Summary of Directive 2001/18/EC – Plant Biotechnology Information Center

SUMMARY OF:

Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms

Full text of Directive 2001/18/EC

WHAT DOES THIS DIRECTIVE DO?

It aims to make the procedure for granting consent for the deliberate release and placing on the market of genetically modified organisms (GMOs)* more efficient and more transparent.
It also limits such consent to a period of 10 years (renewable) and introduces compulsory monitoring after GMOs have been placed on the market.

KEY POINTS

This directive provides:

a system for assessing case-by-case the environmental risks associated with releasing GMOs;
common objectives for monitoring GMOs after their deliberate release on the market; and
a mechanism that modifies, suspends or terminates deliberately released GMOs once information regarding the risks of releasing becomes available.
GMO labelling and public consultation is made compulsory. The European Commission is obliged to consult the competent scientific committees on any question affecting human health or the environment.
Registers must be established for the purpose of recording information on genetic modifications in GMOs alongside their location. Rule on the operation of these registers are laid down in Decision 2004/204/EC.

The Commission must publish a report on the experience of GMOs placed on the market and a summary of the measures taken by EU countries to implement this directive every 3 years.
While this directive allows EU countries to restrict or prohibit the release of GMOs that constitute a risk to human health and the environment, Directive (EU) 2015/412 amends it allowing for EU countries to prohibit or restrict GMOs on wider grounds such as town and country planning, land use, socio-economic impacts, co-existence and public policy.

FROM WHEN DOES THIS DIRECTIVE APPLY?

It entered into force on 17 April 2001. EU countries had to incorporate it in their national law by 17 October 2002.

BACKGROUND

This directive is only one of the several building blocks of the EU’s legal framework for GMOs. The other building blocks are directives and regulations (focusing on issues like genetically modified food or transboundary movements of GMOs) that work to protect human and animal health and the environment, put in place harmonised procedures, and ensure the traceability of GMOs placed on the market.

KEY TERMS

Deliberate release of GMOs: in the context of this legislation, any intentional introduction into the environment of GMOs without specific containment measures.
Genetically modified organisms: using techniques of modern biotechnology called gene technology, the genetic make-up of living cells and organisms can be modified. This allows man to breed plants and animals which can, for example, have a higher yield or resist disease.