The release of a genetically modified organism (GMO) into the environment, without taking precise confinement measures, will result in contact between this GMO and the surrounding environment.

There are two broad categories of release of GMOs into the environment:

Deliberate release for any other purpose than for placing on the marketThat is, the introduction of GMOs into the environment for experimental purposes, also commonly known as field or clinical trials. These types of releases are mainly carried out for the purposes of study, research, demonstration and development of novel varieties. The behaviour of the GMO in an open environment and its interactions with other organisms and the environment are studied. In Legislation, these releases are referred to as Part B releases.
Placing on the market for commercial purposesIf the results of the experimental release are positive, the company may decide to place the GMO on the market, that is, make it available to third parties free of charge or for a fee. The GMO may be placed on the market for purposes of cultivation, importation or transformation of GMOs into industrial products. In Legislation, these releases are referred to as Part C releases.


Why and how are releases regulated?

Although considerable work has been carried out in the field of GMOs, and a large amount of data has been gathered, there are still concerns with regard to the safety of human health and the environment.

Consequently, in the EU and Malta, there are strict regulations that control the release of GMOs into the environment. The Deliberate release into the environment of genetically modified organisms regulations (S.L. 549. 60) give effect to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms & repealing Directive 90/220/EEC. ERA is the designated Competent Authority in Malta for the implementation of these Regulations in terms of viable non-food/feed. Genetically modified food and feed are addressed through the Food safety commission.

The Regulations  apply to all GMOs, although plants have been the subject of most interest in recent years. The Regulations adopt a step-by-step approval process on a case-by-case assessment of the risks to human health and the environment before any GMO, such as maize, tomatoes, or microorganisms, can be released into the environment.

The entire regulatory process is underpinned by a detailed environmental risk assessment, prepared by the applicant, who examines and evaluates any possible harmful consequences of releasing a particular GMO.

Products derived from GMOs, such as paste or ketchup from a GMO tomato, are not covered by these regulations.

Getting approval for an experimental releaseLink
Procedural steps & timescales for the placing on the market of GMOsLink
Getting approval for placing on the marketLink
Procedural steps & timescales for the placing on the market of GMOsLink
GMOs authorised for experimental purposes in MaltaLink
GMOs authorised for placing on the EU marketLink


For any additional queries, you may check the frequently asked questions (FAQs)​, contact us via e-mail address on [email protected] or through telephone number 2292 3500.

Other links