Approval of GM crops in Europe is very time consuming and expensive
Genetically modified (GM) crops that are approved for cultivation or use in Europe contain foreign genes from micro-organisms and/or genes that are designed by mankind. These genes have been used for selection of GM cells during the process of genetic modification, or these genes are introduced for its target traits, such as resistance to insects or herbicides. In Europe there has been serious opposition to the introduction of genes from micro-organisms into crops. This has led to a very stringent approval policy in Europe, described in Directive 2001/18/EC and Regulation (EC) 1829/2003.
The approval procedure for GM crops for cultivation and marketing in Europe is generally too expensive and time consuming for small and medium enterprises (SMEs) and for public institutions (universities and research centres). Consequently, only a few giant agro-chemical companies have submitted dossiers to the EFSA for approval of plants in Europe. This reduces the agro-biodiversity of approved crops considerably. The danger of limited genetic diversity of GM crops may lead to break down of pest resistance, on huge areas, as happened earlier to hybrid corn in the USA. This is not the aim of the European Directive on GMOs.

The European GMO Regulation is a serious obstacle
The current European regulation for GMOs is based on transgenes. The regulation does not distinguish cisgenic plants from transgenic plants. Consequently, approval of cisgenic crops is too time-consuming and too expensive for SMEs and public institutions.

In view of the inherent safety of cisgenic plants, we propose faster and cheaper approval of cisgenic crops. This can be achieved by adding Cisgenesis to the list of GM technologies that are exempted from the European GMO Regulation (see Annex 1B in Directive 2001/18). The cisgenic crops contain only genes that can be used in classical breeding too. Cisgenesis is as safe as or even safer than classical breeding. It will lead to a more efficient improvement of crops, a strong reduction of fungicide usage, and higher food quality. Faster and cheaper approval will allow also SMEs (Small and Medium sized Enterprises) and public institutions to use cisgenesis for a variety of crops, therefore leading to a wider agro-biodiversity in Europe and thus to a more sustainable agriculture.