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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 an essential oil obtained from the aerial parts of

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from gum resin of

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the fruit of

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an extract of condensed tannins from

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of

Following a request from the European Commission, 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 a tincture derived from the fruit of

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 vitamin B

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 feed additives prepared from

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the re-evaluation of the safety and efficacy of carmine (sensory additive, functional group: colourants - substances that add or restore colour in feeds) for cats and dogs. The additive consists of aluminium lakes of carminic acid (carmines), which are complexes of aluminium and carminic acid. Carminic acid, produced from the female insect

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 essential oils from the bark and the leaves of

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an aqueous extract of

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 an essential oil from leaves, stalks and twigs of

An ever-increasing number of interstellar organic complex molecules, iCOMs, are continuously detected along the formation process of a Sun-like star thanks to millimeter and centimeter observations. Large interferometers in the (sub)mm range, such as IRAM-NOEMA and ALMA, showed the presence of iCOMs from the early stages of star formation such as pre-stellar dense cores [1], to protoplanetary disks [2], the place where planets form. The discovery of new complex molecules in different space environments leads us to ask how organic chemistry works in space. To interpret the distribution and abundance of iCOMs observed along the formation process of a Sun-like star, it is fundamental to understand their formation mechanisms, the chemical transformations they undergo, the processes responsible for their release in the gas phase such as the thermal desorption process, and how the solid phase interactions between iCOMs and grain surfaces influence the desorption and the subsequent gas phase presence of molecular species. In laboratory, it is possible to simulate interstellar ices analogs formed by iCOMs mixed with grains, process them through UV irradiation, simulate their thermal desorption through Temperature Programmed Desorption (TPD) experiments, study their evolution, the photolysis processes they undergo, and the formation of new species through mass spectra analyses. We will show our published laboratory results on TPD experiments of astrophysical relevant ice mixtures of water, acetonitrile, and acetaldehyde from olivine grains used as interstellar dust analogs on which the icy mixtures were condensed at 17 K, showing how the interactions between the molecules and the surface of grains can modify the thermal desorption process and their release in gas phase [3]. Moreover, the ice mixtures were subjected to in situ UV irradiation to study both photolysis processes and the formation of new molecules [4]. Experimental method: We assembled an ultra-high vacuum (UHV) chamber (P∼ 6.68 · 10-10 mbar) with feedthroughs for gas-phase deposition from a prechamber (P ∼ 10-7 mbar), where the ice mixtures were prepared controlling the partial pressures. The UHV chamber interfaces with a Quadrupole Mass Spectrometer for mass spectrometry, with an ARS closed-cycle helium cryocooler able to get a temperature of 11 K, and with a 300 W UV-enhanced Newport Xenon lamp to UV irradiation. Results: We found that in the presence of grains, only a fraction of acetaldehyde and acetonitrile desorbs at about 100 K and 120 K respectively, while 40% of the molecules are retained by grains of the order of 100 μm up to 80 K higher temperatures. In protoplanetary disks, submicrometric interstellar grains begin to agglomerate into fluffy aggregates of hundreds of microns. Our results show that in protoplanetary regions with temperatures higher than 100 K, where we expect to no longer have iCOMs in the solid phase, a fraction of these molecules can instead survive on the grains. The presence of the grains can allow the delivery of molecules in the innermost part of the disks, in the Earth-like planets forming region broadening the snow lines of O- and N-bearing molecules. The snow lines should therefore be thought of as “snow regions”. Moreover, we found that UV irradiation and olivine are efficient in producing new species possibly deriving from photodissociation, recombination, isomerization, and hydrogen addition reactions. Among these, formamide, urea, glycolaldehyde, and ethanolamine are worthy of mention for their role as prebiotic building blocks. Through laboratory studies, it is possible to improve our understanding of the chemical-physical interactions between molecules and the surface of grains, a process that can significantly affect the presence of molecular species both in the gas phase and in the small planets on short orbits providing an estimate of the fraction of molecules released at various temperatures. Through mass analysis, it is possible to study both photolysis processes and the formation of new molecules. These studies offer the necessary support to the observational data and may help our understanding of the formation and origin of iCOMs. References: [1] Bacmann A. et al (2012) A&A, 541, id.L12. [2] Walsh C. et al. (2016) ApJL, 823. [3] Corazzi M. A. et al (2021) ApJ, 913. [4] Corazzi M. A. (2002) submitted on ApJ.

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 assessment of the application for the renewal of authorisation of naringin as a sensory additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of naringin under the current authorised conditions of use is safe for the target species, the consumers and the environment. Naringin does not cause severe irritation or corrosion to eyes, is not irritant to the skin and is not classified as a dermal sensitiser. The FEEDAP Panel cannot conclude on the possible respiratory sensitisation of the additive, due to the lack of data. 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 Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the re-evaluation of the authorisation of sepiolite as a feed additive for all animal species. The FEEDAP Panel considered that sepiolite is unlikely to be absorbed. Harmful amounts of residues of any chemical component in edible tissues/products, as a consequence of the use of sepiolite as a feed additive, are not expected. Sepiolite is not genotoxic and does not induce any toxicity effects following oral administration and, therefore, it was considered safe for the consumers. The additive was considered safe for dairy cows at the recommended use level with a safety factor of 2.5. The conclusion was extrapolated to other dairy ruminants but owing to the lack of sufficient data, no conclusions can be drawn on the safety of the additive for the other target species/categories. Based on the results of a chronic inhalation toxicity study, the additive is considered a respiratory irritant. Owing to the dusting potential of the additive and its silica content, handling the additive was considered a risk by inhalation for the users. It is not irritant or corrosive to skin or eyes. Due to the nickel content, it is considered a skin and respiratory sensitiser. The additive was considered safe for the environment. The FEEDAP Panel concluded that sepiolite was efficacious as a thickener-suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use.

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 supplementary information submitted on the safety of 37 compounds belonging to different chemical groups, when used as sensory additives (flavourings) in feed for all animal species formerly assessed by the Panel in the context of the re-evaluation of these feed additives. The FEEDAP Panel concludes that ethyl oleate [09.192] and benzyl cinnamate [09.738] are safe at the proposed use level of 5 mg/kg complete feed for all animal species, the consumer and the environment; ethyl salicylate [09.748] is safe up to the maximum proposed use level of 5 mg/kg complete feed for all animal species and the consumer. No new data were submitted on the safety for the user that would allow the FEEDAP Panel to change its previous conclusion for 26 out of the 37 compounds under assessment. The use of 4-terpinenol [02.072], linalyl butyrate [09.050], linalyl formate [09.080], linalyl propionate [09.130], linalyl isobutyrate [09.423], isopulegol [02.167] and 1,2-dimethoxy-4-(prop-1-enyl)-benzene [04.013] as flavouring additives at the proposed use level of 5 mg/kg in feed for all animal species is considered safe for the environment. The use of 3-methyl-2-cyclopenten-1-one [07.112] at 0.5 mg/kg and methyl dihydrojasmonate [09.520] at 5 mg/kg in feed for all animal species except marine animals is considered safe for the environment.

Gellan gum (GG) was chemically modified with methacrylic moieties to produce a photocrosslinkable biomaterial ink, hereinafter called methacrylated GG (GGMA), with improved physico-chemical properties, mechanical behavior and stability under physiological conditions. Afterwards, GGMA was functionalized by incorporating two different bioactive compounds, a naturally derived eumelanin extracted from the black soldier fly (BSF-Eumel), or hydroxyapatite nanoparticles (HAp), synthesized by the sol–gel method. Different ink formulations based on GGMA (2 and 4% (w/v)), BSF-Eumel, at a selected concentration (0.3125 mg/mL), or HAp (10 and 30% wHAp/wGGMA) were developed and processed by three-dimensional (3D) printing. All the functionalized GGMA-based ink formulations allowed obtaining 3D-printed GGMA-based scaffolds with a well-organized structure. For both bioactive signals, the scaffolds with the highest GGMA concentration (4% (w/v)) and the highest percentage of infill (45%) showed the best performances in terms of morphological and mechanical properties. Indeed, these scaffolds showed a good structural integrity over 28 days. Given the presence of negatively charged groups along the eumelanin backbone, scaffolds consisting of GGMA/BSF-Eumel demonstrated a higher stability. From a mechanical point of view, GGMA/BSF-Eumel scaffolds exhibited values of storage modulus similar to those of GGMA ones, while the inclusion of HAp at 30% (wHAp/wGGMA) led to a storage modulus of 32.5 kPa, 3.5-fold greater than neat GGMA. In vitro studies proved the capability of the bioactivated 3D-printed scaffolds to support 7F2 osteoblast cell growth and differentiation. BSF-Eumel and HAp triggered a different time-dependent physiological response in the osteoblasts. Specifically, while the ink with BSF-Eumel acted as a stimulus towards cell proliferation, reaching the highest value at 14 days, a higher expression of alkaline phosphatase activity was detected for scaffolds consisting of GGMA and HAp. The overall findings demonstrated the possible use of these biomaterial inks for 3D-printed bone tissue-engineered scaffolds.

Human health and animal health risk assessment of combined exposure to multiple chemicals use the same steps as single-substance risk assessment, namely problem formulation, exposure assessment, hazard assessment and risk characterisation. The main unique feature of combined RA is the assessment of combined exposure, toxicity and risk. Recently, the Scientific Committee of the European Food Safety Authority (EFSA) published two relevant guidance documents. The first one “Harmonised methodologies for the human health, animal health and ecological risk assessment of combined exposure to multiple chemicals” provides principles and explores methodologies for all steps of risk assessment together with a reporting table. This guidance supports also the default assumption that dose addition is applied for combined toxicity of the chemicals unless evidence for response addition or interactions (antagonism or synergism) is available. The second guidance document provides an account of the scientific criteria to group chemicals in assessment groups using hazard-driven criteria and prioritisation methods, i.e., exposure-driven and risk-based approaches. This manuscript describes such principles, provides a brief description of EFSA’s guidance documents, examples of applications in the human health and animal health area and concludes with a discussion on future challenges in this field.

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 olibanum extract from

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5'-inosinate (IMP) produced by fermentation using

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 an essential oil from the flowers of

The design of modern devices that can fulfil the requirements for sustainability and renewable energy applications calls for both new materials and a better understanding of the mixing of existing materials. Among those, surely organic–inorganic hybrids are gaining increasing attention due to the wide possibility to tailor their properties by accurate structural design and materials choice. In this work, we’ll describe the tight interplay between porous Si and two melanic polymers permeating the pores. Melanins are a class of biopolymers, known to cause pigmentation in many living species, that shows very interesting potential applications in a wide variety of fields. Given the complexity of the polymerization process beyond the formation and structure, the full understanding of the melanins' properties remains a challenging task. In this study, the use of a melanin/porous Si hybrid as a tool to characterize the polymer’s properties within mesopores gives new insights into the conduction mechanisms of melanins. We demonstrate the dramatic effect induced on these mechanisms in a confined environment by the presence of a thick interface. In previous studies, we already showed that the interactions at the interface between porous Si and eumelanin play a key role in determining the final properties of composite materials. Here, thanks to a careful monitoring of the photoconductivity properties of porous Si filled with melanins obtained by ammonia-induced solid-state polymerization (AISSP) of 5,6-dihydroxyindole (DHI) or 1,8-dihydroxynaphthalene (DHN), we investigate the effect of wet, dry, and vacuum cycles of storage from the freshly prepared samples to months-old samples. A computational study on the mobility of water molecules within a melanin polymer is also presented to complete the understanding of the experimental data. Our results demonstrate that: (a) the hydration-dependent behavior of melanins is recovered in large pores (≈ 60 nm diameter) while is almost absent in thinner pores (≈ 20 nm diameter); (b) DHN-melanin materials can generate higher photocurrents and proved to be stable for several weeks and more sensitive to the wet/dry variations.

Melanins are a wide class of natural pigments biosynthesized by different kinds of living organisms throughout all of the life domains, from bacteria to fungi, plants, and mammals. The biological functions played by these natural pigments are different (i.e., camouflage, radioprotection, thermoregulation) and ascribable to a peculiar set of physical-chemical properties making melanins a unique class of biopolymers. Among these, allomelanins from 1,8-dihydroxynaphthalene (1,8-DHNmel) produced by some Ascomycetes have recently attracted particular interest for their robustness and ability to protect fungi against both hostile (i.e., attack from fungicidal agents) and extreme (i.e., high energy radiations) environments. Starting from this background, in this mini-review we offer a panorama of the recent advances on the oxidative chemistry of 1,8-DHN leading to the formation of allomelanin mimics with tailored structural and functional properties for technological applications.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of two rosemary extracts obtained from the ■■■■■ of Rosmarinus officinalis L., as a technological (antioxidant) feed additive for cats and dogs. The two rosemary extracts were obtained through two different solvent extraction methods, acetone and ethanol. The additives were specified to contain carnosic acid and carnosol as the reference antioxidative compounds at a minimum content of their sum as ≥ 10% in the case of the acetone extract and ≥ 5% for the ethanol extract. Based on the data available, the FEEDAP Panel concluded that the maximum safe concentrations of the additives in feed were 300 and 50 mg/kg feed, for dogs and cats, respectively. No data on potential effects on respiratory system were available; however, as the products are in liquid form, the FEEDAP Panel considered that the exposure through inhalation is unlikely. The additives were shown to be irritant to skin and consequently they were considered also eye irritants. Due to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additives to be skin sensitisers. The food and feed matrices in which the additives are intended to be used are of comparable nature. Therefore, the antioxidant effect observed when the additives are used in food is expected to be observed also when the additives are used in feed at the recommended concentrations.

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 an essential oil from the whole plant Cinnamomum camphora (L.) J. Presl (camphor white oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the additive is safe up to the maximum proposed use levels in complete feed of 30 mg/kg for piglets, pigs for fattening, sows, horses, rabbits, fish, ornamental fish and dogs and of 50 mg/kg for calves (milk replacer), cattle for fattening, dairy cows, sheep and goats. For the other species, the calculated safe concentration in complete feed is 28 mg/kg for chickens for fattening, 42 mg/kg for laying hens, 37 mg/kg for turkeys for fattening and 22 mg/kg for cats. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers were identified following the use of the additive at the use level considered safe in feed for the target species. The essential oil under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the additive under the proposed conditions in animal feed was not expected to pose a risk for the environment. Camphor white oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

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 monosodium l‐glutamate monohydrate produced by fermentation using Corynebacterium glutamicum KCCM 80187 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is genetically modified and viable cells of the production strain, and its DNA were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. Monosodium l‐glutamate monohydrate produced using C. glutamicum KCCM 80187 is considered safe for the target species, for the consumer and for the environment. Moreover, it is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. The FEEDAP Panel expressed reservations on the use of the additive in water for drinking due to concerns on its impact on the hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed.

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 a tincture from the bark of Cinnamomum verum J. Presl (cinnamon tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a water/ethanol ■■■■■ solution, with a dry matter content of approximately 0.9%. The product contains on average 0.344% polyphenols (of which 0.001% are flavonoids) and 0.001% cinnamaldehyde. Methyleugenol was present at the limit of detection in one out of the five batches examined. The FEEDAP Panel concluded that cinnamon tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for all animal species except horses. For horses, the maximum proposed use level of 60 mg/kg complete feed is considered safe. No safety concern would arise for the consumer from the use of cinnamon tincture up to the highest proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the cinnamon tincture as a flavour in animal feed is not expected to pose a risk for the environment. Since C. verum and cinnamon bark extracts are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the tincture under application.

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 expressed sweet orange oil and its fractions obtained from the fruit peels of Citrus sinensis (L.) Osbeck, when used as sensory additives (flavourings) in feed and water for drinking for all animal species. The presence of perillaldehyde was identified as a source of potential concern. However, in target species fed citrus by‐products as part of daily feed, the use of the expressed orange oil and its fractions was not expected to increase the exposure to perillaldehyde to a relevant extent (< 10%). For dogs, cats, ornamental fish and ornamental birds not normally exposed to citrus by‐products, no conclusion can be drawn. For the other species, the FEEDAP Panel concluded that the additives under assessment are safe at the maximum proposed use levels in complete feed. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additives up to the maximum proposed use level in feed. The additives under assessment should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. The use of the additives under the proposed conditions of use in animal feed was not expected to pose a risk for the environment. Expressed orange oil and its fractions were recognised to flavour food. Since their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bovaer® 10 as a zootechnical additive for ruminants for milk production and reproduction. Systemic exposure or site of contact toxicity for the active substance 3‐nitrooxypropanol (3‐NOP), for which genotoxicity has not been fully clarified, in the target species, is unlikely based on ADME data available. Consequently, the FEEDAP Panel concluded that Bovaer® 10 was safe for dairy cows at the maximum recommended level. However, as a margin of safety could not be established, the FEEDAP Panel could not conclude on the safety of the additive for other animal species/categories. The FEEDAP Panel considered that the consumer was exposed to 3‐nitrooxypropionic acid (NOPA), which is one of the 3‐NOP metabolites. NOPA was not genotoxic based on the studies provided. The FEEDAP Panel concluded that the use of Bovaer® 10 in animal nutrition under the conditions of use proposed was of no concern for consumer safety and for the environment. The FEEDAP Panel concluded that the active substance 3‐NOP may be harmful if inhaled. It is irritant (but not corrosive) to skin, irritant to the eyes but it is not a skin sensitiser. As the genotoxicity of 3‐NOP is not completely elucidated, the exposure through inhalation of the additive may represent an additional risk for the user. The Panel concluded that the additive has a potential to be efficacious in dairy cows to reduce enteric methane production under the proposed conditions of use. This conclusion was extrapolated to all other ruminants for milk production and reproduction.

The additive under assessment is a dried aqueous ethanol extract of Melissa officinalis L. leaves, intended to be used as a sensory additive (flavouring compound) in feed for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid. In a previous assessment, considering the contradictory data from the Ames tests and uncertainty about the qualitative and quantitative presence of flavonoids and other compounds in the extract from M. officinalis L. leaves, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive at the proposed use levels of up to 100 mg/kg complete feed for the target species, the consumer and the user. The new data submitted identified luteolin 3′‐glucuronide as the only flavonoid present in the additive, improved the characterisation of the hydroxycinnamates present and demonstrated that the additive is not genotoxic. The FEEDAP Panel concludes that the additive under assessment is safe up to the maximum proposed use level of 100 mg/kg complete feed for all animal species. The use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of the additive up to the highest safe level in animal nutrition. The exposure of users to dusts from the additive is not of concern. No data are provided on irritant properties for eyes or skin, thus no conclusion can be drawn on these aspects. Due to the nature of the additive, it may be assumed to be potentially both a skin and respiratory sensitiser.

The specific concentrations of colistin in non‐target feed for food‐producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels of colistin in feed that showed to have an effect on growth promotion/increased yield were reported. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these antimicrobials.

The specific concentrations of tilmicosin, tylosin and tylvalosin in non‐target feed for food‐producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield, were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for tilmicosin and tylosin, whilst for tylvalosin no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these three antimicrobials.

The specific concentrations of sulfonamides in non‐target feed for food‐producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data are available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were identified for three sulfonamides: sulfamethazine, sulfathiazole and sulfamerazine. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these antimicrobials.

The specific concentrations of tetracycline, chlortetracycline, oxytetracycline and doxycycline in non‐target feed for food‐producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. The FARSC for these four tetracyclines was estimated. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for tetracycline, chlortetracycline, oxytetracycline, whilst for doxycycline no suitable data for the assessment were available. Uncertainties and data gaps associated with the levels reported were addressed. It was recommended to perform further studies to supply more diverse and complete data related to the requirements for calculation of the FARSC for these antimicrobials.

The specific concentrations of tiamulin and valnemulin in non‐target feed for food‐producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for tiamulin, while for valnemulin no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these two antimicrobials.

The specific concentrations of apramycin, paromomycin, neomycin and spectinomycin in non‐target feed for food‐producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield, were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC for these antimicrobials, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for apramycin and neomycin, whilst for paromomycin and spectinomycin, no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these four antimicrobials.

The European Commission requested EFSA to assess, in collaboration with EMA, the specific concentrations of antimicrobials resulting from cross‐contamination in non‐target feed for food‐producing animals below which there would not be an effect on the emergence of, and/or selection for, resistance in microbial agents relevant for human and animal health, as well as the levels of the antimicrobials which could have a growth promotion/increase yield effect. The assessment was performed for 24 antimicrobial active substances, as specified in the mandate. This scientific opinion describes the methodology used, and the main associated data gaps and uncertainties. To estimate the antimicrobial levels in the non‐target feed that would not result in emergence of, and/or selection for, resistance, a model was developed. This ‘Feed Antimicrobial Resistance Selection Concentration’ (FARSC) model is based on the minimal selective concentration (MSC), or the predicted MSC (PMSC) if MSC for the most susceptible bacterial species is unavailable, the fraction of antimicrobial dose available for exposure to microorganisms in the large intestine or rumen (considering pharmacokinetic parameters), the daily faecal output or rumen volume and the daily feed intake. Currently, lack of data prevents the establishment of PMSC and/or FARSC for several antimicrobials and animal species. To address growth promotion, data from an extensive literature search were used. Specific assessments of the different substances grouped by antimicrobial classes are addressed in separate scientific opinions. General conclusions and recommendations were made.

An optimized extraction protocol for eumelanins from black soldier flies (BSF-Eumel) allows an in-depth study of natural eumelanin pigments, which are a valuable tool for the design and fabrication of sustainable scaffolds. Here, water-soluble BSF-Eumel sub-micrometer colloidal particles were used as bioactive signals for developing a composite biomaterial ink for scaffold preparation. For this purpose, BSF-Eumel was characterized both chemically and morphologically; moreover, biological studies were carried out to investigate the dose-dependent cell viability and its influence on human mesenchymal stem cells (hMSCs), with the aim of validating suitable protocols and to find an optimal working concentration for eumelanin-based scaffold preparation. As proof of concept, 3D printed scaffolds based on methacrylated hyaluronic acid (MEHA) and BSF-Eumel were successfully produced. The scaffolds with and without BSF-Eumel were characterized in terms of their physico-chemical, mechanical and biological behaviours. The results showed that MEHA/BSF-Eumel scaffolds had similar storage modulus values to MEHA scaffolds. In terms of swelling ratio and stability, these scaffolds were able to retain their structure without significant changes over 21 days. Biological investigations demonstrated the ability of the bioactivated scaffolds to support the adhesion, proliferation and osteogenic differentiation of human mesenchymal stem cells.

The tincture derived from Verbascum thapsus L. (great mullein tincture) is intended to be used as a sensory additive in feed for all animal species. The product is a water/ethanol solution, with a dry matter content of ˜ 2.8% and contains on average 0.216% polyphenols including 0.093% flavonoids. According to a previous assessment, the additive was not characterised in full and about 82% of the dry matter fraction remained uncharacterised (representing 2.26% of the tincture). There was also uncertainty on the potential presence of iridoid glycosides in the tincture. Therefore, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive at the proposed use levels of up to 50 g/kg complete feed for all animal species or for the consumer. The applicant has provided new data which show that the unidentified fraction consists of crude fibre, other carbohydrates, and protein. The tincture also contains aucubin (0.004%). Considering the genotoxic potential of aucubin and other related iridoids, no conclusions can be drawn for long‐living animals (pets and other non‐food producing animals, horses and animals for reproduction). For short‐living animals (animals for fattening), the FEEDAP Panel concludes that the tincture is safe at the maximum proposed use level of 50 mg/kg complete feed and that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No safety concerns would arise for the consumer from the use of the tincture up to the highest safe level in animal nutrition. In the absence of data, no conclusions can be drawn on the potential of the tincture to be a dermal/eye irritant or a skin sensitiser.

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 assessment of the application for renewal of authorisation of vitamin B6 (pyridoxine hydrochloride) produced by chemical synthesis as a feed additive for all animal species. The applicant has provided data demonstrating that the additive in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of pyridoxine hydrochloride under the current authorised conditions of use is safe for the target species, the consumers and the environment. Pyridoxine hydrochloride is non‐irritant to skin and eyes. In the absence of data, no conclusion can be drawn on skin sensitisation potential. Pyridoxine hydrochloride may cause photosensitisation. Despite the lack of data on inhalation toxicity, the additive is not dusty and exposure through inhalation is unlikely. There is 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, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5’‐guanylate produced by fermentation with Corynebacterium stationis KCCM 10530 and Escherichia coli K‐12 KFCC 11067 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The additive does not raise safety concerns under the proposed conditions of use for the target species, consumers the users and the environment. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) expressed reservations on the use of the additive in water for drinking due to concerns on its impact on hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed.

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 an essential oil from the leaves of Citrus x aurantium L. (petitgrain bigarade oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use level of 125 mg/kg complete feed for ornamental fish. For the other species, the calculated safe concentrations in complete feed are 10 mg/kg for chicken for fattening, 14 mg/kg for laying hen, 13 mg/kg for turkey for fattening, 17 mg/kg for piglet, 20 mg/kg for pig for fattening, 25 mg/kg for lactating sow, 43 mg/kg for veal calf (milk replacer), 38 mg/kg for cattle for fattening, sheep, goat and horse, 24 mg/kg for dairy cow, 15 mg/kg for rabbit, 42 mg/kg for salmon, 44 mg/kg for dog and 8 mg/kg for cat. The FEEDAP Panel considered that the use level in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. Simultaneous use in feed and water for drinking may lead to the maximum safe dose being exceeded. No concerns for consumer safety were identified following the use of the additive up to the highest safe level in feed. The essential oil under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. The use of the additive in animal feed under the proposed conditions was not expected to pose a risk for the environment. Petitgrain bigarade oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

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 vitamin B2 98% and vitamin B2 80% in the form of riboflavin produced by fermentation with a genetically modified strain of Bacillus subtilis (KCCM 10445) as nutritional additives in feed and water for drinking for all animal species. The production strain harbours antimicrobial resistance genes. With the data available the Panel is not in the position to confirm the correspondence between the strain deposited under accession number KCCM 10445 and the strain under the current assessment. The production strain and its recombinant DNA were not detected in the final products. Therefore, the additives do not pose any safety concern associated with the genetic modification of the production strain. The additives are safe for the target species, the consumer and the environment. Vitamin B2 80% is not hazardous by inhalation. In the absence of data, no conclusions on the possible risk by inhalation of vitamin B2 98% can be reached. Neither vitamin B2 98% nor vitamin B2 80% are irritant to skin or eyes. In the absence of data, no conclusions on the skin sensitisation potential of the additives can be reached. The additives under assessment are effective in covering the animals’ requirements for vitamin B2 when administered via feed and/or water for drinking.

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 expressed mandarin oil from the fruit peels of Citrus reticulata Blanco, when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for poultry, 33 mg/kg for pigs, 30 mg/kg for ruminants, 40 mg/kg for horse, and 15 mg/kg for salmon and rabbit. The presence of perillaldehyde was identified as a source of potential concern. However, in target species fed citrus by‐products as part of daily feed the use of the expressed mandarin oil in feed was not expected to increase the exposure to perillaldehyde to a relevant extent (< 4%). For companion animals and ornamental fish not normally exposed to citrus by‐products, no conclusion can be drawn. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additive up to the maximum proposed use level in feed. The essential oil under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. The use of the additive in animal feed under the proposed conditions of use was not expected to pose a risk for the environment. Expressed mandarin oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

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 assessment of the application for renewal of authorisation of all‐rac‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.

Danisco Xylanase 40000 G/L is the trade name of the feed additive under assessment and contains endo‐1,4‐beta‐xylanase produced by a genetically modified strain of Trichoderma reesei. It is authorised for use in chickens for fattening, laying hens, ducks, turkeys for fattening, all minor poultry species, weaned piglets and pigs for fattening. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation, a reduction of the minimum recommended level in turkeys for fattening and the extension of use to all poultry species (other than ducks) for fattening or reared for laying/breeding and for laying, suckling piglets and minor growing porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the EFSA Panel on Additives and products or Substances used in Animal Feed (FEEDAP) to reconsider previous conclusions that the additive remains safe for the animal species/categories, the consumer and the environment under the authorised conditions of use. This conclusion applies also to the new target species/categories for which a request of use is made. The additive is not irritant to skin but should be considered as a possible eye irritant and, in common with other proteinaceous substances, respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for chickens for fattening, laying hens, ducks, all minor poultry species, weaned piglets and pigs for fattening. The additive has the potential to be efficacious at 625 U/kg complete feed in all poultry species for fattening (including turkeys) or reared for laying/breeding, and for laying and 2,000 U/kg complete feed in suckling piglets and all minor growing porcine species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of RRR‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of RRR‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of RRR‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.