The Union legislation

Directive 2001/18/EC (Consolidated version) on the deliberate release into the environment of GMOs, has repealed Directive 90/220/EEC that was the first European legal instrument for the evaluation of the potential risks deriving from the deliberate release of GMOs in the environment.

Directive 2001/18/EC, by implementing the Cartagena Protocol on Biosafety, establishes a common methodology for all Member States of the European Union to:

■ perform a risk assessment on the basis of scientific arguments common and relevant;

■ improve the management of all the risks (direct and indirect, immediate and delayed) for the environment and human and animal health;

■ rule monitoring activities after release or placing on the market of GMOs as such or in products, and indicates the common criteria on modalities so and the rules for traceability;

■ promote information and public consultation on experimental releases.

The principles contained in Directive 2001/18/EC have been extended to the authorization of GM food and feed with Regulation (EC) n. 1829 of 22 September 2003 and, for the complexity of the matter, the issue of opinion on the safety assessment has been entrusted to European Authority for Food Safety (EFSA), established by Regulation (EC) n. 178 of 28 January 2002, in order to protect human and animal health, the environment and the interests of consumers.
Traceability and labelling of GMOs and products derived from such organisms (food and feed containing GM material) is governed by Regulation (EC) n. 1830 of 22 september 2003.

In order to regulate the export of GMOs from the EU to third countries was adopted Regulation (EC) No. 1946 of July 15 2003, amending the Directive 2001/18/CE, with the aim to establish a common system of notification and information for transboundary movements, ensuring even in exports coherent implementation of the Cartagena Protocol.

Article 26a of Directive 2001/18/EC provides that Member States may take appropriate measures to avoid the unintended presence of genetically modified organisms (GMOs) in other products. This applies in particular to avoiding the presence of GMOs in other crops, such as conventional or organic.

The European Commission has identified the general principles for the development of coexistence measures at national level with the Recommendation of 13 July 2010.

On 13 March 2015 Directive (EU) 2015/412, amending Directive 2001/18/E as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, was published on the Official Journal of the European Union.