Following requests from the Competent Authority of the United Kingdom and from the European Commission (EC), the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on applications EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985 respectively, both submitted by Monsanto under Regulation (EC) No 1829/2003. While application EFSA-GMO-UK-2008-57 is for the placing on the market of cotton MON 15985 for food and feed uses, EFSA-GMO-RX-MON15985 is for the renewal of authorisation for continued marketing of:
- food additives produced from cotton MON 15985, authorised under Directive 89/107/EEC;
- feed produced from cotton MON 15985 (feed materials and feed additives), authorised under Directive 70/524/EEC.
After the date of entry into force of Regulation (EC) No 1829/2003, the products mentioned above were notified to the EC in accordance with Articles 8(1)(b) or 20(1)(b) of this Regulation and subsequently included in the European Union (EU) Register of authorised GMOs.
Since both EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985 cover cotton MON 15985, the EFSA GMO Panel provides a single scientific opinion, valid for both applications.
The EFSA GMO Panel evaluated cotton MON 15985 with reference to the scope and appropriate principles described in its guidance documents for the risk assessment of genetically modified (GM) plants and derived food and feed (EFSA, 2006a; EFSA GMO Panel, 2011a), environmental risk assessment (ERA) (EFSA GMO Panel, 2010a) and for renewal of authorisations of existing GMO products lawfully placed on the market (EFSA, 2006b). The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins. An evaluation of the comparative analyses of compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expressed proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of environmental impacts and the post-market environmental monitoring (PMEM) plan was also undertaken.
The scope of applications EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985 covers the MON 15985 event in cotton species Gossypium hirsutum L. and G. barbadense L. The genus Gossypium consists of more than 50 species, two of which are the most commonly cultivated species (G. hirsutum and G. barbadense). The composition of cottonseed from G. barbadense does not differ from that of seed from G. hirsutum to the extent that a food and feed risk assessment of one species would not be applicable also to the other.
Cotton MON 15985 was obtained by the transformation of GM cotton MON 531 (unique identifier MON-ØØ531-6) with a DNA fragment carrying two expression cassettes: cry2Ab2 and uidA. While expression of the Cry2Ab2 protein confers resistance to the major lepidopteran cotton pests including the cotton bollworm, tobacco budworm and the pink bollworm, the GUS E377K protein, produced by the uidA gene, was used as a histochemical marker during product development.
Cotton MON 531 has been developed to produce a synthetic variant of the Cry1Ac protein. In addition, cotton MON 531 contains a kanamycin resistance gene (nptII) under plant expression signals and the streptomycin/spectinomycin resistance gene aadAunder the control of its bacterial promoter. Cotton MON 531 has been assessed previously (EFSA GMO Panel, 2011b) on the basis of experimental data. No concerns were identified for human and animal health and the environment. The molecular characterisation data provided for cotton MON 15985 did not give rise safety issues.
The EFSA GMO Panel could not complete the assessment of the agronomic and phenotypic characteristics of cotton MON 15985 on the basis of the data provided (a single season and fewer than eight sites (EFSA, 2006a; EFSA GMO Panel 2011a)). Therefore, the EFSA GMO Panel could not conclude on the potential occurrence of unintended effects based on the outcome of the agronomic and phenotypic analysis. The EFSA GMO Panel concludes that the compositional data give no indication that the genetic modification induces unintended effects for which further assessment is needed. The EFSA GMO Panel concludes that cotton MON 15985 is as safe and nutritious as its conventional counterpart and that it is unlikely that the overall allergenicity of the whole plant is changed.
Applications EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985 cover the import, processing, and food and feed uses of cotton MON 15985. Therefore, there is no requirement for scientific information on possible environmental effects associated with the cultivation of cotton MON 15985. In accordance with its guidance document on the ERA of GM plants (EFSA, 2010a), the EFSA GMO Panel follows a weight of evidence approach in collating and assessing appropriate information from various data sources (e.g. molecular and compositional data, available agronomic and phenotypic data from field trials performed by the applicant, literature) in order to assess the likelihood of unintended effects on the environment. Notwithstanding the incompleteness of the agronomic and phenotypic dataset, the EFSA GMO Panel followed a weight of evidence approach and, considering the scope of this application and the poor ability of cotton to survive outside cultivated fields, concluded that there is very low likelihood of any adverse environmental impacts due to the accidental release into the environment of viable seeds from cotton MON 15985. The aadA and oriV sequences in MON 15985 may facilitate the stabilisation of nptII through double homologous recombination in plasmid sequences in the environment. However, considering the limited presence of intact DNA from MON 15985 in feed and processed feed owing to the low percentage of cotton plant material allowed in feed products, and the limited occurrence of horizontal transfer of DNA from plant material to bacteria, the EFSA GMO Panel concludes that it is highly unlikely that cotton MON 15985 will contribute to the environmental prevalence of nptII genes. The scope of the PMEM plan provided by the applicant is in line with the intended uses of cotton MON 15985. Furthermore, the EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in the general surveillance plan.
In delivering its scientific opinion, the EFSA GMO Panel considered applications EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985, additional information submitted by the applicant on request of the Panel, the scientific comments submitted by Member States and relevant scientific publications. In accordance with its guidance document for renewal of authorisations of existing GMO products (EFSA, 2006b), the EFSA GMO Panel took into account the new information, experience and data on cotton MON 15985 that became available during the authorisation period.
The EFSA GMO Panel considers that the dossiers presented by the applicant had deficiency in the data set relative to agronomic and phenotypic trials, however the EFSA GMO Panel concludes that cotton MON 15985, as described in applications EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985, is as safe as its conventional counterpart and non-GM cotton commercial varieties, and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of these applications.