Lieve Herman’s research while affiliated with EFSA European Food Safety Authority and other places

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐arginine produced with a genetically modified strain of Corynebacterium glutamicum (KCCM 80393) when used as a nutritional additive in feed and water for drinking for all animal species and categories. The Panel concluded that the product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. No DNA of the production strain was detected in the final product. l‐Arginine produced by fermentation with C. glutamicum KCCM 80393 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 l‐arginine in water for drinking. The use of l‐arginine produced by fermentation with C. glutamicum KCCM 80393 in animal nutrition is considered safe for the consumers and for the environment. Regarding the user safety, 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 by fermentation with C. glutamicum KCCM 80393 is regarded as an efficacious source of the essential amino acid l‐arginine for non‐ruminant nutrition. For the supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of the proposed amendment of the EU specifications of Rebaudioside M produced via enzyme‐catalysed bioconversion (E960c(i) or E 960c(ii)), to include a different microorganism strain in the definition. Rebaudioside M is produced via enzymatic bioconversion from Stevia leaf extract, using the genetically modified yeast strain K. phaffii CGMCC 7539. The final product is composed mostly of rebaudioside M (> 97%) and a mixture of rebaudiosides A, B and D at various concentrations. The Panel considered that the proposed amendment of the specifications is justified with respect to the inclusion of a new microorganism strain, taking into account that the manufacturing process and the submitted analytical data are already covered by the parameters listed in the existing EU specifications for E 960c(i) and E 960c(ii). The Panel considered that it is in the remit of the risk managers to decide whether the proposed changes in the specifications should result in an amendment of the already existing EU specifications of E960c(i) or E960c(ii). Viable cells and DNA from the production strain are not present in the final product; hence, the manufacturing process does not raise a safety concern. The Panel considered that the proposed food additive has the same physicochemical characteristics of E 960c(i) or E 960c(ii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of Rebaudioside M produced from K. phaffii CGMCC 7539. The Panel concluded that there is no safety concern with respect to the proposed amendment to the EU specifications of E 960c(i) or E 960c(ii) related to the use of the new genetically modified strain K. phaffii CGMCC 7539 in the manufacturing process of the food additive Rebaudioside M produced via enzyme‐catalysed bioconversion.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of xylanase (produced with Komagataella phaffii DSM 25376) and β‐glucanase (produced with Komagataella phaffii DSM 26469) (ENZY CARBOPLUS®) 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, turkeys for fattening and all avian species reared for laying or breeding purposes. The applicant requested a modification of the terms of the current authorisation for chickens for fattening and reared for laying, as well as an extension of use to all poultry. The FEEDAP Panel concluded that the additive is safe for all poultry. The use of the additive is considered safe for the consumers and the environment. The FEEDAP Panel concluded that the additive is not a skin or eye irritant nor a dermal sensitiser, but it is considered a respiratory sensitiser. The Panel concluded that the additive has the potential to be efficacious as a zootechnical additive for all poultry under the proposed conditions of use.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 32324, B. subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit 10) as a zootechnical feed additive for all poultry species. The additive in a less concentrated form (GalliPro® Fit) is already authorised for use in feed and water for drinking for poultry for fattening, reared for laying or reared for breeding. With the current application, the applicant is seeking the authorisation for use in feed and water for drinking for all poultry. In addition, the applicant is seeking the modification of the terms of the existing authorisation by introducing a new formulation with a 10‐fold increased concentration of the active agents in the additive (from 3.2 × 10⁹ to 3.2 × 10¹⁰ colony forming units (CFU)/g additive). The FEEDAP Panel concluded that the additive is considered safe for the target species, including poultry species for laying and breeding, consumers and the environment at the proposed conditions of use. Both forms of the additive are non‐irritant to the eyes but are considered skin and respiratory sensitisers, and any exposure through skin and respiratory tract is considered a risk. The additive has the potential to be efficacious as a zootechnical additive in all poultry at 1.6 × 10⁹ CFU/kg feed and 5.4 × 10⁸ CFU/L water for drinking.

An alternative processing method for the production of renewable fuels from rendered animal fats, pretreated using standard processing methods 1–5 or method 7 and used cooking oils, derived from Category 3 animal by‐products, was assessed. The alternative method is based on a fluidised catalytic cracking co‐processing treatment with a preheat stage by at least 145°C and a pressure of at least 1.4 barg for at least 13 s, followed by a reactor stage by at least 500°C for 2 s. The applicant selected the use of spores of pathogenic bacteria as primary indicators without carrying out a full hazard identification, which is acceptable as per previous EFSA evaluations. The EFSA BIOHAZ Panel considers that the application and supporting literature contain sufficient evidence to support that the alternative method can achieve a reduction of at least 12 log10 of C. botulinum spores and 5 log10 of the spores of other pathogenic bacteria. The Hazard Analysis and Critical Control Point plan contained some inadequacies: the reception of raw materials should be considered a prerequisite (with acceptance criteria) rather than a critical control point and quantitative limits for temperature and holding time at the reactor should be defined. The information provided by the applicant suggests that appropriate corrective actions are in place for dealing with risks associated with interdependent processes and with the intended end use of the products. The applicant also considers as part of the alternative processing method the operation under an unplanned shutdown. EFSA only assesses the alternative processing methods under normal operating conditions. Thus, the procedures under an unplanned shutdown were not assessed as part of the alternative processing method. Overall, the alternative method under evaluation is considered equivalent to the processing methods currently approved in the Commission Regulation (EU) No 142/2011.

Carbapenemase‐producing Enterobacterales (CPE) have been reported in the food chain in 14 out of 30 EU/EFTA countries. Commonly reported genes are blaVIM‐1, blaOXA‐48 and blaOXA‐181, followed by blaNDM‐5 and blaIMI‐1. Escherichia coli, target of most of the studies, Enterobacter cloacae complex, Klebsiella pneumoniae complex and Salmonella Infantis are the most frequent CPE. E. coli isolates show a high clonal diversity. IncHI2 (blaVIM‐1 and blaOXA‐162), IncC (blaVIM‐1 and blaNDM‐1), IncX3 (blaNDM‐5 and blaOXA‐181), IncI and IncL (blaOXA‐48) plasmids are frequently reported. Most reports are from terrestrial food‐producing animals and their environments – mainly pigs, followed by bovines and poultry and with occasional reports of meat thereof (targets of the EU monitoring and follow up trace back investigations). Few studies have investigated foods of aquatic animal origin and of non‐animal origin, finding a great CPE diversity. A notable increase in the number of CPE detections has been observed, predominantly from pigs, with a surge in certain countries in 2021 (blaOXA‐181, Italy) and 2023 (blaOXA‐48, Spain; blaOXA‐181, blaOXA‐48, blaOXA‐244 and blaNDM‐5, Portugal). Very few data points to circumstantial evidence of CPE transmission, clonal and/or horizontal gene spread within the food chain and from/to humans. Various methods are used in the EU/EFTA countries to detect and characterise CPE in the food chain. Improvement of their sensitivity should be investigated. Ten out of 30 EU/EFTA countries have specific contingency plans for CPE control, being epidemiological investigations (e.g. trace‐back) a common action included in those plans. Overall, data remain scarce for the bacterial species and sources beyond those systematically monitored. Recommendations to fill data gaps on other bacterial species and sources, dissemination pathways and optimisation of detection methods are given. A One Health approach to address the drivers of CPE spread in the food chain is needed.

The food enzyme cellulose 1,4‐β‐cellobiosidase (non‐reducing end) (EC 3.2.1.91) is produced with the non‐genetically modified Trichoderma citrinoviride strain C1‐5‐2 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in ten 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 eight food manufacturing processes. It was estimated to be up to 0.568 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 1962 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 3454. A search for the homology of the amino acid sequence of the cellulose 1,4‐β‐cellobiosidase (non‐reducing end) to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme 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.

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus niger strain XYL by DSM Food specialties. An evaluation of this food enzyme was made previously, in which EFSA could not conclude on its safety due to data gaps in a genotoxicity test. Subsequently, the applicant provided new data. 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 food enzyme is intended to be used in four food manufacturing processes. Dietary exposure was estimated to be up to 0.281 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 4095 mg TOS/kg bw per day for males and of 4457 mg TOS/kg bw per day for females, respectively, the highest doses tested. When compared with the estimated dietary exposure, it results in a margin of exposure of at least 14,573. A search for the homology of the amino acid sequence of the endo‐1,4‐β‐xylanase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. Based on the new data and the data provided previously, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

The European Commission requested EFSA to provide a scientific opinion on the equivalence between the heat treatment process of feathers and down with dry heat to a temperature of 100°C for 30 min and the treatment set up in Commission Regulation (EU) No 142/2011, in terms of inactivation of relevant pathogens. To be considered at least equivalent to the methods in the legislation, the alternative method should be able to reduce the concentration of Enterococcus faecalis or Salmonella Senftenberg by at least 5 log10 and the infectious titre of Anelloviridae and Circoviridae by at least 3 log10. An extensive literature search (ELS) was conducted to identify studies in which the log10 reduction or the D value of the indicators were determined after dry heating in matrices with low moisture/water activity. The ELS did not provide any study on the inactivation of E. faecalis by dry heating. For S. Senftenberg, there was no clear data demonstrating a 5 log10 reduction. For Anelloviridae and Circoviridae there was limited evidence and only one study reported 1 log10 reduction after 30 min at 120°C. Given the available data and sources of uncertainty, it is not possible to conclude on a 5 log10 reduction of E. faecalis using the proposed method due to lack of evidence. Similarly, a comparable reduction of S. Senftenberg cannot be concluded due to conflicting evidence. For Anelloviridae and Circoviridae, it was not possible to conclude that a 3 log10 reduction is achieved with the proposed method, as only one study on dry heat was retrieved, which did not demonstrate such a reduction. Therefore, based on data available to date, applying dry heat to feathers and down at 100°C for 30 min cannot be considered equivalent to the treatment specified in the Regulation, in terms of inactivation of relevant pathogens.

Water used in post‐harvest handling and processing operations is an important risk factor for microbiological cross‐contamination of fruits, vegetables and herbs (FVH). Industrial data indicated that the fresh‐cut FVH sector is characterised by process water at cooled temperature, operational cycles between 1 and 15 h, and product volumes between 700 and 3000 kg. Intervention strategies were based on water disinfection treatments mostly using chlorine‐based disinfectants. Water replenishment was not observed within studied industries. The industrial data, which included 19 scenarios were used to develop a guidance for a water management plan (WMP) for the fresh‐cut FVH sector. A WMP aims to maintain the fit‐for‐purpose microbiological quality of the process water and consists of: (a) identification of microbial hazards and hazardous events linked to process water; (b) establishment of the relationship between microbiological and physico‐chemical parameters; (c) description of preventive measures; (d) description of intervention measures, including their validation, operational monitoring and verification; and (e) record keeping and trend analysis. A predictive model was used to simulate water management outcomes, highlighting the need for water disinfection treatments to maintain the microbiological quality of the process water and the added value of water replenishment. Relying solely on water replenishment (at realistic feasible rates) does not avoid microbial accumulation in the water. Operational monitoring of the physico‐chemical parameters ensures that the disinfection systems are operating effectively. Verification includes microbiological analysis of the process water linked to the operational monitoring outcomes of physico‐chemical parameters. Although Escherichia coli and Listeria spp. could be indicators for assessing water quality, food business operators should set up and validate a tailored WMP to identify physico‐chemical parameters, as well as microbial indicators and their threshold levels, as performance standards for maintaining the fit‐for‐purpose microbiological quality of the process water during post‐harvest handling and processing operations.