Upon request of the European Commission, the European Food Safety Authority (EFSA) evaluated the concerns raised by Bulgaria and the accompanying documentation submitted under Article 34 of Regulation (EC) 1829/2003 in support of its request to prohibit the cultivation of the genetically modified (GM) maize MON 810 in the European Union.
EFSA did not identify new arguments related to maize MON 810 or the Cry1Ab protein that reveal new scientific evidence in terms of risk to human and animal health or the environment. In addition, EFSA did not further consider the peer-reviewed publications, referred to by Bulgaria, that were previously addressed in its scientific outputs on maize MON 810 or related Bt maize events expressing Cry1Ab protein, or those of its GMO Panel.
For completeness of the evaluation, EFSA considered the proceedings abstract by Büchs et al. (2004) referred to in the report submitted by Bulgaria. However, due to limitations of the publication format and in the absence of sufficient information on the experimental design of the study and data generation and analysis, EFSA could not draw any conclusions on the reliability and relevance of this abstract for the present evaluation nor for the risk assessment of maize MON 810 in general. Therefore EFSA strongly recommends Member States who invoke safeguard clauses under Directive 2001/18/EC or emergency measures under Regulation (EC) No 1829/2003 to supply relevant new scientific data of a quality which can be subjected to detailed scientific scrutiny.
EFSA therefore concludes that neither the arguments put forward by Bulgaria nor the supporting documentation reveal new scientific evidence, in terms of risk to human and animal health or the environment, that would support the adoption of an emergency measure on the cultivation of maize MON 810 under Article 34 of Regulation (EC) 1829/2003. In the absence of new relevant scientific evidence, EFSA concludes that its previous risk assessment conclusions and risk management recommendations on maize MON 810 and those of its GMO Panel remain valid and applicable.