In this page:
Users, which foresee to access after 15th March 2017, of Spanish genetic resources from wild taxa whose activities involves the utilization of genetic resources. In this context, ‘utilization of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in the Law 42/2007, of 13 December, on natural heritage and biodiversity.
The European Commission is preparing several sectorial guidance documents on the interpretation of the term utilization within the scope of the Regulation (EU) No 511/2014, which are foreseen to be published soon. It is recommended that users consider these guidelines to establish whether activities carried out with genetic resources constitute ‘utilization’, and therefore fall within the scope of this bylaw.
The bylaw 124/2017, of 24 February, regulates the access to genetics resources from wild taxa in situ, i.e. in their natural habitats, and ex situ, i.e. outside their natural habitats.
Access to the following Spanish genetics resources for their utilization does not fall in the scope of the bylaw 124/2017, of 24 February
Additionally, access authorization is not necessary when:
*Exclusively taxonomic purposes (definition in Art. 2.3. Spanish ABS bylaw): Application of principles and methods for identification, delimitation and classification of living beings, which requires the study of their phylogenetic relationships as well as the evolutionary and ecological processes that have generated biodiversity using morphological, physiological, genetics, behavioral and environmental data.
The Bylaw 124/2017, of 24 February, establishes proceedings and access authorizations for both the utilization for non-commercial research purposes and the utilization for commercial purposes.
In both cases, an access authorization is required previously to the access to genetic resources
A) Access for the utilization for non-commercial research purposes.
The access application, together with a signed declaration by the user, will be addressed to the competent access authority (see section 1.3.).
The competent access authority will examine the access application and the user declaration, and will request the opinion of the responsible authority for providing prior informed consent and establishing mutually agreed terms who may establish conditions to the access.
Finally, the competent access authority will grant the access authorization.
B) Access for the utilization for commercial purposes.
User must obtain the prior informed consent and the mutually agreed terms from the corresponding competent authority previously to submit the access application.
The access application together with the prior informed consent and the mutually agreed terms will be addressed to the competent access authority, who will examine the documents and grant the access authorization.
Both the competent authorities to apply prior informed consent and negotiate mutually agreed terms, and the competent access authorities depend on the nature of the requested genetic resources from wild taxa. Next table shows the relationship between the genetic resources and the corresponding competent authorities:
Genetic Resource | Competent authority for prior informed consent and mutually agreed terms | Competent access authority |
---|---|---|
Marine genetic resources | Dirección General de Sostenibilidad de la Costa y del Mar del MITECO | Dirección General de Biodiversidad y Calidad Ambiental del MITECO |
Genetic resources in public domain | Authority of the General Administration of the State to which that public domain is assigned | Dirección General de Biodiversidad y Calidad Ambiental del MITECO |
Genetic resources in state institutions of ex situ conservation | Managing authority of the state institution of ex situ conservation | Dirección General de Biodiversidad y Calidad Ambiental del MITECO |
Genetic resources from terrestrial wild taxa distributed along the territory of more than one autonomous community | Authority established by the autonomous community where the genetic resource is accessed | Dirección General de Biodiversidad y Calidad Ambiental del MITECO |
Others (e.g. endemic species in an autonomous community) | Authority established by the autonomous community where the genetic resource is accessed | Authority established by the autonomous community where the genetic resource is accessed |
Since the bylaw 124/2017, of 24 February, has just come into force, the autonomous communities are still in the process of appointing their competent authorities. This website will be updated with the information on the designations of those competent authorities.
The application to both access for the utilization for non-commercial research purposes and access for the utilization for commercial purposes can be accessed at the Ministry for Ecological Transition (MITECO)’s website:
https://sede.mapama.gob.es/portal/site/se/procedimientos-intermedio?theme_id=5
Users must own a digital certificate to do the online application.
According to article 16.4 of the Law 39/2015, of 1 October, on the Public Administration and the Common Administrative Procedure, the access application can be also submitted at:
When the access application is not submitted through the online system at MITECO’s website, it must be addressed to the competent access authority.
When the access is for the utilization for commercial purposes, users must obtain the prior informed consent and the mutually agreed terms from the corresponding competent authority previously to submit the access application.
Attention: Access authorization to Spanish genetic resources does not exempt users from the obligation to obtain as many others authorization established by other currently regulations in force.
If an expiration date takes place, it will appear on the access authorization. The access authorization will be valid only for the authorized utilization of the genetic resources for which it has been granted. To carry out a different utilization to that authorized, the user will have to apply for a new access authorization. Specially, if an access authorization was granted for a non-commercial utilization, and the research and development result in a commercial utilization, the user must apply for a new access authorization.
Furthermore, the access authorization will also include the information relating to the sampling number of the genetic resource and the dates for sampling. If additional samplings are required, the user must apply for a new access authorization.
The access to Spanish genetic resources without obtaining the required access authorization as described in the Bylaw 124/2017, of 24 February, is considered an administrative infringement:
- Very serious infringement when profits are higher than 100.000 euros. In this case, the user may be fined 200.001 to 2.000.000 euros.
- Serious infringement when profits are lower than 100.000 euros. In this case, the user may be fined 3.001 to 200.000 euros.
Access authorization to Spanish genetic resources does not exempt users from the obligation to obtain as many others authorizations established by other currently regulations in force.