The deliberate release of genetically modified organisms into the environment is regulated by Directive 2001/18/EC. Part B of the Directive applies to their experimental release; Part C applies to the authorization of their placing on the market. Member States are restricted to deciding on the authorisation of experimental release on their own authority; all other decisions on GMOs are made at a community level.
The Directive defines that an application must be submitted before GMOs can be released into the environment or placed on the market. The applicant must submit a detailed document to the relevant national authority of the Member State. Applications must include detailed documentation including full environmental risk assessment, a risk management measures and an emergency plan, and in the case of a product recommendations relating to instructions for use and labelling. The deliberate release of GMOs may not start until the relative authorisation is provided by the competent authority. The Directive also states that public opinion must also be considered during the decision-making process. The Directive also includes provisions regarding the monitoring of authorised GMOs after their appearance on the market.
Only GMOs that have been proven to be suitable and pose no risk to human health or the environment, may be granted authorisation for release by the competent authority. The competent authority of the country sends applications to the European Commission, which forwards them to all Member States. The Member States provide their opinions on the request for authorisation, and if any of them raise an objection, a common decision will take place.
The Directive also declares that Member States cannot ban or restrict the trade of GMO products that have been authorised in accordance with the Directive. There are also cases, when new scientific information becomes available, based on which it may be assumed that the given GMO has a harmful effect on human health or on the environment. In such cases the Member State may ban the cultivation of GMO in question within its own territory. Several countries have introduced safeguard clauses of this kind, including Hungary.
