Abstract The food enzyme is a cysteine endopeptidase complex, containing papain (EC 3.4.22.2), chymopapain (EC 3.4.22.6), caricain (EC 3.4.22.30) and glycyl endopeptidase (EC 3.4.22.25), obtained from the latex of unripe Carica papaya L. by Enzyme Development Corporation. It is intended to be used in 13 food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining 12 food manufacturing processes. It was estimated to be up to 20.963 mg TOS/kg body weight per day. This exposure is up to one order of magnitude higher than the intake of the corresponding fraction from unripe C. papaya L. latex. Considering the overestimation of the exposure to the food enzyme–TOS, in a realistic exposure scenario, both values can be expected to be within the same order of magnitude. Toxicological studies were not required according to the current guidance. Among the four proteins in the cysteine endopeptidase complex, papain and chymopapain are known food allergens. Homology searches with the amino acid sequences of the four proteins in the complex to known allergens identified matches with six food and eight respiratory allergens. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. Based on the data provided, the origin of the food enzyme being an edible plant source and the estimated dietary exposure, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.

During the assessment of cannabidiol (CBD) as a novel food, in 2022 the NDA Panel identified significant data gaps. Concerns focused on potential adverse effects on the liver, gastrointestinal tract, endocrine, nervous and reproductive systems. Literature searches covering animal and human studies from the previous Statement until June 2024 confirmed the persistence of these gaps, as many of the new studies suffer from methodological limitations, including non‐standardised protocols, short durations and concomitant treatment with medicine. Pharmacokinetic studies confirmed that CBD's bioavailability is variable, influenced by delivery matrix and food intake. Its ability to cross the placenta and accumulate systemically raises further safety concerns. Animal studies revealed consistent liver toxicity, with liver weight and histopathological changes emerging as sensitive endpoints. Human trials indicated hepatotoxic potential, particularly when CBD is used in combination with other medications. Gastrointestinal effects were reported at higher doses, while neurological and psychiatric safety data remain insufficient. Animal studies on reproductive toxicity reinforced the concern regarding this endpoint. Neurodevelopmental effects following prenatal exposure were observed, suggesting long‐lasting, sex‐specific outcomes. Endocrine disruptions were noted, including altered thyroid hormone levels and adrenal histopathology. No studies addressed immunotoxicity, though CBD's interaction with immune pathways warrants caution. The Panel performed benchmark dose modelling based on GLP‐compliant subchronic studies to identify a toxicological reference point. By applying an uncertainty factor of 400, a provisional safe dose of 0.0275 mg/kg bw per day (approximately 2 mg/day for a 70 kg adult) was derived. This provisional safe dose applies solely to food supplement formulations with CBD purity ≥ 98%, without nanoparticles, for which the production process is considered safe and genotoxicity is ruled out. The Panel concludes that, based on all available data, the safety of CBD for individuals under 25 years of age, pregnant or lactating women, and those on concurrent medications, cannot be established.

Following a request of the European Commission, EFSA assessed fish and other seafood consumption patterns and consumer awareness of related health risks and benefits across the 27 Member States, Iceland and Norway. Awareness of existence of consumption national advice and to which extent this advice influence consumers consumption behaviour were also examined. To address these objectives, two surveys were conducted in 2023 and 2024 among adolescents, adults and pregnant women. Data were collected through computer‐assisted telephone interviews by means of a combined Food Propensity and Awareness Questionnaire. The surveys covered 38 fish species grouped by their maximum levels of mercury (1.0, 0.5 and 0.3 mg/kg). Respondents were asked about consumption frequency, awareness of contaminants and knowledge of national dietary advice. The analysis showed that fish and other seafood consumption increased between the two surveys across all countries and species categories, regardless of whether updated advice was issued. Awareness of chemical contaminants was generally low, with mercury being the most recognised contaminant. Awareness of national advice was moderate and slightly higher among pregnant women but reported changes in consumption behaviour linked to this advice were limited. Information sources also played a role in shaping consumer behaviour and these varied per country and population group. Uncertainties were identified and recommendations listed to improve future assessments.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro B.V. Arnhem (NL) Freienbach Branch submitted a request to the competent national authority in the Netherlands to set an import tolerance for the active substance dimethomorph in table and wine grapes. The data submitted in support of the request indicated no need to modify the existing EU maximum residue level (MRL) for table and wine grapes. Adequate analytical methods for enforcement are available to control the residues of dimethomorph in plant matrices at the validated limit of quantification (LOQ) of 0.005 mg/kg and allow the quantitation of both E‐ and Z‐isomer individually. Since dimethomorph is a non‐approved active substance under Regulation (EC) No 1107/2009, EFSA performed a dietary consumer risk assessment considering only Codex MRLs and import tolerances implemented in the EU MRL legislation in addition to the new data provided with this import tolerance application in grapes. Provided that EU uses are withdrawn, the related MRLs are lowered to the LOQ, and the conclusions of the targeted MRL review are implemented, EFSA concluded, based on the risk assessment, that consumer exposure from the import tolerance for dimethomorph on grapes does not exceed the toxicological reference values. Consequently, the import tolerance is unlikely to pose a risk to consumers' health.

The qualified presumption of safety (QPS) process was developed to provide a harmonised safety assessment approach to support EFSA Scientific Panels and Units. The QPS approach assesses the taxonomic identity, body of relevant knowledge and safety of microorganisms intentionally added to the food and feed chain. Safety concerns identified for a taxonomic unit (TU) are, where possible, reflected by ‘qualifications’ that should be assessed at the strain level by EFSA's Scientific Panels. During the period covered by this Statement, no new information warranted changes to the status of previously recommended QPS TUs. The QPS list was updated to verify the correctness of the names and the completeness of synonyms. Of the 47 microorganisms notified to EFSA between April and September 2025 (28 as feed additives, 11 as food enzymes or additives, 6 as novel foods, none as plant protection products and 2 as food contact materials), 43 were not evaluated. These latter included 9 filamentous fungi and 9 Escherichia coli (all excluded from the QPS evaluation), and 25 already present on the QPS list. One of the other four notifications, Heyndrickxia faecalis (previously known as Weizmannia faecalis), had been assessed recently within this 3‐years QPS cycle. The remaining 3 were assessed for a possible QPS status. Microchloropsis gaditana, Bacillus thermoamylovorans (both notified for the first time) and an additional TU, Aurantiochytrium acetophilum, not evaluated previously, which was included in response to an internal request. B. thermoamylovorans cannot be granted the QPS status due to the lack of body of knowledge. A. acetophilum cannot be granted the QPS status due to a limited body of knowledge. M. gaditana can be granted the QPS status with the qualification for ‘production purpose only’.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactococcus lactis DSM 34262 when used as a technological additive (acidity regulator) in feed for all animal species. The additive is intended to be incorporated into feed materials of plant origin with high moisture content (dry matter range between 25% and 40%). The bacterial species L. lactis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance. The FEEDAP Panel concluded that the preparation of L. lactis DSM 34262 is safe for the target species, consumers and the environment. Regarding user safety, the additive should be considered as a skin and respiratory sensitiser. Exposure of users via dermal and respiratory routes is considered a risk. The FEEDAP Panel concluded that incorporation of L. lactis DSM 34262 at a minimum concentration of 1.0 × 108 CFU/kg feed material has the potential to reduce the pH of feed materials of plant origin at the proposed conditions of use.

EFSA developed an updated guidance document on the submission of data for the evaluation of the safety and efficacy of decontaminating substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption (referred to as ‘food’). The decontaminating substances may be either chemicals (e.g. carboxylic acids, peroxy acids or proteins), biological agents (e.g. bacteriophages) or combinations thereof. The purpose of the treatment, including the food(s) and the pathogenic microorganisms intended to be targeted, the application methods (e.g. dipping, spraying) and conditions of the treatment used (e.g. concentration) need to be stated. Information to be provided relates to (i) the safety to humans of the applied substances and their reaction products (including degradation products) remaining in the treated food; (ii) the efficacy, i.e. whether a reduction of the prevalence and/or numbers of target pathogenic microorganisms is consistently achieved and is statistically significant compared to a control sample; (iii) the potential emergence of acquired reduced susceptibility to the substance itself and/or to other biocides and/or of resistance to therapeutic antimicrobials; and (iv) the environmental safety of the decontaminating substances.

The food enzyme is a cysteine endopeptidase complex, containing papain (EC 3.4.22.2), chymopapain (EC 3.4.22.6), caricain (EC 3.4.22.30) and glycyl endopeptidase (EC 3.4.22.25), obtained from the latex of unripe Carica papaya L. by Troplandis BVBA. Dietary exposure was evaluated for seven food manufacturing processes and was estimated to be up to 6.104 mg TOS/kg body weight per day. This exposure is in the same order of magnitude as the intake of the corresponding fraction from unripe C. papaya L. latex. Toxicological studies were not required according to the current guidance. Among the four proteins in the cysteine endopeptidase complex, papain and chymopapain are known food allergens. Homology searches of the amino acid sequences of the four proteins in the complex to known allergens identified matches with six food and eight respiratory allergens. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. Based on the data provided, the origin of the food enzyme being an edible plant source and the estimated dietary exposure, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use. However, the Panel notes the presence of multiple mycotoxins in all food enzyme batches indicating deficiencies in the quality assurance system.

This opinion assesses the risk of avian influenza H5N1 B3.13 genotype virus infection in EU dairy cattle. Introduction of the virus into EU dairy cattle, poultry or wild birds via trade or migratory birds from the US is assessed as highly unlikely. The potential impact in case of introduction is estimated as high for most Member States. Measures assessed as most effective to prevent introduction of the virus are avoiding importation of cattle and poultry from infected countries, and cleaning and disinfection of milking equipment. Measures assessed as most effective to prevent spread of the virus in the EU are milking hygiene, banning movement of cattle in infected areas, avoiding the exchange of workers, vehicles and equipment, and implementing biosecurity measures before entering farms. Regarding adaptation of current highly pathogenic avian influenza (HPAI) surveillance, a proportional, risk‐based preparedness strategy is recommended, including (i) awareness raising to strengthen passive and syndromic surveillance, (ii) targeted investigations of suspicions/outbreaks after confirmed exposure of cattle to HPAI, (iii) using sensitive diagnostics on multiple sample types and (iv) regional active surveillance (bulk milk reverse transcription quantitative polymerase chain reaction (RT‐qPCR)) following first detections in cattle. In case the virus is identified in wild birds or poultry, surveillance of dairy farms in the affected area should be considered. The contamination of bulk milk is considered very likely, if EU dairy herds become infected, as cows may not show clear clinical signs and may shed the virus before changes in milk become apparent. If EU bulk milk or colostrum are contaminated with the virus, food‐borne exposure of consumers to viable virus would be highest for raw drinking milk, raw colostrum and raw milk cream. To date, however, no confirmed cases of food‐borne human infection with H5N1 B3.13 genotype virus have been reported.

Amphibians (specifically Xenopus laevis) are used as the model species to assess potential endocrine‐disrupting properties in non‐mammalian species through thyroid modality. The amphibian metamorphosis assay is the most frequently available test. Attempts have been made to modify this protocol in order to make it more fit for purpose and overcome potential limitations. In light of these developments, EFSA, with the support of the Working Group on Endocrine Disruptors, under the auspices of a self‐task mandate here endeavours to clarify the pros and cons of newly proposed amphibian protocols when compared with the standard guideline tests. Moreover, recommendations to facilitate the interpretation of findings in relation to changes in thyroid histopathology have been included.