The use in research or teaching of biological agents, which includes genetically modified organisms (GMOs), biological agents (bacteria, viruses, fungi, parasites) and samples potentially contaminated with biological agents, can be harmful to human health and the environment.
In accordance with current legislation, it is compulsory to notify the competent authority of activities with biological agents that require a biological containment level 2 or higher (art. 10 and annex IV of RD 664/1997).
In the case of genetically modified organisms (GMOs), this obligation affects the four levels of biological risk (Law 9/2003, RD 178/2004).
| Activity | |
|---|---|
| Type 1 | Activities with no or negligible risk |
| Type 2 | Low-risk activities |
| Type 3 | *Moderate-risk activities |
| Type 4 | *High-risk activities |
| *Type 3 and 4 activities cannot be carried out at the UB due to the lack of suitable facilities. | |
Authorisations Ministry for Ecological Transition and the demographic challenge
The notification and subsequent authorisation is subject to the payment of administrative fees; however, given that the University of Barcelona is a public university, notifications processed through the Ministry for Ecological Transition and the Demographic Challenge 
of the Spanish Government are exempted from administrative taxes in this area (Law 9/2003 of 25 April. Art.29.4).
To submit an application, the following forms must be filled in and submitted, which will differ according to the level of risk of the activity.
Before this external notification, the scientific leader of the activity will contact the Biosafety Committee of the UB (CBSUB) by email (cbsub@ub.edu) to communicate their intention to notify. Notifications must be reviewed before being submitted for the Biosecurity Committee, and it will also be necessary to carry out and document a risk assessment of the activity with biological agents.
Authorisations for activities and the GMO Register of Catalonia
In order to be able to use genetically modified organisms (GMOs) in Catalonia, the activities carried out must be authorised and registered.
In this sense, any centre or organisation in Catalonia that wishes to work with GMOs in conditions of confined use or wishes to carry out voluntary non-commercial release (field trials) with GMOs must present a notification or request for authorisation to the corresponding competent body (Law 9/2003, of 25 April). In the event that the competence corresponds to the Generalitat de Catalunya, the Catalan Biosafety Commission is the competent body for the exercise of functions in GMO matters, as established in Decree 62/2015, of 28 April. According to this Decree, all these uses of GMOs in Catalonia are registered in theGMO Register of Catalonia.
Legislation
- Law 9/2003 of 25 April 2003 establishing the legal regime for the contained use, deliberate release and placing on the market of genetically modified organisms.
- ROYAL DECREE 178/2004, of 30 January 2004, approving the general regulations for the development and implementation of Law 9/2003, of 25 April 2003, which establishes the legal regime for the contained use, voluntary release and marketing of genetically modified organisms.
- DECREE 62/2015, of 28 April, establishing measures for the exercise of the powers of the Generalitat de Catalunya in the field of genetically modified organisms
Links
- Ministry for Ecological Transition and the Demographic Challenge. Notifications and authorisations Generalitat de Catalunya
- GMO authorisations
- Generalitat de Catalunya, Communication on Biological Agents