EU regulations (Regulation (EC) No 1829/2003) regarding GMOs is precautionary based, imposing a pre-market authorisation for any GMO to be placed on the market and a post-market environmental monitoring for any authorised GMO. This ensures a high level of protection of human and animal health and the environment.
EU GMO legislation outlines specific procedures for assessing and approving GMOs that are time-limited and transparent. Risk assessment of GMOs is conducted on the basis of harmonised criteria amongst Member States, which are considered as being amongst the most stringent globally.
The European Food Safety Authority (EFSA), in collaboration with Member States' scientific bodies, is responsible for risk assessment which needs to demonstrate that, under its intended conditions of use, the product is safe for human and animal health and the environment.
The risk assessment is the basis upon which the Commission proposes a decision to Member States approving or rejecting authorisation for the placing on the market of a GMO. Both the Commission and Member States are therefore involved in the authorisation of GMOs.
Legislation also imposes a post-market monitoring of the environment for each authorised GMO enabling the Commission and Member States to take appropriate action in case non-anticipated adverse effects arise.
Directive (EU) 2015/412 also gives Member States increased control to decide on cultivation of genetically modified crops, under certain conditions, at two distinct time periods:
- During the authorization process: a Member State can request to alter the geographical scope of the application to ensure that its territory will not be covered by EU authorisation;
- After a GMO has been authorized: a Member State may prohibit or restrict the cultivation of the crop based on grounds related amongst others to environmental or agricultural policy objectives, or other compelling reasons such as town and country-planning, land use, socio-economic impacts, co-existence and public policy.
Before the enforcement of this Directive, Member States could provisionally prohibit or restrict use of a GMO on their territory only if they held new evidence that the organism concerned posed a risk to human health or the environment or in the case of an emergency. No Member State which had adopted a so-called "safeguard clause" had ever been in a position to provide new evidence (Directive (EU) 2015/412).
Finally, to provide consumers with information and freedom of choice, traceability and labelling requirements are imposed for any authorised GMO.
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