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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

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.

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

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 (SargH

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

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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 CO

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ECONASE ® XT (endo‐1,4‐β‐xylanase) produced by a genetically modified strain of Trichoderma reesei (CBS 140027) as a zootechnical feed additive for piglets (weaned), pigs for fattening, chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding and minor poultry species. The recipient strain and the production strain T. reesei CBS 140027 are considered safe. The additive is safe for chickens for fattening and weaned piglets at the maximum recommended doses (16,000 and 24,000 BXU/kg feed, respectively) with a wide margin of safety (100‐fold and 50‐fold, respectively). These conclusions are extended to chickens reared for laying and to pigs for fattening at 16,000 and 24,000 BXU/kg feed, respectively. The additive is safe for turkeys for fattening or reared for breeding at 16,000 BXU/kg feed. The FEEDAP Panel cannot conclude on the safety of the additive for laying hens and for minor poultry species for laying at the proposed conditions of use. The information provided does not allow to conclude on the safety of the use of ECONASE XT ® P/L produced by T. reesei CBS 140027 in animal nutrition for the consumers. The use of the additive under assessment in animal nutrition does not raise safety concerns for the environment. ECONASE ® XT L is non‐irritant to the skin or to the eyes. In absence of data, the FEEDAP Panel cannot conclude on the potential of the solid product to be irritant to skin and eyes and on the potential of the additive in all forms to be a dermal sensitiser. All forms of the additive should be considered as respiratory sensitisers. All forms of the additive are considered efficacious at the minimum recommended levels for the target 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 the coccidiostat Nilablend™ 200G containing lasalocid A sodium and nicarbazin. Nilablend™ 200G is not safe for chickens for fattening at the proposed maximum use level of 50 mg lasalocid A sodium + 50 mg nicarbazin/kg complete feed. Concurrent administration of Nilablend™ 200G (containing lasalocid A sodium) with tiamulin and certain other medicinal substances should be avoided. Lasalocid A sodium has 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. No information on the interactions of nicarbazin with feed materials, other approved additives or medicinal products have been provided. No data were submitted on the microbiological safety of nicarbazin. The toxicological package for lasalocid A sodium and nicarbazin identified no observed adverse effect levels (NOAELs) that could be the basis for setting health‐based guidance values (e.g. an acceptable daily intake (ADI)). The Panel concluded that a concern for the genotoxicity of nicarbazin in Nilablend™ 200G cannot be excluded and that clarification on the mechanism of action of the test items would be needed. Therefore, the FEEDAP Panel is not in the position to establish an ADI for DNC on which to base the assessment of consumer safety. Nilablend™ 200G is considered toxic by inhalation, corrosive and irritant to eyes, slightly irritant to the skin but not a skin sensitiser. Inhalation exposure is considered a risk to persons handling the additive. The FEEDAP Panel cannot conclude on the safety of Nilablend™ 200G for the environment due to a possible risk for aquatic compartment (freshwater) for DNC. The efficacy of Nilablend® 200G was demonstrated.

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 efficacy of amprolium hydrochloride (COXAM ®) for chickens for fattening and chickens reared for laying. COXAM ® is a coccidiostat intended to be used to control coccidiosis in chickens for fattening and chickens reared for laying up to 12 weeks of age at a dose of 125 mg amprolium hydrochloride (HCl)/kg complete feed. In its former opinion, the FEEDAP Panel was not in the position to conclude on the efficacy of COXAM ® for chickens for fattening and chickens reared for laying due to insufficient number of positive and significant effects on relevant parameters in one of the anticoccidial sensitivity tests (ASTs) evaluated. In the present submission, an additional AST has been provided by the applicant. In this study, challenge by an Eimeria inoculum of low pathogenicity indicated the coccidiostatic potential of amprolium HCl based on the reduction of intestinal lesions. Considering the results of three floor pen trials and two ASTs described and assessed in a previous EFSA opinion and taking into account the newly submitted AST, the FEEDAP Panel concludes that COXAM ® is efficacious in controlling coccidiosis in chickens for fattening at a dose of 125 mg amprolium HCl/kg complete feed. This conclusion is extended to chickens reared for laying.

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.

Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6‐phytase produced by a genetically modified strain of K. phaffii. The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene. Although Nutrase PTS 10,000 (thermostable granulate) and Nutrase PG 10,000 (granulate) do not raise concern regarding the presence of viable cells of the production strain and its recombinant DNA, uncertainties remain on the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder). The FEEDAP Panel cannot conclude on the safety of the additive, in any form, for the target species for which application is made due to major limitations in the study in chickens for fattening provided. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concludes that additive does not pose a toxicological safety concern regarding the consumers of the products obtained from animals receiving the additive. The additive, in its all formulations, is not a skin or eye irritant and is not dermal sensitiser. However, owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The active substance of the additive is a protein and as such would not raise concerns for the environment. Considering that the production strain harbours AMR genes and there is uncertainties regarding the presence of viable cells and DNA of the production strain in Nutrase PL 10,000 (liquid) and Nutrase PD 100,000 (powder), the Panel cannot conclude on the safety of these two formulations of the additive for the target species, consumer, user and environment. Owing to the lack of data, the FEEDAP Panel cannot conclude on the efficacy of the additive.

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 coccidiostat STENOROL ® containing halofuginone hydrobromide (halofuginone HBr) as active substance. The FEEDAP Panel was not able to conclude on the safety of STENOROL ® for chickens and turkeys for fattening at the highest proposed use level. No incompatibilities or interactions with feedingstuffs, carriers, other approved additives or medicinal drugs are expected. Halofuginone HBr does not have antimicrobial activity at the highest dose proposed; it is not expected to exert adverse effects on chicken gut microbiota or select for resistance and cross‐resistance with other antimicrobials. The Panel cannot conclude on the genotoxic potential of halofuginone HBr since an appropriate in vivo follow‐up to exclude the mutagenic effect of the compound was not available. Therefore, the FEEDAP Panel cannot conclude on the safety of halofuginone HBr for the consumer. The additive is toxic by inhalation, dermal and ocular routes and is very irritant to both the eye and the skin. It is considered also a skin sensitiser. Inhalation exposure is considered a risk to persons handling the additive. Since the lack of genotoxic potential of halofuginone HBr has not been adequately demonstrated, it should be considered as an additional potential concern to users handling the additive. Due to limitations in some of the ecotoxicological studies, no conclusions can be drawn on the safety of the additive for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of STENOROL ® in chickens for fattening and in turkeys for fattening.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of Cygro® 10G. The active substance of Cygro® 10G is the polyether ionophore maduramicin ammonium‐α, a coccidiostat intended to be used in feed for turkeys for fattening. In a former opinion, the FEEDAP Panel concluded that the efficacy of Cygro® 10G in turkeys for fattening had not been sufficiently demonstrated. In the present submission, new efficacy studies have been provided by the applicant. A positive effect of Cygro® 10G in preventing coccidiosis in turkeys was shown in three anticoccidial sensitivity tests (ASTs). However, owing to the lack of floor pen studies showing a positive effect, the FEEDAP Panel is not in the position to conclude on the efficacy of Cygro® 10G for turkeys for fattening.

EFSA requested its Scientific Committee to prepare a guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a beneficial health effect) or not. The guidance document provides a general framework for establishing the biological relevance of observations at various stages of the assessment. Biological relevance is considered at three main stages related to the process of dealing with evidence: Development of the assessment strategy. In this context, specification of agents, effects, subjects and conditions in relation to the assessment question(s): Collection and extraction of data; Appraisal and integration of the relevance of the agents, subjects, effects and conditions, i.e. reviewing dimensions of biological relevance for each data set. A decision tree is developed to assist in the collection, identification and appraisal of relevant data for a given specific assessment question to be answered., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1296/full

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 casei when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 108 CFU (when used alone) or 5 × 107 CFU (when used in combination) kg/fresh matter. The species L. casei 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 absence of resistance to antibiotics of human and veterinary significance. As the identity of the strain was clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed treated silage and the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy of the additive. The additive should be considered to have the potential to be a respiratory sensitiser. Five 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. The mini‐silos were stored for 90 days at 20–24°C. At the end of the ensiling period, the content of the silos was analysed and dry matter losses determined. Results showed that the L. casei strain applied at a minimum dose of 5 × 107 CFU/kg 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.

The additive OPTIPHOS ® is a preparation of 6‐phytase that is authorised for use in avian species, weaned piglets, pigs for fattening and sows. The applicant seeks for an extension of use of the product to finfish, at a dose range between 250 and 1,000 OTU/kg feed. The FEEDAP Panel concluded in a previous opinion that there are no concerns for consumer safety and no risks for the environment are expected from the use of the product as feed additive. Moreover, it was concluded that the additive is not a skin/eye irritant or a skin sensitiser, but has the potential to be a respiratory sensitiser. The Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. The results of a tolerance study performed in juvenile rainbow trout (Oncorhynchus mykiss) showed no negative effects of the additive on the fish when offered up to 100 times the maximum recommended dose. Therefore, the Panel concluded that the additive is safe for the rainbow trout and extrapolated this conclusion to all finfish. The Panel evaluated three efficacy trials, two performed in rainbow trout and one in Atlantic salmon (Salmo salar). In these studies, the performance of the fish was monitored as well as phosphorus digestibility and phosphorus retention parameters. In the three trials, the performance and the phosphorus retention were improved by the additive at the lowest tested dose (in rainbow trouts at 250 OTU/kg feed and in Atlantic salmon at 500 OTU/kg feed). The FEEDAP Panel concluded that the additive has a potential to be efficacious in rainbow trout and salmon at 500 OTU/kg. The Panel extrapolated the conclusion to all finfish species.

AviMatrix® (benzoic acid, calcium formate and fumaric acid) is intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed of chickens for fattening, chickens reared for laying, minor avian species for fattening and minor avian species reared to point of lay to increase performance. The additive has not been authorised in the EU. In 2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion in which, owing to insufficient tolerance data and the limited and inconsistent evidence of efficacy, a definitive conclusion on the safety and efficacy of the additive as a zootechnical additive could not be drawn. Additional data have been provided by the applicant related to the safety and the efficacy of the additive for the target species, which is the subject of this opinion. The FEEDAP Panel considers that the additive is tolerated by chickens for fattening up to the maximum recommended dose (1,000 mg/kg complete feed); this conclusion can be extended to chickens reared for laying. However, since no conclusion could be drawn on the margin of safety, the safety of the additive to minor avian species for fattening and to point of lay cannot be extrapolated. Data from three trials provided evidence that AviMatrix® at 500 mg/kg complete feed had the potential to improve the performance of chickens for fattening. The dose proposed for use with chickens reared for laying and minor poultry species for fattening and to point of lay is the same as that demonstrated being efficacious in a physiologically similar major species (chickens for fattening) and it can be reasonably assumed that the mode of action is the same. Consequently, the conclusion on efficacy for chickens for fattening can be extended to chickens reared for laying and extrapolated to minor poultry species for fattening and to point of lay.

PHYZYME ® XP 5000 G/L is a feed additive that contains 6‐phytase produced by a genetically modified strain of Schizosaccharomyces pombe. The applicant requested for the renewal of the authorisation for PHYZYME ® XP 5000 G and L to be used as a feed additive in chickens for fattening, laying hens, turkeys for fattening, ducks for fattening, piglets (weaned), pigs for fattening and sows. This scientific opinion concerns the renewal of the authorisation of the additive for those species. To support the request, the applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment. The application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Following a request from the European Commission, the 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 B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strain to be established and evidence that it is not toxigenic and does not show acquired resistance to relevant antibiotics. In a previous opinion, the strain was found to meet the criteria for the QPS approach. Since no concerns are expected from other components of the additive, B‐Act® is presumed safe for the target species, consumers and the environment. In the same opinion, no conclusions could be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B‐Act® was considered a potential respiratory sensitiser. Since the use of B‐Act® with the target species is considered unlikely to introduce hazards for users of the product not already considered, the conclusions previously reached apply to the current application. B‐Act® at the recommended dose of 1.6 × 109 colony forming units (CFU)/kg feed has the potential to be efficacious in turkeys for fattening. Since the same dose is proposed for the minor poultry species for fattening or raised for laying, the conclusions can be extended/extrapolated to these species. The conclusions on the compatibility of B‐Act® with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal/lower than those for chickens.

EFSA requested the Scientific Committee to develop a guidance document on the use of the weight of evidence approach in scientific assessments for use in all areas under EFSA's remit. The guidance document addresses the use of weight of evidence approaches in scientific assessments using both qualitative and quantitative approaches. Several case studies covering the various areas under EFSA's remit are annexed to the guidance document to illustrate the applicability of the proposed approach. Weight of evidence assessment is defined in this guidance as a process in which evidence is integrated to determine the relative support for possible answers to a question. This document considers the weight of evidence assessment as comprising three basic steps: (1) assembling the evidence into lines of evidence of similar type, (2) weighing the evidence, (3) integrating the evidence. The present document identifies reliability, relevance and consistency as three basic considerations for weighing evidence., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1295/full

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of authorisation of lecithins as a feed additive for all animal species. Lecithins are currently authorised for use in feed for all animal species (Commission Implementing Regulation (EU) 2017/2325). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion of the additive lecithins in 2016. The Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as emulsifier. The requested modification refers to the alignment of the specifications of the feed additive to the specifications set for lecithins when used as food additives, and the inclusion in the authorisation of rapeseed among the botanical sources of hydrolysed and de‐oiled lecithins and of de‐oiled hydrolysed soybean lecithins as an additional form of the additive. Based on the data available, all the lecithins of different botanical origin and their forms under application meet the specifications set for the use of lecithins as a food additive. The Panel therefore recommended applying the specifications set for food additive to the lecithins under application. In its previous opinion, the Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as an emulsifier. The Panel is not aware of any information related to the use of rapeseed as an additional source of hydrolysed liquid lecithins and de‐oiled lecithin powder that would modify the previous conclusions.

ECONASE® XT is an enzyme preparation with endo‐1,4‐β‐xylanase which is authorised as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. The authorisation of the additive for pigs for fattening is at 24,000 BXU/kg feed. The applicant asked for a modification on the conditions of use in pigs for fattening, which consists in the reduction of the minimum recommended level from 24,000 BXU/kg feed to 16,000 BXU/kg feed. In previous opinions, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the safety of the product when used as a feed additive and concluded that the use of the product raises no concerns for consumer safety and no risks for the environment are expected. The Panel also concluded that the additive is non‐irritant to the skin, and the liquid form is non‐irritant to the eyes and is not a dermal sensitiser; however, it is considered a respiratory sensitiser. Regarding the use of the additive in pigs for fattening, the Panel concluded that under the conditions of use, the additive is safe for pigs for fattening and that it can be efficacious at 24,000 BXU/kg. In the current application, the applicant provided three efficacy trials to support the efficacy at 16,000 BXU/kg feed. Two of these studies had been previously evaluated by the FEEDAP Panel and supported the efficacy at 16,000 BXU/kg feed. The third study revealed a significant effect of the additive on the feed to gain ratio in pigs for fattening at 20,000 BXU/kg feed (analysed content). The FEEDAP Panel concluded that the additive has a potential to be efficacious in pigs for fattening as a zootechnical additive at the dose of 20,000 BXU/kg feed.

The additive is a natural mixture of talc and chlorite (NTMC) that contains at least 75% of talc and chlorite as main components. The additive is intended for use as a technological additive (functional groups: (i) anticaking agents) in premixtures and feedingstuffs for all animal species at use levels of 1,000–50,000 mg/kg. No safe dietary level of NMTC could be identified for piglets, chickens for fattening and dairy cows. The use of NMTC in animal nutrition is considered not to pose a risk for the consumer of animal tissues and products from animals fed the additive. Talc could cause serious lung disease if repeatedly inhaled in large quantities over a long period. Talc is not irritant to skin and eyes. In the absence of data, no conclusion can be drawn on the skin sensitisation potential of the product. The components of the additive (talc, chlorite, dolomite and magnesite) are ubiquitous in the environment, being natural components of soil. Therefore, it is not expected that its use as a feed additive would adversely affect the environment. The additive NMTC is efficacious as an anticaking agent.

Amylofeed® is a preparation of endo‐1,3(4)‐β‐glucanase, endo‐1,4‐β‐xylanase and α‐amylase aimed to be used as a feed additive for piglets and young minor porcine species. In a previous assessment, the safety of the additive for the target species, user and environment were established. However, the safety for the consumer and the efficacy of the product could not be established. In that previous assessment, the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided did not allow the Panel to conclude on the safety for the consumer. The applicant has now provided new data/information to assess the safety for the consumer and also new studies in order to support the efficacy of the additive in the target species. The enzymes present in the product are obtained from two different strains and from two different fermentation processes. In the current assessment, the applicant provided complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products. New genotoxicity studies were submitted by the applicant and the results showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study performed and previously submitted were valid for the current assessment; the results showed no evidence for adverse effects. Consequently, the Panel concluded that the additive is safe for the consumers when used as a feed additive. For the evaluation of the efficacy of the additive, the Panel considered four long‐term trials done in weaned piglets. Based on these data, the Panel concluded that the additive has a potential to be efficacious in weaned piglets at the nominal dose of 500 mg/kg feed and extrapolated this conclusion to growing minor porcine species.

l‐Arginine is considered to be a non‐essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l‐arginine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (KCCM 10741P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations at or below thresholds specified by EFSA; thus, C. glutamicum KCCM 10741P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded 99.8%, and no impurities of concern were detected. The use of l‐arginine produced by C. glutamicum KCCM 10741P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. l‐Arginine produced by C. glutamicum KCCM 10741P is considered corrosive to skin and eyes and therefore poses a risk by inhalation. The additive is an effective source of arginine for all species. For the supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against microbial degradation in the rumen.

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.

Natuphos® E is a feed additive that contains a 6‐phytase available in powder, granulated and liquid forms which is intended to be used as a feed additive for avian and porcine species. The production strain of the phytase present in the product is a genetically modified strain of Aspergillus niger. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the genetic modification of the production strain does not give rise to safety concerns. The production strain and its DNA were not detected in the concentrate used to formulate the products. Based on the tolerance studies provided, the Panel concluded that the additive is safe for the target species under the conditions of use with a wide margin of safety. The Panel also concluded that the use of the product as a feed additive does not give rise to concerns for consumers. Evidence was provided showing that the additive is not toxic by inhalation or irritant for skin or eyes, however, it should be regarded as a dermal sensitiser and a potential respiratory sensitiser. The use of the additive as a feed additive poses no risks to the environment. Based on the efficacy studies provided, the Panel concluded that the additive has the potential to be efficacious in chickens for fattening, turkeys for fattening, piglets, pigs for fattening and sows. These conclusions were extended to chickens reared for laying, turkeys reared for breeding and extrapolated to minor poultry species and other avian species for fattening and to the point of lay and to minor porcine species. The Panel considered that there was insufficient information to conclude on the efficacy in laying hens.

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 Probion Forte® when used in feed for chickens for fattening. Probion Forte® is a preparation containing viable spores of a strain of Bacillus subtilis and Bacillus coagulans intended for use in feed for chickens for fattening at the minimum dose of 1 × 108 and a maximum of 2 × 108 colony‐forming units (CFU)/kg feedingstuffs. In the view of the FEEDAP Panel, the identity of the bacterial strains is established as B. subtilis and B. coagulans and their susceptibility to relevant antibiotics is demonstrated. However, both bacterial strains belong to species capable of producing toxins. The absence of a toxigenic potential has not been demonstrated and, therefore, these strains do not qualify for a qualified presumption of safety (QPS) approach to safety assessment and separate studies on target animals and consumer safety are required. The data provided did not allow concluding on the safety for chickens for fattening or the consumers. Probion Forte® is not a skin or eye irritant but should be considered a potential respiratory sensitiser. No conclusion can be drawn on the skin sensitisation potential of the additive. In the absence of evidence that the two active agents are not toxigenic, Probion Forte® is considered as a hazard for those handling the additive. Probion Forte® is considered safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of Probion Forte® for chickens for fattening from the data provided.

The additive under assessment is a preparation of Bacillus amyloliquefaciens NCIMB 3022 intended for use as a technological additive in forages for all animal species at a proposed minimum dose of 5 × 107 CFU/kg fresh materials. The species B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. This approach requires the identification of the strain and evidence that it is not toxigenic and does not show acquired resistance to relevant antibiotics. In a previous assessment, the identity and susceptibility to clinically relevant antibiotics of the active agent was established but the lack of toxigenic potential could not be demonstrated. Therefore, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the product for target animals, consumers, users or the environment. In the same opinion, the potential of the additive to improve aerobic stability of silages at the proposed dose was not convincingly demonstrated. A new cytotoxicity study was conducted using methanol extracts. The methanol extract was cytotoxic at the inclusion level of 5%, while no cytotoxicity was observed at lower concentrations. The current guidance on Bacillus requires absence of toxic effect using the non‐concentrated supernatant. Since the applicant was unable to determine the correlation between the methanol extracts and the Bacillus supernatant concentrations, the FEEDAP Panel is unable to conclude on the toxigenic potential of the strain based on the current data. An additional efficacy study with a similar protocol to the ones previously assessed was conducted. The study showed an improved aerobic stability when added to forage at the proposed dose. However, the FEEDAP Panel remains unable to conclude on the efficacy of the additive to improve the ensiling process on the basis of a single positive result.

Following a request from the European Commission, the European Food Safety Authority 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 Probiotic Lactina® for chickens for fattening and rabbits. The additive is a preparation containing viable cells of six strains of lactic acid bacteria intended for use in feed at the proposed dose of 2.5 × 109 CFU/kg complete feedingstuffs. The identity of all of the component strains of Probiotic Lactina® was established in a previous opinion, five of which qualify for the qualified presumption of safety (QPS) approach to safety assessment. As no antibiotic resistance of concern was detected in these strains, following the QPS approach, the use of these five strains in feedingstuffs is presumed safe for target species; consumers of products from animals fed the additive and the environment. The identity and safety of the sixth strain, Enterococcus faecium NBIMCC 8270, was also established in the previous and current opinions. The FEEDAP Panel concludes that Probiotic Lactina® is safe for rabbits (suckling and weaned) at the recommended inclusion level of 2.5 × 109 CFU/kg feed and reiterates its former conclusion that the product is safe for chickens for fattening at 1 × 1010 CFU/kg feed. The FEEDAP Panel considers Probiotic Lactina® to be safe for consumers of products derived from treated animals when used at the conditions proposed. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of Probiotic Lactina® to skin and eyes or on its dermal sensitisation. Owing to the proteinaceous nature of the active agents, the additive is considered to be a potential respiratory sensitiser. No conclusions can be drawn on the efficacy of Probiotic Lactina® for chickens for fattening and rabbits (suckling/weaned).

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.

Levucell® SB is a feed additive based on viable cells of a strain Saccharomyces cerevisiae marketed in three formulations: SB20 with a minimum concentration of 2 × 1010 CFU/g viable yeast cells and SB10 ME and SB Titan, both microencapsulated forms with a minimum concentration of 1 × 1010 CFU/g viable yeast cells. In 2014, EFSA was requested by the European Commission to re‐evaluate the product when used as a zootechnical additive in feed for sows and weaned piglets. The safety of the additive for consumers, users, the environment and target animals and its efficacy for sows was established at that time. In that instance, the FEEDAP also concluded on the potential Levucell® SB to improve growth of piglets based on one study where supplementation of the additive was done at the recommended dose of 2 × 109 CFU/kg feedingstuffs and two at 1 × 109 CFU/kg feedingstuffs, and considered that the effective dose was 2 × 109 CFU/kg feedingstuffs. Two additional feeding trials in weaned piglets receiving the additive at 1 × 109 CFU/kg feedingstuffs are the subject of this assessment. Due to the high mortality, one of the studies was not considered. In the remaining study, the supplementation of Levucell® SB to weaned piglets at 1 × 109 CFU/kg feed resulted in a significant improvement of feed to gain ratio. Taking into account the two trials from the initial application which showed significant effects at 1 × 109 CFU/kg feed, the FEEDAP Panel concludes that Levucell® SB has the potential to improve performance of weaned piglets when added to feed at 1 × 109 CFU/kg complete feedingstuffs. Results of the efficacy studies can be applied to any of the three available formulations when used to deliver the same dose.

FRA ® Octazyme C Dry is a product that presents α‐galactosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, endo‐1,4‐β‐glucanase, mannan‐endo‐1,4‐β‐mannosidase, pectinase, protease and endo‐1,4‐β‐xylanase. It is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. The enzymes present in the additive are obtained from six different fermentation processes with four different microorganisms, Trichoderma citroviride, Aspergillus niger, Bacillus licheniformis and Bacillus amyloliquefaciens. In the tolerance and efficacy trials done in the target species, major limitations on the analysed enzyme activities in the feed were identified. These limitations did not permit the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to conclude on the safety and efficacy of FRA ® Octazyme C Dry for the target species. The Panel concluded that the additive raises no concerns for the consumers of food products obtained from animals fed with the additive. No specific data were submitted to address the safety for the user, in the absence of such data the FEEDAP Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties. Owing to the nature of the active substances, the additive should be considered a potential respiratory sensitiser. The use of FRA® Octazyme C Dry as a feed additive poses no risks to the environment.

Following a request from the European Commission, the 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 Calsporin® when used in feed for dogs. The additive contains viable spores of a single strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. This approach requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of previous opinions and since concerns are not expected from other components of the additive, Calsporin® is presumed safe for all target species, including dogs, and for the environment. In a previous opinion, the Panel also concluded that the additive is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. The use of the additive in dogs is considered unlikely to introduce hazards for users of the product not already considered as part of the first assessment. Therefore, the conclusions reached apply to the current application. Four studies were supplied aiming at investigating the effects of the supplementation of Calsporin® to the faecal consistency of dogs. Overall, there is a small but significant increase in faecal dry matter content and benefits seen in a subjective assessment of faecal consistency. However, the biological relevance of changes of this magnitude for the animal is questionable, as are the practical benefits for the owner.

Following a request from the European Commission, the 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 Alterion NE ® when used in feed for chickens for fattening and chickens reared for laying. Alterion NE ® is a preparation containing viable spores of Bacillus subtilis DSM 29784 intended for use in feed for the target species at the recommended dose of 1 × 108 CFU/kg complete feedingstuffs. B. subtilis is a species considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of a previous opinion and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. In the same opinion, the FEEDAP Panel concluded that Alterion NE ® is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion could be drawn on the dermal sensitisation of the additive. Alterion NE ® at the recommended dose 1 × 108 CFU/kg feed has the potential to be efficacious in minor poultry species for fattening and reared for laying. B. subtilis DSM 29784 is compatible with the coccidiostats monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, robenidine hydrochloride and decoquinate at the respective authorised levels.

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 renewal of the authorisation of Actisaf Sc47 as a zootechnical additive for lambs for fattening, minor dairy ruminants, horses and pigs for fattening. In 2006, 2007 and 2008, the FEEDAP Panel adopted opinions on the safety and efficacy of Actisaf Sc47 when used in lambs for fattening, minor dairy ruminants, horses and pigs for fattening. Actisaf Sc47 is the trade name for a feed additive based on viable cells of Saccharomyces cerevisiae CNCM I‐4407 with no carrier. It is currently authorised for use in sows, piglets, pigs for fattening, cattle for fattening, calves for rearing, dairy cows, dairy buffaloes, lambs for fattening, dairy sheep, dairy goats, horses, rabbits for fattening and non‐food producing rabbits. Actisaf Sc47 is marketed in three forms: standard, powder and HR. All of them are authorised with a declared minimal concentration of viable yeast cells in the additive of 5 × 109 CFU/g. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. In previous opinions, Actisaf Sc47 was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Additionally, it was not found to be a skin or eye irritant. No new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions on the safety of Actisaf Sc47. Therefore, the Panel considers that the additive Actisaf SC47 remains safe under the approved conditions for lambs for fattening, minor dairy ruminants, horses and pigs for fattening, the consumer, user and the environment.

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.

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.

Riboflavin (80%) is a feed additive produced by fermentation of a genetically modified Bacillus subtilis strain. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of riboflavin (80%) based on a dossier supplied by the applicant. The Panel concluded that neither the production strain nor its recombinant DNA was detected in the final product, and therefore, the additive does not give rise to any safety concern with regard to the genetic modification of the production strain. The Community Reference Laboratory on Feed additives, in the context of an official control, reported on the presence of recombinant DNA in samples of the additive. The European Commission asked EFSA to deliver a new opinion on the safety of Vitamin B2 (80%) based on the new data, complementing the former one. The analysed samples contained DNA belonging to the production strain, including the genetic modification. Moreover, one of the samples contained viable cells from the production strain. Because the production strain carries antimicrobial resistance genes introduced by the genetic modification, the FEEDAP Panel considers that Riboflavin (80%) poses a risk for the spread of viable cells and DNA of a genetically modified strain‐harbouring genes coding for resistance to antimicrobials.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening, based on a dossier submitted for the modification of the terms of authorisation of the additive. The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000mg/kg complete feedingstuffs. The applicant proposed the introduction of an additional manufacturing process, which introduces an impurity (dimethylamino-ethanol (DMAE)) in the additive at concentrations up to 0.09%. The EFSA Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the proposed modification would not substantially affect the previous assessment as related to the safety of the environment and the efficacy of the product. Since the safety of the active substance was established, the current assessment has dealt with the impurity DMAE. Considering the toxicological profile of DMAE, the estimated intake by the target animal and consumers, and making use of the Threshold of Toxicological Concern (TTC) approach, the Panelconcluded that Taminizer D, manufactured by the DMAE route, is safe for both chickens for fattening and consumers, up to the maximum level of 1,000 mg/kg feed. The FEEDAP Panelextends its conclusions about Taminizer D produced by the original method to cover also Taminizer D produced by the new DMAE method. There is minimal risk to users from dust produced as a result of normal handling of the additive. Taminizer D is not irritant to skin but may be irritant to eyes; it is regarded as a potential skin sensitiser. The FEEDAP Panelrecommended to set a specification for the DMAE content in the additive.

Hemicell® HT/HT‐L is an additive that presents endo‐1,4‐β‐mannanase produced by a genetically modified strain of Paenibacillus lentus. This additive is aimed to be used as a feed additive for chickens for fattening/reared for laying, turkeys for fattening/reared for breeding, weaned piglets, pigs for fattening and minor poultry and porcine species. In a previous assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) established the safety of the additive regarding the production strain, target species, consumer and user. However, limitations on the data regarding the absence of the production strain and its DNA did not permit to conclude on the safety of the additive for the environment. In that assessment, the Panel considered that the additive has a potential to be efficacious in the target species with the exception of pigs for fattening and in minor porcine species. The applicant provided new data to address the limitations identified. New data provided allowed the FEEDAP Panel to conclude that production strain and its recombinant DNA are not detected in the intermediate product used to formulate the additive. Therefore, the Panel concluded that the additive does not pose any environmental safety concern. Regarding the efficacy in pigs for fattening, the applicant provided a new analysis of the trials previously assessed which allowed the Panel to conclude that the additive has a potential to improve the feed to gain ratio at 32,000 U/kg feed. No data was provided regarding the efficacy in minor porcine species. However, considering the data available in major porcine species and that the mode of action of enzymes is well‐known and can be reasonably be considered to be similar among porcine species the Panel extrapolated the conclusion drawn in pigs for fattening to minor porcine species for fattening.

The product under assessment is a preparation containing single strains of Saccharomyces cerevisiae, Lactobacillus plantarum and Lactobacillus casei to be used as a technological additive to improve the ensiling process. EFSA has been previously requested by the European Commission to evaluate this product. The safety of the additive for consumers, users, the environment and target animals was established at that time. Results from a number of in vitro ensiling studies made using a variety of grass forage and maize samples were also presented. These efficacy studies showed no evidence that the additive had the potential to conserve nutrients and so improve the production of silage. There was, however, evidence for improved aerobic stability once the ensiled material was exposed to air, but because of the apparent variability in the additive mix, an effective dose could not be established. The applicant has now provided a number of additional ensiling studies confirming that the additive when applied at 80 mL/tonne significantly increases the aerobic stability of ensiled material after exposure to air. This was shown in forage materials with dry matter contents varying between 30% and 70%. Fluorescence in situ hybridisation methods were also introduced to better characterise the additive. Although this method allows individual strains to be separately enumerated, bacterial and yeast numbers are expressed as cell numbers/mL and include counts of both viable and non‐viable cells. As a result values cannot be equated to colony‐forming units, the basis of any authorisation and the functional properties of the additive. Consequently, the Panel remains unable to identify a minimum specification for the product or a minimum effective dose.

In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of l‐tryptophan produced by fermentation using three strains of Escherichia coli, when used as a nutritional additive for all animal species. The Panel concluded that the safety of l‐tryptophan produced by E. coli SARI12091203 for target animals, consumers, users and the environment could not be assessed because the data submitted did not permit the identity and safety of the strain, and the purity of the additive, to be determined. During the current assessment, the applicant withdrew the application for l‐tryptophan produced by E. coli SARI12091203. l‐Tryptophan produced by E. coli DSM 25084 or KCCM 11132P was considered safe for non‐ruminant target species, the consumer and the environment. For both products, the level of endotoxins and the possible dusting potential indicated a risk by inhalation for the user. In the absence of data, a potential for dermal sensitisation could not be excluded. The Commission gave the applicant the possibility of submitting complementary information to allow the FEEDAP Panel to complete its assessment. The additional data on the characterisation of the additives and on their potential for inhalation toxicity and as skin sensitisers are the subject of the current opinion. Due to improvements in the manufacturing process, the level of endotoxins present in the l‐tryptophan produced by E. coli KCCM 11132P has been markedly reduced; consequently, the endotoxin content does not represent a health risk for the user. The additive has a low acute toxicity by inhalation and is not considered as a potential skin sensitiser. l‐Tryptophan produced by E. coli DSM 25084 is not considered a skin sensitiser. The level of endotoxins in this product, however, represents a risk by inhalation for the user handling the additive.

The additive Hemicell®‐L is a liquid preparation of endo‐1,4‐β‐mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and considered to be safe. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) evaluated the genetic modification and concluded that the sequences introduced to obtain the production strain did not raise safety concerns. The production strain and its DNA were not detected in the additive. The Panel concluded that the additive is safe for chickens for fattening and turkeys for fattening at the recommended level. These conclusions were extended or extrapolated to the other target species under application. The Panel concluded that the results obtained in the toxicological studies performed with the fermentation products of the recipient strain and of another genetically modified strain obtained from the same recipient strain could support the safety for the consumer of the product obtained with the new production strain. The additive is not a dermal or eye irritant and it is not a dermal sensitiser. However, considering that the active substance is a protein, the additive should be regarded as a potential sensitiser. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for the target species at 79,200 U/kg.

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.

The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 11473). It is intended to be used in feed and water for drinking for all animal species and categories. It was not possible to characterise the genetic modification with the information provided. Uncertainty remained on the possible presence of cells from the production strain and their recombinant DNA in the product. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the product l‐threonine, produced by fermentation with Escherichia coli CGMCC 11473 for the target species, consumers and the environment. The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of threonine containing additives via water for drinking and feed. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be an irritant for skin and eyes or to be a skin sensitiser. There is a risk from the exposure by inhalation to endotoxins for persons handling the additive. The product under assessment is considered an efficacious source of the amino acid l‐threonine for all animal species. For l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

A total of 11 enzymes were assessed including alpha‐amylase, endo‐1,4‐beta‐glucanase, endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase as silage additives for all animal species. These enzymes are obtained by fermentation of bacterial or fungi non‐genetically modified production strains. Throughout information regarding the production strains of each product were provided, including the origin and history of modifications and allowing their identification. The identification was conclusive for 8 of 10 production strains. For three of the strains, more information/data would still be required in order to conclude. Three of the amylases are produced by bacterial strains that belong to a species that is considered by EFSA to be suitable for the Qualified Presumption of Safety approach to safety assessment. The identity of the strains has been established and the qualifications were met, and consequently, those products were regarded as safe. For the products derived from fungal strains, the strains or resulting products were tested for the presence of secondary metabolites which could be of toxicological concern. These were found to be below the limits of detection or the strain not capable of producing them. Considering all the information provided by the applicant, the Panel concluded that these products can be regarded as safe for the target species, consumer and the environment. In the absence of data, the Panel could not conclude on the skin and eye irritancy or skin sensitisation potential of the products under evaluation. These products should be considered to have the potential to be a respiratory sensitiser. For some of the products under evaluation, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that they have a potential to improve the characteristic of the silage material; for some other products, the Panel could not conclude on their efficacy.

RONOZYME ® WX is an additive that contains endo‐1,4‐β‐xylanase which is authorised for use as a feed additive in poultry for fattening, weaned piglets and pigs for fattening. The applicant has requested for an extension of the use to laying hens. The Panel on additives and Products or Substances used in Animal Feed (FEEDAP) delivered in 2012 an opinion on the safety and efficacy of RONOZYME ® WX when used as a feed additive for poultry, piglets (weaned) and pigs for fattening and another one in 2016 on the change of the production strain proposed by the applicant. In those opinions, the FEEDAP Panel concluded that the use of the product as a feed additive raises no concerns for consumer safety or for the environment. Considering the safety for the user, the Panel concluded that the additive is not a skin or eye irritant but could not conclude on its skin sensitisation potential; however, the additive was considered a potential respiratory sensitiser. The Panel considered that the new use of RONOZYME ® WX would not modify those conclusions. The applicant submitted a tolerance study in laying hens the results of which permitted the Panel to conclude that the additive is safe for laying hens at the recommended dose of 100 FXU/kg feed. In order to support the efficacy of the additive in laying hens, the applicant submitted three long‐term trials. In all three trials, the groups receiving the xylanase at the recommended dose showed a lower feed intake and a better feed to egg mass ratio. However, in one of the three trials, these reductions were seen concurrently with a decrease in the laying rate. This result casts doubts on the efficacy of the additive, and therefore, the Panel considered that there was not sufficient evidence to conclude on the efficacy of the product.