Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of xylanase (produced with Komagataella phaffii DSM 25376) and β‐glucanase (produced with K. phaffii DSM 26469) (ENZY CARBOPLUS®) as a zootechnical feed additive (functional group: digestibility enhancers). The additive is authorised for use in feed for all poultry, weaned piglets and minor weaned porcine species. The applicant requested an extension of use to all porcine species for fattening and reared for production. The FEEDAP Panel concluded that the additive is safe for all porcine species for fattening and reared for reproduction, the consumers and the environment. The additive is not a skin or eye irritant nor a dermal sensitiser, but it is considered a respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive at a level of 1400 LXU and 120 LGU per kg feed for all porcine species for fattening and reared for reproduction.
Abstract 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 powdered Xanthobacter sp. SoF1 biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a bacterial biomass powder and is proposed to be used as an ingredient in several food categories, targeting the general population. The information provided on the production process, composition, stability and specifications of the NF is sufficient and does not raise safety concerns. Consistent with the modest protein quality of the NF, proteolytic fermentation in the colon gave rise to branched SCFA and ammonia. In the Caco‐2 model, colonic fermentation induced a modest increase in epithelial permeability, without evidence of cytotoxicity or reduced cell viability. Based on the data provided, the Panel considers that there are no concerns regarding genotoxicity. In a 90‐day oral toxicity study, no adverse effects were observed up to the highest dose tested, 1500 mg/kg body weight (bw) per day. Under the proposed conditions of use, the highest 95th percentile intake estimates of the NF ranged from 0.765 mg/kg bw per day in infants to 7.092 mg/kg bw per day in other children. Taking into account the identity, production process, compositional data and the absence of toxicity in the provided studies, the Panel considers that the resulting margins of exposure (MoE) are sufficient, with the lowest MoE being 212 for other children. The Panel considers that the allergenic potential of the NF is unknown and that cross‐reactivity to known allergens cannot be excluded. The Panel concludes that the NF is safe under the proposed conditions of use.
Abstract 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 The Netherlands for the pesticide active substance Bacillus velezensis strain FZB42 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 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 Bacillus velezensis strain FZB42 as a fungicide for seed treatment, soil drenching and drip irrigation (field, permanent and non‐permanent protected structures) in tomato and lettuce against rhizoctonia sp.; tuber treatment and in‐furrow application in potato against rhizoctonia sp., and wheat seed treatment against Gaeumannomyces graminis. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Issues not finalised are identified.
Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Belgium, for the pesticide active substance cypermethrin are reported. The peer review was requested by the European Commission following the submission and evaluation of confirmatory information, as set out in the renewal of approval of cypermethrin under Regulation (EC) No 1107/2009, focused on the relative toxicity of individual cypermethrin isomers (four enantiomeric pairs). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, where relevant to the scope of this evaluation, are presented. The submitted information was considered suitable for a qualitative, but not quantitative, comparison of the individual cypermethrin enantiomers. Issues not finalised and critical areas of concerns previously identified in the renewal peer review remain applicable.
Abstract The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data for cycloxydim, which had been identified as unavailable in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005. To address the data gaps identified for spring onions, lamb's lettuces, escaroles, cresses and land cresses, additional residue trials on spring onions and open‐leaf lettuce varieties were submitted sufficiently addressing the Article 12 data gaps. Based on the new information provided, the tentative MRL in spring onions was confirmed. For lamb's lettuces, a lower MRL than the tentative MRL was considered sufficient, while for escaroles, land cresses and cresses, higher MRLs than the tentative MRLs would be needed to support the authorised and adjusted southern European Union (SEU) uses. No new information on analytical methods was submitted for herbal infusions from roots, therefore this data gap remains not addressed and the existing tentative MRL cannot be confirmed. EFSA updated the consumer risk assessment and concluded that the short‐term and long‐term dietary intake of residues resulting from the existing authorised uses of cycloxydim is unlikely to present a risk to consumer health.
