The EU domestic legal framework, based on a prior risk assessment
before authorisation is given, is applicable. The EU has put in
place a comprehensive system of risk assessment and risk management
dealing with releases into the environment or placing on the market
of GMOs, whether imported into or developed within the EC. The
notification provided by the company indending to market a GMO must
include a full risk assessment of the risks to human and animal
health and to the environment, which is assessed by the European
Food Safety Authority (EFSA), with an active involvement of Member
States, notably as regards the authorisation of GMOs for
cultivation, where they carry out the intial risk assessment. The
aim of the environmental risk assessment is, on a case by case
basis, to identify and evaluate potential adverse effects of the
GMO, both direct and indirect, immediate or delayed, on human
health and the environment.
See
http://www.efsa.europa.eu/en/science/gmo/gmo_guidance.html
In accordance with the precautionary principle, environmental risk
assessments must be based on the following principles:
GMO characteristics and GMO use that have the potential to cause
adverse effects are to be compared to characteristics and use of
the non-modified organism from which the GMO is derived;
Risk assessment should be carried out in a scientifically sound
and transparent manner based on available scientific and technical
data;
Risk assessment should be carried out on a case by case
basis;
New information on the GMO and its effects may need to be
readdressed in order to determine whether the risk has changed and
whether there is a need for amending the risk management
accordingly.
Article 4 of Directive 2001/18/EC on the deliberate release into
the environment of genetically modified organisms demands that any
person submitting a notification under the authorisation procedures
for GMO releases into the environment or placing on the market of
GMOs as or in products needs to carry out an environmental risk
assessment. Annex III of the Directive specifies the information
that may be necessary to carry out the risk assessment. The
environmental risk assessment comprises several steps that need to
be addressed:
Identification of characteristics which may cause adverse
effects. These characteristics will vary from case to case and may
include direct effects on human health or the environment as well
as indirect effects occurring through a causal chain of events,
through interactions with other organisms, transfer of genetic
material or changes in use or management. As observations of
indirect effects are likely to be delayed, immediate effects during
the period of the release of the GMO as well as delayed effects
that become apparent at a later stage or after termination of the
release need to be considered.
Evaluation of the potential consequences of each adverse effect,
if it occurs.
Evaluation of the likelihood of the occurrence of each identified
potential adverse effect.
Estimation of the risk posed by each identified characteristic of
the GMO.
Application of management strategies for risks from the
deliberate release or marketing of GMOs.
Determination of the overall risk of the GMO.Annex VII of the
Directive provides guidance on the monitoring plan as part of the
risk management strategy. More specific guidance notes are provided
in Council Decision 2002/811/EC of 3 October 2002. The objective of
the monitoring plan is to confirm that any assumption regarding the
occurrence and impact of potential adverse effects of the GMO or
its use in the risk assessment are correct, and to identify the
occurrence of adverse effects of the GMO or its use which were not
identified in the risk assessment.
The design of the monitoring plan should, among others:
Be detailed on a case by case basis;
Take into account the characteristics of the GMO, its use and
scale of use, and the range of relevant environmental
conditions;
Incorporate general surveillance for unanticipated adverse
effects;
Provide for case-specific monitoring for a sufficient time period
to detect immediate and direct as well as, where appropriate,
delayed and indirect effects which have been identified in risk
assessment.;
Provide for the use of already established routine surveillance
practices where appropriate
The EC has cooperated with members of the European Economic Area
(Norway, Iceland and Liechtenstein) on the issue of antibiotic
resistance markers in risk assessment.
