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Following a request from the European Commission, EFSA assessed the 2017 post-market environmental monitoring (PMEM) report on the cultivation of Cry1Ab-expressing maize event MON 810. Like previous years, partial compliance with refuge requirements is reported for Spain. European and Mediterranean corn borer populations collected from North-eastern Spain during the 2017 maize growing season and tested for Cry1Ab susceptibility show no symptoms of resistance to maize MON 810. No complaints about unexpected field damage caused by corn borers were received through the farmer complaint system. The assessment of farmer questionnaires and relevant scientific publications does not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810. No information about the use of existing networks involved in environmental monitoring is provided. Overall, EFSA concludes that the evidence reported in the 2017 PMEM report does not invalidate previous EFSA and GMO Panel evaluations on the safety of maize MON 810. As in previous years, EFSA identifies methodological and reporting shortcomings pertaining to resistance monitoring that need revision in future PMEM reports. In particular, the monitoring plan, as implemented in 2017, is not sufficiently sensitive to detect the recommended 3% resistance allele frequency. Consequently, EFSA strongly recommends the consent holder to: (1) achieve full compliance with refuge requirements in areas where maize MON 810 adoption is high (i.e. North-eastern Spain); (2) increase the sensitivity of the resistance monitoring plan and address previously mentioned methodological, analytical and/or reporting limitations for resistance monitoring and farmer questionnaires; and (3) perform a F2-screen on European and Mediterranean corn borer populations from North-eastern Spain. Moreover, relevant stakeholders should implement a methodological framework to enable making best use of existing networks involved in environmental monitoring for the general surveillance of genetically modified plants.

Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The available evidence, including the results of the post‐market monitoring plan, confirms that the use of Lantharenol® in cat food at the maximum authorised concentration of 7.5 g/kg of complete feed is safe for cats. In the absence of new data, the FEEDAP Panel reiterates its previous conclusion that Lantharenol® does not pose a risk by inhalation and is not an irritant to skin or eye and not a dermal sensitiser. The FEEDAP Panel considers that there is no need for a continuation of a specific post‐market monitoring plan.

In this statement, the EFSA GMO Panel responds to a request from the European Commission (EC) to assess the safety of soybean MON 87705 oil for commercial frying. The applicant provided exposure assessments based on total and partial substitutions of conventional soybean, rapeseed and sunflower oils with the soybean MON 87705 oil in foods (salad dressings, margarines and spreads, mayonnaise, crackers and salty snacks and soybean/rapeseed/sunflower oils processed foods). No distinction was made between commercial and domestic use, nor whether the oils were used in frying or not. The EFSA GMO Panel considers that this exposure scenario is the most pertinent in that it addresses not only the question raised by the EC about the possible use of soybean MON 87705 oil in frying, but also other possible food uses. Having assessed total replacement, the most conservative scenario arising from both domestic and commercial use of the oil, the EFSA GMO Panel concluded that the use of soybean MON 80775 oil does not impact on human health and nutrition. The Panel recommends a post‐market monitoring plan for the marketed foods and feed.

Cotton T304-40 contains a single insert consisting of the cry1Ab and the bar expression cassettes, providing insect resistance and herbicide tolerance, respectively. Bioinformatic analyses and genetic stability studies did not raise safety issues. Levels of the Cry1Ab and PAT proteins in cotton T304-40 have been sufficiently analysed. No biologically relevant differences were identified in the compositional analysis when the seed of T304-40 was compared with its conventional counterpart and non-GM cotton varieties. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the newly introduced Cry1Ab and PAT proteins. Based on the information available, there is no evidence that the genetic modification might significantly change the overall allergenicity of cotton T304-40. Nutritional equivalence of cotton T304-40 to its conventional counterparts was indicated by compositional data. The EFSA GMO Panel concludes that cotton T304-40 is as safe and nutritious as its conventional counterpart and that it is unlikely that the overall allergenicity of the whole plant is changed. There are no indications of an increased likelihood of establishment and spread of feral cotton plants. Considering its intended uses as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from cotton T304-40 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of cotton T304-40. The EFSA GMO Panel considers that the information available for cotton T304-40 addresses the scientific comments raised by the Member States and states that cotton T304-40, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses as proposed by the applicant.

This scientific opinion reports an evaluation of a risk assessment for placing on the market the genetically modified (GM) insect-resistant maize MIR162 for food and feed uses, import and processing. Maize MIR162 contains a single insert consisting of the vip3Aa20 and pmi expression cassettes. The Vip3Aa20 protein confers resistance against certain lepidopteran pests and phosphomannose isomerase (PMI) serves as a selection marker. Bioinformatic analyses of the inserted DNA and flanking regions do not raise safety concerns. The levels of Vip3Aa20 and PMI proteins in maize MIR162 have been sufficiently analysed. The stability of the genetic modification has been demonstrated. Comparative analyses established that there are no biologically relevant differences in the compositional, agronomic or phenotypic characteristics of maize MIR162 compared with its conventional counterpart, and its composition falls within the range of non-GM commercial varieties, except for the expression of the Vip3Aa20 and PMI proteins. The safety assessment identified no concerns regarding potential toxicity and allergenicity of Vip3Aa20 and PMI proteins or of maize MIR162. A feeding study on broiler chickens confirmed that grain produced by maize MIR162 is as nutritious as that produced by its conventional counterpart and a non-GM commercial variety. There are no indications of an increased likelihood of establishment and spread of feral maize plants. Considering its intended use as food and feed, interactions with the biotic and abiotic environment were not considered to be an issue. Risks associated with an unlikely but theoretically possible horizontal gene transfer from maize MIR162 to bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses of maize MIR162. In conclusion, the EFSA GMO Panel considers that information available for maize MIR162 addresses scientific comments raised by Member States and that maize MIR162, as described in this application, is as safe as its conventional counterpart and non-GM commercial varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.