Agriculture Reference
In-Depth Information
derived products in the early 1990s.
3
Two types of regulatory systems can
be distinguished. Whereas some countries, such as the United States and
Canada, have enacted “product-based” legislations, the EU's regulatory
system for GMO and derived foods and feeds is “process based.”
Directives on the Deliberate Release of GMO
The EU began to govern the deliberate release of GMO into the environ-
ment in 1990 when Directive 90/220/EEC entered into force. The scope
of this Directive covered experimental releases as well as the placing on
the market of GMO for cultivation, import, and/or processing.
4
AuthorizationProcedureforthePlacingontheMarketofGMO
The authorization requires a case-by-case assessment of the potential
risks to human and animal health of each GMO to be placed on the
market. Applications are forwarded to the EU member-state where the
GMO or derived product is to be placed on the market for the first
time. The application must be accompanied by data and results obtained
from laboratory and greenhouse research, as well as from developmental
releases, concerning the ecosystems that could be affected by the use of
the product, and by an assessment of any risks to human health and the
environment related to the GMO.
The risk assessment is performed by the Competent Authority
(CA) of the EU member-state that receives the application. The other
member-states are invited to provide comments. If the CA confirms in
its opinion that the information provided by the applicant establishes
that the placing on the market of the GMO would not pose a risk to
human health and the environment, and if no objections are raised by
3
OECD. 2003. Biotechnology Regulatory Developments in OECDMember Countries.
OECD. Paris.
4
Directive 90/220/EEC. Official Journal of the European Communities L 117: 15-27,
8.5.1990.
