European Genetic Engineering Law

In the EU, Directive 2001/18 regulates the conditions under which genetically modified organisms (GMOs) may be released into the environment.¹  It is undisputed that gene drive organisms are forms of GMO.

The transposition of the requirements of the EU Directive into national law is mandatory for all member states. Only the EU institutions can make changes to the directive. Since 2015, however, member states have been able to prohibit the cultivation of genetically modified plants on their territory even if approval has been granted for them at EU level (opt-out). In theory, this also applies to gene drive organisms.

Directive 2001/18 requires member states to take all necessary measures to avoid adverse effects from releases of GMO on the environment and human health . It is not possible to weigh conceivable advantages for human health up against possible disadvantages for the environment. Both protection goals are of equal importance. The reference to the precautionary principle obliges the competent authorities to take measures to prevent a negative effect even if full scientific or technical certainty and knowledge has not yet been obtained.²

Legal interpretation of the EU directive 2001/18 with regard to gene drive organisms 

According to the EU’s Genetic Engineering Directive 2001/18, any release of a GMO requires approval, which may only be granted if it has been established, on the basis of a prior risk assessment involving the member states and the European Commission, that the release will not have any harmful effects on human health or the environment. The protection of the environment and human health must be ensured in accordance with the precautionary principle. The period of validity of the authorization must not exceed ten years. The released GMO and its potential effects must be monitored throughout the period according to a monitoring plan to be submitted. The aim of the directive 2001/18 is to prevent the uncontrolled spread of GMOs into the environment and their outcrossing to other organisms. Even the spread of a GMO in the environment beyond the planned site of release is assessed as a negative effect in this context. If there is a risk to the environment or human health, approval for a release may not be granted.

Recital 4 of the directive underlines the specific problem of deliberate release of GMOs into the environment: “Living organisms released into the environment in large or small quantities for experimental purposes or in the form of commercial products may reproduce in the environment and spread beyond national borders, thereby affecting other member states. The effects of such releases may be irreversible.“

To identify and assess risks to the environment and human health, a risk assessment must identify any new risks prior to any release of a GMO into the environment.³ Annex II of the Directive sets out the requirements for this risk assessment. It requires that all intended and unintended, direct and indirect, immediate and delayed, long-term and cumulative long-term effects of the release be examined.⁴ Cumulative long-term effects include, among others, effects of the released GMOs on food chains, flora and fauna, and biodiversity. The effects on altered population dynamics and genetic diversity of target species, as well as their competitors, prey, hosts, symbionts, predators, parasites and pathogens must also be covered by the risk assessment.⁵

Furthermore, it is specified that possible negative effects are not to be excluded from the assessment of risks because they are unlikely to occur. Furthermore, it is stated that there is no distinction between significant and other (negligible) negative effects.⁶ The guideline thus prescribes a worst-case scenario as the basis of the risk assessment and requires that it be assumed that every potential negative effect will also occur.

For safety reasons, the directive recommends that the release of a GMO should be carried out step by step and that each subsequent step should only be taken if the assessment of the previous steps did not indicate any adverse effects on human health or the environment. However, a step by step procedure will not be possible due to the nature of gene drive organisms: Sufficiently reliable proof of the harmlessness of a GDO can only be provided if the GDO has been released into the environment and there has been no evidence of hazards to the environment or human health over several generations. However, the release of even just a few genes drive organisms results in their possibly irreversible spread in the environment. According to the current state of research, once GDOs have been released, their spread cannot be limited or be recovered with certainty, and their effects in nature cannot be reversed.

In order to take into account the particular risk posed by a self-replicating spread into the environment, the approval of a GMO can be granted for a maximum of 10 years. After that, it must either be renewed or it expires. Once the approval has expired, the GMO may not be found in the environment any longer. It is not apparent how this provision would be complied with in relation to GDO.⁷ Directive 2001/18 was designed and enacted to regulate the release of genetically modified crops. It assumes that the effect and spread of GMO in nature can be limited in space and time. However, according to the current state of research, this assumption does not hold for  gene drive organisms.

Release of gene drive organisms not possible within the framework of current EU law

The purpose of gene drive organisms is to spread independently in the environment, to interbreed with wild conspecifics and to pass on their modified genes to as many offspring as possible in order to spread them throughout the entire population of a species. Because this is clearly contrary to the current provisions of directive 2001/18 with regard to the protection of the environment, it is not possible to authorize the release of a gene drive organism into the environment under European law.

Member states of the EU are therefore legally obliged to ensure that no GDOs would be found within their political borders. Article 4 of Directive 2001/18 also requires that “in the case of an unauthorized release (…) the member state concerned shall ensure that the necessary measures are taken to terminate the release or placing on the market, to initiate countermeasures if necessary and to inform the public of the respective member state, the Commission and the other member states.”

For this reason, it is in the self-interest of the EU and all EU member states to prevent the release of GDO that can reach their territory, including in states outside the EU.


[1] EUR-Lex Website (2001). Publications Office of the European Union. 32001L0018. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission statement. Official Journal L 106, 17/04/2001 P. 0001 – 0039. Online: [last accessed 07/12/2020].

[2] cf. ibid. EU Directive 2001/18: Article 4

[3] cf. ibid. EU Directive 2001/18: Articles 6 (2) and 13 (2) and Annex 4.

[4] cf. ibid. EU Directive 2001/18, Annex II C. 1.1

[5] cf. ibid. EU Directive 2001/18, Annex II C.2.1

[6] cf. ibid. EU Directive 2001/18, Annex II C.3.

[7] cf. ibid. EU Directive 2001/18, Article 13