EFSA Journal最新文献

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Trichoderma reseei strain AR-822 by AB Enzymes GmbH. 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 five 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 four food manufacturing processes. It was estimated to be up to 0.127 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, resulted in a margin of exposure of at least 7874. A search for the homology of the amino acid sequence of the triacylglycerol lipase 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 conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Ireland and co-rapporteur Member State, Poland, for the pesticide active substance dichlorprop-P and the variant dichlorprop-P-2-ethylhexyl and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached based on the evaluation of the representative uses of dichlorprop-P as herbicide on cereals, grassland and grass seed crops and of the variant dichlorprop-P-2-ethylhexyl as a plant growth regulator on citrus. MRLs were assessed in mandarin and lemon. The conclusions from 2018 were updated in 2024 following the request from the European Commission regarding the endocrine disruption properties. The conclusions were further updated in 2025 in the context of the peer review required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council for an amendment in approval conditions. The purpose of this application was to extend the existing approval to include the ester variant dichlorprop-P-2-ethylhexyl under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market. The reliable end points, 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.

EFSA has received a request for a rapid risk assessment for cereulide from the European Commission. Cereulide is a heat-stable emetic toxin produced by Bacillus cereus, recently detected in infant formulae from multiple manufacturers. This led to precautionary recalls across several countries. EFSA was requested to determine the acute reference dose (ARfD) for cereulide in infants, based on available toxicological data, and provide information on the acute consumption of infant formulae from EFSA's food consumption database. From the available toxicological data, emesis was considered as the critical endpoint for the acute effects of cereulide. A study in adult Asian house shrews was considered as the most appropriate for benchmark dose (BMD) modelling, and a BMDL₁₀ of 4.2 μg/kg body weight (bw), corresponding to a 10% increased risk of emesis, was derived. An ARfD of 0.014 μg/kg bw was then derived by applying a default uncertainty factor (UF) of 100 and an additional UF of 3 for reduced xenobiotic metabolism and renal excretion in infants. Available consumption data confirmed EFSA's previous recommendation to use a high consumption value of 260 mL/kg bw for estimating acute exposure to cereulide via infant formulae. When assessing acute exposure from follow-on formulae, a P95 consumption value of 140 mL/kg bw was considered more appropriate. Cereulide concentrations above 0.054 μg/L and 0.1 μg/L in reconstituted infant formulae and follow-on formulae, respectively, may therefore exceed the derived ARfD.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co-rapporteur Member State France for the pesticide active substance paraffin oil CAS 64742-46-7 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of paraffin oil CAS 64742-46-7 as an insecticide on citrus trees. 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.

This Scientific Opinion assesses the welfare of turkeys of all ages (Meleagris gallopavo gallopavo) on farm in relation to the type and condition of the litter, type and availability of enrichment (including covered veranda and outdoor range), space allowance, concentrations of ammonia and carbon dioxide, effective environmental temperature, group size, nest conditions, lighting conditions and hatchery conditions, by using 19 welfare consequences and associated animal-based measures (ABMs) for their assessment. In addition, the risks posed by the practices of flock thinning and removal of hens, mutilations (i.e. beak trimming, desnooding and toe trimming), artificial insemination (including semen collection) and feed restriction are assessed, with the latter two practices only in turkey breeders. The welfare consequences of breeding is assessed. Recommendations to prevent and/or mitigate relevant welfare consequences in fattening and breeder turkeys include increasing space allowance compared to the currently provided space, avoiding feed and water deprivation of newly-hatched poults for more than 48 h, and providing enrichment such as elevated platforms, straw-bales and a covered veranda. It is recommended to maintain dry litter conditions, i.e. below a threshold of 35%–40% humidity. Beak trimming, desnooding and toe trimming as well as the associated welfare consequences can be avoided if the recommended housing and management practices are implemented, e.g. increasing space allowance and providing suitable enrichment. It is recommended to discontinue flock thinning and avoid quantitative feed restriction, the latter currently practised in breeder toms. Also, it is recommended to place more emphasis on leg health and less on weight gain in genetic selection. The selected ABMs to monitor relevant welfare consequences at the slaughterhouse are total mortality, plumage damage, carcass condemnation, wounds, breast blisters and footpad dermatitis.

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Greece, and co-rapporteur Member State, France, for the pesticide active substance paraffin oil (CAS 72623-86-0) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of paraffin oil (CAS 72623-86-0) as an insecticide on seed potatoes. 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.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Belchim BV submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level (MRL) for the active substance cyflumetofen in sweet peppers/bell peppers. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for sweet peppers/bell peppers. Adequate analytical methods for enforcement are available to control the residues of cyflumetofen (sum of isomers) in plant matrices 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 uses of cyflumetofen according to the reported agricultural practices is unlikely to present a risk to consumer health.