The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Denmark, for the pesticide active substance Beauveria bassiana strain R444 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 Beauveria bassiana strain R444 as an insecticide on tomatoes and as an acaricide on stone fruits. 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. Issues not finalised are identified.
In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to carry out a targeted review of the maximum residue levels (MRLs) for difluoroacetic acid (DFA), following the availability of data on DFA residue levels in commodities for which EU MRLs are based on Codex MRLs. EFSA identified the Codex MRLs implemented into EU legislation that may affect the corresponding MRLs for DFA and perform consumer risk assessment using current residue definitions and the health-based guidance values, applying the latest version of the pesticide residues intake model (PRIMo) model (revision 3.1). Based on the data available, EFSA derived MRL proposals for DFA in the relevant commodities. The exposure calculations performed by EFSA showed that the proposed MRLs do not result in consumer intake concerns.
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 S-acetyl glutathione (SAG) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of > 97% (w/w) SAG, which is an acetylated tripeptide (i.e. cysteine, glutamic acid and glycine) obtained through chemical synthesis. The information provided on the production process, composition and specifications of the NF did not raise safety concerns. The NF contains perchlorate, although its intake through this NF, added to the background dietary exposure, remains below the tolerable daily intake (TDI) established by EFSA, across the age groups. The NF is proposed to be used as a food supplement and as food for special medical purposes at a maximum dose of 300 mg NF/day, targeting the general population excluding individuals below 10 years of age, and pregnant or lactating women. A BMDL10 of 877 mg/kg bw per day was derived for the increase in the liver-to-body weight ratio from benchmark dose modelling, leading to a safe dose of 4.39 mg/kg bw per day after applying an uncertainty factor of 200. This corresponds to safe intake levels of 190, 269 and 307 mg/day for young adolescents (from 10 to < 14 years), older adolescents (from 14 to < 18 years) and adults, respectively. Human clinical data on orally administered glutathione support the safety of the NF in adults. The Panel concludes that the NF is safe at the proposed conditions of use of 300 mg/day for adults, excluding pregnant and lactating women. For young and older adolescents, the Panel considers that the NF is safe when consumed at intake levels up to 190 and 269 mg/day, respectively, assuming similar tolerance on a body weight basis as compared to adults.
Pinewood nematode (PWN) (Bursaphelenchus xylophilus) is a destructive pest of Pinus trees worldwide which depends for transmission on the cerambycid insects of the genus Monochamus. EFSA was asked to assess the potential role of young host plants for afforestation or reforestation planting as a pathway for PWN. According to legislation (EU COM/2023/415 final), these seedlings are not older than 2 years. Based on communication with SNPF (Syndicat National des Pépiniéristes Forestiers), such pine seedlings are assumed to have a collar diameter no more than 12 mm. It was evaluated that seedlings, by their physical dimensions, cannot sustain the complete developmental cycle of the vector insect Monochamus galloprovincialis. In particular, the reported empirical data on the minimum width of the head capsule of the phloem-based larval stage (L2) of 0.89-1.03 mm would not fit the 0.44-mm thick phloem of a 2-year-old pine tree, and the minimum 15-mm long pupal chamber with minimum observed inclination of 30° from the vertical of the heartwood, where L3 + L4 end feeding, would ultimately stretch beyond the 6-mm radius of the seedling and hence stick outside of the seedling. Observations of over 2000 beetle exit holes revealed that the branch diameter associated with successful insect development was larger than 20 mm, with a median of 90 mm. It was further evaluated that a vector-independent transmission between seedlings would necessitate direct contact of injured roots, which contrasts with prescribed procedures and good practice. The Panel considers the sequence of events leading to the transmission of nematodes through a seedling is highly implausible. Transmission would necessitate (i) nematode infestation of seedlings in a nursery, (ii) trade and planting of a symptom-free but nematode-infested seedling, (iii) its asymptomatic growth in the field to a tree size that allows vector development after years, (iv) the decline of this tree to attract vector egg laying while keeping nematodes in a developmental stage enabling insect vector transmission. Therefore, the Panel does not consider pine seedlings for afforestation or reforestation that are not older than 2 years and that have a root collar diameter of no more than 12 mm a pathway for PWN.
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 Belgium for the pesticide active substance choline hydrogen phosphonate and the assessment of an application 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 choline hydrogen phosphonate as a fungicide on grapevine and sports turf. MRLs were assessed in honey. 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.
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of a feed additive consisting of Saccharomyces cerevisiae CNCM I-1079 for dogs and all other Canidae, intended for use as a zootechnical additive (functional group: gut flora stabilisers). In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of the additive under the proposed conditions of use. The applicant therefore submitted supplementary information, including four efficacy trials in dogs. The studies assessed faecal dry matter, faecal consistency and faecal immunoglobulin A (IgA). In two trials, supplementation with the additive resulted in a significantly higher faecal IgA content; in one of these trials, an improvement in faecal consistency was also observed, whereas in the other, a higher faecal dry matter content was also identified. However, the remaining two trials did not show significant positive effects on the key parameters considered adequate to support efficacy. The FEEDAP Panel concluded that the available evidence is insufficient to demonstrate the efficacy of the additive to improve faecal consistency or faecal IgA content in dogs. Therefore, the Panel could not conclude on the efficacy of the additive for all Canidae.
Abstract The EFSA Panel on Food Contact Materials assessed the safety of the 1,3‐benzenedicarboxamide, 5‐[[[cis‐4‐(1,1‐dimethylethyl)cyclohexyl]carbonyl]amino]‐N1,N3‐bis[cis‐4‐(1‐methylethyl)cyclohexyl]‐, to be used as a clarifying agent in polypropylene at up to 0.08% w/w. The final articles are intended for contact with all types of food except foods containing more than 10% ethanol, infant formula or mineral water intended to be used to reconstitute infant formula. They are intended for long‐term storage at room temperature and below, including hot fill and heating conditions. The migration of the substance was below the limit of quantification of 0.05 mg/kg food in 10% ethanol, with values estimated up to 0.031 mg/kg in olive oil. The migration of the trans isomers can be estimated up to 0.0006 mg/kg food. The total mass transfer of all impurities was individually below 0.05 mg/kg food. The Panel excluded genotoxicity concerns for the substance based on in vitro studies. Trans isomers and relevant impurities were assessed using in silico and literature data and did not raise concerns for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 0.08% w/w in polypropylene homo‐ and co‐polymers, and the manufactured materials and articles are: (i) for single and repeated use, in contact up to and above 6 months at room temperature and below, including hot‐fill conditions and/or heating up to 70°C ≤ T ≤ 100°C for maximum t = 120/2^((T − 70)/10) min; and (ii) are used in contact with all types of food, excluding beverages with an ethanol content above 10%, infant formula, including reconstituted infant formula and human milk.
Abstract The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase, EC 3.2.1.41) is produced with the genetically modified Bacillus licheniformis strain NZYM‐LU by Novozymes A/S. The safety of this food enzyme was evaluated previously, and it 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 three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of five food manufacturing processes. As the food enzyme–Total Organic Solids (TOS) are removed from the final foods in two processes, the dietary exposure to the food enzyme–TOS was estimated for the remaining three food manufacturing processes. It was calculated to be up to 1.394 mg TOS/kg body weight per day in European populations. Based on the revised exposure estimation 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 subtilisin (EC 3.4.21.62) is produced with the non-genetically modified Bacillus licheniformis strain NZYM-CX by Novozymes A/S. The safety of this food enzyme was evaluated previously and it did not give rise to safety concerns when used in eight food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of 11 food manufacturing processes. As the food enzyme-Total Organic Solids (TOS) are removed in two processes, the dietary exposure to the food enzyme-TOS was estimated for the remaining nine food manufacturing processes. It was calculated to be up to 2.654 mg TOS/kg body weight per day in European populations. Based on the new data, the revised dietary 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.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lasalocid A sodium (Avatec® 150G) as a coccidiostat for turkeys, pheasants, guinea fowl, quails and partridges. The additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel was not in a position to conclude on the safety of the additive for the target species. The use of lasalocid A sodium at the highest proposed level of 125 mg/kg complete feed for turkeys up to 16 weeks of life and in growing pheasants, partridges, quails and guinea fowl remains safe for the consumer under the current conditions of the authorisation. The proposed reduction of the withdrawal time to 3 days is considered safe for the consumer. The existing maximum residue levels (MRLs) for poultry tissues ensure consumer safety. The additive is irritant to the skin and eye and the respiratory tract, but it is not a dermal sensitiser. Exposure of the users by any route is considered a risk. The use of the additive at the proposed conditions of use does not pose a risk for the terrestrial and aquatic compartments nor to sediment. No concern for groundwater is expected. The additive is unlikely to bioaccumulate and the risk for secondary poisoning is considered low. Lasalocid A sodium from Avatec® 150G has the potential to control coccidiosis in turkeys for fattening, turkeys reared for reproduction and pheasants at the minimum use level of 75 mg/kg complete feed. The data provided do not allow the Panel to conclude on the coccidiostatic effect of the additive in guinea fowl, quails and partridges.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the renewal of montmorillonite-illite mixed layer clay mineral as a technological feed additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel cannot conclude whether the additive montmorillonite-illite mixed layer clay mineral remains safe for the target species under the current conditions of the authorisation. The Panel also concludes that the use of the additive in animal nutrition remains safe for the consumer and for the environment under the current conditions of the authorisation. The additive should be considered as a skin and respiratory sensitiser. In absence of data, the FEEDAP Panel is not in the position to conclude on the eye irritation of the additive. Exposure of users by any route is considered a risk and should be minimised. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of sodium nitrite when used as a technological additive (functional group: silage additives) to improve the ensiling characteristics of all types of fresh plant material for pigs, bovines, poultry, sheep, goats, rabbits and horses, up to a maximum concentration of 900 mg sodium nitrite/kg fresh matter. The additive is specified to be used only in the form of premixtures. Based on the data provided, the Panel concluded that, since nitrite is a normal constituent of silage and the use of the additive would not result in a substantial change in the exposure of animals, sodium nitrite as a silage additive is considered safe for the target species, consumers and the environment. Regarding user safety, sodium nitrite should be considered an eye irritant. This conclusion would apply, in principle, to any preparation/premixture containing the additive. No conclusion could be drawn on the potential of sodium nitrite to be a skin irritant or skin sensitiser. In the absence of data, the Panel could not conclude on the efficacy of sodium nitrite alone as a silage additive. The use of sodium nitrite in combination with other substances has the potential to improve the production of silage made from all types of fresh plant material by enhancing the preservation of nutrients and to improve the aerobic stability of silage made from easy‐to‐ensile fresh plant materials.
Abstract The applicant Bayer AG Crop Science Division submitted a request to the competent national authority in Germany to evaluate the confirmatory data for the active substance fluopyram that were identified in the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005. Within the same submission, the applicant also requested, in accordance with Article 6 of Regulation (EC) No 396/2005, to set an import tolerance for fluopyram in limes. To address the Article 12 data gaps, new residue trials on lemons, tomatoes, melons, escaroles, land cresses and leeks were submitted. The additional trials on grapefruits and oranges were included as well although not required. No new residue trials were submitted to support tentative MRLs for bananas, Chinese cabbage/pe‐tsai, spinaches chards/beet leaves and globe artichokes. The new information provided, together with the assessment of alternative GAPs, enabled the derivation of revised MRLs. In the result of the assessment, the tentative MRLs were confirmed for grapefruits, oranges, lemons, mandarins, bananas and tomatoes. Moreover, lower MRLs were derived for spring onions, melons and watermelons, globe artichokes and leeks, while higher MRLs were derived for escaroles, land cresses and red mustards. In the absence of supporting data, and in line with the rotational crop assessment performed in the MRL review, an MRL of 0.15 mg/kg remains supported for Chinese cabbages/pe‐tsai, spinaches and chards/beet leaves. The available residue data enabled the derivation, by extrapolation, of an import tolerance MRL of 0.9 mg/kg for limes. A revision of the consumer risk assessment for fluopyram was performed, and a consumer concern was not identified.
At the request of the European Commission, EFSA assessed the 2024 post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810, which expresses the Cry1Ab protein. Using a weight-of-evidence approach and considering information provided by the consent holder and the Competent Authorities of Portugal and Spain, EFSA concluded that the PMEM report provides no evidence of unexpected adverse effects on human and animal health, or on the environment associated with the cultivation of maize MON 810 in 2024. Refuge compliance was generally high in Spain and fully achieved in Portugal. However, uncertainty remains in situations where clusters of small maize MON 810 fields may collectively exceed the 5-ha threshold requiring refuge implementation. No evidence of practical resistance to Cry1Ab was identified in European corn borer populations sampled in north-eastern Spain in 2024. Nevertheless, the consistently low Cry1Ab susceptibility observed in Mediterranean corn borer populations from this area between 2022 and 2024, together with unexpected field damage reported in Girona in 2021 as well as indications of resistance alleles detected in 2024, indicate that a decrease in susceptibility cannot be excluded. EFSA also considers that the current resistance monitoring strategy lacks sufficient sensitivity for the early detection of resistance evolution. General surveillance activities, including farmer questionnaires in Spain and annual literature searches, did not identify unanticipated adverse effects. However, uncertainty remains regarding the potential exposure of highly sensitive non-target Lepidoptera to maize MON 810 pollen due to the lack of implementation data on isolation distances toward protected habitats. EFSA also identified methodological and reporting shortcomings in both case-specific monitoring and general surveillance, while welcoming the continued efforts of the Competent Authorities of Spain to address data gaps and support refinement of monitoring and risk management measures. After more than two decades of cultivation without evidence of unexpected adverse environmental effects, EFSA considers that general surveillance could be streamlined to focus on two core elements: (1) a strengthened farmer complaint system, complemented where appropriate by existing plant health and pest monitoring networks; and (2) transparent and comprehensive annual literature searches.
Abstract Genetically modified RF3 Canola Quality (CQ) Brassica juncea was developed to confer tolerance to glufosinate‐based herbicides and to restore fertility in Barnase‐expressing plants. The RF3 event was originally developed in Brassica napus and has previously been assessed by EFSA in application EFSA‐GMO‐RX‐MS8‐RF3. The GMO Panel assessment of the molecular characterisation data and bioinformatics analyses did not raise issues that would require specific food and feed safety assessments. None of the identified differences in the agronomic, phenotypic and compositional characteristics tested between RF3 CQ B. juncea and its comparator need further assessment, except for yield, crude fat, aspartic acid and behenic acid (C22:0), which underwent additional evaluation and were found to not raise any environmental impact and safety or nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the PAT/bar and Barstar proteins as expressed in RF3 CQ B. juncea and finds no evidence that the genetic modification would change the overall allergenicity of RF3 CQ B. juncea. In the context of this application, the consumption of food and feed from RF3 CQ B. juncea does not represent a nutritional concern in humans and animals. The GMO Panel concludes that RF3 CQ B. juncea is as safe as the comparator and CQ non‐GM B. juncea varieties tested, and no post‐market monitoring of food and feed is considered necessary. In the case of release of RF3 CQ B. juncea material, including viable seeds, into the environment, this would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of RF3 CQ B. juncea. The GMO Panel concludes that RF3 CQ B. juncea is as safe as its comparator and the tested CQ non‐GM B. juncea varieties with respect to potential effects on human and animal health and the environment.
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of nicarbazin (NICACOX®) as a coccidiostat for chickens for fattening and chickens reared for laying. The FEEDAP Panel concluded that NICACOX® is safe for chickens for fattening and chickens reared for laying when used at concentrations up to 80 mg nicarbazin/kg complete feed during the first 21 days of life. The use of the additive under the proposed conditions (maximum use level of 80 mg/kg complete feed for 21 days) is considered safe for the consumer, provided that a withdrawal period of 5 days is ensured. Nicarbazin is not a skin nor eye irritant and is not a dermal sensitiser. In the absence of specific data on the final additive, the FEEDAP Panel cannot conclude on the safety of NICACOX® for the users. The use of nicarbazin (DNC and HDP) from NICACOX® in complete feed for chickens for fattening does not pose a risk for the terrestrial and aquatic compartments nor to sediment under the proposed condition of use. No concern for groundwater is expected, and no risk of secondary poisoning is identified. Nicarbazin from NICACOX®, given at a level of 75 mg/kg complete feed for the first 21 days of life is effective in preventing coccidiosis of chickens for fattening and chickens reared for laying in the corresponding time period.
Abstract 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 Sweden and co‐rapporteur Member State Italy for the pesticide active substance Trichoderma asperellum T34 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 2020/103. The conclusions were reached on the basis of the evaluation of the representative uses of T. asperellum T34 as a fungicide on ornamentals, tomato, sweet pepper, aubergine, cucumber, melon, watermelon, zucchini and pumpkin. 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. Data gaps were identified.
The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the non-genetically modified Aspergillus luchuensis strain AP2 903-6 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in three food manufacturing processes. Dietary exposure was estimated to be up to 0.551 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. The toxicity studies were carried out with a food enzyme containing endo-polygalacturonase and pectinesterase activities, which is further processed to obtain the food enzyme under assessment. 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 2182 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 3960. A search for the homology of the amino acid sequence of the pectinesterase to known allergens was made and matches with two respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this 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.
The food enzyme containing endo-polygalacturonase (1,4-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) and pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) activities is produced with the non-genetically modified Aspergillus luchuensis strain AP2 903-6 by Shin Nihon Chemical Co. Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight 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 seven food manufacturing processes. It was estimated to be up to 0.584 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 2182 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 3736. A search for the homology of the amino acid sequences to known allergens was made and matches with 14 respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure 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.
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 lacto-N-triose II (LNTri II) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) LNTri II, but it also contains d-glucose, d-galactose, d-lactose and lacto-N-triitol. The NF is produced by fermentation with a genetically modified strain (Kluyveromyces lactis DSM 709-2-02) of K. lactis DSM 70799. The information on the identity, production process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant formula (IF), follow-on formula (FOF), food supplements (FS) and food for special medical purposes (FSMP). The target population is the general population. In line with other HiMOs, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake of the NF. The anticipated daily intake from its use in IF is similar to the estimated natural mean highest daily intake in breastfed infants. The anticipated daily intake from the NF as a food ingredient at the maximum proposed use levels exceeds the intake level of breastfed infants on a body weight basis in infants and children. Of note, higher exposure can be obtained from LNTri II as it is a by-product in the already authorised HiMOs (e.g. Lacto-N-tetraose). In addition, the natural intake estimate does not consider the formation of LNTri II at gastrointestinal level by gut microbiota fermentation or acid hydrolysis. The Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns and concludes that the NF is safe under the proposed conditions of use.
