The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of jagua (genipin-glycine) blue as a new food additive. Jagua (genipin-glycine) blue is obtained by water extraction of the ground pulp of the peeled, unripe fruits of L. and is the result of a reaction between genipin (iridoid present in the fruit) and externally added glycine. This reaction leads to the formation of a blue-coloured polymer and minor colouring components. In vitro Caco-2 cell permeability test demonstrated a low permeability of jagua (genipin-glycine) blue, but repeated dose toxicity studies showed organs discoloration and green-coloured urine, demonstrating some absorption. The toxicological data set comprised acute, sub-chronic toxicity, genotoxicity studies and also a 12-month toxicity study including in utero exposure. Jagua (genipin-glycine) blue was not genotoxic, and no adverse effects were observed in the repeated dose toxicity studies up to the highest doses tested. The Panel derived an acceptable daily intake (ADI) of 34 mg/kg bw per day or 12 mg/kg bw per day expressed as blue polymer, based on a no observed adverse effect level (NOAEL) of 3385 mg/kg bw per day, the highest dose tested, from the 12-month toxicity study and an uncertainty factor of 100. At the proposed maximum use level exposure assessment scenario, the 95th percentile of exposure approximately ranged from 1 mg/kg bw per day in the elderly to 27 mg/kg bw per day in toddlers. The Panel noted that both the mean and 95th percentile estimates of exposure did not exceed the proposed ADI in all population groups. The same was true for the exposure to the blue polymer assuming a 40% content in the proposed food additive. The Panel concluded there is no safety concern for jagua (genipin-glycine) blue as a food additive at the proposed use and use levels.

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 an extension of use for the Novel Food (NF) 'oleoresin from containing astaxanthin (ATX)' pursuant to Regulation (EU) 2015/2283. The NF is already authorised under Regulation (EU) 2015/2283 as an ingredient for use in food supplements (FS) as defined in Directive 2002/46/EC. The NF is produced by supercritical CO extraction of the homogenised and dried biomass of cultivated and contains approximately 10% w/w ATX With the present dossier, the applicant seeks authorisation for an extension of use of the NF for the use in dairy analogues, including beverage whiteners and fruit juices as defined by Directive 2001/112/EC. 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 the authorised use of the NF in 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.

The EFSA Panel on Food Contact Materials (FCM) assessed the safety of phosphorus acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters, intended to be used as additive in acrylonitrile-butadiene-styrene copolymers (ABS) and high impact polystyrene (HIPS). The substance is a polymer with < 10% w/w low molecular weight fraction (< 1000 Da). The safety of its use in HIPS and ABS was already evaluated by the EFSA CEP Panel in 2019 and 2021, respectively. This opinion assesses the safety of the extension of the use to up to 0.25% w/w for ABS and to the contact with alcoholic and fatty food for HIPS. Migration tests were carried out with food simulants and samples containing the substance at the maximum intended levels. For ABS, the specific migration was below the limit of detection (LoD) of 0.005 mg/kg food (3% acetic acid and 10% ethanol) and up to 0.007 mg/kg food (20% and 50% ethanol). For HIPS, the specific migration was up to 0.020 mg/kg food (20% ethanol) and up to 0.039 mg/kg food (50% ethanol). The assessment of toxicological data was reported in the previous opinions and the corresponding conclusions are considered still valid. The FCM Panel concluded that the substance is not of safety concern for the consumer if its migration does not exceed 0.05 mg/kg food and it is used in ABS at up to 0.25% w/w in contact with aqueous, acidic, alcoholic and oil-in-water emulsion foods, and in HIPS at up to 0.2% w/w in contact with all types of food, in both materials for long term storage at room temperature and below, after hot-fill and/or heating up to 100°C for up to 2 h. The use in contact with human milk and infant formula was excluded and hence was not addressed in this assessment.

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 containing astaxanthin (ATX)' pursuant to Regulation (EU) 2015/2283. The NF is produced by homogenising, crushing and spray-drying of the biomass of cultivated 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.

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 egg membrane collagen peptides as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is derived from farmed chicken eggs. It is produced by enzymatic hydrolysis, and it contains 15%-30% collagen peptides. The production process is sufficiently described and does not raise safety concerns. The applicant proposed to market the NF for use in food supplements for adults, excluding pregnant and lactating women, at a maximum daily dose of 500 mg. Taking into account the nature of the NF, the compositional data and information on the production process, the Panel considers that no toxicological studies are required for the NF. The Panel concludes that the NF, egg membrane collagen peptides, is safe under the proposed conditions of use.

The food enzyme AMP deaminase (AMP aminohydrolase; EC 3.5.4.6) is produced with the non-genetically modified strain AE-DNTS by Amano Enzyme Inc. In a previous evaluation, the Panel could not conclude on the safety of this food enzyme due to uncertainties on the characterisation of the food enzyme batches for commercialisation and the batch used in the toxicological studies. In this assessment, the Panel evaluated the new data provided by the applicant and completed the safety evaluation of this food enzyme. The food enzyme is intended to be used in two food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.001 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 275 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 275,000. Based on the new data provided and the previous evaluation, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

This report presents results of surveillance on transmissible spongiform encephalopathies in bovines, sheep, goats, cervids and other species, and genotyping in sheep and goats, carried out in 2024 by 27 EU Member States (EU27, MS), the UK (in respect of Northern Ireland, (XI)) and 8 non-EU reporting countries: Bosnia and Herzegovina, Iceland, Montenegro, North Macedonia, Norway, Serbia, Switzerland and Türkiye. In total, 980,624 bovines were tested by EU27 and XI (+3.4% compared to 2023), with 3 atypical bovine spongiform encephalopathy (BSE) cases reported (2 H-type: 1 in France, 1 in Ireland; 1 L-type in Poland); and 41,397 bovines by 8 non-EU reporting countries with no BSE cases reported. Four additional BSE cases were reported by the UK (1 classical and 1 H-type), the USA (1 L-type), Brazil (1 H-type). In total, 277,064 sheep were tested in EU27 and XI (-2.7% compared to 2023). In sheep, 458 scrapie cases were reported by 14 MS and XI: 380 classical scrapie (CS) by 6 MS (139 index cases (IC)) with genotypes of susceptible groups in 98.9% of the cases; 78 atypical scrapie (AS) (78 IC) by 13 MS. In non-EU reporting countries 25,337 sheep were tested, with Iceland reporting 61 CS and 2 AS cases, and Norway 9 AS cases. Random genotyping was reported by five MS and susceptible genotypes accounted for 7.8%. In goats, out of 93,960 tested (-8.5% compared to 2023), 71 cases of scrapie were reported, all from EU27 and XI: 65 CS (14 IC) by five MS and 6 AS (6 IC) by three MS. None of the genotyped cases in goats carried polymorphisms at codon 146 and 222. In total, 1761 cervids were tested for chronic wasting disease by 9 MS, none tested positive. Norway tested 10,932 cervids with 2 European moose positive, Serbia tested 186 animals and Iceland 96 animals.

In 2025, and as of 5 November 2025, 14 countries in Europe reported 1 096 locally acquired human cases of WNV infection with known place of infection. The earliest and latest date of onset were on 19 May 2025 and 27 October 2025, respectively. Locally acquired cases have been reported by (773), (95), (62), (59), (49), (31), (13), (4), (3), (2), (2), (1), (1) and (1). In Europe, 95 deaths were reported. Case numbers reported this year are above the average for the past decade (751). However, these figures remain lower than those seen in 2018, 2022, and 2024 - years when virus circulation was particularly intense, with over 1 300 cases reported by this point in the year. As the latter figures are based on consolidated data, while the current year's data remain delayed and incomplete, direct comparisons should be made with caution. This year, Italy experienced a large outbreak, with 773 confirmed human infections, including 71 fatalities (case fatality rate of 9.2%, which is within the expected range). This is the highest number of human WNV infections reported by Italy at this time of the year. Most cases (265) were reported from the Lazio region (Latina, Roma and Frosinone), followed by 133 cases reported by the Campania region (Napoli, Caserta, Salerno and Avellino). Other regions are reporting similar numbers as in previous years. As of 5 November 2025, locally acquired human cases of WNV infection have been reported in 155 regions across 14 countries. This compares with 187 regions across 18 countries during the same period in 2024. All 14 countries have previously reported human cases of WNV. During the current transmission season, 35 regions reported human cases of WNV infection for the first time ever: by in Genova (ITC33), Sondrio (ITC44), Avellino (ITF34), Brindisi (ITF44), Catanzaro (ITF63), Reggio di Calabria (ITF65), Palermo (ITG12), Messina (ITG13), Siracusa (ITG19), Nuoro (ITG2E), Sud Sardegna (ITG2H), Grosseto (ITI1A), Massa-Carrara (ITI11), Arezzo (ITI18), Siena (ITI19), Latina (ITI44) and Frosinone (ITI45); by in Paris (FR101), Yvelines (FR103), Essonne (FR104), Hauts-de-Seine (FR105), Seine-Saint-Denis (FR106), Val-de-Marne (FR107), Val-d'Oise (FR108), Seine-Maritime (FRD22), Lot-et-Garonne (FRI14), Haute-Garonne (FRJ23), Tarn-et-Garonne (FRJ28), Puy-de-Dôme (FRK14), Ardèche (FRK22) and Vaucluse (FRL06); by in Aschaffenburg, Landkreis (DE264); by in Irakleio (EL431) and Lakonia, Messinia (EL653); by in Alicante/Alacant (ES521) and Almería (ES611); by in Splitsko-dalmatinska županija (HR035); by * in Pejë (XK003); by in Sălaj (RO116); and by in Çanakkale (TR222). As observed in previous years, most cases are among males aged 65 years and older. The hospitalisation rate is similar to previous years, with 85% of cases hospitalised this year compared to 91% in the past decade. The high hospitalisation rate is due to the nature of WNV surveillance, which tends to predominantly capture the most severe cases. The case fatality rate so far this year is 8.9%, which is below but comparable to the 10% observed in the previous decade. Neurological manifestations were reported in 56% of cases this year, compared to 66% in the previous decade. In general, a dominance of neurological cases is expected, as cases with more severe symptoms are more likely to be diagnosed. From the veterinary perspective, 178 WNV outbreaks among equids and 345 outbreaks among birds have been reported in Europe in 2025. The earliest start date of an outbreak among equids and birds was on 15 January 2025 in Germany and 16 February 2025 in Italy, while the latest onset of an outbreak among equids and birds was, respectively, on 21 October 2025 in France and 22 October 2025 in Italy. Outbreaks among equids were reported by (86), (55), (10), (9), (7), (5), (4), (1) and (1). Outbreaks among birds were reported by (318), (15), (3), (3), (2), (2), (1) and (1). In the Animal Disease Information System (ADIS) database, no information was provided on the exact equid species reported, whereas species details were available for birds. The bird species associated with the highest number of reported outbreaks in 2025 were the carrion crow (95) and the common magpie (59), followed by the common wood-pigeon (30), common kestrel (18), northern goshawk (10), herring gull (9), little owl (9), rock dove (9), unidentified Accipitridae (9) and hooded crow (8). In addition, several other bird species were involved in between one and seven outbreaks. In June, July and August 2025, equid outbreaks exceeded the 10-year monthly average (2015-2024) but fell below it in September and October, while bird outbreaks remained under the three-year monthly mean (2022-2024) for most months, except in August and September 2025. As of 5 November 2025, outbreaks in birds and/or equids have been reported in 111 regions across 10 countries. Of the 10 countries that submitted data in 2025, eight had reported WNV outbreaks in birds and/or equids to ADIS in previous years, reflecting endemicity in these territories. In contrast, reported WNV outbreaks for the first time ever to ADIS in 2025, with three outbreaks in wild birds. Two outbreaks involved Eurasian jackdaws, and one involved carrion crows, all recorded in August 2025. Both bird species are generally resident, although Eurasian jackdaws from northern and eastern Europe may migrate south during winter. These outbreaks occurred in the administrative units of Mechelen (BE212) and Halle-Vilvoorde (BE241). Additionally, in October 2025, reported a WNV outbreak in equids to ADIS for the first time. The outbreak occurred in the administrative unit of Groot-Rijnmond (NL366). However, this was not the first detection of the virus in the Netherlands, where WNV was first documented in mosquitoes, birds and humans back in 2020. Besides the three new regions in Belgium and in the Netherlands up to 5 November 2025, outbreaks in birds and/or equids were reported for the first time to ADIS in 26 regions: by  in Arezzo (ITI18), Ascoli Piceno (ITI18), Caltanissetta (ITG15), Firenze (ITI14), Foggia (ITF46), Frosinone (ITI45), L'Aquila (ITF11), Lecco (ITC43), Ragusa (ITG18), Reggio Calabria (ITF65), Siracusa (ITG19) and Sondrio (ITC44); by in Haute-Garonne (FRJ23), Loiret (FRB06), Oise (FRE22), Paris (FR101), Tarn (FRJ27), Val-de-Marne (FR107), Vaucluse (FRL06) and Yvelines (FR103); by in Koprivničko-križevačka županija (HR063) and in Bjelovarsko-bilogorska županija (HR021); by in Almería (ES611) and Menorca (ES533); by in Innsbruck (AT332); and by in Rhein-Neckar-Kreis (DE128). Furthermore, in 2025, outbreaks in equids were reported in the Greek region of Thasos-Kavala (EL515), marking the first such report in animals since the last recorded outbreak 12 years prior. Reports of WNV outbreaks during the winter, when mosquito activity is minimal, should be carefully evaluated as they raise questions about the timing of infection. Two such reports - one outbreak in equids reported by Germany in January 2025, and one in birds reported by Italy in February 2025 - warrant cautious interpretation, as they may reflect residual detection (e.g. lingering antibodies or viral RNA from infections acquired in the year before) rather than active transmission in 2025. Seven countries - Croatia, France, Germany, Greece, Hungary, Italy and Spain - reported both WNV human cases and outbreaks in equids and/or birds. This year, Italy accounted for the majority of the human cases (71%) and the outbreaks in equids and birds (77%). Following an intense circulation of the virus in some regions of the country during the summer and the early autumn, the transmission is now reaching an end. This high number of human cases and outbreaks in birds and equids was likely due to favourable climate conditions and ecological hotspots (e.g. wetlands, agricultural areas) that influenced mosquito vector populations and the distribution and behaviour of animal hosts. Intensive surveillance in Italy may also have contributed to high detection rates of human cases and outbreaks in birds and equids. The reporting of WNV outbreaks in birds marks the first detection of the virus in Belgium. Notably, the country has never recorded any locally acquired human cases. This development signals a significant step in the local emergence of WNV and points to a likely recent introduction of the virus into the national ecosystem. These findings underline the need for enhanced surveillance and increased public health preparedness. The identification of WNV cases in humans and animals within previously unaffected areas underscores the continuing geographic expansion of the virus, likely driven by conducive environmental conditions and ecological factors. In addition, increased surveillance or monitoring sensitivity and raised awareness in these areas might play a role in the detection of the cases. Owing to delays in diagnosis and reporting, as well as the fact that most of the WNV infections are asymptomatic or subclinical, the case numbers provided in this report likely underestimate the true number of cases. Of note, the seasonal surveillance in humans primarily focuses on capturing laboratory-confirmed cases, which contributes to the diagnostic delay. Given that the weather conditions are much less favourable for WNV transmission in Europe, the number of human cases and outbreaks in equids and birds is steadily decreasing. The transmission season is reaching its end, and only a few sporadic cases are expected in the coming weeks.

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified strain TTME 6280 KY by Kerry Ingredients & Flavours Ltd. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in nine food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in three processes, dietary exposure was calculated for the remaining six food manufacturing processes. It was estimated to be up to 2.273 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 homology of the amino acid sequence of the α-amylase 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.

The food enzyme glucan 1,4-α-glucosidase (4-α-d-glucan glucohydrolase; EC 3.2.1.3) is produced with the genetically modified 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.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is prepared from the pregastric tissues of calves, kids and lambs by DSM Food Specialties B.V. No issue of concern was identified from the food enzyme manufacturing process. The food enzyme is intended to be used in two food manufacturing processes. As cheese production is a traditional use of this food enzyme, dietary exposure was not calculated. For the use in the production of flavouring preparations from dairy products, dietary exposure was estimated to be up to 0.001 mg total organic solids/kg body weight per day in European populations, which is lower than the intake of the corresponding fraction from pregastric tissues. The Panel considered toxicological testing unnecessary. A search for the homology of the amino acid sequences of the triacylglycerol lipases 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 that the likelihood is low. Based on the data provided, the origin of the food enzyme being edible animal tissues and a dietary exposure to the food enzyme comparable to its source in regular diet, 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, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on UV-treated oil from yellow mealworm ( larvae) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from farmed larvae and consists mainly of fat (~99%). It is obtained by mechanical separation and is subsequently exposed to UVB radiation to enhance vitamin D content. UV-treatment substantially increased vitamin D levels. Under the proposed use levels, the NF represents a significant contributor to vitamin D intake from foods (including the background diet and fortified foods), accounting for up to half of the intake in older children, adolescents, and adults. Combined intakes from foods and the NF remained below the tolerable upper intake level (UL) for all age groups. Analytical data showed that contaminant levels were below regulatory limits established for other foods, and intake estimates indicated that consumption of the NF would not substantially increase overall dietary exposure to undesirable substances. The Panel further notes that there are no safety concerns regarding the stability of the NF. The NF is intended for use as an ingredient in a range of food products, including bakery products, sauces, dairy desserts, and fats. The target population is the general population. Toxicological studies, including newly submitted in vitro genotoxicity tests, did not raise safety concerns. Animal studies indicated that vitamin D from the NF is bioavailable. The intake of the NF is not nutritionally disadvantageous. The Panel notes that allergic reactions may occur upon consumption, due to primary sensitisation or cross-reactivity with other allergens. The Panel concludes that the NF is safe under the proposed uses and use levels.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta Lifescience submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance dodine in grapes. The data submitted in support of the request were found to be sufficient to derive MRL proposals for table and wine grapes. Adequate analytical methods for enforcement are available to control the residues of dodine in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of dodine according to the reported agricultural practices is unlikely to present a risk to consumer health.

Following the submission of dossier GMFF-2023-21252 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified maize NK603 × T25, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize NK603 × T25 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21252 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize NK603 × T25.

The conclusions of 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 Denmark for the pesticide active substance phenmedipham are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of phenmedipham as a herbicide on sugar beet/fodder beet. The conclusions were updated with regard to the endocrine disrupting properties and the genotoxicity assessment following a mandate received from the European Commission in January 2019 and its update in January 2024, respectively. 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.

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is prepared from the pregastric tissues of calves, kids and lambs by RENCO New Zealand Limited. No issue of concern was identified from the food enzyme manufacturing process. The food enzyme is intended to be used in two food manufacturing processes. As cheese production is a traditional use of this food enzyme, dietary exposure was not calculated. For the use in the production of flavouring preparations from dairy products, a dietary exposure was estimated to be up to 0.645 mg total organic solids/kg body weight per day in European populations, which is lower than the intake of the corresponding fraction from pregastric tissues. The Panel considered toxicological testing unnecessary. Adverse reactions upon dietary exposure to triacylglycerol lipases have not been reported and allergies to proteins from calves, kids and lambs are rare. 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, uncertainty remains with respect to the microbiological safety of the food enzyme. Therefore, the Panel cannot conclude on the safety of the food enzyme triacylglycerol lipase obtained from the pregastric tissues of calves, kids and lambs.

Between 6 September and 14 November 2025, 1,443 highly pathogenic avian influenza (HPAI) A(H5) virus detections were reported in wild birds across 26 countries in Europe. This number was four times higher than in the same period in 2024 and the highest overall for those weeks since at least 2016. Almost all the detections (99%) were due to HPAI A(H5N1) viruses, and most of them belonged to EA-2024-DI.2.1, a new sub-lineage of the EA-2024-DI.2 genotype. These HPAI virus detections in wild birds involved increasing numbers of waterfowl species (ducks, geese and swans) that were found positive in large parts of Europe. In addition, high numbers of common cranes were affected across a wide band stretching from northeast to southwest Europe. Given the unprecedented high circulation of HPAI virus in the wild bird population compared to previous years, and the associated high environmental contamination, strict biosecurity measures and early detection of infected poultry establishments are urgently needed to prevent introductions from wild to domestic birds and further spread among poultry establishments. Prompt removal of wild bird carcasses is indicated to reduce the risk of infection for other wild and domestic birds and mammals.

The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain CCTCC M 2023118 by Sunson Industry Group Co., Ltd. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. Consequently, it does not fulfil the requirements for the qualified presumption of safety approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. No concerns were identified from the food enzyme manufacturing process. Citrinin was detected in all food enzyme preparation batches at a concentration exceeding 405 μg/kg. The food enzyme is intended to be used in six food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining four food manufacturing processes. It was estimated to be up to 5.166 mg TOS/kg body weight per day in European populations. A search for the homology of the amino acid sequence of the α-amylase to known allergens was made and two matches with respiratory allergens were 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 on the presence of citrinin in the food enzyme preparation, the Panel could not exclude genotoxicity and carcinogenicity concerns for the food enzyme.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) in barley, wheat and rye for pinoxaden. The data submitted in support of the requests were found to be sufficient to derive an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of M4 (SYN 505164) and M6 (SYN 502836), the metabolites of pinoxaden included in the residue definitions in cereal grains, individually at a validated limit of quantification (LOQ) of 0.01 mg/kg. Additionally, in a separate application submitted to Italy as well, the applicant requested the evaluation of the confirmatory data identified during the MRL review conducted under Article 12 of Regulation (EC) No 396/2005 as not available. To address the MRL review data gap, a new confirmatory analytical methodology for animal matrices was submitted. This data gap was considered satisfactorily addressed. The information provided did not require a revision of the existing MRLs in products of animal origin, which are confirmed. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of pinoxaden according to the reported agricultural practices is unlikely to present a risk to consumer health.

The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) is produced with the non-genetically modified microorganism strain HBI-AC01 by HBI Enzymes Inc. The food enzyme was considered free from viable cells of the production strain. It is intended to be used in three 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 two food manufacturing processes. It was estimated to be up to 0.475 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 349 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 735. A search for the homology of the amino acid sequence of the cellulase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure 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.

The European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the derivation of a health-based guidance value (HBGV) for Δ-tetrahydrocannabinol (Δ-THC) in food with an assessment of the occurrence of Δ-THC and the co-occurrence with Δ-THC in hemp and hemp-derived products. Data from a clinical study were used to inform on the relative potency between Δ-THC and Δ-THC. The point estimate of the relative potency (ratio Δ-THC/Δ-THC) was in the range between 1 and 1.4, with 95% confidence between 0.97 and 1.63. Based on this range, the CONTAM Panel, using a conservative approach, set a relative potency factor of one for Δ-THC. The CONTAM Panel had previously set an acute reference dose (ARfD) of 1 μg/kg body weight for Δ-THC derived from adverse effects on human central nervous system (CNS). Given the similarity in the effects and the mode of action between Δ-THC and Δ-THC, the Panel considered that the established ARfD can be considered as a group ARfD for the sum of Δ- and Δ THC. Regarding the occurrence of Δ-THC, the majority of samples were left censored, in particular for hemp infusion leaves, hemp seed oil and hemp seeds (96%-99%). Highest detection rates and levels were found in the categories 'Sugar and similar, confectionery and water-based sweet desserts' and 'Products for non-standard diets, food imitates and food supplements'. Of 1145 samples, both substances were detected together in only 96 samples. If the two substances are produced naturally, a Δ-THC to Δ-THC ratio below 1 is expected; however, many of the samples, positive for Δ-THC, were above this ratio indicating either addition of semi-synthetic Δ-THC, formation during processing or enrichment of the natural Δ-THC.