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Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus rhamnosus when used as a technological additive intended to improve ensiling at a proposed application rate of 5.0 × 107 colony‐forming units (CFU)/kg fresh material. The bacterial species L. rhamnosus is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Seven studies with laboratory‐scale silos were made using samples of forage of differing dry matter and water‐soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing dry matter loss and enhancing protein preservation. This was shown at the proposed application rate of 5 × 107 CFU/kg forage.

Abstract 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.

Abstract Hemicell® HT is a feed additive with endo‐1,4‐β‐d‐mannanase as the main enzymatic activity that is available in solid (HT) and liquid (HT‐L) forms. The production strain of the enzyme is a genetically modified strain of Paenibacillus lentus. The recipient strain is considered to be safe, the sequences introduced to obtain the production strain do not raise safety concerns. The absence of the production strain and of recombinant DNA in the product was not proven. The additive is safe for the target species at the corresponding recommended doses. The use of Hemicell® HT as a feed additive does not give rise to concerns for consumers. Hemicell® HT and Hemicell® HT‐L are not irritant to the skin and eyes; Hemicell® HT is a skin sensitiser. No specific data were provided on the effects on the respiratory system; however, considering the nature of the active substance, the additive is considered a potential respiratory sensitiser. The active substance of the additive is a protein, and as such, it will be degraded/inactivated during passage through the digestive tract of the animals or in the environment. However, uncertainty remains on the absence of the production strain and of recombinant DNA in the product, consequently, the EFSA FEEDAP Panel could not conclude on the environmental safety of the product with regard to the genetically modified production strain. The additive has the potential to be efficacious in chickens for fattening at 32,000 U/kg feed and at 48,000 U/kg feed in turkeys for fattening and weaned piglets. These conclusions were extended to chickens reared for laying and turkeys reared for breeding and extrapolated to minor poultry species for fattening or reared for laying/breeding. The Panel could not conclude on the efficacy of the product in pigs for fattening or in minor porcine species.

Abstract Biomin® BBSH 797 is the trade name for a feed additive containing viable cells of an unnamed bacterium (DSM 11798). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) produced an opinion on the safety and efficacy of this additive when used with pigs concluding that the additive itself did not raise any safety concern. It was confirmed that the additive could reduce the trichothecene, deoxynivalenol (DON), producing the less toxic de‐epoxy metabolite. The applicant is now seeking authorisation for the use of the additive in feed for all avian species and, since the current authorisation only covers DON, the amending of this authorisation to include all trichothecene mycotoxins. Chickens and turkeys for fattening and laying hens showed no adverse effects when the additive was added to diets at 1000 times the recommended dose. Consequently, the additive is considered safe for these species/categories when used at the recommended dose of 1.7 × 108 colony‐forming units (CFU)/kg complete feed. This conclusion is extended to all avian species. The use of the additive in feed for all avian species is not expected to introduce concerns for consumers, users or the environment not previously considered. In vitro and in vivo studies showed that the inclusion of the additive at the recommended dose of 1.7 × 108 CFU/kg was effective in reducing contaminating DON in feed when given to avian species with a concomitant production of the less toxic de‐epoxy metabolite. The additive was shown to reduce the 12,13‐epoxide group of representative trichothecenes. It would be reasonable to assume a similar reaction with other mycotoxins of the same structural type independent of the animal species or category receiving contaminated feed. The additive is compatible with the coccidiostats monensin sodium, salinomycin sodium, narasin, narasin/nicarbazin, nicarbazin, robenidine hydrochloride and diclazuril.

Abstract Following a request from the European Commission, the EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus plantarum when used as a technological additive intended to improve the ensiling process at a minimum proposed dose of 5.0 × 107 colony‐forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Seven studies with laboratory‐scale silos were made using samples of forage of differing dry matter and water‐soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing the pH and increasing lactic acid concentration and protein preservation. This was shown at the proposed application rate of 5 × 107 CFU/kg forage.

Abstract The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the NOAEL approach for deriving a Reference Point (RP). Most of the modifications made to the SC guidance of 2009 concern the section providing guidance on how to apply the BMD approach. Model averaging is recommended as the preferred method for calculating the BMD confidence interval, while acknowledging that the respective tools are still under development and may not be easily accessible to all. Therefore, selecting or rejecting models is still considered as a suboptimal alternative. The set of default models to be used for BMD analysis has been reviewed, and the Akaike information criterion (AIC) has been introduced instead of the log‐likelihood to characterise the goodness of fit of different mathematical models to a dose–response data set. A flowchart has also been inserted in this update to guide the reader step‐by‐step when performing a BMD analysis, as well as a chapter on the distributional part of dose–response models and a template for reporting a BMD analysis in a complete and transparent manner. Finally, it is recommended to always report the BMD confidence interval rather than the value of the BMD. The lower bound (BMDL) is needed as a potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL per ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re‐evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 SC guidance was used, in particular when the exposure is clearly smaller (e.g. more than one order of magnitude) than the health‐based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the expected wide application of the BMD approach.

Abstract Levucell SB® is a feed additive consisting of viable cells of a strain of Saccharomyces cerevisiae currently authorised as a zootechnical additive for piglets and sows. The applicant is now seeking authorisation as a zootechnical additive (other zootechnical additive) for use with chickens for fattening and minor poultry species. The EFSA FEEDAP Panel in a previous opinion concluded that the additive fulfilled the requirements for the qualified presumption of safety (QPS) approach to safety assessment and thus could be presumed safe for the target species, consumers and the environment. Since the additive which is the subject of the present application has the same formulations as that considered previously, following the QPS approach, the same conclusions on target animal consumer and environmental safety apply when used with poultry. The use of the additive with diets for the new target species is considered unlikely to introduce hazards for users of the product not already considered in the previous assessment. When used with poultry feed, the additive is intended to aid the reduction of carcass contamination with enteropathogens and so improve the quality of poultry products. Five studies were submitted with chickens fed diets with or without the additive and then (in four studies) artificially challenged with Salmonella. The fifth study relied on the natural incidence of Salmonella. The prevalence of Salmonella contamination was estimated by examining the carcass directly and/or by detection in caecal, cloacal or faecal samples. Considering overall the results of the five studies, there is evidence that the addition of Levucell SB® to diets at a dose of 2 × 1010 CFU/kg feed can aid the reduction of carcass contamination with Salmonella spp.. This conclusion can be extrapolated to minor avian species for fattening when used at the same dose, but not to minor poultry species for laying.

Chlordecone (Kepone) (CLD) is a highly persistent pesticide which was extensively used in the French West Indies; high levels of CLD can still currently be found in large agricultural areas. As CLD transfers from soil to animals mainly via involuntary ingestion, the consumption of foodstuffs derived from animals raised in contaminated areas may significantly contribute to exposure of humans to CLD. The present study was designed to test the efficacy of two different activated carbons (ACs) sources in limiting CLD transfer from soil to animal. Three soils (ASs) were prepared according to the OECD guideline 207. One standard soil (SS) lacking AC, and two modified preparations of SS supplemented with 2% coconut-based activated carbon (ORBO), SSO or with 2% lignite-based one (DARCO), SSD. All three soils were spiked with 10 μg of kepone per g of dry matter and aged for three weeks. This study involved 15 goat kids randomly assigned to the 3 experimental groups (n = 5/group), which were fed the experimental matrices at an exposure dose of 10 μg CLD per kg of body weight per day. After 21 d of oral exposure, CLD in adipose tissue and liver were analysed by LC-MS-MS. A significant decrease of 63.7% and 74.7% of CLD concentrations in adipose tissue and liver, respectively, were obtained from animals exposed using SS containing DARCO as compared to those receiving only SS. Decreases in CLD levels of 98.2% (adipose tissue) and 98.7% (liver) were obtained for animals exposed using SS containing ORBO. This study leads us to conclude that (i) the presence of AC in CLD-contaminated soil strongly reduces CLD bioavailability, and (ii) the efficacy depends on the nature and characteristics of the AC used.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of dry grape extract when added to water for drinking for all animal species and categories. The additive under assessment (dry grape extract) is a mixture of two extracts from the seeds and skin of Vitis vinifera subsp. vinifera. The FEEDAP Panel has previously issued an opinion on the safety and efficacy of this dry grape extract when added to feed. It was concluded that the additive is safe at the maximum proposed use level (100 mg/kg complete feed) for all animal species except dogs, for which no safe dietary concentration could be established. The FEEDAP Panel also concluded that there were no concerns for consumer safety and that no risks for the environment were to be expected and could not conclude on the safety for the user. Since consumer, user and environmental safety are independent of the mode of delivery of the additive, the conclusions reached in the previous opinion also apply to use in water. For a number of target species, the established safe concentration in feed could be exceeded if a maximum proposed dose in water (100 mg/L) was applied. Considering the margin of safety identified in the previous assessment, a maximum concentration of 50 mg/L water for drinking is considered safe for all animal species except dogs. Since the major component of the additive, the proanthocyanidin‐rich seed extract, is recognised to provide flavour in food and its function in water for drinking for animals would be essentially the same, no demonstration of efficacy is considered necessary.

Abstract FUMzyme® is an enzyme‐based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for avian species. It is produced from a genetically modified strain of Komagataella pastoris. The additive is already authorised for use with pigs. During the course of this assessment, it was shown that the production strain and its recombinant genes are not present in the final product. Safety for the consumer, the user and the environment were also established. The extension of its use to all avian species is not expected to alter these conclusions. Chickens and turkeys for fattening and laying hens showed no adverse effect when given feed containing 100 times the maximum recommended dose. Consequently, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive is safe for poultry when used within the dose range proposed (15–300 U/kg feed) and extends this conclusion to all other avian species. Five short‐term feeding studies were made in which poultry were given feed contaminated with fumonisins with or without the additive. Each included a measure of the concentration of fumonisin B1 and its breakdown products and showed that the enzyme was able to significantly reduce the concentration of fumonisin in faeces and various points in the digestive tract and increase the concentration of the degradation products. In addition, ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis, was significantly reduced by the addition of FUMzyme® at the minimum proposed dose, when added to diets contaminated with fumonisins. FUMzyme® has the capacity to degrade fumonisins in feed, at concentrations below the Guidance limits operating in the EU in chickens and turkeys for fattening and laying hens at the minimum recommended dose of 15 U/kg complete feed. This conclusion can be extrapolated to all avian species.

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 binder for all animal species. The additive is composed of bentonite and algae belonging to Ulva spp. The additive is considered safe for weaned piglets, dairy cows and chickens for fattening at the maximum recommended dose of 125 mg/kg complete feed (a wide margin of safety is established in weaned piglets and dairy cows); this conclusion is extrapolated to all animal species. The additive is not genotoxic. As bentonite is essentially not absorbed from the gut lumen and algae from Ulva spp. are not expected to be of concern for human consumption, the FEEDAP Panel considers that the use of the additive in animal nutrition is safe for consumers. The additive is not an irritant to the skin or the eyes and it is considered to have low inhalation toxicity. However, the additive has a high dusting potential and contains a high proportion of fine particles. A high level of inhalation exposure to an inert dust may be hazardous. In the absence of data, the Panel could not conclude on dermal sensitisation. As the components of the additive are of natural origin (soil and marine environment), it is not expected that the use of the additive in animal nutrition would adversely affect the environment. The FEEDAP Panel could not conclude on the efficacy of the additive for all animal species.

Abstract Feedlyve AXC is a feed additive that is available in liquid and solid formulations and contains endo‐1,4‐β‐xylanase which is produced by a strain of Trichoderma longibrachiatum. The tolerance trial submitted did not comply with the requirements of tolerance trials, and therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for the target species. The enzyme concentrate gave negative results in a bacterial reverse mutation assay and in an in vitro chromosome aberration assay. Moreover, the substance was negative in an in vivo micronucleus test in the rat bone marrow and the results of the subchronic oral toxicity study showed no adverse effects. However, the correspondence of the test item used and the fermentation product that is currently used to prepare the additive was not established. Therefore, the FEEDAP Panel was not in a position to conclude on the safety for the consumer of the additive. The tests conducted in order to address the safety for the user indicated that the test items were not toxic by inhalation, not irritant to the eyes or skin but showed a dermal sensitisation potential. However, the relationship between the test items and the additive for which re‐evaluation is sought were not fully established. The additive is considered as a potential respiratory sensitiser. No risks to the environment are expected. The results of five trials showed that 100 AXC U/kg feed increased the content of apparent metabolisable energy of the diets in one trial, and 80 AXC U/kg feed improved the feed to gain ratio in two other trials. The trials providing evidence of efficacy at 80 AXC U/kg feed showed some limitations, and therefore, the Panel considered that there is not sufficient data to conclude on the efficacy of the additive.

Abstract 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 proposed modification of the terms of the authorisation regarding the formulation of the product Maxiban® G160 (narasin and nicarbazin). The applicant has proposed to modify the concentration of Microtracer‐F‐Red in the additive from the currently authorised 11 g/kg to a range of 4–11 g/kg. Based on data submitted on the composition and the stability, the FEEDAP Panel concluded that the physicochemical properties of the additive were not affected by the proposed modification. Therefore, the assessment of safety and efficacy made for the former formulation with 11 g Microtracer‐F‐Red/kg is still valid for the newly applied formulation.

Abstract The additive Natugrain® TS/TS L contains endo‐1,4‐β‐xylanase and endo‐1,4‐β‐glucanase and it is available in solid and liquid forms. This additive is authorised for use in piglets and pigs for fattening, poultry species and ornamental birds. The currently authorised dose for chickens reared for laying and for minor poultry species for laying is 560 TXU and 250 TGU per kg feed. The applicant requested to reduce the dose to 280 TXU and 125 TGU per kg feed in these target species/categories. Safety aspects regarding the use of this additive in feed including the safety of the genetic modification of the production strain, the safety for the consumers, for the users and for the environment were previously assessed. The Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected. Both forms were considered potential skin and respiratory sensitisers. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is not aware of any new information that would lead it to reconsider the conclusions drawn previously. The FEEDAP Panel had previously evaluated a tolerance trial carried out with chickens for fattening and another one in laying hens and concluded that the additive is safe at the dose of 840 TXU and 375 TGU per kg feed. This conclusion was extended to chickens reared for laying and extrapolated to minor poultry species for laying. The proposed reduction in the minimum recommended dose would not affect that conclusion. Based on the results obtained in efficacy studies, the FEEDAP Panel concluded that the additive is efficacious in chickens for fattening and laying hens at 280 TXU and 125 TGU per kg feed. This conclusion can be extended to chickens reared for laying and extrapolated to minor poultry species for laying.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of selenium‐enriched yeast (Saccharomyces cerevisiae NCYC R397) for all animal species, based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is currently authorised as selenomethionine produced by S. cerevisiae NCYC R397 as a nutritional additive (compound of trace elements) with a minimum selenium content of 2,000 mg/kg. The applicant proposed the inclusion of an additional formulation with a minimum content of selenium in the additive of 3,000 mg/kg. Considering that there are no changes in (i) the manufacturing of the product compared to the former application, and (ii) the conditions of use already authorised, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) stated that the modification requested would not affect safety and efficacy of the product, with the exception of safety for the target animals and safety for the users. The applicant provided data of 15 batches which supported a specification for a minimum selenium content of 3,000 mg/kg, with at least 63% and 17% of the organic selenium content from selenomethionine and selenocysteine, respectively. The FEEDAP Panel concluded that there are no concerns for the safety of the target animals based on its previous assessment and an additional study on homogeneity of the additive. Selenium is hazardous upon inhalation; owing to the high dusting potential, persons handling the additive are at risk by inhalation. The additive is an irritant for the eyes, skin and mucosae, should be considered as a dermal sensitiser, and likely as a respiratory sensitiser.

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 tartrazine (E 102) for cats and dogs, ornamental fish, grain‐eating ornamental birds and small rodents. Tartrazine (E 102), an authorised food colourant, is intended to be used as a feed additive for cats, dogs, ornamental fish, grain‐eating ornamental birds and small rodents. The following tartrazine concentrations in complete feed were considered safe for cats: 433 mg/kg; for dogs: 520 mg/kg; for ornamental birds: 63 mg/kg; for ornamental fish: 1,924 mg/kg; and for small rodents: 2,000 mg/kg. Inhalation exposure of tartrazine is regarded as hazardous. Tartrazine is considered as a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of tartrazine to skin or eyes. Tartrazine is effective in adding colour to feedingstuffs.

Abstract Feedlyve AGL is a feed additive that is available in liquid and solid formulations and contains endo‐1,3(4)‐β‐glucanase, which is produced by a strain of Aspergillus niger. The tolerance trial submitted did not comply with the requirements of tolerance trials, and consequently, the study was considered not valid. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for the target species. The enzyme concentrate gave negative results in a bacterial reverse mutation assay and in an in vitro chromosome aberration assay. Moreover, the substance was negative in an in vivo micronucleus test in the rat bone marrow and the results of the subchronic oral toxicity study showed no adverse effects. However, the correspondence of the test item used and the fermentation product that is currently used to prepare the additive was not established. Therefore, the FEEDAP Panel was not in a position to conclude on the safety for the consumer of the additive. The tests conducted in order to address the safety for the user indicated that the test items were not toxic by inhalation, not irritant to the eyes or skin but showed a dermal sensitisation potential. However, the relationship between the test items and the additive for which re‐evaluation is sought were not fully established. The additive is considered as a potential respiratory sensitizer. No risks to the environment are expected. The results of two efficacy trials showed that 100 AGL U/kg feed increased the apparent metabolisable energy of the diets in one trial and improved the body weight gain and the gain to feed ratio in another trial. However, a third trial showing significant and positive effects would be required to positively conclude on the efficacy of the product.

Abstract Axtra® PHY 20000 TPT2 is a solid preparation that contains a 6‐phytase produced with a genetically modified strain of Trichoderma reesei. The production strain and its recombinant DNA were not detected in Axtra® PHY 20000 TPT2. From the results obtained in tolerance studies, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for the target species at 2,000 FTU/kg feed. The studies provided to address the safety for the consumer were performed with the fermentation product that is used to formulate the additive and the results do not indicate any reason for concern for consumer safety arising from the use of the product as a feed additive. The studies provided to address the safety for the user were performed with the fermentation product that is used to formulate the additive and have been assessed in a previous opinion. Considering the results of those studies and the substances used during the formulation of Axtra® PHY 20000 TPT2, this formulation is not considered a dermal sensitiser. However, it should be considered a potential irritant to skin, eyes and the respiratory tract, and owing to the nature of the active substance, it should be considered a potential respiratory sensitiser. However, the exposure by inhalation is expected to be negligible. No risks to the environment are expected from the use of Axtra® PHY 20000 TPT2 as a feed additive. Based on the results of efficacy studies, the Panel concluded that the additive has the potential to be efficacious at 250 FTU/kg feed.

Abstract The additive B‐Act® is a preparation containing viable spores of a strain of Bacillus licheniformis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1.6 × 109 colony‐forming unit (CFU)/kg complete feedingstuffs. B. licheniformis is considered by EFSA to be suitable for the qualified presumption of safety approach for establishing safety. As the identity of the active agent was established and the lack of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance were demonstrated, the additive is presumed safe for the target species, consumers and the environment. In the absence of data, no conclusion can be drawn on the skin/eye irritation or skin sensitisation potential. The dustiness of the preparations tested indicated a potential for users to be exposed via inhalation. B‐Act® should be considered to have the potential to be a respiratory sensitiser. B‐Act® at the recommended dose 1.6 × 109 CFU/kg feed has some potential to improve the feed to gain ratio of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. licheniformis DSM 28710 is compatible with decoquinate, diclazuril, halofuginone, nicarbazin, robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin and salinomycin sodium.

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 11 compounds belonging to chemical group 10. They are currently authorised as flavours in food. The FEEDAP Panel concludes that: diacetyl [07.052] is safe at the proposed maximum use level of 25 mg/kg complete feed for all target species, except piglets, chickens for fattening, laying hens and cats, for which the proposed normal use level of 5 mg/kg is safe; 3‐hydroxybutan‐2‐one [07.051], 3‐methylcyclo‐pentan‐1,2‐dione [07.056], 3‐ethylcyclopentan‐1,2‐dione [07.057], pentan‐2,3‐dione [07.060], 3,4‐dimethylcyclopentan‐1,2‐dione [07.075], 3,5‐dimethyl cyclopentan‐1,2‐dione [07.076], hexan‐3,4‐dione [07.077] and sec‐butan‐3‐onyl acetate [09.186] are safe at the proposed maximum dose level of 5 mg/kg for all target species; 2,6,6‐trimethylcyclohex‐2‐en‐1,4‐dione [07.109] and 3‐methylnona‐2,4‐dione [07.184] are safe only at concentrations below the proposed use levels (0.5 mg/kg for cattle, salmonids and non‐food producing animals, and 0.3 mg/kg 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. For 3‐hydroxybutan‐2‐one [07.051], diacetyl [07.052], pentan‐2,3‐dione [07.060], hexan‐3,4‐dione [07.077], 2,6,6‐trimethylcyclohex‐2‐en‐1,4‐dione [07.109], 3‐methylnona‐2,4‐dione [07.184] and sec‐butan‐3‐onyl acetate [09.186], the maximum proposed use levels are considered safe for the environment. For cyclopentanediones (3‐methylcyclopentan‐1,2‐dione [07.056], 3‐ethylcyclopentan‐1.2‐dione [07.057], 3,4 dimethylcyclopentan‐1,2‐dione [07.075] and 3,5‐dimethylcyclopentan‐1,2‐dione [07.076]) usage at levels up to 0.5 mg/kg feed is unlikely to have an adverse effect on the terrestrial or freshwater environments. 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.

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 maltol, a compound belonging to chemical group 12 (maltol derivatives and ketodioxane derivatives). Maltol is currently authorised as a flavour in food. The FEEDAP Panel concludes that maltol added to the feed of all animal species is safe at the normal use level of 5 mg/kg feed. The high use level of 25 mg/kg feed is safe for all animal species except for piglets, chickens for fattening, laying hens and cats. No safety concern would arise for the consumer from the use of these compounds up to the highest proposed level in feeds. No specific data on the safety for the user were provided. In the material safety data sheet, hazards for skin and eye contact and respiratory system are recognised for maltol. The proposed maximum use level in feed for maltol is unlikely to pose a risk for the terrestrial and fresh water environments. Because maltol is used in food as flavouring, and its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

Abstract Lactobacillus brevis is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1 × 108 colony‐forming units (CFU)/kg fresh material. The species L. brevis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than the susceptibility to antibiotics of human and veterinary significance. Although identity was established, the strain was found resistant to ampicillin and clindamycin and may pose a risk for the spread of genes coding for resistance to these antibiotics. Therefore, the use of this strain as a silage additive is not considered safe for target animals, and consumers of products from animals fed the treated silage. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Although L. brevis is ubiquitous in the environment, due to its antibiotic resistance, the FEEDAP Panel cannot conclude on the extent of the risk of horizontal gene transfer to other bacteria in the environment. Six studies with laboratory‐scale silos were made using forage of differing water‐soluble carbohydrate content. Replicate silos containing forages treated at the proposed application rate were compared to identical silos containing the same but untreated forage. After opening and exposure to air, an increase of 3°C over ambient was taken to indicate aerobic deterioration. The additive showed a potential to significantly improve the aerobic stability of silage produced from easy, moderately difficult and difficult to ensile forage at a minimum application rate of 1 × 108 CFU/kg plant material.

Abstract The additive is a preparation of 3‐phytase which is produced by a genetically modified strain of Komagataella pastoris. The production strain and its recombinant DNA were not detected in the final product. Therefore, the additive does not give rise to safety concerns with regard to the genetic modification of the production strain. Based on the results of the tolerance studies provided, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening and laying hens at the dose of 1,000 FTU/kg feed. However, a margin of safety could not be established for laying hens. The production strain belongs to a species considered to qualify for the qualified presumption of safety (QPS) approach to safety assessment when used for enzyme production. Since the identity of the strain was unambiguously established and the genetic modification raised no concerns, the FEEDAP Panel concludes that the use of the additive as a feed additive is of no concerns for consumers. The additive is not an irritant to eyes and skin, and it is not a dermal sensitiser. Owing to the proteinaceous nature of the active substance, the additive is a potential respiratory sensitiser, however, exposure may be limited. The use of the product as a feed additive does not pose risks to the environment. The Panel concluded that the additive has a potential to increase the availability of phytate phosphorus in chickens for fattening at 500 FTU/kg and in laying hens at 1,000 FTU/kg feed.

Young children with their hand-to-mouth activity may be exposed to contaminated soils. However few studies assessing exposure of organic compounds sequestrated in soil were realized. The present study explores the impact of different organic matters on retention of NDL-PCBs during digestive processes using commercial humic substances in a close digestive model of children: the piglet. Six artificial soils were used. One standard soil, devoid of organic matter, and five amended versions of this standard soil with either fulvic acid, humic acid, Sphagnum peat, activated carbon or a mix of Sphagnum peat and activated carbon (95∶5) (SPAC) were prepared. In order to compare the different treatments, we use spiked oil and negative control animals. Forty male piglets were randomly distributed in 7 contaminated and one control groups (n = 5 for each group). During 10 days, the piglets were fed artificial soil or a corn oil spiked with 19,200 ng of Aroclor 1254 per g of dry matter (6,000 ng.g⁻¹ of NDL-PCBs) to achieve an exposure dose of 1,200 ng NDL-PCBs.Kg⁻¹ of body weight per day. NDL-PCBs in adipose tissue were analyzed by GC-MS. Fulvic acid reduced slightly the bioavailability of NDL-PCBs compared to oil. Humic acid and Sphagnum peat reduced it significantly higher whereas activated carbon reduced the most. Piglets exposed to soil containing both activated carbon and Shagnum peat exhibited a lower reduction than soil with only activated carbon. Therefore, treatment groups are ordered by decreasing value of relative bioavailability as following: oil ≥ fulvic acid>Sphagnum peat ≥ Sphagnum peat and activated carbon ≥ Humic acid>>activated carbon. This suggests competition between Sphagnum peat and activated carbon. The present study highlights that quality of organic matter does have a significant effect on bioavailability of sequestrated organic compounds.

Fluorene is one of the most abundant polycyclic aromatic hydrocarbons in air and may contribute to the neurobehavioral alterations induced by the environmental exposure of humans to PAHs. Since no data are available on fluorene neurotoxicity, this study was conducted in adult rats to assess the behavioral toxicity of repeated fluorene inhalation exposure. Male rats (n = 18/group) were exposed nose-only to 1.5 or 150 ppb of fluorene 6 hours/day for 14 consecutive days, whereas the control animals were exposed to non-contaminated air. At the end of the exposure, animals were tested for activity and anxiety in an open-field and in an elevated-plus maze, for short-term memory in a Y-maze, and for spatial learning in an eight-arm maze. The results showed that the locomotor activity and the learning performances of the animals were unaffected by fluorene. In parallel, the fluorene-exposed rats showed a lower level of anxiety than controls in the open-field, but not in the elevated-plus maze, which is probably due to a possible difference in the aversive feature of the two mazes. In the same animals, increasing blood and brain levels of fluorene monohydroxylated metabolites (especially the 2-OH fluorene) were detected at both concentrations (1.5 and 150 ppb), demonstrating the exposure of the animals to the pollutant and showing the ability of this compound to be metabolized and to reach the cerebral compartment. The present study highlights the possibility for a 14-day fluorene exposure to induce some specific anxiety-related behavioral disturbances, and argues in favor of the susceptibility of the adult brain when exposed to volatile fluorene.