Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the additive consisting of Saccharomyces cerevisiae NBRC 0203 and Lacticaseibacillus rhamnosus NBRC 3425 when used as a technological additive to improve ensiling of all fresh plant material for all animal species at a proposed minimum concentration of 4.0 × 102 and 3.2 × 106 colony forming units (CFU)/kg fresh plant material, respectively. The bacterial species S. cerevisiae and L. rhamnosus are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strains was established, the absence of resistance to antimycotics was confirmed for S. cerevisiae and no acquired antimicrobial resistance genes were detected in L. rhamnosus. Therefore, the FEEDAP Panel concluded that the use of both strains as a silage additive is considered safe for all the animal species, consumers and the environment. Regarding user safety, inhalation and dermal exposure are considered a risk. No conclusions can be drawn on the eye irritancy potential of the additive. The FEEDAP Panel concluded that the additive at a minimum level of 4.0 × 102S. cerevisiae NBRC 0203 and 3.2 × 106L. rhamnosus NBRC 3425 CFU/kg fresh plant material has the potential to improve the production and fermentation quality of silage made from easy and moderately difficult to ensile fresh plant material, with dry matter (DM) content ranging from 31% to 51%.

The food enzyme phospholipase A2 (phosphatidylcholine 2‐acylhydrolase; EC 3.1.1.4) is produced with the genetically modified Trichoderma reesei strain RF8793 by AB Enzymes GmbH. In a previous opinion, the total organic solids (TOS) values could not be calculated, which led to the inability to establish the representativeness of the batch used for toxicological examination and to calculate the dietary exposure. In this assessment, EFSA completes the safety evaluation of this food enzyme by taking into account the chemical compositional data from new food enzyme batches. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.008 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 125,000. Based on the new data and the previous evaluation, 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 Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of ascorbic acid, sodium ascorbate, calcium ascorbate, ascorbyl palmitate, sodium calcium ascorbyl phosphate, sodium ascorbyl phosphate (as sources of vitamin C) as feed additives for all animal species. The applicants have provided data demonstrating that the additives currently in the market comply with the conditions of authorisation. Thus, the FEEDAP Panel concludes that the additives remain safe for the target species, consumers and the environment. Regarding the user safety, ascorbic acid and sodium ascorbyl phosphate are not irritant to the skin or eyes and are not dermal sensitisers. Sodium ascorbate is not a skin sensitiser, but the Panel cannot conclude on its potential to be irritant to skin and eyes. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety of calcium ascorbate for the user. Ascorbyl palmitate is not irritant to skin and eyes and is not a dermal sensitiser. Sodium calcium ascorbyl phosphate should not be considered a skin and eye irritant nor a skin sensitiser.There is no need to assess the efficacy of the additives in the context of the renewal of the authorisation.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐tryptophan produced with a genetically modified strain of Escherichia coli (CCTCC M 2024517) as a nutritional additive in feed and water for drinking for all animal species and categories. The l‐tryptophan produced by fermentation with E. coli CCTCC M 2024517 did not give rise to any safety concern regarding the genetic modifications of the production strain. No viable cells nor DNA of the production strain was detected in the final product. The use of l‐tryptophan produced with E. coli CCTCC M 2024517 in feed is safe for the target species when supplemented in appropriate amounts to the diet according to their nutritional needs. The FEEDAP Panel had concerns on the use of l‐tryptophan in water for drinking. The use of l‐tryptophan produced by fermentation with E. coli CCTCC M 2024517 in animal nutrition was considered safe for the consumers of products from animals receiving the additive and for the environment. The FEEDAP Panel could not conclude on the potential of the additive to be an irritant to skin and/or eyes and to be a potential skin sensitiser. The additive was regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation.

Following an application from PepsiCo International, submitted pursuant to Article 19 of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the modification of an authorised health claim related to beta‐glucans from oats or barley and reduction of postprandial glycaemic responses. The proposed modification concerns a reduction of the lowest effective dose from 4 g to 2 g of beta‐glucans (BG) per 30 g of available carbohydrates (avCHO). Beta‐glucans from oat and barley, which are the subject of the health claim, have been sufficiently characterised. A reduction of postprandial glycaemic responses is a beneficial physiological effect in the context of the food/constituent and the target population for this claim. The applicant submitted 21 pertinent published human intervention studies (59 trial comparisons) investigating the effect of beta‐glucans from oat or barley on the postprandial incremental area under the curve (iAUC) for glucose using matched comparators and conducted a dose–response meta‐regression analysis. Four published systematic reviews and dose–response meta‐regression analyses were also provided. In weighing the evidence, the Panel considered that the human intervention studies did not consistently show a significant effect of beta‐glucans from oats or barley on postprandial glucose iAUC at doses between 2 and < 4 g BG/30 g avCHO, and that dose–response data suggest a lowest effective dose above the 2 g/30 g avCHO proposed by the applicant. The Panel concludes that a consistent effect of beta‐glucans from oats or barley on the reduction of postprandial glycaemic responses has not been demonstrated under the conditions of use proposed by the applicant of at least 2 g BG/30 g avCHO consumed with a meal.

Following an application from Mediconomics APS, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Denmark, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to calcium sulphate and reduction in body weight. The Panel considers that the food constituent, calcium sulphate, is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight adults. The applicant submitted two human intervention studies investigating the effect of calcium sulphate on body weight. The Panel notes that no conclusions can be drawn from any of the human intervention studies submitted for the scientific substantiation of the claim and that no convincing evidence has been provided for a mechanism by which calcium sulphate could exert the claimed effect in vivo in humans. The Panel concludes that a cause and effect relationship has not been established between the consumption of calcium sulphate and a beneficial physiological effect on body weight under the proposed conditions of use.

Abstract The provision of historical control data (HCD) is a data requirement for pesticide active substances established by European legislation. HCD are data from studies conducted under the same or similar conditions as the toxicity study under assessment (index study). The collation, use and interpretation of HCD is currently not harmonised. The Panel on Plant Protection Products and their Residues developed this Scientific Opinion to elucidate the requirements for the use of HCD for interpretation of studies used for regulatory purposes, clarify how HCD should be compiled as part of the regulatory dossier and assist the interpretation of HCD in the context of the evaluation of regulatory studies. This Opinion proposes a stepwise, quantitative approach using a decision scheme which includes seven distinct steps grouped in three overall clusters of activity: (1) planning, (2) evaluation of the HCD and (3) use of HCD. In the planning phase, a protocol for collating the relevant HCD as well as their expected evaluation and analysis should be developed. Cluster 2 deals with the data requirements for HCD, including their use for quantitative statistical analysis. A final set of HCD is selected and the variability within and between studies is modelled. Statistical comparison of the HCD with the concurrent control data set and integration of the HCD into the analysis of the index study is carried out in cluster 3, including an influence or sensitivity analysis. To demonstrate the application of the decision scheme to different data types, three case studies have been prepared. The Opinion also offers templates to improve harmonisation for data submission and discusses confounding/covariate aspects related to HCD interpretation. Practical application of the Opinion requires a close exchange of toxicological and statistical input in the analysis of data and derivation of conclusions. It is recommended to consider this interaction between the disciplines every time submission and interpretation of HCD is planned.

Following the submission of dossier GMFF‐2024‐21890 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seeds US LLC, 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 genetically modified cotton GHB614 × LLCotton25, 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, 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 sequences of the events in cotton GHB614 × LLCotton25 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF‐2024‐21890 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on cotton GHB614 x LLCotton25.

The EFSA Panel on Plant Health performed a pest categorisation of Coccus viridis (Hemiptera: Coccidae), the green coffee scale, for the territory of the European Union (EU), following the commodity risk assessment of Jasminum polyanthum from Uganda, in which C. viridis was identified as a pest of possible concern to the EU. Coccus viridis is distributed in tropical and subtropical areas of the Americas, Africa, Asia and Oceania. In the EU, C. viridis occurs on the Azores and Madeira Islands (Portugal). It is a polyphagous pest, feeding on plant species belonging to more than 200 genera from 72 plant families, primarily on coffee (Coffea arabica), guava (Psidium guajava) and cacao (Theobroma cacao) plants. Hosts that are grown in the EU include Apium graveolens, Citrus spp., Eriobotrya japonica, Eucalyptus camaldulensis, Mangifera indica, Pyrus communis and some ornamental plants. Plants for planting, fruits, vegetables and cut flowers provide potential pathways for entry into the EU. Climatic conditions and availability of host plants in southern and central EU countries would allow this species to establish and spread. However, since little is known about the pest‐specific temperature requirements, and considering its tropical and subtropical origin, there is uncertainty about its ability to establish outdoors in central EU. Nevertheless, establishment could occur in greenhouses and on indoor plantings in such areas. Introduction and spread of C. viridis would likely have an economic impact in the EU, but there is uncertainty on the magnitude. This insect is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. Phytosanitary measures are available to reduce the likelihood of entry and further spread. While the magnitude of impact in the EU is associated with uncertainty, all criteria assessed by EFSA for consideration as a potential quarantine pest are met.

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 Bacillus velezensis CECT 5940 (Ecobiol®) as a zootechnical feed additive for laying hens and other birds for egg production. The additive is authorised for use in feed for chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (except for reproduction). With the current application the applicant is seeking the authorisation for a new use in feed for laying hens and other bird species kept for egg production purposes. In addition, the applicant is seeking the modification of the strain taxonomy in the Ecobiol® authorisation for chickens for fattening and reared for laying from B. amyloliquefaciens CECT 5940 to B. velezensis CECT 5940. The FEEDAP Panel concluded that the active agent should be taxonomically designated as B. velezensis CECT 5940. The FEEDAP Panel concluded that Ecobiol® is also considered safe for the target species, including laying hens and other birds for egg production, consumer and the environment at the proposed conditions of use. Regarding user safety, the additive is considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The additive is not irritant to eyes. The Panel concluded that Ecobiol® has the potential to be efficacious as a zootechnical additive when added at 1 × 109 CFU/kg in the feed for chickens for fattening and laying hens. The conclusion reached in these species can be extrapolated to all poultry.