Evaluation of the EU legislative Framework in the Field of Cultivation of GMOs
Organisations (industry, farming groups, research organisations, non-governmental organisations and other stakeholders) can also register themselves on a database for this survey by entering their details on the GHK website at http://gmregister.ghkint.com/ .
The present exercise aims at the evaluation of the regulatory framework of the cultivation of GMOs under Directive 2001/18/EC on the deliberate release into the environment of GMOs (hereinafter: the Directive) and Regulation (EC) No 1829/2003 on GM food and feed (hereinafter: the Regulation) and the marketing of their other uses under the Directive.
The aim of the evaluation is to assess to what extent the legislative framework on the cultivation and marketing of GMOs and its up to date implementation have achieved its objective of protecting human and animal health, the environment and consumers' interest, while ensuring the effective and efficient functioning of the internal market.
The evaluation shall provide the Commission with key findings and lessons of experience from past and current implementation of EU legislation and will introduce prospective options for the future.
The report will be in particular designed to:
- provide the Commission's policymakers and managers with information on the implementation of the current legislation,
- identify problems in the design and implementation of the current legislation,
- recommend options for potential future action,
- identify, where available, the potential social, economic and environmental impacts of the current implementation and of recommended options for action,
- create the basis for the conduct of a possible impact assessment concerning the review of broader aspects of the GMO legislation.
The evaluation will not cover all aspects of the legislation concerning cultivation and marketing of GMOs and will solely focus on selected key areas of the regulatory framework.
The evaluation will cover the provisions concerning following topics:
- The risk assessment and risk management of GMOs under the Directive, and specifically for cultivation under the Regulation, including authorisation procedures;
- Risk communication;
- The national safeguard measures under Directive 2001/18/EC and emergency measures under the Regulation on the cultivation of GMOs;
- The applicable rules on confidentiality and data protection
- The zero-tolerance of unauthorised GM material in seeds;
An overall assessment of the entire scope of the respective legislation would follow, if deemed necessary, after the conclusion of this evaluation and within the framework of a potential impact assessment. The present evaluation does not cover the EU legislative framework in the field of GM food and feed as this is covered by a parallel evaluation launched by the Commission. The medicinal uses of GMOs are regulated under a different regime (Regulation(EC) No 726/2004) which falls outside the scope of this evaluation. An analysis of field trials management in Member States and prevention of accidental entry of GMOs on the market has recently been carried out by CSL upon Commission's request and is going to be published soon.