. Monimax® has the potential to control coccidiosis in turkeys for fattening at a minimum concentration of 40 mg monensin and 40 mg nicarbazin/kg complete feed.

Safety and efficacy of an essential oil from Origanum vulgare subsp. hirtum (Link) letsw. var. Vulkan when used as a sensory additive in feed for all animal species.

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 an essential oil from Origanum vulgare subsp. hirtum var Vulkan (DOS 00001) when used as a sensory feed additive for all animal species. Analysis of the oil identified 34 components accounting for > 99% of the oil, with carvacrol being the most prevalent (> 60%). Five tolerance studies in three species (chickens for fattening, weaned piglets and dairy cows) were made to assess the safety for the target species. The recommended use level of 150 mg additive/kg feed was shown to be safe for chickens for fattening and weaned piglets and this conclusion is extended to all poultry and porcine species grown for meat production. A dose of 500 mg additive/head and day (equivalent to ~ 25 mg/kg complete feed) was also demonstrated safe for the dairy cow. The Panel concluded that since the recommended use level differs between the dairy cow and the non-ruminants tested the lower use level of 25 mg additive/kg feed could be applied to all target animals not included above. Residue studies (meat, liver, fat milk and eggs) showed that the exposure of consumers to products from animals given the additive at the recommended use level did not raise safety concerns. The additive should be considered as an irritant to skin and eyes, and to have a potential for sensitisation of susceptible individuals. Use in animal production of the essential oil extracted from O. vulgare is not expected to pose a risk for the environment. Since oregano and its extracts is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

Safety and efficacy of pyrazine derivatives including saturated ones belonging to chemical group 24 when used as flavourings for all animal species.

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 22 compounds belonging to chemical group 24 (pyrazine derivatives). They are currently authorised as flavours in food. The FEEDAP Panel concludes that: 2,3-diethylpyrazine [14.005], 2-ethyl-3-methylpyrazine [14.006], 5,6,7,8-tetrahydroquinoxaline [14.015], 2,3,5,6-tetramethylpyrazine [14.018], 2,3,5-trimethylpyrazine [14.019], 2,5-dimethylpyrazine [14.020], 2,6-dimethylpyrazine [14.021], 2-ethylpyrazine [14.022], 2-ethyl-3,5-dimethylpyrazine [14.024], 2,5 or 6-methoxy-3-methylpyrazine [14.025], 2-methylpyrazine [14.027], acetylpyrazine [14.032], 6,7-dihydro-5-methyl-5H-cyclopenta(b)pyrazine [14.037], 2-isobutyl-3-methoxypyrazine [14.043], 2-acetyl-3-ethylpyrazine [14.049], 2,3-dimethylpyrazine [14.050], 2,3-diethyl-5-methylpyrazine [14.056], 2-(sec-butyl)-3-methoxypyrazine [14.062], 3,(5- or 6-)-dimethyl-2-ethylpyrazine [14.100], 2-ethyl-3-methoxypyrazine [14.112] and 2-methoxy-3-methylpyrazine [14.126] are safe at the proposed maximum dose level (0.5 mg/kg complete feed) as feed for cattle, salmonids and non-food-producing animals, and at the proposed normal use level of 0.1 mg/kg complete feed for pigs and poultry; 5-methylquinoxaline [14.028] are safe only at concentrations below the proposed use levels (0.08 mg/kg complete feed for cattle, salmonids and non-food-producing animals, and 0.05 mg/kg complete feed for pigs and poultry). No safety concern would arise for the consumer from the use of these compounds up to the highest proposed level in feeds. Hazards for skin and eye contact, and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The proposed maximum use levels in feed are unlikely to have detrimental effects on the terrestrial and fresh water compartments. Because all the compounds under assessment are used in food as flavourings and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

Safety and efficacy of aryl-substituted primary alcohol, aldehyde, acid, ester and acetal derivatives belonging to chemical group 22 when used as flavourings for all animal species.

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 18 compounds belonging to chemical group (CG) 22. They are currently authorised as flavours in food. The FEEDAP Panel concludes that: cinnamaldehyde [05.014] is safe at the maximum use level of 125 mg/kg complete feed for salmonids, veal calves and dogs, and at 25 mg/kg for the remaining target species; cinnamyl alcohol [02.017], 3-phenylpropan-1-ol [02.031], 3-(p-cumenyl)-2-methylpropionaldehyde [05.045], α-methylcinnamaldehyde [05.050], 3-phenylpropanal [05.080], cinnamic acid [08.022], cinnamyl acetate [09.018], cinnamyl butyrate [09.053], 3-phenylpropyl isobutyrate [09.428], cinnamyl isovalerate [09.459], cinnamyl isobutyrate [09.470], ethyl cinnamate [09.730], methyl cinnamate [09.740] and isopentyl cinnamate [09.742] are safe at the proposed maximum use level of 5 mg/kg complete feed for all target species; 2-phenylpropanal [05.038], α-pentylcinnamaldehyde [05.040] and α-hexylcinnamaldehyde [05.041] are safe at the proposed maximum dose level of 5 mg/kg complete feed for all target species except cats, for which 1 mg/kg is safe. No safety concern would arise for the consumer from the use of these compounds up to the highest proposed level in feeds. Irritation and sensitisation hazards for skin and irritation for eye are recognised for the majority of the compounds under application. Respiratory exposure may also be hazardous. For the majority of the compounds belonging to CG 22, the maximum proposed use levels are considered safe for the environment. For α-pentylcinnamaldehyde and α-hexylcinnamaldehyde, a use level up to 0.1 mg/kg feed would not cause a risk for the terrestrial and fresh water compartments. Because all the compounds under assessment are used in food as flavourings and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

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® 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® 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® 150G. The use of lasalocid A sodium from Avatec® 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.