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In Pesticide Action Network Europe v Commission (Case T-536/22), Pesticide Action Network Europe (PAN Europe) contested the renewal by the European Commission of the active substance cypermethrin. This substance is used or is marketed as an insecticide in large-scale commercial agricultural applications as well as in consumer products for domestic purposes (ant and cockroach killer). PAN Europe sought the annulment of the European Commission's decision of 23 June 2022 by which the latter rejected the request for internal review made by PAN Europe in accordance with Regulation (EC) No. 1367/2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters. The applicant argued, in essence, that where a risk is established with sufficient certainty by the European Food Safety Authority (EFSA), the Commission could not disregard the conclusions of the scientific assessment by relying on its powers as risk manager. In stressing the discretion enjoyed by the Commission, the General Court dismissed the action of PAN Europe. This casenote suggests that the General Court applied the precautionary principle too formally. [ABSTRACT FROM AUTHOR]

This report addresses the problem formulation step of scientific assessments to support the European Food Safety Authority (EFSA) in the development of guidance. The current report is comprised of a review of published literature on approaches for problem formulation, an environmental scan of two years of scientific assessments published in the EFSA Journal, classification of each publication as to its questions and sub‐questions, and a proposed framework and drafted handbook of recommendations to guide problem formulation. Over 700 EFSA publications were reviewed to identify scientific assessment activities, questions, and sub‐questions. A framework was developed to: 1) translate the mandate into assessment questions; 2) define the sub‐questions of each assessment and their relationship, optionally including a conceptual model; and 3) select the approach to take in designing the methods of the protocol for the assessment. The framework and guidance for problem formulation describe the role of literature scans, question formulation, relationships among sub‐questions, and screening and prioritizing sub‐questions. The report includes proposed cross‐cutting language with a common set of terms to promote understanding and application across diverse EFSA domains. For question formulation, the acronym APRIO was proposed, referring to A(gent), P(athway), R(eceptor), I(ntervention), and O(utput) as variously essential elements of all EFSA questions and sub‐questions. [ABSTRACT FROM AUTHOR]

Following the adoption of Regulation (EU) No 1169/2011 on food information to consumers, the European Commission requested EFSA to update its 'Guidance on safety evaluation of sources of nutrients and bioavailability of the nutrient from the sources' regarding the scientific principles and data requirements for the scientific assessment of all new forms of micronutrients and to derive a conversion factor for new micronutrient sources or forms of micronutrients to be authorised for addition to foods, including food supplements. This guidance outlines the scientific principles that the NDA Panel will consider for the assessment of the safety and the quantification of the relative bioavailability of new sources of micronutrients, which applicants are requested to consider when preparing their applications. It also outlines the data requirements for dossiers. Applicants should integrate the data presented in different sections to provide their overall considerations on how the information provided supports the safety of the new micronutrient source and the quantification of its relative bioavailability compared to a reference source under the proposed conditions of use. As preparatory work for the development of this guidance, EFSA launched an Expert Survey and held an online workshop on 9th March 2023 inviting scientific input from stakeholders and scientific experts, the report of which is now available online in the EFSA's webpage. [ABSTRACT FROM AUTHOR]

The European Commission asks scientific and technical assistance from EFSA to determine the impact of the revision of the Australian monitoring programme on its ability to detect microbiological contamination. Considering that, in 2010, the European Commission determined the current Australian monitoring programme to be equivalent to the EU requirements for microbiological monitoring further to an EFSA scientific assessment, the current and proposed programmes were described and the total number of alerts was compared using a probabilistic modelling approach. In the current programme, only beef and sheep carcasses are monitored using three‐class moving window sampling plans, while in the proposed programme, carcass, bulk meat, primal and offal are monitored using four two‐class sampling plans and Salmonella testing is excluded. The models revealed that the current programme provides a higher number of alerts for APC, while the proposed monitoring programme provides a higher number of alerts for E. coli. For APC and E. coli combined, the mean, 5th and 95th centiles of the uncertainty distribution of the total number of alerts in the current and the proposed monitoring programme are 201 [179, 227] and 172 [149, 194] for beef, and 199 [175, 222] and 2897 [2795, 3008] for sheep, respectively. For Salmonella, there are no alerts for the proposed programme since sampling is excluded while for the current programme, the estimated mean, 5th and 95th centiles of the uncertainty distribution of the number of alerts for a 5‐year period were 143 [126, 144] for heifer/steer, 1.6 [0, 4] for cow/bull and 0 [0, 0] for lamb/sheep. Overall, for APC and E. coli, the estimated total number of alerts was similar (beef) or higher (sheep) for the proposed compared to the current programme. In contrast, Salmonella sampling is excluded from the proposed programme and thus cannot detect the number of current alerts. [ABSTRACT FROM AUTHOR]

EFSA Strategy 2027 outlines the need for fit‐for‐purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the 'Draft framework for protocol development for EFSA's scientific assessments' published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub‐questions is proposed: the 'APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross‐cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub‐questions, including uncertainty analysis. Five possible approaches to answering individual (sub‐)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi‐formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and – not covered in this guidance – generating empirical evidence ex novo. The guidance is complemented by a standalone 'template' for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7349/full [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to review a scientific assessment related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling. The EC requested EFSA to consider comments raised by the German authorities in relation to: (a) the maximum amount of mustard protein that could be consumed from the emulsifiers manufactured from behenic acid (E470a, E471 and E477) on a single occasion and (b) the minimal observed eliciting dose (MOED) triggering allergic reactions in mustard‐allergic individuals. The maximum amount of mustard protein content in behenic acid was re‐assessed in view of new analytical data provided by the applicant. Intake estimates by the EFSA ANS Panel for E471 (adults) were used as a proxy for the combined intake (E470a, E471 and E477). Food challenge data and systematic reviews thereof deriving population minimal observed eliciting dose distributions for mustard protein were used to calculate the MOED and estimate the risk. The margin of exposure between the MOED (0.26 mg mustard protein) and the maximum amount of mustard protein that could be consumed from the emulsifiers on a single occasion (0.00895475 mg) is 29. It is predicted that between 0.1% and 1% of the mustard allergic population would react with mild objective symptoms to that dose. Overall, the assessment is conservative, particularly in relation to the exposure. Based on the information and data available, the NDA Panel concludes that it is extremely unlikely (≤ 1% probability) that oral consumption of emulsifiers to be manufactured using behenic acid from mustard seeds (i.e. E470a, E471 and E477) will trigger an allergic reaction in mustard‐allergic individuals under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

This report evaluates the training courses delivered under the contract OC/EFSA/SCER/2017/01 ‐ Lot 1. Within the period of January 2018 to February 2022 a total of 21 training courses were provided, eight on‐site training courses in Parma at EFSA, six virtual training courses during the Covid‐19 pandemic and seven eLearning courses comprising various numbers of modules. The courses covered different aspects of chemical and biological risk assessment and related tools, namely i) harmonisation of risk assessment methodologies for human health and ecological risk assessment of combined exposure to multiple chemicals (mixture assessment), ii) risk assessment of the application of nanoscience and nanotechnologies in agro/food/feed (nanotoxicity); iii) science‐based criteria for identifying endocrine disruptors in the context of EU legislation on pesticides and biocides (endocrine disruption); iv) principles on genotoxicity on scientific assessment (genotoxicity) and v) computational toxicology approaches and tools (in silico). All tutors were experts in their field and had previously performed training courses on these topics. The target participants of the training courses were members of EFSA's Scientific Committee/Panels and their working groups as well as employees from national and international regulatory agencies associated with risk assessment of feed and food compounds. Members of the EFSA Networks as well as EFSA scientific staff also participated in the training courses. Courses were evaluated based on the feedback of participants and continuously improved also by integrating updated or new EFSA guidance documents. [ABSTRACT FROM AUTHOR]

The EFSA asked the Panel on Animal Health and Welfare to develop a guidance document on good practice in conducting scientific assessments in animal health using modelling. In previous opinions, the AHAW Panel has responded to two‐thirds of animal health‐related mandates using some kind of modelling. These models range from simple to complex, employing a combination of scientific, economic, socio‐economic or other types of data. Hence, there is strong interest in the development of a guidance document to integrate modelling efforts into the routine process of EFSA working groups. In this document, an 'operating procedure' (OP) for the use of modelling within an AH working group is presented. The OP provides a detailed flowchart enabling modelling to be transparently and consistently integrated in the assessment. The OP is structured into phases. These phases combine the relevant standard operating procedures and working instructions of EFSA with the modelling process. Each phase includes roles and actions to be taken, expected output and the sequence of agreements that need to be made between all partners in the scientific assessment. In conclusion, it is expected that adherence to the OP will improve transparency of models in EFSA outputs, and it is recommended to adopt it as a standard procedure when responding to AHAW mandates. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 4‐methyl‐5‐vinylthiazole [15.018] belonging to chemical group 29 (thiazoles, thiophene and thiazoline), when used as sensory additive (flavourings) in feed for all animal species. The FEEDAP Panel concluded that 4‐methyl‐5‐vinylthiazole [15.018] was safe at the maximum proposed use level of 0.5 mg/kg complete feed for veal calves (milk replacer), dogs, salmonids and ornamental fish. For the other species, the calculated safe concentrations in complete feed are: 0.4 mg/kg for cattle for fattening, sheep/goat, horses and cats; 0.3 mg/kg for sows and dairy cows; 0.2 mg/kg for piglets, pigs for fattening, rabbits and laying hens; and 0.1 mg/kg for chickens for fattening and turkeys for fattening. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 0.1 mg/kg complete feed. No safety concern would arise for the consumer from the use the additive up to the maximum proposed use level in feed. The additive should be considered as irritant to skin and eyes and the respiratory tract, and as dermal and respiratory sensitisers. The use of 4‐methyl‐5‐vinylthiazole [15.018] as a flavour in animal feed was not expected to pose a risk to the environment. Since the compound under assessment is used in food as flavouring and its function in feed is essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the leaves of Salvia officinalis L. (sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that sage oil is considered safe up to the maximum proposed use levels in complete feed of 20 mg/kg for ornamental fish. For the other species, the calculated safe concentrations in complete feed were 3 mg/kg for chickens for fattening and turkeys for fattening, 4 mg/kg for laying hens and rabbits, 5 mg/kg for piglets, 6 mg/kg for pigs for fattening, 7 mg/kg for sows and dairy cows, 11 mg/kg for veal calves (milk replacers) and salmonids, 10 mg/kg for cattle for fattening, sheep/goats and horses, 12 mg/kg for dogs and 2 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 2 mg/kg complete feed. The FEEDAP Panel considered that the use of sage oil in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, sage oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the leaves of S. officinalis is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of urea as nutritional feed additive. The additive is authorised for use in ruminants with functional rumen (3d1). The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been substantially modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the target species, consumer and for the environment when used as a source of non‐protein nitrogen under current conditions of use, in ruminants with functional rumen. In the absence of new data, the FEEDAP Panel is not in the position to conclude on the user safety. The Panel retains that previously made conclusion on the efficacy remains valid. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Lentilactobacillus diolivorans (formerly Lactobacillus diolivorans) DSM 33625 when used as a technological additive to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg forage. The bacterial species L. diolivorans is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive is not a skin or an eye irritant. In the absence of data, no conclusion can be drawn on the skin sensitisation of the additive. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The FEEDAP Panel concluded that Lentilactobacillus diolivorans DSM 33625 at a minimum concentration of 1 × 108 CFU/kg forage may extend the aerobic stability of silage prepared from easy and moderately difficult to ensile forage material with a DM range of 32–65%. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo‐1,4‐beta‐xylanase produced by Trichoderma reesei ATCC PTA‐5588, protease produced by Bacillus subtilis CBS 148232, and alpha‐amylase produced by Bacillus licheniformis ATCC SD‐6525, Axtra® XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the ■■■■■ used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase. Moreover, the Panel could not conclude on the efficacy in laying hens. The applicant submitted some new information to address some of the limitations previously identified. Moreover, the applicant declared a change in the production strain of the protease, substituting B. subtilis ATCC SD‐2107 for B. subtilis CBS 148232. The Panel concluded that the additive is safe for the target species at the recommended use level (1,000 xylanase U, 100 amylase U and 2,000 protease U per kg feed). The additive is safe for the consumers of food products obtained from animals fed with the additive and raises no concerns for the environment. The Panel could not conclude on the skin/eye irritancy potential of the additive nor on its dermal sensitisation potential. Owing to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay at the level of 2,000 xylanase U, 200 amylase U and 4,000 protease U per kg feed (double the minimum recommended use level). Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for laying hens. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of a product consisting of viable spores of Bacillus velezensis NRRL B‐67257 as a zootechnical additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species. The additive has the tradename Correlink™ ABS747 Bacillus subtilis and is not currently authorised in the European Union. It is intended for use in complete feed for the target species at a minimum inclusion level of 1.5 × 108 CFU/kg complete feed. In a previous opinion the FEEDAP Panel could not conclude on the efficacy of the additive for the poultry species due to the potential cross‐contamination of the control diets in two of the three studies provided. The applicant has provided supplementary information to exclude this possibility. The new data showed that the gene used as marker in the previous analyses is non‐specific of the NRRL B‐67257 strain, which precluded the adequate quantification of the active agent in the feeds used in the studies. Moreover, in a second analysis, the active agent could not be isolated from the field excreta samples collected from either from the treated or the control group of one of the formerly submitted efficacy studies. The Panel concluded that the methodology was not able to discriminate between the strain under assessment and the background. Therefore, the FEEDAP Panel was not in the position to conclude on the efficacy of Correlink™ ABS747 for all growing poultry species based on the data newly provided. [ABSTRACT FROM AUTHOR]

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 renewal of the authorisation of endo‐1,4‐β‐xylanase produced by Trichoderma reesei CBS 143953 and endo‐1,3(4)‐β‐glucanase produced by T. reesei CBS 143945 (Axtra® XB 201 TPT/L) as a zootechnical feed additive (digestibility enhancers) for poultry and pigs. The endo‐1,4‐β‐xylanase and endo‐1,3(4)‐β‐glucanase are produced by a genetically modified strain of T. reesei and a non‐genetically modified strain of T. reesei, respectively. The applicant also requested a reduction of the minimum recommended level for turkeys for fattening and the extension of use to other species/categories. The Panel concluded that the additive complies with the conditions of the current authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider previous conclusions on the safety of the additive. These conclusions apply also to the new target species/categories for which a request of use was made, suckling piglets. The Panel concluded that the additive should be considered irritant to eyes and a respiratory sensitiser. However, no conclusions could be drawn on the skin irritancy/sensitisation potential of the additive. No change in the authorisation conditions were requested for poultry species (other than turkeys), weaned piglets, pigs for fattening, sows and minor porcine species; therefore there was no need for an assessment on the efficacy of the additive for those species/categories. The Panel concluded that the additive has the potential to be efficacious in turkeys for fattening/reared for breeding and in suckling piglets (for the period in which solid feed is administered) at an intended level of 610 xylanase U/kg and 76 glucanase U/kg feed. However, the Panel noted that the actual effective level used in the studies supporting this conclusion was approximately 50% higher than the intended level. [ABSTRACT FROM AUTHOR]

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 safety and efficacy of 6‐phytase produced by the genetically modified strain Trichoderma reesei CBS 146250 (Axtra® PHY GOLD 30L, Axtra® PHY GOLD 30 T and Axtra® PHY GOLD 65G) as a zootechnical feed additive for all poultry species and all pigs. The FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry species and all pigs at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive does not give rise to concerns for consumers and the environment. Owing to the lack of data obtained with the final formulations, the Panel cannot conclude on the potential of the additive to be irritant to eyes or skin. Due to the proteinaceous nature of the active substance, it is considered a respiratory sensitiser. The panel concludes that the additive is efficacious in increasing the phosphorus utilisation when supplemented at 500 FTU/kg for all growing poultry species and all pigs, and at 300 FTU/kg in laying hens and other laying birds. [ABSTRACT FROM AUTHOR]

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 Lactiplantibacillus plantarum ssp. plantarum (formerly Lactobacillus plantarum ssp. plantarum) DSM 8862 and Lactiplantibacillus plantarum ssp. argentoratensis (formerly Lactobacillus plantarum ssp. argentoratensis) DSM 8866 as a technological additive to improve ensiling of forage for all animal species. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not a skin irritant but no conclusions can be drawn on the eye irritancy potential of the additive nor to the skin sensitisation potential. The additive should be considered a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives to improve ensiling of forages consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively, for all animal species. The additives are intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 107 colony forming units (CFU) of E. faecium ATCC 53519/kg forage or 5 × 106 CFU of E. faecium ATCC 55593/kg forage, respectively. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy owing to the lack of sufficient evidence for an improvement on the nutrient preservation during the ensiling process. The new data submitted by the applicant as supplementary information provided not enough weight of evidence on the effects of the additives on the ensiling of easy, moderately difficult and difficult to ensile material, and therefore, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives to improve ensiling of forages consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) strains ATCC 55058 and ATCC 55942, respectively, for all animal species. Both additives are intended for use with all forages and for all animal species at a proposed minimum concentration of 5 × 106 colony forming units (CFU)/kg forage. In two previous opinions, the FEEDAP Panel could not conclude on their efficacy due to the absence of any significant evidence of nutrient preservation. Based on three new efficacy studies provided by the applicant as supplementary information, the FEEDAP Panel concluded that the addition of L. plantarum strains ATCC 55058 or ATCC 55942, have the potential to improve the ensiling process by reducing protein degradation in all type of forages as indicated by the reduction of ammonia production. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an aqueous extract of Citrus limon (L.) Osbeck (Citrozest®) when used as a zootechnical additive in feed for weaned piglets and all growing poultry species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is safe for the target species up to the maximum proposed use level of 1,000 mg/kg complete feed. No concerns for consumers were identified following the use of additive up to the highest safe level in feed. The additive should be considered a skin and eye irritant, and a potential corrosive. The use of Citrozest® as a feed additive is considered safe for the environment. In the absence of adequate data, the FEEDAP Panel could not conclude on the efficacy of Citrozest® as a zootechnical additive for weaned piglets and all growing poultry species under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the characterisation and safety of vitamin B2/riboflavin produced by fermentation with a genetically modified strain of Bacillus subtilis (KCCM 10445) as a nutritional additive in feed and water for drinking for all animal species. In 2021, the FEEDAP Panel issued an opinion on the safety and efficacy of vitamin B2 98% and vitamin B2 80% in the form of riboflavin produced by B. subtilis KCCM 10445. In that assessment, the Panel could not confirm the correspondence of the deposited strain under accession number KCCM 10445 with the strain used for production owing to discrepancies in the description of the genetic modification steps. Moreover, in the absence of data, no conclusions on the skin sensitisation potential of vitamin B2 98% and vitamin B2 80% nor on the possible risk by inhalation of vitamin B2 98% could be reached. For the present assessment, the applicant provided supplementary information to partially address the limitations identified in that assessment. Based on the results of a bioinformatic analysis between the strain deposited under accession number KCCM 10445 with the strain used for production under assessment, the Panel confirmed the correspondence between the two strains. As no new data have been submitted on the safety of the additives, the conclusions from the Panel remain that the use of vitamin B2/riboflavin produced by B. subtilis KCCM 10445 is safe for the target species, the consumer and the environment. Vitamin B2 80% is not hazardous by inhalation. In the absence of data, no conclusions on the possible risk by inhalation of vitamin B2 98% could be reached. Neither the vitamin B2 98% nor the vitamin B2 80% are irritant to skin or eyes. In the absence of data, no conclusions on the skin sensitisation potential of the additives could be reached. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of a product consisting of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32264 as a zootechnical additive for cats. The additive is a preparation of viable cells of L. reuteri DSM 32264 and it has not been previously authorised as a feed additive in the European Union. The additive is intended for use in complete feed for cats at a minimum inclusion level of 6 × 109 colony forming units (CFU) per animal and day. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of L. reuteri DSM 32264 for cats. The applicant has provided supplementary information to support the efficacy of the additive for cats. Based on the data provided, the FEEDAP Panel concluded that L. reuteri DSM 32264 has the potential to improve faecal consistency by reducing the moisture content of stools from cats receiving the additive at 1 × 1010 CFU/kg feed. However, the Panel had some reservations on the effects in the moisture content, which if maintained overtime, might cast doubts on the benefits on the long‐term use of the additive since it could lead to constipation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and the efficacy of the feed additives cellulase (produced by Aspergillus niger CBS 120604), beta‐glucanase (produced by Aspergillus neoniger MUCL 39199) and xylanases (produced by Trichoderma citrinoviride MUCL 39203 and CBS 614.94) as silage additives for all animal species. In 2018, the FEEDAP Panel evaluated 11 enzymes to be used as silage additives. In that opinion, the additives, including the production strains, were characterised in full and their safety and efficacy were evaluated. However, the Panel could not conclude on the identification of the production strains of the xylanase produced by the strain with deposit number MUCL 39203 (product referred as to J) and the glucanase produced by strain with deposit number MUCL 39199 (product referred as to L). The Panel could not conclude either on the efficacy of the products J, L as well as for the cellulase produced by the strain with deposit number CBS 120604 (product referred as to H) and the xylanase produced by the strain with deposit number CBS 614.94 (product referred to as K). The newly submitted information showed that the species for the xylanase produced by the strain with deposit number MUCL 39203 (product J), should be changed into Trichoderma citrinoviride, and that the species of the production strain for the glucanase produced by the strain with deposit number MUCL 39199 (product L), should be changed into Aspergillus neoniger. The Panel concluded that the four additives have the potential to reduce the protein degradation during the ensiling process when added at the corresponding inclusion levels in different types of forages. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Pediococcus pentosaceus DSM 32292 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 5 x 107 colony forming units (CFU)/kg forage. The bacterial species P. pentosaceus is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach. As the identity of the strain has been established and no antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 5 x 107 CFU/kg forage has the potential to improve the production of silages from moderately difficult to ensile forages. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32203 as a zootechnical additive for dogs. The additive is a preparation of viable cells of L. reuteri DSM 32203 and it has not been previously authorised as a feed additive in the European Union. The additive is intended for use in complete feed for dogs at a minimum use level of 6 x 109 colony forming units (CFU) per animal and day. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of L. reuteri DSM 32203 for dogs. The applicant has provided supplementary information to support the efficacy of the additive to dogs. Based on the data provided, the FEEDAP Panel concludes that L. reuteri DSM 32203 has the potential to improve faecal consistency by reducing the moisture content of stools from dogs receiving the additive at 1 x 1010 CFU/kg feed. However, the Panel has some reservations on the effects in the moisture content of stools, which if maintained over time might cast doubts on the benefits on the long-term use of the additive since it could lead to constipation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 6‐phytase produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.19) (Nutrase P) for chickens for fattening, other poultry for fattening or reared for laying and ornamental birds. The additive is available in solid (Nutrase PD 100,000, Nutrase PG 10,000 and Nutrase PTS 10,000) and liquid (Nutrase PL 10,000) forms. In 2020, the FEEDAP Panel issued an opinion on the safety and efficacy of the product and concluded that uncertainties remained on the presence of viable cells and recombinant DNA of the production strain in two of the formulations (Nutrase PL 10,000 and Nutrase PD 100,000). Moreover, the Panel could not conclude on the safety and the efficacy of the additive for the target species at the recommended level of 250 FTU/kg complete feed. The applicant provided supplementary information to address the limitations identified in that assessment and requested to increase the minimum recommended use level to 500 FTU/kg complete feed. No viable cells and recombinant DNA of the production strain were detected in Nutrase PL 10,000 and Nutrase PD 100,000. Therefore, the Panel concluded that the additive, in any formulations, does not pose any safety concern with regard to the production strain. Based on the results of a new tolerance trial, the Panel concluded that Nutrase P is safe for the target species. The additive in any formulation is safe for the consumers and the environment, but should be considered a respiratory sensitiser. Considering the two long‐term trials in chickens for fattening previously evaluated and the new trial submitted, the Panel concluded that the additive is efficacious in chickens for fattening, other poultry species for fattening or reared for laying and ornamental birds at 1,500 FTU/kg complete feed. [ABSTRACT FROM AUTHOR]

Following an application from Alzchem Trostberg GmbH, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Austria, 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 creatine and improvement in cognitive function. The Panel considers that the food constituent, creatine, is sufficiently characterised. An improvement in cognitive function in one or more of its domains is a beneficial physiological effect. The applicant identified 21 human intervention studies on creatine supplementation and measures of cognitive function through a literature search. Two additional studies published after the search was conducted were identified through the reference list of a meta‐analysis. In weighing the evidence, the Panel took into account that the acute effect of creatine on working memory, observed in two studies at 20 g/day for 5–7 days, was not seen at lower doses (2.2–14 g/day), or with continuous consumption (5 g/day for 6 weeks following a 5‐day loading phase). Furthermore, the effect on response inhibition at 20 g/day for 7 days was an isolated finding among 10 intervention studies in healthy individuals, with no effects observed on other cognitive domains. The Panel also considered that the three intervention studies conducted in diseased individuals do not support an effect of creatine supplementation on cognition, and that the available evidence for a mechanism by which creatine could exert the claimed effect is weak. The Panel concludes that a cause‐and‐effect relationship has not been established between creatine supplementation and an improvement in cognitive function in one or more of its domains. [ABSTRACT FROM AUTHOR]

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Betula pendula and B. pubescens imported from the United Kingdom (UK) taking into account the available scientific information, including the technical information provided by the UK. The commodities were grouped in the risk assessment as (a) bundles of 10–20 graftwood/budwood (up to 1‐year‐old), (b) bare root plants which include bundles of 25 or 50 seedlings or transplants (1–2 years‐old), bundles of 5, 10 or 15 whips (1–2 years‐old) and single bare root plants (1–7 years‐old), (c) plants in pots which include bundles of 5 and 10 cell‐grown plants (1–2 years‐old) and rooted plants in pots (1–7 years‐old), and (d) large specimen trees up to 15‐years‐old. All pests associated with the commodities were evaluated against specific criteria for their relevance for this opinion. Two EU quarantine pests i.e. Meloidogyne fallax and Phytophthora ramorum (non‐EU isolates) and two protected zone quarantine pests i.e. Entoleuca mammata and Thaumetopoea processionea fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures described in the technical dossier from the UK were evaluated considering the possible limiting factors. For these pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, as larger trees are more likely to be infested mainly due to longer time grown in the field. In addition, larger canopies and root systems are more difficult to inspect, thereby making the detection of pests more challenging on large trees. The likelihood of pest freedom varies among the pests evaluated, with M. fallax being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation (EKE) indicated with 95% certainty that between 9735 and 10,000 per 10,000 large specimen trees will be free from M. fallax. [ABSTRACT FROM AUTHOR]

Genetically modified Komagataella phaffii strain MXY0541 was developed to produce soy leghemoglobin by introducing the LGB2 coding sequence encoding leghemoglobin from soybean (Glycine max). The molecular characterisation data and bioinformatic analyses do not raise any safety concerns. The safety of soy leghemoglobin as a food additive has already been assessed by the EFSA FAF Panel (EFSA‐Q‐2022‐00031). The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of soy leghemoglobin protein as expressed in K. phaffii, and finds no evidence that the genetic modification would change its overall allergenicity. The GMO Panel concludes that the LegH Prep derived from genetically modified K. phaffii strain MXY0541 is safe for human consumption with regard to the effects of the genetic modification. No environmental impact from the use of this product is expected regarding the recombinant DNA sequences possibly remaining in the product. The GMO Panel concludes that LegH Prep from genetically modified K. phaffii strain MXY0541 is safe with respect to potential effects on human health and the environment at the proposed use and use level as far as the impact of the genetic modification is concerned. The overall conclusion is that the genetic modification does not lead to safety issues. [ABSTRACT FROM AUTHOR]

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 Austria and co‐rapporteur Member State Finland for the pesticide active substance fenoxaprop‐P‐ethyl 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 fenoxaprop‐P‐ethyl as a post‐emergence herbicide in wheat, durum wheat, rye, triticale and barley to control annual monocotyledonous weeds. 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. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh or dried flowering stems of Salvia sclarea L. (clary sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for veal calves (milk replacers), cattle for fattening, sheep/goats, 10 mg/kg for horses, 20 mg/kg for dogs, salmonids and ornamental fish. For the other target species, the calculated safe concentrations were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 9 mg/kg for piglets, 11 mg/kg for pigs for fattening, 14 mg/kg for sows, 13 mg/kg for dairy cows, 8 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 4 mg/kg complete feed. The FEEDAP Panel considered that the use level in water of clary sage oil is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of clary sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering stems of S. sclarea is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

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, Italy, and co‐rapporteur Member State, Poland, for the pesticide active substance penoxsulam 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 penoxsulam as a herbicide on rice and chicory. 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 reported where identified. [ABSTRACT FROM AUTHOR]

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 Austria for the pesticide active substance elemental iron 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 elemental iron in field and greenhouses (permanent and non‐permanent structures) via granule application by spreading on all edible and non‐edible crops, ornamental plants and amenity grassland to control molluscs. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae NCYC R618 as a zootechnical feed additive (functional group: gut flora stabiliser) for chickens for fattening and other poultry species for fattening and reared for laying. The additive has never been authorised. The strain under assessment S. cerevisiae (NCYC R618) qualifies for the qualified presumption of safety (QPS) and, consequently, the FEEDAP Panel concluded that the product is safe for the target species, the consumers and the environment. The FEEDAP Panel could not conclude on the skin and eye irritation or skin sensitisation potential of the additive. The additive should be considered a respiratory sensitiser. Due to the lack of sufficient data, the Panel cannot conclude on the efficacy of the additive under the proposed conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme β‐glucosidase (β‐d‐glucoside glucohydrolase, EC 3.2.1.21) is produced with the non‐genetically modified Penicillium guanacastense strain AE‐GLY by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in four food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. The dietary exposure was calculated to be up to 0.206 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Using the no observed adverse effect level reported in the previous opinion (943 mg TOS/kg bw per day), the Panel derived a margin of exposure of at least 4578. Based on the previous evaluation, the assessment of the new data and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme has four declared activities: endo‐polygalacturonase ((1–4)‐α‐d‐galacturonan glycanohydrolase (endo‐cleaving); EC 3.2.1.15), pectinesterase (pectin pectylhydrolase; EC 3.1.1.11), pectin lyase ((1–4)‐6‐O‐methyl‐α‐d‐galacturonan lyase; EC 4.2.2.10) and non‐reducing end α‐l‐arabinofuranosidase (α‐l‐arabinofuranoside non‐reducing end α‐l‐arabinofuranosidase; EC 3.2.1.55). It is produced with the non‐genetically modified Aspergillus niger strain PEC by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in three food manufacturing processes. Subsequently, the applicant has requested to extend its use to include four additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed from the final foods in one food manufacturing process, the dietary exposure to the food enzyme–TOS was estimated only for the remaining six processes. The dietary exposure was calculated to be up to 0.612 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (204 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 333. Based on the previous evaluation, the assessment of the new data and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme carboxypeptidase C (EC 3.4.16.5) is produced with the genetically modified Aspergillus niger strain PEG by DSM Food Specialties B.V. 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 nine food manufacturing processes. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 2.053 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with a xylanase obtained from A. niger strain XEA. The Panel considered this food enzyme as a suitable substitute for the carboxypeptidase to be used in the toxicological studies, because both strains were derived from the same recipient strain, the location of the inserts was comparable, no partial inserts were present and the production methods were essentially the same. Genotoxicity tests did not raise 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 1850 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 901. A homology search for the amino acid sequence of the food enzyme to known allergens was made and one match with a wheat allergen was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, especially in wheat‐allergic individuals, but 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. [ABSTRACT FROM AUTHOR]

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non‐genetically modified Aspergillus tubingensis strain NL151 by Shin Nihon Chemical Co., Ltd. The food enzyme was free from viable cells of the production organism. It is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 0.278 mg total organic solids (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 1669 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 6004. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, the risk of allergic reactions upon dietary exposure cannot be excluded, but 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. [ABSTRACT FROM AUTHOR]

The European Commission asked EFSA to update its 2012 risk assessment on brominated phenols and their derivatives in food, focusing on five bromophenols and one derivative: 2,4,6‐tribromophenol (2,4,6‐TBP), 2,4‐dibromophenol (2,4‐DBP), 4‐bromophenol (4‐BP), 2,6‐dibromophenol (2,6‐DBP), tetrabrominated bisphenol S (TBBPS), tetrabromobisphenol S bismethyl ether (TBBPS‐BME). Based on the overall evidence, the CONTAM Panel considered in vivo genotoxicity of 2,4,6‐TBP to be unlikely. Effects in liver and kidney were considered as the critical effects of 2,4,6‐tribromophenol (2,4,6‐TBP) in studies in rats. A BMDL10 of 353 mg/kg body weight (bw) per day for kidney papillary necrosis in male rats was identified and was selected as the reference point for the risk characterisation. The derivation of a health‐based guidance value was not considered appropriate due to major limitations in the toxicological database. Instead, the margin of exposure (MOE) approach was applied to assess possible health concerns. Around 78,200 analytical results for 2,4,6‐TBP in food were used to estimate dietary exposure for the European population. Considering the resulting MOE values, all far above an MOE of 6000 that does not raise a health concern, and accounting for the uncertainties affecting the exposure and hazard assessments, the CONTAM Panel concluded with at least 95% probability that the current dietary exposure to 2,4,6‐TBP does not raise a health concern. Due to lack of occurrence data, no risk assessment could be performed for breastfed or formula‐fed infants. No risk characterisation could be performed for any of the other brominated phenols and derivatives included in the assessment, due to lack of data both on the toxicity and occurrence. [ABSTRACT FROM AUTHOR]

The food enzyme endo‐1,3(4)‐β‐glucanase (3‐(1–3;1–4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with the non‐genetically modified Talaromyces versatilis strain PF8 by Erbslöh Geisenheim AG. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.110 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 2229 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 20,264. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory or contact allergens were found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but 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. [ABSTRACT FROM AUTHOR]

The food enzyme endonuclease (Aspergillus nuclease S1; EC 3.1.30.1) is produced with the non‐genetically modified Penicillium citrinum strain NP 11–15 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.006 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 1010 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 168,333. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, especially for individuals allergic to Penicillium. However, the likelihood of such reactions will not exceed the likelihood of allergic reactions to Penicillium. 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. [ABSTRACT FROM AUTHOR]

The European Commission (EC) asked EFSA to assess the genotoxicity of beauvericin (BEA). Relevant information, including that which has become available since the 2014 Scientific Opinion on the risks to human and animal health related to the presence of BEA and enniatins in food and feed, was reviewed. In the previous Opinion the Panel concluded that in vitro genotoxicity data were equivocal and there were no in vivo genotoxicity data available. New in vitro studies in mammalian cell lines provided no convincing evidence for induction of chromosomal damage by BEA as measured by micronucleus and chromosome aberration tests or an increase of DNA strand breaks as assessed by the Comet assay. In these studies, no concentration‐dependent effects or potential for interference from associated cytotoxicity were observed. In addition, DNA double‐strand breaks as measured by γ‐H2AX analysis were only observed following exposure to highly cytotoxic BEA concentrations. In vivo studies (Comet and Pig‐a assays, micronucleus test) with BEA were negative. In vitro gene expression studies showed no indication of a DNA damage response and (quantitative) structure activity relationship analysis was also not indicative of genotoxic potential. Some effects of BEA might play an indirect role in the formation of DNA strand breaks. These include increased reactive oxygen species, induction of cell cycle arrest and apoptosis, associated with interference in mitochondrial function and cell signalling. There was no compelling evidence of inflammatory and immunosuppressive effects. Taken together, the available data indicate that BEA is devoid of genotoxic potential. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of a preparation containing a smoke flavouring extract for cats and dogs. The applicant provided data demonstrating that the additive currently on the market does not fully comply with the conditions of authorisation, but with newly proposed specifications based on different analytical methods. Considering that the additive under assessment contains benzofuran and styrene, for which a potential concern for genotoxicity has been identified, and that the whole mixture raises a potential concern for genotoxicity, additional data would be needed to complete the assessment. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for cats and dogs. The additive is authorised for use in feed for cats and dogs, and therefore, there is no need to perform an assessment of the safety for the consumer and the environment. Regarding user safety, the additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to potential genotoxic substances may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lentilactobacillus buchneri DSM 32651 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. buchneri is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The additive is not an eye irritant. The FEEDAP Panel concluded that the additive consisting of L. buchneri DSM 32651 at a minimum concentration of 1 × 108 CFU/kg fresh material may extend the aerobic stability of silage prepared from fresh plant material with a DM range of 28%–45%. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l‐arginine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.401). The additive is intended to be used in feed and water for drinking for all animal species and categories. The genetic modifications introduced do not raise safety concerns. No viable cells or DNA of the production strain were detected in the final product. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not pose any safety concern with regard to the production strain. l‐Arginine produced with E. coli CGMCC 7.401 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed and water. The use of l‐arginine produced with E. coli CGMCC 7.401 in animal nutrition is considered safe for the consumers and for the environment. The endotoxin activity of the additive does not represent a hazard for persons handling the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The additive l‐arginine produced with E. coli CGMCC 7.401 is regarded as an efficacious source of the essential amino acid l‐arginine for non‐ruminant species. For supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lutein‐rich extract of Tagetes erecta L. as sensory additive (functional group: Colourants (ii) substances which, when fed to animals, add colours to food of animal origin) for turkeys for fattening. The additive is already authorised for use in feed for chickens for fattening and minor poultry for fattening and laying hens and minor poultry for laying. The FEEDAP Panel concluded that the use of lutein‐rich extract of T. erecta is safe for turkeys for fattening when used up to the maximum proposed use level of 80 mg total carotenoids/kg complete feed. The Panel concluded that the use of lutein‐rich extract of T. erecta in feed for turkeys for fattening under the proposed conditions of use would not be of concern for the consumer, considering also its use in other poultry for fattening and for laying hens. Regarding user safety, the lutein‐rich extract of T. erecta extract is irritant to skin and eyes and any exposure is considered a risk. The conclusions on user safety reached for the lutein‐rich extract of T. erecta would, in principle, apply to preparations made with it. The use of the additive in feed for turkeys for fattening under the proposed conditions of use is safe for the environment. The FEEDAP Panel concluded that the additive has the potential to colour the skin of turkeys for fattening at the proposed conditions of use. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tea tree oil obtained from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long‐living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.5 mg/kg for turkeys for fattening, 1.7 mg/kg for laying hens, 2.0 mg/kg for piglets, 2.4 mg/kg for pigs for fattening, 3.1 mg/kg for sows, 5.0 mg/kg for veal calves (milk replacer) and salmonids, 4.4 mg/kg for cattle for fattening, sheep/goats and horses, 2.9 mg/kg for dairy cows, 1.8 mg/kg for rabbits, 0.9 mg/kg for cats, 5.3 mg/kg for dogs, 6.6 for crustaceans and 15 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to be of safety concern at 1.1 mg/kg complete feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. Regarding user safety, tea tree oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. It is classified as a reprotoxic substance (category 1B) following CLP criteria and should be handled accordingly. Since M. alternifolia and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product containing endo‐1,4‐β‐xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of Trichoderma reesei (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products. The Panel also concluded that ECONASE® XT is safe for pigs for fattening, laying hens and minor poultry species at the proposed conditions of use. The use of the additive raises no safety concerns for the consumers of products derived from animals fed with the additive or for the environment. The liquid and solid forms of ECONASE® XT are non‐irritant to the skin, but only the liquid forms were confirmed as non‐irritant to the eyes and not dermal sensitisers. The Panel could not conclude on the irritation potential to the eyes and the dermal sensitisation potential for the solid forms. Due to the proteinaceous nature of the active substance, the additive is considered to be a respiratory sensitiser. The additive has the potential to be efficacious in pigs for fattening at 20,000 BXU/kg complete feed, in all laying poultry species at 12,000 BXU/kg complete feed and in minor poultry species other than laying birds at 8000 BXU/kg complete feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐valine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 22721) as a nutritional additive for all animal species. The production strain and its DNA were not detected in the final additive. Therefore, the final product does not give raise to any safety concern regarding the genetic modification of the production strain. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that l‐valine produced using E. coli CGMCC 22721 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of l‐valine produced using E. coli CGMCC 22721 in animal nutrition is considered safe for the consumers and for the environment. The FEEDAP Panel cannot conclude on the potential of l‐valine produced using E. coli CGMCC 22721 to irritant to the skin or eyes, a dermal or respiratory sensitiser due to the lack of data. The endotoxin activity of the additive does not represent a hazard for users handling the additive when exposed by inhalation. The additive l‐valine produced by fermentation using E. coli CGMCC 22721 is regarded as an efficacious source of the essential amino acid l‐valine for non‐ruminant nutrition. For the supplemental l‐valine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]