Rules for using, releasing and selling genetically modified organisms

Automatic summary, not yet reviewed

1. The law regulates contained use, voluntary release and marketing of genetically modified organisms, to avoid risks to human health and the environment. It excludes humans from the definition of genetically modified organism.
2. The autonomous communities authorize contained use and voluntary release, except in cases reserved to the State, such as medicines, State research or commercial plant varieties. The State always authorizes marketing, import and export.
3. Contained use activities are classified by risk (negligible, low, moderate or high). Only moderate and high risk activities need express authorization; for the others, prior notification is generally enough.
4. Any voluntary release into the environment requires prior authorization, with a technical study and a risk assessment including the methodology used. Marketing also requires authorization, valid for at most 10 years, with a monitoring plan, labeling and traceability.
5. The law creates a fee for services of the State Administration, with charges ranging from €1,130 to €12,040 depending on the activity. There are 30% discounts and exemptions for public research projects.
6. Offenses are classified as minor, serious or very serious, with fines of up to €1,200,000 and other penalties such as closing facilities. If the fine is lower than the profit obtained, it is increased to at least twice that profit.

Who it affects

• Companies and individuals working with genetically modified organisms: They must assess risks, notify or request authorization, label, ensure traceability and pay the fee.
• Autonomous communities: They authorize and monitor contained use and voluntary release, except in cases reserved to the State.
• State Administration (Administración General del Estado): It authorizes marketing, import and export, and collects the fee.
• Consumers: They receive information through labeling and public access to granted authorizations.

Words worth knowing

Utilización confinada (contained use)

An activity where a genetically modified organism is modified or used with measures that prevent its contact with people and the environment.

Liberación voluntaria (voluntary release)

Deliberately releasing genetically modified organisms into the environment, without containment measures.

Silencio administrativo desestimatorio (rejecting administrative silence)

If the Administration does not answer an authorization request in time, it is understood to have been denied.

Trazabilidad (traceability)

Keeping and passing on product data at every stage so its movements can be traced back and it can be withdrawn from the market if needed.

Autoliquidación (self-assessment)

The taxpayer calculates and pays the fee using official forms.

It summarizes the law as published in the BOE. It is written by artificial intelligence and may contain mistakes: the official text is what counts. Read the official text · How we make summaries