Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Cotton, LLCotton25, renewal, Articles 11 and 23, Regulation (EC) No 1829/2003
First published in the EFSA Journal
14. November 2018
17. Oktober 2018
Scientific Opinion


Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) 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 LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. 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. In addition, the applicant provided sequence data on the LLCotton25 event using the material from a commercial variety that, according to the applicant, may be imported into the EU at the time of this renewal application. 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. The GMO Panel concludes that there is no evidence in the renewal application EFSA‐GMO‐RX‐010 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on LLCotton25.

Panel members at the time of adoption

Hanspeter Naegeli, Jean‐Louis Bresson, Tamas Dalmay, Ian Crawford Dewhurst, Michelle M Epstein, Leslie George Firbank, Philippe Guerche, Jan Hejatko, Francisco Javier Moreno, Ewen Mullins, Fabien Nogué, Nils Rostoks, Jose Juan Sánchez Serrano, Giovanni Savoini, Eve Veromann and Fabio Veronesi
Panel on Genetically Modified Organisms
EFSA Journal 2018;16(11):5473
Question Number
On request from
European Commission (DG SANTE)