Report on the safety analysis of oilseed rape Ms8 x Rf3 pollen in food or as food

Rapport (0.1 Mb)

Résumé

Following a request from the European Commission, EFSA was asked to assess the safety of oilseed rape Ms8 x Rf3 pollen as food or in food. The EFSA scientific analysis was preformed taking into consideration the following information: i) the EFSA GMO Panel scientific opinion on oilseed rape Ms8 x Rf3 published in 2005; ii) the EFSA GMO Panel scientific opinion for renewal of oilseed rape Ms8 x Rf3 published in 2009; and iii) a scientific literature search.

Oilseed rape Ms8 x Rf3 expresses the Barnase, Barstar and PAT proteins. The Barnase and Barstar proteins are both under the control of tapetum-specific promoter and their expression is highly restricted spatially and temporally. The bar coding sequence, coding for the PAT protein, is under a promoter which is active in all green tissues and in pollen. The stability of the transgene inserts in Ms8 and Rf3 has been demonstrated over multiple generations, implying that the integrity of the inserts was maintained throughout microsporogenesis and pollen production. Bioinformatic analyses of the putative translation products of open reading frames spanning the 5’ and 3’ junction regions of the inserts did not reveal significant similarity to known allergens or toxins. In laboratory experiments, the Barnase and Barstar proteins could not be detected in the pollen. The PAT protein expression was detected in pollen, but the level was not quantified. A search in the open scientific literature did not yield any data on the level of PAT in oilseed rape Ms8xRf3 pollen.

For the food and feed safety assessment, the EFSA GMO Panel previously assessed the safety of the Barnase, Barstar and PAT proteins in oilseed rape Ms8 x Rf3. Updated bioinformatics studies indicated that no similarities exist between the newly expressed proteins Barnase, Barstar and PAT and known toxic proteins or allergens. The EFSA GMO Panel assessed the safety of the PAT protein not only on oilseed rape, but also in other crops and did not identify any issue regarding its potential toxicity and allergenicity.

Additionally, EFSA considered the possibility that unintended effects of the genetic modification might have occurred in oilseed rape Ms8 x Rf3 pollen. Based on the information analysed in this report, there is no indication for unintended effects due to the genetic modification. The EFSA GMO Panel previously concluded that oilseed rape Ms8 x Rf3 is as safe and as nutritious as the non-GM counterpart, in the context of its intended uses.

Considering the available data described in this report, no indication of potential concerns over the safety of the newly expressed Barnase, Barstar and PAT proteins, nor the occurrence of unintended effects in oilseed rape Ms8 x Rf3 pollen that could raise safety concerns, have been identified.