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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 Saccharomyces cerevisiae NCYC R618 as a zootechnical feed additive (functional group: gut flora stabiliser) for chickens for fattening and other poultry species for fattening and reared for laying. The additive has never been authorised. The strain under assessment S. cerevisiae (NCYC R618) qualifies for the qualified presumption of safety (QPS) and, consequently, the FEEDAP Panel concluded that the product is safe for the target species, the consumers and the environment. The FEEDAP Panel could not conclude on the skin and eye irritation or skin sensitisation potential of the additive. The additive should be considered a respiratory sensitiser. Due to the lack of sufficient data, the Panel cannot conclude on the efficacy of the additive under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme β‐glucosidase (β‐d‐glucoside glucohydrolase, EC 3.2.1.21) is produced with the non‐genetically modified Penicillium guanacastense strain AE‐GLY by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in four food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. The dietary exposure was calculated to be up to 0.206 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Using the no observed adverse effect level reported in the previous opinion (943 mg TOS/kg bw per day), the Panel derived a margin of exposure of at least 4578. Based on the previous evaluation, the assessment of the new data and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme has four declared activities: endo‐polygalacturonase ((1–4)‐α‐d‐galacturonan glycanohydrolase (endo‐cleaving); EC 3.2.1.15), pectinesterase (pectin pectylhydrolase; EC 3.1.1.11), pectin lyase ((1–4)‐6‐O‐methyl‐α‐d‐galacturonan lyase; EC 4.2.2.10) and non‐reducing end α‐l‐arabinofuranosidase (α‐l‐arabinofuranoside non‐reducing end α‐l‐arabinofuranosidase; EC 3.2.1.55). It is produced with the non‐genetically modified Aspergillus niger strain PEC by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in three food manufacturing processes. Subsequently, the applicant has requested to extend its use to include four additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed from the final foods in one food manufacturing process, the dietary exposure to the food enzyme–TOS was estimated only for the remaining six processes. The dietary exposure was calculated to be up to 0.612 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (204 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 333. Based on the previous evaluation, the assessment of the new data and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme carboxypeptidase C (EC 3.4.16.5) is produced with the genetically modified Aspergillus niger strain PEG by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in nine food manufacturing processes. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 2.053 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with a xylanase obtained from A. niger strain XEA. The Panel considered this food enzyme as a suitable substitute for the carboxypeptidase to be used in the toxicological studies, because both strains were derived from the same recipient strain, the location of the inserts was comparable, no partial inserts were present and the production methods were essentially the same. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1850 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 901. A homology search for the amino acid sequence of the food enzyme to known allergens was made and one match with a wheat allergen was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, especially in wheat‐allergic individuals, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non‐genetically modified Aspergillus tubingensis strain NL151 by Shin Nihon Chemical Co., Ltd. The food enzyme was free from viable cells of the production organism. It is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 0.278 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1669 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 6004. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The European Commission asked EFSA to update its 2012 risk assessment on brominated phenols and their derivatives in food, focusing on five bromophenols and one derivative: 2,4,6‐tribromophenol (2,4,6‐TBP), 2,4‐dibromophenol (2,4‐DBP), 4‐bromophenol (4‐BP), 2,6‐dibromophenol (2,6‐DBP), tetrabrominated bisphenol S (TBBPS), tetrabromobisphenol S bismethyl ether (TBBPS‐BME). Based on the overall evidence, the CONTAM Panel considered in vivo genotoxicity of 2,4,6‐TBP to be unlikely. Effects in liver and kidney were considered as the critical effects of 2,4,6‐tribromophenol (2,4,6‐TBP) in studies in rats. A BMDL10 of 353 mg/kg body weight (bw) per day for kidney papillary necrosis in male rats was identified and was selected as the reference point for the risk characterisation. The derivation of a health‐based guidance value was not considered appropriate due to major limitations in the toxicological database. Instead, the margin of exposure (MOE) approach was applied to assess possible health concerns. Around 78,200 analytical results for 2,4,6‐TBP in food were used to estimate dietary exposure for the European population. Considering the resulting MOE values, all far above an MOE of 6000 that does not raise a health concern, and accounting for the uncertainties affecting the exposure and hazard assessments, the CONTAM Panel concluded with at least 95% probability that the current dietary exposure to 2,4,6‐TBP does not raise a health concern. Due to lack of occurrence data, no risk assessment could be performed for breastfed or formula‐fed infants. No risk characterisation could be performed for any of the other brominated phenols and derivatives included in the assessment, due to lack of data both on the toxicity and occurrence. [ABSTRACT FROM AUTHOR]

The food enzyme endo‐1,3(4)‐β‐glucanase (3‐(1–3;1–4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Talaromyces versatilis strain PF8 by Erbslöh Geisenheim AG. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.110 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2229 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure resulted in a margin of exposure of at least 20,264. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory or contact allergens were found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme endonuclease (Aspergillus nuclease S1; EC 3.1.30.1) is produced with the non‐genetically modified Penicillium citrinum strain NP 11–15 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.006 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1010 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 168,333. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, especially for individuals allergic to Penicillium. However, the likelihood of such reactions will not exceed the likelihood of allergic reactions to Penicillium. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The European Commission (EC) asked EFSA to assess the genotoxicity of beauvericin (BEA). Relevant information, including that which has become available since the 2014 Scientific Opinion on the risks to human and animal health related to the presence of BEA and enniatins in food and feed, was reviewed. In the previous Opinion the Panel concluded that in vitro genotoxicity data were equivocal and there were no in vivo genotoxicity data available. New in vitro studies in mammalian cell lines provided no convincing evidence for induction of chromosomal damage by BEA as measured by micronucleus and chromosome aberration tests or an increase of DNA strand breaks as assessed by the Comet assay. In these studies, no concentration‐dependent effects or potential for interference from associated cytotoxicity were observed. In addition, DNA double‐strand breaks as measured by γ‐H2AX analysis were only observed following exposure to highly cytotoxic BEA concentrations. In vivo studies (Comet and Pig‐a assays, micronucleus test) with BEA were negative. In vitro gene expression studies showed no indication of a DNA damage response and (quantitative) structure activity relationship analysis was also not indicative of genotoxic potential. Some effects of BEA might play an indirect role in the formation of DNA strand breaks. These include increased reactive oxygen species, induction of cell cycle arrest and apoptosis, associated with interference in mitochondrial function and cell signalling. There was no compelling evidence of inflammatory and immunosuppressive effects. Taken together, the available data indicate that BEA is devoid of genotoxic potential. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of a preparation containing a smoke flavouring extract for cats and dogs. The applicant provided data demonstrating that the additive currently on the market does not fully comply with the conditions of authorisation, but with newly proposed specifications based on different analytical methods. Considering that the additive under assessment contains benzofuran and styrene, for which a potential concern for genotoxicity has been identified, and that the whole mixture raises a potential concern for genotoxicity, additional data would be needed to complete the assessment. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for cats and dogs. The additive is authorised for use in feed for cats and dogs, and therefore, there is no need to perform an assessment of the safety for the consumer and the environment. Regarding user safety, the additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to potential genotoxic substances may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lentilactobacillus buchneri DSM 32651 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. buchneri is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The additive is not an eye irritant. The FEEDAP Panel concluded that the additive consisting of L. buchneri DSM 32651 at a minimum concentration of 1 × 108 CFU/kg fresh material may extend the aerobic stability of silage prepared from fresh plant material with a DM range of 28%–45%. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l‐arginine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.401). The additive is intended to be used in feed and water for drinking for all animal species and categories. The genetic modifications introduced do not raise safety concerns. No viable cells or DNA of the production strain were detected in the final product. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not pose any safety concern with regard to the production strain. l‐Arginine produced with E. coli CGMCC 7.401 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed and water. The use of l‐arginine produced with E. coli CGMCC 7.401 in animal nutrition is considered safe for the consumers and for the environment. The endotoxin activity of the additive does not represent a hazard for persons handling the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The additive l‐arginine produced with E. coli CGMCC 7.401 is regarded as an efficacious source of the essential amino acid l‐arginine for non‐ruminant species. For supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lutein‐rich extract of Tagetes erecta L. as sensory additive (functional group: Colourants (ii) substances which, when fed to animals, add colours to food of animal origin) for turkeys for fattening. The additive is already authorised for use in feed for chickens for fattening and minor poultry for fattening and laying hens and minor poultry for laying. The FEEDAP Panel concluded that the use of lutein‐rich extract of T. erecta is safe for turkeys for fattening when used up to the maximum proposed use level of 80 mg total carotenoids/kg complete feed. The Panel concluded that the use of lutein‐rich extract of T. erecta in feed for turkeys for fattening under the proposed conditions of use would not be of concern for the consumer, considering also its use in other poultry for fattening and for laying hens. Regarding user safety, the lutein‐rich extract of T. erecta extract is irritant to skin and eyes and any exposure is considered a risk. The conclusions on user safety reached for the lutein‐rich extract of T. erecta would, in principle, apply to preparations made with it. The use of the additive in feed for turkeys for fattening under the proposed conditions of use is safe for the environment. The FEEDAP Panel concluded that the additive has the potential to colour the skin of turkeys for fattening at the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tea tree oil obtained from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long‐living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.5 mg/kg for turkeys for fattening, 1.7 mg/kg for laying hens, 2.0 mg/kg for piglets, 2.4 mg/kg for pigs for fattening, 3.1 mg/kg for sows, 5.0 mg/kg for veal calves (milk replacer) and salmonids, 4.4 mg/kg for cattle for fattening, sheep/goats and horses, 2.9 mg/kg for dairy cows, 1.8 mg/kg for rabbits, 0.9 mg/kg for cats, 5.3 mg/kg for dogs, 6.6 for crustaceans and 15 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to be of safety concern at 1.1 mg/kg complete feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. Regarding user safety, tea tree oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. It is classified as a reprotoxic substance (category 1B) following CLP criteria and should be handled accordingly. Since M. alternifolia and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product containing endo‐1,4‐β‐xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of Trichoderma reesei (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products. The Panel also concluded that ECONASE® XT is safe for pigs for fattening, laying hens and minor poultry species at the proposed conditions of use. The use of the additive raises no safety concerns for the consumers of products derived from animals fed with the additive or for the environment. The liquid and solid forms of ECONASE® XT are non‐irritant to the skin, but only the liquid forms were confirmed as non‐irritant to the eyes and not dermal sensitisers. The Panel could not conclude on the irritation potential to the eyes and the dermal sensitisation potential for the solid forms. Due to the proteinaceous nature of the active substance, the additive is considered to be a respiratory sensitiser. The additive has the potential to be efficacious in pigs for fattening at 20,000 BXU/kg complete feed, in all laying poultry species at 12,000 BXU/kg complete feed and in minor poultry species other than laying birds at 8000 BXU/kg complete feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐valine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 22721) as a nutritional additive for all animal species. The production strain and its DNA were not detected in the final additive. Therefore, the final product does not give raise to any safety concern regarding the genetic modification of the production strain. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that l‐valine produced using E. coli CGMCC 22721 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of l‐valine produced using E. coli CGMCC 22721 in animal nutrition is considered safe for the consumers and for the environment. The FEEDAP Panel cannot conclude on the potential of l‐valine produced using E. coli CGMCC 22721 to irritant to the skin or eyes, a dermal or respiratory sensitiser due to the lack of data. The endotoxin activity of the additive does not represent a hazard for users handling the additive when exposed by inhalation. The additive l‐valine produced by fermentation using E. coli CGMCC 22721 is regarded as an efficacious source of the essential amino acid l‐valine for non‐ruminant nutrition. For the supplemental l‐valine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of the feed additive consisting of 3‐phytase produced with a genetically modified strain of Komagataella phaffii (CECT 13171). The additive is intended to be used as a zootechnical additive for poultry species, pigs for fattening and minor porcine species for fattening. In a previous opinion, the EFSA Panel on Additives and Products or Substance used in Animal Feed (FEEDAP) Panel could not conclude on the taxonomic identification of the production strain. Moreover, the presence of viable cells of the production strain in the final formulations of the product could not be excluded. Therefore, no conclusions could be drawn on the safety for the target species, consumers, users and environment. In the present submission, the applicant provided supplementary information regarding the characterisation of the production strain and the absence of its viable cells in the final product. Based on the data provided, the identification of CECT 13171 as K. phaffii was confirmed and no viable cells of the production strain were detected in the final formulations of the additive. The FEEDAP Panel concluded that the 3‐phytase produced with the genetically modified strain K. phaffii CECT 13171 does not give rise to any safety concern as regard to the production strain. Consequently, the additive, in both its liquid and solid formulations, is safe for the target species, consumers, users and environment. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a Camellia oleifera C.Abel seed extract (Cosap®) as technological feed additive for all animal species except fin fish. In the absence of adequate tolerance studies in the target species or toxicological studies with the additive under assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of C. oleifera extract for the target species. The use of the additive in animal nutrition is not expected to cause concern for consumer safety. The additive is considered as irritant to the eyes and mucous membranes. No conclusions can be reached on the potential of the additive to be irritant to the skin or to be a dermal sensitiser. The use of the additive under the proposed conditions of use is considered safe for the terrestrial compartment. However, no conclusion can be reached on the safety of the additive for the environment when used in feed of aquatic animals other than fin fish. The Panel concluded that the additive has the potential to be efficacious as an emulsifier when used according to proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of fumaric acid as a technological and sensory additive (functional groups: preservative and flavouring compounds, respectively) and for a new use of the additive as a technological additive (functional group: acidity regulator) for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that fumaric acid remains safe under the authorised conditions of use for the terrestrial animals, consumers and the environment. However, the Panel cannot conclude on the safety for the aquatic animals under all authorised condition of use. Fumaric acid is irritant to skin, eyes and respiratory tract, and should be considered a skin and respiratory sensitiser due to the presence of nickel. The Panel also considers that the new use of the additive as an acidity regulator under proposed conditions of use would not introduce risks not already considered. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation (for its use as preservative and flavouring compound). The Panel is not in the position to conclude on the efficacy of fumaric acid as an acidity regulator in feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the flowering tops of Thymbra capitata (L.) Cav. (Spanish type origanum oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for poultry species, 30 mg/kg for pigs and horses, 20 mg/kg for ruminants, 25 mg/kg for rabbits, dogs, cats and ornamental fish, and 125 mg/kg for salmonids. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 15 mg/kg complete feed. 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. The use of the additive in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since T. capitata and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Spanish sage oil from the leaves of Salvia officinalis ssp. lavandulifolia (Vahl) Gams (Spanish sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level of 14 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use of Spanish sage oil 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. The use of Spanish sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the leaves of S. officinalis ssp. lavandulifolia (Vahl) Gams is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

The food enzyme, a triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3), is produced with the non‐genetically modified Limtongozyma cylindracea strain AE‐LAYH (B) by Amano Enzyme Inc. It is intended to be used in six food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.315 mg TOS/kg body weight (bw) per day in European populations. As the production strain qualifies for the quality presumption of safety (QPS) approach of safety assessment and no issue of concern arising from the production process of the food enzyme were identified, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A homology search for the amino acid sequence of the food enzyme to those of known allergens was made and one match with a honeybee venom allergen was found. The Panel considered that a risk of allergic reactions by dietary exposure, particularly in individuals allergic to honey, cannot be excluded, but is considered to be low. Based on the data provided, the QPS status of the production strain and the absence of issues of concern arising from the food enzyme manufacturing process, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Bacillus subtilis strain RTI477 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. subtilis strain RTI477 as a fungicide for the control of soil‐borne diseases in greenhouses (permanent) and walk‐in tunnels and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance Bacillus velezensis strain RTI301 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. velezensis strain RTI301 as a fungicide for the control of soil‐borne diseases in greenhouses (permanent) and walk‐in tunnels (non‐permanent) and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Spain for the pesticide active substance bensulfuron‐methyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of bensulfuron‐methyl as an herbicide on rice and spring cereals (spring wheat, spring barley, oat, rye, triticale). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of curdlan as a new food additive used as firming and gelling agent, stabiliser, thickener. Curdlan is a high molecular weight polysaccharide consisting of β‐1,3‐linked glucose units, produced by fermentation from Rhizobium radiobacter biovar 1 strain NTK‐u. The toxicological dataset consisted of sub‐chronic, chronic and carcinogenicity, reproductive and developmental toxicity studies as well as genotoxicity. In vivo data showed that curdlan is not absorbed as such but is extensively metabolised by the gut microbiota into CO2 and other innocuous compounds. Curdlan was not genotoxic and was well‐tolerated with no overt organ‐specific toxicity. Effects observed at very high doses of curdlan, such as decreased growth and increased cecum weight, are common for indigestible bulking compounds and therefore considered physiological responses. In a combined three‐generation reproductive and developmental toxicity study, decreased pup weight was observed during lactation at 7500 mg curdlan/kg body weight (bw) per day, the highest dose tested. The Panel considered the observed effects as treatment‐related and adverse, although likely secondary to nutritional imbalance and identified a conservative no observed adverse effect level (NOAEL) of 2500 mg/kg bw per day. Despite the limitations noted in the dataset, the Panel was able to conclude applying the margin of exposure (MOE) approach. Given that curdlan and its break‐down products are not absorbed and that the identified adverse effect is neither systemic nor local, no adjustment factor was deemed necessary. Thus, an MOE of at least 1 was considered sufficient. The highest exposure estimate was 1441 mg/kg bw per day in toddlers at the 95th percentile of the proposed maximum use level exposure assessment scenario. The Panel concluded that there is no safety concern for the use of curdlan as a food additive at the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

In accordance with the EFSA Strategy 2027 outlining the need for fit‐for‐purpose protocols for EFSA generic scientific assessments, the EFSA Panel on Plant Health (PLH Panel) developed standard protocols to harmonise the problem formulation process and outputs for mandates addressing recurrent scientific questions. Three types of recurring EFSA plant health mandates require generic scientific assessments: (i) pest categorisation; (ii) commodity risk assessment for the purpose of derogation to provisions of the EU plant health law and (iii) quantitative pest risk assessment. The three standard protocols are tailored to the appropriate level of detail and build on the existing guidance documents laying out the methods for conducting risk assessment in the plant health domain. To develop a standard protocol for pest categorisation, the PLH Panel adapted the latest version of the standard template reporting the evidence needs and the assessment questions to conclude whether a pest fulfils the criteria for being considered a potential quarantine pest for the EU. To develop a standard protocol for commodity risk assessment, the PLH Panel adapted the procedure and standard templates used for commodity risk assessment of high risk plants. To develop a standard protocol for quantitative pest risk assessments (qPRA), the Panel reviewed the existing guidance document on qPRA and the qPRAs published by the PLH Panel. The hierarchy of assessment questions and sub‐questions used were identified and extracted. Based on this, a hierarchically organised IT‐tool was formulated as protocol for the planning and documentation of future qPRAs. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Finland, and co‐rapporteur Member State, Croatia, for the pesticide active substance amidosulfuron and the assessment of confirmatory data following the Article 12 MRL review are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of amidosulfuron as a post‐emergence herbicide on winter cereals, spring cereals, flax and grass/pasture (all field uses). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified. [ABSTRACT FROM AUTHOR]

The European Commission requested EFSA to update the scientific guidance for the preparation of notifications for authorisation of traditional foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by applicants when submitting traditional food notifications pursuant to Article 14 and traditional food applications pursuant to Article 16 of Regulation (EU) 2015/2283. The safety of a traditional food should be substantiated by data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Potential health hazards identified on the basis of compositional data and/or data from the experience of continued use should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food. Furthermore, information needed in sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, toxicological information, nutritional information and allergenicity is also described. The applicant should integrate and interpret the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they are to be discussed in relation to the anticipated intake of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Plant Health performed a group pest categorisation for the EU territory of non‐EU Scolytinae (Coleoptera: Curculionidae) on non‐coniferous hosts, which total 6495 known species. Most species attack apparently healthy, weakened or dead trees, either feeding on the phloem ('bark beetles' subgroup) or on fungi inoculated into the sapwood ('ambrosia beetles' subgroup). Smaller subgroups feed and reproduce in seeds and fruits, or in herbaceous plants. Some species are polygynous, the males initiate a gallery or a chamber on or in a new host and attract females. Others are monogamous, and the females initiate the new galleries. Many species respond to primary volatile attractants emitted by the hosts, and some produce aggregation pheromones that attract conspecifics of both sexes. The species attacking living hosts are often associated with fungi that contribute to weakening the host defences and provide nutrients to the insects. Some are inbreeding; the males in the offspring mate with their sisters and rarely leave their natal tree. The larvae of all species develop and pupate within their hosts. Based on catalogues and other published data, a database was constructed providing information on hosts, feeding and reproductive habits, geographic distribution and the Köppen–Geiger climate types in countries where species occur. The Scolytinae were screened to exclude species in the following categories: (i) 708 species attacking conifers; (ii) 127 species present in at least four EU Member States and (iii) 440 species occurring in areas with climatic conditions not occurring in the EU. Among the remaining 5220 species, 88 species known for their mobility, occupying at least two landmasses separated by geographical barriers and some of which had impact levels documented in literature, were extracted. They were grouped into four subcategories: (i) 12 species with high impact on plant health; (ii) 16 species with low or doubtful impact; (iii) 48 species with no impact; (iv) 12 species with no impact and which had never been recorded as 'introduced' in the consulted catalogues but occurring on at least two landmasses. All 88 species could enter the EU with wood or wood products, or with plants for planting, and could establish because host plants are available, and climate is suitable in parts of the EU. Control measures to inhibit introduction are available. There is considerable uncertainty regarding the potential impact of many species. Methods for the reliable identification of many species are lacking. For some species of non‐EU Scolytinae on non‐coniferous hosts, all criteria assessed by EFSA for consideration as potential quarantine pest are met. Nevertheless, the Panel was not able to develop a method to discriminate confidently between species that clearly meet the criteria for potential quarantine pest status and those that do not. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactococcus lactis NCIMB 30117 as a technological additive for use in forage for all animal species. The additive aims to improve the production of silage and is authorised for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered as a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation, and eye and skin irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) NCIMB 30236 as a technological additive for use in forage for all animal species. The additive aims at improving the production of silage and is currently authorised for all animal species. The applicant provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered a skin and respiratory sensitiser. No conclusions can be drawn on the eye and skin irritancy potential of the additive. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance difenoconazole. To assess the occurrence of difenoconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Council Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the European Food Safety Authority (EFSA) assessed the 2022 post‐market environmental monitoring (PMEM) report on the cultivation of Cry1Ab‐expressing maize event MON 810. Overall, the 2022 PMEM report provides no evidence of adverse effects of maize MON 810 cultivation. It shows a high level of compliance with refuge requirements by Spanish and Portuguese farmers growing maize MON 810, but uncertainty remains on compliance in areas where the clustered surface of maize MON 810 farms exceeds 5 ha. There are no signs of practical resistance to Cry1Ab in the field in corn borer populations collected in north‐eastern Spain in 2022, although a decrease in Cry1Ab susceptibility in Mediterranean corn borer populations from this area cannot be excluded. Information retrieved through farmer questionnaires in Spain and from the scientific literature reveals no unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. Uncertainties remain on whether 'very highly' and 'extremely' sensitive non‐target lepidoptera are potentially exposed to harmful amounts of MON 810 pollen. EFSA notes that several recommendations made in the frame of the assessment of previous PMEM reports remain unaddressed and identified additional shortcomings in the 2022 PMEM report that require further consideration by the consent holder in future annual PMEM reports. Particularly, EFSA emphasises the urgent need to increase the sensitivity of the insect resistance monitoring strategy and implement mitigation measures to ensure that the exposure of non‐target lepidoptera to maize MON 810 pollen is reduced to levels of no concern. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance 1‐methylcyclopropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council for an amendment in approval conditions. The current approval of 1‐methylcyclopropene includes the specific provision 'Only uses as plant growth regulator for post‐harvest storage in sealable warehouse may be authorised'. The applicant AgroFresh Holding France SAS submitted, in accordance with Article 7 of Reg. (EC) 1107/2009, an application to remove this specific provision in order to allow member states to authorise the use of products containing 1‐methylcyclopropene on outdoor crops pre‐harvest. The conclusions were reached on the basis of the evaluation of the representative use(s) of 1‐methylcyclopropene as a plant growth regulator via spray application on pome fruit. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials (FCM) assessed the safety of the substances 'wax, rice bran, oxidised' and 'wax, rice bran, oxidised, calcium salt', used as additives up to 0.3% in polyethylene terephthalate (PET), polyamide (PA), thermoplastic polyurethane (TPU), polylactic acid (PLA) and poly(vinyl chloride) (PVC) in contact with all food types for long‐term storage at room temperature and below, after hot‐fill and/or heating. The substances consist of the chemical classes wax esters, carboxylic acids, alcohols and calcium salts of acids, along with an unidentified organic fraction up to ■■■■■ w/w. Migration into 10% ethanol and 4% acetic acid was below 0.012 mg/kg for each chemical class, and about 0.001 mg/kg for the unidentified fraction. In isooctane, migration was up to 0.297 mg/kg food for wax esters, below 0.01 mg/kg food for the other chemical classes and about 0.02 mg/kg food for the unidentified fraction. The contact with dry food and food simulated by 20% ethanol were considered covered by the migration tests with aqueous simulants. Based on genotoxicity assays and compositional analyses, the constituents of the chemical classes did not raise a concern for genotoxicity. The potential migration of individual constituents or groups of chemically‐related compounds of the unidentified fraction would result in exposures below (for aqueous food) and above (for fatty food) the threshold of toxicological concern for genotoxic carcinogens. Therefore, the FCM Panel concluded that the substances are not of safety concern for the consumer, if used as additives up to 0.3% w/w in PET, PLA and rigid PVC materials and articles intended for contact with all food types except for fatty foods, for long‐term storage at room temperature and below, including hot‐fill and/or heating up to 100°C for up to 2 h. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the tolerable upper intake level (UL) for vitamin E. As α‐tocopherol is recognised as the only essential form of vitamin E, the Panel restricted its evaluation to α‐tocopherol. Systematic reviews of the literature were conducted to assess evidence on priority adverse health effects of excess intake of vitamin E, namely risk of impaired coagulation and bleeding, cardiovascular disease and prostate cancer. The effect on blood clotting and associated increased risk of bleeding is considered as the critical effect to establish an UL for vitamin E. No new evidence has been published that could improve the characterisation of a dose–response. The ULs for vitamin E from all dietary sources, which were previously established by the Scientific Committee on Food, are retained for all population groups, i.e. 300 mg/day for adults, including pregnant and lactating women, 100 mg/day for children aged 1–3 years, 120 mg/day for 4–6 years, 160 mg/day for 7–10 years, 220 mg/day for 11–14 years and 260 mg/day for 15–17 years. A UL of 50 mg/day is established for infants aged 4–6 months and a UL of 60 mg/day for infants aged 7–11 months. ULs apply to all stereoisomeric forms of α‐tocopherol. ULs do not apply to individuals receiving anticoagulant or antiplatelet medications (e.g. aspirin), to patients on secondary prevention for CVD or to patients with vitamin K malabsorption syndromes. It is unlikely that the ULs for vitamin E are exceeded in European populations, except for regular users of food supplements containing high doses of vitamin E. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application of renewal of Levilactobacillus brevis DSM 16680 as a technological feed additive (functional group: silage additives) for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers and the environment. Regarding user safety, the additive should be considered as an eye irritant and a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Lietpak (EU register number RECYC327), which uses the EREMA MPR technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are heated in a ■■■■■ reactor under vacuum. Having examined the challenge test provided, the Panel concluded that the ■■■■■ decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 μg/kg food, derived from the exposure scenario for infants, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on glucosyl hesperidin (GH) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, which is produced from hesperidin and dextrin by enzymatic reactions, is a powder consisting mainly of monoglucosyl hesperidin (MGH) and unreacted hesperidin (flavonoid), which account in total for up to 92.8% (on dry basis) of the product. The applicant proposed to use the NF in specific drinks and food supplements leading to a maximum intake of up to 364 mg per day for adults. The target population is the general population, except for food supplements for which the proposed target population is children from 1 year onwards and adults. Taking into consideration the composition of the NF and the proposed uses, the consumption of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90‐day oral toxicity study conducted with the NF, the Panel considers the NOAEL at the mid‐dose group, i.e. ~ 1000 mg/kg body weight (bw) per day. By applying an uncertainty factor of 200, the resulting intake providing sufficient margin of exposure for humans would be 5 mg/kg bw per day. The available human intervention studies did not report clinically relevant changes in haematological or clinical chemistry parameters following the administration of GH/MGH at supplemental doses of up to 3 g/day for 12 weeks. Overall, the Panel considers that the margin of exposure (~ 200) between the intake of the NF at the proposed uses and use levels and the NOAEL from the 90‐day study is sufficient. The Panel concludes that the NF, glucosyl hesperidin, is safe for the target population at the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of diclazuril (Clinacox® 0.5%) as a coccidiostat for chickens for fattening and chickens reared for laying. The additive currently on the market complies with the existing conditions of authorisation. The additive remains safe for the target species and the consumer under the authorised conditions of use. The additive is irritant to skin, eyes and respiratory tract but is not a skin sensitiser. Exposure by inhalation cannot be excluded. The FEEDAP Panel cannot conclude on the safety for the environment of diclazuril from Clinacox® 0.5% due to lack of data. Diclazuril from Clinacox® 0.5% at a concentration of 1 mg diclazuril/kg complete feed has the potential to control coccidiosis in chickens for fattening. This conclusion is extended to chickens reared for laying. Development of resistance to diclazuril of field Eimeria spp. strains isolated from chickens should be monitored. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Additives and Flavourings was requested to evaluate 14 flavouring substances assigned to the Flavouring Group Evaluation 80 (FGE.80), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Thirteen substances have already been considered in FGE.80 and its revision and in FGE.96 [FL‐no: 10.005, 10.024, 10.025, 10.050, 10.061, 10.069, 10.070, 10.072, 10.169, 13.009, 13.012, 13.161 and 16.055]. The remaining flavouring substance 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057] has been cleared with respect to genotoxicity in FGE.217Rev3 and it is considered in this revision 2 of FGE.80. The substance [FL‐no: 10.057] was evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, threshold of toxicological concern (TTC) and available data on metabolism and toxicity. The Panel concluded that [FL‐no: 10.057] does not give rise to safety concerns at its levels of dietary intake, when estimated on the basis of the 'Maximised Survey‐derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered and the information provided was complete for [FL‐no: 10.057]. However, for the flavouring substance [FL‐no: 10.057] in the present revision and for eight substances evaluated in previous revisions, the 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) values are above the TTC for their structural class (III). For four substances previously evaluated in FGE.80Rev1 and in FGE.96, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 13 flavouring substances, data on uses and use levels should be provided to finalise their safety evaluations. For [FL‐no: 10.050, 10.069 and 13.161], information on the composition of stereoisomeric mixtures is needed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the feed additive consisting of endo‐1,4‐beta‐xylanase (produced with Trichoderma reesei MUCL 49755) and endo‐1,3(4)‐beta‐glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) for the renewal of its authorisation as zootechnical feed additive for pigs for fattening, minor porcine species for fattening and turkeys for fattening. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive Avemix® XG 10 with calcium carbonate + wheat flour and Avemix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) noted that no data were submitted to support compliance of the formulation of Avemix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both forms of the additive remain safe for pigs for fattening, minor porcine species for fattening and turkeys for fattening, consumers and the environment. Regarding the safety for the user, Avemix® XG 10 formulated with calcium carbonate + sepiolite and Avemix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of Avemix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in all its formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Bacillus licheniformis strain DSM 34099 by Kerry Group Services International, Ltd. (KGSI). The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in two food manufacturing processes. Dietary exposure was estimated to be up to 7.263 mg total organic solids/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests, other than an assessment of allergenicity, were considered unnecessary by the Panel. A search for the identity of the amino acid sequence of the food enzyme to known allergens was made and one match with a food allergen from kiwi fruit was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to kiwi fruit, cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Saccharomyces cerevisiae strain LALL‐MA+ by Danstar Ferment AG. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the processing of cereals and other grains for production of baked products. Dietary exposure was estimated to be up to 0.014 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the identity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found, three with respiratory allergens and one with an allergen from mosquito (injected). The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

Microorganisms, genetically modified or not, may be used in the food chain either as active agents, biomasses or as production organisms of substances of interest. The placement of such microorganisms or their derived substances/products in the European market may be subject to a premarket authorisation process. The authorisation process requires a risk assessment in order to establish the safety and/or the efficacy of the microorganism(s) when used in the food chain as such, as biomasses or as production strains. This includes a full molecular characterisation of the microorganism(s) under assessment. For certain regulated products, the use of whole genome sequence (WGS) data of the microorganism is established as a requirement for the risk assessment. In this regard, data obtained from WGS analysis can provide information on the unambiguous taxonomic identification of the strains, on the presence of genes of concern (e.g. those encoding virulence factors, resistance to antimicrobials of clinical relevance for humans and animals, production of harmful metabolites or of clinically relevant antimicrobials) and on the characterisation of genetic modification(s) (where relevant). This document provides recommendations to applicants on how to describe and report the results of WGS analyses in the context of an application for market authorisation of a regulated product. Indications are given on how to perform genome sequencing and the quality criteria/thresholds that should be reached, as well as the data and relevant information that need to be reported, if required. This updated document replaces the EFSA 2021 Statement and reflects the current knowledge in technologies and methodologies to be used to generate and analyse WGS data for the risk assessment of microorganisms. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Poland and co‐rapporteur Member State Hungary for the pesticide active substance triclopyr (variant triclopyr‐butotyl) and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of triclopyr (variant triclopyr‐butotyl) as a herbicide on established pasture and non‐recreational amenity grassland (field use). MRLs were assessed in rice. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Loigolactobacillus coryniformis DSM 34345 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with all fresh plant material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. coryniformis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the FEEDAP Panel concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive containing Loigolactobacillus coryniformis DSM 34345 should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. One preparation was shown not to be irritant to skin or eyes. However, the Panel cannot assess the irritation potential of other possible preparations. The FEEDAP Panel concluded that Loigolactobacillus coryniformis DSM 34345 has the potential to improve the production of silages prepared from all fresh plant materials at a minimum concentration of 1 × 108 CFU/kg fresh material. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Belgium, and co‐rapporteur Member State, Austria, for the pesticide active substance lenacil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of lenacil as a herbicide on sugar and fodder beet (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified. [ABSTRACT FROM AUTHOR]