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 grain and flour from perennial intermediate wheatgrass (IWG) (Thinopyrum intermedium) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF, composed primarily of carbohydrates, proteins and water, is produced by cultivating the IWG plant and subsequently processing it to yield either grains or flour. The target population proposed by the applicant is the general population and the NF is proposed as a food ingredient in several food products. Considering the nutritional profile of the NF and the proposed conditions of use, its consumption is considered not nutritionally disadvantageous, and the Panel considers that no toxicological studies are required on this NF. The microbiological analyses for several batches of the NF revealed high microbial counts regarding total aerobic microbial count, Enterobacteriaceae, yeasts and moulds, highlighting excessive variability in the hygiene conditions along the production process. The NF has the same potential as wheat, barley and rye to trigger IgE‐mediated allergic reactions in cereal‐allergic individuals and/or adverse reactions in individuals with coeliac disease under the proposed conditions of use. The Panel notes that, due to the high microbial loads observed in both IWG grain and flour batches, the microbiological quality of the NF is compromised. The potential presence of Enterobacteriaceae and opportunistic pathogen Pantoea species, such as P. agglomerans, and further released compounds could pose safety concerns. Moreover, the provided stability data do not support a 12‐month shelf‐life for the NF. Based on the available data, the Panel concludes that the safety of the NF, grain and flour from perennial intermediate wheatgrass (Thinopyrum intermedium) cannot be established.

The food enzyme mannan endo‐1,4‐β‐mannosidase (1,4‐β‐d‐mannan mannanohydrolase; EC 3.2.1.78) is produced with the non‐genetically modified microorganism Aspergillus niger strain AE‐HCM 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 three food manufacturing processes. Subsequently, the applicant requested to extend its use to include ten additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of 13 food manufacturing processes. As the food enzyme–total organic solids (TOS) are not carried into the final foods in one food manufacturing process, the dietary exposure to the food enzyme–TOS was estimated for the remaining 12 processes. The dietary exposure was calculated to be up to 0.586 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (728 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 1242. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

The food enzyme sucrose:sucrose fructosyltransferase (sucrose:sucrose 1′‐β‐d‐fructosyltransferase; EC 2.4.1.99) is produced with the genetically modified Yarrowia lipolytica strain E4772 by SEQENS. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is free from viable cells of the production organism, but not free from recombinant DNA. The food enzyme is intended to be used in the processing of sugars for the production of fructo‐oligosaccharides. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.088 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 sucrose: sucrose fructosyltransferase 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 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 XEA 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 two 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 six food manufacturing processes. The dietary exposure was calculated to be up to 0.316 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1852 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 5861. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) reviewed the maximum residue levels (MRLs) for copper compounds in light of the EFSA Scientific Committee opinion on the re‐evaluation of the health‐based guidance values (HBGVs) and exposure assessment from all sources. Based on the exposure calculations performed according to three different scenarios, the updated occurrence data and the residues from the new intended uses are not expected to have an impact on the chronic exposure calculations conducted under the framework of the EFSA Scientific Committee assessment. Therefore, the conclusions of the previous assessment by EFSA Scientific Committee are still valid. Since the current copper exposure is expected to cover all sources of copper, including the uses of copper as plant protection products (PPPs), it can be concluded that the authorised PPP uses for copper compounds and the new intended PPP uses present no health risk for the population, including children. Due to copper being also a micronutrient and ubiquitous in the environment, as requested in the mandate, the dietary risk assessment was performed following a different approach than the standard methodology for the dietary risk assessment of pesticide residues in the framework of setting and reviewing MRLs under Regulation (EC) No 396/2005 and in the peer review of pesticides under Regulation (EU) No 1107/2009. Therefore, all MRL proposals are suggested for further consideration by risk managers.

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.

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.

Following a request from the European Commission, the EFSA Panel on Plant Health performed a quantitative risk assessment for the EU of Phlyctinus callosus (Coleoptera: Curculionidae), a polyphagous pest occurring in Australia, New Zealand and South Africa. The current risk assessment focused on potential pathways for entry, the climatic conditions allowing establishment, the expected spread capacity and the impact considering a time horizon of 10 years (2023–2032). The Panel identified the import of apples, cut flowers and table grapes as the most relevant entry pathways. Over the next 10 years, an annual median estimate of approximately 49.5 (90% certainty range, CR, ranging from 4.0 to 881.2) potential P. callosus founder populations are expected. When the probability of establishment is considered and climatic indicators are used to define the areas in the EU where establishment is possible, the model estimated a median of 1 founder population every 1.3 years (90% CR: 1 every 30.8 years to 23.3 per year) in the scenario where the areas are defined by the union of all the climatic indicators and 1 founder population every 11.9 years (90% CR: 1 every 256.6 years to 2.5 per year) in the scenario where establishment is possible only in the areas defined by the climatic indicator of minimum soil temperature. The estimated number of founder populations per year is mostly driven by the probability of establishment in the rural areas, infestation rate in table grapes and the probability of transfer to a suitable host in the rural area. The risk of entry for cut flowers and apples is substantially lower than the risk from the table grapes. If such founder populations were to establish, P. callosus is estimated to spread by natural dispersal and common agricultural practices at a rate of 15.5 m/year (90% CR 5.1–46.8 m/year) after a lag phase of 4.0 years (90% CR 1.3–8.7 years). The impact, expressed as percentage loss of the production directly attributable to P. callosus in the areas where establishment is possible and assuming farmers do not apply specific control measures was estimated at 0.5% (90% CR 0.01%–2.8%) for cut flowers/foliage, 5.2% (90% CR 2.2%–11.7%) for apples and 2% (90% CR 1.3%–5.2%) for table grapes. Options for risk reduction are discussed, but their effectiveness is not quantified.

The EFSA Panel on Plant Health performed a pest categorisation of Bailey's rust mite, Calepitrimerus baileyi Keifer (Acariformes: Eriophyidae), following the commodity risk assessment of Malus domestica plants from Türkiye performed by EFSA, in which C. baileyi was identified as a pest of possible concern to the European Union. This mite is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. The eriophyid is known to occur in Africa, America, Asia, Europe (Greece and Serbia) and Oceania on Malus spp., which is the only confirmed host genus for C. baileyi. Plants for planting of Malus spp. are the main potential pathway for entry into the EU. However, plants for planting of the genus Malus Mill. are considered as high-risk plants (EU 2018/2019) and therefore prohibited from entering the EU unless granted a country-specific derogation. This is the case for the import of Malus spp. plants for planting from Serbia ((EU) 2020/1361 corrected by 2022/1309). Therefore, this derogation could provide a plausible entry pathway for C. baileyi into the EU. Climatic conditions and the ample availability of the host, Malus spp., in the EU are conducive for establishment, as proven by the occurrence of C. baileyi in Greece. However, the species is not reported as having an impact in Greece, despite reports of damage outside the EU. Measures to prevent further entry and spread of C. baileyi in the EU are available. C. baileyi satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. However, uncertainties about the distribution of C. baileyi within the EU and its impact on apples in the EU are considered key and affect the confidence of conclusions for this categorisation.