Contained facilities and activities with GMOs
In order to use for the first time facilities intended to work with genetically modified organisms (GMOs) it is mandatory to notify the Department of Climate Action, Food and Rural Agenda, whether the activities are contained (laboratory, greenhouse, animal facility, etc.) or whether material is to be released into the environment without a commercial purpose (field trials, clinical trials, on farms, etc.).
This previous notification is not required for subsequent activities of type 1. For initial or subsequent type 2 contained uses in previously notified facilities, a notification must be submitted. For initial or subsequent type 3 and type 4 contained uses, the corresponding express authorisation must be obtained.
| Activity | First | Subsequent |
|---|---|---|
| Type 1 | YES (notification) | NO |
| Type 2 | YES (notification) | YES (notification) |
| Type 3 | YES (authorisation) | YES (authorisation) |
| Type 4 | YES (authorisation) | YES (authorisation) |
(*) Type 4 activities may not be carried out at the UAB due to a lack of suitable facilities.
To apply for the necessary administrative authorisations, the appropriate forms must be completed.
When the activity with GMOs is aimed at a potential use in human or veterinary medicine or for commercial purposes the notifications or authorisations must be submitted to the Spanish Ministry for the Ecological Transition.
On receiving the notifications the administration may authorise the facility and assign it a containment level (from 1 to 3) that allows it to be used for activities in accordance with the same level of risk (from 1 to 3). Whatever the case, the environmental risk assessment must be attached.
It should be remembered that, in case of starting any new type 1 activity in type 1 facilities already registered, it will not be necessary to present any new communication to the administration but if it is necessary to indicate this in the internal register (IBC application).