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The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data for ametoctradin, which had been identified as unavailable in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. To address the data gaps, additional information was submitted for analytical methods, residue trials on primary and rotational crops, storage stability and a feeding study in ruminants. The data gaps were considered satisfactorily addressed. The new information provided confirmed existing MRLs for spring onions, barley, oat, rye, wheat and hops and required an increase of MRLs for certain products of animal origin. A revision of the consumer risk assessment for ametoctradin was also performed, including the contribution of residues in rotational crops, and indicated no consumer health concerns. However, the chronic consumer risk assessment for products of animal origin shall be regarded as indicative, pending toxicological information on the metabolites M650F01 and M650F06.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lactiplantibacillus plantarum DSM 34271 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. plantarum 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. plantarum DSM 34271 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. plantarum DSM 34271 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.

Following the submission of dossier GMFF-2023-21253 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 stearidonic acid producing genetically modified soybean MON 87769, 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, post-market 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 sequence of the event in soybean MON 87769 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2023-21253 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87769.

Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the revision of the safe level of intake for supplemental docosahexaenoic acid (DHA). Systematic reviews of the literature were conducted to identify human intervention studies administering supplemental DHA alone from a source with an eicosapentaenoic acid (EPA)/DHA ratio < 0.3 for at least 8 weeks, without restrictions on population or outcome. Hazard identification focused on bleeding complications (including bleeding time, platelet function and blood clotting parameters), glucose homeostasis, blood lipid profile, markers of lipid peroxidation, immune function, pregnancy endpoints and safety, tolerability and adverse events. The risk of spontaneous bleeding was selected as the critical effect on which to base the UL/safe level of intake for supplemental DHA alone. In the absence of adequate data to characterise a dose–response relationship and identify a reference point, no UL for supplemental DHA alone can be established for any population group. Therefore, the Panel derived a safe level of intake, which differs from a UL in that it is based on intakes up to which no adverse effects have been observed. Based on the available evidence, the Panel retains the safe level of intake of 1 g/day for supplemental DHA alone established in 2012 for all population groups (i.e. infants, children, adolescents and adults, including pregnant and lactating women). This safe level of intake applies to DHA added to foods or consumed as food supplements in any chemical form (e.g. triacylglycerols, ethyl esters, phospholipids) from sources (e.g. fish oil concentrates, algal oils, krill oils) containing DHA alone or mostly DHA (i.e., EPA/DHA ratio < 0.3).

The European Commission requested the EFSA Panel on Plant Health to evaluate the likelihood of pest freedom at entry in the EU, including both regulated and non-regulated pests, potentially associated with unrooted cuttings of the genera Petunia and Calibrachoa produced under physical isolation in Uganda. The relevance of any pest for this opinion was based on evidence collected according to specific criteria, following the methodology used for high-risk plants adapted for the specificity of this assessment. Twelve EU-regulated pests [Bemisia tabaci (non-European populations), cowpea mild mottle virus (CpMMV, Carlavirus vignae), potato leaf roll virus (PLRV, Polerovirus PLRV), potato spindle tuber viroid (PSTVd, Pospiviroid fusituberis), potato virus S (PVS, Carlavirus sigmasolani, non-EU isolates), potato virus × (PVX, Potexvirus ecspotati, non-EU isolates), Ralstonia solanacearum, Ralstonia pseudosolanacearum, Scirtothrips dorsalis, tomato leaf curl Uganda virus (ToLCUV), tomato spotted wilt virus (TSWV, Orthotospovirus tomatomaculae) and tomato yellow leaf curl virus (TYLCV, Begomovirus coheni)] and one non-regulated pest (Nipaecoccus viridis) were selected for further evaluation. For the selected pests, the risk mitigation measures implemented in Uganda and described in the technical dossier were evaluated taking into account the factors reducing their efficacy. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest. The degree of pest freedom varies between the pests evaluated, with the contact-transmitted viroid and virus [potato spindle tuber viroid (PSTVd, P. fusituberis) and potato virus × (PVX, P. ecspotati, non-EU isolates)] being the pests most frequently expected on Petunia and Calibrachoa spp. imported unrooted cuttings. Expert knowledge elicitation indicated, with 95% certainty, that between 9916 and 10,000 per 10,000 Petunia and Calibrachoa spp. unrooted cuttings would be free from these pests.

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.

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 Enzybel International SA. It is intended to be used in nine food manufacturing processes. Since residual amounts of the food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining eight food manufacturing processes. It was estimated to be up to 0.409 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. The toxicological studies provided were not required according to the current guidance; nevertheless, they were evaluated as supporting evidence. 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.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France and co-rapporteur Member State Austria for the pesticide active substance pydiflumetofen and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of pydiflumetofen as a fungicide field application on pome fruits, grapes, potato, fruiting vegetables, cucurbits and Brassica vegetables and updated following the request from Commission to consider additional information submitted and review the risk assessment. The conclusions were further updated at the request of European Commission to review the exposure and risk assessments for pydiflumetofen in light of a newly available 28-day inhalation toxicity study that was not included in the initial assessment report. Finally, EFSA was mandated to provide a summary of the assessment of the representative formulation in an updated conclusion. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Following the submission of application GMFF-2023-21236 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, increased oleic acid genetically modified soybean MON 87705, 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, post-market 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 sequence of the event in soybean MON 87705 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application GMFF-2023-21236 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87705.

The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the genetically modified microorganismTrichoderma reesei strain DP-Nzq40 by Danisco US Inc. 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. It is intended to be used in the processing of grains and other cereals for the production of distilled alcohol. Since residual amounts of total organic solids (TOS) are removed by distillation, toxicological data were not considered necessary and dietary exposure was not calculated. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and matches with two respiratory allergens were found. The Panel considered that a risk of allergic reactions to the food enzyme can be excluded for the production of distilled alcohol. 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.