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The variability of climatic conditions throughout the year and the physiological maturity of plant material can have effects on the nutritional value of plants and the productive performance of animals. The aim was to determine the effect of three tropical forage species (Tithonia diversifolia, Erythrina poeppigiana and Cratylia argentea) harvested at four cutting ages (30, 45, 60 and 75 days), during the dry and rainy seasons on in vitro gas production, rumen pH, volatile fatty acids (VFA) and CH4 production. A completely randomized design in a factorial arrangement (three forage species, four cutting ages and two seasons) was used. Four Brahman bulls of 250.0 ± 20.5 kg of live weight were used, provided with a ruminal cannula for the extraction of ruminal fluid. The animals were kept separately in individual pens, where they were fed with P. maximum and water was provided ad libitum. Gas production among forage species was lower (p = 0.0001) in T. diversifolia and E. poeppigiana in the dry season. The cutting age had an influence on gas production, showing lower production (p = 0.0164) at 30 and 45 days in the dry season. The VFA production showed differences for the effect between forages in the rainy season, with higher values (p < 0.05) for acetic, propionic and butyric acid in the species E. poeppigiana, C. argéntea and T. diversifolia respectively. CH4 production showed differences between forage species, showing the lowest (p = 0.0001) production of CH4 in T. diversifolia for the dry and rainy seasons. It is concluded that the use of shrubby species (T. diversifolia, E. poeppigiana and C. argéntea) in ruminant production systems in the rainy and dry seasons, with an early regrowth age (30 and 45 days), present a promising alternative on the reduction of CH4.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co-rapporteur Member State France for the pesticide active substance aluminium silicate calcined (kaolin calcined) and the considerations as regards the Article 12 MRL review of Regulation (EC) No 396/2005 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 aluminium silicate calcined (kaolin calcined) as an insect repellent via broadcast spray application on grapevine, apricot tree, almond tree, cherry tree, hazel tree, walnut tree, peach tree, apple tree, pear tree, quince tree, nashi tree, plum tree, citrus tree, lavender, lavandin and olive tree, as proposed by the applicants. The reliable endpoints, 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.

This study aims to analyze the relationships between culture and nature associated with food sovereignty of the P'urhépecha people of Michoacán, central Mexico. We explore how food sovereignty could be analyzed by decentering humans. Firstly, we examine the context and meaning of food sovereignty based on information on the P'urhépecha culture, its history and food patterns. Then, we discuss the concept of food sovereignty from three perspectives: (1) How food sovereignty could be understood by decentering humans; (2) How to define food sovereignty from a relational perspective; and (3) How to do justice to an ontological plurality that involves non-human organisms. We conclude the need of considering new ways to understand food sovereignty, emphasizing the relational perspectives that include non-human entities.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Slovenia, and co-rapporteur Member State, Finland, for the pesticide active substance rimsulfuron are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of rimsulfuron as an herbicide on maize, potato and tomato and updated following the request to update the risk assessment of rimsulfuron in view of the renewal process under Commission Implementing Regulation (EU) No 844/2012. 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.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Latvia, and co-rapporteur Member State, Romania, for the pesticide active substance quartz sand 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 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 field uses of quartz sand as a game repellent on deciduous and coniferous trees (professional use and non-professional use), orchards, ornamental shrubs and trees in forestry (professional use and non-professional use) and seedlings of conifer and deciduous trees in forestry (professional use). 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. No concerns are identified.

The conclusions of 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 Malta for the pesticide active substance abamectin 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 abamectin as an insecticide and acaricide on tomato and strawberry, and updated following the request from Commission to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The risk assessment to bees and non-target arthropods was also updated. 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.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member States, the United Kingdom (former) and France (after withdrawal of the United Kingdom from the EU), for the pesticide active substance isoflucypram. 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 use of isoflucypram as a fungicide on wheat, rye, triticale, barley and oats (field use). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Czech Republic for the pesticide active substance limestone powder (calcium carbonate) 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 use of limestone powder in paste form as a repellent in forest plantations and forest tree nurseries (field uses). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. No concerns are identified.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Italy, and co-rapporteur Member State, France, for the pesticide active substance oxamyl and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, 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 oxamyl as a nematicide on potato and tobacco (field use), on tomato (permanent greenhouse), on cucurbits (edible and inedible peel), pepper, aubergine and plants nurseries of the above-mentioned crops on soil bed preparation (permanent greenhouse). The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co-rapporteur Member State, Denmark, for the pesticide active substance triflusulfuron-methyl 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 triflusulfuron-methyl as a herbicide on sugar beet, fodder beet, red beet, chicory and witloof (field uses). The peer review also provided considerations on whether exposure to humans and the environment from the representative uses of triflusulfuron-methyl can be considered negligible, taking into account the European Commission's draft guidance on this topic. 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. An evaluation of data concerning the necessity of triflusulfuron-methyl as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non-chemical methods is also presented.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the Netherlands and co-rapporteur Member State Finland for the pesticide active substance rape seed oil 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 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 professional and non-professional uses of rape seed oil as an acaricide on pome fruit trees (field use), berries, vegetables, ornamentals (greenhouse and field uses) and as an insecticide on potatoes (field use). 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.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Ireland, and co-rapporteur Member State, Portugal, for the pesticide active substance aluminium ammonium sulfate 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 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 aluminium ammonium sulfate as a repellent on row crops (salad, brassica, carrots and other vegetable crops), combinable crops (grains, pulses and oilseed rape), grassland (primarily amenity and sports turf), orchards and forestry, amenity and ornamentals including use on hard surfaces. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework and assessments not finalised are listed.

The aim of this work was to know the differential composition of the dissolved fraction of a glyphosate-based herbicide (GBH), commercialized as GLIFOPAC, when reaches different aquatic environment...

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co-rapporteur Member State, Spain, for the pesticide active substance heptamaloxyloglucan 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 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 use of heptamaloxyloglucan as a plant elicitor on grapevines for protection against frost damage (field use). 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 not identified.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the Czech Republic (CZ) and co‐rapporteur Member State France (FR) for the pesticide active substance sheep fat 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 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 sheep fat as a repellent on deciduous and coniferous trees in forestry. 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.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the Czech Republic and co‐rapporteur Member State France for the pesticide active substance fish oil 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 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 fish oil as a game repellent on deciduous and coniferous trees in forestry. 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.

In Mexico, pigmented creole corn varieties are used for its consumption in a great diversity of foods. Purple corn has a high content of phytochemicals (health promoters). The extrusion process improved the accessibility of these phytochemicals. The aim of this work was to evaluate the effect of extrusion factors on the nutraceutical and functional properties of nixtamalized purple corn flour, and determine the optimal process conditions that allows obtaining a flour with the best characteristics to be used in the preparation of a beverage. The processing factors were temperature (T = 50-170 °C) and screw speed (SS = 50-240 rpm). The properties evaluated were total phenolic compounds (TPC), total anthocyanins (TA) antioxidant activity (AOX), and water solubility index (WSI). The optimization was carried out using the response surface methodology. The optimization yielded the following values: AOX: 676.34 µmol ET/100 g, TPC: 299.61 mg EGA/100 g, TA: 29.9 mg EC3G/100 g and WSI: 6.31%, under process conditions T = 50 °C and SS = 50 rpm. It was demonstrated that it is possible to generate a flour with the use of pigmented corn native to the state of Guerrero, with suitable properties for developed new corn based products.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom (France after Brexit), for the pesticide active substance asulam and the assessment of applications 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 use of asulam (variant evaluated asulam‐sodium) as a herbicide on spinach and tulip, hyacinth and lily for bulb production. MRLs were assessed in spinach. The conclusions were updated with regard to the endocrine‐disrupting properties following a mandate received from the European Commission in February 2019. In addition, the peer review also provided considerations on whether exposure to humans and the environment from the representative uses of asulam‐sodium can be considered negligible, taking into account the European Commission's draft guidance on this topic. 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. Concerns are identified. An evaluation of data concerning the necessity of asulam‐sodium as a herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods is also presented.

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, Spain, for the pesticide active substance Spodoptera exigua multicapsid nucleopolyhedrovirus 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 Spodoptera exigua multicapsid nucleopolyhedrovirus as an insecticide on pepper and leafy vegetables (lettuce crops) (field, greenhouse and walk‐in tunnel uses). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

STUDY QUESTION Are there significant differences between the available commercial oil brands used for human IVF? SUMMARY ANSWER Important differences have been detected among the tested oil brands in their potential to stabilize culture conditions and, more importantly, in their direct effect on embryo development and viability. WHAT IS KNOWN ALREADY Mineral oil is a critical component of the human culture system due to its protective and stabilizing roles during in vitro embryo development. Many different oils are available on the market, with differences in their viscosity, density and overall quality. STUDY DESIGN, SIZE, DURATION Thirteen different commercial oil brands were compared. PARTICIPANTS/MATERIALS, SETTING, METHODS Each oil was firstly analyzed to assess its viscosity, density, peroxide value and potential oxidation. Secondly, the capacity of each oil to reduce pH, osmolality and temperature fluctuations during embryo culture and manipulation was compared. Lastly, a sensitive mouse embryo assay (MEA) protocol, previously optimized to detect toxicity in oils samples, was used to compare the overall quality of the different brands in terms of embryo developmental rates up to the blastocyst stage. At the end of the MEAs, a triple labeling protocol was applied to analyze Oct4+ cells, apoptotic cells and total cell counts in the blastocysts obtained by fluorescence microscopy. MAIN RESULTS AND THE ROLE OF CHANCE Significant divergences were detected in the rise of osmolality and the equilibration and stability of pH between different oils, which could be correlated to their physico-chemical characteristics. In particular, oil samples with a higher viscosity tended to offer an additional protection against fluctuations in the culture conditions, however, the differences in temperature stability between oils were minor. Two out of the 13 oil samples, which were commercially available, were identified as embryo-toxic by applying the MEA protocol with increased sensitivity for toxicity detection. Additionally, substantial differences in the total number of cells and the number of cells in the inner cell mass of the obtained blastocysts were also detected between oil groups. LIMITATIONS, REASONS FOR CAUTION A single lot of oil was used for each brand and, thus, lot-to-lot variations in oil quality could not be determined. However, several bottles from the same oil were included to account for potential intra-lot variability. WIDER IMPLICATIONS OF THE FINDINGS Commercial oils differ in both their physical characteristics and their performance in maintaining the stability of the culture conditions during in vitro embryo culture. Oil selection is important for embryo culture success. Additionally, the detection of embryo-toxic oils which had already been released to the human IVF market showcases the importance of applying sensitive MEA protocols for a better detection of toxicity in this type of samples. STUDY FUNDING/COMPETING INTEREST(S) This study was privately funded. TRIAL REGISTRATION NUMBER N/A.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Greece, and co‐rapporteur Member State, Austria, for the pesticide active substance pelargonic acid (nonanoic acid) 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 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 use of pelargonic acid as a herbicide on vineyards, potatoes, paths and places with woody plants, ornamental shrubs, ornamentals lawn, home gardens and allotments, paths and open areas with tree growth, woody ornamentals, decorative lawns, turf (field use). The reliable end points appropriate for use in regulatory risk assessment are presented. Assessments not finalised and missing information identified as being required by the regulatory framework are listed.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Poland, and co‐rapporteur Member State, France, for the pesticide active substance benthiavalicarb (variant assessed benthiavalicarb‐isopropyl) 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 use of benthiavalicarb‐isopropyl as a fungicide on potato (field use). The peer review also provided considerations on whether exposure to humans and the environment from the representative uses of benthiavalicarb‐isopropyl can be considered negligible, taking into account the European Commission's draft guidance on this topic. 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. An evaluation of data concerning the necessity of benthiavalicarb‐isopropyl as a fungicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods, is also presented.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Sweden, and co‐rapporteur Member State, Italy, for the pesticide active substance bifenazate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of bifenazate as an acaricide on strawberry, fruiting vegetables (tomatoes, peppers, aubergines, cucumbers, courgettes, melons, watermelons), flowering and ornamental plants and nursery ornamentals and updated following the request to peer review the exposure and risk assessments for bifenazate. 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.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Spain, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance clofentezine and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative use of clofentezine as an acaricide on citrus, pome fruits, strawberry, tomatoes and aubergine. The peer review also provided considerations on whether exposure to humans and the environment from the representative uses of clofentezine can be considered negligible, taking into account the European Commission's draft guidance on this topic. 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. An evaluation of data concerning the necessity of clofentezine as acaricide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods is also presented.

The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance acibenzolar‐S‐methyl are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information with regard to the endocrine disruption potential of the substance. The conclusions were reached on the basis of the evaluation of the representative uses of acibenzolar‐S‐methyl as a plant activator on pome fruit, tomato and tobacco. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Assessments not finalised together with the missing information identified as being required by the regulatory framework are listed.

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 France for the pesticide active substances that are Straight Chain Lepidopteran Pheromones (SCLPs) and the considerations as regards the inclusion of the substances in Annex IV of Regulation (EC) No 396/2005 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 representative uses of some SCLPs as semiochemicals used to protect grapes, pome fruits, walnuts, rice and any other crop (where Chilo suppressalis may be a pest) (all field uses). 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.

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, France, for the pesticide active substance Bacillus amyloliquefaciens strain IT‐45 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 use of Bacillus amyloliquefaciens strain IT‐45 as a fungicide on citrus (field use, application to soil via drip irrigation systems). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

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, the Netherlands and co‐rapporteur Member State, Greece, for the pesticide active substance potassium hydrogen carbonate 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 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 potassium hydrogen carbonate as a fungicide on strawberry, wine and table grapes, pome fruits, stone fruits, ornamentals and cucurbits. 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 not identified.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Spain and co‐rapporteur Member State Hungary for the pesticide active substance calcium carbonate 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 calcium carbonate as a repellent on deciduous and coniferous trees in forestry. 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. No concerns were identified.

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, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain EG2348 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 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 Bacillus thuringiensis kurstaki strain EG2348 as an insecticide on pome fruits (field use), solanaceous fruiting vegetables (uses in permanent greenhouse and walk‐in tunnel) and ornamentals (field, permanent greenhouse and walk‐in tunnel uses). 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.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Spain, and co‐rapporteur Member State, Greece, for the pesticide active substance phosmet and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, 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 phosmet as an insecticide on citrus fruits, pome fruits, peaches/nectarines and potatoes (field uses). 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.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Germany, and co‐rapporteur Member State, Denmark, for the pesticide active substance Bacillus amyloliquefaciens strain QST 713, formerly Bacillus subtilis strain QST 713, 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 Bacillus amyloliquefaciens strain QST 713 as a fungicide on strawberry (field and greenhouse uses) and grapes (field use). 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.

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, Spain, for the pesticide active substances Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 and the considerations as regards the inclusion of the substances 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 use of Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 as an elicitor on tomato (permanent greenhouse production systems). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed.

Aedes aegypti is a mosquito that carries dengue virus, yellow fever and other diseases transmitted to humans. Organophosphorus larvicides are used to control the proliferation of this mosquito, which has generated a high degree of resistance; hence, new alternatives such as bio-larvicides formulated with plant extracts are of great interest. The aims of this study were to evaluate the ethanolic extract of Azadirachta indica leaves as a larvicide against Aedes aegypti and to determine the main compounds present in it by GC-MS. In the assay, three concentrations of ethanolic extract were used (10 mg L-1, 20 mg L-1, and 50 mg L-1). This was performed thrice against a positive control (commercial larvicide: spores and endotoxic crystals of Bacillus thuringiensis var. israelensis Serotype H-14) and negative control (water). After 72 h of incubation, it was observed higher larval mortality (93%) in the ethanolic extract at a concentration of 50 mg L-1; the extracts at 10 mg L-1 and 20 mg L-1 shown larval mortality of 47% and 70%, respectively. The majority compound determined by the GC-MS analysis was phytol (14.4% area). The results obtained in this study demonstrated the larvicidal potential of the ethanolic extract of A. indica against larvae of A. aegypti. RESUMEN Aedes aegypti es un mosquito portador del virus del dengue, la fiebre amarilla y otras enfermedades transmitidas a los humanos. Los larvicidas organofosforados se utilizan para controlar la proliferación de este mosquito, el cual ha generado un alto grado de resistencia, por lo que las nuevas alternativas de biolarvicidas formulados con extractos de plantas son de gran interés. Los objetivos de este estudio fueron evaluar el extracto etanólico de hojas de Azadirachta indica como larvicida contra Aedes aegypti e identificar los principales compuestos químicos GC-MS. En el ensayo, se utilizaron tres concentraciones de extracto de etanol (10 mg L-1, 20 mg L-1 y 50 mg L-1), este se realizó por triplicado contra un control positivo (larvicida comercial: Esporas y cristales endotóxicos de Bacillus thuringiensis var. israelensis Serotipo H-14) y un control negativo (agua). Después de 72 horas de incubación, se observó una mayor mortalidad larval (93%) en el extracto etanólico a una concentración de 50 mg L-1, y los extractos a 10 mg L-1 y 20 mg L-1 mostraron una mortalidad larval del 47% y 70% respectivamente. El compuesto con mayor abundancia determinado por el análisis CG-MS fue el fitol (área del 14,4%). Los resultados obtenidos en este estudio demostraron el potencial larvicida del extracto de etanol de A. indica contra las larvas de A. aegypti.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Greece for the pesticide active substance mancozeb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of mancozeb as a fungicide on wheat (winter/spring), grapevine, potatoes and tomatoes. 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.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State The Netherlands and co‐rapporteur Member State Germany for the pesticide active substance Bacillus thuringiensis ssp. aizawai strain GC‐91 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 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 Bacillus thuringiensis ssp. aizawai strain GC‐91 as an insecticide on pome fruits (apple, pear), grapes and sports turf (field uses) and tomato (greenhouse uses). 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.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Beauveria bassiana strain 203 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 203 as an insecticide on Phoenix canariensis (field use, indoor and greenhouse applications) and Phoenix dactylifera (field use) in southern Europe. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

The conclusions of 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 Hungary for the pesticide active substance Pythium oligandrum strain M1 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 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 Pythium oligandrum strain M1 as a fungicide on oil seed rape, wheat and spring barley (field use). 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.

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, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain SA‐11 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 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 Bacillus thuringiensis subsp. kurstaki strain SA‐11 as an insecticide on pome fruits (field use), protected tomato (including permanent greenhouses and walk‐in tunnels) and turf (field use). 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.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State The Netherlands and co‐rapporteur Member State Germany for the pesticide active substance Bacillus thuringiensis ssp. aizawai strain ABTS‐1857 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 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 Bacillus thuringiensis ssp. aizawai strain ABTS‐1857 as an insecticide on fruiting vegetables (pepper, field and greenhouse uses). 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.

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, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain SA‐12 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 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 Bacillus thuringiensis subsp. kurstaki strain SA‐12 as an insecticide on pome fruits (field use), protected tomato (including permanent greenhouses and walk‐in tunnels) and ornamentals (field use). 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.

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, the Netherlands, and co‐rapporteur Member State, France, for the pesticide active substance Metarhizium brunneum BIPESCO 5/F52 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 Metarhizium brunneum BIPESCO 5/F52 as an insecticide and acaricide on meadows, grassland, amenity turf, maize, wine and table grape, potato, allium vegetables (only field uses) and ornamentals (floriculture, tree nurseries and perennials), strawberry, currants and berries, solanaceae fruiting vegetables (field and greenhouse uses) and cucurbit fruiting vegetables (only greenhouse uses). 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.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co‐rapporteur Member State, Latvia, for the pesticide active substance cyazofamid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cyazofamid as a fungicide on potato, tomato and cucurbits and were updated for non‐target organisms. 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.

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 Italy for the pesticide active substance lavandulylsenecioateare 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 evaluated as a pheromone comprising manual applications to control Planococcusficus (vine mealybug) populations by mating disruption in table grape, wine grape, raisins and any other crops where P. ficus may be a pest in Southern Europe. The reliable endpoints,appropriate for use in regulatory risk assessmentare presented. Missing information identified as being required by the regulatory framework is listed.Concerns are identified.

The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance tri‐allate are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data. The conclusions were reached on the basis of the evaluation of the representative uses of tri‐allate as a herbicide on cereals (barley and wheat). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified.

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, the Czech Republic, for the pesticide active substance flumioxazin are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of flumioxazin as a herbicide on winter wheat and sunflower (pre‐ and post‐emergence). The conclusions were updated with regard to the endocrine‐disrupting properties. The reliable end points concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Hungary, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Purpureocillium lilacinum strain 251, formerly called Paecilomyces lilacinus strain 251, 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 Purpureocillium lilacinum strain 251 as a biological nematicide on tomato and cucumber (uses in the field and permanent greenhouses). 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.

The conclusions of 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 Italy for the pesticide active substance captan are reported and the confirmatory data following the Article 12 of Regulation (EC) No 396/2005 as well. 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 captan as a fungicide on pome fruit, peaches and nectarines, plums, cherry, tomato, strawberries (field use) and strawberries (greenhouse application). 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.

The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Greece, for the pesticide active substance dithianon are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology and residues data. The conclusions were reached on the basis of the evaluation of the representative uses of dithianon as a fungicide on table and wine grapes and on pome fruit. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified.