RESUMO
Following the joint submission of dossier GMFF-2022-9170 under Regulation (EC) No 1829/2003 from Bayer Agriculture B.V. and Corteva Agriscience Belgium B.V., the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant and insect resistant genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, a search for additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-9170 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × MON 88017 × 59122 and 8 out of 10 of its subcombinations.
RESUMO
Following the submission of dossier GMFF-2022-3670 under Regulation (EC) No 1829/2003 from Corteva Agriscience Belgium BV and Bayer Agriculture BV, the Panel on genetically modified organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant and insect-resistant genetically modified maize MON 89034 × 1507 × NK603, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and a search for additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in maize MON 89034 × 1507 × NK603 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal dossier GMFF-2022-3670 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 89034 × 1507 × NK603.
RESUMO
Genetically modified (GM) maize MON 94804 was developed to achieve a reduction in plant height by introducing the GA20ox_SUP suppression cassette. The molecular characterisation and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the agronomic/phenotypic and compositional differences identified between maize MON 94804 and its conventional counterpart needs further assessment, except for ear height, plant height and levels of carbohydrates in forage, which do not raise safety or nutritional concerns. The Panel on Genetically Modified Organisms (GMO Panel) does not identify safety concerns regarding the toxicity and allergenicity of the GA20ox_SUP precursor-miRNA and derived mature miRNA as expressed in maize MON 94804 and finds no evidence that the genetic modification would change the overall allergenicity of maize MON 94804. In the context of this application, the consumption of food and feed from maize MON 94804 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 94804 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 94804 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 94804. The GMO Panel concludes that maize MON 94804 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.
RESUMO
Genetically modified maize DP202216 was developed to confer tolerance to glufosinate-ammonium-containing herbicides and to provide an opportunity for yield enhancement under field conditions. These properties were achieved by introducing the mo-pat and zmm28 expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP202216 and its comparator needs further assessment, except for the levels of stearic acid (C18:0), which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the PAT and ZMM28 proteins as expressed in maize DP202216, and finds no evidence that the genetic modification would change the overall allergenicity of maize DP202216. In the context of this application, the consumption of food and feed from maize DP202216 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP202216 is as safe as the comparator and non-GM reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP202216 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP202216. The GMO Panel concludes that maize DP202216 is as safe as its comparator and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.
RESUMO
Genetically modified maize DP23211 was developed to confer control of certain coleopteran pests and tolerance to glufosinate-containing herbicide. These properties were achieved by introducing the pmi, mo-pat, ipd072Aa and DvSSJ1 expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP23211 and its conventional counterpart needs further assessment, except for those in levels of histidine, phenylalanine, magnesium, phosphorus and folic acid in grain, which do not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD072Aa, PAT and PMI proteins and the DvSSJ1 dsRNA and derived siRNAs newly expressed in maize DP23211, and finds no evidence that the genetic modification impacts the overall safety of maize DP23211. In the context of this application, the consumption of food and feed from maize DP23211 does not represent a nutritional concern in humans and animals. Therefore, no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP23211 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP23211. The GMO Panel concludes that maize DP23211 is as safe as its conventional counterpart and the tested non-GM reference varieties with respect to potential effects on human and animal health and the environment.
RESUMO
Genetically modified maize DP915635 was developed to confer tolerance to glufosinate herbicide and resistance to corn rootworm pests. These properties were achieved by introducing the ipd079Ea, mo-pat and pmi expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize DP915635 and its conventional counterpart needs further assessment, except for the levels of crude protein in forage, which does not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the IPD079Ea, PAT and PMI proteins expressed in maize DP915635. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize DP915635. In the context of this application, the consumption of food and feed from maize DP915635 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize DP915635 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize DP915635 grains into the environment, this would not raise environmental safety concerns. The post market environmental monitoring plan and reporting intervals are in line with the intended uses of maize DP915635. The GMO Panel concludes that maize DP915635 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.
RESUMO
Following the submission of dossier GMFF-2022-9450 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect protected genetically modified maize MON 810, for food and feed uses (including pollen), excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, an evaluation of the literature retrieved by a scoping review, additional studies performed by or on behalf of the applicant and updated bioinformatics analyses. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MON 810 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in dossier GMFF-2022-9450 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MON 810.
RESUMO
Following an application from Greenleaf Medical AB, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Sweden, 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 Appethyl® and reduction of body weight. Appethyl® is an aqueous extract from spinach leaves standardised by the manufacturing process and its lipase/colipase inhibition capacity in vitro. The Panel considers that the food is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight/obese individuals. The applicant identified a total of three human intervention studies that investigated the effects of Appethyl® on body weight as being pertinent to the claim. In weighing the evidence, the Panel took into account that Appethyl® (5 g/day for 12 weeks) had no effect on body weight as compared to placebo under minimal dietary counselling and moderate physical activity, and that no beneficial physiological effects are to be expected for the target population of overweight/obese individuals from the weight loss that could be attributed to the intervention with Appethyl® under predefined energy restriction and moderate physical activity. The Panel also considered that the effect of Appethyl® (5 g/day for 24 weeks) on body weight maintenance after initial weight loss shown in one study has not been replicated in different settings, which questions the external validity of the results, and that no evidence was provided for a plausible mechanism by which daily consumption of Appethyl® could exert a sustained effect on body weight in humans. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of Appethyl® and a reduction of body weight under the conditions of use proposed by the applicant.
RESUMO
Following an application from Procter & Gamble BV pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the 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 choline and contribution to normal liver function of the foetus and exclusively breastfed infant. The scope of the application was proposed to fall under a health claim referring to children's development and health. The Panel considers that choline is sufficiently characterised. The claimed effect proposed by the applicant is contribution 'to normal foetal and infant development, especially liver'. The proposed target population is 'unborn fetuses and breastfed infants'. Choline is involved in the structure of cell membranes, cell signalling, metabolism and transport of lipids and cholesterol and neurotransmitter synthesis. Although choline can be synthesised de novo by the human body, depletion-repletion studies in humans show that low choline intake leads to liver dysfunction and muscle damage, which are reverted by the administration of dietary choline. For these functions, de novo synthesis of choline by the human body is insufficient and choline must be obtained from dietary sources. No human studies have addressed the effect of low maternal dietary choline intake on liver function in the fetus or exclusively breastfed infants. However, the Panel considers that the biological role of choline in normal liver function and dietary choline being essential for the function applies to all ages, including fetus and infants. The Panel concludes that a cause and effect relationship has been established between the intake of choline by pregnant and lactating women and contribution to normal liver function of the fetus and exclusively breastfed infants.
RESUMO
The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from a whey protein concentrate and used in an infant and follow-on formula manufactured by FrieslandCampina Nederland B.V., which submitted a dossier to the European Commission to request an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in the manufacture of infant and/or follow-on formula. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.4 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to a growth equivalent to a formula manufactured from intact cow's milk protein with a protein content of 2.1 g/100 kcal. Data on gastrointestinal tolerance of the formula did not raise any concerns. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. Given that it is consumed with complementary foods and the protein source is nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow-on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 2.4 g/100 kcal protein and complies with the compositional criteria of Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.
RESUMO
Genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 was developed by crossing to combine six single events: Bt11, MIR162, MIR604, MON 89034, 5307 and GA21, the GMO Panel previously assessed the 6 single maize events and 27 out of the 56 possible subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the six-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that six-event stack maize, as described in this application, is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable six-event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in 29 of the maize subcombinations not previously assessed and covered by the scope of this application and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the six-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21. The GMO Panel concludes that six-event stack maize and the 30 subcombinations covered by the scope of the application are as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.
RESUMO
Genetically modified cotton COT102 was developed to confer resistance against several lepidopteran species. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the differences in the agronomic-phenotypic and compositional characteristics between cotton COT102 and its non-GM comparator needs further assessment, except for levels of acid detergent fibre, which do not raise safety or nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the Vip3Aa19 and APH4 proteins as expressed in cotton COT102 and finds no evidence that the genetic modification would change the overall allergenicity of cotton COT102. In the context of this application, the consumption of food and feed from cotton COT102 does not represent a nutritional concern for humans and animals. The GMO Panel concludes that cotton COT102 is as safe as the non-GM comparator and non-GM cotton varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable cotton COT102 seeds into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton COT102. The GMO Panel concludes that cotton COT102 is as safe as its non-GM comparator and the tested non-GM cotton varieties with respect to potential effects on human and animal health and the environment.
RESUMO
Following the submission of application EFSA-GMO-RX-024 under Regulation (EC) No 1829/2003 from BASF Agricultural Solutions Seed US LLC, the Panel on Genetically Modified Organisms of EFSA was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide tolerant genetically modified oilseed rape MS8, RF3 and MS8 × RF3, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in oilseed rape MS8, RF3 and MS8 × RF3 considered for renewal are identical to the sequences of the originally assessed events, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-024 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape MS8, RF3 and MS8 × RF3.
RESUMO
The European Commission requested the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to assess new scientific information on maize MIR162, and to indicate whether the previous conclusions on the safety of maize MIR162 as a single event and as a part of stacked events remain valid. The new information is included in a European patent that reports a decrease in male fertility in some MIR162 inbred lines, pointing to a potential link between such decrease and the Vip3 protein expressed by maize MIR162. The EFSA GMO Panel evaluated the data provided by the patent owner and found scarce support for a causal link between Vip3 and decreased fertility. The general hypothesis of an association between event MIR162 and altered fertility could not be confirmed. The EFSA GMO Panel conducted the safety assessment based on the conservative assumption that such an association exists. The EFSA GMO Panel concluded that a decrease in male fertility would have no impact on the previous conclusions on maize MIR162 and stacked events containing MIR162.
RESUMO
Genetically modified maize GA21 × T25 was developed by crossing to combine two single events: GA21 and T25. The GMO Panel previously assessed the two single maize events and did not identify safety concerns. No new data on the single maize events were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in maize GA21 × T25 does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that maize GA21 × T25, as described in this application, is as safe as its conventional counterpart and the non-GM reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable maize GA21 × T25 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize GA21 × T25. Post-market monitoring of food and feed is not considered necessary. The GMO Panel concludes that maize GA21 × T25 is as safe as its conventional counterpart and the non-GM reference varieties tested, with respect to potential effects on human and animal health and the environment.
RESUMO
EFSA carries out the risk assessment of genetically modified plants for food and feed uses under Regulation (EU) No 503/2013. Exposure assessment - anticipated intake/extend of use shall be an essential element of the risk assessment of genetically modified feeds, as required by Regulation (EU) No 503/2013. Estimates of animal dietary exposure to newly expressed proteins should be determined to cover average consumption across all the different species, age, physiological and productive phases of farmed and companion animals, and identify and consider particular consumer groups with expected higher exposure. This statement is aimed at facilitating the reporting of the information that applicants need to provide on expected animal dietary exposure to newly expressed proteins and to increase harmonisation of the application dossiers to be assessed by the EFSA GMO Panel. Advice is provided on the selection of proper feed consumption and feed concentration data, and on the reporting of exposure's estimates. An overview of the different uncertainties that may be linked to the estimations is provided. This statement also explains how to access an Excel calculator which should be used in future applications as basis to provide a more consistent presentation of estimates of expected animal dietary exposure.
RESUMO
Genetically modified maize MON 87419 was developed to confer tolerance to dicamba- and glufosinate-based herbicides. These properties were achieved by introducing the dmo and pat expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MON 87419 and its conventional counterpart needed further assessment, except for the levels of arginine and protein in grains which did not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono-oxygenase (DMO) and phosphinothricin N-acetyltransferase (PAT) proteins as expressed in maize MON 87419. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize MON 87419. In the context of this application, the consumption of food and feed from maize MON 87419 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 87419 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87419 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87419. The GMO Panel concludes that maize MON 87419 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.
RESUMO
Following the submission of application EFSA-GMO-RX-022 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant and herbicide-tolerant genetically modified soybean MON 87701 × MON 89788, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the events in soybean MON 87701 × MON 89788 considered for renewal are identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-022 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87701 × MON 89788.
RESUMO
Following the submission of application EFSA-GMO-RX-023 under Regulation (EC) No 1829/2003 from Bayer Agriculture BV on behalf of Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified soybean 40-3-2, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in soybean 40-3-2 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-023 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean 40-3-2.
RESUMO
Following the submission of application EFSA-GMO-RX-021 under Regulation (EC) No 1829/2003 from Bayer CropScience LP, the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect-resistant genetically modified soybean MON 87701, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequences of the event in soybean MON 87701 considered for renewal is identical to the sequences of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-021 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 87701.
