In vitro and in vivo assessment of a CLD sequestration strategy in Nitisol using contrasted carbonaceous materials.

Chlordecone (Kepone) (CLD) is a highly persistent pesticide formerly used in the French West Indies. High levels of this pesticide may be found in soils and constitute a subsequent source of contamination for outdoor-reared animals due to involuntary ingestion of consistent amounts of soil. In that context, carbonaceous materials may be used to amend soil to efficiently decrease the bioavailability of such organic pollutants. The present study aims to assess the efficiency of diverse amendments of a contaminated Guadeloupe nitisol using two physiologically based approaches. A set of 5 carbonaceous materials (ORBO, DARCO, Coco CO2, Oak P1.5, Sargasso biochar) was tested and used to amend Nitisol at 2% (mass basis). Bioaccessibility assessment was performed using the Ti-PBET assay (n = 4). The relative bioavailability part involved 24 piglets randomly distributed into 6 experimental groups (n = 4). All groups were exposed during 10 days to a contaminated soil, amended or not with carbon-based matrices. A significant decrease in relative bioaccessibility and CLD concentrations in liver were observed for all amended groups in comparison to the control group, with the exception of the biochar amended soil in the bioaccessibility assay (p < 0.05). Extent of this reduction varied from 22 to more than 82% depending on the carbonaceous matrix. This decrease was particularly important for the ORBO™ activated carbon for which bioaccessibility and relative bioavailability were found lower than 10% for both methodologies.

Antillean contaminated soils amendment with microwave prepared sargassum biochar: A promising solution to reduce chlordecone transfer to laying hens and piglets?

The use of Sargassum spp., a brown invasive algae, for the production of biochars (BCs) or activated carbons (ACs) and their efficiency to sequestrate chlordecone (CLD) in soil has been recently suggested. The objective of this study was to assess the potential of microwave prepared Sargasso biochar (BCS) amendment in Andosol on the bioavailability of chlordecone in laying hens and piglets, when exposed to this matrix. The efficiency of BCS was compared to a commercial activated carbon, DARCO® (ACD), used as a positive control and to an unamended soil. Samples of CLD-contaminated Andosol were amended with 2% of each carbonaceous matrix and let maturing for 3 months. Thereafter, adequate doses of soil were administered into the laying hens and piglets diets every day during the exposure phase, to simulate involuntary soil ingestion which may happen in practical conditions when animals are reared outside. Finally, bioavailability tests were carried out on target tissue (liver, muscle, adipose tissues and egg yolk). The results showed that the highest reduction of CLD bioavailability was obtained with ACD in both animal species. For laying hens, ACD showed reductions of around 60% (liver: 59%, muscle: 57% and egg yolk: 56%) whereas the BCS showed reduction of around 30% (liver: 31%, muscle: 26% and egg yolk: 30%) compared to the unamended soil. For piglets, only the liver showed interpretable results with reduction of 65% with ACD and 41% with BCS. Overall, BCS is efficient reducing CLD availability but in a lower extend than ACD. This discrepancy may be explained by the variations of physico-chemical characteristics that exist between the two matrices, resulting, from the additional activation phase for DARCO®. Therefore, to improve the efficiency of BCS it would be interesting to move towards DARCO® characteristics by determining out the optimal microwave pyrolysis parameters.

Safety and efficacy of a feed additive consisting of monensin sodium (Coxidin®) for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (Huvepharma N.V.).

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.

Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH).

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.

Assessment of the feed additive consisting of diclazuril (Clinacox® 0.5%) for chickens for fattening and chickens reared for laying for the renewal of its authorisation (Elanco GmbH).

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.

Guidance on the assessment of the efficacy of feed additives.

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.

Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.).

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.

Relative bioavailability of soil-bound polychlorinated biphenyls in lactating goats.

Livestock may be exposed to organic pollutants via ingestion of contaminated matrices such as fodder or soil. The question on contribution of soil-bound polychlorinated biphenyls (PCB) to livestock exposure was not yet considered. The aim of this study was to assess the relative bioavailability of soil-bound PCB by assessing milk excretion of indicator PCB (I-PCB) after ingestion by goats of graded levels of PCB (mainly PCB forms 153, 180, and 138) in soil-contaminated feeds or in oil-contaminated feeds. Eight multiparous Alpine goats were grouped in 4 pairs on the basis of body weight and milk yield. In each pair, one goat was assigned to the soil feeds and the other one to the oil feeds. The experiment consisted of a 7-d adaptation period, followed by a 96-d exposure period. The exposure period was divided into 3 successive 32-d periods during which each goat received either 3 soil feeds or 3 oil feeds, distributed in increasing rank of contamination. During the last week of each 32-d period, milk from each goat was collected during 3 successive 24-h periods, stored at -20°C, and freeze dried before analysis (extraction by accelerated solvent extraction, followed by gas chromatography-mass spectrometry analysis). Bioavailability of I-PCB from soil or spiked oil feeds was estimated by means of the slope-ratio method from I-PCB concentration in milk in response to ingested I-PCB. Relative bioavailability was found to vary from 36 to 50% for PCB 118, 138, and 153 and it was 73% for PCB 180. When considered globally, the response obtained with the I-PCB was estimated to 51%. Relative bioavailability was not established for PCB 52 and 101, compounds known to be readily cleared and showing low concentrations in milk. For PCB 28, no significant interaction was found between matrix and dose. This experiment reveals that PCB bound to soil are potentially liberated from soil during the digestive process and may undergo absorption, distribution, metabolism, and excretion. Thus, soil has to be considered as a risk matrix for ruminants and rearing practices in contaminated areas should strictly reduce the risk of soil ingestion by the ruminants.

Effects of particle size and amendment rates of Sargassum biochar on chlordecone sequestration in West Indian soils.

The use of biochars (BCs) and activated carbons as a way of sequestering soil-bound pollutants such as chlordecone (CLD) is increasingly being studied. This study aims at assessing the impact of Sargassum BC/AC particle size and Sargassum BC amendment rate on CLD adsorption in Nitisol and in Andosol. Four different types of carbonaceous matrices were tested: Sargasso carbon activated by phosphoric acid (SargH3PO4), Sargasso carbon activated by steam (SargH2O), biochar of Sargasso (Ch Sarg700), and a commercial activated carbon (ORBO™). In a first experiment, CLD contaminated Andosol and Nitisol were amended with 2% of each carbonaceous matrix divided into four particles size classes (< 50 µm, 50-150 µm, 150-200 µm, and > 200 µm). In a second experiment, the contaminated soils were amended with the biochar of Sargasso at five application rates (0, 0.25, 0.5, 1, and 2% (w/w)). After a 4-month aging, environmental availability tests were carried out on the soils of both experiments. The results of the first experiment showed that the best reductions of CLD environmental availability were obtained in both soils with the biochar of Sargasso and the ORBO™. More specifically, in nitisol, particle size under 50 µm of biochar of Sargasso and AC ORBO™ showed a CLD environmental availability reduction up to 72 ± 2.6% and 79 ± 2.6%. In Andosol, there was no significant difference between the three particle sizes (< 50 µm, 50-150 µm, and 150-200 µm) of the biochar of Sargasso on the reduction of environmental availability (average reduction of 43 ± 2.5%). The results of the second experiment showed that an amendment rate increase improves the immobilization of CLD. When the amendment rate was increased from 0.25 to 2%, the environmental availability was reduced by 43% in Nitisol and 50% in Andosol.

Safety and efficacy of a feed additive consisting of halofuginone hydrobromide (STENOROL®) for chickens for fattening and turkeys for fattening/reared for breeding (Huvepharma N.V.).

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.

Assessment of the feed additive consisting of robenidine hydrochloride (Cycostat® 66G) for rabbits for breeding and rabbits for fattening for the renewal of its authorisation (Zoetis).

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.

Risks for animal health related to the presence of ochratoxin A (OTA) in feed.

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.

Safety and efficacy of a feed additive consisting of benzoic acid (Kalama® Animal Feed Grade Benzoic acid) for weaned piglets and pigs for fattening (Emerald Kalama Chemical, B.V).

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.

Safety and efficacy of a feed additive consisting of monensin sodium (Elancoban® G200) for chickens for fattening, chickens reared for laying and turkeys (Elanco GmbH).

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.

In vivo validation of the unified BARGE method to assess the bioaccessibility of arsenic, antimony, cadmium, and lead in soils.

The relative bioavailability of arsenic, antimony, cadmium, and lead for the ingestion pathway was measured in 16 soils contaminated by either smelting or mining activities using a juvenile swine model. The soils contained 18 to 25,000 mg kg(-1) As, 18 to 60,000 mg kg(-1) Sb, 20 to 184 mg kg(-1) Cd, and 1460 to 40,214 mg kg(-1) Pb. The bioavailability in the soils was measured in kidney, liver, bone, and urine relative to soluble salts of the four elements. The variety of soil types, the total concentrations of the elements, and the range of bioavailabilities found were considered to be suitable for calibrating the in vitro Unified BARGE bioaccessibility method. The bioaccessibility test has been developed by the BioAccessibility Research Group of Europe (BARGE) and is known as the Unified BARGE Method (UBM). The study looked at four end points from the in vivo measurements and two compartments in the in vitro study ("stomach" and "stomach and intestine"). Using benchmark criteria for assessing the "fitness for purpose" of the UBM bioaccessibility data to act as an analogue for bioavailability in risk assessment, the study shows that the UBM met criteria on repeatability (median relative standard deviation value <10%) and the regression statistics (slope 0.8 to 1.2 and r-square > 0.6) for As, Cd, and Pb. The data suggest a small bias in the UBM relative bioaccessibility of As and Pb compared to the relative bioavailability measurements of 3% and 5% respectively. Sb did not meet the criteria due to the small range of bioaccessibility values found in the samples.

Safety and efficacy of a feed additive consisting of lasalocid A sodium (Avatec® 150G) for chickens for fattening and chickens reared for laying (Zoetis Belgium SA).

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.

Safety of a feed additive consisting of halofuginone hydrobromide (STENOROL®) for chickens for fattening and turkeys (Huvepharma N.V.).

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.

Safety of a feed additive consisting of semduramicin sodium (Aviax 5%) for chickens for fattening (Phibro Animal Health s.a.).

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.

Efficacy of a feed additive consisting of nicarbazin (Coxar®) for use in turkeys for fattening (Huvepharma N.V.).

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.

Characterization of chlordecone distribution and elimination in ewes during daily exposure and depuration.

To reduce the exposure of the French West Indies population to the pollutant chlordecone (CLD), the contamination of consumed products must be reduced. One of the strategies to secure safe animal products is related to the depuration of contaminated animals. In order to set up this strategy in situ, characterizing CLD distribution and elimination appears to be essential. The aim of this study is to characterize CLD distribution and elimination in ewes, and establish correlations between CLD concentrations in tissues following a continuous oral contamination period and a depuration period. The experiment consisted in a 90-d period of CLD exposure via daily feeding at 0.01 mg kg-1 body weight, followed by a 127-d period of depuration. A total of 24 ewes were sequentially slaughtered and serum, liver, perirenal fat, subcutaneous fat, shaft muscle, longissimus dorsi muscle and heart samples were collected. CLD concentrations in serum and tissues were analyzed by GC-MS/MS and LC-MS/MS, respectively. Whatever the time of sampling, CLD concentrations in liver were significantly higher than in other collected tissues. However, the results showed that fat tissues stored the higher portion of CLD body burden, followed by muscle, liver, serum and heart. CLD half-lives did not differ significantly between tissues including serum and ranged between 20.2 ± 4.0 and 24.1 ± 4.9 d. Two linear models were developed to estimate CLD concentration in tissues from a blood sample. This study illustrates the theoretical methodology to estimate the time required to decontaminate farm animals from a blood sample.