This document provides the scientific opinion of the Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on request from the European Commission an application submitted by Bayer CropScience under Regulation (EC) No 1829/2003 (reference EFSA-GMO-RX-MS8-RF3) for renewal of the authorisation for continued marketing of existing products produced from genetically modified oilseed rape Ms8, Rf3 and Ms8 x Rf3.
The scope of this application covers the continued marketing of (1) existing foods produced from oilseed rape Ms8, Rf3 and Ms8 x Rf3 (processed oil) and (2) existing feeds produced from oilseed rape Ms8, Rf3 and Ms8 x Rf3, which were lawfully placed on the market in the Community before the date of entry into force of Regulation (EC) No 1829/2003. After the date of entry into force of Regulation (EC) No 1829/2003 these products were notified to the European Commission according to Articles 8(1) (a) and 20(1) (b) of that Regulation and included in the Community Register of genetically modified food and feed[1].
The EFSA GMO Panel has previously issued a scientific opinion related to notification C/BE/96/01 for the placing on the market of glufosinate-tolerant hybrid oilseed rape Ms8 x Rf3 derived from genetically modified parental lines Ms8 and Rf3 for import and processing for feed and industrial uses under Part C of Directive 2001/18/EC. In this earlier opinion, the EFSA GMO Panel concluded that “the placing on the market of Ms8, Rf3 and Ms8 x Rf3 oilseed rape for import and processing for feed and industrial purposes is unlikely to have an adverse effect on human or animal health or, in the context of its proposed uses, on the environment. This is in addition to the present uses of oil for food purposes and processed meal for feed purposes, both derived from Ms8 x Rf3 oilseed rape, which are already lawfully placed on the market.”
In delivering the present opinion, the EFSA GMO Panel considered the information provided in the renewal application (reference EFSA-GMO-RX-MS8-RF3) as well as additional information submitted by the applicant upon request of the EFSA GMO Panel. In accordance with the Guidance Document for renewal of authorisations of existing GMO products, the EFSA GMO Panel has taken into account the new information, experience and data, which have become available during the authorisation period.
Regarding the molecular data which have already been evaluated in the context of the previous notification on oilseed rape Ms8, Rf3 and Ms8 x Rf3, the EFSA GMO Panel refers to its previous scientific opinion. The scientific assessment included the transformation process, the vectors used and the transgenic constructs in the GM oilseed rape. The further assessment presented here is based on the information provided by the applicant in application EFSA-GMO-RX-MS8-RF3, including an updated molecular characterization. These updated molecular and bioinformatic analyses provided for oilseed rape Ms8 and Rf3 as well as additional data, provided upon request of the EFSA GMO Panel, do not indicate any concerns.
According to the information provided by the applicant, food and feed products produced from oilseed rape Ms8, Rf3 and Ms8 x Rf3 that have been approved in the EU, have been consumed without reports of adverse effects. Bioinformatic studies comparing the amino acid sequences of the newly expressed Barnase, Barstar and PAT proteins in oilseed rape Ms8, Rf3 and Ms8 x Rf3 with amino acid sequences in updated databases of toxic or allergenic proteins confirmed the results of the older studies which identified no relevant similarities to known toxic or allergenic proteins. In addition, a 42-day feeding study in broiler chickens showed that the tested material of oilseed rape Ms8 x Rf3 is nutritionally equivalent to its non-GM counterpart.
The scope of this application excludes import of viable plant material and cultivation. Therefore, there is no requirement for scientific information on environmental safety assessment of accidental release or cultivation of oilseed rape Ms8, Rf3 and Ms8 x Rf3. A post-market environmental monitoring plan for oilseed rape Ms8, Rf3 and Ms8 x Rf3 is not required.
The EFSA GMO Panel concludes that there is no new information provided by the applicant or in the scientific literature that would require changes of its previous scientific opinion on oilseed rape Ms8, Rf3 and Ms8 x Rf3. Therefore, the EFSA GMO Panel reiterates the previous conclusions that GM oilseed rape Ms8, Rf3 and Ms8 x Rf3 is unlikely to have an adverse effect on human and animal health or, in the context of its proposed uses, on the environment. This also applies to the products which are the subject of the present application.
Opinion
