EFSA's GMO Panel provides reply to European Commission request on GM rice LLRICE601

The GMO Panel has evaluated the available scientific data on LLRICE601. According to the Statement of the Panel issued today there is insufficient data to provide a full risk assessment in accordance with EFSA’s GM guidance[1]. On the basis of the available molecular and compositional data and the toxicological profile of a newly introduced protein[2], the Panel considers that the consumption of imported long grain rice containing trace levels of LLRICE601 is not likely to pose an imminent safety concern to humans or animals. The Panel Statement will now be forwarded to the European Commission and Member States who are responsible for risk management measures in relation to LLRICE601.

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific support concerning the safety of the long grain GM rice LLRICE601 which had been inadvertently released in the United States (US) and exported to the European Union (EU). EFSA was asked to examine the scientific data available and inform the European Commission if these data were sufficient to carry out a safety assessment according to EU legislation.

EFSA’s Panel on Genetically Modified Organisms (GMO) met on 13th and 14th September 2006 to consider the request of the European Commission and examine the available scientific data on the LLRICE601 issue. EFSA’s Panel took into consideration all relevant scientific information, including data from Bayer Crop Science (the company which has developed LLRICE601), existing scientific data on a very similar GMO rice strain[3] and risk assessments carried out by the US authorities.

The EFSA GMO Panel has issued a Statement which says that the available data[4] are not sufficient to allow the safety of LLRICE601 to be assessed in accordance with EFSA guidance for risk assessment and EFSA is unable to carry out a full risk assessment. However, based on the available scientific data, EFSA’s GMO Panel has come to the following conclusions:

  • The data package indicates the presence of a newly introduced protein, called PAT. EFSA’s GMO Panel has previously assessed other PAT proteins and concluded that these do not pose any health concern.
  • With respect to morphology, agronomic performance and compositional analysis LLRICE601 does not differ significantly from conventional rice (except for the PAT protein), however, at present there is a lack of data to verify this assumption.
  • Exposure levels to LLRICE601 in the EU Member States cannot be estimated accurately from the data provided and little is known with respect to the extent of LLRICE601 in the rice supply. However, US data[5] suggests the low inadvertent presence of LLRICE601.
  • Based on the available data, EFSA’s GMO Panel considers that the consumption of imported long grain rice containing trace levels of LLRICE601 is not likely to pose an imminent safety concern to humans or animals.
Notes to editors

EFSA is presently reviewing an application for a similar GM rice produced by Bayer Crop Science, LLRICE62 (http://www.efsa.europa.eu/en/efsajournal/pub/588.htm)

The presence of LLRICE601 has not been reported in medium or short-grain rice.

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[1] http://www.efsa.europa.eu/en/gmo/gmoguidance.htm 
[2] PAT (phospinothricin acetyl transferase) is a protein which confers tolerance to the phytotoxic activity of glufosinate ammonium, the active ingredient of the Liberty ® herbicide.
[3] EFSA is currently carrying out a risk assessment on GM rice from Bayer Crop Science (LLRICE62) which is very similar to LLRICE601.
[4] This particular type of GM rice was not intended for commercial market purposes in the US and EU and therefore the company has not prepared the necessary comprehensive scientific data foreseen for a GMO application under EU legislation.
[5] US rice producers have estimated that the presence of LLRICE601 might be below 0.1%.