EFSA Journal最新文献

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.

The European Commission submitted to the EFSA Panel on Plant Health a Dossier from the United States proposing the use of a vacuum–steam–heat treatment as a stand-alone phytosanitary measure to mitigate the risk of entry of Bretziella fagacearum, Geosmithia morbida and its vector Pityophthorus juglandis (thousand cankers disease complex) into the EU when trading oak (Quercus alba, Q. rubra) and walnut (Juglans nigra) logs with bark from the US. The proposed treatment consists of heating the sapwood to 56°C for 30 min at a depth of 5 cm from the cambium under vacuum and steam conditions. EFSA assessed the likelihood that logs of oak and walnut target species would be free from EU quarantine pests, basing its evaluation solely on the efficacy of the proposed treatment. In addition to B. fagacearum, G. morbida and P. juglandis, 14 other EU quarantine pests were identified as relevant because they are present in the US and are potentially associated with the commodities. The assessment was based on the information provided by the applicant country and on systematic literature reviews conducted by EFSA to determine the survival temperature and wood colonisation depth of the target pests. The evidence gathered was evaluated through an Expert Knowledge Elicitation (EKE) to estimate the likelihood of pest freedom of logs after the treatment assuming that all logs were infested. The vacuum–steam–heat treatment substantially reduces the presence of target pests infesting the sapwood. The EKE indicated with 95% certainty that between 9021 and 10,000 treated Q. alba logs per 10,000 and that between 9347 and 10,000 treated Q. rubra logs per 10,000 will be free from B. fagacearum. The EKE indicated with 95% certainty that between 9862 and 10,000 treated J. nigra logs per 10,000 will be free from G. morbida and that between 9948 and 10,000 treated J. nigra logs per 10,000 will be free from P. juglandis. However, the treatment is expected to be much less effective against pests which infest wood deeper than 5 cm from the cambium such as the species Arrhenodes minutus. The EKE indicated with 95% certainty that between 1109 and 10,000 logs per 10,000 will be free from A. minutus.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer AG Crop Science Division submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance deltamethrin in kiwi, melons and watermelons. The data submitted in support of the request were found to be sufficient to derive MRL proposals for kiwi, melons and watermelons. Adequate analytical methods for enforcement are available to control the residues of deltamethrin on the commodity under consideration at the validated 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 deltamethrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative and affected by non-standard uncertainties, due to the lack of information on the actual occurrence of residues of trans-deltamethrin and alpha-R-deltamethrin in certain crops and on the toxicological profile of both isomers.

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

The food enzyme β-fructofuranosidase (β-d-fructofuranoside fructohydrolase; EC 3.2.1.26) is produced with the non-genetically modified Aspergillus sp. strain ATCC 20611 by Beghin Meiji. The food enzyme was free from viable cells of the production organism. It is intended to be used in the processing of sugars for the production of fructo-oligosaccharides (FOS). Since residual amounts of total organic solids of the food enzyme are removed in FOS syrups, dietary exposure was not calculated. The toxicological studies were assessed as supportive evidence. 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 920 mg TOS/kg body weight (bw) per day, the highest dose tested. A search for the homology of the amino acid sequence of the β-fructofuranosidase 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 papain (EC 3.4.22.2) is extracted from the latex of unripe Carica papaya L. by Nagase (Europe) GmbH. It is intended to be used in six food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.112 mg TOS/kg body weight per day. This exposure is up to one order of magnitude lower than 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, were evaluated as supporting evidence. For the allergenicity assessment, the Panel considered the papain as well as three other cysteine endopeptidases known to be present in the food enzyme. Papain and chymopapain are known food allergens. In addition, homology searches of the amino acid sequences of the four proteins to known allergens identified matches with 6 food and 8 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 EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of a modified manufacturing process for the food additive enzymatically produced steviol glycosides (E 960c). The new process converts purified steviol glycosides extracted from Stevia rebaudiana leaves through enzymatic bioconversion catalysed by glucosyltransferase and sucrose synthase enzymes, both produced using three newly developed genetically modified strains of Escherichia coli (CDX-044 W3110-TKO, CDX-045 W3110-TKO and CDX-047 W3110-TKO). This modification of the manufacturing process yields two distinct preparations of steviol glycosides: SBP1, composed predominantly of rebaudioside M, and SBP2, composed predominantly of rebaudioside D. The modification leads to changes in the definition of the food additive, residual protein, residual solvents, microbiological criteria and particle size. The Panel concurred with the applicant's proposal to introduce two new entries in Commission Regulation (EU) No. 231/2012 corresponding to SBP1, predominantly rebaudioside M, and SBP2, predominantly rebaudioside D. The manufacturing process does not raise a safety concern since no viable cells nor DNA of the production strains remained in the final product; in addition, the food enzyme–total organic solid (TOS) are removed to at least 99%, and consequently, the exposure to the food enzyme–TOS via consumption of SPB1 and SPB2 can be considered negligible. The Panel considered that rebaudioside M and D produced by this new manufacturing process have the same physicochemical characteristics as the corresponding rebaudioside M and D present in E 960c(i), (ii) and (iii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of SBP1 and SBP2. The Panel concluded that there is no safety concern with respect to the proposed modification of the food additive enzymatically produced steviol glycoside E 960c related to the use of the new genetically modified strains of E. coli in the production process of SBP1 and SBP2.

The food enzyme containing cellulase (EC 3.2.1.4), endo-1,3(4)-β-glucanase (EC 3.2.1.6) and endo-1,4-β-xylanase (EC 3.2.1.8) activities is produced with the non-genetically modified Trichoderma reesei strain AR-999 by AB-Enzymes GmbH. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in 11 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 eight food manufacturing processes. It was estimated to be up to 4.031 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 1000 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 248. A search for the homology of the amino acid sequence of the cellulase, endo-1,3(4)-β-glucanase and endo-1,4-β-xylanase to known allergens was made and a match with one food allergen was found. 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 panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.