Scientific Opinion on application (EFSA-GMO-BE-2010-81) for the placing on the market of genetically modified herbicide-tolerant oilseed rape Ms8, Rf3 and Ms8 x Rf3 for food containing or consisting of, and food produced from or containing ingredients produced from, oilseed rape Ms8, Rf3 and Ms8 x Rf3 (with the exception of processed oil) under Regulation (EC) No 1829/2003 from Bayer

This scientific opinion is a risk assessment for the placing on the market of the genetically modified (GM) herbicide-tolerant oilseed rape (OSR) Ms8, Rf3 and Ms8xRf3 for food containing or consisting of, and food produced from or containing ingredients produced from, these GM plants. OSR Ms8 (male sterile) and Rf3 (fertility restorer) are the parents of OSR Ms8xRf3, which is fertile, contains the bar, barstar and barnase genes, and is tolerant to glufosinate-ammonium-containing herbicides. Integrity of the inserts present in the single events was demonstrated in the stack. Molecular characterisation did not reveal any safety issues. No biologically relevant differences were identified in the composition or agronomic and phenotypic characteristics of OSR Ms8xRf3, as compared with its non-GM comparator, except for the newly expressed proteins. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of OSR Ms8, Rf3 and Ms8xRf3. A broiler study confirmed that OSR Ms8xRf3 is as nutritious as its non-GM comparator. There are no indications of an increased likelihood of establishment and spread of feral OSR Ms8, Rf3 and Ms8xRf3 plants, or of hybridising wild relatives, unless exposed to glufosinate-ammonium-containing herbicides. Considering the intended uses, potential interactions of feral OSR Ms8, Rf3 and Ms8xRf3 plants with the biotic and abiotic environment are not considered an issue. Environmental risks associated with a possible horizontal transfer into bacteria have not been identified. The monitoring plan and reporting intervals are in line with the intended uses. In conclusion, the EFSA GMO Panel considers that the information available for OSR Ms8, Rf3 and Ms8xRf3 addresses the scientific comments raised by Member States and that OSR Ms8, Rf3 and Ms8xRf3 are unlikely to have an adverse effect on human and animal health or on the environment, in the context of their intended uses.

© European Food Safety Authority, 2012

Following the submission of an application (EFSA-GMO-BE-2010-81) under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on the safety of genetically modified (GM) herbicide-tolerant oilseed rape Ms8 (Unique Identifier ACS-BNØØ5-8), Rf3 (Unique Identifier ACS-BNØØ3-6) and Ms8 x Rf3 (Unique Identifier ACS-BNØØ5-8 x ACS-BNØØ3-6) for food containing or consisting of, and food produced from or containing ingredients produced from, oilseed rape Ms8, Rf3 and Ms8 x Rf3 (with the exception of processed oil).

In delivering its scientific opinion, the EFSA GMO Panel considered the application EFSA-GMO-BE-2010-81, additional information supplied by the applicant, scientific comments submitted by the Member States, and relevant scientific publications. Furthermore, relevant information from previous applications for the placing on the European Union market of oilseed rape Ms8, Rf3 and Ms8 x Rf3 was taken into account. The scope of application EFSA-GMO-BE-2010-81 is for food containing or consisting of, and food produced from or containing ingredients produced from, oilseed rape Ms8, Rf3 and Ms8 x Rf3 (with the exception of processed oil) within the EU, as for any non-GM oilseed rape, but excludes cultivation in the EU. The EFSA GMO Panel evaluated oilseed rape Ms8, Rf3 and Ms8 x Rf3 with reference to the intended uses and appropriate principles described in its guidance documents for the risk assessment of GM plants and derived food and feed (EFSA, 2006a), for the risk assessment of GM plants containing stacked transformation events (EFSA, 2007a) and on the post-market environmental monitoring (PMEM) of GM plants (EFSA, 2006b, 2011a). The scientific risk assessment included molecular characterisation of the inserted DNA and expression of the corresponding proteins. An assessment of the comparative analysis of composition and phenotypic and agronomic characteristics was undertaken, and the safety of the new proteins and the whole food was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An assessment of the environmental impacts and PMEM plan were undertaken.

Oilseed rape Ms8, Rf3 and Ms8 x Rf3 have been the subject of earlier risk assessments by the EFSA GMO Panel with the scope covering: (i) import and processing, and feed and industrial uses in 2005; and (ii) the renewal of the authorisation for continued marketing of existing food and food ingredients produced from oilseed rape Ms8, Rf3 and Ms8 x Rf3, and feed materials produced from oilseed rape Ms8, Rf3 and Ms8 x Rf3 in 2009. The EFSA GMO Panel concluded that oilseed rape Ms8, Rf3 and Ms8 x Rf3 are unlikely to have an adverse effect on human and animal health or, in the context of its proposed uses, on the environment. In addition, EFSA recently published a technical report on a safety analysis of pollen derived from oilseed rape Ms8 x Rf3 in food or as food (EFSA, 2012). In this report, EFSA concluded that, considering the data available, no indication of potential concerns over the safety of the newly expressed phosphinothricin acetyl transferase (PAT) protein, barnase and barstar proteins, nor the occurrence of unintended effects in oilseed rape Ms8 x Rf3 pollen, have been identified that could raise safety concerns (EFSA, 2012).

In oilseed rape Ms8, the genes bar and barnase are introduced conferring tolerance to the herbicidal active ingredient glufosinate-ammonium, and male sterility, respectively. Oilseed rape Rf3 is also tolerant to glufosinate-ammonium, and expresses a restorer of fertility as a consequence of the introduced genes bar and barstar, respectively.

Molecular analysis has confirmed that the Ms8 and Rf3 inserts are present and that their structures are retained in oilseed rape Ms8 x Rf3. Result of the bioinformatic analyses of the flanking sequences and the open reading frames spanning the insert–genomic DNA junctions did not reveal safety issues. The levels of the PAT protein in oilseed rape Ms8 x Rf3 were similar to those of the single oilseed rape events Ms8 and Rf3.

The comparative analysis indicated that no biologically relevant differences were identified in the compositional, agronomic and phenotypic characteristics of oilseed rape Ms8 x Rf3 compared with its non-GM comparator oilseed rape, except for the newly expressed PAT, barnase and barstar proteins.

The safety of the newly expressed proteins present in oilseed rape Ms8, Rf3 and Ms8 x Rf3 were previously assessed by the EFSA GMO Panel in 2005 and 2009, and no safety concerns were identified for humans or animals, in the context of their intended uses. A 42-day broiler feeding study confirmed that oilseed rape Ms8 x Rf3 was as nutritious as its non-GM comparator. The new information provided in the present application does not raise concerns regarding toxicity and allergenicity of oilseed rape Ms8, Rf3 and Ms8 x Rf3. Thus, the EFSA GMO Panel reiterates its previous conclusion that oilseed rape Ms8, Rf3 and Ms8 x Rf3 are unlikely to have an adverse effect on human and animal health, in the context of their intended uses.

As this application does not cover cultivation of oilseed rape Ms8, Rf3 and Ms8 x Rf3, there is no requirement for scientific information on the possible environmental effects associated with the cultivation of oilseed rape Ms8, Rf3 and Ms8 x Rf3. In the event of the accidental release into the environment of viable oilseed rape Ms8, Rf3 and Ms8 x Rf3 seeds unintentionally present in food, there are no indications of an increased likelihood of establishment and spread of feral oilseed rape Ms8, Rf3 and Ms8 x Rf3, unless exposed to glufosinate-ammonium-containing herbicides. Likewise, evidence indicates that hybridising wild relatives that may theoretically have acquired the herbicide tolerance trait through vertical gene flow are neither more likely to establish nor to spread than their non-GM comparators in the absence of glufosinate-ammonium-containing herbicides. Considering the intended uses of oilseed rape Ms8, Rf3 and Ms8 x Rf3, potential interactions of feral oilseed rape Ms8, Rf3 and Ms8 x Rf3 plants with the biotic and abiotic environment are not considered to be an issue due to the low levels of exposure. Due to the intended uses of oilseed rape Ms8, Rf3 and Ms8 x Rf3, only a low level exposure of bacteria in the environment, including those in the gastrointestinal tract, to recombinant DNA from oilseed rape Ms8, Rf3 and Ms8 x Rf3 is expected. The unlikely but theoretically possible transfer of the recombinant genes from oilseed rape Ms8, Rf3 and Ms8 x Rf3 to bacteria does not raise concerns due to the lack of a selective advantage that would be provided to the recipients in the receiving environments. Additionally, tolerance and resistance to glufosinate-ammonium is widespread among bacteria in the environment making it unlikely that horizontal gene transfer would add to this natural background. The scope of the PMEM plan provided by the applicant is in line with the intended uses of oilseed rape Ms8, Rf3 and Ms8 x Rf3. Furthermore, the EFSA GMO Panel agrees with the reporting intervals proposed by the applicant in its general surveillance plan.

In conclusion, the EFSA GMO Panel considers that the information available for oilseed rape Ms8, Rf3 and Ms8 x Rf3 addresses the scientific issues described in its relevant guidance documents and the scientific comments raised by the Member States, and that oilseed rape Ms8, Rf3 and Ms8 x Rf3 are unlikely to have an adverse effect on human and animal health or on the environment, in the context of their intended uses.

GMO, oilseed rape, Ms8, Rf3, Ms8 x Rf3, herbicide tolerant, human and animal health, food, Regulation (EC) No 1829/2003