Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of carvacrol, cinnamaldehyde and capsicum oleoresin (XTRACT EVOLUTION‐B, CODE X60‐6930) (4d11) as a zootechnical feed additive for chickens for fattening for the renewal of its authorisation. The applicant provided evidence that the additive currently in the market complies with the conditions of the existing authorisation and that the production process has not been modified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for the target species, consumers and the environment. Regarding user safety, the additive should be considered a skin, eye and respiratory tract irritant and a skin sensitiser. Exposure of users by any route is considered a risk. The present application for renewal of the authorisation does not include any proposed modification that would have an impact on the efficacy of the additive, and therefore, there is no need to re‐assess the efficacy of the additive.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation containing alpha‐galactosidase (EC 3.2.1.22) and endo‐1,4‐beta‐xylanase (EC 3.2.1.8) (Capsozyme SB Plus) as a zootechnical feed additive (functional group: digestibility enhancers). The additive is already authorised for use in feed for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying and ornamental birds. The applicant is seeking an extension of use to turkeys for fattening and reared for breeding at the minimum inclusion level of 14 alpha‐galactosidase activity units (GALU) and 18 endo‐1,4‐beta‐xylanase activity units (AXC) per kg of complete feed and a maximum inclusion level of 20 GALU and 25 AXC units per kg of complete feed. Based on the results observed in a tolerance trial in chickens for fattening that had been previously evaluated, the FEEDAP Panel concluded that Capsozyme SB Plus is safe for turkeys for fattening and reared for breeding at the maximum recommended level of 20 GALU and 25 AXC units per kg complete feed. The use of the feed additive in turkeys for fattening and reared for breeding under the proposed conditions of use is considered safe for consumers and the environment. Regarding safety for the user, Capsozyme SB Plus is considered a respiratory sensitiser and exposure by inhalation is considered a risk. No conclusions could be reached on the potential of the additive to be irritant to the skin or eyes or a skin sensitiser. Capsozyme SB Plus is considered to be efficacious in turkeys for fattening and reared for laying at the proposed minimum use level of 14 GALU and 18 AXC units per kg complete feed.

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 the safety of the Novel Food (NF) ‘algal meal from Haematococcus (H.) pluvialis containing astaxanthin (ATX)’ pursuant to Regulation (EU) 2015/2283. The NF is produced by homogenising, crushing and spray‐drying of the biomass of cultivated H. pluvialis and contains approximately 5% w/w ATX. It has been marketed in food supplements (FS) since the 90s. With the present dossier, the applicant seeks authorisation as a NF for its use in dairy analogues, including beverage whiteners and fruit juices as defined by Directive 2001/112/EC. The NF has been already assessed by the Panel in 2014. The applicant performed an intake assessment for ATX, which covered combined exposure from the background diet with the consumption of fish and crustacea plus intakes of the NF from the intended new uses. In such a scenario, the exposure for all population groups is below or at the acceptable daily intake (ADI) of 0.2 mg/kg bw per day. When adding also potential intake of ATX from FS, for children of 3 years of age and older and adolescents, the combined exposure from all three sources exceeds the ADI. For adults, the combined estimated intake is at the level of the ADI. The Panel concludes that the NF is safe at the intended new uses (dairy analogues, including beverage whiteners and fruit juices), provided that FS containing ATX are not consumed on the same day by children and adolescents.

Genetically modified maize DP202216 × NK603 × DAS 40278‐9 was developed by crossing to combine three single events: DP202216, NK603 and DAS‐40278‐9. The three‐event stack maize expresses PAT, CP4 EPSPS, CP4 EPSPS L124P, AAD‐1 and the maize endogenous protein with altered expression (EPAE) ZMM28 to confer herbicide tolerance and to provide the potential for yield enhancement (PYE) under field conditions. The GMO Panel previously assessed the three single maize events and one of the sub‐combinations and did not identify safety concerns. No new data on the single maize events or the assessed sub‐combination were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins and the EPAE in the three‐event stack maize does not give rise to food and feed safety or nutritional concerns. The GMO Panel concludes that three‐event stack maize, as described in this application, is as safe as the non‐GM comparator and non‐GM reference varieties tested and no post‐market monitoring of food/feed is considered necessary. In the case of the release of processed maize DP202216 × NK603 × DAS 40278‐9 or accidental spillage of viable GM maize grains, into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in two of the maize sub‐combinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed sub‐combination and the three‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216 × NK603 × DAS 40278‐9. The GMO Panel concludes that this three‐event stack maize and its sub‐combinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Anthropogenic activities, such as industrial processes, urban development, intensive agriculture and waste disposal, have significantly contributed to the continuous introduction and accumulation of a wide array of xenobiotic compounds into natural ecosystems. Among them, emerging contaminants (ECs) such as pharmaceuticals, endocrine‐disrupting chemicals (EDCs), and per‐ and polyfluoroalkyl substances (PFAS) are of increasing concern due to their persistence, bioactivity and limited regulation. ECs enter ecosystems through diverse pathways including wastewater discharge, agricultural runoff and atmospheric deposition. Once released, many of these xenobiotics can bioaccumulate in organisms and enter the food chain, posing serious risks to food safety and public health. Traditional physico‐chemical remediation methods are often insufficient or environmentally taxing, prompting a shift toward bio‐based alternatives like bioremediation. These approaches, which rely on the activity of microbial communities to degrade pollutants, offer more sustainable solutions but require further interdisciplinary research to optimise their use. The One Health framework provides an effective model for addressing the complex risks posed by xenobiotics. This research programme aims to harmonise methodologies for cumulative dietary risk assessment across Europe and explore microbial strategies for xenobiotic degradation. By integrating microbiomics, toxicology, environmental science and food safety, this approach supports the development of safer food systems and more effective pollution management in line with the ‘farm to fork’ and One Health principles.

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 the extension of use of galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from milk‐derived lactose using β‐galactosidases. The applicant proposed to extend the use of GOS to several food categories (non‐alcoholic beverages, confectionery, chewing gum, cocoa and chocolate‐based products and protein products). The target population is the general population. GOS is already authorised and included in the Union list of NFs for use in several foods, including infant formula, and in food supplements. The Panel estimated that the proposed extension of use would result in a highest 95th percentile intake of GOS from all food uses, of up to 48.5 g/day in adults. As compared to the exposure to GOS from the currently authorised food uses (at the highest P95), the proposed extension of use is expected to result in an increase in intake of GOS of up to 17%. The information provided on the proposed use levels and anticipated intake does not raise safety concerns. The Panel concludes that the proposed extension of use of GOS is safe under the proposed conditions of use.

Abstract Application EFSA‐GMO‐DE‐2019‐157 (oilseed rape LBFLFK) was submitted to EFSA to be risk assessed as full‐scope, i.e. for import, processing, and food and feed uses, within the EU. Oilseed rape LBFLFK was developed to alter its fatty acid profile and to confer tolerance to imidazolinone herbicides. Oilseed rape LBFLFK contains two inserts, not genetically linked, each consisting of a single copy of the T‐DNA, which contains 13 expression cassettes (coding for 11 unique proteins). The Panel on Genetically Modified Organisms (GMO Panel) was unable to conclude on the safety of oilseed rape LBFLFK when considering the full‐scope of this application. The safety of the elongases and desaturases newly expressed in oilseed rape LBFLFK cannot be established. Similarly, the safety and nutritional adequacy of the oil and full‐fat seeds derived from oilseed rape LBFLFK for its use in terrestrial farmed and companion animals and in aquaculture cannot be established. However, the GMO Panel concludes that the consumption of refined, bleached and deodorised (RBD) oil from oilseed rape LBFLFK is safe and does not represent any nutritional concern in humans under the conditions of use proposed by the applicant. Considering the potential safety concerns, LBFLFK oil should not be used for high‐temperature applications. Post‐market monitoring is appropriate to confirm the expected consumption and the application of conditions of uses in humans. Furthermore, the GMO Panel did not identify any environmental concerns related to increased persistence and invasiveness or to any potential for gene transfer from oilseed rape LBFLFK, and concludes that it poses no risks for terrestrial non‐target organisms (NTOs) or biogeochemical cycles in this environment. The GMO Panel cannot conclude on the safety of oilseed rape LBFLFK to NTOs or biogeochemical cycles in the aquatic environment. Based on this, the GMO Panel is unable to conclude on the adequacy of the post‐market environmental monitoring plan proposed by the applicant.

ABSTRACTThe food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan glucohydrolase; EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐DM by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 3.430 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 1070 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 312. A search for the homology of the amino acid sequence of the glucan 1,4‐α‐glucosidase to known allergens was made and a match with one respiratory allergen was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of 6‐phytase produced by the genetically modified strain Aspergillus oryzae DSM 33737 (HiPhorius™) as a zootechnical feed additive for all poultry, all porcine species and all fin fish. In a previous opinion, the FEEDAP Panel concluded that the additive is safe for the target species, consumers and the environment. The Panel also concluded that the additive is not a skin and eye irritant but should be considered as skin and respiratory sensitiser. The Panel concluded that the additive had the potential to be efficacious as a zootechnical additive when included in the diet of poultry for fattening or reared for laying/breeding, reproductive porcine species and all fin fish. However, due to the lack of sufficient data, the Panel was not in the position to conclude on the efficacy for laying and reproductive poultry and growing porcine species. The applicant provided new trials to support the efficacy of the additive in those target species. Based on the data provided in the previous and current applications, the Panel concluded that the additive has the potential to be efficacious in all poultry and all porcine species.